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 Disruptor...

  2. 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...

  3. PSD Guidance Document

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  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. Guidance Documents for Marine Fuel

    EPA Pesticide Factsheets

    The following guidance documents apply to marine fuel used in ocean-going vessels. All vessels that operate in the North American Emission Control Area (ECA) must generally use fuel with 1,000 ppm sulfur or less.

  6. Guidance Documents for Inert Ingredients

    EPA Pesticide Factsheets

    These guidance documents provide information on various inert ingredient issues, including the general process for submitting petitions or requests, adding trade names to our database, and doing searches related to inert ingredients.

  7. 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 ...

  8. 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 ...

  9. 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: National Protection and Programs Directorate, DHS. ACTION: 60-Day notice and request for comments; new... and Programs Directorate. Title: Guidance Document Request and Evaluation. Form: Not Applicable....

  10. BENCHMARK DOSE TECHNICAL GUIDANCE DOCUMENT ...

    EPA Pesticide Factsheets

    The U.S. EPA conducts risk assessments for an array of health effects that may result from exposure to environmental agents, and that require an analysis of the relationship between exposure and health-related outcomes. The dose-response assessment is essentially a two-step process, the first being the definition of a point of departure (POD), and the second extrapolation from the POD to low environmentally-relevant exposure levels. The benchmark dose (BMD) approach provides a more quantitative alternative to the first step in the dose-response assessment than the current NOAEL/LOAEL process for noncancer health effects, and is similar to that for determining the POD proposed for cancer endpoints. As the Agency moves toward harmonization of approaches for human health risk assessment, the dichotomy between cancer and noncancer health effects is being replaced by consideration of mode of action and whether the effects of concern are likely to be linear or nonlinear at low doses. Thus, the purpose of this project is to provide guidance for the Agency and the outside community on the application of the BMD approach in determining the POD for all types of health effects data, whether a linear or nonlinear low dose extrapolation is used. A guidance document is being developed under the auspices of EPA's Risk Assessment Forum. The purpose of this project is to provide guidance for the Agency and the outside community on the application of the benchmark dose (BMD) appr

  11. Revised precautionary measures to reduce the possible transmission of Creutzfeldt-Jakob disease (CJD) by blood and blood products; guidance document; availability--FDA. Notice.

    PubMed

    1997-09-23

    The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Revised Precautionary Measures to Reduce the Possible Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood Products," dated December 11, 1996. The guidance document is intended to provide recommendations to the blood industry and may include information useful to other interested persons.

  12. Guidance Documents and Sample Forms for Central Data Exchange (CDX) Registration and e-PMN Software (Thin Client)

    EPA Pesticide Factsheets

    For users submitting electronic notices through CDX, this page contains guidance documents and sample forms to help you, submit Premanufacture Notices (PMN), Bona Fide and biotechnology notices, among others.

  13. Much more than just another guidance document.

    PubMed

    Kulkarni, K

    2016-11-01

    As a pediatric hematologist oncologist with clinical and research interests in thrombosis in high-risk pediatric populations, and also as a member of the ISTH Early Career Task Force, I had the opportunity to develop a guidance document on 'Thromboprophylaxis for central venous catheters in the pediatric population' for the 'Guidelines and Guidance Documents' committee. In this communication, I share my experiences to date; I discuss my excitement and initial success, the steep learning curve required to build research acumen, the lessons learnt, and the opportunities and challenges faced. My experience with preparing the guidance document was much more than writing 'just another guidance document'. © 2016 International Society on Thrombosis and Haemostasis.

  14. International Conference on Harmonisation; guidance on the M4 Common Technical Document--Quality: Questions and Answers/Location Issues; availability. Notice.

    PubMed

    2004-06-09

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M4: The CTD--Quality: Questions and Answers/Location Issues." 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 provides further clarification for preparing the quality components of an application file in the common technical document (CTD) format. The guidance addresses the relationship between linked sections for certain parameters (such as polymorphism and particle size), and it addresses location issues (by indicating the section in which to place requested information). The guidance is intended to ease the preparation of paper and electronic submissions, facilitate regulatory reviews, and simplify the exchange of regulatory information among regulatory authorities.

  15. 21 CFR 312.145 - Guidance documents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... for a copy of the CDER list should be directed to the Office of Training and Communications, Division...

  16. 21 CFR 316.50 - Guidance documents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Products Development will maintain and make publicly available a list of guidance documents that apply to... Federal Register. A request for a copy of the list should be directed to the Office of Orphan Products Development (HF-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857....

  17. Stressor Identification Guidance Document | Science Inventory ...

    EPA Pesticide Factsheets

    EPA has made availabile the Stressor Identification Guidance Document (EPA 822-B-00-025) published under the authority of Section 304(a)(2) of the Clean Water Act (CWA). This technical guidance document is designed to assist water quality managers in identifying unknown causes of biological impairments in any type of water body. Section 101(a) of the Clean Water Act states that it is the objective of the Act to restore and maintain the chemical, physical and biological integrity of the Nation's waters. To achieve this objective, numerous States and Tribes are using biological assessments and biocriteria to help protect the Nation's waters. Using these tools, State and Tribal water quality experts are finding water bodies where the fish, invertebrate, algae or plant communities (or other aquatic life) have been detrimentally impacted by different singular or multiple causes. In many cases, the cause, or causes, of these biological impairments have not yet been identified. The Stressor Identification Guidance Document provides a logical, scientific process by which State, Tribal, and other water quality experts can evaluate available information to identify the stressor(s) causing the biological impairments. The process has three main steps: (1) List candidate causes of impairment, (2) analyze the evidence, and (3) characterize the causes. When evidence is adequate, using this guidance, investigators should be able to successfully identify the likely cause, or ca

  18. 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.

  19. 76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ... Federal Motor Carrier Safety Administration Regulatory Guidance Concerning Electronic Signatures and... guidance. SUMMARY: FMCSA issues regulatory guidance concerning the use of electronic signatures and... information regarding FMCSA's acceptance of electronic signature on documents required by the Federal Motor...

  20. Assay Characterization Guidance Documents | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    CPTAC characterized assays are defined as those that meet the criteria described in the Assay Characterization Guidance Document. This guidance document aligns with recommendations by the research community as “fit-for-purpose” validation requirements of targeted proteomics assays.

  1. 75 FR 22812 - Guidance for Industry on Tobacco Health Document Submission; Availability; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Guidance for Industry on Tobacco Health Document Submission... April 20, 2010 (75 FR 20606). The notice announced the availability of a guidance entitled...

  2. Guidance documents relating to landfills and contaminants

    SciTech Connect

    Schomaker, N.B.; Zunt, D.A.

    1990-01-01

    The Environmental Protection Agency is developing and updating a series of Technical Guidance Documents to provide best engineering control technology to meet the needs of the Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response Compensation and Liability Act (CERCLA), respectively. These documents are the compilation of the research efforts to date relating to containment of pollutants from waste disposal to the land as relates to residuals management. The specific areas of research being conducted under the RCRA land disposal program relates to laboratory, pilot and field validation studies in cover systems, waste leaching and solidification, liner systems and disposal facility evaluation. The specific areas of research being conducted under the CERCLA uncontrolled waste sites (Superfund) program relate to in situ treatment, solidification/stabilization for treating hazardous waste, combustion technologies, best demonstrated available technology (BDAT), on-site treatment technologies, emerging biosystems, expert systems, personnel health protection equipment, and site and situation assessment. The Guidance Documents are intended to assist both the regulated community and the permitting authorities, as well as the Program Offices, and Regions, as well as the states and other interested parties, with the latest information relevant to waste management.

  3. Alcoa Public Notice Documents

    EPA Pesticide Factsheets

    This document is the United States Environmental Protection Agency, Region 2's (EPA Region 2) response to and approval of the request for a risk-based disposal of polychlorinated biphenyl (PCB) remediation waste (as defined at 40 C.F.R. §761.3).

  4. 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).

  5. 75 FR 2145 - Draft Guidance for Industry on Tobacco Health Document Submission; Availability; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Tobacco Health Document... entitled ``Tobacco Health Document Submission.'' The notice published with an inadvertent error in the... CONTACT: May Nelson, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate...

  6. 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.

  7. 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…

  8. POTW Sludge Sampling and Analysis Guidance Document

    EPA Pesticide Factsheets

    In view of the variability of municipal sludge quality,appropriate procedures must be followed to collect and analyze samples that accurately represent each POTW's sludge quality.This manual was developed to provide that guidance to POTW operators, engin

  9. 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

    ... are no longer up to date, and for which more current information is available, will be withdrawn... guidances that are no longer up to date. CDER is also actively reviewing the draft guidances to determine... this process as transparent as possible. DATES: General comments on Agency guidance documents...

  10. 2008 Rapanos Guidance and Related Documents

    EPA Pesticide Factsheets

    This memo provides guidance to EPA regions and Corps districts implementing the Supreme Court's decision in the consolidated cases Rapanos v. US and Carabell v. US which address the jurisdiction over waters of the U.S. under the Clean Water Act.

  11. 21 CFR 314.445 - Guidance documents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Miscellaneous Provisions § 314.445 Guidance... directed to the Office of Training and Communications, Division of Drug Information, Center for...

  12. 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

    ... 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 the... operations. The five draft guidance documents are entitled as follows: Compost and Vermicompost in...

  13. GUIDANCE DOCUMENT ON IMPLEMENTATION OF THE ...

    EPA Pesticide Factsheets

    The Agreement in Principle for the Stage 2 M-DBP Federal Advisory Committee contains a list of treatment processes and management practices for water systems to use in meeting additional Cryptosporidium treatment requirements under the LT2ESWTR. This list, termed the microbial toolbox, includes watershed control programs, alternative intake locations, pretreatment processes, additional filtration barriers, inactivation technologies, and enhanced plant performance. The intent of the microbial toolbox is to provide water systems with broad flexibility in selecting cost-effective LT2ESWTR compliance strategies. Moreover, the toolbox allows systems that currently provide additional pathogen barriers or that can demonstrate enhanced performance to receive additional Cryptosporidium treatment credit. Provide guidance to utilities with surface water supplies and to state drinking water programs on the use of different treatment technologies to reduce the level of Cryptosporidium in drinking water. Technologies included in the guidance manual may be used to achieve compliance with the requirements of the LT2ESWTR.

  14. 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.

  15. 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.

  16. Guidance Documents on Substantial Risk Notifications under TSCA

    EPA Pesticide Factsheets

    Guidance documents for TSCA Section 8(e) which states 'Any person who manufactures a chemical substance and obtains information that the chemical is harmful to health or the environment shall inform the EPA.'

  17. 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.

  18. 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

  19. 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.

  20. 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.

  1. 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.

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

    SciTech Connect

    Kentucky Division of Oil and Gas

    1999-10-28

    This report is a summary of the accomplishments toward completion of ''A Guidance Document for Kentucky's Oil and Gas Operators.'' During this quarter, the document received continued review and editing in an electronic format to satisfy the United States Department of Energy (DOE). Comments received from oil and gas operators reviewing this document prompted contact to be made with the United States Environmental Protection Agency (USEPA) to develop an addendum section to provide better explanation of USEPA requirements for Class II injection wells in Kentucky. During February of this year the consultant hired to develop the Class II, UIC addendum section to the Guidance Document met with the USEPA and state personnel responsible for regulation of the Class II, UIC program in Kentucky. At this meeting a review of the federal and state regulatory procedures used for administration of the UIC program was made. Emphasis was directed to summarizing the addendum section in a format usable b y the small oil and gas operators in Kentucky. A draft of the addendum section is underway incorporating the ideas and comments received during this meeting. During the next quarter, a meeting of the subcommittee and Region IV of the USEPA will be scheduled. A review of a draft of the addendum section of the document will be made and necessary revisions incorporated toward final completion of the Guidance Document.

  3. Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document

    SciTech Connect

    Astuto-Gribble, Lisa M; Caskey, Susan Adele

    2014-07-01

    The purpose of this document is threefold: 1) to describe the laboratory bio safety and biosecurity risk assessment process and its conceptual framework; 2) provide detailed guidance and suggested methodologies on how to conduct a risk assessment; and 3) present some practical risk assessment process strategies using realistic laboratory scenarios.

  4. A Guidance Document for Kentucky's Oil and Gas Operations

    SciTech Connect

    None, None

    1998-11-10

    This technical report is a summary of the progress made for "A Guidance Document for Kentucky's Oil and Gas Operators". During this quarter, the document received continued review and editing in an elec-tronic format to satisfy the United States Department of Energy (DOE). Comments received from oil and gas operators reviewing this document prompted contact to be made with the United States Environmental Protection Agency (USEPA) to develop an addendum section to provide better explanation of USEPA requirements for Class II injection wells in Kentucky.

  5. MARSSIM recommended in states' guidance document for decommissioning.

    PubMed

    McBaugh, Debra; Stoffey, Phillip; Shuman, Howard; Young, Robert; Zannoni, Dennis

    2003-06-01

    States appreciate guidance for activities done infrequently or at only a few locations in the state. For many states, this is the case for decommissioning. Some states have reactors being decommissioned, some DOE sites undergoing cleanup, and some uranium mill or radium sites. Many, however, only occasionally do a small facility cleanup or, once in a great while, a large one. For this reason, most states participated in the readily available MARSSIM training and now recommend its use. For this same reason, the CRCPD Committee on Decontamination and Decommissioning (E24) developed a brief guidance document for state and licensee use.

  6. 75 FR 48179 - Comprehensive List of Guidance Documents at the Food and Drug Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-09

    ...The Food and Drug Administration (FDA) is publishing a comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's Good Guidance Practices (GGPs). It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or......

  7. Studying Wind Energy/Bird Interactions: A Guidance Document

    SciTech Connect

    Anderson, R.; Morrison, M.; Sinclair, K.

    1999-12-01

    This guidance document is a product of the Avian Subcommittee of the National Wind Coordinating Committee (NWCC). The NWCC was formed to better understand and promote responsible, credible, and comparable avian/wind energy interaction studies. Bird mortality is a concern and wind power is a potential clean and green source of electricity, making study of wind energy/bird interactions essential. This document provides an overview for regulators and stakeholders concerned with wind energy/bird interactions, as well as a more technical discussion of the basic concepts and tools for studying such interactions.

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

    SciTech Connect

    Bender Rick

    1999-10-28

    This technical report is a summary of the accomplishments toward completion of ''A Guidance Document for Kentucky's Oil and Gas Operators''. During this quarter, the document received continued review and editing in an electronic format to satisfy the United States Department of Energy (DOE). Comments received from oil and gas operators reviewing this document prompted contact to be made with the United States Environmental Protection Agency (U. S. EPA) to develop an addendum section to provide better explanation of U.S. EPA requirements for Class II injection wells in Kentucky. During May of this year the consultant hired to develop the Class II, UIC addendum section to the guidance document met a second time with the U.S. EPA and state personnel responsible for regulation of the Class II, UIC program in Kentucky, to review a draft of the document. This draft was discussed during the meeting with the U.S. EPA and will receive additional editing and comment during the next quarter.

  9. The World Health Organization’s Safe Abortion Guidance Document

    PubMed Central

    Van Look, Paul F. A.; Cottingham, Jane

    2013-01-01

    We discuss the history of the World Health Organization’s (WHO’s) development of guidelines for governments on providing safe abortion services, which WHO published as Safe Abortion: Technical and Policy Guidance for Health Systems in 2003 and updated in 2012. We show how the recognition of the devastating impact of unsafe abortion on women’s health and survival, the impetus of the International Conference on Population and Development and its five-year follow-up, and WHO’s progressive leadership at the end of the century enabled the organization to elaborate guidance on providing safe abortion services. Guideline formulation involved extensive review of published evidence, an international technical expert meeting to review the draft document, and a protracted in-house review by senior WHO management. PMID:23409886

  10. 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...

  11. 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...

  12. 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).

  13. 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

    ... entitled ``Documenting Statistical Analysis Programs and Data Files.'' This guidance is provided to inform study statisticians of recommendations for documenting statistical analyses and data files submitted to... guidance entitled ``Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files...

  14. Effectiveness guidance document (EGD) for acupuncture research - a consensus document for conducting trials

    PubMed Central

    2012-01-01

    Background There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making. Methods Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved. Results Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture. PMID:22953730

  15. Energy Efficiency/Renewable Energy Programs in State Implementation Plans - Guidance Documents

    EPA Pesticide Factsheets

    final document that provides guidance to States and local areas on quantifying and including emission reductions from energy efficiency and renewable energy measures in State Implementation Plans (SIPS).

  16. 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...

  17. 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...

  18. 75 FR 20606 - Guidance for Industry on Tobacco Health Document Submission; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-20

    ... 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 Submission... the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). DATES: Submit written...

