WorldWideScience

Sample records for cgtp draft guidance

  1. 76 FR 50231 - Mobile Medical Applications Draft Guidance; Public Workshop

    Science.gov (United States)

    2011-08-12

    ... notice of availability for the draft guidance (76 FR 43689, July 21, 2011): FDA's recently- issued draft... workshop discussion, a ``mobile medical app'' is a mobile application that meets the definition of ``device... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications Draft Guidance; Public...

  2. 75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella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 HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Prevention of Salmonella... availability of a draft guidance entitled ``Prevention of Salmonella Enteritidis in Shell Eggs...

  3. 75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability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 HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Acidified Foods; Availability... provide the upper bound estimates of anticipated impact of the guidance on the acidified food industry and.... 0910-0037; 73 FR 11649 at 11650, March 4, 2008). In that analysis, we estimated that there are...

  4. 75 FR 36421 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing...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 HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes Reportable in Annual Reports; Availability AGENCY: Food and... the availability of a draft guidance for industry entitled ``CMC Postapproval Manufacturing...

  5. 75 FR 41452 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”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 QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting'' AGENCY: Council on Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``Federal Greenhouse Gas Accounting...

  6. 77 FR 69632 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability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......

  7. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Reporting for Manufacturers.'' This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance is intended......

  8. 76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella

    Science.gov (United States)

    2011-03-23

    ... for industry entitled ``Testing for Salmonella Species in Human Foods and Direct- Human-Contact Animal... testing procedures for Salmonella spp. in human foods (except shell eggs) and direct-human- contact animal... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Testing for Salmonella...

  9. 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... Registration of Pharmaceuticals for Human Use. The draft guidance includes criteria for initiation of...

  10. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-04-05

    ... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability...) is announcing the availability of draft special controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft special controls guidance document for each of the...

  11. 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...

  12. 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...

  13. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Science.gov (United States)

    2012-03-09

    ... ``Drug Safety Information-- FDA's Communication to the Public.'' This draft guidance updates and revises the March 2007 guidance entitled ``Drug Safety Information-- FDA's Communication to the Public.'' This... Safety Information--FDA's Communication to the Public.'' This draft guidance updates and revises a...

  14. 78 FR 55263 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Science.gov (United States)

    2013-09-10

    ... Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for...

  15. 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; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Guidance for...

  16. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Science.gov (United States)

    2011-02-28

    ...--Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies...--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).'' This draft... announcing the availability of a draft guidance for industry entitled ``Medication...

  17. 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...

  18. 76 FR 60847 - Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission...

    Science.gov (United States)

    2011-09-30

    ... media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological... issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance,...

  19. 78 FR 57859 - Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation...

    Science.gov (United States)

    2013-09-20

    ... Potential of Drugs: Nonclinical Evaluation; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Endocrine Disruption Potential of Drugs: Nonclinical Evaluation.'' This... determine the potential for a drug to disrupt the endocrine system. This draft guidance also...

  20. 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...

  1. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Science.gov (United States)

    2013-11-06

    ... the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific...

  2. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Science.gov (United States)

    2013-08-02

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... guidance for industry entitled ``Bioequivalence Recommendations for Mesalamine.'' The...

  3. 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... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Recommendation... design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs)...

  4. 77 FR 18827 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection...

    Science.gov (United States)

    2012-03-28

    ... Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... industry entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide...

  5. 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...

  6. 78 FR 13069 - Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood...

    Science.gov (United States)

    2013-02-26

    ... Register of June 26, 2003 (68 FR 38083), FDA announced the availability of the draft guidance entitled... copies of the draft guidance to the Office of Communication, Outreach and Development (HFM- 40), Center... for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville...

  7. 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...

  8. 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... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Recommendations for... INFORMATION: I. Background In the Federal Register of Wednesday, September 11, 2013 (78 FR 55727),...

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

    Science.gov (United States)

    2011-12-02

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate......

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

    Science.gov (United States)

    2012-03-02

    ... Biological Products'' on November 2 and 3, 2010 (75 FR 61497, October 5, 2010) (November 2010 public hearing... biosimilar product development. We agree with this approach and have begun with the three draft guidance... HUMAN SERVICES Food and Drug Administration Draft Guidances Relating to the Development of...

  11. 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..., and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). The draft guidance...

  12. 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...

  13. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Science.gov (United States)

    2013-06-05

    ...-1 Infection: Developing Antiretroviral Drugs for Treatment; Availability AGENCY: Food and Drug... Antiretroviral Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in all phases of development of antiretroviral drugs for the treatment of HIV. This draft guidance revises the guidance...

  14. 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...

  15. 78 FR 69693 - Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for...

    Science.gov (United States)

    2013-11-20

    ... the draft guidance to the Office of Communication, Outreach and Development (HFM- 40), Center for... Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD...

  16. 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)...

  17. 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...

  18. 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.

  19. 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...

  20. 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... Spring, MD 20993-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-20574, appearing on page... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications Draft Guidance; Public...

  1. 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...

  2. 76 FR 58311 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05; Ongoing Review of Operating Experience

    Science.gov (United States)

    2011-09-20

    ... Guidance (LR-ISG), LR-ISG-2011-05, ``Ongoing Review of Operating Experience.'' This LR-ISG provides... draft LR-ISG-2011-05 to clarify guidance on how the ongoing review of operating experience should be... COMMISSION Draft License Renewal Interim Staff Guidance LR-ISG-2011-05; Ongoing Review of...

  3. 76 FR 14024 - Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework...

    Science.gov (United States)

    2011-03-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Non-Penicillin Beta-Lactam... guidance for industry entitled ``Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework.'' This... non- penicillin beta-lactam antibiotics. The draft guidance is intended to assist manufacturers...

  4. 76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

    Science.gov (United States)

    2011-01-07

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Electronic Source Documentation in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical......

  5. 77 FR 71194 - Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

    Science.gov (United States)

    2012-11-29

    ... Investigational Cellular and Gene Therapy Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION...). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination... Investigational Cellular and Gene Therapy Products,'' dated November 2012. The draft guidance document...

  6. 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)...

  7. 77 FR 58399 - Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium...

    Science.gov (United States)

    2012-09-20

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311; FDA-2007-D- 0433... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... guidance for industry entitled ``Bioequivalence Recommendations for Pentosan Polysulfate Sodium.''...

  8. 78 FR 19271 - Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel...

    Science.gov (United States)

    2013-03-29

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311; FDA-2007-D- 0433... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... guidance for industry entitled ``Bioequivalence Recommendations for Metronidazole Vaginal Gel.''...

  9. 75 FR 29350 - Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as...

    Science.gov (United States)

    2010-05-25

    ... 2007'' and gave interested parties an opportunity to submit comments by July 27, 2009 (74 FR 27803... FR 46434). This draft guidance is the second edition of that guidance entitled ``Questions and... Registry is to provide a ``reliable mechanism to track patterns of adulteration in food would...

  10. 75 FR 52755 - Draft Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing...

    Science.gov (United States)

    2010-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Acute Bacterial Skin and Skin... guidance for industry entitled ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for... the development of antimicrobial drugs for the treatment of acute bacterial skin and skin...

  11. 75 FR 50771 - Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products...

    Science.gov (United States)

    2010-08-17

    ... Federal Register of May 22, 2001 (66 FR 28182) (the 2001 final guidance), has been developed for... Industry on Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients... comments of a draft revised guidance for industry ( 100) entitled ``Residual Solvents in New...

  12. 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.

  13. 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...

  14. 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...

  15. 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...

  16. 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''...

  17. 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...

  18. 77 FR 20026 - Draft Guidance for Industry: Modified Risk Tobacco Product Applications; Availability; Agency...

    Science.gov (United States)

    2012-04-03

    ... appropriate, and other forms of information technology. Draft Guidance for Industry: Modified Risk Tobacco... collection of information: Daniel Gittleson, Office of Information Management, Food and Drug Administration... the Office of Management and Budget (OMB) for each collection of information they conduct or...

  19. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-07-28

    ... April 5, 2010 (75 FR 17093), FDA published a notice announcing the availability of draft special... for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  20. 78 FR 21128 - Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food...

    Science.gov (United States)

    2013-04-09

    ... itself (hardware) as well as to any firmware or software intended to operate on or to control the instrument. This draft guidance also addresses software that is distributed as a stand alone device for use... Development, Center for Biologics Evaluation and Research, RKWL Bldg., suite 601, 11400 Rockville...

  1. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Science.gov (United States)

    2011-05-24

    ... HUMAN SERVICES Food and Drug Administration (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  2. 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:...

  3. 77 FR 7585 - Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability

    Science.gov (United States)

    2012-02-13

    .... Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... industry entitled ``Bioequivalence Recommendations for Rifaximin,'' one for the 200- milligram...

  4. 75 FR 52425 - Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling...

    Science.gov (United States)

    2010-08-25

    ... restaurant chains that have locations in more than one jurisdiction (Ref. 3). On March 23, 2010, the... Access Persons with access to the Internet may obtain the draft guidance at http://www.fda.gov/Food.... Burton, K. Bates, and K. Huggins, ``Coming to a Restaurant Near You? Potential Consumer Responses...

  5. 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...

  6. 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...

  7. 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: Notice. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of the...

  8. 76 FR 34999 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-06-15

    ... Methicillin-Resistant Staphylococcus Aureus for Culture-Based Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug...

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

    Science.gov (United States)

    2012-10-02

    ...The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Initial Completeness Assessments for Type II API DMFs Under GDUFA.'' Under the Generic Drug User Fee Amendments of 2012 (GDUFA), holders of certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are referenced......

  10. 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...

  11. 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...

  12. 77 FR 19672 - Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for...

    Science.gov (United States)

    2012-04-02

    ... Administration (FDA) is correcting a notice that appeared in the Federal Register of March 2, 2012 (77 FR 12853...-3529, email: biosimilarspublicmtg@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In FR Doc. 2012-5070... HUMAN SERVICES Food and Drug Administration Draft Guidances Relating to the Development of...

  13. 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)

  14. 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...

  15. 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... of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act...

  16. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Science.gov (United States)

    2013-02-19

    ... Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is... information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is...

  17. 76 FR 9529 - Migratory Birds; Draft Eagle Conservation Plan Guidance

    Science.gov (United States)

    2011-02-18

    ... Fish and Wildlife Service 50 CFR Part 22 RIN 1018-AX53 Migratory Birds; Draft Eagle Conservation Plan...; Division of Migratory Bird Management; U.S. Fish and Wildlife Service; 4401 North Fairfax Drive, Mail Stop... Protection Act (BGEPA), the Migratory Bird Treaty Act, and the Endangered Species Act. BGEPA prohibits...

  18. 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... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration,...

  19. 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... manufacturing practice (cGMP) compliance specific to manufacturing, processing, and dose unit sampling and... following guidances: 1. ``Manufacturing, Processing, or Holding Active Pharmaceutical...

  20. 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...

  1. 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... published on May 10, 2012, Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel....gov @epa.gov. Mail: Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using...

  2. 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...

  3. 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...

  4. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Science.gov (United States)

    2011-02-16

    ... Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using... industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.'' The draft guidance is intended to describe best...

  5. CHARACTERISTICS OF ORGANIC EMISSIONS FROM HAZARDOUS WASTE INCINERATION PROCESSES UNDER THE NEW EPA DRAFT RISK BURN GUIDANCE: MEASUREMENT ISSUES

    Science.gov (United States)

    EPA's recently published draft Risk Burn Guidance recommends that hazardous waste combustion facilities complete a mass balance of the total organics (TOs) that may be emitted from the combustor. TOs, consisting of three distinct fractions (volatile, semivolatile, and nonvolatile...

  6. CHARACTERIZATION OF ORGANIC EMISSIONS FROM HAZARDOUS WASTE INCINERATION PROCESSES UNDER THE NEW EPA DRAFT RISK BURN GUIDANCE: MEASUREMENT ISSUES

    Science.gov (United States)

    The paper discusses measurement issues relating to the characterization of organic emissions from hazardous waste incineration processes under EPA's new risk burn guidance. The recently published draft quidance recommends that hazardous waste combustion facilities complete a mass...

  7. 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

    ... specifically address children's toy laser products. FDA recently issued a proposed rule (78 FR 37723) that... HUMAN SERVICES Food and Drug Administration Minimizing Risk for Children's Toy Laser Products; Draft... availability of the draft guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This...

  8. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Science.gov (United States)

    2010-02-26

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft...

  9. 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....

  10. 78 FR 37230 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-06-20

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 74669). This notice announces draft product-specific recommendations, either new or revised, that... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration,...

  11. 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... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration,...

  12. 78 FR 20925 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-04-08

    ... (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 74669). This notice announces draft product-specific recommendations, either new or revised,...

  13. 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...

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

    International Nuclear Information System (INIS)

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

  15. 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...

  16. 76 FR 52995 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05: Ongoing Review of Operating...

    Science.gov (United States)

    2011-08-24

    ... Interim Staff Guidance (LR-ISG), LR-ISG-2011-05, ``Ongoing Review of Operating Experience.'' This LR-ISG... draft LR-ISG-2011-05 to clarify guidance on how the ongoing review of operating experience should be... applicants should obligate themselves to the ongoing review of operating experience for license renewal....

