Science.gov

Sample records for notice guidance documents

  1. 76 FR 60022 - Endocrine Disruptor Screening Program; Weight-of-Evidence Guidance Document; Notice of Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ... the endocrine system. The combined results and information will also be used to identify which tests... AGENCY Endocrine Disruptor Screening Program; Weight-of-Evidence Guidance Document; Notice of Availability AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA's Endocrine...

  2. 76 FR 9381 - Notice of Availability of Interim Staff Guidance Documents for Spent Fuel Storage Casks

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-17

    ... dry cask storage systems under Title 10 of the Code of Federal Regulations (10 CFR) part 71 and 10 CFR... COMMISSION Notice of Availability of Interim Staff Guidance Documents for Spent Fuel Storage Casks AGENCY... Gordon, Structural Mechanics and Materials Branch, Division of Spent Fuel Storage and...

  3. 75 FR 53353 - Notice of Availability of Final Interim Staff Guidance Document No. 25 “Pressure and Helium...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... COMMISSION Notice of Availability of Final Interim Staff Guidance Document No. 25 ``Pressure and Helium... Guidance Document No. 25 (ISG-25) ``Pressure and Helium Leakage Testing of the Confinement Boundary of... helium leakage testing and ASME Code required pressure (hydrostatic/pneumatic) testing that is...

  4. Regulatory guidance document

    SciTech Connect

    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.

  5. 75 FR 45678 - Notice of Availability of Interim Staff Guidance Document for Fuel Cycle Facilities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... of a safety significant event or condition. The NRC, however, does not agree that the time of..., Appendix A--Reportable Safety Events,'' Revision 0, has been issued and is provided for information... guidance may later be issued as an NRC Regulatory Guide. II. Discussion of Significant Comments and...

  6. THE STRESSOR IDENTIFICATION GUIDANCE DOCUMENT

    EPA Science Inventory

    THE STRESSOR IDENTIFICATION GUIDANCE DOCUMENT

    Susan M. Cormier, ORD/NRMRL, Susan B. Norton, ORD/NCEA, Glenn W. Suter, II ORD/NCEA, William Swietlik, OW lOST

    Science Question(s):

    MYP Science Question: How can multiple and possibly related causes of biological ...

  7. 21 CFR 314.445 - Guidance documents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Miscellaneous Provisions § 314.445 Guidance documents. (a) FDA has made available guidance documents under § 10.115 of this chapter to help you to...) maintains a list of guidance documents that apply to CDER's regulations. The list is maintained on...

  8. 21 CFR 312.145 - Guidance documents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Guidance documents. 312.145 Section 312.145...

  9. 21 CFR 316.50 - Guidance documents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... USE ORPHAN DRUGS Availability of Information § 316.50 Guidance documents. FDA's Office of Orphan... Federal Register. A request for a copy of the list should be directed to the Office of Orphan...

  10. 21 CFR 601.29 - Guidance documents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... for Biologics Evaluation and Research (CBER) maintains a list of guidance documents that apply to the... Register. You may request a copy of the CBER list from the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug...

  11. 21 CFR 312.145 - Guidance documents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... requirements of this part. (b) The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) maintain lists of guidance documents that apply to the centers' regulations... for a copy of the CDER list should be directed to the Office of Training and Communications,...

  12. 78 FR 41412 - Notice of Availability of Policy Document

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-10

    ... HUMAN SERVICES Health Resources and Services Administration Notice of Availability of Policy Document AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Final Agency Guidance and... . Background: HHS' Health Resources and Services Administration (HRSA) provides grants to eligible...

  13. Environmental restoration value engineering guidance document

    SciTech Connect

    1995-07-01

    This document provides guidance on Value Engineering (VE). VE is an organized team effort led by a person trained in the methodology to analyze the functions of projects, systems, equipment, facilities, services, and processes for achieving the essential functions at the lowest life cycle cost while maintaining required performance, reliability, availability, quality, and safety. VE has proven to be a superior tool to improve up-front project planning, cut costs, and create a better value for each dollar spent. This document forms the basis for the Environmental Restoration VE Program, describes the VE process, and provides recommendations on when it can be most useful on ER projects.

  14. 76 FR 26177 - National Organic Program: Notice of Final Guidance for Accredited Certifying Agents and Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... on five draft guidance documents (75 FR 62693). The topics covered in the draft documents addressed... Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs is to ensure that... Service 7 CFR Part 205 National Organic Program: Notice of Final Guidance for Accredited Certifying...

  15. 75 FR 22812 - Guidance for Industry on Tobacco Health Document Submission; Availability; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... April 20, 2010 (75 FR 20606). The notice announced the availability of a guidance entitled ``Tobacco.... SUPPLEMENTARY INFORMATION: In FR Doc. 2010-9134, appearing on page 20606, in the Federal Register of Tuesday... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Tobacco Health Document...

  16. Codes and standards and other guidance cited in regulatory documents

    SciTech Connect

    Nickolaus, J.R.; Bohlander, K.L.

    1996-08-01

    As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800).

  17. Transmission line environmental assessment guidance document

    SciTech Connect

    Jackson, J.; Pentecost, E.; Muzzarelli, J.

    1994-01-01

    Since 1939, U.S. utility companies have been required to obtain a Presidential Permit to construct electric transmission lines that cross a U.S. border and connect with a foreign utility. The purpose of this document is to provide Presidential Permit applicants with two types of guidance: (1) on the type of environmental and project descriptive information needed to assess the potential impacts of the proposed and alternative actions and (2) on compliance with applicable federal and state regulations. The main three chapters present information on the purpose and content of this document (Chapter 1); legislative, regulatory, and consultation requirements for transmission line interconnect projects (Chapter 2); and identification of basic transmission system design parameters and environmental data requirements for analysis of potential impacts of the proposed action (Chapter 3). Chapter 3 also includes information on possible techniques or measures to mitigate impacts. Appendix A presents an overview of NEPA requirements and DOE`s implementing procedures. Appendix B summarizes information on legislation that may be applicable to transmission line projects proposed in Presidential Permit applications.

  18. Transition to Postsecondary: New Documentation Guidance for Access to Accommodations

    ERIC Educational Resources Information Center

    Klotz, Mary Beth

    2012-01-01

    The Association on Higher Education and Disability (AHEAD) recently developed a conceptual framework that substantially revises its guidance for disability documentation for accommodations in higher education settings. This new document, "Supporting Accommodation Requests: Guidance on Documentation Practices," was written in response to the…

  19. 75 FR 9607 - National Protection and Programs Directorate; Guidance Document Request and Evaluation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-03

    ... SECURITY National Protection and Programs Directorate; Guidance Document Request and Evaluation AGENCY... guidance document request form and the guidance document evaluation form will help OEC stakeholders to... stakeholders. OEC will use the evaluation information for continuous improvement to its documents....

  20. TECHNICAL GUIDANCE DOCUMENT: THE FABRICATION OF POLYETHYLENE FML FIELD SEAMS

    EPA Science Inventory

    This technical guidance document is meant to augment the numerous construction quality control and construction assurance (CQC and CQA) guidelines that are presently available for high density polyethylene (HDPE) liner installation and inspection.

  1. Guidance document for structured reporting of diuresis renography.

    PubMed

    Taylor, Andrew T; Blaufox, M Donald; De Palma, Diego; Dubovsky, Eva V; Erbaş, Belkis; Eskild-Jensen, Anni; Frøkiær, Jørgen; Issa, Muta M; Piepsz, Amy; Prigent, Alain

    2012-01-01

    This Guidance Document for structured reporting of diuresis renography in adults was developed by the International Scientific Committee of Radionuclides in Nephro-urology (ISCORN; http://www.iscorn.org). ISCORN chose diuresis renography for its first structured report Guidance Document because suspected obstruction is the most common reason for referral, most radionuclide renal studies are conducted at institutions that perform fewer than 3 studies per week, and a large percentage of studies are interpreted by physicians with limited training in nuclear medicine. Ten panelists were asked to categorize specific reporting elements as essential, recommended, optional (without sufficient data to support a higher ranking), and unnecessary (does not contribute to scan interpretation or quality assurance). The final document was developed through an iterative series of comments and questionnaires with a majority vote required to place an element in a specific category. The Guidance Document recommends a reporting structure organized into indications, clinical history, study procedure, findings and impression and specifies the elements considered essential or recommended in each category. The Guidance Document is not intended to be restrictive but, rather, to provide a basic structure and rationale so that the diuresis renography report will: (1) communicate the results to the referring physician in a clear and concise manner designed to optimize patient care; (2) contain the essential elements required to evaluate and interpret the study; (3) clearly document the technical components of the study necessary for accountability, quality assurance and reimbursement; and (4) encourage clinical research by facilitating better comparison and extrapolation of results between institutions.

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

    NASA Technical Reports Server (NTRS)

    Hayhurst, Kelly J. (Editor)

    2008-01-01

    The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the development documents from the GCS project. Volume 2 contains three appendices: A. Guidance and Control Software Development Specification; B. Design Description for the Pluto Implementation of the Guidance and Control Software; and C. Source Code for the Pluto Implementation of the Guidance and Control Software

  3. Guidance document publications list - Office of Environmental Policy and Assistance RCRA/CERCLA Division (EH-413)

    SciTech Connect

    1995-08-01

    This document provides a listing of Guidance Documents from the RCRA/CERCLA Division for August 1995. Documents are listed under the following categories: RCRA Guidance Manuals; RCRA Information Briefs; CERCLA Guidance Manuals; CERCLA Regulatory Bulletins; RCRA/CERCLA Guidance Manuals; TSCA Guidance Manuals; TSCA Information Briefs; and, Cross Cut Manuals.

  4. Guidance and Control Software Project Data - Volume 1: Planning Documents

    NASA Technical Reports Server (NTRS)

    Hayhurst, Kelly J. (Editor)

    2008-01-01

    The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the planning documents from the GCS project. Volume 1 contains five appendices: A. Plan for Software Aspects of Certification for the Guidance and Control Software Project; B. Software Development Standards for the Guidance and Control Software Project; C. Software Verification Plan for the Guidance and Control Software Project; D. Software Configuration Management Plan for the Guidance and Control Software Project; and E. Software Quality Assurance Activities.

  5. Guidance and Control Software Project Data - Volume 3: Verification Documents

    NASA Technical Reports Server (NTRS)

    Hayhurst, Kelly J. (Editor)

    2008-01-01

    The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the verification documents from the GCS project. Volume 3 contains four appendices: A. Software Verification Cases and Procedures for the Guidance and Control Software Project; B. Software Verification Results for the Pluto Implementation of the Guidance and Control Software; C. Review Records for the Pluto Implementation of the Guidance and Control Software; and D. Test Results Logs for the Pluto Implementation of the Guidance and Control Software.

  6. 76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ... produced within two working days of a request (62 FR 16370). FMCSA rescinds that interpretation and motor... or documents Rescind existing Questions 1 and 2 (62 FR 16370), retain existing Questions 3 and 4... of losing or altering data). Today's guidance establishes parity between paper and electronic...

  7. 75 FR 68009 - Office of New Reactors; Notice of Availability of the Final Staff Guidance Standard Review Plan...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ... COMMISSION Office of New Reactors; Notice of Availability of the Final Staff Guidance Standard Review Plan... (Agencywide Documents Access and Management System (ADAMS) Accession No. ML102230082). The NRC staff issues revisions to SRP sections to facilitate timely implementation of the current staff guidance and...

  8. TECHNICAL GUIDANCE DOCUMENT: QUALITY ASSURANCE AND QUALITY CONTROL FOR WASTE CONTAINMENT FACILITIES

    EPA Science Inventory

    This Technical Guidance Document provides comprehensive guidance on procedures for quality assurance and quality control for waste containment facilities. The document includes a discussion of principles and concepts, compacted soil liners, soil drainage systems, geosynthetic dr...

  9. 75 FR 20606 - Guidance for Industry on Tobacco Health Document Submission; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-20

    ... (74 FR 68629), FDA announced the availability of a draft guidance entitled ``Tobacco Health Document... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Tobacco Health Document Submission... Administration (FDA) is announcing the availability of a guidance entitled ``Tobacco Health Document...

  10. Codes and standards and other guidance cited in regulatory documents. Revision 1

    SciTech Connect

    Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R.

    1994-08-01

    As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800).

  11. 75 FR 24718 - Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Documenting Statistical Analysis...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 197 entitled ``Documenting Statistical Analysis Programs and Data Files.'' This guidance is provided to...

  12. Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document

    PubMed Central

    2014-01-01

    Background There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. Methods The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. Results Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design. PMID:24885146

  13. 75 FR 2145 - Draft Guidance for Industry on Tobacco Health Document Submission; Availability; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... Register of December 28, 2009 (74 FR 68629). The notice announced the availability of a draft guidance...., Rockville, MD 20850-3229, 240-276-1717, May.Nelson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In FR Doc. E9... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Tobacco Health...

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

    EPA Science Inventory

    This Technical Guidance Document is intended to augment the numerous construction quality control and construction quality assurance (CQC and CQA) documents that are available far materials associated with waste containment systems developed for Superfund site remediation. In ge...

  15. 75 FR 359 - Guidance on Simultaneous Transmission Import Limit Studies; Notice Allowing Post-Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Guidance on Simultaneous Transmission Import Limit Studies; Notice Allowing... provide guidance for performing Simultaneous Transmission Import Limit (SIL) studies. All...

  16. 75 FR 32860 - Regulatory Guidance Concerning the Preparation of Drivers' Record of Duty Status To Document...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ..., 1997 (62 FR 16370, 16408), FMCSA published ``Regulatory Guidance for the Federal Motor Carrier Safety... original handwritten record, and subsequent electronic submission to the motor carrier of a scanned image... electronic scanned electronic image along with any supporting documents. ] The guidance is applicable to...

  17. Targetting and guidance program documentation. [a user's manual

    NASA Technical Reports Server (NTRS)

    Harrold, E. F.; Neyhard, J. F.

    1974-01-01

    A FORTRAN computer program was developed which automatically targets two and three burn rendezvous missions and performs feedback guidance using the GUIDE algorithm. The program was designed to accept a large class of orbit specifications and to automatically choose a two or three burn mission depending upon the time alignment of the vehicle and target. The orbits may be specified as any combination of circular and elliptical orbits and may be coplanar or inclined, but must be aligned coaxially with their perigees in the same direction. The program accomplishes the required targeting by repeatedly converging successively more complex missions. It solves the coplanar impulsive version of the mission, then the finite burn coplanar mission, and finally, the full plane change mission. The GUIDE algorithm is exercised in a feedback guidance mode by taking the targeted solution and moving the vehicle state step by step ahead in time, adding acceleration and navigational errors, and reconverging from the perturbed states at fixed guidance update intervals. A program overview is presented, along with a user's guide which details input, output, and the various subroutines.

  18. 77 FR 63355 - Proposed Revision to Emergency Action Level Development Guidance Document

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-16

    ... revision to the Nuclear Energy Institute (NEI) 99-01, proposed Revision 6, ``Development of Emergency... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Proposed Revision to Emergency Action Level Development Guidance Document AGENCY:...

  19. 78 FR 48175 - Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ..., gonorrhea, Lyme disease, streptococcal pharyngitis and tonsillitis, uncomplicated urinary tract infections... Neutropenia--Developing Antimicrobial Drugs for Treatment''--issued July 1998. 7. ``Lyme Disease--Developing... ``Administrative Practices and Procedures; Good Guidance Practices'' (GGP) (65 FR 56468; September 19, 2000)....

  20. Guidance Document for PMF Applications with the Multilinear Engine

    EPA Science Inventory

    This document serves as a guide for users of the Multilinear Engine version 2 (ME-2) for source apportionment applications utilizing positive matrix factorization (PMF). It aims to educate experienced source apportionment analysts on available ME rotational tools and provides gui...

  1. 75 FR 35510 - License Renewal Interim Staff Guidance Process, Revision 2 Notice of Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... COMMISSION License Renewal Interim Staff Guidance Process, Revision 2 Notice of Availability AGENCY: Nuclear... license renewal interim staff guidance (LR-ISG) process. This revision is entitled, ``License Renewal Interim Staff Guidance Process, Revision 2'' (revised LR-ISG process). The LR-ISG process describes...

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

    NASA Technical Reports Server (NTRS)

    Hayhurst, Kelly J. (Editor)

    2008-01-01

    The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes configuration management and quality assurance documents from the GCS project. Volume 4 contains six appendices: A. Software Accomplishment Summary for the Guidance and Control Software Project; B. Software Configuration Index for the Guidance and Control Software Project; C. Configuration Management Records for the Guidance and Control Software Project; D. Software Quality Assurance Records for the Guidance and Control Software Project; E. Problem Report for the Pluto Implementation of the Guidance and Control Software Project; and F. Support Documentation Change Reports for the Guidance and Control Software Project.

  3. Announcement—guidance document for acquiring reliable data in ecological restoration projects

    USGS Publications Warehouse

    Stapanian, Martin A.; Rodriguez, Karen; Lewis, Timothy E.; Blume, Louis; Palmer, Craig J.; Walters, Lynn; Schofield, Judith; Amos, Molly M.; Bucher, Adam

    2016-01-01

    The Laurentian Great Lakes are undergoing intensive ecological restoration in Canada and the United States. In the United States, an interagency committee was formed to facilitate implementation of quality practices for federally funded restoration projects in the Great Lakes basin. The Committee's responsibilities include developing a guidance document that will provide a common approach to the application of quality assurance and quality control (QA/QC) practices for restoration projects. The document will serve as a “how-to” guide for ensuring data quality during each aspect of ecological restoration projects. In addition, the document will provide suggestions on linking QA/QC data with the routine project data and hints on creating detailed supporting documentation. Finally, the document will advocate integrating all components of the project, including QA/QC applications, into an overarching decision-support framework. The guidance document is expected to be released by the U.S. EPA Great Lakes National Program Office in 2017.

  4. Impact of guidance documents on translational large animal studies of cartilage repair.

    PubMed

    Pfeifer, Christian G; Fisher, Matthew B; Carey, James L; Mauck, Robert L

    2015-10-21

    Promising therapies for cartilage repair are translated through large animal models toward human application. To guide this work, regulatory agencies publish recommendations ("guidance documents") to direct pivotal large animal studies. These are meant to aid in study design, outline metrics for judging efficacy, and facilitate comparisons between studies. To determine the penetrance of these documents in the field, we synthesized the recommendations of the American Society for Testing and Materials, U.S. Food and Drug Administration, and European Medicines Agency into a scoring system and performed a systematic review of the past 20 years of preclinical cartilage repair studies. Our hypothesis was that the guidance documents would have a significant impact on how large animal cartilage repair studies were performed. A total of 114 publications meeting our inclusion criteria were reviewed for adherence to 24 categories extracted from the guidance documents, including 11 related to study design and description and 13 related to study outcomes. Overall, a weak positive trend was observed over time (P = 0.004, R(2) = 0.07, slope = 0.63%/year), with overall adherence (the sum of study descriptors and outcomes) ranging from 32 ± 16% to 58 ± 14% in any individual year. There was no impact of the publication of the guidance documents on adherence (P = 0.264 to 0.50). Given that improved adherence would expedite translation, we discuss the reasons for poor adherence and outline approaches to increase and promote their more widespread adoption.

  5. 12 CFR 1024.3 - Questions or suggestions from public and copies of public guidance documents.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 8 2012-01-01 2012-01-01 false Questions or suggestions from public and copies of public guidance documents. 1024.3 Section 1024.3 Banks and Banking BUREAU OF CONSUMER FINANCIAL PROTECTION REAL ESTATE SETTLEMENT PROCEDURES ACT (REGULATION X) § 1024.3 Questions or suggestions from...

  6. 12 CFR 1024.3 - Questions or suggestions from public and copies of public guidance documents.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 8 2013-01-01 2013-01-01 false Questions or suggestions from public and copies of public guidance documents. 1024.3 Section 1024.3 Banks and Banking BUREAU OF CONSUMER FINANCIAL PROTECTION REAL ESTATE SETTLEMENT PROCEDURES ACT (REGULATION X) § 1024.3 Questions or suggestions from...

  7. TECHNICAL APPROACHES TO CHARACTERIZING AND CLEANING UP BROWNFIELDS SITES: GUIDANCE DOCUMENT

    EPA Science Inventory

    NRMRL-CIN-1741 SAIC. Technical Approaches to Characterizing and Cleaning up Brownfields Sites. EPA/625/R/00/009 (NTIS PB2002-105021) , Available: 68-C7-0011. The guidance document gives assistance to communities, decision-makers, states and municipalities, academia, and the p...

  8. 75 FR 62693 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents and Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

    ... Budget (OMB) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The... Agricultural Marketing Service 7 CFR Part 205 National Organic Program: Notice of Draft Guidance for Accredited... availability with request for comments. SUMMARY: The National Organic Program (NOP) is announcing...

  9. 78 FR 19637 - National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ...) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials for Organic Crop Production AGENCY:...

  10. Equipment design guidance document for flammable gas waste storage tank new equipment

    SciTech Connect

    Smet, D.B.

    1996-04-11

    This document is intended to be used as guidance for design engineers who are involved in design of new equipment slated for use in Flammable Gas Waste Storage Tanks. The purpose of this document is to provide design guidance for all new equipment intended for application into those Hanford storage tanks in which flammable gas controls are required to be addressed as part of the equipment design. These design criteria are to be used as guidance. The design of each specific piece of new equipment shall be required, as a minimum to be reviewed by qualified Unreviewed Safety Question evaluators as an integral part of the final design approval. Further Safety Assessment may be also needed. This guidance is intended to be used in conjunction with the Operating Specifications Documents (OSDs) established for defining work controls in the waste storage tanks. The criteria set forth should be reviewed for applicability if the equipment will be required to operate in locations containing unacceptable concentrations of flammable gas.

  11. 77 FR 5415 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents, Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-03

    ... Budget (OMB) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The...; ] 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...

  12. 59 FR- Human Health and Environmental Risk Ranking; Notice of Availability of Proceedings Document from...

    Federal Register 2010, 2011, 2012, 2013, 2014

    1994-08-30

    ... AGENCY Human Health and Environmental Risk Ranking; Notice of Availability of Proceedings Document from Relative Risk Ranking Conference AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of Availability. SUMMARY: EPA is announcing the availability of a document entitled ``Proceedings...

  13. 46 CFR 502.226 - Decision based on official notice; public documents.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 9 2014-10-01 2014-10-01 false Decision based on official notice; public documents. 502... based on official notice; public documents. (a) Official notice may be taken of such matters as might be... contrary. (b) Whenever there is offered in evidence (in whole or in part) a public document, such as...

  14. Development of a guidance document for lightning protection of DOE facilities

    SciTech Connect

    Hasbrouck, R.T.; Majumdar, K.C.

    1995-12-01

    The authors are developing a guidance document for the lightning protection of US Department of Energy (DOE) facilities to satisfy the requirements of the department`s order DOE 5480.28, Natural Phenomena Hazards (NPH) Mitigation Performance Goals for Structures, Systems and Components (SSCs). This order specifies a systematic process of well defined and integrated design and evaluation criteria for the protection of SSCs. The document introduces the idea of Lightning Hazard Management because there is no single document that presents a unified approach to lightning protection. Earlier versions of the US National Fire Protection Association (NFPA) Code, Lightning Protection, NFPA-78, only addressed the protection of structures. This is also true of the International Lightning Protection Standard, IEC-1024 and the Underwriters Laboratories recently issued Standard for Safety, Lightning Protection Components, UL 96.

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

    SciTech Connect

    Roberts, Jesse D.; Jason Magalen; Craig Jones

    2014-06-01

    This guidance document provide s the reader with an overview of the key environmental considerations for a typical offshore wind coastal location and the tools to help guide the reader through a thoro ugh planning process. It will enable readers to identify the key coastal processes relevant to their offshore wind site and perform pertinent analysis to guide siting and layout design, with the goal of minimizing costs associated with planning, permitting , and long - ter m maintenance. The document highlight s site characterization and assessment techniques for evaluating spatial patterns of sediment dynamics in the vicinity of a wind farm under typical, extreme, and storm conditions. Finally, the document des cribe s the assimilation of all of this information into the conceptual site model (CSM) to aid the decision - making processes.

  16. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

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

  17. 77 FR 36533 - Notice of Availability of the Benchmark Dose Technical Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-19

    ... conducted workshops and symposia about the application of BMD methodology and the development of relevant guidance. The BMD document focuses on the use of the BMD methodology for human health risk assessments. The... of an agency-wide guidance development program by a technical panel of the EPA's Risk...

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

    EPA Science Inventory

    The development of this anaerobic digester (AD) foaming guidance document is based on the need for a specific detailed methodology that water resource recovery facilities (WRRF) personnel can follow and implement to manage or mitigate AD foam incidents. This guidance manual is th...

