Sample records for staff guidance document
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International Nuclear Information System (INIS)
Johnson, R.L.
1994-01-01
The Nuclear Regulatory Commission staff is conducting numerous activities to improve the integration of its regulatory guidance documents (i.e., License Application Review Plan (LARP) and open-quotes Format and Content for the License Application for the High-Level Waste repositoryclose quotes (FCRG)) and pre-license application (LA) reviews. Those activities related to the regulatory guidance documents consist of: (1) developing an hierarchy of example evaluation findings for LARP; (2) identifying LARP review plan interfaces; (3) conducting an integration review of LARP review strategies; (4) correlating LARP to the ongoing technical program; and (5) revising the FCRG. Some of the more important strategies the staff is using to improve the integration of pre-LA reviews with the LA review include: (1) use of the draft LARP to guide the staff's pre-LA reviews; (2) focus detailed pre-LA reviews on key technical uncertainties; (3) identify and track concerns with DOE's program; and (4) use results of pre-LA reviews in LA reviews. The purpose of this paper is to describe these ongoing activities and strategies and discuss some of the new work that is planned to be included in LARP Revision 1 and the final FCRG, which are scheduled to be issued in late 1994. These activities reflect both the importance the staff has placed on integration and the staff's approach to improving integration in these areas. The staff anticipates that the results of these activities, when incorporated in the FCRG, LARP, and pre-LA reviews, will improve its guidance for DOE's ongoing site characterization program and LA annotated outline development
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76 FR 9381 - Notice of Availability of Interim Staff Guidance Documents for Spent Fuel Storage Casks
2011-02-17
.... FOR FURTHER INFORMATION CONTACT: Matthew Gordon, Structural Mechanics and Materials Branch, Division... transportation packaging licensing actions.'' This ISG document would provide guidance to the NRC staff when... a fee. Comments and questions on ISG-23 should be directed to Matthew Gordon, Structural Mechanics...
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2011-05-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document... of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Class II...
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2010-11-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0514] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance...
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2012-03-19
... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...
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2011-07-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...
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2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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2011-08-09
... selection inclusion and exclusion criteria section. The revisions define and differentiate the required... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...
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2011-04-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0189] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS...
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2010-11-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0275] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability AGENCY: Food and Drug Administration, HHS. [[Page...
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2011-03-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0028] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS...
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2011-02-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0645] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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2011-04-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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2011-07-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0500] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration...
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2010-11-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0515] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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2010-11-29
...] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY... announcing the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration... single copies of the guidance document entitled ``Guidance for Industry and Food and Drug Administration...
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76 FR 74834 - Interim Staff Guidance on Aging Management Program for Steam Generators
2011-12-01
... for Steam Generators AGENCY: Nuclear Regulatory Commission. ACTION: Interim staff guidance; issuance... (LR-ISG), LR-ISG-2011-02, ``Aging Management Program for Steam Generators.'' This LR-ISG provides the...) document, NEI 97-06, ``Steam Generator Program Guidelines,'' (NRC's Agencywide Documents Access and...
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2012-04-06
...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...
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78 FR 40199 - Draft Spent Fuel Storage and Transportation Interim Staff Guidance
2013-07-03
.... ML13056A516. NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21... current or future applicants The NRC staff has no intention to impose the draft ISG positions on existing... of the effective date of this guidance The NRC staff has no intention to impose the draft ISG...
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2010-08-31
...] Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and... guidance entitled ``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document is intended to describe FDA's current policies with respect to civil money penalties and no...
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2010-04-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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2010-07-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug...
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78 FR 49782 - Interim Staff Guidance on Changes During Construction
2013-08-15
... Construction AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; request for comment... During Construction.'' This ISG provides guidance to the NRC staff on the Preliminary Amendment Request...-ISG-025 ``Interim Staff Guidance on Changes during Construction under 10 CFR Part 52'' is available...
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2011-05-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-D-0102] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and...
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2011-04-25
...] Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No... entitled ``Civil Money Penalties and No- Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document describes FDA's current policies with respect to civil money penalties and no-tobacco-sale orders...
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2010-02-02
... the guidance provided to the NRC staff in Section 1.0, ``Introduction and Interfaces,'' of NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants,'' concerning the... maintains ADAMS, which provides text and image files of NRC's public documents. These documents may be...
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Regulatory systems-based licensing guidance documentation
International Nuclear Information System (INIS)
Delligatti, M.S.
1991-01-01
The US Nuclear Regulatory Commission (NRC) has developed a series of licensing guidance documents based on the regulatory requirements in Part 60 of Title 10 of the Code of Federal Regulations (10 CFR Part 60). This regulatory systems-based approach to licensing guidance documentation relies on the definition of the high-level waste repository in 10 CFR Part 60. A document which is important for the frame-work it gives to other programmatic licensing guidance is the Draft Regulatory Guide open-quotes Format and Content for the License Application for the High-Level Waste Repositoryclose quotes (FCRG). The FCRG describes a format and content acceptable to NRC for a high-level waste repository license application pursuant to the requirements of 10 CFR Part 60. Other licensing guidance documents will be compatible with the FCRG
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2011-12-09
... the Final Staff Guidance Section 1.0, Revision 2 on Introduction and Interfaces AGENCY: Nuclear... Plants: LWR Edition,'' Section 1.0, Revision 2 on ``Introduction and Interfaces'' (Agencywide Documents Access and Management System (ADAMS) Accession No. ML112730393). The NRC staff issues revisions to SRP...
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International Nuclear Information System (INIS)
1994-05-01
The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM's evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7
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2013-05-01
..., ``Flow- Accelerated Corrosion,'' based on the staff's review of several license renewal applications' flow-accelerated corrosion AMPs and stakeholder input. ADDRESSES: Please refer to Docket ID NRC-2012... learned and to address emergent issues not covered in license renewal guidance documents, such as the GALL...
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2011-07-26
... Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is... Stimulation Systems.'' This guidance document describes a means by which a repetitive transcranial magnetic... guidance document is being immediately implemented as the special control for rTMS systems, but it remains...
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2013-02-19
...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...
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2011-05-24
... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...
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Energy Technology Data Exchange (ETDEWEB)
Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A. [Nuclear Regulatory Commission, Washington, DC (United States). Div. of Industrial and Medical Nuclear Safety; Tingle, W. [Dept. of Environment, Health, and Natural Resources, Raleigh, NC (United States). Div. of Radiation Protection
1997-05-01
As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ``Applications for the Use of Sealed Sources in Portable Gauging Devices,`` and in NMSs Policy and guidance Directive 2-07, ``Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.`` This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications.
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International Nuclear Information System (INIS)
Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A.; Tingle, W.
1997-05-01
As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ''Applications for the Use of Sealed Sources in Portable Gauging Devices,'' and in NMSs Policy and guidance Directive 2-07, ''Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.'' This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications
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2013-01-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...
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Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption
DEFF Research Database (Denmark)
Satya, Sneha; Wade, Mike; Hass, Ulla
This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing and Asses......This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing...... on testing and assessment of endocrine disrupters (EDTA AG). In November 2010, comments were requested from the WNT, the EDTA AG, the Task Force on Hazard Assessment and experts involved in the assessment of chemicals. The EDTA AG addressed the comments from the WNT at a meeting held in April 2011...... the conclusions and next steps recommended in the draft guidance document are sensible and helpful when assessed in light of comprehensive datasets. The draft guidance document and the three case studies were reviewed again and revised at a meeting of the EDTA AG in December 2011. The draft guidance document...
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76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents
2011-01-04
... guidance, including memoranda and letters, may no longer be relied upon to the extent they are inconsistent... Concerning Electronic Signatures and Documents AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: FMCSA issues regulatory guidance concerning the...
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2010-06-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0281] Draft Guidance for Industry and Food and Drug Administration Staff; ```Harmful and Potentially Harmful... Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff...
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21 CFR 601.29 - Guidance documents.
2010-04-01
... Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Guidance documents. 601.29 Section 601.29 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS...
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2012-04-06
...] Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information...
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Guidance and Control Software Project Data - Volume 1: Planning Documents
Hayhurst, Kelly J. (Editor)
2008-01-01
The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the planning documents from the GCS project. Volume 1 contains five appendices: A. Plan for Software Aspects of Certification for the Guidance and Control Software Project; B. Software Development Standards for the Guidance and Control Software Project; C. Software Verification Plan for the Guidance and Control Software Project; D. Software Configuration Management Plan for the Guidance and Control Software Project; and E. Software Quality Assurance Activities.
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Guidance and Control Software Project Data - Volume 3: Verification Documents
Hayhurst, Kelly J. (Editor)
2008-01-01
The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the verification documents from the GCS project. Volume 3 contains four appendices: A. Software Verification Cases and Procedures for the Guidance and Control Software Project; B. Software Verification Results for the Pluto Implementation of the Guidance and Control Software; C. Review Records for the Pluto Implementation of the Guidance and Control Software; and D. Test Results Logs for the Pluto Implementation of the Guidance and Control Software.
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21 CFR 312.145 - Guidance documents.
2010-04-01
... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. [65 FR... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Guidance documents. 312.145 Section 312.145 Food...
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Guidance and Control Software Project Data - Volume 2: Development Documents
Hayhurst, Kelly J. (Editor)
2008-01-01
The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the development documents from the GCS project. Volume 2 contains three appendices: A. Guidance and Control Software Development Specification; B. Design Description for the Pluto Implementation of the Guidance and Control Software; and C. Source Code for the Pluto Implementation of the Guidance and Control Software
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Guidance documents relating to landfills and contaminants
Energy Technology Data Exchange (ETDEWEB)
Schomaker, N.B.; Zunt, D.A.
1990-01-01
The Environmental Protection Agency is developing and updating a series of Technical Guidance Documents to provide best engineering control technology to meet the needs of the Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response Compensation and Liability Act (CERCLA), respectively. These documents are the compilation of the research efforts to date relating to containment of pollutants from waste disposal to the land as relates to residuals management. The specific areas of research being conducted under the RCRA land disposal program relates to laboratory, pilot and field validation studies in cover systems, waste leaching and solidification, liner systems and disposal facility evaluation. The specific areas of research being conducted under the CERCLA uncontrolled waste sites (Superfund) program relate to in situ treatment, solidification/stabilization for treating hazardous waste, combustion technologies, best demonstrated available technology (BDAT), on-site treatment technologies, emerging biosystems, expert systems, personnel health protection equipment, and site and situation assessment. The Guidance Documents are intended to assist both the regulated community and the permitting authorities, as well as the Program Offices, and Regions, as well as the states and other interested parties, with the latest information relevant to waste management.
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75 FR 35510 - License Renewal Interim Staff Guidance Process, Revision 2 Notice of Availability
2010-06-22
... Related Regulatory Functions.'' An electronic copy of the revised LR-ISG process is available in the NRC's Agencywide Documents Access and Management System (ADAMS) under Accession No. ML100920158. The revised LR-ISG... interim changes to certain NRC license renewal guidance documents. These guidance documents facilitate the...
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Environmental restoration value engineering guidance document
International Nuclear Information System (INIS)
1995-07-01
This document provides guidance on Value Engineering (VE). VE is an organized team effort led by a person trained in the methodology to analyze the functions of projects, systems, equipment, facilities, services, and processes for achieving the essential functions at the lowest life cycle cost while maintaining required performance, reliability, availability, quality, and safety. VE has proven to be a superior tool to improve up-front project planning, cut costs, and create a better value for each dollar spent. This document forms the basis for the Environmental Restoration VE Program, describes the VE process, and provides recommendations on when it can be most useful on ER projects
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2012-07-03
...] Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection Devices Applied... Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to... guidance, entitled ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device...
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2010-04-29
...] Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for... the Internet. To receive ``Draft Guidance for Industry and Food and Drug Administration Staff; User... and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and...
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2013-02-26
... marketing applications, (2) what is meant by ``due diligence'' in obtaining financial disclosures from...: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...
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2013-03-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...
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2013-09-25
... FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and...] Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability...) is announcing the availability of the guidance entitled ``Mobile Medical Applications.'' The FDA is...
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Equipment design guidance document for flammable gas waste storage tank new equipment
International Nuclear Information System (INIS)
Smet, D.B.
1996-01-01
This document is intended to be used as guidance for design engineers who are involved in design of new equipment slated for use in Flammable Gas Waste Storage Tanks. The purpose of this document is to provide design guidance for all new equipment intended for application into those Hanford storage tanks in which flammable gas controls are required to be addressed as part of the equipment design. These design criteria are to be used as guidance. The design of each specific piece of new equipment shall be required, as a minimum to be reviewed by qualified Unreviewed Safety Question evaluators as an integral part of the final design approval. Further Safety Assessment may be also needed. This guidance is intended to be used in conjunction with the Operating Specifications Documents (OSDs) established for defining work controls in the waste storage tanks. The criteria set forth should be reviewed for applicability if the equipment will be required to operate in locations containing unacceptable concentrations of flammable gas
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Air pollution and public health: a guidance document for risk managers.
Craig, Lorraine; Brook, Jeffrey R; Chiotti, Quentin; Croes, Bart; Gower, Stephanie; Hedley, Anthony; Krewski, Daniel; Krupnick, Alan; Krzyzanowski, Michal; Moran, Michael D; Pennell, William; Samet, Jonathan M; Schneider, Jurgen; Shortreed, John; Williams, Martin
2008-01-01
This guidance document is a reference for air quality policymakers and managers providing state-of-the-art, evidence-based information on key determinants of air quality management decisions. The document reflects the findings of five annual meetings of the NERAM (Network for Environmental Risk Assessment and Management) International Colloquium Series on Air Quality Management (2001-2006), as well as the results of supporting international research. The topics covered in the guidance document reflect critical science and policy aspects of air quality risk management including i) health effects, ii) air quality emissions, measurement and modeling, iii) air quality management interventions, and iv) clean air policy challenges and opportunities.
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2012-07-27
...] Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510(k... serious and sometimes fatal consequences to patients. This guidance provides recommendations to 510(k... unintended connections between enteral and nonenteral devices. This draft guidance is not final nor is it in...
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Hayhurst, Kelly J. (Editor)
2008-01-01
The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes configuration management and quality assurance documents from the GCS project. Volume 4 contains six appendices: A. Software Accomplishment Summary for the Guidance and Control Software Project; B. Software Configuration Index for the Guidance and Control Software Project; C. Configuration Management Records for the Guidance and Control Software Project; D. Software Quality Assurance Records for the Guidance and Control Software Project; E. Problem Report for the Pluto Implementation of the Guidance and Control Software Project; and F. Support Documentation Change Reports for the Guidance and Control Software Project.
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2011-10-03
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...
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2013-02-28
... FDA review staff in making decisions about the placement and content of pediatric information in human... assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic...] Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human...
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2011-11-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of...
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Studying Wind Energy/Bird Interactions: A Guidance Document
Energy Technology Data Exchange (ETDEWEB)
Anderson, R. [California Energy Commission (US); Morrison, M. [California State Univ., Sacramento, CA (US); Sinclair, K. [Dept. of Energy/National Renewable Energy Lab. (US); Strickland, D. [WEST, Inc. (US)
1999-12-01
This guidance document is a product of the Avian Subcommittee of the National Wind Coordinating Committee (NWCC). The NWCC was formed to better understand and promote responsible, credible, and comparable avian/wind energy interaction studies. Bird mortality is a concern and wind power is a potential clean and green source of electricity, making study of wind energy/bird interactions essential. This document provides an overview for regulators and stakeholders concerned with wind energy/bird interactions, as well as a more technical discussion of the basic concepts and tools for studying such interactions.
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National Center on Safe Supportive Learning Environments, 2017
2017-01-01
Improving school climate takes time and commitment from a variety of people in a variety of roles. This document outlines key action steps that noninstructional staff--including guidance counselors, social workers, school psychologists, office staff, bus drivers, maintenance and facility staff, and food service staff--can take to support school…
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Draft Updates to the Planning for Natural Disaster Debris Guidance and to Related Documents
EPA is requesting comment on the draft update of the Planning for Natural Disaster Debris Guidance, along with two other documents. This Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.
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Schwartz, Jennifer A T; Pearson, Steven D
2013-06-24
Despite increasing concerns regarding the cost of health care, the consideration of costs in the development of clinical guidance documents by physician specialty societies has received little analysis. To evaluate the approach to consideration of cost in publicly available clinical guidance documents and methodological statements produced between 2008 and 2012 by the 30 largest US physician specialty societies. Qualitative document review. Whether costs are considered in clinical guidance development, mechanism of cost consideration, and the way that cost issues were used in support of specific clinical practice recommendations. Methodological statements for clinical guidance documents indicated that 17 of 30 physician societies (57%) explicitly integrated costs, 4 (13%) implicitly considered costs, 3 (10%) intentionally excluded costs, and 6 (20%) made no mention. Of the 17 societies that explicitly integrated costs, 9 (53%) consistently used a formal system in which the strength of recommendation was influenced in part by costs, whereas 8 (47%) were inconsistent in their approach or failed to mention the exact mechanism for considering costs. Among the 138 specific recommendations in these guidance documents that included cost as part of the rationale, the most common form of recommendation (50 [36%]) encouraged the use of a specific medical service because of equal effectiveness and lower cost. Slightly more than half of the largest US physician societies explicitly consider costs in developing their clinical guidance documents; among these, approximately half use an explicit mechanism for integrating costs into the strength of recommendations. Many societies remain vague in their approach. Physician specialty societies should demonstrate greater transparency and rigor in their approach to cost consideration in documents meant to influence care decisions.
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2010-09-28
... method comparison section and the sample selection inclusion and exclusion criteria section. The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...
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2012-06-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...
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2013-02-08
...] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco... guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked... civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic...
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2013-12-04
...] Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers... the guidance entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked... issuance of civil money penalties for violations of regulations issued under the Federal Food, Drug, and...
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Environmental Guidance Program Reference Book: American Indian Religious Freedom Act
Energy Technology Data Exchange (ETDEWEB)
1987-11-01
This Reference Book contains a copy of the American Indian Religious Freedom Act and guidance for DOE compliance with the statute. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Updates that include important new requirements will be provided periodically.
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2011-12-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...
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Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document
Energy Technology Data Exchange (ETDEWEB)
Astuto-Gribble, Lisa M; Caskey, Susan Adele
2014-07-01
The purpose of this document is threefold: 1) to describe the laboratory bio safety and biosecurity risk assessment process and its conceptual framework; 2) provide detailed guidance and suggested methodologies on how to conduct a risk assessment; and 3) present some practical risk assessment process strategies using realistic laboratory scenarios.
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Energy Efficiency/Renewable Energy Programs in State Implementation Plans - Guidance Documents
final document that provides guidance to States and local areas on quantifying and including emission reductions from energy efficiency and renewable energy measures in State Implementation Plans (SIPS).
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2011-09-30
...-2011-02; Aging Management Program for Steam Generators AGENCY: Nuclear Regulatory Commission. ACTION... License Renewal Interim Staff Guidance (LR-ISG), LR-ISG-2011-02, ``Aging Management Program for Steam... using Revision 3 of NEI 97-06 to manage steam generator aging. The Draft LR-ISG revises the NRC staff's...
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Guidance document for revision of DOE Order 5820.2A, Radioactive Waste Technical Support Program
International Nuclear Information System (INIS)
Kudera, D.E.; McMurtrey, C.D.; Meagher, B.G.
1993-04-01
This document provides guidance for the revision of DOE Order 5820.2A, ''Radioactive Waste Management.'' Technical Working Groups have been established and are responsible for writing the revised order. The Technical Working Groups will use this document as a reference for polices and procedures that have been established for the revision process. The overall intent of this guidance is to outline how the order will be revised and how the revision process will be managed. In addition, this document outlines technical issues considered for inclusion by a Department of Energy Steering Committee
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Configuration management: Phase II implementation guidance
Energy Technology Data Exchange (ETDEWEB)
1994-03-01
Configuration management (CM) is essential to maintaining an acceptable level of risk to the public, workers, environment, or mission success. It is a set of activities and techniques used to maintain consistency among physical and functional configuration, applicable requirements, and key documents. This document provides guidance for continuing the implementation of CM in a phased and graded manner. It describes a cost-effective approach to documented consistency with requirements, with early emphasis on items most important to safety and environmental protection. It is intended to help responsible line managers and configuration management staff personnel in meeting the Energy Systems configuration management policy standard.
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2010-05-05
...] Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability AGENCY... documenting statistical analyses and data files submitted to the Center for Veterinary Medicine (CVM) for the... on Documenting Statistical Analysis Programs and Data Files; Availability'' giving interested persons...
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2011-03-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0457] Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated... other electrical continence devices; protective garment for incontinence; surgical mesh; electrosurgical...
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Rogers, Andy; Chapple, Claire-Louise; Murray, Maria; Platton, David; Saunderson, John
2017-11-01
There has been concern expressed by the UK regulator, the Health & Safety Executive, regarding the management of occupation dose for healthcare radiation workers who work across multiple organizations. In response to this concern, the British Institute of Radiology led a working group of relevant professional bodies to develop guidance in this area. The guidance addresses issues of general system management that would apply to all personal dosimetry systems, regardless of whether or not the workers within that system work across organizational boundaries, along with exploring efficient strategies to comply with legislation where those workers do indeed work across organizational boundaries. For those specific instances, the guidance discusses both system requirements to enable organizations to co-operate (Ionising Radiation Regulations 1999 Regulation 15), as well as specific instances of staff exposure. This is broken down into three categories-low, medium and high risk. A suggested approach to each is given to guide employers and their radiation advisers in adopting sensible strategies for the monitoring of their staff and the subsequent sharing of dosimetry data to ensure overall compliance with both dose limits and optimization requirements.
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2011-01-07
... Web page at http://www.fda.gov/RegulatoryInformation/Guidances/default.htm . FDA guidances are issued and updated regularly. We recommend you check the Web site to ensure that you have the most up-to-date... electronic diaries provided by study subjects. When paper source documents are available for review, tracing...
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75 FR 9607 - National Protection and Programs Directorate; Guidance Document Request and Evaluation
2010-03-03
... information for continuous improvement to its documents. Guidance document request forms and evaluation forms... Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the... will be accepted until May 3, 2010. This process is conducted in accordance with 5 CFR 1320.1...
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76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...
2011-01-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0635] Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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2011-07-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0530] Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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2011-08-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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2010-08-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...
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2013-03-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0168] Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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2010-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0076] (formerly Docket No. 2007D-0387) Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies--Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS...
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2010-09-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0367] Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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2010-09-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0459] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori; Availability AGENCY: Food...
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2012-12-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1161] Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...
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2013-06-07
... adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail... and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION... June 2013. FDA is providing this final guidance document to assist industry in developing technical and...
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This Technical Guidance Document is intended to augment the numerous construction quality control and construction quality assurance (CQC and CQA) documents that are available far materials associated with waste containment systems developed for Superfund site remediation. In ge...
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2011-01-05
... electronic or written comments on the draft guidance by April 5, 2011. ADDRESSES: Submit written requests for... INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the..., plasma, and blood. These devices are used to aid in the diagnosis of Lyme disease. This document does not...
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Energy Technology Data Exchange (ETDEWEB)
Kudera, D.E.; McMurtrey, C.D.; Meagher, B.G.
1993-04-01
This document provides guidance for the revision of DOE Order 5820.2A, ``Radioactive Waste Management.`` Technical Working Groups have been established and are responsible for writing the revised order. The Technical Working Groups will use this document as a reference for polices and procedures that have been established for the revision process. The overall intent of this guidance is to outline how the order will be revised and how the revision process will be managed. In addition, this document outlines technical issues considered for inclusion by a Department of Energy Steering Committee.
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2012-07-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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2012-05-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0384] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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Vos JH; Janssen MPM; SEC
2005-01-01
Risks of both new and existing substances and of biocides in Europe are being evaluated using the Technical Guidance Document (TGD). The European Water Framework Directive refers to this document for establishing Environmental Quality Standards (EQSs) for water. Another guidance document for the
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2013-01-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...
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2011-08-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...
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2011-12-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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2011-02-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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2010-04-29
...] Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic... and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and...
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Codes and standards and other guidance cited in regulatory documents
International Nuclear Information System (INIS)
Nickolaus, J.R.; Bohlander, K.L.
1996-08-01
As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC's Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800)
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Codes and standards and other guidance cited in regulatory documents
Energy Technology Data Exchange (ETDEWEB)
Nickolaus, J.R.; Bohlander, K.L.
1996-08-01
As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800).
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2010-02-24
... NUCLEAR REGULATORY COMMISSION [NRC-2010-0047] Office of New Reactors: Interim Staff Guidance on Assessing Ground Water Flow and Transport of Accidental Radionuclide Releases; Solicitation of Public... ground water flow and transport of accidental radionuclide releases necessary to demonstrate compliance...
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The development of this anaerobic digester (AD) foaming guidance document is based on the need for a specific detailed methodology that water resource recovery facilities (WRRF) personnel can follow and implement to manage or mitigate AD foam incidents. This guidance manual is th...
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2010-11-12
... annually from approximately 25 application holders. FDA professionals familiar with Dear Health Care... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0319] Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters...
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EPA is requesting comment on the draft Planning for Natural Disaster Debris Guidance, and two other documents. The Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.
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2013-01-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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2012-10-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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Standard Review Plan Update and Development Program. Implementing Procedures Document
Energy Technology Data Exchange (ETDEWEB)
1992-05-01
This implementing procedures document (IPD) was prepared for use in implementing tasks under the standard review plan update and development program (SRP-UDP). The IPD provides comprehensive guidance and detailed procedures for SRP-UDP tasks. The IPD is mandatory for contractors performing work for the SRP-UDP. It is guidance for the staff. At the completion of the SRP-UDP, the IPD will be revised (to remove the UDP aspects) and will replace NRR Office Letter No. 800 as long-term maintenance procedures.
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2012-08-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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2010-11-15
... the Final Staff Guidance; Standard Review Plan, Section 13.6.6, Revision 0 on Cyber Security Plan... Reports for Nuclear Power Plants,'' Section 13.6.6, Revision 0 on ``Cyber Security Plan'' (Agencywide... reviews to amendments to licenses for operating reactors or for activities associated with review of...
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Environmental guidance for public participation in environmental restoration activities
Energy Technology Data Exchange (ETDEWEB)
1991-11-01
The US Department of Energy (DOE) is issuing this document, entitled Guidance on Public Participation for US Department of Energy Environmental Restoration Activities, to summarize policy and provide guidance for public participation in environmental restoration activities at DOE Headquarters, Field Offices, facilities, and laboratories. While the Office of Environmental Restoration and Waste Management (EM) has environmental restoration responsibility for the majority of DOE sites and facilities, other DOE Project Offices have similar responsibilities at their sites and facilities. This guidance is applicable to all environment restoration activities conducted by or for DOE under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA); the Resource Conservation and Recovery Act of 1976 (RCRA) as amended by the Hazardous and Solid Waste Amendments of 1984 (HSWA) (corrective actions only); and the National Environmental Policy Act of 1969 (NEPA). This guidance also is applicable to CERCLA remedial action programs under the Uranium Mill Tailings Radiation Control Act of 1978 and the Formerly Utilized Sites Remedial Action Program, where DOE is the designated lead. The primary objectives of this guidance document are as follows: acclimate DOE staff to a changing culture that emphasizes the importance of public participation activities; provide direction on implementing these public participation activities; and, provide consistent guidance for all DOE Field Offices and facilities. The purpose of this document is to provide guidance on conducting effective public participation activities for environmental restoration activities under CERCLA; RCRA corrective actions under sections 3004(u), 3004(v), and 3008(h); and NEPA public participation activities.
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International Nuclear Information System (INIS)
Lachaume, Jean-Luc; Niel, Jean-Christophe
2013-01-01
A first document indicates the improvement guidelines for the ASTRID project based on the French experience in the field of sodium-cooled fast neutron reactors, addresses the safety objectives as they are presented for the ASTRID project, discusses how the project includes a regulation and design referential, and how it addresses various aspects of the design approach (ranking and analysis of operation situations, defence in depth, use of probabilistic studies, safety classification and qualification to accidental situations, taking internal and external aggressions into account and taking severe accidents into account at the design level). It comments the guidelines related to the first two barriers, to main safety functions (control of reactivity and of reactor cooling, containment of radioactive and toxic materials), to dismantling, to R and D for safety support. A second document is a letter sent by the ASN to the GPR (permanent group of experts in charge of nuclear reactors) about the safety guidance document for the ASTRID prototype. The third document is the answer and contains comments and recommendations by this group about the content of this document, and therefore addresses the same topics as the first document. The last document defines the framework of the approach to this document
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Development of a treatability variance guidance document for US DOE mixed-waste streams
International Nuclear Information System (INIS)
Scheuer, N.; Spikula, R.; Harms, T.
1990-03-01
In response to the US Department of Energy's (DOE's) anticipated need for variances from the Resource Conservation and Recovery Act (RCRA) Land Disposal Restrictions (LDRs), a treatability variance guidance document was prepared. The guidance manual is for use by DOE facilities and operations offices. The manual was prepared as a part of an ongoing effort by DOE-EH to provide guidance for the operations offices and facilities to comply with the RCRA (LDRs). A treatability variance is an alternative treatment standard granted by EPA for a restricted waste. Such a variance is not an exemption from the requirements of the LDRs, but rather is an alternative treatment standard that must be met before land disposal. The manual, Guidance For Obtaining Variance From the Treatment Standards of the RCRA Land Disposal Restrictions (1), leads the reader through the process of evaluating whether a variance from the treatment standard is a viable approach and through the data-gathering and data-evaluation processes required to develop a petition requesting a variance. The DOE review and coordination process is also described and model language for use in petitions for DOE radioactive mixed waste (RMW) is provided. The guidance manual focuses on RMW streams, however the manual also is applicable to nonmixed, hazardous waste streams. 4 refs
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Codes and standards and other guidance cited in regulatory documents. Revision 1
International Nuclear Information System (INIS)
Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R.
1994-08-01
As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC's Bulletins, Information Notices, Circulars, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800)
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Codes and standards and other guidance cited in regulatory documents. Revision 1
Energy Technology Data Exchange (ETDEWEB)
Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R. [Pacific Northwest Lab., Richland, WA (United States)
1994-08-01
As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800).
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2011-03-28
... design certification (DC) application for new nuclear power reactors under Title 10 of the Code of... NUCLEAR REGULATORY COMMISSION [NRC-2010-0033; DC/COL-ISG-021] Office of New Reactors; Final Interim Staff Guidance on the Review of Nuclear Power Plant Designs Using a Gas Turbine Driven Standby...
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Improvements in inservice testing regulatory guidance
Energy Technology Data Exchange (ETDEWEB)
Campbell, P.L.
1996-12-01
Over the last few years, the NRC has issued guidance to licensees toward improving the quality of requests for relief or alternatives to the code requirements and bring some measure of consistency to the implementation of the code requirements. Based on the majority of the recent submittals, the overall quality has improved. If all of the steps in the internal process for responding to the requests are timely, the review of an updated program can be completed in six to nine months. When a single or only a few requests are submitted, the staff is generally able to complete an evaluation in less than three months. When schedules are related to outages or exigent circumstances, the NRC responds accordingly. The improvements in schedules can be attributed to publication of staff guideline documents, licensees` efforts in preparing more complete descriptions and justification and an increase in the number of NRC technical staff reviewers assigned to IST.
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Improvements in inservice testing regulatory guidance
International Nuclear Information System (INIS)
Campbell, P.L.
1996-01-01
Over the last few years, the NRC has issued guidance to licensees toward improving the quality of requests for relief or alternatives to the code requirements and bring some measure of consistency to the implementation of the code requirements. Based on the majority of the recent submittals, the overall quality has improved. If all of the steps in the internal process for responding to the requests are timely, the review of an updated program can be completed in six to nine months. When a single or only a few requests are submitted, the staff is generally able to complete an evaluation in less than three months. When schedules are related to outages or exigent circumstances, the NRC responds accordingly. The improvements in schedules can be attributed to publication of staff guideline documents, licensees' efforts in preparing more complete descriptions and justification and an increase in the number of NRC technical staff reviewers assigned to IST
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Guidance for performing preliminary assessments under CERCLA
Energy Technology Data Exchange (ETDEWEB)
NONE
1991-09-01
EPA headquarters and a national site assessment workgroup produced this guidance for Regional, State, and contractor staff who manage or perform preliminary assessments (PAs). EPA has focused this guidance on the types of sites and site conditions most commonly encountered. The PA approach described in this guidance is generally applicable to a wide variety of sites. However, because of the variability among sites, the amount of information available, and the level of investigative effort required, it is not possible to provide guidance that is equally applicable to all sites. PA investigators should recognize this and be aware that variation from this guidance may be necessary for some sites, particularly for PAs performed at Federal facilities, PAs conducted under EPA`s Environmental Priorities Initiative (EPI), and PAs at sites that have previously been extensively investigated by EPA or others. The purpose of this guidance is to provide instructions for conducting a PA and reporting results. This guidance discusses the information required to evaluate a site and how to obtain it, how to score a site, and reporting requirements. This document also provides guidelines and instruction on PA evaluation, scoring, and the use of standard PA scoresheets. The overall goal of this guidance is to assist PA investigators in conducting high-quality assessments that result in correct site screening or further action recommendations on a nationally consistent basis.
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Debast, S.B.; Bauer, M.P.; Kuijper, E.J.; et al.,
2014-01-01
In 2009 the first European Society of Clinical Microbiology and Infection (ESCMID) treatment guidance document for Clostridium difficile infection (CDI) was published. The guideline has been applied widely in clinical practice. In this document an update and review on the comparative effectiveness
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2010-02-03
... Management System (ADAMS) Accession No. ML092640035). This ISG provides new guidance information for applicants submitting a combined license (COL) or design certification (DC) for construction and operation of... (SRP), Section 8.3.1 and Sections 9.5.4 through 9.5.8. The NRC staff issues DC/COL-ISGs to facilitate...
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2013-01-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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Toxic Substances Control Act. Environmental Guidance Program Reference Book: Revision 6
Energy Technology Data Exchange (ETDEWEB)
1992-05-15
This Reference Book contains a current copy of the Toxic Substances Control Act and those regulations that implement the statute and appear to be most relevant to DOE activities. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Questions concerning this Reference Book may be directed to Mark Petts, EH-231 (202/586-2609).
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Environmental Guidance Program reference book: Toxic substances control act. Revision 7
Energy Technology Data Exchange (ETDEWEB)
NONE
1994-12-01
This Reference Book contains a current copy of the Toxic Substances Control Act and those regulations that implement the statute and appear to be most relevant to DOE activities. The document is provided to DOE staff for informational purposes only and should not be interpreted as legal guidance. Questions concerning this Reference Book may be directed to Mark Petts, EH-231 (202/586-2609).
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Clark, Alex; Browne, Sarah; Boardman, Liz; Hewitt, Lealah; Light, Sophie
2016-01-01
UK National Autism Strategy (Department of Health, 2010 and National Institute for Health and Care Excellence guidance (NICE, 2012) states that frontline staff should have a good understanding of Autism. Fifty-six clinical and administrative staff from a multidisciplinary community Learning Disability service completed an electronic questionnaire…
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International Nuclear Information System (INIS)
Pittiglio, C.L. Jr.; Starmer, R.J.; Hedges, D.
1990-10-01
This document provides the Nuclear Regulatory Commission's staff guidance to an applicant on meeting the quality control (QC) requirements of Title 10 of the Code of Federal Regulations, Part 61, Section 61.12 (10 CFR 61.12), for a low-level waste disposal facility. The QC requirements combined with the requirements for managerial controls and audits are the basis for developing a quality assurance (QA) program and for the guidance provided herein. QA guidance is specified for site characterization activities necessary to meet the performance objectives of 10 CFR Part 61 and to limit exposure to or the release of radioactivity. 1 tab
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International Nuclear Information System (INIS)
Gupta, D.; Peshel, J.; Bunting, J.
1991-07-01
The staff of the US Nuclear Regulatory Commission has prepared this staff technical position for the purpose of compiling and further clarifying previous staff positions on regulatory considerations in the design and construction of the exploratory shaft facility (ESF). (The US Department of Energy (DOE) now refers to the ESF as the ''exploratory studies facility.'' DOE's change in terminology does not affect the positions taken in this guidance.) This document lists the key regulations in 10 CFR Part 60 that should be considered in the design and construction of the ESF and presents the staff position statements and corresponding discussions. 13 refs., 1 fig
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Arnold, G.; Boesten, J.J.T.I.; Clook, M.
2013-01-01
The Guidance Document is intended to provide guidance for notifiers and authorities in the context of the review of plant protection products (PPPs) and their active substances under Regulation (EC) 1107/2009. The scientific opinion on the science behind the development of a risk assessment of plant
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Talman, Lena; Gustafsson, Christine; Stier, Jonas; Wilder, Jenny
2017-06-21
This study investigated what areas of International Classification of Functioning, Disability and Health were documented in implementation plans for adults with profound intellectual disability or profound intellectual and multiple disabilities with focus on participation. A document analysis of 17 implementation plans was performed and International Classification of Functioning, Disability and Health was used as an analytic tool. One hundred and sixty-three different codes were identified, especially in the components Activities and participation and Environmental factors. Participation was most frequently coded in the chapters Community, social and civic life and Self-care. Overall, the results showed that focus in the implementation plans concerned Self-care and Community, social and civic life. The other life areas in Activities and participation were seldom, or not at all, documented. A deeper focus on participation in the implementation plans and all life areas in the component Activities and participation is needed. It is important that the documentation clearly shows what the adult wants, wishes, and likes in everyday life. It is also important to ensure that the job description for staff contains both life areas and individual preferences so that staff have the possibility to work to fulfill social and individual participation for the target group. Implications for rehabilitation There is a need for functioning working models to increase participation significantly for adults with profound intellectual disability or profound intellectual and multiple disabilities. For these adults, participation is achieved through the assistance of others and support and services carried out must be documented in an implementation plan. The International Classification of Functioning, Disability and Health can be used to support staff and ensure that information about the most important factors in an individual's functioning in their environment is not omitted in
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Dyachenko, F. V.; Petrova, T. I.
2017-11-01
Efficiency and reliability of the equipment in fossil power plants as well as in combined cycle power plants depend on the corrosion processes and deposit formation in steam/water circuit. In order to decrease these processes different water chemistries are used. Today the great attention is being attracted to the application of film forming amines and film forming amine products. The International Association for the Properties of Water and Steam (IAPWS) consolidated the information from all over the World, and based on the research studies and operating experience of researchers and engineers from 21 countries, developed and authorized the Technical Guidance Document: “Application of Film Forming Amines in Fossil, Combined Cycle, and Biomass Power Plants” in 2016. This article describe Russian and International technical guidance documents for the cycle water chemistries based on film forming amines at fossil and combined cycle power plants.
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From cure to palliation: staff communication, documentation, and transfer of patient.
Löfmark, Rurik; Nilstun, Tore; Bolmsjö, Ingrid Agren
2005-12-01
In the transition from curative treatment to palliative care of a general end-of-life patient population, the internal communication of the acute care staff seems to be less than optimal. The communication had reference to the dialogue within the staff both before and after the decision to concentrate on palliative care, and possible transfer of the patient. This survey of Swedish nurses and physicians showed that most of 780 respondents wanted more internal communication, and a more individualized procedure of decision-making. All staff should be informed about the decision made but full agreement was not seen as realistic. The largest difference of opinion between nurses and physicians concerned the involvement of nurses in the decision-making about the transition. A uniform documentation of the decision to transfer care focus was the ideal. Approximately every fourth patient in acute care is transferred to receive palliative care. Only approximately half of the respondents had any training in palliative care and the majority wanted more training. There seems to be a need for more palliative care training, perhaps somewhat different for each specialty. Furthermore, a common language to enable nurses and physicians to communicate more easily may improve the transition process.
