WorldWideScience

Sample records for cgtp draft guidance

  1. 75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability

    Science.gov (United States)

    2010-09-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Acidified Foods; Availability...) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Acidified Foods... requests for single copies of the draft guidance entitled ``Guidance for Industry: Acidified Foods'' to...

  2. 76 FR 50231 - Mobile Medical Applications Draft Guidance; Public Workshop

    Science.gov (United States)

    2011-08-12

    ... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications Draft Guidance; Public Workshop... ``Mobile Medical Applications,'' how FDA should approach accessories and particularly mobile medical... guidance document entitled ``Mobile Medical Applications,'' how FDA should approach accessories...

  3. 75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella

    Science.gov (United States)

    2010-08-12

    ...-1493. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 9, 2009 (74 FR 33030... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Prevention of Salmonella... availability of a draft guidance entitled ``Prevention of Salmonella Enteritidis in Shell Eggs...

  4. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Science.gov (United States)

    2011-11-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Evaluating the Effectiveness... draft guidance for industry 217 entitled ``Evaluating the Effectiveness of Anticoccidial Drugs in Food... and food-producing mammals. Draft guidance for industry 217 supersedes the CVM draft guidance...

  5. 77 FR 20025 - Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution...

    Science.gov (United States)

    2012-04-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Compliance Policy for... guidance for industry entitled ``Compliance Policy on Reporting Drug Sample Distribution Information Under... availability of a draft guidance for industry entitled ``Compliance Policy on Reporting Drug...

  6. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Science.gov (United States)

    2011-02-18

    ... guidance for industry entitled ``Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.'' The draft guidance is intended to assist the pharmaceutical industry and other investigators... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Clinical...

  7. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Science.gov (United States)

    2013-11-06

    ... Recommendations for Iron Sucrose; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific guidance... iron sucrose injection. The draft guidance is a revised version of a previously issued draft...

  8. 75 FR 41452 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Science.gov (United States)

    2010-07-16

    ... Leadership in Environmental, Energy, and Economic Performance (74 FR 52117) in order to establish an... QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting'' AGENCY: Council on Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``Federal Greenhouse Gas Accounting...

  9. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-01-05

    ... INFORMATION: I. Background This draft guidance recommends studies for establishing the performance... Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the...

  10. 75 FR 36421 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing...

    Science.gov (United States)

    2010-06-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes Reportable in Annual Reports; Availability AGENCY: Food and... the availability of a draft guidance for industry entitled ``CMC Postapproval Manufacturing...

  11. 75 FR 63189 - Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human...

    Science.gov (United States)

    2010-10-14

    ... Boards (IRBs)) and the pharmaceutical industry, concerning whether various types of human research... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Investigational New Drug... Drug Administration (FDA) is announcing the availability of a draft guidance for industry...

  12. 77 FR 69632 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

    Science.gov (United States)

    2012-11-20

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Electronic Source Data in Clinical Investigations.'' This document revises and updates the draft guidance entitled ``Electronic Source Documentation in Clinical Investigations.'' This revised draft document provides guidance to sponsors, contract research organizations (CROs), data......

  13. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Science.gov (United States)

    2013-02-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Providing Information About... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Providing Information...

  14. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Science.gov (United States)

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and...

  15. 76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella

    Science.gov (United States)

    2011-03-23

    ... human foods and direct-human-contact animal foods. It does not create or confer any rights for or on any... in Human Foods and Direct-Human-Contact Animal Foods; Availability AGENCY: Food and Drug... Direct-Human-Contact Animal Foods.'' The draft guidance, when finalized, is intended for firms...

  16. 76 FR 13629 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation...

    Science.gov (United States)

    2011-03-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chemistry, Manufacturing, and... guidance for industry 216 entitled ``Chemistry, Manufacturing, and Controls (CMC) Information--Fermentation...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for...

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

    Science.gov (United States)

    2013-02-04

    ... S10 Photosafety Evaluation of Pharmaceuticals; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``S10 Photosafety Evaluation of Pharmaceuticals.'' The draft guidance was prepared under.... In November 2012, the ICH Steering Committee agreed that a draft guidance entitled ``S10...

  18. 77 FR 24722 - Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability

    Science.gov (United States)

    2012-04-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Safety of Nanomaterials in... ``Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.'' The draft guidance, when finalized, will represent FDA's current thinking on the safety assessment of nanomaterials in cosmetic...

  19. 77 FR 8262 - Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs...

    Science.gov (United States)

    2012-02-14

    ... Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.'' The draft... Applications for Positron Emission Tomography (PET) drugs.'' The draft guidance summarizes the IND process...

  20. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Science.gov (United States)

    2013-05-31

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Rheumatoid Arthritis... guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.''...

  1. 76 FR 55927 - Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial...

    Science.gov (United States)

    2011-09-09

    ... draft guidance provides responses to questions FDA has received on the Family Smoking Prevention and... effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR...

  2. 76 FR 34715 - Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the...

    Science.gov (United States)

    2011-06-14

    ... the Application of Nanotechnology''. This guidance is intended to provide industry with FDA's current... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; Availability AGENCY: Food and...

  3. 76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

    Science.gov (United States)

    2011-01-07

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Electronic Source... industry entitled ``Electronic Source Documentation in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and...

  4. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Science.gov (United States)

    2011-07-21

    ... Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance entitled ``Mobile Medical Applications.'' FDA is issuing this draft guidance to inform... select software applications intended for use on mobile platforms (mobile applications or ``mobile...

  5. 78 FR 49271 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Science.gov (United States)

    2013-08-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Frequently Asked Questions About Medical Foods; Second Edition.''...

  6. 78 FR 74154 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Science.gov (United States)

    2013-12-10

    ... Wednesday, September 11, 2013 (78 FR 55727), announcing the availability of the draft guidance for industry... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Recommendations...

  7. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Science.gov (United States)

    2010-10-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for...

  8. 77 FR 59928 - Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for...

    Science.gov (United States)

    2012-10-01

    ... resistance to most antibacterial drugs on in vitro susceptibility testing. ] This draft guidance is being... responsible for cIAIs, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. This draft guidance includes recommendations for an...

  9. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Science.gov (United States)

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... ``Drug Safety Information-- FDA's Communication to the Public.'' This draft guidance updates and...

  10. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Science.gov (United States)

    2010-01-20

    ... guidance practices regulation. FDA withdrew the 1994 draft on January 5, 2005 (70 FR 824) and is now... Staff; Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications... Administration (FDA) is announcing the availability of the draft guidance document entitled ``Heart...

  11. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Science.gov (United States)

    2011-02-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Medication Guides... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Medication Guides... healthcare professional for administration to a patient instead of being dispensed directly to the...

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

    Science.gov (United States)

    2010-07-16

    ... does provide for lower civil money penalties for violations of access, advertising, and promotion... electronic or written comments on the draft guidance and on the proposed collection of information by September 14, 2010. ADDRESSES: Submit electronic comments on the draft guidance, including...

  13. 78 FR 68852 - Draft Guidance for Industry on Acrylamide in Foods; Availability

    Science.gov (United States)

    2013-11-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Acrylamide in Foods...: Acrylamide in Foods.'' The draft guidance is intended to provide information that may help growers, manufacturers, and food service operators reduce acrylamide in certain foods. Acrylamide is a chemical that...

  14. 77 FR 24722 - Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes...

    Science.gov (United States)

    2012-04-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Assessing the Effects of... Additives; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... Food Ingredients That Are Color Additives.'' The draft guidance, when finalized, will explain...

  15. 76 FR 58018 - Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products...

    Science.gov (United States)

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Selection Studies for... entitled ``Self-Selection Studies for Nonprescription Drug Products.'' The draft guidance is intended to provide recommendations to industry on the design of self- selection studies for nonprescription...

  16. 76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2011-12-02

    ... draft guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  17. 75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Science.gov (United States)

    2010-10-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Early Clinical Trials With Live... availability of a draft document entitled ``Guidance for Industry: Early Clinical Trials with Live... submission of INDs for early clinical trials with live biotherapeutic products (LBPs). DATES: Although...

  18. 75 FR 9228 - Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability

    Science.gov (United States)

    2010-03-01

    ... ``Non- Inferiority Clinical Trials.'' This draft guidance provides sponsors and review staff in the... announcing the availability of a draft guidance for industry entitled ``Non-Inferiority Clinical Trials... clinical trials. It does not create or confer any rights for or on any person and does not operate to...

  19. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2010-09-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Helicobacter pylori; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... pylori.'' This draft guidance document provides industry and agency staff with updated...

  20. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-06-28

    ... HUMAN SERVICES Food and Drug Administration Implanted Blood Access Devices for Hemodialysis; Draft... availability of the draft guidance entitled ``Implanted Blood Access Devices for Hemodialysis.'' This guidance was developed to support the reclassification of the Implanted Blood Access Devices for...

  1. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Science.gov (United States)

    2010-04-29

    ... publishing a notice of availability for a draft guidance entitled ``Draft Guidance for Industry and FDA Staff... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug...

  2. 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

    ... Staff; User Fees for 513(g); Requests for Information; Availability AGENCY: Food and Drug Administration... the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.'' This draft guidance describes the user fees associated with 513(g) requests...

  3. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Science.gov (United States)

    2013-02-08

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil Money... retail outlets. This draft guidance is not final nor is it in effect at this time. DATES: Although...

  4. 75 FR 13765 - Draft Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Products for...

    Science.gov (United States)

    2010-03-23

    ... clinical trials. This guidance is intended to assist the pharmaceutical industry and other investigators... for Treatment.'' This guidance is intended to assist the pharmaceutical industry and other... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Irritable Bowel...

  5. 78 FR 19637 - National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials...

    Science.gov (United States)

    2013-04-02

    ...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service National Organic Program: Notice of Draft Guidance... Agricultural Marketing Service (AMS) invites organic producers, handlers, certifying agents, material... to Toni Strother, Agricultural Marketing Specialist, National Organic Program, USDA-AMS-NOP,...

  6. Ministry of Industry and Information Technology: Guidance Drafted to Promote Merging and Restructuring of Enterprises

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    @@ In June 2009, the Accelerating Corporate Merging and Restructuring Guidance planed by the Department of Industrial Policies of MIIT has been drafted, which intended to promote the implementation of key industrial restructuring and revitalization plan.

  7. 76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft

    Science.gov (United States)

    2011-09-07

    ....'' The draft guidance, when finalized, will represent OHRP's and FDA's current thinking on this topic and... field and click on ``Search.'' On the next page, click the ``Submit a Comment'' action and follow the... the FDA Web site at...

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

    Science.gov (United States)

    2011-11-10

    ... HUMAN SERVICES Food and Drug Administration 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 Investigations; Availability AGENCY: Food and Drug Administration,...

  9. 78 FR 55727 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Science.gov (United States)

    2013-09-11

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive Petitions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

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

    Science.gov (United States)

    2013-04-09

    ... HUMAN SERVICES Food and Drug Administration 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 and Drug Administration (FDA) is announcing...

  11. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Science.gov (United States)

    2012-01-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  12. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Science.gov (United States)

    2011-08-16

    ... HUMAN SERVICES Food and Drug Administration 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. SUMMARY: The Food and Drug Administration (FDA)...

  13. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-10-03

    ... part of the Food and Drug Administration Modernization Act of 1997 (FDAMA). The process created by this... Administration Staff: De Novo Classification Process (Evaluation of Automatic Class III Designation) This draft... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug...

  14. 77 FR 67379 - Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed...

    Science.gov (United States)

    2012-11-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... pathogen nucleic acids extracted from a single appropriate human specimen or culture. This draft...

  15. 78 FR 40199 - Draft Spent Fuel Storage and Transportation Interim Staff Guidance

    Science.gov (United States)

    2013-07-03

    ... COMMISSION Draft Spent Fuel Storage and Transportation Interim Staff Guidance AGENCY: Nuclear Regulatory... Regulatory Commission (NRC) requests public comment on Draft Spent Fuel Storage and Transportation Interim... given in NUREG-1927 ``Standard Review Plan for Renewal of Spent Fuel Dry Cask Storage System...

  16. 76 FR 55068 - Mobile Medical Applications Draft Guidance; Public Workshop; Correction

    Science.gov (United States)

    2011-09-06

    ... FR 50231). The document announced a public workshop entitled ``Mobile ] Medical Applications Draft... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications Draft Guidance; Public Workshop... Spring, MD 20993-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-20574, appearing on...

  17. 78 FR 54899 - Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug...

    Science.gov (United States)

    2013-09-06

    ...) System for Drug Establishment Registration.'' This draft guidance specifies the UFI system for... guidance specifies the UFI system as follows. At this time, FDA's preferred UFI for a drug establishment is... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Specification of the...

  18. 75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Science.gov (United States)

    2010-08-03

    ... guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This... Systems.'' This draft guidance provides recommendations to developers and manufacturers of TDDS, TMDS, and... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Drug in...

  19. 78 FR 24211 - Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling...

    Science.gov (United States)

    2013-04-24

    ... closure design (December 13, 2012, 77 FR 74196), and the third guidance will focus on minimizing risks... Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability AGENCY: Food and... the availability of a draft guidance for industry entitled ``Safety Considerations for...

  20. 77 FR 7586 - Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray...

    Science.gov (United States)

    2012-02-13

    ... 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence...

  1. 75 FR 62693 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents and Certified...

    Science.gov (United States)

    2010-10-13

    ... Budget (OMB) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The... operations. The five draft guidance documents are entitled as follows: Compost and Vermicompost in Organic... Production and Handling (NOP 5026) and Compost and Vermicompost in Organic Crop Production (NOP 5021)...

  2. 76 FR 82306 - Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability

    Science.gov (United States)

    2011-12-30

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Use of Histology in Biomarker... ``Use of Histology in Biomarker Qualification Studies.'' This guidance is intended to assist sponsors that conduct biomarker qualification studies for which histology is a reference standard. This...

  3. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-08-06

    ... July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of draft guidance documents for 11 neurological and physical medicine devices. The document was published... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  4. SSTAC/ARTS review of the draft Integrated Technology Plan (ITP). Volume 6: Controls and guidance

    Science.gov (United States)

    1991-01-01

    Viewgraphs of briefings from the Space Systems and Technology Advisory Committee (SSTAC)/ARTS review of the draft Integrated Technology Plan (ITP) on controls and guidance are included. Topics covered include: strategic avionics technology planning and bridging programs; avionics technology plan; vehicle health management; spacecraft guidance research; autonomous rendezvous and docking; autonomous landing; computational control; fiberoptic rotation sensors; precision instrument and telescope pointing; microsensors and microinstruments; micro guidance and control initiative; and earth-orbiting platforms controls-structures interaction.

  5. 78 FR 19495 - Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment...

    Science.gov (United States)

    2013-04-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Scale-Up and Post-Approval... post-approval changes (SUPAC) draft guidance for industry entitled ``SUPAC: Manufacturing...

  6. 77 FR 5857 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Science.gov (United States)

    2012-02-06

    ... COMMISSION Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...: On November 2, 2011 (76 FR 67764), the U.S. Nuclear Regulatory Commission (NRC) published for public comment Draft NUREG, ``Common- Cause Failure Analysis in Event and Condition Assessment: Guidance...

  7. 75 FR 29537 - Draft Transportation Conformity Guidance for Quantitative Hot-spot Analyses in PM2.5

    Science.gov (United States)

    2010-05-26

    .... In its March 10, 2006 final rule (71 FR 12468), EPA stated that quantitative PM 2.5 and PM 10 hot... (58 FR 62188) and has subsequently published several amendments. II. Background on the Draft Guidance... its March 2006 final rule (71 FR 12502), this draft guidance was developed in coordination with...

  8. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease; Availability AGENCY: Food and Drug Administration... a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment...

  9. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Science.gov (United States)

    2013-03-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device Submissions; Availability AGENCY: Food... announcing the availability of the draft guidance entitled ``Types of Communication During the Review...

  10. 78 FR 56719 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Science.gov (United States)

    2013-09-13

    ...: Action Level'' that appeared in the Federal Register of July 15, 2013 (78 FR 42086). The draft guidance...-1639. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 15, 2013 (78 FR 42086... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Arsenic in Apple...

  11. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Science.gov (United States)

    2011-08-19

    ... Register of July 14, 2011 (76 FR 41506). In the notice, FDA requested comments on a draft guidance document... 14, 2011 (76 FR 41506), FDA published a notice announcing the availability of the draft guidance... Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and...

  12. 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

    ... (DEHP). In particular, the draft guidance recommends that the pharmaceutical industry avoid the use of... Products.'' This draft guidance provides the pharmaceutical industry with CDER's current thinking on the... recommends that the pharmaceutical industry avoid the use of these two specific phthalates as excipients...

  13. 77 FR 48990 - Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility...

    Science.gov (United States)

    2012-08-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Necessity of the Use of Food... availability of a draft guidance for industry entitled ``Necessity of the Use of Food Categories in Food... Industry on Necessity of the Use of Food Product Categories in Registration of Food Facilities''...

  14. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Science.gov (United States)

    2011-12-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes; Availability AGENCY: Food and Drug... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and...

  15. 76 FR 34180 - National Organic Program; Notice of Draft Guidance for Accredited Certifying Agents and Certified...

    Science.gov (United States)

    2011-06-13

    ... Agricultural Marketing Service 7 CFR Part 205 National Organic Program; Notice of Draft Guidance for Accredited..., Agricultural Marketing Specialist, National Organic Program, USDA-AMS-NOP, 1400 Independence Ave., SW., Room... may be submitted by mail to: Toni Strother, Agricultural Marketing Specialist, National...

  16. Proposed draft permit guidance for genetically modified animal disease organisms and their vectors

    International Nuclear Information System (INIS)

    This paper consists of proposed draft guidance and represents the author's opinions only. They are presented below solely for the purpose of open discussion and comments on the subject of genetically modified arthropod regulations and should not be construed as representing actual or current regulations or opinions of the USDA, Animal and Plant Health Inspection Service (APHIS). (author)

  17. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-11-07

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of...

  18. 77 FR 74852 - Draft Guidance for Industry on Certification of Designated Medical Gases; Availability

    Science.gov (United States)

    2012-12-18

    ... process created by the Food and Drug Administration Safety and Innovation Act (FDASIA) for certain medical... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Certification of Designated Medical Gases; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  19. 77 FR 58999 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2012-09-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the... abbreviated new ] drug application (ANDA) review process more efficient. DATES: Although you can comment...

  20. 75 FR 1790 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB...

    Science.gov (United States)

    2010-01-13

    ... of February 3, 2006 (71 FR 5861), which describes FDA's intention to update the process for... HUMAN SERVICES Food and Drug Administration Draft Guidance for Institutional Review Boards, Clinical...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  1. 78 FR 31943 - Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

    Science.gov (United States)

    2013-05-28

    ... each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of... for the manufacturing of drugs. This draft guidance is being issued consistent with FDA's...

  2. 75 FR 49913 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Science.gov (United States)

    2010-08-16

    ..., Energy, and Economic Performance (74 FR 52117) in order to establish an integrated strategy toward... QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting'' AGENCY: Council on... and accounting procedures. On April 5, 2010, DOE-FEMP submitted the final recommendations on...

  3. 76 FR 55923 - Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco...

    Science.gov (United States)

    2011-09-09

    ... Plans for Cigarettes and Smokeless Tobacco Products (OMB Control Number 0910--New) This draft guidance... products. Section 4 of FCLAA states that each cigarette package and advertisement must bear one of nine... tobacco product package and advertisement must bear one of four required warning statements and...

  4. 76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

    Science.gov (United States)

    2011-07-12

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  5. 76 FR 52958 - Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing...

    Science.gov (United States)

    2011-08-24

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Neglected Tropical Diseases... sponsors in the clinical development of drugs for the treatment or prevention of neglected diseases of the... same as for approval of drugs for diseases endemic in the United States; and (4) FDA is committed...

  6. 77 FR 48989 - Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of...

    Science.gov (United States)

    2012-08-15

    ... 9, 2010 (75 FR 54889). Comments we received on the draft guidance have been considered and the... Assessment (C-CASA) categories, along with definitions and explanations; (3) revises the advice on which... C-CASA categories eliminates the need for any additional coding; (7) provides multiple...

  7. 76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Science.gov (United States)

    2011-07-05

    ... NDI and any other dietary ingredients in the dietary supplement ``have been present in the food supply... notification requirements for dietary supplements that contain an NDI (62 FR 49886, September 23, 1997). The... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements:...

  8. 78 FR 310 - Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format...

    Science.gov (United States)

    2013-01-03

    ... the FD&C Act, FDA is issuing this draft guidance, announcing its determination that submission types... 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,...

  9. 76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

    Science.gov (United States)

    2011-12-06

    ..., including CTR, CTT, and Low Glucose Suspend systems. On June 22, 2011 (76 FR 36542), FDA announced the... Staff; the Content of Investigational Device Exemption and Premarket Approval Applications for... document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational...

  10. 78 FR 57859 - Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation...

    Science.gov (United States)

    2013-09-20

    ... determine the potential for a drug to disrupt the endocrine system. This draft guidance also discusses... compounds that have the potential to 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,...

  11. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Science.gov (United States)

    2012-10-02

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments of 2012 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  12. 78 FR 9709 - Draft Guidance Regarding Voluntary Inspection of Vessels for Compliance With the Maritime Labour...

    Science.gov (United States)

    2013-02-11

    ... SECURITY Coast Guard Draft Guidance Regarding Voluntary Inspection of Vessels for Compliance With the Maritime Labour Convention, 2006 AGENCY: Coast Guard, DHS. ACTION: Notice of availability and request for.... vessels for voluntary compliance with the Maritime Labour Convention, 2006 (Convention), which enters...

  13. 78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

    Science.gov (United States)

    2013-09-13

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioanalytical Method... and the reliability of these data are of critical importance to the interpretation of the...

  14. 75 FR 32791 - Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of...

    Science.gov (United States)

    2010-06-09

    ... Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents... Smokeless Tobacco To Protect Children and Adolescents.'' The draft guidance is intended to help small... smokeless tobacco in order to protect children and adolescents. DATES: Although you can comment on...

  15. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-07-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. SUMMARY: The Food and Drug Administration (FDA) is reopening until September 7, 2010, the comment...

  16. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-04-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... six of them from the premarket notification requirements of the Federal Food, Drug, and Cosmetic...

  17. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Science.gov (United States)

    2012-12-13

    ... HUMAN SERVICES Food and Drug Administration 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 Food and Drug Administration (FDA) is announcing...

  18. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Science.gov (United States)

    2012-02-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  19. 78 FR 68460 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Science.gov (United States)

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of the comment period. SUMMARY: The Food and Drug...

  20. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

    ... HUMAN SERVICES Food and Drug Administration 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 Drug Administration (FDA) is announcing the availability...

  1. 75 FR 29350 - Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as...

    Science.gov (United States)

    2010-05-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007... information to the industry in complying with the Reportable Food Registry requirements prescribed by the...

  2. 77 FR 3777 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-01-25

    ... (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30386), FDA announced the availability of a draft... FR 62793). This notice announces draft product- specific recommendations, either new or revised, that... RLDs) Mifepristone Milnacipran HCl Minocycline HCl Minoxidil (multiple RLDs) Mirtazapine...

  3. 78 FR 69691 - Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and...

