21 CFR 312.145 - Guidance documents.

Science.gov (United States)

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...

Guidance and Control Software Project Data - Volume 2: Development Documents

Science.gov (United States)

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

Offshore Wind Guidance Document: Oceanography and Sediment Stability (Version 1) Development of a Conceptual Site Model.

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.

Guidance to regulations on trade with emission permits for carbon dioxide; Vaegledning till lagstiftning om handel med utslaeppsraetter foer koldioxid

Energy Technology Data Exchange (ETDEWEB)

2008-07-15

This guidance is intended to facilitate application of the rules on emissions trading. The guidance is principally concerned with issues relating to permit appraisal and monitoring, but also discusses some terms common to permits and allocations, such as installation and operator. The guidance follows the same structure as the Swedish Environmental Protection Agency regulations (NFS 2007:5) in order to provide direct support for the rules. The focus is on providing a general description of the responsibilities of the operator and application of the rules. In addition, some difficult terms and relationships are explained. However, no exhaustive description of the operator's responsibilities is given, nor are the rules on verification described. We therefore recommend that the guidance should be read in conjunction with the Trading Act, the Trading Ordinance and the Swedish Environmental Protection Agency regulations. The first chapter presents a brief description of the purpose of the trading scheme, and is followed by a chapter in which the rules on applying for permits and the application procedure are reviewed. The next chapter gives a description of how the operator should monitor emissions and how the rules for the monitoring plan work, as well as the options that exist for simplified monitoring. The next chapter looks at notifications the operator might have to make and what they should contain. Guidance is also provided on how the county administrative board should process these notifications. The conditions of the permit decision are also briefly described. This is followed by a short chapter on the emissions report and the materiality threshold. The final chapter comments on certain parts of the annexes to the regulations. The EU Emissions Trading Directive has been implemented in Sweden through the Emissions Trading Act (2004:1199) (the Trading Act), the Emissions Trading Ordinance (2004:1205), the Swedish Environmental Protection Agency regulations

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

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

Hanford Facility Dangerous Waste Permit Application, 222-S Laboratory Complex

International Nuclear Information System (INIS)

WILLIAMS, J.F.

2000-01-01

The Hanford Facility Dangerous Waste Permit Application is considered to be a single application organized into a General Information Portion (document number DOE/RL-91-28) and a Unit-Specific Portion. The scope of the Unit-Specific Portion is limited to Part B permit application documentation submitted for individual, operating treatment, storage, and/or disposal units, such as the 222-S Laboratory Complex (this document, DOE/RL-91-27). Both the General Information and Unit-Specific portions of the Hanford Facility Dangerous Waste Permit Application address the content of the Part B permit application guidance prepared by the Washington State Department of Ecology (Ecology 1987 and 1996) and the U.S. Environmental Protection Agency (40 Code of Federal Regulations 270), with additional information needs defined by the Hazardous and Solid Waste Amendments and revisions of Washington Administrative Code 173-303. For ease of reference, the Washington State Department of Ecology alpha-numeric section identifiers from the permit application guidance documentation (Ecology 1996) follow, in brackets, the chapter headings and subheadings. Documentation contained in the General Information Portion is broader in nature and could be used by multiple treatment, storage, and/or disposal units (e.g., the glossary provided in the General Information Portion). Wherever appropriate, the 222-S Laboratory Complex permit application documentation makes cross-reference to the General Information Portion, rather than duplicating text. Information provided in this 222-S Laboratory Complex permit application documentation is current as of August 2000

PSD Increment Consumption Guidance

Science.gov (United States)

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.

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

Air pollution and public health: a guidance document for risk managers.

Science.gov (United States)

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.

Guidance and Control Software Project Data - Volume 4: Configuration Management and Quality Assurance Documents

Science.gov (United States)

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.

Forest Products Industry Permitting Information

Science.gov (United States)

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.

Low-level burial grounds dangerous waste permit application design documents

International Nuclear Information System (INIS)

1990-08-01

This document serves a supplement to the already existing ''Low-Level Burial Ground Dangerous Waste Permit Application Design Documents.'' This paper contains information regarding drawings, construction specifications, and liner/leachate compatibility test plans

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.

Determination on Whether Specialty Minerals Inc. Must be Included in the Simpson Paper Company Shasta Mill Application for a Title V Operating Permit as a Support Facility.

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Draft Updates to the Planning for Natural Disaster Debris Guidance and to Related Documents

Science.gov (United States)

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.

Cost consideration in the clinical guidance documents of physician specialty societies in the United States.

Science.gov (United States)

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.

77 FR 36273 - Public Meeting on Draft Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using...

Science.gov (United States)

2012-06-18

... duration and well closure; area of review; information submitted with the permit application; and... Fracturing Activities Using Diesel Fuels--Draft: Underground Injection Control Program Guidance 84.'' The... permits under the Safe Drinking Water Act to ensure protection of underground sources of drinking water...

Hanford Facility dangerous waste permit application, liquid effluent retention facility and 200 area effluent treatment facility

International Nuclear Information System (INIS)

Coenenberg, J.G.

1997-01-01

The Hanford Facility Dangerous Waste Permit Application is considered to 10 be a single application organized into a General Information Portion (document 11 number DOE/RL-91-28) and a Unit-Specific Portion. The scope of the 12 Unit-Specific Portion is limited to Part B permit application documentation 13 submitted for individual, 'operating' treatment, storage, and/or disposal 14 units, such as the Liquid Effluent Retention Facility and 200 Area Effluent 15 Treatment Facility (this document, DOE/RL-97-03). 16 17 Both the General Information and Unit-Specific portions of the Hanford 18 Facility Dangerous Waste Permit Application address the content of the Part B 19 permit application guidance prepared by the Washington State Department of 20 Ecology (Ecology 1987 and 1996) and the U.S. Environmental Protection Agency 21 (40 Code of Federal Regulations 270), with additional information needs 22 defined by the Hazardous and Solid Waste Amendments and revisions of 23 Washington Administrative Code 173-303. For ease of reference, the Washington 24 State Department of Ecology alpha-numeric section identifiers from the permit 25 application guidance documentation (Ecology 1996) follow, in brackets, the 26 chapter headings and subheadings. A checklist indicating where information is 27 contained in the Liquid Effluent Retention Facility and 200 Area Effluent 28 Treatment Facility permit application documentation, in relation to the 29 Washington State Department of Ecology guidance, is located in the Contents 30 Section. 31 32 Documentation contained in the General Information Portion is broader in 33 nature and could be used by multiple treatment, storage, and/or disposal units 34 (e.g., the glossary provided in the General Information Portion). Wherever 35 appropriate, the Liquid Effluent Retention Facility and 200 Area Effluent 36 Treatment Facility permit application documentation makes cross-reference to 37 the General Information Portion, rather than duplicating

Hanford Facility dangerous waste permit application, liquid effluent retention facility and 200 area effluent treatment facility

Energy Technology Data Exchange (ETDEWEB)

Coenenberg, J.G.

1997-08-15

The Hanford Facility Dangerous Waste Permit Application is considered to 10 be a single application organized into a General Information Portion (document 11 number DOE/RL-91-28) and a Unit-Specific Portion. The scope of the 12 Unit-Specific Portion is limited to Part B permit application documentation 13 submitted for individual, `operating` treatment, storage, and/or disposal 14 units, such as the Liquid Effluent Retention Facility and 200 Area Effluent 15 Treatment Facility (this document, DOE/RL-97-03). 16 17 Both the General Information and Unit-Specific portions of the Hanford 18 Facility Dangerous Waste Permit Application address the content of the Part B 19 permit application guidance prepared by the Washington State Department of 20 Ecology (Ecology 1987 and 1996) and the U.S. Environmental Protection Agency 21 (40 Code of Federal Regulations 270), with additional information needs 22 defined by the Hazardous and Solid Waste Amendments and revisions of 23 Washington Administrative Code 173-303. For ease of reference, the Washington 24 State Department of Ecology alpha-numeric section identifiers from the permit 25 application guidance documentation (Ecology 1996) follow, in brackets, the 26 chapter headings and subheadings. A checklist indicating where information is 27 contained in the Liquid Effluent Retention Facility and 200 Area Effluent 28 Treatment Facility permit application documentation, in relation to the 29 Washington State Department of Ecology guidance, is located in the Contents 30 Section. 31 32 Documentation contained in the General Information Portion is broader in 33 nature and could be used by multiple treatment, storage, and/or disposal units 34 (e.g., the glossary provided in the General Information Portion). Wherever 35 appropriate, the Liquid Effluent Retention Facility and 200 Area Effluent 36 Treatment Facility permit application documentation makes cross-reference to 37 the General Information Portion, rather than duplicating

Honda Permits to Install 1 Year Aggregation

Science.gov (United States)

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.

PSD Permit for the Marblehead Lime Company

Science.gov (United States)

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.

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.

Energy Efficiency/Renewable Energy Programs in State Implementation Plans - Guidance Documents

Science.gov (United States)

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).

8 CFR 211.3 - Expiration of immigrant visas, reentry permits, refugee travel documents, and Form I-551.

Science.gov (United States)

2010-01-01

... permits, refugee travel documents, and Form I-551. 211.3 Section 211.3 Aliens and Nationality DEPARTMENT... Expiration of immigrant visas, reentry permits, refugee travel documents, and Form I-551. An immigrant visa, reentry permit, refugee travel document, or Form I-551 shall be regarded as unexpired if the rightful...

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

75 FR 24718 - Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability

Science.gov (United States)

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...

76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

Science.gov (United States)

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...

75 FR 9607 - National Protection and Programs Directorate; Guidance Document Request and Evaluation

Science.gov (United States)

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...

USDA Forest Service, Rocky Mountain Region PSD Permit Completeness Determination

Science.gov (United States)

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.

Request for Guidance on PSD Applicability Determinations for Boiler Emissions

Science.gov (United States)

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.

Hanford facility dangerous waste permit application, general information portion

International Nuclear Information System (INIS)

Hays, C.B.

1998-01-01

The Hanford Facility Dangerous Waste Permit Application is considered to be a single application organized into a General Information Portion (document number DOE/RL-91-28) and a Unit-Specific Portion. Both the General Information and Unit-Specific portions of the Hanford Facility Dangerous Waste Permit Application address the content of the Part B permit application guidance prepared by the Washington State Department of Ecology (Ecology 1996) and the U.S. Environmental Protection Agency (40 Code of Federal Regulations 270), with additional information needed by the Hazardous and Solid Waste Amendments and revisions of Washington Administrative Code 173-303. Documentation contained in the General Information Portion is broader in nature and could be used by multiple treatment, storage, and/or disposal units (e.g., the glossary provided in this report)

TECHNICAL GUIDANCE DOCUMENT: CONSTRUCTION QUALITY MANAGEMENT FOR REMEDIAL ACTION AND REMEDIAL DESIGN WASTE CONTAINMENT SYSTEMS

Science.gov (United States)

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...

Guidance document for revision of DOE Order 5820.2A, Radioactive Waste Technical Support Program. Revision 1

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.

Comparison of the guidance documents in support of EU risk assessments with those for the derivation of EU water quality standards

NARCIS (Netherlands)

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

Applicability of NSR Review Circumvention Guidance to 3M - Maplewood, Minnesota

Science.gov (United States)

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.

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)

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).

Fisher Sand & Gravel New Mexico, Inc. General Air Quality Permit: Related Documents

Science.gov (United States)

Documents related to the Fisher Sand & Gravel – New Mexico, Inc., Grey Mesa Gravel Pit General Air Quality Permit for New or Modified Minor Source Stone Quarrying, Crushing, and Screening Facilities in Indian Country.

Guidance for writing permits for the use or disposal of sewage sludge. Draft report

Energy Technology Data Exchange (ETDEWEB)

1993-03-01

Section 405(d) of the Clean Water Act (CWA) directs the U.S. Environmental Protection Agency (EPA) to develop regulations containing guidelines for the use and disposal of sewage sludge. On February 19th, 1993, EPA published final regulations at 40 Code of Federal Regulations (CFR) Part 503 as the culmination of a major effort to develop technical standards in response to Section 405(d). These regulations govern three sewage sludge use and disposal practices: land application, surface disposal, and incineration. A key element in EPA's implementation of the Part 503 regulations is educating Agency and State personnel about these new requirements. Although the regulations are generally directly enforceable against all persons involved in the use and disposal of sewage sludge, they will also be implemented through permits issued to treatment works treating domestic sewage as defined in 40 CFR 122.22. Thus, the primary focus of the manual is to assist permit writers in incorporating the Part 503 requirements into permits; it serves as an update to the Guidance for Writing Case-by-Case Permit Conditions for Municipal Sewage Sludge (PB91-145508/HDM).

Guidance Document on Anaerobic Digester Foaming Prevention and Control Methods (WERF Report INFR1SG10a)

Science.gov (United States)

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...

Public Comment Period Open for the Draft Update to the Planning for Natural Disaster Debris Guidance and to Related Documents

Science.gov (United States)

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.