  19. 32 CFR 701.64 - Publication of adopted regulatory documents for the guidance of the public.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 5 2014-07-01 2014-07-01 false Publication of adopted regulatory documents for the guidance of the public. 701.64 Section 701.64 National Defense Department of Defense (Continued... Affecting the Public § 701.64 Publication of adopted regulatory documents for the guidance of the public. (a...

  20. 32 CFR 701.64 - Publication of adopted regulatory documents for the guidance of the public.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 5 2013-07-01 2013-07-01 false Publication of adopted regulatory documents for the guidance of the public. 701.64 Section 701.64 National Defense Department of Defense (Continued... Affecting the Public § 701.64 Publication of adopted regulatory documents for the guidance of the public. (a...

  1. NAFTA Guidance Document for Conducting Terrestrial Field Dissipation Studies

    EPA Pesticide Factsheets

    Harmonized guidance for TFD studies that demonstrate transformation, transport and fate of pesticides under representative actual use conditions. Field studies substantiate physicochemical, mobility and biotransformation data from laboratory studies.

  2. 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.

  3. Iowa Department of Education Guidance Document. Response to Intervention

    ERIC Educational Resources Information Center

    Iowa Department of Education, 2011

    2011-01-01

    The purpose of this document is to provide an overview of Response to Intervention (RtI), including essential components. Iowa's RtI document is designed to provide the state with common language and understanding of RtI, why RtI is important for improving student results, general timelines for implementation and answers to Frequently Asked…

  4. DOD Renewable Energy Projects: Improved Guidance Needed for Analyzing and Documenting Costs and Benefits

    DTIC Science & Technology

    2016-09-01

    DOD RENEWABLE ENERGY PROJECTS Improved Guidance Needed for Analyzing and Documenting Costs and Benefits Report to...Accountability Office Highlights of GAO-16-487, a report to congressional committees September 2016 DOD RENEWABLE ENERGY PROJECTS Improved Guidance...and consumption of renewable energy . Also, DOD policy calls for investing in cost-effective renewable energy and improving energy security

  5. 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:...

  6. Lead (Pb) National Ambient Air Quality Standards (NAAQS) Implementation Guidance Documents

    EPA Pesticide Factsheets

    This page contains implementation guidance documents for the 1978 and 2008 Lead (Pb) NAAQS. Some of the topics covered are: RACM/RACT, RFP, new source review, designations, emissions inventories, attainment dates, and transition policy

  7. 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

    ... Transit Administration 49 CFR Part 611 Notice of Availability of Proposed New Starts and Small Starts Policy Guidance AGENCY: Federal Transit Administration (FTA), DOT. ACTION: Notice of availability of proposed policy guidance; request for comments. SUMMARY: The Federal Transit Administration (FTA)...

  8. 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...

  9. Guidance document for preparing water sampling and analysis plans for UMTRA sites. Final [report

    SciTech Connect

    Not Available

    1993-09-01

    A water sampling and analysis plan (WSAP) is required for each Uranium Mill Tailings Remedial Action (UMTRA) site to provide rationale for groundwater and surface water sampling at disposal sites and former processing sites. The WSAP identifies and justifies the sampling locations, analytical parameters, detection limits, and sampling frequencies for the groundwater and surface water monitoring stations at each site. Section 2.0 of this WSAP Guidance Document describes the WSAP format. Sections 3.0 and 4.0 provide guidance for selecting sampling frequencies and sampling locations, respectively. Section 5.0 contains criteria for selecting analytical parameters. Section 6.0 provides guidance for the contents of each site`s WSAP file. Finally, Section 7.0 presents the references used to prepare this document. The purpose of this guidance document is to provide a consistent technical approach for sampling and monitoring activities performed under WSAPs and a consistent format for WSAP documents. This document is designed for use by the Technical Assistance Contractor (TAC) to prepare WSAPs and by the US Department of Energy (DOE), Nuclear Regulatory Commission, state and tribal agencies, regulatory agencies, and the public to evaluate the contents of the WSAPS. This guidance document may be updated periodically based on new or changing regulations.

  10. 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.

  11. 32 CFR 701.64 - Publication of adopted regulatory documents for the guidance of the public.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 5 2011-07-01 2011-07-01 false Publication of adopted regulatory documents for... Affecting the Public § 701.64 Publication of adopted regulatory documents for the guidance of the public. (a...—substantive rules of general applicability adopted as authorized by law, and statements of general policy or...

  12. 32 CFR 701.64 - Publication of adopted regulatory documents for the guidance of the public.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Publication of adopted regulatory documents for... Affecting the Public § 701.64 Publication of adopted regulatory documents for the guidance of the public. (a...—substantive rules of general applicability adopted as authorized by law, and statements of general policy or...

  13. 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.

  14. PRN 93-11: Supplemental Guidance for PR Notice 93-7 - Labeling Revisions Required by the WPS

    EPA Pesticide Factsheets

    This pesticide registration notice augments the guidance provided by PR notice 97-3 to provide options that you may choose to allow efficient production and distribution of products that comply with PR Notice 93-7.

  15. Cost consideration in the clinical guidance documents of physician specialty societies in the United States.

    PubMed

    Schwartz, Jennifer A T; Pearson, Steven D

    2013-06-24

    Despite increasing concerns regarding the cost of health care, the consideration of costs in the development of clinical guidance documents by physician specialty societies has received little analysis. To evaluate the approach to consideration of cost in publicly available clinical guidance documents and methodological statements produced between 2008 and 2012 by the 30 largest US physician specialty societies. Qualitative document review. Whether costs are considered in clinical guidance development, mechanism of cost consideration, and the way that cost issues were used in support of specific clinical practice recommendations. Methodological statements for clinical guidance documents indicated that 17 of 30 physician societies (57%) explicitly integrated costs, 4 (13%) implicitly considered costs, 3 (10%) intentionally excluded costs, and 6 (20%) made no mention. Of the 17 societies that explicitly integrated costs, 9 (53%) consistently used a formal system in which the strength of recommendation was influenced in part by costs, whereas 8 (47%) were inconsistent in their approach or failed to mention the exact mechanism for considering costs. Among the 138 specific recommendations in these guidance documents that included cost as part of the rationale, the most common form of recommendation (50 [36%]) encouraged the use of a specific medical service because of equal effectiveness and lower cost. Slightly more than half of the largest US physician societies explicitly consider costs in developing their clinical guidance documents; among these, approximately half use an explicit mechanism for integrating costs into the strength of recommendations. Many societies remain vague in their approach. Physician specialty societies should demonstrate greater transparency and rigor in their approach to cost consideration in documents meant to influence care decisions.

  16. 75 FR 12553 - Notice of Availability of Final Policy Document

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-16

    ... Information Notice'' (PIN) 2010-01) to describe the documentation that will be considered by the Health...- identify as public agencies (also referred to in previous PINs as ``public entities'' or ``public... Service Act, as amended, and/or for Federally Qualified Health Center Look- Alike designation. The...

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

    PubMed

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

    2017-02-09

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

  18. 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

    ...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials for Organic Crop Production AGENCY: Agricultural... operations, material evaluation programs, and other organic industry stakeholders. The first set of...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 24 CFR 3500.3 - Questions or suggestions from public and copies of public guidance documents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Questions or suggestions from... PROCEDURES ACT § 3500.3 Questions or suggestions from public and copies of public guidance documents. Any questions or suggestions from the public regarding RESPA, or requests for copies of HUD Public...

  4. 24 CFR 3500.3 - Questions or suggestions from public and copies of public guidance documents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Questions or suggestions from... PROCEDURES ACT § 3500.3 Questions or suggestions from public and copies of public guidance documents. Any questions or suggestions from the public regarding RESPA, or requests for copies of HUD Public...

  5. A guidance document for Kentucky`s oil and gas operations: July 1-September 30, 1997

    SciTech Connect

    1998-09-01

    This technical report is a summary of the progress made on `A guidance Document for Kentucky`s Oil and Gas Operator`s`. During this quarter, the document received continued review and editing in an electronic format to satisfy the United States Department of Energy (DOE). Comments received from oil and gas operators reviewing this document prompted contact to be made with the United States Environmental Protection Agency (USEPA) to develop an addendum section to provide better explanation of USEPA requirements for Class 11 injection wells.

  6. 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.

  7. Guidance for Avoiding Incomplete Premanufacture Notices or Bona Fides in the New Chemicals Program

    EPA Pesticide Factsheets

    This page contains documents to help you avoid having an incomplete Premanufacture notice or Bona Fide . The documents go over the chemical identity requirements and common errors that result in incompletes.

  8. Transferring critically ill patients home to die: developing a clinical guidance document.

    PubMed

    Coombs, Maureen A; Darlington, Anne-Sophie; Long-Sutehall, Tracy; Richardson, Alison

    2015-09-01

    With preferred place of care at the time of death a key consideration in end of life care, it is important that transfer home be considered for critically ill patients who want this as part of their end of life care. However, there is limited guidance available to inform the transfer of critically ill patients home to die. To develop clinical guidance on the practice of transferring patients home to die for doctors and nurses in critical care. Consensus methodology. At a one-day national event, stakeholders from cross-community and hospital settings engaged in group work wherein 'virtual clinical teams' mapped out, and agreed on, the processes involved in transferring critically ill patients home to die. Using two clinical cases and nominal group technique, factors were identified that promoted and inhibited transfer home and areas in need of development. Findings from the day informed development of a clinical guidance document. Eighty-five stakeholders attended the event from across England. The majority of stakeholders strongly agreed that transfer of critically ill patients home to die was a good idea in principle. Stakeholders identified 'access to care in the community' (n = 22, 31.4%) and 'unclear responsibility for care of patient' (n = 17, 24.3%) as the most important barriers. Consensus was reached on the processes and decision-making required for transfer home and was used to inform content of a clinical practice guidance document. This underwent further refinement following review by 14 clinicians. A final document in the form of a flow chart was developed. Transferring critically ill patients home to die is a complex, multifactorial process involving health care agencies across the primary and secondary care interface. The guidance developed from this consensus event will enable staff to actively consider the practice of transferring home to die in appropriate patients. © 2015 British Association of Critical Care Nurses.

  9. 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,...

  10. EANM Dosimetry Committee guidance document: good practice of clinical dosimetry reporting.

    PubMed

    Lassmann, M; Chiesa, C; Flux, G; Bardiès, M

    2011-01-01

    Many recent publications in nuclear medicine contain data on dosimetric findings for existing and new diagnostic and therapeutic agents. In many of these articles, however, a description of the methodology applied for dosimetry is lacking or important details are omitted. The intention of the EANM Dosimetry Committee is to guide the reader through a series of suggestions for reporting dosimetric approaches. The authors are aware of the large amount of data required to report the way a given clinical dosimetry procedure was implemented. Another aim of this guidance document is to provide comprehensive information for preparing and submitting publications and reports containing data on internal dosimetry. This guidance document also contains a checklist which could be useful for reviewers of manuscripts submitted to scientific journals or for grant applications. In addition, this document could be used to decide which data are useful for a documentation of dosimetry results in individual patient records. This may be of importance when the approval of a new radiopharmaceutical by official bodies such as EMA or FDA is envisaged.

  11. 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.

  12. 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)...

  13. 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...

  14. 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...

  15. NAFTA Guidance Document on Data Requirements for Tolerances on Imported Commodities in the United States and Canada

    EPA Pesticide Factsheets

    The purpose of this document is to provide detailed guidance on data requirements that meet the North American Free Trade Agreement standards for the establishment of pesticide import tolerances or maximum residue levels in Canada and the United States.

  16. OASIS skin and wound integumentary assessment items: applying the WOCN guidance document.

    PubMed

    Baranoski, Sharon; Thimsen, Kathi

    2003-03-01

    This supplement provides home care nurses, therapists, and clinical managers a tool for understanding of how the Wound, Ostomy, and Continence Nurses (WOCN) Guidance Document on OASIS Skin and Wound Status M0 Items 2001 should be used. The supplement is a pictorial guide that clarifies definitions by linking them to photos using the skin integrity OASIS M0 items as an outline. The additional visual cues enable the clinician to clearly observe subtle characteristics that lead to a more reliable OASIS score and appropriate reimbursement by choosing the correct Home Health Resource Group (HHRG).

  17. Documenting the remedial response: Adapting and applying administrative record guidance to Department of Defense installations

    SciTech Connect

    Savage, L.S.; Capito, B.P.

    1995-12-31

    The Administrative Record (AR) is a CERCLA-mandated collection of material that documents the selection of a remedial response at National Priority List (NPL) sites. It is a massive file that is established to serve legal as well as community relations functions. The US Environmental Protection Agency (USEPA) has promulgated guidance for those who are required to establish and maintain ARs; however, this guidance was developed for single-site, USEPA cleanups (i.e., industrial NPL sites). Department of Defense (DoD) facilities are tested on the NPL by installation; a single installation usually encompasses multiple sites, sometimes 25 or more. The USEPA Administrative Record guidance must be adapted before being applied to DoD installations. This paper will present the AR approach developed by the US Navy, Atlantic Division, Naval Facilities Engineering Command (LANTDIV) through its contractor Baker Environmental (Baker). The AR project was conducted as part of the Comprehensive Long-term Environmental Action Navy (CLEAN) contract. The CLEAN program is designed to address environmental problems resulting from past, formerly accepted waste management practices.

  18. 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

    ... 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 wide-area anthrax attack from developing anthrax as a result of exposure to aerosolized Bacillus anthracis spores...

  19. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Guidance on Simultaneous Transmission Import Limit Studies for the Northwest Region; Notice of Pre-Filing Technical Conference for Northwest Region Transmission Owners April 5,...

  20. The Water Framework Directive: The Challenges of Testing and Validation of Guidance Documents

    NASA Astrophysics Data System (ADS)

    Barth, F.; Bidoglio, G.; Murray, C. N.; Zaldivar, J.; Bouraoui, F.

    On the 23rd October 2000 the European Parliament and Council passed a Directive establishing a framework of community action in the field of water policy (Water Framework Directive- FWD). The Water Framework Directive (FWD) raises major challenges, these include an extremely demanding timetable, in particular in the nine preparatory years; the complexity of the text and the diversity of possible solutions to scientific, technical and practical questions. A further problem is that a common understanding and methodologies for the application of the different areas of the FWD do not necessarily exist. Member States have, historically, developed approaches to monitoring, impact assessment, economic analysis etc. that will need to be compared in order to be certain that they provide comparable level of results over the range of ecosystems covered in the European Union. Accession Countries will also have to start to adjust their environmental legislation to be compatible with EU Directives and standards. The Framework Water Directive imposes a series of deadlines for the reporting by Member States to the European Commission. In order to respond to this problem a Common Strategy on the Implementation of the Water Framework Directive is being developed by the European Commission and Member States. The aim of the development of this Common Strategy is to allow, as far as possible, a coherent and harmonious implementation of the Directive. Focus is on methodological questions related to a common understanding of the technical and scientific implications of the Directive. The aim is to clarify and develop, where appropriate, supporting technical and scientific information to assist in the practical implementation of the Directive. Guidance documents, advice for operational methods and other supporting documents will be developed for this purpose. A modular structure has been chosen for the overall strategy. The main modules are the key activities for the implementation

  1. 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.

  2. 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...

  3. 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.

  4. Methodological guidance documents for evaluation of ethical considerations in health technology assessment: a systematic review.

    PubMed

    Assasi, Nazila; Schwartz, Lisa; Tarride, Jean-Eric; Campbell, Kaitryn; Goeree, Ron

    2014-04-01

    Despite the advances made in the development of ethical frameworks for health technology assessment (HTA), there is no clear agreement on the scope and details of a practical approach to address ethical aspects in HTA. This systematic review aimed to identify existing guidance documents for incorporation of ethics in HTA to provide an overview of their methodological features. The review identified 43 conceptual frameworks or practical guidelines, varying in their philosophical approach, structure, and comprehensiveness. They were designed for different purposes throughout the HTA process, ranging from helping HTA-producers in identification, appraisal and analysis of ethical data to supporting decision-makers in making value-sensitive decisions. They frequently promoted using analytical methods that combined normative reflection with participatory approaches. The choice of a method for collection and analysis of ethical data seems to depend on the context in which technology is being assessed, the purpose of analysis, and availability of required resources.

  5. Request For Guidance in Drafting a SIP Deficiency Notice For Michigan's Nonattainment New Source Review Program

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  6. 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 Standards...

  7. 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...

  8. 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

    ...This notice proposes guidance in the form of a revised circular on the Federal Transit Administration's research, technical assistance, and training programs and seeks comment thereon. Proposed FTA Circular 6100.1D, ``Research, Technical Assistance, and Training Programs: Application Instructions and Program Management Guidelines,'' modifies FTA's existing FTA Circular 6100.1C, ``Transit Research and Technology Programs: Application Instructions and Program Management Guidelines'' to reflect current policy and new FTA programs, restructures the circular, and clarifies FTA's requirements and processes.