    Science.gov (United States)

    2013-11-20

    ... Federal Register of January 25, 2012 (77 FR 3779), FDA announced the availability of a guidance entitled..., and Prominence in Advertising and Promotional Labeling; Availability AGENCY: Food and Drug... Advertising and Promotional Labeling.'' When finalized, the draft guidance will replace the guidance of...

  4. 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

    ... G-PP&E and Implementation Guidance for Estimating the Historical Cost of G-PP&E AGENCY: Federal... Guidance on the Accounting for the Disposal of G-PP&E and Implementation Guidance for Estimating the Historical Cost of G- PP&E. The Exposure Drafts are available on the FASAB home page...

  5. 75 FR 21632 - Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle...

    Science.gov (United States)

    2010-04-26

    ... Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification Submissions; Availability AGENCY... announcing the availability of the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump... Life Cycle: Infusion Pump-- Premarket Notification Submissions'' to the Division of Small...

  6. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Science.gov (United States)

    2011-02-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Electronic Healthcare Data Sets; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic...

  7. 75 FR 41871 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2010-07-19

    ... Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug... HUMAN SERVICES Food and Drug Administration International Conference on Harmonisation; Draft Guidance on... Harmonisation Regions; Annex 14 on Bacterial Endotoxins Test General Chapter; Availability AGENCY: Food and...

  8. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Science.gov (United States)

    2012-07-31

    ... HUMAN SERVICES Food and Drug Administration 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. ] SUMMARY: The Food and Drug Administration (FDA)...

  9. 77 FR 16842 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-03-22

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 3777). This notice announces draft product-specific recommendations, either new or revised, that... Nitrate (multiple RLDs), P Pimecrolimus, Procarbazine, Propylthiouracil, S Sumatriptan, T...

  10. 78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-11-06

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... recommendations for comment. Recommendations were last announced in the Federal Register on June 20, 2013 (78 FR... Draft Product-Specific BE Recommendations for Drug Products B Bedaquiline fumarate....

  11. 77 FR 56851 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-09-14

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... recommendations for comment. Recommendations were last announced in the Federal Register of June 14, 2012 (77 FR... Thalidomide Tretinoin (multiple RLDs and dosage forms) III. Drug Products for Which Revised Draft...

  12. 77 FR 74669 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-12-17

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 56851). This notice announces draft product-specific recommendations, either new or revised, that... Risedronate sodium T Tacrolimus Thalidomide Tinidazole For a complete history of previously published...

  13. 78 FR 48175 - Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances

    Science.gov (United States)

    2013-08-07

    ... ``Administrative Practices and Procedures; Good Guidance Practices'' (GGP) (65 FR 56468; September 19, 2000). The..., and vuvlovaginal candidiasis; Clinical trials for developing antimicrobial drugs and packaging of... Infections--Developing Antimicrobial Drugs for Treatment''--issued July 1998. 12. ``Vulvovaginal...

  14. 77 FR 40354 - Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels-Draft

    Science.gov (United States)

    2012-07-09

    ... AGENCY Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels--Draft... covers hydraulic fracturing using diesel fuels related to oil and gas activities. Permits for oil and gas... published on May 10, 2012, Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using...

  15. 77 FR 7584 - Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin...

    Science.gov (United States)

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin for Quality; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Heparin for Drug and Medical Device Use: Monitoring Crude Heparin...

  16. 77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

    Science.gov (United States)

    2012-04-11

    ... Trade Area. In the Federal Register of May 19, 1997 (62 FR 27470), FDA published a notice announcing the availability of the E2C guidance. In the Federal Register of February 5, 2004 (69 FR 5551), FDA also published... Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance...

  17. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Science.gov (United States)

    2011-12-19

    ... Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability AGENCY: Food and... the availability of the draft guidance entitled ``Evaluation of Sex Differences in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences...

  18. 78 FR 72901 - Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal...

    Science.gov (United States)

    2013-12-04

    ... November 23, 1998 (63 FR 64723), FDA announced the availability of a guidance entitled ``Enforcement Policy... withdrawn. In a notice published in the Federal Register of June 7, 2002 (67 FR 39409), FDA announced the... HUMAN SERVICES Food and Drug Administration Draft Guidance; Pharmacy Compounding of Human Drug...

  19. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Science.gov (United States)

    2013-11-14

    ... guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a... HUMAN SERVICES Food and Drug Administration Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and...

  20. 77 FR 36273 - Public Meeting on Draft Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using...

    Science.gov (United States)

    2012-06-18

    ... AGENCY Public Meeting on Draft Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using... agency has developed on the use of diesel fuels in oil and gas hydraulic fracturing and to solicit input... discuss ``Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel...

  1. 76 FR 72006 - Draft Interim Staff Guidance: Evaluations of Uranium Recovery Facility Surveys of Radon and Radon...

    Science.gov (United States)

    2011-11-21

    ... COMMISSION Draft Interim Staff Guidance: Evaluations of Uranium Recovery Facility Surveys of Radon and Radon... Recovery Facility Surveys of Radon and Radon Progeny in Air and Demonstrations of Compliance with 10 CFR 20... that existing guidance does not sufficiently detail how the NRC staff reviews surveys of radon...

  2. 77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

    Science.gov (United States)

    2012-12-17

    ... Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability AGENCY: Food and... the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials... provide guidance to industry on enrichment strategies that can be used in clinical trials intended...

  3. 78 FR 20116 - Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering...

    Science.gov (United States)

    2013-04-03

    ... Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement... availability of draft guidance for industry and FDA staff entitled ``Glass Syringes for Delivering Drug and... glass syringes that comply with the ISO 11040-4 standard when connected to devices (``connecting...

  4. 76 FR 70768 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Science.gov (United States)

    2011-11-15

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft... November 2, 2011 (76 FR 67764). This action is necessary to correct an erroneous date for submission...

  5. 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

    ... HUMAN SERVICES Food and Drug Administration Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug... specifically address children's toy laser products. FDA recently issued a proposed rule (78 FR 37723)...

  6. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of... Service Act, and those entities required to self-identify under GDUFA, will submit information separately... techniques, when appropriate, and other forms of information technology. Under GDUFA, and as described in...

  7. 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

    ...EPA is requesting comment on draft EPA guidance to auto manufacturers for weighting the greenhouse gas (GHG) emissions of a flexible fuel vehicle operating on E85 with the GHG emissions of the vehicle operating on conventional gasoline, when calculating the compliance value to use for EPA's GHG emissions standards. EPA also invites comment on the analysis used by EPA to determine the weighting......

  8. 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

    ... HUMAN SERVICES Food and Drug Administration 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 Administration (FDA) is announcing the availability of...

  9. 76 FR 35665 - Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products...

    Science.gov (United States)

    2011-06-17

    ... Enforcement Policy for Over-the- Counter Sunscreen Drug Products Marketed Without an Approved Application... ``Enforcement Policy--OTC Sunscreen Drug Products Marketed Without an Approved Application.'' The draft guidance... enforcement policy for certain OTC sunscreen products marketed without an approved new drug application....

  10. 76 FR 36543 - Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and...

    Science.gov (United States)

    2011-06-22

    ... and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design;...

  11. 76 FR 14024 - Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework...

    Science.gov (United States)

    2011-03-15

    ... non- penicillin beta-lactam antibiotics. The draft guidance is intended to assist manufacturers in... Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4370,...

  12. 77 FR 57094 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-09-17

    ... Generic Drug Facilities, Sites, and Organizations; Availability; Correction AGENCY: Food and Drug... notice that appeared in the Federal Register of Monday, August 27, 2012 (77 FR 51811). The document announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities,...

  13. 78 FR 70953 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Science.gov (United States)

    2013-11-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee... Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)'', published in the Federal Register of September 10, 2013 (78 FR 55261). In that notice, FDA requested public...

  14. 77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Science.gov (United States)

    2012-08-27

    ... generic drugs. This draft guidance is intended to provide answers to common questions from generic drug... effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA also requires...

  15. 78 FR 42085 - Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting...

    Science.gov (United States)

    2013-07-15

    ...: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans... Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study... draft guidance for industry entitled ``Pediatric Study Plans: Content of and Process for...

  16. 76 FR 6143 - Draft Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug...

    Science.gov (United States)

    2011-02-03

    ... Applications--Content and Format for New Drug Applications and Abbreviated New Drug Applications; Availability...) is announcing the availability of a draft guidance entitled ``PET Drug Applications-- Content and... Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain...

  17. 78 FR 42086 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Science.gov (United States)

    2013-07-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for Action Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice; Availability AGENCY: Food and Drug Administration, HHS....

  18. 78 FR 74154 - Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and...

    Science.gov (United States)

    2013-12-10

    ... Physical Attributes of Generic Tablets and Capsules; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and...

  19. 75 FR 53316 - Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money...

    Science.gov (United States)

    2010-08-31

    ...'' that were published by FDA in the Federal Register of March 19, 2010 (75 FR 13225) (21 CFR part 1140... Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability...) is announcing the availability of a draft guidance entitled ``Civil Money Penalties and...

  20. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Science.gov (United States)

    2010-04-22

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public...) (added by the Food and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and...

  1. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Science.gov (United States)

    2010-02-26

    ... entitled ``Adaptive Design Clinical Trials for Drugs and Biologics.'' The draft guidance provides sponsors... Evaluation and Research (CBER) with information regarding adaptive design clinical trials when used in drug... design clinical trials (i.e., clinical, statistical, regulatory) call for special consideration, when...

  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

    ... HUMAN SERVICES Food and Drug Administration 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: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  3. 75 FR 32952 - Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially...

    Science.gov (United States)

    2010-06-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... the Federal Food, Drug, and Cosmetic Act''; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  4. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Science.gov (United States)

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration 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 Drug Administration (FDA) is announcing the availability...

  5. 76 FR 69040 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2011-11-07

    .... 76, No. 215 / Monday, November 7, 2011 / Notices#0;#0; ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Class II...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  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

    ... HUMAN SERVICES Food and Drug Administration 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 Drug Administration (FDA) is announcing the availability...

  7. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May Result in a Prescription Drug Shortage; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration (FDA)...

  8. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Science.gov (United States)

    2011-12-13

    ... HUMAN SERVICES Food and Drug Administration 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 Drug Administration (FDA) is announcing the availability of a...

  9. Outcome of the public consultation on the draft guidance for renewal applications of genetically modified food and feed authorised under Regulation (EC) No 1829/2003

    OpenAIRE

    Andersson, Christer; Gropp, Jürgen; Naegeli, Hanspeter; Nogué, Fabien; Rostoks, Nils; Sweet, Jeremy; Dumont, Antonio Fernandez; Gomes, Ana; Mestdagh, Sylvie; Paoletti, Claudia; Ramon, Matthew; Waigmann, Elisabeth

    2015-01-01

    A public consultation on the draft guidance for renewal applications of genetically modified food and feed authorised under Regulation (EC) No 1829/2003 endorsed by the Panel on Genetically Modified Organisms of the European Food Safety Authority was launched on 4 November 2014 and ended on 4 January 2015. The European Food Safety Authority received 114 comments on this draft guidance from 20 interested parties. Through its dedicated working group, the Panel on Genetically Modified Organisms ...

  10. 77 FR 71194 - Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

    Science.gov (United States)

    2012-11-29

    ..., and xenotransplantation. The guidance is intended to clarify current expectations regarding the..., therapeutic vaccination, and xenotransplantation. The guidance is intended to clarify current...

  11. 78 FR 68030 - Draft Guidance on Intellectual Property Rights for the National Network for Manufacturing...

    Science.gov (United States)

    2013-11-13

    ... National Network for Manufacturing Innovation and Draft Institute Performance Metrics for the National Network for Manufacturing Innovation AGENCY: National Institute of Standards and Technology, Department of Commerce. ACTION: Notice. SUMMARY: The Advanced Manufacturing National Program Office (AMNPO), hosted...

  12. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ... Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Availability AGENCY: Food... Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.'' This guidance provides recommendations to... Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.'' The guidance is applicable...

  13. 76 FR 60055 - Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products...

    Science.gov (United States)

    2011-09-28

    ...), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The draft... any tobacco product standard in effect under section 907 of the FD&C Act (21 U.S.C. 387g). Under... product and does not have an order in effect under section 910(c)(1)(A)(i) of the FD&C Act, as...

  14. Drafting.

    Science.gov (United States)

    Hughes, Larry R.

    This guide to teaching drafting, one in a series of instructional materials for junior high industrial arts education, is designed to assist teachers as they plan and implement new courses of study and as they make revisions and improvements in existing courses in order to integrate classroom learning with real-life experiences. This drafting…

  15. Costa, Hermes Augusto, Sindicalismo global ou metáfora adiada? Discursos e práticas transnacionais da CGTP e da CUT.

    Directory of Open Access Journals (Sweden)

    Olinda Lousã

    2012-10-01

    Full Text Available Sindicalismo global ou metáfora adiada? Discursos e práticas transnacionais da CGTP e da CUT é o resultado da tese de doutoramento em Sociologia de Hermes Augusto Costa, docente da Faculdade de Economia da Universidade de Coimbra e investigador do Centro de Estudos Sociais. O livro, organizado em 5 capítulos, reflecte um conjunto de experiências de investigação, desenvolvido ao longo de vários anos. A pesquisa, dedicada à procura de um “sindicalismo de língua portuguesa”, dividiu-se entre Po...

  16. Rating of transport and radiation source events. Draft additional guidance for the INES national officers for pilot use and feedback

    International Nuclear Information System (INIS)

    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)

  17. 77 FR 58399 - Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium...

    Science.gov (United States)

    2012-09-20

    ... Recommendations for Pentosan Polysulfate Sodium Capsule; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Bioequivalence Recommendations for Pentosan Polysulfate Sodium.'' The... drug applications (ANDAs) for pentosan polysulfate sodium capsule. DATES: Although you can comment...

  18. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability

    Science.gov (United States)

    2012-11-06

    ... 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence...), approved by FDA on December 27, 2005, is a thalidomide analogue indicated for the treatment of:...

  19. 75 FR 13562 - Revised Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Renal Function...

    Science.gov (United States)

    2010-03-22

    ... 15, 1998 (63 FR 27094), FDA announced the availability of a guidance entitled ``Pharmacokinetics in... Patients With Impaired Renal Function--Study Design, Data Analysis, and Impact on Dosing and Labeling... ``Pharmacokinetics in Patients With Impaired Renal Function--Study Design, Data Analysis, and Impact on Dosing...

  20. 77 FR 18827 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection...

    Science.gov (United States)

    2012-03-28

    ... Recommendations for Iron Sucrose Injection; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific...) for iron sucrose injection. DATES: Although you can comment on any guidance at any time (see 21 CFR...

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

    Energy Technology Data Exchange (ETDEWEB)

    None

    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.

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

    International Nuclear Information System (INIS)

    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

  3. Design and analysis of field studies with bees: A critical review of the draft EFSA guidance.

    Science.gov (United States)

    Bakker, Frank

    2016-07-01

    The specific protection goal, primary assessment endpoints, acceptable effect thresholds, and experimental design proposed in the European Food Safety Authority (EFSA) update of the bee guidance document are subjected to critical review. It is concluded that the negligible effect criteria were established without sufficient regulatory definition and without convincing scientific argumentation. For the assessment endpoints, effects on hive strength lack temporal definition and the reduction to numbers of bees is inappropriate to evaluate effects. Restricting mortality assessments to homing failure is not theoretically justified and specific criteria were incorrectly derived. The combination of acute effect estimates with models for chronic stressors is biased risk assessment and a temporal basis for the acceptability of effects is missing. Effects on overwintering success cannot be experimentally assessed using the proposed criteria. The experimental methodology proposed is inappropriate and the logistical consequences, in particular those related to replication and land use are such that field studies are no longer a feasible option for the risk assessment. It may be necessary to explore new lines of thought for the set-up of field studies and to clearly separate experimentation from monitoring. Integr Environ Assess Manag 2016;12:422-428. © 2015 SETAC. PMID:26436642

  4. 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

    ... brief oral comments at the meeting on the draft document. The draft document and appendix are available via the internet on the Risk Assessment Forum Web page ( http://www.epa.gov/raf/DDEF/index.htm ). When... period (76 FR 33752-33753), which was subsequently extended to 60 days (76 FR 43999). The public...

  5. 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…

  6. 78 FR 39736 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Science.gov (United States)

    2013-07-02

    ... of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Availability AGENCY: Food and... Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' dated July 2013. The draft... assist in designing early-phase clinical trials of CGT products. DATES: Although you can comment on...

  7. 76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

    Science.gov (United States)

    2011-12-28

    ... Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and...) Paradigm Guidance. FDA recognizes and supports efforts for global convergence of regulatory systems, and...

  8. 77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

    Science.gov (United States)

    2012-07-13

    ... seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. VI... guidance to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA... New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-796-6380; or Stephen...

  9. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Science.gov (United States)

    2012-04-13

    ... concerns regarding the development of antimicrobial resistance in human and animal bacterial pathogens when... those products consistent with FDA's GFI 209, ``The Judicious Use of Medically Important Antimicrobial... of a final guidance entitled ``The Judicious Use of Medically Important Antimicrobial Drugs in...

  10. 76 FR 2328 - National Organic Program: Notice of Draft Guidance Concerning “Made With Organic (Specified...

    Science.gov (United States)

    2011-01-13

    ... in the final product may be produced using excluded methods (i.e., genetically modified organisms... (genetically modified organisms), sewage sludge, or ionizing radiation, but may be produced using synthetic... Management and Budget (OMB) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR...

  11. 78 FR 69690 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Science.gov (United States)

    2013-11-20

    ... of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment Period... entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular... assist in designing early-phase clinical trials of CGT products. In the notice, we requested comments...

  12. 78 FR 7784 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of...

    Science.gov (United States)

    2013-02-04

    ... Clinical Trials To Support Approval of Human Drugs and Biological Products; Extension of Comment Period... entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological... guidance to industry on enrichment strategies that can be used in clinical trials intended to...

  13. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Science.gov (United States)

    2013-06-14

    ... HUMAN SERVICES Food and Drug Administration Content of Premarket Submissions for Management of... Administration (FDA) is announcing the availability of the draft guidance entitled ``Content of Premarket... draft guidance document entitled ``Content of Premarket Submissions for Management of Cybersecurity...

  14. RCRA (Resource Conservation and Recovery Act) personnel training guidance manual for owners or operators of hazardous-waste-management facilities. Draft report

    Energy Technology Data Exchange (ETDEWEB)

    1980-09-01

    The manual provides guidance to an audience consisting of owners or operators of hazardous waste-management facilities and also regulatory personnel responsible for facility permitting. Information is provided concerning general training strategies and program design, types of training, training modules pertinent to hazardous-waste management, suggested training module elements, and sources of information.

  15. 75 FR 57469 - Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues

    Science.gov (United States)

    2010-09-21

    ... (73 FR 72804). OHRP received comments on the draft guidance document from 30 individuals and... Federal Register on December 1, 2008 (73 FR 72804). OHRP received comments on the draft guidance document... HUMAN SERVICES Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related...

  16. 76 FR 26177 - National Organic Program: Notice of Final Guidance for Accredited Certifying Agents and Certified...

    Science.gov (United States)

    2011-05-06

    ... on five draft guidance documents (75 FR 62693). The topics covered in the draft documents addressed... Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs is to ensure that... four final guidance documents are entitled as follows: ``Compost and Vermicompost in Organic...

  17. Civil Drafting.

    Science.gov (United States)

    Schertz, Karen; Kellum, Mary, Ed.

    This curriculum guide contains a course in civil drafting to train entry-level workers for jobs in the field. The module contains 12 instructional units that cover the following topics: (1) introduction to civil drafting; (2) map scales and measurement; (3) standard symbols and abbreviations; (4) interpretation of surveyor's notations; (5) legal…

  18. 78 FR 69992 - Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of Ciguatera...

    Science.gov (United States)

    2013-11-22

    ..., 2013 (78 FR 18273), FDA made available a draft guidance entitled ``Guidance for Industry: Purchasing... HUMAN SERVICES Food and Drug Administration 21 CFR Part 123 Guidance for Industry on Purchasing Reef... announcing the availability of a guidance for industry entitled ``Guidance for Industry: Purchasing Reef...

  19. 78 FR 68101 - Environmental Issues Associated With New Reactors and Specific Environmental Guidance for...

    Science.gov (United States)

    2013-11-13

    ... (NRC) published a request for public comment on draft Interim Staff Guidance (ISG) ESP/COL-ISG 026, ``Interim Staff Guidance on Environmental Issues Associated with New Reactors'' and draft ISG ESP/ COL-ISG... NRC-2013-0212 for ESP/COL- ISG-026 or NRC-2013-0211 for ESP/COL-ISG-027. Address questions about...

  20. Drafting Fundamentals. Drafting Module 1. 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. The guide contains a cross-reference table of instructional materials. Ten units cover drafting fundamentals: (1) introduction to drafting; (2) general safety;…

  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. State of Washington radiation guidance for Hanford

    International Nuclear Information System (INIS)

    Cleanup of the U.S. Department of Energy's Hanford site is being managed through the Hanford Federal Facility Agreement and Consent Order known as the Tri-Party Agreement. The participants are the U.S. Department of Energy, the U.S. Environmental Protection Agency, and the State of Washington, with the Department of Ecology being the lead for the State of Washington. Through a memorandum of understanding the Department of Health is designated as the primary state agency for protection of human health and the environment from ionizing radiation. As part of this responsibility, the Department of Health is developing radiation cleanup guidance for Hanford cleanup. Another reason for developing State guidance is that there are no federal regulations that provide guidance on residual radioactivity on lands that will be released for public use. The U.S. Nuclear Regulatory Commission and the U.S. Environmental Protection Agency both have prepared draft regulations, but the issuance of these is uncertain. The state guidance is compatible with draft federal guidance and includes numerical guidance for residual contamination, modeling parameters, look-up tables, and land use categories. This guidance will apply until such a time as they are superseded by applicable federal regulations or the state environmental radiation standard

  3. 76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Science.gov (United States)

    2011-08-17

    ... entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This guidance provides... Systems.'' This guidance provides recommendations to developers and manufacturers of TDDS, TMDS, and... August 3, 2010 (75 FR 45640), FDA announced the availability of the draft version of this guidance....

  4. 78 FR 56750 - Interim Staff Guidance on Environmental Issues Associated With New Reactors

    Science.gov (United States)

    2013-09-13

    ... COMMISSION Interim Staff Guidance on Environmental Issues Associated With New Reactors AGENCY: Nuclear... Notice: Draft Interim Staff Guidance on Environmental Issues Associated with New Reactors. ML12326A742 Interim Staff Guidance-026, Environmental Issues Associated with New Reactors. ML12326A811...

  5. 76 FR 82308 - Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers...

    Science.gov (United States)

    2011-12-30

    .... The guidance is intended for any HCT/P establishment that performs a manufacturing step and is... 1271, subpart E. The guidance is intended for any HCT/P establishment that performs a manufacturing... 16, 2009 (74 FR 3055), FDA announced the availability of the draft guidance of the same title...

  6. 77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

    Science.gov (United States)

    2012-07-03

    ... Register of October 21, 2009 (74 FR 54053), FDA announced the availability of the draft guidance documents... 20993, 301-796- 2563, and Mary Pastel, Center for Devices and Radiological Health, Food and...