Technical Document on Control of Nitrogen Oxides From Municipal Waste Combustors

Science.gov (United States)

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.

Synthesis of the IRSN report on its analysis of the safety guidance package (DOrS) of the ASTRID reactor project. Safety guidance document for the ASTRID prototype: Referral to the GPR. Opinion related to the safety guidance document of the ASTRID reactor project. ASTRID prototype: Safety guidance document for the ASTRID prototype

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

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

HER2 testing of gastro-oesophageal adenocarcinoma: a commentary and guidance document from the Association of Clinical Pathologists Molecular Pathology and Diagnostics Committee.

Science.gov (United States)

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.

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)

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).

Request for Clarification of EPA Guidance on the Alternative Fuels Exemption under the PSD Program

Science.gov (United States)

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.

European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection

NARCIS (Netherlands)

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

EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)

NARCIS (Netherlands)

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

76 FR 9381 - Notice of Availability of Interim Staff Guidance Documents for Spent Fuel Storage Casks

Science.gov (United States)

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...

Cycle water chemistry based on film forming amines at power plants: evaluation of technical guidance documents

Science.gov (United States)

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.

Response to Request for Guidance on PSD Definition Referencing Cogeneration Gas Turbines that are Separated by One-Half Mile

Science.gov (United States)

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.

Guidance Document - Full-cost Recovery for Molybdenum-99 Irradiation Services: Methodology and Implementation

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

Response to Request for Guidance on Use of Pre-1990 ERC' s and Adjusting for RACT at Time of Use

Science.gov (United States)

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.

78 FR 48175 - Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances

Science.gov (United States)

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...

Permitting Considerations for Installation of Inlet Air Foggers on Simple Cycle Combustion Turbines at the Duke Power Lincoln Combustion Turbine Facility

Science.gov (United States)

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.

IRIS Summary and Supporting Documents for Methylmercury ...

Science.gov (United States)

In January 2001, U.S. EPA finalized the guidance for methylmercury in the water quality criteria for states and authorized tribes. The links below take you to the best resources for this guidance. This final Guidance for Implementing the January 2001 Methylmercury Water Quality Criterion provides technical guidance to states and authorized tribes on how they may want to use the January 2001 fish tissue-based recommended water quality criterion for methylmercury in surface water protection programs (e.g., TMDLs, NPDES permitting). The guidance addresses questions related to water quality standards adoption (e.g., site-specific criteria, variances), assessments, monitoring, TMDLs, and NPDES permitting. The guidance consolidates existing EPA guidance where relevant to mercury.

Hanford facility dangerous waste permit application, general information portion. Revision 3

International Nuclear Information System (INIS)

Sonnichsen, J.C.

1997-01-01

Part B permit application documentation has been, or is anticipated to be, submitted. Documentation for treatment, storage, and/or disposal units undergoing closure, or for units that are, or are anticipated to be, dispositioned through other options, will continue to be submitted by the Permittees in accordance with the provisions of the Hanford Federal Facility Agreement and Consent Order. However, the scope of the General Information Portion includes information that could be used to discuss operating units, units undergoing closure, or units being dispositioned through other options. Both the General Information and Unit-Specific portions of the Hanford Facility Dangerous Waste Permit Application address the contents of the Part B permit application guidance documentation prepared by the Washington State Department of Ecology and the U.S. Environmental Protection Agency, with additional information needs defined by revisions of Washington Administrative Code 173-303 and by the Hazardous and Solid Waste Amendments. Documentation contained in the General Information Portion is broader in nature and could be used by multiple treatment, storage, and/or disposal units (i.e., either operating units, units undergoing closure, or units being dispositioned through other options)

Hanford facility dangerous waste permit application, general information portion. Revision 3

Energy Technology Data Exchange (ETDEWEB)

Sonnichsen, J.C.

1997-08-21

Part B permit application documentation has been, or is anticipated to be, submitted. Documentation for treatment, storage, and/or disposal units undergoing closure, or for units that are, or are anticipated to be, dispositioned through other options, will continue to be submitted by the Permittees in accordance with the provisions of the Hanford Federal Facility Agreement and Consent Order. However, the scope of the General Information Portion includes information that could be used to discuss operating units, units undergoing closure, or units being dispositioned through other options. Both the General Information and Unit-Specific portions of the Hanford Facility Dangerous Waste Permit Application address the contents of the Part B permit application guidance documentation prepared by the Washington State Department of Ecology and the U.S. Environmental Protection Agency, with additional information needs defined by revisions of Washington Administrative Code 173-303 and by the Hazardous and Solid Waste Amendments. Documentation contained in the General Information Portion is broader in nature and could be used by multiple treatment, storage, and/or disposal units (i.e., either operating units, units undergoing closure, or units being dispositioned through other options).

76 FR 44594 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

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...

Nuclear Regulatory Commission staff approaches to improving the integration of regulatory guidance documents and prelicensing reviews

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

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.

Evaluation of the endocrine activity of 2,4,6-tribromophenol, benzanthrone and benzophenone-2 based on Appendix 7.8-5 of REACH guidance document

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...

Development of guidance and methodical documents for providing the decommissioning of radiation-hazardous objects

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)

Threshold guidance update

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

Significant Guidance Issued by the Federal Transit Administration

Data.gov (United States)

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...

Significant Guidance Issued by the Federal Aviation Administration

Data.gov (United States)

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...

Significant Guidance Issued by the Federal Highway Administration

Data.gov (United States)

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...

NASA-STD-7009 Guidance Document for Human Health and Performance Models and Simulations

Science.gov (United States)

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.

Guidance document for preparing water sampling and analysis plans for UMTRA Project sites. Revision 1

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

75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

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...

76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

Science.gov (United States)

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...

Consolidated guidance about materials licenses: Program-specific guidance about portable gauge licenses. Final report; Volume 1

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.

Consolidated guidance about materials licenses: Program-specific guidance about portable gauge licenses. Final report; Volume 1

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

77 FR 34390 - Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To...

Science.gov (United States)

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...

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.)

Significant Guidance Issued by the Federal Motor Carrier Safety Administration

Data.gov (United States)

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...

Environmental guidance documents for exploration, development, Production, and transportation of crude oil and natural gas in texas: Quarterly technical report, January 1, 1997-March 31, 1997

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

Requirements, guidance and logic in planning environmental investigations: Approval versus implementation

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

Standardization Documents

Science.gov (United States)

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

Significant Guidance Issued by the Office of the Secretary of Transportation

Data.gov (United States)

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...

Straight Delegation Issues Concerning Sections 111 and 112 Requirements and Title V

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Information Regarding Implementation of the Emission Trading Program Pursuant to 45 CSR28, Air Pollutant Emissions Banking and Trading

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Model Attorney General's Opinion

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Citation Oil and Gas Corporation... Title V Applicability Determination

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Credible Evidence Boilerplate Language

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Overview of Clean Air Title V Financial Management and Reporting: A Handbook for Financial Officers and Program Managers

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Great Salt Lake Minerals Source Determination

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

United Salt Northeast PSD Determination

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Matrix of Title V-Related And Air Grant-Eligible Activities

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Definition of Regulated Pollutant for Particulate Matter for Purposes of Title V

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Aerospace Ground Equipment, Hush Houses, and Jet Engine Test Cells

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Should DuPont and DUSA International be Considered a Single Source for Title V and PSD

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Region 3 James Madison University Single Source Determination

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Title V Applicability Issues Related to the Cincinnati/Northern Kentucky International Airport

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Consideration of Fugitives in Open-Air Cattle Operations

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. 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.

Automatic Commercial Permit Sets

Energy Technology Data Exchange (ETDEWEB)

Grana, Paul [Folsom Labs, Inc., San Francisco, CA (United States)

2017-12-21

Final report for Folsom Labs’ Solar Permit Generator project, which has successfully completed, resulting in the development and commercialization of a software toolkit within the cloud-based HelioScope software environment that enables solar engineers to automatically generate and manage draft documents for permit submission.

76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

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...

77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

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...

Draft federal GHG accounting and reporting : technical support document

Science.gov (United States)

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...

76 FR 48870 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

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...

76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

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...

75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

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...

76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

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...

76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

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...

76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

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...

76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

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...

Dissecting Attending Surgeons' Operating Room Guidance: Factors That Affect Guidance Decision Making.

Science.gov (United States)

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

Hanford facility dangerous waste permit application

International Nuclear Information System (INIS)

1991-01-01

This document, Set 2, the Hanford Facility Dangerous Waste Part B Permit Application, consists of 15 chapters that address the content of the Part B checklists prepared by the Washington State Department of Ecology (Ecology 1987) and the US Environmental Protection Agency (40 CFR 270), with additional information requirements mandated by the Hazardous and Solid Waste Amendments of 1984 and revisions of WAC 173-303. For ease of reference, the Washington State Department of Ecology checklist section numbers, in brackets, follow the chapter headings and subheadings. This permit application contains ''umbrella- type'' documentation with overall application to the Hanford Facility. This documentation is broad in nature and applies to all TSD units that have final status under the Hanford Facility Permit

75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

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...

76 FR 61098 - Guidance for 1-Hour SO2

Science.gov (United States)

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.

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)

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)

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

Guidance document for prepermit bioassay testing of low-level radioactive waste

International Nuclear Information System (INIS)

Anderson, S.L.; Harrison, F.L.

1990-11-01

In response to the mandate of Public Law 92-532, the Marine Protection, Research, and Sanctuaries Act (MPRSA) of 1972, as amended, the Environmental Protection Agency (EPA) has developed a program to promulgate regulations and criteria to control the ocean disposal of radioactive wastes. The EPA seeks to understand the mechanisms for biological response of marine organisms to the low levels of radioactivity that may arise from the release of these wastes as a result of ocean-disposal practices. Such information will play an important role in determining the adequacy of environmental assessments provided to the EPA in support of any disposal permit application. Although the EPA requires packaging of low-level radioactive waste to prevent release during radiodecay of the materials, some release of radioactive material into the deep-sea environment may occur when a package deteriorates. Therefore, methods for evaluating the impact on biota are being evaluated. Mortality and phenotypic responses are not anticipated at the expected low environmental levels that might occur if radioactive materials were released from the low-level waste packages. Therefore, traditional bioassay systems are unsuitable for assessing sublethal effects on biota in the marine environment. The EPA Office of Radiation Programs (ORP) has had an ongoing program to examine sublethal responses to radiation at the cellular level, using cytogenetic end points. This technical guidance report represents prepermit bioassay procedures that potentially may be applicable to the assessment of effects from a mixture of radionuclides that could be released from a point source at the ocean bottom. Methodologies along with rationale and a discussion of uncertainty are presented for the sediment benthic bioassay protocols identified in this report

Guidance document for prepermit bioassay testing of low-level radioactive waste

Energy Technology Data Exchange (ETDEWEB)

Anderson, S.L.; Harrison, F.L.

1990-11-01

In response to the mandate of Public Law 92-532, the Marine Protection, Research, and Sanctuaries Act (MPRSA) of 1972, as amended, the Environmental Protection Agency (EPA) has developed a program to promulgate regulations and criteria to control the ocean disposal of radioactive wastes. The EPA seeks to understand the mechanisms for biological response of marine organisms to the low levels of radioactivity that may arise from the release of these wastes as a result of ocean-disposal practices. Such information will play an important role in determining the adequacy of environmental assessments provided to the EPA in support of any disposal permit application. Although the EPA requires packaging of low-level radioactive waste to prevent release during radiodecay of the materials, some release of radioactive material into the deep-sea environment may occur when a package deteriorates. Therefore, methods for evaluating the impact on biota are being evaluated. Mortality and phenotypic responses are not anticipated at the expected low environmental levels that might occur if radioactive materials were released from the low-level waste packages. Therefore, traditional bioassay systems are unsuitable for assessing sublethal effects on biota in the marine environment. The EPA Office of Radiation Programs (ORP) has had an ongoing program to examine sublethal responses to radiation at the cellular level, using cytogenetic end points. This technical guidance report represents prepermit bioassay procedures that potentially may be applicable to the assessment of effects from a mixture of radionuclides that could be released from a point source at the ocean bottom. Methodologies along with rationale and a discussion of uncertainty are presented for the sediment benthic bioassay protocols identified in this report.

Moisture Control Guidance for Commercial and Public ...