  9. 76 FR 33752 - Notice of Availability of the External Review Draft of the Guidance for Applying Quantitative...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-09

    ... AGENCY Notice of Availability of the External Review Draft of the Guidance for Applying Quantitative Data... Draft of ``Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for... Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies...

  10. 76 FR 43999 - Notice of Availability of the External Review Draft of the Guidance for Applying Quantitative...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Notice of Availability of the External Review Draft of the Guidance for Applying Quantitative Data... Review Draft of ``Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors...

  11. 77 FR 76049 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-26

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

  12. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY...

  13. 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 public...

  14. 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...

  15. 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 public...

  16. 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 public...

  17. 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 public...

  18. USSOCOM Needs to Consistently Follow Guidance to Revalidate Capability Requirements and Maintain Supporting Documentation for Special Operation Peculiar Programs (Redacted)

    DTIC Science & Technology

    2015-02-04

    Decision Support (KM/ DS ) system as required by Joint Chiefs of Staff guidance. Specifically, KM/ DS did not contain Findings (cont’d) requirements...took corrective action to upload capability requirement documents into KM/ DS ; therefore, we did not make recommendations for Finding B. a...Program Capabilities 13 Management Actions Taken To Upload SO-P Documentation into KM/ DS . 14 Management Comments on the Finding and Our Response 14

  19. 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

    ... Reactors; Notice of Availability of the Final Staff Guidance Standard Review Plan Section 13.6.2, Revision 1 on Physical Security--Design Certification AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of Availability. SUMMARY: The NRC is issuing its Final Revision 1 to NUREG-0800, ``Standard Review...

  20. 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. ACTION...

  1. 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 Administration...

  2. Building a UNESCO National Education Support Strategy (UNESS) Document: 2008-2013. Guidance Note. Education Policies and Strategies 11

    ERIC Educational Resources Information Center

    United Nations Educational, Scientific and Cultural Organization (UNESCO), 2006

    2006-01-01

    This is a Guidance Note for designing a UNESCO National Education Support Strategy (UNESS) document. This guide is meant to be indicative, evolving and inclusive. It presents a number of useful questions one may ask when analysing national development policies and priorities, mapping donors' interventions in-country and accordingly, defining…

  3. Draft guidance for industry; exports and imports under the FDA Export Reform and Enhancement Act of 1996--FDA. Notice.

    PubMed

    1998-06-12

    The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, "FDA Draft Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996." The draft guidance document addresses issues pertaining to the exportation of human drugs, animal drugs, biologics, food additives, and devices as well as the importation of components, parts, accessories, or other articles for incorporation or further processing into articles intended for export.

  4. 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,...

  5. 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,...

  6. 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,...

  7. 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,...

  8. 78 FR 32681 - Notice of Proposed Information Collection: Comment Request; Condominium Project Approval Document...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ... URBAN DEVELOPMENT Notice of Proposed Information Collection: Comment Request; Condominium Project... of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. HUD is... information: Title of Proposal: Condominium Project Approval Document Collection. OMB Control Number,...

  9. Coastal Energy Corporation, Willow Springs, MO - Public Notice Document

    EPA Pesticide Factsheets

    Notice of a proposed Administrative Penalty Assessment against Coastal Energy Corporation, located at 232 Burnham Road, Willow Springs, Missouri, for alleged violations at the facility located at or near that facility

  10. RAS testing of colorectal carcinoma—a guidance document from the Association of Clinical Pathologists Molecular Pathology and Diagnostics Group.

    PubMed

    Wong, Newton A C S; Gonzalez, David; Salto-Tellez, Manuel; Butler, Rachel; Diaz-Cano, Salvador J; Ilyas, Mohammad; Newman, William; Shaw, Emily; Taniere, Philippe; Walsh, Shaun V

    2014-09-01

    Analysis of colorectal carcinoma (CRC) tissue for KRAS codon 12 or 13 mutations to guide use of anti-epidermal growth factor receptor (EGFR) therapy is now considered mandatory in the UK. The scope of this practice has been recently extended because of data indicating that NRAS mutations and additional KRAS mutations also predict for poor response to anti-EGFR therapy. The following document provides guidance on RAS (i.e., KRAS and NRAS) testing of CRC tissue in the setting of personalised medicine within the UK and particularly within the NHS. This guidance covers issues related to case selection, preanalytical aspects, analysis and interpretation of such RAS testing.

  11. 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…

  12. 77 FR 18828 - Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

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

  13. Garen Goebel, Washington County, KS - Public Notice Document

    EPA Pesticide Factsheets

    Environmental Protection Agency (“EPA”) is providing notice of a proposed Administrative Penalty Assessment against Garen Goebel for alleged violations of Section 301of the Clean Water Act, 33 U.S.C. § 1311 at a site located in Washington County, Kansas.

  14. Policy & Guidance

    EPA Pesticide Factsheets

    Policy documents represent EPA's official interpretation or view of specific issues. Guidance documents are published to further clarify regulations and to assist in implementation of environmental regulations.

  15. 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....

  16. In Situ Soil Venting - Full Scale Test Hill AFB, Guidance Document, Literature Review. Volume 1

    DTIC Science & Technology

    1991-08-01

    high bulk density to reduce diffusive path length. AWARE, Inc., (now Eckenfelder , Inc.) has performed experimental and theoretical work on in situ soil...operating guidance. The Eckenfelder work has continued with a one-year field study (Reference 33), consisting of a single 4-inch vent 20-foot-deep

  17. 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.

  18. 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…

  19. 76 FR 71353 - Idaho: Notice of Filing of Decision Document

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-17

    ... signed a report titled ``Grays Lake Administrative Navigability Determination and Omitted Lands and... decisions related to Grays Lake. This decision document will be considered filed for the purposes of survey... Grays Lake and no in-lake avulsion. In addition to those decisions, the report also presents an...

  20. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; 30- Day Notices, 135-Day Premarket Approval Supplements and 75-Day Humanitarian Device Exemption Supplements for Manufacturing Method or Process Changes; Availability AGENCY: Food and Drug Administration...

  1. In Situ Soil Venting - Full Scale Test, Hill AFB, Guidance Document. Volume 2

    DTIC Science & Technology

    1991-08-01

    reverse if necessary and identity by block number)FIELD GROUP SJBGROuP FI06 13 Soil Venting Fuel Spill Remediation06 Bioremediation Vacuum Extraction...The first volume is a complete literature review of previous soil venting research and field work. Volume II is a guidance manual which provides...removal of volatile contaminant spills in unsaturated zone soils. In this technique , the soil is decontaminated in place by pulling air through the

  2. 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

    ... Documents and Assignment of OMB Control Number AGENCY: Office of the Assistant Secretary for Housing... completion of the process required by the Paperwork Reduction Act and the assignment of the OMB control... presentation to OMB for final approval and assignment of a control number under the Paperwork Reduction Act. In...

  3. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Third-Party Documentation Facsimile..., Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette...

  4. 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

    ... Energy Regulatory Commission Copper Valley Electric Association; Notice of Scoping Document 2 and... Application. b. Project No.: 13124-002. c. Applicant: Copper Valley Electric Association (Copper Valley) d..., Copper Valley Electric Association, P.O. Box 45, Mile 187 Glenn Highway, Glennallen, Alaska 99588,...

  5. 29 CFR 500.5 - Filing of applications, notices and documents.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 3 2010-07-01 2010-07-01 false Filing of applications, notices and documents. 500.5 Section 500.5 Labor Regulations Relating to Labor (Continued) WAGE AND HOUR DIVISION, DEPARTMENT OF LABOR REGULATIONS MIGRANT AND SEASONAL AGRICULTURAL WORKER PROTECTION General Provisions § 500.5 Filing...

  6. 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 §...

  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 § 2903...

  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, 2014 CFR

    2014-01-01

    ... 7 Agriculture 15 2014-01-01 2014-01-01 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. 7 CFR 2903.17 - Award document and notice of award.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 15 2013-01-01 2013-01-01 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 §...

  11. 7 CFR 2903.17 - Award document and notice of award.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 15 2012-01-01 2012-01-01 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 §...

  12. How accessible was information about H1N1 flu? Literacy assessments of CDC guidance documents for different audiences.

    PubMed

    Lagassé, Lisa P; Rimal, Rajiv N; Smith, Katherine C; Storey, J Douglas; Rhoades, Elizabeth; Barnett, Daniel J; Omer, Saad B; Links, Jonathan

    2011-01-01

    We assessed the literacy level and readability of online communications about H1N1/09 influenza issued by the Centers for Disease Control and Prevention (CDC) during the first month of outbreak. Documents were classified as targeting one of six audiences ranging in technical expertise. Flesch-Kincaid (FK) measure assessed literacy level for each group of documents. ANOVA models tested for differences in FK scores across target audiences and over time. Readability was assessed for documents targeting non-technical audiences using the Suitability Assessment of Materials (SAM). Overall, there was a main-effect by audience, F(5, 82) = 29.72, P<.001, but FK scores did not vary over time, F(2, 82) = .34, P>.05. A time-by-audience interaction was significant, F(10, 82) = 2.11, P<.05. Documents targeting non-technical audiences were found to be text-heavy and densely-formatted. The vocabulary and writing style were found to adequately reflect audience needs. The reading level of CDC guidance documents about H1N1/09 influenza varied appropriately according to the intended audience; sub-optimal formatting and layout may have rendered some text difficult to comprehend.

  13. 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...

  14. 75 FR 8970 - Guidance for Industry on Submission of Documentation in Applications for Parametric Release of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-26

    ... Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat... ``Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products.... 2201, Silver Spring, MD 20993-0002; the Communications Staff (HFV-12), Center for Veterinary...

  15. 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...

  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

    ... Preparation of Drivers' Record of Duty Status To Document Compliance With the Hours-of-Service Requirements.... FMCSA has determined that the current requirement may be satisfied through the preparation of an... the preparation of the RODS, in duplicate. However, FMCSA has opted for a more pragmatic...

  17. In Situ Soil Venting - Full Scale Test, Hill AFB. Volume 3. Guidance Document, Literature Review

    DTIC Science & Technology

    1991-08-01

    s ý GCE Form A•pproved REPORT DOCUMENTATION PAGE CMBNO 070401’ihs a EERORT C ,RI Y C•.ASSFCA ,ON ’t .• ESTR !CTiVE MARKINGS .a SECURT’Y CLASSiFICAT... labor -intensive, operating costs are relatively low. Major operating costs are sampling, sample analysis, power, maintenance, and emissions control

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. Sexual Harassment Guidance: Harassment of Students by School Employees, Other Students, or Third Parties. Federal Register, Part VII: Department of Education, Office of Civil Rights. Notice.

    ERIC Educational Resources Information Center

    Federal Register, 1997

    1997-01-01

    This document contains the final policy guidance issued by the Assistant Secretary for Civil Rights, which is called the "Sexual Harassment Guidance." Sexual harassment of students is prohibited by Title IX of the Education Amendments of 1972. The guidance provides educational institutions with information regarding the standards that are used by…

  3. 76 FR 6458 - Notice of Intent to File Competing License Applications, Filing of Pre-Application Documents...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-04

    ... Energy Regulatory Commission Notice of Intent to File Competing License Applications, Filing of Pre-Application Documents (PADs), Commencement of Pre-Filing Process, and Scoping; Request for Comments on the... Filing: Notices of Intent to File Competing License Applications for a New License and Commencing...

  4. 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

    ... radiation releases are not specifically reportable under Appendix A unless the release receives media... media inquiries about these routine radiation releases should not result in a required report to the NRC....'' In the example of an effluent release which has some impact on the environment, media attention would...

  5. 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

    ... Gordon, Structural Mechanics and Materials Branch, Division of Spent Fuel Storage and Transportation... ISG-23 should be directed to Matthew Gordon, Structural Mechanics and Materials Branch, Division of.... Michele Sampson, Acting Chief, Structural Mechanics and Materials Branch, Division of Spent Fuel Storage...

  6. International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice.

    PubMed

    2009-04-08

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q10 Pharmaceutical Quality System." 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 a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH guidances on "Q8 Pharmaceutical Development" and "Q9 Quality Risk Management."

  7. 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.

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

    PubMed

    Crobach, M J T; Planche, T; Eckert, C; Barbut, F; Terveer, E M; Dekkers, O M; Wilcox, M H; Kuijper, E J

    2016-08-01

    In 2009 the first European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guideline for diagnosing Clostridium difficile infection (CDI) was launched. Since then newer tests for diagnosing CDI have become available, especially nucleic acid amplification tests. The main objectives of this update of the guidance document are to summarize the currently available evidence concerning laboratory diagnosis of CDI and to formulate and revise recommendations to optimize CDI testing. This update is essential to improve the diagnosis of CDI and to improve uniformity in CDI diagnosis for surveillance purposes among Europe. An electronic search for literature concerning the laboratory diagnosis of CDI was performed. Studies evaluating a commercial laboratory test compared to a reference test were also included in a meta-analysis. The commercial tests that were evaluated included enzyme immunoassays (EIAs) detecting glutamate dehydrogenase, EIAs detecting toxins A and B and nucleic acid amplification tests. Recommendations were formulated by an executive committee, and the strength of recommendations and quality of evidence were graded using the Grades of Recommendation Assessment, Development and Evaluation (GRADE) system. No single commercial test can be used as a stand-alone test for diagnosing CDI as a result of inadequate positive predictive values at low CDI prevalence. Therefore, the use of a two-step algorithm is recommended. Samples without free toxin detected by toxins A and B EIA but with positive glutamate dehydrogenase EIA, nucleic acid amplification test or toxigenic culture results need clinical evaluation to discern CDI from asymptomatic carriage.

  9. 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

    ... alternative; (3) Identification of resource issues to be analyzed in the environmental document, including... scoping pursuant to the National Environmental Policy Act; (2) Review and discuss existing conditions and... environmental document pursuant to the National Environmental Policy Act. (e) Method of notice. The public...

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

    PubMed

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

    2015-06-24

    Among the challenges confronting patients with rare diseases is a dearth of treatment options. The development of safe and effective new therapies is hampered by challenges associated with conducting clinical trials in small populations. In this article, we describe how the Duchenne muscular dystrophy community-led by Parent Project Muscular Dystrophy-created a proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration. This unprecedented undertaking involved a broad coalition of more than 80 stakeholders collaborating across nine time zones to produce a document in only 6 months. We hope that other rare disease communities and advocacy organizations can use our experience as a model for developing their own draft guidance documents.

  11. 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;…

  12. Safety pharmacology in focus: new methods developed in the light of the ICH S7B guidance document.

    PubMed

    Pugsley, Michael K; Curtis, Michael J

    2006-01-01

    'Safety' continues to be a growth area in 'Pharmacology'. This issue of Journal of Pharmacological and Toxicological Methods is the third to be focused on methods development in the safety pharmacology area. The unusual nature of safety pharmacology mandates that methods development be done with, not only scientific validation, but also, adherence to the mandates of legislation to the forefront. This focused issue draws on a broad range of global safety pharmacology experts, many of whom operate in the industrial milieu. They have reviewed and updated current models, validated modifications, and have also introduced novel methodology important to the conduct of non-clinical safety pharmacology studies. The contributors were all active participants at the 5th Annual Safety Pharmacology Society (SPS) meeting held in Mannheim, Germany September 25-28, 2005. The publications presented here describe in vitro and in vivo pharmacological methods development that has been informed by the S7A regulatory guidance document for pre-clinical safety testing of drugs. While S7A describes the 'core battery' of methods used to characterize the safety pharmacology profile of a compound, the most recent news in Safety Pharmacology involves ratification of the related S7B safety guidance document. Unlike the past, S7B heralds a new era for the pharmaceutical industry since it now sets out how to address safety concerns of a new chemical entity (NCE) in relation to adverse actions on ventricular repolarization, a topic that has vexed industry and regulatory authorities for many years. Unsurprisingly there are many papers in the present issue that address this specific aspect of safety pharmacology. These include results from the Health and Environmental Sciences Institute of the International Life Sciences Institute (ILSI/HESI) initiative, in which non-clinical in vitro (hERG and Purkinje fiber) and in vivo (QT dog study) assays were found to be useful in the determination of drug

  13. 75 FR 359 - Guidance on Simultaneous Transmission Import Limit Studies; Notice Allowing Post-Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ... on Simultaneous Transmission Import Limit Studies; Notice Allowing Post-Technical Conference Comments... Simultaneous Transmission Import Limit (SIL) studies. All interested persons are invited to file written...

  14. 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...