  7. 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

  8. 77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

    Science.gov (United States)

    2012-11-23

    .... On June 22, 2011 (76 FR 36542), FDA announced the availability of the draft guidance document... Investigational Device Exemption (IDE) and Premarket Approval Applications (PMA) for Low Glucose Suspend (LGS) Device Systems.'' On December 6, 2011 (76 FR 76166), FDA announced the availability of the draft...

  9. 75 FR 78231 - Management of Energy and Water Efficiency in Federal Buildings: Availability of Guidance

    Science.gov (United States)

    2010-12-15

    ... of Energy Efficiency and Renewable Energy Management of Energy and Water Efficiency in Federal... water management. This draft guidance is available at: http://www1.eere.energy.gov/femp/pdfs/draft_EISA.... Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE), Federal Energy...

  10. 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;…

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

    DEFF Research Database (Denmark)

    Satya, Sneha; Wade, Mike; Hass, Ulla;

    Assessment). In 2010, the OECD Secretariat presented the objectives and a draft outline of the document at the meeting of the Working Group of National Coordinators of the Test Guidelines Programme (WNT). The document was then developed by two consultants in close cooperation with an advisory group on...... progress report was presented to the WNT at its 2011 meeting. In May 2011, comments were requested from the WNT on the changes made to the draft Guidance Document. In parallel to the finalisation of the draft Guidance document, three case studies were then developed by the consultants to valuate whether...

  12. Modelling polymer draft gears

    Science.gov (United States)

    Wu, Qing; Yang, Xiangjian; Cole, Colin; Luo, Shihui

    2016-09-01

    This paper developed a new and simple approach to model polymer draft gears. Two types of polymer draft gears were modelled and compared with experimental data. Impact characteristics, in-train characteristics and frequency responses of these polymer draft gears were studied and compared with those of a friction draft gear. The impact simulations show that polymer draft gears can withstand higher impact speeds than the friction draft gear. Longitudinal train dynamics simulations show that polymer draft gears have significantly longer deflections than friction draft gears in normal train operations. The maximum draft gear working velocities are lower than 0.2 m/s, which are significantly lower than the impact velocities during shunting operations. Draft gears' in-train characteristics are similar to their static characteristics but are very different from their impact characteristics; this conclusion has also been reached from frequency response simulations. An analysis of gangway bridge plate failures was also conducted and it was found that they were caused by coupler angling behaviour and long draft gear deflections.

  13. 76 FR 81513 - Guidance for Industry: Prevention of Salmonella

    Science.gov (United States)

    2011-12-28

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a... September 8, 2009. In the Federal Register of August 12, 2010 (75 FR 48973), FDA made available a draft... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Prevention of Salmonella...

  14. 76 FR 67746 - Revised Guidance for Industry on Impurities: Residual Solvents in New Veterinary Medicinal...

    Science.gov (United States)

    2011-11-02

    ... (75 FR 50771), FDA published a notice of availability for a draft revised guidance entitled ``Residual... (referred to as pharmaceuticals or veterinary medicinal products in this guidance) for the safety of the... Harmonization of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years...

  15. 78 FR 57395 - Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

    Science.gov (United States)

    2013-09-18

    ... ``Electronic Source Data in Clinical Investigations.'' This document provides guidance to sponsors, contract... accurate and complete data. In the Federal Register of November 20, 2012 (77 FR 69632), FDA issued a draft... FR 76049)). Most of the comments sought clarification on the topics discussed in the guidance....

  16. 76 FR 71577 - Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication...

    Science.gov (United States)

    2011-11-18

    ..., 2011 (76 FR 10908), FDA announced the availability of a draft guidance for industry entitled... Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies; Availability... Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).'' This guidance addresses...

  17. 76 FR 63303 - Guidance for Industry on Warnings and Precautions, Contraindications, and Boxed Warning Sections...

    Science.gov (United States)

    2011-10-12

    ... (71 FR 3999), FDA issued final guidances on the content and format of the ``Adverse Reactions'' and ``Clinical Studies'' sections of labeling. In the Federal Register of October 19, 2009 (74 FR 53507), FDA... Register of March 3, 2009 (74 FR 9250), FDA issued a draft guidance on the content and format of...

  18. 75 FR 40756 - Implementation Guidance for Physical Protection of Byproduct Material; Category 1 and Category 2...

    Science.gov (United States)

    2010-07-14

    ... Federal Regulations. The proposed rule was published on June 15, 2010 (75 FR 33902), and the public...; ] NUCLEAR REGULATORY COMMISSION 10 CFR Part 37 RIN 3150-AI12 Implementation Guidance for Physical Protection... Regulatory Commission. ACTION: Notice of availability of draft guidance for public comment. SUMMARY: The U....

  19. 78 FR 70307 - Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

    Science.gov (United States)

    2013-11-25

    ... Federal Register of November 29, 2012 (77 FR 71194), FDA announced the availability of the draft guidance... therapy, therapeutic vaccination, xenotransplantation, and certain biologic-device combination products..., xenotransplantation, and certain biologic-device combination products. The guidance is intended to clarify...

  20. 75 FR 35492 - Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus-Developing...

    Science.gov (United States)

    2010-06-22

    ... Federal Register of March 29, 2005 (70 FR 15868), FDA announced the availability of a draft guidance... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for Treatment; Availability AGENCY: Food and...

  1. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Science.gov (United States)

    2013-01-24

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian...

  2. 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...... acceptable. Rather, it presents examples drawn from evaluations already carried out 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 by the NDA Panel on 10 September 2010, was...

  3. 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.

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

    International Nuclear Information System (INIS)

    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

  5. Basic Drafting: Book Two.

    Science.gov (United States)

    Davis, Ronald; And Others

    The second of a two-book course in drafting, this manual consists of 12 topics in the following units: sketching techniques, geometric constructions, orthographic views, dimensioning procedures, basic tolerancing, auxiliary views, sectional views, inking tools and techniques, axonometrics, oblique, perspective, and computer-aided drafting.…

  6. Basic Drafting: Book One.

    Science.gov (United States)

    Davis, Ronald; And Others

    The first of a two-book course in drafting, this manual consists of 13 topics in the following units: introduction to drafting, general safety, basic tools and lines, major equipment, applying for a job, media, lettering, reproduction, drawing sheet layout, architect's scale usage, civil engineer's scale usage, mechanical engineer's scale usage,…

  7. [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.

  8. 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...

  9. 78 FR 24425 - Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-04-25

    ... studies on an old system. The draft of this guidance was issued on January 5, 2009 (74 FR 302). The... HUMAN SERVICES Food and Drug Administration Assay Migration Studies for In Vitro Diagnostic Devices... availability of the guidance entitled ``Assay Migration Studies for In Vitro Diagnostic Devices.''...

  10. 78 FR 14097 - Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and...

    Science.gov (United States)

    2013-03-04

    ... Federal Register of July 19, 2007 (72 FR 39631), FDA announced the availability of the draft guidance... HUMAN SERVICES Food and Drug Administration Pulse Oximeters--Premarket Notification Submissions... availability of the guidance entitled ``Pulse Oximeters--Premarket Notification Submissions .'' This...

  11. 76 FR 2681 - Amended Environmental Impact Statement Filing System Guidance for Implementing 40 CFR 1506.9 and...

    Science.gov (United States)

    2011-01-14

    ... AGENCY Amended Environmental Impact Statement Filing System Guidance for Implementing 40 CFR 1506.9 and... guidelines to implement its EIS filing responsibilities. The purpose of the EPA Filing System Guidelines is to provide guidance to Federal agencies on filing EISs, including draft, final, and supplemental...

  12. 77 FR 51530 - Amended Environmental Impact Statement Filing System Guidance for Implementing 40 CFR 1506.9 and...

    Science.gov (United States)

    2012-08-24

    ... AGENCY Amended Environmental Impact Statement Filing System Guidance for Implementing 40 CFR 1506.9 and... guidelines to implement its EIS filing responsibilities. The purpose of the EPA Filing System Guidelines is to provide guidance to Federal agencies on filing EISs, including draft, final, and supplemental...

  13. 75 FR 6210 - Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary...

    Science.gov (United States)

    2010-02-08

    ... Register of November 24, 2008 (73 FR 71009), FDA announced the availability of a draft guidance for... Name Review'' (concept paper) (73 FR 58604, October 7, 2008). FDA acknowledges that information in the... HUMAN SERVICES Food and Drug Administration Guidance for Industry on the Contents of a...

  14. 76 FR 6087 - Draft Weapons Safety Assessment on the Use of Enhanced Weapons; Notice of Availability and...

    Science.gov (United States)

    2011-02-03

    ... COMMISSION 10 CFR Part 73 RIN 3150-AI49 Draft Weapons Safety Assessment on the Use of Enhanced Weapons... guidance document entitled ``Weapons Safety Assessment'' (WSA). This guidance would be used by licensees and certificate holders applying to the NRC to obtain enhanced weapons under the NRC's proposed...

  15. 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…

  16. 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

  17. Drafting: Current Trends and Future Practices

    Science.gov (United States)

    Jensen, C.

    1976-01-01

    Various research findings are reported on drafting trends which the author feels should be incorporated into teaching drafting: (1) true position and geometric tolerancing, (2) decimal and metric dimensioning, (3) functional drafting, (4) automated drafting, and (5) drawing reproductions. (BP)

  18. International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; guidance for industry; availability. Notice.

    Science.gov (United States)

    2015-01-27

    The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "S10 Photosafety Evaluation of Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance outlines details on when photosafety testing is warranted and on possible assessment strategies; it should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals. This guidance finalizes the draft guidance issued on February 4, 2013.

  19. 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......, endorsed by the NDA Panel on 25 March 2011, was released for public consultation from 26 April 2011 to 31 August 2011....

  20. Corporate information management guidance

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-08-01

    At the request of the Department of Energy`s (DOE) Information Management (IM) Council, IM representatives from nearly all Headquarters (HQ) organizations have been meeting over the past year as the Corporate Guidance Group (CGG) to develop useful and sound corporate information management (IM) guidance. The ability of the Department`s IM community to develop such unified guidance continues to be critical to the success of future Departmental IM planning processes and the establishment of a well-coordinated IM environment between Headquarters and field organizations. This report, with 26 specific corporate IM guidance items documented and unanimously agreed to, as well as 12 items recommended for further development and 3 items deferred for future consideration, represents a highly successful effort by the IM community. The effort has proven that the diverse DOE organizations can put aside individual preferences and work together towards a common and mutually beneficial goal. In examining most areas and issues associated with information management in the Department, they have developed specific, far-reaching, and useful guidance. The IM representatives recommend that the documented guidance items provided in this report and approved by the DOE IM Council be followed by all IM organizations. The representatives also strongly recommend that the guidance process developed by the CGG be the single process for developing corporate IM guidance.

  1. 76 FR 49773 - International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or...

    Science.gov (United States)

    2011-08-11

    ... European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and..., 2009 (74 FR 38033), FDA published a notice announcing the availability of a draft guidance entitled...'s current thinking on this topic. It does not create or confer any rights for or on any person...

  2. 77 FR 50372 - Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella...

    Science.gov (United States)

    2012-08-21

    ..., 2009 (74 FR 33030), we issued a final rule requiring shell egg producers to implement measures to... the Federal Register of July 13, 2011 (76 FR 41157), we made available a draft guidance entitled... Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During...

  3. 77 FR 59929 - Guidance for Industry on Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With...

    Science.gov (United States)

    2012-10-01

    ... August 22, 2008 (73 FR 49684), which in turn revised the draft guidance for industry entitled ``Acute... ``Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary... treatment of acute bacterial exacerbations of chronic bronchitis in patients with chronic...

  4. 78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

    Science.gov (United States)

    2013-03-06

    ... impairment resulting from ocular pathology such as retinitis pigmentosa. Vision impairment, or low vision, is... implanted on or beneath the retina, and those on or beneath the outer surface of the globe that use... of April 17, 2009 (74 FR 17872), FDA announced the availability of the draft guidance. Comments...

  5. 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.

  6. 76 FR 67439 - External Peer Review Meeting for Draft Microbial Risk Assessment Guideline: Pathogenic...

    Science.gov (United States)

    2011-11-01

    ... AGENCY External Peer Review Meeting for Draft Microbial Risk Assessment Guideline: Pathogenic... guidance for a 60 day comment period (76 FR 44586-44587). The public comment period ended on September 26... attend this peer review meeting as observers. Time will be set aside at the meeting for observers to...

  7. Caught in the Draft

    Science.gov (United States)

    Edge, Ron

    2007-01-01

    We've all seen (in movies, newscasts, or perhaps in person) the violent effect of the downwash that occurs when a helicopter hovers over the ground. Leaves, grass, and debris are dramatically blown about. We've also sat in front of circulating room fans and felt a large draft, whereas there seems to be very little air movement behind the fan. The…

  8. 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...

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

    International Nuclear Information System (INIS)

    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

  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...... 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 by the NDA Panel on 24 November 2011...

  11. 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 of the....../outcome measures which are acceptable. Rather, it presents examples drawn from evaluations already carried out 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 by the NDA Panel on 25...

  12. 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...

  13. My view on occupation guidance

    Institute of Scientific and Technical Information of China (English)

    2012-01-01

    Occupation instruction needs to the support of theories,in the case of the occupation guidance theory is not very developed in our country,It has very important sense that absorbing and drawing lessons from the advanced occupation guidance theory,and targeting guidance to occupation guidance work,.

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

    International Nuclear Information System (INIS)

    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

  15. Drafting--Basic, Drafting--Intermediate: 9255.01.

    Science.gov (United States)

    Dade County Public Schools, Miami, FL.

    The course has no prerequisites, offers instruction in basic drafting room techniques and procedures, and also covers job opportunities and industrial methods in engineering. The student is introduced to and asked to perform fundamental drafting problems with working drawings, using multiview and auxiliary views and sections. The course also…

  16. Regulatory guidance document

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    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.

  17. 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).

  18. The Counseling & Guidance Curriculum.

    Science.gov (United States)

    Ediger, Marlow

    Counseling and guidance services are vital in any school curriculum. Counselors may themselves be dealing with students of diverse abilities and handicaps. Counselors may have to work with students affected by drug addiction, fetal alcohol syndrome, homelessness, poverty, Acquired Immune Deficiency Syndrome (AIDS) and divorce. Students may present…

  19. Regulatory guidance document

    International Nuclear Information System (INIS)

    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

  20. Career guidance on the move

    DEFF Research Database (Denmark)

    Thomsen, Rie

    2013-01-01

    This article is about how the notion of place can be used in an analysis of career guidance practices and their development. It is about how a focus on the context of career guidance can develop an awareness of the place where guidance is practiced and support the development of career guidance...... in new places. In this article I introduce an analytical perspective on place; I give the example of the guidance café a practice development that took place into serious consideration because it was an attempt to develop career guidance practice through relocating it....

  1. 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

  2. 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

  3. 46 CFR 167.55-1 - Draft marks and draft indicating systems.

    Science.gov (United States)

    2010-10-01

    ... NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... are of uniform height equal to the vertical spacing between consecutive marks. (f) Draft marks must...

  4. 78 FR 45930 - Guidance for Industry: Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal...

    Science.gov (United States)

    2013-07-30

    ... Register of April 13, 2011 (76 FR 20686), FDA announced the availability of a draft guidance for industry...--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and... new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA to...

  5. 76 FR 39101 - EPA and Army Corps of Engineers Guidance Regarding Identification of Waters Protected by the...

    Science.gov (United States)

    2011-07-05

    ...) announced availability of draft guidance (76 FR 24479) that describes how the agencies will identify waters protected by the Federal Water Pollution Control Act Amendments of 1972 (Clean Water Act or CWA or Act) and....mil . SUPPLEMENTARY INFORMATION: In the May 2, 2011, issue of the Federal Register (76 FR 24479),...

  6. 76 FR 22905 - Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties...

    Science.gov (United States)

    2011-04-25

    ..., 2010 (75 FR 13225) (21 CFR part 1140). The Tobacco Control Act also authorizes FDA to impose a no... Register of August 31, 2010 (75 FR 53316), FDA announced the availability of the draft guidance of the same... Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability...

  7. New Interpretations of Guidance Role

    Science.gov (United States)

    Kerlan, Julius H.; Ryan, Charles W.

    1972-01-01

    A panoramic view of Guidance Division general sessions and workshops covering some exemplary career guidance programs, as well as such topics as career choice, leadership, evaluation, and program development and management. Presented at the Guidance division session of the American Vocational Association 1971 annual meeting. (Editor/MU)

  8. Environmental guidance regulatory bulletin

    International Nuclear Information System (INIS)

    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

  9. 31 CFR 500.406 - Drafts under irrevocable letters of credit; documentary drafts.

    Science.gov (United States)

    2010-07-01

    ... credit; documentary drafts. 500.406 Section 500.406 Money and Finance: Treasury Regulations Relating to...; documentary drafts. Section 500.201 prohibits the presentation, acceptance or payment of: (a) Drafts or other...) Documentary drafts in which any designated national has on or since the “effective date” had any interest....

  10. Guidance of Nonlinear Systems

    Science.gov (United States)

    Meyer, George

    1997-01-01

    The paper describes a method for guiding a dynamic system through a given set of points. The paradigm is a fully automatic aircraft subject to air traffic control (ATC). The ATC provides a sequence of way points through which the aircraft trajectory must pass. The way points typically specify time, position, and velocity. The guidance problem is to synthesize a system state trajectory which satisfies both the ATC and aircraft constraints. Complications arise because the controlled process is multi-dimensional, multi-axis, nonlinear, highly coupled, and the state space is not flat. In addition, there is a multitude of possible operating modes, which may number in the hundreds. Each such mode defines a distinct state space model of the process by specifying the state space coordinatization, the partition of the controls into active controls and configuration controls, and the output map. Furthermore, mode transitions must be smooth. The guidance algorithm is based on the inversion of the pure feedback approximations, which is followed by iterative corrections for the effects of zero dynamics. The paper describes the structure and modules of the algorithm, and the performance is illustrated by several example aircraft maneuvers.

  11. Teaching Legislative Drafting: A Simulation Approach.

    Science.gov (United States)

    Stern, Barry Jeffrey

    1988-01-01

    An approach to teaching legislative drafting uses limited traditional classroom instruction and intensive exposure to the process of legislative drafting through a classroom simulation in which students revise the Massachusetts criminal code. (MSE)

  12. 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.

  13. Waste burner overfire draft system

    Energy Technology Data Exchange (ETDEWEB)

    Kahlert, G.; Pommer, L.; Davis, J.; Whebell, B.

    1977-11-22

    An overfire draft system for a waste burner is disclosed. Such system comprises air vents arranged circumferentially around the base of the burner for communicating the interior of the burner to the atmosphere and a draft modulated damper plate located in each air vent for automatically regulating the volume of overfire air delivered to the interior of the burner. Each draft modulated damper plate is provided with a lower lip which is deflected by a predetermined angle with respect to the plate to create an aerodynamic lift effect with large opening moment to assist the damper plate in its response under low air velocity conditions, and an oppositely deflected upper lip with proportionately less bent surface to avoid flutter or hunting of the damper as it approaches the maximum open position and to provide added dynamic opening force. The overfire draft system is also provided with ducts connected to the air vents and oriented so as to direct air tangentially around the base of the burner and toward the lower inside wall of the burner so as to minimize the disturbance of the inside air. The waste burner may also be provided with draft modulated or forced air vents arranged circumferentially at mid-elevation around the burner and duct means connected to such vents and directed at a small angle with the radius of the burner so as to cause turbulence in the flame zone and reduce the vertical velocity of gases above the fire, thus reducing emission of particulate materials.

  14. 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.…

  15. Mechnical Drawing/Drafting Curriculum Guide.

    Science.gov (United States)

    Gregory, Margaret R.; Benson, Robert T.

    This curriculum guide consists of materials for teaching a course in mechanical drawing and drafting. Addressed in the individual units of the guide are the following topics: the nature and scope of drawing and drafting, visualization and spatial relationships, drafting tools and materials, linework, freehand lettering, geometric construction,…

  16. 49 CFR 229.61 - Draft system.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Draft system. 229.61 Section 229.61 Transportation... TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Draft System § 229.61 Draft system. (a) A.... Suspension System...

  17. Discussing Diverse Perspectives on Guidance

    Science.gov (United States)

    Gonzalez-Mena, Janet; Shareef, Intisar

    2005-01-01

    Ideas about discipline and guidance get extremely complex when they intersect with culture and oppression. Some groups of people who are targets of racism have to protect their children from the oppressive practices of racist individuals and institutions. Their methods of guidance and discipline may be different from those of groups for whom…

  18. 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...... institution of power in terms of choice opportunities and ´self-develoåment practices” in educational systems, the paper will discuss how the relationship between guidance and consumerism can be conceptualized in order to evaluate (and critically discuss) the consequences of the expansion of consumerism......The paper presents a conceptual framework for the relationship between guidance and consumerism, which can be applied in evaluating (and critically discussing) the consequences of this development for students, institutions and professionals. Guidance has moved from the margins to the center...

  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. RH Packaging Program Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Washington TRU Solutions LLC

    2006-11-07

    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&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) §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. 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

  1. RH Packaging Program Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Washington TRU Solutions LLC

    2008-01-12

    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&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

  2. RCA annual report 1996. Draft

    International Nuclear Information System (INIS)

    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

  3. 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...

  4. Draft Transportation Institutional Plan

    International Nuclear Information System (INIS)

    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

  5. Draft Transportation Institutional Plan

    Energy Technology Data Exchange (ETDEWEB)

    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.

  6. Response to work activity guidance

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This memorandum is concerning the request from the FY95 Platte-Kansas Rivers Ecosystem Work Activity Guidance for refuge managers to review the purposes of refuges...

  7. Guidance Systems of Fighter Aircraft

    Directory of Open Access Journals (Sweden)

    K.N. Rajanikanth

    2005-07-01

    Full Text Available Mission performance of a fighter aircraft is crucial for survival and strike capabilities in todays' aerial warfare scenario. The guidance functions of such an aircraft play a vital role inmeeting the requirements and accomplishing the mission success. This paper presents the requirements of precision guidance for various missions of a fighter aircraft. The concept ofguidance system as a pilot-in-loop system is pivotal in understanding and designing such a system. Methodologies of designing such a system are described.

  8. 77 FR 34390 - Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To...

    Science.gov (United States)

    2012-06-11

    ... Industry: Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products,'' Availability AGENCY: Food and... to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and...

  9. Advantage of a lead swimmer in drafting

    CERN Document Server

    Westerweel, J; Pennings, P; Yilmaz, B

    2016-01-01

    We present results from model tests to investigate the effect of drafting in swimming, in particular for the lead swimmer. The drag for scaled-model passive swimmers was determined accurately at Froude numbers comparable to conditions for actual human swimmers. Several positions of a draft swimmer at different separations behind and alongside the lead swimmer were investigated. It was found that a lead swimmer can experience an advantage from a draft swimmer. Several other positions of the draft swimmer relative to the frontal wave generated by the lead swimmer were also considered. These results indicate favourable and undesirable positions during passing.

  10. 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...

  11. 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.