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2012-07-13
... feedback. It is also our intention to hold timely meetings with appropriate staff and managers present, if... sponsors. When final, this document will supersede ``Pre- IDE Program: Issues and Answers--Blue Book Memo...
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International Nuclear Information System (INIS)
Westmacott, Chad; Cameron, Ron
2012-02-01
At the request of its member countries, the OECD Nuclear Energy Agency (NEA) became involved in global efforts to ensure a reliable supply of molybdenum-99 ( 99 Mo) and its decay product, technetium-99m (' 99m Tc), the most widely used medical radioisotope. The NEA established the High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) in 2009. Under its first mandate (June 2009-2011), the HLG-MR examined the major issues that affect the short-, medium- and long-term reliability of 99 Mo/' 99m Tc supply and then developed a policy approach to move the supply chain to a sustainable basis and ensure security of supply. The objectives of the HLG-MR during its second mandate (July 2011-2013) are to work towards increasing the long-term security of supply of 99 Mo and ' 99m Tc, especially through the implementation of the HLG-MR policy approach and its associated recommendations. This will entail actions to maintain transparency on global developments, continue communication with the supply chain and end users, evaluate progress toward implementation and provide additional information and analysis where necessary. A key action under the second mandate is to provide guidance on the implementation of the HLG-MR policy approach. This document provides guidance to reactor and alternative production technology (e.g., cyclotrons, accelerators) operators on how to undertake full-cost identification and implement full-cost recovery. The document also discusses issues related to levelling the playing field between old and new reactors. In order to move toward a long-term secure supply of 99 Mo and ' 99m Tc, the HLG-MR policy approach will need to be implemented by all countries that have an impact on the global market - as producers or consumers. A key recommendation of the policy approach is the implementation of full-cost identification and recovery by operators of 99 Mo-producing research reactors or alternative technologies. This document provides the
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2013-08-07
... guidances (number 19 through 22), contact the Office of Pharmaceutical Science in CDER. 23. ``Qualifying for... to the pharmaceutical industry. In most cases, FDA has developed other guidances and resources to... guidances: 1. ``Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients''--issued April 1998...
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2010-09-08
... conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH... approval) into class II (special controls). DATES: Submit written or electronic comments on this guidance... electronic access to the guidance. Submit electronic comments on the guidance to http://www.regulations.gov...
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A review of NRC staff uses of probabilistic risk assessment
Energy Technology Data Exchange (ETDEWEB)
1994-03-01
The NRC staff uses probabilistic risk assessment (PRA) and risk management as important elements its licensing and regulatory processes. In October 1991, the NRC`s Executive Director for Operations established the PRA Working Group to address concerns identified by the Advisory Committee on Reactor Safeguards with respect to unevenness and inconsistency in the staff`s current uses of PRA. After surveying current staff uses of PRA and identifying needed improvements, the Working Group defined a set of basic principles for staff PRA use and identified three areas for improvements: guidance development, training enhancements, and PRA methods development. For each area of improvement, the Working Group took certain actions and recommended additional work. The Working Group recommended integrating its work with other recent PRA-related activities the staff completed and improving staff interactions with PRA users in the nuclear industry. The Working Group took two key actions by developing general guidance for two uses of PRA within the NRC (that is, screening or prioritizing reactor safety issues and analyzing such issues in detail) and developing guidance on basic terms and methods important to the staff`s uses of PRA.
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Myklebust, Kjellaug K; Bjørkly, Stål; Råheim, Målfrid
2018-02-01
To gain insight into mental health staff's perception of writing progress notes in an acute and subacute psychiatric ward context. The nursing process structures nursing documentation. Progress notes are intended to be an evaluation of a patient's nursing diagnoses, interventions and outcomes. Within this template, a patient's status and the care provided are to be recorded. The therapeutic nurse-patient relationship is recognised as a key component of psychiatric care today. At the same time, the biomedical model remains strong. Research literature exploring nursing staff's experiences with writing progress notes in psychiatric contexts, and especially the space given to staff-patient relations, is sparse. Qualitative design. Focus group interviews with mental health staff working in one acute and one subacute psychiatric ward were conducted. Systematic text condensation, a method for transverse thematic analysis, was used. Two main categories emerged from the analysis: the position of the professional as an expert and distant observer in the progress notes, and the weak position of professional-patient interactions in progress notes. The participants did not perceive that the current recording model, which is based on the nursing process, supported a focus on patients' resources or reporting professional-patient interactions. This model appeared to put ward staff in an expert position in relation to patients, which made it challenging to involve patients in the recording process. Essential aspects of nursing care related to recovery and person-centred care were not prioritised for documentation. This study contributes to the critical examination of the documentation praxis, as well as to the critical examination of the documentation tool as to what is considered important to document. © 2017 John Wiley & Sons Ltd.
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2011-08-24
... Rulemaking Web Site: Go to http://www.regulations.gov and search for documents filed under Docket ID NRC... Lessons Learned (GALL) Report,'' and the NRC staff's aging management review procedures and acceptance criteria in NUREG-1800, Revision 2, ``Standard Review Plan for Review of License Renewal Applications for...
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Energy Technology Data Exchange (ETDEWEB)
Roberts, Jesse D.; Jason Magalen; Craig Jones
2014-06-01
This guidance document provide s the reader with an overview of the key environmental considerations for a typical offshore wind coastal location and the tools to help guide the reader through a thoro ugh planning process. It will enable readers to identify the key coastal processes relevant to their offshore wind site and perform pertinent analysis to guide siting and layout design, with the goal of minimizing costs associated with planning, permitting , and long - ter m maintenance. The document highlight s site characterization and assessment techniques for evaluating spatial patterns of sediment dynamics in the vicinity of a wind farm under typical, extreme, and storm conditions. Finally, the document des cribe s the assimilation of all of this information into the conceptual site model (CSM) to aid the decision - making processes.
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Information architecture. Volume 3: Guidance
Energy Technology Data Exchange (ETDEWEB)
NONE
1997-04-01
The purpose of this document, as presented in Volume 1, The Foundations, is to assist the Department of Energy (DOE) in developing and promulgating information architecture guidance. This guidance is aimed at increasing the development of information architecture as a Departmentwide management best practice. This document describes departmental information architecture principles and minimum design characteristics for systems and infrastructures within the DOE Information Architecture Conceptual Model, and establishes a Departmentwide standards-based architecture program. The publication of this document fulfills the commitment to address guiding principles, promote standard architectural practices, and provide technical guidance. This document guides the transition from the baseline or defacto Departmental architecture through approved information management program plans and budgets to the future vision architecture. This document also represents another major step toward establishing a well-organized, logical foundation for the DOE information architecture.
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Energy Technology Data Exchange (ETDEWEB)
1991-12-31
This Reference Book contains a current copy of the Comprehensive Environmental Response Compensation, and Liability Act and those regulations that implement the statute and appear to be most relevant to Department of Energy (DOE) activities. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Updates that include important new requirements will be provided periodically. Questions concerning this Reference Book may be directed to Mark Petts, EH-231 (FTS 896-2609 or Commercial 202/586-2609).
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DEFF Research Database (Denmark)
Duis, Karen; Holbech, Henrik; Velasco-Santamaría, Yohana M.
Within a project funded by the German Federal Environment Agency, the practicability of Appendix 7.8-5 of REACH guidance document R.7b was evaluated using three case study substances. Shortcomings in the guidance were identified. An assessment of potential endocrine activity in aquatic vertebrates...
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Clean Water Act (excluding Section 404). Environmental guidance program reference book: Revision 6
Energy Technology Data Exchange (ETDEWEB)
1993-01-15
This Reference Book contains a current copy of the Clean Water Act (excluding Section 404) and those regulations that implement the statutes and appear to be most relevant to US Department of Energy (DOE) activities. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Updates that include important new requirements will be provided periodically. Questions concerning this Reference Book may be directed to Mark Petts, EH-231 (202/586-2609).
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International Nuclear Information System (INIS)
Ermakov, A.
2015-01-01
Federal Center for Nuclear and Radiation Safety (JSC FCNRS) developed and approbated guidance and methodical documents for providing the facility to radiologically safe status in the course of Building B decommissioning activity at JSC VNIINM (A.A. Bochvar High-Technology Scientific Research Institute for Inorganic Materials). The scope of application of the documents developed is as follows: - preliminary segregation of radwaste into streams during its collection and preparation for removal from facilities/sites under decommissioning; - express assessment of specific activity (activity) of radwaste generated in the course of dismantling and decontamination activities; - radiological survey of premises and building structures following completion of dismantling and decontamination activities; - SRW processing (compaction, reduction in size), packaging, characterisation and containerisation in order to reduce risks of spread of radioactive contamination. Documents that have been developed can be used both at nuclear facilities/ sites similar to the JSC VNIINM Building B in terms of work stages and types of waste to be generated, and other facilities/ sites taking into consideration their peculiarities. (author)
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A review of NRC staff uses of probabilistic risk assessment
International Nuclear Information System (INIS)
1994-03-01
The NRC staff uses probabilistic risk assessment (PRA) and risk management as important elements its licensing and regulatory processes. In October 1991, the NRC's Executive Director for Operations established the PRA Working Group to address concerns identified by the Advisory Committee on Reactor Safeguards with respect to unevenness and inconsistency in the staff's current uses of PRA. After surveying current staff uses of PRA and identifying needed improvements, the Working Group defined a set of basic principles for staff PRA use and identified three areas for improvements: guidance development, training enhancements, and PRA methods development. For each area of improvement, the Working Group took certain actions and recommended additional work. The Working Group recommended integrating its work with other recent PRA-related activities the staff completed and improving staff interactions with PRA users in the nuclear industry. The Working Group took two key actions by developing general guidance for two uses of PRA within the NRC (that is, screening or prioritizing reactor safety issues and analyzing such issues in detail) and developing guidance on basic terms and methods important to the staff's uses of PRA
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International Nuclear Information System (INIS)
Wickham, L.E.
1986-01-01
The Department of Energy (DOE) is developing the concept of threshold quantities for use in determining which waste materials must be handled as radioactive waste and which may be disposed of as nonradioactive waste at its sites. Waste above this concentration level would be managed as radioactive or mixed waste (if hazardous chemicals are present); waste below this level would be handled as sanitary waste. Last years' activities (1984) included the development of a threshold guidance dose, the development of threshold concentrations corresponding to the guidance dose, the development of supporting documentation, review by a technical peer review committee, and review by the DOE community. As a result of the comments, areas have been identified for more extensive analysis, including an alternative basis for selection of the guidance dose and the development of quality assurance guidelines. Development of quality assurance guidelines will provide a reasonable basis for determining that a given waste stream qualifies as a threshold waste stream and can then be the basis for a more extensive cost-benefit analysis. The threshold guidance and supporting documentation will be revised, based on the comments received. The revised documents will be provided to DOE by early November. DOE-HQ has indicated that the revised documents will be available for review by DOE field offices and their contractors
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International Nuclear Information System (INIS)
Ellingson, A.C.
1980-09-01
This is 1 of 15 documents designed to illustrate how an Environmental, Safety and Health (ES and H) Assurance Program may be implemented. The generic definition of ES and H Assurance Programs is given in a companion document entitled An Environmental, Safety and Health Assurance Program Standard. This document is concerned with ES and H audit and appraisal activities of an ES and H Staff Organization as they might be performed in an institution whose ES and H program is based upon the ES and H Assurance Program Standard. An annotated model plan for ES and H Staff audits and appraisals is presented and discussed
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Staff Performance Analysis: A Method for Identifying Brigade Staff Tasks
National Research Council Canada - National Science Library
Ford, Laura
1997-01-01
... members of conventional mounted brigade staff. Initial analysis of performance requirements in existing documentation revealed that the performance specifications were not sufficiently detailed for brigade battle staffs...
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CANDU severe accident management guidance update
International Nuclear Information System (INIS)
Jones, L.; Popov, N.; Gilbert, L.; Weed, J.
2014-01-01
The CANDU Owners Group (COG) developed a set of generic and initial station-specific Severe Accident Management Guidance (SAMG) documents to mitigate the consequences to the public in the event of a severe accident. The generic portion of the COG SAMG was completed in 2006; the overall project including the station-specific phase was completed in April 2007. Over the years, the CANDU industry and utilities have continuously increased the knowledge base for SAMG and have incorporated various engineered features based on the knowledge obtained. As a result of the event that occurred at the Fukushima Daiiachi nuclear power plant (NPP) in Japan, the Canadian Nuclear Safety Commission (CNSC) established the CNSC Fukushima Task Force. The results of the task force were documented in INFO-0828, CNSC Staff Action Plan on the CNSC Fukushima Task Force Recommendations. Among the recommendation documented in INFO-828 were Fukushima Action Items (FAIs) directed towards the CANDU utilities in Canada; a portion of which are related to SAMG documentation updates and directed at enhancing SAM response. A COG joint project was established to support the closure of the CNSC FAIs and to revise the current CANDU documentation accordingly. This paper provides a high level summary of the COG project scope and results. It also demonstrates that the CANDU SAMG programs in Canada provide robust protection and mitigation of severe accidents. (author)
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CANDU severe accident management guidance update
Energy Technology Data Exchange (ETDEWEB)
Jones, L., E-mail: lisa.m.jones@opg.com [Ontario Power Generation, Pickering, ON (Canada); Popov, N., E-mail: nik.popov@rogers.com [Candu Owners Group, Toronto, ON (Canada); Gilbert, L., E-mail: lovell.gilbert@brucepower.com [Bruce Power, Tiverton, ON (Canada); Weed, J., E-mail: jeff.weed@candu.gov [Candu Owners Group, Toronto, ON (Canada)
2014-07-01
The CANDU Owners Group (COG) developed a set of generic and initial station-specific Severe Accident Management Guidance (SAMG) documents to mitigate the consequences to the public in the event of a severe accident. The generic portion of the COG SAMG was completed in 2006; the overall project including the station-specific phase was completed in April 2007. Over the years, the CANDU industry and utilities have continuously increased the knowledge base for SAMG and have incorporated various engineered features based on the knowledge obtained. As a result of the event that occurred at the Fukushima Daiiachi nuclear power plant (NPP) in Japan, the Canadian Nuclear Safety Commission (CNSC) established the CNSC Fukushima Task Force. The results of the task force were documented in INFO-0828, CNSC Staff Action Plan on the CNSC Fukushima Task Force Recommendations. Among the recommendation documented in INFO-828 were Fukushima Action Items (FAIs) directed towards the CANDU utilities in Canada; a portion of which are related to SAMG documentation updates and directed at enhancing SAM response. A COG joint project was established to support the closure of the CNSC FAIs and to revise the current CANDU documentation accordingly. This paper provides a high level summary of the COG project scope and results. It also demonstrates that the CANDU SAMG programs in Canada provide robust protection and mitigation of severe accidents. (author)
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International Nuclear Information System (INIS)
Pentecost, E.D.; Vinikour, W.S.
1993-08-01
This guidance document (1) provides instructions on preparing the components of an ecological work plan to complement the overall site remedial assessment investigation/feasibility study (RI/FS) work plan and (2) directs the user on how to implement ecological tasks identified in the plan. Under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfired Amendments and Reauthorization Act of 1986 (SARA), an RI/FS work plan win have to be developed as part of the site-remediation scoping the process. Specific guidance on the RI/FS process and the preparation of work plans has been developed by the US Environmental Protection Agency (EPA 1988a). This document provides guidance to US Department of Energy (DOE) staff and contractor personnel for incorporation of ecological information into environmental remediation planning and decision making at CERCLA sites. An overview analysis of early ecological risk assessment methods (i.e., in the 1980s) at Superfund sites was conducted by the EPA (1989a). That review provided a perspective of attention given to ecological issues in some of the first RI/FS studies. By itself, that reference is of somewhat limited value; it does, however, establish a basis for comparison of past practices in ecological risk with current, more refined methods
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River City High School Guidance Services: A Conceptual Model.
American Coll. Testing Program, Iowa City, IA.
This model describes how the guidance staff at a hypothetical high school communicated the effectiveness of the guidance program to students, parents, teachers, and administrators. A description of the high school is presented, and guidance services and personnel are described. A conceptual model responding to student needs is outlined along with…
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Significant Guidance Issued by the Federal Transit Administration
Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...
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Significant Guidance Issued by the Federal Aviation Administration
Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...
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Significant Guidance Issued by the Federal Highway Administration
Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...
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NASA-STD-7009 Guidance Document for Human Health and Performance Models and Simulations
Walton, Marlei; Mulugeta, Lealem; Nelson, Emily S.; Myers, Jerry G.
2014-01-01
Rigorous verification, validation, and credibility (VVC) processes are imperative to ensure that models and simulations (MS) are sufficiently reliable to address issues within their intended scope. The NASA standard for MS, NASA-STD-7009 (7009) [1] was a resultant outcome of the Columbia Accident Investigation Board (CAIB) to ensure MS are developed, applied, and interpreted appropriately for making decisions that may impact crew or mission safety. Because the 7009 focus is engineering systems, a NASA-STD-7009 Guidance Document is being developed to augment the 7009 and provide information, tools, and techniques applicable to the probabilistic and deterministic biological MS more prevalent in human health and performance (HHP) and space biomedical research and operations.
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International Nuclear Information System (INIS)
1995-09-01
A water sampling and analysis plan (WSAP) is prepared for each Uranium Mill Tailings Remedial Action (UMTRA) Project site to provide the rationale for routine ground water sampling at disposal sites and former processing sites. The WSAP identifies and justifies the sampling locations, analytical parameters, detection limits, and sampling frequency for the routine ground water monitoring stations at each site. This guidance document has been prepared by the Technical Assistance Contractor (TAC) for the US Department of Energy (DOE). Its purpose is to provide a consistent technical approach for sampling and monitoring activities performed under the WSAP and to provide a consistent format for the WSAP documents. It is designed for use by the TAC in preparing WSAPs and by the DOE, US Nuclear Regulatory Commission, state and tribal agencies, other regulatory agencies, and the public in evaluating the content of WSAPS
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International Nuclear Information System (INIS)
Plung, D.L.; Montgomery, T.T.; Glasstetter, S.R.
1986-01-01
In support of the programs at the Waste Isolation Pilot Plant (WIPP), the Publications and Procedures Section developed a documentation plan that provides an integrated document hierarchy; further, this plan affords several unique features: 1) the format for procedures minimizes the writing responsibilities of the technical staff and maximizes use of the writing and editing staff; 2) review cycles have been structured to expedite the processing of documents; and 3) the numbers of documents needed to support the program have been appreciably reduced
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One Chance to Get it Right: understanding the new guidance for care of the dying person.
Sykes, Nigel
2015-09-01
Following criticism of the Liverpool Care of the Dying Pathway (LCP), widely used to guide care of dying people in British health-care settings, the UK Government set up an independent review which in 2013 recommended that use of the LCP be discontinued. In response, the Leadership Alliance for the Care of Dying People, a coalition of a wide range of stakeholders, recently published guidance entitled One Chance to Get it Right. This guidance contains five Priorities of Care for the dying person that are intended to guide clinical staff and will inform Care Quality Commission inspections of health-care providers. This article summarizes the background to One Chance to Get it Right and the guidance it contains. One Chance to Get it Right, More Care, Less Pathway and related guidance documents. The need to improve the standard of end-of-life care in every clinical setting. The value of a pathway-based approach to end-of-life care in a context where well-implemented programmes of staff education in the subject are lacking. Public concern with, and scrutiny of, the quality of dying in the UK health-care system, particularly in hospitals but also the ability of patients to die well at home where that is their place of choice. Effective methods of teaching end of life care to all clinical staff; the effect upon families of caring for a dying relative at home; the optimum type, quantity and source of external support to informal carers that is perceived by them as adequate and enables the ill person to die well in in their own home; fuller understanding of the physiology of dying. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Staff/bed and staff/patient ratios in South African public sector mental ...
African Journals Online (AJOL)
Objectives. To document staff/bed and staff/patient ratios in public. sector mental health services in South Africa. Design. Cross-sectional survey. Method. Aquestionnaire was distributed to provincial mental health co-ordinators requesting numbers of full-time equivalent (FTE) staff who provide mental health care at all ...
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Guidance for organizing a local radiation protection program in medical care
International Nuclear Information System (INIS)
Sarby, B.; Jorulf, H.
2000-12-01
The following report is intended to be a guidance of how to organize a local radiation protection program and how it can be incorporated into daily medical care. The report is based on knowledge derived from participation and observations from inspections and the experience from hospitals who for a long time have been working in a well documented organisation. The organisation is described in local. The aim with these documents is to achieve a clear distribution of duties and responsibilities between the licence holder and directors concerned. Furthermore, a basic thought is to establish an efficient form of collaboration between the diverse staff categories and to achieve continuity in the embodiment of new laws and regulations. At that it is important to organise 'the local radiation committee' to operate in close collaboration with the dally medical care
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2012-06-11
... recommendations for plasma-derived products, including albumin and products containing plasma-derived albumin, in..., submit either electronic or written comments on the draft guidance by September 10, 2012. ADDRESSES... electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http...
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Guidance for a harmonized emission scenario document (ESD) on ballast water discharge
Energy Technology Data Exchange (ETDEWEB)
Zipperle, Andreas [BIS - Beratungszentrum fuer integriertes Sedimentmanagement, Hamburg (Germany); Gils, Jos van [DELTARES, Delft (Netherlands); Hattum, Bert van [Amsterdam Univ. (Netherlands). IVM - Institute for Environmental Studies; Heise, Susanne [BIS - Beratungszentrum fuer integriertes Sedimentmanagement, Hamburg (Germany); Hamburg Univ. of Applied Sciences (Germany)
2011-05-15
The present report provides guidance for a harmonized Emission Scenario Document (ESD) for the exposure assessment as part of the environmental risk assessment process which applicants seeking approval of a ballast water management system (BWMS) need to perform prior to notification and authorisation procedures. Despite the global variability of the marine environment, ballast water discharges and treatment methods, exposure assessments need to be comparable between different applications. In order to achieve this, this ESD points out the following aspects: - Applicants should use standardized scenarios in order to predict mean exposure. These should reflect generic situations, independent of region or port so that results are widely applicable. In addition to a harbour scenario, a standardized shipping lane scenario should be considered, - During or right after ballast water discharge, high concentrations may persist in a water body for a certain length of time until extensive mixing results in mean concentrations. Not taking exposure to peak concentrations within gradients into account could lead to an underestimation of risk, especially for rapidly degrading substances. Efforts have been made to approximate maximum exposure concentration with simple dilution factors. Their applicability was checked by near-field-evaluations. - Chemical properties determine the environmental fate of substances. If they are ambiguous, selection of a specific set of data strongly influences the result of an exposure assessment. Guidance is given on what to do about lacking data. - In order to harmonize the exposure assessments, reliable chemical model software should be used. A discussion on the requirements of suitable software and an evaluation of MAMPEC is given in this report. (orig.)
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Significant Guidance Issued by the Federal Motor Carrier Safety Administration
Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...
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International Nuclear Information System (INIS)
Savage, L.
1997-01-01
The following technical report provides a detailed status report of the DOE grant project entitled ''Environmental Guidance Documents for Exploration, Development, Production, and Transportation of Crude Oil and Natural Gas in Texas.'' The grant funding allocated is for the purpose of provided the Railroad Commission of Texas (Commission) with resources and capabilities to draft, publish and distribute documents that provide guidance to oil and gas operators on issues concerning oil and gas naturally occurring radioactive material (NORM) waste, oil and gas hazardous waste, remediation of crude oil spills, management of non-hazardous oil and gas wastes, and mechanical integrity testing of Class II injection and disposal wells
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76 FR 75771 - Emergency Planning Guidance for Nuclear Power Plants
2011-12-05
... Guidance for Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Issuance of NUREG... Support of Nuclear Power Plants;'' NSIR/DPR-ISG-01, ``Interim Staff Guidance Emergency Planning for Nuclear Power Plants;'' and NUREG/CR-7002, ``Criteria for Development of Evacuation Time Estimate Studies...
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Moffitt, Christine M.
2017-01-01
Western New Zealand Mudsnail Conference in Seattle. Targeted hatchery workshops were conducted with staff at Dworshak National Fish Hatchery Complex (ID), Similkameen Pond, Oroville WA, and Ringold Springs State Hatchery (WA).As a result of communications with hatchery staff, invasive species managers, and on site assessments of hatchery facilities, the document was modified and enhanced. Additional resources were added to keep it up to date. The result is a more simplified tool that can lead hatchery or management personnel through the process of risk assessment and provide an introduction to the risk management and communication process.In addition to the typical HACCP processes, this tool adds steps to rate and consider uncertainty and the weight of evidence regarding options and monitoring results . Uncertainty of outcome exists in most tools that can be used to control or prevent NZMS or other invasive mollusks from infesting an area. In additional this document emphasizes that specific control tools and plans must be tailored to each specific setting to consider the economic, environmental and social influences. From the testing and evaluation process, there was a strong recognition that a number of control and prevention tools previously suggested and reported in the literature from laboratory and small scale trials may not be compatible with regional and national regulations, economic constraints, social or cultural constraints, engineering or water chemistry characteristics of each facility.The options for control are summarized in the second document, Review of Control Measures for Hatcheries Infested with NZMS (Appendix A) that provides sources for additional resources and specific tools, and guidance regarding the feasibility and success of each approach. This tool also emphasizes that management plans need to be adaptive and incorporate oversight from professionals familiar with measuring risks of fish diseases, and treatments (e.g. the fish health
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The staff regulations of the Agency
International Nuclear Information System (INIS)
2002-01-01
Following the first comprehensive review of the Provisional Staff Regulations conducted by the Secretariat, the Board of Governors approved on 12 June 2002 amendments to the Provisional Staff Regulations including the removal of the attribute 'provisional' from their title. The revised Staff Regulations of the Agency are set forth in this document for the information of all Members of the Agency. There is a subject index at the end of the document
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International Nuclear Information System (INIS)
Brice, D.A.; Meredith, D.V.; Harris, M.Q.
1993-01-01
In today's litigious society, it is important for both private parties and government to plan and conduct environmental investigations in a scientifically sound manner, documenting the purpose, methods, and results in a consistent fashion throughout the exercise. Planning documents are prepared during the initial phases of environmental investigations. Project objectives, including data quality requirements, specific work to be conducted to fulfill data needs, and operating procedures are specified. Regulatory agency approval of these documents is often required prior to plan implementation. These approvals are necessary and appropriate to fulfilling the agency's mandated role. Many guidance documents prepared by regulatory agencies suggest the content and format of various scoping documents. These guidances help standardize thought processes and considerations in planning, and provide a template to ensure that both the plan and the proposed work will fulfill regulatory requirements. This work describes the preparation and use of guidance documents for planning environmental studies. The goals and some of the pitfalls of such documents are discussed. Guidance should include the following elements: the purpose of the guidance and a description of where it applies; the type of items to be addressed in planning; identification of requirements are applicable to all projects for which the guidance is intended; identification of requirements only applicable in certain situations; a description of items to facilitate planning; a suggested format for fulfilling requirements; example applications of the guidance. Disagreements arise between planners and reviewers/approvers when elements of guidance are used as leverage to require work not directly related to project objectives. Guidance may be inappropriately used as a milestone by which site-specific plans are judged. Regulatory agency review and approval may be regarded as a primary objective of the plan
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2011-08-01
Specifications and Standards; Guide Specifications; CIDs; and NGSs . Learn. Perform. Succeed. STANDARDIZATION DOCUMENTS Federal Specifications Commercial...national or international standardization document developed by a private sector association, organization, or technical society that plans ...Maintain lessons learned • Examples: Guidance for application of a technology; Lists of options Learn. Perform. Succeed. DEFENSE HANDBOOK
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Significant Guidance Issued by the Office of the Secretary of Transportation
Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...
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HANDBOOK: HAZARDOUS WASTE INCINERATION MEASUREMENT GUIDANCE
This publication, Volume III of the Hazardous Waste Incineration Guidance Series, contains general guidance to permit writers in reviewing hazardous waste incineration permit applications and trial burn plans. he handbook is a how-to document dealing with how incineration measure...
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PSD Increment Consumption Guidance
This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.
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Directory of Open Access Journals (Sweden)
Adams Cindy L
2008-06-01
Full Text Available Abstract Background Enteric outbreaks associated with child care centres (CCC have been well documented internationally and in Canada. The current literature focuses on identifying potential risk factors for introduction and transmission of enteric disease, but does not examine why these risk factors happen, how the risk is understood and managed by the staff of CCCs, or what challenges they experience responding to enteric illness. The purpose of this study was to explore the understanding, knowledge and actions of CCC staff regarding enteric illness and outbreaks, and to identify challenges that staff encounter while managing them. Methods Focus groups were conducted with staff of regulated CCCs in Southern Ontario. Five focus groups were held with 40 participants. An open ended style of interviewing was used. Data were analyzed using content analysis. Results CCC staff play an important role in preventing and managing enteric illness. Staff used in-depth knowledge of the children, the centre and their personal experiences to assist in making decisions related to enteric illness. The decisions and actions may differ from guidance provided by public health officials, particularly when faced with challenges related to time, money, staffing and parents. Conclusion CCC staff relied on experience and judgment in coordination with public health information to assist decision-making in the management of enteric illness and outbreaks. Advice and guidance from public health officials to CCC staff needs to be consistent yet flexible so that it may be adapted in a variety of situations and meet regulatory and public health requirements.
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Draft federal GHG accounting and reporting : technical support document
2010-07-01
This is a technical support document (TSD) that accompanies the Federal Greenhouse Gas Accounting and Reporting Guidance (or Guidance). This document provides detailed information on the inventory reporting process and accepted calculation methodolog...
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Chen, Xiaodong Phoenix; Williams, Reed G; Smink, Douglas S
2015-01-01
The amount of guidance provided by the attending surgeon in the operating room (OR) is a key element in developing residents' autonomy. The purpose of this study is to explore factors that affect attending surgeons' decision making regarding OR guidance provided to the resident. We used video-stimulated recall interviews (VSRI) throughout this 2-phase study. In Phase 1, 3 attending surgeons were invited to review separately 30 to 45 minute video segments of their prerecorded surgical operations to explore factors that influenced their OR guidance decision making. In Phase 2, 3 attending surgeons were observed and documented in the OR (4 operations, 341min). Each operating surgeon reviewed their videotaped surgical performance within 5 days of the operation to reflect on factors that affected their decision making during the targeted guidance events. All VSRI were recorded. Thematic analysis and manual coding were used to synthesize and analyze data from VSRI transcripts, OR observation documents, and field notes. A total of 255 minutes of VSRI involving 6 surgeons and 7 surgical operations from 5 different procedures were conducted. A total of 13 guidance decision-making influence factors from 4 categories were identified (Cohen's κ = 0.674): Setting (case schedule and patient morbidity), content (procedure attributes and case progress), resident (current competency level, trustworthiness, self-confidence, and personal traits), and attending surgeon (level of experience, level of comfort, preferred surgical technique, OR training philosophy, and responsibility as surgeon). A total of 5 factors (case schedule, patient morbidity, procedure attributes, resident current competency level, and trustworthiness) influenced attending surgeons' pre-OR guidance plans. "OR training philosophy" and "responsibility as surgeon" were anchor factors that affected attending surgeons' OR guidance decision-making patterns. Surgeons' OR guidance decision making is a dynamic process
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Staff Directory | Cancer Prevention Fellowship Program
The Cancer Prevention Fellowship Program values the contributions of its fellows and works to provide relevant and useful experiences in research and education in return. Our staff is here to provide unwavering support and guidance to each fellow as they progress through the program.
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International Nuclear Information System (INIS)
Caplin, J.; Page, G.; Smith, D.; Wiblin, C.
1994-08-01
The Nuclear Regulatory Commission (NRC) is conducting an enhanced participatory rulemaking to establish radiological criteria for the decommissioning of NRC licensed facilities. The NRC obtained comments on the scope, issues, and approaches through a series of workshops (57 FR 58727), Generic Environmental Impact Statement (GEIS) scoping meetings (58 FR 33570), a dedicated electronic bulletin board system (58 FR 37760), and written submissions. A summary of workshop and scope-meeting comments was published as NUREG/CR-6156. On February 2, 1994, the Commission published in the Federal Register (59 FR 4868) a notice that the NRC staff had prepared a ''staff draft'' proposed rule on radiological criteria for decommissioning. Copies of the staff draft were distributed to the Agreement States, participants in the earlier meetings, and other interested parties for comment. This report summarizes the comments identified from the 96 docketed letters received on the staff draft. No analysis or response is included in this report. The comments reflect a broad spectrum of viewpoints. Two subjects on which the commenters were in general agreement were (1) that the enhanced participatory rulemaking should proceed, and (2) that the forthcoming GEIS and guidance documents are needed for better understanding of the draft rule
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76 FR 61098 - Guidance for 1-Hour SO2
2011-10-03
...Notice is hereby given that the EPA has posted its draft non- binding guidance titled, ``Guidance for 1-Hour SO2 NAAQS SIP Submissions'' on its Web site. The EPA invites public comments on this guidance document during the comment period specified below, and plans to issue an updated version of the guidance after reviewing timely submitted comments.
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NPP License Renewal and Aging Management: Revised Guidance
International Nuclear Information System (INIS)
Hull, A.B.; Hiser, A.L.; Lindo-Talin, S.E.
2012-01-01
Based on the Atomic Energy Act, the NRC issues licenses for commercial power reactors to operate for up to 40 years and allows these licenses to be renewed for up to another 20 years. NRC has approved license renewal (LR) for well over 50% of U.S. located reactors originally licensed to operate for 40 years. Of these 104 reactors (69 PWRs, 35 BWRs), the NRC has issued renewed licenses for 71 units and is currently reviewing applications for another 15 units. As of May 1, 2012, ten plants at nine sites had entered their 41st year of operation and thus are in their first period of extended operation (PEO). Five more plants will enter the PEO by the end of 2012. One foundation of the license renewal process has been license renewal guidance documents (LRGDs). The U.S. Nuclear Regulatory Commission (NRC) revised key guidance documents used for nuclear power LR in 2010 and 2011. These include NUREG-1800, 'Standard Review Plan for Review of License Renewal Applications,' revision 2 (SRP-LR), and NUREG-1801, 'Generic Aging Lessons Learned (GALL) Report,' revision 2 (GALL Report). The guidance documents were updated to reflect lessons learned and operating experience gained since the guidance documents were last issued in 2005. The reactor LRGDs referenced in this poster can all be accessed at http://www.nrc.gov/reactors/operating/licensing/renewal/guidance.html (author)
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Documentation and Development. Experience in Algeria
Tchuigoua, J. Founou
1972-01-01
A description of the activities of the Documentation, Library and Archives Department of the Algiers Chamber of Commerce and Industry, which is run by a small staff on a modest budget, provides documentation services for the staff of the Chamber of Commerce and also assists other centers in Algeria. (Author)
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NPP License Renewal and Aging Management: Revised Guidance
International Nuclear Information System (INIS)
Hull, A.B.; Hiser, A.L.; Lindo-Talin, S.E.
2012-01-01
Based on the Atomic Energy Act, the NRC issues licenses for commercial power reactors to operate for up to 40 years and allows these licenses to be renewed for up to another 20 years. NRC has approved license renewal for well over 50% of U.S. located reactors originally licensed to operate for 40 years. Of these 104 reactors (69 PWRs, 35 BWRs), the NRC has issued renewed licenses for 71 units and is currently reviewing applications for another 15 units. As of May 1, 2012, ten plants at nine sites had entered their 41st year of operation and thus are in their first period of extended operation (PEO). Five more plants will enter the PEO by the end of 2012. One foundation of the license renewal process has been license renewal guidance documents (LRGDs). The U.S. Nuclear Regulatory Commission (NRC) revised key guidance documents used for nuclear power license renewal in 2010 and 2011. These include NUREG-1800, 'Standard Review Plan for Review of License Renewal Applications,' revision 2 (SRP-LR), and NUREG-1801, 'Generic Aging Lessons Learned (GALL) Report,' revision 2 (GALL Report). The guidance documents were updated to reflect lessons learned and operating experience gained since the guidance documents were last issued in 2005. (author)
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International Nuclear Information System (INIS)
Brown, Simon; Lehman, Margot; Ferrari-Anderson, Janet; Glyde, Alan; Burmeister, Elizabeth; Nicol, David
2011-01-01
Increased accuracy when using fiducial markers for prostate localisation is well documented. This project aimed to establish the improvement in accuracy when using gold markers for daily prostate localisation, to assess patient satisfaction and morbidity from the transrectal implantation of gold seed markers and establish staff attitudes towards the newly introduced processes. Twenty patients with prostate cancer had three gold seeds implanted into the base, apex and central zone of the prostate transrectally using ultrasound guidance. Surveys were conducted to assess staff and patient satisfaction with the process of gold seed localisation. The gold markers were used to localise the prostate on a daily basis using megavoltage electronic portal imaging. Measurements were taken to establish the increase in accuracy when using gold fiducial markers compared with using the surrounding bony anatomy. Inter-fraction motion (1 standard deviation (SD)) of the fiducial markers was 2.20, 4.28 and 4.27 mm in the LR, SI and AP directions, respectively. Intra-fraction prostate motion (1 SD) was measured as 0.8 mm LR, 1.1 mm SI and 2.0 mm AP. The patient survey showed that the insertion and associated side effects were acceptable, with 5% of patients stating that the seed insertion was worse than the prostate biopsy, and 23.1% of patients experienced short duration (1–2 days) haematuria. The staff survey showed that daily online image guidance was achievable without affecting patient throughput. Thirty percent of treatment staff believed that performing online daily localisation did not add any extra time to a standard treatment, and the remaining 70% thought that the added time was minimal (2–4 min). Gold fiducial markers are an accurate, reliable and tolerable method of daily prostate localisation.
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2012-11-09
... appropriate human specimen or culture. This draft guidance is not final nor is it in effect at this time... nucleic acids extracted from a single appropriate human specimen or culture. For the purposes of this... diseases. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good...
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Guidance for closure of existing DOE LLW disposal sites
International Nuclear Information System (INIS)
Blanchfield, L.
1987-01-01
During FY 1986, a closure guidance document was developed. The purpose of this document is to provide guidance in support of DOE Order 5820.2 to site operating contractors for the stabilization and closure of existing low-level waste (LLW) shallow land disposal sites at US Department of Energy (DOE) facilities. Guidance is provided to aid operators in placing existing LLW sites in a closed conditions, i.e., a condition in which a nonoperational site meets postclosure performance requirements and can be shown, within a high degree of confidence, to perform as anticipated in the future, under the most cost-effective maintenance approach. Guidance is based on the philosophy that closure should be planned and performed using a systems approach. Plans for FY 1987 call for revision of the document to incorporate more information on closure of LLW sites also containing radioactive mixed waste and/or transuranic waste. 4 references, 3 figures, 2 tables
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75 FR 70254 - PSD and Title V Permitting Guidance for Greenhouse Gases
2010-11-17
... Guidance for Greenhouse Gases AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability..., ``PSD and Title V Permitting Guidance for Greenhouse Gases'' on its significant guidance Internet Web... guidance titled, ``PSD and Title V Permitting Guidance for Greenhouse Gases.'' This document has been...