Science.gov (United States)

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

Preparation of waste analysis plans under the Resource Conservation and Recovery Act (Interim guidance)

International Nuclear Information System (INIS)

1993-03-01

This document is organized to coincide with the suggested structure of the actual Waste Analysis Plans (WAP) discussed in the previous section. The contents of the remaining eleven chapters and appendices that comprise this document are described below: Chapter 2 addresses waste streams, test parameters, and rationale for sampling and analytical method selection; test methods for analyzing parameters; proceduresfor collecting representative samples; and frequency of sample collection and analyses. These are the core WAP requirements. Chapter 3 addresses analysis requirements for waste received from off site. Chapter 4addresses additional requirements for ignitable, reactive, or incompatible wastes. Chapter 5 addresses unit-specific requirements. Chapter 6 addresses special procedures for radioactive mixed waste. Chapter 7 addresses wastes subject to the land disposal restrictions. Chapter 8 addresses QA/QC procedures. Chapter 9 compares the waste analysis requirements of an interim status facility with those of a permitted facility. Chapter 10 describes the petition process required for sampling and analytical procedures to deviate from accepted methods, such as those identified in promulgated regulations. Chapter 11 reviews the process for modification of WAPs as waste type or handling practices change at a RCRA permitted TSDF. Chapter 12 is the list of references that were used in the preparation of this guidance. Appendix A is a sample WAP addressing physical/chemical treatment and container storage. Appendix B is a sample WAP addressing an incinerator and tank systems. Appendix C discusses the relationship of the WAP to other permitting requirements and includes specific examples of how waste analysis is used to comply with certain parts of a RCRA permit. Appendix D contains the exact wording for the notification/certification requirements under theland disposal restrictions

76 FR 66925 - Guidance for 1-Hour SO2

Science.gov (United States)

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.

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.)

European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection.

Science.gov (United States)

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.

50 CFR 20.64 - Foreign export permits.

Science.gov (United States)

2010-10-01

... 50 Wildlife and Fisheries 6 2010-10-01 2010-10-01 false Foreign export permits. 20.64 Section 20... WILDLIFE AND PLANTS (CONTINUED) MIGRATORY BIRD HUNTING Importations § 20.64 Foreign export permits. No... such birds are accompanied by export permits, tags, or other documentation required by applicable...

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.

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

Consideration of health inequalities in systematic reviews: a mapping review of guidance.

Science.gov (United States)

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

75 FR 35510 - License Renewal Interim Staff Guidance Process, Revision 2 Notice of Availability

Science.gov (United States)

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...

77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Science.gov (United States)

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...

State Waste Discharge Permit ST-4502 Implementation Plan

Energy Technology Data Exchange (ETDEWEB)

BROWN, M.J.; LECLAIR, M.D.

2000-09-27

Plan has been developed to demonstrate compliance with regulatory requirements set forth in Permit ST-3502 and as a line management tool for use in maintaining configuration control of permit as well as documentation used to implement permit requirements.

State Waste Discharge Permit ST-4502 Implementation Plan

International Nuclear Information System (INIS)

BROWN, M.J.; LECLAIR, M.D.

2000-01-01

Plan has been developed to demonstrate compliance with regulatory requirements set forth in Permit ST-3502 and as a line management tool for use in maintaining configuration control of permit as well as documentation used to implement permit requirements

Hanford facility dangerous waste permit application, 242-A evaporator

International Nuclear Information System (INIS)

Engelmann, R.H.

1997-01-01

The Hanford Facility Dangerous Waste Permit Application is considered to be a single application organized into a General Information Portion (document number DOE/RL-91-28) and a Unit-Specific Portion. The scope of the Unit-Specific Portion is limited to Part B permit application documentation submitted for individual, 'operating' treatment, storage, and/or disposal units, such as the 242-A Evaporator (this document, DOE/RL-90-42)

Project W-314 phase I environmental permits and approvals plan

International Nuclear Information System (INIS)

TOLLEFSON, K.S.

1999-01-01

This document describes the range of environmental actions, including required permits and other agency approvals, for Project W-314 activities in the Hanford Site's Tank Waste Remediation System. This document outlines alternative approaches to satisfying applicable environmental standards, and describes selected strategies for acquiring permits and other approvals needed for waste feed delivery to proceed. This document also includes estimated costs and schedule to obtain the required permits and approvals based on the selected strategy. It also provides estimated costs for environmental support during design and construction based on the preliminary project schedule provided

78 FR 18353 - Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility...

Science.gov (United States)

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...

75 FR 22813 - Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of...

Science.gov (United States)

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...

Hanford Facility Dangerous Waste Permit Application, 200 Area Effluent Treatment Facility

International Nuclear Information System (INIS)

1993-08-01

The 200 Area Effluent Treatment Facility Dangerous Waste Permit Application documentation consists of both Part A and a Part B permit application documentation. An explanation of the Part A revisions associated with this treatment and storage unit, including the current revision, is provided at the beginning of the Part A section. Once the initial Hanford Facility Dangerous Waste Permit is issued, the following process will be used. As final, certified treatment, storage, and/or disposal unit-specific documents are developed, and completeness notifications are made by the US Environmental Protection Agency and the Washington State Department of Ecology, additional unit-specific permit conditions will be incorporated into the Hanford Facility Dangerous Waste Permit through the permit modification process. All treatment, storage, and/or disposal units that are included in the Hanford Facility Dangerous Waste Permit Application will operate under interim status until final status conditions for these units are incorporated into the Hanford Facility Dangerous Waste Permit. The Hanford Facility Dangerous Waste Permit Application, 200 Area Effluent Treatment Facility contains information current as of May 1, 1993

Hanford Facility Dangerous Waste Permit Application, 200 Area Effluent Treatment Facility

Energy Technology Data Exchange (ETDEWEB)

1993-08-01

The 200 Area Effluent Treatment Facility Dangerous Waste Permit Application documentation consists of both Part A and a Part B permit application documentation. An explanation of the Part A revisions associated with this treatment and storage unit, including the current revision, is provided at the beginning of the Part A section. Once the initial Hanford Facility Dangerous Waste Permit is issued, the following process will be used. As final, certified treatment, storage, and/or disposal unit-specific documents are developed, and completeness notifications are made by the US Environmental Protection Agency and the Washington State Department of Ecology, additional unit-specific permit conditions will be incorporated into the Hanford Facility Dangerous Waste Permit through the permit modification process. All treatment, storage, and/or disposal units that are included in the Hanford Facility Dangerous Waste Permit Application will operate under interim status until final status conditions for these units are incorporated into the Hanford Facility Dangerous Waste Permit. The Hanford Facility Dangerous Waste Permit Application, 200 Area Effluent Treatment Facility contains information current as of May 1, 1993.

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

Quality Assurance Guidance for the Collection of Meteorological Data Using Passive Radiometers

Science.gov (United States)

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 ...

ADM guidance-Ceramics: guidance to the use of fractography in failure analysis of brittle materials.

Science.gov (United States)

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.

Report 3: Guidance document on practices to model and implement Extreme Weather hazards in extended PSA

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)

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.

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.)

The LawsAndFamilies questionnaire on legal family formats for same-sex and/or different-sex couples : Text of the questions and of the accompanying guidance document.

NARCIS (Netherlands)

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

300 area TEDF permit compliance monitoring plan

International Nuclear Information System (INIS)

BERNESKI, L.D.

1998-01-01

This document presents the permit compliance monitoring plan for the 300 Area Treated Effluent Disposal Facility (TEDF). It addresses the compliance with the National Pollutant Discharge Elimination System (NPDES) permit and Department of Natural Resources Aquatic Lands Sewer Outfall Lease

300 area TEDF permit compliance monitoring plan

Energy Technology Data Exchange (ETDEWEB)

BERNESKI, L.D.

1998-11-20

This document presents the permit compliance monitoring plan for the 300 Area Treated Effluent Disposal Facility (TEDF). It addresses the compliance with the National Pollutant Discharge Elimination System (NPDES) permit and Department of Natural Resources Aquatic Lands Sewer Outfall Lease.

Permissible state permit/fee systems for radioactive materials transportation

International Nuclear Information System (INIS)

Friel, L.

1987-01-01

Many state permit/fee systems for radioactive materials transportation have been ruled inconsistent with federal law invalidated by the courts. As the date for repository operation, and its associated transportation, draws near, more states can be expected to adopt permit/fee systems. Examination of the U.S. Department of Transportation's advisory rulings and federal court cases on previous permit/fee systems gives general guidance on the type of permit/fee systems most likely to withstand challenges. Such a system would: have a simplified permit application with minimal information requirements; address a federally-defined class of hazardous or radioactive materials; allow access to all shipments conducted in compliance with federal law; charge a fee reasonably related to the costs imposed on the state by the transportation; and minimize the potential for re-directing shipments to other jurisdictions

Hanford facility dangerous waste permit application, low-level burial grounds

International Nuclear Information System (INIS)

Engelmann, R.H.

1997-01-01

The Hanford Facility Dangerous Plaste Permit Application is considered to be a single application organized into a General Information Portion (document number DOE/RL-91-28) and a Unit-Specific Portion. The scope of the Unit-Specific Portion is limited to Part B permit application documentation submitted for individual, 'operating' treatment, storage, and/or disposal units, such as the Low-Level Burial Grounds (this document, DOE/RL-88-20)

Hanford facility dangerous waste permit application, low-level burial grounds

Energy Technology Data Exchange (ETDEWEB)

Engelmann, R.H.

1997-08-12

The Hanford Facility Dangerous Plaste Permit Application is considered to be a single application organized into a General Information Portion (document number DOE/RL-91-28) and a Unit-Specific Portion. The scope of the Unit-Specific Portion is limited to Part B permit application documentation submitted for individual, `operating` treatment, storage, and/or disposal units, such as the Low-Level Burial Grounds (this document, DOE/RL-88-20).

RCRA Programmatic Information Policy and Guidance

Data.gov (United States)

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...

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

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

Remediation General Permit (RGP) for Massachusetts & New Hampshire

Science.gov (United States)

Documents, links & contacts for the Notice of Availability of the National Pollutant Discharge Elimination System (NPDES) General Permit for Remediation Activity Discharges – the Remediation General Permit in MA (MAG910000) and NH (NHG910000).

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.

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).

Pacific Custom Materials, Petition to Object to Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

76 FR 40338 - Marine Mammals; Photography Permit No. 16360

Science.gov (United States)

2011-07-08

... Mammals; Photography Permit No. 16360 AGENCY: National Marine Fisheries Service (NMFS), National Oceanic... photography of cetaceans off Hawaii. ADDRESSES: The permit and related documents are available for review upon... photography on 12 cetacean species had been submitted by the above-named applicant. The requested permit has...

Data requirement comparison between the fixed site upgrade rule guidance compendium and the Structured Assessment Approach Licensee Submittal Document

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.

PERMITTING HAZARDOUS WASTE INCINERATORS

Science.gov (United States)

This publication is a compilation of information presented at a seminar series designed to address the issues that affect the issuance of hazardous waste incineration permits and to improve the overall understanding of trial burn testing. pecifically, the document provides guidan...

78 FR 52203 - Guidance for Industry on Compliance With Regulations Restricting the Sale and Distribution of...

Science.gov (United States)

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...

BENCHPAR PROJECT. How to Incorporate ThermaI-Hydro-Mechanical Coupled Processes into Performance Assessments and Design Studies for Radioactive Waste Disposal in Geological Formations. Guidance Document

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

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.

44 CFR 71.4 - Documentation.

Science.gov (United States)

2010-10-01

..., 1983; and (3) A community issued final certificate of occupancy or other use permit or equivalent proof... other use permit or equivalent proof certifying that the building was completed (walled and roofed) by... been met, the documentation shall consist of a written statement from the governmental body or...

75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

Science.gov (United States)

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...

Hanford Site Guide for Preparing and Maintaining Fenerator Group Pollution Prevention Program Documentation

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

78 FR 13069 - Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood...

Science.gov (United States)

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...

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

Petition to Object to the GCC Dacotah Portland Cement Title V Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

Science.gov (United States)

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...

Guidance document on practices to model and implement Earthquake hazards in extended PSA (final version). Volume 1

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)

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

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

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.

50 CFR 300.182 - HMS international trade permit.

Science.gov (United States)

2010-10-01

... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false HMS international trade permit. 300.182... FISHERIES REGULATIONS International Trade Documentation and Tracking Programs for Highly Migratory Species § 300.182 HMS international trade permit. (a) General. An importer, entering for consumption fish or...

Safeguarding critical e-documents implementing a program for securing confidential information assets

CERN Document Server

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

Analytical laboratory quality assurance guidance in support of EM environmental sampling and analysis activities

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)

Document Organization Using Kohonen's Algorithm.

Science.gov (United States)

Guerrero Bote, Vicente P.; Moya Anegon, Felix de; Herrero Solana, Victor

2002-01-01

Discussion of the classification of documents from bibliographic databases focuses on a method of vectorizing reference documents from LISA (Library and Information Science Abstracts) which permits their topological organization using Kohonen's algorithm. Analyzes possibilities of this type of neural network with respect to the development of…

SPAR-H Step-by-Step Guidance

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.

Hanford Site guide for preparing and maintaining generator group pollution prevention program documentation

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

Annual Hanford Site Environmental Permitting status report

International Nuclear Information System (INIS)

SONNICHSEN, J.C.

