WorldWideScience

Sample records for cgtp draft guidance

  1. 78 FR 53792 - Draft Guidance for Reciprocity

    Science.gov (United States)

    2013-08-30

    ...The U.S. Nuclear Regulatory Commission (NRC) is revising its licensing guidance for reciprocity. The NRC is requesting public comment on draft NUREG-1556, Volume 19, Revision 1, ``Consolidated Guidance about Materials Licenses: Guidance for Agreement State Licensees about NRC Form 241 `Report of Proposed Activities in Non- Agreement States, Areas of Exclusive Federal Jurisdiction, of Offshore......

  2. 75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella

    Science.gov (United States)

    2010-08-12

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Prevention of Salmonella... availability of a draft guidance entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During... ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation''...

  3. 75 FR 63189 - Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human...

    Science.gov (United States)

    2010-10-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Investigational New Drug... Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled... draft guidance for industry entitled ``Investigational New Drug Applications (INDs)--Determining...

  4. 77 FR 3777 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-01-25

    ... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS... additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations... guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' explaining...

  5. 77 FR 10536 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-02-22

    ... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS... additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations... guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which...

  6. 78 FR 20925 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-04-08

    ... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS... additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations... guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which...

  7. 77 FR 35688 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-06-14

    ... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS... additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations... guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which...

  8. 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... physical medicine devices. FDA has developed a draft special controls guidance document for each of the 11... Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes; Draft Guidance for...

  9. 77 FR 69632 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

    Science.gov (United States)

    2012-11-20

    ... entitled ``Electronic Source Data in Clinical Investigations.'' This document revises and updates the draft... in FDA- regulated clinical investigations. The revised draft guidance promotes capturing source data... draft guidance for industry entitled ``Electronic Source Data in Clinical Investigations.''...

  10. 78 FR 31943 - Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

    Science.gov (United States)

    2013-05-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Contract Manufacturing... guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality Agreements.'' This... draft guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality...

  11. 77 FR 20025 - Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution...

    Science.gov (United States)

    2012-04-03

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

  12. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Science.gov (United States)

    2011-02-18

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

  13. 76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft

    Science.gov (United States)

    2011-09-07

    ... HUMAN SERVICES Guidance on Exculpatory Language in Informed Consent, Draft AGENCY: Office for Human... the availability of a draft guidance entitled, ``Guidance on Exculpatory Language in Informed Consent.'' The draft guidance, when finalized, will represent OHRP's and FDA's current thinking on this topic...

  14. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Science.gov (United States)

    2013-05-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Rheumatoid Arthritis... guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.'' This... products developed as drug-device combination products. This guidance revises the guidance for...

  15. 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...

  16. 78 FR 66744 - Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2013-11-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Pulmonary Tuberculosis... industry entitled ``Pulmonary Tuberculosis: Developing Drugs for Treatment.'' The purpose of the draft... guidance for industry entitled ``Pulmonary Tuberculosis: Developing Drugs for Treatment.'' The purpose...

  17. 78 FR 55263 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Science.gov (United States)

    2013-09-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Fluticasone... bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fluticasone...

  18. 77 FR 7586 - Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray...

    Science.gov (United States)

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Recommendation... Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Bioequivalence... of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for...

  19. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Science.gov (United States)

    2013-12-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... the availability of a revised draft guidance for industry entitled ``Bioequivalence Recommendations... bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for paliperidone...

  20. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-01-05

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

  1. 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...

  2. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Science.gov (United States)

    2013-11-06

    ... iron sucrose injection. The draft guidance is a revised version of a previously issued draft guidance... sucrose injection (Draft Iron Sucrose Injection BE Recommendations of 2013). Venofer (iron sucrose... the Agency's recommendations for BE studies to support ANDAs for iron sucrose injection (Draft......

  3. 75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

    Science.gov (United States)

    2010-01-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Assessment of Abuse Potential... and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled... availability of a draft guidance for industry entitled ``Assessment of Abuse Potential of Drugs.'' Under...

  4. 77 FR 58999 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2012-09-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug... availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and... of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and...

  5. 78 FR 19271 - Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel...

    Science.gov (United States)

    2013-03-29

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... guidance for industry entitled ``Bioequivalence Recommendations for Metronidazole Vaginal Gel.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to...

  6. 77 FR 58399 - Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium...

    Science.gov (United States)

    2012-09-20

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... guidance for industry entitled ``Bioequivalence Recommendations for Pentosan Polysulfate Sodium.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated...

  7. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Science.gov (United States)

    2013-08-02

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... guidance for industry entitled ``Bioequivalence Recommendations for Mesalamine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new...

  8. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Science.gov (United States)

    2013-06-05

    ... No. FDA-2013-D-0589] Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral...

  9. 77 FR 40068 - Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and...

    Science.gov (United States)

    2012-07-06

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria'' dated June 2012. The draft guidance document provides blood establishments that collect blood and blood components with......

  10. 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...

  11. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Availability AGENCY: Food... guidances to industry on ``Bioavailability and Bioequivalence Studies for Orally Administered Drug...

  12. 77 FR 76049 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction

    Science.gov (United States)

    2012-12-26

    ... guidance entitled ``Electronic Source Data in Clinical Investigations.'' The document was published with an... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice;...

  13. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Science.gov (United States)

    2011-05-24

    ... Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Availability AGENCY... FDA Staff: Financial Disclosure by Clinical Investigators.'' This draft guidance is intended to assist... governing financial disclosure by clinical investigators. This guidance provides FDA's responses to the...

  14. 77 FR 7585 - Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability

    Science.gov (United States)

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... industry entitled ``Bioequivalence Recommendations for Rifaximin,'' one for the 200- milligram (mg... specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug...

  15. 75 FR 9228 - Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability

    Science.gov (United States)

    2010-03-01

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Non- Inferiority Clinical Trials.'' This draft guidance provides sponsors and review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) with the agency's interpretation of the underlying principles involved in the......

  16. 77 FR 24722 - Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes...

    Science.gov (United States)

    2012-04-25

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

  17. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Science.gov (United States)

    2012-03-09

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

  18. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-11-07

    ... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...] [FR Doc No: 2011-28766] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De...

  19. 77 FR 12853 - Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for...

    Science.gov (United States)

    2012-03-02

    ... 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 Biosimilar Products; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  20. 78 FR 74154 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Science.gov (United States)

    2013-12-10

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

  1. 78 FR 52931 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2013-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of...

  2. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Science.gov (United States)

    2011-11-23

    ... Doc No: 2011-30149] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in...: The Food and Drug Administration (FDA) is announcing the availability of draft guidance for...

  3. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2010-09-23

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

  4. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Science.gov (United States)

    2010-10-25

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

  5. 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...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... provide recommendations to industry on the design of self- selection studies for nonprescription...

  6. 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...: Acrylamide in Foods.'' The draft guidance is intended to provide information that may help...

  7. 77 FR 48989 - Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of...

    Science.gov (United States)

    2012-08-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Suicidal Ideation and... availability of a draft guidance for industry entitled ``Suicidal Ideation and Behavior: Prospective Assessment... prospectively assessing the occurrence of treatment-emergent suicidal ideation and behavior in clinical...

  8. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Science.gov (United States)

    2011-02-28

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

  9. 78 FR 13069 - Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood...

    Science.gov (United States)

    2013-02-26

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated March 2013. The draft guidance document provides revised recommendations for screening and testing of donors and management......

  10. 78 FR 32668 - Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood...

    Science.gov (United States)

    2013-05-31

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture'' dated June 2013. The draft guidance document provides manufacturers of licensed Whole Blood and blood components intended for......

  11. 76 FR 65735 - Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire...

    Science.gov (United States)

    2011-10-24

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components'' dated October 2011. The draft guidance document recognizes the abbreviated donor history questionnaire and......

  12. 77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

    Science.gov (United States)

    2012-04-11

    ... HUMAN SERVICES Food and Drug Administration International Conference on Harmonisation; Draft Guidance... draft guidance was prepared under the auspices of the International Conference on Harmonisation of.... Regarding the ICH: Michelle Limoli, Office of International Programs, Food and Drug Administration,...

  13. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2011-01-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Size of Beads in Drug... industry entitled ``Size of Beads in Drug Products Labeled for Sprinkle.'' This draft guidance provides... guidance for industry entitled ``Size of Beads in Drug Products Labeled for Sprinkle.'' This draft...

  14. 78 FR 70953 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Science.gov (United States)

    2013-11-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee... Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)'', published in... draft guidance entitled ``Draft Guidance for Industry on Generic Drug User Fee Amendments of...

  15. 78 FR 53791 - Draft Program-Specific Guidance About Irradiator Licenses

    Science.gov (United States)

    2013-08-30

    ...The U.S. Nuclear Regulatory Commission (NRC) is revising its licensing guidance for irradiator licenses. The NRC is requesting public comment on draft NUREG-1556, Volume 6, Revision 1, ``Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 Irradiator Licenses.'' The document has been updated from the previous revision to include safety culture,......

  16. 77 FR 11133 - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for...

    Science.gov (United States)

    2012-02-24

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Complicated Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs). Specifically, this guidance addresses FDA's current......

  17. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Science.gov (United States)

    2011-11-10

    ... to evaluate medical devices under FDA's IDE regulations. In an effort to promote timely clinical... available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical...

  18. 77 FR 59928 - Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for...

    Science.gov (United States)

    2012-10-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Complicated Intra-Abdominal... guidance for industry entitled ``Complicated Intra-Abdominal Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for...

  19. 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...

  20. 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.

  1. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Science.gov (United States)

    2012-01-03

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

  2. 75 FR 13562 - Revised Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Renal Function...

    Science.gov (United States)

    2010-03-22

    ..., such as changes in absorption, plasma protein binding, transport, and tissue distribution. These... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Revised Draft Guidance for Industry on Pharmacokinetics...

  3. 78 FR 70953 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Science.gov (United States)

    2013-11-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate'', published in... for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol...

  4. 78 FR 52777 - Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection...

    Science.gov (United States)

    2013-08-26

    ... on Bioequivalence Recommendations for Risperidone Injection; Availability AGENCY: Food and Drug... provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new... availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Specific...

  5. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Science.gov (United States)

    2011-01-07

    .... Regarding dietary supplements: John Sheehan, Center for Food Safety and Applied Nutrition (HFS-315), Food... Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360bbb- 3). This draft guidance also...

  6. 78 FR 57859 - Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation...

    Science.gov (United States)

    2013-09-20

    ... entitled ``Endocrine Disruption Potential of Drugs: Nonclinical Evaluation.'' Endocrine disruptors are... its progeny. Any component of the endocrine system can be a target of endocrine disruptors, although... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Endocrine...

  7. 75 FR 8045 - National Environmental Policy Act (NEPA) Draft Guidance, Establishing, Applying, and Revising...

    Science.gov (United States)

    2010-02-23

    ... QUALITY National Environmental Policy Act (NEPA) Draft Guidance, Establishing, Applying, and Revising Categorical Exclusions Under the National Environmental Policy Act AGENCY: Council on Environmental Quality... Exclusions Under the National Environmental Policy Act.'' SUMMARY: On February 18, 2010, the Council...

  8. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Science.gov (United States)

    2011-06-22

    ... Staff: The Content of Investigational Device Exemption and Premarket Approval Applications for Low... document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of... Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA)...

  9. 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... Veterinary Medicinal Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... 216 entitled ``Chemistry, Manufacturing, and Controls (CMC) Information--...

  10. 75 FR 62693 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents and Certified...

    Science.gov (United States)

    2010-10-13

    ... 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)...

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

    Science.gov (United States)

    2010-08-17

    ... 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 Veterinary... veterinary use by the International Cooperation on Harmonisation of Technical Requirements for...

  12. 77 FR 74196 - Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication...

    Science.gov (United States)

    2012-12-13

    ... Product Design To Minimize Medication Errors; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors... using a systems approach to minimize medication errors relating to product design. The draft...

  13. 77 FR 8262 - Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs...

    Science.gov (United States)

    2012-02-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft...

  14. 78 FR 17943 - Draft Program-Specific Guidance About Fixed Gauge Licenses

    Science.gov (United States)

    2013-03-25

    .... ACTION: Draft NUREG; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is... NUREG-1556, Volume 4, Revision 1, ``Consolidated Guidance About Materials Licenses: Program-Specific...- 4737, or by email to pdr.resource@nrc.gov . The draft NUREG-1556, Volume 4, Revision 1, is available...

  15. 78 FR 69690 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Science.gov (United States)

    2013-11-20

    ...The Food and Drug Administration (FDA) is extending the comment period for the draft guidance for industry entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' that appeared in the Federal Register of July 2, 2013 (78 FR 39736). The draft guidance document provides sponsors of Investigational New Drug......

  16. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... guidance may do so by using the Internet. To receive ``Draft Guidance for Industry and Food and Drug... and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug,...

  17. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Science.gov (United States)

    2010-12-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Solvents in Animal... guidance for industry 211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers... availability of a draft guidance for industry 211 entitled ``Residual Solvents in Animal ] Drug...

  18. 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

    ... children's toy laser products within IEC Class 1 emission limits in order to minimize the risk they pose to... No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry... guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This draft guidance is to...

  19. 77 FR 19672 - Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for...

    Science.gov (United States)

    2012-04-02

    ... guidances relating to the development of biosimilar products. The document published with an incorrect date... HUMAN SERVICES Food and Drug Administration Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments; Correction AGENCY: Food and Drug Administration,...

  20. 78 FR 27116 - Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New...

    Science.gov (United States)

    2013-05-09

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 312 Draft Guidance for Industry on Charging for... Investigational Drugs Under an IND--Qs & As.'' This guidance is intended to provide information for industry... for industry entitled ``Charging for Investigational Drugs Under an IND--Qs & As.'' In 2009,...

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

    Science.gov (United States)

    2011-08-24

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of neglected diseases of the developing world. Specifically,......

  2. 77 FR 74669 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-12-17

    ... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS... additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations... industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the...

  3. 78 FR 37230 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-06-20

    ... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS... additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations... industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the...

  4. 78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-11-06

    ... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS... additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations... industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the...

  5. 75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Science.gov (United States)

    2010-08-03

    ... and Related Drug Delivery Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This draft guidance provides recommendations to developers and manufacturers of transdermal drug...

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

    Science.gov (United States)

    2013-07-02

    ... Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Biologics... of this guidance meet the definition of ``biological product'' in section 351(i) of the Public...

  7. 75 FR 1060 - Draft Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure...

    Science.gov (United States)

    2010-01-08

    ... necessary for manufacturing an MNP. The purpose of this draft guidance is to provide to industry... guidance, if a manufacturer obtains information after releasing a MNP under its Plan leading to...

  8. 78 FR 69691 - Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and...

    Science.gov (United States)

    2013-11-20

    ..., 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 the... placement, size, prominence, and frequency in promotional labeling and advertising for prescription...

  9. International Conference on Harmonisation; draft guidance on E2F Development Safety Update Report; availability. Notice.

    Science.gov (United States)

    2008-08-05

    The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "E2F Development Safety Update Report." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes the format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR would serve as a harmonized, annual clinical trial safety report that would be standard among the three ICH regions. The DSUR could be submitted in the United States in place of an annual report for an investigational new drug application (IND). The harmonized DSUR is intended to promote a consistent approach to annual clinical safety reporting among the ICH regions and enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities.