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Guidance for nuclear medicine staff on radiopharmaceuticals drug interaction
International Nuclear Information System (INIS)
Santos-Oliveira, Ralph
2009-01-01
Numerous drug interactions related to radiopharmaceuticals take place every day in hospitals many of which are not reported or detected. Information concerning this kind of reaction is not abundant, and nuclear medicine staff are usually overwhelmed by this information. To better understand this type of reaction, and to help nuclear medicine staff deal with it, a review of the literature was conducted. The results show that almost all of radiopharmaceuticals marketed around the world present drug interactions with a large variety of compounds. This suggests that a logical framework to make decisions based on reviews incorporating adverse reactions must be created. The review also showed that researchers undertaking a review of literature, or even a systematic review that incorporates drug interactions, must understand the rationale for the suggested methods and be able to implement them in their review. Additionally, a global effort should be made to report as many cases of drug interaction with radiopharmaceuticals as possible. With this, a complete picture of drug interactions with radiopharmaceuticals can be drawn. (author)
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2012-02-15
... report will alert FDA to trends or clusters of events that might be a safety issue otherwise unreported...] Agency Information Collection Activities; Proposed Collection; Comment Request: Guidance for Industry and... of information technology. Guidance for Industry and Food and Drug Administration Staff; Class II...
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Moisture Control Guidance for Commercial and Public ...
This document provides guidance to designers, construction mangers, and building operation/maintenance managers to improve IEQ and reduce risks of encountering IEQ problems due to insufficient moisture control. EPA will be producing a document entitled
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National Environmental Policy Act guidance: A model process
International Nuclear Information System (INIS)
Angle, B.M.; Lockhart, V.A.T.; Sema, B.; Tuott, L.C.; Irving, J.S.
1995-04-01
The ''Model National Environmental Policy Act (NEPA) Process'' includes: References to regulations, guidance documents, and plans; training programs; procedures; and computer databases. Legislative Acts and reference documents from Congress, US Department of Energy, and Lockheed Idaho Technologies Company provide the bases for conducting NEPA at the Idaho National Engineering Laboratory (INEL). Lockheed Idaho Technologies Company (LITCO) NEPA / Permitting Department, the Contractor Environmental Organization (CEO) is responsible for developing and maintaining LITCO NEPA and permitting policies, guidance, and procedures. The CEO develops procedures to conduct environmental evaluations based on NEPA, Council on Environmental Quality (CEQ) regulations, and DOE guidance. This procedure includes preparation or support of environmental checklists, categorical exclusion determinations, environmental assessment determinations, environmental assessments, and environmental impact statements. In addition, the CEO uses this information to train personnel conducting environmental evaluations at the INEL. Streamlining these procedures fosters efficient use of resources, quality documents, and better decisions on proposed actions
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76 FR 66925 - Guidance for 1-Hour SO2
2011-10-28
...The EPA is announcing an extension of the public comment period for its draft non-binding guidance titled, ``Guidance for 1-Hour SO2 SIP Submissions.'' The draft of the guidance document is currently on the EPA's Web site. The EPA is extending the comment period for an additional 30-day period and invites public comments on this guidance during this period. The EPA plans to issue an updated version of the guidance after reviewing timely submitted comments.
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Energy Technology Data Exchange (ETDEWEB)
None
1992-03-01
This Reference Book contains a current copy of the Clean Water Act (Section 404) and the Rivers and Harbors Act (Sections 9 and 10) and those regulations that implement those sections of the statutes and appear to be most relevant to DOE activities. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Updates that include important new requirements will be provided periodically. Questions concerning this Reference Book may be directed to Mark Petts, IH-231 (FTS 896-2609 or Commercial 202/586-2609).
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Health Service use of ionising radiations: Guidance
International Nuclear Information System (INIS)
1995-01-01
This booklet gives outline guidance on the use of ionising radiations in the Health Service in the United Kingdom. Extensive reference is made to documents where more detailed information may be found. The guidance covers general advice on the medical use of ionising radiations, statutory requirements, and guidance on selected Health Service issues such as patient identification procedures, information management systems, deviations from prescribed radiation dose, imaging and radiotherapy. (57 references) (U.K.)
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Debast, S B; Bauer, M P; Kuijper, E J
2014-03-01
In 2009 the first European Society of Clinical Microbiology and Infection (ESCMID) treatment guidance document for Clostridium difficile infection (CDI) was published. The guideline has been applied widely in clinical practice. In this document an update and review on the comparative effectiveness of the currently available treatment modalities of CDI is given, thereby providing evidence-based recommendations on this issue. A computerized literature search was carried out to investigate randomized and non-randomized trials investigating the effect of an intervention on the clinical outcome of CDI. The Grades of Recommendation Assessment, Development and Evaluation (GRADE) system was used to grade the strength of our recommendations and the quality of the evidence. The ESCMID and an international team of experts from 11 European countries supported the process. To improve clinical guidance in the treatment of CDI, recommendations are specified for various patient groups, e.g. initial non-severe disease, severe CDI, first recurrence or risk for recurrent disease, multiple recurrences and treatment of CDI when oral administration is not possible. Treatment options that are reviewed include: antibiotics, toxin-binding resins and polymers, immunotherapy, probiotics, and faecal or bacterial intestinal transplantation. Except for very mild CDI that is clearly induced by antibiotic usage antibiotic treatment is advised. The main antibiotics that are recommended are metronidazole, vancomycin and fidaxomicin. Faecal transplantation is strongly recommended for multiple recurrent CDI. In case of perforation of the colon and/or systemic inflammation and deteriorating clinical condition despite antibiotic therapy, total abdominal colectomy or diverting loop ileostomy combined with colonic lavage is recommended. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.
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Identification of technical guidance related to ground water monitoring
Energy Technology Data Exchange (ETDEWEB)
Vogelsberger, R.R.; Smith, E.D.; Broz, M.; Wright, J.C. Jr.
1987-05-01
Monitoring of ground water quality is a key element of ground water protection and is mandated by several federal and state laws concerned with water quality or waste management. Numerous regulatory guidance documents and technical reports discuss various aspects of ground water monitoring, but at present there is no single source of guidance on procedures and practices for ground water monitoring. This report is intended to assist US Department of Energy (DOE) officials and facility operating personnel in identifying sources of guidance for developing and implementing ground water monitoring programs that are technically sound and that comply with applicable regulations. Federal statutes and associated regulations were reviewed to identify requirements related to ground water monitoring, and over 160 documents on topics related to ground water monitoring were evaluated for their technical merit, their utility as guidance for regulatory compliance, and their relevance to DOE's needs. For each of 15 technical topics involved in ground water monitoring, the report presents (1) a review of federal regulatory requirements and representative state requirements, (2) brief descriptions of the contents and merits of available guidance documents and technical references, and (3) recommendations of the guidance documents or other technical resources that appear to be most appropriate for use in DOE's monitoring activities. The contents of the report are applicable to monitoring activities involving both radioactive and nonradioactive substances. The main sources of regulatory requirements considered in the report are the Atomic Energy Act (including the Uranium Mill Tailings Radiation Control Act), Resource Conservation and Recovery Act, Comprehensive Environmental Response, Compensation and Liability Act, Safe Drinking Water Act, Toxic Substances Control Act, and Federal Water Pollution Control Act.
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Identification of technical guidance related to ground water monitoring
International Nuclear Information System (INIS)
Vogelsberger, R.R.; Smith, E.D.; Broz, M.; Wright, J.C. Jr.
1987-05-01
Monitoring of ground water quality is a key element of ground water protection and is mandated by several federal and state laws concerned with water quality or waste management. Numerous regulatory guidance documents and technical reports discuss various aspects of ground water monitoring, but at present there is no single source of guidance on procedures and practices for ground water monitoring. This report is intended to assist US Department of Energy (DOE) officials and facility operating personnel in identifying sources of guidance for developing and implementing ground water monitoring programs that are technically sound and that comply with applicable regulations. Federal statutes and associated regulations were reviewed to identify requirements related to ground water monitoring, and over 160 documents on topics related to ground water monitoring were evaluated for their technical merit, their utility as guidance for regulatory compliance, and their relevance to DOE's needs. For each of 15 technical topics involved in ground water monitoring, the report presents (1) a review of federal regulatory requirements and representative state requirements, (2) brief descriptions of the contents and merits of available guidance documents and technical references, and (3) recommendations of the guidance documents or other technical resources that appear to be most appropriate for use in DOE's monitoring activities. The contents of the report are applicable to monitoring activities involving both radioactive and nonradioactive substances. The main sources of regulatory requirements considered in the report are the Atomic Energy Act (including the Uranium Mill Tailings Radiation Control Act), Resource Conservation and Recovery Act, Comprehensive Environmental Response, Compensation and Liability Act, Safe Drinking Water Act, Toxic Substances Control Act, and Federal Water Pollution Control Act
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Consideration of health inequalities in systematic reviews: a mapping review of guidance.
Maden, Michelle
2016-11-28
Given that we know that interventions shown to be effective in improving the health of a population may actually widen the health inequalities gap while others reduce it, it is imperative that all systematic reviewers consider how the findings of their reviews may impact (reduce or increase) on the health inequality gap. This study reviewed existing guidance on incorporating considerations of health inequalities in systematic reviews in order to examine the extent to which they can help reviewers to incorporate such issues. A mapping review was undertaken to identify guidance documents that purported to inform reviewers on whether and how to incorporate considerations of health inequalities. Searches were undertaken in Medline, CINAHL and The Cochrane Library Methodology Register. Review guidance manuals prepared by international organisations engaged in undertaking systematic reviews, and their associated websites were scanned. Studies were included if they provided an overview or discussed the development and testing of guidance for dealing with the incorporation of considerations of health inequalities in evidence synthesis. Results are summarised in narrative and tabular forms. Twenty guidance documents published between 2009 and 2016 were included. Guidance has been produced to inform considerations of health inequalities at different stages of the systematic review process. The Campbell and Cochrane Equity Group have been instrumental in developing and promoting such guidance. Definitions of health inequalities and guidance differed across the included studies. All but one guidance document were transparent in their method of production. Formal methods of evaluation were reported for six guidance documents. Most of the guidance was operationalised in the form of examples taken from published systematic reviews. The number of guidance items to operationalise ranges from 3 up to 26 with a considerable overlap noted. Adhering to the guidance will require more
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2012-11-28
... Guidance for the Individual Plant Examination of External Events (IPEEE) for Severe Accident... Insights from the Fukushima Dai-ichi Accident,'' dated March 12, 2012 (ADAMS Accession No. ML12053A340... resulting nuclear accident, at the Fukushima Dai-ichi nuclear power plant in March 2011. Enclosure 1 to the...
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2013-03-26
... SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on... document entitled ``Guidance for Industry: Blood Establishment Computer System Validation in the User's... document to http://www.regulations.gov or written comments to the Division of Dockets Management (see...
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Site Screening and Technical Guidance for Monitored Natural Attenuation at DOE Sites
Energy Technology Data Exchange (ETDEWEB)
Borns, D.J.; Brady, P.V.; Brady, W.D.; Krupka, K.M.; Spalding, B.P.; Waters, R.D.; Zhang, P.
1999-03-01
Site Screening and Technical Guidance for Monitored Natural Attenuation at DOE Sites briefly outlines the biological and geochemical origins of natural attenuation, the tendency for natural processes in soils to mitigate contaminant transport and availability, and the means for relying on monitored natural attenuation (MNA) for remediation of contaminated soils and groundwaters. This report contains a step-by-step guide for (1) screening contaminated soils and groundwaters on the basis of their potential for remediation by natural attenuation and (2) implementing MNA consistent with EPA OSWER Directive 9200.4-17. The screening and implementation procedures are set up as a web-based tool (http://www.sandia.gov/eesector/gs/gc/na/mnahome.html) to assist US Department of Energy (DOE) site environmental managers and their staff and contractors to adhere to EPA guidelines for implementing MNA. This document is intended to support the Decision Maker's Framework Guide and Monitoring Guide both to be issued from DOE EM-40. Further technical advances may cause some of the approach outlined in this document to change over time.
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2010-04-30
...] Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test... availability of a document entitled ``Guidance for Industry: Requalification Method for Reentry of Blood Donors... document entitled ``Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred...
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Guidance on enforcement of the requirements of the surface water treatment rule
International Nuclear Information System (INIS)
1992-06-01
The document provides guidance on several specific issues relating to the enforcement of the Surface Water Treatment Rule. The guidance deals with the provisions of the Rule relating to unfiltered systems. Enforcements of the requirements relating to the filtered systems will be dealt with in a later document
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Quality Assurance Guidance for the Collection of Meteorological Data Using Passive Radiometers
This document augments the February 2000 guidance entitled Meteorological Monitoring Guidance for Regulatory Modeling Applications and the March 2008 guidance entitled Quality Assurance Handbook for Air Pollution Measurement Systems Volume IV: Meteorological Measurements Version ...
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ADM guidance-Ceramics: guidance to the use of fractography in failure analysis of brittle materials.
Scherrer, Susanne S; Lohbauer, Ulrich; Della Bona, Alvaro; Vichi, Alessandro; Tholey, Michael J; Kelly, J Robert; van Noort, Richard; Cesar, Paulo Francisco
2017-06-01
To provide background information and guidance as to how to use fractography accurately, a powerful tool for failure analysis of dental ceramic structures. An extended palette of qualitative and quantitative fractography is provided, both for in vivo and in vitro fracture surface analyses. As visual support, this guidance document will provide micrographs of typical critical ceramic processing flaws, differentiating between pre- versus post sintering cracks, grinding damage related failures and occlusal contact wear origins and of failures due to surface degradation. The documentation emphasizes good labeling of crack features, precise indication of the direction of crack propagation (dcp), identification of the fracture origin, the use of fractographic photomontage of critical flaws or flaw labeling on strength data graphics. A compilation of recommendations for specific applications of fractography in Dentistry is also provided. This guidance document will contribute to a more accurate use of fractography and help researchers to better identify, describe and understand the causes of failure, for both clinical and laboratory-scale situations. If adequately performed at a large scale, fractography will assist in optimizing the methods of processing and designing of restorative materials and components. Clinical failures may be better understood and consequently reduced by sending out the correct message regarding the fracture origin in clinical trials. Copyright © 2017 The Academy of Dental Materials. All rights reserved.
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Guidance for Identifying, Selecting and Evaluating Open Literature Studies
This guidance for Office of Pesticide Program staff will assist in their evaluation of open literature studies of pesticides. It also describes how we identify, select, and ensure that data we use in risk assessments is of sufficient scientific quality.
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International Nuclear Information System (INIS)
Alzbutas, R.; Ostapchuk, S.; Borysiewicz, M.; Decker, K.; Kumar, Manorma; Haeggstroem, A.; Nitoi, M.; Groudev, P.; Parey, S.; Potempski, S.; Raimond, E.; Siklossy, T.
2016-01-01
The goal of this report is to provide guidance on practices to model Extreme Weather hazards and implement them in extended level 1 PSA. This report is a joint deliverable of work package 21 (WP21) and work package 22 (WP22). The general objective of WP21 is to provide guidance on all of the individual hazards selected at the End Users Workshop. This guidance is focusing on extreme weather hazards, namely: extreme wind, extreme temperature and snow pack. Other hazards, however, are considered in cases where they are correlated/ associated with the hazard under discussion. Guidance developed refers to existing guidance whenever possible. As it was recommended by end users this guidance covers questions of developing integrated and/or separated extreme weathers PSA models. (authors)
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75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...
2010-01-20
... conferencing and electronic submissions, Mammography Matters, and other device-oriented information. A search... or electronic comments on the draft guidance by April 20, 2010. ADDRESSES: Submit written requests... the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit...
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Water chemistry guidance in nuclear power plants in Japan
International Nuclear Information System (INIS)
Uchida, Shunsuke; Okada, Hidetoshi; Suzuki, Hiroaki; Naitoh, Masanori
2012-01-01
Water chemistry plays important roles in safe and reliable plant operation which are very critical for future power rate increases as well as aging plant management. Water chemistry control is required to satisfy the need for improved integrity of target materials, and at the same time it must be optimal for all materials and systems in a plant. Optimal water chemistry can be maintained by expert engineers who are knowledgeable about plant water chemistry, who have sufficient experience with plant operation, and whose knowledge is based on fundamental technologies. One of the latest subjects in the field of water chemistry is achieving suitable technical transfers, in which the achievements and experience with plant water chemistry accumulated by experts are successfully transferred to the next generation of engineers. For this purpose, documents on experience with water chemistry are being compiled as the guidance for water chemistry control and water chemistry standards, e.g., standards for chemical analysis procedures and guidance for water chemistry control procedures. This paper introduces the latest activities in Japan in establishing water chemistry guidance involving water chemistry standards, guidance documents and their supporting documents. (orig.)
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2013-11-13
... New Reactors and Specific Environmental Guidance for Integral Pressurized Water Reactors Reviews... Environmental Issues Associated with New Reactors'' and draft ISG ESP/ COL-ISG-027, ``Interim Staff Guidance on...://www.regulations.gov and search for Docket ID NRC-2013-0212 for ESP/COL- ISG-026 or NRC-2013-0211 for...
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Working with Staff Using Baumrind's Parenting Styles Framework
Veldhuis, Hollace Anne
2012-01-01
The author's presentation at the staff meeting centered on Diana Baumrind's parenting styles framework (Baumrind, 1967). Baumrind believed that there were four requirements for effective guidance: nurturing, communication, maturity demands, and control. She rated parents on these four dimensions and identified the pattern of parenting that…
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Development of Safety Review Guidance for Research and Training Reactors
International Nuclear Information System (INIS)
Oh, Kju-Myeng; Shin, Dae-Soo; Ahn, Sang-Kyu; Lee, Hoon-Joo
2007-01-01
The KINS already issued the safety review guidance for pressurized LWRs. But the safety review guidance for research and training reactors were not developed. So, the technical standard including safety review guidance for domestic research and training reactors has been applied mutates mutandis to those of nuclear power plants. It is often difficult for the staff to effectively perform the safety review of applications for the permit by the licensee, based on peculiar safety review guidance. The NRC and NSC provide the safety review guidance for test and research reactors and European countries refer to IAEA safety requirements and guides. The safety review guide (SRG) of research and training reactors was developed considering descriptions of the NUREG- 1537 Part 2, previous experiences of safety review and domestic regulations for related facilities. This study provided the safety review guidance for research and training reactors and surveyed the difference of major acceptance criteria or characteristics between the SRG of pressurized light water reactor and research and training reactors
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Waaldijk, C.; Lorenzo, Villaverde J.M.; Nikolina, N.; Zago, G.
2016-01-01
This Working Paper of the research project FamiliesAndSocieties contains the text of the LawsAndFamilies questionnaire, plus the text of the guidance document provided to legal experts answering this questionnaire. These texts are preceded by a brief introduction to the background, aims and
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10 CFR 2.1505 - Role of the NRC staff.
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Role of the NRC staff. 2.1505 Section 2.1505 Energy... Legislative Hearings § 2.1505 Role of the NRC staff. The NRC staff shall be available to answer any Commission or presiding officer's questions on staff-prepared documents, provide additional information or...
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RCRA Programmatic Information Policy and Guidance
U.S. Environmental Protection Agency — This asset includes program policy and guidance documents that are used by the EPA regions, states, tribes and private parties to implement the hazardous waste...
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Training the staff of the regulatory body for nuclear facilities: A competency framework
International Nuclear Information System (INIS)
2001-11-01
only a small staff are examples of training programmes, and their development, for individual staff members. Maintaining the qualification and competence of regulatory staff would also be addressed.To respond to the above requests and recommendations, the purpose of this technical document is to provide guidance on training and qualification based on the competency framework required for the regulatory body to perform its functions. The main aim is to support the Regulatory Bodies supervising nuclear facilities such as nuclear power plants and research reactors. To support regulatory training activities in nuclear installation safety, the IAEA has also developed two standardized training courses to provide basic knowledge needed for work in nuclear safety. A basic professional training course on nuclear safety was organized for the first time in 1999 in Saclay, France, in English. In 2000, the course was provided in Romania, in English, and in Brazil, in Spanish. In 2001, the course was organized as a six-week course in Saclay, France for the European countries and in Argonne, USA, for the Asian countries. For the course, a textbook was developed and used that included test questions to support and control learning. At the next level of specialized knowledge, a training course on regulatory control of nuclear power plants, aimed at new staff members in regulatory organizations with varying experience levels, has been organized in Europe on an annual basis from 1995 to 2001 in the framework of the Department of Technical Co-operation. A textbook has also been developed and used for this training course
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Training the staff of the regulatory body for nuclear facilities: A competency framework
International Nuclear Information System (INIS)
2002-11-01
only a small staff are examples of training programmes, and their development, for individual staff members. Maintaining the qualification and competence of regulatory staff would also be addressed.To respond to the above requests and recommendations, the purpose of this technical document is to provide guidance on training and qualification based on the competency framework required for the regulatory body to perform its functions. The main aim is to support the Regulatory Bodies supervising nuclear facilities such as nuclear power plants and research reactors. To support regulatory training activities in nuclear installation safety, the IAEA has also developed two standardized training courses to provide basic knowledge needed for work in nuclear safety. A basic professional training course on nuclear safety was organized for the first time in 1999 in Saclay, France, in English. In 2000, the course was provided in Romania, in English, and in Brazil, in Spanish. In 2001, the course was organized as a six-week course in Saclay, France for the European countries and in Argonne, USA, for the Asian countries. For the course, a textbook was developed and used that included test questions to support and control learning. At the next level of specialized knowledge, a training course on regulatory control of nuclear power plants, aimed at new staff members in regulatory organizations with varying experience levels, has been organized in Europe on an annual basis from 1995 to 2001 in the framework of the Department of Technical Co-operation. A textbook has also been developed and used for this training course
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Quality assurance guidance for low-level radioactive waste disposal facility: Final report
International Nuclear Information System (INIS)
Pittiglio, C.L. Jr.
1989-01-01
This document provides guidance to an applicant on meeting the quality control (QC) requirements for a low-level waste (LLW) disposal facility. The QC requirements are the basis for developing of a quality assurance (QA) program and for the guidance provided herein. The criteria are basic to any QA program. The document specifically establishes QA guidance for the design, construction, and operation of those structures, systems, components, as well as, for site characterization activities necessary to meet the performance objectives and to limit exposure to our release of radioactivity. 7 refs
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Sandia Software Guidelines, Volume 2. Documentation
Energy Technology Data Exchange (ETDEWEB)
NONE
1995-09-01
This volume is one in a series of Sandia Software Guidelines intended for use in producing quality software within Sandia National Laboratories. In consonance with the IEEE Standards for software documentation, this volume provides guidance in the selection of an adequate document set for a software project and example formats for many types of software documentation. A tutorial on life cycle documentation is also provided. Extended document thematic outlines and working examples of software documents are available on electronic media as an extension of this volume.
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PIV Logon Configuration Guidance
Energy Technology Data Exchange (ETDEWEB)
Lee, Glen Alan [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)
2016-03-04
This document details the configurations and enhancements implemented to support the usage of federal Personal Identity Verification (PIV) Card for logon on unclassified networks. The guidance is a reference implementation of the configurations and enhancements deployed at the Los Alamos National Laboratory (LANL) by Network and Infrastructure Engineering – Core Services (NIE-CS).
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Energy Technology Data Exchange (ETDEWEB)
Parziale, A.A.; Sacks, I.J.
1980-12-01
We compared the Structured Assessment Approach's (SAA) Licensee Submittal Document (LSD) with the Fixed Site Physical Protection Upgrade Rule Guidance Compendium Standard Format and Content (SFC) Guide using correlation matrices to see how well the data requirements of the SFC Guide coincided with those of a specific automated vulnerability assessment technique for fixed-site nuclear fuel cycle facilities, namely, SAA. We found that a limited SAA assessment is possible using the SFC Guide, but significant and critical safeguards vulnerabilities might be missed. Also, it was found that in some cases the organization and format of the SFC Guide input data and information made the preparation of data for the SAA somewhat awkward. 2 refs., 2 tabs.
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International Nuclear Information System (INIS)
1996-05-01
This report documents the Nuclear Regulatory Commission (NRC) staff review of public comments provided in response to the NRC's proposed amendments to 10 Code of Federal Regulations (CFR) Part 51, which establish new requirements for the environmental review of applications for the renewal of operating licenses of nuclear power plants. The public comments include those submitted in writing, as well as those provided at public meetings that were held with other Federal agencies, State agencies, nuclear industry representatives, public interest groups, and the general public. This report also contains the NRC staff response to the various concerns raised, and highlights the changes made to the final rule and the supporting documents in response to these concerns
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2013-08-22
... guidance document consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance...] Guidance for Industry on Compliance With Regulations Restricting the Sale and Distribution of Cigarettes... Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' This guidance is...
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Academic staff recruitment and retention challenges at the University ...
African Journals Online (AJOL)
Academic staff recruitment and retention challenges at the University of Botswana medical school. ... To document the medical school's staff recruitment and retention trends and challenges, and to propose ... AJOL African Journals Online.
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International Nuclear Information System (INIS)
Stephansson, O.; Andersson, Johan
2005-02-01
The objective of this Guidance Document is to provide advice on how to incorporate thermo-hydro-mechanical (THM) coupled processes into Performance Assessments (PAS) and design studies for radioactive waste disposal in geological formations to be experienced in a European context. The document has been generated by the EU research project BENCHPAR: Benchmark Tests and Guidance on Coupled Processes for Performance Assessment of Nuclear Waste Repositories. The document starts in Section 1 with an explanation of why numerical analyses incorporating THM mechanisms are required for radioactive waste studies and provides background material on the subject. Then, the THM processes and their interactions are explained in Section 2. Three case examples of THM numerical analysis are presented in Section 3 to illustrate the type of work that can be conducted to study the near-field, upscaling, and the far-field. For the three cases, there is discussion on the main findings, the relevance to a safety case, the relative importance of the different couplings, and the uncertainties involved. The importance and priority of the THM couplings are then summarized in Section 4. It is especially important to be able to technically audit the numerical analyses in order to establish that all the relevant variables, parameters and mechanisms have been included in the modelling and hence that the numerical model adequately represents the rock and engineering reality. Accordingly, recommended soft and hard auditing procedures are presented in Section 5. In this Guidance Document, we emphasize especially that the most important step in numerical modelling is not executing the calculations per se, but the earlier conceptualization of the problem regarding the dominant processes, the material properties and parameters, the engineering perturbations, and their mathematical presentations. The associated modelling component of addressing the uncertainties and estimating their influence on the
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Long-Term Stewardship Baseline Report and Transition Guidance
Energy Technology Data Exchange (ETDEWEB)
Kristofferson, Keith
2001-11-01
Long-term stewardship consists of those actions necessary to maintain and demonstrate continued protection of human health and the environment after facility cleanup is complete. As the Department of Energy’s (DOE) lead laboratory for environmental management programs, the Idaho National Engineering and Environmental Laboratory (INEEL) administers DOE’s long-term stewardship science and technology efforts. The INEEL provides DOE with technical, and scientific expertise needed to oversee its long-term environmental management obligations complexwide. Long-term stewardship is administered and overseen by the Environmental Management Office of Science and Technology. The INEEL Long-Term Stewardship Program is currently developing the management structures and plans to complete INEEL-specific, long-term stewardship obligations. This guidance document (1) assists in ensuring that the program leads transition planning for the INEEL with respect to facility and site areas and (2) describes the classes and types of criteria and data required to initiate transition for areas and sites where the facility mission has ended and cleanup is complete. Additionally, this document summarizes current information on INEEL facilities, structures, and release sites likely to enter long-term stewardship at the completion of DOE’s cleanup mission. This document is not intended to function as a discrete checklist or local procedure to determine readiness to transition. It is an overarching document meant as guidance in implementing specific transition procedures. Several documents formed the foundation upon which this guidance was developed. Principal among these documents was the Long-Term Stewardship Draft Technical Baseline; A Report to Congress on Long-Term Stewardship, Volumes I and II; Infrastructure Long-Range Plan; Comprehensive Facility Land Use Plan; INEEL End-State Plan; and INEEL Institutional Plan.
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HUMAN FACTORS GUIDANCE FOR CONTROL ROOM EVALUATION
International Nuclear Information System (INIS)
OHARA, J.; BROWN, W.; STUBLER, W.; HIGGINS, J.; WACHTEL, J.; PERSENSKY, J.J.
2000-01-01
The Human-System Interface Design Review Guideline (NUREG-0700, Revision 1) was developed by the US Nuclear Regulatory Commission (NRC) to provide human factors guidance as a basis for the review of advanced human-system interface technologies. The guidance consists of three components: design review procedures, human factors engineering guidelines, and a software application to provide design review support called the ''Design Review Guideline.'' Since it was published in June 1996, Rev. 1 to NUREG-0700 has been used successfully by NRC staff, contractors and nuclear industry organizations, as well as by interested organizations outside the nuclear industry. The NRC has committed to the periodic update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool in the face of emerging and rapidly changing technology. This paper addresses the current research to update of NUREG-0700 based on the substantial work that has taken place since the publication of Revision 1
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International Nuclear Information System (INIS)
PLACE, B.G.
1999-01-01
This document provides guidance to generator groups for preparing and maintaining documentation of Pollution Prevention/Waste Minimization (P2/WMin) Program activities. The guidance is one of a hierarchical series that includes the Hanford Site Waste Minimization and Pollution Prevention Awareness Program Plan (DOE-RL, 1998a) and Prime Contractor implementation plans describing programs required by Resource Conservation and Recovery Act of 1976 (RCRA) 3002(b) and (300501) (RCRA and EPA, 1994). Documentation guidance for the following five P2/WMin elements are discussed: Fiscal Year (FY) Goals; Budget and Staffing; Waste Minimization (WMinn ) Assessments (WMAs); Pollution Prevention (P2) Reporting; WMin Certification
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2013-02-26
... components, including Source Plasma. The guidance announced in this notice replaces the draft guidance... before it begins work on the final version of the guidance, submit either electronic or written comments... the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit...
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Safety of magnetic fusion facilities: Guidance
International Nuclear Information System (INIS)
1996-05-01
This document provides guidance for the implementation of the requirements identified in DOE-STD-6002-96, Safety of Magnetic Fusion Facilities: Requirements. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While the requirements in DOE-STD-6002-96 are generally applicable to a wide range of fusion facilities, this Standard, DOE-STD-6003-96, is concerned mainly with the implementation of those requirements in large facilities such as the International Thermonuclear Experimental Reactor (ITER). Using a risk-based prioritization, the concepts presented here may also be applied to other magnetic fusion facilities. This Standard is oriented toward regulation in the Department of Energy (DOE) environment as opposed to regulation by other regulatory agencies. As the need for guidance involving other types of fusion facilities or other regulatory environments emerges, additional guidance volumes should be prepared. The concepts, processes, and recommendations set forth here are for guidance only. They will contribute to safety at magnetic fusion facilities
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The Staff Association and its history
Staff Association
2015-01-01
The Staff Association will celebrate its 60th birthday in the spring of 2015. We are collecting all information about the sixty years of the Staff Association. In particular, we are looking at publications of the Staff Association, which started with the “Staff Association Journal”, in 1955, which later became “Le Proton déchainé”, then, more simply, “Proton” in 1982 (the figure on the left shows the different mutations of our magazine). In our collection we are missing a few issues, in particular № 1 (dated mid-1955). Dear reader, if have any old issues of this magazine, or of Graviton (figure on the right), another magazine edited by the Staff Association, or any other material or information that might help us document the history of the Staff Association, we would very much like to have a copy of the material or your contribution (written or oral). Please contact the Staff Association Sec...
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2011-02-18
... final version of the guidance, submit either electronic or written comments on the draft guidance by... electronic access to the guidance document. Submit electronic comments on the draft guidance to http://www... body tissue or fluid (e.g., blood, plasma, cerebrospinal fluid). Drug response results from the...
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International Nuclear Information System (INIS)
Decker, K.; Hirata, K.; Groudev, P.
2016-01-01
The current report provides guidance for the assessment of seismo-tectonic hazards in level 1 and 2 PSA. The objective is to review existing guidance, identify methodological challenges, and to propose novel guidance on key issues. Guidance for the assessment of vibratory ground motion and fault capability comprises the following: - listings of data required for the hazard assessment and methods to estimate data quality and completeness; - in-depth discussion of key input parameters required for hazard models; - discussions on commonly applied hazard assessment methodologies; - references to recent advances of science and technology. Guidance on the assessment of correlated or coincident hazards comprises of chapters on: - screening of correlated hazards; - assessment of correlated hazards (natural and man-made); - assessment of coincident hazards. (authors)
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Quality assurance application in the documentation of nuclear research reactor
International Nuclear Information System (INIS)
Nababan, N.
1999-01-01
For each nuclear research reactor a document control system should be established and should be provide for preparation, review, approval, issuance, distribution, revision and validation (where appropriate) of documents essential to the management, performance and verification of work. In the document control system the responsibilities for each participating organization or individual should be defined in writing. The types of document include, but are not limited to document comprising the QA program, safety requirements, maintenance and operating procedures, inspection instructions, inspection and test reports, assessment reports, drawings, data files, calculations, specifications, computer codes, purchase orders and related documents, vendor supplied documents and work instruction. Management should identify the need for documents and should provide guidance to the organizations and people preparing them. The guidance should cover the status, scope and contents and the policies, standards and codes witch apply. It should also explain the need for feedback of experience. Plant modification or the results of assessments could also give rise to the need for a new document
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Staff/population ratios in South African public sector mental health ...
African Journals Online (AJOL)
To document existing staff/population ratios per 100 000 population in South African public sector mental health services. Design. Cross-sectional survey. ... The staff/population ratios per 100 000 population for selected personnel categories (with the interprovincial ranges in brackets) were as follows: total nursing staff 15.6 ...
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Quality assurance guidance for a low-level radioactive waste disposal facility
International Nuclear Information System (INIS)
Pittiglio, C.L. Jr.; Hedges, D.
1991-04-01
This document provides guidance to an applicant on meeting the quality control (QC) requirements of 10 CFR 61.12(j) for a low-level radioactive waste (LLRW) disposal facility. The QC requirements, plus audits and managerial controls requirements, establish the need for developing a quality assurance (QA) program and the guidance provided herein. The criteria developed for this document are similar to the criteria developed for Appendix B to Title 10 of the Code of Federal Regulations (10 CFR) Part 50. Although Appendix B is not a regulatory requirement for an LLRW disposal facility, the criteria that were developed for 10 CFR Part 50 are basic to any QA program. This document establishes QA guidance for the design, construction, and operation of those structures, engineered or natural systems, and components whose function is required to meet the performance objectives of Subpart C of 10 CFR Part 61 and to limit exposure to or release of radioactivity. 7 refs
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Planning guidance for the Chemical Stockpile Emergency Preparedness Program
Energy Technology Data Exchange (ETDEWEB)
Shumpert, B.L.; Watson, A.P.; Sorensen, J.H. [and others
1995-02-01
This planning guide was developed under the direction of the U.S. Army and the Federal Emergency Management Agency (FEMA) which jointly coordinate and direct the development of the Chemical Stockpile Emergency Preparedness Program (CSEPP). It was produced to assist state, local, and Army installation planners in formulating and coordinating plans for chemical events that may occur at the chemical agent stockpile storage locations in the continental United States. This document provides broad planning guidance for use by both on-post and off-post agencies and organizations in the development of a coordinated plan for responding to chemical events. It contains checklists to assist in assuring that all important aspects are included in the plans and procedures developed at each Chemical Stockpile Disposal Program (CSDP) location. The checklists are supplemented by planning guidelines in the appendices which provide more detailed guidance regarding some issues. The planning guidance contained in this document will help ensure that adequate coordination between on-post and off-post planners occurs during the planning process. This planning guide broadly describes an adequate emergency planning base that assures that critical planning decisions will be made consistently at every chemical agent stockpile location. This planning guide includes material drawn from other documents developed by the FEMA, the Army, and other federal agencies with emergency preparedness program responsibilities. Some of this material has been developed specifically to meet the unique requirements of the CSEPP. In addition to this guidance, other location-specific documents, technical studies, and support studies should be used as needed to assist in the planning at each of the chemical agent stockpile locations to address the specific hazards and conditions at each location.
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2011-12-19
... performance of medical devices in women. This information can be of benefit to patients and their medical... draft guidance before it begins work on the final version of the guidance, submit either electronic or...
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Smallwood, Robert F
2012-01-01
Practical, step-by-step guidance for corporations, universities and government agencies to protect and secure confidential documents and business records Managers and public officials are looking for technology and information governance solutions to "information leakage" in an understandable, concise format. Safeguarding Critical E-Documents provides a road map for corporations, governments, financial services firms, hospitals, law firms, universities and other organizations to safeguard their internal electronic documents and private communications.Provides practical, step-by-step guidance o
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International Nuclear Information System (INIS)
1994-05-01
This document introduces QA guidance pertaining to design and implementation of laboratory procedures and processes for collecting DOE Environmental Restoration and Waste Management (EM) ESAA (environmental sampling and analysis activities) data. It addresses several goals: identifying key laboratory issues and program elements to EM HQ and field office managers; providing non-prescriptive guidance; and introducing environmental data collection program elements for EM-263 assessment documents and programs. The guidance describes the implementation of laboratory QA elements within a functional QA program (development of the QA program and data quality objectives are not covered here)
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Energy Technology Data Exchange (ETDEWEB)
April M. Whaley; Dana L. Kelly; Ronald L. Boring; William J. Galyean
2012-06-01
Step-by-step guidance was developed recently at Idaho National Laboratory for the US Nuclear Regulatory Commission on the use of the Standardized Plant Analysis Risk-Human Reliability Analysis (SPAR-H) method for quantifying Human Failure Events (HFEs). This work was done to address SPAR-H user needs, specifically requests for additional guidance on the proper application of various aspects of the methodology. This paper overviews the steps of the SPAR-H analysis process and highlights some of the most important insights gained during the development of the step-by-step directions. This supplemental guidance for analysts is applicable when plant-specific information is available, and goes beyond the general guidance provided in existing SPAR-H documentation. The steps highlighted in this paper are: Step-1, Categorizing the HFE as Diagnosis and/or Action; Step-2, Rate the Performance Shaping Factors; Step-3, Calculate PSF-Modified HEP; Step-4, Accounting for Dependence, and; Step-5, Minimum Value Cutoff.
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International Nuclear Information System (INIS)
Place, B.G.