  12. 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...... of the NDA Panel on such health claims. Thus, this guidance 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 will include an exhaustive list of beneficial effects and studies/outcome measures...... that are acceptable. Rather, it presents examples drawn from evaluations already carried out 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 was endorsed by the NDA Panel on 16 September 2011...

  13. 78 FR 56752 - Interim Staff Guidance Specific Environmental Guidance for Integral Pressurized Water Reactors...

    Science.gov (United States)

    2013-09-13

    ... COMMISSION Interim Staff Guidance Specific Environmental Guidance for Integral Pressurized Water Reactors... and operate integral pressurized water reactors (iPWR). This guidance applies to environmental reviews... Environmental Guidance for iPWR Reviews.'' The purpose of this ISG is to clarify the NRC guidance...

  14. Westinghouse severe accident management guidance overview and current status

    International Nuclear Information System (INIS)

    The Westinghouse Owners Group has completed a major development program in Severe Accident Management. This program draws on all presently available sources of information in the field, including in the field, including NRC, NUMARC and EPRI programs, plant specific Individual Plant Examinations and Probabilistic Safety Assessments, and other international activities. The program has developed a full set of Severe Accident Management Guidance (SAMG) applicable to Westinghouse and Westinghouse licensee PWR plant. The SAMG enhances the capabilities of the plant emergency response team for accident sequences that progress to fuel damage, and therefore beyond the range of applicability of present guidance in the form of Emergency Operating Procedures. Since the first draft of SAMG was transmitted officially to the WOG members and the NRC in July 1993, many activities have been carried out by the different organizations involved, and although no significant changes to the SAMG structure have resulted from these activities, several enhancement have been included, mainly from the comments recorded during the generic SAMG validation exercise at the Point Beach plant. With the issue in June 1994 of the revision 0 SAMG, some plants in the U.S. and abroad are already implementing plant specific guidelines. This paper provides an overview of the SAMG package, and also describe the most important comments and feedback from the validation and review efforts. (author)

  15. Agent Based Individual Traffic guidance

    DEFF Research Database (Denmark)

    Wanscher, Jørgen Bundgaard

    2004-01-01

    can be obtained through cellular phone tracking or GPS systems. This information can then be used to provide individual traffic guidance as opposed to the mass information systems of today -- dynamic roadsigns and trafficradio. The goal is to achieve better usage of road and time. The main topic......When working with traffic planning or guidance it is common practice to view the vehicles as a combined mass. >From this models are employed to specify the vehicle supply and demand for each region. As the models are complex and the calculations are equally demanding the regions and the detail...

  16. Data Element Dictionary: Facilities. Preliminary Draft.

    Science.gov (United States)

    Thomas, Charles R.

    The draft includes--(1) comments on file structure, (2) descriptions of dictionary organization and format, (3) alphabetical lists of elements, and (4) facilities related elements in dictionary form. The data element definitions in this draft are compatible with the Higher Education Facilities Classification and Inventory Procedures Manual, which…

  17. 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...

  18. Construction Techniques. Drafting Module 2. 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. The guide contains a cross-reference table of instructional materials. Four units cover construction techniques: (1) drawing sheet layout; (2) sketching; (3)…

  19. Automated drafting system uses computer techniques

    Science.gov (United States)

    Millenson, D. H.

    1966-01-01

    Automated drafting system produces schematic and block diagrams from the design engineers freehand sketches. This system codes conventional drafting symbols and their coordinate locations on standard size drawings for entry on tapes that are used to drive a high speed photocomposition machine.

  20. Guidance for evidence-informed policies about health systems: rationale for and challenges of guidance development.

    Science.gov (United States)

    Bosch-Capblanch, Xavier; Lavis, John N; Lewin, Simon; Atun, Rifat; Røttingen, John-Arne; Dröschel, Daniel; Beck, Lise; Abalos, Edgardo; El-Jardali, Fadi; Gilson, Lucy; Oliver, Sandy; Wyss, Kaspar; Tugwell, Peter; Kulier, Regina; Pang, Tikki; Haines, Andy

    2012-01-01

    In the first paper in a three-part series on health systems guidance, Xavier Bosch-Capblanch and colleagues examine how guidance is currently formulated in low- and middle-income countries, and the challenges to developing such guidance.

  1. Long-Term Stewardship Baseline Report and Transition Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Kristofferson, Keith

    2001-11-01

    Long-term stewardship consists of those actions necessary to maintain and demonstrate continued protection of human health and the environment after facility cleanup is complete. As the Department of Energy’s (DOE) lead laboratory for environmental management programs, the Idaho National Engineering and Environmental Laboratory (INEEL) administers DOE’s long-term stewardship science and technology efforts. The INEEL provides DOE with technical, and scientific expertise needed to oversee its long-term environmental management obligations complexwide. Long-term stewardship is administered and overseen by the Environmental Management Office of Science and Technology. The INEEL Long-Term Stewardship Program is currently developing the management structures and plans to complete INEEL-specific, long-term stewardship obligations. This guidance document (1) assists in ensuring that the program leads transition planning for the INEEL with respect to facility and site areas and (2) describes the classes and types of criteria and data required to initiate transition for areas and sites where the facility mission has ended and cleanup is complete. Additionally, this document summarizes current information on INEEL facilities, structures, and release sites likely to enter long-term stewardship at the completion of DOE’s cleanup mission. This document is not intended to function as a discrete checklist or local procedure to determine readiness to transition. It is an overarching document meant as guidance in implementing specific transition procedures. Several documents formed the foundation upon which this guidance was developed. Principal among these documents was the Long-Term Stewardship Draft Technical Baseline; A Report to Congress on Long-Term Stewardship, Volumes I and II; Infrastructure Long-Range Plan; Comprehensive Facility Land Use Plan; INEEL End-State Plan; and INEEL Institutional Plan.

  2. 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 ...

  3. Content and Strategies for Teaching Computer Aided Drafting.

    Science.gov (United States)

    Becker, Kurt

    1991-01-01

    A Delphi panel of 15 experts determined that (1) computer-assisted drafting (CAD) and traditional drafting are complementary; (2) differences in teaching strategies related to use of computers versus traditional drafting instruments; and (3) traditional drafting knowledge and skills are very important for CAD. (SK)

  4. Teacher Guidance of Knowledge Construction

    Science.gov (United States)

    Schwarz, Baruch; Dreyfus, Tommy; Hadas, Nurit; Hershkowitz, Rina

    2004-01-01

    This paper focuses on how teachers guide construction of knowledge in classrooms. We suggest that guidance hinges on the kind of dialogue teachers choose to engage students in. We propose several classroom dialogue types relevant for the construction of knowledge and suggest that critical dialogue is particularly effective for knowledge…

  5. DOE Waste Treatability Group Guidance

    International Nuclear Information System (INIS)

    This guidance presents a method and definitions for aggregating U.S. Department of Energy (DOE) waste into streams and treatability groups based on characteristic parameters that influence waste management technology needs. Adaptable to all DOE waste types (i.e., radioactive waste, hazardous waste, mixed waste, sanitary waste), the guidance establishes categories and definitions that reflect variations within the radiological, matrix (e.g., bulk physical/chemical form), and regulated contaminant characteristics of DOE waste. Beginning at the waste container level, the guidance presents a logical approach to implementing the characteristic parameter categories as part of the basis for defining waste streams and as the sole basis for assigning streams to treatability groups. Implementation of this guidance at each DOE site will facilitate the development of technically defined, site-specific waste stream data sets to support waste management planning and reporting activities. Consistent implementation at all of the sites will enable aggregation of the site-specific waste stream data sets into comparable national data sets to support these activities at a DOE complex-wide level

  6. DOE Waste Treatability Group Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Kirkpatrick, T.D.

    1995-01-01

    This guidance presents a method and definitions for aggregating U.S. Department of Energy (DOE) waste into streams and treatability groups based on characteristic parameters that influence waste management technology needs. Adaptable to all DOE waste types (i.e., radioactive waste, hazardous waste, mixed waste, sanitary waste), the guidance establishes categories and definitions that reflect variations within the radiological, matrix (e.g., bulk physical/chemical form), and regulated contaminant characteristics of DOE waste. Beginning at the waste container level, the guidance presents a logical approach to implementing the characteristic parameter categories as part of the basis for defining waste streams and as the sole basis for assigning streams to treatability groups. Implementation of this guidance at each DOE site will facilitate the development of technically defined, site-specific waste stream data sets to support waste management planning and reporting activities. Consistent implementation at all of the sites will enable aggregation of the site-specific waste stream data sets into comparable national data sets to support these activities at a DOE complex-wide level.

  7. Systematic policy and forward guidance

    OpenAIRE

    Plosser, Charles I.

    2014-01-01

    Money Marketeers of New York University, Inc., Down Town Association, March 25, 2014, New York, NY President Charles Plosser discusses the relationship between systematic policy and forward guidance. He explains how understanding both practices can provide insights into effective monetary policy in normal and unusual times, or in extreme conditions when policy is constrained by the zero lower bound on nominal interest rates.

  8. Business plan in brief. Draft

    International Nuclear Information System (INIS)

    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

  9. Engineering Guidance: A Human Resource Development.

    Science.gov (United States)

    Snarponis, Joseph M.; Prien, John D.

    1979-01-01

    Describes the role of The National Society of Professional Engineers (NSPE) in providing guidance activities for students. Discusses structional organization, goals, and guidance activities for engineering and technical and professional societies. (MA)

  10. Quality Assurance in University Guidance Services

    Science.gov (United States)

    Simon, Alexandra

    2014-01-01

    In Europe there is no common quality assurance framework for the delivery of guidance in higher education. Using a case study approach in four university career guidance services in England, France and Spain, this article aims to study how quality is implemented in university career guidance services in terms of strategy, standards and models,…

  11. Providing Career Guidance for Young Women.

    Science.gov (United States)

    Colby, Pamela G.

    This module is directed at personnel working or planning to work in the areas of guidance, counseling, placement and follow-through in junior and senior high school settings, grades 7-12. The module topic is career guidance for young women of junior and senior high school age, aand the focus will be on providing nonbiased career guidance which…

  12. The Self in Guidance: Assumptions and Challenges.

    Science.gov (United States)

    Edwards, Richard; Payne, John

    1997-01-01

    Examines the assumptions of "self" made in the professional and managerial discourses of guidance. Suggests that these assumptions obstruct the capacity of guidance workers to explain their own practices. Drawing on contemporary debates over identity, modernity, and postmodernity, argues for a more explicit debate about the self in guidance. (RJM)

  13. Guidance manual for constructed wetlands.

    OpenAIRE

    Ellis, John Bryan; Shutes, R. Brian E.; Revitt, D. Mike

    2003-01-01

    This Guidance Manual was produced to provide up to date information on the design, costs, construction, operation and maintenance of constructed wetlands used for the treatment of highway runoff. Information is provided on the different types of wetlands and their mode of operation, the design and planting of a wetland system and the retrofitting of treatment structures, the performance and costs of wetlands and their operation and maintenance requirements. The benefits of wetlands in encoura...

  14. Current materiality guidance for auditors

    OpenAIRE

    McKee, Thomas E.; Eilifsen, Aasmund

    2000-01-01

    Auditors have to make materiality judgments on every audit. This is a difficult process, as both quantitative and qualitative factors have to be evaluated. Additionally, there is no formal guidance for how to implement the materiality concepts discussed in the auditing standards. Although they are sometimes difficult to make, good materiality judgments are crucial for the conduct of a successful audit as poor judgments can result in an audit that is ineffective and/or inefficient. This report...

  15. 78 FR 41401 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Animal Feed...

    Science.gov (United States)

    2013-07-10

    ... Collection; Comment Request; Draft Animal Feed Regulatory Program Standards; Availability AGENCY: Food and... associated with the draft Animal Feed Regulatory Program Standards (AFRPS). The draft feed standards are... appropriate, and other forms of information technology. Draft Animal Feed Regulatory Program...

  16. Optimum PN Guidance Law for Maneuvering Target

    Institute of Scientific and Technical Information of China (English)

    SUN Bao-cai; QI Zai-kang

    2007-01-01

    An optimum PN guidance law for maneuvering target is developed using optimal control theory. By estimating the target position and setting the cost function, the guidance law can be deduced even without knowing the missile lateral acceleration. Since the quadratic cost function can make a compromise between the miss distance andthe control constraint, the optimum guidance law obtained is more general. Also, introduced line of sight rate as the input, a practical form of this guidance law is derived. The simulation results show the effectiveness of the guidance laws.

  17. Alaska gold rush trails study: Preliminary draft

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — Preliminary study draft, with maps, of seven gold rush trails in Alaska, to determine suitability for inclusion in the National Scenic Trails system and their...

  18. 77 FR 5415 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents, Certified...

    Science.gov (United States)

    2012-02-03

    ...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 National Organic Program: Notice of... Certified Organic Products AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice of availability with..., Agricultural Marketing Specialist, National Organic Program, USDA-AMS- NOP, 1400 Independence Ave. SW.,...

  19. 78 FR 63219 - International Conference on Harmonisation; Draft Guidance on Elemental Impurities; Availability

    Science.gov (United States)

    2013-10-23

    ... Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA... represent the Agency's current thinking on this topic. It does not create or confer any rights for or on...

  20. 76 FR 38187 - International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of...

    Science.gov (United States)

    2011-06-29

    ...; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers..., will represent the Agency's current thinking on this topic. It does not create or confer any rights...

  1. 78 FR 27115 - Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use...

    Science.gov (United States)

    2013-05-09

    ... (21 CFR part 312, subpart I) went into effect on October 13, 2009 (74 FR 40900). These regulations..., including for emergency use; (2) intermediate-size patient population access; and (3) larger population access under a treatment protocol or treatment investigational new drug application (IND)....

  2. 76 FR 31615 - Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products...

    Science.gov (United States)

    2011-06-01

    ... led in some cases to diagnostic use of laboratory tests with unproven performance characteristics and... such tests for clinical diagnostic purposes may mislead healthcare providers and cause serious adverse... Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only:...

  3. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Science.gov (United States)

    2011-11-10

    ... the development and review of IDE applications (21 CFR 812.20) for early feasibility studies of... feasibility studies may be appropriate early in device development when nonclinical testing methods are not... of an early feasibility study IDE application and explains the requirements applicable...

  4. 76 FR 53909 - Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Science.gov (United States)

    2011-08-30

    ... addressed in pharmacopeial standards. The European Pharmacopeia currently applies accuracy of subdivision..., weight variation, and loss of mass-- while the United States Pharmacopeia published a Stimuli article...

  5. 77 FR 20030 - Draft Guidance for Industry: Reporting Harmful and Potentially Harmful Constituents in Tobacco...

    Science.gov (United States)

    2012-04-03

    ... category and subcategory; and mean weight and standard deviation of tobacco in product. We estimate that...; extraction method; separation method; detection method; and mean quantity and standard deviation of HPHCs... method; separation method; detection method; and mean quantity and standard deviation of HPHCs....

  6. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Science.gov (United States)

    2011-06-22

    ... are many devices available that help patients manage the disease, FDA recognizes the need for new and... artificial pancreas device system. An artificial pancreas system is a type of autonomous system that adjusts... types of artificial pancreas systems depending upon the nature of the control algorithm. They can...

  7. 77 FR 11133 - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for...

    Science.gov (United States)

    2012-02-24

    ... infection caused by bacterial pathogens that show resistance to most antibacterial drugs on in vitro... entitled ``Complicated Urinary Tract Infections and Pyelonephritis--Developing Antimicrobial Drugs...

  8. 76 FR 27331 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-05-11

    ... recommendations for studies to establish the analytical and clinical performance of IVDs intended for C... directly from human specimens. This document is limited to studies intended to establish the performance... Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for...

  9. 76 FR 34999 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-06-15

    ... studies for establishing the performance characteristics of in vitro diagnostic devices for the detection... industry and Agency staff with recommendations for studies for establishing the performance... Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection...

  10. 76 FR 569 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-01-05

    ... recommendations for studies to establish the analytical and clinical performance of nucleic acid-based in vitro... recommendations for studies to establish the analytical and clinical performance of nucleic acid-based IVDs... Staff; Establishing the Performance Characteristics of Nucleic Acid- Based In Vitro Diagnostic...

  11. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Science.gov (United States)

    2013-01-22

    ... product that is approved under one marketing application, i.e., a biologics license application (BLA), a... product, as defined in 21 CFR 3.2(e), that is approved under one marketing application, i.e., a BLA, an... to a combination product approved under one marketing application (BLA, NDA, or PMA). In...

  12. 77 FR 34958 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors...

    Science.gov (United States)

    2012-06-12

    ... 20852-1448 (1-800-835-4709 or 301-827-1800); or the Division of Small Manufacturers, International and... studies for which IRB oversight is being transferred; ensuring availability and retention of pertinent records; establishing an effective date for the transfer; conducting a review of research by the...

  13. 77 FR 39710 - Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and...

    Science.gov (United States)

    2012-07-05

    ..., 2006 (71 FR 77314), FDA published a proposed rule on organ-specific warnings and related labeling for OTC IAAA drug products. In the Federal Register of April 29, 2009 (74 FR 19385), FDA published the final rule (2009 final rule). In the Federal Register of November 25, 2009 (74 FR 61512), FDA...

  14. 78 FR 57394 - Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human...

    Science.gov (United States)

    2013-09-18

    ... products. In the Federal Register of January 24, 2006 (71 FR 3922), FDA published a final rule on labeling... Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format... Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content...

  15. 77 FR 69631 - Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing...

    Science.gov (United States)

    2012-11-20

    ... Reducing Burden, Delay, and Ambiguity for Investigators,'' in the Federal Register of July 26, 2011 (76 FR... Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research... Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and...

  16. 76 FR 6685 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommended Warning for...

    Science.gov (United States)

    2011-02-07

    ... of January 13, 1989 (54 FR 1602), FDA revoked the exemption for patient examination gloves from... requirements for patient examination gloves. On December 12, 1990 (55 FR 51254), FDA published regulations... Report included: (1) Aerosolized powder on natural rubber latex (NRL) gloves carrying allergenic...

  17. 78 FR 44483 - Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of...

    Science.gov (United States)

    2013-07-24

    .... Background In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a final rule requiring shell egg... Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production... Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage,...

  18. 77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

    Science.gov (United States)

    2012-02-27

    ... surveillance processes, including application submission, review, compliance with good manufacturing practices... good manufacturing practices (CGMP) for PET drugs. The procedures were finalized and an implementation...://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm085783.htm . Recognizing that many...

  19. 77 FR 20026 - Draft Guidance for Industry: Modified Risk Tobacco Product Applications; Availability; Agency...

    Science.gov (United States)

    2012-04-03

    ... determine the effect of issuance of an order on consumer perception, behavior, and health, and enable FDA to... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products...

  20. 75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

    Science.gov (United States)

    2010-01-27

    ... abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change... Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit... Abuse (NIDA), as described in a Memorandum of Understanding (MOU) of March 8, 1985 (50 FR 9518). When...

  1. 78 FR 20926 - Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International...

    Science.gov (United States)

    2013-04-08

    ... accordance with ICH E2C (see 62 FR 27470 (May 19, 1997) and 69 FR 5551 (Feb. 5, 2004)) instead of a PADER... experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The... drugs) or a Periodic Adverse Experience Report (PAER) (for biologics) (21 CFR 314.80(c)(2) and...

  2. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Science.gov (United States)

    2013-12-04

    ... Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act... ``Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug... intended to assist human drug compounders that choose to register as outsourcing facilities...

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

    Science.gov (United States)

    2013-12-04

    ... Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic... entitled ``Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B... register as outsourcing facilities (outsourcing facilities). DATES: Although you can comment on...

  4. 78 FR 13686 - Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human...

    Science.gov (United States)

    2013-02-28

    ... the BPCA and assessments submitted in response to a PREA study requirement must be described in... ] FDASIA). In addition, when pediatric studies under PREA are fully or partially waived by FDA because... in the pediatric population should be consistently placed in the proper sections within...

  5. 77 FR 8883 - Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a...

    Science.gov (United States)

    2012-02-15

    ... conducting comparative structural and functional analysis, animal testing, human pharmacokinetics and... product with respect to structure, function, animal toxicity, human pharmacokinetics and...

  6. An Interim Report on NASA's Draft Space Technology Roadmaps

    Science.gov (United States)

    2011-01-01

    Ground and Launch Systems Processing B Panel 2: Robotics, Communications, and Navigation TA04 Robotics, TeleRobotics, and Autonomous Systems TA05 Communication and Navigation Systems C Panel 3: Instruments and Computing TA08 Science Instruments, Observatories, and Sensor Systems TA11 Modeling, Simulation, Information Technology, and Data Processing D Panel 4: Human Health and Surface Exploration TA06 Human Health, Life Support, and Habitation Systems TA07 Human Exploration Destination Systems E Panel 5: Materials Panel TA10 Nanotechnology TA12 Materials, Structures, Mechanical Systems, and Manufacturing TA14 Thermal Management Systems F Panel 6: Entry, Descent, and Landing Panel TA09 Entry, Descent, and Landing Systems In addition to drawing on the expertise represented on the steering committee and panels, the committee obtained input from each of 14 public workshops held on each of the 14 roadmaps. At these 1-day workshops, invited speakers, guests, and members of the public engaged in discussions on the different technology areas and their value to NASA. Broad community input was also solicited from a public website, where more than 240 public comments were received on the draft roadmaps in response to application of criteria (such as benefit, risk and reasonableness, and alignment with NASA and national goals) that the steering committee established. This interim report reflects the results of deliberations by the steering committee in light of these public inputs as well as additional inputs from the six panels. The steering committee's final report will be completed early in 2012. That report will prioritize the technologies that span the entire scope of the 14 roadmaps and provide additional guidance on crosscutting themes and other relevant topics.

  7. The hydrodynamics of dolphin drafting

    Directory of Open Access Journals (Sweden)

    Weihs Daniel

    2004-05-01

    Full Text Available Abstract Background Drafting in cetaceans is defined as the transfer of forces between individuals without actual physical contact between them. This behavior has long been surmised to explain how young dolphin calves keep up with their rapidly moving mothers. It has recently been observed that a significant number of calves become permanently separated from their mothers during chases by tuna vessels. A study of the hydrodynamics of drafting, initiated in the hope of understanding the mechanisms causing the separation of mothers and calves during fishing-related activities, is reported here. Results Quantitative results are shown for the forces and moments around a pair of unequally sized dolphin-like slender bodies. These include two major effects. First, the so-called Bernoulli suction, which stems from the fact that the local pressure drops in areas of high speed, results in an attractive force between mother and calf. Second is the displacement effect, in which the motion of the mother causes the water in front to move forwards and radially outwards, and water behind the body to move forwards to replace the animal's mass. Thus, the calf can gain a 'free ride' in the forward-moving areas. Utilizing these effects, the neonate can gain up to 90% of the thrust needed to move alongside the mother at speeds of up to 2.4 m/sec. A comparison with observations of eastern spinner dolphins (Stenella longirostris is presented, showing savings of up to 60% in the thrust that calves require if they are to keep up with their mothers. Conclusions A theoretical analysis, backed by observations of free-swimming dolphin schools, indicates that hydrodynamic interactions with mothers play an important role in enabling dolphin calves to keep up with rapidly moving adult school members.

  8. 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…

  9. 31 CFR 515.406 - Drafts under irrevocable letters of credit; documentary drafts.