  15. 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

    ...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 National Organic Program: Notice of... Certified Organic Products AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice of availability with request for comments. SUMMARY: The National Organic Program (NOP) is announcing the availability of...

  16. Prevention and management of foot problems in diabetes: a Summary Guidance for Daily Practice 2015, based on the IWGDF Guidance Documents.

    PubMed

    Schaper, N C; Van Netten, J J; Apelqvist, J; Lipsky, B A; Bakker, K

    2016-01-01

    In this 'Summary Guidance for Daily Practice', we describe the basic principles of prevention and management of foot problems in persons with diabetes. This summary is based on the International Working Group on the Diabetic Foot (IWGDF) Guidance 2015. There are five key elements that underpin prevention of foot problems: (1) identification of the at-risk foot; (2) regular inspection and examination of the at-risk foot; (3) education of patient, family and healthcare providers; (4) routine wearing of appropriate footwear; and (5) treatment of pre-ulcerative signs. Healthcare providers should follow a standardized and consistent strategy for evaluating a foot wound, as this will guide further evaluation and therapy. The following items must be addressed: type, cause, site and depth, and signs of infection. There are seven key elements that underpin ulcer treatment: (1) relief of pressure and protection of the ulcer; (2) restoration of skin perfusion; (3) treatment of infection; (4) metabolic control and treatment of co-morbidity; (5) local wound care; (6) education for patient and relatives; and (7) prevention of recurrence. Finally, successful efforts to prevent and manage foot problems in diabetes depend upon a well-organized team, using a holistic approach in which the ulcer is seen as a sign of multi-organ disease, and integrating the various disciplines involved. Copyright © 2015 John Wiley & Sons, Ltd.

  17. 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 STATUTE...

  18. 39 CFR 963.3 - Petition; notice of hearing; answer; filing and copies of documents; summary judgment.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 39 Postal Service 1 2012-07-01 2012-07-01 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 STATUTE...

  19. 39 CFR 963.3 - Petition; notice of hearing; answer; filing and copies of documents; summary judgment.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 39 Postal Service 1 2013-07-01 2013-07-01 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 STATUTE...

  20. 39 CFR 963.3 - Petition; notice of hearing; answer; filing and copies of documents; summary judgment.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 39 Postal Service 1 2011-07-01 2011-07-01 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 STATUTE...

  1. 39 CFR 963.3 - Petition; notice of hearing; answer; filing and copies of documents; summary judgment.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 39 Postal Service 1 2014-07-01 2014-07-01 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 STATUTE...

  2. 76 FR 17412 - Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-29

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Intent To File License Application, Filing of Pre- Application... National Historic Preservation Act. m. Free Flow Power filed a Pre-Application Document (PAD), including...

  3. 76 FR 17411 - Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-29

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Intent To File License Application, Filing of Pre- Application... National Historic Preservation Act. m. Free Flow Power filed a Pre-Application Document (PAD), including...

  4. 75 FR 73106 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... Clostridium difficile; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... Clostridium difficile.'' This draft guidance document describes FDA's recommendations concerning 510(k... Clostridium difficile (C. difficile). This draft guidance is not final nor is it in effect at this time....

  5. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period...

  6. 76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Treatment of Urinary Incontinence.'' This guidance document describes FDA's recommendations for clinical...

  7. 76 FR 49772 - Guidance for Industry: Bar Code Label Requirements-Questions and Answers; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-11

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Bar Code Label Requirements--Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for...

  8. 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

    ... Organic Production and Handling (NOP 5025)''; and ``The Use of Chlorine Materials in Organic Production... the use of chlorine materials. The five draft guidances can be viewed on-line at http://www.ams.usda... ``NOP 5026--The Use of Chlorine Materials in Organic Production and Handling''. Based upon the...

  9. Software Documentation for the Bartlesville Public Schools: Part One. The Bartlesville System Total Guidance Information Support System.

    ERIC Educational Resources Information Center

    Roberts, Tommy L.; And Others

    The Total Guidance Information Support System (TGISS), is an information storage and retrieval system for counselors. The total TGISS, including hardware and software, extends the counselor's capabilities by providing ready access to student information under secure conditions. The hardware required includes: (1) IBM 360/50 central processing…

  10. 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 to...

  11. The challenge of challenge testing to monitor Listeria monocytogenes growth on ready-to-eat foods in Europe by following the European Commission (2014) Technical Guidance document.

    PubMed

    Álvarez-Ordóñez, Avelino; Leong, Dara; Hickey, Bernadette; Beaufort, Annie; Jordan, Kieran

    2015-09-01

    European Regulation (EC) No. 2073/2005 lays down the microbiological criteria for certain microorganisms in foods and the implementing rules to be complied with by food business operators (FBOs) in Europe when implementing general and specific hygiene measures. In relation to Listeria monocytogenes, this regulation covers primarily ready-to-eat (RTE) food products, and requires different microbiological criteria depending on the ability of the food product to support growth of L. monocytogenes. In addition, this regulation establishes that food safety is the responsibility of the FBO. The FBO can conduct studies to evaluate the growth of L. monocytogenes that may be present in the product during the shelf-life under reasonably foreseeable storage conditions of distribution, storage and use in order to investigate compliance with the criteria throughout the shelf-life of the product. The European Union Community Reference Laboratory for L. monocytogenes published a revised technical guidance document in June 2014 for conducting shelf-life studies on L. monocytogenes in RTE foods. This review article describes the recently published European guidance document, with special focus on the design of challenge studies to determine the growth potential of L. monocytogenes on foods. Information is given particularly on what a challenge test is and when one is advisable. The factors to be considered and the laboratory methodology to be applied when performing a challenge test to determine the growth potential of L. monocytogenes in a defined food matrix are also described. Results of recent research articles applying challenge tests to determine the growth of L. monocytogenes in a range of foodstuffs are summarized and discussed. Finally, recommendations for obtaining data that can contribute to any further revision of the guidance document and for addressing the main challenges of challenge testing for FBOs are presented. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. 78 FR 66746 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... Public of Web Site Location of Fiscal Year 2014 Proposed Guidance Development AGENCY: Food and Drug... the Web site location where the Agency will post two lists of guidance documents the Center for... updates to the A-list and B-list announced in this notice. This notice announces the Web site location...

  13. 75 FR 35510 - License Renewal Interim Staff Guidance Process, Revision 2 Notice of Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... FURTHER INFORMATION CONTACT: Mr. Matthew Homiack, Division of License Renewal, Office of Nuclear Reactor... Matthew.Homiack@nrc.gov . ADDRESSES: Documents created or received after November 1, 1999, are available...

  14. International Conference on Harmonisation; revised guidance on Q3B(R) Impurities in New Drug Products; Availability. Notice.

    PubMed

    2003-11-14

    The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q3B(R) Impurities in New Drug Products.'' The revised guidance, which updates a guidance on the same topic published in the Federal Register of May 19, 1997 (the 1997 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The revised guidance is intended to provide guidance to applicants for drug marketing registration on the content and qualification of impurities in new drug products produced by chemically synthesized new drug substances not previously registered in a country, region, or member State. The revised guidance clarifies the 1997 guidance, adds information, and provides consistency with more recently published ICH guidances. The revised guidance complements the ICH guidance entitled "Q3A(R) Impurities in New Drug Substances.''

  15. 77 FR 36533 - Notice of Availability of the Benchmark Dose Technical Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-19

    ... process involves evaluating the dose-response relationship between exposure to the agent and the observed effect. The dose-response assessment is a two-step process: (1) Defining a point of departure (POD); and... document discusses computation of BMD values and their confidence limits, data requirements, dose-...

  16. 77 FR 47079 - Notice of Availability of Draft Policy Document for Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-07

    ... Medicaid programs), its implementing regulations, or policies. HRSA's Bureau of Primary Health Care is... notice, please contact the Office of Policy and Program Development, Bureau of Primary Health Care, HRSA... HUMAN SERVICES Health Resources and Services Administration Notice of Availability of Draft Policy...

  17. 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

    ... 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... document is immediately in effect as the special control for the ovarian adnexal mass assessment score...

  18. 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.

  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. 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.

  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. International Conference on Harmonisation; revised guidance on Q3A impurities in new drug substances; availability. Notice.

    PubMed

    2003-02-11

    The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q3A(R) Impurities in New Drug Substances." The revised guidance, which updates a guidance on the same topic published in the Federal Register of January 4, 1996 (the 1996 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The revised guidance clarifies the 1996 guidance, adds information, and provides consistency with more recently published ICH guidances. The revised guidance is intended to provide guidance to applicants for drug marketing registration on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a country, region, or member State.

  3. 77 FR 45410 - Advisory Committee on Historical Diplomatic Documentation; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... September 6, 2012, to provide date of birth, valid government-issued photo identification number and type... Control System (VACS- D) database. Please see the Security Records System of Records Notice (State-36) at...

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

    PubMed

    Kühnisch, J; Ekstrand, K R; Pretty, I; Twetman, S; van Loveren, C; Gizani, S; Spyridonos Loizidou, M

    2016-02-01

    The European Academy of Paediatric Dentistry (EAPD) encourages prevention and arrest of active dental caries. Therefore, the present guidance provides evidence- and clinically-based recommendations for detecting and diagnosing early/non-cavitated caries lesions, risk assessment and disease management. A search of different databases was conducted using all terms related to the subject. Relevant papers were identified after a review of their titles, abstracts or full texts. Three workshops were held during the corresponding EAPD interim seminar in Brussels in 2015. Several statements were agreed upon and, furthermore, gaps in our knowledge were identified. Following the systematic reviews and outcomes of the seminars, it was concluded that visual and radiographic caries detection should be utilised as a basic diagnostic approach to locate, assess and monitor non-cavitated caries lesions in primary and permanent teeth. As another important evaluation step, a caries risk assessment should be performed at a child's first dental visit, and reassessments should be performed on a regular basis. It is widely accepted that non-cavitated caries lesions can be managed non-invasively in the majority of cases. The spectrum of measures includes a low cariogenicity tooth-friendly diet, daily and appropriate management of the biofilm, home and within the dental office/surgery usage of fluorides as well as sealing techniques. The detection and management of non-cavitated caries is an essential aspect of preventive dentistry. Therefore, the EAPD encourages oral health care providers and caregivers to implement preventive practices that can arrest early caries and improve individual and public dental health.

  5. Hide It in Plain Sight--File Essential Documents and Find Them at a Moment's Notice.

    ERIC Educational Resources Information Center

    Ranck, Edna Runnels

    2000-01-01

    Notes that child care directors need a flexible and structured filing and retrieval system for all their documents, but most importantly, their essential documents. Provides a case study, a "to do" list for reorganizing a child care program's filing system, an inventory and supply order list, and a list of essential document categories.…

  6. 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

    ... Guidance provides that FMCSA use a form of arbitration known as ``Night Baseball,'' under which each party... determination. FMCSA is proposing to revise the Guidance to eliminate the ``Night Baseball'' format, and to... Guidance's ``Night Baseball'' format, each party presents to the Arbitrator evidence supporting the penalty...

  7. Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to find a balance between different pressures

    PubMed Central

    Apolone, G; Joppi, R; Bertele', V; Garattini, S

    2005-01-01

    Despite important progress in understanding the molecular factors underlying the development of cancer and the improvement in response rates with new drugs, long-term survival is still disappointing for most common solid tumours. This might be because very little of the modest gain for patients is the result of the new compounds discovered and marketed recently. An assessment of the regulatory agencies' performance may suggest improvements. The present analysis summarizes and evaluates the type of studies and end points used by the EMEA to approve new anticancer drugs, and discusses the application of current regulations. This report is based on the information available on the EMEA web site. We identified current regulatory requirements for anticancer drugs promulgated by the agency and retrieved them in the relevant directory; information about empirical evidence supporting the approval of drugs for solid cancers through the centralised procedure were retrieved from the European Public Assessment Report (EPAR). We surveyed documents for drug applications and later extensions from January 1995, when EMEA was set up, to December 2004. We identified 14 anticancer drugs for 27 different indications (14 new applications and 13 extensions). Overall, 48 clinical studies were used as the basis for approval; randomised comparative (clinical) trial (RCT) and Response Rate were the study design and end points most frequently adopted (respectively, 25 out of 48 and 30 out of 48). In 13 cases, the EPAR explicitly reported differences between arms in terms of survival: the range was 0–3.7 months, and the mean and median differences were 1.5 and 1.2 months. The majority of studies (13 out of 27, 48%) involved the evaluation of complete and/or partial tumour responses, with regard to the end points supporting the 27 indications. Despite the recommendations of the current EMEA guidance documents, new anticancer agents are still often approved on the basis of small single arm

  8. 78 FR 64142 - 30-Day Notice of Proposed Information Collection: Condominium Project Approval Document Collection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Condominium Project Approval... submitted the proposed information collection requirement described below to the Office of Management and... Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:...

  9. Sulfur Dioxide (SO2) Primary Standards Documents from Current Review - Federal Register Notices

    EPA Pesticide Factsheets

    EPA develops and publishes a notice of proposed rulemaking regarding the review of the SO2 national ambient air quality standards (NAAQS). A public comment period follows. Taking into account comments received on the proposed rule, EPA issues a final rule.

  10. 75 FR 38109 - Notice of Availability of Draft Policy Document for Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-01

    ... HUMAN SERVICES Health Resources and Services Administration Notice of Availability of Draft Policy... information on FTCA for Health Center Program grantees funded under section 330 of the Public Health Service... health centers, health care for the homeless centers, and public housing primary care centers. Health...

  11. 18 CFR 2.1 - Initial notice; service; and information copies of formal documents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Federal hydroelectric projects. (vii) Natural gas pipeline certificates, exportations, and importations...). (B)-(C) (D) Applications pursuant to section 207. (E) (iii) Hydroelectric, Federal Power Act. (A... unconstructed projects, or notice of declaration of intention, sections 4(e), 23(a)(b). (C) Applications...

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... carrier, to an addressee's last known address or by personal delivery. Service of documents and papers... upon personal delivery. (c) Whenever this part requires service of a NOVA, NOPS, NIDP, document, or... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Filing and service of...

  13. The Title V guidance notebook

    SciTech Connect

    Powell, R.D.; McCutchen, G.D.

    1998-12-31

    In October 1997, the Air and Waste Management Association (A and WMA) made available a notebook consisting of documents pertaining to implementation of the operating permits program required by title V of the Clean Air Act and the Environmental Protection Agency`s (EPA) part 70 operating permits regulations. The documents include guidance memos/letters, questions/answers, several specialty documents, and related Federal Register notices that have been produced by EPA since inception of the program with the Clean Air Act amendments of 1990. The notebook contents were made available by EPA and the project was carried out under an EPA contract to A and WMA. The work was performed by RTP Environmental Associates Inc. of Raleigh, North Carolina. The notebook contains more than 75 documents; all the materials EPA believes relevant to implementation of the part 70 program by States, local agencies, territories, and Indian tribes. The documents that comprise the notebook are organized by subject matter and each is given a reference number for purposes of referring to the document. The part 70 operating permits regulations are annotated with document reference numbers to indicate where a document relates to a specific section of the regulations. In addition, documents are indexed four ways; by date, by author, alphabetically by title, and by reference number. Abstracts of each document are included in the notebook to allow the user to determine if the document is of interest. The notebook user, therefore, should be able to readily locate documents and be aware of all materials that affect any area of interest the user may have. The notebook will periodically be updated to add any new materials generated since the last update. The notebook should also be of interest to sources who must obtain a part 70 operating permit and to the general public interested in following implementation of the program. Notebooks may be purchased from A and WMA.

  14. Navigation and vessel inspection circular No. 10-94. Guidance for determination and documentation of the Oil Pollution Act of 1990 (OPA 90) phase-out schedule for existing single hull vessels carrying oil in bulk. Final report

    SciTech Connect

    1994-12-22

    The purpose of this Circular is to provide guidance regarding the determination and documentation of phase-out dates for single hull vessels subject to chapter 37 of Title 46, U.S. Code, constructed or adapted to carry or that carry oil in bulk as cargo or cargo residue and operating on waters subject to the jurisdiction of the United States.

  15. Overseas Environmental Baseline Guidance Document

    DTIC Science & Technology

    2007-05-01

    45°F or less. Dry cleaning machines and control devices must be operated according to manufacturer recommendations. C2.3.4. Chromium ...Electroplating and Chromium Anodizing Tanks. Electroplating and anodizing tanks must comply with one of the three methods below for controlling chromium ...emissions. Implement one of the following methods that is most appropriate to suit local conditions: C2.3.4.1. Option 1: Limit chromium emissions in

  16. 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.