1999-01-01

The information contained in, and/or referenced in, this Annual Hanford Site Environmental Permitting Status Report addresses Permit Condition II.W (Other Permits and/or Approvals) of the Dangerous Waste Portion of the Resource Conservation and Recovery Act Permit for the Treatment, Storage, and Disposal of Dangerous Waste, issued by the Washington State Department of Ecology (WA7890008967). Condition II.W specifies that the Permittees are responsible for obtaining all other applicable federal, state, and local permits authorizing the development and operation of the Hanford Facility. Condition II.W further specifies that the Permittees are to use their best efforts to obtain such permits. For the purposes of this Permit Condition, ''best efforts'' mean submittal of documentation and/or approval(s) in accordance with schedules specified in applicable regulations, or as determined through negotiations with the applicable regulatory agencies

77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

Science.gov (United States)

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...

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.

Asset Management Plans, Appraisal Guidance for 2003-04.

Science.gov (United States)

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…

A review of Grey and academic literature of evaluation guidance relevant to public health interventions.

Science.gov (United States)

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

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.

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.

Permit application modifications

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-11-01

This document contains the Permit Application Modifications for the Y-12 Industrial Landfill V site on the Oak Ridge Reservation. These modifications include the assessment of stability of the proposed Landfill V under static and loading conditions. Analyses performed include the general slope stability, veneer stability of the bottom liner and cover system, and a liquefaction potential assessment of the foundation soils.

Permit application modifications

International Nuclear Information System (INIS)

1995-11-01

This document contains the Permit Application Modifications for the Y-12 Industrial Landfill V site on the Oak Ridge Reservation. These modifications include the assessment of stability of the proposed Landfill V under static and loading conditions. Analyses performed include the general slope stability, veneer stability of the bottom liner and cover system, and a liquefaction potential assessment of the foundation soils

78 FR 39284 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

Science.gov (United States)

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...

Project W-521, waste feed delivery systems environmental permits and approvals plan

International Nuclear Information System (INIS)

TOLLEFSON, K.S.

1999-01-01

This document has been prepared to define the specific environmental requirements applicable to Project W-521. The document describes the permits and approvals necessary for the project to design, construct, and install planned upgrades, and provides a schedule of activities and provides cost estimates to complete the required permitting and approval activities

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)

Permitting plan for Project W-340, Tank 241-C-106 manipulator retrieval arm

International Nuclear Information System (INIS)

Tollefson, K.S.

1995-01-01

This document describes the regulatory requirements and describes alternative strategies for obtaining permits and approvals for Project W-340, Tank 241-C-106 Manipulator Retrieval Arm. A comprehensive review of environmental regulations has indicated that several environmental reviews, permits, and approvals are required before design, construction, and operation of the facility. The environmental reviews, permits, and approvals, as well the regulatory authority potentially applicable to the Project W-340 Long Reach Manipulator Arm include the following: National Environmental Policy Act of 1969 -- US Department of Energy, Headquarters; State Environmental Policy Act of 1971 -- State of Washington Department of Ecology; Air Permitting; Dangerous Waste Permitting; Miscellaneous Reviews/Permits/Approvals. This document describes the environmental reviews, permits, and approval requirements for the project. It provides a summary of permit application data requirements, alternative strategies for permit completion and approval, as well as the estimated probability of success for each alternative strategy

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

Ci PERMIT

CERN Multimedia

Relations with the Host States Service

1999-01-01

The Swiss Permanent Mission to the International Organisations at Geneva recalls that only the spouses and children of members of personnel resident in Switzerland and in possession of a legitimation card of types 'B', 'C', 'D' or 'E' issued by the Swiss Federal Department of Foreign Affairs are entitled to benefit from a Ci Permit.The 'demande d'attestation de permis Ci' (request for a Ci permit attestation) can be sent to the Mission only through Personnel Division (Administrative Services, Office 33/1-025).Additional information on access by family members of CERN officials to the Swiss labour market are available to you on the Web site of the Relations with the Host States Service (cf. document entitled 'Employment in Switzerland for spouses and children of CERN officials' dated March 1996).Relations with the Host States Servicehttp://www.cern.ch/relations/Tel. 72848

Petition for the Administrator to Obect to TVA's Shawnee Fossil Plant's Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Order Denying Petition to Object to Operating Permit for TVA's Shawnee Fossil Plant

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

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

Data Management-Supplement to Section 106 Tribal Guidance

Science.gov (United States)

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.

ADM guidance-Ceramics: all-ceramic multilayer interfaces in dentistry.

Science.gov (United States)

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.

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

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

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.

Tennessee Valley Authority, Paradise Fossil Plant; Petition to Object to Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-database.

76 FR 9028 - Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability

Science.gov (United States)

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...

Web Air Permits (WAP R7)

Data.gov (United States)

U.S. Environmental Protection Agency — THIS DATA ASSET NO LONGER ACTIVE: This is metadata documentation for Web Air Permits in Region 7 (WAP R7), a Lotus Notes application that once tracked comment...

76 FR 6143 - Draft Guidance for Industry on “Target Animal Safety and Effectiveness Protocol Development and...

Science.gov (United States)

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...

Draft Title V Operating Permit: Andeavor Field Services, LLC - Walker Hollow Compressor Station

Science.gov (United States)

Draft Operating Permit (Permit Number: V-UO-000979-2017.00), statement of basis, public notice bulletin, and the administrative permit docket (application and other supporting documents) for the Andeavor Walker Hollow Compressor Station.

[International trend of guidance for nanomaterial risk assessment].

Science.gov (United States)

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.

Draft Title V Operating Permit: Andeavor Field Services, LLC - Walker Hollow Compressor Station

Science.gov (United States)

Draft Title V Operating Permit, statement of basis, public notice bulletin, and the administrative permit docket (application and other supporting documents) for the Draft Part 71 Permit for Andeavor Field Services, LLC - Walker Hollow CS.

Petition to Object to the Carmeuse Lime and Stone Plant, Manitowoc, Wisconsin, Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Petition to have the Administrator Object to Weyerhaeuser - Barnesville Wood Products Title V Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

77 FR 6625 - Meeting the Challenge of Pandemic Influenza: Ethical Guidance for Leaders and Health Care...

Science.gov (United States)

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...

Permitting mixed waste treatment, storage and disposal facilities: A mixed bag

International Nuclear Information System (INIS)

Ranek, N.L.; Coalgate, J.L.

1995-01-01

The Federal Facility Compliance Act of 1992 (FFCAct) requires the U.S. Department of Energy (DOE) to make a comprehensive national inventory of its mixed wastes (i.e., wastes that contain both a hazardous component that meets the Resource Conservation and Recovery Act (RCRA) definition of hazardous waste and a radioactive component consisting of source, special nuclear, or byproduct material regulated under the Atomic Energy Act (AEA)), and of its mixed waste treatment technologies and facilities. It also requires each DOE facility that stores or generates mixed waste to develop a treatment plan that includes, in part, a schedule for constructing units to treat those wastes that can be treated using existing technologies. Inherent in constructing treatment units for mixed wastes is, of course, permitting. This paper identifies Federal regulatory program requirements that are likely to apply to new DOE mixed waste treatment units. The paper concentrates on showing how RCRA permitting requirements interrelate with the permitting or licensing requirements of such other laws as the Atomic Energy Act, the Clean Water Act, and the Clean Air Act. Documentation needed to support permit applications under these laws are compared with RCRA permit application documentation. National Environmental Policy Act (NEPA) documentation requirements are also addressed, and throughout the paper, suggestions are made for managing the permitting process

Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health

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...

78 FR 78974 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

Science.gov (United States)

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...

AVIS: analysis method for document coherence

International Nuclear Information System (INIS)

Henry, J.Y.; Elsensohn, O.

1994-06-01

The present document intends to give a short insight into AVIS, a method which permits to verify the quality of technical documents. The paper includes the presentation of the applied approach based on the K.O.D. method, the definition of quality criteria of a technical document, as well as a description of the means of valuating these criteria. (authors). 9 refs., 2 figs

78 FR 32668 - Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood...

Science.gov (United States)

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...

21 CFR 10.115 - Good guidance practices.

Science.gov (United States)

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...

Moisture Control Guidance for Commercial and Public Buildings (EPA 402-F-13053)

Science.gov (United States)

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...

Quality assurance and quality control in mammography: a review of available guidance worldwide.

Science.gov (United States)

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.

75 FR 62820 - Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA

Science.gov (United States)

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...

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

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

Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance.

Science.gov (United States)

Hakoum, Maram B; Jouni, Nahla; Abou-Jaoude, Eliane A; Hasbani, Divina Justina; Abou-Jaoude, Elias A; Lopes, Luciane Cruz; Khaldieh, Mariam; Hammoud, Mira Zein; Al-Gibbawi, Mounir; Anouti, Sirine; Guyatt, Gordon; Akl, Elie A

2017-10-05

To provide a detailed and current characterisation of funding of a representative sample clinical trials. We also aimed to develop guidance for standardised reporting of funding information. We addressed the extent to which clinical trials published in 2015 in any of the 119 Core Clinical Journals included a statement on the funding source (eg, whether a not-for-profit organisation was supported by a private-for-profit organisation), type of funding, amount and role of funder. We used a stepwise approach to develop a guidance and an instrument for standardised reporting of funding information. Of 200 trials, 178 (89%) included a funding statement, of which 171 (96%) reported being funded. Funding statements in the 171 funded trials indicated the source in 100%, amount in 1% and roles of funders in 50%. The most frequent sources were governmental (58%) and private-for-profit (40%). Of 54 funding statements in which the source was a not-for-profit organisation, we found evidence of undisclosed support of those from private-for-profit organisation(s) in 26 (48%). The most frequently reported roles of funders in the 171 funded trials related to study design (42%) and data analysis, interpretation or management (41%). Of 139 randomised controlled trials (RCTs) addressing pharmacological or surgical interventions, 29 (21%) reported information on the supplier of the medication or device. The proposed guidance addresses both the funding information that RCTs should report and the reporting process. Attached to the guidance is a fillable PDF document for use as an instrument for standardised reporting of funding information. Although the majority of RCTs report funding, there is considerable variability in the reporting of funding source, amount and roles of funders. A standardised approach to reporting of funding information would address these limitations. Future research should explore the implications of funding by not-for-profit organisations that are supported by for

50 CFR 13.12 - General information requirements on applications for permits.

Science.gov (United States)

2010-10-01

... available, occupation, and any business, agency, organizational, or institutional affiliation associated... permits, together with any additional justification, including supporting documentation as required by the... permit Section Importation at nondesignated ports: Scientific 14.31 Deterioration prevention 14.32...

Closure of hazardous and mixed radioactive waste management units at DOE facilities

International Nuclear Information System (INIS)

1990-06-01

This is document addresses the Federal regulations governing the closure of hazardous and mixed waste units subject to Resource Conservation and Recovery Act (RCRA) requirements. It provides a brief overview of the RCRA permitting program and the extensive RCRA facility design and operating standards. It provides detailed guidance on the procedural requirements for closure and post-closure care of hazardous and mixed waste management units, including guidance on the preparation of closure and post-closure plans that must be submitted with facility permit applications. This document also provides guidance on technical activities that must be conducted both during and after closure of each of the following hazardous waste management units regulated under RCRA

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

Variable & Recode Definitions - SEER Documentation

Science.gov (United States)

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.

RH Packaging Program Guidance

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

78 FR 42086 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

Science.gov (United States)

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...

Recycled Water Reuse Permit Renewal Application for the Central Facilities Area Sewage Treatment Plant

Energy Technology Data Exchange (ETDEWEB)

Lewis, Mike [Idaho National Lab. (INL), Idaho Falls, ID (United States)

2014-09-01

This renewal application for a Recycled Water Reuse Permit is being submitted in accordance with the Idaho Administrative Procedures Act 58.01.17 “Recycled Water Rules” and the Municipal Wastewater Reuse Permit LA-000141-03 for continuing the operation of the Central Facilities Area Sewage Treatment Plant located at the Idaho National Laboratory. The permit expires March 16, 2015. The permit requires a renewal application to be submitted six months prior to the expiration date of the existing permit. For the Central Facilities Area Sewage Treatment Plant, the renewal application must be submitted by September 16, 2014. The information in this application is consistent with the Idaho Department of Environmental Quality’s Guidance for Reclamation and Reuse of Municipal and Industrial Wastewater and discussions with Idaho Department of Environmental Quality personnel.

Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: A scoping review.

Science.gov (United States)

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.

Ethics challenges and guidance related to research involving adolescent post-abortion care: a scoping review.