  19. Development of a guidance document for lightning protection of DOE facilities

    SciTech Connect

    Hasbrouck, R.T.; Majumdar, K.C.

    1995-02-06

    The purpose of this guidance document is to introduce Lighting Hazard Management, a unified approach that combines hazard identification and facility categorization (not discussed in this paper) with a new concept -- the Lighting Safety System. We do not intend to develop a brand new lightning code or standard, but rather reference other codes, standards and guides that we determine to be applicable. Using the graded approach to systematic risk management allows for in-depth protection and aids in ensuring personnel safety and optimizing resource protection.

  20. Publication of OIG compliance program guidance for clinical laboratories--HHS. Notice.

    PubMed

    1998-08-24

    This Federal Register notice sets forth the OIG's recently-issued Compliance Program Guidance for Clinical Laboratories. The OIG had previously developed and published a model compliance plan for the clinical laboratory industry on March 3, 1997. This Compliance Program Guidance for Clinical Laboratories is intended to be more consistent with compliance program guidances issued by the OIG with respect to the hospital industry and to home health agencies, and serves to clarify various aspects of the original model plan. As with previously-issued compliance program guidances, we believe that the development of this guidance for clinical laboratories will continue as a positive step towards promoting a higher level of ethical and lawful conduct throughout the entire health care community.

  1. International Conference on Harmonisation; Guidance on Q11 Development and Manufacture of Drug Substances; availability. Notice.

    PubMed

    2012-11-20

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q11 Development and Manufacture of Drug Substances.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products. PMID:23227566

  2. 77 FR 64531 - Notice of Availability of Guidance for Protecting Responders' Health During the First Week...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... Responders' Health During the First Week Following a Wide-Area Anthrax Attack.'' 74 FR 55246. DHS solicited... Following a Wide-Area Aerosol Anthrax Attack AGENCY: Office of Health Affairs, DHS. ACTION: Notice of... Anthrax Attack. This guidance provides recommendations for protecting personnel responding to a...

  3. 76 FR 13444 - Advisory Committee on Historical Diplomatic Documentation; Notice of Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-11

    ... Committee on Historical Diplomatic Documentation; Notice of Charter Renewal The Advisory Committee on Historical Diplomatic Documentation is renewing its charter for a period of two years. This Advisory..., Executive Secretary, Advisory Committee on Historical Diplomatic Documentation, Department of State,...

  4. 78 FR 12134 - Advisory Committee on Historical Diplomatic Documentation; Notice of Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... Committee on Historical Diplomatic Documentation; Notice of Charter Renewal The Advisory Committee on Historical Diplomatic Documentation is renewing its charter for a period of two years. This Advisory..., Executive Secretary, Advisory Committee on Historical Diplomatic Documentation, Department of State,...

  5. An Analysis of Documents from State Departments of Education Relating to Comprehensive Career Guidance Programs and of FY 1974 and 1975 Part C Project Documents Relating to Guidance. Research and Development Series No. 133.

    ERIC Educational Resources Information Center

    Vetter, Louise; Ransom, Robert M.

    Fifty states and Washington, D.C., were invited to submit documents for an analysis relating to comprehensive career guidance programs (CCGP). These documents were prepared by state departments of education and directors of FY 1974 and 1975 projects funded through the Vocational Education Research Program under Section 131 of Part C of the…

  6. 76 FR 61098 - Guidance for 1-Hour SO2

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

    ...Notice is hereby given that the EPA has posted its draft non- binding guidance titled, ``Guidance for 1-Hour SO2 NAAQS SIP Submissions'' on its Web site. The EPA invites public comments on this guidance document during the comment period specified below, and plans to issue an updated version of the guidance after reviewing timely submitted...

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

    SciTech Connect

    Kudera, D.E.; McMurtrey, C.D.; Meagher, B.G.

    1993-04-01

    This document provides guidance for the revision of DOE Order 5820.2A, ``Radioactive Waste Management.`` Technical Working Groups have been established and are responsible for writing the revised order. The Technical Working Groups will use this document as a reference for polices and procedures that have been established for the revision process. The overall intent of this guidance is to outline how the order will be revised and how the revision process will be managed. In addition, this document outlines technical issues considered for inclusion by a Department of Energy Steering Committee.

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

    NASA Technical Reports Server (NTRS)

    Walton, Marlei; Mulugeta, Lealem; Nelson, Emily S.; Myers, Jerry G.

    2014-01-01

    Rigorous verification, validation, and credibility (VVC) processes are imperative to ensure that models and simulations (MS) are sufficiently reliable to address issues within their intended scope. The NASA standard for MS, NASA-STD-7009 (7009) [1] was a resultant outcome of the Columbia Accident Investigation Board (CAIB) to ensure MS are developed, applied, and interpreted appropriately for making decisions that may impact crew or mission safety. Because the 7009 focus is engineering systems, a NASA-STD-7009 Guidance Document is being developed to augment the 7009 and provide information, tools, and techniques applicable to the probabilistic and deterministic biological MS more prevalent in human health and performance (HHP) and space biomedical research and operations.

  9. 78 FR 14791 - Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-07

    ..., Plant, and Equipment Cost Accumulation, Assignment, and Allocation. The Exposure Draft is available on... ADVISORY BOARD Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and Equipment Cost Accumulation, Assignment, and Allocation AGENCY: Federal Accounting...

  10. 75 FR 76482 - Notice of Web Availability and Opportunity for Public Comment on Updated Guidance for the Section...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-08

    ... the Section 202 Supportive Housing for the Elderly and Section 811 Supportive Housing for Persons With... of a draft notice updating HUD's guidance for the Section 202 Supportive Housing for the Elderly...

  11. Publication of the OIG compliance program guidance for home health agencies--OIG. Notice.

    PubMed

    1998-08-01

    This Federal Register notice sets forth the recently issued Compliance Program Guidance for Home Health Agencies developed by the Office of Inspector General (OIG) in cooperation with, and with input from, several provider groups and industry representatives. Many home health care providers have expressed interest in better protecting their operations from fraud and abuse through the adoption of a voluntary compliance program. The OIG has previously developed and published compliance program guidances focused on the clinical laboratory and hospital industries (62 FR 9435, March 3, 1997 and 63 FR 8987, February 23, 1998, respectively). We believe that the development of this compliance program guidance for the home health industry will continue as a positive step towards promoting a higher level of ethical and lawful conduct throughout the entire health care community.

  12. Publication of the OIG compliance program guidance for hospitals--OIG. Notice.

    PubMed

    1998-02-23

    This Federal Register notice sets forth the recently issued compliance program guidance for hospitals developed by the Office of Inspector General (OIG) in cooperation with, and with input from, several provider groups and industry representatives. Many providers and provider organizations have expressed an interest in better protecting their operations from fraud and abuse through the adoption of voluntary compliance programs. The first compliance guidance, addressing clinical laboratories, was prepared by the OIG and published in the Federal Register on March 3, 1997. We believe the development of this second program guidance, for hospitals, will continue as a positive step towards promoting a higher level of ethical and lawful conduct throughout the health care industry.

  13. 75 FR 68009 - Office of New Reactors; Notice of Availability of the Final Staff Guidance Standard Review Plan...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ... COMMISSION Office of New Reactors; Notice of Availability of the Final Staff Guidance Standard Review Plan... System (ADAMS) Accession No. ML102571602). The NRC staff issues revisions to SRP sections to facilitate timely implementation of the current staff guidance and to facilitate reviews to amendments to...

  14. 76 FR 22662 - Notice of Intent To Apply Certain Supervisory Guidance to Savings and Loan Holding Companies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-22

    ... Board Supervision and Regulation (SR) letter 04-18, ``Bank Holding Company Rating System,'' and 69 FR... rating system guidance and policies may be necessary to accommodate SLHCs and differences in their... Chapter II Notice of Intent To Apply Certain Supervisory Guidance to Savings and Loan Holding...

  15. 75 FR 68009 - Office of New Reactors; Notice of Availability of the Final Staff Guidance Standard Review Plan...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ... COMMISSION Office of New Reactors; Notice of Availability of the Final Staff Guidance Standard Review Plan... Management System (ADAMS) Accession No. ML102510273). The NRC staff issues revisions to SRP sections to facilitate timely implementation of the current staff guidance and to facilitate reviews to amendments...

  16. 78 FR 55282 - Federal Housing Administration (FHA) Healthcare Facility Documents: Notice of Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... URBAN DEVELOPMENT Federal Housing Administration (FHA) Healthcare Facility Documents: Notice of... published in the Federal Register a notice that announced that FHA's healthcare facility documents completed... concluded a 10-month process through which HUD solicited public comment to update 115 healthcare...

  17. 78 FR 56719 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... 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; Extension of Comment Period AGENCY: Food and Drug...

  18. 78 FR 42086 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    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....

  19. Asbestos-Containing Materials in School Buildings: A Guidance Document. Part 1.

    ERIC Educational Resources Information Center

    Environmental Protection Agency, Washington, DC. Office of Toxic Substances.

    The Environmental Protection Agency (EPA) has worked with the states to develop a program for accurate information and guidance to deal with the problem of school buildings constructed with asbestos-containing materials. This is the first of two guidance manuals that are a major part of this program and are being mailed to all public school…

  20. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of... for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA requested comments on draft guidance documents for 11 neurological and physical medicine...

  1. 78 FR 49280 - 30-Day Notice of Proposed Information Collection: Third-Party Documentation Facsimile Transmittal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Third-Party Documentation Facsimile..., 2013. A. Overview of Information Collection Title of Information Collection: Third-Party Documentation... of the need for the information and proposed use: The use of the Third-Party Documentation...

  2. 47 CFR 0.422 - Current action documents and public notices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 1 2011-10-01 2011-10-01 false Current action documents and public notices. 0.422 Section 0.422 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION General Information Forms and Documents Available Upon Request § 0.422 Current action documents and...

  3. 47 CFR 0.422 - Current action documents and public notices.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 1 2012-10-01 2012-10-01 false Current action documents and public notices. 0.422 Section 0.422 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION General Information Forms and Documents Available Upon Request § 0.422 Current action documents and...

  4. 47 CFR 0.422 - Current action documents and public notices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Current action documents and public notices. 0.422 Section 0.422 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION General Information Forms and Documents Available Upon Request § 0.422 Current action documents and...

  5. 47 CFR 0.422 - Current action documents and public notices.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 1 2014-10-01 2014-10-01 false Current action documents and public notices. 0.422 Section 0.422 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION General Information Forms and Documents Available Upon Request § 0.422 Current action documents and...

  6. 47 CFR 0.422 - Current action documents and public notices.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 1 2013-10-01 2013-10-01 false Current action documents and public notices. 0.422 Section 0.422 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION General Information Forms and Documents Available Upon Request § 0.422 Current action documents and...

  7. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

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

  8. 15 CFR 904.3 - Filing and service of notices, documents, and other papers.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... papers. (a) Service of a NOVA (§ 904.101), NOPS (§ 904.302), NIDP (§ 904.303), Notice of Proposed... upon personal delivery. (c) Whenever this part requires service of a NOVA, NOPS, NIDP, document,...

  9. 15 CFR 904.3 - Filing and service of notices, documents, and other papers.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... papers. (a) Service of a NOVA (§ 904.101), NOPS (§ 904.302), NIDP (§ 904.303), Notice of Proposed... upon personal delivery. (c) Whenever this part requires service of a NOVA, NOPS, NIDP, document,...

  10. 15 CFR 904.3 - Filing and service of notices, documents, and other papers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... papers. (a) Service of a NOVA (§ 904.101), NOPS (§ 904.302), NIDP (§ 904.303), Notice of Proposed... upon personal delivery. (c) Whenever this part requires service of a NOVA, NOPS, NIDP, document,...

  11. 15 CFR 904.3 - Filing and service of notices, documents, and other papers.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... papers. (a) Service of a NOVA (§ 904.101), NOPS (§ 904.302), NIDP (§ 904.303), Notice of Proposed... upon personal delivery. (c) Whenever this part requires service of a NOVA, NOPS, NIDP, document,...

  12. 15 CFR 904.3 - Filing and service of notices, documents, and other papers.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... papers. (a) Service of a NOVA (§ 904.101), NOPS (§ 904.302), NIDP (§ 904.303), Notice of Proposed... upon personal delivery. (c) Whenever this part requires service of a NOVA, NOPS, NIDP, document,...

  13. 76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It... traceability of electronic source data and source records maintained at the site for FDA inspection....

  14. Space shuttle GN and C equation document: Entry and transition guidance

    NASA Technical Reports Server (NTRS)

    Marcus, F. J.

    1973-01-01

    The entry-guidance routine presented is designed to take the orbiter vehicle from entry interface through the critical heating phase of entry down to the start of the approach phase. The material includes: (1) a functional flow diagram, (2) input and output variables, (3) a description of equations, and (4) detailed flow diagrams.

  15. Asbestos-Containing Materials in School Buildings: A Guidance Document. Part 2.

    ERIC Educational Resources Information Center

    Sawyer, Robert N.; Spooner, Charles M.

    Part 2 of the Environmental Protection Agency (EPA) guidance manuals consists of more detailed information on asbestos identification and control methods. Available information on sprayed asbestos-containing materials in buildings is summarized. Guidelines are presented for the detection and monitoring, removal or encapsulation, and disposal of…

  16. 78 FR 36507 - Notice of Availability of a Treatment Evaluation Document; Methyl Bromide Fumigation of Blueberries

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ... Animal and Plant Health Inspection Service Notice of Availability of a Treatment Evaluation Document... to immediately add to the Plant Protection and Quarantine Treatment Manual an additional treatment... fly. We have prepared a treatment evaluation document that describes the new treatment schedule...

  17. 76 FR 20688 - Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... Supplements for Manufacturing Method or Process Changes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration...

  18. Solicitation of information and recommendations for developing OIG compliance program guidance for the durable medical equipment industry--HHS. Notice.

    PubMed

    1998-08-01

    This Federal Register notice seeks the input and recommendations of interested parties into the OIG's development of a compliance program guidance for the durable medical equipment (DME) industry, its providers and suppliers. Many providers and provider organizations have expressed an interest in better protecting their operations from fraud and abuse. Previously, the OIG has developed compliance program guidances for hospitals, clinical laboratories and home health agencies. In order to provide clear and meaningful guidance to those segments of the health care industry involved in the supply and distribution of DME, we are soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop compliance program guidance and reduce fraud and abuse within the DME industry.

  19. Technical guidance document for environmental requirements of commercial OTEC licensing regulations (15 CFR Part 981)

    SciTech Connect

    Not Available

    1981-09-01

    This document provides a potential OTEC applicant with the insights believed needed to satisfy the environmental information requirements of the regulations for licensing commercial OTEC facilities and plantships. This information should be used by applicants to define the site-specific details of the needed environmental assessment, and the details should then form a basis for pre-application consultations on the environmental requirements.

  20. SEDIMENT TOXICITY IDENTIFICATION EVALUATION (TIE)PHASE I,II,III GUIDANCE DOCUMENT

    EPA Science Inventory

    Sediment contamination in the United States has been amply documented and, in order to comply with the 1972 Clean Water Act, the U.S. Environmental Protection Agency must address the issue of toxic sediments. Contaminated sediments from a number of freshwater and marine sites hav...

  1. The Role of Reference Condition in Biological Assessment and Criteria: An EPA Guidance Document

    NASA Astrophysics Data System (ADS)

    Southerland, M. T.; Larsen, D. P.; Davis, W. S.

    2005-05-01

    The U.S. Environmental Protection Agency is preparing a document to provide States, Tribes, and other practitioners with guidelines on the reference condition concept and how to apply it in their water management programs, particularly for assessing the condition of aquatic resources. These guidelines are intended to broaden the implementation of biological monitoring and assessment, to increase the consistency among States and Tribes, and to improve the success of individual programs. Establishing and using the reference condition concept appropriately is critical to implementing biocriteria and tiered aquatic life uses to protect and restore water resource quality. This document will cover the following topics: a description of the concept of reference condition and related concepts (including minimally disturbed, least disturbed, and attainable conditions); methods for characterizing reference and related conditions; the role of water body classification to partition natural variability; setting thresholds to determine achievement of a target condition; and application of the concept in heavily modified regions (e.g., urban landscapes; agricultural regions) and waterbodies (reservoirs, regulated rivers). A section on frequently asked questions and answers is included. Throughout the document, examples are drawn from existing State and Tribal programs to illustrate specific applications that are consistent with the guidelines.

  2. The 2015 IWGDF guidance documents on prevention and management of foot problems in diabetes: development of an evidence-based global consensus.

    PubMed

    Bakker, K; Apelqvist, J; Lipsky, B A; Van Netten, J J

    2016-01-01

    Foot problems complicating diabetes are a source of major patient suffering and societal costs. Investing in evidence-based, internationally appropriate diabetic foot care guidance is likely among the most cost-effective forms of healthcare expenditure, provided it is goal-focused and properly implemented. The International Working Group on the Diabetic Foot (IWGDF) has been publishing and updating international Practical Guidelines since 1999. The 2015 updates are based on systematic reviews of the literature, and recommendations are formulated using the Grading of Recommendations Assessment Development and Evaluation system. As such, we changed the name from 'Practical Guidelines' to 'Guidance'. In this article we describe the development of the 2015 IWGDF Guidance documents on prevention and management of foot problems in diabetes. This Guidance consists of five documents, prepared by five working groups of international experts. These documents provide guidance related to foot complications in persons with diabetes on: prevention; footwear and offloading; peripheral artery disease; infections; and, wound healing interventions. Based on these five documents, the IWGDF Editorial Board produced a summary guidance for daily practice. The resultant of this process, after reviewed by the Editorial Board and by international IWGDF members of all documents, is an evidence-based global consensus on prevention and management of foot problems in diabetes. Plans are already under way to implement this Guidance. We believe that following the recommendations of the 2015 IWGDF Guidance will almost certainly result in improved management of foot problems in persons with diabetes and a subsequent worldwide reduction in the tragedies caused by these foot problems.

  3. 76 FR 72710 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-25

    ... July 16, 2010 (75 FR 41498), FDA published a notice of availability of the draft guidance document... Collection; Comment Request; Draft Guidance for Tobacco Retailers on Tobacco Retailer Training Programs... collection provisions of the draft guidance entitled ``Tobacco Retailer Training Programs.'' DATES:...

  4. 76 FR 72951 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... (74 FR 46433), FDA announced the availability of the draft guidance. Comments on the draft guidance... Differentiation of Human Papillomaviruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Differentiation of Human Papillomaviruses.'' This guidance document provides industry and Agency staff...

  5. 76 FR 24507 - HUD Multifamily Rental Project Closing Documents: Notice Announcing Final Approved Documents and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ...: I. Background On January 21, 2010 (75 FR 3544) and consistent with the Paperwork Reduction Act of... that had originally commenced on August 2, 2004. On December 22, 2010 (75 FR 80517), HUD published a 30... documents themselves, to which they are expected to adhere. The advantage of this language is that...

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

    SciTech Connect

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

    1990-11-01

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

  7. 7 CFR 2903.17 - Award document and notice of award.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 15 2011-01-01 2011-01-01 false Award document and notice of award. 2903.17 Section 2903.17 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF ENERGY POLICY AND NEW USES, DEPARTMENT OF AGRICULTURE BIODIESEL FUEL EDUCATION PROGRAM Award Administration §...

  8. 24 CFR 4.5 - Notice and documentation of assistance subject to section 102(a).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Notice and documentation of assistance subject to section 102(a). 4.5 Section 4.5 Housing and Urban Development Office of the Secretary, Department of Housing and Urban Development HUD REFORM ACT Accountability in the Provision of HUD...

  9. 7 CFR 2903.17 - Award document and notice of award.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Award document and notice of award. 2903.17 Section 2903.17 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF ENERGY POLICY AND NEW USES, DEPARTMENT OF AGRICULTURE BIODIESEL FUEL EDUCATION PROGRAM Award Administration §...

  10. 77 FR 31564 - Notice of Availability of a Treatment Evaluation Document; Methyl Bromide Fumigation of Cottonseed

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-29

    ... Federal Register on April 6, 2012 (77 FR 20752-20756), EPA proposed to reinstate the tolerance of methyl... Animal and Plant Health Inspection Service Notice of Availability of a Treatment Evaluation Document... add to the Plant Protection and Quarantine Treatment Manual a treatment schedule for methyl...

  11. 75 FR 52305 - Notice of Availability of a Treatment Evaluation Document

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-25

    ... Animal and Plant Health Inspection Service Notice of Availability of a Treatment Evaluation Document... public that we have determined that it is necessary to revise a treatment schedule in the Plant Protection and Quarantine Treatment Manual and to retain the current treatment schedule with a...

  12. 77 FR 69915 - Advisory Committee on Historical Diplomatic Documentation; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-21

    ... Historical Diplomatic Documentation's meeting location on December 10-11, 2012 has changed from that provided in the previous Federal Register Notice at 77 FR 5292, February 2, 2012. The new location will be at... to validate the identity of individuals who enter Department facilities. The data will be...

  13. 78 FR 9105 - Advisory Committee on Historical Diplomatic Documentation; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-07

    ... meeting of the Advisory Committee on Historical Diplomatic Documentation on February 25-26 has changed from that provided in the previous Federal Register Notice at 78 FR 1298, January 8, 2013. The...); and Executive Order 13356. The purpose of the collection is to validate the identity of...

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

    PubMed

    Debast, S B; Bauer, M P; Kuijper, E J

    2014-03-01

    In 2009 the first European Society of Clinical Microbiology and Infection (ESCMID) treatment guidance document for Clostridium difficile infection (CDI) was published. The guideline has been applied widely in clinical practice. In this document an update and review on the comparative effectiveness of the currently available treatment modalities of CDI is given, thereby providing evidence-based recommendations on this issue. A computerized literature search was carried out to investigate randomized and non-randomized trials investigating the effect of an intervention on the clinical outcome of CDI. The Grades of Recommendation Assessment, Development and Evaluation (GRADE) system was used to grade the strength of our recommendations and the quality of the evidence. The ESCMID and an international team of experts from 11 European countries supported the process. To improve clinical guidance in the treatment of CDI, recommendations are specified for various patient groups, e.g. initial non-severe disease, severe CDI, first recurrence or risk for recurrent disease, multiple recurrences and treatment of CDI when oral administration is not possible. Treatment options that are reviewed include: antibiotics, toxin-binding resins and polymers, immunotherapy, probiotics, and faecal or bacterial intestinal transplantation. Except for very mild CDI that is clearly induced by antibiotic usage antibiotic treatment is advised. The main antibiotics that are recommended are metronidazole, vancomycin and fidaxomicin. Faecal transplantation is strongly recommended for multiple recurrent CDI. In case of perforation of the colon and/or systemic inflammation and deteriorating clinical condition despite antibiotic therapy, total abdominal colectomy or diverting loop ileostomy combined with colonic lavage is recommended.

  15. Solicitation of information and recommendations for developing OIG compliance program guidance for certain Medicare+Choice organizations--OIG, HHS. Notice.

    PubMed

    1998-09-22

    This Federal Register notice seeks the input and recommendations of interested parties into the OIG's development of a compliance program guidance for Medicare+Choice organizations that offer coordinated care plans (M+CO/CCPs). The OIG has previously developed compliance program guidances for hospitals, clinical laboratories and home health agencies in order to provide clear and meaningful guidance to those segments of the health care industry. In an effort to provide similar guidance to certain M+C organizations, we are soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop compliance program guidance and reduce fraud and abuse within M+CO/CCPs.

  16. 75 FR 74734 - Guidance on Institutional Review Board Approval of Research With Conditions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-01

    ... OHRP's first formal guidance on this topic. The document, which is available on OHRP's Web site at http... notice in the Federal Register on November 6, 2009 (74 FR 57486). OHRP received comments on the draft guidance document from 12 individuals and organizations, and those comments were considered as the...

  17. 75 FR 18497 - Guidance on Simultaneous Transmission Import Limit Studies for the Northwest Region; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-12

    ... Energy Regulatory Commission Guidance on Simultaneous Transmission Import Limit Studies for the Northwest... in the Northwest region an opportunity to ask questions regarding the Simultaneous Transmission... on SIL studies \\1\\ and the December 16, 2009 Technical Conference ``Guidance on...

  18. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

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

    PubMed

    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.

  20. PR notice 86-5. Notice to producers, formulators, distributors and registrants

    SciTech Connect

    Not Available

    1986-07-01

    The document is one in the series of Pesticide Regulatory Notices, usually called PR Notices, which supplement the laws and regulations governing pesticide regulation in the US. These notices clarify, interpret and explain regulatory requirements and policies. They are directed at pesticide registrants and other parties interested in detailed procedures of regulation. The notice discusses data to be submitted to the Environmental Protection Agency (EPA) in a standard format. This Notice also provides additional guidance about, and illustrations of, the required formats.