1998-01-01
This document provides guidance to generator groups for preparing and maintaining documentation of Pollution Prevention Waste Minimization (P2/WMin) Program activities. The guidance is one of a hierarchical series that includes the Hanford Site Waste Minimization and Pollution Prevention Awareness Program Plan (DOE-RL, 1998a) and Prime contractor implementation plans describing programs required by Resource Conservation and Recovery Act of 1976 (RCRA) 3002(b) and 3005(h) (RCRA and EPA, 1994). Documentation guidance for the following five P2/WMin elements are discussed: Fiscal Year (FY) Goals; Budget and Staffing; Waste Minimization (WMin) Assessments (WMAs); Quarterly Pollution Prevention (P2) Reporting WMin Certification
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Energy Technology Data Exchange (ETDEWEB)
Schafer, S.; Nithiananthan, S.; Mirota, D. J.; Uneri, A.; Stayman, J. W.; Zbijewski, W.; Schmidgunst, C.; Kleinszig, G.; Khanna, A. J.; Siewerdsen, J. H. [Department of Biomedical Engineering, Johns Hopkins University, Baltimore, Maryland 21202 (United States); Department of Computer Science, Johns Hopkins University, Baltimore, Maryland 21218 (United States); Department of Biomedical Engineering, Johns Hopkins University, Baltimore, Maryland 21202 (United States); Siemens Healthcare XP Division, Erlangen (Germany); Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, Maryland 21239 (United States); Department of Biomedical Engineering, Johns Hopkins University, Baltimore, Maryland 21202 and Department of Computer Science, Johns Hopkins University, Baltimore, Maryland 21218 (United States)
2011-08-15
, and {approx}3-4 lower at the exit side). The in-room dose (microsievert) per unit scan dose (milligray) ranged from {approx}21 {mu}Sv/mGy on average at tableside to {approx}0.1 {mu}Sv/mGy at 2.0 m distance to isocenter. All protocols involve surgical staff stepping behind a shield wall for each CBCT scan, therefore imparting {approx}zero dose to staff. Protocol implementation in preclinical cadaveric studies demonstrate integration of the C-arm with a navigation system for spine surgery guidance-specifically, minimally invasive vertebroplasty in which the system provided accurate guidance and visualization of needle placement and bone cement distribution. Cumulative dose including multiple intraoperative scans was {approx}11.5 mGy for CBCT-guided thoracic vertebroplasty and {approx}23.2 mGy for lumbar vertebroplasty, with dose to staff at tableside reduced to {approx}1 min of fluoroscopy time ({approx}40-60 {mu}Sv), compared to 5-11 min for the conventional approach. Conclusions: Intraoperative CBCT using a high-performance mobile C-arm prototype demonstrates image quality suitable to guidance of spine surgery, with task-specific protocols providing an important basis for minimizing radiation dose, while maintaining image quality sufficient for surgical guidance. Images demonstrate a significant advance in spatial resolution and soft-tissue visibility, and CBCT guidance offers the potential to reduce fluoroscopy reliance, reducing cumulative dose to patient and staff. Integration with a surgical guidance system demonstrates precise tracking and visualization in up-to-date images (alleviating reliance on preoperative images only), including detection of errors or suboptimal surgical outcomes in the operating room.
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Guidance for emergency planning in nuclear power plants
International Nuclear Information System (INIS)
Magnusson, Tommy; Ekdahl, Maria
2008-06-01
Ringhals has been a model for this study, but the purpose has been to make the report applicable at all nuclear power plants in Sweden. The work has been done in close co-operation with the Swedish nuclear power plants and Rescue Services in the nuclear power municipalities Oesthammar, Oskarshamn, and Varberg. The internal fire brigade at the nuclear power plants has also been involved. A document will also be published as a further guidance at efforts of the type fires, which are mentioned in the enclosed document. After a fire in a switchgear room in 2005 the need of making the existing effort planning more effective at nuclear power plants was observed. The idea with the planning is to plan the effort in order to give the operational and emergency staff a good and actual support to come to a decision and to start the mission without delay. The risk information is showed by planning layouts, symbols and drawings as basis, give risk information and effort information. The effort information shows outer arrangements, manual action points, fire installations, passive fire safety etc. The risk information is shown by risk symbols. Their purpose is to give a fast overview of the existing risks. Reactor safety effects is the ruling influence if an effort has to be done in order to secure safety for a third person. In order to make an effort in an area personal risks for rescue staff, such as electricity risks, radiological risks, chemicals and gas bottles with compressed gases, has to be eliminated. For complicated missions detailed instructions are needed in order to handle specific risks. In a group discussion different people with pertinent knowledge has to value which problematic efforts need detailed instruction. Missions that have to be analyzed in a work group as above are: fire may affect the reactor safety, fire that may threaten the structural integrity, chemical discharge with big consequence on environment/third person and handling of gas system (compressed
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Asset Management Plans, Appraisal Guidance for 2003-04.
Department for Education and Skills, London (England).
This document is one in a series which aims to assist Local Authorities in Britain with asset management planning (AMPs) for schools. AMPs set out the information needed, and the criteria used, to make decisions about spending on school premises. The document provides guidance on the appraisal of school AMPs in 2002 to inform 3-year formulaic…
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Denford, Sarah; Abraham, Charles; Callaghan, Margaret; Aighton, Peter; De Vocht, Frank; Arris, Steven
2017-09-12
Public Health evaluation is essential to understanding what does and does not work, and robust demonstration of effectiveness may be crucial to securing future funding. Despite this, programs are often implemented with poor, incomplete or no evaluation. Public health practitioners are frequently required to provide evidence for the effectiveness of their services; thus, there is a growing need for evaluation guidance on how to evaluate public health programs. The aim of this study is to identify accessible high-quality, evaluation guidance, available to researchers and practitioners and to catalogue, summarise and categorise the content of a subset of accessible, quality guides to evaluation. We systematically reviewed grey and academic literature for documents providing support for evaluation of complex health interventions. Searches were conducted January to March 2015, and included academic databases, internet search engines, and consultations with academic and practicing public health experts. Data were extracted by two authors and sent to the authors of the guidance documents for comments. Our initial search identified 402 unique documents that were screened to identify those that were (1) developed by or for a national or international organization (2) freely available to all (3) published during or after 2000 (4) specific to public health. This yielded 98 documents from 43 organisations. Of these, 48 were reviewed in detail. This generated a detailed catalogue of quality evaluation guidance. The content included in documents covers 37 facets of evaluation. A wide range of guidance on evaluation of public health initiatives is available. Time and knowledge constraints may mean that busy practitioners find it challenging to access the most, up-to-date, relevant and useful guidance. This review presents links to and reviews of 48 quality guides to evaluation as well as categorising their content. This facilitates quick and each access to multiple selected
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Guidance Manual for Conducting Screening Level Ecological Risk Assessments at the INEL
Energy Technology Data Exchange (ETDEWEB)
R. L. VanHorn; N. L. Hampton; R. C. Morris
1995-06-01
This document presents reference material for conducting screening level ecological risk assessments (SLERAs)for the waste area groups (WAGs) at the Idaho National Engineering Laboratory. Included in this document are discussions of the objectives of and processes for conducting SLERAs. The Environmental Protection Agency ecological risk assessment framework is closely followed. Guidance for site characterization, stressor characterization, ecological effects, pathways of contaminant migration, the conceptual site model, assessment endpoints, measurement endpoints, analysis guidance, and risk characterization are included.
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78 FR 39284 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis
2013-07-01
... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2013-0320; FRL-9830-1] Technical Guidance for Assessing Environmental Justice in Regulatory Analysis AGENCY: Environmental Protection Agency (EPA). ACTION: Notice... Environmental Protection Agency (EPA) issued for public comment a document entitled, ``Technical Guidance for...
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Hanford Site Guide for Preparing and Maintaining Generator Group Pollution Prevention Documentation
International Nuclear Information System (INIS)
PLACE, B.G.
2000-01-01
This document provides guidance to generator groups for preparing and maintaining documentation of Pollution Prevention/Waste Minimization (P2/WMin) Program activities. The guidance is one of a hierarchical series that includes the Hanford Site Waste Minimization and Pollution Prevention Awareness Program Plan (DOE-RL, 2000) and Prime Contractor implementation plans describing programs required by Resource Conservation and Recovery Act of 1976 (RCRA) 3002(b) and 3005(h) (RCRA and EPA, 1994) and Department of Energy Acquisition Regulations (DEAR) (48 CFR 970.5204-2 and 48 CFR 970.5204-78). Documentation guidance for the following five P2/WMin elements is discussed: Fiscal Year (FY) Goals; Budget and Staffing; Pollution Prevention (P2) Reporting; WMin Certification; and Waste Minimization (WMin) Assessments (WMAs)
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Environmental guidance regulatory bulletin
International Nuclear Information System (INIS)
1997-01-01
This document describes the background on expanding public participation in the Resource Conservation and Recovery Act and DOE's response. The bulletin also describes the changes made by the final rule to existing regulations, guidance provided by EPA in the preamble and in the revised RCRA Public Participation Manual, the relationship between public participation and environmental justice, and DOE's recent public participation and environmental justice initiatives
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Directory of Open Access Journals (Sweden)
Melanie Calvert
Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in
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Data Management-Supplement to Section 106 Tribal Guidance
The document supplements the Tribal 106 Guidance by providing useful suggestions and tips to tribes about how to establish a data management system that reflects tribal water quality goals and objectives.
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ADM guidance-Ceramics: all-ceramic multilayer interfaces in dentistry.
Lohbauer, Ulrich; Scherrer, Susanne S; Della Bona, Alvaro; Tholey, Michael; van Noort, Richard; Vichi, Alessandro; Kelly, J Robert; Cesar, Paulo F
2017-06-01
This guidance document describes the specific issues involved in dental multilayer ceramic systems. The material interactions with regard to specific thermal and mechanical properties are reviewed and the characteristics of dental tooth-shaped processing parameters (sintering, geometry, thickness ratio, etc.) are discussed. Several techniques for the measurement of bond quality and residual stresses are presented with a detailed discussion of advantages and disadvantages. In essence no single technique is able to describe adequately the all-ceramic interface. Invasive or semi-invasive methods have been shown to distort the information regarding the residual stress state while non-invasive methods are limited due to resolution, field of focus or working depth. This guidance document has endeavored to provide a scientific basis for future research aimed at characterizing the ceramic interface of dental restorations. Along with the methodological discussion it is seeking to provide an introduction and guidance to relatively inexperienced researchers. Copyright © 2017 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.
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Security in the transport of radioactive material - interim guidance for comment
International Nuclear Information System (INIS)
Legoux, P.; Wangler, M.
2004-01-01
While the IAEA has provided specific guidance for physical protection in the transport of nuclear material, its previous publications have only provided some general guidelines for security of non-nuclear radioactive material in transport. Some basic practical advice has been provided in the requirements of the International Basic Safety Standards for Protection against Ionising Radiation and for the Safety of Radiation Sources (BSS) [1]. These guidelines were primarily directed toward such issues as unintentional exposure to radiation, negligence and inadvertent loss. Recently, the IAEA published a document on the security of sources, which included some general guidance on providing security during transport of the sources. However, it is clear that more guidance is needed for security during the transport of radioactive material in addition to those already existing for nuclear material. Member States have requested guidance on the type and nature of security measures that might be put in place for radioactive material in general during its transport and on the methodology to be used in choosing and implementing such measures. The purpose of the TECDOC on Security in the Transport of Radioactive Material being developed by the IAEA is to provide an initial response to that request. This interim guidance is being developed with a view to harmonizing the security guidance - as much as possible - with existing guidance from the IAEA for the transport of radioactive sources and nuclear material. It is also intended to harmonize with model requirements developed in 2002-2003 by the United Nations Economic and Social Council's Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonised System of Classification and Labelling of Chemicals which was issued as general security guidelines for all dangerous goods, including radioactive material, and that will shortly be implemented as binding regulations by the international modal authorities
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Security in the transport of radioactive material - interim guidance for comment
Energy Technology Data Exchange (ETDEWEB)
Legoux, P.; Wangler, M. [International Atomic Energy Agency, Vienna (Austria)
2004-07-01
While the IAEA has provided specific guidance for physical protection in the transport of nuclear material, its previous publications have only provided some general guidelines for security of non-nuclear radioactive material in transport. Some basic practical advice has been provided in the requirements of the International Basic Safety Standards for Protection against Ionising Radiation and for the Safety of Radiation Sources (BSS) [1]. These guidelines were primarily directed toward such issues as unintentional exposure to radiation, negligence and inadvertent loss. Recently, the IAEA published a document on the security of sources, which included some general guidance on providing security during transport of the sources. However, it is clear that more guidance is needed for security during the transport of radioactive material in addition to those already existing for nuclear material. Member States have requested guidance on the type and nature of security measures that might be put in place for radioactive material in general during its transport and on the methodology to be used in choosing and implementing such measures. The purpose of the TECDOC on Security in the Transport of Radioactive Material being developed by the IAEA is to provide an initial response to that request. This interim guidance is being developed with a view to harmonizing the security guidance - as much as possible - with existing guidance from the IAEA for the transport of radioactive sources and nuclear material. It is also intended to harmonize with model requirements developed in 2002-2003 by the United Nations Economic and Social Council's Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonised System of Classification and Labelling of Chemicals which was issued as general security guidelines for all dangerous goods, including radioactive material, and that will shortly be implemented as binding regulations by the international modal
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2011-05-02
..., you may submit written requests for single copies of the draft guidance to the Office of Communication... critical to ensuring a reusable device is appropriately prepared for its next use. II. Significance of.... 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on...
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Regulatory Guidance for Lightning Protection in Nuclear Power Plants
International Nuclear Information System (INIS)
Kisner, Roger A.; Wilgen, John B.; Ewing, Paul D.; Korsah, Kofi; Antonescu, Christina E.
2006-01-01
Oak Ridge National Laboratory (ORNL) was engaged by the U.S. Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) to develop the technical basis for regulatory guidance to address design and implementation practices for lightning protection systems in nuclear power plants (NPPs). Lightning protection is becoming increasingly important with the advent of digital and low-voltage analog systems in NPPs. These systems have the potential to be more vulnerable than older analog systems to the resulting power surges and electromagnetic interference (EMI) when lightning strikes facilities or power lines. This paper discusses the technical basis for guidance to licensees and applicants covered in Regulatory Guide (RG) 1.204, Guidelines for Lightning Protection of Nuclear Power Plants, issued August 2005. RG 1.204 describes guidance for practices that are acceptable to the NRC staff for protecting nuclear power structures and systems from direct lightning strikes and the resulting secondary effects.
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2011-02-16
...] Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability AGENCY: Food and... Therapy Products'' dated January 2011. The guidance document provides manufacturers of cellular and gene... for Industry: Potency Tests for Cellular and Gene Therapy Products'' dated January 2011. The guidance...
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Wong, Newton A C S; Amary, Fernanda; Butler, Rachel; Byers, Richard; Gonzalez, David; Haynes, Harry R; Ilyas, Mohammad; Salto-Tellez, Manuel; Taniere, Philippe
2018-05-01
The use of biologics targeted to the human epidermal growth factor receptor 2 (HER2) protein is the latest addition to the armamentarium used to fight advanced gastric or gastro-oesophageal junction adenocarcinoma. The decision to treat with the biologic trastuzumab is completely dependent on HER2 testing of tumour tissue. In 2017, the College of American Pathologists, American Society for Clinical Pathology and the American Society of Clinical Oncology jointly published guidelines for HER2 testing and clinical decision making in gastro-oesophageal adenocarcinoma. The Association of Clinical Pathologists Molecular Pathology and Diagnostics Committee has issued the following document as a commentary of these guidelines and, in parallel, to provide guidance on HER2 testing in National Health Service pathology departments within the UK. This guidance covers issues related to case selection, preanalytical aspects, analysis and interpretation of such HER2 testing. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Supporting staff in employment: the emotional wellbeing of staff in an NHS psychiatric hospital.
Patterson, I D; Bell, J S
2000-09-01
The objective of this study was to assess the emotional wellbeing of a broad sample of NHS employees in a psychiatric setting; to seek their views on sources of distress; and to identify preferred ways of dealing with it. A cross-sectional postal survey, employing two questionnaires: GHQ-28, and a semi-structured questionnaire. These were sent to a nominal 50% sample (n = 599). The population was the staff of a large Scottish psychiatric service. A 47.9% response rate was achieved; 32.9% of respondents exceeded a cut-off score of four on the GHQ-28. Neither occupational, group nor gender effects were significant on this measure. The reporting of emotionally-distressing problems affecting their performance was found to be more common amongst doctors; males, overall, showed a non-significant trend towards having been affected more than females by such problems; and older staff (above 45) were affected significantly more often than younger staff. Almost a third of staff were unaware of the availability of an internal organisational resource (the Occupational Health service). NHS Trusts should ensure the culture at work is appropriate from a preventative point of view and be aware that factors outwith the workplace can affect employees emotional wellbeing and performance. Preventative and supportive measures to minimise psychological distress in the workforce should be considered; the Scottish Needs Assessment Programme: Mental Health in the Workplace offers useful guidance.
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2011-02-03
... this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), to reduce the time to... Development and Submission.'' The purpose of this document is to provide sponsors guidance in preparation of...
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[International trend of guidance for nanomaterial risk assessment].
Hirose, Akihiko
2013-01-01
In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.
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2012-02-08
... DEPARTMENT OF VETERANS AFFAIRS Meeting the Challenge of Pandemic Influenza: Ethical Guidance for... guidance document entitled ``Meeting the Challenge of Pandemic Influenza: Ethical Guidance for Leaders and... should indicate that they are submitted in response to ``Meeting the Challenge of Pandemic Influenza...
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Request for Guidance on PSD Applicability Determinations for Boiler Emissions
This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.
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DEFF Research Database (Denmark)
Tetens, Inge
2011-01-01
The Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked by the European Food Safety Authority (EFSA) t to draft guidance on scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. This guidance has been drawn from scientific...... opinions of the NDA Panel on such health claims. Thus, this guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in these areas. It is not intended that the document should include an exhaustive list of beneficial effects...
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2013-12-27
... chapter granting FDA authority to regulate the manufacture, marketing, and distribution of tobacco... related to substantial equivalence. In a Level 1 guidance document issued under the Good Guidances Practices regulation (21 CFR 10.115), FDA provides recommendations intended to assist persons submitting...
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Guidance for nuclear medicine staff on radiopharmaceuticals drug interaction
Directory of Open Access Journals (Sweden)
Ralph Santos-Oliveira
2009-12-01
Full Text Available Numerous drug interactions related to radiopharmaceuticals take place every day in hospitals many of which are not reported or detected. Information concerning this kind of reaction is not abundant, and nuclear medicine staff are usually overwhelmed by this information. To better understand this type of reaction, and to help nuclear medicine staff deal with it, a review of the literature was conducted. The results show that almost all of radiopharmaceuticals marketed around the world present drug interactions with a large variety of compounds. This suggests that a logical framework to make decisions based on reviews incorporating adverse reactions must be created. The review also showed that researchers undertaking a review of literature, or even a systematic review that incorporates drug interactions, must understand the rationale for the suggested methods and be able to implement them in their review. Additionally, a global effort should be made to report as many cases of drug interaction with radiopharmaceuticals as possible. With this, a complete picture of drug interactions with radiopharmaceuticals can be drawn.Diversos casos de interações medicamentosas com radiofármacos ocorrem diariamente na rotina hospitalar, contudo muitos deles não são notificados ou mesmo percebidos. Informações a respeito desse tipo de reação não é abundante e os profissionais da medicina nuclear muitas vezes estão assoberbados por essas informações. De modo a entender esse tipo de reação e auxiliar a medicina nuclear a lidar com essa situação uma revisão da literatura foi realizada. Os resultados mostraram que a totalidade dos radiofármacos comercializados no mundo apresentam interação medicamentosa com uma enorme variedade de outros medicamentos. Dessa forma sugere-se que revisões sobre radiofármacos inclua um capítulo sobre efeitos adversos. Além disso, um esforço mundial para notificar efeitos adversos deve ser realizado, pois somente
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2013-05-31
..., including Source Plasma, with recommendations intended to assist with determining which reporting mechanism... final version of the guidance, submit either electronic or written comments on the draft guidance by... INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the...
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21 CFR 10.115 - Good guidance practices.
2010-04-01
... understanding, or other communications directed to individual persons or firms. (c) What other terms have a... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... communication that are excluded from the definition of guidance document to informally communicate new or...
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Understanding the interface between clinical and laboratory staff
Directory of Open Access Journals (Sweden)
Ankie van den Broek
2014-07-01
Objectives: To propose a new conceptual model to gain insight and analyse factors that influence the laboratory–clinical staff interface. Methods: To develop the conceptual model, a literature study was performed, regulatory guidelines and standards for laboratories were analysed and discussions were held with experts on the topic. Result: A conceptual model and analytical framework provided good guidance in understanding and assessing the organisational and personal factors shaping the interface. The model was based on three elements: (1 the three phases of communication (pre-analytical, analytical and post-analytical; (2 the organisational and personal factors of interaction; and (3 the socio-political, economic and cultural context in which clinicians and laboratory staff operate. Conclusion: Assessment of the interface between clinicians and laboratory workers can be performed in a systematic way. Applying this model will provide information to managers of health institutions and heads of laboratories and clinical departments about what happens when clinicians and laboratory staff interact, thus aiding them in designing strategies to improve this interface.
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Zulu, Joseph M; Ali, Joseph; Hallez, Kristina; Kass, Nancy; Michelo, Charles; Hyder, Adnan A
2018-05-02
An increase in post abortion care (PAC) research with adolescents, particularly in low- and middle-income countries, has brought to attention several associated research ethics challenges. In order to better understand the ethics context of PAC research with adolescents, we conducted a scoping review of published literature. Following a systematic search of PubMed, HINARI, and Google Scholar, we analysed articles meeting inclusion criteria to determine common themes across both the ethical challenges related to PAC research with adolescents and any available guidance on the identified challenges. The literature search identified an initial 3321 records of which 14 were included in analysis following screening. Several ethical challenges stem from abortion being a controversial, sensitive, and stigmatized topic in many settings. Ethical dilemmas experienced by researchers conducting adolescent PAC research included: difficulties in convincing local health providers to permit PAC research; challenges in recruiting and seeking consent due to sensitivity of the subject; effectively protecting confidentiality; managing negative effects of interventions; creating a non-prejudicial atmosphere for research; managing emotional issues among adolescents; and dealing with uncertainty regarding the role of researchers when observing unethical health care practices. Suggested strategies for addressing some of these challenges include: using several sources to recruit study participants, using research to facilitate dialogue on abortion, briefing health workers on any observed unethical practices after data collection, fostering a comprehensive understanding of contextual norms and values, selecting staff with experience working with study populations, and avoiding collection of personal identifiers. Addressing ethical challenges that researchers face when conducting PAC research with adolescents requires guidance at the individual, institutional, community, and international
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Moisture Control Guidance for Commercial and Public Buildings (EPA 402-F-13053)
This document provides guidance to designers, construction mangers, and building operation/maintenance managers to improve IEQ and reduce risks of encountering IEQ problems due to insufficient moisture control. EPA will be producing a document entitled "Moisture Control Guida...
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Quality assurance and quality control in mammography: a review of available guidance worldwide.
Reis, Cláudia; Pascoal, Ana; Sakellaris, Taxiarchis; Koutalonis, Manthos
2013-10-01
Review available guidance for quality assurance (QA) in mammography and discuss its contribution to harmonise practices worldwide. Literature search was performed on different sources to identify guidance documents for QA in mammography available worldwide in international bodies, healthcare providers, professional/scientific associations. The guidance documents identified were reviewed and a selection was compared for type of guidance (clinical/technical), technology and proposed QA methodologies focusing on dose and image quality (IQ) performance assessment. Fourteen protocols (targeted at conventional and digital mammography) were reviewed. All included recommendations for testing acquisition, processing and display systems associated with mammographic equipment. All guidance reviewed highlighted the importance of dose assessment and testing the Automatic Exposure Control (AEC) system. Recommended tests for assessment of IQ showed variations in the proposed methodologies. Recommended testing focused on assessment of low-contrast detection, spatial resolution and noise. QC of image display is recommended following the American Association of Physicists in Medicine guidelines. The existing QA guidance for mammography is derived from key documents (American College of Radiology and European Union guidelines) and proposes similar tests despite the variations in detail and methodologies. Studies reported on QA data should provide detail on experimental technique to allow robust data comparison. Countries aiming to implement a mammography/QA program may select/prioritise the tests depending on available technology and resources. •An effective QA program should be practical to implement in a clinical setting. •QA should address the various stages of the imaging chain: acquisition, processing and display. •AEC system QC testing is simple to implement and provides information on equipment performance.
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Williford, Anne; Depaolis, Kathryn J.
2016-01-01
Cyberbullying behavior among youth has become a growing concern among parents, educators, and policymakers due to emerging evidence documenting its harmful consequences on youths' development. As such, schools are increasingly required to address to this form of bullying. Thus, effective responses by school staff are needed. However, no study to…
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75 FR 62820 - Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA
2010-10-13
... Providers of Synthetic Double- Stranded DNA AGENCY: Department of Health and Human Services, Office of the.... Government has developed Guidance that provides a framework for screening synthetic double-stranded DNA (dsDNA). This document, the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA...
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Interim Consequence Management Guidance for a Wide-Area Biological Attack
Energy Technology Data Exchange (ETDEWEB)
Raber, Ellen [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Kirvel, Robert [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); MacQueen, Don [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Love, Adam [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Dombroski, Matthew [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); McGrann, Thomas [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Richards, John [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Melius, Carl [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Bunt, Thomas [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Hibbard, Wilthea [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Greenwalt, Robert [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Miles, Robin [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Dillon, Michael [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Mancieri, Sav [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Harris, Steve [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Michalik, Richard [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Wheeler, Richard [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Hoppes, Bill [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Tucker, Mark [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Krauter, Paula [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Knowlton, Robert [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Yang, Lynn [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Franco, Dave [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Einfeld, Wayne [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Brockman, John [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Betty, Rita [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)
2011-05-17
The Interagency Biological Restoration Demonstration (IBRD) program is a collaborative, interagency effort co-chaired by the Department of Homeland Security and Department of Defense aimed at improving the nation‘s ability to respond to and recover from a large-scale, wide-area, domestic attack involving the release of an environmentally persistent biological warfare agent. The program is focused on understanding interactions between the civilian and military sectors, and in building mutual support to carry out such remediations. This Interim Consequence Management Guidance document provides guidance for decisionmakers in executing activities required to respond to and recover from a biological incident affecting a wide urban area insofar as information is currently available. The spore-forming bacterium Bacillus anthracis is discussed as the biological agent of primary concern because it is the most difficult of known bioterrorism agents to inactivate and is considered to be one of the key threat agents. Most other biological threat agents are much easier to remediate, and in many cases, inactivation would occur naturally within days as a result of environmental exposure; however, the framework and operational questions that need to be addressed are expected to remain the same. The guidance in this document is applicable to (1) enclosed facilities, such as commercial, residential, and continental U.S. military facilities; (2) semi-enclosed facilities, such as subways and public transit facilities; (3) outdoor areas (both localized and wide area), such as building exteriors, streets, parks, and other open spaces; (4) drinking water facilities; and (5) drinking water sources. This document follows an interagency framework [Planning Guidance for Recovery Following Biological Incidents (DHS and EPA 2009)]—which considered Raber et al. (2002) in its development—but takes the framework to a more operational level and provides guidance at key action and decision
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Directory of Open Access Journals (Sweden)
Hannah M L Young
Full Text Available Despite guidance and evidence for the beneficial effects of intradialytic exercise (IDE, such programmes are rarely adopted within practice and little is known about how they may best be sustained. The Theoretical Domains Framework (TDF was used to guide the understanding of the barriers and facilitators to initial and ongoing IDE participation and to understand how these are influential at each stage.Focus groups explored patient (n=24 and staff (n=9 perceptions of IDE prior to the introduction of a programme and, six months later, face to face semi-structured interviews captured exercising patients (n=11 and staffs' (n=8 actual experiences. Data were collected at private and NHS haemodialysis units within the UK. All data were audio-recorded, translated where necessary, transcribed verbatim and subject to framework analysis.IDE initiation can be facilitated by addressing the pre-existing beliefs about IDE through the influence of peers (for patients and training (for staff. Participation was sustained through the observation of positive outcomes and through social influences such as teamwork and collaboration. Despite this, environment and resource limitations remained the greatest barrier perceived by both groups.Novel methods of staff training and patient education should enhance engagement. Programmes that clearly highlight the benefits of IDE should be more successful in the longer term. The barrier of staff workload needs to be addressed through specific guidance that includes recommendations on staffing levels, roles, training and skill mix.
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Waste treatability guidance program. User's guide. Revision 0
International Nuclear Information System (INIS)
Toth, C.
1995-01-01
DOE sites across the country generate and manage radioactive, hazardous, mixed, and sanitary wastes. It is necessary for each site to find the technologies and associated capacities required to manage its waste. One role of DOE HQ Office of Environmental Restoration and Waste Management is to facilitate the integration of the site- specific plans into coherent national plans. DOE has developed a standard methodology for defining and categorizing waste streams into treatability groups based on characteristic parameters that influence waste management technology needs. This Waste Treatability Guidance Program automates the Guidance Document for the categorization of waste information into treatability groups; this application provides a consistent implementation of the methodology across the National TRU Program. This User's Guide provides instructions on how to use the program, including installations instructions and program operation. This document satisfies the requirements of the Software Quality Assurance Plan
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Individual plant examination: Submittal guidance
International Nuclear Information System (INIS)
1989-08-01
Based on a Policy Statement on Severe Accidents Regarding Future Designs and Existing Plants, the performance of a plant examination is requested from the licensee of each nuclear power plant. The plant examination looks for vulnerabilities to severe accidents and cost-effective safety improvements that reduce or eliminate the important vulnerabilities. This document delineates guidance for reporting the results of that plant examination. 38 refs., 2 tabs
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Variable & Recode Definitions - SEER Documentation
Resources that define variables and provide documentation for reporting using SEER and related datasets. Choose from SEER coding and staging manuals plus instructions for recoding behavior, site, stage, cause of death, insurance, and several additional topics. Also guidance on months survived, calculating Hispanic mortality, and site-specific surgery.
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International Nuclear Information System (INIS)
Washington TRU Solutions, LLC
2003-01-01
The purpose of this program guidance document is to provide technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the SARP and/or C of C shall govern. The C of C states: ''...each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, ''Operating Procedures,'' of the application.'' It further states: ''...each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, ''Acceptance Tests and Maintenance Program of the Application.'' Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M and O) contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC approved, users need to be familiar with 10 CFR (section) 71.11, ''Deliberate Misconduct.'' Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. CBFO will evaluate the issue and notify the NRC if required. This document details the instructions to be followed to operate, maintain, and test the RH-TRU 72-B packaging. This Program Guidance standardizes instructions for all users. Users shall follow these instructions. Following these instructions assures that operations are safe and meet the requirements of the SARP. This document is available on the Internet at: ttp://www.ws/library/t2omi/t2omi.htm. Users are responsible for ensuring they are using the current revision and change notices. Sites may prepare their own document using the word
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2013-07-15
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0322... of good manufacturing practices. It also describes FDA's intended sampling and enforcement approach... the guidance, submit either electronic or written comments on the draft guidance by September 13, 2013...
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Improving nurse documentation and record keeping in stoma care.
Law, Lesley; Akroyd, Karen; Burke, Linda
Evidence suggests that nurse documentation is often inconsistent and lacks a coherent and standardized approach. This article reports on research into the use of nurse documentation on a stoma care ward in a large London hospital, and explores the factors that may affect the process of record keeping by nursing staff. This study uses stoma care as a case study to explore the role of documentation on the ward, focusing on how this can be improved. It is based on quantitative and qualitative methods. The medical notes of 56 patients were analysed and in addition, focus groups with a number of nurses were undertaken. Quantitative findings indicate that although 80% of patients had a chart filed in their medical notes, only a small portion of the form was completed by nursing staff. Focus group findings indicate that this is because forms lacked standardization and because the language used was often ambiguous. Staff also felt that such documentation was not viewed by other nurses and so, was not effective in improving patient care. As a result of this study, significant improvements have been made to documentation used on the stoma care ward. This is an important exploration of record keeping within nursing in the context of the Nursing and Midwifery Council's emphasis on the importance of documentation in achieving effective patient outcomes.
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International Nuclear Information System (INIS)
1992-08-01
The staff of the US Nuclear Regulatory Commission has prepared Volume 1 of a safety evaluation report (SER), ''NRC Review of Electric Power Research Institute's Advanced Light Water Reactor Utility Requirements Document -- Program Summary,'' to document the results of its review of the Electric Power Research Institute's ''Advanced Light Water Reactor Utility Requirements Document.'' This SER provides a discussion of the overall purpose and scope of the Requirements Document, the background of the staff's review, the review approach used by the staff, and a summary of the policy and technical issues raised by the staff during its review
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Samuel, Gbeminiyi O; Hoffmann, Sebastian; Wright, Robert A; Lalu, Manoj Mathew; Patlewicz, Grace; Becker, Richard A; DeGeorge, George L; Fergusson, Dean; Hartung, Thomas; Lewis, R Jeffrey; Stephens, Martin L
2016-01-01
Assessments of methodological and reporting quality are critical to adequately judging the credibility of a study's conclusions and to gauging its potential reproducibility. To aid those seeking to assess the methodological or reporting quality of studies relevant to toxicology, we conducted a scoping review of the available guidance with respect to four types of studies: in vivo and in vitro, (quantitative) structure-activity relationships ([Q]SARs), physico-chemical, and human observational studies. Our aims were to identify the available guidance in this diverse literature, briefly summarize each document, and distill the common elements of these documents for each study type. In general, we found considerable guidance for in vivo and human studies, but only one paper addressed in vitro studies exclusively. The guidance for (Q)SAR studies and physico-chemical studies was scant but authoritative. There was substantial overlap across guidance documents in the proposed criteria for both methodological and reporting quality. Some guidance documents address toxicology research directly, whereas others address preclinical research generally or clinical research and therefore may not be fully applicable to the toxicology context without some translation. Another challenge is the degree to which assessments of methodological quality in toxicology should focus on risk of bias - as in clinical medicine and healthcare - or be broadened to include other quality measures, such as confirming the identity of test substances prior to exposure. Our review is intended primarily for those in toxicology and risk assessment seeking an entry point into the extensive and diverse literature on methodological and reporting quality applicable to their work. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
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DEVELOPMENT OF HUMAN FACTORS ENGINEERING GUIDANCE FOR SAFETY EVALUATIONS OF ADVANCED REACTORS
International Nuclear Information System (INIS)
O'HARA, J.; PERSENSKY, J.; SZABO, A.
2006-01-01
Advanced reactors are expected to be based on a concept of operations that is different from what is currently used in today's reactors. Therefore, regulatory staff may need new tools, developed from the best available technical bases, to support licensing evaluations. The areas in which new review guidance may be needed and the efforts underway to address the needs will be discussed. Our preliminary results focus on some of the technical issues to be addressed in three areas for which new guidance may be developed: automation and control, operations under degraded conditions, and new human factors engineering methods and tools
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Builders Challenge Quality Criteria Support Document
Energy Technology Data Exchange (ETDEWEB)
None
2009-06-01
This document provides guidance to U.S. home builders participating in Builders Challenge. To qualify for the Builders Challenge, a home must score 70 or less on the EnergySmart Home Scale (E-Scale). Homes also must meet the Builders Challenge Quality Cri
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Practical guidance for defining a smart grid modernization strategy the case of distribution
Madrigal, Marcelino
2015-01-01
This document provides some practical guidance on how utilities can define their own smart grid vision, identify priorities, and structure investment plans. While most of these strategic aspects apply to any area of the electricity grid, the document focuses on the segment of distribution. The guidance includes key building blocks that are needed to modernize the distribution grid and provides examples of grid modernization projects. Potential benefits that can be achieved (in monetary terms) for a given investment range are also discussed.The concept of the smart grid is relevant to any grid
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2013-11-25
...] Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products... Assessment of Investigational Cellular and Gene Therapy Products'' dated November 2013. The guidance document... products reviewed by the Office of Cellular, Tissue and Gene Therapies (OCTGT). The product areas covered...
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The Provisional Staff Regulations of the Agency
Energy Technology Data Exchange (ETDEWEB)
NONE
1959-06-22
In accordance with Article VII.E of the Statute and of the general principles approved by the General Conference in resolution GC.1(S)/RES/13, the Board of Governors has established 'the terms and conditions on which the Agency's staff shall be appointed, remunerated and dismissed.' The Provisional Staff Regulations thus approved and amended by the Board up to 15 January 1959 are reproduced in this document for the information of all Members of the Agency.
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The Provisional Staff Regulations of the Agency
International Nuclear Information System (INIS)
1959-01-01
In accordance with Article VII.E of the Statute and of the general principles approved by the General Conference in resolution GC.1(S)/RES/13, the Board of Governors has established 'the terms and conditions on which the Agency's staff shall be appointed, remunerated and dismissed.' The Provisional Staff Regulations thus approved and amended by the Board up to 15 January 1959 are reproduced in this document for the information of all Members of the Agency
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Applicability of NSR Review Circumvention Guidance to 3M - Maplewood, Minnesota
This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.
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Upgrading safety documentation for exported nuclear power plants
International Nuclear Information System (INIS)
Rosen, M.
1978-01-01
In view of the generally small regulatory staffs of importing countries, suggestions are given for upgrading the ''export edition'' of the traditionally supplied safety documentation by use of a Supplementary Information Report, written specifically for the needs of a smaller and/or less technically qualified staff, which would highlight the differences that exist between the facility to be constructed and the supposedly similar reference plant of the supplier country; by improvement of supporting safety documentation to allow for adequate understanding of significant safety parameters; and by attention to the needs of smaller countries in the critical operating regulations (Technical Specifications for Operation). (author)
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32 CFR 70.10 - Complaints concerning decisional documents and index entries.
2010-07-01
... declining to list that aspect of the service record as an issue. (v) Guidance as to other types of complaints. The following guidance governs other specified types of complaints: (A) The Stipulation of... noted in the decisional document or index entries: (Authentication) Attachment 2—Joint Service Review...
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2011-08-02
... in an IND. In addition, organizational and editorial revisions were made to improve clarity. The...). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights...
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Characterization of drug-related problems identified by clinical pharmacy staff at Danish hospitals
DEFF Research Database (Denmark)
Kjeldsen, Lene Juel; Birkholm, Trine; Fischer, Hanne
2014-01-01
Background In 2010, a database of drug related problems (DRPs) was implemented to assist clinical pharmacy staff in documenting clinical pharmacy activities locally. A study of quality, reliability and generalisability showed that national analyses of the data could be conducted. Analyses...... at the national level may help identify and prevent DRPs by performing national interventions. Objective The aim of the study was to explore the DRP characteristics as documented by clinical pharmacy staff at hospital pharmacies in the Danish DRP-database during a 3-year period. Setting Danish hospital pharmacies....... Method Data documented in the DRP-database during the initial 3 years after implementation were analyzed retrospectively. The DRP-database contains DRPs reported at hospitals by clinical pharmacy staff. The analyses focused on DRP categories, implementation rates and drugs associated with the DRPs. Main...
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International guidance activities
International Nuclear Information System (INIS)
Richardson, Allan C.B.