  17. STRESSOR IDENTIFICATION: TECHNICAL GUIDANCE DOCUMENT

    EPA Science Inventory

    Since the inception of the Clean Water Act (CWA) in 1972, the rivers, lakes, estuaries, and wetlands of the United States have indeed become cleaner. The standard for meassuring these improvements are both chemical and biological. Yet, we know that many waterbodies still fail to ...

  18. 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

    ...; Class II Special Controls; Guidance Document: Topical Oxygen Chamber for Extremities; Availability... Drug Administration Staff; Class II Special Controls Guidance Documents: Topical Oxygen Chamber for... Guidance Document: Topical Oxygen Chamber for Extremities'' to the Division of Small...

  19. 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

    ... Doc No: 2010-27866] NUCLEAR REGULATORY COMMISSION [NRC-2010-0223] Office of New Reactors; Notice of... Safety Analysis Reports for Nuclear Power Plants,'' Section 13.6.3, Revision 1 on Physical Security...--Early Site Permit AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of Availability. SUMMARY...

  20. Annual Compliance Certification Guidance

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  1. Consolidated Recovered Materials Advisory Notice (RMAN) for the Comprehensive Procurement Guideline (CPG)

    EPA Pesticide Factsheets

    EPA's Comprehensive Procurement Guideline (CPG) designates recycled content products that government agencies should buy. EPA publishes purchasing guidance and recommendations for recycled content levels in Recovered Material Advisory Notices (RMANs) that accompany each CPG, and updates its guidance annually. For the convenience of procurement officials, this document represents a compilation of the five RMANs published by EPA to date.

  2. 75 FR 3543 - HUD Multifamily Rental Project Closing Documents: Proposed Revisions and Updates and Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-21

    ... the context of changed industry conditions since 2004 and 2006, and took into consideration changes..., which reviewed the documents in the context of changed industry conditions. Citations to specific... vicinity, and that the purchase price is based on quality, durability, and scope of work and shall be...

  3. RH Packaging Program Guidance

    SciTech Connect

    Washington TRU Solutions, LLC

    2003-08-25

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

  4. 76 FR 38187 - International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... and evaluating this information across the three regions. This draft guidance is being issued... written comments regarding this document. It is only necessary to send one set of comments. It is no..., HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  5. Acute tier-1 and tier-2 effect assessment approaches in the EFSA Aquatic Guidance Document: are they sufficiently protective for insecticides?

    PubMed

    van Wijngaarden, René P A; Maltby, Lorraine; Brock, Theo C M

    2015-08-01

    The objective of this paper is to evaluate whether the acute tier-1 and tier-2 methods as proposed by the Aquatic Guidance Document recently published by the European Food Safety Authority (EFSA) are appropriate for deriving regulatory acceptable concentrations (RACs) for insecticides. The tier-1 and tier-2 RACs were compared with RACs based on threshold concentrations from micro/mesocosm studies (ETO-RAC). A lower-tier RAC was considered as sufficiently protective, if less than the corresponding ETO-RAC. ETO-RACs were calculated for repeated (n = 13) and/or single pulsed applications (n = 17) of 26 insecticides to micro/mesocosms, giving a maximum of 30 insecticide × application combinations (i.e. cases) for comparison. Acute tier-1 RACs (for 24 insecticides) were lower than the corresponding ETO-RACs in 27 out of 29 cases, while tier-2 Geom-RACs (for 23 insecticides) were lower in 24 out of 26 cases. The tier-2 SSD-RAC (for 21 insecticides) using HC5 /3 was lower than the ETO-RAC in 23 out of 27 cases, whereas the tier-2 SSD-RAC using HC5 /6 was protective in 25 out of 27 cases. The tier-1 and tier-2 approaches proposed by EFSA for acute effect assessment are sufficiently protective for the majority of insecticides evaluated. Further evaluation may be needed for insecticides with more novel chemistries (neonicotinoids, biopesticides) and compounds that show delayed effects (insect growth regulators). © 2014 Society of Chemical Industry.

  6. Assessing the suitability of the OECD 29 guidance document to investigate the transformation and dissolution of silver nanoparticles in aqueous media.

    PubMed

    Wasmuth, Claus; Rüdel, Heinz; Düring, Rolf-Alexander; Klawonn, Thorsten

    2016-02-01

    The OECD guidance document No. 29 was designed to determine the rate and extend to which metals can produce soluble available ionic metal species. This transformation/dissolution protocol was applied to silver nanomaterials. The results prove that concentrations of released Ag(+) at pH 8 were nearly similar at all three different loadings. At pH 6, the concentration of Ag(+) was almost the same at loadings of 10 and 100 mg L(-1) AgNPs. However, the study showed changes in concentrations of nanoparticles and aggregates (operationally defined as the fraction passing a 0.2 µm filter). At the higher pH both the concentrations in the test medium of Ag(+) and of AgNPs (fraction < 0.2 µm) decreased. After 7 days of test duration, 71 µg L(-1) of Ag(+) was found in pH 6 medium (initial loading of 100 mg L(-1)). In pH 8 medium a maximum concentration of 29 µg L(-1) Ag(+) was measured (initial loading of 10 mg L(-1)). The maximum transformation from AgNPs to Ag(+) was 2.7% (27 µg L(-1)) in pH 8 medium (loading of 1 mg L(-1)) after 7 days. At an initial loading of 100 mg L(-1) AgNPs in medium at pH 8, only 0.03% (30 µg L(-1)) were transformed to Ag(+) after 7 days. At the loading of 1 mg L(-1) AgNPs all silver concentrations remain relatively constant for the duration of the test after 7 until 28 days. The results reveal that only low concentrations of Ag(+) are released from AgNPs under the applied conditions. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. 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

    ...The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is inviting comments on Chapter 6 and a new section of Chapter 8 of the draft document, ``Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-pentanedione.'' To view the notice and related materials, visit http://www.regulations.gov and enter......

  8. Health-related quality of life and other patient-reported outcomes in the European centralized drug regulatory process: a review of guidance documents and performed authorizations of medicinal products 1995 to 2003.

    PubMed

    Szende, Agota; Leidy, Nancy K; Revicki, Dennis

    2005-01-01

    The objective of this study was to review and analyze the use of health-related quality of life (HRQL) and other patient-reported outcome (PRO) evaluations for the approval of new pharmaceutical products by the European Medicines Agency (EMEA). All published EMEA guidance documents and regulatory information for products authorized at the EMEA and appearing in the European Public Assessment Report (EPAR) database between 1995 and 2003 were examined for reference to HRQL and other PROs. More than half of the guidance documents for clinical investigation of pharmaceutical products in specific disease areas included reference to HRQL or other PROs. Guidance notes for 10 conditions indicated PROs can serve as primary endpoints in clinical trials, among which three included HRQL outcomes. The review of EPAR documentation uncovered HRQL and other PRO data for 34% of the drugs registered during the period of the review, with cancer-related treatments most frequently including PRO data. There was a trend toward increasing HRQL and other PRO claims in regulatory documents of pharmaceutical products in recent years, with the proportion exceeding 30% from 1999 to 2003. There is further scope for health outcomes researchers and regulatory decision-makers to contribute to the more efficient utilization of PROs and HRQL outcomes. Health researchers need to better justify the inclusion of these outcomes in clinical trials and highlight the added value of PRO data; while the regulators should develop harmonized procedures and capacities to adequately appraise the submitted information.

  9. RH Packaging Program Guidance

    SciTech Connect

    Washington TRU Solutions LLC

    2006-11-07

    The purpose of this program guidance document is to provide the technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the C of C shall govern. The C of C states: "...each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application." It further states: "...each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application." Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M&O) Contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with 10 Code of Federal Regulations (CFR) §71.8, "Deliberate Misconduct." Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the U.S. Department of Energy (DOE) Carlsbad Field Office (CBFO) shall be notified immediately. CBFO will evaluate the issue and notify the NRC if required. In accordance with 10 CFR Part 71, "Packaging and Transportation of Radioactive Material," certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21, "Reporting of Defects and Noncompliance," regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to

  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. 77 FR 70449 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... Public of Web Site Location of Fiscal Year 2013 Proposed Guidance Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the Web site... device guidance documents, FDA has committed to updating its Web site in a timely manner to reflect the...

  12. Guidance on submitting quality system information.

    PubMed

    Donawa, Maria E

    2004-03-01

    The Food and Drug Administration's final guidance document on the type of quality system information that should be submitted in some types of premarket submissions was published in February 2003. The final guidance replaces previous draft guidance. This article discusses the final guidance document.

  13. 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

    ... Bureau of Land Management Amended Notice of Intent To Clarify the Scope of Analysis of the Environmental... Counties, CA AGENCY: Bureau of Land Management, Interior. ACTION: Notice. SUMMARY: The Department of Interior, Bureau of Land Management (BLM) announces its intent to clarify the scope of the Notice of...

  14. 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

    ...] [FR Doc No: 2010-27873] NUCLEAR REGULATORY COMMISSION [NRC-2010-0228] Office of New Reactors; Notice... Physical Security--Combined License and Operating Reactors AGENCY: Nuclear Regulatory Commission (NRC..., ``Standard Review Plan (SRP) for the Review of Safety Analysis Reports for Nuclear Power Plants,'' Section 13...

  15. 75 FR 69709 - Office of New Reactors; Notice of Availability of the Final Staff Guidance; Standard Review Plan...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-15

    ... Cyber Security Plan AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of Availability. SUMMARY... Safety Analysis Reports for Nuclear Power Plants,'' Section 13.6.6, Revision 0 on ``Cyber Security Plan... Section 13.6.6 on ``Cyber Security Plan,'' ADAMS Accession No. ML093560837. There were comments received...

  16. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Electrocardiograph Electrodes.'' The special controls identify the following risks to health... Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph...

  17. CDER photosafety guidance for industry.

    PubMed

    Jacobs, Abigail C; Brown, Paul C; Chen, Conrad; Ellis, Amy; Farrelly, James; Osterberg, Robert

    2004-01-01

    In the Federal Register of January 10, 2000 (65 FR 1399), FDA published a draft guidance entitled "Photosafety Testing." The notice gave interested persons an opportunity to submit comments. As a result of the comments, certain sections of the guidance were reworded to improve clarity. A final guidance was published in May 2003. The final guidance further emphasizes that a flexible approach can be used to address adverse photoeffects and that specific assays are not required. Moreover, it encourages the development of methods that can efficiently be used to evaluate human safety. The guidance describes a consistent, science-based approach for testing of topically and systemically administered drug products.

  18. Guidance and the School. Working Document. European Community Action Programme. Transition of Young People from Education to Adult and Working Life.

    ERIC Educational Resources Information Center

    Banks, John

    This report is one in a series on the work of the 30 pilot projects that form the European Community's second Programme on the Transition from Education to Adult and Working Life. The report reviews new demands on guidance and new approaches that have been developed to meet them, reviews the responses made by the Transition Programme pilot…

  19. 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

    ... Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability.... Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with the requirement of special controls for class II devices...

  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. 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

    ...; Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems... Document: Repetitive Transcranial Magnetic Stimulation Systems.'' This guidance document describes a means by which a repetitive transcranial magnetic stimulation (rTMS) system may comply with the requirement...

  2. 76 FR 76152 - City of Raleigh; Notice of Intent To File License Application, Filing of Pre-Application Document...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-06

    ... Hydropower Licensing approved Raleigh's request to use the Traditional Licensing Process. k. With This notice... regulations thereunder at 50 CFR part 402; (b) NMFS under section 305(b) of the Magnuson-Stevens Fishery...

  3. PSD Increment Consumption Guidance

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  4. Guidance on Determining LAER

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  5. NSR Program Transitional Guidance

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  6. Guidance on Annual Compliance Certifications

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  7. 77 FR 15379 - Protecting Tenants at Foreclosure Act: Additional Guidance on Notification Responsibilities Under...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-15

    ... guidance on the notice, entitled ``Protecting Tenants at Foreclosure: Notice of Responsibilities Placed on... URBAN DEVELOPMENT Protecting Tenants at Foreclosure Act: Additional Guidance on Notification Responsibilities Under the Act With Respect to Occupied Conveyance AGENCY: Office of the Assistant Secretary...

  8. 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...: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and... notice entitled ``Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications...

  9. Interfaces between transport and geologic disposal systems for high-level radioactive wastes and spent nuclear fuel: A new international guidance document

    SciTech Connect

    Pope, R.B.; Baekelandt, L.; Hoorelbeke, J.M.; Han, K.W.; Pollog, T.; Blackman, D.; Villagran, J.E.

    1994-04-01

    An International Atomic Energy Agency (IAEA) Technical Document (TECDOC) has been developed and will be published by the IAEA. The TECDOC addresses the interfaces between the transport and geologic disposal systems for, high-level waste (HLW) and spent nuclear fuel (SNF). The document is intended to define and assist in discussing, at both the domestic and the international level, regulatory, technical, administrative, and institutional interfaces associated with HLW and SNF transport and disposal systems; it identifies and discusses the interfaces and interface requirements between the HLW and SNF, the waste transport system used for carriage of the waste to the disposal facility, and the HLW/SNF disposal facility. It provides definitions and explanations of terms; discusses systems, interfaces and interface requirements; addresses alternative strategies (single-purpose packages and multipurpose packages) and how interfaces are affected by the strategies; and provides a tabular summary of the requirements.

  10. Notice of Data Availability Concerning Renewable Fuels Produced from Barley Documents under the Renewable Fuel Standard Program

    EPA Pesticide Factsheets

    EPA issues a Notice of Data Availability (NODA) to release its lifecycle green-house gas (GHG) analysis of barley used as a feedstock to produce ethanol under the Renewable Fuel Standard (RFS) program. Find the Federal Register and fact sheet on this here.

  11. 75 FR 9592 - FPL Energy Maine Hydro, LLC; Notice of Intent To Prepare an Environmental Document and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-03

    ... Energy Regulatory Commission FPL Energy Maine Hydro, LLC; Notice of Intent To Prepare an Environmental.... Licensee: FPL Energy Maine Hydro, LLC. e. Name of Project: Upper and Middle Dam Storage Project. f... material: FPL Energy Maine Hydro, LLC has filed a copy of its application for a Maine Waterway...

  12. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Intent To File License Application, Filing of Pre- Application... the Advisory Council on Historic Preservation at 36 CFR 800.2. l. Swan Lake North Hydro filed a...

  13. 76 FR 38382 - William Arkoosh; Notice of Intent To File License Application, Filing of Pre-Application Document...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-30

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission William Arkoosh; Notice of Intent To File License Application, Filing of Pre... implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2. l. A copy of the...

  14. Guidance manual for electroplating and metal-finishing pretreatment standards. Final report

    SciTech Connect

    Belefski, M.

    1984-02-01

    This manual provides guidance to Publicly Owned Treatment Works (POTWS) on the application and enforcement of the Categorical Pretreatment Standards for the Electroplating and Metal Finishing Categories. The document is based primarily on two sources: Federal Register notices, which include the official announcements of the Categorical Standards, and the Final Development Documents for Electroplating and Metal Finishing, which provide a summary of the technical support for the regulations. Additional information on the regulations, manufacturing processes, and control technologies can be found in these sources. A listing of the references used in the development of the manual is provided at the end of the document.

  15. The independent living donor advocate: a guidance document from the American Society of Transplantation's Living Donor Community of Practice (AST LDCOP).

    PubMed

    Hays, R E; LaPointe Rudow, D; Dew, M A; Taler, S J; Spicer, H; Mandelbrot, D A

    2015-02-01

    The independent living donor advocate (ILDA) serves a mandated and supportive role in the care of the living organ donor, yet qualifications and role requirements are not clearly defined. Guidance comes from Centers for Medicare and Medicaid Services (CMS) Conditions for Transplant Center Participation and interpretive guidelines, Organ Procurement and Transplantation Network (OPTN) Policy and CMS and OPTN site surveys, yet interpretation of regulations varies. Herein, the AST Living Donor Community of Practice (LDCOP) offers seven recommendations to clarify and optimize the ILDA role: (a) the ILDA must have a certain skill set rather than a specific profession, (b) the ILDA must be educated and demonstrate competence in core knowledge components, (c) the ILDA's primary role is to assess components of informed consent, (d) centers must develop a transparent system to define ILDA independence, (e) the ILDA should have a reporting structure outside the transplant center, (f) the ILDA's role should be integrated throughout the donor care continuum, (g) the ILDA role should include a narrow "veto power." We address controversies in ILDA implementation, and offer pathways to maximize benefits and minimize limitations of approaches that may each meet regulatory requirements but confer different practice benefits. We propose a research agenda to explore the impact of the ILDA.

  16. 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

    ...] Dynamic Positioning Operations Guidance for Vessels Other Than Mobile Offshore Drilling Units Operating on... voluntary guidance titled ``Mobile Offshore Drilling Unit Dynamic Positioning Guidance''. The notice recommended owners and operators of Mobile Offshore Drilling Units (MODUs) follow Marine Technology...