Science.gov (United States)

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

NYPIRG Petition to Object to Yeshiva University's Albert Einstein College of Medicane Title V Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Public Service Company, Fort St. Vrain Station, Petition For Objection to Issuance of Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Honeywell Engines, Systems and Services, Phoenix, Arizona, Petition to Object to Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Response to Petition for EPA to Object to Cash Creek Generation Station's Title V Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

June 30, 2003 Petition for the Administrator to Object to Chemical Lime Company's Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Salt River Project San Tan Generating Station, Petition to Object to Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Petition to Object to the TVA Paradise Fossil Plant, Drakesboro, Kentucky, Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Petition to Object to the Xcel Energy, Hayden Station, Hayden Colorado, Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Hanford Facility dangerous waste permit application, general information

International Nuclear Information System (INIS)

1993-05-01

The current Hanford Facility Dangerous Waste Permit Application is considered to be a single application organized into a General Information Portion (this document, number DOE/RL-91-28) and a treatment, storage, and/or disposal Unit-Specific Portion, which includes documentation for individual TSD units (e.g., document numbers DOE/RL-89-03 and DOE/RL-90-01). Both portions consist of a Part A division and a Part B division. The Part B division consists of 15 chapters that address the content of the Part B checklists prepared by the Washington State Department of Ecology (Ecology 1987) and the US Environmental Protection Agency (40 Code of Federal Regulations 270), with additional information requirements mandated by the Hazardous and Solid Waste Amendments of 1984 and revisions of Washington Administrative Code 173-303. For ease of reference, the Washington State Department of Ecology checklist section numbers, in brackets, follow the chapter headings and subheadings. Documentation contained in the General Information Portion (i.e., this document, number DOE/RL-91-28) is broader in nature and applies to all treatment, storage, and/or disposal units for which final status is sought. Because of its broad nature, the Part A division of the General Information Portion references the Hanford Facility Dangerous Waste Part A Permit Application (document number DOE/RL-88-21), a compilation of all Part A documentation for the Hanford Facility

Wisconsin Public Service, Weston Generating Station; Petition to Object to Issuance of Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-database.

Tennessee Valley Authority, Paradise Fossil Plant; Order Responding Petition to Object to Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-database.

CXA La Paloma, LLC: UIC Class I Permit No.CA10710001

Science.gov (United States)

Documents related to La Paloma Generating Company, LLC's (LPGC) application for a UIC permit renewal (of permit #CA199000001) to operate a Class I injection well facility to dispose of non-hazardous wastewater from the La Paloma Generating Plant.

Active instrumental guidance in interventional magnetic resonance imaging

International Nuclear Information System (INIS)

Wildermuth, S.; Erhart, P.; Leung, D.A.; Goehde, S.; Schoenenberger, A.; Debatin, J.F.

1998-01-01

Purpose: An active MR-based guidance system for visualisation of invasive instruments is described. Methods: The principle of MR tracking is based on the integration of a miniaturised coil into the tip of the instrument itself. A phantom experiment was designed to demonstrate the localising accuracy of this technique. In [dition, bicompatibility and warming effects were evaluated. Preliminary intravascular applications that were performed in animal experiments under MR guidance included embolisation, vascular occlusion as well as transjugular intrahepatic punctures. Percutaneous biopsies, cholecystostomies and laparoscopic applications were also evaluated with MR tracking. Results: Phantom experiments confirmed an excellent localisation accuracy of MR tracking compared to conventional r[iography. At a field strength of 0.5 T, the temperature increase remained below 2 C. Results of phantom experiments revealed a potential of significant heating dependent on the sequence parameters employed. MR tracking allowed a robust, simultaneously biplanar visualisation of the instrument tips in real time. Based on MR 'ro[ map' images, various intravascular and percutaneous interventions were successfully performed in vivo under MR guidance. Conclusions: MR tracking is a flexible concept permitting monitoring in the guidance of instruments in an MR environment. Various preliminary in vitro and in vivo experiments demonstrate safety, localisation accuracy and feasibility of this biplanar localisation technique in real time. (orig.) [de

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

Practical guidance for defining a smart grid modernization strategy the case of distribution

CERN Document Server

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

78 FR 70307 - Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

Science.gov (United States)

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...

75 FR 53316 - Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money...

Science.gov (United States)

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...

32 CFR 70.10 - Complaints concerning decisional documents and index entries.

Science.gov (United States)

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...

FIRE PERMIT NOW ON EDH!

CERN Multimedia

TIS General Safety Group or

2001-01-01

The electronic version of the Fire Permit form is now active. The aim of the Fire Permit procedure is to reduce the risk of fire or explosion. It is mandatory when performing 'hot work' (mainly activities which involve the use of naked flames or other heat sources - e.g. welding, brazing, cutting, grinding, etc.). Its use is explained in the CERN Fire Protection Code E. (Fire Protection) The new electronic form, which is substantially unchanged from the previous authorizing procedure, will be available on the Electronic Document Handling system (https://edh.cern.ch/) as of 1st September 2001. From this date use of the paper version should be discontinued.

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

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

Guidance system operations plan for manned CM earth orbital missions using program SKYLARK 1. Section 4: Operational modes

Science.gov (United States)

Dunbar, J. C.

1972-01-01

The operational modes for the guidance system operations plan for Program SKYLARK 1 are presented. The procedures control the guidance and navigation system interfaces with the flight crew and the mission control center. The guidance operational concept is designed to comprise a set of manually initiated programs and functions which may be arranged by the flight crew to implement a large class of flight plans. This concept will permit both a late flight plan definition and a capability for real time flight plan changes.

Petition Requesting That the Administrator Object to the Title V Permit for JP Pulliam Power Plant

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Petition Requesting the Administrator Object to Title V Permit for Duke Energy Progress's Richmond County Turbines

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

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.

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

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

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

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

76 FR 23824 - Guidance for Industry: “Computer Crossmatch” (Computerized Analysis of the Compatibility Between...

Science.gov (United States)

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...

76 FR 74834 - Interim Staff Guidance on Aging Management Program for Steam Generators

Science.gov (United States)

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...

How Should We Treat the Vulnerable?: Qualitative Study of Authoritative Ethics Documents.

Science.gov (United States)

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.

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)

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....

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

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.

76 FR 60503 - Guidance for Industry on Target Animal Safety and Effectiveness Protocol Development and...

Science.gov (United States)

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...

76 FR 59142 - Guidance for Industry on Reproductive and Developmental Toxicities-Integrating Study Results To...

Science.gov (United States)

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...

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.

Order Responding to October 5, 2000 Petition for the Administrator to Object to Elmhurst Hospital's Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

April 1, 2003 Petition Requesting the Administrator Object to Operating Permit for Eastman Kodak in Rochester, NY

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

The Radioactive Waste Management Advisory Committee's. Advice on issues which need to be addressed in the Guidance to be given to the Environment Agencies on the Principles for determining Radioactive Waste Discharge Authorisations - the 'Principles Document'

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

Project to Increase 777 Airplane Production at Boeing Everett

Science.gov (United States)

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.

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)

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

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.

Guidance document on fat reduction factor, functional barrier concept, phthalates and primary aromatic amines

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...

Permitting plan for project W-236B, initial pretreatment module

International Nuclear Information System (INIS)

Tollefson, K.S.

1995-01-01

The Tank Waste Remediation System pretreatment process mission is to separate high-level and low-level waste fractions. A comprehensive review of environmental regulations has indicated that several environmental reviews, permits, and approvals are required before construction and operation of the facility. This revised document provides a summary of permit application data requirements, alternative strategies for permit completion and approval, as well as the probability of success for each alternative for the Initial Pretreatment Module resulting from recent revisions to the Tri-Party Agreement

75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

Science.gov (United States)

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...

75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

Science.gov (United States)

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...

Towards a standardised approach for evaluating guidelines and guidance documents on palliative sedation: study protocol.

Science.gov (United States)

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

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.

EFSA Panel on Plant Protection Products and their Residues (PPR); EFSA Scientific Opinion on the science behind the revision of the guidance document on dermal absorption

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...

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...

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.

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

Ethics of clinician communication in a changing communication landscape: guidance from professional societies.

Science.gov (United States)

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.

RH Packaging Program Guidance

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

RH Packaging Program Guidance

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

Petition to Object to the Proposed Title V Permit for Public Service Company of New Hampshire's Schiller Station

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

February 18, 2005 Order Responding to Reqest to Object to Operating Permit for Eastman Kodak in Rochester, NY

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Honeywell Engines, Systems and Services, Phoenix, Arizona, Dec. 10, 2007 Petition to Object to Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Petition to Object to the Murphy Oil USA, Inc Meraux Refinery, St. Bernard Parish, Louisiana Title V Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Petition Requesting that the Administrator Object to the Issuance of Title V Operating Permit to Madison-Kipp Corp.

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Response to the Petition to Object to the TVA Paradise Fossil Plant, Drakesboro, Kentucky, Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Pacer Corporation, White Bear Mica Plant near Custer, South Dakota Petition to Object to Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

GCC Dacotah Cement Manufacturing, Order Partially Granting and Partially Denying Petition for Objection to Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

New York Organic Fertilizer Company, Order Granting In Part and Denying In Part Petition For Objection To Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

75 FR 29768 - Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of...

Science.gov (United States)

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...

Report 6: Guidance document. Man-made hazards and Accidental Aircraft Crash hazards modelling and implementation in extended PSA

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

50 CFR 23.51 - What are the requirements for issuing a partially completed CITES document?

Science.gov (United States)

2010-10-01

..., BARTER, EXPORTATION, AND IMPORTATION OF WILDLIFE AND PLANTS (CONTINUED) CONVENTION ON INTERNATIONAL TRADE... CITES documents only when: (i) The permitted trade will have a negligible impact or no impact on the... completed documents benefits both the permit holder and the issuing Management Authority. (2) The proposed...

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)

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Guidance on the scientific requirements for health claims related to physical performance

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...

Hanford Waste Vitrification Plant technical background document for best available radionuclide control technology demonstration

Energy Technology Data Exchange (ETDEWEB)

Carpenter, A.B.; Skone, S.S.; Rodenhizer, D.G.; Marusich, M.V. (Ebasco Services, Inc., Bellevue, WA (USA))

1990-10-01

This report provides the background documentation to support applications for approval to construct and operate new radionuclide emission sources at the Hanford Waste Vitrification Plant (HWVP) near Richland, Washington. The HWVP is required to obtain permits under federal and state statutes for atmospheric discharges of radionuclides. Since these permits must be issued prior to construction of the facility, draft permit applications are being prepared, as well as documentation to support these permits. This report addresses the applicable requirements and demonstrates that the preferred design meets energy, environmental, and economic criteria for Best Available Radionuclide Control Technology (BARCT) at HWVP. 22 refs., 11 figs., 25 tabs.

Hanford Waste Vitrification Plant technical background document for best available radionuclide control technology demonstration

International Nuclear Information System (INIS)

Carpenter, A.B.; Skone, S.S.; Rodenhizer, D.G.; Marusich, M.V.

1990-10-01

This report provides the background documentation to support applications for approval to construct and operate new radionuclide emission sources at the Hanford Waste Vitrification Plant (HWVP) near Richland, Washington. The HWVP is required to obtain permits under federal and state statutes for atmospheric discharges of radionuclides. Since these permits must be issued prior to construction of the facility, draft permit applications are being prepared, as well as documentation to support these permits. This report addresses the applicable requirements and demonstrates that the preferred design meets energy, environmental, and economic criteria for Best Available Radionuclide Control Technology (BARCT) at HWVP. 22 refs., 11 figs., 25 tabs

78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

Science.gov (United States)

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...

Automatic Classification Using Supervised Learning in a Medical Document Filtering Application.

Science.gov (United States)

Mostafa, J.; Lam, W.

2000-01-01

Presents a multilevel model of the information filtering process that permits document classification. Evaluates a document classification approach based on a supervised learning algorithm, measures the accuracy of the algorithm in a neural network that was trained to classify medical documents on cell biology, and discusses filtering…

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

77 FR 40354 - Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels-Draft

Science.gov (United States)

2012-07-09

... through the UIC Class II Program, the well class for oil and gas activities. Geothermal activities are not... inject diesel fuels during hydraulic fracturing related to oil, gas, or geothermal operations must obtain... geothermal activities, the draft guidance only covers hydraulic fracturing using diesel fuels related to oil...

76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

Science.gov (United States)

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...

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

76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Science.gov (United States)

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...

75 FR 14445 - Guidance for Industry on Submitting a Report for Multiple Facilities to the Reportable Food...

Science.gov (United States)

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...

76 FR 22905 - Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties...

Science.gov (United States)

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...

Silica dust control in small-scale building/structure demolition operations using good work practice guidance

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.

Silica dust control in small-scale building/structure demolition operations using good work practice guidance

Science.gov (United States)

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.

Synthetic Minor NSR Permit: Tesoro Logistics-Rockies - Ponderosa Compressor Station

Science.gov (United States)

This page contains documents related to the synthetic minor NSR permit for the Tesoro Logistics-Rockies Ponderosa Compressor Station, located on the Uintah and Ouray Indian Reservation in Uintah County, UT.

WHO Regional Office for Europe guidance for influenza surveillance in humans.

NARCIS (Netherlands)

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

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.

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

Development of guidance for preparing treatability variance petitions from the RCRA Land Disposal Restrictions for DOE [Department of Energy] mixed-waste streams

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

Order Granting and Denying in Part the Petition for Objection to the Xcel Energy, Hayden Station Operating Permit, Hayden Colorado

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Petition to Object to the Eastern Kentucky Power Coop. William C. Dale Power Station, Ford, Kentucky, Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

[Interest of ultrasonographic guidance in paediatric regional anaesthesia].