  10. 77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Science.gov (United States)

    2012-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee... draft guidance for industry entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers... effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees...

  11. 76 FR 13629 - Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and...

    Science.gov (United States)

    2011-03-14

    ... HUMAN SERVICES Food and Drug Administration Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Availability AGENCY: Food and Drug Administration... a revised draft guidance for industry entitled ``User Fee Waivers, Reductions, and Refunds for...

  12. 78 FR 9396 - Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early...

    Science.gov (United States)

    2013-02-08

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

  13. 78 FR 55261 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Science.gov (United States)

    2013-09-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee... a draft guidance for industry entitled ``Generic Drug User Fee Amendments of 2012: Questions and... delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables...

  14. 77 FR 57094 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-09-17

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations; Availability; Correction AGENCY: Food and Drug... announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities,...

  15. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Science.gov (United States)

    2013-03-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... efficiency of the review process. This draft guidance is not final nor is it in effect at this time....

  16. 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...

  17. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Science.gov (United States)

    2010-02-26

    ... current thinking on adaptive design clinical trials for drugs and biologics. It does not create or confer... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Adaptive Design Clinical... entitled ``Adaptive Design Clinical Trials for Drugs and Biologics.'' The draft guidance provides...

  18. 75 FR 8046 - National Environmental Policy Act (NEPA) Draft Guidance, “Consideration of the Effects of Climate...

    Science.gov (United States)

    2010-02-23

    ... QUALITY National Environmental Policy Act (NEPA) Draft Guidance, ``Consideration of the Effects of Climate... Availability, Draft Guidance, ``Consideration of the Effects of Climate Change and Greenhouse Gas Emissions... implementing NEPA, recognizes that it is a visionary and versatile law that can be used effectively to...

  19. 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

    ... for different functions in other dosage forms. Phthalates also are found in other products for uses... Phthalates as Excipients in CDER-Regulated Products.'' This draft guidance provides the pharmaceutical... (DEHP). In particular, the draft guidance recommends that the pharmaceutical industry avoid the use...

  20. 78 FR 18273 - Draft Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of...

    Science.gov (United States)

    2013-03-26

    ... Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning; Availability AGENCY: Food and...: Purchasing Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning.'' The draft guidance... of ciguatera fish poisoning (CFP) from fish that they distribute. The draft guidance is intended...

  1. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-03-19

    ... March 19, 2012 Part II Department of Health and Human Services Food and Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls... SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...

  2. 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...

  3. 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...

  4. 76 FR 36133 - Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products...

    Science.gov (United States)

    2011-06-21

    ... HUMAN SERVICES Food and Drug Administration Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs and Devices and Additional Product Classification...(h) of the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS....

  5. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-10-03

    ... Food, Drug, and Cosmetic Act (FD&C Act), also known as the de novo classification process. FDA is... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation);...

  6. 76 FR 31615 - Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products...

    Science.gov (United States)

    2011-06-01

    ... as the marketing is only for investigational use. The marketing of unapproved and uncleared IVD... Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search....regulations.gov or from the CBER Internet site at...

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

    Science.gov (United States)

    2011-07-21

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  8. 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... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Federal Food, Drug, and Cosmetic Act (the FD&C Act), procedural information on how to fulfill section...

  9. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

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

  10. 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...

  11. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Science.gov (United States)

    2012-12-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  12. 75 FR 1790 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB...

    Science.gov (United States)

    2010-01-13

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

  13. 81 FR 35767 - Pesticides; Draft Guidance for Pesticide Registrants on Herbicide Resistance Management Labeling...

    Science.gov (United States)

    2016-06-03

    ... draft PR Notice (2016-XX) communicates the Agency's approach to addressing herbicide-resistant weeds by...-resistant weeds by providing guidance on labeling, education, training, and stewardship for herbicides... approach to slow the development and spread of herbicide- resistant weeds, and prolong the useful...

  14. 76 FR 80948 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Science.gov (United States)

    2011-12-27

    ... developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions...

  15. 78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...

    Science.gov (United States)

    2013-04-01

    ... and Biosimilar Biological Product Sponsors or Applicants; Availability AGENCY: Food and Drug... availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar... biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the...

  16. 77 FR 18827 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection...

    Science.gov (United States)

    2012-03-28

    ... Recommendations for Iron Sucrose Injection; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...) for iron sucrose injection. DATES: Although you can comment on any guidance at any time (see 21 CFR 10... recommendations. This notice announces the availability of draft BE recommendations for iron sucrose......

  17. 78 FR 310 - Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format...

    Science.gov (United States)

    2013-01-03

    ... the FD&C Act, FDA is issuing this draft guidance, announcing its determination that submission types... files and advertising and promotional labeling submissions. However, FDA accepts and strongly encourages the submission of master files and advertising and promotional labeling materials electronically,...

  18. 76 FR 34180 - National Organic Program; Notice of Draft Guidance for Accredited Certifying Agents and Certified...

    Science.gov (United States)

    2011-06-13

    ... to 4 p.m., Monday through Friday (except official Federal holidays). Persons wanting to visit the... 7, 2011. Ellen King, Acting Administrator, Agricultural Marketing Service. BILLING CODE 3410-02-P ... Agricultural Marketing Service 7 CFR Part 205 National Organic Program; Notice of Draft Guidance for...

  19. 76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2011-12-02

    ... nonionic interactions. Thus, pharmaceutical co-crystals offer the advantage of generating a diverse array... Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This draft guidance...

  20. 76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

    Science.gov (United States)

    2011-07-12

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

  1. 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...

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

    Science.gov (United States)

    2010-08-16

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

  3. 78 FR 24211 - Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling...

    Science.gov (United States)

    2013-04-24

    ... Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability AGENCY: Food and... the availability of a draft guidance for industry entitled ``Safety Considerations for Container... aspects of the container label and carton labeling design for prescription drug and biological...

  4. Regulatory Advocacy Update: ASPS Comments in Response to the FDA Draft Guidance Documents on Human Cell and Tissue Products.

    Science.gov (United States)

    Rubin, J Peter; D'Amico, Richard A; Rodriguez, Ricardo; Coleman, Sydney R; Cederna, Paul; Glasberg, Scot; Neumeister, Michael; Song, David H; Butler, Charles; Hume, Keith M

    2017-02-09

    The Food and Drug Administration (FDA) released draft guidance documents on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the FDA by the American Society of Plastic Surgeons (ASPS).

  5. 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.

  6. 76 FR 5386 - Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components...

    Science.gov (United States)

    2011-01-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Pre-Storage Leukocyte Reduction... blood components intended for transfusion, including recommendations for validation and quality control... for transfusion, including recommendations for validation and quality control monitoring of...

  7. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Science.gov (United States)

    2011-02-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets; Availability AGENCY: Food and Drug Administration, HHS. ACTION:...

  8. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-06-28

    ... HUMAN SERVICES Food and Drug Administration Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  9. 78 FR 78366 - Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability

    Science.gov (United States)

    2013-12-26

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry entitled ``Naming of Drug Products Containing Salt Drug Substances.'' The United...

  10. 78 FR 54899 - Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug...

    Science.gov (United States)

    2013-09-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug Establishment Registration; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  11. 78 FR 22269 - International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA...

    Science.gov (United States)

    2013-04-15

    ...). The draft guidance emphasizes considerations of both safety and quality risk management in... Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061... Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical...

  12. 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... register to attend this peer review meeting as observers. Time will be set aside for observers to give... finalizing the draft document, EPA intends to consider the comments from the external peer review...

  13. International Conference on Harmonisation; draft guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products--FDA. Notice.

    Science.gov (United States)

    1998-06-09

    The Food and Drug Administration (FDA) is publishing a draft guidance entitled "Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products". The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides guidance on general principles for the selection of test procedures and the setting and justification of acceptance criteria for biotechnological and biological products. The draft guidance is intended to assist in the establishment of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.

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

    Science.gov (United States)

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

    2011-01-01

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

  15. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Science.gov (United States)

    2011-12-19

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

  16. 75 FR 29537 - Draft Transportation Conformity Guidance for Quantitative Hot-spot Analyses in PM2.5

    Science.gov (United States)

    2010-05-26

    ... Transportation Conformity Guidance for Quantitative Hot- spot Analyses in PM 2.5 and PM 10 Nonattainment and... Public Comment. SUMMARY: EPA is announcing the availability of a draft transportation conformity guidance... quantitative PM 2.5 and PM 10 hot-spot analyses for project- level transportation conformity determinations...

  17. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of... guidance for industry entitled ``Self- Identification of Generic Drug Facilities, Sites, and... generic drugs to the public and reduce costs to industry, requires that generic drug facilities,...

  18. 78 FR 38349 - Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics...

    Science.gov (United States)

    2013-06-26

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Expedited Programs for... guidance for industry entitled ``Expedited Programs for Serious Conditions--Drugs and Biologics.'' The... for industry entitled ``Expedited Programs for Serious Conditions--Drugs and Biologics.'' This...

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

    Science.gov (United States)

    2013-11-14

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

  1. 77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

    Science.gov (United States)

    2012-12-17

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

  2. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2011-05-18

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

  3. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-06-20

    ...] [FR Doc No: 2012-15025] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis; Availability...

  4. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2010-09-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  5. 76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2011-10-17

    .... 76, No. 200 / Monday, October 17, 2011 / Notices#0;#0; ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability AGENCY: Food and...

  6. 77 FR 16842 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-03-22

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications...; Norethindrone, F Fenofibrate, Fludarabine, Fulvestrant, G Glyburide (multiple RLDs), Granisetron, I Ivermectin...-specific design of BE studies to support ANDAs. They do not create or confer any rights for or on...

  7. 78 FR 48175 - Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances

    Science.gov (United States)

    2013-08-07

    ... changes in interpretation of policies that are of other than minor in nature, or discuss complex... assist industry with clinical evaluation and requirements for drug approval. The guidances identified for... the Division of Anti-Infective Drug Products''--issued February 1997. 6. ``Empiric Therapy of...

  8. 77 FR 5857 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Science.gov (United States)

    2012-02-06

    ...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 and Research.'' The public comment period was scheduled to expire on January 31, 2012. In order to allow the public sufficient time to review and comment on the Draft NUREG, the NRC has decided to......

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

    Science.gov (United States)

    Wilcox, Stephen B; Drucker, Daniel

    2012-03-01

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

  10. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance

    Directory of Open Access Journals (Sweden)

    2006-10-01

    instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual. The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration- February 2006.

  11. 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

    ... Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See the... crude heparin contaminants and to recommend strategies to ensure that the heparin supply chain is not... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Heparin for Drug and...

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

    Science.gov (United States)

    2012-02-21

    ... HUMAN SERVICES Food and Drug Administration (Formerly Docket No. 2006D-0344) Draft Guidance for Industry... in vivo studies of drug metabolism, drug transport, and drug-drug, or drug-therapeutic protein... metabolism and/or drug transport abruptly in individuals who previously had been receiving and tolerating...

  13. 76 FR 72006 - Draft Interim Staff Guidance: Evaluations of Uranium Recovery Facility Surveys of Radon and Radon...

    Science.gov (United States)

    2011-11-21

    ... members of the public from radon-222 and radon-222 progeny from UR facilities including: (1) Surveys of... 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...

  14. 76 FR 14024 - Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework...

    Science.gov (United States)

    2011-03-15

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

  15. 75 FR 78259 - Draft Guidance for Industry on Codevelopment of Two or More Unmarketed Investigational Drugs for...

    Science.gov (United States)

    2010-12-15

    ... to apply to vaccines, gene or cellular therapies, blood products, or medical devices. DATES: Although... vaccines, gene or cellular therapies, or blood products. This draft guidance is being issued consistent... scientific advances have increased our understanding of the pathophysiological processes that underlie...

  16. 78 FR 20116 - Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering...

    Science.gov (United States)

    2013-04-03

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

  17. 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...

  18. 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...

  19. 78 FR 60292 - Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive...

    Science.gov (United States)

    2013-10-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Application Submissions--Refuse-to-Receive Standards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

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

    Science.gov (United States)

    2012-07-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is... Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903...

  1. 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...

  2. 78 FR 42086 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Science.gov (United States)

    2013-07-15

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

  3. 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... Historical Cost of G- PP&E. The Exposure Drafts are available on the FASAB home page http://www.fasab.gov... From the Federal Register Online via the Government Publishing Office FEDERAL ACCOUNTING...

  4. 78 FR 17660 - Draft Guidance for E85 Flexible Fuel Vehicle Weighting Factor for Model Years 2016-2019 Vehicles...

    Science.gov (United States)

    2013-03-22

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

  5. 75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

    Science.gov (United States)

    2010-11-12

    ... information.\\1\\ The study found that there is a correlation between the quality or perceived quality of a DHCP... information more accessible. The draft guidance is intended to improve the quality of DHCP letters to make... letters have shown that the communication quality of DHCP letters--the extent to which the information...

  6. 75 FR 8046 - National Environmental Policy Act (NEPA) Draft Guidance, “NEPA Mitigation and Monitoring.”

    Science.gov (United States)

    2010-02-23

    ... From the Federal Register Online via the Government Publishing Office COUNCIL ON ENVIRONMENTAL QUALITY National Environmental Policy Act (NEPA) Draft Guidance, ``NEPA Mitigation and Monitoring... implementation of the National Environmental Policy Act (NEPA). Enacted in 1970, NEPA is a fundamental tool...

  7. 76 FR 36543 - Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and...

    Science.gov (United States)

    2011-06-22

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

  8. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Science.gov (United States)

    2012-08-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

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

    Science.gov (United States)

    2011-06-17

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

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

    Science.gov (United States)

    2013-07-15

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

  11. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Science.gov (United States)

    2012-05-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  12. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Recovered Plasma, Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Hepatitis B Virus (HBV),......

  13. 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...

  14. 75 FR 43172 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2010-07-23

    ... HUMAN SERVICES Food and Drug Administration International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 13 on Bulk Density and Tapped Density of Powders General Chapter;...

  15. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Science.gov (United States)

    2010-05-20

    ... concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration... devices-- Quality management systems--Requirements for regulatory purposes,'' may voluntarily submit the... Japanese Medical Device Ministry of Health, Labour and Welfare system. This notice of availability...

  16. 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...

  17. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Science.gov (United States)

    2010-04-22

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

  18. 78 FR 12759 - Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting...

    Science.gov (United States)

    2013-02-25

    ... Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency: Guidance for... guidance for industry entitled ``Attachment to Guidance on Antiviral Product Development--Conducting and... important for supporting clinical trials of products in development for the treatment of HCV. HCV...

  19. 78 FR 68030 - Draft Guidance on Intellectual Property Rights for the National Network for Manufacturing...

    Science.gov (United States)

    2013-11-13

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

  20. 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...

  1. 78 FR 56752 - Interim Staff Guidance Specific Environmental Guidance for Integral Pressurized Water Reactors...