  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

    ... and achievable with the use of good manufacturing practices. It also describes FDA's intended sampling... to be protective of human health and to be achievable with the use of good manufacturing practices... with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized,...

  18. 76 FR 67764 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Science.gov (United States)

    2011-11-02

    ... COMMISSION Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...-xxxx, Revision 0, ``Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and... at (301) 492-3446. FOR FURTHER INFORMATION CONTACT: Song-Hua Shen, Division of Risk Analysis,...

  19. 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...

  20. 77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

    Science.gov (United States)

    2012-12-17

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.'' The purpose of this document is to provide guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims......

  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. A política internacional da CGTP e da CUT: Etapas, temas e desafios

    Directory of Open Access Journals (Sweden)

    Hermes Augusto Costa

    2012-10-01

    Full Text Available Apesar de existir enquanto política no seio das organizações sindicais nacionais, a política de relações internacionais (PRI configura-se, todavia, como “parente pobre” do sindicalismo nacional. Depois de enunciar brevemente, na primeira parte, alguns dos obstáculos actuais à construção de uma PRI, este texto debruça-se, na segunda parte, sobre o espaço que as duas principais centrais sindicais de Portugal e do Brasil (a CGTP e a CUT, respectivamente vêm conferindo à PRI. Partindo do trabalho de investigação realizado nos últimos 5 anos junto daquelas organizações sindicais, propõe-se uma distribuição das fases da PRI da CGTP e da CUT, sintetizando-se, na terceira parte, algumas semelhanças e diferenças entre ambas a esse respeito.

  3. 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...

  4. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Science.gov (United States)

    2013-02-08

    ... Tobacco to Protect Children and Adolescents'' (75 FR 13225, March 19, 2010, codified at 21 CFR part 1140... Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil...

  5. 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

    ... Quality.'' This draft guidance provides recommendations that will help API manufacturers, pharmaceutical... test for contamination and should be used in addition to the United States Pharmacopeia (USP) monograph... contaminant OSCS in heparin API manufactured in China. FDA is also concerned about the potential...

  6. 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...

  7. 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...

  8. 77 FR 27451 - Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels-Draft...

    Science.gov (United States)

    2012-05-10

    ... AGENCY Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels--Draft... oil- and gas-related hydraulic fracturing (HF) using diesel fuels where the U.S. Environmental... Safe Drinking Water Act (SDWA) and regulations regarding UIC permitting of oil and gas...

  9. 76 FR 44935 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Science.gov (United States)

    2011-07-27

    ... the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations... Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug... legally marketed device. This draft guidance is not final nor is it in effect at this time....

  10. 78 FR 42085 - Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting...

    Science.gov (United States)

    2013-07-15

    ... 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 Pediatric Study Plans... Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Rosemary Addy, Center...

  11. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Science.gov (United States)

    2010-04-29

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

  12. 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...

  13. 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

    ... AGENCY Draft Guidance for E85 Flexible Fuel Vehicle Weighting Factor for Model Years 2016-2019 Vehicles... weighting the greenhouse gas (GHG) emissions of a flexible fuel vehicle operating on E85 with the GHG... government work days from 8:30 a.m. to 4:30 p.m.; generally, it is open Monday through Friday,...

  14. 78 FR 39736 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Science.gov (United States)

    2013-07-02

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  15. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Science.gov (United States)

    2010-05-25

    ... of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food... Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this draft guidance is to assist sponsors or non-applicants with filling out form FDA 1932, ``Veterinary Adverse...

  16. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-03-19

    ... class II. These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis... work on the final version of the guidance, submit either electronic or written comments on the draft... in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and...

  17. 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

    ... AGENCY External Peer Review Meeting for the Draft Guidance of Applying Quantitative Data To Develop Data... period (76 FR 33752-33753), which was subsequently extended to 60 days (76 FR 43999). The public comment... register to attend this peer review meeting as observers. Time will be set aside for observers to...

  18. 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 ...

  19. Implications of the New Food and Drug Administration Draft Guidance on Human Factors Engineering for Diabetes Device Manufacturers

    OpenAIRE

    Wilcox, Stephen B.; Drucker, Daniel,

    2012-01-01

    This article discusses the implications of the new Food and Drug Administration’s draft guidance on human factors and usability engineering for the development of diabetes-related devices. Important considerations include the challenge of identifying users, when the user population is so dramatically broad, and the challenge of identifying use environments when the same can be said for use environments. Another important consideration is that diabetes-related devices, unlike many other medica...

  20. Use of expert judgement in the HLW regulatory program: US NRC staff draft guidance

    International Nuclear Information System (INIS)

    As with other licensing decisions, the U.S. Nuclear Regulatory Commission's (NRC's) decision to grant or deny a license for a proposed repository at Yucca Mountain will be based on a combination of fact and judgment as set forth by the Department of Energy (DOE) in a license application. Subjective judgments of individual experts and, in some cases, groups of experts will be used by DOE to interpret data obtained during site characterization and to address the many technical issues and inherent uncertainties associated with predicting repository performance for thousands of years. The NRC has traditionally accepted expert judgment to evaluate and interpret the facts which support a license application. Recently, the Performance Assessment and High-level Waste Integration Branch of the NRC has developed regulatory guidance in the form of a draft branch technical position (BTP) that identifies circumstances which may warrant the use of a formal process for obtaining the judgments of more than one expert (i.e. expert elicitation) and describes acceptable procedures for conducting such expert elicitations

  1. 75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Science.gov (United States)

    2010-10-14

    ... Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability AGENCY: Food and Drug... Biotherapeutic Products: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft... Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information'' dated September...

  2. 78 FR 63219 - International Conference on Harmonisation; Draft Guidance on Elemental Impurities; Availability

    Science.gov (United States)

    2013-10-23

    ... CONTACT: Regarding the guidance: John Kauffman, CDER, Food and Drug Administration, 1114 Market St., DPA... Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER,...

  3. 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...

  4. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Science.gov (United States)

    2013-12-05

    ... the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for... Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension; Availability AGENCY: Food and... for Paliperidone Palmitate.'' The guidance provides specific recommendations on the design...

  5. 77 FR 48989 - Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of...

    Science.gov (United States)

    2012-08-15

    ... of Occurrence in Clinical Trials.'' The purpose of this guidance is to assist sponsors in.... Send one self-addressed adhesive label to assist that office in processing your requests. See the... Clinical Trials.'' The purpose of this guidance is to assist sponsors in prospectively assessing...

  6. 78 FR 68030 - Draft Guidance on Intellectual Property Rights for the National Network for Manufacturing...

    Science.gov (United States)

    2013-11-13

    ... Register (77 FR 26509) and may be found at: http://www.gpo.gov/fdsys/pkg/FR-2012-05-04/pdf/2012-10809.pdf... 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...

  7. 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)

  8. 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... for Nitroglycerin Metered Spray/Sublingual Products and Metered Aerosol/ Sublingual Products... Recommendations for Nitroglycerin,'' one for nitroglycerin metered spray/sublingual products and one...

  9. 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..., Silver Spring, MD 20993, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2010-18406, appearing on... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  10. 76 FR 34180 - National Organic Program; Notice of Draft Guidance for Accredited Certifying Agents and Certified...

    Science.gov (United States)

    2011-06-13

    ... Seedlings, and Planting Stock in Organic Crop Production (NOP 5029)''; and ``Evaluating Allowed Ingredients... part 205. The NOP developed ``Seeds, Annual Seedlings, and Planting Stock in Organic Crop Production... Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs is to...

  11. 78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

    Science.gov (United States)

    2013-09-13

    ...)) regulated by the Center for Veterinary Medicine. This guidance was originally issued in 2001. FDA is...), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855... John Kadavil, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish...

  12. 77 FR 20030 - Draft Guidance for Industry: Reporting Harmful and Potentially Harmful Constituents in Tobacco...

    Science.gov (United States)

    2012-04-03

    ... the HPHC list requirement (76 FR 5387, January 31, 2011). The guidance is available on the Internet at..., on August 12, 2011, FDA issued a document (the HPHC notice; 76 FR 50226) in the Federal Register... Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug,...

  13. Draft guidance notes for the protection of persons exposed to ionising radiations in research and teaching

    International Nuclear Information System (INIS)

    These guidance notes have been prepared for those who use ionising radiation in a wide range of research work and teaching, such as that under the control of universities, polytechnics, Government Departments or research organisations and for those who work in industrial research laboratories. Ancillary activities, such as the testing and calibration of equipment and the storage and disposal of radioactive materials, are also covered by these notes so far as they are carried out on the same premises. The guidance notes indicate procedures for the protection of all persons who may be exposed as a result of these practices, i.e. all employed persons, apprentices and students, and members of the public. (author)

  14. 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

  15. 76 FR 77492 - Draft Guidance on Improving the Process for Preparing Efficient and Timely Environmental Reviews...

    Science.gov (United States)

    2011-12-13

    ...,563, 76 FR 3821 (January 21, 2011), available at http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011... Regulation and Regulatory Review,'' Exec. Order 13,563, 76 FR 3821 (January 21, 2011), available at http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf . \\4\\ This guidance is not a rule or...

  16. How a patient advocacy group developed the first proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration

    OpenAIRE

    Furlong, Pat; Bridges, John F P; Charnas, Lawrence; Fallon, Justin R.; Fischer, Ryan; Flanigan, Kevin M.; Franson, Timothy R.; Gulati, Neera; McDonald, Craig; Peay, Holly; Sweeney, H. Lee

    2015-01-01

    Among the challenges confronting patients with rare diseases is a dearth of treatment options. The development of safe and effective new therapies is hampered by challenges associated with conducting clinical trials in small populations. In this article, we describe how the Duchenne muscular dystrophy community–led by Parent Project Muscular Dystrophy–created a proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration. This unprecedented undertaking...

  17. 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...

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

    OpenAIRE

    Olinda Lousã

    2013-01-01

    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...

  19. 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

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

    Science.gov (United States)

    Streibel, Martin; Schoebel, Birgit

    2015-04-01

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

  1. 75 FR 54347 - Draft Guidance for Industry: Bar Code Label Requirements-Questions and Answers (Question 12...

    Science.gov (United States)

    2010-09-07

    ... Guidance (October 5, 2006, 71 FR 58739). In this guidance, FDA is proposing to amend our response to..., Outreach and Development (HFM- 40), Center for Biologics Evaluation and Research (CBER), Food and Drug... CONTACT: Benjamin A. Chacko, Center for Biologics Evaluation and Research (HFM-17), Food and...

  2. 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... Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidances AGENCY: Food...

  3. 75 FR 55797 - Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting...

    Science.gov (United States)

    2010-09-14

    ... specific steps in the hepatitis C virus (HCV) replication cycle. The guidance outlines the types of... Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. ]...

  4. 76 FR 72950 - Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From...

    Science.gov (United States)

    2011-11-28

    ... guidance to the Office of Communication, Outreach and Development (HFM- 40), Center for Biologics... Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD...

  5. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Science.gov (United States)

    2011-05-02

    ... guidance to the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation... Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration,...

  6. 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...

  7. 76 FR 72725 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05: Ongoing Review of Operating Experience

    Science.gov (United States)

    2011-11-25

    ... Guidance (LR-ISG), LR-ISG-2011-05, ``Ongoing Review of Operating Experience.'' This LR-ISG provides... on how the ongoing review of operating experience should be used to ensure the effectiveness of the... their programmatic activities for operating experience reviews are appropriate for considering...

  8. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Science.gov (United States)

    2011-12-19

    ... quality and consistency of available data regarding the performance of medical devices in women. This... Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability AGENCY: Food and... Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences...

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

    Science.gov (United States)

    2011-02-03

    ... for review by the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE... guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration... Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855,...

  11. 76 FR 2328 - National Organic Program: Notice of Draft Guidance Concerning “Made With Organic (Specified...

    Science.gov (United States)

    2011-01-13

    ... Management and Budget (OMB) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432... 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...

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

    Science.gov (United States)

    2013-11-20

    ... 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...

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

    Science.gov (United States)

    2013-02-08

    .... Specifically, this guidance addresses FDA's current thinking regarding the selection of patients with early AD... selection of outcome measures for trials in these populations that are designed to demonstrate a clinical benefit, as well as the manner in which disease modification might be demonstrated, are also...

  14. 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...

  15. 78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

    Science.gov (United States)

    2013-03-06

    ... of April 17, 2009 (74 FR 17872), FDA announced the availability of the draft guidance. Comments on... (myopia, astigmatism, presbyopia). This guidance is intended to assist device manufacturers who plan...

  16. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Science.gov (United States)

    2013-06-14

    ... premarket submissions to provide effective cybersecurity management and to reduce the risk that device... Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity... draft guidance document entitled ``Content of Premarket Submissions for Management of Cybersecurity...

  17. 78 FR 68101 - Environmental Issues Associated With New Reactors and Specific Environmental Guidance for...