Science.gov (United States)

Dadure, C; Raux, O; Rochette, A; Capdevila, X

2009-10-01

The use of ultrasonographic guidance for regional anaesthesia has known recently a big interest in children in recent years. The linear ultrasound probes with a 25 mm active surface area (or probes with 38 mm active surface area in older children), with high sound frequencies in the range 8-14 MHz, allow a good compromise between excellent resolution for superficial structure and good penetration depths. In children, the easiest ultrasound guided blocks are axillar blocks, femoral blocks, fascia iliaca compartment blocks, ilio-inguinal blocks and para-umbilical blocks, caudal blocks. They permit a safe and easy learning curve of these techniques. The main advantage of ultrasound guided regional anaesthesia is the visualization of different anatomical structures and the approximate localization of the tip of needle. The other advantages for ultrasound guided peripheral nerve blocks in children are: faster onset time of sensory and motor block, longer duration of sensory blockade, increase of blockade quality and reduction of local anesthetic injection. The use of ultrasonographic guidance for central block allows to visualize different structures as well as spine and his content. Spinous process, ligament flavum, dura mater, conus medullaris and cerebrospinal fluid are identifiable, and give some information on spine, epidural space and the depth between epidural space and skin. At last, in caudal block, ultrasounds permit to evaluate the anatomy of caudal epidural space, especially the relation of the sacral hiatus to the dural sac and the search of occult spinal dysraphism. Benefit of this technique is the visualization of targeted nerves or spaces and the spread of injected local anaesthetic.

Quality assurance guidance for laboratory assessment plates in support of EM environmental sampling and analysis activities

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

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)

17 CFR Appendix B to Part 36 - Guidance on, and Acceptable Practices in, Compliance With Core Principles

Science.gov (United States)

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...

Guidance for the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health (Revision 1)

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...

GUIDANCE COUNSELOR INSTITUTE FOR HEALTH CAREERS (JULY 7-22, 1966).

Science.gov (United States)

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…

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.

Annual Hanford Site environmental permitting status report

International Nuclear Information System (INIS)

Sonnichsen, J.C.

1998-01-01

The information contained and/or referenced in this Annual Hanford Site Environmental Permitting Status Report (Status Report) addresses the State Environmental Policy Act (SEPA) of 1971 and Condition II.W. of the Resource Conservation and Recovery Act (RCRA) of 1976 Permit, Dangerous Waste Portion (DW Portion). Condition II.W. of the RCRA Permit specifies the Permittees are responsible for all other applicable federal, state, and local permits for the development and operation of the Hanford Facility. Condition II.W. of the RCRA Permit specifies that the Permittees are to use their best efforts to obtain such permits. For the purposes of permit condition, 'best efforts' means submittal of documentation and/or approval(s) in accordance with schedules specified in applicable regulations, or as determined through negotiations with the applicable regulatory agencies. This Status Report includes information on all existing and anticipated environmental permitting. Environmental permitting required by RCRA, the Hazardous and Solid Waste Amendments (HSWA) of 1984, and non-RCRA permitting (solid waste handling, Clean Air Act Amendments of 1990, Clean Water Act Amendments of 1987, Washington State waste discharge, and onsite sewage system) is addressed. Information on RCRA and non-RCRA is current as of July 31, 1998. For the purposes of RCRA and the State of Washington Hazardous Waste Management Act of 1976 [as administered through the Dangerous Waste Regulations, Washington Active Code (WAC) 173-303], the Hanford Facility is considered a single facility. As such, the Hanford Facility has been issued one US Environmental Protection Agency (EPA)/State Identification Number (WA7890008967). This EPA/State identification number encompasses over 60 treatment, storage, and/or disposal (TSD) units. The Washington State Department of Ecology (Ecology) has been delegated authority by the EPA to administer the RCRA, including mixed waste authority. The RCRA permitting approach for

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.

Guidance for the Implementation and Follow-up of Identified Energy and Water Efficiency Measures in Covered Facilities

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.

Melter Disposal Strategic Planning Document

Energy Technology Data Exchange (ETDEWEB)

BURBANK, D.A.

2000-09-25

This document describes the proposed strategy for disposal of spent and failed melters from the tank waste treatment plant to be built by the Office of River Protection at the Hanford site in Washington. It describes program management activities, disposal and transportation systems, leachate management, permitting, and safety authorization basis approvals needed to execute the strategy.

Transsphenoidal pituitary resection with intraoperative MR guidance: preliminary results

Science.gov (United States)

Pergolizzi, Richard S., Jr.; Schwartz, Richard B.; Hsu, Liangge; Wong, Terence Z.; Black, Peter M.; Martin, Claudia; Jolesz, Ferenc A.

1999-05-01

The use of intraoperative MR image guidance has the potential to improve the precision, extent and safety of transsphenoidal pituitary resections. At Brigham and Women's Hospital, an open-bore configuration 0.5T MR system (SIGNA SP, GE Medical Systems, Milwaukee, WI) has been used to provide image guidance for nine transsphenoidal pituitary adenoma resections. The intraoperative MR system allowed the radiologist to direct the surgeon toward the sella turcica successfully while avoiding the cavernous sinus, optic chiasm and other sensitive structures. Imaging performed during the surgery monitored the extent of resection and allowed for removal of tumor beyond the surgeon's view in five cases. Dynamic MR imaging was used to distinguish residual tumor from normal gland and postoperative changes permitting more precise tumor localization. A heme-sensitive long TE gradient echo sequence was used to evaluate for the presence of hemorrhagic debris. All patients tolerated the procedure well without significant complications.

Hanford facility RCRA permit condition II.U.1 report: mapping of underground piping

Energy Technology Data Exchange (ETDEWEB)

Hays, C.B.

1996-09-27

The purpose of this report is to fulfill Condition Il.U.1. of the Hanford Facility (HF) Resource Conservation and Recovery Act (RCRA) Permit. The HF RCRA Permit, Number WA7890008967, became effective on September 28, 1994 (Ecology 1994). Permit Conditions Il.U. (mapping) and II.V. (marking) of the HF RCRA Permit, Dangerous Waste (OW) Portion, require the mapping and marking of dangerous waste underground pipelines subject to the provisions of the Washington Administrative Code (WAC) Chapter 173-303. Permit Condition Il.U.I. requires the submittal of a report describing the methodology used to generate pipeline maps and to assure their quality. Though not required by the Permit, this report also documents the approach used for the field marking of dangerous waste underground pipelines.

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

Patterns for Effectively Documenting Frameworks

Science.gov (United States)

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.

200 Area TEDF interface control document

Energy Technology Data Exchange (ETDEWEB)

Brown, M.J.; Hildebrand, R.A.

1994-11-15

Because the TEDF does not have any treatment or retention capacity, strict control at the generator interface is essential to operate the TEDF in compliance with good engineering practices, Hanford site requirements, and the 216 Discharge Permit. The information in the Interface Control Document (ICD) forms the basis of understanding between all parties involved in the TEDF; DOE, WHC, and the generating facilities. The ICD defines the controlling document hierarchy; LEF, and generator responsibilities; monitoring and sampling requirements; and specifies the TEDF/Generator Interface points.

200 Area TEDF interface control document

International Nuclear Information System (INIS)

Brown, M.J.; Hildebrand, R.A.

1994-01-01

Because the TEDF does not have any treatment or retention capacity, strict control at the generator interface is essential to operate the TEDF in compliance with good engineering practices, Hanford site requirements, and the 216 Discharge Permit. The information in the Interface Control Document (ICD) forms the basis of understanding between all parties involved in the TEDF; DOE, WHC, and the generating facilities. The ICD defines the controlling document hierarchy; LEF, and generator responsibilities; monitoring and sampling requirements; and specifies the TEDF/Generator Interface points

February 18, 2005 Order Responding to Petition for the Administrator to Object to Operating Permit for Eastman Kodak in Rochester, NY

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Petition to the EPA Administrator to Object to the Puerto Rico Electric Power Authority Central San Juan Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

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.

Communication Services and Supports for Individuals with Severe Disabilities: Guidance for Assessment and Intervention

Science.gov (United States)

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

Hydroelectric Generating Facilities General Permit (HYDROGP) for Massachusetts & New Hampshire

Science.gov (United States)

Documents, links & contacts for the Notice of Availability of the Final NPDES General Permits (HYDROGP) for Discharges at Hydroelectric Generating Facilities in Massachusetts (MAG360000) and New Hampshire (NHG360000) and Tribal Lands in the State of MA.

75 FR 5356 - Office of New Reactors; Final Interim Staff Guidance on Post-Combined License Commitments

Science.gov (United States)

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...

78 FR 79328 - Amendments to Material Control and Accounting Regulations and Proposed Guidance for Fuel Cycle...

Science.gov (United States)

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...

Environmental Restoration Contractor Resource Conservation and Recovery Act Permit Implementation Plan

International Nuclear Information System (INIS)

Lewis, R.A.

1996-05-01

This document contains the revised Environmental Restoration Contractor (ERC) Implementation Plan for compliance with the Dangerous Waste and Hazardous and Solid Waste Amendment portions of the Resource Conservation and Recovery Act (RCRA) Permit for the Treatment, Storage, and Disposal of Dangerous Waste (hereafter referred to as the open-quotes Permitclose quotes). The Permit became effective on September 28, 1994. The ERC has developed the Permit Implementation Plan to ensure that the Permit is properly implemented within the ERC project and functions. The plan contains a list of applicable permit conditions, descriptions, responsible organizations, and the status of compliance. The ERC's responsibilities for Permit implementation are identified within both project and functional organizations. Project Managers are responsible for complying with conditions specific to a particular treatment, storage, or disposal (TSD) unit. TSD-specific compliance in include items such as closure plan deliverables, reporting and record keeping requirements, or compliance with non-unit-specific tasks such as spill reporting and emergency response. Functional organizations are responsible for sitewide activities, such as coordinating Permit modifications and developing personnel training programs

Environmental Compliance Guide. Guidance manual for Department of Energy compliance with the Clean Water Act: National Pollutant Discharge Elimination System (NPDES)

Energy Technology Data Exchange (ETDEWEB)

1982-07-01

This manual provides general guidance for Department of Energy (DOE) officials for complying with Sect. 402 of the Clean Water Act (CWA) of 1977 and amendments. Section 402 authorizes the US Environmental Protection Agency (EPA) or states with EPA approved programs to issue National Pollutant Discharge Elimination System (NPDES) permits for the direct discharge of waste from a point source into waters of the United States. Although the nature of a project dictates the exact information requirements, every project has similar information requirements on the environmental setting, type of discharge(s), characterization of effluent, and description of operations and wastewater treatment. Additional information requirements for projects with ocean discharges, thermal discharges, and cooling water intakes are discussed. Guidance is provided in this manual on general methods for collecting, analyzing, and presenting information for an NPDES permit application. The NPDES program interacts with many sections of the CWA; therefore, background material on pertinent areas such as effluent limitations, water quality standards, toxic substances, and nonpoint source pollutants is included in this manual. Modifications, variances, and extensions applicable to NPDES permits are also discussed.

78 FR 77354 - Procedural Rules To Permit Parties To File and Serve Documents Electronically

Science.gov (United States)

2013-12-23

... Commission is permitting electronic filing through an electronic case management system that the Commission will implement in 2014. The electronic case management system will allow the Commission to manage its... 2014, the Commission will begin using a new electronic case management system (e-CMS) in order to more...

USDOT guidance for connected vehicle deployments : institutional and business models and financial sustainability.

Science.gov (United States)

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...

Hanford site guide for preparing and maintaining generator group pollution prevention program documentation

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

Vocational Guidance and Counselling for Young People and Adults in the European Community. Findings of a Conference (Berlin, West Germany, December 7-8, 1989).

Science.gov (United States)

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…

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.

Public Service Company, Fort St. Vrain Station, Order Granting in Part and Denying in Part Petition for Objection to Title V Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

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

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.

LEGITIMATION DOCUMENTS ISSUED BY THE FRENCH MINISTRY OF FOREIGN AFFAIRS

CERN Multimedia

2003-01-01

The French Ministry of Foreign Affairs (hereinafter referred to as "MAE") has sent a reminder of the following rules relating to legitimation documents (special cards, henceforth called "special residence permits" (titres de séjour spéciaux), and attestations de fonctions) that it issues. The Ministry has specified that compliance with these rules is essential to the proper functioning of any International Organization established in France. 1. Types of document and use a) Special CD, FI and AT residence permits They serve as residence permits for members of the personnel and the members of their families who are not of French nationality and who do not have the status of permanent resident (see N.B. below). Vis-à-vis the French authorities, they serve as proof that those holding these cards enjoy the privileges and immunities provided for by the Status Agreement between CERN and France (immunity from legal process in the discharge of their duties, entitlement to drive a vehicle registered in a special ...

