WorldWideScience

Sample records for draft interim guidance

  1. 76 FR 60937 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-02; Aging Management Program for Steam...

    Science.gov (United States)

    2011-09-30

    ...-2011-02; Aging Management Program for Steam Generators AGENCY: Nuclear Regulatory Commission. ACTION... License Renewal Interim Staff Guidance (LR-ISG), LR-ISG-2011-02, ``Aging Management Program for Steam... using Revision 3 of NEI 97-06 to manage steam generator aging. The Draft LR-ISG revises the NRC staff's...

  2. 78 FR 40199 - Draft Spent Fuel Storage and Transportation Interim Staff Guidance

    Science.gov (United States)

    2013-07-03

    .... ML13056A516. NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21... current or future applicants The NRC staff has no intention to impose the draft ISG positions on existing... of the effective date of this guidance The NRC staff has no intention to impose the draft ISG...

  3. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Science.gov (United States)

    2013-12-04

    ... reporting of product information by registered outsourcing facilities under section 503B of the FD&C Act... collection techniques, when appropriate, and other forms of information technology. Under the draft guidance... report should include the following information for all drugs compounded by the outsourcing facility...

  4. 78 FR 49782 - Interim Staff Guidance on Changes During Construction

    Science.gov (United States)

    2013-08-15

    ... Construction AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; request for comment... During Construction.'' This ISG provides guidance to the NRC staff on the Preliminary Amendment Request...-ISG-025 ``Interim Staff Guidance on Changes during Construction under 10 CFR Part 52'' is available...

  5. 78 FR 67442 - Congestion Mitigation and Air Quality Improvement Program Interim Guidance

    Science.gov (United States)

    2013-11-12

    ...] Congestion Mitigation and Air Quality Improvement Program Interim Guidance AGENCY: Federal Highway... Comment. SUMMARY: The FHWA is issuing Interim Guidance on the Congestion Mitigation and Air Quality.../environment/air_quality/cmaq/policy_and_guidance/2008_guidance/ guidance/. DATES: This Interim Guidance is...

  6. 75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Science.gov (United States)

    2010-10-14

    ...] Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft guidance provides... Products: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft guidance...

  7. 75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability

    Science.gov (United States)

    2010-09-27

    ... fermented dairy products, such as yogurt, belong to a separate category that is not relevant to the... the draft guidance, processors of non-acidified foods (e.g., some acid foods or fermented foods) who... regulations. Under the draft guidance, processors of acid foods and fermented foods who conclude that such...

  8. 75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella

    Science.gov (United States)

    2010-08-12

    ...] Draft Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production... entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and... on how to comply with certain provisions contained in FDA's final rule ``Prevention of Salmonella...

  9. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Science.gov (United States)

    2013-12-04

    ... information technology. Under the draft guidance, outsourcing facilities that elect to register should submit... guidance provides information on how an outsourcing facility should submit facility registration...] Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under...

  10. 78 FR 66744 - Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2013-11-06

    ...] Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability...) is announcing the availability of a draft guidance for industry entitled ``Pulmonary Tuberculosis... of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the...

  11. 76 FR 9529 - Migratory Birds; Draft Eagle Conservation Plan Guidance

    Science.gov (United States)

    2011-02-18

    ...-1231-9BPP] RIN 1018-AX53 Migratory Birds; Draft Eagle Conservation Plan Guidance AGENCY: Fish and... mail to: Attention: Eagle Conservation Plan Guidance; Division of Migratory Bird Management; U.S. Fish... implementing statutes including the Bald and Golden Eagle Protection Act (BGEPA), the Migratory Bird Treaty Act...

  12. 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...

  13. 75 FR 984 - Draft Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites

    Science.gov (United States)

    2010-01-07

    ...The Environmental Protection Agency (EPA or the Agency) is announcing a 50-day public comment period for draft recommended interim preliminary remediation goals (PRGs) developed in the Draft Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and Resource Conservation and Recovery Act (RCRA) Sites. EPA's Office of Solid Waste and Emergency and Emergency Response (OSWER) has developed the draft recommended interim PRGs for dioxin in soil. These draft recommended interim PRGs were calculated using existing, peer- reviewed toxicity values and current EPA equations and default exposure assumptions. This Federal Register notice is intended to provide an opportunity for public comment on the draft recommended interim PRGs. EPA will consider any public comments submitted in accordance with this notice and may revise the draft recommended interim PRGs thereafter.

  14. 76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella

    Science.gov (United States)

    2011-03-23

    .... in human foods and direct-human-contact animal foods. It does not create or confer any rights for or... Animal Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... ``Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods.'' The draft guidance...

  15. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Science.gov (United States)

    2011-02-28

    ...] Draft Guidance for Industry on Medication Guides--Distribution Requirements and Inclusion of Medication... a draft guidance for industry entitled ``Medication Guides--Distribution Requirements and Inclusion... Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies (REMS).'' This draft guidance is...

  16. 76 FR 38187 - International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of...

    Science.gov (United States)

    2011-06-29

    ...] International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances... Manufacture of Drug Substances.'' The draft guidance was prepared under the auspices of the International... that a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances'' should be made...

  17. Draft Guidance for Protective Action Strategies Development

    Energy Technology Data Exchange (ETDEWEB)

    Park, Sang Hyun; Jeong, Seung Young; Kim, Wanjoo [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2016-10-15

    National nuclear emergency preparedness and response (EPR) framework has been improved since the Fukushima accident in 2011. There are still many needs to be amended and improved in regulatory requirements and technical criteria to warrant efficacy of the EPR framework. As an important part of the framework, protective actions have to be implemented with optimized and justified manner during whole emergency phases. In this study, to enhance protective action strategies in response to severe accident or general emergency, existing procedures were reviewed. And generic guidance to develop protective action recommendations (PARs) was proposed considering revised EPZ and recent technical information on protective action strategies. The generic guidance for PARs based on facility status was introduced. Revision of EPZ and some recent information on protective action strategies, such as staged evacuation, specific approach for rapidly progressing accident were considered. It would be employed as a basis to develop site-specific strategies of PARs and regulatory guidance for emergency plan by nuclear licensee. It was focused on an early phase of nuclear emergency. Further efforts to develop site specific strategies of PARs and strategies which cover full range of nuclear emergency would be followed by several stake holders.

  18. 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...

  19. 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...

  20. 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.

  1. 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

  2. 78 FR 5830 - Draft Environmental Assessment and Proposed Habitat Conservation Plan for the Interim Operations...

    Science.gov (United States)

    2013-01-28

    ...-FXES11120800000F2-123-F2] Draft Environmental Assessment and Proposed Habitat Conservation Plan for the Interim Operations of PacifiCorp's Klamath Hydroelectric Project on the Klamath River, Klamath County, OR, and... environmental assessment and proposed habitat conservation plan; request for comment. SUMMARY: We, the U.S. Fish...

  3. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Science.gov (United States)

    2013-02-19

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...

  4. 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...

  5. 77 FR 67379 - Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed...

    Science.gov (United States)

    2012-11-09

    ... appropriate human specimen or culture. This draft guidance is not final nor is it in effect at this time... nucleic acids extracted from a single appropriate human specimen or culture. For the purposes of this... diseases. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good...

  6. 77 FR 24722 - Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability

    Science.gov (United States)

    2012-04-25

    ...] Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability AGENCY: Food and... safety assessment of nanomaterials in cosmetic products. This guidance is intended to assist industry in... Cosmetic Products.'' The draft guidance is intended to assist industry in identifying the potential safety...

  7. 75 FR 32791 - Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of...

    Science.gov (United States)

    2010-06-09

    ... FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will...] Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of... Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and...

  8. 76 FR 82306 - Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability

    Science.gov (United States)

    2011-12-30

    ...] Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Use of Histology in Biomarker... studies for which histology is a reference standard. This guidance discusses the processes that should be...

  9. 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...

  10. 75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

    Science.gov (United States)

    2010-01-27

    ... draft guidance before it begins work on the final version of the guidance, submit written or electronic..., prescribing, advertising, manufacturing, promotion, marketing, and use in the practice of medicine. Not...

  11. 78 FR 12759 - Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting...

    Science.gov (United States)

    2013-02-25

    ...; formerly 2005D-0183] Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug... 20852. FOR FURTHER INFORMATION CONTACT: Lisa K. Naeger, Center for Drug Evaluation and Research, Food...

  12. 76 FR 53909 - Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Science.gov (United States)

    2011-08-30

    ...] Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Tablet Scoring... should be met to facilitate the evaluation and labeling of tablets that have been scored. (A scoring...

  13. 75 FR 49913 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Science.gov (United States)

    2010-08-16

    ... provides this draft guidance for public review and comment to ensure accessibility of Federal accounting... COUNCIL ON ENVIRONMENTAL QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting... recommended Federal GHG reporting and accounting procedures. On April 5, 2010, DOE-FEMP submitted the final...

  14. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-10-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

  15. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Science.gov (United States)

    2012-02-23

    ...] Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal... industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug...). This updated draft guidance is intended to provide individuals in the human and animal food industries...

  16. 77 FR 40068 - Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and...

    Science.gov (United States)

    2012-07-06

    ... the draft guidance are not applicable to donors of Source Plasma. DATES: Although you can comment on... electronic or written comments on the draft guidance by September 4, 2012. ADDRESSES: Submit written requests...-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the...

  17. 78 FR 68852 - Draft Guidance for Industry on Acrylamide in Foods; Availability

    Science.gov (United States)

    2013-11-15

    ... placing preparation and cooking instructions on frozen French fry packages. Lastly, the draft guidance is... high-temperature cooking. The draft guidance is intended to suggest a range of possible approaches to... during certain types of high-temperature cooking, and is a concern because it can cause cancer in...

  18. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Science.gov (United States)

    2013-06-05

    ... Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and... 20852. FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug Evaluation and Research, Food...

  19. 77 FR 70167 - Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...

    Science.gov (United States)

    2012-11-23

    ...] Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...

  20. 75 FR 1060 - Draft Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure...

    Science.gov (United States)

    2010-01-08

    .... This draft guidance applies to manufacturers of drug and therapeutic biologic products regulated by...: General preparedness through employee education and immunization, Prioritization of manufactured products... of information technology. The draft guidance recommends that manufacturers of drug and therapeutic...

  1. 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...

  2. Interim Guidance for the Sanitary Control and Surveillance of Field Water Supplies

    Science.gov (United States)

    2005-07-15

    on field water site/area restoration , including the removal and disposal of waste (see chapter 11 and FM 4-02.17). CHAPTER 3 INTRODUCTION TO...chemical addition, coagulation, sedimentation, and various kinds of filtration including multimedia filtration, cartridge filtration, microfiltration ... microfiltration membrane-based pretreatment system. Interim Guidance Pending Publication of TBMED 577 15 July 2005 53 Figure 9-1

  3. Physical protection of shipments of irradiated reactor fuel; Interim guidance. Regulatory report

    International Nuclear Information System (INIS)

    1980-06-01

    During May, 1979, the U.S. Nuclear Regulatory Commission approved for issuance in effective form new interim regulations for strengthening the protection of spent fuel shipments against sabotage and diversion. The new regulations were issued without benefit of public comment, but comments from the public were solicited after the effective date. Based upon the public comments received, the interim regulations were amended and reissued in effective form as a final interim rule in May, 1980. The present document supersedes a previously issued interim guidance document, NUREG-0561 (June, 1979) which accompanied the original rule. This report has been revised to conform to the new interim regulations on the physical protection of shipments of irradiated reactor fuel which are likely to remain in effect until the completion of an ongoing research program concerning the response of spent fuel to certain forms of sabotage, at which time the regulations may be rescinded, modified or made permanent, as appropriate. This report discusses the amended regulations and provides a basis on which licensees can develop an acceptable interim program for the protection of spent fuel shipments

  4. 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.

  5. 77 FR 24722 - Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes...

    Science.gov (United States)

    2012-04-25

    ...] Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes... Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food... determining whether changes in manufacturing process, including the intentional reduction in particle size to...

  6. 76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

    Science.gov (United States)

    2011-08-19

    ... clinical trials of therapeutic drugs and biological products. The draft guidance describes standards... important imaging endpoint is used in a clinical trial of a therapeutic drug or biological product... Services to the Chairman of [[Page 51994

  7. 77 FR 71194 - Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

    Science.gov (United States)

    2012-11-29

    ...] Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy... Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products,'' dated November... Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT). The product areas covered by this...

  8. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Science.gov (United States)

    2012-01-03

    ... organization. These 16 Panels have largely been the driving force for CDRH's internal organizational structure...). The draft guidance, when finalized, will represent the Agency's current thinking on medical device...

  9. 76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2011-12-02

    ... of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate classification of co-crystal solid-state forms. This draft...

  10. 75 FR 7591 - Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and...

    Science.gov (United States)

    2010-02-22

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-SFUND-2009-0907; FRL-9114-6] RIN 2050-ZA05 Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites; Extension of... Interim Preliminary Remediation Goals for Dioxin in Soil at Comprehensive Environmental Response...

  11. 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

  12. 78 FR 14791 - Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and...

    Science.gov (United States)

    2013-03-07

    ... FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and Equipment Cost Accumulation, Assignment, and Allocation AGENCY...) has issued a Federal Financial Accounting Technical Release Exposure Draft entitled Implementation...

  13. 78 FR 18273 - Draft Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of...

    Science.gov (United States)

    2013-03-26

    .... FDA-2013-D-0269] Draft Guidance for Industry on Purchasing Reef Fish Species Associated With the... availability of a draft guidance entitled ``Guidance for Industry: Purchasing Reef Fish Species Associated With... seafood processors who purchase reef fish how to minimize the risk of ciguatera fish poisoning (CFP) from...

  14. 75 FR 32952 - Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially...

    Science.gov (United States)

    2010-06-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0281] Draft Guidance for Industry and Food and Drug Administration Staff; ```Harmful and Potentially Harmful... Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff...

  15. 77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

    Science.gov (United States)

    2012-07-27

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510(k... serious and sometimes fatal consequences to patients. This guidance provides recommendations to 510(k... unintended connections between enteral and nonenteral devices. This draft guidance is not final nor is it in...

  16. 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...

  17. 78 FR 55727 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Science.gov (United States)

    2013-09-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0928] Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive... guidance for industry (GFI 221) entitled ``Recommendations for Preparation and Submission of Animal Food...

  18. 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...

  19. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Science.gov (United States)

    2013-11-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability AGENCY... guidance, FDA recommended an in vivo fasting BE study with pharmacokinetic endpoints and in vitro studies...

  20. 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...

  1. 76 FR 52958 - Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing...

    Science.gov (United States)

    2011-08-24

    ...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug... FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug...

  2. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Science.gov (United States)

    2011-05-24

    ... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...

  3. 77 FR 11133 - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for...

    Science.gov (United States)

    2012-02-24

    ...] Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for Treatment... Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (c...

  4. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Science.gov (United States)

    2010-01-20

    ... conferencing and electronic submissions, Mammography Matters, and other device-oriented information. A search... or electronic comments on the draft guidance by April 20, 2010. ADDRESSES: Submit written requests... the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit...

  5. 75 FR 50771 - Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products...

    Science.gov (United States)

    2010-08-17

    ...] (formerly Docket No. 1999D-4071) Draft Revised Guidance for Industry on Residual Solvents in New Veterinary...) entitled ``Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients... 2001 final guidance), has been developed for veterinary use by the International Cooperation on...

  6. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Science.gov (United States)

    2011-12-19

    ... performance of medical devices in women. This information can be of benefit to patients and their medical... draft guidance before it begins work on the final version of the guidance, submit either electronic or...

  7. Hydrazine blending and storage facility, interim response action, draft implementation document for rinsewater transfer, phase 2

    Energy Technology Data Exchange (ETDEWEB)

    1991-08-09

    This Draft Implementation Document (ID) for Rinsewater Transfer has been prepared as a requirement for conducting and completing the Interim Response Action (IRA) at the Hydrazine Blending and Storage Facility (HBSF) located at Rocky Mountain Arsenal (RMA) in Commerce City, Colorado. This document has been prepared in accordance with requirements set forth in the October 1988 Final Decision Document for the HBSF IRA (Peer, 1988) and the Amendment to the Final Decision Document (HLA, 1991). The HBSF IRA task was separated into two phases that comprise complete decommissioning of the HBSF as cited in the Federal Facility Agreement. The design portion of Phase I of the HBSF IRA included analytical methods development and laboratory certification for analysis of hydrazine fuel compounds (hydrazine, monomethyl hydrazine) (MMH), and unsymmetrical dimethyl hydrazine (UDMH) and n-nitrosodimethylamine (NDMA) in HBSF rinsewater, chemical characterization of hydrazine rinsewater, bench- and pilot-scale testing of ultraviolet (UV) light/chemical oxidation treatment systems for treatment of hydrazine rinsewater, full-scale startup testing of a UV light/chemical oxidation treatment system, and air monitoring during startup testing as described in the Draft Final Treatment Report (HLA, 1991).

  8. Interim guidance risk assessment of the device assembly facility at the Nevada test site

    International Nuclear Information System (INIS)

    Altenbach, T.J.

    1996-05-01

    The risks of plutonium dispersal and/or high explosive detonation from nuclear explosive operations at the Device Assembly Facility were examined in accordance with DOE Order 5610.11 and the Interim Guidance. The assessment consisted of a qualitative task and hazards analysis, and a quantitative risk screening. Results are displayed on risk matrices for the major types of operations. Most accident scenarios were considered to have Low risk; a few scenarios have Moderate risk; and none have High risk. The highest risk scenarios (Moderate category) consist of a high explosive detonation during assembly operations in a cell, with bare conventional high explosive surrounding the pit

  9. 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...

  10. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Science.gov (United States)

    2011-12-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

  11. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Science.gov (United States)

    2010-04-29

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for... the Internet. To receive ``Draft Guidance for Industry and Food and Drug Administration Staff; User... and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and...

  12. 77 FR 48990 - Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility...

    Science.gov (United States)

    2012-08-15

    ...] Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and... industry entitled ``Necessity of the Use of Food Categories in Food Facility Registrations and Updates to... announcing the availability of a draft guidance for industry entitled ``Necessity of the Use of Food...

  13. 75 FR 37450 - Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing...

    Science.gov (United States)

    2010-06-29

    ... animals in order to help minimize antimicrobial resistance development. Based on a consideration of the...] Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals... Medically Important Antimicrobial Drugs in Food- Producing Animals.'' This draft guidance is intended to...

  14. 75 FR 55797 - Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting...

    Science.gov (United States)

    2010-09-14

    ...] Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral... entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment... announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection...

  15. 76 FR 6143 - Draft Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug...

    Science.gov (United States)

    2011-02-03

    ...; formerly Docket No. 00D-0892] Draft Guidance on Positron Emission Tomography Drug Applications--Content and... Applications for Certain Positron Emission Tomography Drug Products; Availability,'' issued on March 10, 2000... and ANDAs.'' The draft guidance is intended to assist manufacturers of certain positron emission...

  16. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2011-01-19

    ...] Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Size of Beads in Drug Products... Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products...

  17. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Science.gov (United States)

    2011-05-02

    ..., you may submit written requests for single copies of the draft guidance to the Office of Communication... critical to ensuring a reusable device is appropriately prepared for its next use. II. Significance of.... 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on...

  18. 78 FR 17660 - Draft Guidance for E85 Flexible Fuel Vehicle Weighting Factor for Model Years 2016-2019 Vehicles...

    Science.gov (United States)

    2013-03-22

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9792-9] Draft Guidance for E85 Flexible Fuel Vehicle... draft EPA guidance to auto manufacturers for weighting the greenhouse gas (GHG) emissions of a flexible... all federal government work days from 8:30 a.m. to 4:30 p.m.; generally, it is open Monday through...

  19. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Science.gov (United States)

    2010-12-03

    ...] Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers... Solvents in Animal Drug Products; Questions and Answers.'' The draft questions and answers (Q&A) guidance addresses the United States Pharmacopeia (USP) General Chapter Residual Solvents that applies to both human...

  20. 77 FR 11550 - Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May...

    Science.gov (United States)

    2012-02-27

    ... proposed information collected is necessary for the proper performance of FDA's functions, including... the draft guidance for industry entitled: ``Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products'' (Absenteeism Draft Guidance) published in the Federal...

  1. 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...

  2. 78 FR 44483 - Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of...

    Science.gov (United States)

    2013-07-24

    ... written requests for single copies of the draft guidance to the Division of Plant and Dairy Food Safety/Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS-315), Food and Drug..., Center for Food Safety and Applied Nutrition (HFS-316), Food and Drug Administration, 5100 Paint Branch...

  3. 78 FR 57859 - Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation...

    Science.gov (United States)

    2013-09-20

    ... the endocrine system. This draft guidance also discusses factors to consider in determining the need... interfere with some aspect of the endocrine system of an organism or its progeny. Any component of the endocrine system can be a target of endocrine disruptors, although the systems most commonly affected...

  4. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ... exposure measures is suitable for documenting BE (e.g., transdermal delivery systems and certain rectal and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1464] Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted...

  5. 75 FR 29350 - Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as...

    Science.gov (United States)

    2010-05-25

    ...] Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established.... The agency is also seeking comments from industry on the Reportable Food Registry requirements, and... the implementation of the Reportable Food Registry on September 8, 2009, and informs industry about...

  6. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Science.gov (United States)

    2011-11-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  7. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Science.gov (United States)

    2011-07-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0530] Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  8. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Science.gov (United States)

    2011-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

  9. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Science.gov (United States)

    2011-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  10. 78 FR 21128 - Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food...

    Science.gov (United States)

    2013-04-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0258] Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  11. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-11-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of...

  12. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2010-09-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0459] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori; Availability AGENCY: Food...

  13. 78 FR 74154 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Science.gov (United States)

    2013-12-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0928] Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive... for industry (GFI 221) entitled ``Recommendations for Preparation and Submission of Animal Food...

  14. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  15. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Science.gov (United States)

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...

  16. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Science.gov (United States)

    2012-12-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1161] Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  17. 77 FR 8262 - Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs...

    Science.gov (United States)

    2012-02-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0081] Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  18. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Science.gov (United States)

    2010-10-25

    ...] Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability AGENCY... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm...

  19. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Science.gov (United States)

    2013-03-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0168] Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  20. 78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...

    Science.gov (United States)

    2013-04-01

    ..., or Office of Communication, Outreach, and Development (HFM-40), Center for Biologics Evaluation and... biological product. This draft guidance describes the Agency's current thinking on how it intends to... review of biosimilar biological products. Because these meetings often will represent critical points in...

  1. 75 FR 41452 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Science.gov (United States)

    2010-07-16

    ... COUNCIL ON ENVIRONMENTAL QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting... Greenhouse Gas Accounting and Reporting.'' SUMMARY: On October 5, 2009, President Obama signed Executive Order (E.O.) 13514--Federal Leadership in Environmental, Energy, and Economic Performance (74 FR 52117...

  2. 77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

    Science.gov (United States)

    2012-02-27

    ... Oversight of PET Drug Products--Questions and Answers.'' The draft guidance provides questions and answers... assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic... PET Drug Products--Questions and Answers.'' In 1997, Congress passed the Food and Drug Administration...

  3. 77 FR 5415 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents, Certified...

    Science.gov (United States)

    2012-02-03

    ... in order to be excluded from the organic certification requirements of Part 205. The NOSB recommended... handling operations that are or are not excluded from organic certification. The draft guidance proposes... excluded from certification and, therefore, must be certified organic operations. \\1\\ NOSB Recommendation...

  4. 78 FR 9709 - Draft Guidance Regarding Voluntary Inspection of Vessels for Compliance With the Maritime Labour...

    Science.gov (United States)

    2013-02-11

    ... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2012-1066] Draft Guidance Regarding Voluntary Inspection of Vessels for Compliance With the Maritime Labour Convention, 2006 AGENCY: Coast Guard... Labour Convention, 2006 (Convention), which enters into force on August 20, 2013. The NVIC will provide...

  5. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability

    Science.gov (United States)

    2012-11-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0433; (formerly Docket No. 2007D-0169)] Draft Guidance for Industry on Bioequivalence Recommendation for...) Acceptable fasting and fed bioequivalence studies on the 25 mg strength, (2) proportional similarity of the...

  6. 78 FR 13686 - Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human...

    Science.gov (United States)

    2013-02-28

    ... FDA review staff in making decisions about the placement and content of pediatric information in human... assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic...] Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human...

  7. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Science.gov (United States)

    2011-01-07

    ... appropriate FDA organizational unit responsible for adverse event reporting compliance when these conditions... regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking... appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions...

  8. 77 FR 48989 - Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of...

    Science.gov (United States)

    2012-08-15

    ...] Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in... ``Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials.'' The purpose of... suicidal ideation and behavior in clinical trials of drug and biological products, including drugs for...

  9. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Science.gov (United States)

    2012-10-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1010] Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical... certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs...

  10. 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...

  11. Safe interim storage of Hanford tank wastes, draft environmental impact statement, Hanford Site, Richland, Washington

    International Nuclear Information System (INIS)

    1994-07-01

    This Draft EIS is prepared pursuant to the National Environmental Policy Act (NEPA) and the Washington State Environmental Policy Act (SEPA). DOE and Ecology have identified the need to resolve near-term tank safety issues associated with Watchlist tanks as identified pursuant to Public Law (P.L.) 101-510, Section 3137, ''Safety Measures for Waste Tanks at Hanford Nuclear Reservation,'' of the National Defense Authorization Act for Fiscal Year 1991, while continuing to provide safe storage for other Hanford wastes. This would be an interim action pending other actions that could be taken to convert waste to a more stable form based on decisions resulting from the Tank Waste Remediation System (TWRS) EIS. The purpose for this action is to resolve safety issues concerning the generation of unacceptable levels of hydrogen in two Watchlist tanks, 101-SY and 103-SY. Retrieving waste in dilute form from Tanks 101-SY and 103-SY, hydrogen-generating Watchlist double shell tanks (DSTs) in the 200 West Area, and storage in new tanks is the preferred alternative for resolution of the hydrogen safety issues

  12. Safe interim storage of Hanford tank wastes, draft environmental impact statement, Hanford Site, Richland, Washington

    Energy Technology Data Exchange (ETDEWEB)

    1994-07-01

    This Draft EIS is prepared pursuant to the National Environmental Policy Act (NEPA) and the Washington State Environmental Policy Act (SEPA). DOE and Ecology have identified the need to resolve near-term tank safety issues associated with Watchlist tanks as identified pursuant to Public Law (P.L.) 101-510, Section 3137, ``Safety Measures for Waste Tanks at Hanford Nuclear Reservation,`` of the National Defense Authorization Act for Fiscal Year 1991, while continuing to provide safe storage for other Hanford wastes. This would be an interim action pending other actions that could be taken to convert waste to a more stable form based on decisions resulting from the Tank Waste Remediation System (TWRS) EIS. The purpose for this action is to resolve safety issues concerning the generation of unacceptable levels of hydrogen in two Watchlist tanks, 101-SY and 103-SY. Retrieving waste in dilute form from Tanks 101-SY and 103-SY, hydrogen-generating Watchlist double shell tanks (DSTs) in the 200 West Area, and storage in new tanks is the preferred alternative for resolution of the hydrogen safety issues.

  13. 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

  14. 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

  15. 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

  16. 78 FR 22269 - International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA...

    Science.gov (United States)

    2013-04-15

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.

  17. 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...

  18. 76 FR 17160 - Office of New Reactors; Final Interim Staff Guidance on the Review of Nuclear Power Plant Designs...

    Science.gov (United States)

    2011-03-28

    ... design certification (DC) application for new nuclear power reactors under Title 10 of the Code of... NUCLEAR REGULATORY COMMISSION [NRC-2010-0033; DC/COL-ISG-021] Office of New Reactors; Final Interim Staff Guidance on the Review of Nuclear Power Plant Designs Using a Gas Turbine Driven Standby...

  19. 75 FR 8412 - Office of New Reactors: Interim Staff Guidance on Assessing Ground Water Flow and Transport of...

    Science.gov (United States)

    2010-02-24

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0047] Office of New Reactors: Interim Staff Guidance on Assessing Ground Water Flow and Transport of Accidental Radionuclide Releases; Solicitation of Public... ground water flow and transport of accidental radionuclide releases necessary to demonstrate compliance...

  20. 78 FR 69691 - Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and...

    Science.gov (United States)

    2013-11-20

    ...] Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and... entitled ``Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.'' When... promotional labeling and advertising for prescription human drugs, including biological drug products, and...

  1. 76 FR 69040 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2011-11-07

    ... Microbiology Devices Advisory Panel (the panel) recommended that in vitro diagnostic devices for Yersinia spp...). The draft guidance, when finalized will represent the Agency's current thinking on in vitro diagnostic...

  2. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Science.gov (United States)

    2010-05-20

    ... Ministry of Health, Labour and Welfare system. This notice of availability and draft guidance satisfy the... collection of information is necessary for the proper performance of FDA's functions, including whether the...

  3. Mars Science Laboratory Entry Guidance Improvements for Mars 2018 (DRAFT)

    Science.gov (United States)

    Garcia-Llama, Eduardo; Winski, Richard G.; Shidner, Jeremy D.; Ivanov, Mark C.; Grover, Myron R.; Prakash, Ravi

    2011-01-01

    In 2011, the Mars Science Laboratory (MSL) will be launched in a mission to deliver the largest and most capable rover to date to the surface of Mars. A follow on MSL-derived mission, referred to as Mars 2018, is planned for 2018. Mars 2018 goals include performance enhancements of the Entry, Descent and Landing over that of its predecessor MSL mission of 2011. This paper will discuss the main elements of the modified 2018 EDL preliminary design that will increase performance on the entry phase of the mission. In particular, these elements will increase the parachute deploy altitude to allow for more time margin during the subsequent descent and landing phases and reduce the delivery ellipse size at parachute deploy through modifications in the entry reference trajectory design, guidance trigger logic design, and the effect of additional navigation hardware.