    Science.gov (United States)

    2010-07-01

    ... 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... “effective date” had any interest, drawn under any irrevocable letter of credit; and (c) Documentary...

  10. 76 FR 59155 - Notice of Availability of South Coast Draft Resource Management Plan Revision and Draft...

    Science.gov (United States)

    2011-09-23

    ... Bureau of Land Management Notice of Availability of South Coast Draft Resource Management Plan Revision and Draft Environmental Impact Statement AGENCY: Bureau of Land Management, Interior. ACTION: Notice... amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land...

  11. 77 FR 74508 - Notice of Availability of the Draft Resource Management Plan Amendment, Draft Environmental...

    Science.gov (United States)

    2012-12-14

    ... Bureau of Land Management Notice of Availability of the Draft Resource Management Plan Amendment, Draft Environmental Impact Statement for the Ring of Fire Resource Management Plan--Haines Planning Area, Alaska... Management Area (ERMA) designation. The Ring of Fire RMP ROD also deferred to a subsequent planning...

  12. 77 FR 42756 - Draft Environmental Impact Statement and Draft Habitat Conservation Plan for Incidental Take of...

    Science.gov (United States)

    2012-07-20

    ... Texas troglobitic water slater (Lirceolus smithii) in case they are listed during the duration of the..., and the Edwards Aquifer Authority; San Antonio Water Systems; City of New Braunfels, Texas; City of... Fish and Wildlife Service Draft Environmental Impact Statement and Draft Habitat Conservation Plan...

  13. Guidance on accidents involving radioactivity

    International Nuclear Information System (INIS)

    This annex contains advice to Health Authorities on their response to accidents involving radioactivity. The guidance is in six parts:-(1) planning the response required to nuclear accidents overseas, (2) planning the response required to UK nuclear accidents a) emergency plans for nuclear installations b) nuclear powered satellites, (3) the handling of casualties contaminated with radioactive substances, (4) background information for dealing with queries from the public in the event of an accident, (5) the national arrangements for incident involving radioactivity (NAIR), (6) administrative arrangements. (author)

  14. Final Draft Strategic Marketing Plan.

    Energy Technology Data Exchange (ETDEWEB)

    United States. Bonneville Power Administration.

    1994-02-01

    The Bonneville Power Administration (BPA) has developed a marketing plan to define how BPA can be viable and competitive in the future, a result important to BPA`s customers and constituents. The Marketing Plan represents the preferred customer outcomes, marketplace achievements, and competitive advantage required to accomplish the Vision and the Strategic Business Objectives of the agency. The Marketing Plan contributes to successful implementation of BPA`s Strategic Business Objectives (SBOs) by providing common guidance to organizations and activities throughout the agency responsible for (1) planning, constructing, operating, and maintaining the Federal Columbia River Power System; (2) conducting business with BPA`s customers; and (3) providing required internal support services.

  15. Flight Guidance System Requirements Specification

    Science.gov (United States)

    Miller, Steven P.; Tribble, Alan C.; Carlson, Timothy M.; Danielson, Eric J.

    2003-01-01

    This report describes a requirements specification written in the RSML-e language for the mode logic of a Flight Guidance System of a typical regional jet aircraft. This model was created as one of the first steps in a five-year project sponsored by the NASA Langley Research Center, Rockwell Collins Inc., and the Critical Systems Research Group of the University of Minnesota to develop new methods and tools to improve the safety of avionics designs. This model will be used to demonstrate the application of a variety of methods and techniques, including safety analysis of system and subsystem requirements, verification of key properties using theorem provers and model checkers, identification of potential sources mode confusion in system designs, partitioning of applications based on the criticality of system hazards, and autogeneration of avionics quality code. While this model is representative of the mode logic of a typical regional jet aircraft, it does not describe an actual or planned product. Several aspects of a full Flight Guidance System, such as recovery from failed sensors, have been omitted, and no claims are made regarding the accuracy or completeness of this specification.

  16. 77 FR 33489 - Draft Offender Tracking System Standard

    Science.gov (United States)

    2012-06-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Office of Justice Programs Draft Offender Tracking System Standard AGENCY: National Institute of Justice. ACTION: Notice of Draft Offender Tracking System Standard, Selection and Application Guide,...

  17. Indiana Bat (Myotis sodalis) Draft Recovery Plan: First Revision

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — U.S. Fish and Wildlife Service's Draft recovery plan for Indiana bats, a Federally endangered species. First revision. The purpose of this draft recovery plan is to...

  18. Collective cell migration: guidance principles and hierarchies.

    Science.gov (United States)

    Haeger, Anna; Wolf, Katarina; Zegers, Mirjam M; Friedl, Peter

    2015-09-01

    Collective cell migration results from the establishment and maintenance of collective polarization, mechanocoupling, and cytoskeletal kinetics. The guidance of collective cell migration depends on a reciprocal process between cell-intrinsic multicellular organization with leader-follower cell behavior and results in mechanosensory integration of extracellular guidance cues. Important guidance mechanisms include chemotaxis, haptotaxis, durotaxis, and strain-induced mechanosensing to move cell groups along interfaces and paths of least resistance. Additional guidance mechanisms steering cell groups during specialized conditions comprise electrotaxis and passive drift. To form higher-order cell and tissue structures during morphogenesis and cancer invasion, these guidance principles act in parallel and are integrated for collective adaptation to and shaping of varying tissue environments. We review mechanochemical and electrical inputs and multiparameter signal integration underlying collective guidance, decision making, and outcome. PMID:26137890

  19. Optimal terminal guidance for exoatmospheric interception

    Institute of Scientific and Technical Information of China (English)

    Yu Wenbin; Chen Wanchun; Yang Liang; Liu Xiaoming; Zhou Hao

    2016-01-01

    In this study, two optimal terminal guidance (OTG) laws, one of which takes into account the final velocity vector constraint, are developed for exoatmospheric interception using optimal control theory. In exoatmospheric interception, because the proposed guidance laws give full consideration to the effect of gravity, they consume much less fuel than the traditional guidance laws while requiring a light computational load. In the development of the guidance laws, a unified optimal guidance problem is put forward, where the final velocity vector constraint can be consid-ered or neglected by properly adjusting a parameter in the cost function. To make this problem ana-lytically solvable, a linear model is used to approximate the gravity difference, the difference of the gravitational accelerations of the target and interceptor. Additionally, an example is provided to show that some achievements of this study can be used to significantly improve the fuel efficiency of the pulsed guidance employed by the interceptor whose divert thrust level is fixed.

  20. Health Service use of ionising radiations: Guidance

    International Nuclear Information System (INIS)

    This booklet gives outline guidance on the use of ionising radiations in the Health Service in the United Kingdom. Extensive reference is made to documents where more detailed information may be found. The guidance covers general advice on the medical use of ionising radiations, statutory requirements, and guidance on selected Health Service issues such as patient identification procedures, information management systems, deviations from prescribed radiation dose, imaging and radiotherapy. (57 references) (U.K.)

  1. Hybrid Guidance System for Relative Navigation Project

    Data.gov (United States)

    National Aeronautics and Space Administration — Future NASA architectures and missions will involve many distributed platforms that must work together. This in turn requires guidance, navigation and control...

  2. 77 FR 69619 - Draft Recommendations of Joint Outreach Team

    Science.gov (United States)

    2012-11-20

    ... Area Power Administration Draft Recommendations of Joint Outreach Team AGENCY: Western Area Power Administration, DOE. ACTION: Notice of Availability of draft recommendations of Western/DOE Joint Outreach Team... Department of Energy (DOE), is publishing the draft recommendations of the Western/DOE Joint Outreach...

  3. 19 CFR 207.63 - Circulation of draft questionnaires.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 3 2010-04-01 2010-04-01 false Circulation of draft questionnaires. 207.63... SUBSIDIZED EXPORTS TO THE UNITED STATES Five-Year Reviews § 207.63 Circulation of draft questionnaires. (a) The Director shall circulate draft questionnaires to the parties for comment in each full review....

  4. 75 FR 9613 - Draft NIJ Restraints Standard for Criminal Justice

    Science.gov (United States)

    2010-03-03

    ... of Justice Programs Draft NIJ Restraints Standard for Criminal Justice AGENCY: National Institute of Justice, Office of Justice Programs, DOJ. ACTION: Notice of Draft NIJ Restraints Standard for Criminal... Restraints Standard for Criminal Justice'' and (2) a draft companion document entitled, ``NIJ...

  5. 76 FR 9209 - Draft NOAA National Aquaculture Policy

    Science.gov (United States)

    2011-02-16

    ... National Aquaculture Policy and Draft DOC National Aquaculture Policy; Notices #0;#0;Federal Register / Vol... and Atmospheric Administration RIN 0648-XA214 Draft NOAA National Aquaculture Policy AGENCY: National...: Notice of availability of draft aquaculture policy; request for comments. SUMMARY: NOAA is seeking...

  6. The Physics of Bump Drafting in Car Racing

    Science.gov (United States)

    Fiolhais, Miguel C. N.; Amor dos Santos, Susana

    2014-01-01

    The technique of bump drafting, also known as two-car drafting in motorsports, is analysed in the framework of Newtonian mechanics and simple aerodynamic drag forces. As an apparent unnatural effect that often pleases the enthusiasts of car racing, bump drafting provides a unique pedagogical opportunity for students to gain insights into the…

  7. 75 FR 57956 - Draft Revision of the Federalwide Assurance

    Science.gov (United States)

    2010-09-23

    ... HUMAN SERVICES Draft Revision of the Federalwide Assurance AGENCY: Department of Health and Human... Assistant Secretary for Health, is announcing the availability of the draft revised Federalwide Assurance (FWA) form and Terms of Assurance, and is seeking comment on these draft documents. OHRP is...

  8. Adaptive Guidance based on Context Profile for Software Process Modeling

    Directory of Open Access Journals (Sweden)

    Hamid Khemissa

    2012-07-01

    Full Text Available This paper aims to define an adaptive guidance for software process modeling. The proposed guidance approach is based on development’s profile context (actor’s role in the process, actor’s qualification and related activities in progress. We introduce new guidance concepts through adaptive guidance meta-model (AGM allowing specific assistance interventions (corrective, constructive and automatic guidance. We illustrate our guidance approach using SPEM formalism extended with these new guidance concepts.

  9. Agent Based Individual Traffic Guidance

    DEFF Research Database (Denmark)

    Wanscher, Jørgen

    This thesis investigates the possibilities in applying Operations Research (OR) to autonomous vehicular traffic. The explicit difference to most other research today is that we presume that an agent is present in every vehicle - hence Agent Based Individual Traffic guidance (ABIT). The next...... evolutionary step for the in-vehicle route planners is the introduction of two-way communication. We presume that the agent is capable of exactly this. Based on this presumption we discuss the possibilities and define a taxonomy and use this to discuss the ABIT system. Based on a set of scenarios we conclude...... that the system can be divided into two separate constituents. The immediate dispersion, which is used for small areas and quick response, and the individual alleviation, which considers the longer distance decision support. Both of these require intrinsicate models and cost functions which at the beginning...

  10. 78 FR 37231 - Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2013-06-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry; Guidance on Abbreviated New Drug... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the...) review process more efficient. DATES: Submit either electronic or written comments on Agency guidances...

  11. DRAFT CAREER PATH - DESCRIPTIONS AND EVALUATION GUIDE

    CERN Multimedia

    1999-01-01

    As indicated in the summary of the Standing Concertation Committee meeting of 3 March 1999, the Committee has approved the above draft guide concerning Career Paths II to VII on a test basis for at least one year.During this period, Personnel Division has been asked to monitor the applicability of this guide for possible future implementation (establishment of vacancies for recruitment, change of career path evaluations, salary survey comparisons) and to report back to the Standing Concertation Committee after approximately one year.Copies of the draft guide are available on request in divisional secretariats.Personnel DivisionTel.74480

  12. Driving change : sustainable development action plans Guidance

    OpenAIRE

    Sustainable Development Commission

    2008-01-01

    This guidance builds upon the Sustainable Development Commission’s previous guidance, Getting Started (August 2005), which set out the basic elements that the Sustainable Development Commission would expect to see in a good Sustainable Development Action Plan. Publisher PDF Original published August 2005.

  13. Minimum variation guidance laws for interceptor missiles

    NARCIS (Netherlands)

    Weiss, M.; Shima, T.

    2014-01-01

    This paper introduces a new approach to guidance law design using linear quadratic optimal control theory, minimizing throughout the engagement the variation of the control input as well as the integral control effort. The guidance law is derived for arbitrary order missile dynamics and target maneu

  14. 75 FR 76079 - Sound Incentive Compensation Guidance

    Science.gov (United States)

    2010-12-07

    ... Office of Thrift Supervision Sound Incentive Compensation Guidance AGENCY: Office of Thrift Supervision... collection. Title of Proposal: Sound Incentive Compensation Guidance. OMB Number: 1550-0129. Form Number: N/A... compensation arrangements at a financial institution do not encourage employees to take excessive risks....

  15. 75 FR 53023 - Sound Incentive Compensation Guidance

    Science.gov (United States)

    2010-08-30

    ... Office of Thrift Supervision Sound Incentive Compensation Guidance AGENCY: Office of Thrift Supervision... collection. Title of Proposal: Sound Incentive Compensation Guidance. OMB Number: 1550-0129. Form Number: N/A... compensation arrangements at a financial institution do not encourage employees to take excessive risks....

  16. 75 FR 22679 - Sound Incentive Compensation Guidance

    Science.gov (United States)

    2010-04-29

    ... Office of Thrift Supervision Sound Incentive Compensation Guidance AGENCY: Office of Thrift Supervision... collection. Title of Proposal: Sound Incentive Compensation Guidance. OMB Number: 1550-0NEW. Form Number: N/A... compensation arrangements at a financial institution do not encourage employees to take excessive risks....

  17. Guidance for performing preliminary assessments under CERCLA

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1991-09-01

    EPA headquarters and a national site assessment workgroup produced this guidance for Regional, State, and contractor staff who manage or perform preliminary assessments (PAs). EPA has focused this guidance on the types of sites and site conditions most commonly encountered. The PA approach described in this guidance is generally applicable to a wide variety of sites. However, because of the variability among sites, the amount of information available, and the level of investigative effort required, it is not possible to provide guidance that is equally applicable to all sites. PA investigators should recognize this and be aware that variation from this guidance may be necessary for some sites, particularly for PAs performed at Federal facilities, PAs conducted under EPA`s Environmental Priorities Initiative (EPI), and PAs at sites that have previously been extensively investigated by EPA or others. The purpose of this guidance is to provide instructions for conducting a PA and reporting results. This guidance discusses the information required to evaluate a site and how to obtain it, how to score a site, and reporting requirements. This document also provides guidelines and instruction on PA evaluation, scoring, and the use of standard PA scoresheets. The overall goal of this guidance is to assist PA investigators in conducting high-quality assessments that result in correct site screening or further action recommendations on a nationally consistent basis.

  18. Career Guidance in the Elementary School

    Science.gov (United States)

    Leonard, George E.

    1971-01-01

    The purpose of this column is to discuss, describe and disseminate information regarding career guidance principles and practices in the elementary schools. Specifically the activities of the Developmental Career Guidance Projects in inner city Detroit are described. The activities emphasize action involvement of children while didactic learning…

  19. How Effective Is Central Bank Forward Guidance?

    NARCIS (Netherlands)

    Kool, C.J.M.; Thornton, D.L.

    2012-01-01

    In this paper, we use survey forecasts to investigate the impact of forward guidance on the predictability of future short- and long-term interest rates in four countries: New Zealand, Norway, Sweden, and the United States. New Zealand began providing forward guidance in 1997, Norway in 2005, and Sw

  20. 78 FR 57450 - State Rail Plan Guidance

    Science.gov (United States)

    2013-09-18

    ... authorized in the Act and available under the High-Speed Intercity Passenger Rail program. This guidance... qualifies States to receive grants for high-speed rail only. Response: Operational information about all... Federal Railroad Administration State Rail Plan Guidance AGENCY: Federal Railroad Administration...

  1. Improving rehabilitation exercise performance through visual guidance.

    Science.gov (United States)

    Lam, Agnes W K; HajYasien, Ahmed; Kulic, Dana

    2014-01-01

    In current physical rehabilitation protocols, patients typically perform exercises without feedback or guidance following the initial demonstrations from the physiotherapist. This paper proposes a system providing continuous visual feedback and guidance to patients to improve quality of motion performance and adherence to instructions. The system consists of body-worn inertial measurement units which continuously measure the patient's pose. The measured pose is overlaid with the instructed motion on a visual display shown to the user during exercise performance. Two user studies were conducted with healthy participants to evaluate the usability of the visual guidance tool. Motion data was collected by the inertial measurement sensors and used to evaluate quality of motion, comparing user performance with and without visual feedback and with or without exercise guidance. The quantitative and qualitative results of the studies confirm that performing the exercises with the visual guidance tool promotes more consistent exercise performance and proper technique. PMID:25570311

  2. An Adaptive Weighted Differential Game Guidance Law

    Institute of Scientific and Technical Information of China (English)

    ZHANG Ping; FANG Yangwang; ZHANG Fengming; XIAO Bingsong; HU Shiguo; ZONG Shuning

    2012-01-01

    For intercepting modern high maneuverable targets,a novel adaptive weighted differential game guidance law based on the game theory of mixed strategy is proposed,combining two guidance laws which are derived from the perfect and imperfect information pattem,respectively.The weights vary according to the estimated error of the target's acceleration,the guidance law is generated by directly using the estimation of target's acceleration when the estimated error is small,and a differential game guidance law with adaptive penalty coefficient is implemented when the estimated error is large.The adaptive penalty coefficients are not constants and they can be adjusted with current target maneuverability.The superior homing performance of the new guidance law is verified by computer simulations.

  3. An adaptive guidance algorithm for aerospace vehicles

    Science.gov (United States)

    Bradt, J. E.; Hardtla, J. W.; Cramer, E. J.

    The specifications for proposed space transportation systems are placing more emphasis on developing reusable avionics subsystems which have the capability to respond to vehicle evolution and diverse missions while at the same time reducing the cost of ground support for mission planning, contingency response and verification and validation. An innovative approach to meeting these goals is to specify the guidance problem as a multi-point boundary value problen and solve that problem using modern control theory and nonlinear constrained optimization techniques. This approach has been implemented as Gamma Guidance (Hardtla, 1978) and has been successfully flown in the Inertial Upper Stage. The adaptive guidance algorithm described in this paper is a generalized formulation of Gamma Guidance. The basic equations are presented and then applied to four diverse aerospace vehicles to demonstrate the feasibility of using a reusable, explicit, adaptive guidance algorithm for diverse applications and vehicles.

  4. 46 CFR 169.755 - Draft marks and draft indicating systems.

    Science.gov (United States)

    2010-10-01

    ... SCHOOL VESSELS Vessel Control, Miscellaneous Systems, and Equipment Markings § 169.755 Draft marks and... projections of the marks onto a vertical plane are of uniform height equal to the vertical spacing...

  5. 76 FR 55941 - Notice of Availability of the Draft Bakersfield Resource Management Plan and Draft Environmental...

    Science.gov (United States)

    2011-09-09

    ... species, geologic, and riparian. Proposed limitations address land use authorizations, livestock grazing... status wildlife and plant species, geologic, and riparian. Proposed limitations address land use... Bureau of Land Management Notice of Availability of the Draft Bakersfield Resource Management Plan...

  6. 76 FR 63676 - Final Division of Safety Systems Interim Staff Guidance DSS-ISG-2010-01: Staff Guidance Regarding...

    Science.gov (United States)

    2011-10-13

    ... COMMISSION Final Division of Safety Systems Interim Staff Guidance DSS-ISG- 2010-01: Staff Guidance Regarding... final Division of Safety Systems Interim Staff Guidance, (DSS-ISG) DSS- ISG-2010-01, ``Staff Guidance... guidance to the NRC staff reviewer to address the increased complexity of recent spent fuel pool...

  7. Augmented Reality Repair Guidance System

    Directory of Open Access Journals (Sweden)

    Sidharth Bhatia

    2012-07-01

    Full Text Available The daily life of a common man revolves around various forms of appliances/gadgets he uses throughout the day such as a mobile phone, laptop, printer, microwave oven, washing machine, etc. Although these appliances/gadgets are taken by most of the people for granted, the problem occurs when any of these things do not work as they are expected to. Getting them to the repair shops for every small glitch is expensive as well as time consuming. Although most of the companies which produce these appliances/gadgets do supply them with basic manuals, which deal with how to solve these minor issues, but reading them and at the same time repairing the corresponding appliance/gadget can be a frustrating task at times. These problems can be reduced to a large extent if some kind of live guidance is available. In this paper we propose a method to do so with the help of an augmented reality based system that will guide the user to carry out small scale repair jobs on these gadgets. All that is required is a decent webcam and a computing device, with a processor of 1 GHz or more and a display screen.

  8. Draft genome sequence of Bacillus endophyticus 2102.

    Science.gov (United States)

    Lee, Yong-Jik; Lee, Sang-Jae; Kim, Sun Hong; Lee, Sang Jun; Kim, Byoung-Chan; Lee, Han-Seung; Jeong, Haeyoung; Lee, Dong-Woo

    2012-10-01

    Bacillus endophyticus 2102 is an endospore-forming, plant growth-promoting rhizobacterium isolated from a hypersaline pond in South Korea. Here we present the draft sequence of B. endophyticus 2102, which is of interest because of its potential use in the industrial production of algaecides and bioplastics and for the treatment of industrial textile effluents. PMID:23012284

  9. Drafting. Advanced Print Reading--Electrical.

    Science.gov (United States)

    Oregon State Dept. of Education, Salem.

    This document is a workbook for drafting students learning advanced print reading for electricity applications. The workbook contains seven units covering the following material: architectural working drawings; architectural symbols and dimensions; basic architectural electrical symbols; wiring symbols; riser diagrams; schematic diagrams; and…

  10. Adding Realism to Technical Drafting Programs

    Science.gov (United States)

    Weaver, Gerald L.

    1976-01-01

    Suggestions for improved, relevant technical drafting programs are presented: (1) making realistic assignments, (2) viewing real projects, (3) duplicating industrial projects, (4) practicing lettering, (5) conducting research, (6) engaging in teamwork, (7) adapting to change, (8) learning to meet deadlines, and (9) stressing the importance of…

  11. Drafting & Design Technology. Technical Committee Report.

    Science.gov (United States)

    Idaho State Dept. of Education, Boise. Div. of Vocational Education.

    This Technical Committee Report prepared by industry representatives in Idaho lists the skills currently necessary for an employee in that state to obtain a job in drafting and design technology, retain a job once hired, and advance in that occupational field. (Task lists are grouped according to duty areas generally used in industry settings, and…

  12. Clarify Drafting Concepts With an Overhead Projector

    Science.gov (United States)

    Dudley, Stanley

    1978-01-01

    Presents techniques for using the overhead projector to help beginning drafting students visualize concepts involving situations where the plane of projection is not parallel to the surface being considered, such as the circle as an ellipse, the true sizes of acute and right angles, and sizes and shapes of oblique surfaces. (TA)

  13. Reduced order model of draft tube flow

    Science.gov (United States)

    Rudolf, P.; Štefan, D.