    Science.gov (United States)

    2013-11-13

    ... COMMISSION Environmental Issues Associated With New Reactors and Specific Environmental Guidance for Integral..., ``Interim Staff Guidance on Environmental Issues Associated with New Reactors'' and draft ISG ESP/ COL-ISG-027, ``Interim Staff Guidance on Specific Environmental Guidance for iPWR Reviews.'' The purpose...

  18. 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...) Device Systems.'' On December 6, 2011 (76 FR 76166), FDA announced the availability of the draft guidance...; The Content of Investigational Device Exemption and Premarket Approval Applications for...

  19. 75 FR 45130 - Draft Compliance Policy Guide Sec. 690.800 Salmonella

    Science.gov (United States)

    2010-08-02

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for FDA staff entitled ``Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed'' (the draft CPG). The draft CPG, when finalized, is intended to provide guidance for FDA staff on regulatory policy relating to animal feed or feed ingredients that come in direct contact with humans, such as pet food......

  20. 78 FR 54949 - Major Project Financial Plan Guidance

    Science.gov (United States)

    2013-09-06

    ... TRANSPORTATION Federal Highway Administration Major Project Financial Plan Guidance AGENCY: Federal Highway Administration (FHWA), DOT. ACTION: Notice; Request for comments. SUMMARY: This notice requests comments on draft Major Project Financial Plan Guidance outlining the procedures the FHWA will follow when reviewing...

  1. 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;…

  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. 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)

  4. 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...

  5. 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...

  6. 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

  7. 75 FR 75809 - Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma...

    Science.gov (United States)

    2010-12-06

    ... (74 FR 13211), FDA announced the availability of the draft guidance entitled ``Guidance for Industry... human cells, tissues, and cellular and tissue-based products (HCT/ Ps). The guidance announced in this... Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated March 2009....

  8. 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...

  9. 76 FR 44049 - Guidance for Fuel Cycle Facility Change Processes

    Science.gov (United States)

    2011-07-22

    ... COMMISSION Guidance for Fuel Cycle Facility Change Processes AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; extension of comment period. SUMMARY: On July 14, 2011 (76 FR 41527), the U.S...: Richard.Jervey@nrc.gov . SUPPLEMENTARY INFORMATION: On July 14, 2011 (76 FR 41527), the NRC published...

  10. 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...

  11. 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...

  12. 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....

  13. 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....

  14. 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...

  15. 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...

  16. 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...

  17. 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.

  18. 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

  19. MYRRHA Draft-2 Design accomplishments

    International Nuclear Information System (INIS)

    One of the main SCK-CEN research facility, namely the Materials Testing Reactor (MTR) BR2, is nowadays in operation for more than 40 years. The need for a safe and economic operation of the European nuclear park for preserving the natural resources, demand the start-up of one or more new MTRs in a very near future. On the other hand the closing of the fuel cycle as well as the development of future energy systems request clearly the use of fast spectrum irradiation facilities. The MYRRHA project started at SCK-CEN in this context, the concept of a new irradiation and testing facility to replace BR2. MYRRHA, being a fast neutron facility, would be a complementary project to the thermal MTR Jules Horowitz Reactor in France. That would give Europe a full research capacity in terms of nuclear research and development for Generation III and IV reactors. At mid-2002, a first pre-design file of MYRRHA (namely the ''MYRRHA Draft - 1'' file with a core nominal power of 30 MWth) has been submitted to an International Technical Guidance Committee (ITGC) for reviewing. No show stopper has been identified in the project. Nevertheless, the ITGC members have recommended: (1) to give more attention to safety studies and iterate to the pre-design before entering the detailed engineering phase; (2) to address some RandD topics to avoid bottlenecks such as fuel pin and assembly development and qualification; (3) to make a decision on the accelerator option (cyclotron or LINAC) and possibly revisit the beam parameters that were already at that moment fixed to 350 MeV*5 mA but mainly derived from the cyclotron technology possibilities. The objective of this effort in the period 2003-2005 was to update and progress the MYRRHA Draft-1 design based on the ITGC evaluation results, the consequences of the safety studies that had to be accomplished on basis of the Draft-1 design and holding the initial objectives of the MYRRHA facility. This resulted at mid-2005 in producing the MYRRHA Draft

  20. Graphic Turbulence Guidance

    Data.gov (United States)

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

  1. Legal contract drafting support

    OpenAIRE

    Pace, Gordon; Duca, Edward

    2012-01-01

    The notary drafts the contract on her computer – fixing a highlighted typo, ignoring the complex grammar warning. More worrying is the clause highlighted with an explanation of how it conflicts with another contract her client has signed. http://www.um.edu.mt/think/legal-contract-drafting-support/

  2. 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,…

  3. 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

  4. 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.''...

  5. 78 FR 72900 - Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco...

    Science.gov (United States)

    2013-12-04

    ... 8, 2013 (78 FR 9396), FDA announced the availability of the draft guidance of the same title. FDA...; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability... (FDA) is announcing the availability of the guidance entitled ``Civil Money Penalties for...

  6. 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...

  7. 78 FR 28228 - Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...

    Science.gov (United States)

    2013-05-14

    ... Healthcare Data; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... Federal Register of February 16, 2011 (76 FR 9027), FDA issued a draft version of this guidance entitled... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration...

  8. 77 FR 14022 - Guidance for Industry: Testing for Salmonella Species in Human Foods and Direct-Human-Contact...

    Science.gov (United States)

    2012-03-08

    ... 23, 2011 (76 FR 16425), FDA made available a draft guidance entitled ``Testing for Salmonella Species... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods; Availability AGENCY: Food and Drug...

  9. 76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505...

    Science.gov (United States)

    2011-04-01

    ... Federal Register of July 15, 2009 (74 FR 34358), FDA announced the availability of a draft guidance for... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Postmarketing Studies and Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act;...

  10. 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...

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

    Science.gov (United States)

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

    2003-11-01

    Recently the CPMP/CVMP sent out for consultation the draft Note for Guidance (dNfG) on the use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorization. We explored the practicability of this dNfG with respect to the verification of the correct identity of starting materials in a generic tablet-manufacturing site. Within the boundaries of the dNfG, a release procedure was developed for 12 substances containing structurally related compounds and substances differing only in particle size. For the method development literature data were also taken into consideration. Good results were obtained with wavelength correlation (WC), applied on raw spectra or second derivative spectra both without smoothing. The defined threshold of 0.98 for raw spectra differentiated between all molecular structures. Both methods were found to be robust over a period of 1 year. For the differentiation between the different particle sizes a subsequent second chemometric technique had to be used. Soft independent modelling of class analogy (SIMCA) with a probability level of 0.01 proved suitable. Internal and external validation I according to the dNfG showed no incorrect rejections or false acceptances. External validation II according to the dNfG was carried out with 95 potentially interfering substances from which 46 were tested experimentally. Macrogol 400 was not distinguished from macrogol 300. For the complete verification of the identity of macrogol 300 test A of the European Pharmacopoeia is needed in addition to the NIRS application. A release procedure developed with WC applied on raw spectra and SIMCA as a second method, which is different from the preferred method of the dNfG, was tested in practice with good results. We conclude that the dNfG has good practicability and that deviations from the preferred methods of the dNfG can also give good differentiation. PMID:14602194

  12. Drafting method of electricity and electron design

    International Nuclear Information System (INIS)

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

  13. Career Directions for Drafting CAD Technicians.

    Science.gov (United States)

    Moore, Pam

    2002-01-01

    Provides information careers for drafting/computer-assisted drafting technicians, including salaries, responsibilities, employment outlook, working conditions, skills needed, and career advancement opportunities. Lists professional drafting organizations. (JOW)

  14. 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. PMID:25730921

  15. Planning Practice Guidance

    OpenAIRE

    Public Health England

    2014-01-01

    The Department for Communities and Local Government has published National Planning Practice Guidance which recognises the importance of local infrastructure planning in the development of healthy communities. The guidance supports the National Planning Policy Framework and now includes a section on health and wellbeing. This guidance sets out the government’s planning policies for England and how these are expected to be applied by local authorities. A significant development in the...

  16. 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....

  17. 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.

  18. 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.

  19. 76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Science.gov (United States)

    2011-08-17

    ... during product design and development--as well as during manufacturing and product life-cycle management... development--as well as during manufacturing and product life-cycle management--to ensure that the amount of... August 3, 2010 (75 FR 45640), FDA announced the availability of the draft version of this guidance....

  20. 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...

  1. 75 FR 73109 - Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support...

    Science.gov (United States)

    2010-11-29

    ... accordingly. In the Federal Register of October 15, 2007 (72 FR 58312), FDA announced a notice of availability... following indications: Acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and acute bacterial otitis media. Since FDA issued the draft guidance, there have been public discussions...

  2. 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...

  3. 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...

  4. 77 FR 10536 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-02-22

    ... (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a... comment. Recommendations were last announced in the Federal Register of January 25, 2012 (77 FR 3777... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration,...

  5. 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... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration,...

  6. 77 FR 35688 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-06-14

    ... (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a... comment. Recommendations were last announced in the Federal Register of March 28, 2012 (77 FR 18827). This... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration,...

  7. 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...

  8. 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

  9. 78 FR 23289 - Public Review of Draft National Shoreline Data Content Standard

    Science.gov (United States)

    2013-04-18

    ... shoreline semantics, data structures and their relationships to builders and users of shoreline data. The... on the FGDC Web site, www.fgdc.gov . DATES: Comments on the draft Coastal and Marine Ecological... providing technical guidance on shoreline semantics, data structures and their relationships to builders...

  10. 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...

  11. 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...

  12. 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...

  13. 77 FR 55480 - Draft Compliance Policy Guide Sec. 690.150 on Labeling and Marketing of Nutritional Products...

    Science.gov (United States)

    2012-09-10

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft compliance policy guide (CPG) entitled ``Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats.'' This draft CPG is intended to provide guidance to FDA staff and industry on how FDA intends to use......

  14. Drafting the Basics

    Science.gov (United States)

    Lamb, Carol M.; Kurtanich, David G.

    2007-01-01

    This paper outlines the work in progress undertaken by the School of Engineering Technology faculty to identify, assess, and develop a course to address the depth and breadth of drafting/plan preparation and plan reading skills required by the various engineering technology programs offered at Youngstown State University. The methodology used to…

  15. 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…

  16. Drafting Lab Management Guide.

    Science.gov (United States)

    Ohio State Univ., Columbus. Instructional Materials Lab.

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

  17. 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,.

  18. 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

  19. Accelerating Cleanup: Focus on 2006. Discussion draft

    International Nuclear Information System (INIS)

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

  20. Students' drafting strategies and text quality

    OpenAIRE

    Piolat, A.; Roussey, JY

    1996-01-01

    The study reports an analysis of the drafts produced by two groups of students during an exam. Drafts were categorized as a function of some of their graphic features (e.g. their length), and of their different planning strategies used for their production (e.g. note draft, organized draft, composed draft). Grades obtained by the students on their essays related to the different categories of drafts. Results show that 2/3 of both groups of students made some kinds of draft. Drafts mostly cons...

  1. 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.

  2. 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

  3. 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).

  4. 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…

  5. India's draft nuclear doctrine

    International Nuclear Information System (INIS)

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

  6. 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 i...... 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....

  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. Employee commute options guidance

    International Nuclear Information System (INIS)

    The Clean Air Act Amendments of 1990 (CAAA) require severe and extreme ozone nonattainment areas and serious carbon monoxide nonattainment areas to establish programs aimed at reducing commute trips to the worksites of large employers. The concerns that lead to the inclusion of the Employee Commute Options (ECO) provision in the Act are that more people are driving than ever before and they are driving longer distances. The purpose of the guidance is to inform the affected State and local jurisdictions of the Clean Air Act requirement, to provide guidance on preparing an approvable State Implementation Plan (SIP) revision, and to discuss various approaches which may help areas achieve Clean Air Act targets through implementation strategies that are the least burdensome and costly to both affected employers and employees

  9. 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...

  10. 75 FR 22814 - Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1...

    Science.gov (United States)

    2010-04-30

    ... (70 FR 43439), FDA announced the availability of the draft guidance of the same title. FDA received...: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV... Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor...

  11. 77 FR 59000 - Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components...

    Science.gov (United States)

    2012-09-25

    ... the Federal Register of January 31, 2011 (76 FR 5386), FDA announced the availability of the draft... for single copies of the guidance to the Office of Communication, Outreach and Development (HFM-40... Evaluation and Research (HFM-17), Food and Drug Administration, 1401 ] Rockville Pike, Suite 200N,...

  12. 76 FR 26307 - Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug...

    Science.gov (United States)

    2011-05-06

    ... the Federal Register in January 2009 (74 FR 2849, January 16, 2009). The final rule requires ANDA... announced the availability of the draft version of this guidance (74 FR 17872). The public comment period... Bioequivalence Data for Abbreviated New Drug Applications; Availability AGENCY: Food and Drug Administration,...

  13. 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),...

  14. 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...

  15. 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

  16. 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

  17. 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...

  18. 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....../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...

  19. 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.