1989-01-01
International principles for setting Protective Action Guides (PAGs) are contained in two key documents that contain identical statements. One is Publication Number 40 of the ICRP, which was issued in 1985. The title is 'Protection of the Public in the Event of Major Radiation Accidents, Principles for Planning'. The other is the IAEA's Safety Series Publication Number 72, also issued in 1985, written by many of the same authors and titled, 'Principles for Establishing Intervention Levels'. The principles that were set forth in these documents were identical, were incomplete, and they are, unfortunately, the only principles that are now in effect, while proposed revisions go through one draft after another. There are several such draft revisions that are of significance. The most important is that of the ICRP. The basic guidance that applies to most planned exposure to radiation is ICRP Publication 26. That document has been under revision by the Commission for a number of years, and the new version will, for the first time, include recommendations for emergency response. They are now getting close to closure, and I think it should be a very much improved and useful document. But it isn't finished yet. Such guidance doesn't get developed in a vacuum, and there have been a couple of parallel efforts which have provided significant input to the ICRP, which is essentially a behind-closed-doors effort. These other efforts are more open. One of these is being carried out within the IAEA, which has convened annual meetings of national experts for a number of years in Vienna, to generate a replacement for Safety Series No. 72, mentioned earlier. There is a meeting scheduled this December to complete this effort; and, hopefully, we will reach closure at that meeting on at least the basic principles. The Nuclear Energy Agency (NEA) has also been at work. It has convened a group of experts from member nations that have been developing recommendations. There is an overlap
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2011-11-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...
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Context-aware patient guidance during blood pressure self-measurement
DEFF Research Database (Denmark)
Sandager, Puk; Lindahl, Camilla; Schlütter, Jacob Mørup
2013-01-01
The importance of accurate measurement of blood pressure in the screening and management of hypertension during pregnancy is well established. Blood pressure levels can be measured manually by healthcare staff or by using a blood pressure self-measurement device, either at home or in the clinic...... the blood pressure self-measurement process. Preliminary results indicate that such active and context-aware guidance leads to more reliable measurements by inhibiting non-adherent patient behavior...
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Guidance levels, achievable doses and expectation levels
International Nuclear Information System (INIS)
Li, Lianbo; Meng, Bing
2002-01-01
The National Radiological Protection Board (NRPB), the International Atomic Energy Agency (IAEA) and the Commission of the European Communities (CEC) published their guidance levels and reference doses for typical X-ray examination and nuclear medicine in their documents in 1993, 1994 and 1996 respectively. From then on, the concept of guidance levels or reference doses have been applied to different examinations in the field of radiology and proved to be effective for reduction of patient doses. But the guidance levels or reference doses are likely to have some shortcomings and can do little to make further reduction of patient dose in the radiology departments where patient dose are already below them. For this reason, the National Radiological Protection Board (NRPB) proposed a concept named achievable doses which are based on the mean dose observed for a selected sample of radiology departments. This paper will review and discuss the concept of guidance levels and achievable doses, and propose a new concept referred to as Expectation Levels that will encourage the radiology departments where patient dose are already below the guidance levels to keep patient dose as low as reasonably achievable. Some examples of the expectation levels based on the data published by a few countries are also illustrated in this paper
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Energy Technology Data Exchange (ETDEWEB)
1993-04-01
The United States Department of Energy (DOE) has declared that all Hanford plutonium production- and operations-related information generated between 1944 and 1972 is declassified. Any documents found and deemed useful for meeting Hanford Environmental Dose Reconstruction (HEDR) objectives may be declassified with or without deletions in accordance with DOE guidance by Authorized Derivative Declassifiers. The September 1992, letter report, Declassifications Requested by the Technical Steering Panel of Hanford Documents Produced 1944--1960, (PNWD-2024 HEDR UC-707), provides an important milestone toward achieving a complete listing of documents that may be useful to the HEDR Project. The attached listing of approximately 7,000 currently classified Hanford-originated documents relative to Hanford Production Facilities Operations between 1961 and 1972 fulfills TSP Directive 89-3. This list does not include such titles as the Irradiation Processing Department, Chemical Processing Department, and Hanford Laboratory Operations monthly reports generated after 1960 which have been previously declassified with minor deletions and made publicly available. Also Kaiser Engineers Hanford (KEH) Document Control determined that no KEH documents generated between January 1, 1961 and December 31, 1972 are currently classified. Titles which address work for others have not been included because Hanford Site contractors currently having custodial responsibility for these documents do not have the authority to determine whether other than their own staff have on file an appropriate need-to-know. Furthermore, these documents do not normally contain information relative to Hanford Site operations.
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General Merchandise 50% Energy Savings Technical Support Document
Energy Technology Data Exchange (ETDEWEB)
Hale, E.; Leach, M.; Hirsch, A.; Torcellini, P.
2009-09-01
This report documents technical analysis for medium-box general merchandise stores aimed at providing design guidance that achieves whole-building energy savings of at least 50% over ASHRAE Standard 90.1-2004.
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Guidance to Risk-Informed Evaluation of Technical Specifications using PSA
International Nuclear Information System (INIS)
Baeckstroem, Ola; Haeggstroem, Anna; Maennistoe, Ilkka
2010-04-01
This report presents guidance for evaluation of Technical Specification conditions with PSA. It covers quality in PSA, how to verify that the PSA model is sufficiently robust and sufficiently complete and general requirements on methods. Acceptance criteria for evaluation of changes in the TS conditions are presented. As the probabilistic safety assessment (PSA) has developed over the years, it has demonstrated to constitute a useful tool for evaluating many aspects of the TS from a risk point of view. and in that way making the PSAs as well as the decision tools better. This also means that it will be possible to take credit for safety system overcapacity as well as inherent safety features and strength of non-safety classed systems. However, PSA is only one of the tools that shall be used in an evaluation process of TS changes (strengthening/relaxation). PSA is an excellent tool to be used to verify the importance, and thereby possibly relaxation, of TS requirements. But, since PSA is only one tool in the evaluation, it is not sufficient in itself for defining which equipment that shall or shall not have TS requirements. The purpose of this guidance document is to provide general requirements, requirements on methods and acceptance criteria on risk-informed evaluation of TS changes based on PSA. The purpose is not to provide a single solution. As part of the review of the TS conditions this guidance specify requirements on: - Quality verification of the PSA model; - Verification that the PSA model is sufficiently robust with regard to SSCs for which requirements both are and are not defined by the TS; - Verification that the SSCs, for which TS demands are to be evaluated, are modelled in a sufficient manner; - Methods for performing the evaluation; - Which evaluation criteria that shall be used (and how that is verified to be correct); - Acceptance criteria: This guidance also briefly discusses the documentation of the analysis of the TS changes. This guidance
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Guidance to risk-informed evaluation of technical specifications using PSA
International Nuclear Information System (INIS)
Baeckstroem, O.; Haeggstroem, A.; Maennistoe, I.
2010-10-01
This report presents guidance for evaluation of Technical Specification conditions with PSA. It covers quality in PSA, how to verify that the PSA model is sufficiently robust and sufficiently complete and general requirements on methods. Acceptance criteria for evaluation of changes in the TS conditions are presented. As the probabilistic safety assessment (PSA) has developed over the years, it has demonstrated to constitute a useful tool for evaluating many aspects of the TS from a risk point of view. and in that way making the PSAs as well as the decision tools better. This also means that it will be possible to take credit for safety system overcapacity as well as inherent safety features and strength of non-safety classed systems. However, PSA is only one of the tools that shall be used in an evaluation process of TS changes (strengthening/relaxation). PSA is an excellent tool to be used to verify the importance, and thereby possibly relaxation, of TS requirements. But, since PSA is only one tool in the evaluation, it is not sufficient in itself for defining which equipment that shall or shall not have TS requirements. The purpose of this guidance document is to provide general requirements, requirements on methods and acceptance criteria on risk-informed evaluation of TS changes based on PSA. The purpose is not to provide a single solution. As part of the review of the TS conditions this guidance specify requirements on: - Quality verification of the PSA model; - Verification that the PSA model is sufficiently robust with regard to SSCs for which requirements both are and are not defined by the TS; - Verification that the SSCs, for which TS demands are to be evaluated, are modelled in a sufficient manner; - Methods for performing the evaluation; - Which evaluation criteria that shall be used (and how that is verified to be correct); - Acceptance criteria: This guidance also briefly discusses the documentation of the analysis of the TS changes. This guidance
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Guidance to risk-informed evaluation of technical specifications using PSA
Energy Technology Data Exchange (ETDEWEB)
Baeckstroem, O.; Haeggstroem, A. (Scandpower AB, Stockholm (Sweden)); Maennistoe, I. (VTT, Helsingfors (Finland))
2010-04-15
This report presents guidance for evaluation of Technical Specification conditions with PSA. It covers quality in PSA, how to verify that the PSA model is sufficiently robust and sufficiently complete and general requirements on methods. Acceptance criteria for evaluation of changes in the TS conditions are presented. As the probabilistic safety assessment (PSA) has developed over the years, it has demonstrated to constitute a useful tool for evaluating many aspects of the TS from a risk point of view. and in that way making the PSAs as well as the decision tools better. This also means that it will be possible to take credit for safety system overcapacity as well as inherent safety features and strength of non-safety classed systems. However, PSA is only one of the tools that shall be used in an evaluation process of TS changes (strengthening/relaxation). PSA is an excellent tool to be used to verify the importance, and thereby possibly relaxation, of TS requirements. But, since PSA is only one tool in the evaluation, it is not sufficient in itself for defining which equipment that shall or shall not have TS requirements. The purpose of this guidance document is to provide general requirements, requirements on methods and acceptance criteria on risk-informed evaluation of TS changes based on PSA. The purpose is not to provide a single solution. As part of the review of the TS conditions this guidance specify requirements on: - Quality verification of the PSA model; - Verification that the PSA model is sufficiently robust with regard to SSCs for which requirements both are and are not defined by the TS; - Verification that the SSCs, for which TS demands are to be evaluated, are modelled in a sufficient manner; - Methods for performing the evaluation; - Which evaluation criteria that shall be used (and how that is verified to be correct); - Acceptance criteria: This guidance also briefly discusses the documentation of the analysis of the TS changes. This guidance
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Guidance to Risk-Informed Evaluation of Technical Specifications using PSA
Energy Technology Data Exchange (ETDEWEB)
Baeckstroem, Ola; Haeggstroem, Anna (Scandpower AB, Stockholm (Sweden)); Maennistoe, Ilkka (VTT, Helsingfors (Finland))
2010-04-15
This report presents guidance for evaluation of Technical Specification conditions with PSA. It covers quality in PSA, how to verify that the PSA model is sufficiently robust and sufficiently complete and general requirements on methods. Acceptance criteria for evaluation of changes in the TS conditions are presented. As the probabilistic safety assessment (PSA) has developed over the years, it has demonstrated to constitute a useful tool for evaluating many aspects of the TS from a risk point of view. and in that way making the PSAs as well as the decision tools better. This also means that it will be possible to take credit for safety system overcapacity as well as inherent safety features and strength of non-safety classed systems. However, PSA is only one of the tools that shall be used in an evaluation process of TS changes (strengthening/relaxation). PSA is an excellent tool to be used to verify the importance, and thereby possibly relaxation, of TS requirements. But, since PSA is only one tool in the evaluation, it is not sufficient in itself for defining which equipment that shall or shall not have TS requirements. The purpose of this guidance document is to provide general requirements, requirements on methods and acceptance criteria on risk-informed evaluation of TS changes based on PSA. The purpose is not to provide a single solution. As part of the review of the TS conditions this guidance specify requirements on: - Quality verification of the PSA model; - Verification that the PSA model is sufficiently robust with regard to SSCs for which requirements both are and are not defined by the TS; - Verification that the SSCs, for which TS demands are to be evaluated, are modelled in a sufficient manner; - Methods for performing the evaluation; - Which evaluation criteria that shall be used (and how that is verified to be correct); - Acceptance criteria: This guidance also briefly discusses the documentation of the analysis of the TS changes. This guidance
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2011-04-28
... Plasma Type)'' dated June 2007. DATES: Submit either electronic or written comments on Agency guidances... the Compatibility Between the Donor's Cell Type and the Recipient's Serum or Plasma Type... Serum or Plasma Type)'' dated April 2011. The guidance document provides blood establishments that...
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How Should We Treat the Vulnerable?: Qualitative Study of Authoritative Ethics Documents.
Zagorac, Ivana
2016-01-01
The aim of this study is to explore what actual guidance is provided by authoritative ethics documents regarding the recognition and protection of the vulnerable. The documents included in this analysis are the Belmont Report, the Declaration of Helsinki, The Council for International Organizations of Medical Sciences (CIOMS) Guidelines, and the UNESCO Universal Declaration on Bioethics and Human Rights, including its supplementary report on vulnerability. A qualitative analysis of these documents was conducted in light of three questions: what is vulnerability, who are the vulnerable, and how should the vulnerable be protected? The results show significant differences among the documents regarding the first two questions. None of the documents provides any guidance on the third question (how to protect the vulnerable). These results suggest a great discrepancy between the acknowledged importance of the concept of vulnerability and a general understanding of the scope, content, and practical implications of vulnerability.
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Revised guidance on reporting of offshore hydrocarbon releases
International Nuclear Information System (INIS)
1996-11-01
The application offshore of the Reporting of Injuries, Disease and Dangerous Occurrences Regulations 1995 (RIDDOR 1995) has resulted in a new statutory reporting form. The definitions in RIDDOR 95 covering offshore hydrocarbon releases have been slightly revised, making it necessary to revise the guidance on reporting of offshore hydrocarbon releases. RIDDOR 1995 does not affect the existing voluntary arrangements for completion of forms. The receipt of correctly completed forms is important to ensure good output data from the database, and the guidance contained in this document is therefore aimed at assisting completion of the voluntary form. (UK)
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A Nordic perspective on career competences and guidance
DEFF Research Database (Denmark)
Thomsen, Rie
This concept note reflects an initiative within the Nordic ELPGN group, in partnership with the Nordic network for adult learning (NVL), to investigate the possibilities for collaboration between the Nordic countries in developing a number of joint documents on career competences and....../or a competence framework for career learning in the Nordic countries. The objective for this concept note is to contribute to a shared Nordic frame of understanding for career competences which can be used in the ongoing development of guidance in the Nordic countries. The intended audience is guidance...... professionals, teachers, researchers, managers, policy makers and clients....
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Code of Nursing Practice for Staff Exposed to Ionizing Radiation (1984)
International Nuclear Information System (INIS)
1984-01-01
This Code, published by the National Health and Medical Research Council and intended for nurses and auxiliary staff provides general guidance on radiation protection. The Code is supplementary to radiation control legislation relating to the use of ionizing radiation in medical practice. The principles established by the recommendations of the International Commission on Radiological Protection (ICRP) have been taken into account. (NEA) [fr
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USNRC regulatory guidance for engineered safety feature air cleaning systems
International Nuclear Information System (INIS)
Bellamy, R.R.
1991-01-01
The need for clear, technically appropriate, and easily implementable guidance for the design, testing, and maintenance of nuclear air cleaning systems has long been recognized. Numerous industry consensus standards have been issued and revised over the last 30 years. Guidance has also been published by the US Nuclear Regulatory Commission in the form of regulations, regulatory guides, standard review plans, NUREG documents, and information notices. This paper will summarize the latest revisions to these documents and emphasize Regulatory Guide 1.52, Design, Testing, and Maintenance Criteria for Post-Accident Engineered-Safety-Feature Atmosphere Cleanup System Air Filtration and Adsorption Units of Light-Water-Cooled Nuclear Power Plants, which was last revised in 1978. The USNRC has undertaken a project to revise this regulatory guide, and the status of that revision is highlighted
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THE RELIGIOUS GUIDANCE FOR PROSTITUTE A Descriptive Study at Palimanan Cirebon
Directory of Open Access Journals (Sweden)
Murip Yahya
2016-02-01
Full Text Available This study attempts to investigate the implementation of religious guidance for prostitute and its influence to Woman Social Institution Silih Asih in Palimanan, Cirebon. It formulated on four research questions: 1 How is the process of religious guidance in Social Institution Silih Asih; 2 What is the participants’s efforts to achieve the goal of religious guidance; 3 How is the material of religious guidance in Social Institution Silih Asih Palimanan; 4 How is the approach and method of religious guidance applied in Social Institution Silih Asih Palimanan to support and achieve the aim of religious guidance. The study used qualitative-naturalistic, research design with descriptive method. The data were collected through observation, interview, and document analysis. The results of the study show that: 1 there were two stages of religious guidance: identification stage and rehabilitation process; 2 the participants were identified by their age, marital status, education background, parents’ job, and reasons of being prostitute; 3 the materials presented on theoretical and natural materials based on Islam thoughts; 4 the religious guidance used various approaches: experience, habituation, emotional, rational, and holistic.
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2011-09-29
... Safety and Effectiveness Protocol Development and Submission.'' The purpose of this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine, Office of New Animal Drug Evaluation. The recommendations included in this guidance are intended...
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2011-09-23
... of study results to assess concerns about human reproductive and developmental toxicities. It does... assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to http://www.regulations.gov...
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2013-04-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0258] Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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Staff training program of CANDU projects in Saskatoon
International Nuclear Information System (INIS)
Huterer, J.
1996-01-01
This paper describes the training process for a nuclear project on a new site. When AECL opened a project office Saskatoon, senior management recognized the need for large scale staff training and made the necessary commitments. Two types of training programs were initiated, general and technical. The general training plan included topics related to nuclear project life cycle. Technical training was discipline and task specific. Based on the job descriptions and staff qualifications, technical training requirements were documented for the entire staff. The training strategy was developed and implemented. Detailed records were maintained to monitor the progress, draw conclusions, and plan training for future nuclear facilities. (author)
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Remedial Investigation/Feasibility Study (RI/FS) process, elements and techniques guidance
Energy Technology Data Exchange (ETDEWEB)
1993-12-01
This manual provides detailed guidance on Remedial Investigation/Feasibility Studies (RI/FSs) conducted pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) at Department of Energy (DOE) facilities. The purpose of the RI/FS, to assess the risk posed by a hazardous waste site and to determine the best way to reduce that risk, and its structure (site characterization, risk assessment, screening and detailed analysis of alternatives, etc.) is defined in the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) and further explained in the Environmental Protection Agency`s (EPA`s) Guidance for Conducting Remedial Investigations and Feasibility Studies Under CERCLA (Interim Final) 540/G-89/004, OSWER Directive 9355.3-01, October 1988. Though issued in 1988, the EPA guidance remains an excellent source of information on the conduct and structure of an RI/FS. This document makes use of supplemental RI/FS-related guidance that EPA has developed since its initial document was issued in 1988, incorporates practical lessons learned in more than 12 years of experience in CERCLA hazardous site remediation, and drawing on those lessons, introduces the Streamlined Approach For Environmental Restoration (SAFER), developed by DOE as a way to proceed quickly and efficiently through the RI/FS process at DOE facilities. Thus as its title implies, this guidance is intended to describe in detail the process and component elements of an RI/FS, as well as techniques to manage the RI/FS effectively.
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International Nuclear Information System (INIS)
Pope, R.B.; Easton, E.P.; Shankman, S.F.
1997-01-01
In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issuance of the guidance in 1997
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International Nuclear Information System (INIS)
Pope, R.B.; Easton, E.P.; Shankman, S.F.; Boyle, R.W.
1997-01-01
In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the U.S. Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issue of the guidance in 1997. (Author)
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Job and task analysis for technical staff
International Nuclear Information System (INIS)
Toline, B.C.
1991-01-01
In September of 1989 Cooper Nuclear Station began a project to upgrade the Technical Staff Training Program. This project's roots began by performing job and Task Analysis for Technical Staff. While the industry has long been committed to Job and Task Analysis to target performance based instruction for single job positions, this approach was unique in that it was not originally considered appropriate for a group as diverse as Tech Staff. Much to his satisfaction the Job and Task Analysis Project was much less complicated for Technical Staff than the author had imagined. The benefits of performing the Job and Task Analysis for Technical Staff have become increasingly obvious as he pursues lesson plan development and course revisions. The outline for this presentation will be as follows: philosophy adopted; preparation of the job survey document; performing the job analysis; performing task analysis for technical staff and associated pitfalls; clustering objectives for training and comparison to existing program; benefits now and in the future; final phase (comparison to INPO guides and meeting the needs of non-degreed engineering professionals); and conclusion. By focusing on performance based needs for engineers rather than traditional academics for training the author is confident the future Technical Staff Program will meet the challenges ahead and will exceed requirements for accreditation
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Transmission of norovirus among NBA players and staff, winter 2010-2011.
Desai, Rishi; Yen, Catherine; Wikswo, Mary; Gregoricus, Nicole A; Provo, Jace E; Parashar, Umesh D; Hall, Aron J
2011-12-01
In December 2010, 24 players and staff members from 13 National Basketball Association teams were affected with gastroenteritis symptoms. Four of 5 stool specimens from ill players and staff tested positive for norovirus genogroup II. We document evidence of transmission both within teams and, potentially, between teams in 2 instances.
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International Nuclear Information System (INIS)
1998-07-01
In January 1998, the Minister for the Environment, Mr Michael Meacher, informed the Radioactive Waste Management Advisory Committee (RWMAC) that, during the coming year, he would welcome the Committee's advice on proposals for guidance from the Department of the Environment, Transport and the Regions (DETR) to the Environment Agencies on assessment principles for determining radioactive waste discharge authorisations. This will hereafter be referred to as the Principles Document. The RWMAC has provided advice on the process of regulating radioactive waste discharges for many years. A summary of some of this activity is given in Annex 1. As a result, it has been pressing for this Principles Document guidance to be made available since its Twelfth Report in 1991. In response to the Minister's request, the RWMAC offered to assemble and submit early advice on what it believes the guidance needs to cover: this document fulfils that offer. The fundamental purpose of the advice is to help promote clarity of the regulatory regime for the benefit of the regulators themselves who must apply it, the industry to whom it is applied and, most importantly, the public whose safety it is designed to protect. Clarification of a number of aspects of the process is also likely to provide opportunity for efficiency gains. At a subsequent stage, the RWMAC will be happy to provide comment on any draft principles documentation prepared by the DETR. The RWMAC acknowledges that some of the issues it raises in this advice could be taken by others to be either outside the scope of the Principles Document or, by implying a need for more fundamental consideration of the discharge authorisation process, could potentially preclude its early publication. In the first instance, reference to an alternative source of relevant advice might suffice, providing this advice is itself easily accessible and understandable. In the second, the issue itself might be one to be fed into the Government's planned
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Managing social difficulties: roles and responsibilities of patients and staff.
Wright, Penny; Bingham, Laura; Taylor, Sally; Hanif, Naheed; Podmore, Emma; Velikova, Galina
2012-01-01
Implementation of guidance on assessment and management of psychosocial and supportive-care problems or needs will be successful only if consideration is given to existing skills, experience and expectations of staff and patients. This study examines the roles and responsibilities of staff, patients and families in relation to management of social difficulties and proposes a pathway for response. A qualitative study was performed using staff and patient interviews. Seventeen doctors and 16 nurses were interviewed using patient scenarios and a support service questionnaire. Patients (n = 41) completed a screening questionnaire (the Social Difficulties Inventory) and were interviewed. Interviews were audio-recorded, transcribed and subjected to a Framework analysis. Analysis examined (1) actions taken by staff and patients in response to social difficulties, (2) reasons given for action taken and (3) perceptions of staff and patients of who was responsible for taking action. Staff were confident concerning clinically related issues (i.e. mobility) but more hesitant concerning difficulties related to money, work and family concerns. Patients liked to cope with problems on their own where possible, would have liked information or support from staff but were uncertain how to access this. Results led to development of a hierarchy of interventions in response to detected social difficulties. For routine assessment of social difficulties, patients, nurses and doctors will have to work collaboratively, with nurses taking a lead in discussion. For specific clinically related problems doctors would play a more primary role. Copyright © 2010 John Wiley & Sons, Ltd.
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Rowley, Elizabeth; Burns, Lauren; Burnham, Gilbert
2013-06-01
To identify the most and least commonly cited security management messages that nongovernmental organizations (NGOs) are communicating to their field staff, to determine the types of documentation that NGOs most often use to communicate key security messages, and to distinguish the points of commonality and divergence across organizations in the content of key security messages. The authors undertook a systematic review of available security policies, manuals, and training materials from 20 international humanitarian NGOs using the InterAction Minimum Operating Security Standards as the basis for a review framework. The most commonly cited standards include analytical security issues such as threat and risk assessment processes and guidance on acceptance, protection, and deterrence approaches. Among the least commonly cited standards were considering security threats to national staff during staffing decision processes, incorporating security awareness into job descriptions, and ensuring that national staff security issues are addressed in trainings. NGO staff receive security-related messages through multiple document types, but only 12 of the 20 organizations have a distinct security policy document. Points of convergence across organizations in the content of commonly cited standards were found in many areas, but differences in security risk and threat assessment guidance may undermine communication between aid workers about changes in local security environments. Although the humanitarian community has experienced significant progress in the development of practical staff security guidance during the past 10 years, gaps remain that can hinder efforts to garner needed resources, clarify security responsibilities, and ensure that the distinct needs of national staff are recognized and addressed.
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Severe accident management guidance for third Qinshan Nuclear Power Plant
International Nuclear Information System (INIS)
Su Changsong
2010-01-01
The paper describes the background, document structure and the summaries of Severe Accident Management Guidance (SAMG) for Third Qinshan Nuclear Power Plant (TQNPP), and also introduces briefly some design features and their impacts on SAMG. (authors)
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Environmental restoration and decontamination and decommissioning safety documentation
International Nuclear Information System (INIS)
Hansen, J.L.; Frauenholz, L.H.; Kerr, N.R.
1993-01-01
This document presents recommendations of a working group designated by the Environmental Restoration and Remediation (ER) and Decontamination and Decommissioning (D ampersand D) subcommittees of the Westinghouse M ampersand O (Management and Operation) Nuclear Facility Safety Committee. A commonalty of approach to safety documentation specific to ER and D ampersand D activities was developed and is summarized below. Allowance for interpretative tolerance and documentation flexibility appropriate to the activity, graded for hazard category, duration, and complexity, was a primary consideration in development of this guidance
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Waste treatability guidance program. User`s guide. Revision 0
Energy Technology Data Exchange (ETDEWEB)
Toth, C.
1995-12-21
DOE sites across the country generate and manage radioactive, hazardous, mixed, and sanitary wastes. It is necessary for each site to find the technologies and associated capacities required to manage its waste. One role of DOE HQ Office of Environmental Restoration and Waste Management is to facilitate the integration of the site- specific plans into coherent national plans. DOE has developed a standard methodology for defining and categorizing waste streams into treatability groups based on characteristic parameters that influence waste management technology needs. This Waste Treatability Guidance Program automates the Guidance Document for the categorization of waste information into treatability groups; this application provides a consistent implementation of the methodology across the National TRU Program. This User`s Guide provides instructions on how to use the program, including installations instructions and program operation. This document satisfies the requirements of the Software Quality Assurance Plan.
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National Research Council Canada - National Science Library
Wampler, Richard
1998-01-01
This report documents the methodology and lessons learned in the development of the Innovative Tools and Techniques for Brigade and Below Staff Training II - Battle Staff Training System II (ITTBBST-BSTS II...
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DEFF Research Database (Denmark)
Hoekstra, Eddo J.; Petersen, Jens Højslev; Bustos, Juana
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food contains four issues for which food inspectors and enforcement laboratories need further guidance. These issues are the concept of the fat reduction factor...
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2012-01-03
... organization. These 16 Panels have largely been the driving force for CDRH's internal organizational structure...). The draft guidance, when finalized, will represent the Agency's current thinking on medical device...
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Törmä, Johanna; Winblad, Ulrika; Saletti, Anja; Cederholm, Tommy
2017-08-29
Suboptimal nutritional practices in elderly care settings may be resolved by an efficient introduction of nutritional guidelines. To compare two different implementation strategies, external facilitation (EF) and educational outreach visits (EOVs), when introducing nutritional guidelines in nursing homes (NHs), and study the impact on staff performance. A quasi-experimental study with baseline and follow-up measurements. The primary outcome was staff performance as a function of mealtime ambience and food service routines. The EF strategy was a 1-year, multifaceted intervention that included support, guidance, practice audit and feedback in two NH units. The EOV strategy comprised one-three-hour lecture about nutritional guidelines in two other NH units. Both strategies were targeted to selected NH teams, which consisted of a unit manager, a nurse and 5-10 care staff. Mealtime ambience was evaluated by 47 observations using a structured mealtime instrument. Food service routines were evaluated by 109 food records performed by the staff. Mealtime ambience was more strongly improved in the EF group than in the EOV group after the implementation. Factors improved were laying a table (p = 0.03), offering a choice of beverage (p = 0.02), the serving of the meal (p = 0.02), interactions between staff and residents (p = 0.02) and less noise from the kitchen (p = 0.01). Food service routines remained unchanged in both groups. An EF strategy that included guidance, audit and feedback improved mealtime ambience when nutritional guidelines were introduced in a nursing home setting, whereas food service routines were unchanged by the EF strategy. © 2017 Nordic College of Caring Science.
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Key Regulatory Issues for Digital Instrumentation and Control Systems at Nuclear Power Plants
International Nuclear Information System (INIS)
Korsah, Kofi; Wood, Richard Thomas
2008-01-01
To help reduce the uncertainty associated with application of digital instrumentation and controls (I and C) technology in nuclear power plants, the Nuclear Regulatory Commission (NRC) has issued six Interim Staff Guidance (ISG) documents that address the current regulatory positions on what are considered the significant digital I and C issues. These six documents address the following topics: Cyber Security, Diversity and Defense-in-Depth, Risk Informed Digital I and C Regulation, Communication issues, Human Factors and the Digital I and C Licensing Process (currently issued as Draft). After allowing for further refinement based on additional technical insight gathered by NRC staff through near-term research and detailed review of relevant experience, it is expected that updated positions ultimately will be incorporated into regulatory guides and staff review procedures. This paper presents an overview of the guidance provided by the NRC-issued ISGs on key technology considerations (i.e., the first five documents above) for safety-related digital I and C systems.
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Abarshi, Ebun; Rietjens, Judith; Caraceni, Augusto; Payne, Sheila; Deliens, Luc; Van Den Block, Lieve
2014-01-01
Sedation in palliative care has received growing attention in recent years; and so have guidelines, position statements, and related literature that provide recommendations for its practice. Yet little is known collectively about the content, scope and methodological quality of these materials. According to research, there are large variations in palliative sedation practice, depending on the definition and methodology used. However, a standardised approach to comparing and contrasting related documents, across countries, associations and governmental bodies is lacking. This paper reports on a protocol designed to enable thorough and systematic comparison of guidelines and guidance documents on palliative sedation. A multidisciplinary and international group of palliative care researchers, identified themes and clinical issues on palliative sedation based on expert consultations and evidence drawn from the EAPC (European Association of Palliative Care) framework for palliative sedation and AGREE II (Appraisal Guideline Research and Evaluation) instrument for guideline assessment. The most relevant themes were selected and built into a comprehensive checklist. This was tested on people working closely with practitioners and patients, for user-friendliness and comprehensibility, and modified where necessary. Next, a systematic search was conducted for guidelines in English, Dutch, Flemish, or Italian. The search was performed in multiple databases (PubMed, CancerLit, CNAHL, Cochrane Library, NHS Evidence and Google Scholar), and via other Internet resources. Hereafter, the final version of the checklist will be used to extract data from selected literature, and the same will be compiled, entered into SPSS, cleaned and analysed systematically for publication. We have together developed a comprehensive checklist in a scientifically rigorous manner to allow standardised and systematic comparison. The protocol is applicable to all guidelines on palliative sedation, and
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International Scavenging for First Responder Guidance and Tools: IAEA Products
Energy Technology Data Exchange (ETDEWEB)
Stern, W. [Brookhaven National Lab. (BNL), Upton, NY (United States); Berthelot, L. [Brookhaven National Lab. (BNL), Upton, NY (United States); Bachner, K. [Brookhaven National Lab. (BNL), Upton, NY (United States)
2017-05-05
In fiscal years (FY) 2016 and 2017, with support from the U.S. Department of Homeland Security (DHS), Brookhaven National Laboratory (BNL) examined the International Atomic Energy Agency (IAEA) radiological emergency response and preparedness products (guidance and tools) to determine which of these products could be useful to U.S. first responders. The IAEA Incident and Emergency Centre (IEC), which is responsible for emergency preparedness and response, offers a range of tools and guidance documents for responders in recognizing, responding to, and recovering from radiation emergencies and incidents. In order to implement this project, BNL obtained all potentially relevant tools and products produced by the IAEA IEC and analyzed these materials to determine their relevance to first responders in the U.S. Subsequently, BNL organized and hosted a workshop at DHS National Urban Security Technology Laboratory (NUSTL) for U.S. first responders to examine and evaluate IAEA products to consider their applicability to the United States. This report documents and describes the First Responder Product Evaluation Workshop, and provides recommendations on potential steps the U.S. federal government could take to make IAEA guidance and tools useful to U.S. responders.
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DEFF Research Database (Denmark)
Petersen, Annette
will be finalised and published only after adoption and publication of this opinion. This opinion has been developed after a public consultation of EFSA on the current guidance document and an outsourced project carried out by the UK Chemicals Regulation Directorate (CRD, 2010). It is not intended...... that have an impact on absorption, a description of important elements in the design of experimental studies and an analysis of available data on dermal absorption of PPPs. The PPR Panel concludes that assessment of dermal absorption in the absence of specific studies can be performed based on default...
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Chaffe, B; Glencross, H; Jones, J; Staves, J; Capps-Jenner, A; Mistry, H; Bolton-Maggs, P; McQuade, M; Asher, D
2014-12-01
The SHOT Adverse Incident Reporting Scheme has consistently reported an unacceptably high level of errors originating in the laboratory setting. In 2006 an initiative was launched in conjunction with the IBMS, SHOT, RCPath, BBTS, UK NEQAS, the NHSE NBTC and the equivalents in Scotland, Wales and Northern Ireland that led to the formation of the UK TLC. The UK TLC in considering the nature and spread of the errors documented by SHOT concluded that a significant proportion of these errors were most likely to be related to either the use of information technology or staff education, staffing levels, skill mix, training and competency issues. In the absence of any formal guidance on these matters, the UK TLC developed a series of recommendations using the results of two laboratory surveys conducted in 2007 and 2008.
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Identifying needs to develop a PBL staff development program
Directory of Open Access Journals (Sweden)
Prarthana Coffin
2013-08-01
Full Text Available Staff development is a crucial element for educational intervention. Recognizing the importance of staff development, this study aims to pin-point suitable methodologies in developing a Problem-Based Learning (PBL academic staff development program for a higher education institute where PBL has become an intervention alternative. The study aims to answer the following research questions 1 how can university academic staff be assisted to acquire pedagogical competences for an initiative of the implementation of PBL curriculum? 2 What kinds of support do university academic staff need in order to maintain PBL implementation? Through a combination of a literature review, interviews with 6 PBL experts which emphasize the importance of PBL facilitators, and document analysis of reflection notes from 18 trainees of a PBL workshop, this study will produce a guideline in developing a PBL Academic Staff Development Program for an institute wishes to implement and retain PBL as the education strategy.
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Bennett, Michelle K.; Ward, Elizabeth C.; Scarinci, Nerina A.
2016-01-01
Background: There is a high prevalence of communication difficulty among older people living in residential-aged care. Such functional deficits can have a negative impact on resident quality of life, staff workplace satisfaction and the provision of quality care. Systematic research investigating the nature of communication management in…
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Guidance on the environmental risk assessment of genetically modified plants
DEFF Research Database (Denmark)
Bartsch, Detlef; Chueca, Cristina; De-Schrijver, Adinda
risk evaluation. The scientific Panel on Genetically Modified Organisms (of the European Food Safety Authority (EFSA GMO Panel) considers seven specific areas of concern to be addressed by applicants and risk assessors during the ERA (1) persistence and invasiveness of the GM plant , or its compatible......This document provides guidance for the environmental risk assessment (ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of genetically modified...... organisms (GMOs). This document provides guidance for assessing potential effects of GM plants on the environment and the rationales for the data requirements for a comprehensive ERA of GM plants. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach...
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WCATS: Waste Documentation, Course No. 8504
Energy Technology Data Exchange (ETDEWEB)
Simpson, Sandy [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)
2016-04-14
This course was developed for individuals at Los Alamos National Laboratory (LANL) who characterize and document waste streams in the Waste Compliance and Tracking System (WCATS) according to Environmental Protection Agency (EPA) Department of Transportation (DOT) regulations, Department of Energy Orders, and other applicable criteria. When you have completed this course, you will be able to recognize how waste documentation enables LANL to characterize and classify hazardous waste for compliant treatment, storage, and disposal, identify the purpose of the waste stream profile (WSP), identify the agencies that provide guidance for waste management, and more.
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Safety of magnetic fusion facilities: Volume 2, Guidance
International Nuclear Information System (INIS)
1995-01-01
This document provides guidance for the implementation of the requirements identified in Vol. 1 of this Standard. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While Vol. 1 is generally applicable in that requirements there apply to a wide range of fusion facilities, this volume is concerned mainly with large facilities such as the International Thermonuclear Experimental Reactor (ITER). Using a risk-based prioritization, the concepts presented here may also be applied to other magnetic fusion facilities. This volume is oriented toward regulation in the Department of Energy (DOE) environment
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Gollust, Sarah E; Dwyer, Anne M
2013-12-01
Cancer experts engage in public communication whenever they promote their research or practice, respond to media inquiries, or use social media. In a changing communication landscape characterized by new technologies and heightened attention to cancer controversies, these activities may pose ethical challenges. This study was designed to evaluate existing resources to help clinicians navigate their public communication activities. We conducted a systematic, qualitative content analysis of codes of ethics, policy statements, and similar documents disseminated by professional medical and nursing societies for their members. We examined these documents for four types of content related to public communication: communication via traditional media; communication via social media; other communication to the public, policy, and legal spheres; and nonspecific language regarding public communication. We identified 46 documents from 23 professional societies for analysis. Five societies had language about traditional news media communication, five had guidance about social media, 11 had guidance about other communication domains, and 15 societies offered general language about public communication. The limited existing guidance focused on ethical issues related to patients (such as privacy violations) or clinicians (such as accuracy and professional boundaries), with less attention to population or policy impact of communication. Cancer-related professional societies might consider establishing more specific guidance for clinicians concerning their communication activities in light of changes to the communication landscape. Additional research is warranted to understand the extent to which clinicians face ethical challenges in public communication.
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International Nuclear Information System (INIS)
2008-01-01
The purpose of this program guidance document is to provide the technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package (also known as the 'RH-TRU 72-B cask') and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the C of C shall govern. The C of C states: 'each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application.' It further states: 'each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application.' Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M and O) Contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations (CFR) 71.8, 'Deliberate Misconduct.' Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the U.S. Department of Energy (DOE) Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required.In accordance with 10 CFR Part 71, 'Packaging and Transportation of Radioactive Material,' certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21, 'Reporting of Defects and Noncompliance,' regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous
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International Nuclear Information System (INIS)
2006-01-01
The purpose of this program guidance document is to provide the technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the C of C shall govern. The C of C states: 'each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application.' It further states: 'each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application.' Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M and O) Contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with 10 Code of Federal Regulations (CFR) 1.8, 'Deliberate Misconduct.' Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the U.S. Department of Energy (DOE) Carlsbad Field Office (CBFO) shall be notified immediately. CBFO will evaluate the issue and notify the NRC if required. In accordance with 10 CFR Part 71, 'Packaging and Transportation of Radioactive Material,' certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21, 'Reporting of Defects and Noncompliance,' regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these
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2013-07-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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International Nuclear Information System (INIS)
1988-01-01
In connection with the occurrences in the Hanau nuclear firms Nukem and Transnuklear, the weekly magazine 'Der Spiegel' published a number of articles and statements on allegedly further irregularities and cases of misconduct by staff members of the Federal Ministry of Research and Technology, including alleged violation of the Non-Proliferation Treaty because of clandestine supply of plutonium to Pakistan and Libya. The documentation presents background information and the response by the Federal Ministry. (DG) [de
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The Provisional Staff Regulations of the Agency
Energy Technology Data Exchange (ETDEWEB)
NONE
1975-11-06
The Provisional Staff Regulations of the Agency, as amended up to 19 September 1975 by the Board of Governors, are set forth in this document for the information of all Members of the Agency. When an individual provision of the Regulations and the Annexes thereto has been amended since their approval by the Board in 1957, this is indicated by a footnote giving the date on which the current text became effective. There is a subject index at the end of the document.