  4. Ethical and social implications of microdosing clinical trial (2). The draft guidance and the future tasks

    International Nuclear Information System (INIS)

    Kurihara, Chieko

    2008-01-01

    Draft of the guidance (GD) for conducting the trial in the title (MCT) was officially announced by Ministry of Health, Labour and Welfare (MHLW) in Dec., 2007, but where the trial part alone was described without the research purposes involved in the starting idea of MCT. The authority invited opinions on the draft until Feb., 2008. This paper describes the detailed content of GD draft and discusses problems in future. GD draft contains: basic concept, range of non-clinical studies necessary for beginning MCT, methods to decide the maximal dose, concept for internal exposure of volunteers when radio-labeled compound is to be administered (for methods by accelerator mass spectrometry (AMS) and positron emission tomography (PET)), quality assurance of the test compound, other notices, and references. The last item contains outlines of concerned laws and regulations (e.g., The Law Concerning Prevention from Radiation Hazards due to Radioisotopes, Etc. and Medical Law); nuclides for AMS (mainly, 14 C) (manufacturing and transporting the test compound containing 14 C, its distribution from MCT client to hospitals, handling in the hospital, and transporting of samples from hospital to AMS facility); and nuclides for PET. Public opinions collected by MHLW will decide the directions hereafter of GD, i.e. the omitted research purposes are additionally incorporated in the present GD draft or are independently described in another newer GD. (R.T.)

  5. The UK's Draft Guidance for Health in SEA in light of HIA community priorities and the UNECE SEA Protocol

    International Nuclear Information System (INIS)

    Posas, Paula J.

    2011-01-01

    The Protocol on Strategic Environmental Assessment (SEA) to the United Nations Economic Commission for Europe (UNECE) Espoo Convention came into force on 11 July 2010. This Protocol, to which the European Union is party, gives a legal basis for enhanced attention to human health in the SEA process. In this context, the United Kingdom's (UK's) 2007 Draft Guidance on Health in Strategic Environmental Assessment represents an important early government-led effort to bring health issues and public health considerations more significantly into the SEA process. Since the UK is a worldwide leader in environmental and various other types of impact assessment, and since other countries may eventually consider its example in efforts to meet UNECE SEA Protocol requirements, scrutiny of its outputs is warranted. This paper thus examines the UK's Draft Guidance from both HIA academic and practitioner perspectives. First it assesses the extent to which the Draft Guidance reflects recent issues and lessons learned in the academic literature. In order to make the assessment, a meta-analysis of 70 HIA-related peer-reviewed articles was undertaken to extract authors' priority recommendations. These recommendations were subsequently compared with the contents of the Draft Guidance. Secondly, the Draft Guidance was assessed for its accordance with recommendations of the UNECE SEA Protocol background paper written by two HIA practitioners. Overall, the Draft Guidance's accordance with both sets of recommendations was found to be high, with only a few easily-remedied gaps. This evaluation suggests that the UK's Draft Guidance can be a useful starting point in the creation of future guidance on health in SEA in both the UK and other countries.

  6. Implications for Occupational Radiation Protection of the New Dose Limit for the Lens of the Eye. Interim Guidance for Use and Comment

    International Nuclear Information System (INIS)

    2013-12-01

    The IAEA Safety Requirements Safety Standards Series No. GSR Part 3 (Interim), Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards, was approved by the IAEA Board of Governors at its meeting in September 2011 and published in November 2011. The equivalent dose limit for the lens of the eye for occupational exposure in planned exposure situations was reduced from 150 mSv per year to 20 mSv per year, averaged over defined periods of five years, with no annual dose in a single year exceeding 50 mSv. This reduction in the dose limit for the lens of the eye follows the recommendation of the International Commission on Radiological Protection (ICRP) in its statement on tissue reactions on 21 April 2011. At the time when the draft General Safety Requirements (GSR) Part 3 was approved by the Commission on Safety Standards, the Secretariat was asked to develop guidance as early as possible to assist Member States in the observance of the new dose limit. In the longer term, the guidance provided in this TECDOC will form the basis for the consensus guidance in relation to the new dose limit for the lens of the eye that is to be provided in two safety guides currently being developed, Occupational Radiation Protection and Radiation Safety in the Medical Uses of Ionizing Radiation. It is expected that these will be published in 2015-2016. It is recognized that guidance material is required before the two safety guides are finalized in order to give Member States the opportunity to put appropriate actions in place and to plan for the introduction of the new dose limit for the lens of the eye. The purpose of the current publication is to provide advice on the implications for occupational radiation protection of the new dose limit for the lens of the eye and to allow comment on detailed recommendations that may be incorporated into the safety guides

  7. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-06-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  8. 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...

  9. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2010-09-28

    ... method comparison section and the sample selection inclusion and exclusion criteria section. The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

  10. 77 FR 12852 - Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for...

    Science.gov (United States)

    2012-03-02

    ... considers your comment on this draft guidance before it begins work on the final version of the guidance... National Health and Nutrition Examination Survey (NHANES) indicate widespread exposure of the general... effects. The ubiquitous presence of phthalates in the environment and the potential consequences of human...

  11. 75 FR 78705 - Issuance of Exposure Drafts on Implementation Guidance on the Accounting for the Disposal of G-PP...

    Science.gov (United States)

    2010-12-16

    ... FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD Issuance of Exposure Drafts on Implementation Guidance on the Accounting for the Disposal of G-PP&E and Implementation Guidance for Estimating the Historical Cost of G-PP&E AGENCY: Federal Accounting Standards Advisory Board. ACTION: Notice. Board Action...

  12. 78 FR 38349 - Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics...

    Science.gov (United States)

    2013-06-26

    ... Therapy.'' This draft guidance is being issued consistent with FDA's good guidance practices regulation... all promotional materials including promotional labeling as well as advertisements intended for... the intended time of initial dissemination of the labeling or initial publication of the advertisement...

  13. 78 FR 9396 - Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early...

    Science.gov (United States)

    2013-02-08

    ...] Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage... ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance outlines FDA... trials that are specifically focused on the treatment of patients with established Alzheimer's disease...

  14. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Science.gov (United States)

    2013-02-08

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco... guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked... civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic...

  15. 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...

  16. 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

  17. Implications of the new Food and Drug Administration draft guidance on human factors engineering for diabetes device manufacturers.

    Science.gov (United States)

    Wilcox, Stephen B; Drucker, Daniel

    2012-03-01

    This article discusses the implications of the new Food and Drug Administration's draft guidance on human factors and usability engineering for the development of diabetes-related devices. Important considerations include the challenge of identifying users, when the user population is so dramatically broad, and the challenge of identifying use environments when the same can be said for use environments. Another important consideration is that diabetes-related devices, unlike many other medical devices, are used constantly as part of the user's lifestyle--adding complexity to the focus on human factors and ease of use emphasized by the draft guidance. © 2012 Diabetes Technology Society.

  18. Development of a road materials database: Interim Report: 1st draft

    CSIR Research Space (South Africa)

    Jones, DJ

    2003-03-01

    Full Text Available The data required for a road materials database has been identified and a basic structure formulated. A set of Excel workbooks and associated worksheets has been developed as a foundation for the database and as an interim means of gathering test...

  19. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Science.gov (United States)

    2011-02-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  20. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Science.gov (United States)

    2012-07-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  1. 78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-08-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  2. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Science.gov (United States)

    2012-05-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0384] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  3. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Science.gov (United States)

    2011-08-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...

  4. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-06-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  5. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Science.gov (United States)

    2013-11-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1279] Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  6. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Science.gov (United States)

    2011-04-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  7. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Science.gov (United States)

    2010-04-29

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic... and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and...

  8. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Science.gov (United States)

    2012-10-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  9. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Science.gov (United States)

    2011-12-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  10. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Science.gov (United States)

    2012-08-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  11. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Science.gov (United States)

    2010-02-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0090] Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability... familiar and less familiar approaches. As more experience is obtained with the less familiar designs...

  12. 75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

    Science.gov (United States)

    2010-11-12

    ... annually from approximately 25 application holders. FDA professionals familiar with Dear Health Care... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0319] Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters...

  13. 78 FR 63218 - Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting...

    Science.gov (United States)

    2013-10-23

    ...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6360, Silver...

  14. 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...

  15. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Science.gov (United States)

    2010-04-22

    ...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...

  16. 75 FR 8046 - National Environmental Policy Act (NEPA) Draft Guidance, “Consideration of the Effects of Climate...

    Science.gov (United States)

    2010-02-23

    ..., ``Consideration of the Effects of Climate Change and Greenhouse Gas Emissions.'' AGENCY: Council On Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``Consideration of the Effects of Climate Change... visionary and versatile law that can be used effectively to address new environmental challenges facing our...

  17. 77 FR 31858 - Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk...

    Science.gov (United States)

    2012-05-30

    ... of the drug. This draft guidance is intended to assist applicants in designing trials to support...., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that... Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Tatiana...

  18. 78 FR 39736 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Science.gov (United States)

    2013-07-02

    ... collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT...-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be...-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER...

  19. 76 FR 53683 - Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to...

    Science.gov (United States)

    2011-08-29

    ... 200N, Rockville, MD 20852-1448; or the Office of Communication, Education and Radiation Programs... describes a modern, risk-based approach to monitoring that focuses on critical study parameters and relies... appropriate, and other forms of information technology. Title: Draft Guidance for Industry: Oversight of...

  20. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Science.gov (United States)

    2010-05-25

    ...] Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry 188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for...

  1. 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...

  2. Draft interim close-out report Fitzner-Eberhardt Arid Lands Ecology Reserve remedial action, Hanford, Washington. Draft A

    International Nuclear Information System (INIS)

    1994-10-01

    The Fitzner-Eberhardt Arid Lands Ecology (ALE) Reserve consists of 120 square miles of shrub-steppe land on the western edge of the Hanford Site. It is located south of Highway 240 and east of the point where the Yakima River borders the site. The land was set aside as a natural research area in 1967 by the Atomic Energy Commission. With the recent change in mission at Hanford from plutonium production to environmental cleanup, much attention has been given to releasing clean tracts of land for other uses. The ALE Reserve is one such tract of land. Consistent with the Record of Decision (ROD) and Preliminary Assessment Screening (PAS), sites identified as having the potential for contamination on the ALE Reserve have been investigated, characterized, and remediated where necessary to comply with MTCA cleanup levels. Hazardous substances released to the environment have either been removed from the site or, in one case when removal was not practical, capped in place. Removal of all of the contaminated soil is supported by the confirmatory sampling results. The existing areas of contamination in the ALE Reserve were considered to be small. In March of 1993, Department of Energy (DOE), the Environmental Protection Agency and the Washington State Department of Ecology signed an Agreement in Principle in which they agreed to expedite cleanup of the ALE Reserve. Cleanup activities and a draft closeout report were to be completed by October 1994. Additionally, DOE proposed to mitigate hazards which may pose a physical threat to wildlife or humans

  3. 77 FR 71019 - Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2012-04; Guidance on...

    Science.gov (United States)

    2012-11-28

    ... Guidance for the Individual Plant Examination of External Events (IPEEE) for Severe Accident... Insights from the Fukushima Dai-ichi Accident,'' dated March 12, 2012 (ADAMS Accession No. ML12053A340... resulting nuclear accident, at the Fukushima Dai-ichi nuclear power plant in March 2011. Enclosure 1 to the...

  4. 76 FR 11506 - Fisheries and Habitat Conservation and Migratory Birds Programs; Draft Land-Based Wind Energy...

    Science.gov (United States)

    2011-03-02

    ...] RIN 1018-AX45 Fisheries and Habitat Conservation and Migratory Birds Programs; Draft Land-Based Wind... Impacts from Wind Turbines (Interim Guidance). As stated in the notice, the comment period on the draft... Minimizing Wildlife Impacts from Wind Turbines. We expect to issue final Guidelines for public use after...

  5. 77 FR 14811 - Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug...

    Science.gov (United States)

    2012-03-13

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review Program.'' This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term ``pre- dissemination review'' is used throughout the guidance to refer to review under the FD&C Act, which is entitled ``Prereview of Television Advertisements.'') The draft guidance describes which TV ads FDA intends to make subject to this provision, explains how FDA will notify sponsors that an ad is subject to review under this provision, and describes the general and center-specific procedures sponsors should follow to submit their TV ads to FDA for pre-dissemination review in compliance with the FD&C Act. These proposed TV ads will be subject to a 45-calendar day review clock by FDA.

  6. 78 FR 68101 - Environmental Issues Associated With New Reactors and Specific Environmental Guidance for...

    Science.gov (United States)

    2013-11-13

    ... New Reactors and Specific Environmental Guidance for Integral Pressurized Water Reactors Reviews... Environmental Issues Associated with New Reactors'' and draft ISG ESP/ COL-ISG-027, ``Interim Staff Guidance on...://www.regulations.gov and search for Docket ID NRC-2013-0212 for ESP/COL- ISG-026 or NRC-2013-0211 for...

  7. Testing REACH draft technical guidance notes for conducting chemical safety assessments-the experience of a downstream user of a preparation.

    Science.gov (United States)

    Gade, Anne Lill; Ovrebø, Steinar; Hylland, Ketil

    2008-07-01

    The goal of REACH is the safe use of chemicals. This study examines the efficiency and usefulness of two draft technical guidance notes in the REACH Interim Project 3.2-2 for the development of the chemical safety report and exposure scenarios. A case study was carried out for a paint system for protection of structural steel. The focuses of the study were risk assessment of preparations based on Derived No Effect Level (DNEL) and Predicted No Effect Concentrations (PNEC) and on effective and accurate communication in the supply chain. Exposure scenarios and generic descriptions of uses, risk management measures, and exposure determinants were developed. The study showed that communication formats, software tools, and guidelines for chemical risk assessment need further adjustment to preparations and real-life situations. Web platforms may simplify such communication. The downstream formulator needs basic substance data from the substance manufacturer during the pre-registration phase to develop exposure scenarios for preparations. Default values need to be communicated in the supply chain because these were critical for the derivation of applicable risk management demands. The current guidelines which rely on the available toxicological knowledge are insufficient to advise downstream users on how to develop exposure scenarios for preparations.

  8. 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...

  9. Emergency Medical Services Public Health Implications and Interim Guidance for the Ebola Virus in the United States

    Directory of Open Access Journals (Sweden)

    Christopher E. McCoy

    2014-11-01

    Full Text Available The 25th known outbreak of the Ebola Virus Disease (EVD is now a global public health emergency and the World Health Organization (WHO has declared the epidemic to be a Public Health Emergency of International Concern (PHEIC. Since the first cases of the West African epidemic were reported in March 2014, there has been an increase in infection rates of over 13,000% over a 6-month period. The Ebola virus has now arrived in the United States and public health professionals, doctors, hospitals, Emergency Medial Services Administrators, Medical Directors, and policy makers have been working with haste to develop strategies to prevent the disease from reaching epidemic proportions. Prehospital care providers (emergency medical technicians and paramedics and medical first responders (including but not limited to firefighters and law enforcement are the healthcare systems front lines when it comes to first medical contact with patients outside of the hospital setting. Risk of contracting Ebola can be particularly high in this population of first responders if the appropriate precautions are not implemented. This article provides a brief clinical overview of the Ebola Virus Disease and provides a comprehensive summary of the Center for Disease Control and Prevention’s Interim Guidance for Emergency Medical Services (EMS Systems and 9-1-1 Public Safety Answering Points (PSAPS for Management of Patients with Known of Suspected Ebola Virus Disease in the United States. [West J Emerg Med. 2014;15(7:-0.

  10. 77 FR 59928 - Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for...

    Science.gov (United States)

    2012-10-01

    ... bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. This draft... infection caused by bacterial pathogens that show resistance to most antibacterial drugs on in vitro...

  11. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Science.gov (United States)

    2013-05-31

    ... products. This guidance revises the guidance for industry entitled ``Clinical Development Programs for... Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave... (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville...

  12. 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...

  13. 76 FR 60847 - Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission...

    Science.gov (United States)

    2011-09-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0691... manufacturing practice regulations for PET drugs. DATES: Although you can comment on any guidance at any time...

  14. Interim guidance on the Standard Review Plan for the review of financial assurance mechanisms for decommissioning under 10 CFR Parts 30, 40, and 70

    International Nuclear Information System (INIS)

    1988-12-01

    Interim Guidance on the Standard Review Plan (SRP) for the Review of Financial Assurance Mechanisms for Decommissioning under 10 CFR Parts 30, 40, and 70 is prepared for the guidance of Nuclear Regulatory Commission staff reviewers in performing reviews of applications from material licensees affected by the decommissioning regulations established June 27, 1988 (53FR24018). The principal purpose of the SRP is to assure the quality and uniformity of staff reviews and to present a base from which to evaluate the financial assurance aspects of the applications. NUREG-1337, identifies who performs the review, the matters that are reviewed, the basis of the review, how the review is performed, and the conclusions that are sought. 3 refs

  15. Draft guidance notes for the protection of persons against ionising radiations arising from veterinary use

    International Nuclear Information System (INIS)

    1983-01-01

    These guidance notes have been prepared for those who use ionising radiation for diagnostic purposes in veterinary practice, either in private practices or in larger institutions. Ancillary activities such as the testing and calibration of equipment are also covered by these notes so far as they are carried out on the same premises. The guidance notes indicate procedures for the protection of all persons who may be exposed as a result of these practices, that is to say all employed and self-employed persons, apprentices and students, and members of the public. (author)

  16. 78 FR 57394 - Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human...

    Science.gov (United States)

    2013-09-18

    ... Drug and Biological Products--Content and Format; Availability AGENCY: Food and Drug Administration... Labeling for Human Prescription Drug and Biological Products--Content and Format.'' The recommendations in... the extent possible, consistent in content and format. DATES: Although you can comment on any guidance...

  17. 78 FR 9702 - Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products...

    Science.gov (United States)

    2013-02-11

    ... approach in both the preclinical and clinical phases of the development of therapeutic protein products to... you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency... entitled ``Immunogenicity Assessment for Therapeutic Protein Products.'' The purpose of this document is to...

  18. 76 FR 55923 - Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco...

    Science.gov (United States)

    2011-09-09

    ... Advertising Act (FCLAA) when that requirement takes effect. On June 22, 2009, the President signed the Family... Advertising Act, as amended by the Family Smoking Prevention and Tobacco Control Act, when that requirement takes effect. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to...

  19. Probabilistic risk assessment (PRA): status report and guidance for regulatory application. Draft report for comment

    International Nuclear Information System (INIS)

    1984-02-01

    This document describes the current status of the methodologies used in probabilistic risk assessment (PRA) and provides guidance for the application of the results of PRAs to the nuclear reactor regulatory process. The PRA studies that have been completed or are underway 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

  20. 76 FR 52995 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05: Ongoing Review of Operating...

    Science.gov (United States)

    2011-08-24

    ... Rulemaking Web Site: Go to http://www.regulations.gov and search for documents filed under Docket ID NRC... Lessons Learned (GALL) Report,'' and the NRC staff's aging management review procedures and acceptance criteria in NUREG-1800, Revision 2, ``Standard Review Plan for Review of License Renewal Applications for...

  1. 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).

  2. A draft of guidance from the scientific Research Programme GEOTECHNOLOGIEN to underpin the implementation of the CCS Directive in Germany

    Science.gov (United States)

    Streibel, Martin; Schoebel, Birgit

    2015-04-01

    interaction of CO2 with the reservoir and the impact of pressure elevation in saline reservoirs; • cap rock and well integrity; • development and test of monitoring methods from the atmosphere down to the reservoir; • development and improvement of numerical methods to simulate injection and spreading of the CO2 plume. During all three phases the knowledge has been incorporated in the risk assessment approach has been further developed. Within this paper we will present a draft of the guidance document which is based on the compilation of results of the early projects and input provided by project partners of the final funding phase of GEOTECHNOLOGIEN.

  3. 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.

  4. Proposed plan for interim remedial measures at the 100-HR-1 Operable Unit, Hanford Site, Richland, Washington. Draft A

    International Nuclear Information System (INIS)

    1994-09-01

    This proposed plan introduces the interim remedial measures for addressing contaminated soil at the 100-HR-1 Operable Unit, located at the Hanford Site. In addition, this plan includes a summary of other alternatives analyzed and considered for the 100-HR-1 Operable Unit. The EPA, DOE, and Washington State Dept. of Ecology believe that a combination of removal, treatment, and disposal technologies, where appropriate, would significantly reduce the potential threats to human health and the environment at the 100-HR-1 Operable Unit high-priority waste sites. The remedial actions described in this proposed plan are designed to minimize human health and ecological risks and ensure that additional contaminants originating from these waste sites are not transported to the groundwater. The 100-HR-1 Operable Unit contains the retention basin for the H reactor cooling system, process effluent trenches, the Pluto crib which received an estimated 260 gallons of radioactive liquid waste, process effluent pipelines, and solid waste sites used for the burial of decontaminated and decommissioned equipment from other facilities. Potential health threats would be from the isotopes of cesium, cobalt, europium, plutonium, and strontium, and from chromium, arsenic, lead, and chysene

  5. 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...

  6. 75 FR 5632 - Office of New Reactors; Interim Staff Guidance on the Review of Nuclear Power Plant Designs Using...

    Science.gov (United States)

    2010-02-03

    ... Management System (ADAMS) Accession No. ML092640035). This ISG provides new guidance information for applicants submitting a combined license (COL) or design certification (DC) for construction and operation of... (SRP), Section 8.3.1 and Sections 9.5.4 through 9.5.8. The NRC staff issues DC/COL-ISGs to facilitate...

  7. Update: Interim Guidance for the Diagnosis, Evaluation, and Management of Infants with Possible Congenital Zika Virus Infection - United States, October 2017.

    Science.gov (United States)

    Adebanjo, Tolulope; Godfred-Cato, Shana; Viens, Laura; Fischer, Marc; Staples, J Erin; Kuhnert-Tallman, Wendi; Walke, Henry; Oduyebo, Titilope; Polen, Kara; Peacock, Georgina; Meaney-Delman, Dana; Honein, Margaret A; Rasmussen, Sonja A; Moore, Cynthia A

    2017-10-20

    CDC has updated its interim guidance for U.S. health care providers caring for infants with possible congenital Zika virus infection (1) in response to recently published updated guidance for health care providers caring for pregnant women with possible Zika virus exposure (2), unknown sensitivity and specificity of currently available diagnostic tests for congenital Zika virus infection, and recognition of additional clinical findings associated with congenital Zika virus infection. All infants born to mothers with possible Zika virus exposure* during pregnancy should receive a standard evaluation at birth and at each subsequent well-child visit including a comprehensive physical examination, age-appropriate vision screening and developmental monitoring and screening using validated tools (3-5), and newborn hearing screen at birth, preferably using auditory brainstem response (ABR) methodology (6). Specific guidance for laboratory testing and clinical evaluation are provided for three clinical scenarios in the setting of possible maternal Zika virus exposure: 1) infants with clinical findings consistent with congenital Zika syndrome regardless of maternal testing results, 2) infants without clinical findings consistent with congenital Zika syndrome who were born to mothers with laboratory evidence of possible Zika virus infection, † and 3) infants without clinical findings consistent with congenital Zika syndrome who were born to mothers without laboratory evidence of possible Zika virus infection. Infants in the first two scenarios should receive further testing and evaluation for Zika virus, whereas for the third group, further testing and clinical evaluation for Zika virus are not recommended. Health care providers should remain alert for abnormal findings (e.g., postnatal-onset microcephaly and eye abnormalities without microcephaly) in infants with possible congenital Zika virus exposure without apparent abnormalities at birth.

  8. General Drafting. Technical Manual.

    Science.gov (United States)

    Department of the Army, Washington, DC.

    The manual provides instructional guidance and reference material in the principles and procedures of general drafting and constitutes the primary study text for personnel in drafting as a military occupational specialty. Included is information on drafting equipment and its use; line weights, conventions and formats; lettering; engineering charts…

  9. 78 FR 78822 - Draft Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals-Acoustic...

    Science.gov (United States)

    2013-12-27

    ... Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals--Acoustic Threshold Levels for... available in electronic form via the Internet at http://www.nmfs.noaa.gov/pr/acoustics/ . You may submit...: Acoustic Guidance. Instructions: All comments received are a part of the public record and will generally...

  10. 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...

  11. 76 FR 55384 - External Peer Review Meeting for the Draft Guidance of Applying Quantitative Data To Develop Data...

    Science.gov (United States)

    2011-09-07

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA/100/J-11/001; FRL-9460-1] External Peer Review Meeting for... attend this peer review meeting as observers. Time will be set aside for observers to give brief oral... the draft document, EPA intends to consider the comments from the external peer review meeting along...

  12. 78 FR 69690 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Science.gov (United States)

    2013-11-20

    ... (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical... Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft... 20852-1448. Send one self-addressed adhesive label to assist the office in processing your request. The...

  13. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Science.gov (United States)

    2012-02-21

    ... industry entitled ``Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and... data analysis in the context of identifying potential drug interactions. The guidance also addresses... Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling.'' Comments were received...

  14. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Science.gov (United States)

    2013-03-05

    ... implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings... guidance to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA... Commerce of the U.S. House of Representatives setting out the goals of section 201(c) of MDUFA II, Title II...

  15. 77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

    Science.gov (United States)

    2012-04-11

    ... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum....regulations.gov . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug...

  16. 78 FR 60292 - Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive...

    Science.gov (United States)

    2013-10-01

    ...--Refuse-to-Receive Standards.'' This guidance is intended to assist applicants preparing to submit to FDA.... 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in... Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Johnny Young, Center for...

  17. 75 FR 29537 - Draft Transportation Conformity Guidance for Quantitative Hot-spot Analyses in PM2.5

    Science.gov (United States)

    2010-05-26

    ... Quantitative Hot- spot Analyses in PM 2.5 and PM 10 Nonattainment and Maintenance Areas AGENCY: Environmental... finalized, this guidance would help state and local agencies complete quantitative PM 2.5 and PM 10 hot-spot... projects. A hot-spot analysis includes an estimation of project-level emissions, air quality modeling, and...

  18. 75 FR 73107 - Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated...

    Science.gov (United States)

    2010-11-29

    ... sponsors and investigators in the development of antimicrobial drugs for the treatment of hospital... of antimicrobial drugs for the treatment of HABP and VABP. This guidance revises and replaces the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0589...

  19. Interim report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1985-06-01

    This Interim Report summarizes the research and development activities of the Superconducting Super Collider project carried out from the completion of the Reference Designs Study (May 1984) to June 1985. It was prepared by the SSC Central Design Group in draft form on the occasion of the DOE Annual Review, June 19--21, 1985. Now largely organized by CDG Divisions, the bulk of each chapter documents the progress and accomplishments to date, while the final section(s) describe plans for future work. Chapter 1, Introduction, provides a basic brief description of the SSC, its physics justification, its origins, and the R&D organization set up to carry out the work. Chapter 2 gives a summary of the main results of the R&D program, the tasks assigned to the four magnet R&D centers, and an overview of the future plans. The reader wishing a quick look at the SSC Phase I effort can skim Chapter 1 and read Chapter 2. Subsequent chapters discuss in more detail the activities on accelerator physics, accelerator systems, magnets and cryostats, injector, detector R&D, conventional facilities, and project planning and management. The magnet chapter (5) documents in text and photographs the impressive progress in successful construction of many model magnets, the development of cryostats with low heat leaks, and the improvement in current-carrying capacity of superconducting strand. Chapter 9 contains the budgets and schedules of the COG Divisions, the overall R&D program, including the laboratories, and also preliminary projections for construction. Appendices provide information on the various panels, task forces and workshops held by the CDG in FY 1985, a bibliography of COG and Laboratory reports on SSC and SSC-related work, and on private industrial involvement in the project.

  20. Draft guidance notes for the protection of persons against ionising radiations arising from medical and dental use

    International Nuclear Information System (INIS)

    1983-01-01

    These guidance notes are presented under the following headings: 1) Limitation of radiation dose. 2) Administrative measures for radiological protection. 3) Medical surveillance. 4) Operational measures for radiological protection. 5) The request for a radiological examination or treatment, whether directly associated or not with illness or injury, together with consideration of the problems of dealing with patients of a reproductive age. 6) Diagnostic use of X-rays. 7) Dental radiography. 8) Therapeutic uses of radiation beams, remotely-operated after-loading equipment and extra-corporeal blood irradiators and neutron activation analysis. 9) Brachytherapy. 10) Diagnostic and therapeutic uses of unsealed radioactive substances. 11) Diagnostic uses of closed sources. 12) The use of nuclear-powered cardiac pacemakers. 13) Patients leaving a hospital after administration of radioactive substances. 14) Precautions after death.. 15) Storage and movement of radioactive materials. 16) Disposal of radioactive waste. 17) Emergency procedures. (U.K.)

  1. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Science.gov (United States)

    2013-06-14

    ...] Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for... draft guidance entitled ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers should consider in preparing...

  2. Interim restorations.

    Science.gov (United States)

    Gratton, David G; Aquilino, Steven A

    2004-04-01

    Interim restorations are a critical component of fixed prosthodontic treatment, biologically and biomechanically. Interim restoration serves an important diagnostic role as a functional and esthetic try-in and as a blueprint for the design of the definitive prosthesis. When selecting materials for any interim restoration, clinicians must consider physical properties, handling properties, patient acceptance, and material cost. Although no single material meets all the requirements and material classification alone of a given product is not a predictor of clinical performance, bis-acryl materials are typically best suited to single-unit restorations, and poly(methylmethacrylate) interim materials are generally ideal for multi-unit, complex, long-term, interim fixed prostheses. As with most dental procedures, the technique used for fabrication has a greater effect on the final result than the specific material chosen.

  3. Interim overdentures.

    Science.gov (United States)

    Fenton, A H

    1976-07-01

    The construction of an interim overdenture using existing removable partial dentures with natural tooth crowns and artificial teeth can be a simple and economical method of providing patients with dentures while tissues heal and teeth are prepared and restored. A more definite prognosis for both the patient and his remaining dentition can be established before the final overdenture is completed. The procedures necessary to provide three types of interim overdentures have been outlined. Patients tolerate this method of changing their dentitions extremely well.

  4. 78 FR 25487 - Final License Renewal Interim Staff Guidance LR-ISG-2012-01: Wall Thinning Due to Erosion Mechanisms

    Science.gov (United States)

    2013-05-01

    ..., ``Flow- Accelerated Corrosion,'' based on the staff's review of several license renewal applications' flow-accelerated corrosion AMPs and stakeholder input. ADDRESSES: Please refer to Docket ID NRC-2012... learned and to address emergent issues not covered in license renewal guidance documents, such as the GALL...