    Science.gov (United States)

    2013-09-13

    ... COMMISSION Interim Staff Guidance Specific Environmental Guidance for Integral Pressurized Water Reactors Reviews AGENCY: Nuclear Regulatory Commission. ACTION: Draft Interim Staff Guidance; request for comment... comment on, draft Interim Staff Guidance (ISG) ESP/COL-ISG-027, ``Interim Staff Guidance...

  2. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability

    Science.gov (United States)

    2012-11-06

    ... availability of revised draft BE recommendations for lenalidomide capsules. Revlimid (lenalidomide capsules.... Revlimid is designated as the reference listed drug, and therefore any ANDAs for generic lenalidomide capsules must demonstrate BE to the Revlimid prior to approval. There are no approved ANDAs for...

  3. 78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

    Science.gov (United States)

    2013-09-13

    ... revising the guidance to reflect advancements in the science and technology of bioanalytical method... to some studies related to the veterinary drug approval process (Investigational New Animal Drugs (INADs), New Animal Drug Applications (NADAs), and Abbreviated New Animal Drug Applications...

  4. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Science.gov (United States)

    2011-11-10

    ... Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies... guidance, FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE requirements. Early feasibility studies allow for limited early...

  5. 76 FR 72710 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Science.gov (United States)

    2011-11-25

    ... to selling tobacco products and that refresher training be provided at least annually and more...-2010-D-0350) and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm... penalties for violations of access, advertising, and promotion restrictions of regulations promulgated...

  6. 76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

    Science.gov (United States)

    2011-08-15

    ... Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document is intended to provide... medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be...

  7. 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... for Biologics Research and Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic...

  8. 76 FR 38187 - International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of...

    Science.gov (United States)

    2011-06-29

    ... guidance to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA...; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers... Management,'' and ``Q10 Pharmaceutical Quality Systems'' as they pertain to the development and...

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

    Energy Technology Data Exchange (ETDEWEB)

    None

    1984-02-01

    This document describes the current status of the methodologies used in probabilistic risk assessment (PRA) and provides guidance for the application of the results of PRAs to the nuclear reactor regulatory process. The PRA studies that have been completed or are underway are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed.

  10. 76 FR 67764 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Science.gov (United States)

    2011-11-02

    ... Report for Comment AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request for comment. ] SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft NUREG, NUREG...-4209, (301) 415-4737, or by email to pdr.resource@nrc.gov . The draft NUREG is available...

  11. Draft Guidance: Response, Remediation, and Recovery Checklist for Chemically Contaminated Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Raber, E; Mancieri, S; Carlsen, T; Fish, C; Hirabayashi-Dethier, J; Intrepido, A; MacQueen, D; Michalik, R; Richards, J

    2007-09-04

    A key part of preparedness in the event of a chemical warfare agent (CWA) or toxic industrial chemical (TIC) release at a large facility, such as an airport or subway, is to develop a concept of operations that allows for an effective incident response and recovery. This document is intended as a component of the concept of operations and will be used in the Emergency Operations Center (EOC) as a decision tool for the Unified Command (UC). The Checklist for Facility Response, Remediation, and Recovery presented in this document is principally focused on the Consequence Management Phase (see Figure 1; LLNL 2007a and 2007b) of a chemical release. Information in this document conforms to the National Response Plan (NRP) (DHS 2004) and the National Incident Management System (NIMS 2004). Under these two guidance documents, personnel responsible for managing chemical response and recovery efforts--that is, the decision-makers--are members of an Incident Command (IC), which is likely to transition to a UC in the event of a CWA or TIC attack. A UC is created when more than one agency has incident jurisdiction or when incidents cross political jurisdictions. The location for primary, tactical-level command and management is referred to as the Incident Command Post (ICP), as described in the NRP. Thus, regardless of whether an IC or a UC is used, the responsible entities are located at an ICP. Agencies work together through designated members of the UC to establish their designated Incident Commanders at a single ICP and to establish a common set of objectives and strategies and a single Incident Action Plan. Initially during the Crisis Management Phase (see Figure 1), the Incident Commander is likely to be the Chief of the fire department that serves the affected facility. As life-safety issues are resolved and the Crisis Management Phase shifts to the Consequence Management Phase, the work of characterization, decontamination, and facility clearance begins. There will

  12. 78 FR 19495 - Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment...

    Science.gov (United States)

    2013-04-01

    ... Dissolution Testing, and In Vivo Bioequivalence Documentation'' ( http://www.fda.gov/downloads/Drugs/Guidance... Testing and In Vivo Bioequivalence Documentation'' ( http://www.fda.gov/downloads/Drugs/GuidanceCompliance... Vivo Bioequivalence Documentation'' (...

  13. 78 FR 72901 - Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal...

    Science.gov (United States)

    2013-12-04

    ... amended by the Drug Quality and Security Act. When final, the guidance will reflect the Agency's current... section 503A of the FD&C Act included restrictions on the advertising or promotion of the compounding of.... Supreme Court in 2002.\\1\\ Now that section 503A has been amended by the Drug Quality and Security Act...

  14. 77 FR 31858 - Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk...

    Science.gov (United States)

    2012-05-30

    ... certain high-risk or poor prognosis populations of early-stage breast cancer patients. This guidance is... in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint To Support... entitled ``Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast...

  15. 78 FR 7784 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of...

    Science.gov (United States)

    2013-02-04

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

  16. 76 FR 2328 - National Organic Program: Notice of Draft Guidance Concerning “Made With Organic (Specified...

    Science.gov (United States)

    2011-01-13

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

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

    Science.gov (United States)

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

    2008-07-01

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

  18. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Science.gov (United States)

    2013-06-14

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

  19. Final OSWER Vapor Intrusion Guidance

    Science.gov (United States)

    EPA is preparing to finalize its guidance on assessing and addressing vapor intrusion, which is defined as migration of volatile constituents from contaminated media in the subsurface (soil or groundwater) into the indoor environment. In November 2002, EPA issued draft guidance o...

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

    Energy Technology Data Exchange (ETDEWEB)

    1980-09-01

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

  1. Investigations on non-inferiority--the Food and Drug Administration draft guidance on treatments for nosocomial pneumonia as a case for exact tests for binomial proportions.

    Science.gov (United States)

    Röhmel, Joachim; Kieser, Meinhard

    2013-06-30

    This paper addresses statistical issues in non-inferiority trials where the primary outcome is a fatal event. The investigations are inspired by a recent Food and Drug Administration (FDA) draft guideline on treatments for nosocomial pneumonia. The non-inferiority margin suggested in this guideline for the endpoint all-cause mortality is defined on different distance measures (rate difference and odds ratio) and is discontinuous. Furthermore, the margin enables considerable power for the statistical proof of non-inferiority at alternatives that might be regarded as clinically unacceptable, that is, even if the experimental treatment is harmful as compared with the control. We investigated the appropriateness of the proposed non-inferiority margin as well as the performance of possible test statistics to be used for the analysis. A continuous variant of the margin proposed in the FDA guideline together with the unconditional exact test according to Barnard showed favorable characteristics with respect to type I error rate control and power. To prevent harmful new treatments from being declared as non-inferior, we propose to add a 'second hurdle'. We discuss examples and explore power characteristics when requiring both statistical significance and overcoming the second hurdle.

  2. 78 FR 49782 - Interim Staff Guidance on Changes During Construction

    Science.gov (United States)

    2013-08-15

    ... COMMISSION Interim Staff Guidance on Changes During Construction AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing this notice for use of, and to solicit public comment on the draft Interim...

  3. 75 FR 35492 - Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus-Developing...

    Science.gov (United States)

    2010-06-22

    ... availability of a guidance for industry entitled ``Lupus Nephritis Caused By Systemic Lupus Erythematosus... nephritis (LN) caused by systemic lupus erythematosus (SLE). This guidance finalizes the parts of the draft guidance entitled ``Systemic Lupus Erythematosus--Developing Drugs for Treatment'' (the draft...

  4. 76 FR 5102 - Draft NUREG-0561, Revision 2; Physical Protection of Shipments of Irradiated Reactor Fuel...

    Science.gov (United States)

    2011-01-28

    ...; ] NUCLEAR REGULATORY COMMISSION 10 CFR Part 73 RIN 3150-AI64 Draft NUREG-0561, Revision 2; Physical... revision to NUREG-0561, the draft implementation guidance document for a proposed rule to amend its... on the draft revision to NUREG-0561, the NRC has decided to extend the comment period for the...

  5. 75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

    Science.gov (United States)

    2010-08-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application; Availability... the availability of a draft guidance for industry and researchers entitled ``The Radioactive...

  6. 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...

  7. 75 FR 24718 - Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability

    Science.gov (United States)

    2010-05-05

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Documenting Statistical Analysis... guidance entitled ``Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry...

  8. 78 FR 56750 - Interim Staff Guidance on Environmental Issues Associated With New Reactors

    Science.gov (United States)

    2013-09-13

    ... COMMISSION Interim Staff Guidance on Environmental Issues Associated With New Reactors AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; request for comment. SUMMARY: The U.S Nuclear Regulatory Commission (NRC) staff is issuing for use of, and to solicit public comment on, draft...

  9. 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)

  10. Guidance on Port Biological Baseline Surveys (PBBS)

    Digital Repository Service at National Institute of Oceanography (India)

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

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

  11. 75 FR 73109 - Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support...

    Science.gov (United States)

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Antibacterial Drug Products: Use of.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... of the draft guidance for industry entitled ``Antibacterial Drug Products: Use of...

  12. Modelling polymer draft gears

    Science.gov (United States)

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

    2016-09-01

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

  13. 77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

    Science.gov (United States)

    2012-07-03

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

  14. 76 FR 41157 - Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella...

    Science.gov (United States)

    2011-07-13

    ... Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production... Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the draft guidance... rule entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage,...

  15. 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...

  16. 78 FR 3023 - Draft Policy on Donations, Fundraising, and Solicitation

    Science.gov (United States)

    2013-01-15

    ... Fish and Wildlife Service RIN 1018-AY36 Draft Policy on Donations, Fundraising, and Solicitation AGENCY..., and provides general guidance on fundraising by non-Federal entities on the Service's behalf. It also..., fundraising, and solicitation. While donations can be a means to further our mission, not all donations...

  17. 78 FR 25758 - Migratory Birds; Eagle Conservation Plan Guidance: Module 1-Land-Based Wind Energy, Version 2

    Science.gov (United States)

    2013-05-02

    ...-- Land-Based Wind Energy, Version 2 AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of... Guidance: Module 1--Land-based Wind Energy, Version 2 is available. The guidance provides recommendations... issued a draft of The Eagle Conservation Plan Guidance: Module 1-- Land-based Wind Energy for...

  18. Basic Drafting: Book Two.

    Science.gov (United States)

    Davis, Ronald; And Others

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

  19. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Science.gov (United States)

    2013-01-24

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

  20. 77 FR 60126 - Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2012-10-02

    ... HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0971; Formerly Docket FDA-2008-N-0041; Formerly 2008N-0004] Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment... the draft guidance for industry entitled ``Acute Otitis Media--Developing Antimicrobial Drugs...

  1. 77 FR 62247 - Dynamic Positioning Operations Guidance for Vessels Other Than Mobile Offshore Drilling Units...

    Science.gov (United States)

    2012-10-12

    ... recommended owners and operators of Mobile Offshore Drilling Units (MODUs) follow Marine Technology Society... draft guidance from the Marine Technology Society (MTS) DP Committee for Mobile Offshore Drilling Units...] Dynamic Positioning Operations Guidance for Vessels Other Than Mobile Offshore Drilling Units Operating...

  2. 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)

  3. Drafting: Current Trends and Future Practices

    Science.gov (United States)

    Jensen, C.

    1976-01-01

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

  4. 76 FR 6087 - Draft Weapons Safety Assessment on the Use of Enhanced Weapons; Notice of Availability and...

    Science.gov (United States)

    2011-02-03

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

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

    Science.gov (United States)

    Missouri Univ., Columbia. Instructional Materials Lab.

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

  6. [International trend of guidance for nanomaterial risk assessment].

    Science.gov (United States)

    Hirose, Akihiko

    2013-01-01

    In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.

  7. 78 FR 20690 - Draft Environmental Impact Statement, Draft Habitat Conservation Plan, Draft Programmatic...

    Science.gov (United States)

    2013-04-05

    ... (MW). The 301.3-MW Fowler Phase I was constructed in 2008 and consists of 40 Clipper Liberty wind... addressed in the draft HCP or draft EIS; 3. Any new information on white-nose syndrome effects on...

  8. 75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability

    Science.gov (United States)

    2010-09-27

    ... Establishment-Specific Written Quality Control Plans and Recordkeeping for Acidified Foods, and Voluntary...-Specific Written Plan Including Quality Control Procedures for Acidified Foods (One-Time Burden): Currently, acidified foods establishments must employ appropriate quality control procedures to ensure that...

  9. 76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella

    Science.gov (United States)

    2011-03-23

    ... for Salmonella species (spp.) in human foods (except shell eggs) and direct-human-contact animal foods, and the interpretation of test results, when the presence of Salmonella spp. in the food may render... testing procedures for Salmonella spp. in human foods (except shell eggs) and direct-human- contact...

  10. FDA Issues Draft Guidance on Questions and Answers ...

    Science.gov (United States)

    ... ¢â‚¬â„¢s final rule ÃÆ'¢â†šÂ¬Ã…“Prevention of Salmonella Enteritidis in Shell Eggs ...

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

    Science.gov (United States)

    2011-01-14

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

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

    Science.gov (United States)

    2012-08-24

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

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

    Science.gov (United States)

    2010-02-08

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

  14. Graphical Turbulence Guidance - Composite

    Data.gov (United States)

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

  15. On guidance and volatility

    NARCIS (Netherlands)

    Billings, M.B.; Jennings, R.; Lev, B.

    2013-01-01

    Survey evidence suggests that managers voluntarily disclose information, particularly earnings guidance, with an aim toward dampening share price volatility. Yet, consultants and influential institutions advise against providing guidance — citing fears of litigation and market penalties associated w

  16. CAREER GUIDANCE EXPERIENCE ABROAD

    Directory of Open Access Journals (Sweden)

    Sergey N. Tolstoguzov

    2015-01-01

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

  17. 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.

  18. Health system guidance appraisal-concept evaluation and usability testing

    OpenAIRE

    2016-01-01

    Background Health system guidance (HSG) provides recommendations aimed to address health system challenges. However, there is a paucity of methods to direct, appraise, and report HSG. Earlier research identified 30 candidate criteria (concepts) that can be used to evaluate the quality of HSG and guide development and reporting requirements. The objective of this paper was to describe two studies aimed at evaluating the importance of these 30 criteria, design a draft HSG appraisal tool, and te...

  19. All-Ages Lead Model (Aalm) Version 1.05 (External Draft Report)

    Science.gov (United States)

    The All-Ages Lead Model (AALM) Version 1.05, is an external review draft software and guidance manual. EPA released this software and associated documentation for public review and comment beginning September 27, 2005, until October 27, 2005. The public comments will be accepte...

  20. 77 FR 56851 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-09-14

    ...; dextroamphetamine sulfate B Budesonide Bupropion hydrochloride (multiple reference listed drugs (RLDs)) C Calcitonin salmon Carbidopa; levodopa Carglumic acid Ciclesonide Ciprofloxacin; dexamethasone Cyclophosphamide...