  20. 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…

  1. Evaluation of Worktext in Mechanical Drafting

    OpenAIRE

    Erich D. Cruz

    2015-01-01

    This study aimed to evaluate Worktext in Drafting Technology 4 (Mechanical Drafting) for Bachelor of Technology (BT) major in Drafting Technology. It was conducted at University of Rizal System with twenty Drafting and Mechanical Technology professors as respondents. The study used the descriptive evaluative method to describe and evaluate the developed Worktext in DT 4 using the questionnaire-checklist in gathering data. They were asked to evaluate the worktext through the following: objecti...

  2. 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

  3. 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

  4. Draft Transportaion Business Plan

    International Nuclear Information System (INIS)

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

  5. 32 CFR 989.19 - Draft EIS.

    Science.gov (United States)

    2010-07-01

    ... impacts, and anyone else requesting the entire draft EIS (40 CFR 1502.19 and 1506.6). (2) The EPF sponsors... comments (40 CFR 1503.4). The EPF must incorporate in the Final EIS its responses to comments on the Draft... proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of...

  6. 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...

  7. Plowshare radiation protection guidance

    International Nuclear Information System (INIS)

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

  8. Draft 1988 mission plan amendment

    International Nuclear Information System (INIS)

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

  9. 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 PlatteKansas Rivers Ecosystem Work Activity Guidance for refuge managers to review the purposes of refuges...

  10. 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.

  11. Autonomous gliding entry guidance with

    OpenAIRE

    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 traje...

  12. Drafting with Design in Mind

    Science.gov (United States)

    Daugherty, Michael K.; Carter, Vinson

    2011-01-01

    Design and drafting are subjects long taught in technology education, and subjects that retain high status in the profession. Admittedly, since the initial publication of Standards for Technological Literacy in 2000, design has taken on a larger role and meaning in the technology education profession. However, design continues to be delivered…

  13. AGILE DRAFTING OF OUTSOURCING CONTRACTS

    DEFF Research Database (Denmark)

    Schlichter, Bjarne Rerup; Storgaard, Kristian

    2015-01-01

    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...

  14. 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

  15. Cognitive Style and Drafting Performance.

    Science.gov (United States)

    Guster, Dennis

    1986-01-01

    The relationships between drafting performance and the cognitive style construct of field dependence/field independence are examined. The analysis revealed that the performance of the field-independent individual is likely to be superior to that of the field-dependent student. (Author/CT)

  16. 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

  17. 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.

  18. 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...

  19. Guidance for External Events Analysis

    International Nuclear Information System (INIS)

    This Guidance for External Events Analysis was developed under a contract with the Nordic PSA Group, and aims at creating a common framework for analysis of external events as part of a nuclear power plant Probabilistic Safety Assessment. Thus, the purpose of this Guidance is to constitute a common methodological guidance for the analysis of external events at Nordic nuclear power plants. This will make it possible for the utilities to perform these analyses in a cost-efficient way, assuring simultaneously the quality of the analyses. The Guidance is meant to clarify the scope of the analysis of external events, to provide guidance for the performance of the analysis, and to help in defining, subcontracting and reviewing the work. The analysis procedure includes four phases, addressing project planning, identification of external events, screening of events, and probabilistic analysis. The aim is first to do as complete an identification of potential single and combined external events as possible. Thereafter, as many external events as possible are screened out as early as possible. The screening capability is increased during the project, using the continuously acquired information on the events and on their effects on the plant

  20. Information architecture. Volume 3: Guidance

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-04-01

    The purpose of this document, as presented in Volume 1, The Foundations, is to assist the Department of Energy (DOE) in developing and promulgating information architecture guidance. This guidance is aimed at increasing the development of information architecture as a Departmentwide management best practice. This document describes departmental information architecture principles and minimum design characteristics for systems and infrastructures within the DOE Information Architecture Conceptual Model, and establishes a Departmentwide standards-based architecture program. The publication of this document fulfills the commitment to address guiding principles, promote standard architectural practices, and provide technical guidance. This document guides the transition from the baseline or defacto Departmental architecture through approved information management program plans and budgets to the future vision architecture. This document also represents another major step toward establishing a well-organized, logical foundation for the DOE information architecture.

  1. 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)

  2. Environmental dosimetry performance criteria: Pilot test of proposed ANSI draft standard N13.29

    International Nuclear Information System (INIS)

    American National Standards Institute (ANSI) standards are a source of technical guidance on the application of passive radiation detectors in personnel and environmental monitoring programs. The proposed new ANSI Draft N13.29 describes performance tests for environmental dosimetry providers that are analogous to those now required in personnel dosimetry. The objective of this study was to pilot test the procedural specifications before Draft N13.29 is submitted for final balloting. The results of the performance tests are relevant to environmental surveillance programs, which may be affected if Draft N13.29 is approved. Seven environmental dosimetry providers submitted dosimeters for the pilot test, which included two phases. The first phase involved exposing dosimeters to laboratory gamma, beta, and x-ray sources at routine and accident dose levels. In the second phase, dosimeters were subjected to 90 d of simulated environmental conditions in a chamber that cycled through prescribed temperature and humidity parameters and lighting conditions. Two participants passed all categories of the laboratory test phase, and all seven passed the environmental test phase. The authors report here on the results of the performance tests; additional results relevant to finalizing Draft N13.29 are detailed elsewhere

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

    International Nuclear Information System (INIS)

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

  4. Guidance at the educational marketplace

    DEFF Research Database (Denmark)

    Lystbæk, Christian Tang

    `agent´ on the educational "market´, assisting (potential) students into and around the `marketplace´. Consequently, guidance is also an important `agent´ for educational institutions that increasingly use marketing strategies to promote themselves on the market to attract and hold on to their “customers......” in order for the institutions to increase their ´market value´, `sales” and “turnover”. Thus, the expansion of guidance is nurtured by the expansion of the logic of marketization and consumerism. Drawing on Foucauldian perspectives in educational research, which highlight the expansion of powerful...

  5. 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.

  6. US Food and Drug Administration draft recommendations on radioactive contamination of food

    International Nuclear Information System (INIS)

    Recommendations on accidental radioactive contamination of human food were issued in 1982 by the Food and Drug Administration (FDA). The recommendations provided guidance to State and local government officials in the exercise of their respective authorities, and were applicable to emergency response planning and to the conduct of radiation protection activities associated with the production, processing, distribution, and use of human food accidentally contaminated with radioactive material. Review of the 1982 FDA recommendations, stimulated by the events following the 1986 accident at Chernobyl, indicated that it would be appropriate to update the recommendations to incorporate newer scientific information and radiation protection philosophy, to include experience gained since 1982, and to take into account international advances. This paper presents a brief outline of the FDA's approach to its draft revision. the most recent draft was circulated for interagency review in November 1994. Modification made in response to the comments received are included in this paper. 20 refs., 6 tabs

  7. 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.

  8. 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

  9. 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.

  10. Autonomous gliding entry guidance with

    Directory of Open Access Journals (Sweden)

    Guo Jie

    2015-10-01

    Full Text Available 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.

  11. 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.

  12. 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)

  13. 1 CFR 21.1 - Drafting.

    Science.gov (United States)

    2010-01-01

    ... 1 General Provisions 1 2010-01-01 2010-01-01 false Drafting. 21.1 Section 21.1 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS PREPARATION OF DOCUMENTS SUBJECT TO CODIFICATION General § 21.1 Drafting. (a) Each agency that prepares...

  14. Teaching Drafting 101: What Comes First?

    Science.gov (United States)

    Carkhuff, Don

    2006-01-01

    Employers require pristine drawings that convey clarity and precision for the production of goods. Can a change in sequence of instruction be expeditious and help teachers better prepare their students for the workplace? Research suggests that combining traditional drafting and computer-aided drafting (CAD) instruction makes sense. It is analogous…

  15. 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.

  16. 27 CFR 20.101 - Drafting formulas.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Drafting formulas. 20.101 Section 20.101 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT... Process Approval Policies § 20.101 Drafting formulas. (a) In preparing Form 5150.19, the...

  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. 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,…

  19. Agent Based Individual Traffic guidance

    DEFF Research Database (Denmark)

    Wanscher, Jørgen Bundgaard

    2004-01-01

    vehicle 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 of...... the road network is aggregated. As a result the calculations reveal only what the mass of vehicles are doing and not what a single vehicle is doing. This is the crucial difference to ABIT (Agent Based Individual Trafficguidance). ABIT is based on the fact that information on the destination of each...

  20. Microfluidic control of axonal guidance

    Science.gov (United States)

    Gu, Ling; Black, Bryan; Ordonez, Simon; Mondal, Argha; Jain, Ankur; Mohanty, Samarendra

    2014-10-01

    The precision of axonal pathfinding and the accurate formation of functional neural circuitry are crucial for an organism during development as well as during adult central and peripheral nerve regeneration. While chemical cues are believed to be primarily responsible for axonal pathfinding, we hypothesize that forces due to localized fluid flow may directly affect neuronal guidance during early organ development. Here, we report direct evidence of fluid flow influencing axonal migration, producing turning angles of up to 90°. Microfluidic flow simulations indicate that an axon may experience significant bending force due to cross-flow, which may contribute to the observed axonal turning. This method of flow-based guidance was successfully used to fasciculate one advancing axon onto another, showcasing the potential of this technique to be used for the formation of in vitro neuronal circuits.

  1. 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...... 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 of the project were not previously considered. We define a special inseparable cost function and develop a solution complex capable of using this cost function. In relation to calibration and estimation of statistical models used for dynamic route guidance we worked with generating random number...

  2. Review of soil contamination guidance

    International Nuclear Information System (INIS)

    A review of existing and proposed radioactive soil contamination standards and guidance was conducted for United Nuclear Corporation (UNC), Office of Surplus Facilities Management. Information was obtained from both government agencies and other sources during a literature survey. The more applicable standards were reviewed, evaluated, and summarized. Information pertaining to soil contamination for both facility operation and facility decommissioning was obtained from a variety of sources. These sources included: the Code of Federal Regulations, regulatory guides, the Federal Register, topical reports written by various government agencies, topical reports written by national laboratories, and publications from the American National Standards Institute (ANSI). It was difficult to directly compare the standards and guidance obtained from these sources since each was intended for a specific situation and different units or bases were used. However, most of the information reviewed was consistent with the philosophy of maintaining exposures at levels as low as reasonably achievable

  3. 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...

  4. 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...

  5. Review of soil contamination guidance

    International Nuclear Information System (INIS)

    A review of existing and proposed radioactive soil contamination standards and guidance was conducted for United Nuclear Corporation (UNC), Office of Surplus Facilities Management. The more applicable standards were reviewed, evaluated and summarized. Information pertaining to soil contamination for both facility operation and facility decommissioning was obtained from a variety of sources. Most of the information reviewed was consistent with the philosophy of maintaining exposures at levels as low as reasonably achievable

  6. Updates to the U.S. Nuclear Regulatory Commission's Consolidated NMSS Decommissioning Guidance

    International Nuclear Information System (INIS)

    In September 2003, U.S. Nuclear Regulatory Commission (NRC) staff in the Office of Nuclear Material Safety and Safeguards (NMSS) consolidated and updated the policies and guidance of its decommissioning program in a three-volume NUREG report, NUREG-1757, 'Consolidated NMSS Decommissioning Guidance' [1,2,3]. This NUREG report provides guidance on: planning and implementing license termination under the NRC's License Termination Rule (LTR), in 10 CFR Part 20, Subpart E; complying with the radiological criteria for license termination; and complying with the requirements for financial assurance and record-keeping for decommissioning and timeliness in decommissioning of materials facilities. The staff plans to periodically update NUREG-1757, so that it reflects current NRC decommissioning policy. In September 2005, the staff issued, for public comment, draft Supplement 1 to NUREG-1757 [4], which contains proposed updates to the three volumes of NUREG-1757. Draft Supplement 1 includes new and revised decommissioning guidance that addresses some of the LTR implementation issues, which were analyzed by the staff in two Commission papers (SECY-03-0069, Results of the LTR Analysis [5]; and SECY-04-0035, Results of the LTR Analysis of the Use of Intentional Mixing of Contaminated Soil [6]). These issues include restricted use and institutional controls, onsite disposal of radioactive materials under 10 CFR 20.2002, selection and justification of exposure scenarios based on reasonably foreseeable future land use (realistic scenarios), intentional mixing of contaminated soil, and removal of material after license termination (a follow-up to the LTR Analysis issue on the relationship between the LTR and the current case-by-case approach for release of solid materials). The staff also developed new and revised guidance on other issues, including the risk-informed graded approach for engineered barriers. This paper is a follow-up to a poster session and paper at Waste Management

  7. Radionuclide Data Quality Evaluation Guidance

    International Nuclear Information System (INIS)

    A considerable amount of radioanalytical data is generated during various phases of the characterization and remediation of radiologically-contaminated sites and properties. It is critical that data generated from the analysis of collected samples be to a level of quality usable by the project and acceptable to stakeholders. In July 2004, the final version of a multi-agency guidance manual entitled Multi-Agency Radiological Analytical Protocols Manual (MARLAP) was issued by the Environmental Protection Agency, Department of Energy, Department of Homeland Security, Nuclear Regulatory Commission, Department of Defense, National Institute of Standards and Technology, U. S. Geological Survey, Food and Drug Administration, and the States of Kentucky and California. The authors' purpose is to introduce readers to some key elements of MARLAP as it relates to radioanalytical lab quality control, and to demonstrate how these guidance elements can be effectively incorporated into mature radioanalytical lab operations and data validation regimes. Based upon the logic and statistical methodologies presented in MARLAP, the authors have revised existing project-specific Radioanalytical Data Evaluation Guidance (RadDEG) used at the FUSRAP Maywood Site in Maywood, NJ. The RadDEG allows users to qualify data in a meaningful way by tying the usability of the data to its activity and uncertainty relative to project action levels and QC results. This exercise may be useful to other projects looking to implement a MARLAP-based approach into their project/site-specific data evaluation methodologies. (authors)

  8. 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.