  5. 78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

    Science.gov (United States)

    2013-02-22

    ... medical devices to take timely action to correct violative devices or remove them from the marketplace...] Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft Guidance for... draft guidance entitled ``Distinguishing Medical Device Recalls From Product Enhancements; Reporting...

  6. Report to the NRC on guidance for preparing scenarios for emergency preparedness exercises at nuclear generating stations. Draft report for comment

    International Nuclear Information System (INIS)

    Martin, G.F.; Hickey, E.E.; Moeller, M.P.; Schultz, D.H.; Bethke, G.W.

    1986-03-01

    A scenario guidance handbook was prepared to assist emergency planners in developing scenarios for emergency preparedness exercises at nuclear power plants. The handbook provides guidance for the development of the objectives of an exercise, the descriptions of scenario events and responses, and the instructions to the participants. Information concerning implementation of the scenario, critiques and findings, and generation and format of scenario data are also included. Finally, examples of manual calculational techniques for producing radiological data are included as an appendix

  7. Basis for Interim Operation for the K-Reactor in Cold Standby

    Energy Technology Data Exchange (ETDEWEB)

    Shedrow, B.

    1998-10-19

    The Basis for Interim Operation (BIO) document for K Reactor in Cold Standby and the L- and P-Reactor Disassembly Basins was prepared in accordance with the draft DOE standard for BIO preparation (dated October 26, 1993).

  8. Basis for Interim Operation for the K-Reactor in Cold Standby

    International Nuclear Information System (INIS)

    Shedrow, B.

    1998-01-01

    The Basis for Interim Operation (BIO) document for K Reactor in Cold Standby and the L- and P-Reactor Disassembly Basins was prepared in accordance with the draft DOE standard for BIO preparation (dated October 26, 1993)

  9. 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.

  10. Regulatory guidance for license renewal

    International Nuclear Information System (INIS)

    Thoma, John A.

    1991-01-01

    The proposed 10 CFR Part 54 rule proceduralizes the process for license renewal by identifying both the administrative and technical requirements for a renewal application. To amplify and support this regulation, written guidance has been provided in the form of a draft Regulatory Guide (DG 1009) and a draft Standard Review Plan for License Renewal (NUREG 1299). This guidance is scheduled to be finalized in 1992. Similar guidance will be provided for the proposed revisions to 10 CFR Part 51 concerning the environmental aspects of license renewal. (author)

  11. EPA Releases Draft Policy to Reduce Animal Testing for Skin Sensitization

    Science.gov (United States)

    The document, Draft Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing, describes the science behind the non-animal alternatives that can now be used to identify skin sensitization.

  12. 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.

  13. Interim Reliability Evaluation Program procedures guide

    International Nuclear Information System (INIS)

    Carlson, D.D.; Gallup, D.R.; Kolaczkowski, A.M.; Kolb, G.J.; Stack, D.W.; Lofgren, E.; Horton, W.H.; Lobner, P.R.

    1983-01-01

    This document presents procedures for conducting analyses of a scope similar to those performed in Phase II of the Interim Reliability Evaluation Program (IREP). It documents the current state of the art in performing the plant systems analysis portion of a probabilistic risk assessment. Insights gained into managing such an analysis are discussed. Step-by-step procedures and methodological guidance constitute the major portion of the document. While not to be viewed as a cookbook, the procedures set forth the principal steps in performing an IREP analysis. Guidance for resolving the problems encountered in previous analyses is offered. Numerous examples and representative products from previous analyses clarify the discussion

  14. Interim format and content for a physical security plan for nuclear power plants

    International Nuclear Information System (INIS)

    1977-02-01

    The document serves as interim guidance to assist the licensee or applicant in the preparation of a physical security plan. It is to be used in conjunction with interim acceptance criteria for physical security programs, which will be distributed at a later date

  15. 78 FR 53792 - Draft Guidance for Reciprocity

    Science.gov (United States)

    2013-08-30

    ... section of this document. FOR FURTHER INFORMATION CONTACT: Tomas Herrera, Office of Federal and State...-0001; telephone: 301-415- 7138; email: Tomas.Herrera@nrc.gov . SUPPLEMENTARY INFORMATION: I. Accessing...

  16. National NIF Diagnostic Program Interim Management Plan

    International Nuclear Information System (INIS)

    Warner, B

    2002-01-01

    The National Ignition Facility (NIF) has the mission of supporting Stockpile Stewardship and Basic Science research in high-energy-density plasmas. To execute those missions, the facility must provide diagnostic instrumentation capable of observing and resolving in time events and radiation emissions characteristic of the plasmas of interest. The diagnostic instrumentation must conform to high standards of operability and reliability within the NIF environment. These exacting standards, together with the facility mission of supporting a diverse user base, has led to the need for a central organization charged with delivering diagnostic capability to the NIF. The National NIF Diagnostics Program (NNDP) has been set up under the aegis of the NIF Director to provide that organization authority and accountability to the wide user community for NIF. The funds necessary to perform the work of developing diagnostics for NIF will be allocated from the National NIF Diagnostics Program to the participating laboratories and organizations. The participating laboratories and organizations will design, build, and commission the diagnostics for NIF. Restricted availability of funding has had an adverse impact, unforeseen at the time of the original decision to projectize NIF Core Diagnostics Systems and Cryogenic Target Handing Systems, on the planning and initiation of these efforts. The purpose of this document is to provide an interim project management plan describing the organizational structure and management processes currently in place for NIF Core Diagnostics Systems. Preparation of a Program Execution Plan for NIF Core Diagnostics Systems has been initiated and a current draft is provided as Attachment 1 to this document. The National NIF Diagnostics Program Interim Management Plan provides a summary of primary design criteria and functional requirements, current organizational structure, tracking and reporting procedures, and current planning estimates of project scope

  17. Radon: guidance on protective measures for new dwellings

    International Nuclear Information System (INIS)

    1991-01-01

    This report gives guidance for reducing the presence of radon in new dwellings and hence reducing the risk to occupants of exposure to radon. This is a follow-up to the interim guidance of 1988. The report provides comprehensive practical details on the methods of protection including both primary and secondary measures. (UK)

  18. 76 FR 75771 - Emergency Planning Guidance for Nuclear Power Plants

    Science.gov (United States)

    2011-12-05

    ... Guidance for Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Issuance of NUREG... Support of Nuclear Power Plants;'' NSIR/DPR-ISG-01, ``Interim Staff Guidance Emergency Planning for Nuclear Power Plants;'' and NUREG/CR-7002, ``Criteria for Development of Evacuation Time Estimate Studies...

  19. 77 FR 14047 - Guidance for Decommissioning Planning During Operations

    Science.gov (United States)

    2012-03-08

    ...)-4014, ``Decommissioning Planning During Operations.'' This action is necessary to correct the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2011-0286] Guidance for Decommissioning Planning During Operations AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; correction. SUMMARY: The U...

  20. Draft Transportaion Business Plan

    International Nuclear Information System (INIS)

    1985-08-01

    The Office of Civilian Radioactive Waste Management (OCRWM) is responsible for establishing a transportation system to support shipment of spent fuel and high-level radioactive waste to repositories and storage facilities developed under the Nuclear Waste Policy Act of 1982 (NWPA). An element that assists in fulfilling that responsibility is a business plan for acquiring and operating a transportation system. The Draft Transportation Business Plan is an interim step in the process of procuring the transportation system. It sets the context for business strategy decisions by providing pertinent background information, describing the legislation and policies governing transportation under the NWPA, and with establishing the transportation system. It also serves as an instrument for initiating communication between OCRWM and other interested parties. Included in the docuument are strategies for procuring shipping casks and transportation support services. Additionally, in the spirit of the NWPA directive to utilize the private sector to the maximum extent possible, opportunities for business ventures are obvious throughout the system development cycle

  1. Rating of transport and radiation source events. Draft additional guidance for the INES national officers for pilot use and feedback; Echelle de classement des incidents de radioprotection: document d'application du systeme international propose par l'AIEA pour les sources radioactives et les transports

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2004-09-15

    The International Nuclear Event Scale (INES) is a means for promptly communicating to the public in consistent terms the safety significance of any reported event associated with radioactive material and/or radiation and to any event occurring during the transport of radioactive material. As described in the 2001 Edition of the INES User.s Manual, events are classified on the scale at seven levels: the upper levels (4-7) are termed accidents. and the lower levels (1-3) incidents. Events which have no safety significance are classified below scale at Level 0 and termed deviations. An overview of the principles for the rating under INES together with flow charts summarizing the rating process is provided in Appendix I. The 2001 Edition of the INES User.s Manual provides some guidance for the rating of transport and radiation source events. At the technical meeting held in 2002 the INES National Officers requested the IAEA/NEA Secretariat to prepare additional guidance. Progress was reported at the Technical Meeting of the INES National Officers in March 2004 where preparation of this draft additional guidance was requested for pilot use. This note provides additional guidance on the rating of transport and radiation source events. It is for pilot use and feedback and is broadly consistent with the INES User.s Manual. It provides more detailed information and an expanded approach for the rating based on actual exposure of workers and members of the public. It is designed to be used as a self-standing document with limited need for reference to the INES User Manual. (author)

  2. Guidance on Port Biological Baseline Surveys (PBBS)

    Digital Repository Service at National Institute of Oceanography (India)

    Awad, A.; Haag, F.; Anil, A.C.; Abdulla, A.

    This publication has been prepared by GBP, IOI, CSIR-NIO and IUCN in order to serve as guidance to those who are planning to carry out a port biological baseline survey, in particular in the context of Ballast Water Management. It has been drafted...

  3. Report of the Fourth interim meeting of the Seabed Working Group Engineering Studies Task Group, 3-6 October 1983, at Rijks Geologische Dienst, Haarlem, The Netherlands

    International Nuclear Information System (INIS)

    Talbert, D.M.

    1984-06-01

    This report presents the results of the fourth interim meeting of the Seabed Working Group's (SWG) Engineering Studies Task Group (ESTG). This task group is charged with determining whether the engineering technology exists to emplace waste canisters in deep ocean sediments. The fourth interim meeting, held at Rijks Geologische Dienst, Haarlem, The Netherlands, 3-6 October 1983, reviewed progress made by the various national programs since the ESTG third interim meeting (July 1982) and developed a table of requirements for processing samples for a geotechnical properties data base. Other items addressed were (1) potential methods of instrumenting penetrators to obtain in situ measurements, (2) procedures for evaluating and quantifying the disturbed zone created by an emplaced penetrator, (3) review and modification of the current draft version of the SWG Five-Year Plan, (4) review and extension of the ESTG detailed plan for penetrator tests, and (5) details of the penetrator tests scheduled for March 1984 in the Nares Abyssal Plain using the research vessel M/V TYRO. The review of the national programs indicated significant progress when measured against the integrated ESTG five-year plan which results in a joint evaluation of engineering feasibility of subseabed disposal based upon (1) a demonstration of an emplacement capability, (2) an evaluation of the zone of sediment disturbance created during emplacement, (3) the existence of acceptable emplacement models, and (4) an acceptable engineering data base. A table of geotechnical sample-processing requirements is being developed to provide guidance for the other task groups that may have the opportunity to furnish suitable geotechnical samples to the ESTG as well as to provide some measure of consistency within the ESTG for the development of the engineering data base for the SWG study areas

  4. CMM Interim Check (U)

    Energy Technology Data Exchange (ETDEWEB)

    Montano, Joshua Daniel [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2015-03-23

    Coordinate Measuring Machines (CMM) are widely used in industry, throughout the Nuclear Weapons Complex and at Los Alamos National Laboratory (LANL) to verify part conformance to design definition. Calibration cycles for CMMs at LANL are predominantly one year in length. Unfortunately, several nonconformance reports have been generated to document the discovery of a certified machine found out of tolerance during a calibration closeout. In an effort to reduce risk to product quality two solutions were proposed – shorten the calibration cycle which could be costly, or perform an interim check to monitor the machine’s performance between cycles. The CMM interim check discussed makes use of Renishaw’s Machine Checking Gauge. This off-the-shelf product simulates a large sphere within a CMM’s measurement volume and allows for error estimation. Data was gathered, analyzed, and simulated from seven machines in seventeen different configurations to create statistical process control run charts for on-the-floor monitoring.

  5. The Nord interim store

    International Nuclear Information System (INIS)

    Leushacke, D.F.; Rittscher, D.

    1996-01-01

    In line with the decision taken in 1990 to shut down and decommission the Greifswald and Rheinsberg Nuclear Power Stations, the waste management concept of the Energiewerke Nord is based on direct and complete decommissioning of the six shut down reactor units within the next fifteen years. One key element of this concept is the construction and use of the Zwischenlager Nord (Nord Interim Store, ZLN) for holding the existing nuclear fuels and for interim and decay storage of the radioactive materials arising in decommissioning and demolition. The owner and operator of the store is Energiewerke Nord GmbH. The interim store has the functions of a processing and Energiewerke Nord GmbH. The interim store has the functions of a processing and treatment station and buffer store for the flows of residues arising. As a radioactive waste management station, it accommodates nuclear fuels, radioactive waste or residues which are not treated any further. It is used as a buffer store to allow the materials accumulating in disassembly to be stored temporarily before or after treatment in order to ensure continuous loading of the treatment plants. When operated as a processing station, the ZLN is able to handle nearly all types of radioactive waste and residues arising, except for nuclear fuels. These installations allow the treatment of radioactive residues to be separated from the demolition work both physically and in time. The possibilities of interium storage and buffer storage of untreated waste and waste packages make for high flexibility in logistics and waste management strategy. (orig.) [de

  6. Image Guidance

    Science.gov (United States)

    Guidance that explains the process for getting images approved in One EPA Web microsites and resource directories. includes an appendix that shows examples of what makes some images better than others, how some images convey meaning more than others

  7. Interim fiscal profile, Benton and Franklin counties, Washington: Working draft

    Energy Technology Data Exchange (ETDEWEB)

    Dong, F.B.; Dugan, M.K.; Clark, D.C.

    1988-02-01

    This report presents a fiscal profile of Benton and Franklin counties, and of the cities of Richland, Kennewick, and Pasco. Overall, changes in operating revenues and expenditures in these jurisdictions have corresponded with changes in the local economy. The combined operating expenditures of Benton County, Franklin County, Kennewick, Pasco, and Richland, expressed in current dollars, tripled between 1975 and 1985, increasing from $18.1 million to $55.0 million, an annual average increase of 11.8 percent. During this time, the population of the Benton-Franklin MSA increased from 100,000 to 140,900 people, and the national all-items price index for urban consumers doubled, increasing from 161.2 to 322.2. Adjusted for inflation, per capita expenditures by these governments increased only slightly during this period, from $361.8 in 1975 to $390.3 in 1985. Employment in the Benton-Franklin MSA rose from 40,080 workers in 1970 to a peak of 75,900 in 1981 before declining to 61,100 in 1985, primarily due to the loss of 9,928 jobs in the Washington Public Power Supply System after 1981. The MSA's population followed a similar trend, with a slight lag. In 1970, total population in the Benton-Franklin MSA was 93,356 people. The MSA's population grew rapidly during the late 1970s, reached a peak of 147,900 persons in 1982, and then declined to 139,300 in 1986. 23 refs., 16 figs., 14 tabs.

  8. Basic Drafting. Revised.

    Science.gov (United States)

    Schertz, Karen

    This introductory module on drafting includes the technical content and tasks necessary for a student to be employed in an entry-level drafting occupation. The module contains 18 instructional units that cover the following topics: introduction to drafting; tools and equipment; supplies and materials; sketching; scales; drawing format; lettering;…

  9. Interim storage study report

    Energy Technology Data Exchange (ETDEWEB)

    Rawlins, J.K.

    1998-02-01

    High-level radioactive waste (HLW) stored at the Idaho Chemical Processing Plant (ICPP) in the form of calcine and liquid and liquid sodium-bearing waste (SBW) will be processed to provide a stable waste form and prepare the waste to be transported to a permanent repository. Because a permanent repository will not be available when the waste is processed, the waste must be stored at ICPP in an Interim Storage Facility (ISF). This report documents consideration of an ISF for each of the waste processing options under consideration.

  10. Interim storage report

    International Nuclear Information System (INIS)

    Rawlins, J.K.

    1998-02-01

    High-level radioactive waste (HLW) stored at the Idaho Chemical Processing Plant (ICPP) in the form of calcine and liquid and liquid sodium-bearing waste (SBW) will be processed to provide a stable waste form and prepare the waste to be transported to a permanent repository. Because a permanent repository will not be available when the waste is processed, the waste must be stored at ICPP in an Interim Storage Facility (ISF). This report documents consideration of an ISF for each of the waste processing options under consideration

  11. Comments on OECD discussion draft on revisions to Chapter I of the Transfer Pricing Guidelines

    NARCIS (Netherlands)

    Burgers, Irene; van Herwaarden, A.J.

    2015-01-01

    These comments provide recommendations for improved transfer pricing guidance and were submitted in response to an invitation by the OECD to interested parties to submit written comments on a discussion draft regarding the OECD Transfer Pricing Guidelines

  12. Draft project management update to the Iowa DOT Project Development Manual : final report.

    Science.gov (United States)

    2016-08-01

    This work supported drafting project management guidance for the Iowa Department of Transportation (DOT). The goal is to : incorporate a greater focus on project management in their project development process. : A technical advisory committee (TAC) ...

  13. PRN 2002-X Draft: False or Misleading Pesticide Product Brand Name

    Science.gov (United States)

    This notice provides guidance to registrants and distributors on pesticide product brand names that may be false or misleading, either by themselves or in association with particular company names or trademarks. It is a draft.

  14. Interim guidance on the safe transport of uranium hexafluoride

    International Nuclear Information System (INIS)

    1991-06-01

    Uranium hexafluoride (UF 6 ) is a radioactive material that has significant non-radiological hazardous properties. In conformity with international regulatory practice for dangerous goods transport, these properties are classed as ''subsidiary risks'', although they predominate in the cases of depleted and natural UF 6 . UF 6 is transported as a solid material below atmospheric pressure. The IAEA Regulations for the Safe Transport of Radioactive Material, 1985 Edition, Safety Series No. 6, make recommendations that aimed to provide an adequate level of safety against radiological and criticality hazards. The basis for these is that the stringency of package performance requirements, operational procedures and approval and administrative procedures is graded relative to the severity of the hazard. The cylinders used for transporting UF 6 are also used in the production, storage and use of the material and that the fraction of their life cycle in which transport is involved is small. Consideration must also be given to the large number of existing cylinders (estimated to be between 60,000 and 70,000). Specific recommendations provided for UF 6 transport, listed in Section II, are additional to the requirements of the Regulations. The intent of these additional recommendations is to restrict contamination and to provide protection to workers and to the general public against the chemical hazard possibly resulting from a severe accident involving the transport of UF 6 , and in addition against the consequences of explosive rupture of small bare cylinders of UF 6 . 20 refs, figs and tabs

  15. Spent fuel interim storage

    International Nuclear Information System (INIS)

    Bilegan, Iosif C.

    2003-01-01

    The official inauguration of the spent fuel interim storage took place on Monday July 28, 2003 at Cernavoda NNP. The inaugural event was attended by local and central public authority representatives, a Canadian Government delegation as well as newsmen from local and central mass media and numerous specialists from Cernavoda NPP compound. Mr Andrei Grigorescu, State Secretary with the Economy and Commerce Ministry, underlined in his talk the importance of this objective for the continuous development of nuclear power in Romania as well as for Romania's complying with the EU practice in this field. Also the excellent collaboration between the Canadian contractor AECL and the Romanian partners Nuclear Montaj, CITON, UTI, General Concret in the accomplishment of this unit at the planned terms and costs. On behalf of Canadian delegation, spoke Minister Don Boudria. He underlined the importance which the Canadian Government affords to the cooperation with Romania aiming at specific objectives in the field of nuclear power such as the Cernavoda NPP Unit 2 and spent fuel interim storage. After traditional cutting of the inaugural ribbon by the two Ministers the festivities continued on the Cernavoda NPP Compound with undersigning the documents regarding the project completion and a press conference

  16. 76 FR 64327 - Office of Oceanic and Atmospheric Research Draft Strategic Plan

    Science.gov (United States)

    2011-10-18

    ...: 111003608-1608-01] Office of Oceanic and Atmospheric Research Draft Strategic Plan AGENCY: Office of Oceanic... notice announces that OAR's draft Strategic Plan (FY12- 18) is available for public review and comment... next six years. These goals and objectives will provide guidance and strategic direction for program...

  17. ETF interim design review

    International Nuclear Information System (INIS)

    Steiner, D.; Rutherford, P.H.

    1980-01-01

    A three-day ETF Interim Design Review was conducted on July 23-25, 1980, at the Sheraton Potomac Inn in Rockville, Maryland. The intent of the review was to provide a forum for an in-depth assessment and critique of all facets of the ETF design by members of the fusion community. The review began with an opening plenary session at which an overview of the ETF design was presented by D. Steiner, manager of the ETF Design Center, complemented by a physics overview by P.H. Rutherford, chairman of the ETF/INTOR Physics Committee. This was followed by six concurrent review sessions over the next day and a half. The review closed with a plenary session at which the Design Review Board presented its findings. This document consists of the viewgraphs for the opening plenary session and an edited version of the presentations made by Steiner and Rutherford

  18. Interim geotechnical data report

    International Nuclear Information System (INIS)

    1986-01-01

    This issue, the Interim Geotechnical Field Data Report, presents information obtained from the geotechnical activities at the WIPP site underground facilities since the last quarterly report. It also includes cumulative plots which contain all previous data. Finally, it continues the geotechnical analyses and interpretations of the data. The GFDR is organized into two principal parts. The first part, Geotechnical Field Data, presents in graphical form all the data collected since April 1982 from the geomechanical instruments. Presented in the second part, Evaluation and Analyses, are preliminary interpretations and analyses of the data. In this report, continuing geotechnical assessment of all the facility features is presented. Also included in the second part are separate sections on evaluation and interpretation of the instrumentation measurements, and an updated description and evaluation of observed behavior of the underground openings

  19. Federal Interim Storage program

    International Nuclear Information System (INIS)

    Johnson, E.R.; McBride, J.A.

    1984-01-01

    The DOE has developed a program for providing Federal Interim Storage servies for spent nuclear fuel which complies with the requirements of the Nuclear Waste Policy Act of 1982. Although very little constructive activity in providing storage facilities can be undertaken by DOE until fuel has been certified by NRC as eligible for FIS, DOE planning and background information is such as to provide reasonable assurance that its obligations can be fulfilled when the required certifications have been issued. A fee structure providing fuel recovery of all costs associated with the FIS program, as required by the Act, has been developed. It provides for an equitable distribution of costs among users, based on the quantity of fuel requiring storage

  20. 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

  1. 75 FR 73108 - Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products...

    Science.gov (United States)

    2010-11-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0584... Products.'' This guidance updates recommendations regarding degradation products and updates the draft... information on listing of degradation products, setting acceptance criteria, and qualifying degradation...

  2. Guidance for Reviewing OCSPP 850.2100 Avian Oral Toxicity Studies Conducted with Passerine Birds

    Science.gov (United States)

    Guidance based on comparison of results from the TG223 validation studies to results from avian acute oral studies previously submitted to EPA for two test chemicals following EPA's 850.2100 (public draft) guidelines.

  3. Regulatory systems-based licensing guidance documentation

    International Nuclear Information System (INIS)

    Delligatti, M.S.

    1991-01-01

    The US Nuclear Regulatory Commission (NRC) has developed a series of licensing guidance documents based on the regulatory requirements in Part 60 of Title 10 of the Code of Federal Regulations (10 CFR Part 60). This regulatory systems-based approach to licensing guidance documentation relies on the definition of the high-level waste repository in 10 CFR Part 60. A document which is important for the frame-work it gives to other programmatic licensing guidance is the Draft Regulatory Guide open-quotes Format and Content for the License Application for the High-Level Waste Repositoryclose quotes (FCRG). The FCRG describes a format and content acceptable to NRC for a high-level waste repository license application pursuant to the requirements of 10 CFR Part 60. Other licensing guidance documents will be compatible with the FCRG

  4. 340 Waste Handling Facility interim safety basis

    International Nuclear Information System (INIS)

    Bendixsen, R.B.

    1995-01-01

    This document establishes the interim safety basis (ISB) for the 340 Waste Handling Facility (340 Facility). An ISB is a documented safety basis that provides a justification for the continued operation of the facility until an upgraded final safety analysis report is prepared that complies with US Department of Energy (DOE) Order 5480.23, Nuclear Safety Analysis Reports. The ISB for the 340 Facility documents the current design and operation of the facility. The 340 Facility ISB (ISB-003) is based on a facility walkdown and review of the design and operation of the facility, as described in the existing safety documentation. The safety documents reviewed, to develop ISB-003, include the following: OSD-SW-153-0001, Operating Specification Document for the 340 Waste Handling Facility (WHC 1990); OSR-SW-152-00003, Operating Limits for the 340 Waste Handling Facility (WHC 1989); SD-RE-SAP-013, Safety Analysis Report for Packaging, Railroad Liquid Waste Tank Cars (Mercado 1993); SD-WM-TM-001, Safety Assessment Document for the 340 Waste Handling Facility (Berneski 1994a); SD-WM-SEL-016, 340 Facility Safety Equipment List (Berneski 1992); and 340 Complex Fire Hazard Analysis, Draft (Hughes Assoc. Inc. 1994)

  5. 75 FR 18241 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-04-09

    ... Guide, DG-8036, ``Personnel Monitoring Device--Direct-Reading Pocket Dosimeters.'' FOR FURTHER.... The draft regulatory guide (DG), entitled, ``Personnel Monitoring Device--Direct-Reading Pocket... this guide included guidance on indirect-reading pocket dosimeters, this guide excludes such dosimeters...

  6. Interim Design Report

    CERN Document Server

    Choubey, S.; Goswami, S.; Berg, J.S.; Fernow, R.; Gallardo, J.C.; Gupta, R.; Kirk, H.; Simos, N.; Souchlas, N.; Ellis, M.; Kyberd, P.; Benedetto, E.; Fernandez-Martinez, E.; Efthymiopoulos, I.; Garoby, R.; Gilardoni, S.; Martini, M.; Prior, G.; Ballett, P.; Pascoli, S.; Bross, A.; Geer, S.; Johnstone, C.; Kopp, J.; Mokhov, N.; Morfin, J.; Neuffer, D.; Parke, S.; Popovic, M.; Strait, J.; Striganov, S.; Blondel, A.; Dufour, F.; Laing, A.; Soler, F.J.P; Lindner, M.; Schwetz, T.; Alekou, A.; Apollonio, M.; Aslaninejad, M.; Bontoiu, C.; Dornan, P.; Eccleston, R.; Kurup, A.; Long, K.; Pasternak, J.; Pozimski, J.; Bogacz, A.; Morozov, V.; Roblin, Y.; Bhattacharya, S.; Majumdar, D.; Mori, Y.; Planche, T.; Zisman, M.; Cline, D.; Stratakis, D.; Ding, X.; Coloma, P.; Donini, A.; Gavela, B.; Lopez Pavon, J.; Maltoni, M.; Bromberg, C.; Bonesini, M.; Hart, T.; Kudenko, Y.; Mondal, N.; Antusch, S.; Blennow, M.; Ota, T.; Abrams, R.J.; Ankenbrandt, C.M.; Beard, K.B.; Cummings, M.A.C.; Flanagan, G.; Johnson, R.P.; Roberts, T.J.; Yoshikawa, C.Y.; Migliozzi, P.; Palladino, V.; de Gouvea, A.; Graves, V.B.; Kuno, Y.; Peltoniemi, J.; Blackmore, V.; Cobb, J.; Witte, H.; Mezzetto, M.; Rigolin, S.; McDonald, K.T.; Coney, L.; Hanson, G.; Snopok, P.; Tortora, L.; Andreopoulos, C.; Bennett, J.R.J.; Brooks, S.; Caretta, O.; Davenne, T.; Densham, C.; Edgecock, R.; Kelliher, D.; Loveridge, P.; McFarland, A.; Machida, S.; Prior, C.; Rees, G.; Rogers, C.; Thomason, J.W.G.; Booth, C.; Skoro, G.; Karadzhov, Y.; Matev, R.; Tsenov, R.; Samulyak, R.; Mishra, S.R.; Petti, R.; Dracos, M.; Yasuda, O.; Agarwalla, S.K.; Cervera-Villanueva, A.; Gomez-Cadenas, J.J.; Hernandez, P.; Li, T.; Martin-Albo, J.; Huber, P.; Back, J.; Barker, G.; Harrison, P.; Meloni, D.; Tang, J.; Winter, W.

    2011-01-01

    The International Design Study for the Neutrino Factory (the IDS-NF) was established by the community at the ninth "International Workshop on Neutrino Factories, super-beams, and beta- beams" which was held in Okayama in August 2007. The IDS-NF mandate is to deliver the Reference Design Report (RDR) for the facility on the timescale of 2012/13. In addition, the mandate for the study [3] requires an Interim Design Report to be delivered midway through the project as a step on the way to the RDR. This document, the IDR, has two functions: it marks the point in the IDS-NF at which the emphasis turns to the engineering studies required to deliver the RDR and it documents baseline concepts for the accelerator complex, the neutrino detectors, and the instrumentation systems. The IDS-NF is, in essence, a site-independent study. Example sites, CERN, FNAL, and RAL, have been identified to allow site-specific issues to be addressed in the cost analysis that will be presented in the RDR. The choice of example sites shou...

  7. 77 FR 64999 - Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility...

    Science.gov (United States)

    2012-10-24

    ...] Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and... industry entitled ``Necessity of the Use of Food Product Categories in Food Facility Registrations and... made available a draft guidance entitled ``Guidance for Industry: Necessity of the Use of Food [[Page...

  8. 24 CFR 35.1330 - Interim controls.

    Science.gov (United States)

    2010-04-01

    ... Lead-Paint Hazard Evaluation and Hazard Reduction Activities § 35.1330 Interim controls. Interim..., cleanable covering or coating, such as metal coil stock, plastic, polyurethane, or linoleum. (3) Surfaces...

  9. Draft PRN 2006-A: Use of Antimicrobial Pesticide Products in Heating, Ventilation, Air Conditioning and Refrigeration Systems (HVAC&R)

    Science.gov (United States)

    This draft notice provides guidance to registrants of EPA-registered antimicrobial products whose labels bear general directions related to hard, non-porous or porous surfaces, but which are not but which are not specifically registered for HVAC uses.