    2014-03-01

    Swirling flow with compact coherent structures is very good candidate for proper orthogonal decomposition (POD), i.e. for decomposition into eigenmodes, which are the cornerstones of the flow field. Present paper focuses on POD of steady flows, which correspond to different operating points of Francis turbine draft tube flow. Set of eigenmodes is built using a limited number of snapshots from computational simulations. Resulting reduced order model (ROM) describes whole operating range of the draft tube. ROM enables to interpolate in between the operating points exploiting the knowledge about significance of particular eigenmodes and thus reconstruct the velocity field in any operating point within the given range. Practical example, which employs axisymmetric simulations of the draft tube flow, illustrates accuracy of ROM in regions without vortex breakdown together with need for higher resolution of the snapshot database close to location of sudden flow changes (e.g. vortex breakdown). ROM based on POD interpolation is very suitable tool for insight into flow physics of the draft tube flows (especially energy transfers in between different operating points), for supply of data for subsequent stability analysis or as an initialization database for advanced flow simulations.

  14. Draft genome sequence of Virgibacillus halodenitrificans 1806.

    Science.gov (United States)

    Lee, Sang-Jae; Lee, Yong-Jik; Jeong, Haeyoung; Lee, Sang Jun; Lee, Han-Seung; Pan, Jae-Gu; Kim, Byoung-Chan; Lee, Dong-Woo

    2012-11-01

    Virgibacillus halodenitrificans 1806 is an endospore-forming halophilic bacterium isolated from salterns in Korea. Here, we report the draft genome sequence of V. halodenitrificans 1806, which may reveal the molecular basis of osmoadaptation and insights into carbon and anaerobic metabolism in moderate halophiles. PMID:23105070

  15. Draft Genome Sequence of Virgibacillus halodenitrificans 1806

    OpenAIRE

    Lee, Sang-Jae; Lee, Yong-Jik; Jeong, Haeyoung; Lee, Sang Jun; Lee, Han-Seung; Pan, Jae-Gu; Kim, Byoung-Chan; Lee, Dong-Woo

    2012-01-01

    Virgibacillus halodenitrificans 1806 is an endospore-forming halophilic bacterium isolated from salterns in Korea. Here, we report the draft genome sequence of V. halodenitrificans 1806, which may reveal the molecular basis of osmoadaptation and insights into carbon and anaerobic metabolism in moderate halophiles.

  16. 75 FR 63851 - Draft Friends Organizations Policy

    Science.gov (United States)

    2010-10-18

    ... Fish and Wildlife Service Draft Friends Organizations Policy AGENCY: Fish and Wildlife Service... effectiveness in achieving the Service's mission through partnerships with Friends organizations (volunteer/advocate). Today, Friends organizations play a vital role in helping to fulfill the Service's mission...

  17. CFD based draft tube hydraulic design optimization

    Science.gov (United States)

    McNabb, J.; Devals, C.; Kyriacou, S. A.; Murry, N.; Mullins, B. F.

    2014-03-01

    The draft tube design of a hydraulic turbine, particularly in low to medium head applications, plays an important role in determining the efficiency and power characteristics of the overall machine, since an important proportion of the available energy, being in kinetic form leaving the runner, needs to be recovered by the draft tube into static head. For large units, these efficiency and power characteristics can equate to large sums of money when considering the anticipated selling price of the energy produced over the machine's life-cycle. This same draft tube design is also a key factor in determining the overall civil costs of the powerhouse, primarily in excavation and concreting, which can amount to similar orders of magnitude as the price of the energy produced. Therefore, there is a need to find the optimum compromise between these two conflicting requirements. In this paper, an elaborate approach is described for dealing with this optimization problem. First, the draft tube's detailed geometry is defined as a function of a comprehensive set of design parameters (about 20 of which a subset is allowed to vary during the optimization process) and are then used in a non-uniform rational B-spline based geometric modeller to fully define the wetted surfaces geometry. Since the performance of the draft tube is largely governed by 3D viscous effects, such as boundary layer separation from the walls and swirling flow characteristics, which in turn governs the portion of the available kinetic energy which will be converted into pressure, a full 3D meshing and Navier-Stokes analysis is performed for each design. What makes this even more challenging is the fact that the inlet velocity distribution to the draft tube is governed by the runner at each of the various operating conditions that are of interest for the exploitation of the powerhouse. In order to determine these inlet conditions, a combined steady-state runner and an initial draft tube analysis, using a

  18. CFD based draft tube hydraulic design optimization

    International Nuclear Information System (INIS)

    The draft tube design of a hydraulic turbine, particularly in low to medium head applications, plays an important role in determining the efficiency and power characteristics of the overall machine, since an important proportion of the available energy, being in kinetic form leaving the runner, needs to be recovered by the draft tube into static head. For large units, these efficiency and power characteristics can equate to large sums of money when considering the anticipated selling price of the energy produced over the machine's life-cycle. This same draft tube design is also a key factor in determining the overall civil costs of the powerhouse, primarily in excavation and concreting, which can amount to similar orders of magnitude as the price of the energy produced. Therefore, there is a need to find the optimum compromise between these two conflicting requirements. In this paper, an elaborate approach is described for dealing with this optimization problem. First, the draft tube's detailed geometry is defined as a function of a comprehensive set of design parameters (about 20 of which a subset is allowed to vary during the optimization process) and are then used in a non-uniform rational B-spline based geometric modeller to fully define the wetted surfaces geometry. Since the performance of the draft tube is largely governed by 3D viscous effects, such as boundary layer separation from the walls and swirling flow characteristics, which in turn governs the portion of the available kinetic energy which will be converted into pressure, a full 3D meshing and Navier-Stokes analysis is performed for each design. What makes this even more challenging is the fact that the inlet velocity distribution to the draft tube is governed by the runner at each of the various operating conditions that are of interest for the exploitation of the powerhouse. In order to determine these inlet conditions, a combined steady-state runner and an initial draft tube analysis

  19. Sustainability guidance pack for suppliers: May 2011

    OpenAIRE

    2013-01-01

    This document provides guidance on specific sustainability topics to inform and support suppliers in meeting sustainability obligations. Suppliers are any organisation providing services, overlay and equipment for or on behalf of LOCOG, including at venues.

  20. Integrated Entry Guidance for Reusable Launch Vehicle

    Institute of Scientific and Technical Information of China (English)

    NING Guo-dong; ZHANG Shu-guang; FANG Zhen-ping

    2007-01-01

    A method for the implementation of integrated three-degree-of-freedom constrained entry guidance for reusable launch vehicle is presented. Given any feasible entry conditions, terminal area energy management interface conditions, and the reference trajectory generated onboard then, the method can generate a longitudinal guidance profile rapidly, featuring linear quadratic regular method and a proportional-integral-derivative tracking law with time-varying gains, which satisfies all the entry corridor constraints and meets the requirements with high precision. Afterwards, by utilizing special features of crossrange parameter, establishing bank-reversal corridor,and determining bank-reversals according to dynamically adjusted method, the algorithm enables the lateral entry guidance system to fly a wide range of missions and provides reliable and good performance in the presence of significant aerodynamic modeling uncertainty.Fast trajectory guidance profiles and simulations with a reusable launch vehicle model for various missions and aerodynamic uncertainties are presented to demonstrate the capacity and reliability of this method.

  1. The Guidance Clinic - An Alternative to Suspension

    Science.gov (United States)

    Stiavelli, Richard E.; Sykes, Dudley E.

    1972-01-01

    A guidance clinic program for disruptive students, based on behavior modification theory and positive reinforcement, has proven effective in dealing with junior and senior high school students who ordinarily would be suspended or excluded from school. (AN)

  2. 7 CFR 1794.7 - Guidance.

    Science.gov (United States)

    2010-01-01

    ... Analysis, Stop 1522, 1400 Independence Avenue, SW., Washington, DC 20250-1522. (b) Water and waste program... appropriate State Director. State Directors may provide supplemental guidance to meet state and local laws...

  3. Drill machine guidance using natural occurring radiation

    International Nuclear Information System (INIS)

    A drilling machine guidance system is described which uses only the naturally occuring radiation within the seam or stratum of interest. The apparatus can be used for guiding horizontal drilling machines through coal seams and the like. (U.K.)

  4. RCRA Programmatic Information Policy and Guidance

    Data.gov (United States)

    U.S. Environmental Protection Agency — This asset includes program policy and guidance documents that are used by the EPA regions, states, tribes and private parties to implement the hazardous waste...

  5. Vocational guidance: origin, evolution and current state

    OpenAIRE

    Di Doménico, Cristina; Vilanova, Alberto

    2000-01-01

    The socio-professional sources of the vocational guidance are reviwed, in the world and in Latin America. It stands out that psychology, as science and as a profession, possesses vigorous links to this practice that, however, tends to its epistemic and praxic emancipation in some nations. The contemporary prob- lems of the guidance are presented in their economic, politics, cultural and pro-fessional dimensions.

  6. ROUTE PLAN DESIGNER FOR TRACTOR GUIDANCE SYSTEMS

    DEFF Research Database (Denmark)

    Sveistrup, Daniel; Jørgensen, Rasmus Nyholm; Green, Ole;

    2010-01-01

    Earlier works have shown field trial designs to be very labor extensive, even when combining autoguidancesystems with conventional machinery.Designing routes for semi-automated systems in a controlled manner is both resource demandingand complicated. Different types of auto-guidance systems vary...... was outlined, it took less thanone hour entering the design into the software and generating the auto-guidance files.KeywordsGIS, Auto steering systems, plot trial design, full-scale field trials, Java...

  7. 78 FR 74162 - Draft Criminal Justice Offender Tracking System Standard and Companion Documents

    Science.gov (United States)

    2013-12-10

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Office of Justice Programs Draft Criminal Justice Offender Tracking System Standard and Companion Documents... draft documents: (1) A draft standard entitled, ``Criminal Justice Offender Tracking System...

  8. 78 FR 54906 - Draft Supplemental Environmental Impact Report/Environmental Impact Statement for a Proposed...

    Science.gov (United States)

    2013-09-06

    ... Fish and Wildlife Service Draft Supplemental Environmental Impact Report/Environmental Impact Statement... Coachella Valley Conservation Commission (CVCC), has prepared a joint draft Supplemental Environmental Impact Report/Environmental Impact Statement (draft Supplemental EIR/EIS) under the...

  9. 78 FR 65980 - Notice of Availability for Public Review and Comment: Draft EPA Climate Change Adaptation...

    Science.gov (United States)

    2013-11-04

    ... AGENCY Notice of Availability for Public Review and Comment: Draft EPA Climate Change Adaptation... have produced draft Climate Change Adaptation Implementation Plans (``Implementation Plans'') that... health and the environment. As EPA articulated in its draft Agency Climate Change Adaptation Plan,...

  10. Staff supplement to the draft report on human engineering guide to control room evaluation: response to comments, sample checklist, draft systems review guidelines, and evaluation procedures

    International Nuclear Information System (INIS)

    This staff supplement to Draft Report NUREG/CR-1580, Human Engineering Guide to Control Room Evaluation, provides staff responses to comments on the draft report and supplemental material not provided in the draft report. The supplemental material includes new draft guidelines for the systems review of nuclear power plant control rooms and sample checklists and corresponding human engineering guidelines

  11. Circling particles and drafting in optical vortices

    OpenAIRE

    Reichert, Michael; Stark, Holger

    2004-01-01

    Particles suspended in a viscous fluid circle in optical vortices generated by holographic optical-tweezer techniques [Curtis J E and Grier D G 2003 Phys. Rev. Lett. 90 133901]. We model this system and show that hydrodynamic interactions between the circling particles determine their collective motion. We perform a linear-stability analysis to investigate the stability of regular particle clusters and illustrate the limit cycle to which the unstable modes converge. We clarify that drafting o...

  12. The Development of a Lifelong Guidance System in Hungary

    Science.gov (United States)

    Watts, A. G.; Borbely-Pecze, Bors Tibor

    2011-01-01

    The development of a lifelong guidance system in Hungary Systematic work is currently being undertaken in Hungary to develop a lifelong guidance system, in line with principles outlined by leading international organisations. The origins of career guidance in Hungary, and the nature of the current career guidance system, are outlined. The main…

  13. Earlier Guidance Opportunities: Priorities for the 1970's.

    Science.gov (United States)

    Nemec, William E., Ed.

    "Earlier Guidance Opportunities (EGO): Priorities for the 1970's" was the topic for this Ohio Elementary Guidance Conference. In his keynote address entitled "New Perspectives on the Guidance of Younger Children - Can We Afford to Delay Vocational Guidance?" Dr. George E. Hill used EGO to say, "Education Gives Opportunity,""Ego's Grow on…

  14. The voice of users in adult career guidance

    DEFF Research Database (Denmark)

    Plant, Peter

    2012-01-01

    Is the voice of users heard in adult career guidance? Pan-Nordic Research shows that users are seen as recipients rather than agents i adult career guidance.......Is the voice of users heard in adult career guidance? Pan-Nordic Research shows that users are seen as recipients rather than agents i adult career guidance....

  15. Launch flexibility using NLP guidance and remote wind sensing

    Science.gov (United States)

    Cramer, Evin J.; Bradt, Jerre E.; Hardtla, John W.

    1990-01-01

    This paper examines the use of lidar wind measurements in the implementation of a guidance strategy for a nonlinear programming (NLP) launch guidance algorithm. The NLP algorithm uses B-spline command function representation for flexibility in the design of the guidance steering commands. Using this algorithm, the guidance system solves a two-point boundary value problem at each guidance update. The specification of different boundary value problems at each guidance update provides flexibility that can be used in the design of the guidance strategy. The algorithm can use lidar wind measurements for on pad guidance retargeting and for load limiting guidance steering commands. Examples presented in the paper use simulated wind updates to correct wind induced final orbit errors and to adjust the guidance steering commands to limit the product of the dynamic pressure and angle-of-attack for launch vehicle load alleviation.

  16. Raising the Profile of Career Guidance: Educational and Vocational Guidance Practitioner

    Science.gov (United States)

    Hiebert, Bryan

    2009-01-01

    In 2007 the International Association for Educational and Vocational Guidance (IAEVG) launched the Educational and Vocational Guidance Practitioner credential (EVGP) as one means of formally acknowledging the knowledge, skills, and personal attributes that practitioners need in order to provide quality career development services to clients. This…

  17. Code of Conduct on the Safety and Security of Radioactive Sources,and the associated Guidance on the Import and Export of Radioactive Sources

    International Nuclear Information System (INIS)

    The Code of Conduct on the Safety and Security of Radioactive Sources (the Code of Conduct) provides guidance, reflecting international consensus, on how States should safely and securely manage radioactive sources. The drafting of the Code was an exercise in two parts, its initial drafting in 2000, and the extensive revision in 2002-2003. Between the two were, of course, the events of September 2001. While much of the original 2000 Code is still there in the 2003 Code, the revised Code is more substantive, particularly in the areas of security and international trade. In addition, the State level commitment requested by the IAEA General Conference takes the Code beyond the status of a mere recommendation, although it is not legally binding. This paper deals with the scope of the code, provisions of the code, status of the code and import and export guidance. It is concluded that radioactive sources provide many benefits to society, but at the same time, serious accidents have occurred in the past. While their continued use should be encouraged, it must be accompanied by efforts to prevent or minimize such accidents. The Code and the Guidance represent a concerted attempt by IAEA Member States to address the failings which led to those accidents. They also represent an attempt to grapple with the threat of the malicious use of sources in radiological dispersal devices. The priority must be the effective implementation at national level of these standards

  18. Safety of magnetic fusion facilities: Guidance

    International Nuclear Information System (INIS)

    This document provides guidance for the implementation of the requirements identified in DOE-STD-6002-96, Safety of Magnetic Fusion Facilities: Requirements. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While the requirements in DOE-STD-6002-96 are generally applicable to a wide range of fusion facilities, this Standard, DOE-STD-6003-96, is concerned mainly with the implementation of those requirements in large facilities such as the International Thermonuclear Experimental Reactor (ITER). Using a risk-based prioritization, the concepts presented here may also be applied to other magnetic fusion facilities. This Standard is oriented toward regulation in the Department of Energy (DOE) environment as opposed to regulation by other regulatory agencies. As the need for guidance involving other types of fusion facilities or other regulatory environments emerges, additional guidance volumes should be prepared. The concepts, processes, and recommendations set forth here are for guidance only. They will contribute to safety at magnetic fusion facilities

  19. Safety of magnetic fusion facilities: Guidance

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-05-01

    This document provides guidance for the implementation of the requirements identified in DOE-STD-6002-96, Safety of Magnetic Fusion Facilities: Requirements. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While the requirements in DOE-STD-6002-96 are generally applicable to a wide range of fusion facilities, this Standard, DOE-STD-6003-96, is concerned mainly with the implementation of those requirements in large facilities such as the International Thermonuclear Experimental Reactor (ITER). Using a risk-based prioritization, the concepts presented here may also be applied to other magnetic fusion facilities. This Standard is oriented toward regulation in the Department of Energy (DOE) environment as opposed to regulation by other regulatory agencies. As the need for guidance involving other types of fusion facilities or other regulatory environments emerges, additional guidance volumes should be prepared. The concepts, processes, and recommendations set forth here are for guidance only. They will contribute to safety at magnetic fusion facilities.

  20. 78 FR 48201 - Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2013-01; Guidance for...

    Science.gov (United States)

    2013-08-07

    ... COMMISSION Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2013-01; Guidance for... Lessons-Learned Project Directorate Interim Staff Guidance (JLD-ISG), JLD-ISG-2013-01, ``Guidance for... to http://www.nrc.gov/reading-rm/doc-collections/isg/japan-lessons-learned.html and refer to...

  1. Measuring Integrated Socioemotional Guidance at School: Factor Structure and Reliability of the Socioemotional Guidance Questionnaire (SEG-Q)

    Science.gov (United States)

    Jacobs, Karen; Struyf, Elke

    2013-01-01

    Socioemotional guidance of students has recently become an integral part of education, however no instrument exists to measure integrated socioemotional guidance. This study therefore examines the factor structure and reliability of the Socioemotional Guidance Questionnaire. Psychometric properties of the Socioemotional Guidance Questionnaire and…

  2. 78 FR 12761 - Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy...

    Science.gov (United States)

    2013-02-25

    ... of May 2, 2006 (71 FR 25844), we announced the availability of a guidance entitled ``Guidance on the... Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and... ``Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under...

  3. Stabilization and commitment : forward guidance in economies with rational expectations

    OpenAIRE

    Hughes Hallett, Andrew; Acocella, Nicola

    2016-01-01

    We construct a theory of forward guidance in economic policy making in order to provide a framework for explaining the role and strategic advantages of including forward guidance as an explicit part of policy design. We do this by setting up a general policy problem in which forward guidance plays a role, and then examine the consequences for performance when that guidance is withdrawn. We show that forward guidance provides enhanced controllability and stabilizability—especially where such p...

  4. Safety assessment guidance in the International Atomic Energy Agency RADWASS Program

    Energy Technology Data Exchange (ETDEWEB)

    Vovk, I.F.; Seitz, R.R.

    1995-12-31

    The IAEA RADWASS programme is aimed at establishing a coherent and comprehensive set of principles and standards for the safe management of waste and formulating the guidelines necessary for their application. A large portion of this programme has been devoted to safety assessments for various waste management activities. Five Safety Guides are planned to be developed to provide general guidance to enable operators and regulators to develop necessary framework for safety assessment process in accordance with international recommendations. They cover predisposal, near surface disposal, geological disposal, uranium/thorium mining and milling waste, and decommissioning and environmental restoration. The Guide on safety assessment for near surface disposal is at the most advanced stage of preparation. This draft Safety Guide contains guidance on description of the disposal system, development of a conceptual model, identification and description of relevant scenarios and pathways, consequence analysis, presentation of results and confidence building. The set of RADWASS publications is currently undergoing in-depth review to ensure a harmonized approach throughout the Safety Series.

  5. Guidance Manual for preparing Nuclear and Radiological Emergency Preparedness and Response Plan

    International Nuclear Information System (INIS)

    The Nuclear and Radiological Emergency Preparedness and Response Plan(NREPRP) describes the capabilities, responsibilities and authorities of government agencies and a conceptual basis for integrating the activities of these agencies to protect public health and safety. The NREPRP addresses issues related to actual or perceived radiation hazard requiring a national response in order to: i. Provide co-ordination of a response involving multi-jurisdictions or significant national responsibilities; or ii. Provide national support to state and local governments. The objective of this research is to establish Guidance Manual for preparing a timely, organized and coordinated emergency response plan for Authorities/agencies to promptly and adequately determine and take actions to protect members of the public and emergency workers. The manual will not provide sufficient details for an adequate response. This level of details is contained in standard operating procedures that are being developed based on the plan developed. Base on the data obtain from integrated planning levels and responsibility sharing, the legal document of major government agencies participating in NREPRP form the legal basis for the response plan. Also the following documents should be some international legal binding documents. Base on the international safety requirement and some countries well developed NREPRP, we have drafted a guidance manual for new comer countries for easy development of their countries NREPRP. Also we have taken in to consideration lessons learn from most accident especially Fukushima accident

  6. VTOL shipboard letdown guidance system analysis

    Science.gov (United States)

    Phatak, A. V.; Karmali, M. S.

    1983-01-01

    Alternative letdown guidance strategies are examined for landing of a VTOL aircraft onboard a small aviation ship under adverse environmental conditions. Off line computer simulation of shipboard landing task is utilized for assessing the relative merits of the proposed guidance schemes. The touchdown performance of a nominal constant rate of descent (CROD) letdown strategy serves as a benchmark for ranking the performance of the alternative letdown schemes. Analysis of ship motion time histories indicates the existence of an alternating sequence of quiescent and rough motions called lulls and swells. A real time algorithms lull/swell classification based upon ship motion pattern features is developed. The classification algorithm is used to command a go/no go signal to indicate the initiation and termination of an acceptable landing window. Simulation results show that such a go/no go pattern based letdown guidance strategy improves touchdown performance.

  7. Ship motion pattern directed VTOL letdown guidance

    Science.gov (United States)

    Phatak, A. V.; Karmali, M. S.; Paulk, C. H., Jr.

    1983-01-01

    This paper examines ship motion pattern directed letdown guidance strategies for landing a VTOL aircraft onboard a small aviation ship under adverse environmental conditions. Off-line computer simulation of the shipboard landing task is utilized for assessing the relative merits of the proposed guidance schemes. A sum of seventy sinusoids representation is used to model the ship motion time histories. The touchdown performance of a nonimal constant-rate-of-descent (CROD) letdown strategy serves as a benchmark for ranking the performance of the alternative letdown schemes.

  8. Geometric Dimensioning and Tolerancing. Drafting Module 9. 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. The guide contains a cross-reference table of instructional materials. This unit covers geometric dimensioning and tolerancing. The unit contains the…

  9. 76 FR 12989 - Draft Fish and Wildlife Service Friends Policy

    Science.gov (United States)

    2011-03-09

    ... a Federal Register notice dated October 18, 2010 (75 FR 63851), we announced availability for public... Fish and Wildlife Service RIN 1018-AX35 Draft Fish and Wildlife Service Friends Policy AGENCY: Fish and... comment period on our draft Fish and Wildlife Service Friends Policy, which we made available for...