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The Provisional Staff Regulations of the Agency
International Nuclear Information System (INIS)
1975-01-01
The Provisional Staff Regulations of the Agency, as amended up to 19 September 1975 by the Board of Governors, are set forth in this document for the information of all Members of the Agency. When an individual provision of the Regulations and the Annexes thereto has been amended since their approval by the Board in 1957, this is indicated by a footnote giving the date on which the current text became effective. There is a subject index at the end of the document
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2010-05-27
... manufacturers of plasma derivatives with comprehensive FDA recommendations intended to minimize the possible...CJD) by Blood and Blood Products''' dated August 2006 (2006 draft guidance). DATES: Submit electronic... the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit...
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International Nuclear Information System (INIS)
Kahia, S.; Brinkman, H.; Bareith, A.; Siklossy, T.; Vinot, T.; Mateescu, T.; Espargilliere, J.; Burgazzi, L.; Ivanov, I.; Bogdanov, D.; Groudev, P.; Ostapchuk, S.; Zhabin, O.; Stojka, T.; Alzbutas, R.; Kumar, M.; Nitoi, M.; Farcasiu, M.; Borysiewicz, M.; Kowal, K.; Potempski, S.
2016-01-01
The goal of this report is to provide guidance on practices to model man-made hazards (mainly external fires and explosions) and accidental aircraft crash hazards and implement them in extended Level 1 PSA. This report is a joint deliverable of work package 21 (WP21) and work package 22 (WP22). The general objective of WP21 is to provide guidance on all of the individual hazards selected at the first ASAMPSA-E End Users Workshop (May 2014, Uppsala, Sweden). The objective of WP22 is to provide the solutions for purposes of different parts of man-made hazards Level 1 PSA fulfilment. This guidance is focusing on man-made hazards, namely: external fires and explosions, and accidental aircraft crash hazards. Guidance developed refers to existing guidance whenever possible. The initial part of guidance (WP21 part) reflects current practices to assess the frequencies for each type of hazards or combination of hazards (including correlated hazards) as initiating event for PSAs. The sources and quality of hazard data, the elements of hazard assessment methodologies and relevant examples are discussed. Classification and criteria to properly assess hazard combinations as well as examples and methods for assessment of these combinations are included in this guidance. In appendixes additional material is presented with the examples of practical approaches to aircraft crash and man-made hazard. The following issues are addressed: 1) Hazard assessment methodologies, including issues related to hazard combinations. 2) Modelling equipment of safety related SSC, 3) HRA, 4) Emergency response, 5) Multi-unit issues. Recommendations and also limitations, gaps identified in the existing methodologies and a list of open issues are included. At all stages of this guidance and especially from an industrial end-user perspective, one must keep in mind that the development of man-made hazards probabilistic analysis must be conditioned to the ability to ultimately obtain a representative risk
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International Nuclear Information System (INIS)
Johnson, R.L.; Holonich, J.J.; Lee, M.P.; Delligatti, M.S.
1993-01-01
The Nuclear Regulatory Commission staff has recently started a new initiative to develop the License Application Review Plan (LARP) which the staff will use in its reviews of the U.S. Department of Energy's (DOE's) license application (LA) for a geologic repository for the disposal of high-level radioactive waste (HLW). This paper describes the staff's approach for developing the LARP, the development schedule and current status, the organization and content of the LARP, and the staff's LA review strategy. Therefore, it gives a preview of the draft LARP which will be made available in late 1993. It also describes how the LARP will be used as guidance to the staff in conducting reviews of regulatory and technical issues important to the licensing of a geologic repository. Finally, the benefits to the NRC staff, DOE, and other parties are discussed
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Energy Technology Data Exchange (ETDEWEB)
Belles, Randy [ORNL; Flanagan, George F. [ORNL; Voth, Marcus [Boston Government Services, LLC
2018-05-01
Development of non-power molten salt reactor (MSR) test facilities is under consideration to support the analyses needed for development of a full-scale MSR. These non-power MSR test facilities will require review by the US Nuclear Regulatory Commission (NRC) staff. This report proposes chapter adaptations for NUREG-1537 in the form of interim staff guidance to address preparation and review of molten salt non-power reactor license applications. The proposed adaptations are based on a previous regulatory gap analysis of select chapters from NUREG-1537 for their applicability to non-power MSRs operating with a homogeneous fuel salt mixture.
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Remedial design and remedial action guidance for the Idaho National Engineering Laboratory
International Nuclear Information System (INIS)
1993-10-01
The US Department of Energy, Idaho Operations Office (DOE-ID), the US Environmental Protection Agency, Region X (EPA), and the Idaho Department of Health and Welfare (IDHW) have developed this guidance on the remedial design and remedial action (RD/RA) process. This guidance is applicable to activities conducted under the Idaho National Engineering Laboratory (INEL) Federal Facility Agreement and Consent Order (FFA/CO) and Action Plan. The INEL FFA/CO and Action Plan provides the framework for performing environmental restoration according to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The guidance is intended for use by the DOE-ID, the EPA, and the IDHW Waste Area Group (WAG) managers and others involved in the planning and implementation of CERCLA environmental restoration activities. The scope of the guidance includes the RD/RA strategy for INEL environmental restoration projects and the approach to development and review of RD/RA documentation. Chapter 2 discusses the general process, roles and responsibilities, and other elements that define the RD/RA strategy. Chapters 3 through 7 describe the RD/RA documents identified in the FFA/CO and Action Plan. Chapter 8 provides examples of how this guidance can be applied to restoration projects. Appendices are included that provide excerpts from the FFA/CO pertinent to RD/RA (Appendix A), a applicable US Department of Energy (DOE) orders (Appendix B), and an EPA Engineering ''Data Gaps in Remedial Design'' (Appendix C)
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Technical Document on Control of Nitrogen Oxides From Municipal Waste Combustors
This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.
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Guidance for Developing Principal Design Criteria for Advanced (Non-Light Water) Reactors
Energy Technology Data Exchange (ETDEWEB)
Holbrook, Mark [Idaho National Lab. (INL), Idaho Falls, ID (United States); Kinsey, Jim [Idaho National Lab. (INL), Idaho Falls, ID (United States)
2015-03-01
In July 2013, the US Department of Energy (DOE) and US Nuclear Regulatory Commission (NRC) established a joint initiative to address a key portion of the licensing framework essential to advanced (non-light water) reactor technologies. The initiative addressed the “General Design Criteria for Nuclear Power Plants,” Appendix A to10 Code of Federal Regulations (CFR) 50, which were developed primarily for light water reactors (LWRs), specific to the needs of advanced reactor design and licensing. The need for General Design Criteria (GDC) clarifications in non-LWR applications has been consistently identified as a concern by the industry and varied stakeholders and was acknowledged by the NRC staff in their 2012 Report to Congress1 as an area for enhancement. The initiative to adapt GDC requirements for non-light water advanced reactor applications is being accomplished in two phases. Phase 1, managed by DOE, consisted of reviews, analyses and evaluations resulting in recommendations and deliverables to NRC as input for NRC staff development of regulatory guidance. Idaho National Laboratory (INL) developed this technical report using technical and reactor technology stakeholder inputs coupled with analysis and evaluations provided by a team of knowledgeable DOE national laboratory personnel with input from individual industry licensing consultants. The DOE national laboratory team reviewed six different classes of emerging commercial reactor technologies against 10 CFR 50 Appendix A GDC requirements and proposed guidance for their adapted use in non-LWR applications. The results of the Phase 1 analysis are contained in this report. A set of draft Advanced Reactor Design Criteria (ARDC) has been proposed for consideration by the NRC in the establishment of guidance for use by non-LWR designers and NRC staff. The proposed criteria were developed to preserve the underlying safety bases expressed by the original GDC, and recognizing that advanced reactors may take
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Planning, Conducting, and Documenting Data Analysis for Program Improvement
Winer, Abby; Taylor, Cornelia; Derrington, Taletha; Lucas, Anne
2015-01-01
This 2015 document was developed to help technical assistance (TA) providers and state staff define and limit the scope of data analysis for program improvement efforts, including the State Systemic Improvement Plan (SSIP); develop a plan for data analysis; document alternative hypotheses and additional analyses as they are generated; and…
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Energy Technology Data Exchange (ETDEWEB)
Korsah, Kofi [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Muhlheim, Michael David [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Wood, Richard [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)
2016-04-01
The US Nuclear Regulatory Commission (NRC) is initiating a new rulemaking project to develop a digital system common-cause failure (CCF) rule. This rulemaking will review and modify or affirm the NRC's current digital system CCF policy as discussed in the Staff Requirements Memorandum to the Secretary of the Commission, Office of the NRC (SECY) 93-087, Policy, Technical, and Licensing Issues Pertaining to Evolutionary and Advanced Light Water Reactor (ALWR) Designs, and Branch Technical Position (BTP) 7-19, Guidance on Evaluation of Defense-in-Depth and Diversity in Digital Computer-Based Instrumentation and Control Systems, as well as Chapter 7, Instrumentation and Controls, in NRC Regulatory Guide (NUREG)-0800, Standard Review Plan for Review of Safety Analysis Reports for Nuclear Power Plants (ML033580677). The Oak Ridge National Laboratory (ORNL) is providing technical support to the NRC staff on the CCF rulemaking, and this report is one of several providing the technical basis to inform NRC staff members. For the task described in this report, ORNL examined instrumentation and controls (I&C) technology implementations in nuclear power plants in the light of current CCF guidance. The intent was to assess whether the current position on CCF is adequate given the evolutions in digital safety system implementations and, if gaps in the guidance were found, to provide recommendations as to how these gaps could be closed.
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DEFF Research Database (Denmark)
Tetens, Inge
The Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked by the European Food Safety Authority (EFSA) to draft guidance on scientific requirements for health claims related to physical performance. This guidance has been drawn from scientific opinions of the NDA Panel on such health...... claims. Thus, this guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in this area. It is not intended that the document should include an exhaustive list of beneficial effects and studies/outcome measures which...
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International Nuclear Information System (INIS)
1987-07-01
In 1975, the General Electric Company (GE) published a Nuclear Reactor Study, also referred to as ''the Reed Report,'' an internal product-improvement study. GE considered the document ''proprietary'' and thus, under the regulations of the Nuclear Regulatory Commission (NRC), exempt from mandatory public disclosure. Nonetheless, members of the NRC staff reviewed the document in 1976 and determined that it did not raise any significant new safety issues. The staff also reached the same conclusion in subsequent reviews. However, in response to recent inquiries about the report, the staff reevaluated the Reed Report from a 1987 perspective. This re-evaluation, documented in this staff report, concluded that: (1) there are no issues raised in the Reed Report that support a need to curtail the operation of any GE boiling water reactor (BWR); (2) there are no new safety issues raised in the Reed Report of which the staff was unaware; and (3) although certain issues addressed by the Reed Report are still being studied by the NRC and the industry, there is no basis for suspending licensing and operation of GE BWR plants while these issues are being resolved
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Test plan guidance for transuranic-contaminated arid landfill remedial technology development
International Nuclear Information System (INIS)
Evans, J.; Shaw, P.
1995-05-01
This document provides guidance for preparing plans to test or demonstrate buried waste assessment or remediation technologies supported by the U.S. Department of Energy's Landfill Stabilization Focus Area, Transuranic-Contaminated Arid Landfill Product Line. This document also provides guidance for development of data quality objectives, along with the necessary data to meet the project objectives. The purpose is to ensure that useful data of known quality are collected to support conclusions associated with the designated demonstration or test. A properly prepared test plan will integrate specific and appropriate objectives with needed measurements to ensure data will reflect the Department of Energy Office of Technology Development's mission, be consistent with Landfill Stabilization Focus Area test goals, and be useful for the Department of Energy Environmental Restoration and Waste Management programs and other potential partners (e.g., commercial concerns). The test plan becomes the planning and working document for the demonstration or test to be conducted ensuring procedures are followed that will allow data of sufficient quality to be collected for comparison and evaluation
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2013-03-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0205 (Formerly 2007D-0252)] Pulse Oximeters--Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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2013-06-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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2013-11-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1279] Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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2010-04-01
... comprehensive and accurate trade reconstructions. (a) Guidance. An electronic trading facility on which... entry and trade details and safely storing audit trail data. An electronic trading facility should have... trade-related information to permit electronic trading facility staff to detect trading abuses and to...
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2010-05-07
.... One provision restricts the use of a trade or brand name of a nontobacco product as the trade or brand... . Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food... manufacturers may not use a trade or brand name of a nontobacco product as the trade or brand name for a...
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Guidance manual for conducting technology demonstration activities
International Nuclear Information System (INIS)
Jolley, R.L.; Morris, M.I.; Singh, S.P.N.
1991-12-01
This demonstration guidance manual has been prepared to assist Martin Marietta Energy Systems, Inc. (Energy Systems), staff in conducting demonstrations. It is prepared in checklist style to facilitate its use and assumes that Energy Systems personnel have project management responsibility. In addition to a detailed step-by-step listing of procedural considerations, a general checklist, logic flow diagram, and several examples of necessary plans are included to assist the user in developing an understanding of the many complex activities required to manage technology demonstrations. Demonstrations are pilot-scale applications of often innovative technologies to determine the commercial viability of the technologies to perform their designed function. Demonstrations are generally conducted on well-defined problems for which existing technologies or processes are less than satisfactory in terms of effectiveness, cost, and/or regulatory compliance. Critically important issues in demonstration management include, but are not limited to, such factors as communications with line and matrix management and with the US Department of Energy (DOE) and Energy Systems staff responsible for management oversight, budgetary and schedule requirements, regulatory compliance, and safety
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Guidance manual for conducting technology demonstration activities
Energy Technology Data Exchange (ETDEWEB)
Jolley, Robert L.; Morris, Michael I.; Singh, Suman P.N.
1991-12-01
This demonstration guidance manual has been prepared to assist Martin Marietta Energy Systems, Inc. (Energy Systems), staff in conducting demonstrations. It is prepared in checklist style to facilitate its use and assumes that Energy Systems personnel have project management responsibility. In addition to a detailed step-by-step listing of procedural considerations, a general checklist, logic flow diagram, and several examples of necessary plans are included to assist the user in developing an understanding of the many complex activities required to manage technology demonstrations. Demonstrations are pilot-scale applications of often innovative technologies to determine the commercial viability of the technologies to perform their designed function. Demonstrations are generally conducted on well-defined problems for which existing technologies or processes are less than satisfactory in terms of effectiveness, cost, and/or regulatory compliance. Critically important issues in demonstration management include, but are not limited to, such factors as communications with line and matrix management and with the US Department of Energy (DOE) and Energy Systems staff responsible for management oversight, budgetary and schedule requirements, regulatory compliance, and safety.
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Qualifications and training of staff of the regulatory body for nuclear power plants
International Nuclear Information System (INIS)
1979-01-01
This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the Agency's Safety Series No.50-C-G, entitled ''Governmental Organization for the Regulation of Nuclear Power Plants: A Code of Practice'', and is mainly concerned with the qualifications and training requirements of the staff of bodies regulating nuclear power plants. It is not concerned with staff for regulating other phases of the fuel cycle, such as fuel fabrication and management. This Guide provides recommendations and guidance for establishing the qualifications required for the staff of the regulatory body. These requirements include academic training, work experience and other abilities. It also establishes the training programmes and activities necessary for personnel within the regulatory body
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Safeguards-by-Design: Guidance for Independent Spent Fuel Dry Storage Installations (ISFSI)
Energy Technology Data Exchange (ETDEWEB)
Trond Bjornard; Philip C. Durst
2012-05-01
This document summarizes the requirements and best practices for implementing international nuclear safeguards at independent spent fuel storage installations (ISFSIs), also known as Away-from- Reactor (AFR) storage facilities. These installations may provide wet or dry storage of spent fuel, although the safeguards guidance herein focuses on dry storage facilities. In principle, the safeguards guidance applies to both wet and dry storage. The reason for focusing on dry independent spent fuel storage installations is that this is one of the fastest growing nuclear installations worldwide. Independent spent fuel storage installations are typically outside of the safeguards nuclear material balance area (MBA) of the reactor. They may be located on the reactor site, but are generally considered by the International Atomic Energy Agency (IAEA) and the State Regulator/SSAC to be a separate facility. The need for this guidance is becoming increasingly urgent as more and more nuclear power plants move their spent fuel from resident spent fuel ponds to independent spent fuel storage installations. The safeguards requirements and best practices described herein are also relevant to the design and construction of regional independent spent fuel storage installations that nuclear power plant operators are starting to consider in the absence of a national long-term geological spent fuel repository. The following document has been prepared in support of two of the three foundational pillars for implementing Safeguards-by-Design (SBD). These are: i) defining the relevant safeguards requirements, and ii) defining the best practices for meeting the requirements. This document was prepared with the design of the latest independent dry spent fuel storage installations in mind and was prepared specifically as an aid for designers of commercial nuclear facilities to help them understand the relevant international requirements that follow from a country’s safeguards agreement with
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2010-03-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0260] Guidance for Industry on Submitting a Report for Multiple Facilities to the Reportable Food Electronic... Act of 2007.'' The document provides guidance to the industry in complying with the Reportable Food...
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International Nuclear Information System (INIS)
Muianga, C V; Rice, C H; Succop, P
2009-01-01
Work practices can influence exposure, especially in small-scale operations conducted by mobile work crews. This study evaluated the use of information on good work practice in control guidance sheets adapted from UK Silica Essentials guidance sheets by trained workers and supervisors employed in small-scale concrete and masonry demolition operations. A one-page employee silica task-based control guidance sheet for each of four demolition tasks and multiple-page silica control guidance for supervisors were developed. Interactive, hands-on worker training on these task-based good work practice controls was developed. Training was presented to 26 participants from two demolition crews. Feedback on the training and task-based good work practice control guidance sheets was elicited. Observations of work practices were made before and after training. Participants indicated gains in knowledge and checklists were used to document skill attainment. The quality of the training and usefulness of the material/skills was rated high by trainees. Increased use of water to suppress dust and wet cleaning methods on the job were documented following the training. Additional follow-up after training is required to determine long-term impact on sustained changes in work practices, and to evaluate the need for refresher training.
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Muianga, C. V.; Rice, C. H.; Succop, P.
2009-02-01
Work practices can influence exposure, especially in small-scale operations conducted by mobile work crews. This study evaluated the use of information on good work practice in control guidance sheets adapted from UK Silica Essentials guidance sheets by trained workers and supervisors employed in small-scale concrete and masonry demolition operations. A one-page employee silica task-based control guidance sheet for each of four demolition tasks and multiple-page silica control guidance for supervisors were developed. Interactive, hands-on worker training on these task-based good work practice controls was developed. Training was presented to 26 participants from two demolition crews. Feedback on the training and task-based good work practice control guidance sheets was elicited. Observations of work practices were made before and after training. Participants indicated gains in knowledge and checklists were used to document skill attainment. The quality of the training and usefulness of the material/skills was rated high by trainees. Increased use of water to suppress dust and wet cleaning methods on the job were documented following the training. Additional follow-up after training is required to determine long-term impact on sustained changes in work practices, and to evaluate the need for refresher training.
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Hospital accreditation: staff experiences and perceptions.
Bogh, Søren Bie; Blom, Ane; Raben, Ditte Caroline; Braithwaite, Jeffrey; Thude, Bettina; Hollnagel, Erik; Plessen, Christian von
2018-06-11
Purpose The purpose of this paper is to understand how staff at various levels perceive and understand hospital accreditation generally and in relation to quality improvement (QI) specifically. Design/methodology/approach In a newly accredited Danish hospital, the authors conducted semi-structured interviews to capture broad ranging experiences. Medical doctors, nurses, a quality coordinator and a quality department employee participated. Interviews were audio recorded and subjected to framework analysis. Findings Staff reported that The Danish Healthcare Quality Programme affected management priorities: office time and working on documentation, which reduced time with patients and on improvement activities. Organisational structures were improved during preparation for accreditation. Staff perceived that the hospital was better prepared for new QI initiatives after accreditation; staff found disease specific requirements unnecessary. Other areas benefited from accreditation. Interviewees expected that organisational changes, owing to accreditation, would be sustained and that the QI focus would continue. Practical implications Accreditation is a critical and complete hospital review, including areas that often are neglected. Accreditation dominates hospital agendas during preparation and surveyor visits, potentially reducing patient care and other QI initiatives. Improvements are less likely to occur in areas that other QI initiatives addressed. Yet, accreditation creates organisational foundations for future QI initiatives. Originality/value The authors study contributes new insights into how hospital staff at different organisational levels perceive and understand accreditation.
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2011-11-07
... Microbiology Devices Advisory Panel (the panel) recommended that in vitro diagnostic devices for Yersinia spp...). The draft guidance, when finalized will represent the Agency's current thinking on in vitro diagnostic...
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Batra, Peter; Aquilino, Mary L; Farris, Karen B
2015-01-01
To evaluate pharmacy staff perspectives of a 2-year pharmacy intervention aimed at reducing unintended pregnancy in 18- to 30-year-old women. Pharmacy staff completed a 48-item, self-administered paper survey consisting of scaled and open-ended questions. 55 community pharmacies in 12 Iowa counties. All pharmacy staff participated, including pharmacists, pharmacy technicians, and other pharmacy employees. Online continuing education (CE) training was made available to all pharmacy staff. Promotional materials including posters, brochures, and shelf talkers were displayed in all of the pharmacies. Pharmacy staff perceptions and self-reported behaviors related to displaying posters, brochures, and shelf talkers in their pharmacies and providing contraceptive information and counseling to patients/customers. A total of 192 (43% return rate) pharmacy staff responded. Only 44% of respondents consistently provided contraceptive information and counseling, yet more than 90% felt that talking with patients/customers about contraceptives was easy, and more than 50% could do so privately. The study showed increased pharmacy staff desire to make this topic a priority. Community pharmacy staff can play a key role in educating and counseling young adult women about contraceptive health and pregnancy planning. This study indicates that staff are comfortable providing this service and that patients/customers are open to receiving guidance from pharmacists. However, pharmacy staff are missing additional opportunities to provide information and counseling. There is also a need for greater attention to provision of nonprescription contraceptive education.
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HANDBOOK: GUIDANCE ON SETTING PERMIT CONDITIONS AND REPORTING TRIAL BURN RESULTS
This Handbook provides guidance for establishing operational conditions for incinerators. he document provides a means for state and local agencies to achieve a level of consistency in setting permit conditions that will result in establishment of more uniform permit conditions n...
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WHO Regional Office for Europe guidance for influenza surveillance in humans.
Brown, C.S.; Andraghetti, R.; Paget, J.
2009-01-01
Recent international mandates, and the emergent circulation of pandemic (H1N1) 2009 virus in human populations, call for strengthening influenza surveillance to better target seasonal influenza control programmes and support pandemic preparedness. This document provides technical guidance to
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2010-05-20
... Ministry of Health, Labour and Welfare system. This notice of availability and draft guidance satisfy the... collection of information is necessary for the proper performance of FDA's functions, including whether the...
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International Nuclear Information System (INIS)
1988-12-01
Interim Guidance on the Standard Review Plan (SRP) for the Review of Financial Assurance Mechanisms for Decommissioning under 10 CFR Parts 30, 40, and 70 is prepared for the guidance of Nuclear Regulatory Commission staff reviewers in performing reviews of applications from material licensees affected by the decommissioning regulations established June 27, 1988 (53FR24018). The principal purpose of the SRP is to assure the quality and uniformity of staff reviews and to present a base from which to evaluate the financial assurance aspects of the applications. NUREG-1337, identifies who performs the review, the matters that are reviewed, the basis of the review, how the review is performed, and the conclusions that are sought. 3 refs
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Vocational guidance in social volunteering
Directory of Open Access Journals (Sweden)
Nikolay S. Pryazhnikov
2017-03-01
Full Text Available The paper discusses the possibilities and limitations of vocational guidance in the social volunteering system. The essence of volunteer work is closely related with assistance to desperate people in searching for the meaning of living, often coinciding with labour activity that are deemed in terms of “the main matter of life” and “the leading activity”. For adolescents, it is the choice of career, and for adults, it is the work proper (i.e. an essential condition for personal self-realization. The problem of “forced volunteering” for experts in vocational guidance also means that they often have to work voluntarily and unselfishly outside the official guidelines. To clarify the terms «volunteer» and «a person in desperate need of help» the study used the method of analyzing the documents, e.g. the Regulations on Social Volunteering, the generalization of psychological sources, the initial survey of university students as active supporters of the volunteer movement, On the essence of volunteering and the place of career guidance in selfless social work. Vocational guidance is not excluded from the general system of volunteerism, but has an insufficiently defined status and low popularity among participants in social volunteering. Also, the problem of «forced volunteering» of experts in career counseling, which often requires voluntary and unselfish performance of quality work outside the framework of official instructions, is also indicated. Simultaneously, positive aspects of such disinterested career initiatives are noted, in particular, less control by the official inspectors (or customers and, accordingly, greater freedom of creativity than when someone else does the work.
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Standard Review Plan Maintenance Program implementing procedures document
International Nuclear Information System (INIS)
1996-11-01
The implementing Procedures Document (IPD) was developed by the Inspection Program Projects Branch, Office of Nuclear Reactor Regulation, with assistance from Pacific Northwest National Laboratory, for the Standard Review Plan Maintenance Program (SRP-MP). The SRP-MP was established to maintain the Standard Review Plan (SRP) on an on-going basis. The IPD provides guidance, including an overall approach and procedures, for SRP-MP tasks. The objective of the IPD is to ensure that modifications to SRP need to reflect current NRC requirements and guidance are identified and that a consistent methodology is used to develop and revise SRP sections
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International Nuclear Information System (INIS)
Harms, T.; Scheuer, N.; Martin, R.; Van Epp, T.; Triplett, M.
1990-01-01
In response to the Department of Energy's (DOE) anticipated need for variances from the Resource Conservation and Recovery Act (RCRA) Land Disposal Restriction (LDR) treatment requirements, a treatability variance guidance document is being prepared for use by DOE facilities and operations offices. The guidance document, although applicable to non-mixed hazardous waste streams, provides specific guidance regarding radioactive mixed-waste streams. Preparation of the guidance manual has involved developing an overview of the Land Disposal Restrictions, as well as an overview of the petition preparation process. The DOE internal review requirements are specifically addressed in the manual. Specific data requirements and engineering analyses are also described. A discussion of EPA's criteria for granting a treatability variance is also provided. A checklist for completeness of the petition is provided. Model language for use in DOE treatability variance petitions will be provided in a petition for a DOE waste stream as an appendix to the document
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International Nuclear Information System (INIS)
1994-05-01
This document is one of several guidance documents developed to support the EM (DOE Environmental Restoration and Waste Management) Analytical Services program. Its purpose is to introduce assessment plates that can be used to conduct performance assessments of an organization's or project's ability to meet quality goals for analytical laboratory activities. These assessment plates are provided as non-prescriptive guidance to EM-support organizations responsible for collection of environmental data for remediation and waste management programs at DOE facilities. The assessments evaluate objectively all components of the analytical laboratory process to determine their proper selection and use
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Staff management, training and knowledge management
International Nuclear Information System (INIS)
Makino, Hitoshi; Umeki, Hiroyuki; Capouet, M.; Depaus, C.; Berckmans, A.
2014-01-01
Staff management/training and knowledge management are organisational issues that are particularly sensitive in long-term projects stretching over decades like the development and operation of a geological repository. The IAEA has already issued several publications that deal with this issue (IAEA, 2006, 2008). Organisational aspects were also discussed in the framework of a topical session organised by the Integration Group for the Safety Case (IGSC) at its annual meeting in 2009 and were regarded as a topic deserving future attention (NEA, 2009a). More recently, the Forum on Stakeholder Confidence (FSC) identified organisational, mission and behavioural features as attributes of confidence and trust (NEA, 2013). They also identified that aspects such as structural learning capacity, high levels of skill and competence in relevant areas, specific management plan, good operating records, transparency and consistency are associated with confidence building in a safety case. These aspects are considerably related to staff training/management and knowledge management. The IGSC has initiated a proposal of study dedicated to staff training/management and knowledge management with the objective to highlight how these recent concerns and the requirements issued by the IAEA are concretely implemented in the national programmes. The goal of this study is to acknowledge the differences of views and needs for staff management and knowledge management at different stages of individual programmes and between implementer and regulator. As a starting point to this study, the JAEA and ONDRAF/NIRAS prepared a draft questionnaire in order to succinctly capture processes and tools that the national organisations have implemented to meet the requirements and address the issues set out in the field of staff and knowledge management. For the purpose of this study, a questionnaire is now under development, which will be presented on the occasion of this symposium with guidance based on a
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2013-04-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0642] Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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2013-08-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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Local public document room directory. Revision 7
International Nuclear Information System (INIS)
1998-04-01
This directory (NUREG/BR-0088, Revision 7) lists local public document rooms (LPDRs) for commercial nuclear power plants with operating or possession-only licenses or under construction, plus the LPDRs for potential high-level radioactive waste repository sites, gaseous diffusion plants, certain fuel cycle facilities, certain low-level waste disposal facilities, and any temporary LPDRs established for the duration of licensing proceedings. In some instances, the LPDR libraries maintain document collections for more than one licensed facility. The library staff members listed are the persons most familiar with the LPDR collections. Reference librarians in the NRC Headquarters Public Document Room (PDR) are also available to assist the public in locating NRC documents
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Sampling quality assurance guidance in support of EM environmental sampling and analysis activities
International Nuclear Information System (INIS)
1994-05-01
This document introduces quality assurance guidance pertaining to the design and implementation of sampling procedures and processes for collecting environmental data for DOE's Office of EM (Environmental Restoration and Waste Management)
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DEFF Research Database (Denmark)
Sjödin, Anders Mikael
2018-01-01
of additional health claim applications related to antioxidants, oxidative damage and cardiovascular health, and the information collected from a Grant launched in 2014. This guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to the antioxidants......EFSA asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health published in 2011. The update takes into accounts experiences gained with evaluation......, oxidative damage and cardiovascular health. The document was subject to public consultation (from 12 July to 3 September 2017). This document supersedes the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health published in 2011...
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GUIDANCE COUNSELOR INSTITUTE FOR HEALTH CAREERS (JULY 7-22, 1966).
MORGAN, PHILIP W.
THE INSTITUTE, SPONSORED BY A FEDERATED CHARITY REPRESENTING 78 NONPROFIT VOLUNTARY HOSPITALS IN NEW YORK CITY, WAS ATTENDED BY 48 HIGH SCHOOL AND EMPLOYMENT SERVICE COUNSELORS. THE NEED FOR SUCH INSTITUTES WAS DOCUMENTED BY A PRE-INSTITUTE QUESTIONNAIRE TO LICENSED GUIDANCE COUNSELORS. TO EVALUATE THE INSTITUTE, THE PROFESSIONAL EXAMINATION…
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Glossary of CERCLA, RCRA and TSCA related terms and acronyms. Environmental Guidance
Energy Technology Data Exchange (ETDEWEB)
1993-10-01
This glossary contains CERCLA, RCRA and TSCA related terms that are most often encountered in the US Department of Energy (DOE) Environmental Restoration and Emergency Preparedness activities. Detailed definitions are included for key terms. The CERCLA definitions included in this glossary are taken from the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), as amended and related federal rulemakings. The RCRA definitions included in this glossary are taken from the Resource Conservation and Recovery Act (RCRA) and related federal rulemakings. The TSCA definitions included in this glossary are taken from the Toxic Substances and Control Act (TSCA) and related federal rulemakings. Definitions related to TSCA are limited to those sections in the statute and regulations concerning PCBs and asbestos.Other sources for definitions include additional federal rulemakings, assorted guidance documents prepared by the US Environmental Protection Agency (EPA), guidance and informational documents prepared by the US Department of Energy (DOE), and DOE Orders. The source of each term is noted beside the term. Terms presented in this document reflect revised and new definitions published before July 1, 1993.
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Energy Technology Data Exchange (ETDEWEB)
None
2012-09-01
This document provides specific guidance to agencies on the implementation and follow-up of energy and water efficiency measures identified and undertaken per Section 432 of the Energy Independence and Security Act of 2007 (EISA) (42 U.S.C. 8253(f)(4) and (5)) This guidance also provides context for how these activities fit into the comprehensive approach to facility energy and water management outlined by the statute and incorporates by reference previous DOE guidance released for Section 432 of EISA and other related documents. 42 U.S.C. 8253(f)(7)(A) specifies that facility energy managers shall certify compliance for each covered facility with the 42 U.S.C. 8253(f)(2)-(5) requirements via a web-based tracking system and make it publicly available. This document also describes the role of the tracking system that has been developed for the collection and reporting of data needed for the demonstration of compliance and progress toward meeting all energy and water efficiency requirements outlined in the statute.
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Request for Clarification of EPA Guidance on the Alternative Fuels Exemption under the PSD Program
This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.
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Nurse manager engagement: what it means to nurse managers and staff nurses.
Gray, Linda R; Shirey, Maria R
2013-01-01
To describe what nurse manager engagement means to nurse managers and staff nurses by incorporating an organizational dashboard to document engagement outcomes. Retaining engaged nurse managers is crucial for individual performance and organizational outcomes. However, nurse manager engagement is currently underreported in the literature. Existing data from the 2010 Employee Opinion Survey at the Baylor University Medical Center in Dallas, Texas, were used to measure staff engagement among 28 nurse managers and 1497 staff nurses. The data showed a 21% gap between manager and staff nurse engagement levels, with managers showing higher engagement levels than staff. No clear depiction of nurse manager engagement emerged. Consequently, an expanded definition of nurse manager engagement was developed alongside a beginning dashboard of engagement outcomes. The findings have implications for overcoming barriers that affect staff nurse engagement, improving outcomes, and creating definitions of nurse manager engagement.
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Coastal nonpoint pollution control program: Program development and approval guidance
International Nuclear Information System (INIS)
1993-01-01
The document, developed by NOAA and EPA, contains guidance for states in developing and implementing their coastal nonpoint pollutant source programs. It describes the requirements that must be met, including: the geographic scope of the program; the pollutant sources to be addressed; the types of management measures used; the establishment of critical areas; technical assistance, public participation, and administrative coordination; and, the process for program submission and Federal approval. The document also contains the criteria by which NOAA and EPA will review the states' submissions
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Energy Technology Data Exchange (ETDEWEB)
Magnusson, Tommy; Ekdahl, Maria (Ringhals AB, Vaeroebacka (Sweden))
2008-06-15
Ringhals has been a model for this study, but the purpose has been to make the report applicable at all nuclear power plants in Sweden. The work has been done in close co-operation with the Swedish nuclear power plants and Rescue Services in the nuclear power municipalities Oesthammar, Oskarshamn, and Varberg. The internal fire brigade at the nuclear power plants has also been involved. A document will also be published as a further guidance at efforts of the type fires, which are mentioned in the enclosed document. After a fire in a switchgear room in 2005 the need of making the existing effort planning more effective at nuclear power plants was observed. The idea with the planning is to plan the effort in order to give the operational and emergency staff a good and actual support to come to a decision and to start the mission without delay. The risk information is showed by planning layouts, symbols and drawings as basis, give risk information and effort information. The effort information shows outer arrangements, manual action points, fire installations, passive fire safety etc. The risk information is shown by risk symbols. Their purpose is to give a fast overview of the existing risks. Reactor safety effects is the ruling influence if an effort has to be done in order to secure safety for a third person. In order to make an effort in an area personal risks for rescue staff, such as electricity risks, radiological risks, chemicals and gas bottles with compressed gases, has to be eliminated. For complicated missions detailed instructions are needed in order to handle specific risks. In a group discussion different people with pertinent knowledge has to value which problematic efforts need detailed instruction. Missions that have to be analyzed in a work group as above are: fire may affect the reactor safety, fire that may threaten the structural integrity, chemical discharge with big consequence on environment/third person and handling of gas system (compressed
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2010-04-22
...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...
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MANAGING HUMAN FACTORS IN IMPLEMENTING ELECTRONIC DOCUMENT SYSTEM IN THE PUBLIC SECTOR
Directory of Open Access Journals (Sweden)
TOMS LEIKUMS
2012-05-01
Full Text Available Document management underlies the activities of almost every organization. Correctly managed correspondence and organized document circulation characterize successful performance particularly in the public sector organizations. Even though production of documents itself is not the main task of governmental institutions, document creation and processing are crucial processes for the provision of basic functions in public sector. In the 21st century it gets more important to use the new possibilities offered by modern technologies, including electronic document management. Public sector itself is a heavy bureaucratic apparatus in the need of elasticity and ability to change its working processes and habits in order to gradually switch to the digital environment. Western European countries have already turned to electronic document management whilst most of the Eastern European countries, including Latvia, have just recently started a gradual electronization of document circulation. When implementing electronic document management systems in the public sector organizations, it often comes to resistance of the staff and unwillingness to change the accustomed methods of work – paper format document circulation. Both lower level staff and higher level managers put obstacles to electronic document management. In this article author inspects cases of successful practice and analyses possible action mechanisms that could convince public sector personnel of advantages of electronic document circulation and prepare them to switch to work with digital documents.
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Patterns for Effectively Documenting Frameworks
Aguiar, Ademar; David, Gabriel
Good design and implementation are necessary but not sufficient pre-requisites for successfully reusing object-oriented frameworks. Although not always recognized, good documentation is crucial for effective framework reuse, and often hard, costly, and tiresome, coming with many issues, especially when we are not aware of the key problems and respective ways of addressing them. Based on existing literature, case studies and lessons learned, the authors have been mining proven solutions to recurrent problems of documenting object-oriented frameworks, and writing them in pattern form, as patterns are a very effective way of communicating expertise and best practices. This paper presents a small set of patterns addressing problems related to the framework documentation itself, here seen as an autonomous and tangible product independent of the process used to create it. The patterns aim at helping non-experts on cost-effectively documenting object-oriented frameworks. In concrete, these patterns provide guidance on choosing the kinds of documents to produce, how to relate them, and which contents to include. Although the focus is more on the documents themselves, rather than on the process and tools to produce them, some guidelines are also presented in the paper to help on applying the patterns to a specific framework.