  1. 75 FR 60494 - Notice of Proposed Guidance and Request for Comment on the Federal Transit Administration's...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-30

    ... Transit Administration's Research, Technical Assistance, and Training Programs: Application Instructions... proposes guidance in the form of a revised circular on the Federal Transit Administration's research..., ``Research, Technical Assistance, and Training Programs: Application Instructions and Program...

  2. 77 FR 13999 - Notice of Availability and Opportunity for Comments (Establishment Guidance for the Selection of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-08

    ...; ] DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service Notice of Availability and Opportunity for... Laboratory) AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice of availability and opportunity for comments. SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing the availability...

  3. 76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-20

    ...; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use... Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.'' This guidance document... ``Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use''...

  4. Documentation.

    ERIC Educational Resources Information Center

    Burt, Lorna; Lewandowski, Carol

    This workbook, designed for workplace literacy courses, contains materials for a course on documentation. The six sessions of the course cover the following topics: (1) general principles of procedure writing; (2) principles of clear communication (clarity, audience, visuals) and identification of systems types, accounts, and customer requests;…

  5. International Conference on Harmonisation; Guidance on E2F Development Safety Update Report; availability. Notice.

    PubMed

    2011-08-23

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E2F Development Safety Update Report." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR will serve as a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. The DSUR can 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. PMID:21894658

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

    PubMed

    2008-08-01

    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. PMID:18949880

  7. 75 FR 62820 - Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

    ...- Stranded DNA AGENCY: Department of Health and Human Services, Office of the Secretary. ACTION: Notice... provides a framework for screening synthetic double-stranded DNA (dsDNA). This document, the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (the Guidance), sets forth...

  8. 78 FR 2038 - Notice of Availability of Proposed New Starts and Small Starts Policy Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-09

    ... Investment Projects published elsewhere in this issue of the Federal Register. Specifically, this proposed... capital investment projects each time the agency makes significant changes to the process and criteria... announcing the availability of proposed policy guidance to sponsors of New Starts and Small Starts...

  9. 78 FR 49372 - Notice of Availability of New Starts and Small Starts Policy Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ... cities, transit operators, state agencies, metropolitan planning organizations, non-profit organizations... Planning and Environment, telephone (202) 366-5159 or Elizabeth.Day@dot.gov . For legal matters, Scott... published on January 9, 2013, at 78 FR 2038. The final policy guidance is available in its entirety on...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-13

    ... Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs is to ensure... and Sources of Vitamins and Minerals For Organic Livestock Feed, Feed Supplements, and Feed Additives... (NOP 5029)'', and ``Evaluating Allowed Ingredients and Sources of Vitamins and Minerals For...

  11. 77 FR 3838 - Notice of Availability of Proposed New Starts/Small Starts Policy Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... the Notice of Proposed Rulemaking for Major Capital Investment Projects by describing the detailed measures proposed for evaluation of projects seeking New Starts and Small Starts funding and the way these measures would be used in project ratings if adopted. The proposed regulations and appendix are intended...

  12. Current Assessment and Classification of Suicidal Phenomena using the FDA 2012 Draft Guidance Document on Suicide Assessment: A Critical Review

    PubMed Central

    Giddens, Jennifer M.; Sheehan, Kathy Harnett

    2014-01-01

    Objective: Standard international classification criteria require that classification categories be comprehensive to avoid type II error. Categories should be mutually exclusive and definitions should be clear and unambiguous (to avoid type I and type II errors). In addition, the classification system should be robust enough to last over time and provide comparability between data collections. This article was designed to evaluate the extent to which the classification system contained in the United States Food and Drug Administration 2012 Draft Guidance for the prospective assessment and classification of suicidal ideation and behavior in clinical trials meets these criteria. Method: A critical review is used to assess the extent to which the proposed categories contained in the Food and Drug Administration 2012 Draft Guidance are comprehensive, unambiguous, and robust. Assumptions that underlie the classification system are also explored. Results: The Food and Drug Administration classification system contained in the 2012 Draft Guidance does not capture the full range of suicidal ideation and behavior (type II error). Definitions, moreover, are frequently ambiguous (susceptible to multiple interpretations), and the potential for misclassification (type I and type II errors) is compounded by frequent mismatches in category titles and definitions. These issues have the potential to compromise data comparability within clinical trial sites, across sites, and over time. Conclusion: These problems need to be remedied because of the potential for flawed data output and consequent threats to public health, to research on the safety of medications, and to the search for effective medication treatments for suicidality. PMID:25520889

  13. Unified powered flight guidance

    NASA Technical Reports Server (NTRS)

    Brand, T. J.; Brown, D. W.; Higgins, J. P.

    1973-01-01

    A complete revision of the orbiter powered flight guidance scheme is presented. A unified approach to powered flight guidance was taken to accommodate all phases of exo-atmospheric orbiter powered flight, from ascent through deorbit. The guidance scheme was changed from the previous modified version of the Lambert Aim Point Maneuver Mode used in Apollo to one that employs linear tangent guidance concepts. This document replaces the previous ascent phase equation document.

  14. 39 CFR 963.3 - Petition; notice of hearing; answer; filing and copies of documents; summary judgment.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 39 Postal Service 1 2010-07-01 2010-07-01 false Petition; notice of hearing; answer; filing and copies of documents; summary judgment. 963.3 Section 963.3 Postal Service UNITED STATES POSTAL SERVICE PROCEDURES RULES OF PRACTICE IN PROCEEDINGS RELATIVE TO VIOLATIONS OF THE PANDERING ADVERTISEMENTS...

  15. 75 FR 16202 - Office of New Reactors; Interim Staff Guidance on Ensuring Hazard-Consistent Seismic Input for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ... COMMISSION Office of New Reactors; Interim Staff Guidance on Ensuring Hazard-Consistent Seismic Input for...). ACTION: Notice of availability. SUMMARY: The NRC staff is issuing its Final Interim Staff Guidance (ISG... Interaction Analyses,'' (Agencywide Documents Access and Management System (ADAMS) Accession No....

  16. 75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... Pressure Wound Therapy; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... Pressure Wound Therapy (NPWT).'' This guidance document describes a means by which non-powered suction... Device Intended for Negative Pressure Wound Therapy (NPWT)'' to the Division of Small...

  17. Best clinical practice guidance for management of early caries lesions in children and young adults: an EAPD policy document.

    PubMed

    Richards, Derek

    2016-06-01

    Scope and purposeThe guidance provides evidence- and clinically-based recommendations for detecting and diagnosing early/non-cavitated caries lesions, risk assessment and disease management.MethodologyThe guidance development is based on three reviews(1,2,3) and an interim seminar and workshop organised by the European Academy of Paediatric Dentistry in Brussels in May 2015.Review and updatingNo indication of a review or update schedule is given.RecommendationsSeven recommendations on caries detection and diagnosis, four recommendations on caries risk assessment and 11 on the management of the early carious lesion were made and they are briefly summarised in the table below.Research RecommendationsCaries detection and diagnosisThere is a need for more research in the primary dentition because most of the available studies consider only the permanent dentitionRadiograph subtraction studies need to be conductedOngoing evaluation of new methods and devicesThere is a need for well-designed prevention studies on early childhood caries which will provide sufficient and strong evidence of the cost-effectivenessThere is a significant need to bring the knowledge and learning to regular dental practice, to all the paediatric health care providers, the children and their parents.Caries risk assessmentClinical trials to assess the validity of models and single risk factors, as well as the role of confounding factors (eg age, lifestyle, socio-economy and socio-demography), for predicting caries.Further quantitative and qualitative health professional and parents would be helpful to identify perceptions and barriers to carrying out a CRA and to deliver a risk-based preventive care that could bridge the social inequalities in dental health.More research on the implementation of risk-based caries prevention and to establish the cost-effectiveness of such strategies.

  18. Best clinical practice guidance for management of early caries lesions in children and young adults: an EAPD policy document.

    PubMed

    Richards, Derek

    2016-06-01

    Scope and purposeThe guidance provides evidence- and clinically-based recommendations for detecting and diagnosing early/non-cavitated caries lesions, risk assessment and disease management.MethodologyThe guidance development is based on three reviews(1,2,3) and an interim seminar and workshop organised by the European Academy of Paediatric Dentistry in Brussels in May 2015.Review and updatingNo indication of a review or update schedule is given.RecommendationsSeven recommendations on caries detection and diagnosis, four recommendations on caries risk assessment and 11 on the management of the early carious lesion were made and they are briefly summarised in the table below.Research RecommendationsCaries detection and diagnosisThere is a need for more research in the primary dentition because most of the available studies consider only the permanent dentitionRadiograph subtraction studies need to be conductedOngoing evaluation of new methods and devicesThere is a need for well-designed prevention studies on early childhood caries which will provide sufficient and strong evidence of the cost-effectivenessThere is a significant need to bring the knowledge and learning to regular dental practice, to all the paediatric health care providers, the children and their parents.Caries risk assessmentClinical trials to assess the validity of models and single risk factors, as well as the role of confounding factors (eg age, lifestyle, socio-economy and socio-demography), for predicting caries.Further quantitative and qualitative health professional and parents would be helpful to identify perceptions and barriers to carrying out a CRA and to deliver a risk-based preventive care that could bridge the social inequalities in dental health.More research on the implementation of risk-based caries prevention and to establish the cost-effectiveness of such strategies. PMID:27339231

  19. E4 AND COOPERATIVE AGREEMENTS: GUIDANCE TO EXTRAMURAL ORGANIZATIONS FOR DOCUMENTING CONFORMANCE TO ANSI/ASQC E4-1994

    EPA Science Inventory

    This paper makes suggestions on how to comply with ANSI/ASQC E4-1994 while avoiding some of the frustration. Some options for writing a quality system document compliant with E4 are given, along with a model outline, to provide assistance in interpreting requirements.

  20. 78 FR 9688 - Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ... (77 FR 74003) (FRL-9362-3). In that document, EPA requested comment on a draft PR notice that provided... AGENCY Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Mold... for Antimicrobial Pesticide Products with Mold-Related Label Claims. This document extends the...

  1. Safeguards Guidance Document for Designers of Commercial Nuclear Facilities: International Nuclear Safeguards Requirements and Practices For Uranium Enrichment Plants

    SciTech Connect

    Robert Bean; Casey Durst

    2009-10-01

    This report is the second in a series of guidelines on international safeguards requirements and practices, prepared expressly for the designers of nuclear facilities. The first document in this series is the description of generic international nuclear safeguards requirements pertaining to all types of facilities. These requirements should be understood and considered at the earliest stages of facility design as part of a new process called “Safeguards-by-Design.” This will help eliminate the costly retrofit of facilities that has occurred in the past to accommodate nuclear safeguards verification activities. The following summarizes the requirements for international nuclear safeguards implementation at enrichment plants, prepared under the Safeguards by Design project, and funded by the U.S. Department of Energy (DOE) National Nuclear Security Administration (NNSA), Office of NA-243. The purpose of this is to provide designers of nuclear facilities around the world with a simplified set of design requirements and the most common practices for meeting them. The foundation for these requirements is the international safeguards agreement between the country and the International Atomic Energy Agency (IAEA), pursuant to the Treaty on the Non-proliferation of Nuclear Weapons (NPT). Relevant safeguards requirements are also cited from the Safeguards Criteria for inspecting enrichment plants, found in the IAEA Safeguards Manual, Part SMC-8. IAEA definitions and terms are based on the IAEA Safeguards Glossary, published in 2002. The most current specification for safeguards measurement accuracy is found in the IAEA document STR-327, “International Target Values 2000 for Measurement Uncertainties in Safeguarding Nuclear Materials,” published in 2001. For this guide to be easier for the designer to use, the requirements have been restated in plainer language per expert interpretation using the source documents noted. The safeguards agreement is fundamentally a

  2. 46 CFR 502.226 - Decision based on official notice; public documents.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... official report, decision, opinion, or published scientific or economic statistical data issued by any of... judicially noticed by the courts, or of technical or scientific facts within the general knowledge of...

  3. 76 FR 44594 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems... Document: Repetitive Transcranial Magnetic Stimulation Systems.'' This guidance document describes a...

  4. 76 FR 15359 - Notice of Proposed Revision to Guidance for the Use of Binding Arbitration Under the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-21

    ... Federal Register on January 17, 2008 (73 FR 3316). II. Background On March 4, 2004, FMCSA published in the Federal Register (69 FR 10288) its Guidance for the use of binding arbitration as an alternative dispute... Guidance provides that FMCSA use a form of arbitration known as ``Night Baseball,'' under which each...

  5. 77 FR 34249 - Notice of Final Revision to Guidance for the Use of Binding Arbitration Under the Administrative...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... published in the Federal Register (69 FR 10288) its Guidance for the use of binding arbitration as an... its proposal to eliminate the ``Night Baseball'' format from the Guidance (76 FR 15359). Several years... conflict of interest with respect to the issue in controversy, unless that interest is fully disclosed...

  6. Lease Operations Environmental Guidance Document

    SciTech Connect

    Bureau of Land Management

    2001-02-14

    This report contains discussions in nine different areas as follows: (1) Good Lease Operating Practices; (2) Site Assessment and Sampling; (3) Spills/Accidents; (4) Containment and Disposal of Produced Waters; (5) Restoration of Hydrocarbon Impacted Soils; (6) Restoration of Salt Impacted Soils; (7) Pit Closures; (8) Identification, Removal and Disposal of Naturally Occurring Radioactive Materials (NORM); and (9) Site Closure and Construction Methods for Abandonment Wells/Locations. This report is primary directed towards the operation of oil and gas producing wells.

  7. DOE performance indicators guidance document

    SciTech Connect

    Not Available

    1992-12-01

    SEN-29-91 directed that a Department-wide uniform process for trending and analysis of operational data be established for DOE facilities. This Performance Indicator (PI) Program establishes a uniform system for trending and analyzing operational data providing an important tool to help assess and support progress in improving performance and strengthening both DOE and contractor line management control of operations. DOE, similar to the commercial nuclear industry, considers that facilities with good performance, as measured by an overall set of performance indicators, are well-managed facilities. The Performance Indicator Program established by SEN-29-91 is but one of several initiatives undertaken by DOE to instill a new DOE and DOE contractor line management culture committed to achieving a rising standard of acceptable performance. Line management trending and analysis of data depicting the performance of their facilities is an essential element in creating this culture of ``continuous improvement,`` where performance gains achieved are maintained and early identification of deteriorating environmental, safety, and health conditions is accomplished.

  8. 75 FR 80517 - HUD Multifamily Rental Project Closing Documents-Revisions and Updates Notice of Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-22

    ..., 2004 (69 FR 46214) that advised that, consistent with the PRA, it was publishing for public comment a... comments (see HUD's notice published on August 31, 2006, at 71 FR 51842), HUD was unable to complete the... the Federal Register on January 21, 2010 (75 FR 3544), which solicited public comment for a period...

  9. 76 FR 18542 - Copper Valley Electric Association; Notice of Scoping Document 2 and Soliciting Scoping Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-04

    ....nguyen@ferc.gov . i. Deadline for filing scoping comments: April 27, 2011. All documents may be filed..., 2010, Copper Valley filed a Pre-Application Document (PAD) including a Preliminary Draft Environmental Assessment (PDEA) for the project. Since the filing of the PAD and PDEA, Copper Valley has proposed...

  10. RH Packaging Program Guidance

    SciTech Connect

    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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Clinical Investigators, Industry, and FDA... notice that appeared in the Federal Register of May 24, 2011 (76 FR 30175). The document announced...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

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

  13. 75 FR 47494 - Implementation Guidance for Physical Protection of Byproduct Material; Category 1 and Category 2...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... June 15, 2010 (75 FR 33902) and the public comment period ends October 13, 2010. Documents related to.... The availability of implementation guidance was noticed on July 14, 2010 (75 FR 40756) and the public.... The first meeting ] will be held at the Doubletree Hotel in Austin, Texas. The second meeting will...

  14. 75 FR 62694 - Implementation Guidance for Physical Protection of Byproduct Material Category 1 and Category 2...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

    ... the Code of Federal Regulations. The proposed rule was published on June 15, 2010 (75 FR 33902) and... searching on Docket ID: NRC-2010-0194. On July 14, 2010 (75 FR 40756), the NRC noticed the availability of... and Category 2 Quantities of Radioactive Material; Draft Guidance Document for Comment; Extension...

  15. 75 FR 26837 - Advisory Committee on Historical Diplomatic Documentation Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-12

    ... the public planning to attend must notify Margaret Morrissey, Office of the Historian (202- 663-3529... Documentation, Department of State, Office of the Historian, Washington, DC 20520, telephone (202) 663-1123,...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    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. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New... notice entitled ``Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications... the draft guidance for industry entitled ``Draft Guidance for Industry; Dietary Supplements:...

  18. 78 FR 38683 - Availability of Guidance: Establishments Guidance for the Selection of a Commercial or Private...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-27

    ... Food Safety and Inspection Service Availability of Guidance: Establishments Guidance for the Selection of a Commercial or Private Microbiological Testing Laboratory AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice of availability. SUMMARY: The Food Safety and Inspection Service (FSIS)...

  19. 78 FR 78363 - Notice of Request for Comments on Chapters 6 and 8 of the NIOSH document titled: “Criteria for a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ..., Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention... HUMAN SERVICES Centers for Disease Control and Prevention Notice of Request for Comments on Chapters 6 and 8 of the NIOSH document titled: ``Criteria for a Recommended Standard: Occupational Exposure...

  20. Corporate information management guidance

    SciTech Connect

    1997-08-01

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

  1. 78 FR 13071 - Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Implementation of an Acceptable Full... Donors of Source Plasma; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document...

  2. 76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ...; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System... Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.'' This guidance document... system, but it remains subject to comment in accordance with the agency's good guidance practices...

  3. 77 FR 62247 - Dynamic Positioning Operations Guidance for Vessels Other Than Mobile Offshore Drilling Units...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-12

    ... recommended interim voluntary guidance titled ``Mobile Offshore Drilling Unit Dynamic Positioning Guidance''. The notice recommended owners and operators of Mobile Offshore Drilling Units (MODUs) follow Marine....'' The recommended interim voluntary guidance titled ``Mobile Offshore Drilling Unit (MODU)...

  4. 76 FR 69040 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection... Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro diagnostic devices for Yersinia species (spp.) detection...

  5. 78 FR 36196 - Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... Hematopoietic System'' dated June 2013. The draft guidance document provides recommendations for manufacturers... Affecting the Hematopoietic System'' dated June 2013. The draft guidance document, when finalized, will... Patients with Disorders Affecting the Hematopoietic System.'' That draft guidance, when finalized,...

  6. Document control and document management.

    PubMed

    Djemal, K K

    1999-12-01

    Most schemes for the accreditation (e.g. United Kingdom Accreditation Service) and certification (e.g. BS EN ISO 9002) of laboratories include a requirement to establish and maintain procedures for the management and control of documents generated internally. Such documents include policy statements, procedures, specifications, and some notices and memoranda. Organisations benefit from using agreed and approved information and from knowing that staff are using agreed and approved methods in their operating procedures. Document control systems are likely to become compulsory as accreditation schemes, such as Clinical Pathology Accreditation (CPA) for clinical microbiology laboratories, align with international standards. The Technical Services Division (TSD) in PHLS Headquarters has been developing a control system for various documents that it issues to the PHLS and control of documentation that forms the TSD quality system. The document control system has recently developed into a document management system that provides a mechanism for managing all documents generated or received by the division. TSD's approach is described here to provide laboratories and other organisations with ideas for how they could set up or develop their own document management system to improve accessibility to information. PMID:10598395

  7. 78 FR 15710 - Strong Sensitizer Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-12

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY COMMISSION Strong Sensitizer Guidance AGENCY: Consumer Product Safety Commission. ACTION: Notice of availability. SUMMARY: The U.S. Consumer Product Safety Commission (CPSC or Commission) is announcing...

  8. Information architecture. Volume 3: Guidance

    SciTech Connect

    1997-04-01

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

  9. 76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ...; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use; Availability...: Contact Cooling System for Aesthetic Use.'' This guidance document describes a means by which contact... systems for aesthetic use into class II (special controls). The guidance document is immediately in...

  10. 76 FR 2132 - Notice of Intent To Prepare Land Protection Plan and Associated NEPA Documents for the Proposed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-12

    ... documents. Special mailings, newspaper articles, and other media announcements will inform people of the... photography, and environmental education and interpretation) that are to be facilitated on national...

  11. 18 CFR 5.8 - Notice of commencement of proceeding and scoping document, or of approval to use traditional...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Notice of commencement... alternative procedures. 5.8 Section 5.8 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... thereunder at 50 CFR part 402, section 305(b) of the Magnuson-Stevens Fishery Conservation and Management...

  12. 18 CFR 5.8 - Notice of commencement of proceeding and scoping document, or of approval to use traditional...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Notice of commencement... alternative procedures. 5.8 Section 5.8 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE...

  13. 18 CFR 5.8 - Notice of commencement of proceeding and scoping document, or of approval to use traditional...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Notice of commencement... alternative procedures. 5.8 Section 5.8 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE...

  14. 78 FR 25758 - Amended Notice of Intent To Clarify the Scope of Analysis of the Environmental Document and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-02

    ..., Motorized Vehicle Access Element, Inyo, Kern, Los Angeles and San Bernardino Counties, CA, which was published in the Federal Register on September 13, 2011 (76 FR 56466). By this notice, the BLM is announcing... Element of the California Desert Conservation Area Plan, Inyo, Kern, Los Angeles and San...

  15. Environmental guidance regulatory bulletin

    SciTech Connect

    1997-01-31

    This document describes the background on expanding public participation in the Resource Conservation and Recovery Act and DOE`s response. The bulletin also describes the changes made by the final rule to existing regulations, guidance provided by EPA in the preamble and in the revised RCRA Public Participation Manual, the relationship between public participation and environmental justice, and DOE`s recent public participation and environmental justice initiatives.

  16. 75 FR 50760 - Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ... utilizing ground water, and would not be built on any existing body of water. The project would occupy... Document, and Approving Use of the Traditional Licensing Process August 10, 2010. a. Type of Filing:...

  17. 77 FR 26562 - Mobile Offshore Drilling Unit Dynamic Positioning Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... Guard is publishing this notice to recommend interim voluntary DP system guidance and recommend DP... concern are likely to be the subject of a future rulemaking. II. Interim Voluntary DP System Guidance On..._operations_guidance.cfm . It is particularly important they identify the DP System's Critical Activity...

  18. 75 FR 22681 - Supplemental Guidance on Overdraft Protection Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... goals, including building long term customer relationships, cross selling additional products, and... Guidance on Overdraft Protection Programs (Overdraft Guidance) OTS issued February 18, 2005 (70 FR 8428). OTS issued the Overdraft Guidance after notice and comment. See 69 FR 31858 (June 7, 2004)....

  19. 78 FR 12761 - Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... of May 2, 2006 (71 FR 25844), we announced the availability of a guidance entitled ``Guidance on the... Cosmetic Act; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal... 403(w) of the Federal Food, Drug, and Cosmetic Act,'' dated April 2006, that was announced in...

  20. 76 FR 66714 - Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-27

    ... Document, and Approving Use of the Traditional Licensing Process/Alternative Licensing Procedures; Raymond.... Submitted By: Raymond F. Ward. e. Name of Project: Ward Mill Dam Project. f. Location: On the Watauga River.... Raymond F. Ward filed his request to use the Traditional Licensing Process Procedures on August 31,...

  1. 75 FR 18205 - Notice of Peer Review Meeting for the External Peer Review Drafts of Two Documents on Using...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... Probabilistic Methods To Enhance the Role of Risk Analysis in Decision-Making AGENCY: Environmental Protection... announcing that Eastern Research Group, Inc. (ERG), an EPA contractor for external scientific peer review... to review two draft documents entitled, ``Using Probabilistic Methods to Enhance the Role of...

  2. 77 FR 10491 - City of Aspen; Notice of Intent To File License Application, Filing of Pre-Application Document...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... Applicant Contact: David Hornbacher, City of Aspen, 130 South Galena Street, Aspen, CO 81611. i. FERC... of the National Historic Preservation Act. m. City of Aspen filed a Pre-Application Document (PAD... Commission's regulations. n. A copy of the PAD is available for review at the Commission in the...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... the Federal Register of September 10, 2013 (78 FR 55263). In that notice, FDA requested public comment... FR 55263), FDA announced the notice of availability for the draft guidance entitled ``Draft Guidance... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on...

  4. Guidance for state attainment plans

    SciTech Connect

    Strait, R.

    1994-06-01

    Title I of the Clean Air act Amendments of 1990 significantly changed requirements for regulatory agencies to prepare state implementation plans that demonstrate attainment of the ozone National Ambient Air Quality Standards. State agencies now are required to submit plans that show how they will meet the standards by their attainment date. EPA has published a series of guidance documents to assist states in preparing their plans. In addition, the agency is developing software to assist states in projecting emissions and tracking reductions. This article summarizes the guidance documents and software program.