  10. Drafting. A Bilingual Text = Dibujo Mecanico. Un Texto Bilingue.

    Science.gov (United States)

    Los Angeles Unified School District, CA. Div. of Career and Continuing Education.

    This bilingual instructional text, one in a series of six texts covering various vocational and technical topics, provides secondary level English and Spanish instruction in drafting. Addressed in the individual units are the following topics: safety, drafting tools and techniques, sketching, geometric construction, working drawings, sectioning,…

  11. China's Energy Law Drafted to Cope with Severe Energy Situation

    Institute of Scientific and Technical Information of China (English)

    Wang Tong

    2006-01-01

    @@ To implement the decision of the State Council, State Energy Office, National Development and Reform Commission and Legislative Affairs Office of the State Council held a joint conference in Beijing early this year to establish a drafting team of the Energy Law. As a result, the program of drafting China's Energy Law was unveiled.

  12. 76 FR 9210 - Draft DOC National Aquaculture Policy

    Science.gov (United States)

    2011-02-16

    ... DOC National Aquaculture Policy AGENCY: Commerce. ACTION: Notice of availability of draft aquaculture... draft national aquaculture policy that supports sustainable aquaculture in the United States. The intent of the policy is to guide DOC's actions and decisions on aquaculture and to provide a...

  13. IRIS Toxicological Review of Ammonia (Interagency Science Consultation Draft)

    Science.gov (United States)

    On June 1, 2012, the draft Toxicological Review of Ammonia and the draft charge to external peer reviewers were released for external peer review and public comment. The Toxicological Review and charge were reviewed internally by EPA and by other federal agencies and White House ...

  14. 1 CFR 15.10 - Information on drafting and publication.

    Science.gov (United States)

    2010-01-01

    ... 1 General Provisions 1 2010-01-01 2010-01-01 false Information on drafting and publication. 15.10... drafting and publication. The Director of the Federal Register may prepare, and distribute to agencies... chapter. The Director may also develop and conduct programs of technical instruction....

  15. Advanced Technical Drafting (Industrial Arts) Curriculum Guide. Bulletin 1751.

    Science.gov (United States)

    Louisiana State Dept. of Education, Baton Rouge. Div. of Vocational Education.

    This curriculum guide contains materials for a 17-unit course in advanced technical drafting, a followup to the basic technical drafting course in the industrial arts curriculum for grades 10-12. It is intended for use by industrial arts teachers, supervisors, counselors, administrators, and teacher educators. A three-page course overview provides…

  16. 77 FR 39446 - Draft Parachute Landing Area Standards

    Science.gov (United States)

    2012-07-03

    ... Federal Aviation Administration 14 CFR Part 139 Draft Parachute Landing Area Standards AGENCY: Federal... interested parties to review and comment on the draft ``Parachute Landing Area Standards'' contained in... standards and recommendations for parachute landing areas on airports. This action proposes to clarify...

  17. Business plan: Supplemental draft environmental impact statement. Volume 2. Appendices

    International Nuclear Information System (INIS)

    This document contains the appendices for the Bonneville Power Administration (BPA) Business Plan: Supplemental Draft Environmental Impact Statement. Included are: BPA products and services; Rate design; Methodology and assumptions for numerical analysis; Retail utility operations; Comments and responses to the draft business plan EIS

  18. The Study of Contract Drafting Strategy: Exercises in Mine Detection.

    Science.gov (United States)

    Child, Barbara

    1992-01-01

    A technique to teach the drafting of contracts in legal education is offered. Two form contracts, for real estate sale and purchase, are compared to illustrate the need for careful drafting of contracts. Examination of provisions for repair and maintenance reveals potentially significant differences in language usage. (MSE)

  19. Manual Drafting: A Skill for the 21st Century?

    Science.gov (United States)

    Raudebaugh, Robert A.

    1996-01-01

    Discusses the advantages and disadvantages of teaching manual drafting and concludes that teaching manual drafting in technology education is no longer justified. Recommends teaching drawing in the context of the design process, including all types of drawing, and focusing on freehand techniques for ideation and communication. (JOW)

  20. Performing Mathematical Calculations. Drafting Module 10. 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. The guide contains a cross-reference table of instructional materials. Four units cover construction techniques pertaining to mathematical calculations: (1)…

  1. 78 FR 32377 - Draft 2012 Marine Mammal Stock Assessment Reports

    Science.gov (United States)

    2013-05-30

    .... NMFS solicited public comments on the draft 2012 SARs on August 7, 2012 (77 FR 47043); the 90-day... revised draft 2012 SARs for these ten stocks (78 FR 3399, January 16, 2013). The public comment period on..., mass-stranding, etc. ] The authors mention that the most frequently found disease processes...

  2. 77 FR 44610 - Notice of Availability of Draft Environmental Assessment

    Science.gov (United States)

    2012-07-30

    ... Regulatory Commission (Commission) regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office of... Energy Regulatory Commission Notice of Availability of Draft Environmental Assessment FirstLight Hydro... (Norwich Public Utilities). Staff prepared a draft environmental assessment (EA), which analyzes...

  3. 78 FR 3023 - Draft Policy on Donations, Fundraising, and Solicitation

    Science.gov (United States)

    2013-01-15

    ... the monetary value of the donation. This draft policy also covers soliciting donations and fundraising... Fish and Wildlife Service RIN 1018-AY36 Draft Policy on Donations, Fundraising, and Solicitation AGENCY... Wildlife Service (Service) proposes to establish a policy that covers Service procedures for...

  4. 75 FR 13599 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-03-22

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of issuance and availability of Draft Regulatory Guide, DG-8040, ``Health Physics Surveys During Enriched Uranium-235 Processing and...

  5. 78 FR 17942 - Draft of SWGDOC Standard for Indentation Examinations

    Science.gov (United States)

    2013-03-25

    ... Office of Justice Programs Draft of SWGDOC Standard for Indentation Examinations AGENCY: National..., Scientific Working Group for Forensic Document Examination will make available to the general public a draft document entitled, ``SWGDOC Standard for Indentation Examinations''. The opportunity to provide comments...

  6. Business Plan : Supplemental Draft Environmental Impact Statement, Volume 2, Appendices.

    Energy Technology Data Exchange (ETDEWEB)

    United States. Bonneville Power Administration.

    1995-02-01

    This document contains the appendices for the Bonneville Power Administration (BPA) Business Plan: Supplemental Draft Environmental Impact Statement. Included are: BPA products and services; Rate design; Methodology and assumptions for numerical analysis; Retail utility operations; Comments and responses to the draft business plan EIS.

  7. 77 FR 29317 - Fiscal Year 2012 Draft Work Plan

    Science.gov (United States)

    2012-05-17

    ... Year 2012 Draft Work Plan AGENCY: Denali Commission. ACTION: Notice. SUMMARY: The Denali Commission... plans for future spending and that the annual Work Plan be published in the Federal Register, providing... serves to announce the 30-day opportunity for public comment on the Denali Commission Draft Work Plan...

  8. 77 FR 47373 - Fiscal Year 2012 Draft Work Plan; Correction

    Science.gov (United States)

    2012-08-08

    ... Year 2012 Draft Work Plan; Correction AGENCY: Denali Commission. ACTION: Notice; second correction..., concerning request for comments on the Draft Work Plan for Federal Fiscal Year 2012. This revision to Fiscal Year 2012 Work Plan is to provide clarifying edits. In particular, Section 304(b)(3) of the...

  9. 77 FR 30509 - Fiscal Year 2012 Draft Work Plan

    Science.gov (United States)

    2012-05-23

    ... Year 2012 Draft Work Plan AGENCY: Denali Commission. ACTION: Notice; Correction. SUMMARY: The Denali... work plans for future spending and that the annual Work Plan be published in the Federal Register... announce the 30-day opportunity for public comment on the Denali Commission Draft Work Plan for...

  10. 77 FR 11116 - Draft National Plan To Address Alzheimer's Disease

    Science.gov (United States)

    2012-02-24

    ... HUMAN SERVICES Draft National Plan To Address Alzheimer's Disease AGENCY: Office of the Assistant.... SUMMARY: HHS is soliciting public input on the draft National Plan to Address Alzheimer's Disease, which... . Background On January 4, 2011, President Barack Obama signed into law the National Alzheimer's Project...

  11. Nanomaterial Case Studies: Nanoscale Titanium Dioxide (External Review Draft)

    Science.gov (United States)

    This draft document presents two case studies of nanoscale titanium dioxide (nano-TiO2) used (1) to remove arsenic from drinking water and (2) as an active ingredient in topical sunscreen. The draft case studies are organized around a comprehensive environmental asses...

  12. 77 FR 55222 - Notice of Availability of the Draft Resource Management Plan Amendment and the Draft...

    Science.gov (United States)

    2012-09-07

    ... other public participation activities at least 15 days in advance through public notices, media releases... threatened and endangered plant and animal species. Alternative C also incorporates a managed development.../Draft EIS include air and water quality, biological resources, wild horse and rangeland management,...

  13. Numerical simulation of draft tube flow of a bulb turbine

    Energy Technology Data Exchange (ETDEWEB)

    Coelho, J.G. [Federal University of Triangulo Mineiro, Institute of Technological and Exact Sciences, Avenida Doutor Randolfo Borges Junior, 1250 – Uberaba – MG (Brazil); Brasil, A.C.P. Jr. [University of Brasilia, Department of Mechanical Engineering, Campus Darcy Ribeiro, Brasilia – DF (Brazil)

    2013-07-01

    In this work a numerical study of draft tube of a bulb hydraulic turbine is presented, where a new geometry is proposed. This new proposal of draft tube has the unaffected ratio area, a great reduction in his length and approximately the same efficiency of the draft tube conventionally used. The numerical simulations were obtained in commercial software of calculation of flow (CFX-14), using the turbulence model SST, that allows a description of the field fluid dynamic near to the wall. The simulation strategy has an intention of identifying the stall of the boundary layer precisely limits near to the wall and recirculations in the central part, once those are the great causes of the decrease of efficiency of a draft tube. Finally, it is obtained qualitative and quantitative results about the flow in draft tubes.

  14. A review of dynamics modelling of friction draft gear

    Science.gov (United States)

    Wu, Qing; Cole, Colin; Luo, Shihui; Spiryagin, Maksym

    2014-06-01

    Longer and heavier trains mean larger in-train forces and more complicated force patterns. Practical experience indicates that the development of fatigue failure of coupling systems in long heavy trains may differ from conventional understanding. The friction-type draft gears are the most widely used draft gears. The ever developing heavy haul transport environment requires further or new understanding of friction draft gear behaviour and its implications for train dynamics as well as fatigue damage of rolling stock. However, modelling of friction draft gears is a highly nonlinear question. Especially the poor predictability, repeatability and the discontinuity of friction make this task more challenging. This article reviews current techniques in dynamics modelling of friction draft gears to provide a starting point that can be used to improve existing or develop new models to achieve more accurate force amplitude and pattern predictions.

  15. Guidance for Developing Principal Design Criteria for Advanced (Non-Light Water) Reactors

    Energy Technology Data Exchange (ETDEWEB)

    Holbrook, Mark [Idaho National Lab. (INL), Idaho Falls, ID (United States); Kinsey, Jim [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2015-03-01

    In July 2013, the US Department of Energy (DOE) and US Nuclear Regulatory Commission (NRC) established a joint initiative to address a key portion of the licensing framework essential to advanced (non-light water) reactor technologies. The initiative addressed the “General Design Criteria for Nuclear Power Plants,” Appendix A to10 Code of Federal Regulations (CFR) 50, which were developed primarily for light water reactors (LWRs), specific to the needs of advanced reactor design and licensing. The need for General Design Criteria (GDC) clarifications in non-LWR applications has been consistently identified as a concern by the industry and varied stakeholders and was acknowledged by the NRC staff in their 2012 Report to Congress1 as an area for enhancement. The initiative to adapt GDC requirements for non-light water advanced reactor applications is being accomplished in two phases. Phase 1, managed by DOE, consisted of reviews, analyses and evaluations resulting in recommendations and deliverables to NRC as input for NRC staff development of regulatory guidance. Idaho National Laboratory (INL) developed this technical report using technical and reactor technology stakeholder inputs coupled with analysis and evaluations provided by a team of knowledgeable DOE national laboratory personnel with input from individual industry licensing consultants. The DOE national laboratory team reviewed six different classes of emerging commercial reactor technologies against 10 CFR 50 Appendix A GDC requirements and proposed guidance for their adapted use in non-LWR applications. The results of the Phase 1 analysis are contained in this report. A set of draft Advanced Reactor Design Criteria (ARDC) has been proposed for consideration by the NRC in the establishment of guidance for use by non-LWR designers and NRC staff. The proposed criteria were developed to preserve the underlying safety bases expressed by the original GDC, and recognizing that advanced reactors may take

  16. 78 FR 73555 - Deepwater Horizon Oil Spill; Draft Programmatic and Phase III Early Restoration Plan and Draft...

    Science.gov (United States)

    2013-12-06

    ... ERP/PEIS groups 12 project types into two categories: (1) Contribute to Restoring Habitats and Living... announced in the May 6, 2013 Federal Register notice (78 FR 26319), and the document now proposes these 28... Environmental Impact Statement (Draft Phase III ERP/PEIS). The Draft Phase III ERP/PEIS considers...

  17. Managing the Drafting Process: Creating a New Model for the Workplace.

    Science.gov (United States)

    Shwom, Barbara L.; Hirsch, Penny L.

    1994-01-01

    Discusses the development of a pragmatic model of the writing process in the workplace, focusing on the importance of "drafting" as part of that process. Discusses writers' attitudes about drafting and the structures of the workplace that drafting has to accommodate. Introduces a drafting model and discusses results of using this model in the…

  18. 75 FR 69078 - Workshop To Review Draft Materials for the Lead (Pb) Integrated Science Assessment (ISA)

    Science.gov (United States)

    2010-11-10

    ... AGENCY Workshop To Review Draft Materials for the Lead (Pb) Integrated Science Assessment (ISA) AGENCY... a workshop to evaluate initial draft materials for the Pb Integrated Science Assessment (ISA) is... the scientific content of initial draft materials or sections for the draft ISA. Workshop...

  19. Hypermedia Authoring with Writing Process Guidance

    Science.gov (United States)

    Chang, Kuo-En; Sung, Yao-Ting; Zheng, Jie-Wen

    2007-01-01

    A writing process of five stages, setting the topic and goals, planning the outline, organising the structure, building the content, and reviewing, is proposed to guide hypermedia authoring. To explore the effects of the system designed with writing-process guidance, this study enrolled 108 seventh graders at a junior high school as experimental…

  20. Guidance for performing site inspections under CERCLA

    Energy Technology Data Exchange (ETDEWEB)

    1992-09-01

    This guidance presents EPA`s site inspection (SI) strategy. The strategy discusses procedural guidelines to investigate potential Superfund (CERCLA) sites for evaluation pursuant to the Hazard Ranking System (HRS), revised in accordance with the Superfund Amendments and Reauthorization Act of 1986. The HRS is the primary means by which EPA evaluates sites for superfund`s National Priorities List (NPL).

  1. A Four-Year Career Guidance Program.

    Science.gov (United States)

    Sherrell, C. Eleanor; Spaulding, Barbara G.

    The counseling staff at a suburban, comprehensive, four-year high school in southern California developed and implemented a Career Guidance program for grades nine through twelve. With assistance and cooperation from teachers, students participated in exploration of vocational interests, personal values, and individual aptitudes in Grades 9 and…

  2. Museum Personnel's Opinions on Mobile Guidance Systems

    Science.gov (United States)

    Yoshimura, Hirokazu; Sekiguchi, Hiromi; Yabumoto, Yoshitaka

    2007-01-01

    While opinions from the general public are certainly important, opinions from the museum staff are also necessary to improve user service systems. this article introduces two groups of museum staff who have evaluated the usability of mobile guidance systems in Japanese museums. One group is the research team who used the PDA system in the National…

  3. Modern control theory for Army missile guidance

    Science.gov (United States)

    Travassos, R. H.; Levari, H.; Gupta, N. K.

    1982-11-01

    A Singular perturbation guidance law has been developed for medium-range surface-to-air missiles. This guidance law is a significant extension of a previously developed guidance law for short-range missiles; in medium-range intercepts, the problem of energy management should be addressed in addition to homing guidance. The mathematical formulation has been simplified by introducing separation of time scales. Target Trajectory Estimation: A recursive algorithm for estimation of autoregressive moving average (ARMA) model parameters from noisy samples has been developed. Application of this algorithm to parameter estimation problems has exhibited its fast convergence and unbiasedness in the presence of noise, even with short data records. The algorithm has two versions, a Recursive Maximum Likelihood (RML) form and a Recursive Prediction Error (RPE) form, both of which possess a parallel structure that makes them highly suitable for parallel-processing implementation. Adaptive autopilots: Lattice-form algorithms have been developed for fast, recursive identification and control of time-varying systems. These algorithms have excellent numerical properties and a modular structure that makes them suitable for on-board real-time implementation.

  4. MR Thermometry for guidance of thermal therapy

    NARCIS (Netherlands)

    Sprinkhuizen, S.M.

    2010-01-01

    The research described in this thesis has aimed to further investigate magnetic resonance (MR) thermometry (MRT) techniques as to become a reliable guidance tool for thermal therapy. The various physical processes allowing for temperature measurements based upon the MR signal are described. It is de

  5. Epilepsy in the Classroom: Guidance for Educators.

    Science.gov (United States)

    Lassner, Lee M.

    This paper for educators, school psychologists, and counselors attempts to provide guidance for meeting the needs of students with epilepsy. Stressed throughout the paper are ways to provide for the child's special needs while fostering his/her self esteem and full participation in classroom activities. The paper addresses the following topics:…

  6. Autonomous gliding entry guidance with geographic constraints

    Institute of Scientific and Technical Information of China (English)

    Guo Jie; Wu Xuzhong; Tang Shengjing

    2015-01-01

    This paper presents a novel three-dimensional autonomous entry guidance for relatively high lift-to-drag ratio vehicles satisfying geographic constraints and other path constraints. The guidance is composed of onboard trajectory planning and robust trajectory tracking. For trajectory planning, a longitudinal sub-planner is introduced to generate a feasible drag-versus-energy profile by using the interpolation between upper boundary and lower boundary of entry corridor to get the desired trajectory length. The associated magnitude of the bank angle can be specified by drag profile, while the sign of bank angle is determined by lateral sub-planner. Two-reverse mode is utilized to satisfy waypoint constraints and dynamic heading error corridor is utilized to satisfy no-fly zone constraints. The longitudinal and lateral sub-planners are iteratively employed until all of the path constraints are satisfied. For trajectory tracking, a novel tracking law based on the active disturbance rejection control is introduced. Finally, adaptability tests and Monte Carlo simulations of the entry guidance approach are performed. Results show that the proposed entry guidance approach can adapt to different entry missions and is able to make the vehicle reach the prescribed target point precisely in spite of geographic constraints.

  7. 33 CFR 385.5 - Guidance memoranda.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Guidance memoranda. 385.5 Section 385.5 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROGRAMMATIC REGULATIONS FOR THE COMPREHENSIVE EVERGLADES RESTORATION PLAN General...

  8. Effective Child Guidance: An Educator's Guidebook.

    Science.gov (United States)

    Hill, Brent Mathews

    This guidebook is designed to assist educators in becoming more effective child guidance leaders within the school system. Sections discuss the following areas: (1) indicators of current emotional problems; (2) children's common emotional problems, including fears, separation and loss, misbehavior motivations, aggressiveness, stealing, lying,…

  9. Legal consideration on draft water act

    OpenAIRE

    Ayanoğlu, Sedat; Yıldırım, Hülya Deniz

    2014-01-01

    Legal consideration on draft  water actAbstract: Very old regulations are found on water which is an indispensible natural spring and a need for the continuation of life.  Nowadays the importance of water law is increasing as a new branch of law. Although recognition of the right of ownership on springs, this branch of law as a sub branch of  law of natural springs has a character of public law  due to the importance of the subject which is regulated by it. Since water has different propertie...

  10. Controlled guidance of handwriting in Parkinson's Disease patients. Can a sonic aid improve tau guidance measures

    OpenAIRE

    Baxter, Holly

    2006-01-01

    Aim: To identify, using “tau theory” (Lee, 1998), i) if there are significant differences in tau guidance of handwriting between PD patients and normal healthy controls, and if so, ii) whether tau guidance for these actions can be improved by use of external sound cues attempting to provide missing intrinsic tG information. Method: Four patients with Parkinson’s disease (mean age 69 years) were compared with a healthy control on data recorded by Selspot cameras during handwr...

  11. Draft 1992 Resource Program : Technical Report.

    Energy Technology Data Exchange (ETDEWEB)

    United States. Bonneville Power Administration.

    1992-01-01

    The 1992 Resource Program will propose actions to meet future loads placed on the Bonneville Power Administration (BPA). It will also discuss and attempt to resolve resource-related policy issues. The Resource Program assesses resource availability and costs, and analyzes resource requirements and alternative ways of meeting those requirements through both conservation and generation resources. These general resource conclusions are then translated to actions for both conservation and generation. The Resource Program recommends budgets for the Office of Energy Resources for Fiscal Years (FY) 1994 and 1995. BPA`s Resource Program bears directly on an important BPA responsibility: the obligation under the Northwest Power Act{sup 3} to meet the power requirements of public and private utility and direct service industrial (DSI) customers according to their contractual agreements. BPA`s Draft 1992 Resource Program is contained in four documents: (1) 1992 Resource Program Summary; (2) Technical Report; (3) Technical Assumptions Appendix; and, (4) Conservation Implementation Plan. This volume is the Draft 1992 Resource Program Technical Report, a comprehensive document that provides supporting data and analyses for Resource Program recommendations.

  12. Draft 1992 Resource Program : Technical Report.

    Energy Technology Data Exchange (ETDEWEB)

    United States. Bonneville Power Administration.

    1992-01-01

    The 1992 Resource Program will propose actions to meet future loads placed on the Bonneville Power Administration (BPA). It will also discuss and attempt to resolve resource-related policy issues. The Resource Program assesses resource availability and costs, and analyzes resource requirements and alternative ways of meeting those requirements through both conservation and generation resources. These general resource conclusions are then translated to actions for both conservation and generation. The Resource Program recommends budgets for the Office of Energy Resources for Fiscal Years (FY) 1994 and 1995. BPA's Resource Program bears directly on an important BPA responsibility: the obligation under the Northwest Power Act{sup 3} to meet the power requirements of public and private utility and direct service industrial (DSI) customers according to their contractual agreements. BPA's Draft 1992 Resource Program is contained in four documents: (1) 1992 Resource Program Summary; (2) Technical Report; (3) Technical Assumptions Appendix; and, (4) Conservation Implementation Plan. This volume is the Draft 1992 Resource Program Technical Report, a comprehensive document that provides supporting data and analyses for Resource Program recommendations.