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

  2. 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.

  3. Pipe drafting and design

    CERN Document Server

    Parisher, Roy A

    2011-01-01

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

  4. Pipe drafting and design

    CERN Document Server

    Parisher, Roy A; Parisher

    2000-01-01

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

  5. 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.

  6. Shuttle entry guidance revisited

    Science.gov (United States)

    Mease, Kenneth D.; Kremer, Jean-Paul

    1992-01-01

    The Shuttle entry guidance concept is reviewed which is aimed at tracking a reference drag trajectory that leads to the specified range and velocity for the initiation of the terminal energy management phase. An approximate method of constructing the domain of attraction is proposed, and its validity is ascertained by simulation. An alternative guidance law yielding global exponential tracking in the absence of control saturation is derived using a feedback linearization method. It is noted that the alternative guidance law does not improve on the stability and performance of the current guidance law, for the operating domain and control capability of the Shuttle. It is suggested that the new guidance law with a larger operating domain and increased lift-to-drag capability would be superior.

  7. Shuttle entry guidance

    Science.gov (United States)

    Harpold, J. C.; Graves, C. A., Jr.

    1978-01-01

    This paper describes the design of the entry guidance for the Space Shuttle Orbiter. This guidance provides the steering commands for trajectory control from initial penetration of the earth's atmosphere until the terminal area guidance is activated at an earth-relative speed of 2500 fps. At this point, the Orbiter is at a distance of about 50 nmi from the runway threshold, and at an altitude of about 80,000 ft. The entry guidance design is based on an analytic solution of the equations of motion defining the drag acceleration profile that meets the terminal criteria of the entry flight while maintaining the flight within systems and operational constraints. Guidance commands, which are based on a control law that ensures damping of oscillatory type trajectory motion, are computed to steer the Orbiter to this drag acceleration profile.

  8. Shuttle entry guidance revisited

    Science.gov (United States)

    Mease, Kenneth D.; Kremer, Jean-Paul

    1992-08-01

    The Shuttle entry guidance concept is reviewed which is aimed at tracking a reference drag trajectory that leads to the specified range and velocity for the initiation of the terminal energy management phase. An approximate method of constructing the domain of attraction is proposed, and its validity is ascertained by simulation. An alternative guidance law yielding global exponential tracking in the absence of control saturation is derived using a feedback linearization method. It is noted that the alternative guidance law does not improve on the stability and performance of the current guidance law, for the operating domain and control capability of the Shuttle. It is suggested that the new guidance law with a larger operating domain and increased lift-to-drag capability would be superior.

  9. 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,.

  10. 75 FR 32963 - Notice of Availability of the Draft Resource Management Plan and Draft Environmental Impact...

    Science.gov (United States)

    2010-06-10

    ... Bureau of Land Management Notice of Availability of the Draft Resource Management Plan and Draft... Management (BLM) has prepared a Draft Resource Management Plan (RMP) and Draft Environmental Impact Statement... . Mail: Bureau of Land Management, Attention: Brad Higdon, 226 Cruz Alta, Taos, New Mexico 87571....

  11. Anticipatory guidance through DVD.

    Science.gov (United States)

    Franz, Sandra; McMahon, Pamela M; Calongne, Laurinda; Steele-Moses, Susan K

    2014-03-01

    The major purpose of the study was to determine if a 5-minute DVD is an effective method for communicating anticipatory guidance to parents at their child's 4-month well-child visit. A total of 84 caregivers were randomly assigned to receive anticipatory guidance through standard care (written anticipatory guidance handout and free talk) or DVD (DVD format + standard care). Participants completed a brief questionnaire immediately before and after their visit. As anticipated, knowledge scores improved significantly from pre-test to post-test. There was also a significant interaction between format used for anticipatory guidance and time. Specifically, there was greater improvement in knowledge over time for parents in the DVD group as compared with the standard care group. Additionally, the mean knowledge level of those in the DVD group as compared with those in the standard care group trended toward significance. Finally, visit length was shortened by nearly 3 minutes in the DVD group, and close to 100% of all respondents, regardless of anticipatory guidance format, indicated that they were very satisfied with their visit and amount of information learned.

  12. Waste burner overfire draft system

    Energy Technology Data Exchange (ETDEWEB)

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

    1977-11-22

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

  13. 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...

  14. 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...

  15. The World Health Organization's safe abortion guidance document.

    Science.gov (United States)

    Van Look, Paul F A; Cottingham, Jane

    2013-04-01

    We discuss the history of the World Health Organization's (WHO's) development of guidelines for governments on providing safe abortion services, which WHO published as Safe Abortion: Technical and Policy Guidance for Health Systems in 2003 and updated in 2012. We show how the recognition of the devastating impact of unsafe abortion on women's health and survival, the impetus of the International Conference on Population and Development and its five-year follow-up, and WHO's progressive leadership at the end of the century enabled the organization to elaborate guidance on providing safe abortion services. Guideline formulation involved extensive review of published evidence, an international technical expert meeting to review the draft document, and a protracted in-house review by senior WHO management.

  16. E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability. Notice.

    Science.gov (United States)

    2016-07-19

    The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers'' (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance.

  17. Career guidance on the move

    DEFF Research Database (Denmark)

    Thomsen, Rie

    2013-01-01

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

  18. 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.

  19. 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).

  20. AGILE DRAFTING OF OUTSOURCING CONTRACTS

    DEFF Research Database (Denmark)

    Schlichter, Bjarne Rerup; Storgaard, Kristian

    2015-01-01

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

  1. 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.

  2. PROFESSIONAL GUIDANCE: EXPERIENCE REPORT

    Directory of Open Access Journals (Sweden)

    Fabiana Pinto de Almeida Bizarria

    2014-05-01

    Full Text Available This article presents an account of a career guidance with a group of five teenagers ( 16 and 19 , students of pre-university preparatory course offered by a public university in the state of Ceará . The work group dynamics was from a privileged form of performance by allowing a greater enrichment of the discussions , considering the heterogeneity and diversity of the group . To address relevant issues in career guidance based on the theory Socio-Historical , a roadmap of action process was constructed from three axes . Each axis has worked in two sessions that match a date. The first axis called " meaning of choice," worked on thematic choice process . With regard to the axis " World of Work " was discussed idealizations and representations about the professions , the labor market and the vestibular / ESMS . Emotional links with the professions , skills and ideas on skills and information professions : Finally , the " self " axis, which contains the themes was developed .

  3. Advantage of a lead swimmer in drafting

    CERN Document Server

    Westerweel, J; Pennings, P; Yilmaz, B

    2016-01-01

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

  4. Guidance of Nonlinear Systems

    Science.gov (United States)

    Meyer, George

    1997-01-01

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

  5. Bioequivalence Demonstration for Ω-3 Acid Ethyl Ester Formulations: Rationale for Modification of Current Guidance.

    Science.gov (United States)

    Maki, Kevin C; Johns, Colleen; Harris, William S; Puder, Mark; Freedman, Steven D; Thorsteinsson, Thorsteinn; Daak, Ahmed; Rabinowicz, Adrian L; Sancilio, Frederick D

    2017-02-08

    The US Food and Drug Administration (FDA) draft guidance for establishing bioequivalence (BE) of ω-3 acid ethyl esters (containing both eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] as ethyl esters), used to treat severe hypertriglyceridemia, recommends the conduct of 2 studies: one with participants in the fasting state and one with participants in the fed state. For the fasting study, the primary measures of BE are baseline-adjusted EPA and DHA levels in total plasma lipids. For the fed study, the primary measures of BE are EPA and DHA ethyl esters in plasma. This guidance differs from that established for icosapent ethyl (EPA ethyl esters) in which the primary measure of BE is baseline-adjusted total EPA in plasma lipids for both the fasting and fed states. The FDA guidance for ω-3 acid ethyl esters is not supported by their physiologic characteristics and triglyceride-lowering mechanisms because EPA and DHA ethyl esters are best characterized as pro-drugs. This article presents an argument for amending the FDA draft guidance for ω-3 acid ethyl esters to use baseline-adjusted EPA and DHA in total plasma lipids as the primary measures of BE for both fasting and fed conditions. This change would harmonize the approaches for demonstration of BE for ω-3 acid ethyl esters and icosapent ethyl (EPA ethyl esters) products for future development programs and is the most physiologically rational approach to BE testing.

  6. Pipe Drafting with CAD. Teacher Edition.

    Science.gov (United States)

    Smithson, Buddy

    This teacher's guide contains nine units of instruction for a course on computer-assisted pipe drafting. The course covers the following topics: introduction to pipe drafting with CAD (computer-assisted design); flow diagrams; pipe and pipe components; valves; piping plans and elevations; isometrics; equipment fabrication drawings; piping design…

  7. Data Element Dictionary: Facilities. Preliminary Draft.

    Science.gov (United States)

    Thomas, Charles R.

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

  8. Restructuring Guidance and Counseling Programs.

    Science.gov (United States)

    Snyder, Beverly A.; Daly, Timothy P.

    1993-01-01

    Briefly reviews counseling profession's call for revitalization and transformation in school counseling and guidance programs. Summarizes one school system's efforts during late 1980s and early 1990s to transform its program from services and crisis orientation into a comprehensive developmental model based on Myrick's developmental guidance and…

  9. Guidance in the Secondary School

    Science.gov (United States)

    Kumar, V. Jurist Lional

    2010-01-01

    Secondary School Students face a lot of problems in their body as well as in mind due to puberty that tends to adolescence stage. Adolescence has peculiar characters of their own. They need proper Guidance and Counselling to tackle their own problems. Guidance is described as a counselling service to assist the individual in achieving self…

  10. Guidance at the educational marketplace

    DEFF Research Database (Denmark)

    Lystbæk, Christian Tang

    in educational policies and institutions. As educational systems have expanded and, further, have been restructured with the expansion of choice opportunities since the 1980s, guidance has become prioritized as a form of counseling or coaching, which can support students. Thus, guidance has become an important...

  11. Interstitial guidance of cancer invasion.

    Science.gov (United States)

    Gritsenko, Pavlo G; Ilina, Olga; Friedl, Peter

    2012-01-01

    Cancer cell invasion into healthy tissues develops preferentially along pre-existing tracks of least resistance, followed by secondary tissue remodelling and destruction. The tissue scaffolds supporting or preventing guidance of invasion vary in structure and molecular composition between organs. In the brain, the guidance is provided by myelinated axons, astrocyte processes, and blood vessels which are used as invasion routes by glioma cells. In the human breast, containing interstitial collagen-rich connective tissue, disseminating breast cancer cells preferentially invade along bundled collagen fibrils and the surface of adipocytes. In both invasion types, physical guidance prompted by interfaces and space is complemented by molecular guidance. Generic mechanisms shared by most, if not all, tissues include (i) guidance by integrins towards fibrillar interstitial collagen and/or laminins and type IV collagen in basement membranes decorating vessels and adipocytes, and, likely, CD44 engaging with hyaluronan; (ii) haptotactic guidance by chemokines and growth factors; and likely (iii) physical pushing mechanisms. Tissue-specific, resticted guidance cues include ECM proteins with restricted expression (tenascins, lecticans), cell-cell interfaces, and newly secreted matrix molecules decorating ECM fibres (laminin-332, thrombospondin-1, osteopontin, periostin). We here review physical and molecular guidance mechanisms in interstitial tissue and brain parenchyma and explore shared principles and organ-specific differences, and their implications for experimental model design and therapeutic targeting of tumour cell invasion.

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

    Science.gov (United States)

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

  13. 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

  14. 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

  15. 78 FR 73555 - Deepwater Horizon Oil Spill; Draft Programmatic and Phase III Early Restoration Plan and Draft...

    Science.gov (United States)

    2013-12-06

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

  16. Pandemic influenza guidance for corporations.

    Science.gov (United States)

    2011-06-01

    The purpose of this guidance document is to assist members of the American College of Occupational and Environmental Medicine (ACOEM), and the organizations for which they work, in managing the impact of a pandemic of influenza or other contagious respiratory disease on patients, employees, and business. This guidance document outlines actions to take before and during an influenza pandemic on the basis of two main strategies: (1) reducing the spread of the virus within facilities; and (2) providing medical care and medical surveillance to client/patient populations. Facilities in which ACOEM members serve include government agencies and the military, universities, and corporations, which generally have multiple locations/sites and their own medical staff, with members responsible for medical care and disease control. This guidance is for organizations with outpatient occupational medicine services, to be used as appropriate. Medical centers should also use guidance that addresses additional employee and external patient care needs.1–3 The ACOEM fully supports implementation of occupational influenza programs that conform with guidance from the Centers for Disease Control and Prevention (CDC), with other guidance from the US Department of Health and Human Services (DHHS), and Occupational Safety and Health Administration (OSHA) regulations and guidance.

  17. RH Packaging Program Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Washington TRU Solutions, LLC

    2003-08-25

    The purpose of this program guidance document is to provide technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the SARP and/or C of C shall govern. The C of C states: ''...each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, ''Operating Procedures,'' of the application.'' It further states: ''...each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, ''Acceptance Tests and Maintenance Program of the Application.'' Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M&O) contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC approved, users need to be familiar with 10 CFR {section} 71.11, ''Deliberate Misconduct.'' Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. CBFO will evaluate the issue and notify the NRC if required. This document details the instructions to be followed to operate, maintain, and test the RH-TRU 72-B packaging. This Program Guidance standardizes instructions for all users. Users shall follow these instructions. Following these instructions assures that operations are safe and meet the requirements of the SARP. This document is available on the Internet at: ttp://www.ws/library/t2omi/t2omi.htm. Users are responsible for ensuring they are using the current

  18. Response to work activity guidance

    Data.gov (United States)

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

  19. CDM Convective Forecast Planning guidance

    Data.gov (United States)

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

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

    DEFF Research Database (Denmark)

    Tetens, Inge

    The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies to draft guidance on scientific requirements for health claims related to functions of the nervous system, including psychological functions. This guidance has been drawn from scientific opinions...... of the NDA Panel on such health claims. Thus, this guidance represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in these areas. It is not intended that the document will include an exhaustive list of beneficial effects and studies/outcome measures...... that are acceptable. Rather, it presents examples drawn from evaluations already carried out to illustrate the approach of the Panel, as well as some examples which are currently under consideration within ongoing evaluations. A draft of this guidance document was endorsed by the NDA Panel on 16 September 2011...

  1. Guidance molecules in lung cancer

    OpenAIRE

    Nasarre, Patrick; Potiron, Vincent; Drabkin, Harry; Roche, Joëlle

    2010-01-01

    Guidance molecules were first described in the nervous system to control axon outgrowth direction. They are also widely expressed outside the nervous system where they control cell migration, tissue development and establishment of the vascular network. In addition, they are involved in cancer development, tumor angiogenesis and metastasis. This review is primarily focused on their functions in lung cancer and their involvement in lung development is also presented. Five guidance molecule fam...

  2. 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.

  3. Guidance Systems of Fighter Aircraft

    OpenAIRE

    K.N. Rajanikanth; Rao, R S; P. S. Subramanyam; Ajai Vohra

    2005-01-01

    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 s...

  4. 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...

  5. 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...

  6. 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.

  7. 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...

  8. 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.