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How Does Nursing Staff Perceive the Use of Electronic Handover Reports? A Questionnaire-Based Study
Directory of Open Access Journals (Sweden)
Torbjørg Meum
2011-01-01
Full Text Available Following the implementation of electronic nursing records in a psychogeriatric ward, we examined nursing staff's attitudes and perceptions to the implementation of an electronic handover routine. A web-based anonymous and secure questionnaire was distributed by e-mail to all nursing staff at a psychogeriatric ward at a university hospital. Most respondents were satisfied with the electronic handover, and they believed they managed to keep informed by the new routine. The simultaneous introduction of a morning meeting, to ensure a forum for oral professional discussion, was a success. A minority of staff did not fully trust the information conveyed in the electronic handover, and a significant proportion expressed a need for guidance in using the system. Staff that had a high level of trust in written reports believed these saved time, had little trouble finding time and a place to read the reports, and were more positive to the new handover routine.
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Organizational Consequences of Staff Turnover in Outpatient Substance Abuse Treatment Programs
Knight, Danica K.; Edwards, Jennifer R.; Flynn, Patrick M.
2014-01-01
The purpose of this study was to examine the impact of staff turnover on perceptions of organizational demands and support among staff who remained employed in substance abuse treatment programs. The sample consisted of 353 clinical staff from 63 outpatient agencies. Two scales from the Survey of Organizational Functioning (SOF) measured work-environment demands (Stress, Inadequate Staffing), and three measured supportive work relationships (Communication, Cohesion, Peer Collaboration). Results from a series of multilevel models documented that counselors working in programs that had previously experienced high staff turnover perceived higher demands and lower support within their organization, even after controlling for other potentially burdensome factors such as budget, census, and individual measures of workload. Two individual-level variables, caseload and tenure, were important determinants of work-environment demands, but were not related to supportive work relationships. Findings suggest that staff turnover increases workplace demands and decreases perceptions of support, and underscore the need to reduce stress and minimize subsequent turnover among clinical staff. PMID:22154028
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International Nuclear Information System (INIS)
Ciraj-Bjelac, Olivera; Bozovic, Predrag; Arandjic, Danijela; Antic, Vojislav; Selakovic, Jovana; Pavlovic, Sinisa
2016-01-01
The purpose of this study was to assess the patient exposure and staff eye dose levels during implantation procedures for all types of pacemaker therapy devices performed under fluoroscopic guidance and to investigate potential correlation between patients and staff dose levels. The mean eye dose during pacemaker/defibrillator implementation was 12 μSv for the first operator, 8.7 μSv for the second operator/nurse and 0.50 μSv for radiographer. Corresponding values for cardiac re-synchronisation therapy procedures were 30, 26 and 2.0 μSv, respectively. Significant (p < 0.01) correlation between the eye dose and the kerma-area product was found for the first operator and radiographers, but not for other staff categories. The study revealed eye dose per procedure and eye dose normalised to patient dose indices for different staff categories and provided an input for radiation protection in electrophysiology procedures. (authors)
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The Provisional Staff Regulations of the Agency. Amendments to Annexes II and III
Energy Technology Data Exchange (ETDEWEB)
NONE
1971-08-06
On 8 June 1971 the Board of Governors made amendments to Annexes II and III to the Provisional Staff Regulations which superseded the earlier amendments to those Annexes set forth in document INFCIRC/6/Rev. 2/Mod. 1. Paragraphs 2-4 of that document are accordingly modified.
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Large Hospital 50% Energy Savings: Technical Support Document
Energy Technology Data Exchange (ETDEWEB)
Bonnema, E.; Studer, D.; Parker, A.; Pless, S.; Torcellini, P.
2010-09-01
This Technical Support Document documents the technical analysis and design guidance for large hospitals to achieve whole-building energy savings of at least 50% over ANSI/ASHRAE/IESNA Standard 90.1-2004 and represents a step toward determining how to provide design guidance for aggressive energy savings targets. This report documents the modeling methods used to demonstrate that the design recommendations meet or exceed the 50% goal. EnergyPlus was used to model the predicted energy performance of the baseline and low-energy buildings to verify that 50% energy savings are achievable. Percent energy savings are based on a nominal minimally code-compliant building and whole-building, net site energy use intensity. The report defines architectural-program characteristics for typical large hospitals, thereby defining a prototype model; creates baseline energy models for each climate zone that are elaborations of the prototype models and are minimally compliant with Standard 90.1-2004; creates a list of energy design measures that can be applied to the prototype model to create low-energy models; uses industry feedback to strengthen inputs for baseline energy models and energy design measures; and simulates low-energy models for each climate zone to show that when the energy design measures are applied to the prototype model, 50% energy savings (or more) are achieved.
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AECB staff annual report of Point Lepreau G.S. for the year 1990
International Nuclear Information System (INIS)
1991-05-01
This report is a review by AECB staff of the operation of Point Lepreau Nuclear Generating Station during 1990. The review is based on information contained in the various documents submitted by New Brunswick Power under the terms of the Operating Licence and on information gathered by AECB staff during routine site monitoring, inspections and audits
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Brady, Nancy C.; Bruce, Susan; Goldman, Amy; Erickson, Karen; Mineo, Beth; Ogletree, Bill T.; Paul, Diane; Romski, Mary Ann; Sevcik, Rose; Siegel, Ellin; Schoonover, Judith; Snell, Marti; Sylvester, Lorraine; Wilkinson, Krista
2015-01-01
The National Joint Committee for the Communication Needs of People with Severe Disabilities (NJC) reviewed literature regarding practices for people with severe disabilities in order to update guidance provided in documents originally published in 1992. Changes in laws, definitions, and policies that affect communication attainments by persons with severe disabilities are presented, along with guidance regarding assessment and intervention practices. A revised version of the Communication Bill of Rights, a powerful document that describes the communication rights of all individuals, including those with severe disabilities is included in this article. The information contained within this article is intended to be used by professionals, family members, and individuals with severe disabilities to inform and advocate for effective communication services and opportunities. PMID:26914467
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This Spring 2016 document is intended for the use of EPA staff, State and Local regulatory agencies and their staff, and industry plant managers for the NESHAP for the Portland Cement Manufacturing Industry.
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2013-12-30
..., 72, 74, and 150 [NRC-2009-0096 and NRC-2013-0195] RIN 3150-AI61 Amendments to Material Control and Accounting Regulations and Proposed Guidance for Fuel Cycle Facility Material Control and Accounting Plans... of this document. NRC's Agencywide Documents Access and Management System (ADAMS): You may access...
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Streamlining the license renewal review process
International Nuclear Information System (INIS)
Dozier, J.; Lee, S.; Kuo, P.T.
2001-01-01
The staff of the NRC has been developing three regulatory guidance documents for license renewal: the Generic Aging Lessons Learned (GALL) report, Standard Review Plan for License Renewal (SRP-LR), and Regulatory Guide (RG) for Standard Format and Content for Applications to Renew Nuclear Power Plant Operating Licenses. These documents are designed to streamline the license renewal review process by providing clear guidance for license renewal applicants and the NRC staff in preparing and reviewing license renewal applications. The GALL report systematically catalogs aging effects on structures and components; identifies the relevant existing plant programs; and evaluates the existing programs against the attributes considered necessary for an aging management program to be acceptable for license renewal. The GALL report also provides guidance for the augmentation of existing plant programs for license renewal. The revised SRP-LR allows an applicant to reference the GALL report to preclude further NRC staff evaluation if the plant's existing programs meet the criteria described in the GALL report. During the review process, the NRC staff will focus primarily on existing programs that should be augmented or new programs developed specifically for license renewal. The Regulatory Guide is expected to endorse the Nuclear Energy Institute (NEI) guideline, NEI 95-10, Revision 2, entitled 'Industry Guideline for Implementing the Requirements of 10 CFR Part 54 - The License Renewal Rule', which provides guidance for preparing a license renewal application. This paper will provide an introduction to the GALL report, SRP-LR, Regulatory Guide, and NEI 95-10 to show how these documents are interrelated and how they will be used to streamline the license renewal review process. This topic will be of interest to domestic power utilities considering license renewal and international ICONE participants seeking state-of-the-art information about license renewal in the United States
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222-S Laboratory Quality Assurance Plan. Revision 1
International Nuclear Information System (INIS)
Meznarich, H.K.
1995-01-01
This Quality Assurance Plan provides,quality assurance (QA) guidance, regulatory QA requirements (e.g., 10 CFR 830.120), and quality control (QC) specifications for analytical service. This document follows the U.S Department of Energy (DOE) issued Hanford Analytical Services Quality Assurance Plan (HASQAP). In addition, this document meets the objectives of the Quality Assurance Program provided in the WHC-CM-4-2, Section 2.1. Quality assurance elements required in the Guidelines and Specifications for Preparing Quality Assurance Program Plans (QAMS-004) and Interim Guidelines and Specifications for Preparing Quality Assurance Project Plans (QAMS-005) from the US Environmental Protection Agency (EPA) are covered throughout this document. A quality assurance index is provided in the Appendix A. This document also provides and/or identifies the procedural information that governs laboratory operations. The personnel of the 222-S Laboratory and the Standards Laboratory including managers, analysts, QA/QC staff, auditors, and support staff shall use this document as guidance and instructions for their operational and quality assurance activities. Other organizations that conduct activities described in this document for the 222-S Laboratory shall follow this QA/QC document
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2016-07-01
This document provides guidance material in regards to Institutional and Business issues as well as Financial Sustainability for the CV Pilots Deployment Concept Development Phase. This material also provides part of the foundation for the Performanc...
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Improving nurse documentation and record keeping in stoma care
Law, Lesley; Akroyd, Karen; Burke, Linda
2010-01-01
Evidence suggests that nurse documentation is often inconsistent and lacks a coherent and standardized approach. This article reports on research into the use of nurse documentation on a stoma care ward in a large London hospital, and explores the factors that may affect the process of record keeping by nursing staff. This study uses stoma care as a case study to explore the role of documentation on the ward, focusing on how this can be improved. It is based on quantitative and qualitative me...
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Endocrine Disruptor Screening Program (EDSP) Universe of Chemicals and General Validation Principles
This document was developed by the EPA to provide guidance to staff and managers regarding the EDSP universe of chemicals and general validation principles for consideration of computational toxicology tools for chemical prioritization.
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International Nuclear Information System (INIS)
1995-12-01
This manual provides the necessary guidance to contractor generator groups for developing and maintaining documentation of their pollution prevention (P2) program activities. Preparation of program documentation will demonstrate compliance with contractor and U.S. Department of Energy (DOE) requirements, as well as state and federal regulations. Contractor waste generator groups are no longer required to prepare and update facility waste minimization plans. Developing and maintaining program documentation replace this requirement
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de Vries, Heinz J., Ed.
1990-01-01
This document reports on a conference centered around three topics: vocational guidance in the Member States of the European Community (EC), the "Europeanization" of vocational guidance, and approaches to cross-frontier vocational guidance. Among the recommendations of the conference participants are the following: the tasks of…
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Guidance document to the BC emission offsets regulation
International Nuclear Information System (INIS)
2010-11-01
British Columbia's (BC) emission offset regulations were established under the Greenhouse Gas Reduction Targets Act passed in 2007. Targets for greenhouse gas (GHG) emission reductions included a 6 percent reduction by 2012; an 18 percent reduction by 2016; a 33 percent reduction by 2020; and an 80 percent reduction by 2050. Carbon neutral agreements began in 2008, and covered emissions produced from government business travel and by provincial government ministries and agencies. This report presented a list of key recommendations developed by the Pacific Carbon Trust for use in future carbon offset projects. Recommendations included the use of correct emission factors when quantifying projected emission reductions from an offset project; the use of a robust data management system; and the use of evidence in supporting additionality arguments. The document outlined planning procedures for project baseline selection processes, protocol selections, and the identification of sources sinks and reservoirs. Issues related to quantification and measurements, emissions factors, and accuracy and uncertainty were also addressed. Validation, verification, and contracting options were also presented. 6 tabs., 3 figs.
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Guidance on meeting DOE order requirements for traceable nondestructive assay measurements
International Nuclear Information System (INIS)
1994-05-01
Purpose of this guide is to facilitate accuracy and precision of nondestructive assay measurements through improvement of the materials and process of traceability. This document provides DOE and its contractor facilities with guidance to establish traceability to the national measurement base for site-prepared NDA working reference materials
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Guidance for Federal Agencies on Executive Order 13693 - Federal Fleet Management
Energy Technology Data Exchange (ETDEWEB)
None, None
2017-01-02
Document contains guidance on the federal fleet requirements of Executive Order 13693: Planning for Federal Sustainability in the Next Decade and helps federal agencies subject to the executive order develop an overall approach for reducing total fleet greenhouse gas (GHG) emissions and fleet-wide per-mile GHG emissions.
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Nuclear criticality safety staff training and qualifications at Los Alamos National Laboratory
International Nuclear Information System (INIS)
Monahan, S.P.; McLaughlin, T.P.
1997-01-01
Operations involving significant quantities of fissile material have been conducted at Los Alamos National Laboratory continuously since 1943. Until the advent of the Laboratory's Nuclear Criticality Safety Committee (NCSC) in 1957, line management had sole responsibility for controlling criticality risks. From 1957 until 1961, the NCSC was the Laboratory body which promulgated policy guidance as well as some technical guidance for specific operations. In 1961 the Laboratory created the position of Nuclear Criticality Safety Office (in addition to the NCSC). In 1980, Laboratory management moved the Criticality Safety Officer (and one other LACEF staff member who, by that time, was also working nearly full-time on criticality safety issues) into the Health Division office. Later that same year the Criticality Safety Group, H-6 (at that time) was created within H-Division, and staffed by these two individuals. The training and education of these individuals in the art of criticality safety was almost entirely self-regulated, depending heavily on technical interactions between each other, as well as NCSC, LACEF, operations, other facility, and broader criticality safety community personnel. Although the Los Alamos criticality safety group has grown both in size and formality of operations since 1980, the basic philosophy that a criticality specialist must be developed through mentoring and self motivation remains the same. Formally, this philosophy has been captured in an internal policy, document ''Conduct of Business in the Nuclear Criticality Safety Group.'' There are no short cuts or substitutes in the development of a criticality safety specialist. A person must have a self-motivated personality, excellent communications skills, a thorough understanding of the principals of neutron physics, a safety-conscious and helpful attitude, a good perspective of real risk, as well as a detailed understanding of process operations and credible upsets
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Energy Technology Data Exchange (ETDEWEB)
O' Hara, J.M.
2009-11-30
Human performance models (HPMs) are simulations of human behavior with which we can predict human performance. Designers use them to support their human factors engineering (HFE) programs for a wide range of complex systems, including commercial nuclear power plants. Applicants to U.S. Nuclear Regulatory Commission (NRC) can use HPMs for design certifications, operating licenses, and license amendments. In the context of nuclear-plant safety, it is important to assure that HPMs are verified and validated, and their usage is consistent with their intended purpose. Using HPMs improperly may generate misleading or incorrect information, entailing safety concerns. The objective of this research was to develop guidance to support the NRC staff's reviews of an applicant's use of HPMs in an HFE program. The guidance is divided into three topical areas: (1) HPM Verification, (2) HPM Validation, and (3) User Interface Verification. Following this guidance will help ensure the benefits of HPMs are achieved in a technically sound, defensible manner. During the course of developing this guidance, I identified several issues that could not be addressed; they also are discussed.
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International Nuclear Information System (INIS)
O'Hara, J.M.
2009-01-01
Human performance models (HPMs) are simulations of human behavior with which we can predict human performance. Designers use them to support their human factors engineering (HFE) programs for a wide range of complex systems, including commercial nuclear power plants. Applicants to U.S. Nuclear Regulatory Commission (NRC) can use HPMs for design certifications, operating licenses, and license amendments. In the context of nuclear-plant safety, it is important to assure that HPMs are verified and validated, and their usage is consistent with their intended purpose. Using HPMs improperly may generate misleading or incorrect information, entailing safety concerns. The objective of this research was to develop guidance to support the NRC staff's reviews of an applicant's use of HPMs in an HFE program. The guidance is divided into three topical areas: (1) HPM Verification, (2) HPM Validation, and (3) User Interface Verification. Following this guidance will help ensure the benefits of HPMs are achieved in a technically sound, defensible manner. During the course of developing this guidance, I identified several issues that could not be addressed; they also are discussed.
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Guidance notes for the protection of persons against ionising radiations arising from veterinary use
International Nuclear Information System (INIS)
1988-01-01
These notes are not intended to provide detailed guidance on all the conditions that apply to veterinary practice but rather to indicate the types of arrangements which should be employed in order to comply with the main requirements of the Regulations. They also aim to establish a pattern by which good radiological practice can be achieved and radiation doses to veterinary surgeons, radiographic staff, and anyone else involved, minimised. (author)
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Interim guidance for the safe transport of reprocessed uranium
International Nuclear Information System (INIS)
1994-06-01
Increasingly reprocessed uranium is being used for the fabrication of nuclear fuel elements. Different intermediate reprocessing steps are carried out at different locations. Therefore, transportation of uranium material is necessary. Due to the difference in isotope composition of reprocessed uranium then unirradiated uranium a doubt is casted on the presumption that packages used for the transport of unirradiated uranium are automatically suitable for reprocessed uranium compounds. The Standing Advisory Group on the Safe Transport of Radioactive Material (SAGSTRAM) recommended that the issue be reviewed by consultants and that a document be developed that would give guidance to users of the Regulations. This TECDOC is the result of the endeavors of the experts convened at two Consultants Services meetings. It contains guidance on the provisions in the current Regulations as well as proposals for changes to the new Revised Edition whose publication is planned for 1996. This document demonstrates that under the present Transport Regulations it is possible in most cases to ship reprocessed uranium compounds in the same packages as unirradiated uranium compounds. In few cases a more stringent package type is required. 8 refs, 22 figs, 19 tabs
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UK regulatory standards - the 'Guidance on requirements for authorisation'
International Nuclear Information System (INIS)
Williams, C.R.
1999-01-01
In the United Kingdom, disposal of radioactive waste requires an authorisation under the Radioactive Substances Act 1993. The power to grant such authorisations rests with the Environment Agency for disposals in England and Wales, and with similar Agencies in Scotland and Northern Ireland - namely the Scottish Environment Protection Agency (SEPA) and the Environment and Heritage Service (EHS) of the Department of the Environment for Northern Ireland. In 1997, following two rounds of consultation, the Environment Agency jointly with SEPA and EHS published a document 'Disposal Facilities on Land for Low and Intermediate Level Radioactive Wastes: Guidance on Requirements for Authorisation' - the GRA document. The GRA document outlines the regulatory framework governing the disposal of radioactive waste, general guidance on procedures, the principles and criteria against which proposals for a disposal facility will be assessed, and the radiological and technical requirements which a facility will be expected to meet. In particular, the document states that, in the period after control is withdrawn, the assessed radiological risk from a facility to a representative member of the potentially exposed group at greatest risk should be consistent with a risk target of 10 -6 per year. The document also specifies the information which a developer will need to provide, to demonstrate that a proposal is consistent with the principles and requirements, and identifies other, non-risk-based, criteria. In March 1997, the Secretary of State for the Environment rejected a planning appeal by United Kingdom Nirex Ltd for an underground Rock Characterisation Facility located near Sellafield in Cumbria. That decision has effectively delayed the construction of any deep repository in the UK. Subsequently a House of Lords Select Committee has commenced a major review of nuclear waste management. The Environment Agency continues to be responsible for the authorisation of the shallow
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Documentation and verification required for type A packaging use
Energy Technology Data Exchange (ETDEWEB)
O`Brien, J.H.
1997-07-30
This document furnishes knowledge and methods for verifying compliance with the U.S. Department of Transportation (DOT) packaging requirements for shipping Type A quantities of radioactive material. The primary emphasis is on the requirements identified in 49 CFR 173.415(a), which states, ``Each offeror of a Specification 7A package must maintain on file for at least one year after the shipment, and shall provide to DOT on request, complete documentation of tests and an engineering evaluation of comparative data showing that the construction methods, packaging design, and materials of construction comply with that specification.`` This guidance document uses a checklist to show compliance.
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Documentation and verification required for type A packaging use
International Nuclear Information System (INIS)
O'Brien, J.H.
1997-01-01
This document furnishes knowledge and methods for verifying compliance with the U.S. Department of Transportation (DOT) packaging requirements for shipping Type A quantities of radioactive material. The primary emphasis is on the requirements identified in 49 CFR 173.415(a), which states, ''Each offeror of a Specification 7A package must maintain on file for at least one year after the shipment, and shall provide to DOT on request, complete documentation of tests and an engineering evaluation of comparative data showing that the construction methods, packaging design, and materials of construction comply with that specification.'' This guidance document uses a checklist to show compliance
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2011-01-31
... of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville... harmful constituents, including smoke constituents, to health in each tobacco product by brand and by quantity in each brand and subbrand.'' The guidance discusses the meaning of the term ``harmful and...
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Lavonen, Jari; Lattu, Matti; Juuti, Kalle; Meisalo, Veijo
2006-01-01
An ICT strategy and an implementation plan for teacher education were created in a co-operative process. Visions and expectations of staff members and students were registered by questionnaires and by making notes during sessions in which the strategy was created. Thereafter, an implementation document, where the staff development programme and…
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Final Documentation: Incident Management And Probabilities Courses of action Tool (IMPACT).
Energy Technology Data Exchange (ETDEWEB)
Edwards, Donna M.; Ray, Jaideep; Tucker, Mark D.; Whetzel, Jonathan; Cauthen, Katherine Regina
2018-03-01
This report pulls together the documentation produced for the IMPACT tool, a software-based decision support tool that provides situational awareness, incident characterization, and guidance on public health and environmental response strategies for an unfolding bio-terrorism incident.
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Organizational consequences of staff turnover in outpatient substance abuse treatment programs.
Knight, Danica K; Becan, Jennifer E; Flynn, Patrick M
2012-03-01
The purpose of this study was to examine the impact of staff turnover on perceptions of organizational demands and support among staff who remained employed in substance abuse treatment programs. The sample consisted of 353 clinical staff from 63 outpatient agencies. Two scales from the Survey of Organizational Functioning measured work environment demands (stress and inadequate staffing), and 3 measured supportive work relationships (communication, cohesion, and peer collaboration). Results from a series of multilevel models documented that counselors working in programs that had previously experienced high staff turnover perceived higher demands and lower support within their organization, even after controlling for other potentially burdensome factors such as budget, census, and individual measures of workload. Two individual-level variables, caseload and tenure, were important determinants of work environment demands but were not related to supportive work relationships. Findings suggest that staff turnover increases workplace demands, decreases perceptions of support, and underscores the need to reduce stress and minimize subsequent turnover among clinical staff. Copyright © 2012 Elsevier Inc. All rights reserved.
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EMP Attachment 3 DOE-SC PNNL Site Dose Assessment Guidance
Energy Technology Data Exchange (ETDEWEB)
Snyder, Sandra F.
2011-12-21
This Dose Assessment Guidance (DAG) describes methods to use to determine the Maximally-Exposed Individual (MEI) location and to estimate dose impact to that individual under the U.S. Department of Energy Office of Science (DOE-SC) Pacific Northwest National Laboratory (PNNL) Site Environmental Monitoring Plan (EMP). This guidance applies to public dose from radioactive material releases to the air from PNNL Site operations. This document is an attachment to the Pacific Northwest National Laboratory (PNNL) Environmental Monitoring Plan (EMP) and describes dose assessment guidance for radiological air emissions. The impact of radiological air emissions from the U.S. Department of Energy Office of Science (DOE-SC) PNNL Site is indicated by dose estimates to a maximally exposed member of the public, referred to as the maximally exposed individual (MEI). Reporting requirements associated with dose to members of the public from radiological air emissions are in 40 CFR Part 61.94, WAC 246-247-080, and DOE Order 458.1. The DOE Order and state standards for dose from radioactive air emissions are consistent with U.S. Environmental Protection Agency (EPA) dose standards in 40 CFR 61.92 (i.e., 10 mrem/yr to a MEI). Despite the fact that the current Contract Requirements Document (CRD) for the DOE-SC PNNL Site operations does not include the requirement to meet DOE CRD 458.1, paragraph 2.b, public dose limits, the DOE dose limits would be met when EPA limits are met.
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MONITORED GEOLOGIC REPOSITORY LIFE CYCLE COST ESTIMATE ASSUMPTIONS DOCUMENT
International Nuclear Information System (INIS)
R.E. Sweeney
2001-01-01
The purpose of this assumptions document is to provide general scope, strategy, technical basis, schedule and cost assumptions for the Monitored Geologic Repository (MGR) life cycle cost (LCC) estimate and schedule update incorporating information from the Viability Assessment (VA) , License Application Design Selection (LADS), 1999 Update to the Total System Life Cycle Cost (TSLCC) estimate and from other related and updated information. This document is intended to generally follow the assumptions outlined in the previous MGR cost estimates and as further prescribed by DOE guidance
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Monitored Geologic Repository Life Cycle Cost Estimate Assumptions Document
International Nuclear Information System (INIS)
Sweeney, R.
2000-01-01
The purpose of this assumptions document is to provide general scope, strategy, technical basis, schedule and cost assumptions for the Monitored Geologic Repository (MGR) life cycle cost estimate and schedule update incorporating information from the Viability Assessment (VA), License Application Design Selection (LADS), 1999 Update to the Total System Life Cycle Cost (TSLCC) estimate and from other related and updated information. This document is intended to generally follow the assumptions outlined in the previous MGR cost estimates and as further prescribed by DOE guidance
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Edwards, Rhiannon Tudor; Charles, Joanna Mary; Lloyd-Williams, Huw
2013-10-24
If Public Health is the science and art of how society collectively aims to improve health, and reduce inequalities in health, then Public Health Economics is the science and art of supporting decision making as to how society can use its available resources to best meet these objectives and minimise opportunity cost. A systematic review of published guidance for the economic evaluation of public health interventions within this broad public policy paradigm was conducted. Electronic databases and organisation websites were searched using a 22 year time horizon (1990-2012). References of papers were hand searched for additional papers for inclusion. Government reports or peer-reviewed published papers were included if they; referred to the methods of economic evaluation of public health interventions, identified key challenges of conducting economic evaluations of public health interventions or made recommendations for conducting economic evaluations of public health interventions. Guidance was divided into three categories UK guidance, international guidance and observations or guidance provided by individual commentators in the field of public health economics. An assessment of the theoretical frameworks underpinning the guidance was made and served as a rationale for categorising the papers. We identified 5 international guidance documents, 7 UK guidance documents and 4 documents by individual commentators. The papers reviewed identify the main methodological challenges that face analysts when conducting such evaluations. There is a consensus within the guidance that wider social and environmental costs and benefits should be looked at due to the complex nature of public health. This was reflected in the theoretical underpinning as the majority of guidance was categorised as extra-welfarist. In this novel review we argue that health economics may have come full circle from its roots in broad public policy economics. We may find it useful to think in this broader
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International Nuclear Information System (INIS)
1996-02-01
This guidance document has two purposes: it provides guidance for writing site-specific long-term surveillance plans (LTSP) and it describes site surveillance, monitoring, and long-term care techniques for Title I disposal sites of the Uranium Mill Tailings Radiation Control Act (UMTRCA) (42 USC Section 7901 et seq.). Long-term care includes monitoring, maintenance, and emergency measures needed to protect public health and safety and the environment after remedial action is completed. This document applies to the UMTRCA-designated Title I disposal sites. The requirements for long-term care of the Title I sites and the contents of the LTSPs are provided in U.S. Nuclear Regulatory Commission (NRC) regulations (10 CFR Section 40.27) provided in Attachment 1
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Health effects assessment of staff involved in medical practices of radiation exposures
Energy Technology Data Exchange (ETDEWEB)
Popescu, I.A.; Lacob, O. [Institute of Public Health Iasi, Radiation Hygiene Lab. (Romania); Roman, I.; Havarneanu, D. [Institute of Public Health Iasi, Occupational Medicine Dept. (Romania)
2006-07-01
This study aimed, starting from new national recommendation appearance, to detect health effects of medical staff from six counties of Moldavia region involved in radiation practices and to create a national register data for radiation-induce cancer. Staff involved in medical ionizing radiation uses in Romania - health care level I are monitored on recent new recommendations for three years. The micro nuclei high levels and morphological lymphocytes changes vs. clinical diagnostic can be considered as early possible malignant signs. The micro nuclei test, although unspecific, as a new exam in our legislation can bring useful information on staff exposure and provides a guidance to occupational physician in making his medical recommendations. This cytogenetic test does not seem to correlate with smoking habit or length of exposure. Micro nuclei test both in oral mucous epithelial cells and peripheral culture lymphocytes can be considered of much specificity and correlates with a recent acute exposure level. The conclusions of individual health status surveillance and assessment of personal dose equivalent are very useful data for recording in the radiation cancer-induced register.
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Health effects assessment of staff involved in medical practices of radiation exposures
International Nuclear Information System (INIS)
Popescu, I.A.; Lacob, O.; Roman, I.; Havarneanu, D.
2006-01-01
This study aimed, starting from new national recommendation appearance, to detect health effects of medical staff from six counties of Moldavia region involved in radiation practices and to create a national register data for radiation-induce cancer. Staff involved in medical ionizing radiation uses in Romania - health care level I are monitored on recent new recommendations for three years. The micro nuclei high levels and morphological lymphocytes changes vs. clinical diagnostic can be considered as early possible malignant signs. The micro nuclei test, although unspecific, as a new exam in our legislation can bring useful information on staff exposure and provides a guidance to occupational physician in making his medical recommendations. This cytogenetic test does not seem to correlate with smoking habit or length of exposure. Micro nuclei test both in oral mucous epithelial cells and peripheral culture lymphocytes can be considered of much specificity and correlates with a recent acute exposure level. The conclusions of individual health status surveillance and assessment of personal dose equivalent are very useful data for recording in the radiation cancer-induced register
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Supplemental design requirements document, Project W026
International Nuclear Information System (INIS)
Weidert, J.R.
1993-01-01
This document supplements and extends the Functional Design Criteria, SP-W026-FDC-001, for the Waste Receiving and Processing Facility (WRAP), Module 1. It provides additional detailed requirements, summarizes key Westinghouse Hanford Company design guidance, and establishes baseline technical agreements to be used in definitive design of the WRAP-1 facility. Revision 3 of the Supplemental Design Requirements Document has been assigned an Impact Level of 3ESQ based on the content of the entire revision. The actual changes made from Revision 2 have an Impact Level of 3S and the basis for these changes was previously reviewed and approved per WHC correspondence No. 9355770
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Human-system Interfaces to Automatic Systems: Review Guidance and Technical Basis
International Nuclear Information System (INIS)
O'Hara, J.M.; Higgins, J.C.
2010-01-01
Automation has become ubiquitous in modern complex systems and commercial nuclear power plants are no exception. Beyond the control of plant functions and systems, automation is applied to a wide range of additional functions including monitoring and detection, situation assessment, response planning, response implementation, and interface management. Automation has become a 'team player' supporting plant personnel in nearly all aspects of plant operation. In light of the increasing use and importance of automation in new and future plants, guidance is needed to enable the NRC staff to conduct safety reviews of the human factors engineering (HFE) aspects of modern automation. The objective of the research described in this report was to develop guidance for reviewing the operator's interface with automation. We first developed a characterization of the important HFE aspects of automation based on how it is implemented in current systems. The characterization included five dimensions: Level of automation, function of automation, modes of automation, flexibility of allocation, and reliability of automation. Next, we reviewed literature pertaining to the effects of these aspects of automation on human performance and the design of human-system interfaces (HSIs) for automation. Then, we used the technical basis established by the literature to develop design review guidance. The guidance is divided into the following seven topics: Automation displays, interaction and control, automation modes, automation levels, adaptive automation, error tolerance and failure management, and HSI integration. In addition, we identified insights into the automaton design process, operator training, and operations.
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Expanding services in a shrinking economy: desktop document delivery in a dental school library.
Gushrowski, Barbara A
2011-07-01
How can library staff develop and promote a document delivery service and then expand the service to a wide audience? The setting is the library at the Indiana University School of Dentistry (IUSD), Indianapolis. A faculty survey and a citation analysis were conducted to determine potential use of the service. Volume of interlibrary loan transactions and staff and equipment capacity were also studied. IUSD Library staff created a desktop delivery service (DDSXpress) for faculty and then expanded the service to practicing dental professionals and graduate students. The number of faculty using DDSXpress remains consistent. The number of practicing dental professionals using the service is low. Graduate students have been quick to adopt the service. Through careful analysis of capacity and need for the service, staff successfully expanded document delivery service without incurring additional costs. Use of DDSXpress is continually monitored, and opportunities to market the service to practicing dental professionals are being investigated.
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2010-12-22
... familiar with the updated closing documents, the existing closing documents, which these updated closing... assures the industry and the public that sufficient staff will be available and thoroughly familiar with... documents that are updated for current commercial legal standards, balanced with the public policy role that...
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Accident Analysis Guidance for Completion of 10 CFR 830-Compliant DSAs
International Nuclear Information System (INIS)
Vincent, A.
2002-01-01
Safety analysis contractors responsible for existing nuclear facilities are required to submit a Documented Safety Analysis to the Department of Energy for approval by April 2003. Recognizing that schedule and resource limitations may be significant, an initiative is underway to make available a set of guidance tools. The guidance is in the form of a peer-reviewed Accident Analysis Guidebook, a series of application guides for ''safe harbor'' computer codes, establishment of a configuration-controlled collection of safety analysis software and a central registry to maintain it, and periodic analytical training on accident analysis methods. Delivery of the majority of these products is scheduled to be in FY 2003
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Best Available Technology (economically achievable) guidance document for the Hanford Site
International Nuclear Information System (INIS)
1988-07-01
This document provides Westinghouse Hanford Company (Westinghouse Hanford) and the US Department of Energy (DOE) with a step-by-step procedure for the identification and documentation of the Best Available Technology (BAT) economically achievable for treating liquid effluents on the Hanford Site. The BAT determination is a key element in the DOE strategy to eliminate use of the soil column for contaminated effluents disposal. Following application of BAT, a liquid effluent is considered suitable for discharge to the environment, including the soil column. Liquid effluents on the Hanford Site are currently disposed of in accordance with DOE orders that require protection of public health and safety, and to the extent possible, minimize adverse impacts on the environment. The determination of BAT on a liquid effluent will only occur after the effluent meets all applicable release limits. As a result, the application of BAT may involve an additional level of control, as well as contribute to the overall Hanford Site as low as reasonably achievable (ALARA) program. 27 refs., 7 figs., 1 tab
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Lavin, Mary Ann; Harper, Ellen; Barr, Nancy
2015-04-14
The electronic health record (EHR) is a documentation tool that yields data useful in enhancing patient safety, evaluating care quality, maximizing efficiency, and measuring staffing needs. Although nurses applaud the EHR, they also indicate dissatisfaction with its design and cumbersome electronic processes. This article describes the views of nurses shared by members of the Nursing Practice Committee of the Missouri Nurses Association; it encourages nurses to share their EHR concerns with Information Technology (IT) staff and vendors and to take their place at the table when nursing-related IT decisions are made. In this article, we describe the experiential-reflective reasoning and action model used to understand staff nurses' perspectives, share committee reflections and recommendations for improving both documentation and documentation technology, and conclude by encouraging nurses to develop their documentation and informatics skills. Nursing issues include medication safety, documentation and standards of practice, and EHR efficiency. IT concerns include interoperability, vendors, innovation, nursing voice, education, and collaboration.
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Probabilistic risk assessment (PRA) reference document. Final report
International Nuclear Information System (INIS)
Murphy, J.A.
1984-09-01
This document describes the current status of probabilistic risk assessment (PRA) as practiced in the nuclear reactor regulatory process. The PRA studies that have been completed or are under way are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed. This document was issued for comment in February 1984 entitled Probabilistic Risk Assessment (PRA): Status Report and Guidance for Regulatory Application. The comments received on the draft have been considered for this final version of the report
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International Nuclear Information System (INIS)
Johnson, R.L.; Linehan, J.J.
1991-01-01
The US Nuclear Regulatory Commission (NRC) staff has updated its initial regulatory strategy for the High-Level Waste Repository Licensing Program. The update describes changes to the initial strategy and summarizes progress and future activities. This paper summarizes the first update of the regulatory strategy. In general the overall strategy of identifying and reducing uncertainties is unchanged. Identifying regulatory and institutional uncertainties is essentially complete, and therefore, the current and future emphasis is on reducing those regulatory and institutional uncertainties identified to date. The NRC staff has improved the methods of reducing regulatory uncertainties by (1) enhancing the technical basis preparation process for potential rulemakings and guidance and (2) designing a new guidance document, called a staff position, for clarifying regulatory uncertainties. For guiding the US DOE's reduction of technical uncertainties, the NRC staff will give more emphasis to prelicense application reviews and less emphasis on preparing staff technical positions
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2013-01-22
... intends to provide the underlying principles to determine the type of marketing submission that may be... industry and FDA staff on the underlying principles to determine the type of marketing submission that may... Modifications to a Combination Product Approved Under Certain Marketing Applications; Availability AGENCY: Food...
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75 FR 20606 - Guidance for Industry on Tobacco Health Document Submission; Availability
2010-04-20
..., adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and... documents in a digital format, which FDA strongly encourages in order to improve the management and...
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International Nuclear Information System (INIS)
1989-12-01
The Uranium Mill Tailings Radiation Control Act (UMTRCA) of 1978, Public Law 95-604 (PL95-604), grants the Secretary of Energy the authority and responsibility to perform such actions as are necessary to minimize radiation health hazards and other environmental hazards caused by inactive uranium mill sites. This Technical Approach Document (TAD) describes the general technical approaches and design criteria adopted by the US Department of Energy (DOE) in order to implement remedial action plans (RAPS) and final designs that comply with EPA standards. It does not address the technical approaches necessary for aquifer restoration at processing sites; a guidance document, currently in preparation, will describe aquifer restoration concerns and technical protocols. This document is a second revision to the original document issued in May 1986; the revision has been made in response to changes to the groundwater standards of 40 CFR 192, Subparts A--C, proposed by EPA as draft standards. New sections were added to define the design approaches and designs necessary to comply with the groundwater standards. These new sections are in addition to changes made throughout the document to reflect current procedures, especially in cover design, water resources protection, and alternate site selection; only minor revisions were made to some of the sections. Sections 3.0 is a new section defining the approach taken in the design of disposal cells; Section 4.0 has been revised to include design of vegetated covers; Section 8.0 discusses design approaches necessary for compliance with the groundwater standards; and Section 9.0 is a new section dealing with nonradiological hazardous constituents. 203 refs., 18 figs., 26 tabs
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Buried Waste Integrated Demonstration Technology Preparedness and Status Report Guidance
International Nuclear Information System (INIS)
Blacker, P.B.; Bonnenberg, R.W.; Cannon, P.G.; Hyde, R.A.; Watson, L.R.
1994-04-01
A Technology Preparedness and Status Report is required for each Technical Task Plan funded by the Buried Waste Integrated Demonstration. This document provides guidance for the preparation of that report. Major sections of the report will include a subset of the need for the technology, objectives of the demonstration, technology description and readiness evaluation, demonstration requirements, and preparedness checklist and action plan
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2013-03-05
... implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings... guidance to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA... Commerce of the U.S. House of Representatives setting out the goals of section 201(c) of MDUFA II, Title II...
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Advance notification of shipments of nuclear waste and spent fuel: guidance
International Nuclear Information System (INIS)
1982-06-01
U.S. Nuclear Regulatory Commission regulations in 10 CFR 70.5b and 73.37(f) require NRC licensees to notify the governor of a state prior to making a shipment of nuclear waste or spent fuel within or through the state. This guidance document was prepared to assist licensees in carrying out those requirements
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Technical Basis Document (TBD) and user guides
International Nuclear Information System (INIS)
Chiaro, P.J. Jr.