  10. Radioactive waste interim storage in Germany

    International Nuclear Information System (INIS)

    2015-12-01

    The short summary on the radioactive waste interim storage in Germany covers the following issues: importance of interim storage in the frame of radioactive waste management, responsibilities and regulations, waste forms, storage containers, transport of vitrified high-level radioactive wastes from the reprocessing plants, central interim storage facilities (Gorleben, Ahaus, Nord/Lubmin), local interim storage facilities at nuclear power plant sites, federal state collecting facilities, safety, radiation exposure in Germany.

  11. 7 CFR 1735.75 - Interim financing.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Interim financing. 1735.75 Section 1735.75... Involving Loan Funds § 1735.75 Interim financing. (a) A borrower may submit a written request for RUS approval of interim financing if it is necessary to close an acquisition before the loan to finance the...

  12. 7 CFR 1738.21 - Interim financing.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Interim financing. 1738.21 Section 1738.21... Interim financing. (a) Upon notification by RUS that an applicant's application is considered complete, the applicant may enter into an interim financing agreement with a lender other than RUS or use its...

  13. Cluster: Drafting. Course: Introduction to Technical Drafting.

    Science.gov (United States)

    Sanford - Lee County Schools, NC.

    The set of 10 units is designed for use with an instructor as an introduction to technical drafting, and is also keyed to other texts. Each unit contains several task packages specifying prerequisites, rationale for learning, objectives, learning activities to be supervised by the instructor, and learning practice. The units cover: drafting…

  14. 78 FR 54949 - Major Project Financial Plan Guidance

    Science.gov (United States)

    2013-09-06

    ...'' (GA-090-751). That report recommended that Financial Plans include the cost of financing the project... Project Financial Plan Guidance AGENCY: Federal Highway Administration (FHWA), DOT. ACTION: Notice; Request for comments. SUMMARY: This notice requests comments on draft Major Project Financial Plan...

  15. Drafting method of electricity and electron design

    International Nuclear Information System (INIS)

    Gungbon, Junchun

    1989-11-01

    This book concentrates on drafting of electricity and electron design. It deals with The meaning of electricity and electron drafting JIS standard regulation the types of drafting and line and letter, basics drafting with projection drafting method, plan projection and development elevation, Drafting method of shop drawing, practical method of design and drafting, Design and drafting of technic and illustration, Connection diagram, Drafting of wiring diagram for light and illumination, Drafting of development connection diagram for sequence control, Drafting of logic circuit sign of flow chart and manual, drafting for a electron circuit diagram and Drawing of PC board.

  16. 77 FR 14507 - Revision to Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Science.gov (United States)

    2012-03-12

    ... accounting procedures. CEQ provides this draft revision of the guidance for public review and comment to... COUNCIL ON ENVIRONMENTAL QUALITY Revision to Guidance, ``Federal Greenhouse Gas Accounting and..., ``Federal Greenhouse Gas Accounting and Reporting''. SUMMARY: On October 5, 2009, President Obama signed...

  17. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Science.gov (United States)

    2013-01-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...

  18. 75 FR 78231 - Management of Energy and Water Efficiency in Federal Buildings: Availability of Guidance

    Science.gov (United States)

    2010-12-15

    ... Water Efficiency in Federal Buildings: Availability of Guidance AGENCY: Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of availability. SUMMARY: This notice of availability... regarding Federal agency implementation of energy and water efficiency requirements. The draft Guidance for...

  19. Interim Basis for PCB Sampling and Analyses

    International Nuclear Information System (INIS)

    BANNING, D.L.

    2001-01-01

    This document was developed as an interim basis for sampling and analysis of polychlorinated biphenyls (PCBs) and will be used until a formal data quality objective (DQO) document is prepared and approved. On August 31, 2000, the Framework Agreement for Management of Polychlorinated Biphenyls (PCBs) in Hanford Tank Waste was signed by the US. Department of Energy (DOE), the Environmental Protection Agency (EPA), and the Washington State Department of Ecology (Ecology) (Ecology et al. 2000). This agreement outlines the management of double shell tank (DST) waste as Toxic Substance Control Act (TSCA) PCB remediation waste based on a risk-based disposal approval option per Title 40 of the Code of Federal Regulations 761.61 (c). The agreement calls for ''Quantification of PCBs in DSTs, single shell tanks (SSTs), and incoming waste to ensure that the vitrification plant and other ancillary facilities PCB waste acceptance limits and the requirements of the anticipated risk-based disposal approval are met.'' Waste samples will be analyzed for PCBs to satisfy this requirement. This document describes the DQO process undertaken to assure appropriate data will be collected to support management of PCBs and is presented in a DQO format. The DQO process was implemented in accordance with the U.S. Environmental Protection Agency EPA QAlG4, Guidance for the Data Quality Objectives Process (EPA 1994) and the Data Quality Objectives for Sampling and Analyses, HNF-IP-0842/Rev.1 A, Vol. IV, Section 4.16 (Banning 1999)

  20. 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.

  1. 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

  2. Choice and validation of a near infrared spectroscopic application for the identity control of starting materials. practical experience with the EU draft Note for Guidance on the use of near infrared spectroscopy by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorization.

    Science.gov (United States)

    Vredenbregt, M J; Caspers, P W J; Hoogerbrugge, R; Barends, D M

    2003-11-01

    Recently the CPMP/CVMP sent out for consultation the draft Note for Guidance (dNfG) on the use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorization. We explored the practicability of this dNfG with respect to the verification of the correct identity of starting materials in a generic tablet-manufacturing site. Within the boundaries of the dNfG, a release procedure was developed for 12 substances containing structurally related compounds and substances differing only in particle size. For the method development literature data were also taken into consideration. Good results were obtained with wavelength correlation (WC), applied on raw spectra or second derivative spectra both without smoothing. The defined threshold of 0.98 for raw spectra differentiated between all molecular structures. Both methods were found to be robust over a period of 1 year. For the differentiation between the different particle sizes a subsequent second chemometric technique had to be used. Soft independent modelling of class analogy (SIMCA) with a probability level of 0.01 proved suitable. Internal and external validation I according to the dNfG showed no incorrect rejections or false acceptances. External validation II according to the dNfG was carried out with 95 potentially interfering substances from which 46 were tested experimentally. Macrogol 400 was not distinguished from macrogol 300. For the complete verification of the identity of macrogol 300 test A of the European Pharmacopoeia is needed in addition to the NIRS application. A release procedure developed with WC applied on raw spectra and SIMCA as a second method, which is different from the preferred method of the dNfG, was tested in practice with good results. We conclude that the dNfG has good practicability and that deviations from the preferred methods of the dNfG can also give good differentiation.

  3. 76 FR 50231 - Mobile Medical Applications Draft Guidance; Public Workshop

    Science.gov (United States)

    2011-08-12

    ... workshop discussion, a ``mobile medical app'' is a mobile application that meets the definition of ``device... applications are subject to regulation as devices when they meet the definition of a device in section 201(h... man * * * '' or ``* * * intended to affect the structure or any function of the body of man or other...

  4. Uranium exploration of the Colorado Plateau: interim staff report

    International Nuclear Information System (INIS)

    1980-10-01

    This report is an issue of the original draft copy of the Interim Staff Report on Uranium Exploration on the Colorado Plateau, dated June 1951. The original draft copy was only recently located and is being published at this time because of the interest in the contained historical content. The table of contents of this report lists: history of uranium mining; geology; proposed program for the geologic investigations section; general activities of industry and government; and future exploration of sedimentary uranium deposits and anticipated results. Under the proposed program section are: future of the copper-uranium deposits as a source of uranium; uraniferous asphaltite deposits; and commission exploration and future possibilities. The section on general activities of industry and government includes: exploratory and development drilling; field investigations and mapping; early geologic investigations and investigations by the US geological survey; and geophysical exploration. Tables are also presented on: uranium production by districts; US Geological survey drilling statistics; Colorado Exploration Branch drilling statistics; summary of drilling projects; and comparative yearly core-drill statistics on the Colorado Plateau

  5. Computer Assisted Drafting (CNC) Drawings. Drafting Module 6. Instructor's Guide.

    Science.gov (United States)

    Missouri Univ., Columbia. Instructional Materials Lab.

    This Missouri Vocational Instruction Management System instructor's drafting guide has been keyed to the drafting competency profile developed by state industry and education professionals. This unit contains information on computer-assisted drafting drawings. The guide contains a cross-reference table of instructional materials and 20 worksheets.…

  6. ITER Conceptual design: Interim report

    International Nuclear Information System (INIS)

    1990-01-01

    This interim report describes the results of the International Thermonuclear Experimental Reactor (ITER) Conceptual Design Activities after the first year of design following the selection of the ITER concept in the autumn of 1988. Using the concept definition as the basis for conceptual design, the Design Phase has been underway since October 1988, and will be completed at the end of 1990, at which time a final report will be issued. This interim report includes an executive summary of ITER activities, a description of the ITER device and facility, an operation and research program summary, and a description of the physics and engineering design bases. Included are preliminary cost estimates and schedule for completion of the project

  7. Agenda 21 interim balance, 1997

    Energy Technology Data Exchange (ETDEWEB)

    Van Vuuren, D.P.; Bakkes, J.A.

    1997-10-01

    Five years after the `United Nations Conference on Environment and Development (UNCED)`, an interim balance was drawn up to see what was done to meet the ambitious challenges adopted in Agenda 21 during this conference. Such a balance is presented in this report and the complementary brochure, `Developments in Sustainability 1992-1997`, reflecting societal developments and changes in environmental quality, as well as changes in responses to environmental concerns. 24 figs., 12 tabs., 68 refs.

  8. Burn site groundwater interim measures work plan.

    Energy Technology Data Exchange (ETDEWEB)

    Witt, Jonathan L. (North Wind, Inc., Idaho Falls, ID); Hall, Kevin A. (North Wind, Inc., Idaho Falls, ID)

    2005-05-01

    This Work Plan identifies and outlines interim measures to address nitrate contamination in groundwater at the Burn Site, Sandia National Laboratories/New Mexico. The New Mexico Environment Department has required implementation of interim measures for nitrate-contaminated groundwater at the Burn Site. The purpose of interim measures is to prevent human or environmental exposure to nitrate-contaminated groundwater originating from the Burn Site. This Work Plan details a summary of current information about the Burn Site, interim measures activities for stabilization, and project management responsibilities to accomplish this purpose.

  9. [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.

  10. Drafting Lab Management Guide.

    Science.gov (United States)

    Ohio State Univ., Columbus. Instructional Materials Lab.

    This manual was developed to guide drafting instructors and vocational supervisors in sequencing laboratory instruction and controlling the flow of work for a 2-year machine trades training program. The first part of the guide provides information on program management (program description, safety concerns, academic issues, implementation…

  11. Graphic Turbulence Guidance

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Forecast turbulence hazards identified by the Graphical Turbulence Guidance algorithm. The Graphical Turbulence Guidance product depicts mid-level and upper-level...

  12. Graphical Turbulence Guidance - Composite

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Forecast turbulence hazards identified by the Graphical Turbulence Guidance algorithm. The Graphical Turbulence Guidance product depicts mid-level and upper-level...

  13. 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...

  14. CAREER GUIDANCE EXPERIENCE ABROAD

    Directory of Open Access Journals (Sweden)

    Sergey N. Tolstoguzov

    2015-01-01

    Full Text Available The aim of this paper is to describe the experience of careeroriented activities carried out with students of schools in developed and developing countries. Career Guidance in Russia, despite the vast experience of its implementation, is experiencing serious difficulties. In this regard, it is important to take into account the international experience career-oriented activities, such as in the developed countries of North America and the European Union as well as in several Asian countries with rapidly growing economies and a large demographic potential, taking into account the best variants for the Russian education system. Methods. The experience of career-oriented work undertaken with pupils of the USA, Canada, Israel, France, UK, Germany, Denmark, Sweden, Japan, Singapore, China and India is shown on the basis of the comparative analysis of different publications and information sources. The author has made an attempt to generalize the principles of psycho-pedagogical and administrative assistance in professional self-determination of senior pupils abroad. Scientific novelty. The approaches to career-oriented activities in countries with different levels of economic development are compared for the first time. Some principles are revealed. Firstly, the higher the income level per capita in the country, the greater attention is given to vocational guidance. The politics in the developed countries is based on interests of the individual: children’s acquaintance with the world of professions begins already at younger school and the moment of definitive selfdetermination is postponed till the end of their senior stage of education; the possibility of direction change of professional preparation in case of detection of discrepancy of qualities of the pupil to originally selected profile is provided. Career-oriented activity in developing countries, on the contrary, is rigidly coordinated to requirements of economy and a labour market

  15. 75 FR 80287 - Environmental Protection Agency Implementation of OMB Guidance on Drug-Free Workplace Requirements

    Science.gov (United States)

    2010-12-22

    ... of omnibus drug legislation on November 18, 1988. Federal agencies issued an interim final common...; FRL- 9242-2] Environmental Protection Agency Implementation of OMB Guidance on Drug-Free Workplace... Protection Agency is removing its regulation implementing the Governmentwide common rule on drug-free...

  16. Protecting the Investment: Guidance on the Storage of Packaged Wastes in the UK

    International Nuclear Information System (INIS)

    Naish, Chris; Skelton, Paul; Wisbey, Simon

    2016-01-01

    This presentation will cover: • Introduction to the UK guidance on interim storage; • Waste stores in the UK and the Store Operations Forum; • Example Approach 1 – Operational limits and conditions; • Example Approach 2 – Monitoring the evolution of package performance; • IAEA Independent peer review

  17. Next Generation Melter Optioneering Study - Interim Report

    International Nuclear Information System (INIS)

    Gray, M.F.; Calmus, R.B.; Ramsey, G.; Lomax, J.; Allen, H.

    2010-01-01

    The next generation melter (NOM) development program includes a down selection process to aid in determining the recommended vitrification technology to implement into the WTP at the first melter change-out which is scheduled for 2025. This optioneering study presents a structured value engineering process to establish and assess evaluation criteria that will be incorporated into the down selection process. This process establishes an evaluation framework that will be used progressively throughout the NGM program, and as such this interim report will be updated on a regular basis. The workshop objectives were achieved. In particular: (1) Consensus was reached with stakeholders and technology providers represented at the workshop regarding the need for a decision making process and the application of the D 2 0 process to NGM option evaluation. (2) A framework was established for applying the decision making process to technology development and evaluation between 2010 and 2013. (3) The criteria for the initial evaluation in 2011 were refined and agreed with stakeholders and technology providers. (4) The technology providers have the guidance required to produce data/information to support the next phase of the evaluation process. In some cases it may be necessary to reflect the data/information requirements and overall approach to the evaluation of technology options against specific criteria within updated Statements of Work for 2010-2011. Access to the WTP engineering data has been identified as being very important for option development and evaluation due to the interface issues for the NGM and surrounding plant. WRPS efforts are ongoing to establish precisely data that is required and how to resolve this Issue. It is intended to apply a similarly structured decision making process to the development and evaluation of LAW NGM options.

  18. 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...

  19. 76 FR 58790 - Notice of Interim Approval

    Science.gov (United States)

    2011-09-22

    ... to the customers. Rate Scenario 3--Original Cumberland Marketing Policy The third rate alternative... an interim basis to the customers. Rate Scenario 3--Original Cumberland Marketing Policy The third... allocated on an interim basis to the customers. Rate Scenario 3--Original Cumberland Marketing Policy The...

  20. Addendum to IFMIF-CDA interim report

    Energy Technology Data Exchange (ETDEWEB)

    Maekawa, Hiroshi; Ida, Mizuho [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment; eds.

    1996-08-01

    During the second IFMIF-CDA Design Integration Workshop, the conceptual design and contents of `IFMIF-CDA Interim Report` were examined and discussed at both general and group meetings. Based on these discussion, the final IFMIF-CDA Report will be modified from the `Interim Report`. This report describes the outline of these modification. (author)

  1. Addendum to IFMIF-CDA interim report

    International Nuclear Information System (INIS)

    Maekawa, Hiroshi; Ida, Mizuho

    1996-08-01

    During the second IFMIF-CDA Design Integration Workshop, the conceptual design and contents of 'IFMIF-CDA Interim Report' were examined and discussed at both general and group meetings. Based on these discussion, the final IFMIF-CDA Report will be modified from the 'Interim Report'. This report describes the outline of these modification. (author)

  2. Fusion Breeder Program interim report

    International Nuclear Information System (INIS)

    Moir, R.; Lee, J.D.; Neef, W.

    1982-01-01

    This interim report for the FY82 Fusion Breeder Program covers work performed during the scoping phase of the study, December, 1981-February 1982. The goals for the FY82 study are the identification and development of a reference blanket concept using the fission suppression concept and the definition of a development plan to further the fusion breeder application. The context of the study is the tandem mirror reactor, but emphasis is placed upon blanket engineering. A tokamak driver and blanket concept will be selected and studied in more detail during FY83

  3. 78 FR 20925 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-04-08

    ... hydrochloride Desvenlafaxine Dutasteride; tamsulosin hydrochloride E Estramustine phosphate sodium Ethinyl... tromethamine L Loratadine M Miconazole Minocycline hydrochloride Mitotane N Nevirapine P Phentermine hydrochloride; topiramate R Rimexolone Rizatriptan benzoate [[Page 20926

  4. 77 FR 74669 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-12-17

    ... Phenoxybenzamine hydrochloride Q Quinine sulfate R Risedronate sodium T Tacrolimus Thalidomide Tinidazole For a... Gabapentin P Piroxicam S Sodium Phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate [[Page 74670

  5. 78 FR 37230 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-06-20

    ... 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests..., 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kris Andr[eacute...

  6. Solid waste burial grounds interim safety analysis

    International Nuclear Information System (INIS)

    Saito, G.H.

    1994-01-01

    This Interim Safety Analysis document supports the authorization basis for the interim operation and restrictions on interim operations for the near-surface land disposal of solid waste in the Solid Waste Burial Grounds. The Solid Waste Burial Grounds Interim Safety Basis supports the upgrade progress for the safety analysis report and the technical safety requirements for the operations in the Solid Waste Burial Grounds. Accident safety analysis scenarios have been analyzed based on the significant events identified in the preliminary hazards analysis. The interim safety analysis provides an evaluation of the operations in the Solid Waste Burial Grounds to determine if the radiological and hazardous material exposures will be acceptable from an overall health and safety standpoint to the worker, the onsite personnel, the public, and the environment

  7. Solid waste burial grounds interim safety analysis

    Energy Technology Data Exchange (ETDEWEB)

    Saito, G.H.

    1994-10-01

    This Interim Safety Analysis document supports the authorization basis for the interim operation and restrictions on interim operations for the near-surface land disposal of solid waste in the Solid Waste Burial Grounds. The Solid Waste Burial Grounds Interim Safety Basis supports the upgrade progress for the safety analysis report and the technical safety requirements for the operations in the Solid Waste Burial Grounds. Accident safety analysis scenarios have been analyzed based on the significant events identified in the preliminary hazards analysis. The interim safety analysis provides an evaluation of the operations in the Solid Waste Burial Grounds to determine if the radiological and hazardous material exposures will be acceptable from an overall health and safety standpoint to the worker, the onsite personnel, the public, and the environment.

  8. Introducing Systematic Aging Management for Interim Storage Facilities in Germany

    International Nuclear Information System (INIS)

    Spieth-Achtnich, Angelika; Schmidt, Gerhard

    2014-01-01

    In Germany twelve at-reactor and three central (away from reactor) dry storage facilities are in operation, where the fuel is stored in combined transport-and-storage casks. The safety of the storage casks and facilities has been approved and is licensed for up to 40 years operating time. If the availability of a final disposal facility for the stored wastes (spent fuel and high-level wastes from reprocessing) will be further delayed the renewal of the licenses can become necessary in future. Since 2001 Germany had a regulatory guideline for at-reactor dry interim storage of spent fuel. In this guideline some elements of ageing were implemented, but no systematic approach was made for a state-of-the-art ageing management. Currently the guideline is updated to include all kind of storage facilities (central storages as well) and all kinds of high level waste (also waste from reprocessing). Draft versions of the update are under discussion. In these drafts a systematic ageing management is seen as an instrument to upgrade the available technical knowledge base for possible later regulatory decisions, should it be necessary to prolong storage periods to beyond the currently approved limits. It is further recognized as an instrument to prevent from possible and currently unrecognized ageing mechanisms. The generation of information on ageing can be an important basis for the necessary safety-relevant verifications for long term storage. For the first time, the demands for a systematic monitoring of ageing processes for all safety-related components of the storage system are described. In addition, for inaccessible container components such as the seal system, the neutron shielding, the baskets and the waste inventory, the development of a monitoring program is recommended. The working draft to the revised guideline also contains recommendations on non-technical ageing issues such as the long-term preservation of knowledge, long term personnel planning and long term

  9. Image guidance improves localization of sonographically occult colorectal liver metastases

    Science.gov (United States)

    Leung, Universe; Simpson, Amber L.; Adams, Lauryn B.; Jarnagin, William R.; Miga, Michael I.; Kingham, T. Peter

    2015-03-01

    Assessing the therapeutic benefit of surgical navigation systems is a challenging problem in image-guided surgery. The exact clinical indications for patients that may benefit from these systems is not always clear, particularly for abdominal surgery where image-guidance systems have failed to take hold in the same way as orthopedic and neurosurgical applications. We report interim analysis of a prospective clinical trial for localizing small colorectal liver metastases using the Explorer system (Path Finder Technologies, Nashville, TN). Colorectal liver metastases are small lesions that can be difficult to identify with conventional intraoperative ultrasound due to echogeneity changes in the liver as a result of chemotherapy and other preoperative treatments. Interim analysis with eighteen patients shows that 9 of 15 (60%) of these occult lesions could be detected with image guidance. Image guidance changed intraoperative management in 3 (17%) cases. These results suggest that image guidance is a promising tool for localization of small occult liver metastases and that the indications for image-guided surgery are expanding.

  10. 46 CFR 167.55-1 - Draft marks and draft indicating systems.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Draft marks and draft indicating systems. 167.55-1... NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... aft to the location of the draft marks, due to a raked stem or cut away skeg, the draft must be...

  11. Interim and final storage casks

    International Nuclear Information System (INIS)

    Stumpfrock, L.; Kockelmann, H.

    2012-01-01

    The disposal of radioactive waste is a huge social challenge in Germany and all over the world. As is well known the search for a site for a final repository for high-level waste in Germany is not complete. Therefore, interim storage facilities for radioactive waste were built at plant sites in Germany. The waste is stored in these storage facilities in appropriate storage and transport casks until the transport in a final repository can be carried out. Licensing of the storage and transport casks aimed for use in the public space is done according to the traffic laws and for handling in the storage facility according to nuclear law. Taking into account the activity of the waste to be stored, different containers are in use, so that experience is available from the licensing and operation in interim storage facilities. The large volume of radioactive waste to be disposed of after the shut-down of power generation in nuclear power stations makes it necessary for large quantities of licensed storage and transport casks to be provided soon.

  12. Glass packages in interim storage

    International Nuclear Information System (INIS)

    Jacquet-Francillon, N.

    1994-10-01

    This report summarize the current state of knowledge concerning the behavior of type C waste packages consisting of vitrified high-level solutions produced by reprocessing spent fuel. The composition and the physical and chemical properties of the feed solutions are reviewed, and the vitrification process is described. Sodium alumino-borosilicate glass compositions are generally employed - the glass used at la Hague for LWR fuel solutions, for example, contains 45 % SiO 2 . The major physical, chemical, mechanical and thermal properties of the glass are reviewed. In order to allow their thermal power to diminish, the 3630 glass packages produced (as of January 1993) in the vitrification facilities at Marcoule and La Hague are placed in interim storage for several decades. The actual interim storage period has not been defined, as it is closely related to the concept and organization selected for the final destination of the packages: a geological repository. The glass behavior under irradiation is described. Considerable basic and applied research has been conducted to assess the aqueous leaching behavior of nuclear containment glass. The effects of various repository parameters (temperature, flow rate, nature of the environmental materials) have been investigated. The experimental findings have been used to specify a model describing the kinetics of aqueous corrosion of the glass. More generally all the ''source term'' models developed in France by the CEA or by ANDRA are summarized. (author). 152 refs., 33 figs

  13. Operator licensing examination standards for power reactors. Interim revision 8

    International Nuclear Information System (INIS)

    1997-01-01

    These examination standards are intended to assist NRC examiners and facility licensees to better understand the processes associated with initial and requalification examinations. The standards also ensure the equitable and consistent administration of examinations for all applicants. These standards are for guidance purposes and are not a substitute for the operator licensing regulations (i.e., 10 CFR Part 55), and they are subject to revision or other changes in internal operator licensing policy. This interim revision permits facility licensees to prepare their initial operator licensing examinations on a voluntary basis pending an amendment to 10 CFR Part 55 that will require facility participation. The NRC intends to solicit comments on this revision during the rulemaking process and to issue a final Revision 8 in conjunction with the final rule

  14. India's draft nuclear doctrine

    International Nuclear Information System (INIS)

    Kapur, A.

    2000-01-01

    India's draft nuclear doctrine and its nuclear and missile testing are a response to recent international, regional and domestic developments. Nehru's policy of nuclear disarmament, non-discriminatory international arrangements and unilateral restraint has been overturned in favour of self-reliant security and negotiated nuclear restraints. The draft nuclear doctrine is aimed at transparency and formalization of existing capacities. It is anchored in the United Nations Charter, based on the legitimacy of self-defence and espouses minimum nuclear deterrence. After the launching of Pokhran II, the debate in India has been settled on weaponization and deployment. The doctrine is not country-specific with respect to threat perceptions, but the author posits that the long-term focus is on China and the short-term on Pakistan. The doctrine emphasizes civilian command and control. India's decision to test incurred diplomatic and other economic costs, but afforded new opportunities for the country to assert itself militarily and politically in Asia and in the world. There were no diplomatic costs in issuing the draft nuclear doctrine, but the author estimates the economic costs of a full-blown (triad) Indian nuclear deterrent. (author)

  15. 13 CFR 120.890 - Source of interim financing.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Source of interim financing. 120... Development Company Loan Program (504) Interim Financing § 120.890 Source of interim financing. A Project may use interim financing for all Project costs except the Borrower's contribution. Any source (including...

  16. MX draft proposal

    International Nuclear Information System (INIS)

    1976-01-01

    This is an interim report on the design of a large mirror fusion experiment, MX, that LLL is proposing to construct in FY 78-80. The MX experiment brings together the main elements of our present concept of a mirror reactor: a superconducting magnet and neutral beam injection. The plasma will be created by pulsed beam injection into a plasma stream injected along the magnetic field through the mirrors. This will be followed by sustained injection of high energy neutrals to achieve steady-state conditions for 0.5 to several seconds

  17. Accelerating Cleanup: Focus on 2006. Discussion draft

    International Nuclear Information System (INIS)

    1997-01-01

    This executive summary addresses the activities associated with the National Transuranic (TRU) Program managed by the Carlsbad Area Office (CAO). The CAO programmatically reports to the Assistant Secretary for Environmental Management and receives administrative support through the Albuquerque Operations Office. The mission of the Carlsbad Area Office (CAO) is to protect human health and the environment by opening and operating the Waste Isolation Pilot Plant for site disposal of TRU waste and by establishing an effective system for management of TRU waste from generation to disposal. It includes personnel assigned to the CAO, the Waste Isolation Pilot Plant (WIPP) site operations, and other activities associated with the National TRU Program. The CAO develops and directs implementation of the program, while the DOE Headquarters establishes policy and guidelines. The CAO assesses compliance with the program guidance, as well as the commonality of activities and assumptions among all the sites. Since the development of the February 28, 1997, database used to develop this Discussion Draft, the opening of the WIPP facility for receipt of Contact Handled waste has been delayed from November 1997 to May 1998. This slippage is significant enough to require a change in the milestones and volumes included in the documents to be reviewed by our stakeholders. Changes have been incorporated into this Discussion Draft and its supporting Project Baseline Summaries (PBSs)

  18. Used Fuel Logistics: Decades of Experience with transportation and Interim storage solutions

    Energy Technology Data Exchange (ETDEWEB)

    Orban, G.; Shelton, C.

    2015-07-01

    Used fuel inventories are growing worldwide. While some countries have opted for a closed cycle with recycling, numerous countries must expand their interim storage solutions as implementation of permanent repositories is taking more time than foreseen. In both cases transportation capabilities will have to be developed. AREVA TN has an unparalleled expertise with transportation of used fuel. For more than 50 years AREVA TN has safely shipped more than 7,000 used fuel transport casks. The transportation model that was initially developed in the 1970s has been adapted and enhanced over the years to meet more restrictive regulatory requirements and evolving customer needs, and to address public concerns. The numerous “lessons learned” have offered data and guidance that have allowed for also efficient and consistent improvement over the decades. AREVA TN has also an extensive experience with interim dry storage solutions in many countries on-site but also is working with partners to developed consolidated interim storage facility. Both expertise with storage and transportation contribute to safe, secure and smooth continuity of the operations. This paper will describe decades of experience with a very successful transportation program as well as interim storage solutions. (Author)

  19. 78 FR 66940 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft...

    Science.gov (United States)

    2013-11-07

    ... for such products. These inconsistent interpretations of the definitions may inadvertently result in... amplification products (PSAPs), as well as the regulatory controls that apply to each. This draft guidance is... of clarity regarding how the Agency defines a hearing aid versus a personal sound amplification...

  20. Interim reliability evaluation program (IREP)

    International Nuclear Information System (INIS)

    Carlson, D.D.; Murphy, J.A.

    1981-01-01

    The Interim Reliability Evaluation Program (IREP), sponsored by the Office of Nuclear Regulatory Research of the US Nuclear Regulatory Commission, is currently applying probabilistic risk analysis techniques to two PWR and two BWR type power plants. Emphasis was placed on the systems analysis portion of the risk assessment, as opposed to accident phenomenology or consequence analysis, since the identification of risk significant plant features was of primary interest. Traditional event tree/fault tree modeling was used for the analysis. However, the study involved a more thorough investigation of transient initiators and of support system faults than studies in the past and substantially improved techniques were used to quantify accident sequence frequencies. This study also attempted to quantify the potential for operator recovery actions in the course of each significant accident

  1. Guidance on the scientific requirements for health claims related to gut and immune function

    DEFF Research Database (Denmark)

    Tetens, Inge

    2011-01-01

    The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products Nutrition and Allergies (NDA) to draft guidance on scientific requirements for health claims related to gut and immune function. This guidance has been drawn from scientific opinions of the NDA Panel on such health......, was subjected to public consultation (28 September 2010 to 22 October 2010), and was also discussed at a technical meeting with experts in the field on 2 December 2010 in Amsterdam....