  17. Bioaccumulation factor portions of the proposed water quality guidance for the Great Lakes system

    SciTech Connect

    Not Available

    1993-08-01

    Bioaccumulation factors are being proposed to be used in the derivation of human health and wildlife criteria specific for the Great Lakes Water Quality Initiative (GLWQI). Adopting the use of bioaccumulation factors instead of bioconcentration factors presents a significant change from current Agency guidance. Because there is not an established procedure for determining bioaccumulation factors, national guidance may be eventually modeled on the proposed GLWQI Guidance. The document was produced to facilitate review of and comment on the proposed procedure for determining bioaccumulation factors by persons who may not keep abreast of Federal Register notices, including the larger scientific community. The document is composed of two chapters and one appendix. Chapter 1 describes the development of the proposed procedure for determining bioaccumulation factors; Chapter 2 presents the proposed methodology for development of bioaccumulation factors.

  18. PIV Logon Configuration Guidance

    SciTech Connect

    Lee, Glen Alan

    2016-03-04

    This document details the configurations and enhancements implemented to support the usage of federal Personal Identity Verification (PIV) Card for logon on unclassified networks. The guidance is a reference implementation of the configurations and enhancements deployed at the Los Alamos National Laboratory (LANL) by Network and Infrastructure Engineering – Core Services (NIE-CS).

  19. Secondary Guidance Manual.

    ERIC Educational Resources Information Center

    Bennett, Charlotte; And Others

    This manual outlines the philosophy and organization of the secondary counseling program of the Moore Public Schools (Oklahoma). The school district has made efforts in counseling American Indian students. This document presents the goals and objectives for secondary guidance programs that provide such services as orientation, information,…

  20. Model review and evaluation for application in DOE safety basis documentation of chemical accidents - modeling guidance for atmospheric dispersion and consequence assessment

    SciTech Connect

    Lazaro, M. A.; Woodarad, K.; Hanna, S. R.; Hesse, D. J.; Huang, J. -C.; Lewis, J.; Mazzola, C. A.

    1997-09-01

    The U.S. Department of Energy (DOE), through its Defense Programs (DP), Office of Engineering and Operations Suppon, established the Accident Phenomenology and Consequence (AP AC) Methodology Evaluation Program to identify and evaluate methodologies and computer codes to support accident phenomenological and consequence calculations for both radiological and nonradiological materials at DOE facilities and to identify development needs. The program is also intended to define and recommend "best or good engineering/safety analysis practices" to be followed in preparing ''design or beyond design basis" assessments to be included in DOE nuclear and nonnuclear facility safety documents. The AP AC effort is intended to provide scientifically sound and more consistent analytical approaches, by identifying model selection procedures and application methodologies, in order to enhance safety analysis activities throughout the DOE complex.

  1. Guidance for the New Millenium?

    ERIC Educational Resources Information Center

    McLaren, David J.

    1996-01-01

    Reviews the "Guidance Arrangements" consultation document issued with "Higher Still" (proposed new Scottish upper secondary curricula). Argues that the paper ignores the full implications for educational change in Higher Still and misses the opportunity for timely modernization of school guidance. Advocates a cross-curricular…

  2. Inert Ingredients Overview and Guidance

    EPA Pesticide Factsheets

    This Web page provides information on inert ingredients approved for use in pesticide products and the guidance documents that are available to assist in obtaining approval for a new inert ingredient.

  3. TSCA Inventory Policy and Guidance

    EPA Pesticide Factsheets

    A list of numerous policy statements and guidance documents on how to identify certain chemical substances for the purpose of assigning unique and unambiguous descriptions tor each substance listed on the Inventory.

  4. Septic Systems Guidance, Policy, and Regulations

    EPA Pesticide Factsheets

    EPA has developed several documents outlining its mission, priorities and regulatory authorities as well as guidance and technical information to help communities establish comprehensive septic (onsite) management programs.

  5. Guidance: Treatment of Insurers Under Superfund

    EPA Pesticide Factsheets

    Guidance provides EPA Regional offices with the appropriate procedures to follow in issuing notice letters, developing referrals, and tracking CERCLA enforcement cases that may include insurers as third party defendants.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... document provides guidance to sponsors, contract research organizations (CROs), data management centers... Investigations.'' This revised draft document provides guidance to sponsors, CROs, data management centers... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Electronic Source Data...

  7. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

    PubMed

    2010-01-21

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for 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). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.

  8. Guidance publication proves timely.

    PubMed

    Baillie, Jonathan

    2011-05-01

    The importance of properly identifying, assessing, and managing risk in all areas of engineering practice, the fact that genuine innovation is almost impossible without a certain element of risk-taking, and the need to acknowledge and respond to public concerns, however much some may be ill-founded, over the risks inherent in technological and engineering advances, are highlighted in a new risk guidance document, Guidance on Risk for the Engineering Profession, published by the Engineering Council in London last month. HEJ editor Jonathan Baillie reports.

  9. 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 Risk...

  10. 77 FR 26514 - Notice of Availability of Draft Documents for Public Comment Related to a Fishery Conservation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... for Public Comment Related to a Fishery Conservation Plan and Research Permits for the Washington...: NMFS is reopening the comment period for a draft Environmental Assessment (EA) and Fishery Conservation..., concerning the availability of a draft documents for public comment related to a Fishery Conservation Plan...

  11. 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.

  12. 77 FR 35476 - Proposed Collection; Comment Request for Notice 97-19 and Notice 98-34

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

    ... Internal Revenue Service Proposed Collection; Comment Request for Notice 97-19 and Notice 98-34 AGENCY... 98-34, Guidance for Expatriates under Internal Revenue Code sections 877, 2501, 2107 and 6039F. DATES... and Notice 98-34. Abstract: Notice 97-19 and Notice 98-34 provide guidance regarding the federal...

  13. Surface Water Treatment Rules State Implementation Guidance

    EPA Pesticide Factsheets

    These documents provide guidance to states, tribes and U.S. EPA Regions exercising primary enforcement responsibility under the Safe Drinking Water Act. The documents contain EPA’s recommendations for implementation of the Surface Water Treatment Rules.

  14. Moisture Control Guidance for Commercial and Public ...

    EPA Pesticide Factsheets

    This document provides guidance to designers, construction mangers, and building operation/maintenance managers to improve IEQ and reduce risks of encountering IEQ problems due to insufficient moisture control. EPA will be producing a document entitled

  15. Image Guidance

    EPA Pesticide Factsheets

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

  16. Potable Water Quality Management Guidance Document

    DTIC Science & Technology

    2007-09-01

    action or trigger a response. The response depends on the contaminant. AWWARF – American Water Works Association Research Foundation ClO2 ...must be achieved by using ozone, ClO2 , UV, membranes, bag filtration, cartridge filtration or bank filtration **All unfiltered systems must also...Average Chlorine Dioxide 0.8 (as ClO2 ) 0.8 (as ClO2 ) Daily Samples COMPLIANCE BASED DISINFECTION BYPRODUCTS MCLG (mg/L) MCL (mg/L) ON

  17. A Guidance Document on Airport Noise Control.

    DTIC Science & Technology

    1980-08-01

    so on. This method can also be applied to numbers of sensitive sites ( schools , churches, hospitals, and nursing homes, for example) or to acres of...aviation aircraft. If the runway is oriented so that flight paths avoid population centers , the extension could provide relief for more critical...original runway, 8L, was used as the primary departure runway for heavy 4-engine narrow body aircraft, such as the Boeing 707, schools in the Kalihi

  18. Phytotechnology Technical and Regulatory Guidance Document

    DTIC Science & Technology

    2001-04-01

    throughout the remainder of the plant through the vascular system of the plant known as the xylem . In addition to these essential nutrients, other...the root concentration and xylem sap concentration of a contaminant relative to the concentration in the external solution. Higher RCF and TSCF

  19. Comparison of US Blast Design Guidance Documents

    DTIC Science & Technology

    2010-07-01

    shear reinforcing steel so that the sum of the concrete and steel shear strengths is equal to the equivalent reaction...rev. 1, SBEDS “calculates the required area of shear reinforcing steel so that the sum of the concrete and steel shear strengths is equal to the...greater than 2-degrees typically have fixed supports. 5 In comparison, SBEDS calculates the direct shear capacity of reinforced concrete

  20. 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.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    ... 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 (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Acidified Foods...

  2. 76 FR 38742 - Eleventh Meeting: RTCA Special Committee 220: Automatic Flight Guidance and Control

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... 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 DATES... Appendix 2), notice is hereby given for a Special Committee 220, Automatic Flight Guidance and Control...

  3. 78 FR 37231 - Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing...

  4. Pandemic influenza guidance for corporations.

    PubMed

    2011-06-01

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

  5. 76 FR 75771 - Emergency Planning Guidance for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-05

    ... Regulatory Commission (NRC) is issuing Supplement 3, ``Guidance for Protective Action Strategies,'' to NUREG... Evacuation Time Estimate Studies;'' all dated November, 2011. These documents update implementation guidance...) studies. This document provides guidance for addressing new EP requirements for nuclear power plants based...

  6. 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.

  7. 77 FR 61417 - Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-09

    ...: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Acute Bacterial Sinusitis: Developing Drugs for Treatment.'' This guidance addresses FDA's... an indication for the treatment of acute bacterial sinusitis (ABS). This guidance finalizes...

  8. 75 FR 39949 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-13

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment AGENCY: Food and Drug... notice solicits comments on the information collection in the guidance for industry on special protocol...

  9. 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...

  10. 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 entitled...

  11. 77 FR 2555 - Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-18

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Preparation of Investigational Device... Cartilage; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and.... The guidance supplements recommendations regarding IDE and IND submissions contained in other FDA...

  12. 78 FR 69093 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... a stability protocol, product characterization and relevant manufacturing data. Description of... Collection; Comment Request; Guidance for Industry on Special Protocol Assessment AGENCY: Food and Drug... notice solicits comments on the information collection in the guidance for industry on special...

  13. 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 ...

  14. 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 ...

  15. 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

    ...; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays... Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.'' This guidance document describes a means by which the herpes simplex virus types 1 and 2 serological assay device type may comply with the...

  16. 77 FR 48591 - State Rail Plan Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ... Federal Railroad Administration State Rail Plan Guidance AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Request for Public Comment on Proposed State Rail Plan Guidance..., submission, and acceptance of State rail plans. State rail plans are documents that are required...

  17. HANDBOOK: HAZARDOUS WASTE INCINERATION MEASUREMENT GUIDANCE

    EPA Science Inventory

    This publication, Volume III of the Hazardous Waste Incineration Guidance Series, contains general guidance to permit writers in reviewing hazardous waste incineration permit applications and trial burn plans. he handbook is a how-to document dealing with how incineration measure...

  18. Guidance for Developing TMDLs in California

    EPA Pesticide Factsheets

    This document provides guidance to the State of California concerning its responsibility under section 303(d) of the Clean Water Act concerning the development of TMDLs for water quality-limited segments listed under section 303(d).

  19. 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.

  20. 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…

  1. 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...

  2. 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…

  3. 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.

  4. GUIDANCE FOR CONDUCTING HEALTH RISK ...

    EPA Pesticide Factsheets

    While some potential environmental hazards involve significant exposure to only a single compound, most instances of environmental contamination involve concurrent or sequential exposures to a mixture of compounds that may induce similar or dissimilar effects over exposure periods ranging from short-term to lifetime. Multichemical exposures are ubiquitous, including air and soil pollution from municipal incinerators, leakage from hazardous waste facilities and uncontrolled waste sites, and drinking water containing chemical substances formed during disinfection. To address concerns over health risks from multichemical exposures, EPA issued Guidelines for Health Risk from Exposure to Chemical Mixtures in 1986. Those Guidelines described broad concepts related to mixtures exposure and toxicity and included few specific procedures. Since then, EPA has published additional mixtures guidance documents such as 1989 guidance for the Superfund program on hazardous waste and the 1990 Technical Support Document on Health Risk Assessment of Chemical Mixtures. Because the science of environmental risk assessment continues to evolve, EPA's Risk Assessment Forum established a Technical Work Panel to ensure that the advances in the area of chemical mixtures health risk assessment are reflected in the Agency's guidance materials. This document has been developed by the Technical Work Panel to supplement the earlier guidances and is organized according to the type of data avail

  5. 10 CFR 420.32 - Program guidance/solicitation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Financial Assistance § 420.32 Program guidance/solicitation. After the publication of the notice of... more project(s) under the special projects financial assistance with a detailed program guidance... additional information; (e) Detailed descriptions of each type of program activity for which...

  6. 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…

  7. Clean Air Act Section 112(r) Inspection Guidance Distribution Memorandum

    EPA Pesticide Factsheets

    This memorandum issues and makes immediately effective the document, Guidance for Conducting Risk Management Program Inspections under Clean Air Act Section 112(r), which supersedes the 1999 document on auditing risk management plans/programs.

  8. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... subject to comment in accordance with the Agency's good guidance practices. DATES: Submit...

  9. 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

    ... 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... subject to comment in accordance with the Agency's good guidance practices. DATES: Submit...

  10. 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...

  11. 77 FR 74003 - Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-12

    ... AGENCY Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Mold... Registration Notice (PR Notice) titled ``Guidance on Antimicrobial Pesticide Products with Mold-Related Label... (efficacy) data and labeling for ``mold-related'' pesticide products. EPA believes that the label...

  12. 76 FR 72005 - NUREG-1556, Volume 2, Revision 1, “Consolidated Guidance About Materials Licenses Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... COMMISSION NUREG-1556, Volume 2, Revision 1, ``Consolidated Guidance About Materials Licenses Program... Guidance About Materials Licenses: Program- Specific Guidance About Industrial Radiography Licenses, Draft Report for Comment.'' The document has been updated to include safety culture, security of...

  13. 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.

  14. 75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-05

    ...; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability AGENCY...-Field Digital Mammography System.'' This guidance document describes a means by which a full-field digital mammography (FFDM) system may comply with special controls that apply to these class II...

  15. 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

    ...; Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative... II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative... apparatus devices intended for NPWT may comply with the requirement of special controls for class II devices...

  16. 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.... Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify contact cooling...

  17. 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

    ...; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY... Oxygen Chamber for Extremities.'' This guidance document was developed as a special control to support the reclassification of the topical oxygen chamber for extremities (TOCE) from class III...

  18. 75 FR 80886 - Ninth Meeting-RTCA Special Committee 220: Automatic Flight Guidance and Control

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-23

    ...: 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 meeting... Federal Aviation Administration Ninth Meeting--RTCA Special Committee 220: Automatic Flight Guidance and...

  19. 76 FR 22163 - Tenth Meeting: RTCA Special Committee 220: Automatic Flight Guidance and Control

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-20

    ... 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: The... Committee 220, Automatic Flight Guidance and Control. Agenda Tuesday May 10-Thursday, May 12, 2011...

  20. 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 guidance...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

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

  2. 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 meeting...

  3. 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 meeting...

  4. 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 meeting...

  5. 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 and...

  6. 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 meeting...

  7. 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.

  8. Status of CAA 110(a)(2)(D)(i)(I) SIPs Supplemental Rule Technical Support Document for the Supplemental Notice of Final Rulemaking

    EPA Pesticide Factsheets

    This document describes, for the states of Iowa, Kansas, Michigan, Missouri, Oklahoma and Wisconsin, the status of each Clean Air Act (CAA or Act) 110(a)(2)(D)(i)(I) state implementation plan (SIP) for the 1997 ozone NAAQS.

  9. NSR and PSD Policy and Guidance Index

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  10. Guidance for Determining BACT Under PSD

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  11. 49 CFR 105.25 - Reviewing public documents.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAM DEFINITIONS AND GENERAL PROCEDURES General Procedures Obtaining Guidance and Public Information... Materials Safety Administration's Office of Hazardous Materials Safety. (1) You may obtain documents (e.g...

  12. 49 CFR 105.25 - Reviewing public documents.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... PROGRAM DEFINITIONS AND GENERAL PROCEDURES General Procedures Obtaining Guidance and Public Information... Materials Safety Administration's Office of Hazardous Materials Safety. (1) You may obtain documents (e.g...

  13. 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...

  14. 75 FR 70254 - PSD and Title V Permitting Guidance for Greenhouse Gases

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... AGENCY PSD and Title V Permitting Guidance for Greenhouse Gases AGENCY: Environmental Protection Agency... the EPA has posted its guidance titled, ``PSD and Title V Permitting Guidance for Greenhouse Gases... for Greenhouse Gases.'' This document has been determined to be an EPA Significant Guidance...

  15. 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... will supersede OHRP's November 15, 1996 guidance document entitled ```Exculpatory Language' in Informed...