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

    EPA Science Inventory

    This document augments the February 2000 guidance entitled Meteorological Monitoring Guidance for Regulatory Modeling Applications and the March 2008 guidance entitled Quality Assurance Handbook for Air Pollution Measurement Systems Volume IV: Meteorological Measurements Version ...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... Cosmetic Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... ``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...

  7. 78 FR 63219 - International Conference on Harmonisation; Draft Guidance on Elemental Impurities; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration International Conference on Harmonisation; Draft Guidance on Elemental Impurities; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...

  8. Educational Guidance: New Responses for Inner Cities.

    ERIC Educational Resources Information Center

    Further Education Unit, London (England).

    This document summarizes a project which attempted to develop and evaluate the provision of educational guidance for unemployed adults, especially those from ethnic minority groups in inner city areas in the United Kingdom. This report: (1) outlines the background of the project; (2) indicates key features of the shop-front guidance unit that was…

  9. 75 FR 57469 - Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ... HUMAN SERVICES Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues... Retention and Other Related Issues.'' The guidance document provides OHRP's first formal guidance on this... (73 FR 72804). OHRP received comments on the draft guidance document from 30 individuals...

  10. Endangerment assessment guidance

    SciTech Connect

    Not Available

    1985-11-22

    The directive clarifies the requirement that an endangerment assessment be developed to support all administrative and judicial enforcement actions under Section 106 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and Section 7003 of the Resource Conservation and Recovery Act (RCRA). Before taking enforcement action under these provisions to abate the hazards or potential hazards at a site, the Environmental Protection Agency (EPA) must be able to properly document and justify its assertion that an imminent and substantial endangerment to public health or welfare or the environment may exist. The endangerment assessment provides this documentation and justification. The endangerment assessment is not necessary to support Section 104 actions. It also provides guidance on the content, timing, level of detail, format, and resources required for the preparation of endangerment assessments.

  11. GUIDANCE PACKET.

    ERIC Educational Resources Information Center

    Modern Language Association of America, New York, NY.

    THIS PACKET PROVIDES VOCATIONAL AND ACADEMIC ADVICE TO THE LANGUAGE LEARNER AND USEFUL INFORMATION ABOUT LANGUAGE LEARNING TO TEACHERS, COUNSELORS, AND ADMINISTRATORS. THE DOCUMENTS, PUBLISHED FROM 1963 TO 1967, ARE--(1) "VOCATIONAL OPPORTUNITIES FOR FOREIGN LANGUAGE STUDENTS" BY GILBERT C. KETTELKAMP, (2) "ADVICE TO THE LANGUAGE LEARNER" BY…

  12. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium...; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the... availability of a draft guidance entitled ``Class II Special Controls Guidance Document: Nucleic Acid-Based...

  13. OECD Review of Career Guidance Policies. Australia: Country Note.

    ERIC Educational Resources Information Center

    Organisation for Economic Cooperation and Development, Paris (France).

    Australia's career guidance system and policies were evaluated. The review team met with policymakers and guidance practitioners in four states and at the national level, conducted site visits to various career guidance providers in the public and private sectors, analyzed data from a national questionnaire, and reviewed pertinent documentation.…

  14. OECD Review of Career Guidance Policies. Norway: Country Note.

    ERIC Educational Resources Information Center

    Organisation for Economic Cooperation and Development, Paris (France).

    Norway's career guidance system and policies were evaluated. The review team met with policymakers and guidance practitioners in the public and private sectors, analyzed data from a national questionnaire, and reviewed pertinent documentation. The evaluation focused on the following areas: splitting educational/vocational guidance from personal…

  15. Guidance for identifying, reporting and tracking nuclear safety noncompliances

    SciTech Connect

    1995-12-01

    This document provides Department of Energy (DOE) contractors, subcontractors and suppliers with guidance in the effective use of DOE`s Price-Anderson nuclear safety Noncompliance Tracking System (NTS). Prompt contractor identification, reporting to DOE, and correction of nuclear safety noncompliances provides DOE with a basis to exercise enforcement discretion to mitigate civil penalties, and suspend the issuance of Notices of Violation for certain violations. Use of this reporting methodology is elective by contractors; however, this methodology is intended to reflect DOE`s philosophy on effective identification and reporting of nuclear safety noncompliances. To the extent that these expectations are met for particular noncompliances, DOE intends to appropriately exercise its enforcement discretion in considering whether, and to what extent, to undertake enforcement action.

  16. Disability Documentation: Using All the Data

    ERIC Educational Resources Information Center

    Shaw, Stan F.

    2012-01-01

    Approaches to disability documentation have long been grounds for contention among postsecondary disability service providers. While the new AHEAD Documentation Guidance seems to be creating the usual intensity and heat among its members, there does seem to be a data-based middle ground. The AHEAD Guidance recommends that disability service…

  17. 77 FR 34390 - Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... proposes amendments to the labeling recommendations for plasma-derived products, including albumin and products containing plasma-derived albumin, in the guidance document entitled ``Guidance for Industry... in the 2010 CJD/vCJD guidance for plasma-derived products, including albumin and products...

  18. Hazard baseline documentation

    SciTech Connect

    Not Available

    1994-08-01

    This DOE limited technical standard establishes uniform Office of Environmental Management (EM) guidance on hazards baseline documents that identify and control radiological and nonradiological hazards for all EM facilities. It provides a road map to the safety and health hazard identification and control requirements contained in the Department`s orders and provides EM guidance on the applicability and integration of these requirements. This includes a definition of four classes of facilities (nuclear, non-nuclear, radiological, and other industrial); the thresholds for facility hazard classification; and applicable safety and health hazard identification, controls, and documentation. The standard applies to the classification, development, review, and approval of hazard identification and control documentation for EM facilities.

  19. 78 FR 10503 - Children's Toys and Child Care Articles Containing Phthalates; Final Guidance on Inaccessible...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-14

    .... 2057c(d)(2). 2. Notice of Proposed Guidance In the Federal Register notice of July 31, 2012 (77 FR 45297... stated in the preamble to the proposed guidance (77 FR 45299), the Commission proposed to adopt the lead... other liquid, which could facilitate phthalate migration through a fabric covering. 74 FR 39539...

  20. 78 FR 23578 - Clarifying Guidance, Waivers, and Alternative Requirements for Hurricane Sandy Grantees in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    ... guidance provided at 78 FR 14329. For each waiver and alternative requirement described in this Notice, the... URBAN DEVELOPMENT Clarifying Guidance, Waivers, and Alternative Requirements for Hurricane Sandy... FR 14329, published in the Federal Register on March 5, 2013). This Notice provides...

  1. 76 FR 80948 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ..., November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been... (76 FR 70151), FDA published a notice announcing the availability of the draft guidance entitled ``FDA... Investigational Device Exemption (IDE) Clinical Investigations; Extension of Comment Period AGENCY: Food and...

  2. 76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ... Controls Guidance Document: Topical Oxygen Chamber for Extremities'' (71 FR 17476). Interested persons were... Register of April 6, 2006 (71 FR 17390), FDA's Center for Devices and Radiological Health (CDRH) published...; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability...

  3. 76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-14

    ...; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use; Availability...: Low Level Laser System for Aesthetic Use.'' This guidance document describes a means by which low level laser systems for aesthetic use may comply with the requirement of special controls for class...

  4. 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.

    PubMed

    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.

  5. 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.

    PubMed

    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. PMID:27459749

  6. 78 FR 67442 - Congestion Mitigation and Air Quality Improvement Program Interim Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ... types of rail service in a January 16, 2002, Federal Register notice (67 FR 2278), and in a March 8... Federal Highway Administration Congestion Mitigation and Air Quality Improvement Program Interim Guidance... Mitigation and Air Quality Improvement (CMAQ) Program (Interim Guidance). The Interim Guidance revises...

  7. 76 FR 38742 - Eleventh Meeting: RTCA Special Committee 220: Automatic Flight Guidance and Control

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... Federal Aviation Administration Eleventh Meeting: RTCA Special Committee 220: Automatic Flight Guidance... Committee 220 Meeting: Automatic Flight Guidance and Control. SUMMARY: The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 220: Automatic Flight Guidance and Control...

  8. 76 FR 22163 - Tenth Meeting: RTCA Special Committee 220: Automatic Flight Guidance and Control

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-20

    ... Federal Aviation Administration Tenth Meeting: RTCA Special Committee 220: Automatic Flight Guidance and... meeting: Automatic Flight Guidance and Control. SUMMARY: The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 220: Automatic Flight Guidance and Control. DATES:...

  9. 75 FR 36471 - Seventh Meeting-RTCA Special Committee 220: Automatic Flight Guidance and Control

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... Federal Aviation Administration Seventh Meeting--RTCA Special Committee 220: Automatic Flight Guidance and...: Automatic Flight Guidance and Control meeting. SUMMARY: The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 220: Automatic Flight Guidance and Control. DATES: The...

  10. 75 FR 3959 - Fifth Meeting-RTCA Special Committee 220: Automatic Flight Guidance and Control

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-25

    ... Federal Aviation Administration Fifth Meeting--RTCA Special Committee 220: Automatic Flight Guidance and...: Automatic Flight Guidance and Control meeting. SUMMARY: The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 220: Automatic Flight Guidance and Control. DATES: The...

  11. 76 FR 50809 - Eleventh Meeting: RTCA Special Committee 220: Automatic Flight Guidance and Control

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... Federal Aviation Administration Eleventh Meeting: RTCA Special Committee 220: Automatic Flight Guidance... Special Committee 220 meeting: Automatic Flight Guidance and Control. SUMMARY: The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 220: Automatic Flight Guidance...

  12. 75 FR 59326 - Eighth Meeting-RTCA Special Committee 220: Automatic Flight Guidance and Control

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    ... Federal Aviation Administration Eighth Meeting--RTCA Special Committee 220: Automatic Flight Guidance and...: Automatic Flight Guidance and Control meeting. SUMMARY: The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 220: Automatic Flight Guidance and Control. DATES: The...

  13. 75 FR 15770 - Sixth Meeting-RTCA Special Committee 220: Automatic Flight Guidance and Control

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-30

    ... Federal Aviation Administration Sixth Meeting--RTCA Special Committee 220: Automatic Flight Guidance and...: Automatic Flight Guidance and Control meeting. SUMMARY: The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 220: Automatic Flight Guidance and Control. DATES: The...

  14. 77 FR 40068 - Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... Questioning, Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria...-Transmitted Malaria'' dated June 2012. The draft guidance document provides blood establishments that collect... malaria. This guidance replaces the draft guidance entitled ``Guidance for Industry: Recommendations...

  15. 78 FR 21611 - Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... 1995 This guidance refers to previously approved collections of information found in FDA regulations...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... access to the guidance document. Submit electronic comments on the guidance to...

  16. Navigating through 'a labyrinth' of guidance.

    PubMed

    Pearson, Susan

    2014-09-01

    Devising a strategy to deliver safe water to thousands of outlets spread across numerous buildings is always going to be a challenge, so how do you navigate your way through a bewildering labyrinth of sometimes contradictory guidance documents? Is there, in fact, simply too much guidance? Posing this question at a recent one-day conference on waterborne infections in healthcare facilities, Paul Nolan, authorised water engineer (AE), and operations manager for PFI provider, Lend Lease, took delegates through a review of the latest guidance and regulations, as Susan Pearson reports. PMID:25282983

  17. Guidance for performing preliminary assessments under CERCLA

    SciTech Connect

    1991-09-01

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

  18. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-18

    ... Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for... entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for...

  19. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological... Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.'' This draft guidance document describes a means by which the herpes simplex virus (HSV) serological assay device...

  20. CH Packaging Program Guidance

    SciTech Connect

    None, None

    2009-06-01

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: "each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application." They further state: "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 charges the U.S. Department of Energy (DOE) or the Waste Isolation Pilot Plant (WIPP) management and operating (M&O) contractor with assuring 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. 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. The CBFO will evaluate the issue and notify the NRC if required. In accordance with 10 CFR Part 71, 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 regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these regulations are

  1. CH Packaging Program Guidance

    SciTech Connect

    None, None

    2008-09-11

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: "each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the pplication." They further state: "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 charges the U.S. Department of Energy (DOE) or the Waste Isolation Pilot Plant (WIPP) management and operating (M&O) contractor with assuring 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. 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. The CBFO will evaluate the issue and notify the NRC if required. In accordance with 10 CFR Part 71, 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 regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these regulations are

  2. Organising European technical documentation to avoid duplication.

    PubMed

    Donawa, Maria

    2006-04-01

    The development of comprehensive accurate and well-organised technical documentation that demonstrates compliance with regulatory requirements is a resource-intensive, but critically important activity for medical device manufacturers. This article discusses guidance documents and method of organising technical documentation that may help avoid costly and time-consuming duplication.

  3. Organising European technical documentation to avoid duplication.

    PubMed

    Donawa, Maria

    2006-04-01

    The development of comprehensive accurate and well-organised technical documentation that demonstrates compliance with regulatory requirements is a resource-intensive, but critically important activity for medical device manufacturers. This article discusses guidance documents and method of organising technical documentation that may help avoid costly and time-consuming duplication. PMID:16736662

  4. 78 FR 10181 - Documents To Support Submission of an Electronic Common Technical Document; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... HUMAN SERVICES Food and Drug Administration Documents To Support Submission of an Electronic Common Technical Document; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the following revised...

  5. TECHNICAL RESOURCE DOCUMENT ON MONITORED NATURAL RECOVERY

    EPA Science Inventory

    In 2005, the United States Environmental Protection Agency (EPA) published a document entitled Contaminated Sediment Remediation Guidance for Hazardous Waste Sites (EPA, 2005), which provides technical and policy guidance for project managers and teams making risk manageme...

  6. 78 FR 22554 - Document to Support Submission of an Electronic Common Technical Document-Specifications for File...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-16

    ... HUMAN SERVICES Food and Drug Administration Document to Support Submission of an Electronic Common Technical Document--Specifications for File Format Types Using Electronic Common Technical Document Specifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  7. CH Packaging Program Guidance

    SciTech Connect

    None, None

    2006-04-25

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package TransporterModel II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: "each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application." They further state: "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 charges the U.S. Department of Energy (DOE) or the Waste Isolation Pilot Plant| (WIPP) management and operating (M&O) contractor with assuring 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. Any time a user suspects or has indications that the conditions ofapproval in the C of C were not met, the 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, 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 regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these regulations are

  8. CH Packaging Program Guidance

    SciTech Connect

    None, None

    2007-12-13

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: "each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application." They further state: "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 charges the U.S. Department of Energy (DOE) or the Waste Isolation Pilot Plant (WIPP) management and operating (M&O) contractor with assuring 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. 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. The CBFO will evaluate the issue and notify the NRC if required.In accordance with 10 CFR Part 71, 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 regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these regulations are

  9. International Conference on Harmonisation; 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; availability. Notice.

    PubMed

    2013-05-28

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 13: Bulk Density and Tapped Density of Powders General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Bulk Density and Tapped Density of Powders General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (core ICH Q4B guidance).

  10. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 14 on Bacterial Endotoxins Test General Chapter; availability. Notice.

    PubMed

    2013-10-23

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 14: Bacterial Endotoxins Test General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Bacterial Endotoxins Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (core ICH Q4B guidance).

  11. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6 on Uniformity of Dosage Units General Chapter; availability. Notice.

    PubMed

    2014-06-16

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Uniformity of Dosage Units General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' (core ICH Q4B guidance).

  12. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial texts for use in the International Conference on Harmonisation Regions; Annex 12 on Analytical Sieving General Chapter; availability. Notice.

    PubMed

    2010-09-01

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 12: Analytical Sieving General Chapter." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Analytical Sieving General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This guidance is in the form of an annex to the core guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions" (the core ICH Q4B guidance).

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ...The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability entitled ``Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)'', published in the Federal Register of September 10, 2013 (78 FR 55261). In that notice, FDA requested public comment on the draft guidance. FDA is reopening the comment......

  14. 75 FR 76011 - Annual Guidance Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-07

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 19, 2000 (65 FR 56468), FDA issued... existing guidance documents (65 FR 56468 at 56477; 21 CFR 10.115(f)(5)). The Agency is neither bound by... . Calorie Declaration Vincent DeJesus, CFSAN (HFS- 830), Food and Drug Administration, 5100 Paint...

  15. Assessing Enterprise Capability: Guidance for Schools

    ERIC Educational Resources Information Center

    National Foundation for Educational Research, 2007

    2007-01-01

    This document offers guidance to schools on how assessment can support enterprise education. It presents the interim findings from research carried out by the National Foundation for Educational Research (NFER) for the Department for Education and Skills (DfES) in secondary schools in England. Enterprise capability is the key outcome of enterprise…

  16. Advisory List of Instructional Media Guidance.

    ERIC Educational Resources Information Center

    North Carolina State Dept. of Public Instruction, Raleigh.

    A bibliography of materials relevant to the competency-based guidance curriculum of the North Carolina State Department of Public Instruction is presented in this document. Books for students, books for teacher/counselor use, filmstrips (sound), and videocassettes are listed. Grade ranges are provided for each item, although use of the materials…

  17. Second Annual Career Guidance Institute: Final Report.

    ERIC Educational Resources Information Center

    Schenck, Norma Elaine

    The document reports on the organization and implementation plans for Indiana's Second Annual Career Guidance Institute and the sound/slide programs developed on six career cluster areas. An extensive evaluation analyzes the Institute in light of its objectives, offers insights gained on career opportunities, gives changes in attitude regarding…

  18. Athletics Guidance Aims for Level Field

    ERIC Educational Resources Information Center

    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…

  19. 76 FR 78545 - Guidance Regarding Foreign Base Company Sales Income

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... Internal Revenue Service 26 CFR Part 1 RIN 1545-BI45 Guidance Regarding Foreign Base Company Sales Income... regulations. SUMMARY: This document contains final regulations that provide guidance relating to foreign base... rulemaking in the Federal Register (REG-124590-07, 2008-16 IRB 801, 73 FR 10716, as corrected at 73 FR...

  20. OECD Review of Career Guidance Policies. Denmark: Country Note.

    ERIC Educational Resources Information Center

    Organisation for Economic Cooperation and Development, Paris (France).

    Denmark's career guidance system and policies were evaluated. The review team met with policymakers and guidance practitioners in the public and private sectors, analyzed data from a national questionnaire, and reviewed pertinent documentation. The evaluation focused on the following areas: coordinating mechanisms; the role of Denmark's National…

  1. Exemplary Career Guidance Programs 1995: Secondary and Postsecondary.

    ERIC Educational Resources Information Center

    Cunanan, Esmeralda S.; Maddy-Bernstein, Carolyn

    This document presents nine exemplary career guidance and counseling programs identified by the National Center for Research in Vocational Education's Office of Student Services. Chapter 1 presents a synthesis of the nationally recognized career guidance programs successful in assisting students in their career development. It provides a…

  2. Environmental Guidance Program Reference Book: American Indian Religious Freedom Act

    SciTech Connect

    Not Available

    1987-11-01

    This Reference Book contains a copy of the American Indian Religious Freedom Act and guidance for DOE compliance with the statute. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Updates that include important new requirements will be provided periodically.

  3. OECD Review of Career Guidance Policies. Germany: Country Note.

    ERIC Educational Resources Information Center

    Organisation for Economic Cooperation and Development, Paris (France).

    Germany's career guidance system and policies were evaluated. Data were collected through meetings with policymakers and guidance practitioners in the public and private sectors, an analysis of data from a national questionnaire, and a review of pertinent documentation. The evaluation focused on the following areas: reviewing the role of Germany's…

  4. Guidance for K-12 Administrators' Responses to Influenza

    ERIC Educational Resources Information Center

    Education Digest: Essential Readings Condensed for Quick Review, 2009

    2009-01-01

    This document provides guidance to help decrease the spread of flu among students and school staff during the 2009-2010 school year. It provides tools that school and health officials can choose from based on conditions in their area and recommends actions to take if CDC finds that the flu starts causing more severe disease. The guidance also…

  5. Endangerment assessment guidance. Final report

    SciTech Connect

    Not Available

    1985-10-21

    The directive clarifies the requirement that an endangerment assessment be developed to support all administrative and judicial enforcement actions under Section 106 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and Section 7003 of the Resource Conservation and Recovery Act (RCRA). Before taking enforcement action under these provisions to abate the hazards or potential hazards at a site, the Environmental Protection Agency (EPA) must be able to properly document and justify its assertion that an imminent and substantial endangerment to public health or welfare or the environment may exist. The endangerment assessment provides the documentation and justification. The endangerment assessment is not necessary to support Section 104 actions. It also provides guidance on the content, timing, level of detail, format, and resources required for the preparation of endangerment assessments.

  6. 78 FR 68030 - Possible Models for the Administration and Support of Discipline-Specific Guidance Groups for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ...-specific guidance groups for Forensic Science (78 FR 59654). That Notice of Inquiry may be found at https... Discipline- Specific Guidance Groups for Forensic Science AGENCY: National Institute of Standards and... Administration and Support of Discipline-Specific Guidance Groups for Forensic Science. Due to the lack...

  7. Aiding Vertical Guidance Understanding

    NASA Technical Reports Server (NTRS)

    Feary, Michael; McCrobie, Daniel; Alkin, Martin; Sherry, Lance; Polson, Peter; Palmer, Everett; McQuinn, Noreen

    1998-01-01

    A two-part study was conducted to evaluate modern flight deck automation and interfaces. In the first part, a survey was performed to validate the existence of automation surprises with current pilots. Results indicated that pilots were often surprised by the behavior of the automation. There were several surprises that were reported more frequently than others. An experimental study was then performed to evaluate (1) the reduction of automation surprises through training specifically for the vertical guidance logic, and (2) a new display that describes the flight guidance in terms of aircraft behaviors instead of control modes. The study was performed in a simulator that was used to run a complete flight with actual airline pilots. Three groups were used to evaluate the guidance display and training. In the training, condition, participants went through a training program for vertical guidance before flying the simulation. In the display condition, participants ran through the same training program and then flew the experimental scenario with the new Guidance-Flight Mode Annunciator (G-FMA). Results showed improved pilot performance when given training specifically for the vertical guidance logic and greater improvements when given the training and the new G-FMA. Using actual behavior of the avionics to design pilot training and FMA is feasible, and when the automated vertical guidance mode of the Flight Management System is engaged, the display of the guidance mode and targets yields improved pilot performance.

  8. Guidance for Total Development.

    ERIC Educational Resources Information Center

    Van Hoose, William H.

    Elementary guidance, deriving much of its content from the developmental phenomena of middle childhood, is viewed as the maximization of human potentiality in the total range of the population. Included in the list of elementary school guidance objectives are (1) aiding academic development, (2) helping children develop health self-concepts, (3)…

  9. UMTRA Project document control system manual

    SciTech Connect

    Not Available

    1994-09-01

    This manual defines the Project Document Control System (PDCS) operated by the US DOE Uranium Mill tailings Remedial Action (UMTRA) project Office. The purpose of the PDCS is to provide an active and continuing program for acquiring, controlling, retaining, retrieving, retiring and disposing of all UMTRA Project documents. The PDCS also provides guidance and coordination in transferring documents by various UMTRA Projection document control centers to a central location.

  10. 76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug... Pulse Generator.'' This draft guidance document describes a means by which external pacemaker pulse generators may comply with the requirement of special controls for class II devices. This draft guidance...

  11. 76 FR 72952 - Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  12. 76 FR 20679 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  13. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  14. 76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  15. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  16. 77 FR 35688 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... HUMAN SERVICES Food and Drug Administration Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  17. 78 FR 52777 - Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... HUMAN SERVICES Food and Drug Administration (Formerly Docket No. 2007D-0168) Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  19. 77 FR 35259 - Guidance on Due Diligence Requirements in Determining Whether Securities Are Eligible for Investment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

    ... 29, 2011 (76 FR 73777), the OCC issued proposed guidance together with a notice of proposed... investment securities under section 5(c) of the Home Owners' Loan Act (HOLA), to the extent specified...

  20. 40 CFR 132.1 - Scope, purpose, and availability of documents.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... PROGRAMS WATER QUALITY GUIDANCE FOR THE GREAT LAKES SYSTEM § 132.1 Scope, purpose, and availability of documents. (a) This part constitutes the Water Quality Guidance for the Great Lakes System (Guidance... Critical Programs Act of 1990 (Pub. L. 101-596, 104 Stat. 3000 et seq.). The Guidance in this...