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)

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)

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

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

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.

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

Low-Level Burial Grounds Dangerous Waste Permit Application design documents

International Nuclear Information System (INIS)

1990-01-01

This document presents the Functional Design Criteria for trenches to be constructed to receive solid radioactive mixed waste (RMW) from on and offsite generators. The new RMW disposal facilities are considered modifications to or lateral expansion of the existing low-level waste burial grounds. The new facilities upgrade the existing disposal practice for RMW to the minimum technology requirements of the Resource Conservation and Recovery Act. The proposed locations for the two facilities are: 218-E-10 for drag-off-waste packages and, 218-W-4C for non drag-off waste packages

Implications of DOE O 1027 Guidance on Rad-NESHAP Programs

International Nuclear Information System (INIS)

Fuehne, David P.; Fong, Stephen C.

2012-01-01

This presentation is for the national Radionuclide NESHAP meeting, an embedded topic of the 2012 Health Physics Society Annual Meeting in Sacramento, CA. The Radionuclide NESHAP program is responsible for measuring and reporting the amount of airborne radioactive material released from DOE facilities. The issue at hand is recent guidance put forth by the Department of Energy regarding threshold limits for Category 3 and Category 2 nuclear facilities. Updates to calculation methods have resulted in increased amounts of radioactive material allowed in inventory for facilities before they reach levels which require them to be categorized as a Category 2 or 3 nuclear facility. With larger radioactive material inventories, there may be a corresponding increase in overall facility emissions. This can have permitting and monitoring impacts for DOE sites, as well as political ramifications with citizen organizations. This presentation is intended to raise awareness of the new guidance and associated issues, and to stimulate discussion among DOE Radionuclide NESHAP representatives.

Wisconsin Public Service - Weston Generating Station; Order Denying in Part and Granting in Part a Petition for Objection to the Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-database.

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.

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.

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

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

Public health economics: a systematic review of guidance for the economic evaluation of public health interventions and discussion of key methodological issues.

Science.gov (United States)

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

Guidance for implementing the long-term surveillance program for UMTRA Project Title I Disposal Sites

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

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

Viviendo el documental

OpenAIRE

Álvarez Moreno, Víctor

2017-01-01

En el siguiente trabajo se recoge el proceso de realización y elaboración de un documental en 360 grados sobre la catedral de Valladolid bajo el título Reconstruyendo la catedral. El trabajo une realidad virtual con narrativa periodística. La realidad virtual es una herramienta que permite transformar al espectador en un testigo de la historia. En este caso, se muestra lo que pudo ser la catedral de Valladolid, cuyo objetivo era convertirse en la catedral más grande del territorio europeo. ...

Order Denying the Petition to Object to the Eastern Kentucky Power Coop. William C. Dale Power Station, Ford, Kentucky, Title V Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

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

Guidance on the application of quality assurance for characterizing a low-level radioactive waste disposal site

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

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

City of Richland 300 Area industrial wastewater permit application

International Nuclear Information System (INIS)

1995-05-01

Battelle-Pacific Northwest Labs and Westinghouse Hanford Co. are responsible for operating most of the facilities within the 300 Area; other contractors are also involved. The document gives briefly water/wastewater data: water sources, water usage, water discharge/loss, NPDES permit status, plant sewer outlets size and flow, etc. The document also includes the following attachments: 300 Area building list, Oct. 1993-Oct. 1994 300 Area water balance, waste shipments for CY 1994, complete chemical listing, sanitary sewer sampling results (12/19/94, 1/18/95, 1/15/95), and priority pollutant listings

77 FR 2037 - Marine Mammals; Photography Permit File No. 17032

Science.gov (United States)

2012-01-13

... filmmaker hopes to document the behavior of marine animals in the presence of a gray whale carcass. Filming... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XA929 Marine Mammals; Photography Permit File No. 17032 AGENCY: National Marine Fisheries Service (NMFS), National...

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

Cryogenic and Gas System Piping Pressure Tests (A Collection of PT Permits)

International Nuclear Information System (INIS)

Rucinski, Russell A.

2002-01-01

This engineering note is a collection of pipe pressure testing documents for various sections of piping for the D-Zero cryogenic and gas systems. High pressure piping must conform with FESHM chapter 5031.1. Piping lines with ratings greater than 150 psig have a pressure test done before the line is put into service. These tests require the use of pressure testing permits. It is my intent that all pressure piping over which my group has responsibility conforms to the chapter. This includes the liquid argon and liquid helium and liquid nitrogen cryogenic systems. It also includes the high pressure air system, and the high pressure gas piping of the WAMUS and MDT gas systems. This is not an all inclusive compilation of test documentation. Some piping tests have their own engineering note. Other piping section test permits are included in separate safety review documents. So if it isn't here, that doesn't mean that it wasn't tested. D-Zero has a back up air supply system to add reliability to air compressor systems. The system includes high pressure piping which requires a review per FESHM 5031.1. The core system consists of a pressurized tube trailer, supply piping into the building and a pressure reducing regulator tied into the air compressor system discharge piping. Air flows from the trailer if the air compressor discharge pressure drops below the regulator setting. The tube trailer is periodically pumped back up to approximately 2000 psig. A high pressure compressor housed in one of the exterior buildings is used for that purpose. The system was previously documented, tested and reviewed for Run I, except for the recent addition of piping to and from the high pressure compressor. The following documents are provided for review of the system: (1) Instrument air flow schematic, drg. 3740.000-ME-273995 rev. H; (2) Component list for air system; (3) Pressure testing permit for high pressure piping; (4) Documentation from Run I contained in D-Zero Engineering note

75 FR 47825 - Emergency Exemption; Issuance of Emergency Permit to Rehabilitate Sea Turtles Affected by the...

Science.gov (United States)

2010-08-09

...] Emergency Exemption; Issuance of Emergency Permit to Rehabilitate Sea Turtles Affected by the Deepwater... threaten the Gulf of Mexico environment and its inhabitants, including five sea turtle species. We, the U.S...) permit, to aid sea turtles affected by the oil spill. ADDRESSES: Documents and other information...

75 FR 20606 - Guidance for Industry on Tobacco Health Document Submission; Availability

Science.gov (United States)

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...

Technical approach document

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

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

Permitting plan for the high-level waste interim storage

International Nuclear Information System (INIS)

Deffenbaugh, M.L.

1997-01-01

This document addresses the environmental permitting requirements for the transportation and interim storage of solidified high-level waste (HLW) produced during Phase 1 of the Hanford Site privatization effort. Solidified HLW consists of canisters containing vitrified HLW (glass) and containers that hold cesium separated during low-level waste pretreatment. The glass canisters and cesium containers will be transported to the Canister Storage Building (CSB) in a U.S. Department of Energy (DOE)-provided transportation cask via diesel-powered tractor trailer. Tri-Party Agreement (TPA) Milestone M-90 establishes a new major milestone, and associated interim milestones and target dates, governing acquisition and/or modification of facilities necessary for: (1) interim storage of Tank Waste Remediation Systems (TWRS) immobilized HLW (IHLW) and other canistered high-level waste forms; and (2) interim storage and disposal of TWRS immobilized low-activity tank waste (ILAW). An environmental requirements checklist and narrative was developed to identify the permitting path forward for the HLW interim storage (HLWIS) project (See Appendix B). This permitting plan will follow the permitting logic developed in that checklist

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

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

76 FR 13629 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation...

Science.gov (United States)

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...

77 FR 25733 - Receipt of Applications for Endangered Species Permits

Science.gov (United States)

2012-05-01

.... ADDRESSES: Documents and other information submitted with the applications are available for review, subject... information from public review, we cannot guarantee that we will be able to do so. Permit Application Number..., capture, band, draw blood and conduct laparotomies on yellow-shouldered blackbirds (Agelaius xanthomus) in...

Hazardous waste landfill research

Energy Technology Data Exchange (ETDEWEB)

Schomaker, N.B.

1983-05-01

The hazardous waste land disposal research program is collecting data necessary to support implementation of disposal guidelines mandated by the 'Resource Conservation and Recovery Act of 1976' (RCRA) PL 94-580. This program relating to the categorical area of landfills, surface impoundments, and underground mines encompasses state-of-the-art documents, laboratory analysis, economic assessment, bench and pilot studies, and full scale field verification studies. Over the next five years the research will be reported as Technical Resource Documents in support of the Permit Writers Guidance Manuals. These manuals will be used to provide guidance for conducting the review and evaluation of land disposal permit applications. This paper will present an overview of this program and will report the current status of work in the various categorical areas.

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

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.”

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.”

75 FR 55848 - Pipeline Safety: Request for Special Permit

Science.gov (United States)

2010-09-14

... the special permit segment and to allow the public to review additional documents added to the docket... period of 30 days from the date of publication of this notice in relation to the Federal Register Notice... allows the public to enter comments on any Federal Register notice issued by any agency. Fax: 1-202-493...

Ecological risk assessment guidance for preparation of remedial investigation/feasibility study work plans

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

Waste Acceptance System Requirements document (WASRD)

International Nuclear Information System (INIS)

1993-01-01

This Waste Acceptance System Requirements document (WA-SRD) describes the functions to be performed and the technical requirements for a Waste Acceptance System for accepting spent nuclear fuel (SNF) and high-level radioactive waste (HLW) into the Civilian Radioactive Waste Management System (CRWMS). This revision of the WA-SRD addresses the requirements for the acceptance of HLW. This revision has been developed as a top priority document to permit DOE's Office of Environmental Restoration and Waste Management (EM) to commence waste qualification runs at the Savannah River Site's (SRS) Defense Waste Processing Facility (DWPF) in a timely manner. Additionally, this revision of the WA-SRD includes the requirements from the Physical System Requirements -- Accept Waste document for the acceptance of SNF. A subsequent revision will fully address requirements relative to the acceptance of SNF

77 FR 27451 - Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels-Draft...

Science.gov (United States)

2012-05-10

... (other than diesel fuels) pursuant to hydraulic fracturing operations related to oil, gas, or geothermal... during HF related to oil, gas, or geothermal operations must obtain a UIC permit before injection begins... diesel fuels are available through the UIC Class II Program, the well class for oil and gas activities.\\1...

WIPP's Hazardous Waste Facility Permit Renewal Application

International Nuclear Information System (INIS)

Most, W.A.; Kehrman, R.F.

2009-01-01

Hazardous waste permits issued by the New Mexico Environment Department (NMED) have a maximum term of 10-years from the permit's effective date. The permit condition in the Waste Isolation Pilot Plant's (WIPP) Hazardous Waste Facility Permit (HWFP) governing renewal applications, directs the Permittees to submit a permit application 180 days prior to expiration of the Permit. On October 27, 1999, the Secretary of the NMED issued to the United States Department of Energy (DOE), the owner and operator of WIPP, and to Washington TRU Solutions LLC (WTS), the Management and Operating Contractor and the cooperator of WIPP, a HWFP to manage, store, and dispose hazardous waste at WIPP. The DOE and WTS are collectively known as the Permittees. The HWFP is effective for a fixed term not to exceed ten years from the effective date of the Permit. The Permittees may renew the HWFP by submitting a new permit application at least 180 calendar days before the expiration date, of the HWFP. The Permittees are not proposing any substantial changes in the Renewal Application. First, the Permittees are seeking the authority to dispose of Contact-Handled and Remote-Handled TRU mixed waste in Panel 8. Panels 4 through 7 have been approved in the WIPP Hazardous Waste Facility Permit as it currently exists. No other change to the facility or to the manner in which hazardous waste is characterized, managed, stored, or disposed is being requested. Second, the Permittees also seek to include the Mine Ventilation Rate Monitoring Plan, as Attachment Q in the HWFP. This Plan has existed as a separate document since May 2000. The NMED has requested that the Plan be submitted as part of the Renewal Application. The Permittees have been operating to the Mine Ventilation Rate Monitoring Plan since the Plan was submitted. Third, some information submitted in the original WIPP RCRA Part B Application has been updated, such as demographic information. The Permittees will submit this information in the

300 Area Treated Effluent Disposal Facility permit reopener run plan

International Nuclear Information System (INIS)

Olander, A.R.

1995-01-01

The 300 Area Treated Effluent Disposal Facility (TEDF) is authorized to discharge treated effluent to the Columbia River by National Pollutant Discharge Elimination System permit WA-002591-7. The letter accompanying the final permit noted the following: EPA recognizes that the TEDF is a new waste treatment facility for which full scale operation and effluent data has not been generated. The permit being issued by EPA contains discharge limits that are intended to force DOE's treatment technology to the limit of its capability.'' Because of the excessively tight limits the permit contains a reopener clause which may allow limits to be renegotiated after at least one year of operation. The restrictions for reopening the permit are as follows: (1) The permittee has properly operated and maintained the TEDF for a sufficient period to stabilize treatment plant operations, but has nevertheless been unable to achieve the limitation specified in the permit. (2) Effluent data submitted by the permittee supports the effluent limitation modifications(s). (3) The permittee has submitted a formal request for the effluent limitation modification(s) to the Director. The purpose of this document is to guide plant operations for approximately one year to ensure appropriate data is collected for reopener negotiations

10 CFR 205.328 - Environmental requirements for Presidential Permits-Alternative 1.

Science.gov (United States)

2010-01-01

... Facilities for Transmission of Electric Energy at International Boundaries § 205.328 Environmental... 10 Energy 3 2010-01-01 2010-01-01 false Environmental requirements for Presidential Permits... responsible for the costs of preparing any necessary environmental document, including an Environmental Impact...