  9. Current Trends in Tactical Missile Guidance

    Directory of Open Access Journals (Sweden)

    S. Vathsal

    2005-07-01

    Full Text Available The problem of tactical missile guidance is very challenging and has been treated using several basic metlfodologies in the past four decades. Major techniques can be grouped underclassical guidance laws, modern guidance laws, l'aws for manoeuvring targets, predictive guidance for endgame scenario, and guidance laws based on intelligent control methods. Each technique has some advantages and disadvantages while implementing in a practical system. Guidance law selection is dictated by nature of flight profile like boost, midcourse, terminal homing, etc, and also miss-distance and a single-shot kill probability. This paper presents a brief survey of the existing techniques and current trends in tactical missile guidance.

  10. 76 FR 62087 - Draft Conservation Plan and Draft Environmental Assessment; Dunes Sagebrush Lizard, Texas

    Science.gov (United States)

    2011-10-06

    ... Lizard, Texas AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability; announcement... application includes the draft Texas Conservation Plan for the Dunes Sagebrush Lizard (TCP). The draft TCP... Service (Service) and the Applicant for the dunes sagebrush lizard (Sceloporus arenicolus) throughout...

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

    Science.gov (United States)

    2012-12-14

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

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

    Science.gov (United States)

    2012-07-20

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

  13. 76 FR 59155 - Notice of Availability of South Coast Draft Resource Management Plan Revision and Draft...

    Science.gov (United States)

    2011-09-23

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

  14. Final Draft Strategic Marketing Plan.

    Energy Technology Data Exchange (ETDEWEB)

    United States. Bonneville Power Administration.

    1994-02-01

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

  15. Autonomous Guidance, Navigation and Control

    Science.gov (United States)

    Bordano, A. J.; Mcswain, G. G.; Fernandes, S. T.

    1991-01-01

    The NASA Autonomous Guidance, Navigation and Control (GN&C) Bridging program is reviewed to demonstrate the program plan and GN&C systems for the Space Shuttle. The ascent CN&C system is described in terms of elements such as the general-purpose digital computers, sensors for the navigation subsystem, the guidance-system software, and the flight-control subsystem. Balloon-based and lidar wind soundings are used for operations assessment on the day of launch, and the guidance software is based on dedicated units for atmospheric powered flight, vacuum powered flight, and abort-specific situations. Optimization of the flight trajectories is discussed, and flight-control responses are illustrated for wavelengths of 500-6000 m. Alternate sensors are used for load relief, and adaptive GN&C systems based on alternate gain synthesis are used for systems failures.

  16. 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.

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

    Data.gov (United States)

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

  18. 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...

  19. 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...

  20. 78 FR 27939 - Draft Interagency Risk Assessment-Listeria monocytogenes

    Science.gov (United States)

    2013-05-13

    ... Draft Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens: Notice of... Assessment--Listeria monocytogenes in Retail Delicatessens.'' This draft quantitative risk assessment (QRA... conditions, such as Listeria (L.) monocytogenes contamination of certain ready-to-eat (RTE) foods,...

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

    Science.gov (United States)

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

    2012-01-01

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

  2. 78 FR 19637 - National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials...

    Science.gov (United States)

    2013-04-02

    ..., biochar, corn steep liquor, fatty acids, glycerin, molasses, vegetable protein hydrolysate, vinasse, and... agency #0;statements of organization and functions are examples of documents #0;appearing in this...

  3. 77 FR 20026 - Draft Guidance for Industry: Modified Risk Tobacco Product Applications; Availability; Agency...

    Science.gov (United States)

    2012-04-03

    ... grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors. Congress found that it is essential that, prior to marketing tobacco products for use to reduce harm or the risk of tobacco-related...

  4. 78 FR 44572 - Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability

    Science.gov (United States)

    2013-07-24

    ... preparing products for market launch based on anticipated approval of a pending new drug application (NDA... products in preparation for market launch, FDA considered such requests, informally referred to as PLAIRs... prepare the product for market launch. If FDA grants the PLAIR request, when the product is then...

  5. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Science.gov (United States)

    2010-01-20

    ... approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. A...

  6. 77 FR 20030 - Draft Guidance for Industry: Reporting Harmful and Potentially Harmful Constituents in Tobacco...

    Science.gov (United States)

    2012-04-03

    ... amends the FD&C Act and grants FDA authority to regulate the manufacture, marketing, and distribution of... reports quantities for the abbreviated list of HPHCs at least 90 days prior to marketing the product in... information under section 904(c)(1) at least 90 days prior to delivery for introduction into...

  7. 75 FR 60129 - Draft Guidance for Industry and Investigators on Safety Reporting Requirements for...

    Science.gov (United States)

    2010-09-29

    ... Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit... Ave., Bldg. 51, rm. 6324, Silver Spring, MD 20993-0002, 301- 796-2500; or Laura Rich, Center...

  8. 75 FR 52755 - Draft Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing...

    Science.gov (United States)

    2010-08-27

    ... infections (ABSSSI), impetigo, and minor cutaneous abscesses. FDA's thinking in this area has evolved in... investigators in the development of antimicrobial drugs for the treatment of ABSSSI, impetigo, and...

  9. 78 FR 58545 - Global Unique Device Identification Database; Draft Guidance for Industry; Availability

    Science.gov (United States)

    2013-09-24

    ... for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... information on the database elements that must be submitted to the GUDID and their definitions. We intend...

  10. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Science.gov (United States)

    2013-06-17

    ... New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood... for Industry and FDA Staff: ] Investigational New Drug Applications for Minimally Manipulated... Investigational New Drug Application (IND) for certain hematopoietic progenitor cells from...

  11. 76 FR 32367 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Science.gov (United States)

    2011-06-06

    ... Staff: Financial Disclosure by Clinical Investigators; Correction AGENCY: Food and Drug Administration...: Financial Disclosure by Clinical Investigators.''The document was published with an incorrect docket...

  12. 78 FR 46954 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Science.gov (United States)

    2013-08-02

    ... Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion AGENCY: Food... Trypanosoma cruzi (T. cruzi) infection. DATES: Submit either electronic or written comments on the collection... Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components...

  13. 77 FR 74852 - Draft Guidance for Industry on Certification of Designated Medical Gases; Availability

    Science.gov (United States)

    2012-12-18

    ... process created by the Food and Drug Administration Safety and Innovation Act (FDASIA) for certain medical... information are manufacturers and/or marketers of certain medical gas drug products. Burden Estimate:...

  14. 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...

  15. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Science.gov (United States)

    2012-10-02

    ... Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee... Amendments of 2012 (GDUFA), holders of certain drug master files, namely, Type II active...

  16. 77 FR 8884 - Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a...

    Science.gov (United States)

    2012-02-15

    ... reference product for the purpose of submitting a marketing application through an abbreviated licensure... protein product and a reference product for the purpose of submitting a marketing application through the... requirements for submission of a marketing application, applicants should consult current regulations,...

  17. 77 FR 8883 - Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a...

    Science.gov (United States)

    2012-02-15

    ... protein product is biosimilar to a reference product for the purpose of submitting a marketing application... purpose of submitting a marketing application through the abbreviated licensure pathway under section...

  18. 77 FR 8885 - Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the...

    Science.gov (United States)

    2012-02-15

    ... developing proposed biosimilar products, biologics license application (BLA) holders, and other interested... answers to common questions from sponsors interested in developing proposed biosimilar products, BLA.... 262(k)) for biological products demonstrated to be biosimilar to, or interchangeable with, an...

  19. 77 FR 34958 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors...

    Science.gov (United States)

    2012-06-12

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

  20. 76 FR 80947 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Science.gov (United States)

    2011-12-27

    ... Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies... approaches FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk..., early feasibility studies, as well as outlines the general principles for preparing and reviewing...

  1. 76 FR 27331 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-05-11

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

  2. 76 FR 34999 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-06-15

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

  3. 76 FR 569 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-01-05

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

  4. 77 FR 5415 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents, Certified...

    Science.gov (United States)

    2012-02-03

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

  5. 76 FR 77492 - Draft Guidance on Improving the Process for Preparing Efficient and Timely Environmental Reviews...

    Science.gov (United States)

    2011-12-13

    ... other legally binding requirement and is not legally enforceable. The use of non-mandatory terminology... policies and recommendations. The use of mandatory terminology such as ``shall,'' ``must,'' and ``required... developing a proposed policy, program, management plan, or project. Agencies must integrate the NEPA...

  6. 76 FR 53909 - Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Science.gov (United States)

    2011-08-30

    ... have been scored. (A scoring feature facilitates tablet splitting, which is the practice of breaking or... tablets that have been scored. (A scoring feature facilitates tablet splitting, which is the practice of... splitting of the tablet into fractions when less than a full tablet is desired for a dose. Although...

  7. 77 FR 39959 - Draft Guidance To Implement Requirements for the Treatment of Air Quality Monitoring Data...

    Science.gov (United States)

    2012-07-06

    ... Air Quality Monitoring Data Influenced by Exceptional Events AGENCY: Environmental Protection Agency... for the Treatment of Air Quality Monitoring Data Influenced by Exceptional Events and associated... Treatment of Air Quality Monitoring Data Influenced by Exceptional Events and associated attachments and...

  8. 78 FR 20926 - Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International...

    Science.gov (United States)

    2013-04-08

    ... Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk... its waiver authority to permit applicants to submit an International Conference on Harmonisation...

  9. 76 FR 82306 - Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability

    Science.gov (United States)

    2011-12-30

    ...: Structural features from the molecular to the anatomic level (e.g., genetic composition, receptor expression... and extent of background lesions and (2) a detailed description of the pathology peer review...

  10. 75 FR 41498 - Draft Guidance for Tobacco Retailers on Tobacco Retailer Training Programs; Availability; Agency...

    Science.gov (United States)

    2010-07-16

    ... does provide for lower civil money penalties for violations of access, advertising, and promotion... distribution of a tobacco product, including restrictions on the access to, and the advertising and promotion... to cigarettes and smokeless tobacco products, as well as restrictions on advertising and promotion...

  11. 78 FR 9709 - Draft Guidance Regarding Voluntary Inspection of Vessels for Compliance With the Maritime Labour...

    Science.gov (United States)

    2013-02-11

    ... Maritime Labour Convention, 2006 AGENCY: Coast Guard, DHS. ACTION: Notice of availability and request for.... vessels for voluntary compliance with the Maritime Labour Convention, 2006 (Convention), which enters into... http://www.regulations.gov on or before March 13, 2013 or reach the Docket Management Facility by...

  12. 78 FR 63219 - International Conference on Harmonisation; Draft Guidance on Elemental Impurities; Availability

    Science.gov (United States)

    2013-10-23

    ...://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA-305), Food... Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA... written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send...

  13. 78 FR 7786 - International Conference on Harmonisation; Draft Guidance on S10 Photosafety Evaluation of...

    Science.gov (United States)

    2013-02-04

    ... Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061... Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers.... II. Comments Interested persons may submit to the Division of Dockets Management (see...

  14. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Science.gov (United States)

    2013-12-04

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

  15. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Science.gov (United States)

    2013-12-04

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

  16. 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...

  17. Cooperative Guidance for Multimissile Salvo Attack

    Institute of Scientific and Technical Information of China (English)

    Zhao Shiyu; Zhou Rui

    2008-01-01

    Cooperative guidance problems of multiple missiles are considered in this article. A cooperative guidance scheme, where coordi-nation algorithms and local guidance laws are combined together, is proposed. This scheme actually builds up a hierarchical cooperative guidance architecture, which may provide a general solution to the multimissile cooperative guidance problems. In the case of salvo attacks which require missiles to hit the target simultaneously, both centralized and distributed coordination algorithms are derived based on the impact-time-control guidance (ITCG) law. Numerical simulations are performed to demonstrate the effectiveness of the proposed approaches.

  18. 77 FR 5247 - Draft Integrated Science Assessment for Lead

    Science.gov (United States)

    2012-02-02

    ... AGENCY Draft Integrated Science Assessment for Lead AGENCY: Environmental Protection Agency (EPA). ACTION..., ``Second External Review Draft Integrated Science Assessment for Lead'' (EPA/600/R-10/075B). The document... lead (Pb). EPA is releasing this draft document to seek review by the Clean Air Scientific...

  19. 77 FR 70776 - Draft Integrated Science Assessment for Lead

    Science.gov (United States)

    2012-11-27

    ... AGENCY Draft Integrated Science Assessment for Lead AGENCY: Environmental Protection Agency (EPA). ACTION..., ``Third External Review Draft Integrated Science Assessment for Lead'' (EPA/600/R-10/075C). The document... lead (Pb). EPA is releasing this draft document to seek review by the Clean Air Scientific...

  20. 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...

  1. 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....

  2. 77 FR 5528 - Trust Land Consolidation Draft Plan

    Science.gov (United States)

    2012-02-03

    ... Office of the Secretary Trust Land Consolidation Draft Plan AGENCY: Office of the Secretary, Interior... fractional interests in these lands. We are seeking comments on the draft plan for accomplishing these goals. DATES: Submit comments by March 19, 2012. ADDRESSES: Send comments on the draft plan to: Elizabeth...

  3. 76 FR 9209 - Draft NOAA National Aquaculture Policy

    Science.gov (United States)

    2011-02-16

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

  4. 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...

  5. 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.

  6. Interstitial guidance of cancer invasion.

    NARCIS (Netherlands)

    Gritsenko, P.G.; Ilina, O.; Friedl, P.H.

    2012-01-01

    Cancer cell invasion into healthy tissues develops preferentially along pre-existing tracks of least resistance, followed by secondary tissue remodelling and destruction. The tissue scaffolds supporting or preventing guidance of invasion vary in structure and molecular composition between organs. In

  7. Abortion Information: A Guidance Viewpoint

    Science.gov (United States)

    Wolleat, Patricia L.

    1975-01-01

    A number of questions relating to providing abortion information to teenagers can be raised from legal, ethical and philosophical standpoints. The purpose of this article is to examine abortion information-giving from the perspective of counseling and guidance theory and practice. (Author)

  8. Guidance: Interim Municipal Settlement Policy

    Science.gov (United States)

    Interim guidance and fact sheets regarding settlements involving municipalities or municipal waste under Section 122 CERCLA as amended by SARA. Interim policy sets forth the criteria by which EPA generally determines whether to exercise enforcement discretion to pursue MSW generators and transporters as PRPs.

  9. Teacher Guidance of Knowledge Construction

    Science.gov (United States)

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

    2004-01-01

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

  10. 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.

  11. Atmospheric guidance techniques and performance

    Science.gov (United States)

    Harpold, J. C.; Gavert, D. E.

    1982-01-01

    The Orbiter entry guidance system controls the Space Shuttle Orbiter from the initial atmospheric penetration point to the point at which an earth relative velocity of 2500 feet/second is reached. At the latter point, control of the Orbiter is transferred to the terminal area energy management system. The entry guidance system is based on the concept that the range to be flown during entry is a unique function of the drag deceleration profile flown throughout the entry. The range prediction during entry is based on analytic equations which are simple drag deceleration functions of earth relative velocity above Mach 10.5 and energy with respect to the earth below Mach 10.5. Flight through the entry corridor is accomplished by linking these simple drag deceleration functions together in series in order to define a drag deceleration reference profile. The results of the first three Space Shuttle missions have not only verified the entry guidance concept but have also demonstrated the stability of the guidance system.