  2. DOE UST interim subsurface barrier technologies workshop

    International Nuclear Information System (INIS)

    1992-09-01

    This document contains information which was presented at a workshop regarding interim subsurface barrier technologies that could be used for underground storage tanks, particularly the tank 241-C-106 at the Hanford Reservation

  3. Pipe drafting and design

    CERN Document Server

    Parisher, Roy A

    2011-01-01

    Pipe Drafting and Design, Third Edition provides step-by-step instructions to walk pipe designers, drafters, and students through the creation of piping arrangement and isometric drawings. It includes instructions for the proper drawing of symbols for fittings, flanges, valves, and mechanical equipment. More than 350 illustrations and photographs provide examples and visual instructions. A unique feature is the systematic arrangement of drawings that begins with the layout of the structural foundations of a facility and continues through to the development of a 3-D model. Advanced chapters

  4. Pipe drafting and design

    CERN Document Server

    Parisher, Roy A; Parisher

    2000-01-01

    Pipe designers and drafters provide thousands of piping drawings used in the layout of industrial and other facilities. The layouts must comply with safety codes, government standards, client specifications, budget, and start-up date. Pipe Drafting and Design, Second Edition provides step-by-step instructions to walk pipe designers and drafters and students in Engineering Design Graphics and Engineering Technology through the creation of piping arrangement and isometric drawings using symbols for fittings, flanges, valves, and mechanical equipment. The book is appropriate primarily for pipe

  5. EPA scientific integrity policy draft

    Science.gov (United States)

    Showstack, Randy

    2011-08-01

    The U.S. Environmental Protection Agency (EPA) issued its draft scientific integrity policy on 5 August. The draft policy addresses scientific ethical standards, communications with the public, the use of advisory committees and peer review, and professional development. The draft policy was developed by an ad hoc group of EPA senior staff and scientists in response to a December 2010 memorandum on scientific integrity from the White House Office of Science and Technology Policy. The agency is accepting public comments on the draft through 6 September; comments should be sent to osa.staff@epa.gov. For more information, see http://www.epa.gov/stpc/pdfs/draft-scientific-integrity-policy-aug2011.pdf.

  6. 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.”

  7. 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.”

  8. National Ignition Facility Cryogenic Target Systems Interim Management Plan

    International Nuclear Information System (INIS)

    Warner, B

    2002-01-01

    Restricted availability of funding has had an adverse impact, unforeseen at the time of the original decision to projectize the National Ignition Facility (NIF) Cryogenic Target Handling Systems (NCTS) Program, on the planning and initiation of these efforts. The purpose of this document is to provide an interim project management plan describing the organizational structure and management processes currently in place for NCTS. Preparation of a Program Execution Plan (PEP) for NCTS has been initiated, and a current draft is provided as Attachment 1 to this document. The National Ignition Facility is a multi-megajoule laser facility being constructed at Lawrence Livermore National Laboratory (LLNL) by the National Nuclear Security Administration (NNSA) in the Department of Energy (DOE). Its primary mission is to support the Stockpile Stewardship Program (SSP) by performing experiments studying weapons physics, including fusion ignition. NIF also supports the missions of weapons effects, inertial fusion energy, and basic science in high-energy-density physics. NIF will be operated by LLNL under contract to the University of California (UC) as a national user facility. NIF is a low-hazard, radiological facility, and its operation will meet all applicable federal, state, and local Environmental Safety and Health (ES and H) requirements. The NCTS Interim Management Plan provides a summary of primary design criteria and functional requirements, current organizational structure, tracking and reporting procedures, and current planning estimates of project scope, cost, and schedule. The NIF Director controls the NIF Cryogenic Target Systems Interim Management Plan. Overall scope content and execution schedules for the High Energy Density Physics Campaign (SSP Campaign 10) are currently undergoing rebaselining and will be brought into alignment with resources expected to be available throughout the NNSA Future Years National Security Plan (FYNSP). The revised schedule for

  9. Criteria for preparation and evaluation of radiological emergency response plans and preparedness in support of nuclear power plants. Interim report

    International Nuclear Information System (INIS)

    1980-01-01

    The purpose of this document is to provide a common reference and interim guidance source for: state and local governments and nuclear facility operators in the development of radiological emergency response plans and preparedness in support of nuclear power plants; and Nuclear Regulatory Commission (NRC), Federal Emergency Management Agency (FEMA) and other Federal agency personnel engaged in the review of state, local government, and licensee plans and preparedness

  10. Interim Storage of Spent Nuclear Fuel before Final Disposal in Germany - Regulator's view

    International Nuclear Information System (INIS)

    Arens, G.; Goetz, Ch.; Geupel, Sandra; Gmal, B.; Mester, W.

    2014-01-01

    For spent nuclear fuel management in Germany the concept of dry interim storage in dual purpose casks before direct disposal is applied. The Federal Office for Radiation Protection (BfS) is the competent authority for licensing of interim storage facilities. The competent authority for surveillance of operation is the responsible authority of the respective federal state (Land). Currently operation licenses for storage facilities have been granted for a storage time of 40 years and are based on safety demonstrations for all safety issues as safe enclosure, shielding, sub-criticality and decay heat removal under consideration of operation conditions. In addition, transportability of the casks for the whole storage period has to be provided. Due to current delay in site selection and exploration of a disposal site, an extension of the storage time beyond 40 years could be needed. This will cause appropriate actions by the licensee and the competent authorities as well. A brief description of the regulatory base of licensing and surveillance of interim storage is given from the regulators view. Furthermore the current planning for final disposal of spent nuclear fuel and high level waste and its interconnections between storage and disposal concepts are shortly explained. Finally the relevant aspects for licensing of extended storage time beyond 40 years will be discussed. Current activities on this issue, which have been initiated by the Federal Government, will be addressed. On the regulatory side a review and amendment of the safety guideline for interim storage of spent fuel has been performed and the procedure of periodic safety review is being implemented. A guideline for implementing an ageing management programme is available in a draft version. Regarding safety of long term storage a study focussing on the identification and evaluation of long term effects as well as gaps of knowledge has been finished in 2010. A continuation and update is currently underway

  11. 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.

  12. 75 FR 33629 - Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors...

    Science.gov (United States)

    2010-06-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0168... workshop will be held at the Holiday Inn College Park, 10000 Baltimore Ave., College Park, MD 20740. FOR... intended to assist the agency in developing draft guidance for industry on describing practices for naming...

  13. Methods Data Qualification Interim Report

    International Nuclear Information System (INIS)

    Alessi, R. Sam; Grimmett, Tami; Vang, Leng; McGrath, Dave

    2010-01-01

    The overall goal of the Next Generation Nuclear Plant (NGNP) Data Management and Analysis System (NDMAS) is to maintain data provenance for all NGNP data including the Methods component of NGNP data. Multiple means are available to access data stored in NDMAS. A web portal environment allows users to access data, view the results of qualification tests and view graphs and charts of various attributes of the data. NDMAS also has methods for the management of the data output from VHTR simulation models and data generated from experiments designed to verify and validate the simulation codes. These simulation models represent the outcome of mathematical representation of VHTR components and systems. The methods data management approaches described herein will handle data that arise from experiment, simulation, and external sources for the main purpose of facilitating parameter estimation and model verification and validation (V and V). A model integration environment entitled ModelCenter is used to automate the storing of data from simulation model runs to the NDMAS repository. This approach does not adversely change the why computational scientists conduct their work. The method is to be used mainly to store the results of model runs that need to be preserved for auditing purposes or for display to the NDMAS web portal. This interim report demonstrates the currently development of NDMAS for Methods data and discusses data and its qualification that is currently part of NDMAS.

  14. Interim Hanford Waste Management Plan

    International Nuclear Information System (INIS)

    1985-09-01

    The September 1985 Interim Hanford Waste Management Plan (HWMP) is the third revision of this document. In the future, the HWMP will be updated on an annual basis or as major changes in disposal planning at Hanford Site require. The most significant changes in the program since the last release of this document in December 1984 include: (1) Based on studies done in support of the Hanford Defense Waste Environmental Impact Statement (HDW-EIS), the size of the protective barriers covering contaminated soil sites, solid waste burial sites, and single-shell tanks has been increased to provide a barrier that extends 30 m beyond the waste zone. (2) As a result of extensive laboratory development and plant testing, removal of transuranic (TRU) elements from PUREX cladding removal waste (CRW) has been initiated in PUREX. (3) The level of capital support in years beyond those for which specific budget projections have been prepared (i.e., fiscal year 1992 and later) has been increased to maintain Hanford Site capability to support potential future missions, such as the extension of N Reactor/PUREX operations. The costs for disposal of Hanford Site defense wastes are identified in four major areas in the HWMP: waste storage and surveillance, technology development, disposal operations, and capital expenditures

  15. Methods Data Qualification Interim Report

    Energy Technology Data Exchange (ETDEWEB)

    R. Sam Alessi; Tami Grimmett; Leng Vang; Dave McGrath

    2010-09-01

    The overall goal of the Next Generation Nuclear Plant (NGNP) Data Management and Analysis System (NDMAS) is to maintain data provenance for all NGNP data including the Methods component of NGNP data. Multiple means are available to access data stored in NDMAS. A web portal environment allows users to access data, view the results of qualification tests and view graphs and charts of various attributes of the data. NDMAS also has methods for the management of the data output from VHTR simulation models and data generated from experiments designed to verify and validate the simulation codes. These simulation models represent the outcome of mathematical representation of VHTR components and systems. The methods data management approaches described herein will handle data that arise from experiment, simulation, and external sources for the main purpose of facilitating parameter estimation and model verification and validation (V&V). A model integration environment entitled ModelCenter is used to automate the storing of data from simulation model runs to the NDMAS repository. This approach does not adversely change the why computational scientists conduct their work. The method is to be used mainly to store the results of model runs that need to be preserved for auditing purposes or for display to the NDMAS web portal. This interim report demonstrates the currently development of NDMAS for Methods data and discusses data and its qualification that is currently part of NDMAS.

  16. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Guidance on the scientific requirements for health claims related to bone, joints, skin and oral health

    DEFF Research Database (Denmark)

    Tetens, Inge

    The Panel on Dietetic Products, Nutrition and Allergies (NDA) has been asked by the European Food Safety Authority (EFSA) to draft guidance on the scientific requirements for health claims related to bone, joints, skin, and oral health. This guidance has been drawn from scientific opinions...

  17. System for implement draft reduction

    DEFF Research Database (Denmark)

    2008-01-01

    Abstract of WO 2008095503  (A1) There is disclosed a system and method of reducing draft forces when working soil with agricultural soil working implements (206, 211) creating draft forces, the soil working implements (208, 206, 211) beingoperable connectable to a frame (204, 304, 404, 504, 604......, the second part of the width comprising an other part of said width (212) than the first part (222), so as e.g. to reduce draft forces compared to working both first and second parts at the same time....

  18. Optimal Aerocapture Guidance

    Data.gov (United States)

    National Aeronautics and Space Administration — The main goal of my research is to develop, implement, verify, and validate an optimal numerical predictor-corrector aerocapture guidance algorithm that is...

  19. Coral Reef Guidance

    Science.gov (United States)

    Guidance prepared by EPA and Army Corps of Engineers concerning coral reef protection under the Clean Water Act, Marine Protection, Research, and Sanctuaries Act, Rivers and Harbors Act, and Federal Project Authorities.

  20. Laser Guidance Analysis Facility

    Data.gov (United States)

    Federal Laboratory Consortium — This facility, which provides for real time, closed loop evaluation of semi-active laser guidance hardware, has and continues to be instrumental in the development...

  1. New IAEA guidance on safety culture

    International Nuclear Information System (INIS)

    Haage, Monica; )

    2012-01-01

    Monica Haage described a project for Kozloduy Nuclear Power Plant in Bulgaria which was also funded by the Norwegian government. This project included the development of guidance documents and training on self-assessment and continuous improvement of safety culture. A draft IAEA safety culture survey was also developed as part of this project in collaboration with St Mary's University, Canada. This project was conducted in parallel with an IAEA project to develop new safety reports on safety culture self-assessment and continuous improvement. A safety report on safety culture during the pre-operational phases of NPPs has also been drafted. The IAEA approach to safety culture assessment was outlined and core principles of the approach were discussed. These include the use of several assessment methods (survey, interview, observation, focus groups, document review), and two distinct levels of analysis. The first is a descriptive analysis of the observed cultural characteristics from each assessment method and overarching themes. This is followed by a 'normative' analysis comparing what has been observed with the desirable characteristics of a strong, positive, safety culture, as defined by the IAEA safety culture framework. The application of this approach during recent Operational Safety Assessment Review Team (OSART) missions was described along with key learning points

  2. EFSA Panel on Dietetic Products, Nutrition and Allerg ies (NDA) ; Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations

    DEFF Research Database (Denmark)

    Tetens, Inge

    The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to draft guidance on scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. This guidance has been drawn from scientific...... and studies/outcome measures which are acceptable. Rather, it presents examples drawn from evaluations already carried out in order to illustrate the approach of the Panel, as well as some examples which are currently under consideration within ongoing evaluations. A draft of this guidance document, endorsed...

  3. Offsite dose calculation manual guidance: Standard radiological effluent controls for boiling water reactors

    International Nuclear Information System (INIS)

    Meinke, W.W.; Essig, T.H.

    1991-04-01

    This report contains guidance which may be voluntarily used by licensees who choose to implement the provision of Generic Letter 89-- 01, which allows Radiological Effluent Technical Specifications (RETS) to be removed from the main body of the Technical Specifications and placed in the Offsite Dose Calculation Manual (ODCM). Guidance is provided for Standard Effluent Controls definitions, Controls for effluent monitoring instrumentation, Controls for effluent releases, Controls for radiological environmental monitoring, and the basis for Controls. Guidance on the formulation of RETS has been available in draft form for a number of years; the current effort simply recasts those RETS into Standard Radiological Effluent Controls for application to the ODCM. 11 tabs

  4. 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...

  5. Forced draft wet cooling systems

    International Nuclear Information System (INIS)

    Daubert, A.; Caudron, L.; Viollet, P.L.

    1975-01-01

    The disposal of the heat released from a 1000MW power plant needs a natural draft tower of about 130m of diameter at the base, and 170m height, or a cooling system with a draft forced by about forty vans, a hundred meters in diameter, and thirty meters height. The plumes from atmospheric cooling systems form, in terms of fluid mechanics, hot jets in a cross current. They consist in complex flows that must be finely investigated with experimental and computer means. The study, currently being performed at the National Hydraulics Laboratory, shows that as far as the length and height of visible plumes are concerned, the comparison is favorable to some types of forced draft cooling system, for low and medium velocities, (below 5 or 6m/s at 10m height. Beyond these velocities, the forced draft sends the plume up to smaller heights, but the plume is generally more dilute [fr

  6. EMCS Retrofit Analysis - Interim Report

    Energy Technology Data Exchange (ETDEWEB)

    Diamond, R.C.; Salsbury, T.I.; Bell, G.C.; Huang, Y.J.; Sezgen, A.O.; Mazzucchi, R.; Romberger, J.

    1999-03-01

    This report presents the interim results of analyses carried out in the Phillip Burton Federal Building in San Francisco from 1996 to 1998. The building is the site of a major demonstration of the BACnet communication protocol. The energy management and control systems (EMCS) in the building were retrofitted with BACnet compatible controllers in order to integrate certain existing systems on one common network. In this respect, the project has been a success. Interoperability of control equipment from different manufacturers has been demonstrated in a real world environment. Besides demonstrating interoperability, the retrofits carried out in the building were also intended to enhance control strategies and capabilities, and to produce energy savings. This report presents analyses of the energy usage of HVAC systems in the building, control performance, and the reaction of the building operators. The report does not present an evaluation of the performance capabilities of the BACnet protocol. A monitoring system was installed in the building that parallels many of the EMCS sensors and data were archived over a three-year period. The authors defined pre-retrofit and post-retrofit periods and analyzed the corresponding data to establish the changes in building performance resulting from the retrofit activities. The authors also used whole-building energy simulation (DOE-2) as a tool for evaluating the effect of the retrofit changes. The results of the simulation were compared with the monitored data. Changes in operator behavior were assessed qualitatively with questionnaires. The report summarizes the findings of the analyses and makes several recommendations as to how to achieve better performance. They maintain that the full potential of the EMCS and associated systems is not being realized. The reasons for this are discussed along with possible ways of addressing this problem. They also describe a number of new technologies that could benefit systems of the type

  7. Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

    DEFF Research Database (Denmark)

    Satya, Sneha; Wade, Mike; Hass, Ulla

    This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing and Asses......This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing...... on testing and assessment of endocrine disrupters (EDTA AG). In November 2010, comments were requested from the WNT, the EDTA AG, the Task Force on Hazard Assessment and experts involved in the assessment of chemicals. The EDTA AG addressed the comments from the WNT at a meeting held in April 2011...... the conclusions and next steps recommended in the draft guidance document are sensible and helpful when assessed in light of comprehensive datasets. The draft guidance document and the three case studies were reviewed again and revised at a meeting of the EDTA AG in December 2011. The draft guidance document...

  8. Design review report FFTF interim storage cask

    International Nuclear Information System (INIS)

    Scott, P.L.

    1995-01-01

    Final Design Review Report for the FFTF Interim Storage Cask. The Interim Storage Cask (ISC) will be used for long term above ground dry storage of FFTF irradiated fuel in Core Component Containers (CCC)s. The CCC has been designed and will house assemblies that have been sodium washed in the IEM Cell. The Solid Waste Cask (SWC) will transfer a full CCC from the IEM Cell to the RSB Cask Loading Station where the ISC will be located to receive it. Once the loaded ISC has been sealed at the RSB Cask Loading Station, it will be transferred by facility crane to the DSWC Transporter. After the ISC has been transferred to the Interim Storage Area (ISA), which is yet to be designed, a mobile crane will be used to place the ISC in its final storage location

  9. CMM Interim Check Design of Experiments (U)

    Energy Technology Data Exchange (ETDEWEB)

    Montano, Joshua Daniel [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2015-07-29

    Coordinate Measuring Machines (CMM) are widely used in industry, throughout the Nuclear Weapons Complex and at Los Alamos National Laboratory (LANL) to verify part conformance to design definition. Calibration cycles for CMMs at LANL are predominantly one year in length and include a weekly interim check to reduce risk. The CMM interim check makes use of Renishaw’s Machine Checking Gauge which is an off-the-shelf product simulates a large sphere within a CMM’s measurement volume and allows for error estimation. As verification on the interim check process a design of experiments investigation was proposed to test a couple of key factors (location and inspector). The results from the two-factor factorial experiment proved that location influenced results more than the inspector or interaction.

  10. Choosing a spent fuel interim storage system

    International Nuclear Information System (INIS)

    Roland, V.; Hunter, I.

    2001-01-01

    The Transnucleaire Group has developed different modular solutions to address spent fuel interim storage needs of NPP. These solutions, that are present in Europe, USA and Asia are metal casks (dual purpose or storage only) of the TN 24 family and the NUHOMS canister based system. It is not always simple for an operator to sort out relevant choice criteria. After explaining the basic designs involved on the examples of the TN 120 WWER dual purpose cask and the NUHOMS 56 WWER for WWER 440 spent fuel, we shall discuss the criteria that govern the choice of a given spent fuel interim storage system from the stand point of the operator. In conclusion, choosing and implementing an interim storage system is a complex process, whose implications can be far reaching for the long-term success of a spent fuel management policy. (author)

  11. Interim Administrators in Higher Education: A National Study

    Science.gov (United States)

    Huff, Marie Thielke; Neubrander, Judy

    2015-01-01

    The focus of this paper is on the roles and experiences of interim administrators in higher education. A survey was given to current and recent interim administrators in four-year public universities and colleges across the United States. The goals were to identify the advantages and disadvantages of using and serving as interims, and to solicit…

  12. An Approach for Evaluating the Technical Quality of Interim Assessments

    Science.gov (United States)

    Li, Ying; Marion, Scott; Perie, Marianne; Gong, Brian

    2010-01-01

    Increasing numbers of schools and districts have expressed interest in interim assessment systems to prepare for summative assessments and to improve teaching and learning. However, with so many commercial interim assessments available, schools and districts are struggling to determine which interim assessment is most appropriate to their needs.…

  13. Lessons for outsourcing and interim management relationships.

    Science.gov (United States)

    Macko, W; Kostyack, P T

    1999-01-01

    Few decisions can affect an organization more than the selection of an outsourcing or interim management partner. More and more health care organizations face such decisions in today's competitive market in order to face new business needs. Making these relationships successful can be important for health care organizations seeking competitive advantages or seeking immediately accessible management support. These relationships, however, require careful partner selection and development. Success in outsourcing and interim management relationships is contingent upon a thorough selection process, a strong contract that has clearly and explicitly detailed responsibilities and a culture-sensitive business rapport between the client and selected partner.

  14. 216-T-4 interim stabilization final report

    International Nuclear Information System (INIS)

    Smith, D.L.

    1996-01-01

    This report provides a general description of the activities performed for the interim stabilization of the 216-T-4-1 ditch, 216-T-4-2 ditch, and 216-T-4-2 pond. Interim stabilization was required to reduce the amount of surface-contaminated acres and to minimize the migration of radioactive contamination. Work associated with the 216-T4-1 ditch and 216-T-4-2 pond was performed by the Radiation Area Remedial Action (RARA) Project. Work associated with the 216-T-4-2 ditch was done concurrently but was funded by Westinghouse Hanford Company (WHC) Tank Waste Remediation Systems (TWRS)

  15. Offsite dose calculation manual guidance: Standard radiological effluent controls for pressurized water reactors

    International Nuclear Information System (INIS)

    Meinke, W.W.; Essig, T.H.

    1991-04-01

    This report contains guidance which may be voluntarily used by licensees who choose to implement the provision of Generic Letter 89-01, which allows Radiological Effect Technical Specifications (RETS) to be removed from the main body of the Technical Specifications and placed in the Offsite Dose Calculation Manual (ODCM). Guidance is provided for Standard Effluent Controls definitions, Controls for effluent monitoring instrumentation, Controls for effluent releases, Controls for radiological environmental monitoring, and the basis for Controls. Guidance on the formulation of RETS has been available in draft from (NUREG-0471 and -0473) for a number of years; the current effort simply recasts those RETS into Standard Radiological Effluent Controls for application to the ODCM. Also included for completeness are: (1) radiological environmental monitoring program guidance previously which had been available as a Branch Technical Position (Rev. 1, November 1979); (2) existing ODCM guidance; and (3) a reproduction of generic Letter 89-01

  16. Effectiveness of interim remedial actions at a radioactive waste facility

    International Nuclear Information System (INIS)

    Devgun, J.S.; Beskid, N.J.; Peterson, J.M.; Seay, W.M.; McNamee, E.

    1989-01-01

    Over the past eight years, several interim remedial actions have been taken at the Niagara Falls Storage Site (NFSS), primarily to reduce radon and gamma radiation exposures and to consolidate radioactive waste into a waste containment facility. Interim remedial actions have included capping of vents, sealing of pipes, relocation of the perimeter fence (to limit radon risk), transfer and consolidation of waste, upgrading of storage buildings, construction of a clay cutoff wall (to limit the potential groundwater transport of contaminants), treatment and release of contaminated water, interim use of a synthetic liner, and emplacement of an interim clay cap. An interim waste containment facility was completed in 1986. 6 refs., 3 figs

  17. 77 FR 55480 - Draft Compliance Policy Guide Sec. 690.150 on Labeling and Marketing of Nutritional Products...

    Science.gov (United States)

    2012-09-10

    ... purpose of this CPG is to communicate FDA's strategy with respect to dog and cat food products that are... for Use To Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats; Availability AGENCY..., Treat, or Prevent Disease in Dogs and Cats.'' This draft CPG is intended to provide guidance to FDA...

  18. Interim storage of radioactive waste packages

    International Nuclear Information System (INIS)

    1998-01-01

    This report covers all the principal aspects of production and interim storage of radioactive waste packages. The latest design solutions of waste storage facilities and the operational experiences of developed countries are described and evaluated in order to assist developing Member States in decision making and design and construction of their own storage facilities. This report is applicable to any category of radioactive waste package prepared for interim storage, including conditioned spent fuel, high level waste and sealed radiation sources. This report addresses the following issues: safety principles and requirements for storage of waste packages; treatment and conditioning methods for the main categories of radioactive waste; examples of existing interim storage facilities for LILW, spent fuel and high level waste; operational experience of Member States in waste storage operations including control of storage conditions, surveillance of waste packages and observation of the behaviour of waste packages during storage; retrieval of waste packages from storage facilities; technical and administrative measures that will ensure optimal performance of waste packages subject to various periods of interim storage

  19. Disposal facility data for the interim performance

    International Nuclear Information System (INIS)

    Eiholzer, C.R.

    1995-01-01

    The purpose of this report is to identify and provide information on the waste package and disposal facility concepts to be used for the low-level waste tank interim performance assessment. Current concepts for the low-level waste form, canister, and the disposal facility will be used for the interim performance assessment. The concept for the waste form consists of vitrified glass cullet in a sulfur polymer cement matrix material. The waste form will be contained in a 2 x 2 x 8 meter carbon steel container. Two disposal facility concepts will be used for the interim performance assessment. These facility concepts are based on a preliminary disposal facility concept developed for estimating costs for a disposal options configuration study. These disposal concepts are based on vault type structures. None of the concepts given in this report have been approved by a Tank Waste Remediation Systems (TWRS) decision board. These concepts will only be used in th interim performance assessment. Future performance assessments will be based on approved designs

  20. 33 CFR 385.38 - Interim goals.

    Science.gov (United States)

    2010-07-01

    ..., monitoring and assessment; (ii) Be provided to the independent scientific review panel established in.... The interim goals shall be developed through the use of appropriate models and tools and shall provide... to be required to meet long-term hydrological and ecological restoration goals, based on best...

  1. Interim Storage Facility decommissioning. Final report

    International Nuclear Information System (INIS)

    Johnson, R.P.; Speed, D.L.

    1985-01-01

    Decontamination and decommissioning of the Interim Storage Facility were completed. Activities included performing a detailed radiation survey of the facility, removing surface and imbedded contamination, excavating and removing the fuel storage cells, restoring the site to natural conditions, and shipping waste to Hanford, Washington, for burial. The project was accomplished on schedule and 30% under budget with no measurable exposure to decommissioning personnel

  2. 19 CFR 354.8 - Interim sanctions.

    Science.gov (United States)

    2010-04-01

    ... reconsider imposition of interim sanctions on the basis of new and material evidence or other good cause... Secretary may petition a presiding official to impose such sanctions. (b) The presiding official may impose... person to return material previously provided by the Department and all other materials containing the...

  3. Automotive Mechanics Occupational Performance Survey. Interim Report.

    Science.gov (United States)

    Borcher, Sidney D.; Leiter, Paul B.

    The purpose of this federally-funded interim report is to present the results of a task inventory analysis survey of automotive mechanics completed by project staff within the Instructional Systems Design Program at the Center for Vocational and Technical Education. Intended for use in curriculum development for vocational education programs in…

  4. A Non-Traditional Interim Project.

    Science.gov (United States)

    Brown, Diane; Ward, Dorothy

    1980-01-01

    Describes a project initiated by the Foreign Language Department of Birmingham-Southern College for their Interim term and discusses an interdisciplinary course focusing on Medieval Europe. The course included presentations on German and French language and literature, as well as lectures on the arts, philosophy, and family life of the period.…

  5. 340 waste handling facility interim safety basis

    Energy Technology Data Exchange (ETDEWEB)

    VAIL, T.S.

    1999-04-01

    This document presents an interim safety basis for the 340 Waste Handling Facility classifying the 340 Facility as a Hazard Category 3 facility. The hazard analysis quantifies the operating safety envelop for this facility and demonstrates that the facility can be operated without a significant threat to onsite or offsite people.

  6. ITER interim design report package documents

    International Nuclear Information System (INIS)

    1996-01-01

    This publication contains the Excerpt from the ITER Council (IC-8), the ITER Interim Design Report, Cost Review and Safety Analysis, ITER Site Requirements and ITER Site Design Assumptions and the Excerpt from the ITER Council (IC-9). 8 figs, 2 tabs

  7. LANDFILL BIOREACTOR PERFORMANCE, SECOND INTERIM REPORT

    Science.gov (United States)

    A bioreactor landfill is a landfill that is operated in a manner that is expected to increase the rate and extent of waste decomposition, gas generation, and settlement compared to a traditional landfill. This Second Interim Report was prepared to provide an interpretation of fie...

  8. 340 waste handling facility interim safety basis

    International Nuclear Information System (INIS)

    VAIL, T.S.

    1999-01-01

    This document presents an interim safety basis for the 340 Waste Handling Facility classifying the 340 Facility as a Hazard Category 3 facility. The hazard analysis quantifies the operating safety envelop for this facility and demonstrates that the facility can be operated without a significant threat to onsite or offsite people

  9. 76 FR 62087 - Draft Conservation Plan and Draft Environmental Assessment; Dunes Sagebrush Lizard, Texas

    Science.gov (United States)

    2011-10-06

    ...] Draft Conservation Plan and Draft Environmental Assessment; Dunes Sagebrush Lizard, Texas AGENCY: Fish... draft Texas Conservation Plan for the Dunes Sagebrush Lizard (TCP). The draft TCP will function as a... the Applicant for the dunes sagebrush lizard (Sceloporus arenicolus) throughout its range in Texas...

  10. 76 FR 34097 - Notice of Availability of the Draft Environmental Impact Statement, Including a Draft...

    Science.gov (United States)

    2011-06-10

    ... Impact Statement, Including a Draft Programmatic Agreement, for the Clark, Lincoln, and White Pine...) has prepared a Draft Environmental Impact Statement (EIS) and a Draft Programmatic Agreement (PA.... 100 N., Nephi Beaver Library, 55 W. Center St., Beaver. The Draft EIS describes and analyzes SNWA's...