  16. 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

    ... 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) entitled ``Pesticide Registration (PR) Notice 2012-1: Material Safety Data Sheets as Pesticide Labeling.'' This PR...

  17. Technical Guidance for Title V Permitting of Printing Facilities

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  18. Guidance on Coordination Title IV/Title V Permitting Schedules

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  19. Title IV-Title V Interface Guidance for States

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  20. Title V Fee Demonstration And Additional Fee Demonstation Guidance

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  1. PSD and Title V Permitting Guidance for GHGs

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  2. Additional Guidance on Funding for State and Local Air Programs

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  3. Potential to Emit (PTE) Guidance for Specific Source Categories

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  4. Potential to Emit for MACT Standards -- Guidance on Timing Issues

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  5. Guidance on Limiting Potential to Emit in New Source Permitting

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  6. Periodic Monitoring Guidance for Title V Operating Permits Programs

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  7. 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...

  8. 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...

  9. 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 type...

  10. 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.

  11. 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

  12. 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

  13. Background Report: Recommendations on Guidance for Diagnostic X-Ray Studies in Federal Health Care Facilities

    EPA Pesticide Factsheets

    This document shares the guidance developed by the Interagency Working Group which was formed to develop guidance to reduce unnecessary radiation exposures from the use of x-rays in the healing arts in Federal health care facilities.

  14. Guidance for Halon Emissions Reduction Rule (40 CFR Part 82, Subpart H)

    EPA Pesticide Factsheets

    Document provides guidance for technicians on compliance with EPA's halon emission reduction rule (40 CFR 82, Subpart H). Guidance covers technician training requirements and proper halon disposal and recycling.

  15. Draft Evaluation, Measurement and Verification Guidance for Demand-Side Energy Efficiency

    EPA Pesticide Factsheets

    EPA is sharing draft Evaluation, Measurement and Verification Guidance for Demand-Side Energy Efficiency for public comment. This guidance is not a regulatory document, and is intended to supplement information provided in the Clean Power Plan.

  16. NAFTA Guidance on Data Requirements for Pesticide Import Tolerances: Questions & Answers

    EPA Pesticide Factsheets

    These Qs&As provide details of implementation related to a guidance document describing the data requirements for establishing pesticide import tolerances in Canada and the United States: NAFTA Guidance on Data Requirements for Pesticide Import Tolerances.

  17. Resources, Guidance Materials for the Formaldehyde Emission Standards for Composite Wood Products Rule

    EPA Pesticide Factsheets

    This page provides guidance documents and resources pertaining to formaldehyde including guidance materials pertaining to the Formaldehyde Emissions Standards for Composite Wood Products final rule at 40 CFR part 770.

  18. 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).

  19. 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).

  20. 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).

  1. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 9 on Tablet Friability General Chapter; availability. Notice.

    PubMed

    2010-04-05

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 9: Tablet Friability 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 Tablet Friability 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" (core ICH Q4B guidance).

  2. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7 on Dissolution Test General Chapter; availability. Notice.

    PubMed

    2010-04-05

    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 7: Dissolution 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 Dissolution 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. 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" (core ICH Q4B guidance).

  3. 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

    2010-09-02

    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).

  4. 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.

  5. 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,…

  6. 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…

  7. 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…

  8. 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,…

  9. "Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the Form FDA 356h, 'Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use;'" availability. Food and Drug Administration, HHS. Notice.

    PubMed

    1999-05-10

    The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h, 'Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use.'" This guidance document is intended to assist applicants in the preparation of the content and format of the chemistry, manufacturing, and controls (CMC) section and the establishment description section of a biologics license application (BLA), revised Form FDA 356h, for human blood and blood components intended for transfusion or for further manufacture. In addition, this guidance document provides assistance for the completion of the BLA. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiatives and the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to reduce unnecessary burdens for industry without diminishing public health protection.

  10. 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

  11. 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

  12. Safe abortion: WHO technical and policy guidance.

    PubMed

    Cook, R J; Dickens, B M; Horga, M

    2004-07-01

    In 2003, the World Health Organization published its well referenced handbook Safe Abortion: Technical and Policy Guidance for Health Systems to address the estimated almost 20 million induced abortions each year that are unsafe, imposing a burden of approximately 67 thousand deaths annually. It is a global injustice that 95% of unsafe abortions occur in developing countries. The focus of guidance is on abortion procedures that are lawful within the countries in which they occur, noting that in almost all countries, the law permits abortion to save a woman's life. The guidance treats unsafe abortion as a public health challenge, and responds to the problem through strategies concerning improved clinical care for women undergoing procedures, and the appropriate placement of necessary services. Legal and policy considerations are explored, and annexes present guidance to further reading, international consensus documents on safe abortion, and on manual vacuum aspiration and post-abortion contraception.

  13. The handling of causality in SEA guidance

    SciTech Connect

    Perdicoulis, A. . E-mail: tasso@utad.pt; Hanusch, M. . E-mail: marie.hanusch@ufz.de; Kasperidus, H.D. . E-mail: hans.kasperidus@ufz.de; Weiland, U. . E-mail: ulrike.weiland@ufz.de

    2007-03-15

    Causality, or the relation of cause and effect, is a fundamental notion in science, planning, and management. It is also a fundamental notion in impact assessment, as it relates action proposals with environmental impacts. Building on recent research about causality in impact assessment, this article turns to Strategic Environmental Assessment (SEA) and examines eleven guidance documents to see whether and how they handle causality. The findings of this research, in line with results from similar research in EIA, indicate a weak handling of causality with regards to instruction, obligation, and theoretical support. The recommendations are to investigate the reasons for the observed trend, as there is no evidence in the guidance documents themselves, and to have the fundamental premise of causality in impact assessment safeguarded in future SEA guidance.

  14. Designing Schoolwide Programs. Non-Regulatory Guidance

    ERIC Educational Resources Information Center

    US Department of Education, 2006

    2006-01-01

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

  15. 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…

  16. 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…

  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. FDA final guidance on software validation.

    PubMed

    Donawa, Maria

    2002-04-01

    The United States Food and Drug Administration (FDA) places considerable importance on the validation of software contained in and used to design, develop, or manufacture medical devices. This article discusses a recently published final FDA guidance document on software validation and the reasons for its importance.

  19. 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…

  20. 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…

  1. 78 FR 53792 - Draft Guidance for Reciprocity

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

    ... COMMISSION Draft Guidance for Reciprocity AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request... for reciprocity. The NRC is requesting public comment on draft NUREG-1556, Volume 19, Revision 1... (Reciprocity).'' The document has been updated from the previous revision to include safety culture,...

  2. 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.

  3. 78 FR 25758 - Migratory Birds; Eagle Conservation Plan Guidance: Module 1-Land-Based Wind Energy, Version 2

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-02

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

  4. 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

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

  5. Evaluation of the Challenges in the Implementation of the Guidance and Counselling Programme in Baringo County Secondary Schools, Kenya

    ERIC Educational Resources Information Center

    Boitt, Monicah Lydia. J.

    2016-01-01

    The need for guidance and counselling services in all learning institutions cannot be overstated. In response to this demand, guidance and counselling programme has been implemented since 1971 and more emphasis on its services in 2001 through Legal Notice, No. 95 of the Kenya Gazette that recommended guidance and counseling departments be…

  6. 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…

  7. Strategies for Equality: Guidance, Social Studies, Physical Education.

    ERIC Educational Resources Information Center

    Rutgers, The State Univ., New Brunswick, NJ. Training Inst. for Sex Desegregation of the Public Schools.

    This document contains descriptions of projects in guidance, physical education and social studies which were developed by participants in workshops for nondiscriminatory curriculum development training. Projects and appendices in the guidance section include plans for field trips and open houses in nontraditional careers for men and women; for…

  8. 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…

  9. 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.

  10. Secondary School Counseling Job Description. Georgia Comprehensive Guidance.

    ERIC Educational Resources Information Center

    Georgia State Dept. of Education, Atlanta. Office of Planning and Development.

    This booklet provides guidelines for writing job descriptions for secondary school counselors in Georgia, based on the "Program Planning Guide: Georgia Comprehensive Guidance" model. The counselor's role, as described in the document, focuses on four components: the guidance curriculum, individual planning, responsive services, and…

  11. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... guidance documents do not legally bind FDA, they represent the agency's current thinking. Therefore,...

  12. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... guidance documents do not legally bind FDA, they represent the agency's current thinking. Therefore,...

  13. 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…

  14. 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…

  15. OECD Review of Career Guidance Policies. Netherlands: Country Note.

    ERIC Educational Resources Information Center

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

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

  16. 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…

  17. 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.

  18. RMP Guidance for Propane Storage Facilities - Main Text

    EPA Pesticide Factsheets

    This document is intended as comprehensive Risk Management Program guidance for larger propane storage or distribution facilities who already comply with propane industry standards. Includes sample RMP, and release calculations.

  19. Federal Guidance Report No. 10: The Radioactivity Concentration Guides

    EPA Pesticide Factsheets

    This document provides the calculation of derived limits for the 1960 Radiation Protection Guides reflecting updated models for dosimetry and biological transport. This report has been superseded by Federal Guidance Report No. 11.

  20. Ozone: Stage Two Vapor Recovery Rule and Guidance

    EPA Pesticide Factsheets

    This page includes the guidance document, fact sheet, memorandum, and final rule on removing Stage II Gasoline Vapor Control Programs from State Implementation Plans (SIP) for the Ozone National Ambient Air Quality Standards (NAAQS)

  1. Interim Enforcement Program Response Guidance to Public Data Access Issues

    EPA Pesticide Factsheets

    Written to assist EPA and states when the ECHO web site was launched, this document provides guidance on questions that can arise when compliance and enforcement data are made available to the public.

  2. Guidance on setting priorities for NPL candidate sites. Directive

    SciTech Connect

    Not Available

    1992-10-28

    The guidance document identifies factors that will help EPA regions decide the order in which they should consider sites with completed site inspections for inclusion on the NPL (National Priorities List).

  3. Data Management-Supplement to Section 106 Tribal Guidance

    EPA Pesticide Factsheets

    The document supplements the Tribal 106 Guidance by providing useful suggestions and tips to tribes about how to establish a data management system that reflects tribal water quality goals and objectives.

  4. 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.

  5. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 4A on Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter; availability. Notice.

    PubMed

    2009-04-08

    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 4A: Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests 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 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests 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. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."

  6. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 8 on Sterility Test General Chapter; availability. Notice.

    PubMed

    2009-12-22

    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 8: Sterility 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 Sterility 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. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."

  7. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 10 on Polyacrylamide Gel Electrophoresis General Chapter; availability. Notice.

    PubMed

    2010-04-12

    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 10: Polyacrylamide Gel Electrophoresis 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 Polyacrylamide Gel Electrophoresis 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. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."

  8. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 5 on Disintegration Test General Chapter; availability. Notice.

    PubMed

    2009-12-23

    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 ICH Regions; Annex 5: Disintegration 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 Disintegration 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. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."

  9. 78 FR 20925 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... FDA's Web site. The BE recommendations identified in this notice were developed using the process... the public on FDA's Web site at...

  10. 77 FR 35688 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... FDA's Web site. The BE recommendations identified in this notice were developed using the process... FDA's Web site at...

  11. 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 Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  12. 75 FR 47604 - Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration (formerly 2003D-0571) Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  13. 77 FR 58999 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  14. 78 FR 52931 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... to generic drug manufacturers to follow International Conference on Hamonisation (ICH)...

  15. 75 FR 38595 - Guidance to States Regarding Driver History Record Information Security, Continuity of Operation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-02

    ... Federal Motor Carrier Safety Administration Guidance to States Regarding Driver History Record Information Security, Continuity of Operation Planning, and Disaster Recovery Planning AGENCY: Federal Motor Carrier Safety Administration, DOT. ACTION: Notice. SUMMARY: The Federal Motor Carrier Safety...

  16. 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...

  17. 75 FR 4305 - Regulatory Guidance Concerning the Applicability of the Federal Motor Carrier Safety Regulations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-27

    ... Federal Motor Carrier Safety Administration 49 CFR Chapter III Regulatory Guidance Concerning the Applicability of the Federal Motor Carrier Safety Regulations to Texting by Commercial Motor Vehicle Drivers AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory...

  18. 77 FR 39710 - Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-05

    ... Contain Acetaminophen; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... Over-the-Counter Human Use--Labeling for Products That Contain Acetaminophen.'' The draft guidance is... antirheumatic (IAAA) drug products that contain [[Page 39711

  19. PRN 2000-5: Guidance for Mandatory and Advisory Labeling Statements

    EPA Pesticide Factsheets

    This notice provides guidance for improving the clarity of labeling statements in order to avoid confusing directions and precautions and to prevent the misuse of pesticides. It includes definitions and examples for mandatory and advisory label statements.

  20. 76 FR 79689 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-22

    ... Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... information concerning the establishment and operation of clinical trial data monitoring committees. DATES...

  1. 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.

  2. 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.

  3. Ascent Guidance Comparisons

    NASA Technical Reports Server (NTRS)

    Hanson, John M.; Shrader, M. Wade; Cruzen, Craig A.

    1995-01-01

    This paper contains results from ascent guidance studies conducted at the NASA Marshall Space Flight Center. The studies include investigation of different guidance schemes for a variety of potential launch vehicles. Criteria of a successful ascent guidance scheme are low operations cost, satisfaction of load indicator constraints, and maximization of performance. Results show that open-loop designs as a function of altitude or velocity are preferable to designs that are functions of time. Optimized open-loop trajectories can increase performance while maintaining load indicators within limits. Closed-loop atmospheric schemes that involve linear tangent steering or feedback of velocity terms for trajectory modification did not yield any improvement. Early release of vacuum closed-loop guidance, including use during solid rocket booster operation, yields some improvements. Evaluation of a closed-loop optimization scheme for flying through the atmosphere shows no advantages over open-loop optimization. Dispersion study results for several potential guidance schemes and launch vehicles are included in the paper and are not a discriminator between guidance schemes. The primary cost driver is mission operations philosophy, not choice of guidance scheme. More autonomous guidance schemes can help in movement towards a philosophy that would reduce operations costs.

  4. Shuttle entry guidance revisited

    NASA Technical Reports Server (NTRS)

    Mease, Kenneth D.; Kremer, Jean-Paul

    1992-01-01

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

  5. Shuttle entry guidance

    NASA Technical Reports Server (NTRS)

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

    1978-01-01

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

  6. Shuttle entry guidance revisited

    NASA Astrophysics Data System (ADS)

    Mease, Kenneth D.; Kremer, Jean-Paul

    1992-08-01

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

  7. Shuttle entry guidance revisited

    NASA Technical Reports Server (NTRS)

    Mease, Kenneth D.; Kremer, Jean-Paul

    1992-01-01

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

  8. 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 is...

  9. Scientific Documentation.

    ERIC Educational Resources Information Center

    Pieper, Gail W.

    1980-01-01

    Describes how scientific documentation is taught in three 50-minute sessions in a technical writing course. Tells how session one distinguishes between in-text notes, footnotes, and reference entries; session two discusses the author-year system of citing references; and session three is concerned with the author-number system of reference…

  10. "Notable Documents."

    ERIC Educational Resources Information Center

    Government Publications Review, 1990

    1990-01-01

    This annotated bibliography lists 569 documents from local, state, provincial, and national governments and from international organizations that have been selected on the basis of their reference value and/or subject coverage. Topics covered include health sciences, business and economics, government and politics, social problems, education,…

  11. 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.

  12. Disaster documentation for the clinician.

    PubMed

    Zoraster, Richard M; Burkle, Christopher M

    2013-08-01

    Documentation of the patient encounter is a traditional component of health care practice, a requirement of various regulatory agencies and hospital oversight committees, and a necessity for reimbursement. A disaster may create unexpected challenges to documentation. If patient volume and acuity overwhelm health care providers, what is the acceptable appropriate documentation? If alterations in scope of practice and environmental or resource limitations occur, to what degree should this be documented? The conflicts arising from allocation of limited resources create unfamiliar situations in which patient competition becomes a component of the medical decision making; should that be documented, and, if so, how? In addition to these challenges, ever-present liability worries are compounded by controversies over the standards to which health care providers will be held. Little guidance is available on how or what to document. We conducted a search of the literature and found no appropriate references for disaster documentation, and no guidelines from professional organizations. We review here the challenges affecting documentation during disasters and provide a rationale for specific patient care documentation that avoids regulatory and legal pitfalls.

  13. 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.

  14. 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.

  15. 75 FR 33820 - Debris Contracting Guidance, RP 9580.201

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-15

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Debris Contracting Guidance, RP 9580.201 AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice of availability; request for comments. SUMMARY: The Federal...