  1. Third-party biller compliance guidance emphasizes risk awareness.

    PubMed

    Saner, R J

    1999-03-01

    The voluntary compliance guidance for third-party billing companies released by the HHS Office of Inspector General (OIG) in December 1998, like the OIG's previously released guidance directed at hospitals, home health agencies, and clinical laboratories, identifies seven minimum elements for an effective corporate compliance program: written compliance policies, designation of a compliance officer, ongoing training, open lines of communication, guidelines to ensure the enforcement of compliance standards, internal monitoring and auditing of compliance activity, and procedures to respond to and correct errors. Three areas of concern for third-party billing companies are emphasized in the new guidance document: compliance risk, claims documentation, and disclosure of suspected misconduct or fraud.

  2. A guide to CERCLA site assessment. Environmental Guidance

    SciTech Connect

    Not Available

    1994-02-01

    This Pocket Guide is a condensed version of information provided in three EPA documents: Guidance for Performing Preliminary Assessments Under CERCLA, Guidance for Performing Site Inspections Under CERCLA, and Hazard Ranking System Guidance Manual. Additionally the guide provides a DOE perspective on site assessment issues and information on the Federal Agency Hazardous Waste Compliance Docket as well as data sources for DOE site assessments. The guide is intended to present this information in a simple, portable, and direct manner that will allow the user to effectively focus on those aspects of the site assessment process of interest. The guide is not intended as a substitute for the three EPA guidance documents mentioned previously. DOE investigators should be thoroughly familiar with the EPA guidance before conducting site assessments. Use this pocketguide as an overview of procedures and requirements and as a field guide.

  3. 78 FR 16046 - Proposed Collection; Comment Request for Notice 2010-6

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... Internal Revenue Service Proposed Collection; Comment Request for Notice 2010-6 AGENCY: Internal Revenue...(c)(2)(A)). Currently, the IRS is soliciting comments concerning Notice 2010-6, Relief and Guidance... Section 409A(a). OMB Number: 1545-2164. Notice Number: Notice 2010-6 Abstract: Notice 2010-6 requires...

  4. Termination Documentation

    ERIC Educational Resources Information Center

    Duncan, Mike; Hill, Jillian

    2014-01-01

    In this study, we examined 11 workplaces to determine how they handle termination documentation, an empirically unexplored area in technical communication and rhetoric. We found that the use of termination documentation is context dependent while following a basic pattern of infraction, investigation, intervention, and termination. Furthermore,…

  5. Declassified Documents.

    ERIC Educational Resources Information Center

    Brown, Karen M.

    Journalists and other investigators are daily using declassified government documents to shed light on historical and current events, but few have discovered how to tap the wealth of documents once classified but now in the public realm. An executive order from President Reagan eliminating declassification procedures and allowing released…

  6. 77 FR 9947 - Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

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

  7. 77 FR 6625 - Meeting the Challenge of Pandemic Influenza: Ethical Guidance for Leaders and Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-08

    ...The Department of Veterans Affairs (VA) through its National Center for Ethics in Health Care (NCEHC) invites interested parties to comment on a guidance document entitled ``Meeting the Challenge of Pandemic Influenza: Ethical Guidance for Leaders and Health Care Professionals in the Veterans Health Administration.'' (Guidance). VA is committed to an open and engaged stakeholder process and......

  8. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief; Draft Guidance for Industry and FDA... for Pain Relief Intended for Over the Counter Use; Draft Guidance for Industry and FDA Staff''; (5... Output for Pain Relief; Draft Guidance for Industry and FDA Staff''; (6) ``Class II Special...

  9. 76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft

    Federal Register 2010, 2011, 2012, 2013, 2014

    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... Language in Informed Consent document to the Division of Policy and Assurances, Office for Human...

  10. 78 FR 17943 - Draft Program-Specific Guidance About Fixed Gauge Licenses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ... COMMISSION Draft Program-Specific Guidance About Fixed Gauge Licenses AGENCY: Nuclear Regulatory Commission... revising its licensing guidance for fixed gauge licenses. The NRC is requesting public comment on draft... Guidance About Fixed Gauge Licenses.'' The document has been updated from the previous revision to...

  11. Access to Vocational Guidance for People at Risk of Social Exclusion.

    ERIC Educational Resources Information Center

    Clayton, Pamela M., Ed.; Fojcik, Vavrinec; Greco, Silvana; Hulkko, Johanna; Kelly, Eimer; Kostka, Miroslav; McGill, Paul; Machackova, D.; Maiello, Marco; Makela, Eija; Sinorova, Lenka; Troska, Robert; Ward, Mary

    This document contains 7 papers that evolved from 44 case studies of access to vocational guidance for people at risk of social exclusion in 5 European countries. The following papers are included: "Introduction" (Pamela Clayton); "Access to Vocational Guidance in Italy" (Silvana Greco, Marco Maiello); "Access to Vocational Guidance in Ireland"…

  12. Sandia Software Guidelines, Volume 2. Documentation

    SciTech Connect

    1995-09-01

    This volume is one in a series of Sandia Software Guidelines intended for use in producing quality software within Sandia National Laboratories. In consonance with the IEEE Standards for software documentation, this volume provides guidance in the selection of an adequate document set for a software project and example formats for many types of software documentation. A tutorial on life cycle documentation is also provided. Extended document thematic outlines and working examples of software documents are available on electronic media as an extension of this volume.

  13. 75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    .... 0910-0037; 73 FR 11649 at 11650, March 4, 2008). In that analysis, we estimated that there are 8,950... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Acidified Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration...

  14. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... Affecting the Hematopoietic System.'' That draft guidance, when finalized, is intended to supersede the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Investigational... Hematopoietic System; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  15. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications; 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 of the guidance...

  16. 77 FR 13172 - Guidance on the Use of Rounding in Air Fare Advertisements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-05

    ... recent consumer rule, ``Enhancing Airline Consumer Protections'' (14 CFR 399.84, 76 FR 23110, 23166, Apr... Office of The Secretary Guidance on the Use of Rounding in Air Fare Advertisements AGENCY: Office of the... Fare Advertisements. SUMMARY: The Department is publishing the following notice providing guidance...

  17. 77 FR 24722 - Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes...

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  18. 75 FR 14604 - Guidance for Industry on Anesthetics for Companion Animals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... Federal Register of December 17, 2008, (73 FR 76657), FDA published the notice of availability for a draft... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Anesthetics for Companion Animals... Administration (FDA) is announcing the availability of Guidance for Industry 192 entitled ``Anesthetics...

  19. 77 FR 38305 - Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus-Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ... a notice published in the Federal Register of June 22, 2010 (75 FR 35492), FDA announced the... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus--Developing Medical Products for Treatment; Withdrawal of Guidance AGENCY: Food...

  20. 75 FR 73109 - Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  1. 75 FR 45641 - Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  2. 76 FR 58018 - Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; 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...

  3. 77 FR 13384 - Additional Guidance on Airfare/Air Tour Price Advertisements; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-06

    ... Register of February 27, 2012, in Vol. 38, at 77 FR 11618, on page 11619, in the last paragraph, correct... TRANSPORTATION Office of the Secretary Additional Guidance on Airfare/Air Tour Price Advertisements; Correction... Department published a notice entitled ``Additional Guidance on Airfare/Air Tour Price Advertisements,''...

  4. 78 FR 68852 - Draft Guidance for Industry on Acrylamide in Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  5. 75 FR 67397 - Proposed Guidance on Appointment of Lobbyists to Federal Boards and Commissions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-02

    ... BUDGET Proposed Guidance on Appointment of Lobbyists to Federal Boards and Commissions AGENCY: Office of Management and Budget. ACTION: Notice of proposed guidance. SUMMARY: The Office of Management and Budget (OMB... commissions. That memorandum directed the Office of Management and Budget to propose implementing...

  6. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... 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 revises the March 2007 guidance entitled ``Drug Safety Information-- FDA's Communication to the Public.''...

  7. 78 FR 44572 - Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for...

  8. A CASE STUDY DEMONSTRATING GUIDANCE FOR EVALUATING LANDFILL GAS EMISSIONS FROM CLOSED OR ABANDONED FACILITIES--SOMERSWORTH, NEW HAMPSHIRE

    EPA Science Inventory

    The purpose of the activities described in this document is to provide a demonstration of the procedures and methodologies described within the "Guidance for Evaluating Landfill Gas Emissions from Closed or Abandoned Facilities" (Guidance). This demonstration provides an example ...

  9. 76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... Notifications .'' FDA developed this draft guidance document to provide a contemporary perspective on how FDA... This draft guidance serves to update FDA's perspective on the Agency's approach to the 510(k)...

  10. 75 FR 53971 - Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ...; Impact-Resistant Lenses: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Impact-Resistant Lenses: Questions and Answers.'' This guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including questions on...

  11. 78 FR 14097 - Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ... Federal Register of July 19, 2007 (72 FR 39631), FDA announced the availability of the draft guidance... developed this guidance document to assist industry in preparing a Premarket Notification (510(k)) for...

  12. 76 FR 55068 - Mobile Medical Applications Draft Guidance; Public Workshop; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-06

    ... FR 50231). The document announced a public workshop entitled ``Mobile ] Medical Applications Draft... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications Draft Guidance; Public Workshop... transcripts of the meeting?'' This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce...

  13. 76 FR 48870 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug..., Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD...

  14. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Administration (FDA) is correcting a notice that appeared in the Federal Register of April 25, 2011 (76 FR...

  15. Interoperable Documentation

    NASA Astrophysics Data System (ADS)

    Habermann, T.

    2011-12-01

    Documentation provides the context that adds understanding and knowledge to data. The ISO Standards for documenting data (19115, 19115-2), and services (19119) extend the range of standard documentation considerably beyond previously available approaches. They include increased utilization of technologies like UML, XML and linking and content areas like data quality and processing history. These extensions can build an emerging foundation of data interoperability into an infrastructure for interoperable understanding. This process will involve active collaboration between many environmental data providers and archives all over the world that are currently in the process of adopting and understanding how to effectively use the ISO Standards. I will describe ISO capabilities in the context of parallels between metadata tools and data interoperability approaches currently used by scientists and decision-makers. I will demonstrate how directories shared over the web, transport standards, and community conventions build the foundation for documentation access and data understanding. I will also demonstrate crosswalks and connections between ISO, THREDDS, and NetCDF documentation and some ideas and approaches to improving documentation across the entire spectrum of environmental data and products.

  16. Comprehensive Guidance Programs That Work.

    ERIC Educational Resources Information Center

    Gysbers, Norman C.; And Others

    This monograph describes how the comprehensive guidance model is transforming elementary-secondary school guidance and counseling programs in schools across the country. It incorporates the ideas and experiences of 12 guidance program developers in the actual use of the comprehensive guidance model in diverse school and cultural settings. The book…

  17. Safety of magnetic fusion facilities: Guidance

    SciTech Connect

    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.

  18. Radon Reduction Techniques in Schools: Interim Technical Guidance.

    ERIC Educational Resources Information Center

    Environmental Protection Agency, Washington, DC.

    This technical document is intended to assist school facilities maintenance personnel in the selection, design, and operation of radon reduction systems in schools. The guidance contained in this document is based largely on research conducted in 1987 and 1988 in schools located in Maryland and Virginia. Researchers from the United States…

  19. Asset Management Plans, Appraisal Guidance for 2003-04.

    ERIC Educational Resources Information Center

    Department for Education and Skills, London (England).

    This document is one in a series which aims to assist Local Authorities in Britain with asset management planning (AMPs) for schools. AMPs set out the information needed, and the criteria used, to make decisions about spending on school premises. The document provides guidance on the appraisal of school AMPs in 2002 to inform 3-year formulaic…

  20. 76 FR 9028 - Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ... Industry: Potency Tests for Cellular and Gene Therapy Products'' dated January 2011. The guidance document provides manufacturers of cellular and gene therapy (CGT) products with recommendations for developing... document entitled ``Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products''...

  1. Guidance for UMTRA project surveillance and maintenance

    SciTech Connect

    1986-01-01

    The Guidance for UMTRA Project Surveillance and Maintenance describes the procedures that will be used to verify that Uranium Mill Tailings Remedial Action (UMTRA) Project disposal sites continue to function as designed. The approach of this guidance document is to identify surveillance requirements and maintenance procedures that will be used to comply with NRC license requirements. This document addresses five primary activities: Definition and characterization of final site conditions. Site inspections; Ground-water monitoring; Aerial photography; and Custodial maintenance and contingency repair. Final site conditions will be defined and characterized prior to the completion of remedial actions at a site. As-built drawings will be compiled, a final topographic survey will be performed, a vicinity map will be prepared, and ground and aerial photographs will be taken. Survey monuments, site markers, and signs will be established as will a network of monitoring wells.

  2. 76 FR 80947 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ..., 2011 (76 FR 70150). In the notice, FDA requested comments on the draft guidance that addresses the.... Background In the Federal Register of November 10, 2011 (76 FR 70150), FDA published a notice announcing the... mitigation strategies, under the investigational device exemption (IDE) requirements. The Agency is...

  3. 77 FR 23713 - Pesticides; Final Guidance on Material Safety Data Sheets as Pesticide Labeling; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-20

    ... relationship between EPA-approved labels for pesticides registered under the Federal Insecticide, Fungicide... AGENCY Pesticides; Final Guidance on Material Safety Data Sheets as Pesticide Labeling; Request for.... SUMMARY: The Agency is announcing the availability of a Pesticide Registration Notice (PR Notice)...

  4. Vocational Guidance and the Labour Market: Guidance to Transform or Guidance to Domesticate?

    ERIC Educational Resources Information Center

    Kann, Ulla

    1988-01-01

    Explores the conflict in guidance arising from the desire to consider the needs of society while guaranteeing individual freedom of choice. Discusses the theoretical basis of vocational guidance. Gives examples of "domestication" and "transformation" approaches to guidance and discusses the consequences of viewing guidance as a change strategy.(KO)

  5. Document Monitor

    NASA Technical Reports Server (NTRS)

    1988-01-01

    The charters of Freedom Monitoring System will periodically assess the physical condition of the U.S. Constitution, Declaration of Independence and Bill of Rights. Although protected in helium filled glass cases, the documents are subject to damage from light vibration and humidity. The photometer is a CCD detector used as the electronic film for the camera system's scanning camera which mechanically scans the document line by line and acquires a series of images, each representing a one square inch portion of the document. Perkin-Elmer Corporation's photometer is capable of detecting changes in contrast, shape or other indicators of degradation with 5 to 10 times the sensitivity of the human eye. A Vicom image processing computer receives the data from the photometer stores it and manipulates it, allowing comparison of electronic images over time to detect changes.

  6. Minimum Competencies for Teaching Undergraduate Sport Philosophy Courses. Guidance Document

    ERIC Educational Resources Information Center

    National Association for Sport and Physical Education, 2004

    2004-01-01

    Although sport philosophy is considered to be a sub-discipline with its own unique body of knowledge, sport philosophy is more commonly offered as a single course rather than a degree program. Therefore, these guidelines are offered specifically for the teaching of a single course at the undergraduate level. In order to be effective, the course…

  7. Minimum Competencies in Undergraduate Motor Development. Guidance Document

    ERIC Educational Resources Information Center

    National Association for Sport and Physical Education, 2004

    2004-01-01

    The minimum competency guidelines in Motor Development described herein at the undergraduate level may be gained in one or more motor development course(s) or through other courses provided in an undergraduate curriculum. The minimum guidelines include: (1) Formulation of a developmental perspective; (2) Knowledge of changes in motor behavior…

  8. A Guidance Document for Kentucky's Oil and Gas Operators

    SciTech Connect

    Bender, Rick

    2002-03-18

    The accompanying report, manual and assimilated data represent the initial preparation for submission of an Application for Primacy under the Class II Underground Injection Control (UIC) program on behalf of the Commonwealth of Kentucky. The purpose of this study was to identify deficiencies in Kentucky law and regulation that would prevent the Kentucky Division of Oil and Gas from receiving approval of primacy of the UIC program, currently under control of the United States Environmental Protection Agency (EPA) in Atlanta, Georgia.

  9. Instructional Framework for Fitness Education in Physical Education. Guidance Document

    ERIC Educational Resources Information Center

    National Association for Sport and Physical Education, 2012

    2012-01-01

    The National Association for Sport and Physical Education's (NASPE) Fitness Education Project team gathered insights from professionals across the country who have worked on national and state physical education standards and district curriculum materials; from content and pedagogy specialists; and from current literature to provide what follows:…

  10. Guidance for evaluation of operational emergency plans

    SciTech Connect

    1995-03-01

    The purpose of this document is to provide guidance for development of emergency plans for the USDOE Office of Defense Programs, Office of Energy Research, and Office of Environmental Management facilities. It gathers emergency planning policy and guidance from applicable federal regulations, DOE Orders and related guidance documents. This material, along with recommended good practices, is presented as a checklist against which emergency plans can be reviewed by DOE Headquarters. The Office of Emergency Response (DP-23), Office of Environment, Safety and Health Technical Support (ER-8), and Office of Transportation, Emergency Management and Analytical Services (EM-26) will use this checklist to evaluate plans submitted by DP, ER, and EM field elements. The scope of this document encompasses plans for operational emergencies at DOE facilities, both nuclear and non-nuclear. Operational emergencies, as defined in Attachment 2 to DOE Order 5500.1B (April 30, 1991) are ``significant accidents, incidents, events, or natural phenomena which seriously degrade the safety or security of DOE facilities. Operational Emergencies apply to DOE reactors and other DOE facilities (nuclear and non-nuclear) involved with hazardous materials; DOE-controlled nuclear weapons, components, or test devices; DOE safeguards and security events; and transportation accidents involving hazardous materials under DOE control.``

  11. Performance Documentation.

    ERIC Educational Resources Information Center

    Foster, Paula

    2002-01-01

    Presents an interview with experts on performance documentation. Suggests that educators should strive to represent performance appraisal writing to students in a way that reflects the way it is perceived and evaluated in the workplace. Concludes that educators can enrich their pedagogy with practice by helping students understand the importance…

  12. Technical approach document

    SciTech Connect

    Not Available

    1989-12-01

    The Uranium Mill Tailings Radiation Control Act (UMTRCA) of 1978, Public Law 95-604 (PL95-604), grants the Secretary of Energy the authority and responsibility to perform such actions as are necessary to minimize radiation health hazards and other environmental hazards caused by inactive uranium mill sites. This Technical Approach Document (TAD) describes the general technical approaches and design criteria adopted by the US Department of Energy (DOE) in order to implement remedial action plans (RAPS) and final designs that comply with EPA standards. It does not address the technical approaches necessary for aquifer restoration at processing sites; a guidance document, currently in preparation, will describe aquifer restoration concerns and technical protocols. This document is a second revision to the original document issued in May 1986; the revision has been made in response to changes to the groundwater standards of 40 CFR 192, Subparts A--C, proposed by EPA as draft standards. New sections were added to define the design approaches and designs necessary to comply with the groundwater standards. These new sections are in addition to changes made throughout the document to reflect current procedures, especially in cover design, water resources protection, and alternate site selection; only minor revisions were made to some of the sections. Sections 3.0 is a new section defining the approach taken in the design of disposal cells; Section 4.0 has been revised to include design of vegetated covers; Section 8.0 discusses design approaches necessary for compliance with the groundwater standards; and Section 9.0 is a new section dealing with nonradiological hazardous constituents. 203 refs., 18 figs., 26 tabs.

  13. Quality in Careers Guidance.

    ERIC Educational Resources Information Center

    Plant, Peter

    This paper examines quality issues in career guidance, counseling, and information services in Europe and elsewhere from a range of different perspectives related to economic, ethical, and/or effectiveness criteria. Selected examples from the European Union member states, Canada, and the United States are used to illustrate how quality is…

  14. Vocational Development and Guidance.

    ERIC Educational Resources Information Center

    Tennyson, W. Wesley; And Others

    The vocational education volume considers questions of career development, the role of guidance in the school, vocational training, the relation of self-concept to vocational choice, and occupational information. Twenty-six papers deal with theories of vocational behavior, the success of vocational education programs, and testing information.…

  15. Biological criteria: Technical guidance for streams and small rivers. Revised edition

    SciTech Connect

    Gibson, G.R.; Barbour, M.T.; Stribling, J.B.; Gerritsen, J.; Karr, J.R.

    1996-05-01

    The goal of this document is to help states develop and use biocriteria for streams and small rivers. The document includes a general strategy for biocriteria development, identifies steps in the process, and provides technical guidance on how to complete each step, using the experience and knowledge of existing state, regional, and national surface water programs. This guidance document is designed primarily for water resource managers and biologists familiar with standard biological survey techiques and similarity familiar with the EPA guidance document `Rapid Bioassessment Protocols for Use in Streams and Rivers; Benthic Macroinvertebrates and Fish` (PB95-194759).

  16. Video document

    NASA Astrophysics Data System (ADS)

    Davies, Bob; Lienhart, Rainer W.; Yeo, Boon-Lock

    1999-08-01

    The metaphor of film and TV permeates the design of software to support video on the PC. Simply transplanting the non- interactive, sequential experience of film to the PC fails to exploit the virtues of the new context. Video ont eh PC should be interactive and non-sequential. This paper experiments with a variety of tools for using video on the PC that exploits the new content of the PC. Some feature are more successful than others. Applications that use these tools are explored, including primarily the home video archive but also streaming video servers on the Internet. The ability to browse, edit, abstract and index large volumes of video content such as home video and corporate video is a problem without appropriate solution in today's market. The current tools available are complex, unfriendly video editors, requiring hours of work to prepare a short home video, far more work that a typical home user can be expected to provide. Our proposed solution treats video like a text document, providing functionality similar to a text editor. Users can browse, interact, edit and compose one or more video sequences with the same ease and convenience as handling text documents. With this level of text-like composition, we call what is normally a sequential medium a 'video document'. An important component of the proposed solution is shot detection, the ability to detect when a short started or stopped. When combined with a spreadsheet of key frames, the host become a grid of pictures that can be manipulated and viewed in the same way that a spreadsheet can be edited. Multiple video documents may be viewed, joined, manipulated, and seamlessly played back. Abstracts of unedited video content can be produce automatically to create novel video content for export to other venues. Edited and raw video content can be published to the net or burned to a CD-ROM with a self-installing viewer for Windows 98 and Windows NT 4.0.

  17. Behavior guidance symposium Workshop B report - training implications.

    PubMed

    Law, Clarice S; Karp, Jeffrey M

    2014-01-01

    The purpose of Workshop B was to discuss the implications of this symposium for training of pediatric dental residents and predoctoral dental students, as well as continuing education for general dentists as related to behavior guidance. Participants also considered the implications of the symposium proceedings for practice in terms of informed consent, practice patterns, and provision of information to patients regarding behavior guidance. Workshop B identified a variety of dental educational methodologies used to promote understanding among dentists who provide pediatric dental care to diverse populations. There was a consensus that the indications, use, and documentation of basic behavior guidance techniques need to be defined and clarified by the American Academy of Pediatric Dentistry and disseminated appropriately. Workshop participants called for the development of asynchronous learning activities such as webinars and instructional videos to further educate dental providers treating children and to legitimize the techniques with parents, healthcare providers, and the general public. Major recommendations from the workshop included: 1) solicit, support, and fund research in behavior guidance for diverse populations, 2) clarify best practices for the use and documentation of basic behavior guidance techniques, 3) identify and define new behavior guidance techniques, 4) promote training in motivational interviewing, 5) encourage integration of symposium proceedings throughout dental education curricula, 6) encourage mentorship networks among general dentists treating children and geographically contiguous pediatric dentists, and 7) develop a library of informational videos for parents and the general public about appropriate behavior guidance techniques used when treating children in dental settings. PMID:24717755

  18. Enhancing Access to Vocational Guidance.

    ERIC Educational Resources Information Center

    Clayton, Pam

    1998-01-01

    Issues in vocational guidance for adults include lack of provision, especially for unemployed or disadvantaged people and the need to publicize existing excellent guidance services and demonstrate their usefulness to this population. (SK)

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

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

  20. Vocational Guidance and Human Development.

    ERIC Educational Resources Information Center

    Herr, Edwin L., Ed.

    New knowledge and practices in the area of vocational guidance and human growth and development that have occurred since 1964 as well as future directions for guidance, both nationally and internationally, are covered in this second volume of a decennial volume series sponsored by the National Vocational Guidance Association to up-date the…

  1. An empirical examination of the current state of publically available nanotechnology guidance materials.

    PubMed

    Fleege, Laura; Lawrenz, Frances

    2012-01-01

    As part of "Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight," an empirical search was conducted to identify publicly available resources that guided understanding about human subjects issues in nanomedicine or nanotechnology including policy statements, guidance documents, or consent forms. The authors conducted 5,083 internet searches and analyzed 175 documents. Results show that very little guidance is publicly available and most documents focused on occupational and environmental concerns.

  2. Trajectory shaping rendezvous guidance

    NASA Astrophysics Data System (ADS)

    Klumpp, A. R.