  9. Security of radioactive sources. Interim guidance for comment

    International Nuclear Information System (INIS)

    In previous IAEA publications, there have been only rather general security requirements for non-nuclear radioactive material. These requirements were primarily directed to such issues as unintentional exposure to radiation, negligence and inadvertent loss. However, it is clear that more guidance is needed to not only try and prevent further events involving orphan sources, but also to prevent the deliberate attempt to acquire radioactive sources for malevolent purposes. Member States have requested guidance on the type and nature of security measures that might be put in place and on the methodology to be used in choosing such measures. These requests were also endorsed in the findings of the international conference on 'Security of Radioactive Sources' held in March 2003. Practical advice on assessing and implementing security measures complements the general commitments in the proposed Revised Code of Conduct on Safety and Security of radioactive Sources. A Safety Guide entitled 'Safety and Security of Radiation Sources' that, amongst other things, discusses these issues is being drafted. However, it is recognized that guidance material is required before this document will be finalized in order to allow Member States opportunity to put in place appropriate actions and planning to address current issues. Hence the purpose of the current document is to provide advice on security approaches and to allow comment on detailed recommendations for levels of security on radioactive sources that may be incorporated within the Safety Guide. This report is primarily addressed to Regulatory Authorities but it is also intended to provide guidance to manufacturers, suppliers and users of sources. Its objective is to assist Member States in deciding which security measures are needed to ensure consistency with the International Basic Safety Standards and the Revised Code of Conduct for the Safety and Security of Radioactive Sources. It is recognized that there must be a

  10. Business Plan in Brief : Draft.

    Energy Technology Data Exchange (ETDEWEB)

    United States. Bonneville Power Administration.

    1994-06-01

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

  11. 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

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

    Science.gov (United States)

    2013-02-11

    ..., 2008, issue of the Federal Register (73 FR 3316). Background and Purpose The 94th (Maritime) session of the International Labour Conference (ILC) (Geneva, February 2006) adopted the Maritime Labour... Maritime Labour Convention, 2006 AGENCY: Coast Guard, DHS. ACTION: Notice of availability and request...

  13. 78 FR 68460 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Science.gov (United States)

    2013-11-14

    ... About Medical Foods; Second Edition; Reopening of the Comment Period AGENCY: Food and Drug... Asked Questions About Medical Foods; Second Edition.'' We are reopening the comment period in response... ``Frequently Asked Questions About Medical Foods; Second Edition.'' (We had published earlier versions of...

  14. 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...

  15. 76 FR 27331 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-05-11

    ... Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic Testing; Availability AGENCY: Food and Drug... Diagnostic Devices for Chlamydia Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic Testing... Diagnostic Devices for Chlamydia Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic...

  16. 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...

  17. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-01-05

    ... Antibodies to Borrelia Burgdorferi; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi.'' FDA is... detection of antibodies to Borrelia burgdorferi. These devices are used to aid in the diagnosis of...

  18. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Science.gov (United States)

    2011-11-23

    ... Veterinary Medicine (CVM) thinks are the most appropriate for the evaluation of the effectiveness of... Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self... FURTHER INFORMATION CONTACT: Emily R. Smith, Center for Veterinary Medicine (HFV-135), Food and...

  19. 75 FR 63189 - Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human...

    Science.gov (United States)

    2010-10-14

    ..., Outreach and Development (HFM-40), Center for Biologics Evaluation Research (CBER), Food and Drug... for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 200N, Rockville, MD...

  20. 78 FR 9702 - Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products...

    Science.gov (United States)

    2013-02-11

    ..., Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug... Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite...

  1. 76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

    Science.gov (United States)

    2011-08-19

    ...-0002; or the Office of Communication, Outreach, and Development (HFM-40), Center for Biologics... -0002, 301- 796-2050; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food...

  2. 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...-0002, or the Office of Communication, Outreach and Development (HFM-40), Center for Biologics...-796-2380; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and...

  3. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Science.gov (United States)

    2013-05-31

    ... Office of Communication, Outreach, and Development (HFM-40), Center for Biologics Evaluation and Research... (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448,...

  4. 76 FR 65735 - Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire...

    Science.gov (United States)

    2011-10-24

    ... Communication, Outreach and Development (HFM- 40), Center for Biologics Evaluation and Research (CBER), Food and... INFORMATION CONTACT: Tami Belouin, Center for Biologics Evaluation and Research (HFM-17), Food and...

  5. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Science.gov (United States)

    2011-11-10

    ... Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development (HFM-40), Center for... and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville,...

  6. 76 FR 38187 - International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of...

    Science.gov (United States)

    2011-06-29

    ... Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and... Christopher Joneckis, Center for Biologics Evaluation and Research (HFM-25), Food and Drug...

  7. 77 FR 74852 - Draft Guidance for Industry on Certification of Designated Medical Gases; Availability

    Science.gov (United States)

    2012-12-18

    ... medical gases. Specifically, section 575 provides that oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, and medical air are designated medical gases. Section 576 permits any...

  8. 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...

  9. 75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

    Science.gov (United States)

    2010-01-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... electronic comments to http://www.regulations.gov . See the SUPPLEMENTARY INFORMATION section for electronic... Abuse (NIDA), as described in a Memorandum of Understanding (MOU) of March 8, 1985 (50 FR 9518). When...

  10. 78 FR 44483 - Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of...

    Science.gov (United States)

    2013-07-24

    ... production systems that provide laying hens with access to the outdoors. Laying hens are provided outdoor... laying hens. For producers with fewer than 50,000, but at least 3,000 laying hens, the compliance date... regard to production systems that provide laying hens with access to the outdoors, including...

  11. 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...

  12. 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...

  13. 77 FR 40068 - Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and...

    Science.gov (United States)

    2012-07-06

    ... scientific workshop. In addition, FDA is aware that dengue viruses are endemic in Quintana Roo and Jalisco. FDA is currently evaluating the risk of dengue virus infections in U.S. blood donors that are...

  14. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Science.gov (United States)

    2013-03-11

    ... Container Is Not Made With Natural Rubber Latex'' to the Division of Small Manufacturers, International and... Kux, Assistant Commissioner for Policy. BILLING CODE 4160-01-P ... for inclusion in medical product labeling such as ``latex-free,'' ``does not contain natural...

  15. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Science.gov (United States)

    2010-10-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND...-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY... subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of...

  16. 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...

  17. 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...

  18. 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...

  19. 77 FR 8884 - Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a...

    Science.gov (United States)

    2012-02-15

    ... Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one self- addressed adhesive... appropriate information (e.g., characterization, adventitious agent safety, process controls,...

  20. 76 FR 82306 - Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability

    Science.gov (United States)

    2011-12-30

    ... biomarker studies, and outlines the scientific standards for histology used in biomarker characterization... Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your....'' The discovery, characterization, qualification, and implementation of biomarkers have been...

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

    International Nuclear Information System (INIS)

    The following technical report provides a detailed status report of the DOE grant project entitled ''Environmental Guidance Documents for Exploration, Development, Production, and Transportation of Crude Oil and Natural Gas in Texas.'' The grant funding allocated is for the purpose of provided the Railroad Commission of Texas (Commission) with resources and capabilities to draft, publish and distribute documents that provide guidance to oil and gas operators on issues concerning oil and gas naturally occurring radioactive material (NORM) waste, oil and gas hazardous waste, remediation of crude oil spills, management of non-hazardous oil and gas wastes, and mechanical integrity testing of Class II injection and disposal wells

  2. Quality guidance and quality formation

    DEFF Research Database (Denmark)

    Poulsen, Carsten Stig; Juhl, Hans Jørn; Kristensen, Kai;

    1996-01-01

    This paper presents an extension of the quality guidance model of Steenkamp and van Trijp that includes consumer quality formation processes. Quality expectations and quality experiences are seen as antecedents of perceived overall product quality conceptual model is applied using LISREL to a data...... set on Danish butter cookies. Five plausible models of the relation between expectation, experience and perceived product quality are estimated. Finally one model is selected on the basis of three criteria: chi-square, RMSEA and AIC: The results show a model where expectations are indirectly related...... to perceived quality through experience. Udgivelsesdato: APR...

  3. 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)

  4. 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.

  5. Draft Environmental Impact Statement: Lostwood Proposed Wilderness

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This document is a draft of an analysis of the environmental impact wilderness designation would pose for the proposed Lostwood Wilderness area. Topics covered...

  6. Draft environmental statement : Proposed Valentine Wilderness area

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This document is a draft of an analysis of the environmental impact wilderness designation would pose for the Valentine National Wildlife Refuge. Topics covered...

  7. Regulatory requirements for ISI qualification. Draft

    International Nuclear Information System (INIS)

    The report present drafts for the regulation documents worked out by the Committee of the Use of Atomic Energy for Peaceful Purposes. It contains the Regulatory requirements for ISI qualifications and Regulatory requirements for the Qualification Body

  8. 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...

  9. The draft Mission Plan Amendment

    International Nuclear Information System (INIS)

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

  10. 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

  11. On the Drafting of Confidentiality Agreements

    OpenAIRE

    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 IACCM (International Association for Contract and Commercial Management) has initiated. The main theoretical aspect of the article concerns the application of the value maximization principle (the Coase...

  12. 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.

  13. 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…

  14. 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.)

  15. ICRP guidance on radioactive waste disposal

    International Nuclear Information System (INIS)

    The International Commission on Radiological Protection (ICRP) issued recommendations for a system of radiological protection in 1991 as the 1990 Recommendations. Guidance on the application of these recommendations in the general area of waste disposal was issued in 1997 as Publication 77 and guidance specific to disposal of solid long-lived radioactive waste was issued as Publication 81. This paper summarises ICRP guidance in radiological protection requirements for waste disposal concentrating on the ones of relevance to the geological disposal of solid radioactive waste. Suggestions are made for areas where further work is required to apply the ICRP guidance. (author)

  16. 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...

  17. National report: Switzerland. Implementation of the Code and supplementary Guidance

    International Nuclear Information System (INIS)

    Switzerland has expressed its intention to work towards implementing the provisions of the Code of Conduct on the Safety and Security of Radioactive Sources and its associated guidance. Already at the time of that commitment, most principles of the code were mirrored in Swiss legislation and implemented thus promoting a high-quality radioprotection system. Several provisions however are formally still not completely fulfilled and need to be addressed at the legislative level. The full revision of the Swiss Radiological Protection Ordinance, along with related technical ordinances, which presently takes place and will come into force in a near future, gives the opportunity to integrate the provisions of the code into Swiss legislation and harmonise the key concepts with those of the European BSS, presently drafted. Especially security related provisions, radiation monitoring for detection of orphan sources, categorisation of sources and import-export procedures are being harmonised. As soon as the revision procedure of the new ordinance is closed, the provisions of the Code should be fully integrated into Swiss legislation and regulatory practices. (author)

  18. 77 FR 55222 - Notice of Availability of the Draft Resource Management Plan Amendment and the Draft...

    Science.gov (United States)

    2012-09-07

    ... Draft Environmental Impact Statement for Oil and Gas Development for the White River Field Office in..., and/or mailings. ADDRESSES: You may submit comments related to the WRFO Oil and Gas Development Draft...-878-3805. Mail: BLM--WRFO, 220 East Market Street, Meeker, Colorado 81641. Copies of the WRFO Oil...

  19. 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...

  20. 76 FR 55941 - Notice of Availability of the Draft Bakersfield Resource Management Plan and Draft Environmental...

    Science.gov (United States)

    2011-09-09

    ... proposed ACEC are special status plant species and rare plant community. Proposed limitations address land... Bureau of Land Management Notice of Availability of the Draft Bakersfield Resource Management Plan and Draft Environmental Impact Statement, California AGENCY: Bureau of Land Management, Interior....

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

    Science.gov (United States)

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

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

  2. 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.

  3. 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.

  4. New Tools for Guidance in Business Education.

    Science.gov (United States)

    Shimberg, Benjamin

    Several recently developed measurement instruments, the General Aptitude Test Battery (GATB), the Comparative Guidance and Placement Program (CGP), the Kuder Occupational Interest Survey (DD), the Ohio Vocational Interest Survey (OVIS), and the Gordon Occupational Check List, are considered in connection with guidance testing for occupational…

  5. 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.