  12. A guidance concept for hypersonic aerospacecrafts

    Science.gov (United States)

    Ishimoto, Shinji

    In this paper a guidance concept for hypersonic re-entry flights is presented. The method uses a closed-form guidance technique based on a drag acceleration reference profile. A guidance law for range control is developed. It employs a physical relation between vehicle energy and range instead of a prediction-correction technique used for Shuttle entry guidance. Simulation results show that the algorithm provides good performance.

  13. Providing Career Guidance for Young Women.

    Science.gov (United States)

    Colby, Pamela G.

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

  14. The Self in Guidance: Assumptions and Challenges.

    Science.gov (United States)

    Edwards, Richard; Payne, John

    1997-01-01

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

  15. 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,…

  16. Agent Based Individual Traffic guidance

    DEFF Research Database (Denmark)

    Wanscher, Jørgen Bundgaard

    2004-01-01

    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...... 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...... of the paper is the possibilities of using ABIT when disruptions occur (accidents, congestion, and roadwork). The discussion will be based on realistic case studies....

  17. Teleautonomous guidance for mobile robots

    Science.gov (United States)

    Borenstein, J.; Koren, Y.

    1990-01-01

    Teleautonomous guidance (TG), a technique for the remote guidance of fast mobile robots, has been developed and implemented. With TG, the mobile robot follows the general direction prescribed by an operator. However, if the robot encounters an obstacle, it autonomously avoids collision with that obstacle while trying to match the prescribed direction as closely as possible. This type of shared control is completely transparent and transfers control between teleoperation and autonomous obstacle avoidance gradually. TG allows the operator to steer vehicles and robots at high speeds and in cluttered environments, even without visual contact. TG is based on the virtual force field (VFF) method, which was developed earlier for autonomous obstacle avoidance. The VFF method is especially suited to the accommodation of inaccurate sensor data (such as that produced by ultrasonic sensors) and sensor fusion, and allows the mobile robot to travel quickly without stopping for obstacles.

  18. Review of soil contamination guidance

    Energy Technology Data Exchange (ETDEWEB)

    Mueller, M.A.; Kennedy, W.E. Jr.; Soldat, J.K.

    1981-08-01

    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 (ALARA).

  19. Reentry guidance for Space Shuttle

    Science.gov (United States)

    Causey, W.; Sohoni, V.

    1973-01-01

    An explicit guidance scheme is outlined which provides the appropriate energy management in order for the shuttle orbiter to reach any location within the required footprint. Considering the orbiter as entering the earth's atmosphere, expressions for the downrange, crossrange, and the time of the termination of the entry phase as functions of the control variables are developed. Performing an order-of-magnitude analysis of the terms in these expressions, only dominant terms are retained. Analytical expressions for the elements of the sensitivity matrix which represents the partial derivatives of the desired range with respect to control variables are formulated. Using the Gauss-Jordan inversion technique, the required change in guidance commands as a function of the deviations in the downrange and crossrange are explicitly computed.

  20. 2011 Army Strategic Planning Guidance

    Science.gov (United States)

    2011-03-25

    TESI ) of 22,000 Soldiers, the Army’s total force by the end of the mid-term period is programmed to be 520K (AC). We will achieve a more...dwell ratios, extending TESI authority to adequately man deploying units and sustain the All-Volunteer Force, right-sizing the generating force, and... TESI Temporary End-Strength Increase WMD Weapons of Mass Destruction 2011 ARMY STRATEGIC PLANNING GUIDANCE Page 19 2011

  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. CENELEC Project Report Smart House Roadmap (draft)

    NARCIS (Netherlands)

    Hartog, F.T.H. den; Suters, T.; Parsons, J.; Faller, J.

    2010-01-01

    This CENELEC project report has been drafted by a project team and steering group of representatives of interested parties and is to be endorsed on 2010-11-23. Neither the national members of CENELEC nor the CEN-CENELEC Management Centre can be held accountable for the technical content of this CENE

  3. On the Drafting of Confidentiality Agreements

    DEFF Research Database (Denmark)

    Drewsen, Merete; Lando, Henrik; Cummins, Tim

    2006-01-01

    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 theorem) to the drafting of confidentiality agreements. While the article is not theoretical, its...... prescriptions are open to theoretical dispute; this may especially be the case for the section on the size of damages....

  4. 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…

  5. Provider Services Network Project. Draft Final Report.

    Science.gov (United States)

    Urban and Rural Systems Associates, San Francisco, CA.

    This draft report on the development and testing of a child care Provider Services Network (PSN) model in Santa Clara County, California, includes a handbook (Manual to Optimize a PSN) designed to provide the State Department of Education and regional or local child care coordinating agencies with information needed to develop PSN optimization…

  6. 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.

  7. 78 FR 76297 - Social Media: Consumer Compliance Risk Management Guidance

    Science.gov (United States)

    2013-12-17

    .../or sex or use data ] mining technology to obtain such information from social media sites, the... INSTITUTIONS EXAMINATION COUNCIL Social Media: Consumer Compliance Risk Management Guidance AGENCY: Federal... supervisory guidance entitled ``Social Media: Consumer Compliance Risk Management Guidance'' (Guidance)....

  8. Precision optical navigation guidance system

    Science.gov (United States)

    Starodubov, D.; McCormick, K.; Nolan, P.; Johnson, D.; Dellosa, M.; Volfson, L.; Fallahpour, A.; Willner, A.

    2016-05-01

    We present the new precision optical navigation guidance system approach that provides continuous, high quality range and bearing data to fixed wing aircraft during landing approach to an aircraft carrier. The system uses infrared optical communications to measure range between ship and aircraft with accuracy and precision better than 1 meter at ranges more than 7.5 km. The innovative receiver design measures bearing from aircraft to ship with accuracy and precision better than 0.5 mRad. The system provides real-time range and bearing updates to multiple aircraft at rates up to several kHz, and duplex data transmission between ship and aircraft.

  9. Orthobiologic Interventions Using Ultrasound Guidance.

    Science.gov (United States)

    Malanga, Gerard; Abdelshahed, Dena; Jayaram, Prathap

    2016-08-01

    The application of regenerative therapies for the treatment of musculoskeletal conditions has emerged over the last decade with recent acceleration. These include prolotherapy, platelet-rich plasma, and mesenchymal stem cell therapy. These strategies augment the body's innate physiology to heal pathologic processes. This article presents an overview of platelet-rich plasma and mesenchymal stem cell therapy for the treatment of musculoskeletal injuries. A brief literature review is included, as are techniques for the use of ultrasound guidance to assist with these procedures.

  10. 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...

  11. Agent Based Individual Traffic Guidance

    DEFF Research Database (Denmark)

    Wanscher, Jørgen

    This thesis investigates the possibilities in applying Operations Research (OR) to autonomous vehicular traffic. The explicit difference to most other research today is that we presume that an agent is present in every vehicle - hence Agent Based Individual Traffic guidance (ABIT). The next...... evolutionary step for the in-vehicle route planners is the introduction of two-way communication. We presume that the agent is capable of exactly this. Based on this presumption we discuss the possibilities and define a taxonomy and use this to discuss the ABIT system. Based on a set of scenarios we conclude...

  12. 78 FR 54906 - Draft Supplemental Environmental Impact Report/Environmental Impact Statement for a Proposed...

    Science.gov (United States)

    2013-09-06

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

  13. 77 FR 76474 - Extension of Public Review and Comment Period for the Draft Programmatic Environmental Assessment...

    Science.gov (United States)

    2012-12-28

    ... Draft Programmatic Environmental Assessment for the Recycling of Scrap Metals Originating From... of availability for the Draft Programmatic Environmental Assessment (PEA) for the Recycling of Scrap... address printed in the Draft PEA was correct and now both that email address (...

  14. 75 FR 52355 - Draft National Conversation on Public Health and Chemical Exposures Work Group Reports...

    Science.gov (United States)

    2010-08-25

    ... Prevention Draft National Conversation on Public Health and Chemical Exposures Work Group Reports... exposures. This notice announces the availability of draft National Conversation work group reports for... National Conversation Leadership Council and facilitating the work group process. DATES: Draft work...

  15. 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,...

  16. Accuracy of professional sports drafts in predicting career potential.

    Science.gov (United States)

    Koz, D; Fraser-Thomas, J; Baker, J

    2012-08-01

    The forecasting of talented players is a crucial aspect of building a successful sports franchise and professional sports invest significant resources in making player choices in sport drafts. The current study examined the relationship between career performance (i.e. games played) and draft round for the National Football League, National Hockey League, National Basketball League, and Major League Baseball for players drafted from 1980 to 1989 (n = 4874) against the assumption of a linear relationship between performance and draft round (i.e. that players with the most potential will be selected before players of lower potential). A two-step analysis revealed significant differences in games played across draft rounds (step 1) and a significant negative relationship between draft round and games played (step 2); however, the amount of variance accounted for was relatively low (less than 17%). Results highlight the challenges of accurately evaluating amateur talent.

  17. Flight Guidance System Requirements Specification

    Science.gov (United States)

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

    2003-01-01

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

  18. Optimal terminal guidance for exoatmospheric interception

    Institute of Scientific and Technical Information of China (English)

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

    2016-01-01

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

  19. International governmental agencies and career guidance

    OpenAIRE

    Conger, Stuart

    1999-01-01

    The international Organization for Economic Cooperation and Development (OECD), like many national and international organizations concerned with economic development believes that career guidance has an important role in promoting the development of a country's human resources. (Mapping the future: Young People and career guidance OECD, 1996). Generally the economic development agencies always recommend that career guidance services should be strengthened. Too frequently, however, they do no...

  20. First Draft of the act Programming Language

    Science.gov (United States)

    2014-01-22

    First Draft of the act Programming Language Eleftherios Matsikoudis Christos Stergiou Electrical Engineering and Computer Sciences University of...AND ADDRESS(ES) University of California at Berkeley,Electrical Engineering and Computer Sciences,Berkeley,CA,94720 8. PERFORMING ORGANIZATION... grammar and the syntactic grammar of act, and include an example of a simple actor written in act, demonstrating some of the syntactic features of the

  1. Hybrid Guidance System for Relative Navigation Project

    Data.gov (United States)

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

  2. 78 FR 37231 - Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2013-06-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry; Guidance on Abbreviated New Drug... the availability of a guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and... generic drug review, FDA is recommending that the generic drug industry follow the approach in...

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

    Directory of Open Access Journals (Sweden)

    Xavier Bosch-Capblanch

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

  4. 75 FR 76079 - Sound Incentive Compensation Guidance

    Science.gov (United States)

    2010-12-07

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

  5. 75 FR 22679 - Sound Incentive Compensation Guidance

    Science.gov (United States)

    2010-04-29

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

  6. 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.

  7. 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

  8. 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.

  9. 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.

  10. 76 FR 38650 - Draft Integrated Science Assessment for Lead

    Science.gov (United States)

    2011-07-01

    ... AGENCY Draft Integrated Science Assessment for Lead AGENCY: Environmental Protection Agency. ACTION... Draft Integrated Science Assessment for Lead'' (EPA/600/R-10/075A). The original Federal Register notice... Development as part of the review of the National Ambient Air Quality Standards (NAAQS) for Lead. DATES:...

  11. 77 FR 11116 - Draft National Plan To Address Alzheimer's Disease

    Science.gov (United States)

    2012-02-24

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

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

    Science.gov (United States)

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

  13. 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.

  14. 76 FR 9210 - Draft DOC National Aquaculture Policy

    Science.gov (United States)

    2011-02-16

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

  15. 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.

  16. 77 FR 69619 - Draft Recommendations of Joint Outreach Team

    Science.gov (United States)

    2012-11-20

    ... flexible grid while reducing costs to consumers, Western and DOE formed the JOT. The team conducted a... 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...

  17. Geometric Dimensioning and Tolerancing. Drafting Module 9. Instructor's Guide.

    Science.gov (United States)

    Missouri Univ., Columbia. Instructional Materials Lab.

    This Missouri Vocational Instruction Management System instructor's drafting guide has been keyed to the drafting competency profile developed by state industry and education professionals. The guide contains a cross-reference table of instructional materials. This unit covers geometric dimensioning and tolerancing. The unit contains the…

  18. 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...

  19. 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...

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

    Science.gov (United States)

    2012-08-08

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

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

    Science.gov (United States)

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

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

  3. 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),...

  4. 76 FR 50490 - Draft Comprehensive Conservation Plan and Draft Environmental Impact Statement, Arctic National...

    Science.gov (United States)

    2011-08-15

    ... Statement, Arctic National Wildlife Refuge, Fairbanks, AK AGENCY: Fish and Wildlife Service, Interior... conservation plan (CCP) and draft environmental impact statement (DEIS) for the Arctic National Wildlife Refuge... documents required by the National Environmental Policy Act (NEPA). DATES: To ensure consideration,...

  5. 77 FR 55222 - Notice of Availability of the Draft Resource Management Plan Amendment and the Draft...

    Science.gov (United States)

    2012-09-07

    ..., recreation management, social and economic values, utility corridors, roads and travel management, and visual... Bureau of Land Management Notice of Availability of the Draft Resource Management Plan Amendment and the... Garfield, Moffat and Rio Blanco Counties, CO AGENCY: Bureau of Land Management, Interior. ACTION: Notice...

  6. Space shuttle guidance, navigation, and control design equations. Volume 3: Guidance

    Science.gov (United States)

    1973-01-01

    Space shuttle guidance, navigation, and control design equations are presented. The space-shuttle mission includes three relatively distinct guidance phases which are discussed; atmospheric boost, which is characterized by an adaptive guidance law; extra-atmospheric activities; and re-entry activities, where aerodynamic surfaces are the principal effectors. Guidance tasks include pre-maneuver targeting and powered flight guidance, where powered flight is defined to include the application of aerodynamic forces as well as thruster forces. A flow chart which follows guidance activities throughout the mission from the pre-launch phase through touchdown is presented. The main guidance programs and subroutines used in each phase of a typical rendezvous mission are listed. Detailed software requirements are also presented.

  7. A review of dynamics modelling of friction draft gear

    Science.gov (United States)

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

    2014-06-01

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

  8. 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.

  9. 76 FR 63676 - Final Division of Safety Systems Interim Staff Guidance DSS-ISG-2010-01: Staff Guidance Regarding...

    Science.gov (United States)

    2011-10-13

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

  10. 75 FR 14623 - Notice of Availability of the Draft Imperial Sand Dunes Recreation Area Management Plan and Draft...

    Science.gov (United States)

    2010-03-26

    ... Bureau of Land Management Notice of Availability of the Draft Imperial Sand Dunes Recreation Area... Plan (RAMP)/Draft Environmental Impact Statement (EIS) for the Imperial Sand Dunes Recreation Area... Sand Dunes RAMP/EIS are available in the El ] Centro Field Office at the above address and at the...

  11. 78 FR 17714 - Notice of Availability of the HiLine District Draft Resource Management Plan and Draft...

    Science.gov (United States)

    2013-03-22

    ... management, land tenure, public land access, off-highway vehicles, lands with wilderness characteristics... Bureau of Land Management Notice of Availability of the HiLine District Draft Resource Management Plan and Draft Environmental Impact Statement, MT AGENCY: Bureau of Land Management, Interior....