  11. Interim report of the task force on energy policy

    International Nuclear Information System (INIS)

    2001-01-01

    A Task Force was established by the Premier of British Columbia in August 2001 to draft an energy policy framework for the province. Based on best practices worldwide, and keeping in mind the specific energy needs of British Columbia, this framework aims at fostering energy development in British Columbia, in accordance with exemplary environmental practices. This interim report comprises the preliminary findings of the Task Force, and public input is sought before the final report is finalized and presented to government. The energy sector of British Columbia comprises hydroelectric power, oil, gas and coal resources. In addition, green energy and alternative energy technologies are being developed, such as wind, solar, and wave power, and hydrogen fuel cells. Industry and individual consumers are well served by the highly developed transmission and distribution systems for energy. Several strategic directions were identified by the Task Force for inclusion in the energy policy of British Columbia, to meet its full potential. They are: growth to ensure safe, reliable energy and take advantage of economic opportunities; diversification; competitiveness; industry restructuring and expansion; environmental imperative; government leadership; and community and First Nations' involvement. Some changes are also required for the continuing success of the energy sector in British Columbia: a move to fully competitive markets in the electricity system, the development of natural gas storage capacity in the Lower Mainland, additional considerations for coal use, and the development of alternative energy sources. It is expected that private capital and more energy supply will result from a fully competitive energy market, which in turn would lower energy costs. Jobs and income would increase as a result of the growth in the sector. Diversification makes good economic and environmental sense. tabs., figs

  12. 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

  13. Regulatory guidance document

    International Nuclear Information System (INIS)

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM's evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7

  14. 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).

  15. Interim housing conditions profile, Benton and Franklin Counties, Washington: BWIP Repository Project: Working draft

    International Nuclear Information System (INIS)

    Bolton, P.A.

    1987-11-01

    This report describes the housing stock and its availability in Benton and Franklin counties. Depending on the specific measures, data are presented for the entire MSA, for Benton and Franklin counties separately, for incorporated and unincorporated areas within the counties, and for specific incorporated areas. The most detailed data are available for the two counties and for the major cities of Kennewick and Richland in Benton County and Pasco in Franklin County. In 1986, 64 percent of the population of Benton County and 66 percent of the housing units were in Kennewick and Richland. Seventy-three percent of the population and 75 percent of the housing were in the incorporated area of Benton County. In Franklin County, Pasco accounted for 52 percent of the county's 1986 population and 57 percent of its housing. Fifty-nine percent of the population and 63 percent of the housing were in the incorporated areas of Franklin County. More detailed data are needed to fully describe the housing conditions in the jurisdictions described here. 13 refs., 9 tabs

  16. Interim economic and demographic profile, Benton and Franklin Counties, Washington: Working draft

    International Nuclear Information System (INIS)

    Clark, D.C.

    1987-11-01

    This report is organized into five sections. Section 2 summarizes the methods used to compile and analyze the data presented in the report. It includes a discussion of the Qualilty Assurance context within which the data were collected, analyzed, and stored; a definition of the variables and time period included in the profile; description of the secondary and primary data collection, compilation, and analysis procedures used in preparing the report; and a summary of the database management system that will be used to store and provide access to the data presented in the the report. Section 3 contains the profile information, organized by topic. A combination of tables, figures, and text are used to describe the economic and demographic conditions in Benton and Franklin counties. Section 4 summarizes outstanding technical issues and data requirements, and Section 5 provides a bibliography of the documents and personal communications from which the data in this report were obtained. 27 refs., 4 figs., 17 tabs

  17. Competency Reference for Computer Assisted Drafting.

    Science.gov (United States)

    Oregon State Dept. of Education, Salem. Div. of Vocational Technical Education.

    This guide, developed in Oregon, lists competencies essential for students in computer-assisted drafting (CAD). Competencies are organized in eight categories: computer hardware, file usage and manipulation, basic drafting techniques, mechanical drafting, specialty disciplines, three dimensional drawing/design, plotting/printing, and advanced CAD.…

  18. Draft 1988 mission plan amendment

    International Nuclear Information System (INIS)

    1988-06-01

    This draft 1988 amendment to the Mission Plan for the Civilian Radioactive Waste Management Program has been prepared by the US Department of Energy (DOE). The purpose is to inform the Congress of the DOE's plans for implementing the provisions of the Nuclear Waste Policy Amendments Act of 1987 (P.L. 100-203) for the Civilian Radioactive Waste Management Program. This document is being submitted in draft form to Federal agencies, states, previously affected Indian Tribes, affected units of local government, and the public. After the consideration of comments, this amendment will be revised as appropriate and submitted to the Congress. 39 refs., 7 figs., 4 tabs

  19. Cluster: Drafting. Course: Basic Technical Drafting. Research Project.

    Science.gov (United States)

    Sanford - Lee County Schools, NC.

    The set of six units is designed for use with an instructor in basic technical drafting and is also keyed to other texts. Each unit contains several task packages specifying prerequisites, rationale for learning, objectives, learning activities to be supervised by the instructor, and learning practice. The units cover: pictorial drawing; screw…

  20. Periodic Safety Review in Interim Storage Facilities - Current Regulation and Experiences in Germany

    International Nuclear Information System (INIS)

    Neles, Julia Mareike; Schmidt, Gerhard

    2014-01-01

    Periodic safety reviews in nuclear power plants in Germany have been performed since the end of the 1980's as an indirect follow-up of the accident in Chernobyl and, in the meantime, are formally required by law. During this process the guidelines governing this review were developed in stages and reached their final form in 1996. Interim storage facilities and other nuclear facilities at that time were not included, so the guidelines were solely focused on the specific safety issues of nuclear power plants. Following IAEA's recommendations, the Western European Nuclear Regulator Association (WENRA) introduced PSRs in its safety reference levels for storage facilities (current version in WGWD report 2.1 as of Feb 2011: SRLs 59 - 61). Based on these formulations, Germany improved its regulation in 2010 with a recommendation of the Nuclear Waste Management Commission (Entsorgungskommission, ESK), an expert advisory commission for the federal regulatory body BMU. The ESK formulated these detailed requirements in the 'ESK recommendation for guides to the performance of periodic safety reviews for interim storage facilities for irradiated fuel elements and heat-generating radioactive waste'. Before finalization of the guideline a test phase was introduced, aimed to test the new regulation in practice and to later include the lessons learned in the final formulation of the guideline. The two-year test phase started in October 2011 in which the performance of a PSR will be tested at two selected interim storage facilities. Currently these recommendations are discussed with interested/concerned institutions. The results of the test phase shall be considered for improvements of the draft and during the final preparation of guidelines. Currently the PSR for the first ISF is in an advanced stage, the second facility just started the process. Preliminary conclusions from the test phase show that the implementation of the draft guideline requires interpretation. The aim of a

  1. Draft Transportation Institutional Plan

    International Nuclear Information System (INIS)

    1985-09-01

    The Department of Energy recognizes that the success of its program to develop and implement a national system for nuclear waste management and disposal depends on broad-based public understanding and acceptance. While each program element has its particular sensitivity, the transportation of the waste may potentially affect the greatest number of people, and accordingly is highly visible and potentially issue-laden. Therefore, the Office of Civilian Radioactive Waste Management has developed this Transportation Institutional Plan to lay the foundation for interaction among all interested parties for the purpose of identifying and resolving issues of concern. The Plan is divided into four chapters. Chapter 1 provides bachground information and discusses the purpose of the Plan and the policy guidance for establishing the transportation system. Chapter 2 introduces the major participants who must interact to build both the system itself and the consensus philosophy that is essential for effective operations. Chapter 3 suggests mechanisms for interaction that will ensure wide participation in program planning and implementation. And, finally, Chapter 4 suggests a framework for managing and resolving the issues related to development and operation of the transportation system. A list of acronyms and a glossary are included for the reader's convenience. The Plan's appendices provide supporting material to assist the reader in understanding the roles of the involved institutions. 4 figs., 1 tab

  2. Spent fuel interim management: 1995 update

    International Nuclear Information System (INIS)

    Anderson, C.K.

    1995-01-01

    The problems of interim away-from-reactor spent fuel storage and storage in spent fuel pools at the reactor site are discussed. An overview of the state-of-the-art in the USA, Europe, and Japan is presented. The technical facilities for away-from-reactor storage are briefly described, including wet storage pools, interactive concrete systems, metallic containers, and passive concrete systems. Reprocessing technologies are mostly at the design stage only. It is predicted that during the 20 years to come, about 50 000 tonnes of spent fuel will be stored at reactor sites regardless of the advance of spent fuel reprocessing or interim storage projects. (J.B.). 4 tabs., 2 figs

  3. Pathways to deep decarbonization - Interim 2014 Report

    International Nuclear Information System (INIS)

    2014-01-01

    The interim 2014 report by the Deep Decarbonization Pathways Project (DDPP), coordinated and published by IDDRI and the Sustainable Development Solutions Network (SDSN), presents preliminary findings of the pathways developed by the DDPP Country Research Teams with the objective of achieving emission reductions consistent with limiting global warming to less than 2 deg. C. The DDPP is a knowledge network comprising 15 Country Research Teams and several Partner Organizations who develop and share methods, assumptions, and findings related to deep decarbonization. Each DDPP Country Research Team has developed an illustrative road-map for the transition to a low-carbon economy, with the intent of taking into account national socio-economic conditions, development aspirations, infrastructure stocks, resource endowments, and other relevant factors. The interim 2014 report focuses on technically feasible pathways to deep decarbonization

  4. 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

  5. RCA annual report 1996. Draft

    International Nuclear Information System (INIS)

    1997-02-01

    In accordance with Article VII.4 of the Regional Co-operative Agreement for Research, Development and Training Related to Nuclear Science and Technology 1987 and extended in 1992, a draft report of activities for the calendar year 1996 is submitted

  6. AGILE DRAFTING OF OUTSOURCING CONTRACTS

    DEFF Research Database (Denmark)

    Schlichter, Bjarne Rerup; Storgaard, Kristian

    2015-01-01

    and in several parallel tracks using different competencies. By the use of an illustrative case-study, this paper explores how scrum can be applied to enhance the process of drafting outsourcing contracts. The analysis indicates that the use of an agile method, such as Scrum, can be beneficial in this context...

  7. FSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Guidance on the scientific requirements for health claims related to functions of the ne rvous system, including psycholog ical functions

    DEFF Research Database (Denmark)

    Tetens, Inge

    The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies to draft guidance on scientific requirements for health claims related to functions of the nervous system, including psychological functions. This guidance has been drawn from scientific opinions......, and was released for public consultation from 17 October 2011 to 16 December 2011....

  8. Development of joint regulatory guidance on the management of higher activity radioactive wastes on nuclear licensed sites - 16095

    International Nuclear Information System (INIS)

    Bacon, Mick; Ilett, Doug; Whittall, Andy

    2009-01-01

    In 2006 the UK Government's response (1) to recommendations by its Committee on Radioactive Waste Management (CoRWM) established, in England and Wales, that geological disposal, supported by safe and secure interim storage, is the preferred route for the long-term management of higher-activity radioactive waste (i.e. that which is not suitable for near-surface disposal). It also gave the responsibility for delivering the programme for a deep geological repository to the Nuclear Decommissioning Authority (NDA). The Scottish Government has a policy of long term, near site, near surface safe and secure interim storage. To support the open and transparent approach promised by Government, the Health and Safety Executive (HSE), the Environment Agency and the Scottish Environment Protection Agency (SEPA) are developing joint guidance on the management of higher-activity radioactive waste to explain regulatory objectives in securing safe and secure interim storage and the associated management of radioactive wastes. The guidance comes in two parts: - Guidance on the regulatory process; - Technical guidance modules. The guidance promotes a cradle to grave approach to radioactive waste management and by aligning the regulatory interests of environmental and safety regulators it delivers one of the Government's 'Better Regulation' objectives. This paper describes the process by which the joint guidance was produced with particular emphasis on stakeholder engagement. It describes the key features of the guidance, including the concept of the radioactive waste management case (RWMC). Finally the problems encountered with dissemination and implementation are discussed together with measures taken by the regulators to improve these aspects. (1) : UK Government and the devolved administrations, 'Response to the Report and Recommendations from the Committee on Radioactive Waste Management (CoRWM)', (PB 12303) October 2006. www

  9. Gaz de France interim financial report 2007

    International Nuclear Information System (INIS)

    2007-01-01

    This financial report contains the unaudited condensed financial statements of Gaz de France Group for the first half ended June 30, 2007, which were reviewed by the audit committee on August 27, 2007 and by the board of directors at its meeting on August 28, 2007. It includes forward-looking statements concerning the objectives, strategies, financial position, future operating results and the operations of Gaz de France Group. These statements reflect the Group's current perception of its activities and the markets in which it operates, as well as various estimates and assumptions considered to be reasonable. Content: interim management report (highlights of the first half of 2007, revenues and results for the period, financial structure, data on outstanding stock, outlook); interim consolidated financial statements (consolidated statements of income, consolidated balance sheets, consolidated statements of cash flows, recognized income and expenses, statements of changes in shareholders' equity, note to the consolidated financial statements); statement by the person responsible for the interim financial report; statutory auditors' report. (J.S.)

  10. Tribal child welfare. Interim final rule.

    Science.gov (United States)

    2012-01-06

    The Administration for Children and Families (ACF) is issuing this interim final rule to implement statutory provisions related to the Tribal title IV-E program. Effective October 1, 2009, section 479B(b) of the Social Security Act (the Act) authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The Fostering Connections to Success and Increasing Adoptions Act of 2008 requires that ACF issue interim final regulations which address procedures to ensure that a transfer of responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E benefits or medical assistance under title XIX of the Act (Medicaid) and such services or payments; in-kind expenditures from third-party sources for the Tribal share of administration and training expenditures under title IV-E; and other provisions to carry out the Tribal-related amendments to title IV-E. This interim final rule includes these provisions and technical amendments necessary to implement a Tribal title IV-E program.

  11. The Interim Financial Statements: The Case of Greece

    OpenAIRE

    Rogdaki, E.I.; Kazantzis, Ch.

    1999-01-01

    The following paper refers to the accounting and auditing issues which emerge in the preparation of the interim financial statements of the companies: Firstly, the interim financial statements are defined as being the financial statements that provide useful information about the financial position and the financial results of a company which are realized and accrued during the fiscal year. The interim financial statements can be prepared on a monthly basis, on a quarterly basis or covering a...

  12. 78 FR 20690 - Draft Environmental Impact Statement, Draft Habitat Conservation Plan, Draft Programmatic...

    Science.gov (United States)

    2013-04-05

    .... Background The Fowler Ridge application is unusual in that 355 wind turbines are already in place and have... Agreement, and Draft Implementing Agreement; Application for an Incidental Take Permit, Fowler Ridge Wind... application from Fowler Ridge Wind Farm LLC, Fowler Ridge II Wind Farm LLC, Fowler Ridge III Wind Farm LLC...

  13. Compilation of interim technical research memoranda. Volume I

    International Nuclear Information System (INIS)

    Shanahan, W.R.

    1984-04-01

    Four interim technical research memoranda are presented that describe the results of numerical simulations designed to investigate the dynamics of energetic plasma beams propagating across magnetic fields

  14. 77 FR 62596 - Interim Guidance on State Freight Plans and State Freight Advisory Committees

    Science.gov (United States)

    2012-10-15

    ... consideration of innovative technologies and operational strategies, including intelligent transportation... State that are significant for energy development, mining, agriculture, and timber production, and the... and Innovative Technology Administration (RITA), St. Lawrence Seaway Development Corporation (SLSDC...

  15. 78 FR 13073 - Interim Guidance for Revised Implementation of the International Convention for the Prevention of...

    Science.gov (United States)

    2013-02-26

    ... provided for food wastes, cargo residues, cleaning agents or additives contained in cargo hold, deck, and... other territory or possession over which the United States exercises sovereignty), exclusive economic...

  16. Enforcement under SACM: Interim guidance. Volume 1, Number 3, December 1992. Intermittent bulletin

    International Nuclear Information System (INIS)

    1992-12-01

    The purpose of the Superfund Accelerated Cleanup Model (SACM) is to make Superfund cleanups more timely and efficient. This will be accomplished through more focus on the front end of the process and better integration of all Superfund program components. The bulletin discusses major enforcement areas affected by SACM including: The timing and methodology of PRP searches; timing and content of negotiations with PRPs; notice letters; consultations for early actions; state involvement in enforcement; de minimis settlements; the availability and adequacy of administrative records; and cost recovery and cost documentation

  17. 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.

  18. In Brief: Geoengineering draft statement

    Science.gov (United States)

    Showstack, Randy

    2009-04-01

    The American Meteorological Society (AMS) has prepared a draft policy statement on geoengineering the climate system, which the AMS Council is considering for approval. The statement notes, “Geoengineering will not substitute for either aggressive mitigation or proactive adaptation. It could contribute to a comprehensive risk management strategy to slow climate change and alleviate its negative impacts, but the potential for adverse and unintended consequences implies a need for adequate research, appropriate regulation, and transparent consideration.” The statement, if adopted, indicates that AMS recommends enhanced research on the scientific and technological potential for geoengineering the climate system; additional study of the historical, ethical, legal, political, and societal aspects of the geoengineering issues; and the development and analysis of policy options to promote transparency and international cooperation in exploring geoengineering options along with restrictions on reckless efforts to manipulate the climate system. AMS is accepting comments on the draft statement until 23 April. For more information, visit http://ametsoc.org/policy/draftstatements/index.html#draft.

  19. The Homestake Interim Laboratory and Homestake DUSEL

    Science.gov (United States)

    Lesko, Kevin T.

    2011-12-01

    The former Homestake gold mine in Lead South Dakota is proposed for the National Science Foundation's Deep Underground Science and Engineering Laboratory (DUSEL). The gold mine provides expedient access to depths in excess of 8000 feet below the surface (>7000 mwe). Homestake's long history of promoting scientific endeavours includes the Davis Solar Neutrino Experiment, a chlorine-based experiment that was hosted at the 4850 Level for more than 30 years. As DUSEL, Homestake would be uncompromised by competition with mining interests or other shared uses. The facility's 600-km of drifts would be available for conversion for scientific and educational uses. The State of South Dakota, under Governor Rounds' leadership, has demonstrated exceptionally strong support for Homestake and the creation of DUSEL. The State has provided funding totalling $46M for the preservation of the site for DUSEL and for the conversion and operation of the Homestake Interim Laboratory. Motivated by the strong educational and outreach potential of Homestake, the State contracted a Conversion Plan by world-recognized mine-engineering contractor to define the process of rehabilitating the facility, establishing the appropriate safety program, and regaining access to the facility. The State of South Dakota has established the South Dakota Science and Technology Authority to oversee the transfer of the Homestake property to the State and the rehabilitation and preservation of the facility. The Homestake Scientific Collaboration and the State of South Dakota's Science and Technology Authority has called for Letters of Interest from scientific, educational and engineering collaborations and institutions that are interested in hosting experiments and uses in the Homestake Interim Facility in advance of the NSF's DUSEL, to define experiments starting as early as 2007. The Homestake Program Advisory Committee has reviewed these Letters and their initial report has been released. Options for

  20. The Homestake Interim Laboratory and Homestake DUSEL

    International Nuclear Information System (INIS)

    Lesko, Kevin T.

    2011-01-01

    The former Homestake gold mine in Lead South Dakota is proposed for the National Science Foundation's Deep Underground Science and Engineering Laboratory (DUSEL). The gold mine provides expedient access to depths in excess of 8000 feet below the surface (>7000 mwe). Homestake's long history of promoting scientific endeavours includes the Davis Solar Neutrino Experiment, a chlorine-based experiment that was hosted at the 4850 Level for more than 30 years. As DUSEL, Homestake would be uncompromised by competition with mining interests or other shared uses. The facility's 600-km of drifts would be available for conversion for scientific and educational uses. The State of South Dakota, under Governor Rounds' leadership, has demonstrated exceptionally strong support for Homestake and the creation of DUSEL. The State has provided funding totalling $46M for the preservation of the site for DUSEL and for the conversion and operation of the Homestake Interim Laboratory. Motivated by the strong educational and outreach potential of Homestake, the State contracted a Conversion Plan by world-recognized mine-engineering contractor to define the process of rehabilitating the facility, establishing the appropriate safety program, and regaining access to the facility. The State of South Dakota has established the South Dakota Science and Technology Authority to oversee the transfer of the Homestake property to the State and the rehabilitation and preservation of the facility. The Homestake Scientific Collaboration and the State of South Dakota's Science and Technology Authority has called for Letters of Interest from scientific, educational and engineering collaborations and institutions that are interested in hosting experiments and uses in the Homestake Interim Facility in advance of the NSF's DUSEL, to define experiments starting as early as 2007. The Homestake Program Advisory Committee has reviewed these Letters and their initial report has been released. Options for

  1. International Peer Review of Swedish Nuclear Fuel and Waste Management Company's SR-Can interim report

    International Nuclear Information System (INIS)

    Sagar, Budhi; Bailey, Lucy; Bennett, David G.; Egan, Mike; Roehlig, Klaus

    2004-12-01

    SKB has produced an interim safety assessment report as part of its work to develop a licence application for the construction of a spent nuclear fuel encapsulation plant. The purpose of the interim report is to set out and demonstrate SKB's proposed methodology for long-term safety assessment. The aim of producing an interim report is to allow the Swedish regulatory authorities (SKI and SSI) to review and comment on SKB's proposed methodology before it is used in support of a formal licence application. To help inform their review of SKB's proposed methodology, the authorities appointed an international review team (IRT) to carry out a review of SKB's interim safety assessment report. Comments from the IRT are presented in this document and will be considered by the regulatory authorities in developing their own view of SKB's proposed methodology. The IRT's review included examination of SKB's documentation (the 'Interim Main Report of the Safety Assessment SR-Can' and four supporting documents) and hearings with SKB staff and contractors. The hearings provided an opportunity for the IRT to discuss the SR-Can safety assessment with the authors and contributors to SKB's work. As directed by SKI and SSI, the IRT's review focused on methodological aspects and sought to determine whether SKB's proposed safety assessment methodology: (i) is fit for the purpose of supporting a licence application; (ii) has a reasonable prospect of leading to a safety assessment that is sufficiently comprehensive, reproducible, traceable and transparent; (iii) is compatible with the authorities' regulations and guidance. No evaluation of long term safety or site acceptability was attempted by the IRT. At the request of SKI and SSI, the IRT's review considered and made recommendations on the following issues: Description of the initial state of the repository and its components; Description of features, events and processes (FEPs) relevant to repository evolution; Strategy for safety

  2. 31 CFR 500.406 - Drafts under irrevocable letters of credit; documentary drafts.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Drafts under irrevocable letters of credit; documentary drafts. 500.406 Section 500.406 Money and Finance: Treasury Regulations Relating to... ASSETS CONTROL REGULATIONS Interpretations § 500.406 Drafts under irrevocable letters of credit...

  3. 31 CFR 515.406 - Drafts under irrevocable letters of credit; documentary drafts.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Drafts under irrevocable letters of credit; documentary drafts. 515.406 Section 515.406 Money and Finance: Treasury Regulations Relating to... CONTROL REGULATIONS Interpretations § 515.406 Drafts under irrevocable letters of credit; documentary...

  4. 75 FR 63519 - Notice of Availability of Draft Environmental Assessment and Draft Finding of No Significant...

    Science.gov (United States)

    2010-10-15

    ... reduced for certain environmental resource areas (i.e., for transportation, public and occupational health... NUCLEAR REGULATORY COMMISSION [NRC-2009-0435] Notice of Availability of Draft Environmental... of Availability of Draft Environmental Assessment and Draft Finding of No Significant Impact; Notice...

  5. 78 FR 64493 - Juneau Hydropower, Inc.; Notice of Subsequent Draft License Application (DLA) and Draft...

    Science.gov (United States)

    2013-10-29

    ... Hydropower, Inc.; Notice of Subsequent Draft License Application (DLA) and Draft Preliminary Draft... Hydropower, Inc. e. Name of Project: Sweetheart Lake Hydroelectric Project. f. Location: At the confluence of..., Business Manager, Juneau Hydropower, Inc., P.O. Box 22775, Juneau, AK 99802; 907-789-2775, email: duff...

  6. Non-cable vehicle guidance

    Energy Technology Data Exchange (ETDEWEB)

    Daugela, G.C.; Willott, A.M.; Chopiuk, R.G.; Thornton, S.E.

    1988-06-01

    The purpose is to determine the most promising driverless mine vehicle guidance systems that are not dependent on buried cables, and to plan their development. The project is presented in two phases: a preliminary study and literature review to determine whether suitable technologies exist to justify further work; and an in-depth assessment and selection of technologies for vehicle guidance. A large number of guidance elements are involved in a completely automated vehicle. The technologies that hold the best potential for development of guidance systems for mine vehicles are ultrasonics, radar, lasers, dead reckoning, and guidance algorithms. The best approach to adaptation of these technologies is on a step by step basis. Guidance modules that are complete in themselves and are designed to be integrated with other modules can provide short term benefits. Two modules are selected for development: the dragline operations monitor and automated machine control for optimized mining (AMCOM). 99 refs., 20 figs., 40 tabs.

  7. 40 CFR 80.141 - Interim detergent gasoline program.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Interim detergent gasoline program. 80... (CONTINUED) REGULATION OF FUELS AND FUEL ADDITIVES Detergent Gasoline § 80.141 Interim detergent gasoline... apply to: (i) All gasoline sold or transferred to a party who sells or transfers gasoline to the...

  8. 50 CFR 660.720 - Interim protection for sea turtles.

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 9 2010-10-01 2010-10-01 false Interim protection for sea turtles. 660.720 Section 660.720 Wildlife and Fisheries FISHERY CONSERVATION AND MANAGEMENT, NATIONAL OCEANIC AND... Migratory Fisheries § 660.720 Interim protection for sea turtles. (a) Until the effective date of §§ 660.707...

  9. 12 CFR 541.18 - Interim Federal savings association.

    Science.gov (United States)

    2010-01-01

    ... an existing savings and loan holding company or to facilitate any other transaction the Office may... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Interim Federal savings association. 541.18... REGULATIONS AFFECTING FEDERAL SAVINGS ASSOCIATIONS § 541.18 Interim Federal savings association. The term...

  10. Transuranic waste storage and assay facility (TRUSAF) interim safety basis

    International Nuclear Information System (INIS)

    Gibson, K.D.

    1995-09-01

    The TRUSAF ISB is based upon current facility configuration and procedures. The purpose of the document is to provide the basis for interim operation or restrictions on interim operations and the authorization basis for the TRUSAF at the Hanford Site. The previous safety analysis document TRUSAF hazards Identification and Evaluation (WHC 1977) is superseded by this document

  11. Presidential Transition: The Experience of Two Community College Interim Presidents

    Science.gov (United States)

    Thompson, Matthew D.

    2010-01-01

    The purpose of this qualitative case study was to understand the experiences of two community college interim presidents, their characteristics, and how they led institutions following an abrupt presidential departure. There were two fundamental questions framing this research study, 1. How do two interim community college presidents lead…

  12. Decision on performing interim analysis for comparative clinical trials.

    Science.gov (United States)

    Pak, Kyongsun; Jacobus, Susanna; Uno, Hajime

    2017-09-01

    In randomized-controlled trials, interim analyses are often planned for possible early trial termination to claim superiority or futility of a new therapy. While unblinding is necessary to conduct the formal interim analysis in blinded studies, blinded data also have information about the potential treatment difference between the groups. We developed a blinded data monitoring tool that enables investigators to predict whether they observe such an unblinded interim analysis results that supports early termination of the trial. Investigators may skip some of the planned interim analyses if an early termination is unlikely. We specifically focused on blinded, randomized-controlled studies to compare binary endpoints of a new treatment with a control. Assuming one interim analysis is planned for early termination for superiority or futility, we conducted extensive simulation studies to assess the impact of the implementation of our tool on the size, power, expected number of interim analyses, and bias in the treatment effect. The numerical study showed the proposed monitoring tool does not affect size or power, but dramatically reduces the expected number of interim analyses when the effect of the treatment difference is small. The tool serves as a useful reference when interpreting the summary of the blinded data throughout the course of the trial, without losing integrity of the study. This tool could potentially save the study resources and budget by avoiding unnecessary interim analyses.

  13. General certification procedure of enterprises and interim job enterprises

    CERN Document Server

    Int. At. Energy Agency, Wien

    2002-01-01

    This procedure defines the certification global process of enterprises employing workers of A or B category for nuclear facilities and interim job enterprises proposing workers of A or B category for nuclear facilities. This certification proves the enterprises ability to satisfy the specification ''E'' of the CEFRI and the interim job enterprises to satisfy the specification ''I'' of the CEFRI. (A.L.B.)

  14. 47 CFR 51.715 - Interim transport and termination pricing.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 3 2010-10-01 2010-10-01 false Interim transport and termination pricing. 51.715 Section 51.715 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER... Telecommunications Traffic § 51.715 Interim transport and termination pricing. (a) Upon request from a...

  15. Do Interim Assessments Reduce the Race and SES Achievement Gaps?

    Science.gov (United States)

    Konstantopoulos, Spyros; Li, Wei; Miller, Shazia R.; van der Ploeg, Arie

    2017-01-01

    The authors examined differential effects of interim assessments on minority and low socioeconomic status students' achievement in Grades K-6. They conducted a large-scale cluster randomized experiment in 2009-2010 to evaluate the impact of Indiana's policy initiative introducing interim assessments statewide. The authors used 2-level models to…

  16. Central waste complex interim safety basis

    International Nuclear Information System (INIS)

    Cain, F.G.

    1995-01-01

    This interim safety basis provides the necessary information to conclude that hazards at the Central Waste Complex are controlled and that current and planned activities at the CWC can be conducted safely. CWC is a multi-facility complex within the Solid Waste Management Complex that receives and stores most of the solid wastes generated and received at the Hanford Site. The solid wastes that will be handled at CWC include both currently stored and newly generated low-level waste, low-level mixed waste, contact-handled transuranic, and contact-handled TRU mixed waste

  17. Interim supply in the electricity industry

    Energy Technology Data Exchange (ETDEWEB)

    Strassburg, W

    1977-06-01

    The interim supply or the so-called 'condition without a contract' can occur within the framework of energy supply in the relationship between 1) public utility and tariff customer, 2) public utility and the special last-in-line consumer, 3) supplying and distributing public utility, 4) public utility and territorial administrative body. The present contribution deals with the cases named under (3) and (4). Cases (1) and (2) were dealt with in a previous article. Relevant contract clauses and laws and their effects on contracting partners are discussed.