    The Space Station will bring a great increase in rendezvous traffic. Formerly, rendezvous has been expensive in terms of time and crew involvement. Multiple trajectory adjustments on separate orbits have been required to meet safety, lighting, and geometry requirements. This paper describes a new guidance technique in which the approach trajectory is shaped by a sequence of velocity increments in order to satisfy multiple constraints within a single orbit. The approach phase is planned before the mission, leaving a group of free parameters that are optimized by onboard guidance. Fuel penalties are typically a few percent, compared to unshaped Hohmann transfers, and total fuel costs can be less than those of more time-consuming ways of meeting the same requirements.

  3. 75 FR 53724 - Notice of Availability and Opportunity for Comment on Draft Division of Safety Systems Interim...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... Systems Interim Staff Guidance, (DSS-ISG) DSS-ISG-2010-01, ``Staff Guidance Regarding the Nuclear... COMMISSION Notice of Availability and Opportunity for Comment on Draft Division of Safety Systems Interim Staff Guidance DSS-ISG-2010-01: Staff Guidance Regarding the Nuclear Criticality Safety Analysis...

  4. 75 FR 5632 - Office of New Reactors; Interim Staff Guidance on the Review of Nuclear Power Plant Designs Using...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-03

    ... emergency alternating current power system. This ISG document provides guidance on the implementation of... EGTG systems that are air cooled and diesel oil fueled are considered in this interim guidance. DATES... COMMISSION Office of New Reactors; Interim Staff Guidance on the Review of Nuclear Power Plant Designs...

  5. 76 FR 58846 - Final Interim Staff Guidance: Review of Evaluation To Address Gas Accumulation Issues in Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-22

    ... is to clarify the NRC staff guidance to address issues of gas accumulation in safety related systems... guidance documents. Disposition: On November 12, 2009 (74 FR 58323), the NRC staff issued proposed DC/COL... COMMISSION Final Interim Staff Guidance: Review of Evaluation To Address Gas Accumulation Issues in...

  6. 75 FR 5356 - Office of New Reactors; Final Interim Staff Guidance on Post-Combined License Commitments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... Interim Staff Guidance (ISG) ESP/ DC/COL-ISG-015 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML093561416). This ISG supplements the guidance provided to the NRC staff in Section 1.0... COMMISSION Office of New Reactors; Final Interim Staff Guidance on Post- Combined License Commitments...

  7. 75 FR 8412 - Office of New Reactors: Interim Staff Guidance on Assessing Ground Water Flow and Transport of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ... Interim Staff Guidance (ISG) DC/COL-ISG-014 (Agencywide Documents Access and Management System (ADAMS... COMMISSION Office of New Reactors: Interim Staff Guidance on Assessing Ground Water Flow and Transport of... Certification (DC) applicants additional clarity and guidance for the application of Sections 2.4.12 and...

  8. General Merchandise 50% Energy Savings Technical Support Document

    SciTech Connect

    Hale, E.; Leach, M.; Hirsch, A.; Torcellini, P.

    2009-09-01

    This report documents technical analysis for medium-box general merchandise stores aimed at providing design guidance that achieves whole-building energy savings of at least 50% over ASHRAE Standard 90.1-2004.

  9. Orbitmpi Documentation

    SciTech Connect

    Lisa L. Lowe

    2000-10-05

    Orbitmpi is a parallelized version of Roscoe White's Orbit code. The code has been parallelized using MPI, which makes it portable to many types of machines. The guidelines used for the parallelization were to increase code performance with minimal changes to the code's original structure. This document gives a general description of how the parallel sections of the code run. It discusses the changes made to the original code and comments on the general procedure for future additions to Orbitmpi, as well as describing the effects of a parallelized random number generator on the code's output. Finally, the scaling results from Hecate and from Puffin are presented. Hecate is a 64-processor Origin 2000 machine, with MIPS R12000 processors and 16GB of memory, and Puffin is a PC cluster with 9 dual-processor 450 MHz Pentium III (18 processors max.), with 100Mbits ethernet communication.

  10. 78 FR 28228 - Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Healthcare Data; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA...

  11. 76 FR 5387 - Guidance for Industry and Food and Drug Administration Staff; “`Harmful and Potentially Harmful...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 10, 2010 (75 FR 32952), FDA announced... Food, Drug, and Cosmetic Act''; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' This guidance provides written guidance...

  12. 78 FR 72901 - Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... November 23, 1998 (63 FR 64723), FDA announced the availability of a guidance entitled ``Enforcement Policy... withdrawn. In a notice published in the Federal Register of June 7, 2002 (67 FR 39409), FDA announced the... Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidances AGENCY: Food...

  13. 78 FR 2676 - Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abuse-Deterrent Opioids-- Evaluation and Labeling; 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...

  14. 76 FR 55384 - External Peer Review Meeting for the Draft Guidance of Applying Quantitative Data To Develop Data...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... AGENCY External Peer Review Meeting for the Draft Guidance of Applying Quantitative Data To Develop Data... Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA is announcing that Eastern Research Group, Inc. (ERG..., ``Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies...

  15. 77 FR 69634 - Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of guidance...

  16. 76 FR 20689 - Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ....'' Because of the public health implications of both epidemic and pandemic influenza, the variable nature of... effects under epidemic and pandemic conditions. A draft notice of availability of this guidance was... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Influenza: Developing Drugs...

  17. 78 FR 44573 - Guidance for Industry on Providing Submissions in Electronic Format-Postmarket Non-Expedited...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Providing Submissions in Electronic...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance to industry entitled ``Providing Submissions...

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

    EPA Science Inventory

    The purpose of the activities described in this document is to provide a demonstration of the procedures and methodologies described within the "Guidance for Evaluating Landfill Gas Emissions from Closed or Abandoned Facilities" (Guidance). This demonstration provides an example ...

  19. 40 CFR 132.1 - Scope, purpose, and availability of documents.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... PROGRAMS WATER QUALITY GUIDANCE FOR THE GREAT LAKES SYSTEM § 132.1 Scope, purpose, and availability of documents. (a) This part constitutes the Water Quality Guidance for the Great Lakes System (Guidance... identifies minimum water quality standards, antidegradation policies, and implementation procedures for...

  20. 40 CFR 132.1 - Scope, purpose, and availability of documents.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... PROGRAMS WATER QUALITY GUIDANCE FOR THE GREAT LAKES SYSTEM § 132.1 Scope, purpose, and availability of documents. (a) This part constitutes the Water Quality Guidance for the Great Lakes System (Guidance... identifies minimum water quality standards, antidegradation policies, and implementation procedures for...

  1. 40 CFR 132.1 - Scope, purpose, and availability of documents.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... PROGRAMS WATER QUALITY GUIDANCE FOR THE GREAT LAKES SYSTEM § 132.1 Scope, purpose, and availability of documents. (a) This part constitutes the Water Quality Guidance for the Great Lakes System (Guidance... identifies minimum water quality standards, antidegradation policies, and implementation procedures for...

  2. HFE Process Guidance and Standards for potential application to updating NRC guidance

    SciTech Connect

    Jacques Hugo; J. J. Persensky

    2012-07-01

    The U.S. Nuclear Regulatory Commission (NRC) reviews and evaluates the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodic update and improvement of these guidance documents to ensure that they remain state-of-the-art design evaluation tools. Thus, the NRC has initiated a project with BNL to update the NRC guidance to remain current with recent research on human performance, advances in HFE methods and tools, and new technology. INL supported Brookhaven National Lab (BNL) to update the detailed HFE review criteria contained in NUREG-0711 and NUREG-0700 based on (1) feedback obtained from end users, (2) the results of NRC research and development efforts supporting the NRC staff’s HFE safety reviews, and (3) other material the project staff identify as applicable to the update effort. INL submitted comments on development plans and sections of NUREGs 0800, 0711, and 0700. The contractor prepared the report attached here as the deliverable for this work.

  3. Builders Challenge Quality Criteria Support Document

    SciTech Connect

    2009-06-01

    This document provides guidance to U.S. home builders participating in Builders Challenge. To qualify for the Builders Challenge, a home must score 70 or less on the EnergySmart Home Scale (E-Scale). Homes also must meet the Builders Challenge Quality Cri

  4. Phase contrast image guidance for synchrotron microbeam radiotherapy

    NASA Astrophysics Data System (ADS)

    Pelliccia, Daniele; Crosbie, Jeffrey C.; Larkin, Kieran G.

    2016-08-01

    Recent image guidance developments for preclinical synchrotron microbeam radiotherapy represent a necessary step for future clinical translation of the technique. Image quality can be further improved using x-ray phase contrast, which is readily available at synchrotron facilities. We here describe a methodology for phase contrast image guidance at the Imaging and Medical Beamline at the Australian Synchrotron. Differential phase contrast is measured alongside conventional attenuation and used to improve the image quality. Post-processing based on the inverse Riesz transform is employed on the measured data to obtain noticeably sharper images. The procedure is extremely well suited for applications such as image guidance which require both visual assessment and sample alignment based on semi automatic image registration. Moreover, our approach can be combined with all other differential phase contrast imaging techniques, in all cases where a quantitative evaluation of the refractive index is not required.

  5. Omega documentation

    SciTech Connect

    Howerton, R.J.; Dye, R.E.; Giles, P.C.; Kimlinger, J.R.; Perkins, S.T.; Plechaty, E.F.

    1983-08-01

    OMEGA is a CRAY I computer program that controls nine codes used by LLNL Physical Data Group for: 1) updating the libraries of evaluated data maintained by the group (UPDATE); 2) calculating average values of energy deposited in secondary particles and residual nuclei (ENDEP); 3) checking the libraries for internal consistency, especially for energy conservation (GAMCHK); 4) producing listings, indexes and plots of the library data (UTILITY); 5) producing calculational constants such as group averaged cross sections and transfer matrices for diffusion and Sn transport codes (CLYDE); 6) producing and updating standard files of the calculational constants used by LLNL Sn and diffusion transport codes (NDFL); 7) producing calculational constants for Monte Carlo transport codes that use group-averaged cross sections and continuous energy for particles (CTART); 8) producing and updating standard files used by the LLNL Monte Carlo transport codes (TRTL); and 9) producing standard files used by the LANL pointwise Monte Carlo transport code MCNP (MCPOINT). The first four of these functions and codes deal with the libraries of evaluated data and the last five with various aspects of producing calculational constants for use by transport codes. In 1970 a series, called PD memos, of internal and informal memoranda was begun. These were intended to be circulated among the group for comment and then to provide documentation for later reference whenever questions arose about the subject matter of the memos. They have served this purpose and now will be drawn upon as source material for this more comprehensive report that deals with most of the matters covered in those memos.

  6. Guidance of Nonlinear Systems

    NASA Technical Reports Server (NTRS)

    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.

  7. Guidance of Nonlinear Systems

    NASA Technical Reports Server (NTRS)

    Meyer, George; Null, Cynthia H. (Technical Monitor)

    1996-01-01

    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 coordination, 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.

  8. Controls and guidance: Space

    NASA Technical Reports Server (NTRS)

    Dibattista, John D.

    1988-01-01

    The Space Controls and Guidance Research and Technology Program is directed toward enabling the next generation of space transportation systems, large future spacecraft, and space systems such as the Space Station to have large communication antennas and high precision segmented reflector astrophysical telescopes. The new generation of transportation vehicles has demanding requirements to provide for an order of magnitude reduction in cost as well as an increase in capability. The future orbital facilities have demanding control requirements for pointing and stabilization, momentum management, build-up and growth accomodation, and disturbance management. To address these advanced requirements, the research and development program is designed to provide the generic technology base to support the implementation of advanced guidance, navigation, and control. The area of computational controls will be stressed in order to develop cost effective, high speed, high fidelity control system simulation and analysis and synthesis tools. The trust of this work will be to develop methods and software to enable analysis and real-time hardware-in-the-loop simulation of complex spacecraft for control design certification. To address future orbital facilities requirements, an advanced technology program is underway in system identification, distributed control, integrated controls/structures design methods, and advanced sensors and actuators. Because the behavior of large, light weight per unit area deployable/assembled spacecraft is greatly influenced by the ground environment, the testing and verification activity is both ground- and space-based.

  9. Bilinear tangent yaw guidance

    NASA Technical Reports Server (NTRS)

    Brusch, R. G.

    1979-01-01

    This paper presents a parametric yaw steering law which has been used to provide closed-loop yaw guidance for the launch of the HEAO (High Energy Astronomy Observatory) satellite mission using the Atlas/Centaur launch vehicle. This bilinear tangent steering law provides near optimal yaw steering for maneuvers requiring insertion into orbits with a specified inclination and node. Bilinear tangent steering is shown to be optimal in both the pitch and yaw planes when a uniform gravitational field is assumed. The conditions under which the general bilinear tangent laws degenerate into linear tangent and constant attitude laws are presented. The flight computer implementation of these laws in a rotating coordinate system using real-time integration of the equations of motion is detailed. Explicit solution of the parametric guidance equations requires the inflight solution of (2x2) two-point boundary value problems in the pitch and yaw planes. Excellent results are obtained even for very large (greater than 50 deg) out-of-plane steering angles.

  10. Asbestos/NESHAP adequately wet guidance

    SciTech Connect

    Shafer, R.; Throwe, S.; Salgado, O.; Garlow, C.; Hoerath, E.

    1990-12-01

    The Asbestos NESHAP requires facility owners and/or operators involved in demolition and renovation activities to control emissions of particulate asbestos to the outside air because no safe concentration of airborne asbestos has ever been established. The primary method used to control asbestos emissions is to adequately wet the Asbestos Containing Material (ACM) with a wetting agent prior to, during and after demolition/renovation activities. The purpose of the document is to provide guidance to asbestos inspectors and the regulated community on how to determine if friable ACM is adequately wet as required by the Asbestos NESHAP.

  11. Partial stabilization-based guidance.

    PubMed

    Shafiei, M H; Binazadeh, T

    2012-01-01

    A novel nonlinear missile guidance law against maneuvering targets is designed based on the principles of partial stability. It is demonstrated that in a real approach which is adopted with actual situations, each state of the guidance system must have a special behavior and asymptotic stability or exponential stability of all states is not realistic. Thus, a new guidance law is developed based on the partial stability theorem in such a way that the behaviors of states in the closed-loop system are in conformity with a real guidance scenario that leads to collision. The performance of the proposed guidance law in terms of interception time and control effort is compared with the sliding mode guidance law by means of numerical simulations.

  12. 75 FR 44844 - Proposed Collection; Comment Request for Notice 2007-46 (NOT-146367-06).

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-29

    ...-146367-06), Guidance Regarding Heavy Hybrid Vehicles. DATES: Written comments should be received on or... INFORMATION: Title: Guidance Regarding Heavy Hybrid Vehicles. OMB Number: 1545-2060. Notice Number: Notice... medium-duty and heavy-duty hybrid vehicles to rely on domestic manufacturer's (or, in the case of...

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

    SciTech Connect

    Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A.; Tingle, W.

    1997-05-01

    As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ``Applications for the Use of Sealed Sources in Portable Gauging Devices,`` and in NMSs Policy and guidance Directive 2-07, ``Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.`` This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications.

  14. Environmental guidance for public participation in environmental restoration activities

    SciTech Connect

    Not Available

    1991-11-01

    The US Department of Energy (DOE) is issuing this document, entitled Guidance on Public Participation for US Department of Energy Environmental Restoration Activities, to summarize policy and provide guidance for public participation in environmental restoration activities at DOE Headquarters, Field Offices, facilities, and laboratories. While the Office of Environmental Restoration and Waste Management (EM) has environmental restoration responsibility for the majority of DOE sites and facilities, other DOE Project Offices have similar responsibilities at their sites and facilities. This guidance is applicable to all environment restoration activities conducted by or for DOE under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA); the Resource Conservation and Recovery Act of 1976 (RCRA) as amended by the Hazardous and Solid Waste Amendments of 1984 (HSWA) (corrective actions only); and the National Environmental Policy Act of 1969 (NEPA). This guidance also is applicable to CERCLA remedial action programs under the Uranium Mill Tailings Radiation Control Act of 1978 and the Formerly Utilized Sites Remedial Action Program, where DOE is the designated lead. The primary objectives of this guidance document are as follows: acclimate DOE staff to a changing culture that emphasizes the importance of public participation activities; provide direction on implementing these public participation activities; and, provide consistent guidance for all DOE Field Offices and facilities. The purpose of this document is to provide guidance on conducting effective public participation activities for environmental restoration activities under CERCLA; RCRA corrective actions under sections 3004(u), 3004(v), and 3008(h); and NEPA public participation activities.

  15. Third-party biller compliance guidance emphasizes risk awareness.

    PubMed

    Saner, R J

    1999-03-01

    The voluntary compliance guidance for third-party billing companies released by the HHS Office of Inspector General (OIG) in December 1998, like the OIG's previously released guidance directed at hospitals, home health agencies, and clinical laboratories, identifies seven minimum elements for an effective corporate compliance program: written compliance policies, designation of a compliance officer, ongoing training, open lines of communication, guidelines to ensure the enforcement of compliance standards, internal monitoring and auditing of compliance activity, and procedures to respond to and correct errors. Three areas of concern for third-party billing companies are emphasized in the new guidance document: compliance risk, claims documentation, and disclosure of suspected misconduct or fraud. PMID:10351055

  16. SCP (Site Characterization Plan) conceptual design criteria document

    SciTech Connect

    Naiknimbalkar, N.M.

    1985-05-01

    This SCP Conceptual Design Criteria Document was developed to guide engineering efforts for Engineering Study No. 10, the supporting document for Chapter 6 of the SCP. The document provides regulatory design guidance, design rationale derived from the Generic Requirements for a Mined Geological Disposal System document, site-specific criteria, and design assumptions. Appendices were added to provide additional information on geology and seals design.

  17. Site Characterization Plan (SCP) conceptual design criteria document

    SciTech Connect

    Naiknimbalkar, N.M.

    1986-05-19

    This SCP Conceptual Design Criteria Document was developed to guide engineering effort for Engineering Study No. 10, the supporting document for Chapter 6 of the SCP. The document provides regulatory design guidance, design rationale derived from the Generic Requirements for a Mined Geological Disposal System document, site-specific criteria, and design assumptions. Appendices were added to provide additional information on geology and seals design. 24 figs., 15 tabs.

  18. CDC Guidance for State and Local Public Health Officials and School Administrators for School (K-12) Responses to Influenza during the 2009-2010 School Year

    ERIC Educational Resources Information Center

    Centers for Disease Control and Prevention, 2009

    2009-01-01

    This document provides guidance to help decrease the spread of flu among students and school staff during the 2009-2010 school year. This document expands upon earlier school guidance documents by providing a menu of tools that school and health officials can choose from based on conditions in their area. It recommends actions to take this school…

  19. Buried Waste Integrated Demonstration Technology Preparedness and Status Report Guidance

    SciTech Connect

    Blacker, P.B.; Bonnenberg, R.W.; Cannon, P.G.; Hyde, R.A.; Watson, L.R.

    1994-04-01

    A Technology Preparedness and Status Report is required for each Technical Task Plan funded by the Buried Waste Integrated Demonstration. This document provides guidance for the preparation of that report. Major sections of the report will include a subset of the need for the technology, objectives of the demonstration, technology description and readiness evaluation, demonstration requirements, and preparedness checklist and action plan.

  20. US EPA GLOBAL POSITIONING SYSTEMS - TECHNICAL IMPLEMENTATION GUIDANCE

    EPA Science Inventory

    The U.S. EPA Geospatial Quality Council (GQC) was formed in 1998 to provide Quality Assurance guidance for the development, use, and products of geospatial activities and research. The long-term goals of the GQC are expressed in a living document, currently the EPA Geospatial Qua...

  1. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... understanding, or other communications directed to individual persons or firms. (c) What other terms have a... communication that are excluded from the definition of guidance document to informally communicate new or... publish, both in the Federal Register and on the Internet, a list of possible topics for future...

  2. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... understanding, or other communications directed to individual persons or firms. (c) What other terms have a... communication that are excluded from the definition of guidance document to informally communicate new or... publish, both in the Federal Register and on the Internet, a list of possible topics for future...

  3. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... understanding, or other communications directed to individual persons or firms. (c) What other terms have a... communication that are excluded from the definition of guidance document to informally communicate new or... publish, both in the Federal Register and on the Internet, a list of possible topics for future...

  4. 77 FR 19417 - Proposed Guidance on Leveraged Lending

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

    ... Rulemaking, 77 FR 3408 (January 24, 2012). II. Principal Elements of the Proposed Guidance In April 2001, the... information collection number: FR 4203. ] OMB Control No.: To be assigned by OMB. Estimated number of... documenting enterprise value, risk management expectations for credits awaiting distribution, stress...

  5. Identification of technical guidance related to ground water monitoring

    SciTech Connect

    Vogelsberger, R.R.; Smith, E.D.; Broz, M.; Wright, J.C. Jr.

    1987-05-01

    Monitoring of ground water quality is a key element of ground water protection and is mandated by several federal and state laws concerned with water quality or waste management. Numerous regulatory guidance documents and technical reports discuss various aspects of ground water monitoring, but at present there is no single source of guidance on procedures and practices for ground water monitoring. This report is intended to assist US Department of Energy (DOE) officials and facility operating personnel in identifying sources of guidance for developing and implementing ground water monitoring programs that are technically sound and that comply with applicable regulations. Federal statutes and associated regulations were reviewed to identify requirements related to ground water monitoring, and over 160 documents on topics related to ground water monitoring were evaluated for their technical merit, their utility as guidance for regulatory compliance, and their relevance to DOE's needs. For each of 15 technical topics involved in ground water monitoring, the report presents (1) a review of federal regulatory requirements and representative state requirements, (2) brief descriptions of the contents and merits of available guidance documents and technical references, and (3) recommendations of the guidance documents or other technical resources that appear to be most appropriate for use in DOE's monitoring activities. The contents of the report are applicable to monitoring activities involving both radioactive and nonradioactive substances. The main sources of regulatory requirements considered in the report are the Atomic Energy Act (including the Uranium Mill Tailings Radiation Control Act), Resource Conservation and Recovery Act, Comprehensive Environmental Response, Compensation and Liability Act, Safe Drinking Water Act, Toxic Substances Control Act, and Federal Water Pollution Control Act.

  6. 78 FR 11235 - Information Collection Notice/NASA Great Moonbuggy Race

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ... SPACE ADMINISTRATION Information Collection Notice/NASA Great Moonbuggy Race AGENCY: National Aeronautics and Space Administration (NASA). ACTION: NASA Information Collection Notice; Correction. Federal Register Citation of Previous Announcement: 76 FR 23339, Document Number 2013-01648, Notice Number...

  7. 76 FR 80946 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ... recommendations on postmarketing serious adverse event reporting for nonprescription (over-the-counter) human... that should be included in a serious adverse event report, the label that should be included with the...) and described in the guidance. This guidance document discusses what should be included in a...

  8. 75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

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

  9. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-20

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

  10. 77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    .... On June 22, 2011 (76 FR 36542), FDA announced the availability of the draft guidance document...) Device Systems.'' On December 6, 2011 (76 FR 76166), FDA announced the availability of the draft guidance...; The Content of Investigational Device Exemption and Premarket Approval Applications for...

  11. 75 FR 67987 - Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ... regarding cellular delivery systems. In the Federal Register of April 2, 2009 (74 FR 14992), FDA announced... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Cellular Therapy for Cardiac Disease... Therapy for Cardiac Disease'' dated October 2010. The guidance document provides sponsors who...

  12. 78 FR 20103 - Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-03

    ... AGENCY Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures AGENCY..., on Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures. This document is... for Diagnostic X-rays,'' which was released in October 1976. The recommendations contained in...

  13. 75 FR 41452 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-16

    ... peer-reviewed life cycle methodologies is beyond the scope of the current version of this guidance... request comment on inclusion of life cycle methodologies in future versions of this Guidance document. CEQ... Leadership in Environmental, Energy, and Economic Performance (74 FR 52117) in order to establish...

  14. 75 FR 49913 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... peer-reviewed life cycle methodologies is beyond the scope of the current version of this guidance... request comment on inclusion of life cycle methodologies in future versions of this Guidance document. CEQ..., Energy, and Economic Performance (74 FR 52117) in order to establish an integrated strategy...

  15. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.'' This guidance document has been developed to promote the initiation of clinical investigations to evaluate medical devices under FDA's IDE regulations. In an effort to promote timely clinical investigations in......

  16. Reliability history of the Apollo guidance computer

    NASA Technical Reports Server (NTRS)

    Hall, E. C.