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...

Early site reviews for nuclear power facilities: procedures and possible technical review options. Draft

International Nuclear Information System (INIS)

1978-02-01

The document provides guidance for utility companies, State and other governmental agencies, and others who may request or may wish to participate in an early review of site suitability issues related to a site proposed for a nuclear power or test reactor. Although the emphasis of this document is on a nuclear electric generating station, the guidance provided can be used for a test reactor or other kinds of reactors. The procedures to be followed by applicants for construction permits and by others are described and the possible significant areas of technical review are delineated

Albert Einstein College of Medicine of Yeshiva University, Order Granting in part and Denying in part Petitions for Objection to Permits in Response to Remand

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Citgo Refining and Chemicals, West Plant, Corpus Chrisit, Texas, Order Granting in Part and Denying in Part Petition for Objection to the Title V Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Technical Support Document: 50% Energy Savings Design Technology Packages for Highway Lodging Buildings

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.

Technical Support Document: 50% Energy Savings Design Technology Packages for Medium Office Buildings

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.

Early Site Permit Demonstration Program: Regulatory criteria evaluation report

International Nuclear Information System (INIS)

1993-03-01

The primary objective of the Early Site Plan Demonstration Program (ESPDP) is to demonstrate successfully the use of 10CFR52 to obtain ESPs for one or more US sites for one (or more) ALWR nuclear power plants. It is anticipated that preparation of the ESP application and interaction with NRC during the application review process will result not only in an ESP for the applicant(s) but also in the development of criteria and definition of processes, setting the precedent that facilitates ESPs for subsequent ESP applications. Because siting regulatory processes and acceptance criteria are contained in over 100 separate documents, comprehensive licensing and technical reviews were performed to establish whether the requirements and documentation are self-consistent, whether the acceptance criteria are sufficiently well-defined and clear, and whether the licensing process leading to the issuance of an ESP is unambiguously specified. This document provides appendices A and B of this report. Appendix A contains a list of regulations, regulatory guidance, and acceptance criteria; Appendix B contains a cross-reference index of siting-related documentation

A CASE STUDY DEMONSTRATING U.S. EPA GUIDANCE FOR EVALUATING LANDFILL GAS EMISSIONS FROM CLOSED OR ABANDONED FACILITIES--BUSH VALLEY LANDFILL, HARFORD COUNTY, MARYLAND

Science.gov (United States)

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 ...

Public health economics: a systematic review of guidance for the economic evaluation of public health interventions and discussion of key methodological issues

Science.gov (United States)

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

Guidance documents: Continued support to improve operations of fish hatcheries and field sites to reduce the impact or prevent establishment of New Zealand Mudsnails and other invasive mollusks

Science.gov (United States)

Moffitt, Christine M.

2017-01-01

This project tested and revised a risk assessment/management tool authored by Moffitt and Stockton designed to provide hatchery biologists and others a structure to measure risk and provide tools to control, prevent or eliminate invasive New Zealand mudsnails (NZMS) and other invasive mollusks in fish hatcheries and hatchery operations. The document has two parts: the risk assessment tool, and an appendix that summarizes options for control or management.The framework of the guidance document for risk assessment/hatchery tool combines approaches used by the Hazard Analysis and Critical Control Points (HACCP) process with those developed by the Commission for Environmental Cooperation (CEC), of Canada, Mexico, and the United States, in the Tri-National Risk Assessment Guidelines for Aquatic Alien Invasive Species. The framework approach for this attached first document assesses risk potential with two activities: probability of infestation and consequences of infestation. Each activity is treated equally to determine the risk potential. These two activities are divided into seven basic elements that utilize scientific, technical, and other relevant information in the process of the risk assessment. To determine the probability of infestation four steps are used that have scores reported or determined and averaged. This assessment follows a familiar HACCP process to assess pathways of entry, entry potential, colonization potential, spread potential. The economic, environmental and social consequences are considered as economic impact, environmental impact, and social and cultural influences.To test this document, the Principal Investigator worked to identify interested hatchery managers through contacts at regional aquaculture meetings, fish health meetings, and through the network of invasive species managers and scientists participating in the Western Regional Panel on Aquatic Nuisance Species and the 100th Meridian Initiative's Columbia River Basin Team, and the

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...

Federal Transit Administration's noise and vibration Guidance Manual: Updates after 10 years of experience

Science.gov (United States)

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.

Development of recommended practices and guidance documents for upstream oil and gas flow measurement

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

European Society of Clinical Microbiology and Infectious Diseases: update of the diagnostic guidance document for Clostridium difficile infection.

Science.gov (United States)

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.

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.

Methods Used to Document Procedural Fidelity in School-Based Intervention Research

Science.gov (United States)

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…

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

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.

Multimodal system for the planning and guidance of bronchoscopy

Science.gov (United States)

Higgins, William E.; Cheirsilp, Ronnarit; Zang, Xiaonan; Byrnes, Patrick

2015-03-01

Many technical innovations in multimodal radiologic imaging and bronchoscopy have emerged recently in the effort against lung cancer. Modern X-ray computed-tomography (CT) scanners provide three-dimensional (3D) high-resolution chest images, positron emission tomography (PET) scanners give complementary molecular imaging data, and new integrated PET/CT scanners combine the strengths of both modalities. State-of-the-art bronchoscopes permit minimally invasive tissue sampling, with vivid endobronchial video enabling navigation deep into the airway-tree periphery, while complementary endobronchial ultrasound (EBUS) reveals local views of anatomical structures outside the airways. In addition, image-guided intervention (IGI) systems have proven their utility for CT-based planning and guidance of bronchoscopy. Unfortunately, no IGI system exists that integrates all sources effectively through the complete lung-cancer staging work flow. This paper presents a prototype of a computer-based multimodal IGI system that strives to fill this need. The system combines a wide range of automatic and semi-automatic image-processing tools for multimodal data fusion and procedure planning. It also provides a flexible graphical user interface for follow-on guidance of bronchoscopy/EBUS. Human-study results demonstrate the system's potential.

Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry.

Science.gov (United States)

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.

CERN CERTIFICATE REQUIRED FOR AN APPLICATION FOR A FRENCH RESIDENCE PERMIT ISSUED BY A PREFECTURE

CERN Multimedia

Relations with the Host States Service

2001-01-01

All non-French nationals who reside in France for more than three consecutive months or who, in the case of intermittent periods of residence, are effectively present in France for more than three months in any six-month period must obtain a residence or stay permit (titre de séjour). If members of the CERN personnel and members of their families fulfil those conditions inter alia, they normally receive a legitimation document, which is valid as a residence or stay permit, from the French Ministry of Foreign Affairs (Carte spéciale FI or AT, Carte d'assimilé à un membre de mission diplomatique). However, members of the personnel with permanent resident status (résident permanent) are not, by virtue of that status, entitled to a legitimation document and must obtain a residence permit issued by a Prefecture. For the latter purpose, with the agreement of the Prefecture de l'Ain, CERN (i.e. the Personnel Records Office, Human Resources Division, office 33/1-...

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.

Waste feed delivery environmental permits and approvals plan

International Nuclear Information System (INIS)

Papp, I.G.

1998-01-01

This document describes the range of environmental actions, including required permits and other agency approvals, that may affect waste feed delivery (WFD) activities in the Hanford Site's Tank Waste Remediation System (TWRS). This plan expands on the summary level information in the Tank Waste Remediation System Environmental Program Plan (HNF 1773) to address requirements that are most pertinent to WFD. This plan outlines alternative approaches to satisfying applicable environmental standards, and describes selected strategies for acquiring permits and other approvals needed for WFD to proceed. Appendices at the end of this plan provide preliminary cost and schedule estimates for implementing the selected strategies. The rest of this section summarizes the scope of WFD activities, including important TWRS operating information, and describes in more detail the objectives, structure, and content of this plan

Pairwise Trajectory Management (PTM): Concept Description and Documentation

Science.gov (United States)

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

State waste discharge permit application 400 Area secondary cooling water. Revision 2

International Nuclear Information System (INIS)

1996-01-01

This document constitutes the Washington Administrative Code 173-216 State Waste Discharge Permit Application that serves as interim compliance as required by Consent Order DE 91NM-177, for the 400 Area Secondary Cooling Water stream. As part of the Hanford Federal Facility Agreement and Consent Order negotiations, the US Department of Energy, Richland Operations Office, the US Environmental Protection Agency, and the Washington State Department of Ecology agreed that liquid effluent discharges to the ground on the Hanford Site that affect groundwater or have the potential to affect groundwater would be subject to permitting under the structure of Chapter 173-216 of the Washington Administrative Code, the State Waste Discharge Permitting Program. As a result of this decision, the Washington State Department of Ecology and the US Department of Energy, Richland Operations Office entered into Consent Order DE 91NM-177. The Consent Order DE 91NM-177 requires a series of permitting activities for liquid effluent discharges. Based upon compositional and flow rate characteristics, liquid effluent streams on the Hanford Site have been categorized into Phase 1, Phase 2, and Miscellaneous streams. This document only addresses the 400 Area Secondary Cooling Water stream, which has been identified as a Phase 2 stream. The 400 Area Secondary Cooling Water stream includes contribution streams from the Fuels and Materials Examination Facility, the Maintenance and Storage Facility, the 481-A pump house, and the Fast Flux Test Facility

State waste discharge permit application for cooling water and condensate discharges

Energy Technology Data Exchange (ETDEWEB)

Haggard, R.D.

1996-08-12

The following presents the Categorical State Waste Discharge Permit (SWDP) Application for the Cooling Water and Condensate Discharges on the Hanford Site. This application is intended to cover existing cooling water and condensate discharges as well as similar future discharges meeting the criteria set forth in this document.

Real-time endoscopic guidance using near-infrared fluorescent light for thoracic surgery

Science.gov (United States)

Venugopal, Vivek; Stockdale, Alan; Neacsu, Florin; Kettenring, Frank; Frangioni, John V.; Gangadharan, Sidharta P.; Gioux, Sylvain

2013-03-01

Lung cancer is the leading cause of cancer death in the United States, accounting for 28% of all cancer deaths. Standard of care for potentially curable lung cancer involves preoperative radiographic or invasive staging, followed by surgical resection. With recent adjuvant chemotherapy and radiation studies showing a survival advantage in nodepositive patients, it is crucial to accurately stage these patients surgically in order to identify those who may benefit. However, lymphadenectomy in lung cancer is currently performed without guidance, mainly due to the lack of tools permitting real-time, intraoperative identification of lymph nodes. In this study we report the design and validation of a novel, clinically compatible near-infrared (NIR) fluorescence thoracoscope for real-time intraoperative guidance during lymphadenectomy. A novel, NIR-compatible, clinical rigid endoscope has been designed and fabricated, and coupled to a custom source and a dual channel camera to provide simultaneous color and NIR fluorescence information to the surgeon. The device has been successfully used in conjunction with a safe, FDA-approved fluorescent tracer to detect and resect mediastinal lymph nodes during thoracic surgery on Yorkshire pigs. Taken together, this study lays the foundation for the clinical translation of endoscopic NIR fluorescence intraoperative guidance and has the potential to profoundly impact the management of lung cancer patients.

Order Responding to November 18, 2002 Petitoner's Request that the Administrator Object to the TVA John Sevier Fossil Plant and the TVA Kingston Fossil Plant Operating Permit

Science.gov (United States)

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-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.

Hazardous waste landfill research: U. S. E. P. A. (United States Environmental Protection Agency) Program

Energy Technology Data Exchange (ETDEWEB)

Schomaker, N.B.

1984-06-01

The hazardous waste land disposal research program is collecting data necessary to support implementation of disposal guidelines mandated by the 'Resource Conservation and Recovery Act of 1976' (RCRA) PL 94-580. This program relating to the categorical areas of landfills, surface impoundments, and underground mines encompasses state-of-the-art documents, laboratory analysis, economic assessment, bench and pilot studies, and full-scale field verification studies. Over the next five years the research will be reported as Technical Resource Documents in support of the RCRA Guidance Documents. These documents will be used to provide guidance for conducting the review and evaluation of land disposal permit applications. This paper will present an overview of this program and will report the current status of the work.

Integration of existing systematic reviews into new reviews: identification of guidance needs

Science.gov (United States)

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

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

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).

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).

Year 2000 (Y2K) computer compliance guide; guidance for FDA personnel. Food and Drug Administration. Notice.