  18. Interim supply in the electricity industry

    Energy Technology Data Exchange (ETDEWEB)

    Strassburg, W

    1977-05-01

    The interim supply or the so-called 'condition without a contract' can occur within the framework of energy supply in the relationship between: 1) public utility and tariff customer, 2) public utility and the special last-in-line consumer, 3) supplying and distributing public utility, 4) public utility and territorial administrative body. The contribution at hand deals with the cases under 1) and 2); cases 3) and 4) are dealt with in an article to be published. Relevant contract clauses and laws and their effects on contracting partners are discussed. 41 references.

  19. LEGAL DRAFTING IN CROATIA - CASE STUDY

    Directory of Open Access Journals (Sweden)

    Dario Đerđa

    2017-01-01

    Full Text Available This paper highlights the importance of legal drafting and its essential elements, which has not drawn a lot of attention in the Republic of Croatia so far. The paper emphasises the importance of proportionality in the simplicity and legal distinctness of a legal text in the process of drafting for the purpose of its clarity. The paper also presents objective requirements necessary for quality legal drafting, as well as subjective qualities of the drafters. With the purpose of drawing attention to imperfections in the legal drafting in Croatia, some defi ciencies are presented in the process of drafting and amending of the Utility Services Act. The process of drafting and amending of this Act is a good example of the way how legal drafting should not be done. It contains a lot of defi ciencies and failures that are the result of legal drafting mistakes. At the end, authors expect that the adoption of the Uniform methodology and nomotechnical rules for the drafting of acts enacted by Parliament should contribute to the higher quality of legal texts and to their full adjustment to the general requirements of legal certainty and rule of law.

  20. Interim data quality objectives for waste pretreatment and vitrification. Revision 1

    International Nuclear Information System (INIS)

    Kupfer, M.J.; Conner, J.M.; Kirkbride, R.A.; Mobley, J.R.

    1994-01-01

    The Tank Waste Remediation System (TWRS) is responsible for storing, processing, and immobilizing the Hanford Site tank wastes. Characterization information on the tank wastes is needed so that safety concerns can be addressed, and retrieval, pretreatment, and immobilization processes can be designed, permitted, and implemented. This document describes the near-term tank waste sampling and characterization needs of the Pretreatment, High-Level Waste (HLW) Disposal, and Low-Level Waste (LLW) Disposal Programs to support the TWRS disposal mission. The final DQO (Data Quality Objective) will define specific waste tanks to be sampled, sample timing requirements, an appropriate analytical scheme, and a list of required analytes. This interim DQO, however, focuses primarily on the required analytes since the tanks to be sampled in FY 1994 and early FY 1995 are being driven most heavily by other considerations, particularly safety. The major objective of this Interim DQO is to provide guidance for tank waste characterization requirements for samples taken before completion of the final DQO. The characterization data needs defined herein will support the final DQO to help perform the following: Support the TWRS technical strategy by identification of the chemical and physical composition of the waste in the tanks and Guide development efforts to define waste pretreatment processes, which will in turn define HLW and LLW feed to vitrification processes

  1. Symptomatic treatment in multiple sclerosis-interim analysis of a nationwide registry.

    Science.gov (United States)

    Skierlo, S; Rommer, P S; Zettl, U K

    2017-04-01

    To analyze symptomatic treatment in patients with multiple sclerosis (MS). Multiple sclerosis is a chronic inflammatory disease of the central nervous system, with accumulating disability symptoms like spasticity, voiding disorders, depression, and pain might occur. The nationwide German MS registry was initiated 2001 under guidance of the German MS society (Deutsche MS Gesellschaft). This study was performed as an interim analysis to lay foundation for future work on this topic. A subcohort of 5113 patients was assessed for this interim analysis. The mean age of the patients was 45.3 years; mean EDSS was 4.2. More than two-third of the enrolled patients were females (70.9%). Most frequent symptoms were fatigue (60%), followed by spasticity (52.5%) and voiding disorders (51.7%). The likelihood of treatment was highest for epileptic disorders (68.8%), spasticity (68.5%), pain (60.7%), and depression (58.9%). Multivariate regression analysis showed that retirement was the strongest factor predictive for antispastic treatment (β=.061, P=.005). Almost all patients in this analysis suffer from symptoms due to advanced MS. Treatment for the various symptoms differed tremendously. The likelihood of treatment correlated with the availability of effective therapeutic agents. Clinicians should put more awareness on MS symptoms. Symptomatic treatment may improve quality of life. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. FY17 Status Report: Research on Stress Corrosion Cracking of SNF Interim Storage Canisters.

    Energy Technology Data Exchange (ETDEWEB)

    Schindelholz, Eric John [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Bryan, Charles R. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Alexander, Christopher L. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2017-09-01

    This progress report describes work done in FY17 at Sandia National Laboratories (SNL) to assess the localized corrosion performance of container/cask materials used in the interim storage of spent nuclear fuel (SNF). Of particular concern is stress corrosion cracking (SCC), by which a through-wall crack could potentially form in a canister outer wall over time intervals that are shorter than possible dry storage times. Work in FY17 refined our understanding of the chemical and physical environment on canister surfaces, and evaluated the relationship between chemical and physical environment and the form and extent of corrosion that occurs. The SNL corrosion work focused predominantly on pitting corrosion, a necessary precursor for SCC, and process of pit-to-crack transition; it has been carried out in collaboration with university partners. SNL is collaborating with several university partners to investigate SCC crack growth experimentally, providing guidance for design and interpretation of experiments.

  3. On the Drafting of Confidentiality Agreements

    DEFF Research Database (Denmark)

    Drewsen, Merete; Lando, Henrik; Cummins, Tim

    2006-01-01

    This is not a theoretical paper but an application of existing law and economic contract theory to the issue of how to draft a specific kind of contract. It is addressed to practitioners and is intended for practical use. It will be part of a Wiki (as in Wikipedia) for contract drafting, which...

  4. Summary of comments received on staff draft proposed rule on radiological criteria for decommissioning

    International Nuclear Information System (INIS)

    Caplin, J.; Page, G.; Smith, D.; Wiblin, C.

    1994-08-01

    The Nuclear Regulatory Commission (NRC) is conducting an enhanced participatory rulemaking to establish radiological criteria for the decommissioning of NRC licensed facilities. The NRC obtained comments on the scope, issues, and approaches through a series of workshops (57 FR 58727), Generic Environmental Impact Statement (GEIS) scoping meetings (58 FR 33570), a dedicated electronic bulletin board system (58 FR 37760), and written submissions. A summary of workshop and scope-meeting comments was published as NUREG/CR-6156. On February 2, 1994, the Commission published in the Federal Register (59 FR 4868) a notice that the NRC staff had prepared a ''staff draft'' proposed rule on radiological criteria for decommissioning. Copies of the staff draft were distributed to the Agreement States, participants in the earlier meetings, and other interested parties for comment. This report summarizes the comments identified from the 96 docketed letters received on the staff draft. No analysis or response is included in this report. The comments reflect a broad spectrum of viewpoints. Two subjects on which the commenters were in general agreement were (1) that the enhanced participatory rulemaking should proceed, and (2) that the forthcoming GEIS and guidance documents are needed for better understanding of the draft rule

  5. 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

  6. 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

  7. Sustainable Solutions for Nuclear used Fuels Interim Storage

    International Nuclear Information System (INIS)

    Arslan, Marc; Favet, Dominique; Issard, Herve; Le Jemtel, Amaury; Drevon, Caroline

    2014-01-01

    AREVA has a unique experience in providing sustainable solutions for used fuel management, fitted with the needs of different customers in the world and with regulation in different countries. These solutions entail both recycling and interim storage technologies. In a first part, we will describe the various types of solutions for Interim Storage of UNF that have been implemented around the world for interim storage at reactor or centralized Pad solution in canisters dry storage, vault type storages for dry storage, dry storage of transportation casks (dual purpose) pools for wet storage, The experience for all these different families of interim storages in which AREVA is involved is extensive and will be discussed with respect to the new challenges: increase of the duration of the interim storage (long term interim storage) increase of burn up of the fuels In a second part of the presentation, special recycling features will be presented. In that case, interim storage of the used fuels is ensured in pools. This provides in the long term good conditions for the behaviour of the fuel and its retrievability. With recycling, the final waste (Universal Canister of vitrified fission products and compacted hulls and end pieces): is stable and licensed in many countries for the final disposal (France, UK, Belgium, NL, Switzerland, Germany, Japan, upcoming: Spain, Australia, Italy). Presents neither safety criticality risks nor proliferation risks (AREVA conditioned HLW and LL-ILW are free of IAEA safeguard constraints thanks to AREVA process high recovery and purification yields). It can therefore be safely stored in interim storage for more than 100 years before final disposal. Some economic considerations will also be discussed. In particular, in the case of long term interim storage of used fuels, there are growing uncertainties regarding the future needs of repackaging and transportation, which can result in future cost overruns. Meanwhile, in the recycling policy

  8. Plowshare radiation protection guidance

    International Nuclear Information System (INIS)

    Parker, H.M.

    1969-01-01

    The recommendations of the ICRP and the NCRP were developed primarily for occupational radiation exposures. They were later modified and applied to non-occupational exposures of populations. These, with appropriate interpretations, can be used to provide Plowshare radiation protection guidance. Exposures from Plowshare operations will tend to be acute, arising from radionuclides of relatively short half-life, but will have some chronic aspects due to small amounts of long-lived radionuclides generated. In addition, the neutron activation process of Plowshare technology will produce radionuclides not commonly encountered in routine nuclear energy programs. How these radionuclides contribute to personnel exposure is known for only a few situations that may not be representative of Plowshare exposure. Further complications arise from differences in radionuclide deposition and physiological sensitivity among individuals of different ages and states of health in the exposed population. All parameters necessary to evaluate such exposures are not available, even for good quantitative approximations, resulting in the need for interpretive experience. (author)

  9. Plowshare radiation protection guidance

    Energy Technology Data Exchange (ETDEWEB)

    Parker, H M [Environmental and Life Sciences Division, Battelle Memorial Institute, Pacific Northwest Laboratory, Richland, WA (United States)

    1969-07-01

    The recommendations of the ICRP and the NCRP were developed primarily for occupational radiation exposures. They were later modified and applied to non-occupational exposures of populations. These, with appropriate interpretations, can be used to provide Plowshare radiation protection guidance. Exposures from Plowshare operations will tend to be acute, arising from radionuclides of relatively short half-life, but will have some chronic aspects due to small amounts of long-lived radionuclides generated. In addition, the neutron activation process of Plowshare technology will produce radionuclides not commonly encountered in routine nuclear energy programs. How these radionuclides contribute to personnel exposure is known for only a few situations that may not be representative of Plowshare exposure. Further complications arise from differences in radionuclide deposition and physiological sensitivity among individuals of different ages and states of health in the exposed population. All parameters necessary to evaluate such exposures are not available, even for good quantitative approximations, resulting in the need for interpretive experience. (author)

  10. NGST fine guidance sensor

    Science.gov (United States)

    Rowlands, Neil; Hutchings, John; Murowinski, Richard G.; Alexander, Russ

    2003-03-01

    Instrumentation for the Next Generation Space Telescope (NGST) is currently in the Phase A definition stage. We have developed a concept for the NGST Fine Guidance Sensor or FGS. The FGS is a detector array based imager which resides in the NGST focal plane. We report here on tradeoff studies aimed at defining an overall configuration of the FGS which will meet the performance and interface requirements. A key performance requirement is a noise equivalent angle of 3 milli-arcseconds to be achieved with 95% probability for any pointing of the observatory in the celestial sphere. A key interface requirement is compatibility with the architecture of the Integrated Science Instrument Module (ISIM). The concept developed consists of two independent and redundant FGS modules, each with a 4' x 2' field of view covered by two 2048 x 2048 infrared detector arrays, providing 60 milli-arcsecond sampling. Performance modeling supporting the choice of this architecture and the trade space considered is presented. Each module has a set of readout electronics which perform star detection, pixel-by-pixel correction, and in fine guiding mode, centroid calculation. These readout electronics communicate with the ISIM Command &Data Handling Units where the FGS control software is based. Rationale for this choice of architecture is also presented.

  11. Retention of long-term interim restorations with sodium fluoride enriched interim cement

    Science.gov (United States)

    Strash, Carolyn

    Purpose: Interim fixed dental prostheses, or "provisional restorations", are fabricated to restore teeth when definitive prostheses are made indirectly. Patients undergoing extensive prosthodontic treatment frequently require provisionalization for several months or years. The ideal interim cement would retain the restoration for as long as needed and still allow for ease of removal. It would also avoid recurrent caries by preventing demineralization of tooth structure. This study aims to determine if adding sodium fluoride varnish to interim cement may assist in the retention of interim restorations. Materials and methods: stainless steel dies representing a crown preparation were fabricated. Provisional crowns were milled for the dies using CAD/CAM technology. Crowns were provisionally cemented onto the dies using TempBond NE and NexTemp provisional cements as well as a mixture of TempBond NE and Duraphat fluoride varnish. Samples were stored for 24h then tested or thermocycled for 2500 or 5000 cycles before being tested. Retentive strength of each cement was recorded using a universal testing machine. Results: TempBond NE and NexTemp cements performed similarly when tested after 24h. The addition of Duraphat significantly decreased the retention when added to TempBond NE. NexTemp cement had high variability in retention over all tested time periods. Thermocycling for 2500 and 5000 cycles significantly decreased the retention of all cements. Conclusions: The addition of Duraphat fluoride varnish significantly decreased the retention of TempBond NE and is therefore not recommended for clinical use. Thermocycling significantly reduced the retention of TempBond NE and NexTemp. This may suggest that use of these cements for three months, as simulated in this study, is not recommended.

  12. PROJECT W-551 INTERIM PRETREATMENT SYSTEM PRECONCEPTUAL CANDIDATE TECHNOLOGY DESCRIPTIONS

    Energy Technology Data Exchange (ETDEWEB)

    MAY TH

    2008-08-12

    The Office of River Protection (ORP) has authorized a study to recommend and select options for interim pretreatment of tank waste and support Waste Treatment Plant (WTP) low activity waste (LAW) operations prior to startup of all the WTP facilities. The Interim Pretreatment System (IPS) is to be a moderately sized system which separates entrained solids and 137Cs from tank waste for an interim time period while WTP high level waste vitrification and pretreatment facilities are completed. This study's objective is to prepare pre-conceptual technology descriptions that expand the technical detail for selected solid and cesium separation technologies. This revision includes information on additional feed tanks.

  13. Business plan in brief. Draft

    International Nuclear Information System (INIS)

    1994-06-01

    Competition is revolutionizing the electricity industry, and utilities may never be the same. In the past two decades, government deregulation has transformed the airline, cable television, natural gas, and telecommunications industries. Now, with the passage of new laws which have spurred the growth of independent power and opened up transmission access, the electric utility industry has become the laboratory for change. Here in the Northwest, dramatic changes in the electric industry mean that the Bonneville Power Administration (BPA) is facing real competition. Our customers have more choices than they had in the past. BPA's draft Business Plan is a direct response to this changing environment. The plan presents how we propose to adapt to the new competitive marketplace. This is a summary of the plan and some of the important issues it raises for regional discussion. The draft plan contains much more detail on all the topics mentioned here. Business Plan is BPA's first attempt to integrate the long-term strategic plans of the various parts of the agency with a strategic financial plan. Change is evident throughout the plan--change in our operating environment, in our strategic direction, in our customer and constituent relationships, and in BPA itself as an organization

  14. Hierarchies of belief and interim rationalizability

    Directory of Open Access Journals (Sweden)

    Jeffrey C. Ely

    2006-03-01

    Full Text Available In games with incomplete information, conventional hierarchies of belief are incomplete as descriptions of the players' information for the purposes of determining a player's behavior. We show by example that this is true for a variety of solution concepts. We then investigate what is essential about a player's information to identify behavior. We specialize to two player games and the solution concept of interim rationalizability. We construct the universal type space for rationalizability and characterize the types in terms of their beliefs. Infinite hierarchies of beliefs over conditional beliefs, which we call Delta-hierarchies, are what turn out to matter. We show that any two types in any two type spaces have the same rationalizable sets in all games if and only if they have the same Delta-hierarchies.

  15. Interim report and accounts 1993/94

    International Nuclear Information System (INIS)

    1993-01-01

    An interim set of accounts and reports is presented here for 1993/1994 for the health science company Amersham International. The company's research programs focus on developments in life science research, nuclear medicine and industrial quality and safety assurance, with particular expertise in the application of radioactivity to labelling and detection at the molecular level. This report which covers the half-year to 30 September 1993 shows promising financial results, with turnover, operating profits and earnings per share all having risen. All life science markets report growth although difficult trading conditions are being reported in Europe. Two products in the Healthcare business have achieved progress, a pain palliation agent for bone metastases has been launched in the United States, and European approval has been gained for a new technetium based heart imaging agent. Further growth is expected for the company. (UK)

  16. Safety regulations for radioisotopes, etc. (interim report)

    International Nuclear Information System (INIS)

    1980-01-01

    An (interim) report by an ad hoc expert committee to the Nuclear Safety Commission, on the safety regulations for radioisotopes, etc., was presented. For the utilization of radioisotopes, etc., there is the Law Concerning Prevention of Radiation Injury Due to Radioisotopes, etc. with the advances in this field and the improvement in international standards, the regulations by the law have been examined. After explaining the basic ideas of the regulations, the problems and countermeasures in the current regulations are described: legal system, rationalization in permission procedures and others, inspection on RI management, the system of the persons in charge of radiation handling, RI transport, low-level radioactive wastes, consumer goods, definitions of RIs, radiation and sealed sources, regulations by group partitioning, RI facilities, system of personnel exposure registration, entrusting of inspection, etc. to private firms, and reduction in the works for permission among governmental offices. (author)

  17. Interim Hanford Waste Management Technology Plan

    International Nuclear Information System (INIS)

    1985-09-01

    The Interim Hanford Waste Management Technology Plan (HWMTP) is a companion document to the Interim Hanford Waste Management Plan (HWMP). A reference plan for management and disposal of all existing and certain projected future radioactive Hanford Site Defense Wastes (HSDW) is described and discussed in the HWMP. Implementation of the reference plan requires that various open technical issues be satisfactorily resolved. The principal purpose of the HWMTP is to present detailed descriptions of the technology which must be developed to close each of the technical issues associated with the reference plan identified in the HWMP. If alternative plans are followed, however, technology development efforts including costs and schedules must be changed accordingly. Technical issues addressed in the HWMTP and HWMP are those which relate to disposal of single-shell tank wastes, contaminated soil sites, solid waste burial sites, double-shell tank wastes, encapsulated 137 CsCl and 90 SrF 2 , stored and new solid transuranic (TRU) wastes, and miscellaneous wastes such as contaminated sodium metal. Among the high priority issues to be resolved are characterization of various wastes including early determination of the TRU content of future cladding removal wastes; completion of development of vitrification (Hanford Waste Vitrification Plant) and grout technology; control of subsidence in buried waste sites; and development of criteria and standards including performance assessments of systems proposed for disposal of HSDW. Estimates of the technology costs shown in this report are made on the basis that all identified tasks for all issues associated with the reference disposal plan must be performed. Elimination of, consolidation of, or reduction in the scope of individual tasks will, of course, be reflected in corresponding reduction of overall technology costs

  18. AGR-1 Data Qualification Interim Report

    International Nuclear Information System (INIS)

    Abbott, Machael

    2009-01-01

    Projects for the very-high-temperature reactor (VHTR) program provide data in support of Nuclear Regulatory Commission licensing of the VHTR. Fuel and materials to be used in the reactor are tested and characterized to quantify performance in high temperature and high fluence environments. The VHTR Program has established the NGNP Data Management and Analysis System (NDMAS) to ensure that VHTR data are (1) qualified for use, (2) stored in a readily accessible electronic form, and (3) analyzed to extract useful results. This document focuses on the first NDMAS objective. It describes the data streams associated with the first Advanced Gas Reactor (AGR-1) experiment, the processing of these data within NDMAS, and reports the interim FY09 qualification status of the AGR-1 data to date. Data qualification activities within NDMAS for specific types of data are determined by the data qualification category, which is assigned by the data generator, and include: (1) capture testing, to confirm that the data stored within NDMAS are identical to the raw data supplied, (2) accuracy testing, to confirm that the data are an accurate representation of the system or object being measured, and (3) documentation that the data were collected under an NQA-1 or equivalent QA program. The interim qualification status of the following four data streams is reported in this document: (1) fuel fabrication data, (2) fuel irradiation data, (3) fission product monitoring system (FPMS) data, and (4) Advanced Test Reactor (ATR) operating conditions data. A final report giving the NDMAS qualification status of all AGR-1 data (including cycle 145A) is planned for February 2010

  19. General RMP Guidance - Appendix D: OSHA Guidance on PSM

    Science.gov (United States)

    OSHA's Process Safety Management (PSM) Guidance on providing complete and accurate written information concerning process chemicals, process technology, and process equipment; including process hazard analysis and material safety data sheets.

  20. Proposed Guidance for Preparing and Reviewing Molten Salt Nonpower Reactor Licence Applications (NUREG-1537)

    Energy Technology Data Exchange (ETDEWEB)

    Belles, Randy [ORNL; Flanagan, George F. [ORNL; Voth, Marcus [Boston Government Services, LLC

    2018-05-01

    Development of non-power molten salt reactor (MSR) test facilities is under consideration to support the analyses needed for development of a full-scale MSR. These non-power MSR test facilities will require review by the US Nuclear Regulatory Commission (NRC) staff. This report proposes chapter adaptations for NUREG-1537 in the form of interim staff guidance to address preparation and review of molten salt non-power reactor license applications. The proposed adaptations are based on a previous regulatory gap analysis of select chapters from NUREG-1537 for their applicability to non-power MSRs operating with a homogeneous fuel salt mixture.

  1. A novel speech prosthesis for mandibular guidance therapy in hemimandibulectomy patient: A clinical report

    Directory of Open Access Journals (Sweden)

    Raghavendra Adaki

    2016-01-01

    Full Text Available Treating diverse maxillofacial patients poses a challenge to the maxillofacial prosthodontist. Rehabilitation of hemimandibulectomy patients must aim at restoring mastication and other functions such as intelligible speech, swallowing, and esthetics. Prosthetic methods such as palatal ramp and mandibular guiding flange reposition the deviated mandible. Such prosthesis can also be used to restore speech in case of patients with debilitating speech following surgical resection. This clinical report gives detail of a hemimandibulectomy patient provided with an interim removable dental speech prosthesis with composite resin flange for mandibular guidance therapy.

  2. 77 FR 17091 - Trust Land Consolidation Draft Plan

    Science.gov (United States)

    2012-03-23

    ... DEPARTMENT OF THE INTERIOR Office of the Secretary Trust Land Consolidation Draft Plan AGENCY... reopening the period for commenting on the Cobell Land Consolidation Program Draft Plan (also known as the Trust Land Consolidation Draft Plan), which is the draft plan for accomplishing these goals. DATES...

  3. IRIS Toxicological Review of Ammonia (Revised External Review Draft)

    Science.gov (United States)

    In August 2013, EPA submitted a revised draft IRIS assessment of ammonia to the agency's Science Advisory Board (SAB) and posted this draft on the IRIS website. EPA had previously released a draft of the assessment for public comment, held a public meeting about the draft, and ...

  4. 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

  5. The continuum of behavior guidance.

    Science.gov (United States)

    Nelson, Travis

    2013-01-01

    Behavior guidance is a continuum of techniques, basic and advanced, fundamental to the provision of quality dental care for pediatric patients. This practice must be individualized, pairing the correct method of behavior guidance with each child. To select the appropriate technique, the clinician must have a thorough understanding of each aspect of the continuum and anticipate parental expectations, child temperament, and the technical procedures necessary to complete care. By effectively using techniques within the continuum of behavior guidance, a healing relationship with the family is maintained while addressing dental disease and empowering the child to receive dental treatment throughout their lifetime. Copyright © 2013 Elsevier Inc. All rights reserved.

  6. Predicted percentage dissatisfied with ankle draft.

    Science.gov (United States)

    Liu, S; Schiavon, S; Kabanshi, A; Nazaroff, W W

    2017-07-01

    Draft is unwanted local convective cooling. The draft risk model of Fanger et al. (Energy and Buildings 12, 21-39, 1988) estimates the percentage of people dissatisfied with air movement due to overcooling at the neck. There is no model for predicting draft at ankles, which is more relevant to stratified air distribution systems such as underfloor air distribution (UFAD) and displacement ventilation (DV). We developed a model for predicted percentage dissatisfied with ankle draft (PPD AD ) based on laboratory experiments with 110 college students. We assessed the effect on ankle draft of various combinations of air speed (nominal range: 0.1-0.6 m/s), temperature (nominal range: 16.5-22.5°C), turbulence intensity (at ankles), sex, and clothing insulation (thermal sensation and air speed at ankles are the dominant parameters affecting draft. The seated subjects accepted a vertical temperature difference of up to 8°C between ankles (0.1 m) and head (1.1 m) at neutral whole-body thermal sensation, 5°C more than the maximum difference recommended in existing standards. The developed ankle draft model can be implemented in thermal comfort and air diffuser testing standards. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. Evaluation of Worktext in Mechanical Drafting

    Directory of Open Access Journals (Sweden)

    Erich D. Cruz

    2015-11-01

    Full Text Available This study aimed to evaluate Worktext in Drafting Technology 4 (Mechanical Drafting for Bachelor of Technology (BT major in Drafting Technology. It was conducted at University of Rizal System with twenty Drafting and Mechanical Technology professors as respondents. The study used the descriptive evaluative method to describe and evaluate the developed Worktext in DT 4 using the questionnaire-checklist in gathering data. They were asked to evaluate the worktext through the following: objectives, contents, activities, presentation and style, organization, creativity, evaluation, accuracy, completeness and appropriateness. It was found out that the developed worktext with respect to objectives was highly agree, contents was highly agree, activities was highly agree, presentation and style was agree, creativity was highly agree and evaluation was highly agree. Meaning that the items with highly agree interpretations attained excellent level of acceptability while those with agree interpretations obtained extensive level of acceptability with fully achieved and above average Drafting standards, respectively. It was also found out that the developed worktext in terms of accuracy was high, completeness was very high and appropriateness was likewise very high. The researcher recommends that the developed Worktext in Drafting Technology 4 may be adopted for use by the Bachelor of Technology major in Drafting Technology students.

  8. An overview of current NAMA guidance. Policy Brief

    Energy Technology Data Exchange (ETDEWEB)

    Cameron, L.R. [ECN Policy Studies, Amsterdam (Netherlands)

    2013-05-15

    The International Climate Initiative formed a number of working groups within an Enhanced NAMA Cooperation Group. The Tools and Guides working group seeks to coordinate current efforts on NAMA related tools, guidebooks and templates, as well as reduce repetition of such work by different organisations. As a first step towards this goal, this brief analysis looks at the 8 main guides on NAMA development that have been published, or made available in draft form, as of May 2013. This note summarises the approach found in these guides and identifies a number of areas, or gaps, that would benefit from further effort to provide supporting resources and guidance. It also aims to provide the basis for further discussion within the working group.

  9. Strategic Review of Medical Training and Career Structure Interim Report

    OpenAIRE

    Department of Health (Ireland)

    2013-01-01

    Click here to download Strategic Review of Medical Training and Career Structure Interim Report PDF 44kb Click here to download Strategic Review of Medical Training and Career Structure Terms of Reference PDF 59KB

  10. Fuel Supply Shutdown Facility Interim Operational Safety Requirements

    International Nuclear Information System (INIS)

    BENECKE, M.W.

    2000-01-01

    The Interim Operational Safety Requirements for the Fuel Supply Shutdown (FSS) Facility define acceptable conditions, safe boundaries, bases thereof, and management of administrative controls to ensure safe operation of the facility

  11. Fire Hazards Analysis for the 200 Area Interim Storage Area

    International Nuclear Information System (INIS)

    JOHNSON, D.M.

    2000-01-01

    This documents the Fire Hazards Analysis (FHA) for the 200 Area Interim Storage Area. The Interim Storage Cask, Rad-Vault, and NAC-1 Cask are analyzed for fire hazards and the 200 Area Interim Storage Area is assessed according to HNF-PRO-350 and the objectives of DOE Order 5480 7A. This FHA addresses the potential fire hazards associated with the Interim Storage Area (ISA) facility in accordance with the requirements of DOE Order 5480 7A. It is intended to assess the risk from fire to ensure there are no undue fire hazards to site personnel and the public and to ensure property damage potential from fire is within acceptable limits. This FHA will be in the form of a graded approach commensurate with the complexity of the structure or area and the associated fire hazards

  12. Tank Farm Interim Surface Barrier Materials And Runoff Alternatives Study

    International Nuclear Information System (INIS)

    Holm, M.J.

    2009-01-01

    This report identifies candidate materials and concepts for interim surface barriers in the single-shell tank farms. An analysis of these materials for application to the TY tank farm is also provided.

  13. Interim research assessment 2003-2005 - Computer Science

    NARCIS (Netherlands)

    Mouthaan, A.J.; Hartel, Pieter H.

    This report primarily serves as a source of information for the 2007 Interim Research Assessment Committee for Computer Science at the three technical universities in the Netherlands. The report also provides information for others interested in our research activities.

  14. Interim Feed The Future Population Based Assessment of Cambodia

    Data.gov (United States)

    US Agency for International Development — This is the interim population based survey of Feed the Future in Cambodia for 2015. The data is split into survey modules. Modules A through C includes location...

  15. EPA's Revised Interim Financial Assistance Conflict of Interest Policy

    Science.gov (United States)

    EPA has established the following revised interim policy governing disclosure of actual and potential conflicts of interest (COI Policy) by applicants for, and recipients of, federal financial assistance awards from EPA.