  6. 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

  7. 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.

  8. Learners' Needs in College-Based Guidance.

    Science.gov (United States)

    Further Education Unit, London (England).

    Recent Further Education Unit (FEU) research has provided clear evidence of technical college students' needs for career and educational guidance throughout their program of study. Inhouse technical college guidance services to individuals and institutions offer a number of benefits to both students receiving the services and the institutions…

  9. Why Guidance Works Better than Punishment.

    Science.gov (United States)

    Gartrell, Dan

    1995-01-01

    Examines how guidance techniques address the full spectrum of intervention methods, from prevention to conflict resolution to long-term management strategies. Discusses how punishment affects both children and teachers. Suggests that to put guidance into practice teachers should: be realistic, tailor activities to each child, practice positive…

  10. 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…

  11. 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...

  12. 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

  13. School District Uses Computer Aided Design and Drafting.

    Science.gov (United States)

    Lorentz, Gordon S.

    1988-01-01

    Computer Aided Design and Drafting (CADD) programs are used to teach drafting at an Indiana high school. The school system's maintenance department shared use of the software and equipment to produce original drawings of school buildings. (MLF)

  14. 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...

  15. 75 FR 48382 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-08-10

    ... 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-1228, ``Standard Format and Content...

  16. 75 FR 28073 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-05-19

    ... 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-3039, ``Standard Format and Content...

  17. 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,...

  18. 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.

  19. 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.

  20. 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…

  1. 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...

  2. IRIS Toxicological Review of Methanol (Noncancer) (Interagency Science Discussion Draft)

    Science.gov (United States)

    On May 3, 2013, the Toxicological Review of Methanol (noncancer) (Revised External Review Draft) was posted for public review and comment. Subsequently, the draft Toxicological Review, Appendices, and draft IRIS Summary were reviewed internally by EPA and by other federal agenci...

  3. 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...

  4. 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....

  5. 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...

  6. 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.

  7. 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

  8. Evaluations for draft reports on geological disposal

    International Nuclear Information System (INIS)

    This report summarizes the results of the technical evaluations on two reports which are named as 'Overview of the Geological Disposal Facility' and Considerable Factors on Selection of Potential Sites for Geological Disposal' drafted by NUMO (Nuclear Waste Management Organization of Japan). The review of each draft report has been referred to committee (held on 9th September, 2002) and working group (held on 1st October, 2002) which were organized in order to confirm a progress of implementation of geological disposal by government. (author)

  9. International guidance, evolution and trends

    International Nuclear Information System (INIS)

    Carmen Ruiz Lopez, (CSN) addressed the evolution of some of the fundamental concepts related to the objective of protecting future generations, with the intention of encouraging the discussion, and to determine whether the recent international guidance implied any change in philosophy and approach regarding the practical interpretation and implementation of such fundamental concepts. C. Ruiz presented a general overview of the ICRP and IAEA guidance developments as well as the major changes or reorientations introduced by the latest ICRP Recommendations and IAEA Safety Standards that are relevant to long-term issues of geological disposal, namely, ICRP 103 (2009), ICRP 101 (2006), IAEA Safety Fundamentals SF-1(2006) and WS-R-4. As for the ICRP developments, ICRP 103 confirms the validity of ICRP 81(1998) as the main ICRP reference for long-lived waste disposal. C. Ruiz then noted the extension of the scope of ICPR 81 mentioning some of the principles and recommendations related to the objective of protecting future generations and the view of the Commission for demonstrating compliance. ICRP 103 and ICRP 101 reinforce the importance of transparency in the decision-making process and in the demonstration of confidence in situations of increasing uncertainties about time, giving more weight to the process itself and strengthening the need for an open dialogue between regulator and implementer. In both recommendations the Commission recognises the influence of societal values in the final decision on the level of radiological protection, as well as the influence of social concerns and political aspects in the decision-making process. The evolution of internationally agreed safety fundamental objectives and principles can be observed in the changes from the IAEA's Waste Safety Fundamentals of 1995 to the new Safety Fundamentals of 2006. C Ruiz presented a comparison of both documents focussing on the differences in dealing with fundamental concepts related to the

  10. 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...

  11. 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.

  12. 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...

  13. 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.)

  14. 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...

  15. 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.

  16. Reduced order model of draft tube flow

    International Nuclear Information System (INIS)

    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

  17. Drafting International Commercial Agreements - a Primer

    OpenAIRE

    Wautelet, Patrick

    2011-01-01

    This presentation is used as a basis for a course on drafting international commercial agreements. It is complemented by two cases studies. The course is mainly addressed to non lawyers and is hence rather practice than law oriented. The course is not linked to one jurisdiction or one type of contract in particular, but attempts to address general issues related to international commercial agreements.

  18. Parallel-End-Point Drafting Compass

    Science.gov (United States)

    Cronander, J.

    1986-01-01

    Parallelogram linkage ensures greater accuracy in drafting and scribing. Two members of arm of compass remain parallel for all angles pair makes with hub axis. They maintain opposing end members in parallelism. Parallelogram-linkage principle used on dividers as well as on compasses.

  19. 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…

  20. 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...

  1. Draft Genome Sequence of Lactobacillus rhamnosus 2166.

    OpenAIRE

    Karlyshev, Andrey V.; Melnikov, Vyacheslav G.; Kosarev, Igor V.; Abramov, Vyacheslav M.

    2014-01-01

    In this report, we present a draft sequence of the genome of Lactobacillus rhamnosus strain 2166, a potential novel probiotic. Genome annotation and read mapping onto a reference genome of L. rhamnosus strain GG allowed for the identification of the differences and similarities in the genomic contents and gene arrangements of these strains.

  2. Incorporating CAD Instruction into the Drafting Curriculum.

    Science.gov (United States)

    Yuen, Steve Chi-Yin

    1990-01-01

    If education is to meet the challenged posed by the U.S. productivity crisis and the large number of computer-assisted design (CAD) workstations forecast as necessary in the future, schools must integrate CAD into the drafting curriculum and become aggressive in providing CAD training. Teachers need to maintain close contact with local industries…

  3. First Draft of the Research Agenda

    DEFF Research Database (Denmark)

    Dahl, Hanne Marlene; Pieper, Michael; Fahnøe, Kristian

    This report is a draft of a research agenda that the consortium INNOSERV has provided to the European Commission. It is the result of the work of researchers and insights provided by users, practitioners, experts and policy-makers involving around 20 examples of innovative practices from differen...... context, New Technologies and Measuring outcomes, quality and challenges....

  4. Illinois Occupational Skill Standards: Architectural Drafting Cluster.

    Science.gov (United States)

    Illinois Occupational Skill Standards and Credentialing Council, Carbondale.

    This document, which is intended as a guide for work force preparation program providers, details the Illinois occupational skill standards for programs preparing students for employment in occupations in the architectural drafting cluster. The document begins with a brief overview of the Illinois perspective on occupational skill standards and…

  5. Illinois Occupational Skill Standards: Mechanical Drafting Cluster.

    Science.gov (United States)

    Illinois Occupational Skill Standards and Credentialing Council, Carbondale.

    This document, which is intended as a guide for work force preparation program providers, details the Illinois occupational skill standards for programs preparing students for employment in occupations in the mechanical drafting cluster. The document begins with a brief overview of the Illinois perspective on occupational skill standards and…

  6. 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

  7. Guidance and methods for satisfying low specific activity material and surface contaminated object regulatory requirements

    International Nuclear Information System (INIS)

    The US Department of Transportation (DOT) and the US Nuclear Regulatory Commission (NRC) have prepared a comprehensive set of draft guidance for shippers and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated objects (SCOs). These requirements represent significant departures in some areas from the manner in which these materials and objects were regulated by the earlier versions of the regulations. The proper interpretation and application of the regulatory criteria can require a fairly complex set of decisions be made. To assist those trying to apply these regulatory requirements, a detailed set of logic flow diagrams representing decisions related to multiple factors were prepared and included in the draft report for comment on Categorizing and Transporting Low Specific Activity Materials and Surface Contaminated Objects. These logic flow diagrams, as developed, are specific to the US regulations, but were readily adaptable to the IAEA regulations. The diagrams have been modified accordingly and tied directly to specific paragraphs in IAEA Safety Series No. 6. This paper provides the logic flow diagrams adapted to the IAEA regulations, and demonstrates how these diagrams can be used to assist consignors and inspectors in assessing compliance of shipments with the LSA material and SCO regulatory requirements

  8. 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…

  9. 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.

  10. 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…

  11. 77 FR 40586 - Draft NIST Interagency Report (NISTIR) 7823, Advanced Metering Infrastructure Smart Meter...

    Science.gov (United States)

    2012-07-10

    ... Metering Infrastructure Smart Meter Upgradeability Test Framework; Request for Comments AGENCY: National... Metering Infrastructure Smart Meter Upgradeability Test Framework (Draft NISTIR 7823). This draft document... process for the Advanced Metering Infrastructure (AMI) Smart Meters. The target audience for Draft...

  12. 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,...

  13. 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...

  14. 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

  15. Guidance levels, achievable doses and expectation levels

    Energy Technology Data Exchange (ETDEWEB)

    Li, Lianbo [Hygiene and Anti-epidemic Station of Shandong Province, Jinan (China); Meng, Bing [Hygiene and Anti-epidemic Station of Zibo City, Zibo (China)

    2002-07-01

    The National Radiological Protection Board (NRPB), the International Atomic Energy Agency (IAEA) and the Commission of the European Communities (CEC) published their guidance levels and reference doses for typical X-ray examination and nuclear medicine in their documents in 1993, 1994 and 1996 respectively. From then on, the concept of guidance levels or reference doses have been applied to different examinations in the field of radiology and proved to be effective for reduction of patient doses. But the guidance levels or reference doses are likely to have some shortcomings and can do little to make further reduction of patient dose in the radiology departments where patient dose are already below them. For this reason, the National Radiological Protection Board (NRPB) proposed a concept named achievable doses which are based on the mean dose observed for a selected sample of radiology departments. This paper will review and discuss the concept of guidance levels and achievable doses, and propose a new concept referred to as Expectation Levels that will encourage the radiology departments where patient dose are already below the guidance levels to keep patient dose as low as reasonably achievable. Some examples of the expectation levels based on the data published by a few countries are also illustrated in this paper.

  16. 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.

  17. Constrained reconstructions for 4D intervention guidance

    Science.gov (United States)

    Kuntz, J.; Flach, B.; Kueres, R.; Semmler, W.; Kachelrieß, M.; Bartling, S.

    2013-05-01

    Image-guided interventions are an increasingly important part of clinical minimally invasive procedures. However, up to now they cannot be performed under 4D (3D + time) guidance due to the exceedingly high x-ray dose. In this work we investigate the applicability of compressed sensing reconstructions for highly undersampled CT datasets combined with the incorporation of prior images in order to yield low dose 4D intervention guidance. We present a new reconstruction scheme prior image dynamic interventional CT (PrIDICT) that accounts for specific image features in intervention guidance and compare it to PICCS and ASD-POCS. The optimal parameters for the dose per projection and the numbers of projections per reconstruction are determined in phantom simulations and measurements. In vivo experiments in six pigs are performed in a cone-beam CT; measured doses are compared to current gold-standard intervention guidance represented by a clinical fluoroscopy system. Phantom studies show maximum image quality for identical overall doses in the range of 14 to 21 projections per reconstruction. In vivo studies reveal that interventional materials can be followed in 4D visualization and that PrIDICT, compared to PICCS and ASD-POCS, shows superior reconstruction results and fewer artifacts in the periphery with dose in the order of biplane fluoroscopy. These results suggest that 4D intervention guidance can be realized with today’s flat detector and gantry systems using the herein presented reconstruction scheme.

  18. 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

  19. 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

  20. HUMAN FACTORS GUIDANCE FOR CONTROL ROOM EVALUATION

    International Nuclear Information System (INIS)

    The Human-System Interface Design Review Guideline (NUREG-0700, Revision 1) was developed by the US Nuclear Regulatory Commission (NRC) to provide human factors guidance as a basis for the review of advanced human-system interface technologies. The guidance consists of three components: design review procedures, human factors engineering guidelines, and a software application to provide design review support called the ''Design Review Guideline.'' Since it was published in June 1996, Rev. 1 to NUREG-0700 has been used successfully by NRC staff, contractors and nuclear industry organizations, as well as by interested organizations outside the nuclear industry. The NRC has committed to the periodic update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool in the face of emerging and rapidly changing technology. This paper addresses the current research to update of NUREG-0700 based on the substantial work that has taken place since the publication of Revision 1

  1. 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.

  2. Field-testing of guidance on the appropriate labelling of processed complementary foods for infants and young children in South Africa.