  16. 76 FR 81957 - Mobile Offshore Drilling Unit Guidance Policy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ... SECURITY Coast Guard Mobile Offshore Drilling Unit Guidance Policy AGENCY: Coast Guard, DHS. ACTION: Notice... availability of a draft policy letter entitled, ``Dynamically Positioned Mobile Offshore Drilling Unit (MODU... emergency procedures are critical to the safety of a MODU actively engaged in drilling....

  17. Federal Guidance for Radiation Protection

    EPA Pesticide Factsheets

    EPA produces federal guidance technical reports, which standardize dose and risk assessment and issues radiation protection guidance to federal agencies. This page provides links to federal guidance policy recommendations and technical reports.

  18. 77 FR 13172 - Guidance on the Use of Rounding in Air Fare Advertisements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-05

    ... 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 on the use of rounding in air fare advertisements. FOR FURTHER INFORMATION CONTACT: Nicholas Lowry...

  19. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...

  20. 76 FR 79754 - Twelfth Meeting: RTCA Special Committee 220, Automatic Flight Guidance and Control

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-22

    ... Federal Aviation Administration Twelfth Meeting: RTCA Special Committee 220, Automatic Flight Guidance and Control AGENCY: Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT). ACTION: Notice of RTCA Special Committee 220, Automatic Flight Guidance and Control. SUMMARY: The FAA is issuing...

  1. 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 growers...

  2. 77 FR 13384 - Additional Guidance on Airfare/Air Tour Price Advertisements; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-06

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF 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,'' in...

  3. 79 FR 19620 - Draft Guidance for Industry: Proper Labeling of Honey and Honey Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2014-04-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Proper Labeling of Honey and Honey Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... industry entitled ``Guidance for Industry: Proper Labeling ] of Honey and Honey Products.'' FDA...

  4. 76 FR 55923 - Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Submission of Warning Plans for... Collection; Comment Request AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

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

  6. 76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  7. 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...

  8. 76 FR 52667 - International Conference on Harmonisation; Guidance on E2F Development Safety Update Report...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ... HUMAN SERVICES Food and Drug Administration International Conference on Harmonisation; Guidance on E2F Development Safety Update Report; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled...

  9. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... 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 drug...-crystal solid-state forms. This guidance also provides information about the data the applicant should...

  10. 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

    ... AFFAIRS Meeting the Challenge of Pandemic Influenza: Ethical Guidance for Leaders and Health Care... 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...

  11. 78 FR 50421 - Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ..., Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria...-Transmitted Malaria'' dated August 2013. The guidance document provides blood establishments that collect... malaria. This guidance finalizes the draft guidance of the same title dated June 2012, and supersedes...

  12. 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

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

  13. Moisture Control Guidance for Commercial and Public Buildings (EPA 402-F-13053)

    EPA Science Inventory

    This document provides guidance to designers, construction mangers, and building operation/maintenance managers to improve IEQ and reduce risks of encountering IEQ problems due to insufficient moisture control. EPA will be producing a document entitled "Moisture Control Guida...

  14. Moisture Control Guidance for Commercial and Public Buildings (EPA 402-F-13053)

    EPA Science Inventory

    This document provides guidance to designers, construction mangers, and building operation/maintenance managers to improve IEQ and reduce risks of encountering IEQ problems due to insufficient moisture control. EPA will be producing a document entitled "Moisture Control Guida...

  15. 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 ...

  16. 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

    ...- Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening... ``Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History... guidance document recognizes the standardized full-length and abbreviated donor history questionnaires...

  17. 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 ...

  18. 77 FR 72868 - Compliance Guidance for Small Business Entities on Labeling and Effectiveness Testing; Sunscreen...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-06

    ... HUMAN SERVICES Food and Drug Administration Compliance Guidance for Small Business Entities on Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Notice of Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  19. 78 FR 3418 - Pesticides; Draft Guidance for Pesticide Registrants on Web-Distributed Labeling for Pesticide...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-16

    ... AGENCY Pesticides; Draft Guidance for Pesticide Registrants on Web- Distributed Labeling for Pesticide... (PR Notice) titled ``Web-Distributed Labeling for Pesticide Products.'' PR Notices are issued by the... Internet. Web-distributed labeling would allow users to retrieve a streamlined version of the pesticide...

  20. 77 FR 23267 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-18

    ... Collection; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity... notice solicits comments on Form FDA 3602 and Form FDA 3602A, which will allow domestic and...

  1. EPA Policy and Guidance

    EPA Pesticide Factsheets

    The policy establishes the principles for accessible Electronic and Information Technology (EIT) and complying with Section 508 requirements. The guidance defines EIT and the technical and functional performance criteria necessary for compliance.

  2. Pollinator Risk Assessment Guidance

    EPA Pesticide Factsheets

    This Guidance is part of a long-term strategy to advance the science of assessing the risks posed by pesticides to honey bees, giving risk managers the means to further improve pollinator protection in our regulatory decisions.

  3. 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…

  4. Compliance Assurance Monitoring Technical Guidance Document Appendices by Control Technique

    EPA Pesticide Factsheets

    Compliance assurance monitoring is intended to provide a reasonable assurance of compliance with applicable requirements under the Clean Air Act for large emission units that rely on pollution control device equipment to achieve compliance.

  5. Compliance Assurance Monitoring Technical Guidance Document Appendices by Pollutant

    EPA Pesticide Factsheets

    Compliance assurance monitoring is intended to provide a reasonable assurance of compliance with applicable requirements under the Clean Air Act for large emission units that rely on pollution control device equipment to achieve compliance.

  6. MMRP Guidance Document for Soil Sampling of Energetics and Metals

    DTIC Science & Technology

    2011-10-01

    poisoned by, and where to sample for, WP. Figure 2.2. Detonation of white phosphorus smoke rounds deposit millimeter-sized pieces of WP in shallow...1997) used multi-increment samples to find areas within a large salt marsh that contained particles of WP large enough to poison and kill waterfowl. WP

  7. CT-Analyst GIS Data Processing Guidance Document

    DTIC Science & Technology

    2014-04-30

    some of its more useful add-ons, but in most cases it will be a 90% solution. QGIS – This is an open-source alternative to ArcGIS and is most...do. ImageJ – In order to some of the raster processing you would like to do you will find ArcGIS and QGIS just aren’t setup properly for it...starting set of data is to geo-reference all of it to UTM. If you are using a GIS package like ArcGIS or QGIS this achieved most easily by importing

  8. Water Efficient Installations - A New Army Guidance Document

    DTIC Science & Technology

    2010-06-01

    drip irrigation where appropriate Proper sprinkler heads and placement Rain-sensing technology Freeze-sensing technology Flow rate monitoring equipment...40 Drip /Bubbler Irrigation 50...Detection and Repair 4. Water Efficient Landscaping 5. Water Efficient Irrigation 6. Toilets and Urinals 7. Faucets and Showerheads 8. Boiler/Steam

  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. Technical and Regulatory Guidance Document for Constructed Treatment Wetlands

    DTIC Science & Technology

    2003-12-01

    Wetlands Research Program Technical Report WRP-DE-4. Brix , H., 1993, “Wastewater Treatment in Constructed Wetlands: System Design, Removal...Opelousas, La. Constituents of Concern Influent BOD, 500– 3000 mg/L Regulatory Contact Name Robert Crawford, Louisiana DEQ Plant Hardiness Deep South

  11. Graywater Application for Army Installations - Introducing a New Guidance Document

    DTIC Science & Technology

    2009-05-01

    Reuse - Desalination - Produced Water - Rainwater Harvesting - Ground Water Recharge - GRAYWATER REUSE - Sewer Mining Other Water Use/Alternate Water...uses. • Gray-water or untreated effluent from laundry, dishwashing, and personal hygiene/bathing will not be recycled or reused as part of a United...IMCOM. US Army Corps of Engineers® Engineer Research and Development Center Definitions Graywater = Greywater = Gray Water = Grey Water Blackwater

  12. Guidelines for Teaching Undergraduate Sport Sociology. Guidance Document

    ERIC Educational Resources Information Center

    Coakley, Jay; Riemer, Brenda; Sailes, Gary; Harrison, Louis; Pittman, Beverly

    2009-01-01

    Sport sociology is a subdiscipline of sociology that, since the late 1960s, has produced knowledge about sports as social phenomena in a wide range of societies. It may be included as a major specialization area in graduate programs in kinesiology, sports studies and physical education departments, and is widely offered as a single undergraduate…

  13. 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.

  14. General Risk of Signficant Injury Implementation Guidance Document

    DTIC Science & Technology

    2014-06-16

    TX 78234 JNLWD JNLW14-067 DISTRIBUTION A: Approved for public release. The RSI Technical Working Group (TWG) developed a recommendation for a general... RSI equation that is consistent with the language and intent of DoD Instruction 3200.19. Non-lethal, risk of significant injury, human effects, RSI ...assessing the reversibility of non‐lethal  weapons by determining the risk of significant injury ( RSI ).1 Further, it establishes the health care  capability

  15. 39 CFR 964.9 - Discovery; interrogatories; admission of facts; production and inspection of documents.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... and inspection of documents. Upon motion of any party showing good cause therefor, and upon notice... photographing of any designated documents and or objects, provided that such documents and objects are not...

  16. Space shuttle guidance, navigation and control design equations, volume 1

    NASA Technical Reports Server (NTRS)

    Cox, K. J.

    1971-01-01

    Revised documentation is presented pertaining to the computation requirements for guidance, navigation, and control of the space shuttle orbiter vehicle. Separate sections cover the following areas; (1) reference documents, (2) GN and C system description, (3) GN and C software functional requirements, and (4) coordinate systems and transformations.

  17. 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…

  18. A K-12 Written Guidance Plan. Minimum Standards Implementation Series.

    ERIC Educational Resources Information Center

    Ohio State Dept. of Education, Columbus. Div. of Elementary and Secondary Education.

    One of a series of implementation documents prepared in conjunction with the revised minimum standards adopted in 1983 by the Ohio State Board of Education for elementary and secondary schools, this leadership document addresses the need, the purpose, and the implementation procedures for a K-12 written guidance plan in accordance with the Ohio…

  19. A Unified Approach to Career Guidance Development in Secondary Schools. Phase II. Final Report.

    ERIC Educational Resources Information Center

    Welle, Jan

    Reporting the effectiveness of Phase II of Portland's Career Guidance and Counseling project, this document presents the summative data documenting the goals, objectives, and participant attitudes toward the project. (Phase I centered on strategies to improve counseling staff involvement in cooperative efforts to upgrade career guidance and…

  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'' dated...

  1. Sex Equity in Guidance and Counseling. Searchlight Plus: Relevant Resources in High Interest Areas. No. 53+.

    ERIC Educational Resources Information Center

    Wedenoja, Marilyn

    This document contains a computer search of ERIC database on the topic of sex equity in guidance and counseling and a narrative which highlights documents, identifies issues and trends, and suggests implications for guidance professionals. The impact of sex stereotyping, double standards of health, the increased social awareness of sex bias and…

  2. 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

    ... 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 Valves... for heart valves. This draft guidance document is not final, nor is it in effect at this time. DATES...

  3. Orion Cislunar Guidance and Navigation

    NASA Technical Reports Server (NTRS)

    D'Souza, Christopher; Crain, Timothy; Clark, Fred C.

    2007-01-01

    The Orion vehicle is being designed to provide nominal crew transport to the lunar transportation stack in low Earth orbit, crew abort prior during transit to the moon, and crew return to Earth once lunar orbit is achieved. Design of guidance and navigation algorithms to perform maneuvers in support of these functions is dependent on the support provided by navigation infrastructure, the performance of the onboard GN&C system, and the choice of trajectory maneuver methodology for outbound and return mission phases. This paper documents the preliminary integrated analyses performed by members of the Orion Orbit GN&C System team investigating the navigation update accuracy of a modern equivalent to the Apollo era ground tracking network and the expected onboard dispersion and navigation errors during a lunar mission using a linear covariance error analysis technique.

  4. 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.

  5. 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.

  6. RCRA Programmatic Information Policy and Guidance

    EPA Pesticide Factsheets

    This asset includes program policy and guidance documents that are used by the EPA regions, states, tribes and private parties to implement the hazardous waste management program under the Resource Conservation and Recovery Act (RCRA). This asset does not contain facility-specific information (see RCRA Facility Information data asset). In addition to policy and guidance, included here are training materials, economic analysis, public information, and program performance and other management level data that feeds into the Performance Assessment Tool (see separate data asset). Much of the information in this asset is available through RCRA Online. The RCRA Online database is designed to enable users to locate documents, including publications and other outreach materials, that cover a wide range of RCRA issues and topics.

  7. 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.

  8. 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…

  9. Autonomous millimeter-wave radar guidance systems

    NASA Astrophysics Data System (ADS)

    Schweiker, Kevin S.

    1992-07-01

    Hercules Defense Electronics Systems, Incorporated has applied millimeter wave technologies to a variety of guidance and control problems. This presentation documents the development and integration of an autonomous millimeter wave seeker to the AGM-65(D) (Maverick) air- to-ground missile. The resulting system was successfully demonstrated to search a large area for potential targets, prioritize detections, and guide the missile to the target during recent free-flight tests.

  10. International Conference on Harmonisation; final recommendation for the revision of the permitted daily exposure for the solvent cumene according to the maintenance procedures for the guidance Q3C Impurities: Residual Solvents; availability. Notice.

    PubMed

    2012-02-23

    The Food and Drug Administration (FDA) is announcing the availability of a final recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ``Q3C Impurities: Residual Solvents.'' The recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

  11. Anticipatory guidance through DVD.

    PubMed

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

    2014-03-01

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

  12. Public Notice documents for OXY USA, Inc

    EPA Pesticide Factsheets

    EPA is seeking public comments on a proposed settlement agreement with OXY USA, Inc. EPA will not make a final decision on whether to enter the agreement until after considering public comments on the potential agreement.

  13. GUIDANCE FOR EVALUATING LANDFILL GAS EMISSIONS ...

    EPA Pesticide Factsheets

    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 and Liability Act, Superfund Amendments and Reauthorization Act, and the Resource Conservation and Recovery Act. The document provides procedures and a set of tools for evaluating LFG emissions to ambient air, subsurface vapor migration due to landfill gas pressure gradients, and subsurface vapor intrusion into buildings. The air pathway analysis is used to evaluate the inhalation risks of offsite receptors as well as the hazards of both onsite and offsite methane explosions and landfill fires. information

  14. Documents Pertaining to Resource Conservation and Recovery Act Corrective Action Event Codes

    EPA Pesticide Factsheets

    Document containing RCRA Corrective Action event codes and definitions, including national requirements, initiating sources, dates, and guidance, from the first facility assessment until the Corrective Action is terminated.

  15. 78 FR 52776 - Documents to Support Submission of an Electronic Common Technical Document; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... 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 on the Agency Web site of...

  16. 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.

  17. 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.

  18. ProUCL version 4.1.00 Documentation Downloads

    EPA Pesticide Factsheets

    ProUCL version 4.1.00 represents a comprehensive statistical software package equipped with statistical methods and graphical tools needed to address many environmental sampling and statistical issues as described in various these guidance documents.

  19. Aerospace spacecraft-charging guidelines document

    NASA Technical Reports Server (NTRS)

    Fennell, J. F.; Hall, D. F.; Koons, H. C.; Mizera, P. F.; Vampola, A. F.

    1985-01-01

    A short summary document on spacecraft charging was prepared for use by engineers in the various Aerospace Corporation program offices that support Air Force Space Division programs. The magnetospheric charging environment at near-geosynchronous altitudes is outlined and the mechanisms of charging and discharging are discussed. Statistical results from the P78-2 (SCATHA) satellite engineering experiments are given. The document is intended to be a layman's source for charging information and for design guidance and criteria.

  20. Multimode guidance project low frequency ECM simulator: Hardware description

    NASA Astrophysics Data System (ADS)

    Kaye, H. M.

    1982-10-01

    The Multimode Guidance(MMG) Project, part of the Army/Navy Area Defense SAM Technology Prototyping Program, was established to conduct a feasibility demonstration of multimode guidance concepts. Prototype guidance units for advanced, long range missiles are being built and tested under MMG Project sponsorship. The Johns Hopkins University Applied Physics Laboratory has been designated as Government Agent for countermeasures for this project. In support of this effort, a family of computer-controlled ECM simulators is being developed for validation of contractor's multimode guidance prototype designs. The design of the Low Frequency ECM Simulator is documented in two volumes. This report, Volume A, describes the hardware design of the simulator; Volume B describes the software design. This computer-controlled simulator can simulate up to six surveillance frequency jammers in B through F bands and will be used to evaluate the performance of home-on-jamming guidance modes in multiple jammer environments.