    1972-01-01

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

  17. Beyond Discipline to Guidance: A Primer on the Guidance Alternative.

    ERIC Educational Resources Information Center

    Gartrell, Dan

    As early childhood teachers apply principles of guidance rather than punishment in their classrooms, they face the challenge of avoiding a slippage into traditional discipline practices and transcending the punitive aspects of discipline. Guidance is designed to teach children democratic life skills and therefore goes beyond discipline. Teachers…

  18. The Talos guidance system

    NASA Astrophysics Data System (ADS)

    Gulick, J.; Hyatt, W. C.; Martin, O. M., Jr.

    1982-06-01

    A description is given of the design principles and performance capabilities of the Talos surface-to-air missile's homing system, which over the course of its development came to be virtually unjammable, as well as the associated antiradiation seeker, which enables the Talos to operate against radar signal-emitting targets. The interferometric homing system chosen employs widely spaced, airframe-fixed antennas compatible with ramjet inlet geometry and simpler than the alternative gimballed dish antenna. Early Talos missile guidance systems used scanning interferometry, but for subsequent models a continuous wave interferometer was developed, followed by a monopulse seeker. Attention is given to the use of the Talos system as a long range antiradiation missile for radar suppression in the Vietnam conflict.

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

    SciTech Connect

    Brice, D.A.

    1993-09-09

    In today`s litigious society, it is important for both private parties and government to plan and conduct environmental investigations in a scientifically sound manner, documenting the purpose, methods, and results in a consistent fashion throughout the exercise. Planning documents are prepared during the initial phases of environmental investigations. Project objectives, including data quality requirements, specific work to be conducted to fulfill data needs, and operating procedures are specified. Regulatory agency approval of these documents is often required prior to plan implementation. These approvals are necessary and appropriate to fulfilling the agency`s mandated role. Many guidance documents prepared by regulatory agencies suggest the content and format of various scoping documents. These guidances help standardize thought processes and considerations in planning, and provide a template to ensure that both the plan and the proposed work will fulfill regulatory requirements. This work describes the preparation and use of guidance documents for planning environmental studies. The goals and some of the pitfalls of such documents are discussed. Guidance should include the following elements: the purpose of the guidance and a description of where it applies; the type of items to be addressed in planning; identification of requirements are applicable to all projects for which the guidance is intended; identification of requirements only applicable in certain situations; a description of items to facilitate planning; a suggested format for fulfilling requirements; example applications of the guidance. Disagreements arise between planners and reviewers/approvers when elements of guidance are used as leverage to require work not directly related to project objectives. Guidance may be inappropriately used as a milestone by which site-specific plans are judged. Regulatory agency review and approval may be regarded as a primary objective of the plan.

  20. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... for the Topical Approximation of Skin; Availability AGENCY: Food and Drug Administration, HHS. ACTION... Intended for the Topical Approximation of Skin.'' This guidance document describes a means by which tissue adhesives with adjunct wound closure devices intended for the topical approximation of skin may comply...

  1. 77 FR 429 - Clarification and Further Guidance on the Fireworks Approvals Policy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-05

    ... June 29, 2011 (76 FR 38053). Specifically, this document provides clarification and additional guidance... on the Fireworks Approvals Policy AGENCY: Pipeline and Hazardous Materials Safety Administration... policy that it will only accept fireworks approvals applications from fireworks manufacturers or...

  2. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    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)...

  3. GUIDANCE FOR EVALUATING LANDFILL GAS EMISSIONS FROM CLOSED OR ABANDONED FACILITIES

    EPA Science Inventory

    This document provides guidance to Superfund remedial project managers, on scene coordinators, facility owners, and potentially responsible parties for conducting an air pathway analysis for landfill gas (LFG) emissions under the Comprehensive Environmental Response, Compensation...

  4. Sampling quality assurance guidance in support of EM environmental sampling and analysis activities

    SciTech Connect

    Not Available

    1994-05-01

    This document introduces quality assurance guidance pertaining to the design and implementation of sampling procedures and processes for collecting environmental data for DOE`s Office of EM (Environmental Restoration and Waste Management).

  5. Youth Conservation Corps Guidance.

    ERIC Educational Resources Information Center

    Fish and Wildlife Service (Dept. of Interior), Washington, DC.

    This document provides guidelines for operating Youth Conservation Corps programs under both the Fish and Wildlife Service and the National Park Service. The guide contains 11 units that cover the following topics: (1) enrollees; (2) enrollee payroll; (3) enrollee problems; (4) Youth Conservation Corps staff; (5) accounting; (6) operations; (7)…

  6. Guidance: Agent of the Counterculture.

    ERIC Educational Resources Information Center

    Patouillet, Raymond A.; Marin, Roselyn L.

    1979-01-01

    This article was an introduction to a convention program presented at the Florida Personnel and Guidance Association Convention (Tampa, Nov., 1977) by Raymond Patouillet, shortly before his sudden death. It encapsulates his guidance philosophy, his understanding of the human condition, and his faith in the crucial role of the caring profession.…

  7. Innovative Approaches to Career Guidance.

    ERIC Educational Resources Information Center

    Freeman, Andrew R.

    A key part of a broad-based approach to career education in Australian schools is vocational/career guidance. Various vocational guidance programs have been developed for specific groups in Australian society, including work experience, caravans, and micrographics technology for the handicapped; pre-employment courses and a family education center…

  8. Automated Guidance for Student Inquiry

    ERIC Educational Resources Information Center

    Gerard, Libby F.; Ryoo, Kihyun; McElhaney, Kevin W.; Liu, Ou Lydia; Rafferty, Anna N.; Linn, Marcia C.

    2016-01-01

    In 4 classroom experiments we investigated uses for technologies that automatically score student generated essays, concept diagrams, and drawings in inquiry curricula. We used the automatic scores to assign typical and research-based guidance and studied the impact of the guidance on student progress. Seven teachers and their 897 students…

  9. Considerations for Middle School Guidance

    ERIC Educational Resources Information Center

    Knudsen, Grace

    1971-01-01

    Middle school guidance appears to be neglected. Yet this is a time of searching when pupils who are able to relate are usually willing to be helped. The characteristics of both elementary and secondary school guidance need to be evaluated in order to provide continuity in the junior high schools. (Author/BY)

  10. Guidance Services in Spanish Universities

    ERIC Educational Resources Information Center

    Vidal, Javier; Diez, Gloria; Vieira, Maria J.

    2003-01-01

    Since the 80s, higher education in Spain has undergone important modifications such as greater autonomy, expansion in the number of students and the introduction of more flexible programmes. In this context, guidance services have proliferated in an unstructured way. This paper presents a description of guidance services in Spanish universities…

  11. Guidance in the Secondary School

    ERIC Educational Resources Information Center

    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…

  12. A Guide to Career Guidance.

    ERIC Educational Resources Information Center

    Nejedlo, Robert J., Ed.

    The nineteen articles in this guidebook are by former consultants for vocational guidance workshops at Northern Illinois University. Articles are organized in five parts: identifying students' career guidance needs, providing students with helpful career information, assisting students pursuing career programs, preparing students for career…

  13. Guidance Manual for Conducting Screening Level Ecological Risk Assessments at the INEL

    SciTech Connect

    R. L. VanHorn; N. L. Hampton; R. C. Morris

    1995-06-01

    This document presents reference material for conducting screening level ecological risk assessments (SLERAs)for the waste area groups (WAGs) at the Idaho National Engineering Laboratory. Included in this document are discussions of the objectives of and processes for conducting SLERAs. The Environmental Protection Agency ecological risk assessment framework is closely followed. Guidance for site characterization, stressor characterization, ecological effects, pathways of contaminant migration, the conceptual site model, assessment endpoints, measurement endpoints, analysis guidance, and risk characterization are included.

  14. Signaling from Axon Guidance Receptors

    PubMed Central

    Bashaw, Greg J.; Klein, Rüdiger

    2010-01-01

    Determining how axon guidance receptors transmit signals to allow precise pathfinding decisions is fundamental to our understanding of nervous system development and may suggest new strategies to promote axon regeneration after injury or disease. Signaling mechanisms that act downstream of four prominent families of axon guidance cues—netrins, semaphorins, ephrins, and slits—have been extensively studied in both invertebrate and vertebrate model systems. Although details of these signaling mechanisms are still fragmentary and there appears to be considerable diversity in how different guidance receptors regulate the motility of the axonal growth cone, a number of common themes have emerged. Here, we review recent insights into how specific receptors for each of these guidance cues engage downstream regulators of the growth cone cytoskeleton to control axon guidance. PMID:20452961

  15. Signaling from axon guidance receptors.

    PubMed

    Bashaw, Greg J; Klein, Rüdiger

    2010-05-01

    Determining how axon guidance receptors transmit signals to allow precise pathfinding decisions is fundamental to our understanding of nervous system development and may suggest new strategies to promote axon regeneration after injury or disease. Signaling mechanisms that act downstream of four prominent families of axon guidance cues--netrins, semaphorins, ephrins, and slits--have been extensively studied in both invertebrate and vertebrate model systems. Although details of these signaling mechanisms are still fragmentary and there appears to be considerable diversity in how different guidance receptors regulate the motility of the axonal growth cone, a number of common themes have emerged. Here, we review recent insights into how specific receptors for each of these guidance cues engage downstream regulators of the growth cone cytoskeleton to control axon guidance. PMID:20452961

  16. 40 CFR 194.64 - Documentation of continued compliance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS Public Participation § 194.64 Documentation of... regulations pursuant to section 8(f) of the WIPP LWA and § 194.11, the Administrator will publish a notice...

  17. 40 CFR 194.64 - Documentation of continued compliance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS Public Participation § 194.64 Documentation of... regulations pursuant to section 8(f) of the WIPP LWA and § 194.11, the Administrator will publish a notice...

  18. 40 CFR 194.64 - Documentation of continued compliance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS Public Participation § 194.64 Documentation of... regulations pursuant to section 8(f) of the WIPP LWA and § 194.11, the Administrator will publish a notice...

  19. 40 CFR 194.64 - Documentation of continued compliance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS Public Participation § 194.64 Documentation of... regulations pursuant to section 8(f) of the WIPP LWA and § 194.11, the Administrator will publish a notice...

  20. 40 CFR 194.64 - Documentation of continued compliance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS Public Participation § 194.64 Documentation of... regulations pursuant to section 8(f) of the WIPP LWA and § 194.11, the Administrator will publish a notice...

  1. Autonomous landing guidance program

    NASA Astrophysics Data System (ADS)

    Brown, John A.

    1996-05-01

    The Autonomous Landing Guidance program is partly funded by the US Government under the Technology Reinvestment Project. The program consortium consists of avionics and other equipment vendors, airlines and the USAF. A Sextant Avionique HUD is used to present flight symbology in cursive form as well as millimeter wave radar imagery from Lear Astronics equipment and FLIR Systems dual-channel, forward-looking, infrared imagery. All sensor imagery is presented in raster form. A future aim is to fuse all imagery data into a single presentation. Sensor testing has been accomplished in a Cessna 402 operated by the Maryland Advanced Development Laboratory. Development testing is under way in a Northwest Airlines simulator equipped with HUD and image simulation. Testing is also being carried out using United Airlines Boeing 727 and USAF C-135C (Boeing 707) test aircraft. The paper addresses the technology utilized in sensory and display systems as well as modifications made to accommodate the elements in the aircraft. Additions to the system test aircraft include global positioning systems, inertial navigation systems and extensive data collection equipment. Operational philosophy and benefits for both civil and military users are apparent. Approach procedures have been developed allowing use of Category 1 ground installations in Category 3 conditions.

  2. ICDF Complex Waste Profile and Verification Sample Guidance

    SciTech Connect

    W. M. Heileson

    2006-10-01

    This guidance document will assist waste generators who characterize waste streams destined for disposal at the Idaho Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Disposal Facility (ICDF) Complex. The purpose of this document is to develop a conservative but appropriate way to (1) characterize waste for entry into the ICDF; (2) ensure compliance with the waste acceptance criteria; and (3) facilitate disposal at the ICDF landfill or evaporation pond. In addition, this document will establish the waste verification process used by ICDF personnel to ensure that untreated waste meets applicable ICDF acceptance limits

  3. 2 CFR 200.203 - Notices of funding opportunities.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 2 Grants and Agreements 1 2014-01-01 2014-01-01 false Notices of funding opportunities. 200.203 Section 200.203 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF MANAGEMENT AND BUDGET GUIDANCE Reserved UNIFORM ADMINISTRATIVE REQUIREMENTS, COST PRINCIPLES, AND AUDIT REQUIREMENTS FOR FEDERAL...

  4. Document Update and Compare

    NASA Technical Reports Server (NTRS)

    Knoch, C. F.; Caldwell, D. C.; Caldwell, D. L.

    1983-01-01

    Document Update and Compare programs provide simple computerized documentmaintenance system on Data General NOVA 840 computer. Document Update program allows user to update document either by batch or terminal input. Documents are modified and lists of modifications printed out.

  5. Safety of magnetic fusion facilities: Volume 2, Guidance

    SciTech Connect

    1995-07-01

    This document provides guidance for the implementation of the requirements identified in Vol. 1 of this Standard. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While Vol. 1 is generally applicable in that requirements there apply to a wide range of fusion facilities, this volume is concerned mainly with large facilities such as the International Thermonuclear Experimental Reactor (ITER). Using a risk-based prioritization, the concepts presented here may also be applied to other magnetic fusion facilities. This volume is oriented toward regulation in the Department of Energy (DOE) environment.

  6. [The ergonomic approach to vocational guidance and selection].

    PubMed

    Majski-Cesarec, S

    1995-03-01

    The paper deals with the results of health examinations of elementary school children--eight graders carried out within the programme of vocational guidance in an area of Croatia (the period 1991-1993). The expert's evaluation showed that out of a total of 1983 pupils examined 855 had health disturbances or functional impairments that required properly oriented further vocational training. Advice concerning the choice of school was based on the anticipated requirements and ergonomic characteristics of the pupils future job and their psychophysical abilities. Proper vocational guidance avoids the need for later selection, which is always a complicated problem. This is illustrated by two documented examples.

  7. Guidance for Using Formal Methods in a Certification Context

    NASA Technical Reports Server (NTRS)

    Brown, Duncan; Delseny, Herve; Hayhurst, Kelly; Wiels, Virginie

    2010-01-01

    This paper discusses some of the challenges to using formal methods in a certification context and describes the effort by the Formal Methods Subgroup of RTCA SC-205/EUROCAE WG-71 to propose guidance to make the use of formal methods a recognized approach. This guidance, expected to take the form of a Formal Methods Technical Supplement to DO-178C/ED-12C, is described, including the activities that are needed when using formal methods, new or modified objectives with respect to the core DO-178C/ED-12C document, and evidence needed for meeting those objectives.

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

    SciTech Connect

    Not Available

    1994-05-01

    This document introduces QA guidance pertaining to design and implementation of laboratory procedures and processes for collecting DOE Environmental Restoration and Waste Management (EM) ESAA (environmental sampling and analysis activities) data. It addresses several goals: identifying key laboratory issues and program elements to EM HQ and field office managers; providing non-prescriptive guidance; and introducing environmental data collection program elements for EM-263 assessment documents and programs. The guidance describes the implementation of laboratory QA elements within a functional QA program (development of the QA program and data quality objectives are not covered here).

  9. Heterogeneity in European research integrity guidance: relying on values or norms?

    PubMed

    Godecharle, Simon; Nemery, Benoit; Dierickx, Kris

    2014-07-01

    Similar forms of misconduct are perceived differently throughout Europe. There are no extensive surveys on the guidance on research integrity in the different countries of Europe. Therefore, we performed a systematic content analysis of (biomedical) research integrity guidance documents from all the countries of the European Economic Area. We show that there is strong heterogeneity concerning research integrity guidance on crucial aspects, for example, the defining of research misconduct, at both an international and a national level. We also sought to explain why the guidance documents differ by distinguishing the approaches that underlie them. We distinguished a value-based and a norm-based approach, as well as different perspectives on trust. The current confusing situation concerning research integrity guidance hampers international research and possibly wastes research funds. We risk talking past each other, if we do not take the distinction between these underlying approaches into account.

  10. PR notice 87-9. Notice to pesticide applicants, registrants and petitioners

    SciTech Connect

    Not Available

    1987-08-01

    The document is one in the series of Pesticide Regulatory Notices, usually called PR Notices, which supplement the laws and regulations governing pesticide regulation in the US. These notices clarify, interpret and explain regulatory requirements and policies. They are directed at pesticide registrants and other parties interested in detailed procedures of regulation.

  11. PR notice 87-8. Notice to manufacturers, formulators, distributors, and registrants of pesticides

    SciTech Connect

    Not Available

    1987-06-01

    The document is one in the series of 'Pesticide Regulatory Notices', usually called 'PR Notices', which supplement the laws and regulations governing pesticide regulation in the US. These notices clarify, interpret and explain regulatory requirements and policies. They are directed at pesticide registrants and other parties interested in detailed procedures of regulation.

  12. PR notice 87-10. Notice to pesticide applicants, registrants and petitioners

    SciTech Connect

    Not Available

    1987-10-01

    The document is one in the series of Pesticide Regulatory Notices, usually called PR Notices, which supplement the laws and regulations governing pesticide regulation in the US. These notices clarify, interpret and explain regulatory requirements and policies. They are directed at pesticide registrants and other parties interested in detailed procedures of regulation.

  13. Uprated fine guidance sensor study

    NASA Technical Reports Server (NTRS)

    1984-01-01

    Future orbital observatories will require star trackers of extremely high precision. These sensors must maintain high pointing accuracy and pointing stability simultaneously with a low light level signal from a guide star. To establish the fine guidance sensing requirements and to evaluate candidate fine guidance sensing concepts, the Space Telescope Optical Telescope Assembly was used as the reference optical system. The requirements review was separated into three areas: Optical Telescope Assembly (OTA), Fine Guidance Sensing and astrometry. The results show that the detectors should be installed directly onto the focal surface presented by the optics. This would maximize throughput and minimize point stability error by not incoporating any additional optical elements.

  14. CH Packaging Program Guidance

    SciTech Connect

    Washington TRU Solutions LLC

    2005-02-28

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: "each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application." They further state: "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 charges the Waste Isolation Pilot Plant (WIPP) management and operating (M&O) contractor with assuring 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. 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. The CBFO will evaluate the issue and notify the NRC if required.

  15. RCRA corrective action: Statement of basis and response to comments decision documents

    SciTech Connect

    1994-07-01

    Under the Resource Conservation and Recovery Act (RCRA), Statement of Basis (SB) and Response to Comments (RTC) decision documents are prepared when a corrective action is implemented through either a permit or enforcement order [RCRA {section} 3008(h)]. EPA`s Guidance on RCRA Corrective Action Decision Documents presents a standard format for documenting RCRA corrective action decisions. The guidance clarifies the roles and responsibilities of regulatory agencies in developing and issuing decision documents. DOE, for some corrective actions, may be directed to prepare materials for the Statement of Basis. EPA`s guidance is intended to provide consistency in the organization and content of decision documents as well as promote clear and logical presentations of rationales for remedy selection decisions based on facility-specific information and supporting analysis. This Information Brief summarizes EPA`s guidance on SB and RTC decision documents.

  16. 75 FR 60761 - Medical Device User Fee and Modernization Act; Notice to Public of Web site Location of Fiscal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-01

    ... Public of Web site Location of Fiscal Year 2011 Proposed Guidance Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is announcing the Web site... topics, or suggestions for new or different guidances. This notice announces the Web site location of...

  17. 75 FR 5865 - Proposed Collection; Comment Request for Notice 2010-6

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-04

    ... Internal Revenue Service Proposed Collection; Comment Request for Notice 2010-6 AGENCY: Internal Revenue...(c)(2)(A)). Currently, the IRS is soliciting comments concerning Notice 2010-6, Relief and Guidance... 2010-6. Abstract: Notice 2010-6 requires a corporation to attach to its Federal income tax return...

  18. 77 FR 14047 - Guidance for Decommissioning Planning During Operations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-08

    ... correcting a notice appearing in the Federal Register on February 15, 2012 (77 FR 8751), that re-opened the... February 15, 2012 (77 FR 8751), in the second column, the second bullet from the bottom, last sentence....'' This action is necessary to correct the NRC's Agencywide Documents Access and Management System...

  19. 77 FR 11555 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    .../ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm... Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring... Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration,...

  20. 78 FR 68460 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

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

  1. 77 FR 12853 - Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ... 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 of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing a...

  2. 76 FR 78591 - Corporate Reorganizations; Guidance on the Measurement of Continuity of Interest

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 RIN 1545-BK43 Corporate Reorganizations; Guidance on the Measurement of Continuity of Interest AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice...

  3. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for... Recommendations for Iron Sucrose; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry... Recommendations for Iron Sucrose Injection; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide...

  5. 75 FR 18509 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-12

    ... 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ``Q4B Evaluation and.... In the Federal Register of August 14, 2009 (74 FR 41143), FDA published a notice announcing the... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  6. 75 FR 17148 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... 17, 2009 (74 FR 7447), FDA published a notice announcing the availability of a draft tripartite... guidance made available in the Federal Register of February 21, 2008 (73 FR 9575). When implemented, the... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  7. 75 FR 54153 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    .... In the Federal Register of December 17, 2009 (74 FR 66981), FDA published a notice announcing the... Federal Register of February 21, 2008 (73 FR 9575). When implemented, the annex will provide guidance for... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  8. 75 FR 53973 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    .... In the Federal Register of December 17, 2009 (74 FR 66982), FDA published a notice announcing the... Register of February 21, 2008 (73 FR 9575). When implemented, the annex will provide guidance for industry... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  9. 75 FR 17147 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... Federal Register of August 14, 2009 (74 FR 41144), FDA published a ] notice announcing the availability of... Register of February 21, 2008 (73 FR 9575). When implemented, the annex will provide guidance for industry... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  10. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

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

  11. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

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

  12. 75 FR 33311 - Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 2007D-0169) Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  13. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration..., Including Certain First in Human Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  14. 77 FR 71008 - Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-28

    ... June 22, 2010. In a notice published in the Federal Register of June 8, 2010 (75 FR 32481), FDA... Rotational Warning Plans for Smokeless Tobacco Products; Withdrawal of Guidance AGENCY: Food and Drug... Smokeless Tobacco Products,'' that was announced in the Federal Register on June 8, 2010. DATES:...

  15. 76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-02

    ... stability, as well as enhance processability of the solid material inputs in drug product manufacture... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  16. 77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... HUMAN SERVICES Food and Drug Administration Guidances for Industry and Food and Drug Administration... Approval and Premarket Notification (510(k)) Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  18. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... of the classification. On December 2, 2011 (76 FR 75551), FDA announced the availability of the draft... Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants of new...

  19. 76 FR 49773 - International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-11

    ..., 2009 (74 FR 38033), FDA published a notice announcing the availability of a draft guidance entitled... Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of... Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format...

  20. 76 FR 22064 - Guidance on Reporting Interest Paid to Nonresident Aliens; Hearing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-20

    ..., January 7, 2011 (76 FR 1105) providing guidance on the reporting requirements for interest on deposits... Friday, January 7, 2011 (76 FR 1105). Persons, who wish to present oral comments at the hearing that... Nonresident Aliens; Hearing AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of public...

  1. 76 FR 20595 - Guidance on Reporting Interest Paid to Nonresident Aliens; Hearing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ..., January 18, 2011 (76 FR 2852) and Friday, January 7, 2011 (76 FR 1105) providing guidance on the reporting... Friday, January 7, 2011 (76 FR 1105). Persons, who wish to present oral comments at the hearing that... Nonresident Aliens; Hearing AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of public...

  2. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... Helicobacter pylori; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... detecting Helicobacter pylori (H. pylori). This draft guidance is not final nor is it in effect at this time... Detection of Antibodies to Helicobacter pylori,'' to suggest information that submitters provide that...

  3. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

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

  4. 77 FR 14022 - Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation-Derived...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-08

    ... INFORMATION: I. Background In the Federal Register of March 14, 2011 (76 FR 13629), FDA published the notice... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Chemistry, Manufacturing, and... entitled ``Chemistry, Manufacturing, and Controls (CMC) Information-- Fermentation-Derived...

  5. 75 FR 47604 - Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Federal Register of June 1, 2006 (71 FR 31194), FDA published the notice of withdrawal and revision of... Substance Chemistry, Manufacturing, and Controls Information; Availability AGENCY: Food and Drug... availability of a guidance for industry 169 entitled ``Drug Substance Chemistry, Manufacturing, and...

  6. 78 FR 42387 - Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a new.... 78, No. 135 / Monday, July 15, 2013 / Notices#0;#0; ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Circumstances That Constitute Delaying,...

  7. EPA guidance on the role and responsibilities of psychiatrists.

    PubMed

    Bhugra, D; Ventriglio, A; Kuzman, M R; Ikkos, G; Hermans, M H-M; Falkai, P; Fiorillo, A; Musalek, M; Hoschl, C; Dales, J; Beezhold, J; Rössler, W; Racetovic, G; Gaebel, W

    2015-03-01

    Psychiatry is that branch of the medical profession, which deals with the origin, diagnosis, prevention, and management of mental disorders or mental illness, emotional and behavioural disturbances. Thus, a psychiatrist is a trained doctor who has received further training in the field of diagnosing and managing mental illnesses, mental disorders and emotional and behavioural disturbances. This EPA Guidance document was developed following consultation and literature searches as well as grey literature and was approved by the EPA Guidance Committee. The role and responsibilities of the psychiatrist include planning and delivering high quality services within the resources available and to advocate for the patients and the services. The European Psychiatric Association seeks to rise to the challenge of articulating these roles and responsibilities. This EPA Guidance is directed towards psychiatrists and the medical profession as a whole, towards other members of the multidisciplinary teams as well as to employers and other stakeholders such as policy makers and patients and their families. PMID:25735808

  8. Measuring Client Progression in Adult Guidance

    ERIC Educational Resources Information Center

    Hearne, Lucy

    2007-01-01

    Currently, in the field of guidance, relevant stakeholders including guidance practitioners, educators and policy makers, have identified progression for adults in education and employment as one of the key outcomes of educational guidance. Lifelong guidance is now inextricably linked with lifelong learning as a mechanism to enhance individual…

  9. 33 CFR 385.5 - Guidance memoranda.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., Circulars, Manuals, or Pamphlets, or other appropriate form of guidance. (2) Guidance on the following six... for development of six program-wide guidance memoranda. The Corps of Engineers and the South Florida... agencies, develop the six guidance memoranda described in paragraph (a) of this section for approval by...

  10. Vocational Guidance: A Primary Function of Education.

    ERIC Educational Resources Information Center

    Roehrs, Hermann

    1992-01-01

    Perceives vocational orientation/guidance as a school responsibility. Discusses changing work attitudes, vocational guidance as counseling for life, parents' roles, work experience for 14-16 year olds, continuity between vocational guidance and competent career choice, vocational ethics, and midcareer and retirement guidance. Cites research on…

  11. Information Paper 18: Guidance in Secondary Schools.

    ERIC Educational Resources Information Center

    Ashton, Terry

    1986-01-01

    Traces impetus for introduction of structured guidance into Scottish secondary schools. Identifies 1968 "Orange Paper" as first attempt to set out rationale for guidance. Describes how guidance is organized; outlines tasks of guidance teachers; and presents current developments, training requirements, and trends. (NEC)

  12. Guidelines for Comprehensive Guidance and Counseling Services.

    ERIC Educational Resources Information Center

    Stefkovich, Jacqueline; And Others

    These guidelines are designed to assist local school districts and their Boards of Education in developing and implementing comprehensive guidance and counseling services in thier school systems. The components of the comprehensive guidance program are comprehensive guidance services, certified personnel, and comprehensive guidance facilities.…

  13. Resources for Guidance Program Improvement. Volume 2.

    ERIC Educational Resources Information Center

    Frenza, Mary C., Comp.; and Others

    This guide, for guidance personnel and teachers, is designed to provide ready access to current, practical programs, activities, and references for improving guidance programs. The resources are organized in four sections representing areas of basic concern for guidance personnel. Section 1 presents selected portions of guidance programs from…

  14. Practical guidance for charting ethics consultations.

    PubMed

    Bruce, Courtenay R; Smith, Martin L; Tawose, Olubukunola Mary; Sharp, Richard R

    2014-03-01

    It is generally accepted that appropriate documentation of activities and recommendations of ethics consultants in patients' medical records is critical. Despite this acceptance, the bioethics literature is largely devoid of guidance on key elements of an ethics chart note, the degree of specificity that it should contain, and its stylistic tenor. We aim to provide guidance for a variety of persons engaged in clinical ethics consultation: new and seasoned ethics committee members who are new to ethics consultation, students and trainees in clinical ethics, and those who have significant experience with ethics consultation so that they can reflect on their practice. Toward the goal of promoting quality charting practices in ethics consultations, we propose recommendations on a broad array of questions concerning clinical ethics consultation chart notes, including whether and when to write a chart note, and practical considerations for the tenor, purpose, and content of a chart note. Our broader aim is to promote discussion about good charting practices in clinical ethics, with the hope of contributing to clear standards of excellence in clinical ethics consultation.

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

    PubMed

    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.

  16. Commercial radioactive waste minimization program development guidance

    SciTech Connect

    Fischer, D.K.

    1991-01-01

    This document is one of two prepared by the EG&G Idaho, Inc., Waste Management Technical Support Program Group, National Low-Level Waste Management Program Unit. One of several Department of Energy responsibilities stated in the Amendments Act of 1985 is to provide technical assistance to compact regions Host States, and nonmember States (to the extent provided in appropriations acts) in establishing waste minimization program plans. Technical assistance includes, among other things, the development of technical guidelines for volume reduction options. Pursuant to this defined responsibility, the Department of Energy (through EG&G Idaho, Inc.) has prepared this report, which includes guidance on defining a program, State/compact commission participation, and waste minimization program plans.

  17. Commercial radioactive waste minimization program development guidance

    SciTech Connect

    Fischer, D.K.

    1991-01-01

    This document is one of two prepared by the EG G Idaho, Inc., Waste Management Technical Support Program Group, National Low-Level Waste Management Program Unit. One of several Department of Energy responsibilities stated in the Amendments Act of 1985 is to provide technical assistance to compact regions Host States, and nonmember States (to the extent provided in appropriations acts) in establishing waste minimization program plans. Technical assistance includes, among other things, the development of technical guidelines for volume reduction options. Pursuant to this defined responsibility, the Department of Energy (through EG G Idaho, Inc.) has prepared this report, which includes guidance on defining a program, State/compact commission participation, and waste minimization program plans.

  18. Improvements in inservice testing regulatory guidance

    SciTech Connect

    Campbell, P.L.

    1996-12-01

    Over the last few years, the NRC has issued guidance to licensees toward improving the quality of requests for relief or alternatives to the code requirements and bring some measure of consistency to the implementation of the code requirements. Based on the majority of the recent submittals, the overall quality has improved. If all of the steps in the internal process for responding to the requests are timely, the review of an updated program can be completed in six to nine months. When a single or only a few requests are submitted, the staff is generally able to complete an evaluation in less than three months. When schedules are related to outages or exigent circumstances, the NRC responds accordingly. The improvements in schedules can be attributed to publication of staff guideline documents, licensees` efforts in preparing more complete descriptions and justification and an increase in the number of NRC technical staff reviewers assigned to IST.

  19. [Psychotherapeutically Competent Child Guidance-General Framework and Legal Foundations].

    PubMed

    Menne, Klaus

    2015-01-01

    Assistances in education are pedagogical and therapeutic benefits connected with it. For child guidance as an assistance in education therefore psychotherapeutic competence is constitutive. The article describes the professional and legal framework of a psychotherapy in child guidance. It specifies on the one hand the composition of the multi disciplinary team (including child and youth psychotherapists and psychological psychotherapists) and the additional therapeutic qualifications acquired by the skilled employees. On the other hand it traces the judicial border between a medical psychotherapy with its scientifically recognised psychotherapy procedures and methods and a psychotherapy in child guidance. The applicability of the new law on the rights of patients with its requirements on a contract governing medical treatment (standards of medical specialists, duty to provide information, information provided for self-determination as well as documentation) on child guidance is discussed as well. The author argues for the preservation of psychotherapeutic competence in child guidance as a benefit sui generis and sees precisely in its therapeutic competence its specific contribution to the advancement of the assistances in education.

  20. 49 CFR 1503.429 - Filing of documents with the Enforcement Docket Clerk.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... date of transmission. (e) Service of documents filed with the Enforcement Docket. A person must serve a... Enforcement Docket Clerk when required under this part. (b) Type of service. A person must file a document.... If this e-mail address changes, TSA will provide notice of the change by notice in the...

  1. 49 CFR 1503.429 - Filing of documents with the Enforcement Docket Clerk.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... date of transmission. (e) Service of documents filed with the Enforcement Docket. A person must serve a... Enforcement Docket Clerk when required under this part. (b) Type of service. A person must file a document.... If this e-mail address changes, TSA will provide notice of the change by notice in the...

  2. 49 CFR 1503.429 - Filing of documents with the Enforcement Docket Clerk.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... date of transmission. (e) Service of documents filed with the Enforcement Docket. A person must serve a... Enforcement Docket Clerk when required under this part. (b) Type of service. A person must file a document.... If this e-mail address changes, TSA will provide notice of the change by notice in the...

  3. 49 CFR 1503.429 - Filing of documents with the Enforcement Docket Clerk.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... date of transmission. (e) Service of documents filed with the Enforcement Docket. A person must serve a... Enforcement Docket Clerk when required under this part. (b) Type of service. A person must file a document.... If this e-mail address changes, TSA will provide notice of the change by notice in the...

  4. 49 CFR 1503.429 - Filing of documents with the Enforcement Docket Clerk.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... date of transmission. (e) Service of documents filed with the Enforcement Docket. A person must serve a... Enforcement Docket Clerk when required under this part. (b) Type of service. A person must file a document.... If this e-mail address changes, TSA will provide notice of the change by notice in the...

  5. Waste treatability guidance program. User`s guide. Revision 0

    SciTech Connect

    Toth, C.

    1995-12-21

    DOE sites across the country generate and manage radioactive, hazardous, mixed, and sanitary wastes. It is necessary for each site to find the technologies and associated capacities required to manage its waste. One role of DOE HQ Office of Environmental Restoration and Waste Management is to facilitate the integration of the site- specific plans into coherent national plans. DOE has developed a standard methodology for defining and categorizing waste streams into treatability groups based on characteristic parameters that influence waste management technology needs. This Waste Treatability Guidance Program automates the Guidance Document for the categorization of waste information into treatability groups; this application provides a consistent implementation of the methodology across the National TRU Program. This User`s Guide provides instructions on how to use the program, including installations instructions and program operation. This document satisfies the requirements of the Software Quality Assurance Plan.

  6. Thc continuous emission monitoring guidance for part 503 sewage sludge incinerators

    SciTech Connect

    Not Available

    1994-06-30

    The Envrionmental Protection Agency's guidance document for monitoring of total hydrocarbons (THCs) at sewage sludge incinerators was finalized in response to comments received from Federal, State and local government agencies. The document contains recommendations for compliance with these requirements. It addresses installation, calibration, operation, and maintenance procedures for sewage sludge incinerators in the following areas: (1) THC continuous emissions monitoring (CEM); (2) oxygen CEM; (3) moisture CEM; (4) quality assurance; and (5) recordkeeping and reporting. The document will provide guidance for both the interim and long-term sludge permitting programs.

  7. Generic safety documentation model

    SciTech Connect

    Mahn, J.A.

    1994-04-01

    This document is intended to be a resource for preparers of safety documentation for Sandia National Laboratories, New Mexico facilities. It provides standardized discussions of some topics that are generic to most, if not all, Sandia/NM facilities safety documents. The material provides a ``core`` upon which to develop facility-specific safety documentation. The use of the information in this document will reduce the cost of safety document preparation and improve consistency of information.

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

    SciTech Connect

    PLACE, B.G.

    1998-11-16

    This document provides guidance to generator groups for preparing and maintaining documentation of Pollution Prevention Waste Minimization (P2/WMin) Program activities. The guidance is one of a hierarchical series that includes the Hanford Site Waste Minimization and Pollution Prevention Awareness Program Plan (DOE-RL, 1998a) and Prime contractor implementation plans describing programs required by Resource Conservation and Recovery Act of 1976 (RCRA) 3002(b) and 3005(h) (RCRA and EPA, 1994). Documentation guidance for the following five P2/WMin elements are discussed: Fiscal Year (FY) Goals; Budget and Staffing; Waste Minimization (WMin) Assessments (WMAs); Quarterly Pollution Prevention (P2) Reporting WMin Certification.

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

    SciTech Connect

    PLACE, B.G.

    1999-11-01

    This document provides guidance to generator groups for preparing and maintaining documentation of Pollution Prevention/Waste Minimization (P2/WMin) Program activities. The guidance is one of a hierarchical series that includes the Hanford Site Waste Minimization and Pollution Prevention Awareness Program Plan (DOE-RL, 1998a) and Prime Contractor implementation plans describing programs required by Resource Conservation and Recovery Act of 1976 (RCRA) 3002(b) and (300501) (RCRA and EPA, 1994). Documentation guidance for the following five P2/WMin elements are discussed: Fiscal Year (FY) Goals; Budget and Staffing; Waste Minimization (WMinn ) Assessments (WMAs); Pollution Prevention (P2) Reporting; WMin Certification.

  10. Planning guidance for the Chemical Stockpile Emergency Preparedness Program

    SciTech Connect

    Shumpert, B.L.; Watson, A.P.; Sorensen, J.H.

    1995-02-01

    This planning guide was developed under the direction of the U.S. Army and the Federal Emergency Management Agency (FEMA) which jointly coordinate and direct the development of the Chemical Stockpile Emergency Preparedness Program (CSEPP). It was produced to assist state, local, and Army installation planners in formulating and coordinating plans for chemical events that may occur at the chemical agent stockpile storage locations in the continental United States. This document provides broad planning guidance for use by both on-post and off-post agencies and organizations in the development of a coordinated plan for responding to chemical events. It contains checklists to assist in assuring that all important aspects are included in the plans and procedures developed at each Chemical Stockpile Disposal Program (CSDP) location. The checklists are supplemented by planning guidelines in the appendices which provide more detailed guidance regarding some issues. The planning guidance contained in this document will help ensure that adequate coordination between on-post and off-post planners occurs during the planning process. This planning guide broadly describes an adequate emergency planning base that assures that critical planning decisions will be made consistently at every chemical agent stockpile location. This planning guide includes material drawn from other documents developed by the FEMA, the Army, and other federal agencies with emergency preparedness program responsibilities. Some of this material has been developed specifically to meet the unique requirements of the CSEPP. In addition to this guidance, other location-specific documents, technical studies, and support studies should be used as needed to assist in the planning at each of the chemical agent stockpile locations to address the specific hazards and conditions at each location.

  11. Long-Term Stewardship Baseline Report and Transition Guidance

    SciTech Connect

    Kristofferson, Keith

    2001-11-01

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

  12. The guidance system for Ariane

    NASA Astrophysics Data System (ADS)

    Angus, Alex M.; Gordon, Colin S.; Brunschvig, Alain

    1991-05-01

    The various subsystems that comprise the complete Ariane guidance system are described along with a brief background of earlier developmental instruments and their applications. The Centrale Inertielle is a part of the control and guidance system of the Ariane launcher whose function is to provide a space-stable datum allowing measurement of acceleration and attitude relative to that datum. Consideration is given to the inertial platform, the electronics unit, thermal requirements, coarse alignment and fine-leveling, and the Vehicle Equipment Bay (VEB). The VEB is the main component of the electrical system and is designed to support all the equipment handling the following functions: guidance, navigation and control, sequencer and pyro management, localization and safety management, and telemetry.

  13. Autonomous Guidance, Navigation and Control

    NASA Astrophysics Data System (ADS)

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

    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.

  14. Transportation control measure: State Implementation Plan guidance (revised final report)

    SciTech Connect

    Eisinger, D.S.; Deakin, E.A.; Mahoney, L.A.; Morris, R.E.; Ireson, R.G.

    1990-09-01

    The document has been developed for the United States Environmental Protection Agency to summarize current knowledge about transportation control measures (TCMs). The target audience includes transportation and air quality management staff at all government levels. The guidance development effort is motivated by the need to provide post-1987 guidance to attain National Ambient Air Quality Standards (NAAQS). The document provides descriptions and examples of the most frequently implemented TCMs; institutional guidance such as assessing feasibility, agency responsibilities, and funding; and techniques for monitoring and enforcing TCMs. In addition, the document describes the tools available for evaluating TCM impacts on hydrocarbons, nitrogen oxides, and carbon monoxide emissions. Appendices present approaches to estimate TCM effects on PM-10 emissions; important sources of additional information; implementation experiences in various cities; and rules of thumb to quantitatively evaluate TCM transportation system effects. The information presented demonstrates that there have been significant advances in TCM development over the past decade, and that TCMs are appropriate control options for state implementation plans.

  15. Human Systems Integration: Unmanned Aircraft Control Station Certification Plan Guidance

    NASA Technical Reports Server (NTRS)

    2005-01-01

    This document provides guidance to the FAA on important human factors considerations that can be used to support the certification of a UAS Aircraft Control Station (ACS). This document provides a synopsis of the human factors analysis, design and test activities to be performed to provide a basis for FAA certification. The data from these analyses, design activities, and tests, along with data from certification/qualification tests of other key components should be used to establish the ACS certification basis. It is expected that this information will be useful to manufacturers in developing the ACS Certification Plan,, and in supporting the design of their ACS.

  16. Coastal nonpoint pollution control program: Program development and approval guidance

    SciTech Connect

    Not Available

    1993-01-01

    The document, developed by NOAA and EPA, contains guidance for states in developing and implementing their coastal nonpoint pollutant source programs. It describes the requirements that must be met, including: the geographic scope of the program; the pollutant sources to be addressed; the types of management measures used; the establishment of critical areas; technical assistance, public participation, and administrative coordination; and, the process for program submission and Federal approval. The document also contains the criteria by which NOAA and EPA will review the states' submissions.

  17. Guidance for use of the oil spill liability trust fund

    SciTech Connect

    1997-02-01

    This guidance document has been prepared to assist On-Scene Coordinators (OSCs) and financial management personnel in accessing and using the Oil Spill Liability Trust Fund (OSLTF) in orders to conduct oil pollution removal actions under Section 311(c) of the Clean Water Act (CWA) and Section 1012 of the Oil Pollution Act of 1990 (OPA), and fully accounting for OSLTF funds. This document details the requirments and procedures for use of the OSLTF that are described in the Memorandum of Understanding between the U.S. Environmental Protection Agency and the U.S. Coast Guard for use of the Oil Spill Liability Trust Fund (MOU).

  18. 76 FR 8383 - Office of New Reactors; Interim Staff Guidance on Impacts of Construction of New Nuclear Power...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-14

    ... COMMISSION Office of New Reactors; Interim Staff Guidance on Impacts of Construction of New Nuclear Power... Staff Guidance (ISG) COL-ISG-022 entitled ``Impacts of Construction of ] New Nuclear Power Plants on Operating Units at Multi-Unit Sites'' (Agencywide Documents Access and Management System (ADAMS)...

  19. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  20. 75 FR 10524 - NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ... COMMISSION NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for... document entitled: ``NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action...-4737, or by e-mail to pdr.resource@nrc.gov . NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3,...

  1. 77 FR 14811 - Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... TV ads will be subject to a 45-calendar day review clock by FDA. DATES: Although you can comment on... on this draft guidance before it begins work on the final version of the guidance, submit either... table 1 of this document. There is a 45-day review clock for TV ads submitted under section 503B....

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

    PubMed

    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.

  3. 75 FR 77008 - Notice of Information Collection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... Electronic funds transfer is used for payment under Treasury guidance. In addition, NASA encourages the use... Administration (NASA). ACTION: Notice of information collection. SUMMARY: The National Aeronautics and Space... information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C....

  4. 75 FR 21632 - Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

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

  5. ITERATIVE APPLICATION OF THE EPA'S STRESSOR IDENTIFICATION GUIDANCE DISCOVERS AN ILLICIT DISCHARGE AND RESIDUAL DAM-ASSOCIATED IMPAIRMENT

    EPA Science Inventory

    EPA guidance for identifying causes of biological impairments is becoming more commonly applied by states to analyze evidence, logically determine causes, and document the process. One example is an investigation of biological impairment in the Willimantic River in Connecticut t...

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

    SciTech Connect

    Place, B. G.

    1997-11-25

    This document provides guidance to contractor generator groups for developing and maintaining documentation of Pollution Prevention/Waste. Minimization (P2/WMin) Program activities. The program documentation is intended to demonstrate generator compliance with U.S. Department of Energy (DOE) requirements as well as state and Federal regulations.

  7. Computer software documentation

    NASA Technical Reports Server (NTRS)

    Comella, P. A.

    1973-01-01

    A tutorial in the documentation of computer software is presented. It presents a methodology for achieving an adequate level of documentation as a natural outgrowth of the total programming effort commencing with the initial problem statement and definition and terminating with the final verification of code. It discusses the content of adequate documentation, the necessity for such documentation and the problems impeding achievement of adequate documentation.

  8. Shuttle program. MCC Level C formulation requirements: Entry guidance and entry autopilot

    NASA Technical Reports Server (NTRS)

    Harpold, J. C.; Hill, O.

    1980-01-01

    A set of preliminary entry guidance and autopilot software formulations is presented for use in the Mission Control Center (MCC) entry processor. These software formulations meet all level B requirements. Revision 2 incorporates the modifications required to functionally simulate optimal TAEM targeting capability (OTT). Implementation of this logic in the MCC must be coordinated with flight software OTT implementation and MCC TAEM guidance OTT. The entry guidance logic is based on the Orbiter avionics entry guidance software. This MCC requirements document contains a definition of coordinate systems, a list of parameter definitions for the software formulations, a description of the entry guidance detailed formulation requirements, a description of the detailed autopilot formulation requirements, a description of the targeting routine, and a set of formulation flow charts.

  9. Abortion Information: A Guidance Viewpoint

    ERIC Educational Resources Information Center

    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)

  10. Project Inspire: Vocational Guidance Institute.

    ERIC Educational Resources Information Center

    National Alliance of Businessmen, Washington, DC.

    Two introductory speeches suggest the general social and interracial climate in the United States. It is against this backdrop that Project Inspire is described. Its purpose is the development of a vocational guidance component within the broader school curriculum. Its major objective is elevating the awareness level of students to the work world…

  11. Axon guidance: FLRTing promotes attraction.

    PubMed

    Lowery, Laura Anne

    2014-03-01

    A recent study demonstrates a new mechanism by which crosstalk between multiple guidance cues is integrated during axon pathfinding. FLRT3 is a novel co-receptor for Robo1 that acts as a context-dependent modulator of Netrin-1 attraction in thalamocortical axons.

  12. Reading Guidance: Death and Grief.

    ERIC Educational Resources Information Center

    Smith, Alice Gullen

    1989-01-01

    Gives guidelines for the librarian using reading guidance (similar to bibliotherapy). Provides a nine-item annotated bibliography of novels for children and adolescents on the subject of death and grief. Appends an embryo list of categories suitable for content analysis of any file librarians might wish to keep on books suitable for use in this…

  13. Teacher Guidance of Knowledge Construction

    ERIC Educational Resources Information Center

    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…

  14. Developing Local Lifelong Guidance Strategies.

    ERIC Educational Resources Information Center

    Watts, A. G.; Hawthorn, Ruth; Hoffbrand, Jill; Jackson, Heather; Spurling, Andrea

    1997-01-01

    Outlines the background, rationale, methodology, and outcomes of developing local lifelong guidance strategies in four geographic areas. Analyzes the main components of the strategies developed and addresses a number of issues relating to the process of strategy development. Explores implications for parallel work in other localities. (RJM)

  15. Humanizing Education Through Guidance Counseling.

    ERIC Educational Resources Information Center

    Accola, W. V.

    A computerized information retrieval system has been designed to support the secondary school counseling effort. The system, entitled Total Guidance Information Support System (TGISS), runs on an IBM System/360 Model 65 facility and uses the IBM 2848 Display Control Unit. The software consists of an interactive communications program developed in…

  16. DOE Waste Treatability Group Guidance

    SciTech Connect

    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.

  17. 76 FR 59406 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ...-acquired bacterial pneumonia and the draft document entitled ``Guidance for Industry: Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment,'' published March 2009 (see FDA Web site at...

  18. 77 FR 14773 - Vigue, Peter A.; Notice of Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... Energy Regulatory Commission Vigue, Peter A.; Notice of Filing Take notice that on March 6, 2012, Peter A... to the proceeding. Any person wishing to become a party must file a notice of intervention or motion... subscribers to receive email notification when a document is added to a subscribed docket(s). For...

  19. 77 FR 40608 - Nunn, Samuel A; Notice of Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-10

    ... Energy Regulatory Commission Nunn, Samuel A; Notice of Filing Take notice that on June 29, 2012, Samuel A... to become a party must file a notice of intervention or motion to intervene, as appropriate. Such... notification when a document is added to a subscribed docket(s). For assistance with any FERC Online...

  20. 78 FR 52524 - Environmental Impacts Statements; Notice of Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-23

    ... AGENCY Environmental Impacts Statements; Notice of Availability Responsible Agency: Office of Federal... Environmental Impact Statements Filed 08/12/2013 Through 08/16/2013 Pursuant to 40 CFR 1506.9. Notice: Section...-792-0222, ext. 222. This document was inadvertently omitted from the FR Notice published...