  16. Interim report on long range plan for nuclear physics

    International Nuclear Information System (INIS)

    Anon.

    1995-01-01

    The interim report on the updated NSAC Long Range Plan for Nuclear Physics will be presented to the community for discussion and comment before submission to the funding agencies. The presentation will be coordinated by E. Moniz chair of NSAC

  17. 78 FR 73555 - Deepwater Horizon Oil Spill; Draft Programmatic and Phase III Early Restoration Plan and Draft...

    Science.gov (United States)

    2013-12-06

    ... Environmental Impact Statement (Draft Phase III ERP/PEIS). The Draft Phase III ERP/PEIS considers programmatic... programmatic restoration alternatives. The Draft Phase III ERP/PEIS evaluates these restoration alternatives... the Framework Agreement. The Draft Phase III ERP/PEIS also evaluates the environmental consequences of...

  18. 10 CFR 51.74 - Distribution of draft environmental impact statement and supplement to draft environmental impact...

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Distribution of draft environmental impact statement and supplement to draft environmental impact statement; news releases. 51.74 Section 51.74 Energy NUCLEAR... Impact Statements § 51.74 Distribution of draft environmental impact statement and supplement to draft...

  19. SPLC Sustainable Purchasing Guidance Profile

    Science.gov (United States)

    To help you find the resource that is right for your organization, EPA conducted a scan of the landscape and developed summary profiles of some of the leading sources of sustainable purchasing guidance around the globe.

  20. CDM Convective Forecast Planning guidance

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CDM Convective Forecast Planning (CCFP) guidance product provides a foreast of en-route aviation convective hazards. The forecasts are updated every 2 hours and...

  1. Guidance at the educational marketplace

    DEFF Research Database (Denmark)

    Lystbæk, Christian Tang

    in educational policies and institutions. As educational systems have expanded and, further, have been restructured with the expansion of choice opportunities since the 1980s, guidance has become prioritized as a form of counseling or coaching, which can support students. Thus, guidance has become an important...... `agent´ on the educational "market´, assisting (potential) students into and around the `marketplace´. Consequently, guidance is also an important `agent´ for educational institutions that increasingly use marketing strategies to promote themselves on the market to attract and hold on to their “customers......” in order for the institutions to increase their ´market value´, `sales” and “turnover”. Thus, the expansion of guidance is nurtured by the expansion of the logic of marketization and consumerism. Drawing on Foucauldian perspectives in educational research, which highlight the expansion of powerful...

  2. 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.

  3. TWRS HLW interim storage facility search and evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Calmus, R.B., Westinghouse Hanford

    1996-05-16

    The purpose of this study was to identify and provide an evaluation of interim storage facilities and potential facility locations for the vitrified high-level waste (HLW) from the Phase I demonstration plant and Phase II production plant. In addition, interim storage facilities for solidified separated radionuclides (Cesium and Technetium) generated during pretreatment of Phase I Low-Level Waste Vitrification Plant feed was evaluated.

  4. K basins interim remedial action health and safety plan

    Energy Technology Data Exchange (ETDEWEB)

    DAY, P.T.

    1999-09-14

    The K Basins Interim Remedial Action Health and Safety Plan addresses the requirements of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), as they apply to the CERCLA work that will take place at the K East and K West Basins. The provisions of this plan become effective on the date the US Environmental Protection Agency issues the Record of Decision for the K Basins Interim Remedial Action, currently planned in late August 1999.

  5. Interim Report by Asia International Grid Connection Study Group

    Science.gov (United States)

    Omatsu, Ryo

    2018-01-01

    The Asia International Grid Connection Study Group Interim Report examines the feasibility of developing an international grid connection in Japan. The Group has investigated different cases of grid connections in Europe and conducted research on electricity markets in Northeast Asia, and identifies the barriers and challenges for developing an international grid network including Japan. This presentation introduces basic contents of the interim report by the Study Group.

  6. ITER interim design report package and relevant documents

    International Nuclear Information System (INIS)

    1996-01-01

    This publication documents the technical basis which underlay the Interim Design Report, Cost Review and Safety Analysis submitted to the ITER Councils (IC-8 and IC-9) Records of decisions and the ''ITER Interim Design Report Package''. This publication contains ITER Site Requirements and ITER Site Design Assumptions, TAC-8 Report, SRG Report, CP's Report on Tentative Sequence of Events and Parties' Views on the IDR Package and Parties' Technical Comments on the IDR Package. Figs, tabs

  7. Materials behavior in interim storage of spent fuel

    International Nuclear Information System (INIS)

    Johnson, A.B. Jr.; Bailey, W.J.; Gilbert, E.R.; Inman, S.C.

    1982-01-01

    Interim storage has emerged as the only current spent-fuel management method in the US and is essential in all countries with nuclear reactors. Materials behavior is a key aspect in licensing interim-storage facilities for several decades of spent-fuel storage. This paper reviews materials behavior in wet storage, which is licensed for light-water reactor (LWR) fuel, and dry storage, for which a licensing position for LWR fuel is developing

  8. Interim Safety Basis for Fuel Supply Shutdown Facility

    International Nuclear Information System (INIS)

    BENECKE, M.W.

    2000-01-01

    This ISB, in conjunction with the IOSR, provides the required basis for interim operation or restrictions on interim operations and administrative controls for the facility until a SAR is prepared in accordance with the new requirements or the facility is shut down. It is concluded that the risks associated with tha current and anticipated mode of the facility, uranium disposition, clean up, and transition activities required for permanent closure, are within risk guidelines

  9. [Anterior guidance in complete dentures].

    Science.gov (United States)

    Dubreuil, J; Trevelo, A

    1990-01-01

    Although the anterior guidance in complete dentures is not really a guide, the arrangement of the anterior maxillary and mandibular prosthetic teeth, defines a propulsive line called the virtual anterior guidance, a part from the cinematic criterias. The influence of this guide on cuspal movement is superior, in all mandibular points, to the influence of the condylar pathway. If this line is not respected, the practitioner may have to do excessive grindings during occlusal adjustments.

  10. 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...

  11. The draft Mission Plan Amendment

    International Nuclear Information System (INIS)

    Gale, R.W.

    1987-01-01

    The draft Mission Plan Amendment provides an opportunity for States and Indian Tribes and other involved parties to participate in a process that no other nation affords its citizens. More than just a comment period on a Department of Energy document, the amendment that is to be submitted later this year will lay before Congress, the documentary basis on which to make decisions about the scope and timing of the high-level waste program in what Secretary Herrington has called a ''crossroads'' years. The Amendment will distill the view of the participants and also preset them to Congress as an integral part of the document. After four years of effort, the Nation is being afforded an opportunity to ask itself again whether the Act passed in 1982 is working and remains the best way to protect the public interest

  12. RCRA corrective action program guide (Interim)

    Energy Technology Data Exchange (ETDEWEB)

    1993-05-01

    The US Department of Energy (DOE) is responsible for compliance with an increasingly complex spectrum of environmental regulations. One of the most complex programs is the corrective action program proposed by the US Environmental Protection Agency (EPA) under the authority of the Resource Conservation and Recovery Act (RCRA) as amended by the Hazardous and Solid Waste Amendments (HSWA). The proposed regulations were published on July 27, 1990. The proposed Subpart S rule creates a comprehensive program for investigating and remediating releases of hazardous wastes and hazardous waste constituents from solid waste management units (SWMUs) at facilities permitted to treat, store, or dispose of hazardous wastes. This proposed rule directly impacts many DOE facilities which conduct such activities. This guidance document explains the entire RCRA Corrective Action process as outlined by the proposed Subpart S rule, and provides guidance intended to assist those persons responsible for implementing RCRA Corrective Action at DOE facilities.

  13. Draft Technical Position Subtask 1.1: waste package performance after repository closure. Volume 1

    International Nuclear Information System (INIS)

    Davis, M.S.; Schweitzer, D.G.

    1983-08-01

    This document provides guidance to the DOE on the issues and information necessary for the NRC to evaluate waste package performance after repository closure. Minimal performance objectives of the waste package are required by proposed 10 CFR 60. This Draft Technical Position describes the various options available to the DOE for compliance and discusses advantages and disadvantages of various choices. Examples are discussed dealing with demonstrability, predictability and reasonable assurance. The types of performance are considered. The document summarizes presently identified high priority issues needed to evaluate waste package performance after repository closure. 20 references, 7 tables

  14. Report of the first interim meeting of the Seabed Working Group Engineering Studies Task Group

    International Nuclear Information System (INIS)

    Talbert, D.M.

    1982-02-01

    The first interim meeting of the Engineering Studies Task Group (ESTG) was held at the Delft Soil Mechanics Laboratory, Delft, The Netherlands, on 21-24 September 1981. The main business of the meeting was the development of a network analysis for the ESTG. Significant progress was made; however, substantial further development remains to be accomplished. Other items discussed were (1) progress relevant to engineering studies made in the various national programs since the sixth annual meeting of the Seabed Working Group (SWG) held in Paris, February, 1981; (2) the ESTG Boundary Conditions and Scope of Work as previously defined at the Paris meeting; (3) the Draft II SWG Five-Year Plan; (4) the deep ocean drilling proposal made by the Site Selection Task Group at the Paris meeting and expanded upon at their May, 1981, meeting; and (5) a recent compilation of data from the Nares Abyssal Plain arising from the US Program studies. Finally, consideration was given to a plan for continued work by the ESTG. A brief discussion of the principal items is given. The current state of the network analysis is shown

  15. Proposed rule package on fracture toughness and thermal annealing requirements and guidance for light water reactor vessels

    International Nuclear Information System (INIS)

    Allen Hiser, J.R.

    1993-01-01

    In the framework of updating and clarification of the fracture toughness and thermal annealing requirements and guidance for light water reactor pressure vessels, proposed revisions concerning the pressurized thermal shock rule, fracture toughness requirements and reactor vessel material surveillance program requirements, are described. A new rule concerning thermal annealing requirements and a draft regulatory guide on 'Format and Content of Application for Approval for Thermal Annealing of RPV' are also proposed

  16. Proposed rule package on fracture toughness and thermal annealing requirements and guidance for light water reactor vessels

    Energy Technology Data Exchange (ETDEWEB)

    Allen Hiser, J R [UKAEA Harwell Lab. (United Kingdom). Engineering Div.

    1994-12-31

    In the framework of updating and clarification of the fracture toughness and thermal annealing requirements and guidance for light water reactor pressure vessels, proposed revisions concerning the pressurized thermal shock rule, fracture toughness requirements and reactor vessel material surveillance program requirements, are described. A new rule concerning thermal annealing requirements and a draft regulatory guide on `Format and Content of Application for Approval for Thermal Annealing of RPV` are also proposed.

  17. Evaluation of ERA-Interim precipitation data in complex terrain

    Science.gov (United States)

    Gao, Lu; Bernhardt, Matthias; Schulz, Karsten

    2013-04-01

    Precipitation controls a large variety of environmental processes, which is an essential input parameter for land surface models e.g. in hydrology, ecology and climatology. However, rain gauge networks provides the necessary information, are commonly sparse in complex terrains, especially in high mountainous regions. Reanalysis products (e.g. ERA-40 and NCEP-NCAR) as surrogate data are increasing applied in the past years. Although they are improving forward, previous studies showed that these products should be objectively evaluated due to their various uncertainties. In this study, we evaluated the precipitation data from ERA-Interim, which is a latest reanalysis product developed by ECMWF. ERA-Interim daily total precipitation are compared with high resolution gridded observation dataset (E-OBS) at 0.25°×0.25° grids for the period 1979-2010 over central Alps (45.5-48°N, 6.25-11.5°E). Wet or dry day is defined using different threshold values (0.5mm, 1mm, 5mm, 10mm and 20mm). The correspondence ratio (CR) is applied for frequency comparison, which is the ratio of days when precipitation occurs in both ERA-Interim and E-OBS dataset. The result shows that ERA-Interim captures precipitation occurrence very well with a range of CR from 0.80 to 0.97 for 0.5mm to 20mm thresholds. However, the bias of intensity increases with rising thresholds. Mean absolute error (MAE) varies between 4.5 mm day-1 and 9.5 mm day-1 in wet days for whole area. In term of mean annual cycle, ERA-Interim almost has the same standard deviation of the interannual variability of daily precipitation with E-OBS, 1.0 mm day-1. Significant wet biases happened in ERA-Interim throughout warm season (May to August) and dry biases in cold season (November to February). The spatial distribution of mean annual daily precipitation shows that ERA-Interim significant underestimates precipitation intensity in high mountains and northern flank of Alpine chain from November to March while pronounced

  18. Draft of textbook focused on indirect taxes

    OpenAIRE

    Nováková, Hana

    2012-01-01

    The diploma thesis is about draft of textbook which is focused on indirect taxes for business school. The thesis is divided into theoretical and practical part. The theoretical part is focused on teaching tax issues at business school. Readers are introduced with basic studying documents, for example framework educational program and school educational program. In the following part I have conducted didactic analysis of curriculum and textbook of economics for business schools. The draft of t...

  19. Quality in career guidance: The Danish case

    DEFF Research Database (Denmark)

    Plant, Peter

    2011-01-01

    Quality assurance systems are introduced in career guidance to monitor, control and develop guidance interventions. The Danish case represents at centrally driven, top-down approach......Quality assurance systems are introduced in career guidance to monitor, control and develop guidance interventions. The Danish case represents at centrally driven, top-down approach...

  20. Information management architecture for an integrated computing environment for the Environmental Restoration Program. Environmental Restoration Program, Volume 3, Interim technical architecture

    International Nuclear Information System (INIS)

    1994-09-01

    This third volume of the Information Management Architecture for an Integrated Computing Environment for the Environmental Restoration Program--the Interim Technical Architecture (TA) (referred to throughout the remainder of this document as the ER TA)--represents a key milestone in establishing a coordinated information management environment in which information initiatives can be pursued with the confidence that redundancy and inconsistencies will be held to a minimum. This architecture is intended to be used as a reference by anyone whose responsibilities include the acquisition or development of information technology for use by the ER Program. The interim ER TA provides technical guidance at three levels. At the highest level, the technical architecture provides an overall computing philosophy or direction. At this level, the guidance does not address specific technologies or products but addresses more general concepts, such as the use of open systems, modular architectures, graphical user interfaces, and architecture-based development. At the next level, the technical architecture provides specific information technology recommendations regarding a wide variety of specific technologies. These technologies include computing hardware, operating systems, communications software, database management software, application development software, and personal productivity software, among others. These recommendations range from the adoption of specific industry or Martin Marietta Energy Systems, Inc. (Energy Systems) standards to the specification of individual products. At the third level, the architecture provides guidance regarding implementation strategies for the recommended technologies that can be applied to individual projects and to the ER Program as a whole

  1. The EMEFS model evaluation. An interim report

    Energy Technology Data Exchange (ETDEWEB)

    Barchet, W.R. [Pacific Northwest Lab., Richland, WA (United States); Dennis, R.L. [Environmental Protection Agency, Research Triangle Park, NC (United States); Seilkop, S.K. [Analytical Sciences, Inc., Durham, NC (United States); Banic, C.M.; Davies, D.; Hoff, R.M.; Macdonald, A.M.; Mickle, R.E.; Padro, J.; Puckett, K. [Atmospheric Environment Service, Downsview, ON (Canada); Byun, D.; McHenry, J.N. [Computer Sciences Corp., Research Triangle Park, NC (United States); Karamchandani, P.; Venkatram, A. [ENSR Consulting and Engineering, Camarillo, CA (United States); Fung, C.; Misra, P.K. [Ontario Ministry of the Environment, Toronto, ON (Canada); Hansen, D.A. [Electric Power Research Inst., Palo Alto, CA (United States); Chang, J.S. [State Univ. of New York, Albany, NY (United States). Atmospheric Sciences Research Center

    1991-12-01

    The binational Eulerian Model Evaluation Field Study (EMEFS) consisted of several coordinated data gathering and model evaluation activities. In the EMEFS, data were collected by five air and precipitation monitoring networks between June 1988 and June 1990. Model evaluation is continuing. This interim report summarizes the progress made in the evaluation of the Regional Acid Deposition Model (RADM) and the Acid Deposition and Oxidant Model (ADOM) through the December 1990 completion of a State of Science and Technology report on model evaluation for the National Acid Precipitation Assessment Program (NAPAP). Because various assessment applications of RADM had to be evaluated for NAPAP, the report emphasizes the RADM component of the evaluation. A protocol for the evaluation was developed by the model evaluation team and defined the observed and predicted values to be used and the methods by which the observed and predicted values were to be compared. Scatter plots and time series of predicted and observed values were used to present the comparisons graphically. Difference statistics and correlations were used to quantify model performance. 64 refs., 34 figs., 6 tabs.

  2. Mississippi Curriculum Framework for Drafting and Design Technology (Program CIP: 48.0102--Architectural Drafting Technology) (Program CIP: 48.0101--General Drafting). Postsecondary Programs.

    Science.gov (United States)

    Mississippi Research and Curriculum Unit for Vocational and Technical Education, State College.

    This document, which is intended for use by community and junior colleges throughout Mississippi, contains curriculum frameworks for the two course sequences of the state's postsecondary-level drafting and design technology program: architectural drafting technology and drafting and design technology. Presented first are a program description and…

  3. 78 FR 19733 - Draft General Management Plan and Draft Environmental Impact Statement, Fort Raleigh National...

    Science.gov (United States)

    2013-04-02

    ... announce the dates, times, and locations of public meetings on the draft EIS/GMP through the NPS Planning... delivery to the above address. Electronic copies of the Draft EIS/GMP will be available online at http... through additional interpretive efforts, marketing, and facilities. Alternative C, the NPS preferred...

  4. 76 FR 59155 - Notice of Availability of South Coast Draft Resource Management Plan Revision and Draft...

    Science.gov (United States)

    2011-09-23

    ... policies and emphasis on the management of public lands and local land use planning; and new data that have... DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLCAD06000, L16100000.DP0000] Notice of Availability of South Coast Draft Resource Management Plan Revision and Draft Environmental Impact Statement...

  5. Mississippi Curriculum Framework for General Drafting (Program CIP: 48.0101--Drafting, General). Secondary Programs.

    Science.gov (United States)

    Mississippi Research and Curriculum Unit for Vocational and Technical Education, State College.

    This document, which reflects Mississippi's statutory requirement that instructional programs be based on core curricula and performance-based assessment, contains outlines of the instructional units required in local instructional management plans and daily lesson plans for two secondary-level courses in drafting: drafting I and II. Presented…

  6. 77 FR 74508 - Notice of Availability of the Draft Resource Management Plan Amendment, Draft Environmental...

    Science.gov (United States)

    2012-12-14

    ... eliminated. A maximum of 7,500 summer and winter landings would be permitted in the project area annually... considered, the BLM must receive written comments on the Draft RMP Amendment/Draft EIS within 90 days... meetings or hearings and any other public involvement activities at least 15 days in advance through public...

  7. 76 FR 57760 - Notice of Availability of Draft Resource Management Plan and Draft Environmental Impact Statement...

    Science.gov (United States)

    2011-09-16

    ... approximately 707,000 subsurface acres of Federal mineral estate. Decisions in the Colorado River Valley RMP... Availability of Draft Resource Management Plan and Draft Environmental Impact Statement for the Colorado River Valley Field Office, Colorado AGENCY: Bureau of Land Management, Interior. ACTION: Notice of availability...

  8. 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.

  9. Wind energy and aviation interests - interim guidelines

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-07-01

    The impact on aviation of increasing the number of wind farms in the United Kingdom is discussed by the Wind Energy, Defence and Civil Aviation Interests Working Group, comprising the Department of Trade and Industry, the Civil Aviation Authority, the Ministry of Defence, and the British Wind Energy Association. The report offers guidance to wind farm developers, local authorities and statutory consultees within the aviation community: the main thrust of the guidelines is to support the UK Government's wind energy targets. Although the document does not contain in-depth technical discussions, it does provide references to such information.

  10. Industrial complementarities between interim storage and reversible geological repository - 59237

    International Nuclear Information System (INIS)

    Hoorelbeke, Jean-Michel

    2012-01-01

    The French Act voted in 2006 made the choice of deep geological disposal as the reference option for the long term management of high level (HLW) and intermediate level long-lived waste. The CIGEO repository project aims at avoiding or limiting burden to future generations, which could not be achieved by the extension in time of interim storage. The reversibility as provided by the Act will maintain a liberty of choice for waste management on a duration which is comparable to new storage facility. Interim storage is required to accommodate waste as long as the repository is not available. The commissioning of the repository in 2025 will not suppress needs for interim storage. The paper describes the complementarities between existing and future interim storage facilities and the repository project: repository operational issues and planning, HLW thermal decay, support for the reversibility, etc. It shows opportunities to prepare a global optimization of waste management including the utilization at best of storage capacities and the planning of waste emplacement in the repository in such a way to facilitate operational conditions and to limit cost. Preliminary simulations of storage-disposal scenarios are presented. Thanks to an optimal use of the waste management system, provision can be made for a progressive increase of waste emplacement flow during the first operation phase of the repository. It is then possible to stabilize the industrial activity level of the repository site. An optimal utilization of interim storage can also limit the diversity of waste packages emplaced simultaneously, which facilitates the operation of the repository. 60 years minimum interim storage duration is generally required with respect to HLW thermal output. Extending this interim storage period may reduce the underground footprint of the repository. Regarding reversibility, the capability to manage waste packages potentially retrieved from the repository should be analyzed. The

  11. 78 FR 16676 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Science.gov (United States)

    2013-03-18

    ... the applicable hazards will need to be re-evaluated at multiple stages of the development process. In... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0194... Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k...

  12. 75 FR 41498 - Draft Guidance for Tobacco Retailers on Tobacco Retailer Training Programs; Availability; Agency...

    Science.gov (United States)

    2010-07-16

    ... for violations of access, advertising, and promotion restrictions issued under section 906(d) of the... product, including restrictions on the access to, and the advertising and promotion of, the tobacco... products, as well as restrictions on advertising and promotion of such products, to curb the appeal of...

  13. 75 FR 1790 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB...

    Science.gov (United States)

    2010-01-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0605... clinical investigators and sponsors better understand their responsibilities related to continuing review...-463-6332 or 301-796-3400); or the Office of Communication, Outreach and Development (HFM-40), Center...

  14. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Science.gov (United States)

    2013-08-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369... mesalamine rectal suppositories: A BE study with clinical endpoints and a fasting BE study with... suppositories: A fasting BE study with pharmacokinetic endpoints and comparative in vitro studies (melting point...

  15. 77 FR 7586 - Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray...

    Science.gov (United States)

    2012-02-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369... metered spray/sublingual products: An in vivo fasting study, an in vitro study of unit dose and uniformity... metered aerosol/sublingual products: An in vivo fasting study, an in vitro study of unit dose and...

  16. 78 FR 68460 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Science.gov (United States)

    2013-11-14

    ... interested persons additional time to submit comments. DATES: Submit either electronic or written comments by....gov . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug... Branch Pkwy., College Park, MD 20740, 240-402-1783. SUPPLEMENTARY INFORMATION: I. Background In the...

  17. 77 FR 74852 - Draft Guidance for Industry on Certification of Designated Medical Gases; Availability

    Science.gov (United States)

    2012-12-18

    ... that oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, and medical air are... production of the gas; and certain affirmations that the gas meets applicable compendial standards and that...

  18. 78 FR 46954 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Science.gov (United States)

    2013-08-02

    ... either electronic or written comments on the collection of information by October 1, 2013. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov . Submit... detecting antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors...

  19. 78 FR 58545 - Global Unique Device Identification Database; Draft Guidance for Industry; Availability

    Science.gov (United States)

    2013-09-24

    ... manufacturer) will interface with the GUDID, as well as information on the database elements that must be... information in the proposed rule are subject to review by the Office of Management and Budget (OMB) under the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0636...

  20. 76 FR 72710 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Science.gov (United States)

    2011-11-25

    ... violations of access, advertising, and promotion restrictions of regulations promulgated under section 906(d... advertising and promotion of, cigarettes and smokeless tobacco products; (2) the health and economic effects... employees be notified both verbally and in writing of the importance of complying with laws prohibiting the...

  1. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Science.gov (United States)

    2011-06-22

    ... feedback received from this workshop and the continued communication with investigators in this field has... PMA applications, focusing on critical elements of safety and effectiveness for approval of this..., will represent the Agency's current thinking on LGS Device systems. It does not create or confer any...

  2. 77 FR 69632 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

    Science.gov (United States)

    2012-11-20

    ...., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; Office of Communication, Outreach and Development...., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002; and Office of Critical Path Programs, Office of the... finalized, will represent the Agency's current thinking on capturing, using, and archiving electronic data...

  3. 75 FR 60129 - Draft Guidance for Industry and Investigators on Safety Reporting Requirements for...

    Science.gov (United States)

    2010-09-29

    ...., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach, and...'s ability to review critical safety information, improve safety monitoring of human drug and..., will represent the Agency's current thinking on safety reporting requirements for INDs and BA/BE...

  4. 76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

    Science.gov (United States)

    2011-12-06

    ... feedback received from this workshop and the continued communication with investigators in this field has... included in IDE and PMA applications, focusing on critical elements of safety and effectiveness for... represent the Agency's current thinking on developing investigations of and premarket applications for...

  5. 76 FR 60055 - Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products...

    Science.gov (United States)

    2011-09-28

    ... Tobacco Control Act amends the FD&C Act and grants FDA authority to regulate the manufacture, marketing... product may be introduced into interstate commerce when the tobacco product is new or modified in any way... (PMTA) under section 910(b) of the FD&C Act and receive a marketing authorization order under section...

  6. 78 FR 19637 - National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials...

    Science.gov (United States)

    2013-04-02

    ... which are specifically allowed in section 205.601 of the USDA organic regulations, as well as materials..., filing of petitions and applications and agency #0;statements of organization and functions are examples... Classification of Materials and Materials for Organic Crop Production AGENCY: Agricultural Marketing Service...

  7. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Science.gov (United States)

    2013-01-22

    ... intends to provide the underlying principles to determine the type of marketing submission that may be... industry and FDA staff on the underlying principles to determine the type of marketing submission that may... Modifications to a Combination Product Approved Under Certain Marketing Applications; Availability AGENCY: Food...

  8. 75 FR 52426 - Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling...

    Science.gov (United States)

    2010-08-25

    ... have created logistical challenges for restaurant chains that have locations in more than one...) requires certain chain restaurants and similar retail food establishments with 20 or more locations... operators'') to disclose calories for articles of food. Restaurants and similar retail food establishments...

  9. 77 FR 20030 - Draft Guidance for Industry: Reporting Harmful and Potentially Harmful Constituents in Tobacco...

    Science.gov (United States)

    2012-04-03

    ... to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm... information: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr... applicable in the smoke of each tobacco product.'' Reports must be by the brand and by quantity in each brand...

  10. 77 FR 12853 - Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for...

    Science.gov (United States)

    2012-03-02

    ... are typically manufactured through chemical synthesis. Among other things, section 351(k) of the PHS...) biosimilar application must contain, among other things, information demonstrating that the biological... Division of Dockets Management (see ADDRESSES). A transcript will also be available in either hard copy or...

  11. 77 FR 8883 - Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a...

    Science.gov (United States)

    2012-02-15

    ... reference product for the purpose of submitting a marketing application through an abbreviated licensure... submitting a marketing application through the abbreviated licensure pathway under section 351(k) of the... FDA will use to review applications for biosimilar products; and General scientific principles in...

  12. 77 FR 8884 - Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a...

    Science.gov (United States)

    2012-02-15

    ... products. The Biologics Price Competition and Innovation Act of 2009, enacted as part of the Patient... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0602... Protein Product; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  13. 77 FR 20026 - Draft Guidance for Industry: Modified Risk Tobacco Product Applications; Availability; Agency...

    Science.gov (United States)

    2012-04-03

    ... (21 U.S.C. 387k) to the FD&C Act to prohibit the introduction or delivery for introduction into... 911(b)(1) of the FD&C Act). No person may introduce or deliver for introduction into interstate... advertising and labeling; The conditions for using the product; The formulation of the product; Sample product...

  14. 76 FR 16424 - Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of...

    Science.gov (United States)

    2011-03-23

    ... Tobacco to Protect Children and Adolescents.'' It does not create or confer any rights for or on any... Cigarettes and Smokeless Tobacco To Protect Children and Adolescents; Availability AGENCY: Food and Drug... Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and...

  15. 78 FR 68030 - Draft Guidance on Intellectual Property Rights for the National Network for Manufacturing...

    Science.gov (United States)

    2013-11-13

    ... serve as a regional hub designed to bridge the gap between basic research and product development...-announce-new-efforts-support-manufacturing-innovation-en . Each institute will serve as a regional hub of manufacturing excellence, providing the innovation infrastructure to support regional manufacturing and ensuring...

  16. 76 FR 77492 - Draft Guidance on Improving the Process for Preparing Efficient and Timely Environmental Reviews...

    Science.gov (United States)

    2011-12-13

    ... encourages simple, straightforward, and concise reviews and documentation that are proportionate to and... methods set out in the CEQ Regulations mindful of the following basic principles: NEPA encourages simple... executive orders. Scoping should also be used to begin inter- and intra-governmental coordination if it is...

  17. 78 FR 7786 - International Conference on Harmonisation; Draft Guidance on S10 Photosafety Evaluation of...

    Science.gov (United States)

    2013-02-04

    ... assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic... Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Regarding the...

  18. 77 FR 39959 - Draft Guidance To Implement Requirements for the Treatment of Air Quality Monitoring Data...

    Science.gov (United States)

    2012-07-06

    ... of your comment. If you send an email comment directly to the EPA without going through www... illustrate your concerns, and suggest alternatives. Explain your views as clearly as possible, avoiding the... Action Plan that are useful, (2) whether these concepts should be combined or kept separate and (3...

  19. 78 FR 310 - Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format...

    Science.gov (United States)

    2013-01-03

    ... files and advertising and promotional labeling submissions. However, FDA accepts and strongly encourages the submission of master files and advertising and promotional labeling materials electronically, as... Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501...

  20. 77 FR 74196 - Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication...

    Science.gov (United States)

    2012-12-13

    ... error-prone label and packaging designs. Among these measures, FDA agreed that by the end of FY 2010... minimizing risks with the design of drug product container labels, carton labeling, and packaging... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1005...