1998-09-01
A Technical Basis Document (TBD) should provide the background information for establishment of an instrument's operational requirements. Due to the amount and location of DOE facilities, no one set of requirements is possible. Operational requirements will vary based on the local environments and missions at each facility. Environmental conditions that can affect an instrument's operations are ambient temperature, humidity, and radio frequency, and to a lesser extent, magnetic fields, and interfering ionizing radiations. Consideration should also be made regarding how an instrument is to be used. If an instrument will be transported around the facility, vibration and shock can cause problems if they are not addressed in the TBD. This document provides guidance for the development of a TBD. This document applies to radiation instruments used for personnel and equipment contamination monitoring, dose rate monitoring, and air monitoring
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2011-03-14
...] Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information--Fermentation-Derived... Controls (CMC) Information-- Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products... documentation to submit to support the CMC information for fermentation-derived intermediates, drug substances...
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Hayes, Ben; Richardson, Sally; Hindle, Sarah; Grayson, Katy
2011-01-01
This paper reports an action research project in a school in the UK designed to investigate the impact of a brief Video Interaction Guidance (VIG) intervention in promoting skills of non-teaching staff in positive behaviour management. A summary of the literature in relation to VIG is provided before describing the project and data collected. Ten…
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Security of radioactive sources. Interim guidance for comment
International Nuclear Information System (INIS)
2003-06-01
In previous IAEA publications, there have been only rather general security requirements for non-nuclear radioactive material. These requirements were primarily directed to such issues as unintentional exposure to radiation, negligence and inadvertent loss. However, it is clear that more guidance is needed to not only try and prevent further events involving orphan sources, but also to prevent the deliberate attempt to acquire radioactive sources for malevolent purposes. Member States have requested guidance on the type and nature of security measures that might be put in place and on the methodology to be used in choosing such measures. These requests were also endorsed in the findings of the international conference on 'Security of Radioactive Sources' held in March 2003. Practical advice on assessing and implementing security measures complements the general commitments in the proposed Revised Code of Conduct on Safety and Security of radioactive Sources. A Safety Guide entitled 'Safety and Security of Radiation Sources' that, amongst other things, discusses these issues is being drafted. However, it is recognized that guidance material is required before this document will be finalized in order to allow Member States opportunity to put in place appropriate actions and planning to address current issues. Hence the purpose of the current document is to provide advice on security approaches and to allow comment on detailed recommendations for levels of security on radioactive sources that may be incorporated within the Safety Guide. This report is primarily addressed to Regulatory Authorities but it is also intended to provide guidance to manufacturers, suppliers and users of sources. Its objective is to assist Member States in deciding which security measures are needed to ensure consistency with the International Basic Safety Standards and the Revised Code of Conduct for the Safety and Security of Radioactive Sources. It is recognized that there must be a
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NRC ARDC Guidance Support Status Report
Energy Technology Data Exchange (ETDEWEB)
Holbrook, Mark R. [Idaho National Lab. (INL), Idaho Falls, ID (United States)
2017-07-01
This report provides a summary that reflects the progress and status of proposed regulatory design criteria for advanced non-light water reactor (LWR) designs in accordance with the Level 3 milestone M3AT-17IN2001013 in work package AT-17IN200101. These criteria have been designated as advanced reactor design criteria (ARDC) and they provide guidance to future applicants for addressing the general design criteria (GDC) that are currently applied specifically to LWR designs. This report provides a summary of Phase 2 activities related to the various tasks associated with ARDC development and the subsequent development of ARDC regulatory guidance for sodium fast reactor (SFR) and modular high-temperature gas-cooled reactor (HTGR) designs. Status Report Organization: Section 2 discusses the origin of the GDC and their application to LWRs. Section 3 addresses the objective of this initiative and how it benefits the advanced non-LWR reactor vendors. Section 4 discusses the scope and structure of the initiative. Section 5 provides background on the U.S. Department of Energy (DOE) ARDC team’s original development of the proposed ARDC that were submitted to the NRC for consideration. Section 6 provides a summary of recent ARDC Phase 2 activities. Appendices A through E document the DOE ARDC team’s public comments on various sections of the NRC’s draft regulatory guide DG–1330, “Guidance for Developing Principal Design Criteria for Non-Light Water Reactors.”
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NRC ARDC Guidance Support Status Report
International Nuclear Information System (INIS)
Holbrook, Mark R.
2017-01-01
This report provides a summary that reflects the progress and status of proposed regulatory design criteria for advanced non-light water reactor (LWR) designs in accordance with the Level 3 milestone M3AT-17IN2001013 in work package AT-17IN200101. These criteria have been designated as advanced reactor design criteria (ARDC) and they provide guidance to future applicants for addressing the general design criteria (GDC) that are currently applied specifically to LWR designs. This report provides a summary of Phase 2 activities related to the various tasks associated with ARDC development and the subsequent development of ARDC regulatory guidance for sodium fast reactor (SFR) and modular high-temperature gas-cooled reactor (HTGR) designs. Status Report Organization: Section 2 discusses the origin of the GDC and their application to LWRs. Section 3 addresses the objective of this initiative and how it benefits the advanced non-LWR reactor vendors. Section 4 discusses the scope and structure of the initiative. Section 5 provides background on the U.S. Department of Energy (DOE) ARDC team’s original development of the proposed ARDC that were submitted to the NRC for consideration. Section 6 provides a summary of recent ARDC Phase 2 activities. Appendices A through E document the DOE ARDC team’s public comments on various sections of the NRC’s draft regulatory guide DG–1330, “Guidance for Developing Principal Design Criteria for Non-Light Water Reactors.”
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Alexandria: towards an efficient centralised document management. More efficient business processes
International Nuclear Information System (INIS)
Couvreur, D.
2011-01-01
The capital of SCK-CEN is the knowledge of its staff. There is an enormous amount of information circulating within the research centre. A centralised management for all documents is also critical to efficiently manage, share and unlock the expertise. Since 2009, SCK-CEN has been working on a document management system: Alexandria. A first test draft was completed in 2010.
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PSA applications. Good practices and documentation
International Nuclear Information System (INIS)
Dewailly, J.; Magne, L.
1997-10-01
In this paper, it is shown what the condensed documentation of the main strategic choices and technical assumptions related to a PSA could contain: how to select the internal and external initiating events, how the detail the plant configuration and the general organization of the plant and operating staff, how to highlight the assumptions related to physical models, etc. The proposals in this documentation are based on the R and D D's experience with PSA (construction of PSA models, use of PSA models for operation or maintenance, PSA tools). This document also presents different types of rules or recommendations related to PSA modelling for various applications involved in nuclear power plant operating. Finally, the paper stresses the main difficulties encountered (appropriate use of uncertainties, communication of PSA results to non-specialist users) and it also outlines some prospects for the future. (author)
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Health physics limitations for radiation protection of patients and medical staff
International Nuclear Information System (INIS)
Golikov, V.Ya.; Ermolina, E.P.
1997-01-01
Norm-setting documents regulating the requirements to radiation safety during medical x-ray and radiological procedures are reviewed. Besides the Federal Law On Radiation Safety of the Population and Radiation Safety Norms-96, the authors comment on the norm-setting documents issued later and supplementing the above documents. The authors emphasize the obligatory licensing during medical use of ionizing radiation sources. Effective dose is introduced as the criterion of radiation safety of the patients and staff during prophylactic x-ray examinations. Principles of normsetting, validation, and optimization of medical exposures and criteria of radiation safety of patients are discussed
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Career guidance in communities
DEFF Research Database (Denmark)
Thomsen, Rie
for the development of a critically reflexive career guidance practice. The considerations are organised around seven elements. 1. Creating opportunity, structure and access 2. Entering a community and increasing visibility 3. Providing guidance in communities 4. Exploring potentials in guidance situations 5...... in career guidance practices as well as in the lives of the people in the communities. This paper falls into two parts: The first part considers the collective as the starting point for the development of meaningful career guidance activities. Based on previous research on career guidance in communities......The aim of this paper is to inspire practitioners and professionals to leave their offices to bring career guidance into communities that might not identify with career guidance in the first instance. By making the effort to engage with communities, practitioners may bring about a critical change...
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Energy Technology Data Exchange (ETDEWEB)
Jiang, Wei; Gowri, Krishnan; Lane, Michael D.; Thornton, Brian A.; Rosenberg, Michael I.; Liu, Bing
2009-09-28
This Technical Support Document (TSD) describes the process, methodology and assumptions for development of the 50% Energy Savings Design Technology Packages for Highway Lodging Buildings, a design guidance document intended to provide recommendations for achieving 50% energy savings in highway lodging properties over the energy-efficiency levels contained in ANSI/ASHRAE/IESNA Standard 90.1-2004, Energy Standard for Buildings Except Low-Rise Residential Buildings.
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Energy Technology Data Exchange (ETDEWEB)
Thornton, Brian A.; Wang, Weimin; Lane, Michael D.; Rosenberg, Michael I.; Liu, Bing
2009-09-01
This Technical Support Document (TSD) describes the process and methodology for development of the Advanced Energy Design Guide for Medium Offices (AEDG-MO or the Guide), a design guidance document which intends to provide recommendations for achieving 50% energy savings in medium office buildings that just meet the requirements of ANSI/ASHRAE/IESNA Standard 90.1-2004, Energy Standard for Buildings Except Low-Rise Residential Buildings.
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Baillie, Lesley; Thomas, Nicola
2018-01-01
Person-centred care is internationally recognised as best practice for the care of people with dementia. Personal information documents for people with dementia are proposed as a way to support person-centred care in healthcare settings. However, there is little research about how they are used in practice. The aim of this study was to analyse healthcare staff 's perceptions and experiences of using personal information documents, mainly Alzheimer's Society's 'This is me', for people with dementia in healthcare settings. The method comprised a secondary thematic analysis of data from a qualitative study, of how a dementia awareness initiative affected care for people with dementia in one healthcare organisation. The data were collected through 12 focus groups (n = 58 participants) and 1 individual interview, conducted with a range of healthcare staff, both clinical and non-clinical. There are four themes presented: understanding the rationale for personal information documents; completing personal information documents; location for personal information documents and transfer between settings; impact of personal information documents in practice. The findings illuminated how healthcare staff use personal information documents in practice in ways that support person-centred care. Practical issues about the use of personal information documents were revealed and these may affect the optimal use of the documents in practice. The study indicated the need to complete personal information documents at an early stage following diagnosis of dementia, and the importance of embedding their use across care settings, to support communication and integrated care.
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Human-system Interfaces to Automatic Systems: Review Guidance and Technical Basis
Energy Technology Data Exchange (ETDEWEB)
OHara, J.M.; Higgins, J.C.
2010-01-31
Automation has become ubiquitous in modern complex systems and commercial nuclear power plants are no exception. Beyond the control of plant functions and systems, automation is applied to a wide range of additional functions including monitoring and detection, situation assessment, response planning, response implementation, and interface management. Automation has become a 'team player' supporting plant personnel in nearly all aspects of plant operation. In light of the increasing use and importance of automation in new and future plants, guidance is needed to enable the NRC staff to conduct safety reviews of the human factors engineering (HFE) aspects of modern automation. The objective of the research described in this report was to develop guidance for reviewing the operator's interface with automation. We first developed a characterization of the important HFE aspects of automation based on how it is implemented in current systems. The characterization included five dimensions: Level of automation, function of automation, modes of automation, flexibility of allocation, and reliability of automation. Next, we reviewed literature pertaining to the effects of these aspects of automation on human performance and the design of human-system interfaces (HSIs) for automation. Then, we used the technical basis established by the literature to develop design review guidance. The guidance is divided into the following seven topics: Automation displays, interaction and control, automation modes, automation levels, adaptive automation, error tolerance and failure management, and HSI integration. In addition, we identified insights into the automaton design process, operator training, and operations.
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The purpose of the activities described in this document is to provide a demonstration of the procedures and methodologies described within the "Guidance for Evaluating Landfill Gas Emissions from Closed or Abandoned Facilities" (Guidance). This demonstration provides an example ...
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2013-01-01
Background If Public Health is the science and art of how society collectively aims to improve health, and reduce inequalities in health, then Public Health Economics is the science and art of supporting decision making as to how society can use its available resources to best meet these objectives and minimise opportunity cost. A systematic review of published guidance for the economic evaluation of public health interventions within this broad public policy paradigm was conducted. Methods Electronic databases and organisation websites were searched using a 22 year time horizon (1990–2012). References of papers were hand searched for additional papers for inclusion. Government reports or peer-reviewed published papers were included if they; referred to the methods of economic evaluation of public health interventions, identified key challenges of conducting economic evaluations of public health interventions or made recommendations for conducting economic evaluations of public health interventions. Guidance was divided into three categories UK guidance, international guidance and observations or guidance provided by individual commentators in the field of public health economics. An assessment of the theoretical frameworks underpinning the guidance was made and served as a rationale for categorising the papers. Results We identified 5 international guidance documents, 7 UK guidance documents and 4 documents by individual commentators. The papers reviewed identify the main methodological challenges that face analysts when conducting such evaluations. There is a consensus within the guidance that wider social and environmental costs and benefits should be looked at due to the complex nature of public health. This was reflected in the theoretical underpinning as the majority of guidance was categorised as extra-welfarist. Conclusions In this novel review we argue that health economics may have come full circle from its roots in broad public policy economics. We may
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AECB staff annual report of Bruce NGS 'B' for the year 1988
International Nuclear Information System (INIS)
1989-05-01
The operation of the Bruce 'B' Nuclear Generating Station is monitored and licensing requirements are enforced by the Atomic Energy Control Board (AECB) Bruce project staff, with appropriate support from other AECB personnel. The staff observes operation of the reactors, conducts audits, witnesses important activities, reviews station documentation and reports, and issues approvals where appropriate in accordance with license conditions. As required by a condition of its Operating Licence, Ontario Hydro each year submits Technical Reports which summarize various aspects of the operation of Bruce NGS 'B' during the year. When these reports have been reviewed by AECB staff, a formal Annual Review Meeting is held with the station management to discuss safety-related aspects of the station operation, and to inform Ontario Hydro of AECB staff conclusions with respect to the performance of Ontario Hydro in operating the station during the year
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Personal Staff - Joint Staff - The National Guard
the ARNG Deputy Director of the ARNG Chief of Staff of the ARNG Command Chief Warrant Officer of the Site Maintenance Battle Focused Training Strategy Battle Staff Training Resources News Publications March Today in Guard History Leadership CNGB VCNGB SEA DANG DARNG Joint Staff J-1 J-2 J-3 J-4 J-5 J-6 J
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Guidance on the environmental risk assessment of plant pests
DEFF Research Database (Denmark)
Baker, R.; Candresse, T.; Dormannsne Simon, E.
2011-01-01
The European Food Safety Authority (EFSA) requested the Panel on Plant Health to develop a methodology for assessing the environmental risks posed by harmful organisms that may enter, establish and spread in the European Union. To do so, the Panel first reviewed the methods for assessing...... the environmental risks of plant pests that have previously been used in pest risk assessment. The limitations identified by the review led the Panel to define the new methodology for environmental risk assessment which is described in this guidance document. The guidance is primarily addressed to the EFSA PLH...... (biodiversity) and the functional (ecosystem services) aspects of the environment, this new approach includes methods for assessing both aspects for the first time in a pest risk assessment scheme. A list of questions has been developed for the assessor to evaluate the consequences for structural biodiversity...
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Hanson, Carl E.
2005-09-01
In April 1995, the Federal Transit Administration of the U.S. Department of Transportation issued its guidance manual, ``Transit Noise and Vibration Impact Assessment.'' The manual was written to provide direction for the preparation of noise and vibration sections of environmental documents for public transportation projects in the interest of promoting quality and uniformity in assessments. In the 10 years since its release, the guidance manual has been used as the basis of noise and vibration assessments in over 80 environmental documents and has been used worldwide as a standard method for performing transit noise analyses. An updated version has recently been prepared that takes account of improvements in tools, changes in the environmental assessment procedures, modifications of impact criteria, and experience with mitigation measures. These factors, and other background information, will be discussed to provide insight regarding the revisions in the new edition.
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Energy Technology Data Exchange (ETDEWEB)
Dahl, Eivind; Scheers, Lex; Ting, Frank; Letton, Chip
2005-07-01
As first stated in the Introduction, improvements in multiphase flow meters during the last 15 years have resulted in their increased usage in upstream oil and gas applications, especially in difficult offshore locations both topside and deep subsea. To address user needs for information and standardization in the area, documentation has recently been created under the auspices of the NFOGM, API, and ISO. Our intent here was to familiarize potential users with the three new documents, which should be helpful in a number of respects, e.g., (a) distribution of best knowledge and operational practices on the subject, (b) provision of a common language for discussing multiphase flow, and (c) accounting for the requirements of governing regulatory authorities. At this stage of completion of NFOGM, API, and ISO reports, a natural question arises as to what the future holds for another round of flow measurement documentation. Candidate areas include: 1) In Situ Verification of Multiphase Flow Meters. 2) Wet Gas Flow Measurement. 3) Flare Gas Meters. 4) Virtual Metering. 5) Composition and Phase Behavior Issues In Measurement. 6) Flow Measurement Uncertainty. Addressing certain of these is already being proposed in several possible venues, among which are (1) the DeepStar Consortium, (2) a JIP for investigating total system (meter + flowline + separator) uncertainty organized by a group at Tulsa University, and (3) a program for development of drilling and production capabilities in ultradeep water to be sponsored by the US Department of Energy. The creation of the three documents discussed in this paper demonstrates the benefits that strong international cooperation can achieve in producing standardization documents, ensuring their true global input and acceptance. On the other hand, it should also be questioned why two or more documents are required, which are the result of much duplication of effort. For example, although there are differences between API RP86 and the
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The impact of an oral hygiene education module on patient practices and nursing documentation.
Coke, Lola; Otten, Karine; Staffileno, Beth; Minarich, Laura; Nowiszewski, Candice
2015-02-01
Oral hygiene is inconsistent among patients with cancer and is a national patient care issue. To promote comfort and nutritional status, oral hygiene for patients with cancer is important. The purpose of this study was to develop an evidence-based oral hygiene educational module (EM) for nursing and patient care technician (PCT) staff to promote consistent oral hygiene patient education; evaluate patient understanding of oral hygiene practices post-EM; and determine staff documentation frequency of oral hygiene care. Pre- and post-EM data were collected using a developed oral hygiene assessment tool; nursing documentation data were collected by chart review. Post-EM data were collected eight weeks post-EM. Data were analyzed using frequencies and the Mann-Whitney U test. Twenty-two patient documentation pairs were collected. Compared to pre-EM, admission teaching, patient education, and patient oral hygiene practices improved post-EM. Post-EM oral hygiene documentation and PCT teaching increased.
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International Nuclear Information System (INIS)
1977-09-01
In enacting the Energy Reorganization Act of 1974, Congress included Section 206 which requires the reporting of defects and noncompliances directly to the Nuclear Regulatory Commission (NRC). This congressional action required that the NRC promulgate rules and regulations, as necessary, to assure appropriate implementation of Section 206. In response to this mandate, the NRC drafted a new regulation. Following a period of public comment and revision, the regulation identified as 10 CFR Part 21, Reporting Defects and Noncompliance, was published in a Federal Register Notice on June 6, 1977. To assist NRC licensees and other firms and organizations covered by the new Part 21 regulation, public regional meetings were conducted by staff representatives to explain the rule. At these meetings the staff presented prepared remarks and answered questions on the meaning and application of the rule. Staff remarks contained in the original publication of this document were also provided to those in attendance. At each meeting the staff received a request for the questions and answers discussed by the staff to be made available for use as guidance by the nuclear industry covered by the rule. It was announced that a consolidation of the staff position question/answer guidance would be made available to each organization or firm attending these meetings and for others where a request is made in accordance with the directions printed insidethe front cover of the document. The staff will be guided in its implementation and enforcement of Part 21 by the positions set forth in the document. The revision of NUREG-0302 includes the following three parts relating to 10 CFR Part 21: (1) remarks presented by staff representatives; (2) Federal Register Notice material; and (3) a consolidation of questions and answers from the public regional meetings
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Crobach, M J T; Planche, T; Eckert, C; Barbut, F; Terveer, E M; Dekkers, O M; Wilcox, M H; Kuijper, E J
2016-08-01
In 2009 the first European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guideline for diagnosing Clostridium difficile infection (CDI) was launched. Since then newer tests for diagnosing CDI have become available, especially nucleic acid amplification tests. The main objectives of this update of the guidance document are to summarize the currently available evidence concerning laboratory diagnosis of CDI and to formulate and revise recommendations to optimize CDI testing. This update is essential to improve the diagnosis of CDI and to improve uniformity in CDI diagnosis for surveillance purposes among Europe. An electronic search for literature concerning the laboratory diagnosis of CDI was performed. Studies evaluating a commercial laboratory test compared to a reference test were also included in a meta-analysis. The commercial tests that were evaluated included enzyme immunoassays (EIAs) detecting glutamate dehydrogenase, EIAs detecting toxins A and B and nucleic acid amplification tests. Recommendations were formulated by an executive committee, and the strength of recommendations and quality of evidence were graded using the Grades of Recommendation Assessment, Development and Evaluation (GRADE) system. No single commercial test can be used as a stand-alone test for diagnosing CDI as a result of inadequate positive predictive values at low CDI prevalence. Therefore, the use of a two-step algorithm is recommended. Samples without free toxin detected by toxins A and B EIA but with positive glutamate dehydrogenase EIA, nucleic acid amplification test or toxigenic culture results need clinical evaluation to discern CDI from asymptomatic carriage. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
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PBL as a Tool for Staff Development in the Educational Transformation towards PBL
DEFF Research Database (Denmark)
Du, Xiangyun; Kolmos, Anette; Qvist, Palle
2007-01-01
Abstract Worldwide, the philosophy of problem based and project based learning (PBL) has been implemented as educational models in diverse practice of teaching and learning. Recent years have witnessed more and more educational transformations towards PBL. Despite the diversity of approaches...... and practices in the process of organizational transformation, staff development remains one of key elements in the transformation process in order to teach staff new PBL practice.. A growing body of literature discussing the role of facilitation in PBL, implementation of PBL at different levels in educational...... practice, PBL online; however, little has been documented on the practice of staff development in PBL, especially through online education in the form of PBL. This paper presents the experiences and reflections of using PBL online as a strategy for staff development based on the practice...
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EPRI Guidance for Transition from Operations to Decommissioning
International Nuclear Information System (INIS)
McGrath, Richard; Reid, Richard; Snyder, Michael
2016-01-01
A wide range of key activities are necessary after permanent shutdown of a nuclear power plant before active dismantlement of the plant can begin. This period is typically referred to as the transition period. In some cases these activities are prescribed by regulation and in others they may be more practically driven or even optional. In either case, planning for transition activities should optimally take place prior to final shutdown. Additionally, execution of some transition period activities, such as filing required regulatory submittals, may be performed prior to plant shut down. In addition to general transition period activities such as defueling, management of operational wastes, fulfilling regulatory requirements and changes to plant technical specifications, there are a number of optional activities that may have a long-range impact on future decommissioning activities. This includes activities such as the timing of staff reductions and performance of chemical decontamination. EPRI is nearing completion of a project to develop guidance for transitioning a nuclear power plant to decommissioning. This project includes the following elements: - A review of required and recommended transition period activities. For countries where a clear regulatory framework exists, this includes country-specific requirements; - A review of pending regulatory activities in the US and other countries where there is currently no clear regulatory framework for transitioning to decommissioning; - A summary of activities that have been performed during the transition period for past and current decommissioning sites, as well as current sites that are actively planning decommissioning activities; and - Guidance for development of a transition plan for changing from an operational to decommissioning status. Informed planning of the transition period activities will provide immediate benefits in reducing costs and minimizing the duration of the transition period, as well as longer
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Equal employment opportunity plan development guidance
Energy Technology Data Exchange (ETDEWEB)
None
1978-09-01
The purpose of this publication is to provide instructions for the development of EEO Plans for Fiscal Year 1979. It supplements the National EEO Plan for the Department of Energy issued in August 1978 (DOE/S-0002). The material included should be used immediately as guidance to develop, document, and implement subordinate echelon commitments to EEO. A schedule for the development and submission of EEO Plans is included. Most of the continuing requirements will be published at a later date as part of the directives system. Any comments or helpful suggestions concerned with the program outlined would be appreciated by the Office of Equal Opportunity.
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This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.
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Methods Used to Document Procedural Fidelity in School-Based Intervention Research
Barnett, David; Hawkins, Renee; McCoy, Dacia; Wahl, Elaine; Shier, Ashley; Denune, Hilary; Kimener, Lauren
2014-01-01
There has been a paucity of guidance on the methodological details needed for measuring and sampling the independent variable or actual intervention occurrences in research and practice. Furthermore, the planning and support necessary to document the independent variable in both circumstances may be considerable. The current study extends prior…
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Final technical position on documentation of computer codes for high-level waste management
International Nuclear Information System (INIS)
Silling, S.A.
1983-06-01
Guidance is given for the content of documentation of computer codes which are used in support of a license application for high-level waste disposal. The guidelines cover theoretical basis, programming, and instructions for use of the code
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Energy Technology Data Exchange (ETDEWEB)
Welfonder, E
1986-01-01
The report - starting with an overview of the general structure of documentation - includes in chapter 3 an assortment of the main expectations to be had by the technical staff towards control system documentation. These are divided into: general basic requirements; testable compulsory requirements; practical recommendations and information for the manufacturer. In chapter 4 these documentation requirements are reflected to the present state of technical documentation. The main emphasis of the report however is laid on the sample documentation for one control system area presented in chapter 5. This sample documentation is based on a hierarchically structured and function related documentary method developed by the University of Stuttgart on the basis of the derived requirements and the present usual control system documentation. This function-related documentary method proves to be useful, not only for the technical staff in his rapid search for control system disturbances, but also offers - due to its clear and homogeneous meshed structure - considerable advantages for control system planning, projecting and initial start ups. As the presented documentation method is furthermore independent of the control system manufacturers, it is important that all participants try to use it uniformly.
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Guidance for States Implementing Comprehensive Safeguards Agreements and Additional Protocols
International Nuclear Information System (INIS)
2012-01-01
This publication is aimed at enhancing States' understanding of the safeguards obligations of both the State and the IAEA, and at improving the cooperation between States and the IAEA in safeguards implementation. It is principally intended for State or regional safeguards regulatory authorities and facility operators, and is a reference document that will be supported by detailed guidance and examples in 'Safeguards Implementation Practices' (SIPs) to be published separately.
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Siegfried, Elaine C; Jaworski, Jennifer C; Eichenfield, Lawrence F; Paller, Amy; Hebert, Adelaide A; Simpson, Eric L; Altman, Emily; Arena, Charles; Blauvelt, Andrew; Block, Julie; Boguniewicz, Mark; Chen, Suephy; Cordoro, Kelly; Hanna, Diane; Horii, Kimberly; Hultsch, Thomas; Lee, James; Leung, Donald Y; Lio, Peter; Milner, Joshua; Omachi, Theodore; Schneider, Christine; Schneider, Lynda; Sidbury, Robert; Smith, Timothy; Sugarman, Jeffrey; Taha, Sharif; Tofte, Susan; Tollefson, Megha; Tom, Wynnis L; West, Dennis P; Whitney, Lucinda; Zane, Lee
2018-05-01
Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for "the Agency's current thinking on a particular subject." Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices). © 2018 Wiley Periodicals, Inc.
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Developing strategic plans for effective utilization of research reactors
International Nuclear Information System (INIS)
Ridikas, Danas
2015-01-01
Strategic plans are indispensable documents for research reactors (RRs) to ensure their efficient, optimized and well managed utilization. A strategic plan provides a framework for increasing utilization, while helping to create a positive safety culture, a motivated staff, a clear understanding of real costs and a balanced budget. A strategic plan should be seen as an essential tool for a responsible manager of any RR, from the smallest critical facility to the largest reactor. Results and lessons learned are shown from the IAEA efforts to help the RR facilities developing strategic plans, provide review and advise services, organize national and regional stakeholder/user workshops, prepare further guidance and recommendations, document and publish guidance documents and other supporting materials.
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Developing strategic plans for effective utilization of research reactors
Energy Technology Data Exchange (ETDEWEB)
Ridikas, Danas [International Atomic Energy Agency, Vienna (Austria). Dept. of Nuclear Sciences and Applications
2015-12-15
Strategic plans are indispensable documents for research reactors (RRs) to ensure their efficient, optimized and well managed utilization. A strategic plan provides a framework for increasing utilization, while helping to create a positive safety culture, a motivated staff, a clear understanding of real costs and a balanced budget. A strategic plan should be seen as an essential tool for a responsible manager of any RR, from the smallest critical facility to the largest reactor. Results and lessons learned are shown from the IAEA efforts to help the RR facilities developing strategic plans, provide review and advise services, organize national and regional stakeholder/user workshops, prepare further guidance and recommendations, document and publish guidance documents and other supporting materials.
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The nursing staff's opinion of falls among older persons with dementia. a cross-sectional study
Directory of Open Access Journals (Sweden)
Slaasletten Randi
2011-06-01
Full Text Available Abstract The aim of this study was to describe the nursing staff's opinion of caring for older persons with dementia with the focus on causes of falls, fall-preventing interventions, routines of documentation and report and the nursing staff's experiences and reactions when fall incidents occur. A further aim was to compare these areas between registered nurses (RNs and enrolled nurses (ENs and staff with ≤5 and >5 years of employment in the care units in question. Background Falls are common among older people and persons with dementia constitute an additional risk group. Methods The study had a cross-sectional design and included nursing staff (n = 63, response rate 66% working in four special care units for older persons with dementia. Data collection was conducted with a questionnaire consisting of 64 questions. Results The respondents reported that the individuals' mental and physical impairment constitute the most frequent causes of falls. The findings also revealed a lack of, or uncertainty about, routines of documentation and reporting fall-risk and fall-preventing interventions. Respondents who had been employed in the care units more than five years reported to a higher degree that colours and material on floors caused falls. RNs considered the residents' autonomy and freedom of movement as a cause of falls to a significantly higher degree than ENs. RNs also reported a significantly longer time than ENs before fall incidents were discovered, and they used conversation and closeness as fall-preventing interventions to a significantly higher degree than ENs. Conclusions Individual factors were the most common causes to falls according to the nursing staff. RNs used closeness and dialog as interventions to a significantly higher degree to prevent falls than ENs. Caring of for older people with dementia consisted of a comprehensive on-going assessment by the nursing staff to balance the residents' autonomy-versus-control to minimise fall
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International Nuclear Information System (INIS)
Szukiewicz, A.J.
1981-07-01
This document provides the NRC staff positions regarding selected areas of environmental qualification of safety-related electrical equipment, in the resolution of Unresolved Safety Issue A-24, 'Qualification of Class IE Safety-Related Equipment.' The positions herein are applicable to plants that are or will be in the construction permit (CP) or operating license (OL) review process and that are required to satisfy the requirements set forth in either the 1971 or the 1974 version of IEEE-323 standard
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Building America Guidance for Identifying and Overcoming Code, Standard, and Rating Method Barriers
Energy Technology Data Exchange (ETDEWEB)
Cole, P. C. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Halverson, M. A. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)
2013-09-01
This guidance document was prepared using the input from the meeting summarized in the draft CSI Roadmap to provide Building America research teams and partners with specific information and approaches to identifying and overcoming potential barriers to Building America innovations arising in and/or stemming from codes, standards, and rating methods.
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Directory of Open Access Journals (Sweden)
Daniel Hutton
2016-12-01
Full Text Available Background: Legislation preventing smoking in public places was introduced in England in July 2007. Since then, smoke-free policies have been extended to the majority of hospitals including those providing cancer therapies. Whilst studies have been conducted on the impact and effectiveness of hospital smoke-free policy in the UK and other countries, there have not been any studies with a focus on cancer care providers. Cancer patients are a priority group for smoking cessation and support and this study aimed to examine implementation of the National Institute Clinical Excellence (NICE guidance (PH48 in acute cancer care trusts in the UK. Methods: Participants were recruited from UK radiotherapy and chemotherapy departments (total 80 sites, 65 organisations and asked to complete a 15 min online questionnaire exploring the implementation of NICE guidance at their hospital site. Results: Considerable variability in implementation of the NICE guidance was observed. A total of 79.1% trusts were smoke-free in theory; however, only 18.6% were described as smoke-free in practice. Areas of improvement were identified in information and support for patients and staff including in Nicotine Replacement Therapy (NRT provision, staff training and clarity on e-cigarette policies. Conclusions: While some trusts have effective smoke-free policies and provide valuable cessation support services for patients, improvements are required to ensure that all sites fully adopt the NICE guidance.
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Health physics training of plant staff
International Nuclear Information System (INIS)
Heublein, R.M. Jr.
1982-01-01
The scope of this document entitled Health Physics Training of Plant Staff addresses those critical elements common to all health physics training programs. The incorporation of these elements in a health physics training program will provide some assurances that the trainees are competent to work in the radiological environment of a nuclear plant. This paper provides sufficient detail for the health physicist to make managerial decisions concerning the planning, development, implementation, and evaluation of health physics training programs. Two models are provided in the appendices as examples of performance based health physics training programs
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Pairwise Trajectory Management (PTM): Concept Description and Documentation
Jones, Kenneth M.; Graff, Thomas J.; Carreno, Victor; Chartrand, Ryan C.; Kibler, Jennifer L.
2018-01-01
Pairwise Trajectory Management (PTM) is an Interval Management (IM) concept that utilizes airborne and ground-based capabilities to enable the implementation of airborne pairwise spacing capabilities in oceanic regions. The goal of PTM is to use airborne surveillance and tools to manage an "at or greater than" inter-aircraft spacing. Due to the accuracy of Automatic Dependent Surveillance-Broadcast (ADS-B) information and the use of airborne spacing guidance, the minimum PTM spacing distance will be less than distances a controller can support with current automation systems that support oceanic operations. Ground tools assist the controller in evaluating the traffic picture and determining appropriate PTM clearances to be issued. Avionics systems provide guidance information that allows the flight crew to conform to the PTM clearance issued by the controller. The combination of a reduced minimum distance and airborne spacing management will increase the capacity and efficiency of aircraft operations at a given altitude or volume of airspace. This document provides an overview of the proposed application, a description of several key scenarios, a high level discussion of expected air and ground equipment and procedure changes, a description of a NASA human-machine interface (HMI) prototype for the flight crew that would support PTM operations, and initial benefits analysis results. Additionally, included as appendices, are the following documents: the PTM Operational Services and Environment Definition (OSED) document and a companion "Future Considerations for the Pairwise Trajectory Management (PTM) Concept: Potential Future Updates for the PTM OSED" paper, a detailed description of the PTM algorithm and PTM Limit Mach rules, initial PTM safety requirements and safety assessment documents, a detailed description of the design, development, and initial evaluations of the proposed flight crew HMI, an overview of the methodology and results of PTM pilot training
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Implementing maintenance complement changes and experience with regulatory guide G-323
International Nuclear Information System (INIS)
Bernston, K.; Budau, J.
2009-01-01
G-323, the Canadian Nuclear Safety Commission (CNSC) guidance document on ensuring minimum staff complement, was released as an official document in July 2007. Shortly before the release of this document, Bruce Power was reviewing minimum complement with a particular focus on minimizing the number of maintenance staff on rotating shifts. The goals were both to increase the maintenance being performed on days, where it would be less error likely, and to reduce the number of personnel exposed to the health impacts of shift work. Although G-323 was not in effect at the time, a decision was made to work to the expectations of the document to the extent possible. This paper outlines the experience in performing this work, as well as lessons learned. (author)
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Integration of existing systematic reviews into new reviews: identification of guidance needs
2014-01-01
Background An exponential increase in the number of systematic reviews published, and constrained resources for new reviews, means that there is an urgent need for guidance on explicitly and transparently integrating existing reviews into new systematic reviews. The objectives of this paper are: 1) to identify areas where existing guidance may be adopted or adapted, and 2) to suggest areas for future guidance development. Methods We searched documents and websites from healthcare focused systematic review organizations to identify and, where available, to summarize relevant guidance on the use of existing systematic reviews. We conducted informational interviews with members of Evidence-based Practice Centers (EPCs) to gather experiences in integrating existing systematic reviews, including common issues and challenges, as well as potential solutions. Results There was consensus among systematic review organizations and the EPCs about some aspects of incorporating existing systematic reviews into new reviews. Current guidance may be used in assessing the relevance of prior reviews and in scanning references of prior reviews to identify studies for a new review. However, areas of challenge remain. Areas in need of guidance include how to synthesize, grade the strength of, and present bodies of evidence composed of primary studies and existing systematic reviews. For instance, empiric evidence is needed regarding how to quality check data abstraction and when and how to use study-level risk of bias assessments from prior reviews. Conclusions There remain areas of uncertainty for how to integrate existing systematic reviews into new reviews. Methods research and consensus processes among systematic review organizations are needed to develop guidance to address these challenges. PMID:24956937
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International Nuclear Information System (INIS)
1992-08-01
The staff of the US Nuclear Regulatory Commission has prepared Volume 2 (Parts 1 and 2) of a safety evaluation report (SER), ''NRC Review of Electric Power Research Institute's Advanced Light Water Reactor Utility Requirements Document -- Evolutionary Plant Designs,'' to document the results of its review of the Electric Power Research Institute's ''Advanced Light Water Reactor Utility Requirements Document.'' This SER gives the results of the staff's review of Volume II of the Requirements Document for evolutionary plant designs, which consists of 13 chapters and contains utility design requirements for an evolutionary nuclear power plant (approximately 1300 megawatts-electric)
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Spent Nuclear Fuel Project document control and Records Management Program Description
International Nuclear Information System (INIS)
MARTIN, B.M.
2000-01-01
The Spent Nuclear Fuel (SNF) Project document control and records management program, as defined within this document, is based on a broad spectrum of regulatory requirements, Department of Energy (DOE) and Project Hanford and SNF Project-specific direction and guidance. The SNF Project Execution Plan, HNF-3552, requires the control of documents and management of records under the auspices of configuration control, conduct of operations, training, quality assurance, work control, records management, data management, engineering and design control, operational readiness review, and project management and turnover. Implementation of the controls, systems, and processes necessary to ensure compliance with applicable requirements is facilitated through plans, directives, and procedures within the Project Hanford Management System (PHMS) and the SNF Project internal technical and administrative procedures systems. The documents cited within this document are those which directly establish or define the SNF Project document control and records management program. There are many peripheral documents that establish requirements and provide direction pertinent to managing specific types of documents that, for the sake of brevity and clarity, are not cited within this document
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International Nuclear Information System (INIS)
Pope, R.B.; Easton, E.P.; Cook, J.R.; Boyle, R.W.
1997-01-01
In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant were major changes to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). As these requirements were adopted into regulations in the United States, it was recognised that guidance on how to apply these requirements to large, contaminated/activated pieces of equipment and decommissioning and decontamination (D and D) objects would be needed both by the regulators and those regulated to clarify technical uncertainties and ensure implementation. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance which will present examples of acceptable methods for demonstrating compliance with the revised rules for large items. Concepts being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment before final issuance in 1997. (Author)