    Science.gov (United States)

    Sweet, Lara; Jerling, Johann; Van Graan, Averalda

    2013-01-01

    There is a lack of formal guidance from international normative bodies on the appropriate marketing of processed complementary foods. Such guidance is necessary to protect and promote optimal infant and young child feeding practices. The aim of this study was to field-test, in South Africa, the interim guidance provided by the Maternal, Infant and Young Child Nutrition Working Group's Draft Guide for Marketing Complementary Foods as a potential tool for use by manufacturers and national governments for guiding the appropriate labelling (as a subset of appropriate marketing practices) of complementary foods. This guidance was used to develop a checklist of questions and criteria for each possible answer, which was tested using a comprehensive database of labels from products purchased in South Africa from June to August 2011. One hundred and sixty product labels of 35 manufacturers were analysed, none of which complied with all checklist criteria. Fifty-six (35%) labels did not provide an appropriate age of introduction while 37 (23%) used images of infants appearing younger than 6 months. Nineteen (12%) labels suggested a daily ration too large for a breastfed child, and 32 (20%) potentially promote the manufacturer's infant formula. Only 58 (36%) labels were easy to read. The majority (69% and 92%) of labels provided instructions for safe and appropriate preparation/use and storage, respectively. The Draft Guide for Marketing Complementary Foods was found to be a useful tool for guiding the appropriate labelling of complementary foods, although some changes and additions are recommended to improve understanding, ease of use and to minimise the subjective interpretation of the guidance. PMID:23167582

  3. 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.

  4. 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

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

    Energy Technology Data Exchange (ETDEWEB)

    Muhammed, Kabiru [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of); Jeong, Seung-Young [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2014-10-15

    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. 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.

  7. Aerospace plane guidance using geometric control theory

    Science.gov (United States)

    Van Buren, Mark A.; Mease, Kenneth D.

    1990-01-01

    A reduced-order method employing decomposition, based on time-scale separation, of the 4-D state space in a 2-D slow manifold and a family of 2-D fast manifolds is shown to provide an excellent approximation to the full-order minimum-fuel ascent trajectory. Near-optimal guidance is obtained by tracking the reduced-order trajectory. The tracking problem is solved as regulation problems on the family of fast manifolds, using the exact linearization methodology from nonlinear geometric control theory. The validity of the overall guidance approach is indicated by simulation.

  8. Review of Final Draft Core Standards

    Directory of Open Access Journals (Sweden)

    R. James Milgram

    2013-04-01

    Full Text Available What follows are my comments on the nal draft of the CCSSI Core Mathematics Standards. There are a number of standards including, but not limited to 1-OA(6, 2-OA(2, 2-NBT(5, 3-OA(7, 3-NBT(2, 4-OA(4, 4-OA(6, 4-NF(1, 4-NF(2, 5-OA(3, 8-G(2, 8-G(4, F-LQE(5, G-SRT(4 that are completely unique to this document, andmost of them seem problematic to me. I have repeatedly asked for references justifying the insertions of these or similar standards in previous drafts, but references have not been provided. Consequently, to my knowledge, there is no real research base for including any of these standards in the document.

  9. Overview of a draft of new maintenance standards

    International Nuclear Information System (INIS)

    One of the topics on structural standards in Japan is the completion of a draft of new maintenance standards which covers inservice inspection (ISI), flaw evaluation and repair procedures. This paper describes the background of Japan's current structural codes and standards, the necessity of introducing flaw evaluation, and the outline of the activities of developing the draft of maintenance standards in the Japan Power Engineering Inspection Corporation. The essential features of the draft of maintenance standards for ISI, flaw evaluation, and repair technologies, respectively, and future activities for updating the draft of maintenance standards are presented. (orig.)

  10. Increasing draft capability for retrofit flue gas desulfurization systems

    International Nuclear Information System (INIS)

    The retrofit installation of flue gas desulfurization (FGD) systems results in significantly higher draft losses for existing generating stations. Consequently, the means for increasing draft capability must be included in many FGD retrofit projects. Consideration is given to several alternatives for increasing draft capability. Alternatives are developed for new induced draft (ID) fans to replace the existing ID fans and for new booster fans to supplement the existing ID fans. Both centrifugal and axial fans are evaluated, as are different means of fan volume control. Each alternative is evaluated on the basis of technical merit and economics. Presented are the development of fan alternatives and results of the technical and economic evaluations

  11. A Software Tool for Legal Drafting

    OpenAIRE

    Daniel Gorín; Sergio Mera; Fernando Schapachnik

    2011-01-01

    Although many attempts at automated aids for legal drafting have been made, they were based on the construction of a new tool, completely from scratch. This is at least curious, considering that a strong parallelism can be established between a normative document and a software specification: both describe what an entity should or should not do, can or cannot do. In this article we compare normative documents and software specifications to find out their similarities and differences. The comp...

  12. 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...

  13. Brevi cenni di riflessione sul drafting formale e sul drafting sostanziale. Analisi di due facce della stessa medaglia

    OpenAIRE

    Foschini, Federica

    2013-01-01

    Il drafting normativo ha assunto sempre più importanza e ad oggi riveste un ruolo fondamentale per la produzione legislativa. Breve analisi di alcune problematiche rilevanti, in relazione al dualismo drafting formale e drafting sostanziale, che hanno portato al sopravvento di quest’ultimo sia a livello nazionale che internazionale, in vista di una regolamentazione “sostenibile” da un punto di vista sociale.

  14. Cannabinoid receptor CB2 modulates axon guidance

    DEFF Research Database (Denmark)

    Duff, Gabriel; Argaw, Anteneh; Cecyre, Bruno; Cherif, Hosni; Tea, Nicolas; Zabouri, Nawal; Casanova, Christian; Ptito, Maurice; Bouchard, Jean-François

    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 ...

  15. 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.

  16. 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.

  17. 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 ...

  18. 75 FR 76011 - Annual Guidance Agenda

    Science.gov (United States)

    2010-12-07

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 19, 2000 (65 FR 56468), FDA issued... existing guidance documents (65 FR 56468 at 56477; 21 CFR 10.115(f)(5)). The Agency is neither bound by...--Adulteration With Hypoglycin Administration, 5100 Paint A. Branch Pkwy., College Park, MD 20740,...

  19. 36 CFR 1290.7 - Additional guidance.

    Science.gov (United States)

    2010-07-01

    ... Section 1290.7 Parks, Forests, and Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION JFK... ASSASSINATION RECORDS COLLECTION ACT OF 1992 (JFK ACT) § 1290.7 Additional guidance. (a) A government agency, office, or entity includes, for purposes of interpreting and implementing the JFK Act, all current,...

  20. Patterns of Guidance in Inquiry Learning

    Science.gov (United States)

    Veermans, Marjaana; Lallimo, Jiri; Hakkarainen, Kai

    2005-01-01

    The purpose of this case study was to examine a teacher's guidance of an inquiry learning project in an ordinary elementary-school classroom. The participants in the study were 21 Finnish, grade 4 students (10 years old), from which four students were selected for intensive observation. The technical infrastructure of the study was Computer…

  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. Neighboring optimal guidance theory and computer program

    Science.gov (United States)

    Powers, W. F.

    1974-01-01

    Developments of the linear quadratic optimal control problem are discussed. The theory is applicable to the development of neighboring optimal feedback guidance gains, and is useful as a tool for synthesizing feedback control laws. A computer program which requires only the pertinent matrices of the linear quadratic problem is described.

  3. Laser radar for spacecraft guidance applications

    Science.gov (United States)

    Liebe, C. C.; Abramovici, A.; Bartman, R. K.; Bunker, R. L.; Chapsky, J.; Chu, C. C.; Clouse, D.; Dillon, J. W.; Hausmann, B.; Hemmati, H.; Kornfeld, R. P.; Kwa, C.; Mobasser, S.; Newell, M.; Padgett, C.; Roberts, W. T.; Spiers, G.; Warfield, Z.; Wright, M.

    2003-01-01

    A flight qualified laser radar called LAMP (LAser MaPper) is under development at JPL. LAMP is a guidance and control sensor that can form 3 dimensional images of its field of regard. This paper describes the detailed design of the LAMP sensor.

  4. Athletics Guidance Aims for Level Field

    Science.gov (United States)

    Samuels, Christina A.

    2013-01-01

    A document from the U.S. Department of Education intended to clarify schools' responsibility to make sure students with disabilities have access to extracurricular sports has drawn sharply different opinions. Disability-rights advocates welcome the guidance, while critics say federal officials are pushing requirements that could place new…

  5. 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…

  6. 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

  7. Advances in spacecraft atmospheric entry guidance

    Science.gov (United States)

    Benito Manrique, Joel

    In order to advance entry guidance technology two different research areas have been explored with the objective of increasing the reachable landing area and the landing accuracy for future Mars missions. Currently only the northern hemisphere of Mars is available for landing due to its low elevation. Only low elevation landing sites have the necessary atmospheric density to allow landing using current Entry, Descent and Landing (EDL) technology. In order to reach most of the Ancient Highlands, the majority of the southern hemisphere, advanced EDL technology is needed in multiple fields, including entry guidance. The first research area is the definition and applications of reachable and controllable sets for entry. The definition of the reachable and controllable sets provides a framework for the study of the capabilities of an entry vehicle in a given planet. Reachable and controllable sets can be used to comprehensively characterize the envelope of trajectories that a vehicle can fly, the sites it can reach and the entry states that can be accommodated. The sets can also be used for the evaluation of trajectory planning algorithms and to assist in the selection of the entry or landing sites. In essence, the reachable and controllable sets offer a powerful vehicle and trajectory analysis and design framework that allows for better mission design choices. In order to illustrate the use of the sets, they are computed for a representative Mars mission using two different vehicle configurations. The sets characterize the impact of the vehicle configuration on the entry capability. Furthermore, the sets are used to find the best skip-entry trajectory for a return from the Moon mission, highlighting the utility of the sets in atmospheric maneuvers other than entry. The second research area is the development of the components of an entry guidance algorithm that allow high elevation landing and provide as well high landing accuracy. The approach taken follows the

  8. 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...

  9. 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... Alzheimer's disease. Coordinate Alzheimer's disease research and services across all federal...

  10. 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.

  11. Whet Students' Appetites with Food-Related Drafting Project

    Science.gov (United States)

    Pucillo, John M.

    2010-01-01

    Students sometimes find introductory drafting and design a boring subject. They must learn the basic skills necessary for drafting and architecture and this may require repetition in order to reinforce those skills. One way to keep students interested is to have them draw objects they encounter in their own lives instead of abstract machine parts…

  12. 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 Section 15.10 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL... drafting and publication. The Director of the Federal Register may prepare, and distribute to...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  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. 75 FR 35508 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-06-22

    ... COMMISSION Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-1249, ``Criteria for Use of Computers... CFR Part 73, ``Physical Protection of Plants and Materials,'' regarding the security of digital...

  19. 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.

  20. Applied Physics Modules Selected for Architectural and Civil Drafting Technologies.

    Science.gov (United States)

    Waring, Gene

    Designed for individualized use in an applied physics course in postsecondary vocational-technical education, this series of six learning modules is equivalent to the content of a three-credit hour class in surveying and drafting technology, architectural drafting technology, building construction technology, and civil engineering technology.…

  1. 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)

  2. 78 FR 3399 - Draft 2012 Marine Mammal Stock Assessment Reports

    Science.gov (United States)

    2013-01-16

    ..., 2012 (77 FR 47043); the 90-day public comment period closed on November 5, 2012. Subsequent to.... The 2011 abundance estimate for fin whale, western North Atlantic stock, in the draft 2012 SAR (77 FR... and PBR. The abundance estimate for sei whale, Nova Scotia stock, in the draft 2012 SAR (77 FR...

  3. 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...

  4. 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...

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

    Science.gov (United States)

    2013-10-29

    ... Energy Regulatory Commission Juneau Hydropower, Inc.; Notice of Subsequent Draft License Application (DLA..., 2013. d. Applicant: Juneau Hydropower, Inc. e. Name of Project: Sweetheart Lake Hydroelectric Project.... Applicant Contact: Duff Mitchell, Business Manager, Juneau Hydropower, Inc., P.O. Box 22775, Juneau,...

  6. 77 FR 63301 - Juneau Hydropower, Inc.; Notice of Draft License Application and Preliminary Draft Environmental...

    Science.gov (United States)

    2012-10-16

    ... Energy Regulatory Commission Juneau Hydropower, Inc.; Notice of Draft License Application and Preliminary...: August 31, 2012. d. Applicant: Juneau Hydropower, Inc. e. Name of Project: Sweetheart Lake Hydroelectric... Hydropower, Inc., P.O. Box 22775, Juneau, AK 99802; 907-789-2775, email: duff.mitchell@juneauhydro.com ....

  7. 76 FR 52966 - Kawailoa Wind Energy Generation Facility, Oahu, HI; Draft Habitat Conservation Plan and Draft...

    Science.gov (United States)

    2011-08-24

    ... Fish and Wildlife Service Kawailoa Wind Energy Generation Facility, Oahu, HI; Draft Habitat...-turbine commercial wind energy generation facility at Kawailoa on Kamehameha Schools' Kawailoa Plantation... incidental take of the Covered Species. Another wind energy project, Kaheawa Wind Power I (KWP I),...

  8. 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...

  9. 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 ...

  10. 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.

  11. 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...

  12. 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...