  13. Energy market review releases draft report

    International Nuclear Information System (INIS)

    The Energy Market Review Releases draft report has made recommendations consistent with the Australian Gas Association (AGA)'s submissions in a number of areas. In particular, it has endorsed: 1. the need for an independent review of the gas access regime, to address the deficiencies with current access regulation identified by the Productivity Commission's Review of the National Access Regime; 2. the need for greater upstream gas market competition; 3. the principle that significant regulatory decisions should be subject to clear merits and judicial review; and 4. the need to avoid restrictions on retail energy prices. The report also endorses the need for a 'technology neutral' approach to greenhouse emissions abatement policy. It states that 'many of the current measures employed to reduce greenhouse gas emissions are poorly targeted', and that they 'target technologies or fuel types rather than greenhouse gas abatement.' Additionally, it explicitly recognises the key conclusions of the AGA's recently-released Research Paper, Reducing Greenhouse Emissions from Water Heating: Natural Gas as a Cost-effective Option. The draft report recommends the development of an economy-wide emissions trading system, to achieve a more cost-effective approach to greenhouse abatement

  14. Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    Science.gov (United States)

    The Technical Guidance for Assessing Environmental Justice in Regulatory Analysis (also referred to as the Environmental Justice Technical Guidance or EJTG) is intended for use by Agency analysts, including risk assessors, economists, and other analytic staff that conduct analyse...

  15. Flu Vaccine Guidance for Patients with Immune Deficiency

    Science.gov (United States)

    ... Vaccine Guidance for Patients with Immune Deficiency Share | Flu Vaccine Guidance for Patients with Immune Deficiency This ... is the best tool for prevention of the flu, should patients with immune deficiency be given the ...

  16. Effect of Autopilot Structure on Proportional Navigation Guidance

    Institute of Scientific and Technical Information of China (English)

    XIA Qun-li; LIU Yi-ying; QI Zai-kang

    2007-01-01

    The dynamic characteristics of acceleration autopilot and attitude autopilot are discussed in detail.Also, a comparison study was made between these two different types of control schemes for guidance loop.By means of simulation, it is concluded that the guidance accuracy is mainly determined by the slowest subsystem among different system dynamics.For air-to-ground missiles, with limited terminal guidance time, the control scheme of acceleration autopilot combined with proportional navigation guidance (PNG) law is the better choice.

  17. [Auditory guidance systems for the visually impaired people].

    Science.gov (United States)

    He, Jing; Nie, Min; Luo, Lan; Tong, Shanbao; Niu, Jinhai; Zhu, Yisheng

    2010-04-01

    Visually impaired people face many inconveniences because of the loss of vision. Therefore, scientists are trying to design various guidance systems for improving the lives of the blind. Based on sensory substitution, auditory guidance has become an interesting topic in the field of biomedical engineering. In this paper, we made a state-of-technique review of the auditory guidance system. Although there have been many technical challenges, the auditory guidance system would be a useful alternative for the visually impaired people.

  18. Social media guidance for British Geological Survey staff

    OpenAIRE

    Mitchell, Clive; Noakes, Lauren

    2014-01-01

    Social media guidance for British Geological Survey staff Social media is a great way to communicate BGS science, activities, achievements and services. This guidance is for BGS staff using social media as a way to communicate BGS science and technology. It is based on the Social Media Guidance for Civil Servants (Cabinet Office, 2012) the NERC Electronic Communications Policy (NERC, 2013) and the NERC Code of Conduct. This guidance was first published in Broadcasting the science sto...

  19. Career guidance in a university in mainland China

    OpenAIRE

    Sun, Jing; 孫競

    2013-01-01

    This case study aimed to gain a holistic understanding of career guidance as implemented in a university in Guangdong province. The purpose of the research was to investigate (a) the identifiable content and approaches used in career guidance, (b) contextual factors inside and outside the university that influence career guidance, (c) how the people involved perceive the effect of career guidance on enhancing students' career competencies, (d) problems in delivering and receiving career guida...

  20. One-Dimensional Analysis of Full Load Draft Tube Surge

    OpenAIRE

    Chen, Changkun; Nicolet, Christophe; Yonezawa, Koichi; Farhat, Mohamed; Avellan, François; Tsujimoto, Yoshinobu

    2008-01-01

    One-dimensional stability analysis of a hydraulic system composed of a penstock, a runner, and a draft tube was carried out to determine the cause of the full load draft tube surge. It is assumed that the cavity volume at the runner exit is a function of the pressure at the vortex core evaluated from the instantaneous local pressure at the runner exit and an additional pressure decrease due to the centrifugal force on the swirling flow. It was found that the diffuser effect of the draft tube ...

  1. Acid rain compliance: The need for regulatory guidance

    Energy Technology Data Exchange (ETDEWEB)

    Solomon, B.D. [Environmental Protection Agency, Washington, DC (United States)

    1993-07-01

    This article presents a broad view of the need for regulatory guidance when confronting the problem of acid rain. The two major topics addressed are (1) Why is guidance needed and (2) What kind of guidance is needed. Discussion of rate and accounting treatment of allowances, acid rain compliance planning, and allowance trading and energy efficiency are included.

  2. 75 FR 22681 - Supplemental Guidance on Overdraft Protection Programs

    Science.gov (United States)

    2010-04-29

    ... encourages routine or intentional overdrafts. Rather, it indicated that a savings association should present... Guidance on Overdraft Protection Programs (Overdraft Guidance) OTS issued February 18, 2005 (70 FR 8428). OTS issued the Overdraft Guidance after notice and comment. See 69 FR 31858 (June 7, 2004)....

  3. 14 CFR 25.1329 - Flight guidance system.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Flight guidance system. 25.1329 Section 25... guidance system. (a) Quick disengagement controls for the autopilot and autothrust functions must be... accordance with the requirements of § 25.1309. (c) Engagement or switching of the flight guidance system,...

  4. Concept development of automatic guidance for rotorcraft obstacle avoidance

    Science.gov (United States)

    Cheng, Victor H. L.

    1990-01-01

    The automatic guidance of rotorcraft for obstacle avoidance in nap-of-the-earth flight is studied. A hierarchical breakdown of the guidance components is used to identify the functional requirements. These requirements and anticipated sensor capabilities lead to a preliminary guidance concept, which has been evaluated via computer simulations.

  5. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  6. Vocational guidance: A primary function of education

    Science.gov (United States)

    Röhrs, Hermann

    1992-05-01

    The world of work as part of our dynamic society is the result of a permanent change. This development has an influence on the school and its tasks. Apart from industrialisation there is computerisation which requires, to an important extent, individual judgement and inventiveness on the part of the working population. The school has not only to cope with these changes but has also to try to influence them through vocational orientation and guidance and its continual reform. The aim of the school is the development of a critical sense with the purpose of humanising the whole process. The importance of vocational orientation and guidance is increasing, and they have to become a task of our schools. The topic should therefore also be included in teacher training as well as in further education.

  7. Guidance and justification in particularistic ethics.

    Science.gov (United States)

    Kihlbom, U

    2000-10-01

    This paper argues that, contrary to a common line of criticism followed by scholars such as Helga Kuhse, a particularistic version of virtue ethics properly elaborated, can provide sound moral guidance and a satisfactory account for moral justification of our opinions regarding, for instance, health care practice. In the first part of the paper, three criteria for comparing normative theories with respect to action-guiding power are outlined, and it is argued that the presented particularistic version of virtue ethics actually can provide more guidance than the universalistic theories followed by Kuhse and others. In the second part of the paper it is claimed that universalist normative theories have serious problems accounting for the role that moral principles are supposed to play in the justification, of moral opinions, whereas the present version of virtue ethics accommodates a plausible alternative idea of justification without invoking moral principles or eschewing objectivity. PMID:11758585

  8. Enhanced mission performance from autonomous instrument guidance

    DEFF Research Database (Denmark)

    Jørgensen, John Leif; Jørgensen, Peter Siegbjørn; Betto, Maurizio;

    2006-01-01

    During the last decade improvements in electronics, on-board processing power and software design has lead to significant advances in the development of autonomous instrumentation for spacecraft use. The Advanced Stellar Compass (ASC) and the newly developed micro-ASC (mu ASC) are excellent...... and power consumption makes the mu ASC an ideal instrument for small, high yielding satellite missions. The ASC has hitherto been used by the satellite AOCS and the high accuracy scientific instrument for attitude recovery (among others onboard ORSTED, CHAMP, and GRACE), and satellite high accuracy target...... acquisition and pointing (PROBA). Here three applications of the mu ASC as an autonomous onboard precision guide for precision vector instrumentation are presented. These are autonomous onboard antenna guidance, telescope guidance and tracking and high accuracy and wide range laser rangers....

  9. Practical guidance on undertaking a service evaluation.

    Science.gov (United States)

    Moule, Pam; Armoogum, Julie; Dodd, Emily; Donskoy, Anne-Laure; Douglass, Emma; Taylor, Julie; Turton, Pat

    2016-07-01

    This article describes the basic principles of evaluation, focusing on the evaluation of healthcare services. It emphasises the importance of evaluation in the current healthcare environment and the requirement for nurses to understand the essential principles of evaluation. Evaluation is defined in contrast to audit and research, and the main theoretical approaches to evaluation are outlined, providing insights into the different types of evaluation that may be undertaken. The essential features of preparing for an evaluation are considered, and guidance provided on working ethically in the NHS. It is important to involve patients and the public in evaluation activity, offering essential guidance and principles of best practice. The authors discuss the main challenges of undertaking evaluations and offer recommendations to address these, drawing on their experience as evaluators.

  10. Cannabinoid receptor CB2 modulates axon guidance

    DEFF Research Database (Denmark)

    Duff, Gabriel; Argaw, Anteneh; Cecyre, Bruno;

    2013-01-01

    Navigation of retinal projections towards their targets is regulated by guidance molecules and growth cone transduction mechanisms. Here, we present in vitro and in vivo evidences that the cannabinoid receptor 2 (CB2R) is expressed along the retino-thalamic pathway and exerts a modulatory action ...... CB2R's implication in retinothalamic development. Overall, this study demonstrates that the contribution of endocannabinoids to brain development is not solely mediated by CB1R, but also involves CB2R....

  11. Psychological Agency - Guidance of Visual Attention

    OpenAIRE

    Buehler, Denis

    2014-01-01

    My dissertation contributes to the study of agency by furthering our understanding of individuals' guidance of their acts. When individuals guide a shift of visual attention, their central executive system assigns priority to locations on the priority map. The central executive system is a psychological system for intermodal, often amodal, non-modular processing. The priority map is a representational state with geometrically structured content, representing the field of vision. This represen...

  12. Minisatellite Attitude Guidance Using Reaction Wheels

    OpenAIRE

    Ion STROE; Dan N. Dumitriu

    2015-01-01

    In a previous paper [2], the active torques needed for the minisatellite attitude guidance from one fixed attitude posture to another fixed attitude posture were determined using an inverse dynamics method. But when considering reaction/momentum wheels, instead of this active torques computation, the purpose is to compute the angular velocities of the three reaction wheels which ensure the minisatellite to rotate from the initial to the final attitude. This paper presents this computation of ...

  13. Pollution Control Guidance for Geothermal Energy Development

    Energy Technology Data Exchange (ETDEWEB)

    Hartley, Robert P.

    1978-06-01

    This report summarizes the EPA regulatory approach toward geothermal energy development. The state of knowledge is described with respect to the constituents of geothermal effluents and emissions, including water, air, solid wastes, and noise. Pollutant effects are discussed. Pollution control technologies that may be applicable are described along with preliminary cost estimates for their application. Finally discharge and emission limitations are suggested that may serve as interim guidance for pollution control during early geothermal development.

  14. SWISSMETRO: Combined Propulsion with Levitation and Guidance

    OpenAIRE

    Cassat, A.; Espanet, C.

    2004-01-01

    Swissmetro is a MAGLEV Project between the main cities of Switzerland, designed for a speed up to 500 [km/h] in two tunnels under partial vacuum. Two propulsion variants are considered: - the short stators of the linear homopolar motors are fixed with the tunnel tracks; - the stator of the motors is on board of the vehicles. The levitation, the guidance and the transfer of energy are independent. The authors investigate the possibilities to combine the propulsion with the levitation and the g...

  15. Education, consultation, guidance, students, advisor, teacher

    Directory of Open Access Journals (Sweden)

    M Seyedmajidi

    2013-09-01

    Full Text Available Introduction: Student counseling and supervision play an important role to overcome learning problems and to achieve educational goals. The present study is intended to investigate viewpoints of students regarding educational guidance and advice studying at Babol University of Medical Sciences. Methods: In this descriptive cross-sectional survey, viewpoints of 480 students were collected by a questionnaire. The validity and reliability of the questionnaire had been approved before. Data were analyzed using SPSS version 17 software. Chi- square and ANOVA tests were administered. Results: 61.2% of all participants were female and 38.8% were males with mean age of 21.3±4.0. 37.2% of these students lacked sufficient knowledge and information on how to request from their advisors for help and guidance. Half of students (50.3% reported attendance of advisors and holding routine consultation is inappropriate. Advisors made more educational files for females compare to males (P=0.001. No difference observed regarding educational disciplines of the advisors regarding students were dissatisfied with help and guidance received from paramedics and dentistry students in most fields (87.3% and 81.5% respectively. Conclusion: It seems that either student has no sufficient information about tasks of advisors and/or advisors may not do their tasks properly. It is recommended the students to be acquainted with advisors’ tasks upon their entrance into the university. Training classes for new academics would be helpful.

  16. Reliability history of the Apollo guidance computer

    Science.gov (United States)

    Hall, E. C.

    1972-01-01

    The Apollo guidance computer was designed to provide the computation necessary for guidance, navigation and control of the command module and the lunar landing module of the Apollo spacecraft. The computer was designed using the technology of the early 1960's and the production was completed by 1969. During the development, production, and operational phase of the program, the computer has accumulated a very interesting history which is valuable for evaluating the technology, production methods, system integration, and the reliability of the hardware. The operational experience in the Apollo guidance systems includes 17 computers which flew missions and another 26 flight type computers which are still in various phases of prelaunch activity including storage, system checkout, prelaunch spacecraft checkout, etc. These computers were manufactured and maintained under very strict quality control procedures with requirements for reporting and analyzing all indications of failure. Probably no other computer or electronic equipment with equivalent complexity has been as well documented and monitored. Since it has demonstrated a unique reliability history, it is important to evaluate the techniques and methods which have contributed to the high reliability of this computer.

  17. Skip entry trajectory planning and guidance

    Science.gov (United States)

    Brunner, Christopher William

    A numerical predictor-corrector (NPC) method for trajectory planning and closed-loop guidance of low lift-to-drag (L/D) ratio vehicles during the skip entry phase of a lunar-return mission is presented. The strategy calls for controlling the trajectory by modulation of the magnitude of the vehicle's bank angle. The magnitude of the bank angle used in the skip phase is determined by satisfying the downrange requirement to the landing site. The problem is formulated as a nonlinear univariate root-finding problem. Full three degree of freedom (3DOF) nonlinear trajectory dynamics are included to achieve high accuracy of the landing prediction. In addition, the proposed approach automatically yields a direct entry trajectory when the downrange is such that a skip entry is no longer necessary. The same algorithm repeatedly applied on-board in every guidance cycle realizes closed-loop guidance in the skip entry phase. A number of issues are identified and addressed that are critical in closed-loop implementations. Extensive 3DOF dispersion simulations are performed to evaluate the performance of the proposed approach, and the results demonstrate very reliable and robust performance of the algorithm in highly stressful dispersed conditions. Comparison is made between the proposed algorithm and an earlier skip algorithm developed for the Apollo space program. It is shown that the proposed algorithm is superior to the Apollo algorithm especially when used for entries with long downranges.

  18. 77 FR 71019 - Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2012-04; Guidance on...

    Science.gov (United States)

    2012-11-28

    ... COMMISSION Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2012-04; Guidance on...: Nuclear Regulatory Commission. ACTION: Japan Lessons-Learned Project Directorate Interim Staff Guidance issuance. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing the Final Japan...

  19. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Science.gov (United States)

    2011-05-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...). The document announced the availability of the guidance entitled ``Guidance for Industry and Food and...; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and...

  20. Natural draft: its measurement and modeling in underground mine ventilation systems

    Energy Technology Data Exchange (ETDEWEB)

    Bruce, W.E.

    1986-01-01

    This report is intended to provide an improved understanding of natural draft (natural ventilating pressure) and the effect of natural draft on underground mine ventilation circuits. Attention is focused on measurement of natural draft pressures during ventilation surveys in mechanically ventilated mines and on different methods for modeling natural draft using the measured data. Two different methods are described for mathematically estimating the magnitude of the natural draft pressure. Comparisons are made of results obtained using the different methods. Different procedures are described in regard to modeling natural draft usign the MSHA-modified Penn State computer program. One of the modeling procedures discussed is the existing computer routine for modeling natural draft. Use of the routine is described and illustrated relative to drafts that aid the mechanical ventilation system and relative to drafts that oppose the mechanical ventilation system.

  1. IRIS TOXICOLOGICAL REVIEW OF TETRACHLOROETHYLENE (PERCHLOROETHYLENE) (INTERAGENCY SCIENCE DISCUSSION DRAFT)

    Science.gov (United States)

    EPA is releasing the draft report, Toxicological Review of Tetrachloroethylene (Perchloroethylene), that was distributed to Federal agencies and White House Offices for comment during the Science Discussion step of the IRIS Assessment...

  2. Draft Genome Sequence of Paecilomyces hepiali, Isolated from Cordyceps sinensis.

    Science.gov (United States)

    Yu, Yi; Wang, Wenting; Wang, Linping; Pang, Fang; Guo, Lanping; Song, Lai; Liu, Guiming; Feng, Chengqiang

    2016-01-01

    Paecilomyces hepiali is an endoparasitic fungus that commonly exists in the natural Cordyceps sinensis Here, we report the draft genome sequence of P. hepiali, which will facilitate the exploitation of medicinal compounds produced by the fungus. PMID:27389266

  3. Draft Comprehensive Conservation Plan and Environmental Assessment: National Elk Refuge

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This draft Comprehensive Conservation Plan CCP executive summary was written to guide management on National Elk Refuge for the next 15 years. This plan outlines...

  4. Draft Genome Sequence of Brevibacterium massiliense Strain 541308T

    OpenAIRE

    Roux, Véronique; Robert, Catherine; Gimenez, Grégory; Raoult, Didier

    2012-01-01

    A draft genome sequence of Brevibacterium massiliense, an aerobic bacterium isolated from a human ankle discharge, is described here. CRISPR-associated proteins were found to be encoded in the genome, and analysis of transport proteins was performed.

  5. Developing Low Carbon Transport Policies in Peru - Draft Transport NAMA

    OpenAIRE

    Ramirez Brinez, C. P.; Tyler, N.

    2012-01-01

    The report is an initial draft of a Transport NAMA for Peru. NAMA stands for Nationally Appropriate Mitigation Actions and are a relatively new initiative from the UNFCCC to tackle climate change. The report covers

  6. Replacement of asbestos cement fills in natural draft cooling towers

    Energy Technology Data Exchange (ETDEWEB)

    Gay, G.A.; Stackhouse, D.W.

    1986-01-01

    This paper describes some of the deterioration problems which have been encountered with asbestos cement materials, the environmental and regulatory problems associated with asbestos, and some of the concerns to be addressed replacing fill material in a natural draft tower.

  7. Photographic and drafting techniques simplify method of producing engineering drawings

    Science.gov (United States)

    Provisor, H.

    1968-01-01

    Combination of photographic and drafting techniques has been developed to simplify the preparation of three dimensional and dimetric engineering drawings. Conventional photographs can be converted to line drawings by making copy negatives on high contrast film.

  8. Draft Genome Sequence of Paecilomyces hepiali, Isolated from Cordyceps sinensis

    Science.gov (United States)

    Yu, Yi; Wang, Wenting; Wang, Linping; Pang, Fang; Guo, Lanping; Song, Lai

    2016-01-01

    Paecilomyces hepiali is an endoparasitic fungus that commonly exists in the natural Cordyceps sinensis. Here, we report the draft genome sequence of P. hepiali, which will facilitate the exploitation of medicinal compounds produced by the fungus. PMID:27389266

  9. 2017-2022 Draft Proposed Program - All Areas

    Data.gov (United States)

    Bureau of Ocean Energy Management, Department of the Interior — This file represents the program areas of the Outer Continental Shelf that have been included in the 2017-2022 Outer Continental Shelf Oil and Gas Leasing Draft...

  10. NCPA No. 2: IX comments and responses to Draft JES

    International Nuclear Information System (INIS)

    Comments received from twenty-six separate entities are included. Following each letter or set of comments are staff responses. Sections of the draft environmental statement which have been revised in response to these comments are noted

  11. IRIS Toxicological Review for Acrylamide (Interagency Science Discussion Draft)

    Science.gov (United States)

    EPA is releasing the draft report, Toxicological Review for Acrylamide, that was distributed to Federal agencies and White House Offices for comment during the Science Discussion step of the IRIS Assessment Development Process<...

  12. Report on activities of the white-front survey: Draft

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This draft report summarizes the results of a survey on the YukonKuskokwim Delta that was taken in order to determine productivity and nest site characteristics of...

  13. Submarine Upward Looking Sonar Ice Draft Profile Data and Statistics

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — This data set consists of upward looking sonar draft data collected by submarines in the Arctic Ocean. It includes data from both U.S. Navy and Royal Navy...

  14. Variable structure guidance law for attacking surface maneuver targets

    Institute of Scientific and Technical Information of China (English)

    Han Yanhua; Xu Bo

    2008-01-01

    The characteristics of surface maneuver targets are analyzed and a 3-D relative motion model for missiles and targets is established. A variable structure guidance law is designed considering the characteristics of targets. In the guidance law, the distance between missiles and targets as well as the missile-target relative velocity are all substituted by estimation values. The estimation errors, the target's velocity, and the maneuver acceleration are all treated as bounded disturbance. The guidance law proposed can be implemented conveniently in engineering with little target information. The performance of the guidance system is analyzed theoretically and the numerical simulation result shows the effectiveness of the guidance law.

  15. 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

    ... Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information... ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' Dear... Communication of Important Safety Information.'' Important new information about prescription drug...

  16. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Science.gov (United States)

    2010-05-20

    ... Japanese Medical Device Ministry of Health, Labour and Welfare system. This notice of availability and... Program.'' It does not create or confer any rights for or on any person and does not operate to bind...

  17. 75 FR 40843 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2010-07-14

    ..., which was made available in the Federal Register of February 21, 2008 (73 FR 9575). DATES: Although you... Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug..., will represent the Agency's current thinking on this topic. It does not create or confer any rights...

  18. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Science.gov (United States)

    2011-07-14

    ... labeling. Diagnostic tests have been employed for many years to enhance the use of therapeutic products. Recently, therapeutic products that depend on the use of a diagnostic test to meet their labeled safety and... companion diagnostic devices that have inadequate performance characteristics. To facilitate the...

  19. 78 FR 14791 - Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and...

    Science.gov (United States)

    2013-03-07

    ... From the Federal Register Online via the Government Publishing Office FEDERAL ACCOUNTING STANDARDS..., and Equipment Cost Accumulation, Assignment, and Allocation AGENCY: Federal Accounting Standards..., notice is hereby given that the Accounting and Auditing Policy Committee (AAPC) has issued a...

  20. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-03-19

    ... Acid-Based Systems for Mycobacterium tuberculosis Complex; Notice and Proposed Rule #0;#0;Federal... Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens; Availability AGENCY: Food and Drug... Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in...