  12. 78 FR 46588 - Solicitation of Written Comments on the Global Immunizations Working Group's Draft Report and...

    Science.gov (United States)

    2013-08-01

    ... HUMAN SERVICES Solicitation of Written Comments on the Global Immunizations Working Group's Draft Report and Draft Recommendations for Enhancing the Work of the HHS National Vaccine Program in Global... Immunizations Working Group to assist in addressing these charges. A draft report and draft recommendations...

  13. 78 FR 23289 - Public Review of Draft National Shoreline Data Content Standard

    Science.gov (United States)

    2013-04-18

    ... Geological Survey Public Review of Draft National Shoreline Data Content Standard AGENCY: Department of the Interior, U.S. Geological Survey. ACTION: Notice; request for comments on draft National Shoreline Data... the draft National Shoreline Data Content Standard. The FGDC has developed a draft National...

  14. 75 FR 69078 - Workshop To Review Draft Materials for the Lead (Pb) Integrated Science Assessment (ISA)

    Science.gov (United States)

    2010-11-10

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

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

    Science.gov (United States)

    Shwom, Barbara L.; Hirsch, Penny L.

    1994-01-01

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

  16. 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.

  17. Significant Guidance Issued by the Federal Aviation Administration

    Data.gov (United States)

    Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

  18. Significant Guidance Issued by the Federal Transit Administration

    Data.gov (United States)

    Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

  19. Significant Guidance Issued by the Federal Motor Carrier Safety Administration

    Data.gov (United States)

    Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

  20. Significant Guidance Issued by the Federal Highway Administration

    Data.gov (United States)

    Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

  1. 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.

  2. 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.

  3. Integrated Entry Guidance for Reusable Launch Vehicle

    Institute of Scientific and Technical Information of China (English)

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

    2007-01-01

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

  4. Beyond Black: An Alternative to Ethnocentric Guidance

    Science.gov (United States)

    Goldman, Robert C.

    1977-01-01

    This article is a clarification of the author's personal philosophy in the guidance and counseling of youth and adults, and clarification of commonalities that form the raison d'etre of all student personnel services. (Author)

  5. 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...

  6. Optimal guidance for the space shuttle transition

    Science.gov (United States)

    Stengel, R. F.

    1974-01-01

    A guidance method for the space shuttle's transition from hypersonic entry to subsonic cruising flight is presented. The method evolves from a numerical trajectory optimization technique in which kinetic energy and total energy (per unit weight) replace velocity and time in the dynamic equations. This allows the open end-time problem to be transformed to one of fixed terminal energy. In its ultimate form, E-Guidance obtains energy balance (including dynamic-pressure-rate damping) and path length control by angle-of-attack modulation and cross-range control by roll angle modulation. The guidance functions also form the basis for a pilot display of instantaneous maneuver limits and destination. Numerical results illustrate the E-Guidance concept and the optimal trajectories on which it is based.

  7. Background Perchlorate Source Identification Technical Guidance

    Science.gov (United States)

    2013-12-01

    adapted from and is similar to the forensics approach used for pollutant source tracking (PST) of other contaminants (metals, organics, bacteria ), for...18 ppb Public notice standard New Jersey 5 ppb Draft MCL (pending) New Mexico 1 ppb Drinking water planning level New York 5 & 18 ppb 5 ppb...activity (Ericksen, 1983; Schumacher, 1960). Chilean nitrate deposits have been mined to produce fertilizer and saltpeter for gunpowder for export

  8. 78 FR 50088 - Notice of Availability of the Northwest Colorado Greater Sage-Grouse Draft Resource Management...

    Science.gov (United States)

    2013-08-16

    ... Bureau of Land Management Notice of Availability of the Northwest Colorado Greater Sage- Grouse Draft... Colorado Greater Sage-Grouse Draft Resource Management Plan (RMP) Amendment and Draft Environmental Impact... related to the Northwest Colorado Greater Sage-Grouse Draft RMP Amendment/Draft EIS by any of...

  9. 78 FR 65701 - Notice of Availability of the Nevada and Northeastern California Greater Sage-Grouse Draft Land...

    Science.gov (United States)

    2013-11-01

    ...] Notice of Availability of the Nevada and Northeastern California Greater Sage-Grouse Draft Land Use Plan... Greater Sage-Grouse Draft Land Use Plan (LUP) Amendments and Draft Environmental Impact Statement (EIS... Northeastern California Sub-region Greater Sage-Grouse Draft LUP Amendments/Draft EIS by any of the...

  10. Constituent Aspects of Workplace Guidance in Secondary VET

    Science.gov (United States)

    Swager, Robert; Klarus, Ruud; van Merriënboer, Jeroen J. G.; Nieuwenhuis, Loek F. M.

    2015-01-01

    Purpose: This paper aims to present an integrated model of workplace guidance to enhance awareness of what constitutes good guidance, to improve workplace guidance practices in vocational education and training. Design/methodology/approach: To identify constituent aspects of workplace guidance, a systematic search of Web of Science was conducted,…

  11. The voice of users in adult career guidance

    DEFF Research Database (Denmark)

    Plant, Peter

    2012-01-01

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

  12. The Development of a Lifelong Guidance System in Hungary

    Science.gov (United States)

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

    2011-01-01

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

  13. A Software Tool for Legal Drafting

    CERN Document Server

    Gorín, Daniel; Schapachnik, Fernando; 10.4204/EPTCS.68.7

    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 comparison shows that there are distinctive particularities, but they are restricted to a very specific subclass of normative propositions. The rest, we postulate, can be dealt with software tools. For such an enterprise the \\FormaLex tool set was devised: an LTL-based language and companion tools that utilize model checking to find out normative incoherences in regulations, contracts and other legal documents. A feature-rich case study is analyzed with the presented tools.

  14. A Draft Sequence of the Neandertal Genome

    Science.gov (United States)

    Green, Richard E.; Li, Heng; Zhai, Weiwei; Fritz, Markus Hsi-Yang; Hansen, Nancy F.; Durand, Eric Y.; Malaspinas, Anna-Sapfo; Jensen, Jeffrey D.; Marques-Bonet, Tomas; Alkan, Can; Prüfer, Kay; Meyer, Matthias; Burbano, Hernán A.; Good, Jeffrey M.; Schultz, Rigo; Aximu-Petri, Ayinuer; Butthof, Anne; Höber, Barbara; Höffner, Barbara; Siegemund, Madlen; Weihmann, Antje; Nusbaum, Chad; Lander, Eric S.; Russ, Carsten; Novod, Nathaniel; Affourtit, Jason; Egholm, Michael; Verna, Christine; Rudan, Pavao; Brajkovic, Dejana; Kucan, Željko; Gušic, Ivan; Doronichev, Vladimir B.; Golovanova, Liubov V.; Lalueza-Fox, Carles; de la Rasilla, Marco; Fortea, Javier; Rosas, Antonio; Schmitz, Ralf W.; Johnson, Philip L. F.; Eichler, Evan E.; Falush, Daniel; Birney, Ewan; Mullikin, James C.; Slatkin, Montgomery; Nielsen, Rasmus; Kelso, Janet; Lachmann, Michael; Reich, David; Pääbo, Svante

    2016-01-01

    Neandertals, the closest evolutionary relatives of present-day humans, lived in large parts of Europe and western Asia before disappearing 30,000 years ago. We present a draft sequence of the Neandertal genome composed of more than 4 billion nucleotides from three individuals. Comparisons of the Neandertal genome to the genomes of five present-day humans from different parts of the world identify a number of genomic regions that may have been affected by positive selection in ancestral modern humans, including genes involved in metabolism and in cognitive and skeletal development. We show that Neandertals shared more genetic variants with present-day humans in Eurasia than with present-day humans in sub-Saharan Africa, suggesting that gene flow from Neandertals into the ancestors of non-Africans occurred before the divergence of Eurasian groups from each other. PMID:20448178

  15. A Software Tool for Legal Drafting

    Directory of Open Access Journals (Sweden)

    Daniel Gorín

    2011-09-01

    Full Text Available 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 comparison shows that there are distinctive particularities, but they are restricted to a very specific subclass of normative propositions. The rest, we postulate, can be dealt with software tools. For such an enterprise the FormaLex tool set was devised: an LTL-based language and companion tools that utilize model checking to find out normative incoherences in regulations, contracts and other legal documents. A feature-rich case study is analyzed with the presented tools.

  16. Submarine Upward Looking Sonar Ice Draft Profile Data and Statistics

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — This data set consists of upward looking sonar draft data collected by submarines in the Arctic Ocean. It includes data from both U.S. Navy and Royal Navy...

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

    Science.gov (United States)

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

    2016-07-07

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

  18. 76 FR 62434 - HUD Draft Environmental Justice Strategy

    Science.gov (United States)

    2011-10-07

    ... URBAN DEVELOPMENT HUD Draft Environmental Justice Strategy AGENCY: Office of the Sustainable Housing and... Sustainable Housing and Communities, Department of Housing and Urban Development, 451 7th Street, SW., Room... can be found at...

  19. Draft Genome Sequences of Nine Cyanobacterial Strains from Diverse Habitats

    Science.gov (United States)

    Zhu, Tao; Hou, Shengwei

    2017-01-01

    ABSTRACT Here, we report the annotated draft genome sequences of nine different cyanobacteria, which were originally collected from different habitats, including hot springs, terrestrial, freshwater, and marine environments, and cover four of the five morphological subsections of cyanobacteria. PMID:28254973

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

    Science.gov (United States)

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

  1. Draft Genome Sequence of Coprobacter fastidiosus NSB1T

    Science.gov (United States)

    Chaplin, A. V.; Efimov, B. A.; Khokhlova, E. V.; Kafarskaia, L. I.; Tupikin, A. E.; Kabilov, M. R.

    2014-01-01

    Coprobacter fastidiosus is a Gram-negative obligate anaerobic bacterium belonging to the phylum Bacteroidetes. In this work, we report the draft genome sequence of C. fastidiosus strain NSB1T isolated from human infant feces. PMID:24604645

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

    Science.gov (United States)

    Provisor, H.

    1968-01-01

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

  3. IRIS Toxicological Review for Acrylamide (Interagency Science Discussion Draft)

    Science.gov (United States)

    EPA is releasing the draft report, Toxicological Review for Acrylamide, that was distributed to Federal agencies and White House Offices for comment during the Science Discussion step of the IRIS Assessment Development Process<...

  4. Report on activities of the white-front survey: Draft

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This draft report summarizes the results of a survey on the Yukon-Kuskokwim Delta that was taken in order to determine productivity and nest site characteristics of...

  5. The stack induced draft aerial cooler (SIDAC)

    Energy Technology Data Exchange (ETDEWEB)

    Hircock, N.C. [NC Hircock Process Consulting Ltd., Calgary, AB (Canada)]|[Patching Associates Acoustical Engineering Ltd. Calgary, AB (Canada)

    2007-07-01

    The oil and gas industry uses stack induced draft aerial coolers (SIDAC) for process cooling in noise sensitive areas or in areas where no electrical power is available. The technology produces zero noise, zero operating costs and zero emissions. This paper examined the use, operation and economics of fanless, noiseless aerial coolers. Although retrofitting to convert from fin-fan to SIDAC is not viable, this paper illustrated one common application where the installation of a tapered stack over a cooler could work together with variable speed fan drives to enhance the noise suppression achieved by variable speed fan drives. A stack assisted draft air cooler (SADAC) was installed over a conventional engine cooler enclosing the engine exhaust and muffler. The exhaust stack was also acoustically lined to augment the noise suppression of the engine silencer itself. The waste heat of the engine exhaust, combined with the heat from the cooler discharge, was used to create a negative pressure behind the cooler fan. Therefore, at night the fan could back off in speed. Since fan noise is proportional to speed to the exponent 5, even a 20 per cent reduction of fan speed generates a noticeable noise reduction. The noise directive of the Alberta Energy and Utilities Board is for lower noise levels at night rather than daytime. Therefore, this innovation allows plant operators to run coolers at full capacity in the day while backing off fan speed at night. It was concluded that substantial benefits can be achieved by SIDAC and SADAC technology in the areas of noise control, process improvements and emission reductions. The capital costs of using these devices are comparable with conventional systems, and operating costs are reduced.

  6. 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.

  7. 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.

  8. 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.

  9. 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…

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

    Science.gov (United States)

    Jacobs, Karen; Struyf, Elke

    2013-01-01

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

  11. 78 FR 48201 - Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2013-01; Guidance for...

    Science.gov (United States)

    2013-08-07

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

  12. A study of swirl flow in draft tubes

    Energy Technology Data Exchange (ETDEWEB)

    Dahlhaug, Ole Gunnar

    1997-12-31

    This thesis presents measurements performed inside conical diffuser and bend, draft tubes of model hydro turbines, and draft tube of a prototype hydro turbine. Experimental results for swirling flow in conical diffuser and bend are presented in three different geometries. The axial velocity decreases at the centre of the tube at high swirl numbers because of an axial pressure gradient set up by the downstream frictional damping of the tangential velocities and the pressure increase downstream of the diffuser. Analytical models of the tangential velocity profiles are found and the radial pressure distribution calculated. Good correlation to the measured pressure distribution was achieved. Diffuser efficiency was calculated based on the equations for velocity and pressure profiles, which gave a qualified estimate of the diffuser hydraulic performance. The calculation shows that the bend reduces the efficiency by more than 30%. For a straight tube followed by a diffuser, numerical calculations were done, using K{epsilon}, RNG and RSM turbulence models for all measured swirl numbers. The K{epsilon} model gave best results for the forced vortex profile at low swirl numbers, while the RSM model gave best results at high swirl number. The turbulent kinetic energy at high swirl numbers gave the largest difference between the calculated and the measured values. Measurements on draft tubes in model turbines show the importance of good draft tube design. Prototype measurements on a Francis turbine show how the outlet draft tube flow should be measured for prototype draft tube evaluation. 54 refs., 118 figs., 2 tabs.

  13. 78 FR 68849 - Draft Current Intelligence Bulletin “Update of NIOSH Carcinogen Classification and Target Risk...

    Science.gov (United States)

    2013-11-15

    ... HUMAN SERVICES Centers for Disease Control and Prevention Draft Current Intelligence Bulletin ``Update... following draft document for public comment entitled ``Current Intelligence Bulletin: Update of NIOSH... obtain comments on the draft document, ``Current Intelligence Bulletin: Update of NIOSH...

  14. Guidance Trade-off for Aerocapture Missions

    Science.gov (United States)

    Vernis, P.; Gelly, G.; Ferreira, E.; da Costa, R.; Ortega, G.