  13. Patient guidance on diabetes mellitus self-management

    OpenAIRE

    Nganga, Catherine

    2010-01-01

    The purpose of this literature review was to describe the guidance of diabetic mellitus patients on self-management by reviewing existing literature. The aim of the study was to explore the various areas in which patients need guidance and how guidance can be used as a method of assisting patients achieve self-management. The research question is: how does guidance help patients in achieving self-management? The data collection method involved reviewing relevant literature which consisted ...

  14. 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.

  15. Revision of Electro-Mechanical Drafting Program to Include CAD/D (Computer-Aided Drafting/Design). Final Report.

    Science.gov (United States)

    Snyder, Nancy V.

    North Seattle Community College decided to integrate computer-aided design/drafting (CAD/D) into its Electro-Mechanical Drafting Program. This choice necessitated a redefinition of the program through new curriculum and course development. To initiate the project, a new industrial advisory council was formed. Major electronic and recruiting firms…

  16. 78 FR 70571 - Notice of Availability of the Oregon Greater Sage-Grouse Draft Land Use Plan Amendments and Draft...

    Science.gov (United States)

    2013-11-26

    ... (76 FR 77008) and ended on March 23, 2012. The BLM held scoping open houses in January and February... Bureau of Land Management Notice of Availability of the Oregon Greater Sage-Grouse Draft Land Use Plan... (BLM) has prepared Oregon Greater Sage-Grouse Draft Land Use Plan (LUP) Amendments and a...

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

    Science.gov (United States)

    2013-12-06

    ... Deepwater Horizon Oil Spill; Draft Programmatic and Phase III Early Restoration Plan and Draft Early... as a result of the Deepwater Horizon oil spill. The restoration alternatives are comprised of early... the Framework for Early Restoration Addressing Injuries Resulting from the Deepwater Horizon Oil...

  18. 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... the draft feed standards to the U.S. Food and Drug Administration, Office of Regulatory...

  19. 75 FR 75707 - Request for Public Comment on the Draft National Nanotechnology Initiative Strategy for...

    Science.gov (United States)

    2010-12-06

    ... TECHNOLOGY POLICY Request for Public Comment on the Draft National Nanotechnology Initiative Strategy for... draft National Nanotechnology Initiative (NNI) Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (hereafter referred to as ``draft NNI EHS strategy''). The draft NNI EHS...

  20. 10 CFR 430.4 - Sources for information and guidance.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 3 2010-01-01 2010-01-01 false Sources for information and guidance. 430.4 Section 430.4... Provisions § 430.4 Sources for information and guidance. (a) General. The standards listed in this paragraph... reference. These sources are given here for information and guidance. (b) IESNA. Illuminating...

  1. 21 CFR 7.59 - General industry guidance.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General industry guidance. 7.59 Section 7.59 Food... POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.59 General industry guidance. A recall can be disruptive of a firm's operation and...

  2. 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.

  3. 77 FR 55510 - Guidance on Performing a Seismic Margin Assessment

    Science.gov (United States)

    2012-09-10

    ... COMMISSION Guidance on Performing a Seismic Margin Assessment AGENCY: Nuclear Regulatory Commission. ACTION... Interim Staff Guidance (JLD-ISG), JLD-ISG-2012-04, ``Guidance on Performing a Seismic Margin Assessment in... Assessment in Response to the March 2012, Request for Information Letter,'' (ADAMS Accession No....

  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. Research And Innovation In Elementary School Guidance And Counseling

    Science.gov (United States)

    Keat, Donald B., II

    1973-01-01

    Elementary school teachers were trained in seven guidance learnings over a two-day span so that they could use guidance approaches in their classes. The Guidance Learning Rating Scale was developed to evaluate statements before and after their exposure to confluent education activities. There were significant changes in test scores in the expect…

  6. LAPAROSCOPIC HELLER MIOTOMY USING ENDOSCOPIC GUIDANCE

    Directory of Open Access Journals (Sweden)

    E. Târcoveanu

    2008-10-01

    Full Text Available Heller miotomy is the procedure of choice for the treatment of esophageal achalasia. The paper present our laparoscopic technique using endoscopic guidance for a better visualization of the eso-gastric region and for minimal eso-gastric dissection. We also discussed the advantages of laparoscopic miotomy versus endoscopic dilatation and botulinum toxine injection. The use of associated Dor procedure is also discussed. Conclusions: Laparoscopic esocardiomiotomy is the gold standard treatment for esophageal achalasia with good short and long-term results. The associated Dor operation is useful to avoid the gastroesophageal reflux and esophagitis and to protect the miotomy. Endoscopic guidance is useful for esophageal dissection, during the miotomy and to for the airtight checking of the mucosa.

  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. Taxonometric Guidance for Developing Quality Assurance

    International Nuclear Information System (INIS)

    A taxonomy is an ordered classification system. In error reduction analysis, an examination of the human failures that lead to an event often uses a taxonomy to classify the failures according to some aspect of their characteristics. These classifications provide insights into the forces that kept the persons involved from achieving their intended actions. They also can provide guidance for changing the situation to prevent failure in the future. For example, the corrective action would be different if a therapist pressed the wrong button because several buttons looked alike or they forgot which button to press. Different types of failures lead to particular types of remediation. Taxonomies can provide guidance in selecting between possible corrective actions

  9. Interior View of Drafting Room in ERB

    Science.gov (United States)

    1942-01-01

    Interior view of Drafting Room in Engine Research Building showing men at work at the Aircraft Engine Research Laboratory. This building was considered the research heart of NACA Lewis. It was built by the Sam W. Emerson Company and was completed in 1942. It is a multipurpose flexible space covering more than 4.25 acres and can be changed according to research priorities. The Aircraft Engine Research Center, Cleveland Ohio, is now known as the John H. Glenn Research Center at Lewis Field.

  10. 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...

  11. Study support essentials: guidance for school governors

    OpenAIRE

    Leith, L.; Standen, C.; Vardy, S.

    2010-01-01

    This document is a valuable guide for school governors as it enables them to use the guidance in this document to support their school’s teaching and learning activities outside of the curriculum. It empowers governors to ask leading and challenging questions of their school’s extending learning opportunities strategy. Thereby support the school to raise pupil attainment, attendance and behaviour which all contribute to School Improvement and Performance.

  12. ROUTE PLAN DESIGNER FOR TRACTOR GUIDANCE SYSTEMS

    DEFF Research Database (Denmark)

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

    2010-01-01

    software works in conjunction with Google Earth to import field boundaries,and for viewing, validating and georeferencing completed field trial designs. The software isplatform independent and online distributed by means of the Java development environment.Two case studies were applied for demonstrating...... overall layout 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...

  13. NAVIGATION, GUIDANCE AND CONTROL FOR PLANETARY LANDING

    OpenAIRE

    Perez Montenegro, Carlos Norberto

    2014-01-01

    This dissertation aims to develop algorithms of guidance and control for propulsive terminal phase planetary landing, including a piloting strategy. The algorithms developed here are based on the Embedded Model Control (EMC) principles. Currently, the planetary entry descent and landing are important issues, landing on Mars and Moon has been scientifically rewarding; successful landed robotic systems on the surface of Mars have been achieved. Projects as Mars Science Laboratory MSL inter alia...

  14. 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 ...

  15. 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.

  16. FOMC Forward Guidance and Investor Beliefs

    OpenAIRE

    Arunima Sinha

    2015-01-01

    This paper considers the effect of different dimensions of the FOMC's forward guidance on ex ante investor expectations about future changes in US Treasury yields. Options and Futures data for 2- and 10-year Treasuries is used to extract State-Price Densities of investor beliefs, and the corresponding standard deviation, skewness, and excess kurtosis of these densities are computed. Announcements about extension of the zero-lower bound in 2012-13 are found to reduce the expectations about cra...

  17. 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...

  18. 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...

  19. 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.

  20. Is Career Guidance for the Individual or for the Market? Implications of EU Policy for Career Guidance

    Science.gov (United States)

    Bergmo-Prvulovic, Ingela

    2014-01-01

    This paper explores the essential understanding and underlying perspectives of career implicit in EU career guidance policy in the twenty-first century, as well as the possible implications of these for the future mission of guidance. Career theories, models and concepts that serve career guidance are shaped on the twentieth-century industrial…

  1. 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... Cosmetic Act; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal... 403(w) of the Federal Food, Drug, and Cosmetic Act,'' dated April 2006, that was announced in...

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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 ...

  7. Rethinking the Food and Drug Administration's 2013 guidance on developing drugs for early-stage Alzheimer's disease.

    Science.gov (United States)

    Schneider, Lon S

    2014-03-01

    The February 2013 Food and Drug Administration (FDA) draft guidance for developing drugs for early-stage Alzheimer's disease (AD) creates certain challenges as they guide toward the use of one cognitive outcome to gain accelerated marketing approval for preclinical AD drugs, and a composite clinical scale - the Clinical Dementia Rating Scale in particular - for the primary outcome for prodromal AD clinical trials. In light of the developing knowledge regarding early stage diagnoses and clinical trials outcomes, we recommend that FDA describe its requirements for validating preclinical AD diagnoses for drug development purposes, maintain the principle for requiring coprimary outcomes, and encourage the advancement of outcomes for early stage AD trials. The principles for drug development for early stage AD should not differ from those for clinical AD, especially as the diagnoses of prodromal and early AD impinge on each other. The FDA should not recommend that a composite scale be used as a sole primary efficacy outcome to support a marketing claim unless it requires that the cognitive and functional components of such a scale are demonstrated to be individually meaningful. The current draft guidelines may inadvertently constrain efforts to better assess the clinical effects of new drugs and inhibit innovation in an area where evidence-based clinical research practices are still evolving. PMID:24698029

  8. 78 FR 22269 - International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA...

    Science.gov (United States)

    2013-04-15

    ... M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit... ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit... Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use...

  9. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Science.gov (United States)

    2010-05-20

    ... Voluntary Audit Report Submission Program'' to the Division of Small Manufacturers, International, and... Japanese Medical Device Ministry of Health, Labour and Welfare system. This notice of availability and... set by the International Organization for Standardization (ISO) and identified by the Secretary...

  10. 75 FR 29537 - Draft Transportation Conformity Guidance for Quantitative Hot-spot Analyses in PM2.5

    Science.gov (United States)

    2010-05-26

    ... of project-level emissions, air quality modeling, and a comparison to the relevant national ambient... timely attainment of the relevant national ambient air quality standard(s) (NAAQS) or any interim...: Carbon monoxide (CO), ozone, nitrogen dioxide (NO 2 ) and particulate matter (PM 2.5 and PM 10 ).\\1\\...

  11. 75 FR 1060 - Draft Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure...

    Science.gov (United States)

    2010-01-08

    ... approach to assist in avoiding drug product shortages that may have a negative impact on the national... discuss CDER's intended approach to assist in avoiding shortages that may have a negative impact on...

  12. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Science.gov (United States)

    2012-02-21

    ... on Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling... entitled ``Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling... vivo studies, in vivo study design, and data analysis in the context of identifying potential...

  13. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Science.gov (United States)

    2012-07-31

    ... Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401..., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville...

  14. 78 FR 15955 - Draft Guidance for Industry and Review Staff on Formal Dispute Resolution: Appeals Above the...

    Science.gov (United States)

    2013-03-13

    ... 20993-0002, or the Office of Communication, Outreach and Development (HFM-40), Center for Biologics...-796-0700; or, Sheryl Lard-Whiteford, Center for Biologics Evaluation and Research (HFM-4), Food...

  15. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Science.gov (United States)

    2012-05-10

    ... marketing clearance for a new x-ray imaging device with a pediatric indication should provide data... marketing clearance only for general indications or do not submit adequate data to the FDA to support a..., general radiography and dental radiography, and diagnostic and interventional fluoroscopy devices)...

  16. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-08-27

    ...Submitter tool available on FDA's Web site, or other commercially available tools, and submit the files...-identification will enable quick, accurate, and reliable surveillance of generic drugs and facilitate inspections... Generic Drug Facilities, Sites, and Organizations; Availability AGENCY: Food and Drug Administration,...

  17. 77 FR 75174 - Draft Guidance for Industry on Providing Submissions in Electronic Format-Summary Level Clinical...

    Science.gov (United States)

    2012-12-19

    ... submitted to and reviewed by CDER as described in the Federal Register of June 26, 2003 (68 FR 38067... regulations in 21 CFR part 314, specifically Sec. 314.50(d)(5) Clinical data section and Sec. 314.50(f) Case.... 312.120), and the clinical data section (Sec. 314.50(d)(5)) and case report forms and tabulations...

  18. 77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

    Science.gov (United States)

    2012-07-13

    ... clinical studies conducted outside of the United States to support future U.S. marketing applications (Ref. 1). Consequently, the Pre-Sub program can provide an efficient path from device concept to...

  19. 75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Science.gov (United States)

    2010-08-03

    ... period. This raises a potential safety issue not only to the patient, but also to others including family members, caregivers, children, and pets. For example, adverse events due to a patient's failure to...

  20. 77 FR 14811 - Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug...

    Science.gov (United States)

    2012-03-13

    ... Advertisements--the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad Pre... entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review... advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term...