    In the very late 90's, EADS-ST began home funded studies on aerocapture problems. The objectives of these studies were at that time to prepare a possible cooperation within the NASA/Cnes MSR-Orbiter program by investigating this new orbital insertion technique studying different algorithmic solutions from a guidance point of view. According to these preliminary studies, EADS-ST was retained in 2002 by ESA to study insertion techniques such as aerocapture, aero-gravity assist or aerobraking techniques within the frame of Technological Research Program able to bring solutions to Aurora program. In the frame of the ATPE (Aeroassist Technologies for Planetary Exploration) TRP program, EADS-ST, led by Astrium-Gmbh (now part of EADS-ST), developed and implemented an efficient and simple guidance scheme able to cope with mission requirements for aerocapture on Mars, Venus or the Earth: the Feedback Trajectory Control, or FTC. The development of this guidance scheme was made according to a preliminary trade-off analysis using different guidance schemes. Among those ones was an original predictor-corrector guidance scheme, already analyzed within the frame of the MSR-O mission. But, the FTC algoritm was prefered because of its good results and high simplicity. This paper presents an upgrade of the original Apoapsis Predictor, or AP, with the improvement of its robustness woth respect to off-nomonal flight conditions and its process simplification. A new trade-off analysis is then detailed on a Mars Sample return mission.

  15. 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.

  16. 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

  17. Smoking prevention and cessation in the Africa and Middle East region: a consensus draft guideline for healthcare providers--executive summary.

    Science.gov (United States)

    Ali, Ahmed Yousif M; Safwat, Tarek; Onyemelukwe, Geoffrey; Otaibi, Moh'd Amin Al; Amir, Ashraf A; Nawas, Yousef N; Aouina, Hichem; Afif, Moulay Hicham; Bolliger, Chris T

    2012-01-01

    Despite the abundance of scientific evidence confirming the health consequences of smoking and other forms of tobacco use, the tobacco epidemic remains an important public health problem and by 2030 it is predicted that more than 80% of tobacco deaths will be in developing countries. In Africa and the Middle East, many local factors contribute to the initiation and maintenance of tobacco use. Although efforts to reduce the mortality and morbidity associated with smoking and tobacco dependence are underway, there is a need for guidance on how to utilize appropriate tobacco control policies and psychology- and pharmacology-based therapies to counter tobacco dependence as recommended by the Framework Convention on Tobacco Control (FCTC). A group of tobacco cessation experts from public health services and/or academic institutions in Africa and the Middle East participated in a series of four meetings held in Cairo, Cape Town, and Dubai between May 2008 and February 2011 to develop a draft guideline tailored to their region. This article provides the background to the development of this draft smoking cessation guideline and discusses how the recommendations can be implemented and progress monitored to promote both primary prevention and cessation of tobacco use within our countries. The draft guideline for Africa and the Middle East provides an important resource in combating the devastating effects of tobacco use in these regions which can be further localized through engagement with local stakeholders in the countries of the region.

  18. Virtual Ultrasound Guidance for Inexperienced Operators

    Science.gov (United States)

    Caine, Timothy; Martin, David

    2012-01-01

    Medical ultrasound or echocardiographic studies are highly operator-dependent and generally require lengthy training and internship to perfect. To obtain quality echocardiographic images in remote environments, such as on-orbit, remote guidance of studies has been employed. This technique involves minimal training for the user, coupled with remote guidance from an expert. When real-time communication or expert guidance is not available, a more autonomous system of guiding an inexperienced operator through an ultrasound study is needed. One example would be missions beyond low Earth orbit in which the time delay inherent with communication will make remote guidance impractical. The Virtual Ultrasound Guidance system is a combination of hardware and software. The hardware portion includes, but is not limited to, video glasses that allow hands-free, full-screen viewing. The glasses also allow the operator a substantial field of view below the glasses to view and operate the ultrasound system. The software is a comprehensive video program designed to guide an inexperienced operator through a detailed ultrasound or echocardiographic study without extensive training or guidance from the ground. The program contains a detailed description using video and audio to demonstrate equipment controls, ergonomics of scanning, study protocol, and scanning guidance, including recovery from sub-optimal images. The components used in the initial validation of the system include an Apple iPod Classic third-generation as the video source, and Myvue video glasses. Initially, the program prompts the operator to power-up the ultrasound and position the patient. The operator would put on the video glasses and attach them to the video source. After turning on both devices and the ultrasound system, the audio-video guidance would then instruct on patient positioning and scanning techniques. A detailed scanning protocol follows with descriptions and reference video of each view along with

  19. Active evacuation guidance using sensor agent robot

    Science.gov (United States)

    Ise, Daiki; Mita, Akira

    2012-04-01

    Evacuation systems for buildings are designed based on event scenarios, so they are not prepared for unexpected events that are not included in the scenarios. In this paper, we propose a new active evacuation guidance system using sensor agent robots. We first introduce a Structural Health Monitoring (SHM) system to be used in conjunction with sensor agent robots for active evacuation guidance. Then the role of sensor agent robots is explained. An algorithm to immediately access the safety of the building after a large earthquake is also proposed using only the information taken by a sensor agent robot.

  20. 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.

  1. Enhanced mission performance from autonomous instrument guidance

    DEFF Research Database (Denmark)

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

    2006-01-01

    examples of such autonomous space instrumentation. With its full autonomy, this star tracker is capable of providing, in real-time, the absolute orientation with respect to the celestial reference frame with an accuracy of a few arc seconds. This high accuracy along with the robust operations, low weight...... acquisition and pointing (PROBA). Here three applications of the mu ASC as an autonomous onboard precision guide for precision vector instrumentation are presented. These are autonomous onboard antenna guidance, telescope guidance and tracking and high accuracy and wide range laser rangers....

  2. 77 FR 5057 - Draft Guidelines for Coroner/Medical Examiner Media Relations

    Science.gov (United States)

    2012-02-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Office of Justice Programs Draft Guidelines for Coroner/Medical Examiner Media Relations AGENCY: National... general public a draft document entitled, ``Guidelines for Media Relations: Dissemination of...

  3. 75 FR 27579 - Bison Brucellosis Remote Vaccination, Draft Environmental Impact Statement, Yellowstone National...

    Science.gov (United States)

    2010-05-17

    ... National Park Service Bison Brucellosis Remote Vaccination, Draft Environmental Impact Statement... Availability of the Draft Environmental Impact Statement for a Bison Brucellosis Remote Vaccination Program...(2)(C), the National Park Service announces the availability of the Bison Brucellosis...

  4. 77 FR 3545 - Notice of Availability of the Draft Program Environmental Impact Report (PEIR): Southern...

    Science.gov (United States)

    2012-01-24

    ... Federal Highway Administration Notice of Availability of the Draft Program Environmental Impact Report... (FHWA), DOT. ACTION: Notice of Availability of the Draft Program Environmental Impact Report (PEIR... Environmental Impact Report (PEIR), SCH 2011051018, in accordance with the California Environmental Quality...

  5. 77 FR 60475 - Draft of SWGDOC Standard Classification of Typewritten Text

    Science.gov (United States)

    2012-10-03

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Office of Justice Programs Draft of SWGDOC Standard Classification of Typewritten Text AGENCY: National... general public a draft document entitled, ``SWGDOC Standard Classification of Typewritten Text''....

  6. 75 FR 69475 - Notice Regarding Changed Venue for Public Hearing On a Draft Programmatic Environmental Impact...

    Science.gov (United States)

    2010-11-12

    ... nepacomments@nsf.gov . The presentation slides used by NSF at the public hearings are posted on the NSF Web... perceived inconsistency between the presentation and the Draft PEIS, the language in the Draft PEIS...

  7. 77 FR 14418 - Grand Ditch Breach Restoration Draft Environmental Impact Statement, Rocky Mountain National Park...

    Science.gov (United States)

    2012-03-09

    ... National Park Service Grand Ditch Breach Restoration Draft Environmental Impact Statement, Rocky Mountain... of the Draft Environmental Impact Statement for the Grand Ditch Breach Restoration, Rocky Mountain... Grand Ditch Breach Restoration, Rocky Mountain National Park, Colorado. The purpose of...

  8. IRIS Toxicological Review of Halogenated Platinum Salts and Platinum Compounds (External Review Draft)

    Science.gov (United States)

    EPA released the draft toxicological review for public comment under the Integrated Risk Information System (IRIS) Program. The original draft assessment (January 2009) has been archived but is available on this web page for the sake of transparency.

  9. 75 FR 70557 - Endocrine Disruptor Screening Program; Draft Policies and Procedures for Screening Safe Drinking...

    Science.gov (United States)

    2010-11-17

    ... Protection Agency Endocrine Disruptor Screening Program; Draft Policies and Procedures for Screening Safe..., 2010 / Notices#0;#0; ] ENVIRONMENTAL PROTECTION AGENCY Endocrine Disruptor Screening Program; Draft... requiring Tier 1 screening under the Endocrine Disruptor Screening Program (EDSP) of substances for...

  10. 75 FR 21650 - Coral Reef Restoration Plan, Draft Programmatic Environmental Impact Statement, Biscayne National...

    Science.gov (United States)

    2010-04-26

    ... National Park Service Coral Reef Restoration Plan, Draft Programmatic Environmental Impact Statement... Availability of the Draft Programmatic Environmental Impact Statement for the Coral Reef Restoration Plan... Environmental Impact Statement (DEIS) for the Coral Reef Restoration Plan for Biscayne National Park,...

  11. 75 FR 80819 - Draft Current Intelligence Bulletin “Occupational Exposure to Carbon Nanotubes and Nanofibers”

    Science.gov (United States)

    2010-12-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Draft Current Intelligence Bulletin... risks. A draft Current Intelligence Bulletin entitled ``Occupational Exposure to Carbon Nanotubes...

  12. 77 FR 38705 - Draft Specification for Airport Light Bases, Transformer Housings, Junction Boxes, and...

    Science.gov (United States)

    2012-06-28

    ... Federal Aviation Administration Draft Specification for Airport Light Bases, Transformer Housings... comment on the Draft ``Specification for Airport Light Bases, Transformer Housings, Junction Boxes, and... recommendations for airport light bases, transformer housings, junction boxes and accessories. The FAA has...

  13. Guidance for performing site inspections under CERCLA

    Energy Technology Data Exchange (ETDEWEB)

    1992-09-01

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

  14. Epilepsy in the Classroom: Guidance for Educators.

    Science.gov (United States)

    Lassner, Lee M.

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

  15. 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 ...

  16. 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…

  17. Designing Schoolwide Programs. Non-Regulatory Guidance

    Science.gov (United States)

    US Department of Education, 2006

    2006-01-01

    This guidance offers a renewed vision for the use of the schoolwide program, both as a reform strategy and as a means of realizing the high standards for student achievement envisioned by the No Child Left Behind Act of 2001 (NCLB). It is intended to be used as a companion document to the statute and regulations, as well as a technical assistance…

  18. Cannabinoid receptor CB2 modulates axon guidance

    DEFF Research Database (Denmark)

    Duff, Gabriel; Argaw, Anteneh; Cecyre, Bruno

    2013-01-01

    Navigation of retinal projections towards their targets is regulated by guidance molecules and growth cone transduction mechanisms. Here, we present in vitro and in vivo evidences that the cannabinoid receptor 2 (CB2R) is expressed along the retino-thalamic pathway and exerts a modulatory action ...

  19. MR Thermometry for guidance of thermal therapy

    NARCIS (Netherlands)

    Sprinkhuizen, S.M.

    2010-01-01

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

  20. 33 CFR 385.5 - Guidance memoranda.

    Science.gov (United States)

    2010-07-01

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

  1. 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.

  2. Hypermedia Authoring with Writing Process Guidance

    Science.gov (United States)

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

    2007-01-01

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

  3. 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…

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

    Science.gov (United States)

    Hill, Brent Mathews

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

  5. 77 FR 11550 - Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May...

    Science.gov (United States)

    2012-02-27

    .... Manufacturers can play a critical role in decreasing the impact of shortages by reporting to the FDA...- 0699. A discussion of the scope and logistics of mandatory notification under section 506C of the FD&C.... due to a shortage of an alternative product); and Product discontinuances (e.g. a business decision...

  6. 75 FR 73107 - Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated...

    Science.gov (United States)

    2010-11-29

    ... Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Availability AGENCY... Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment.'' The purpose of... antimicrobial drugs for the treatment of hospital- acquired bacterial pneumonia (HABP) and...

  7. 76 FR 6143 - Draft Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug...

    Science.gov (United States)

    2011-02-03

    ... Applications--Content and Format for New Drug Applications and Abbreviated New Drug Applications; Availability... emission tomography (PET) drugs in submitting new drug applications (NDAs) or abbreviated new drug... Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain......

  8. 78 FR 66366 - Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues...

    Science.gov (United States)

    2013-11-05

    ... Treponema pallidum (Syphilis); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),'' dated... for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis....

  9. 78 FR 63218 - Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting...

    Science.gov (United States)

    2013-10-23

    ... decompensated cirrhosis, and patients pre- or post-liver transplant. More details on clinical virology... for industry ``Establishment and Operation of Clinical Trial Data Monitoring Committees'' have...

  10. 77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

    Science.gov (United States)

    2012-07-27

    ... professionals, hospital purchasing departments, and manufacturers of enteral feeding tubes regarding luer lock... proposed solutions with validation for premarket review. At that time, some manufacturers were using color... demonstrated that reliance on color-coding of enteral devices alone cannot adequately mitigate the risk...

  11. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Science.gov (United States)

    2011-07-14

    ... labeling. Diagnostic tests have been employed for many years to enhance the use of therapeutic products. Recently, therapeutic products that depend on the use of a diagnostic test to meet their labeled safety and... companion diagnostic devices that have inadequate performance characteristics. To facilitate the...

  12. 78 FR 39737 - Draft Guidance for Industry on Antibacterial Therapies for Patients With Unmet Medical Need for...

    Science.gov (United States)

    2013-07-02

    ... programs for new antibacterial drugs. This effort is intended not only to spur development of new drugs for... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New.... Toerner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire...

  13. 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...

  14. 77 FR 27451 - Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels-Draft...

    Science.gov (United States)

    2012-05-10

    ... fluid migration. Should EPA recommend collection of geomechanical data with the permit application to... the 2005 Energy Policy Act (EP Act), Congress revised the SDWA definition of ``underground injection... assumptions and provide any technical information and/or data that you used. If you estimate potential...

  15. 78 FR 78822 - Draft Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals-Acoustic...

    Science.gov (United States)

    2013-12-27

    ... presented using the dual metrics of cumulative sound exposure level and peak sound pressure level. This... of Management and Budget. As such, independent peer review is required prior to broad public dissemination by the Federal Government. NOAA conducted a peer review of the updated acoustic threshold...

  16. 78 FR 14791 - Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and...

    Science.gov (United States)

    2013-03-07

    ... From the Federal Register Online via the Government Publishing Office FEDERAL ACCOUNTING STANDARDS..., and Equipment Cost Accumulation, Assignment, and Allocation AGENCY: Federal Accounting Standards..., notice is hereby given that the Accounting and Auditing Policy Committee (AAPC) has issued a...

  17. 75 FR 41871 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2010-07-19

    ... written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630... Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug... statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets...

  18. 75 FR 40843 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2010-07-14

    ... written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630... Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug... Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic...

  19. 76 FR 82303 - Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About...

    Science.gov (United States)

    2011-12-30

    ... limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)? (3) What... techniques, when appropriate, and other forms of information technology. Title: Industry Responses...

  20. 75 FR 37450 - Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing...

    Science.gov (United States)

    2010-06-29

    ... use of medically important antimicrobial drugs in food-producing animals. In regard to the use of... measures as follows: (1) Limiting medically important antimicrobial drugs to uses in food-producing animals... Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS....