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

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

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.

21 CFR 312.145 - Guidance documents.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...

21 CFR 312.145 - Guidance documents.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...

21 CFR 312.145 - Guidance documents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...

21 CFR 312.145 - Guidance documents.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...

21 CFR 601.29 - Guidance documents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Guidance documents. 601.29 Section 601.29 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS... Register. You may request a copy of the CBER list from the Office of Communication, Training, and...

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

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. he document includes a discussion of principles and concepts, compacted soil liners, soil drainage systems, geosynthetic drai...

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...

77 FR 48591 - State Rail Plan Guidance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-14

... Plan Guidance AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Request for Public Comment on Proposed State Rail Plan Guidance. SUMMARY: FRA is publishing this notice to... plans. State rail plans are documents that are required under Section 303 of the Passenger Rail...

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 withdrawn in the past 5 years.

Year 2000 (Y2K) computer compliance guide; guidance for FDA personnel. Food and Drug Administration. Notice.

PubMed

1999-05-14

The Food and Drug Administration (FDA) is announcing the availability of a new compliance policy guide (CPG) entitled "Year 2000 (Y2K) Computer Compliance" (section 160-800). This guidance document represents the agency's current thinking on the manufacturing and distribution of domestic and imported products regulated by FDA using computer systems that may not perform properly before, or during, the transition to the year 2000 (Y2K). The text of the CPG is included in this notice. This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a new CPG, and it will be included in the next printing of the Compliance Policy Guides Manual. This CPG is intended for FDA personnel, and it is available electronically to the public.

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.

76 FR 61098 - Guidance for 1-Hour SO2

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-03

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

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.'

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-07

...] Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations; Availability... Documentation in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving...

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

... Guidance Document No. 25 ``Pressure and Helium Leakage Testing of the Confinement Boundary of Spent Fuel...: The Division of Spent Fuel Storage and Transportation (SFST) of the Office of Nuclear Materials Safety... Helium Leakage Testing of the Confinement Boundary of Spent Fuel Dry Storage Systems.'' This ISG...

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

PubMed Central

2014-01-01

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

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

Air pollution and public health: a guidance document for risk managers.

PubMed

Craig, Lorraine; Brook, Jeffrey R; Chiotti, Quentin; Croes, Bart; Gower, Stephanie; Hedley, Anthony; Krewski, Daniel; Krupnick, Alan; Krzyzanowski, Michal; Moran, Michael D; Pennell, William; Samet, Jonathan M; Schneider, Jurgen; Shortreed, John; Williams, Martin

2008-01-01

This guidance document is a reference for air quality policymakers and managers providing state-of-the-art, evidence-based information on key determinants of air quality management decisions. The document reflects the findings of five annual meetings of the NERAM (Network for Environmental Risk Assessment and Management) International Colloquium Series on Air Quality Management (2001-2006), as well as the results of supporting international research. The topics covered in the guidance document reflect critical science and policy aspects of air quality risk management including i) health effects, ii) air quality emissions, measurement and modeling, iii) air quality management interventions, and iv) clean air policy challenges and opportunities.

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-19

... ENVIRONMENTAL PROTECTION AGENCY [FRL-9688-7] Notice of Availability of the Benchmark Dose Technical Guidance AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of Availability. SUMMARY: The U.S. Environmental Protection Agency is announcing the availability of Benchmark Dose Technical...

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-26

... components, including Source Plasma. The guidance announced in this notice replaces the draft guidance... before it begins work on the final version of the guidance, submit either electronic or written comments... the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit...

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

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

...: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Class II Special Controls Guidance Document: External Pacemaker Pulse Generator.'' This draft guidance document describes a means by which external pacemaker pulse generators may comply with the...

A Guidance Document for Kentucky's Oil and Gas Operations

DOE Office of Scientific and Technical Information (OSTI.GOV)

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-14

...-0009] Notice of Availability of New Starts and Small Starts Policy Guidance AGENCY: Federal Transit... Administration (FTA) is issuing final policy guidance to sponsors of New Starts and Small Starts projects. This... framework for the New Starts and Small Starts evaluation and rating process; the policy guidance complements...

Draft Updates to the Planning for Natural Disaster Debris Guidance and to Related Documents

EPA Pesticide Factsheets

EPA is requesting comment on the draft update of the Planning for Natural Disaster Debris Guidance, along with two other documents. This Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.

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.

Technical and Regulatory Guidance Document for Constructed Treatment Wetlands

DTIC Science & Technology

2003-12-01

leachate and acid mine drainage. The purpose of this document is to provide technical and regulatory guidance to help regulators, industry, consultants...Contaminants at Industrial Facilities .....................41 Table 4-12 Typical Landfill Leachate Characteristics and Removal Efficiencies...43 Table 4-14 Landfill Leachate Characteristics

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.

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

...] Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability AGENCY... Programs and Data Files.'' This guidance is provided to inform study statisticians of recommendations for documenting statistical analyses and data files submitted to the Center for Veterinary Medicine (CVM) for the...

The World Health Organization's safe abortion guidance document.

PubMed

Van Look, Paul F A; Cottingham, Jane

2013-04-01

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

Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document

DOE Office of Scientific and Technical Information (OSTI.GOV)

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.

Air Force Technical Objective Document FY 87

DTIC Science & Technology

1985-12-01

Air Force Systems Command Edwards Air Force Base. Cal ifornia 93523-5000 NOTICES THIS DOCUMENT IS FOR INFORMATION AND GUIDANCE ONL Y This...acquisition of Air Foree weapon systems . Each Air Foree laboratory annually formulates Q Research and Technology (R& T) Pion in response to available...guidance based on USAF requirements, the identification of scientific and technological opportunities, and the needs of present and projected systems

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).

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

... Related Regulatory Functions.'' An electronic copy of the revised LR-ISG process is available in the NRC's Agencywide Documents Access and Management System (ADAMS) under Accession No. ML100920158. The revised LR-ISG... interim changes to certain NRC license renewal guidance documents. These guidance documents facilitate the...

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

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

78 FR 16279 - HUD Healthcare Facility Documents: Notice Announcing Final Approved Documents and Assignment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-14

... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5623-N-03] HUD Healthcare Facility... notice announces that the healthcare facility documents have completed the notice and comment processes... of Healthcare Programs, Office of Housing, Department of Housing and Urban Development, 451 7th...

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...

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

... FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and Equipment Cost Accumulation, Assignment, and Allocation AGENCY... Guidance on General Property, Plant, and Equipment Cost Accumulation, Assignment, and Allocation. The...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-20

... Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this... search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html... CDRH and CBER are implementing this provision of the law and providing public notice as required. The...

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 public...

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

... of guidance documents that the Center for Devices and Radiological Health (CDRH) is intending to... notice announces the Web site location of the two lists of guidance documents which CDRH is intending to... list. FDA and CDRH priorities are subject to change at any time. Topics on this and past guidance...

76 FR 61367 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-04

... the Agency will post a list of guidance documents the Center for Devices and Radiological Health (CDRH... guidance documents that CDRH is considering for development and providing stakeholders an opportunity to.... This notice announces the Web site location of the list of guidances on which CDRH is intending to work...

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

DTIC Science & Technology

1991-08-01

AD-A254 924 1’) VOL I IN SITU SOIL VENTING - FULL SCALE TEST HILL AFB, GUIDANCE DOCUMENT, LITERATURE REVIEW D. W. DEPAO, S. E. HERBES, J. H . WILSON...D. K. SOLOMON, AND H . L. JENNINGS MARTIN-MARIETTA ENERGY SYSTEMS OAK RIDGE NATIONAL LABORATORY P. O. BOX 2008 OAK RIDGE TN 37831 OTI AUGUST 1991 S...sificat,cn) (U) In Situ Soil Ver.ting - Full Scale Test Hill AFB, Guidance Document, Literature Review 2 PERSO’.AL AUTH-O’.S, a W ApP li- S_ T’.- erber:. H

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-03

... techniques or other forms of information technology, e.g., permitting electronic submissions of responses... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2010-0010] National Protection and Programs Directorate; Guidance Document Request and Evaluation AGENCY: National Protection and Programs Directorate...

Guidance for the emergency use of unapproved medical devices; availability--FDA. Notice.

PubMed

1985-10-22

The Food and Drug Administration (FDA) is announcing guidance, developed by FDA's Center for Devices and Radiological Health (CDRH), with respect to those emergency situations in which the agency would not object to a physician's using a potentially life-saving medical device for a use for which the device ordinarily is required to have, but does not have, an approved application for premarket approval or an investigational device exemption. The guidance is contained in a document entitled "guidance for the Emergency Use of Unapproved Medical Devices."

Restoration Planning: Guidance Document for Natural Resource Damage Assessment Under the Oil Pollution Act of 1990

DOT National Transportation Integrated Search

1996-08-01

The purpose of this document is to provide trustees with general guidance to develop restoration plans under OPA that comply with NEPA's procedural requirements. The focus of this document is to more fully describe the processes and products required...

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...

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

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 5 2012-07-01 2012-07-01 false Publication of adopted regulatory documents for the guidance of the public. 701.64 Section 701.64 National Defense Department of Defense (Continued..., Department of the Navy and Department of Defense documents published in the Federal Register should be made...

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 the guidance of the public. 701.64 Section 701.64 National Defense Department of Defense (Continued..., Department of the Navy and Department of Defense documents published in the Federal Register should be made...

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..., Department of the Navy and Department of Defense documents published in the Federal Register should be made...

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 the guidance of the public. 701.64 Section 701.64 National Defense Department of Defense (Continued..., Department of the Navy and Department of Defense documents published in the Federal Register should be made...

Quieter pavements guidance document

DOT National Transportation Integrated Search

2013-02-01

This report provides guidance and better practice recommendations to the National Park : Service for selecting pavement surfaces to minimize tire-pavement noise. The report : contains an overview of common technologies and methods for quieter pavemen...

Public Comment Period Open for the Draft Update to the Planning for Natural Disaster Debris Guidance and to Related Documents

EPA Pesticide Factsheets

EPA is requesting comment on the draft Planning for Natural Disaster Debris Guidance, and two other documents. The Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.

76 FR 50537 - Regulatory Guidance Concerning Household Goods Carriers Requiring Shippers To Sign Blank or...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

... Concerning Household Goods Carriers Requiring Shippers To Sign Blank or Incomplete Documents AGENCY: Federal.... Basis for This Notice The Agency has received numerous consumer complaints concerning household goods.... The FMCSA is issuing this regulatory guidance to eliminate any ambiguity or confusion concerning the...

Benzene waste operations NESHAP. Waiver guidance document

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1993-01-01

Subpart FF of 40 CFR Part 61 addresses benzene emissions from waste operations at petroleum refineries, chemical manufacturing plants, coke by-product plants, and waste management units that manage wastes from these facilities. Subpart FF, also known as the benzene waste operations national emission standards for hazardous air pollutants (NESHAP), was amended and published in the Federal Register on January 7, 1993. Facilities unable to comply with the NESHAP by April 7, 1993, may apply for a waiver of compliance for a period that shall not extend beyond January 7, 1995. As a condition of the waiver, facilities will be requiredmore » to mitigate benzene air emissions that result from the delay in compliance with the NESHAP. The document outlines the goals and objectives of the benzene waste NESHAP waiver policy, and provides guidance for preparing, reviewing and evaluating waiver requests.« less

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-15

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0254] Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft Report for Comment; Correction AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request for comment; correction. SUMMARY: This document corrects a notice appearing...

78 FR 22257 - Updates to Protective Action Guides Manual: Protective Action Guides (PAGs) and Planning Guidance...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-15

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2007-0268; FRL-9707-2] Updates to Protective Action Guides Manual: Protective Action Guides (PAGs) and Planning Guidance for Radiological Incidents AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of document availability for interim use and public...

78 FR 41412 - Notice of Availability of Policy Document

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Availability of Policy Document AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Final.../policiesregulations/policies/pin201301.html . Background: HHS' Health Resources and Services Administration (HRSA...

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

... Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice... Arsenic in Apple Juice'' (the draft supporting document) and ``A Quantitative Assessment of Inorganic... document entitled ``A Quantitative Assessment of Inorganic Arsenic in Apple Juice.'' The draft guidance...

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.

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

Stakeholders' Guidance Document for Consumer Analytical Devices with a Focus on Gluten and Food Allergens.

PubMed

Popping, Bert; Allred, Laura; Bourdichon, François; Brunner, Kurt; Diaz-Amigo, Carmen; Galan-Malo, Patricia; Lacorn, Markus; North, Jennifer; Parisi, Salvatore; Rogers, Adrian; Sealy-Voyksner, Jennifer; Thompson, Tricia; Yeung, Jupiter

2018-01-01

Until recently, analytical tests for food were performed primarily in laboratories, but technical developments now enable consumers to use devices to test their food at home or when dining out. Current consumer devices for food can determine nutritional values, freshness, and, most recently, the presence of food allergens and substances that cause food intolerances. The demand for such products is driven by an increase in the incidence of food allergies, as well as consumer desire for more information about what is in their food. The number and complexity of food matrixes creates an important need for properly validated testing devices with comprehensive user instructions (definitions of technical terms can be found in ISO 5725-1:1994 and the International Vocabulary of Metrology). This is especially important with food allergen determinations that can have life-threatening consequences. Stakeholders-including food regulators, food producers, and food testing kit and equipment manufacturers, as well as representatives from consumer advocacy groups-have worked to outline voluntary guidelines for consumer food allergen- and gluten-testing devices. These guidelines cover areas such as kit validation, user sampling instructions, kit performance, and interpretation of results. The recommendations are based on (1) current known technologies, (2) analytical expertise, and (3) standardized AOAC INTERNATIONAL allergen community guidance and best practices on the analysis of food allergens and gluten. The present guidance document is the first in a series of papers intended to provide general guidelines applicable to consumer devices for all food analytes. Future publications will give specific guidance and validation protocols for devices designed to detect individual allergens and gluten, as statistical analysis and review of any validation data, preferably from an independent third party, are necessary to establish a device's fitness-for-purpose. Following the

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-13

... Stock in Organic Crop Production (NOP 5029)''; and ``Evaluating Allowed Ingredients and Sources of... finalized, these guidance documents will be available from the NOP through ``The Program Handbook: Guidance... ``Seeds, Annual Seedlings, and Planting Stock in Organic Crop Production (NOP 5029)'', and ``Evaluating...

19 CFR 210.7 - Service of process and other documents; publication of notices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 19 Customs Duties 3 2010-04-01 2010-04-01 false Service of process and other documents... § 210.7 Service of process and other documents; publication of notices. (a) Manner of service. (1) The service of process and all documents issued by or on behalf of the Commission or the administrative law...

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

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2009-0694; FRL-9442-8] Notice of Availability of the External Review Draft of the Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation... Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation...

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 § 2903...

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 § 2903...

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 § 2903...

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 § 2903...

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...

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 public...

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 public...

Cycle water chemistry based on film forming amines at power plants: evaluation of technical guidance documents

NASA Astrophysics Data System (ADS)

Dyachenko, F. V.; Petrova, T. I.

2017-11-01

Efficiency and reliability of the equipment in fossil power plants as well as in combined cycle power plants depend on the corrosion processes and deposit formation in steam/water circuit. In order to decrease these processes different water chemistries are used. Today the great attention is being attracted to the application of film forming amines and film forming amine products. The International Association for the Properties of Water and Steam (IAPWS) consolidated the information from all over the World, and based on the research studies and operating experience of researchers and engineers from 21 countries, developed and authorized the Technical Guidance Document: “Application of Film Forming Amines in Fossil, Combined Cycle, and Biomass Power Plants” in 2016. This article describe Russian and International technical guidance documents for the cycle water chemistries based on film forming amines at fossil and combined cycle power plants.

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.

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.

21 CFR 314.445 - Guidance documents.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Miscellaneous Provisions § 314.445 Guidance...

21 CFR 314.445 - Guidance documents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Miscellaneous Provisions § 314.445 Guidance...

21 CFR 314.445 - Guidance documents.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Miscellaneous Provisions § 314.445 Guidance...

21 CFR 314.445 - Guidance documents.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Miscellaneous Provisions § 314.445 Guidance...

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.

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.

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.

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

...: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration... the guidance entitled, ``Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.'' This guidance document describes a means by which focused ultrasound...

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.

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

PubMed

2012-11-20

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

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

...: Low Level Laser System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' This guidance document describes a means by which low level laser systems for aesthetic use may comply...

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 Drug...

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.

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0465] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... guidance document will serve as the special control for rTMS systems. Section 513(f)(2) of the Federal Food...

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-18

...] Notice of Availability of a Treatment Evaluation Document; Methyl Bromide Fumigation of Blueberries... blueberries for Mediterranean fruit fly and South American fruit fly. We have prepared a treatment evaluation... at neutralizing these fruit flies. We are making the treatment evaluation document available to the...

Defining Staged Procedures for Percutaneous Coronary Intervention Trials: A Guidance Document.

PubMed

Spitzer, Ernest; McFadden, Eugène; Vranckx, Pascal; de Vries, Ton; Ren, Ben; Collet, Carlos; Onuma, Yoshinobu; Garcia-Garcia, Hector M; Lopes, Renato D; Stone, Gregg W; Cutlip, Donald E; Serruys, Patrick W

2018-05-14

Patients in coronary intervention trials may require more than 1 procedure to complete the intended revascularization strategy. However, these staged interventions are not consistently defined. Standardized definitions are needed to allow meaningful comparisons of this outcome among trials. This document provides guidance on relevant parameters involving staged procedures, including minimum data collection and consistent classification of coronary procedures initially identified as staged; the aim is to achieve consistency among clinical trialists, sponsors, health authorities, and regulators. Definitions were developed jointly among representatives of academic institutions and clinical research organizations based on clinical trial experience and published literature. Reasons for staged procedures were identified and include baseline kidney function, contrast load and radiation exposure, lesion complexity, and patient or operator fatigue. Moreover, nonclinical reasons include procedure scheduling and reimbursement. Management of staged procedures should be a standalone section in clinical trial protocols and clinical events committee charters. These documents should clearly define a time window for staged procedures that allows latitude for local policies, while respecting accepted clinical guidelines, and consistency with study objectives. Investigators should document in the case report form the intent to stage a procedure, the lesions to be treated, and the reasons for staging, preferably before randomization. Ideally, all reinterventions, or at least all procedures performed after the recommended time window, those in which data suggest an anticipated procedure due to a worsening condition and those where a revascularization is attempted in the target vessel, should be reviewed by an independent clinical events committee. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

21 CFR 10.115 - Good guidance practices.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., journal articles and editorials, media interviews, press materials, warning letters, memoranda of... document “Guidance Document Submission” and submit it to Division of Dockets Management (HFA-305), 5630... review. (iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will...

21 CFR 10.115 - Good guidance practices.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., journal articles and editorials, media interviews, press materials, warning letters, memoranda of... document “Guidance Document Submission” and submit it to Division of Dockets Management (HFA-305), 5630... review. (iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will...

21 CFR 10.115 - Good guidance practices.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., journal articles and editorials, media interviews, press materials, warning letters, memoranda of... document “Guidance Document Submission” and submit it to Division of Dockets Management (HFA-305), 5630... review. (iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will...

21 CFR 10.115 - Good guidance practices.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., journal articles and editorials, media interviews, press materials, warning letters, memoranda of... document “Guidance Document Submission” and submit it to Division of Dockets Management (HFA-305), 5630... review. (iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-05

... Advertisements AGENCY: Office of the Secretary, Department of Transportation. ACTION: Notice Providing Guidance on the Use of Rounding in Air Fare Advertisements. SUMMARY: The Department is publishing the following notice providing guidance on the use of rounding in air fare advertisements. FOR FURTHER...

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Roberts, Jesse D.; Jason Magalen; Craig Jones

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 amore » 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.« less

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.

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

... Classification of Materials and Materials for Organic Crop Production AGENCY: Agricultural Marketing Service... organic crop production, livestock production, and handling. The second set of draft guidance documents, NOP 5034, provides clarification regarding materials for use in organic crop production. These...

78 FR 9054 - Issuance of Final Guidance Publication

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

... NIOSH-144] Issuance of Final Guidance Publication AGENCY: National Institute for Occupational Safety and... Services (HHS). ACTION: Notice of issuance of final guidance publication. SUMMARY: The National Institute...), announces the availability of the following publication: ``NIOSH Criteria for a Recommended Standard...

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

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Filing and service of notices, documents, and other papers. 904.3 Section 904.3 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE...

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

...: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled, ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities.'' This guidance document was developed as a special control to support the reclassification of the topical oxygen...

76 FR 22106 - Issuance of Final Guidance Publication

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-20

... NIOSH-033] Issuance of Final Guidance Publication AGENCY: National Institute for Occupational Safety and... Health and Human Services (HHS). ACTION: Notice of issuance of final guidance publication. SUMMARY: The... (CDC) announces the availability of the following publication: NIOSH Current Intelligence Bulletin 63...

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

...: Contact Cooling System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled ``Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.'' This guidance document describes a means by which contact cooling systems for aesthetic use may comply with the...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

...] (iii) Hydroelectric, Federal Power Act. (A) Applications for preliminary permits pursuant to section 4... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Initial notice; service; and information copies of formal documents. 2.1 Section 2.1 Conservation of Power and Water Resources...

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

... Production (NOP 5021); Wild Crop Harvesting (NOP 5022); Outdoor Access for Organic Poultry (NOP 5024); Commingling and Contamination Prevention in Organic Production and Handling (NOP 5025); and The Use of Chlorine Materials in Organic Production and Handling (NOP 5026). These draft guidance documents are...

78 FR 54949 - Major Project Financial Plan Guidance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-06

...'' (GA-090-751). That report recommended that Financial Plans include the cost of financing the project... Project Financial Plan Guidance AGENCY: Federal Highway Administration (FHWA), DOT. ACTION: Notice; Request for comments. SUMMARY: This notice requests comments on draft Major Project Financial Plan...

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... DEPARTMENT OF STATE [Public Notice 8192] Advisory Committee on Historical Diplomatic Documentation... Relations of the United States series as well as on the Department's responsibility under statute (22 U.S.C. 4351, et seq.) to open its 30-year old and older records for public review at the National Archives and...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... of proceeding and scoping document, or of approval to use traditional licensing process or... PROCESS § 5.8 Notice of commencement of proceeding and scoping document, or of approval to use traditional... required under § 5.5, filing of the pre-application document pursuant to § 5.6, and filing of any request...

RH Packaging Program Guidance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Washington TRU Solutions, LLC

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 themore » 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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-25

... 220: Automatic Flight Guidance and Control AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of RTCA Special Committee 220: 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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-30

... 220: Automatic Flight Guidance and Control AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of RTCA Special Committee 220: 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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-20

... 220: Automatic Flight Guidance and Control AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of RTCA 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: 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.

RH Packaging Program Guidance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Washington TRU Solutions LLC

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 shipmentmore » 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

RH Packaging Program Guidance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Washington TRU Solutions LLC

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 proceduresmore » 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

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

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Initial notice; service; and information copies of formal documents. 2.1 Section 2.1 Conservation of Power and Water Resources... Order 463, 37 FR 28054, Dec. 20, 1972; 38 FR 3192, Feb. 2, 1973; 44 FR 34941, June 18, 1979; 45 FR 21224...

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

Code of Federal Regulations, 2013 CFR

2013-04-01

... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Initial notice; service; and information copies of formal documents. 2.1 Section 2.1 Conservation of Power and Water Resources...; 38 FR 3192, Feb. 2, 1973; 44 FR 34941, June 18, 1979; 45 FR 21224, Apr. 1, 1980; Order 541, 57 FR...

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

Code of Federal Regulations, 2014 CFR

2014-04-01

... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Initial notice; service; and information copies of formal documents. 2.1 Section 2.1 Conservation of Power and Water Resources...; 38 FR 3192, Feb. 2, 1973; 44 FR 34941, June 18, 1979; 45 FR 21224, Apr. 1, 1980; Order 541, 57 FR...

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

Code of Federal Regulations, 2012 CFR

2012-04-01

... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Initial notice; service; and information copies of formal documents. 2.1 Section 2.1 Conservation of Power and Water Resources...; 38 FR 3192, Feb. 2, 1973; 44 FR 34941, June 18, 1979; 45 FR 21224, Apr. 1, 1980; Order 541, 57 FR...

Phytotechnology Technical and Regulatory Guidance Document

DTIC Science & Technology

2001-04-01

contaminated media is rather new. Throughout the development process of this document, we referred to the science as “ phytoremediation .” Recently...the media containing contaminants, we now refer to “phytotechnologies” as the overarching terminology, while using “ phytoremediation ” more...publication of the ITRC document, Phytoremediation Decision Tree. The decision tree was designed to allow potential users to take basic information

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.

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.

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-26

... obtain the documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmission...BloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: August 20, 2013...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-13

... obtain the documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmission...BloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: February 8, 2013...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-06

...The Department published a notice entitled ``Additional Guidance on Airfare/Air Tour Price Advertisements,'' in the Federal Register of February 27, 2012; the notice contained an incorrect address for the Department.

76 FR 81059 - Guidance Regarding Deduction and Capitalization of Expenditures Related to Tangible Property

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

...This document contains temporary regulations that provide guidance on the application of sections 162(a) and 263(a) of the Internal Revenue Code to amounts paid to acquire, produce, or improve tangible property. The temporary regulations clarify and expand the standards in the current regulations under sections 162(a) and 263(a) and provide certain bright-line tests (for example, a de minimis rule for certain acquisitions) for applying these standards. The temporary regulations also provide guidance under section 168 regarding the accounting for, and dispositions of, property subject to section 168. The temporary regulations also amend the general asset account regulations. The temporary regulations will affect all taxpayers that acquire, produce, or improve tangible property. The text of the temporary regulations also serves as the text of proposed regulations set forth in the notice of proposed rulemaking on this subject appearing elsewhere in this issue of the Federal Register.

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-02

... OFFICE OF MANAGEMENT AND 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) is issuing proposed guidance to Executive Departments and...

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.

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.

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.

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.

Clarification of Guidance for Calculating Actual or Potential Emissions

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.

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.

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…

Standardization Documents

DTIC Science & Technology

2011-08-01

Specifications and Standards; Guide Specifications; CIDs; and NGSs . Learn. Perform. Succeed. STANDARDIZATION DOCUMENTS Federal Specifications Commercial...national or international standardization document developed by a private sector association, organization, or technical society that plans ...Maintain lessons learned • Examples: Guidance for application of a technology; Lists of options Learn. Perform. Succeed. DEFENSE HANDBOOK

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-23

... 220: Automatic Flight Guidance and Control AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of RTCA Special Committee 220: Automatic Flight Guidance and Control meeting. SUMMARY: The FAA is... for a Special Committee 220: Automatic Flight Guidance and Control meeting. The agenda will include...

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...

Re-evaluating ethical concerns in planned emergency research involving critically ill patients: an interpretation of the guidance document from the United States Food and Drug Administration.

PubMed

Smischney, Nathan J; Onigkeit, James A; Hinds, Richard F; Nicholson, Wayne T

2015-01-01

U.S. federal regulations require that certain ethical elements be followed to protect human research subjects. The location and clinical circumstances of a proposed research study can differ substantially and can have significant implications for these ethical considerations. Both the location and clinical circumstances are particularly relevant for research in intensive care units (ICUs), where patients are often unable to provide informed consent to participate in a proposed research intervention. Our goal is to elaborate on the updated 2013 U.S. Food and Drug Administration (FDA) guidance document regarding an exemption from the requirement of obtaining informed consent from patients or their surrogates and to address certain elements within that document, thereby assisting clinicians in developing a framework for emergency research in accordance with the regulatory bodies at their own institutions and in the United States. Review of the 2011 and updated FDA guidance document on exemption from informed consent. The current process of obtaining informed consent within ICUs needs to be revisited, especially for research in which timely informed consent is not likely. In particular, the process of obtaining informed consent may not be appropriate or even ethical for critically ill patients in extremis who require an intervention for which there is no current acceptable standard of care and clinical equipoise exists. We provide clinicians with a viewpoint that further elaborates on the FDA guidance document. The viewpoints provided herein are those of the authors and are therefore inherently limited by the personal views of a selected few. Other clinicians or researchers may not interpret the FDA guidelines in a similar manner. Moreover, the discussion of a guideline document is a limitation in and of itself. The guidelines set forth by the FDA are precisely that-guidelines. Therefore, they may not be followed as outlined in the guidance document within one's own

76 FR 77025 - Office of New Reactors; Notice of Availability of the Final Staff Guidance Section 1.0, Revision...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-09

... the Final Staff Guidance Section 1.0, Revision 2 on Introduction and Interfaces AGENCY: Nuclear... Plants: LWR Edition,'' Section 1.0, Revision 2 on ``Introduction and Interfaces'' (Agencywide Documents Access and Management System (ADAMS) Accession No. ML112730393). The NRC staff issues revisions to SRP...

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.

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.

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-16

... documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements...Vaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: April 10, 2013. Leslie Kux...

76 FR 61756 - Final Guidance on Appointment of Lobbyists to Federal Boards and Commissions

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-05

... OFFICE OF MANAGEMENT AND BUDGET Final Guidance on Appointment of Lobbyists to Federal Boards and Commissions AGENCY: Office of Management and Budget. ACTION: Notice of Final Guidance. SUMMARY: The Office of Management and Budget (OMB) is issuing final guidance to Executive Departments and agencies concerning the...

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.

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

... Committee 220: Automatic Flight Guidance and Control AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of RTCA Special Committee 220: Automatic Flight Guidance and Control meeting. SUMMARY: The... Flight Guidance and Control. DATES: The meeting will be held October 12-14, 2010. October 12th and 13th...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-16

... Committee 220: Automatic Flight Guidance and Control AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Correction of Notice of RTCA Special Committee 220 meeting: Automatic Flight Guidance and Control...: Automatic Flight Guidance and Control DATES: The meeting will be held September 13-15, 2011, from 9 a.m. to...

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

... European Protocol for the Quality Control of the Physical and Technical Aspects of Mammography Screening... entitled ``Physical Laboratory Testing, Breast Compression System'' to follow the Mammography Quality...] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...

Policy and Guidance for the Certification and Continued Airworthiness of Digital Flight Data Recorders Systems

DOT National Transportation Integrated Search

1997-01-16

An FAA Notice gives temporary direction or makes one-time announcements. Notices : remain in effect for 12 months or less. They are self-canceling and my not be : revised or extended. This notice provided guidance material relevant to digital : fligh...

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

... by Blood and Blood Products,'' Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...CJD) by Blood and Blood Products'' dated May 2010 (2010 CJD/vCJD guidance). When finalized, the... Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products' '' dated April 2012. The draft...

Draft federal GHG accounting and reporting : technical support document

DOT National Transportation Integrated Search

2010-07-01

This is a technical support document (TSD) that accompanies the Federal Greenhouse Gas Accounting and Reporting Guidance (or Guidance). This document provides detailed information on the inventory reporting process and accepted calculation methodolog...

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.

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.

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: Automatic Flight Guidance and Control AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of RTCA Special Committee 220 Meeting: Automatic Flight Guidance and Control. SUMMARY: The... Flight Guidance and Control DATES: The meeting will be held August 9-11, 2011, from 9 a.m. to 5 p.m...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-25

... Committee 220: Automatic Flight Guidance and Control AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of RTCA Special Committee 220: Automatic Flight Guidance and Control meeting. SUMMARY: The... Flight Guidance and Control. DATES: The meeting will be held July 13-15, 2010. July 13th and 14th from 9...

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

... selection inclusion and exclusion criteria section. The revisions define and differentiate the required... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-13

... (iPWR). This guidance applies to environmental reviews associated with iPWR applications for limited... received on or before this date. ADDRESSES: You may submit comments by any of the following methods (unless... this document. You may access publicly-available information related to this document by any of the...

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

...; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-23

... COUNCIL ON ENVIRONMENTAL QUALITY National Environmental Policy Act (NEPA) Draft Guidance...: Council on Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``Establishing, Applying... February 18, 2010, the Council on Environmental Quality (CEQ) announced four steps to modernize...

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

...: Topical Oxygen Chamber for Extremities; Availability; Correction AGENCY: Food and Drug Administration, HHS... Special Controls Guidance Documents: Topical Oxygen Chamber for Extremities.'' The document published... Oxygen Chamber for Extremities'' to the Division of Small Manufacturers, International, and Consumer...

78 FR 53792 - Draft Guidance for Reciprocity

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-30

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0186] Draft Guidance for Reciprocity AGENCY: Nuclear... Commission (NRC) is revising its licensing guidance for reciprocity. The NRC is requesting public comment on... Work in Agreement State Jurisdiction (Reciprocity).'' The document has been updated from the previous...

Acid Rain Guidance On Phase II Permitting NOx And Opt-ins

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.

Acid Rain-Title V Guidance on Fees and Incorporation by Reference

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.

Guidance on the Major Source Determination for Certain Hazardous Air Pollutants

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.

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…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-22

.... FDA-2013-D-0269] Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of... guidance for industry entitled ``Guidance for Industry: Purchasing Reef Fish Species Associated with the...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-29

... Metronidazole Vaginal Gel; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... entitled ``Bioequivalence Recommendations for Metronidazole Vaginal Gel.'' The guidance provides specific...) for metronidazole vaginal gel. DATES: Although you can comment on any guidance at any time (see 21 CFR...

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

Pre-Publication to the Planning for Natural Disaster Debris Guidance

EPA Pesticide Factsheets

EPA is requesting comment on the draft update of the Planning for Natural Disaster Debris Guidance, along with two other documents. This Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.

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

... Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and... Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with...

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-04

... Notice 2010-6 AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request for comments... Notice 2010-6, Relief and Guidance on Corrections of Certain Failures of a Nonqualified Deferred...). OMB Number: 1545-2164. Notice Number: Notice 2010-6. Abstract: Notice 2010-6 requires a corporation to...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-27

... ``Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for Treatment...] Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus--Developing Medical Products for Treatment; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

Middle School Developmental Guidance. "Steps to Success."

ERIC Educational Resources Information Center

Orange County Public Schools, Orlando, FL.

This document articulates the goals and objectives of the middle school guidance program in Orange County, Florida Public Schools system. Professional roles and responsibilities are discussed, as well as program implementation. These goals to assist students are listed for the middle school guidance program: (1) understanding the school…

Asymmetrical booster ascent guidance and control system design study. Volume 5: Space shuttle powered explicit guidance. [space shuttle development

NASA Technical Reports Server (NTRS)

Jaggers, R. F.

1974-01-01

An optimum powered explicit guidance algorithm capable of handling all space shuttle exoatospheric maneuvers is presented. The theoretical and practical basis for the currently baselined space shuttle powered flight guidance equations and logic is documented. Detailed flow diagrams for implementing the steering computations for all shuttle phases, including powered return to launch site (RTLS) abort, are also presented. Derivation of the powered RTLS algorithm is provided, as well as detailed flow diagrams for implementing the option. The flow diagrams and equations are compatible with the current powered flight documentation.

Calculating Potential to Emit (PTE) and Other Guidance for Grain Handling 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.

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. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

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

...] Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability AGENCY: Food and... the availability of a document entitled ``Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products'' dated January 2011. The guidance document provides manufacturers of cellular and gene...

USDOT guidance summary for connected vehicle deployments performance measurement.

DOT National Transportation Integrated Search

2016-07-01

The document provides guidance to Pilot Deployers in the timely and successful completion of the Connected VehiclePilot Concept Development Phase deliverables, specifically in the area of performance measurement. Guidance isprovided in developing the...

75 FR 39329 - Interagency Guidance on Asset Securitization Activities

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-08

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision Interagency Guidance on Asset Securitization Activities AGENCY: Office of Thrift Supervision (OTS), Treasury. ACTION: Notice and request for...; and Information Collection Comments, Chief Counsel's Office, Office of Thrift Supervision, 1700 G...

Navigating through 'a labyrinth' of guidance.

PubMed

Pearson, Susan

2014-09-01

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

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jacques Hugo; J. J. Persensky

2012-07-01

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

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

Consideration of health inequalities in systematic reviews: a mapping review of guidance.

PubMed

Maden, Michelle

2016-11-28

Given that we know that interventions shown to be effective in improving the health of a population may actually widen the health inequalities gap while others reduce it, it is imperative that all systematic reviewers consider how the findings of their reviews may impact (reduce or increase) on the health inequality gap. This study reviewed existing guidance on incorporating considerations of health inequalities in systematic reviews in order to examine the extent to which they can help reviewers to incorporate such issues. A mapping review was undertaken to identify guidance documents that purported to inform reviewers on whether and how to incorporate considerations of health inequalities. Searches were undertaken in Medline, CINAHL and The Cochrane Library Methodology Register. Review guidance manuals prepared by international organisations engaged in undertaking systematic reviews, and their associated websites were scanned. Studies were included if they provided an overview or discussed the development and testing of guidance for dealing with the incorporation of considerations of health inequalities in evidence synthesis. Results are summarised in narrative and tabular forms. Twenty guidance documents published between 2009 and 2016 were included. Guidance has been produced to inform considerations of health inequalities at different stages of the systematic review process. The Campbell and Cochrane Equity Group have been instrumental in developing and promoting such guidance. Definitions of health inequalities and guidance differed across the included studies. All but one guidance document were transparent in their method of production. Formal methods of evaluation were reported for six guidance documents. Most of the guidance was operationalised in the form of examples taken from published systematic reviews. The number of guidance items to operationalise ranges from 3 up to 26 with a considerable overlap noted. Adhering to the guidance will require more

International perspectives on social media guidance for nurses: a content analysis.

PubMed

Ryan, Gemma

2016-12-01

Aim This article reports the results of an analysis of the content of national and international professional guidance on social media for the nursing profession. The aim was to consolidate good practice examples of social media guidelines, and inform the development of comprehensive guidance. Method A scoping search of professional nursing bodies' and organisations' social media guidance documents was undertaken using google search. Results 34 guidance documents were located, and a content analysis of these was conducted. Conclusion The results, combined with a review of competency hearings and literature, indicate that guidance should cover the context of social media, and support nurses to navigate and negotiate the differences between the real and online domains to help them translate awareness into actions.

USDOT guidance summary for connected vehicle deployments : deployment outreach.

DOT National Transportation Integrated Search

2016-07-01

This document provides guidance material in regards to the outreach activities in the CV Pilot Deployment ConceptDevelopment Phase and deployment outreach plan in the Deployment Phases. This guidance provides keyrequirements and references in develop...

75 FR 33820 - Debris Contracting Guidance, RP 9580.201

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-15

... DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA-2010-0020] Debris Contracting Guidance, RP 9580.201 AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice of availability; request for comments. SUMMARY: The Federal Emergency Management Agency (FEMA) is...

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

Code of Federal Regulations, 2010 CFR

2010-04-01

... to use the traditional licensing process or alternative procedures, the Commission will issue a... thereunder at 50 CFR part 402, section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act... Document 1. At the same time the Commission issues the notice provided for in paragraph (a) of this Section...

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.

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.

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

2017-02-01

Foot problems complicating diabetes are a source of major patient suffering and societal costs. To prevent, or at least reduce, the adverse effects of foot problems in diabetes, the International Working Group on the Diabetic Foot (IWGDF; www.iwgdf.org) was founded in 1996, consisting of experts from almost all the disciplines involved in the care of patients with diabetes and foot problems. An important output of the IWGDF is the international consensus guidance, continuously updated since 1999. To date, the publications have been translated into 26 languages, and more than 100,000 copies have been distributed globally. The "Summary Guidance for Daily Practice" summarises the essentials of prevention and management of foot problems in persons with diabetes for clinicians who work with these patients on a daily basis. This guidance is the result of a long and careful process that started with the empaneling in 2013 of five working groups consisting of 49 international experts. These experts performed seven targeted systematic reviews to provide the evidence supporting the five chapters of the IWGDF Guidance on prevention; footwear and offloading; diagnosis, prognosis and management of peripheral artery disease; diagnosis and management of foot infections; interventions to enhance healing. In total almost 80,000 studies were detected by our literature review. After review of the title and abstract the reviewers of the different working groups selected only studies that fulfilled a minimal set of quality criteria and ended up with 429 articles for complete quality analysis. The GRADE system was used to translate the evidence from the studies into recommendations for daily clinical practice. The rating of each recommendation takes into account both the strength and the quality of the evidence. The IWGDF Guidance 2015 makes a total of 77 recommendations on prevention and management of foot problems in diabetes. These recommendations were condensed by the editorial

75 FR 19464 - Interagency Guidance on Response Programs for Unauthorized Access to Customer Information and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-14

... for Unauthorized Access to Customer Information and Customer Notice AGENCY: Office of Thrift...: Interagency Guidance on Response Programs for Unauthorized Access to Customer Information and Customer Notice... physical safeguards to: (1) Ensure the security and confidentiality of customer records and information; (2...

USDOT guidance summary for connected vehicle deployments : safety management.

DOT National Transportation Integrated Search

2016-07-01

This document provides guidance material in regards to safety management plan for the CV Pilots DeploymentConcept Development Phase. This guidance provides key concepts and references in developing the SafetyManagement Plan in Task 4, lists relevant ...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-13

... Notice 2010-6 AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request for comments... Notice 2010-6, Relief and Guidance on Corrections of Certain Failures of a Nonqualified Deferred... Compensation Plan to Comply with Section 409A(a). OMB Number: 1545-2164. Notice Number: Notice 2010-6 Abstract...

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 ...

ADM guidance-Ceramics: guidance to the use of fractography in failure analysis of brittle materials.

PubMed

Scherrer, Susanne S; Lohbauer, Ulrich; Della Bona, Alvaro; Vichi, Alessandro; Tholey, Michael J; Kelly, J Robert; van Noort, Richard; Cesar, Paulo Francisco

2017-06-01

To provide background information and guidance as to how to use fractography accurately, a powerful tool for failure analysis of dental ceramic structures. An extended palette of qualitative and quantitative fractography is provided, both for in vivo and in vitro fracture surface analyses. As visual support, this guidance document will provide micrographs of typical critical ceramic processing flaws, differentiating between pre- versus post sintering cracks, grinding damage related failures and occlusal contact wear origins and of failures due to surface degradation. The documentation emphasizes good labeling of crack features, precise indication of the direction of crack propagation (dcp), identification of the fracture origin, the use of fractographic photomontage of critical flaws or flaw labeling on strength data graphics. A compilation of recommendations for specific applications of fractography in Dentistry is also provided. This guidance document will contribute to a more accurate use of fractography and help researchers to better identify, describe and understand the causes of failure, for both clinical and laboratory-scale situations. If adequately performed at a large scale, fractography will assist in optimizing the methods of processing and designing of restorative materials and components. Clinical failures may be better understood and consequently reduced by sending out the correct message regarding the fracture origin in clinical trials. Copyright © 2017 The Academy of Dental Materials. All rights reserved.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2010-0841; FRL-9228-2] PSD and Title V Permitting..., ``PSD and Title V Permitting Guidance for Greenhouse Gases'' on its significant guidance Internet Web... guidance titled, ``PSD and Title V Permitting Guidance for Greenhouse Gases.'' This document has been...

Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances.

PubMed

Oyinlola, Jessie O; Campbell, Jennifer; Kousoulis, Antonis A

2016-07-26

There is currently limited evidence regarding the extent Real World Evidence (RWE) has directly impacted the health and social care systems. The aim of this review is to identify national guidelines or guidances published in England from 2000 onwards which have referenced studies using the governmental primary care data provider the Clinical Practice Research Datalink (CPRD). The methodology recommended by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was followed. Four databases were searched and documents of interest were identified through a search algorithm containing keywords relevant to CPRD. A search diary was maintained with the inclusion/exclusion decisions which were performed by two independent reviewers. Twenty-five guidance documents were included in the final review (following screening and assessment for eligibility), referencing 43 different CPRD/GPRD studies, all published since 2007. The documents covered 12 disease areas, with the majority (N =7) relevant to diseases of the Central Nervous system (CNS). The 43 studies provided evidence of disease epidemiology, incidence/prevalence, pharmacoepidemiology, pharmacovigilance and health utilisation. A slow uptake of RWE in clinical and therapeutic guidelines (as provided by UK governmental structures) was noticed. However, there seems to be an increasing trend in the use of healthcare system data to inform clinical practice, especially as the real world validity of clinical trials is being questioned. In order to accommodate this increasing demand and meet the paradigm shift expected, organisations need to work together to enable or improve data access, undertake translational and relevant research and establish sources of reliable evidence.

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...

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

... Role of Risk Analysis in Decision-Making AGENCY: Environmental Protection Agency (EPA). ACTION: Notice... documents entitled, ``Using Probabilistic Methods to Enhance the Role of Risk Analysis in Decision- Making... Probabilistic Methods to Enhance the Role of Risk Analysis in Decision-Making, with Case Study Examples'' and...

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.

Region 9 Guidance on EPA's 45-Day Review Period forTitle V Permits

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.

Title V Permit Guidance and Template for the Cross-State Air Pollution Rule

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.

Response to Request for Guidance in Defining Adjacent with Respect to Source Aggregation

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.

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…

Guidance on including ITS elements in transportation projects

DOT National Transportation Integrated Search

2001-01-01

The purpose of this document is to provide guidance for including ITS equipment and technologies as part of traditional transportation construction or maintenance projects. This document is not intended to simplify the planning process, rather it is ...

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.

Environmental guidance for public participation in environmental restoration activities

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1991-11-01

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

Guidance for medical screening of commercial aerospace passengers : final report.

DOT National Transportation Integrated Search

2006-01-01

This document provides general guidance for operators of manned commercial aerospace flights (suborbital and orbital) in the medical assessment of prospective passengers. : This guidance is designed to identify those individuals who have medical cond...

USDOT guidance summary for connected vehicle deployments : human use approval.

DOT National Transportation Integrated Search

2016-07-01

This document provides guidance material in regards to human use approval required for the CV Pilots DeploymentConcept Development Phase. Background is provided on relevant Federal guidance and Institutional Review Boards,including specific reference...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0742 (formerly Docket No. 1999D-4396)] Draft Guidance for Clinical Investigators, Industry, and FDA Staff...: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared...

77 FR 65605 - Proposed Collection; Comment Request for Notice 97-45

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-29

... Notice 97-45, Highly Compensated Employee Definition. DATES: Written comments should be received on or... INFORMATION: Title: Highly Compensated Employee Definition. OMB Number: 1545-1550. Notice Number: Notice 97-45. Abstract: Notice 97-45 provides guidance on the definition of highly compensated employee (HCE) within the...

75 FR 77045 - Proposed Collection; Comment Request for Notice 2005-62

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-10

... Notice 2005-62, Modification of Notice 2005-04; Biodiesel and Aviation- Grade Kerosene. DATES: Written...; Biodiesel and Aviation-Grade Kerosene. OMB Number: 1545-1915. Notice Number: Notice 2005-62. Abstract: This... revising the guidance relating to the Certificate for Biodiesel, which is required as a condition for...

Comprehensive Career Guidance. Postsecondary & Adult. Programs and Model.

ERIC Educational Resources Information Center

Moore, Earl J.; Miller, Thomas B.

Divided into four parts, this document describes a comprehensive career guidance model for postsecondary and adult programs. In part 1, the rationale for extending career guidance and counseling into the lifelong learning perspective is explained, the Georgia Life Career Development Model is described, and the components of a process model for…

76 FR 81513 - Guidance for Industry: Prevention of Salmonella

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-28

...] Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and... ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.'' The document provides guidance to egg producers on how to comply with certain provisions contained in FDA's...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

...: In Vitro Diagnostic Devices for Yersinia Species Detection; Availability AGENCY: Food and Drug... availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro...

77 FR 33331 - Regulatory Guidance on the Applicability of Property-Carrier Hours-of-Service Rules to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-06

... Regulatory Guidance on the Applicability of Property-Carrier Hours-of-Service Rules to the Driveaway Operation of Vehicles Designed to Transport Passengers AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: The property-carrier hours-of-service (HOS...

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.

Guidance for PM2.5 Permit Modeling

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.

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…

21 CFR 884.2990 - Breast lesion documentation system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... system is a device for use in producing a surface map of the breast as an aid to document palpable breast... Lesion Documentation System.” See § 884.1(e) for the availability of this guidance document. [68 FR 44415...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-08

...] Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance outlines FDA...

7 CFR 650.11 - Environmental documents.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 6 2010-01-01 2010-01-01 false Environmental documents. 650.11 Section 650.11....11 Environmental documents. (a) NRCS is to use the following documents in compliance with NEPA (see § 650.4): (1) Environmental assessments (EA) (2) Environmental impact statements (EIS) (3) Notice of...

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…

24 CFR 5.502 - Requirements concerning documents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Requirements concerning documents... § 5.502 Requirements concerning documents. For any notice or document (decision, declaration, consent... regulations for requirements concerning communications with persons with disabilities.) ...

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0434] 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...

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."

PIV Logon Configuration Guidance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, Glen Alan

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).

A longitudinal study of changes in noticing and treating patients' overweight by Dutch GPs between 1997 and 2007.

PubMed

van Dijk, Elske; Kampen, Jarl K; Hiddink, Gerrit J; Renes, Reint Jan; van Binsbergen, Jaap J; van Woerkum, Cees M J

2012-04-01

One of the stakeholders in tackling the rise and health consequences of overweight and obesity is the general practice physician (GP). GPs are in a good position to inform and give nutrition guidance to overweight patients. Assessment of working mechanism of determinants of the nutrition guidance practice: noticing patients' overweight and guidance of treatment by GPs [linear analysis of structural relations (LISREL) path model] in a longitudinal study. This longitudinal study measured data in 1992, 1997 and 2007. The 1992 LISREL path model (Hiddink GJ, Hautvast J, van Woerkum CMJ, Fieren CJ, van t'Hof MA. Nutrition guidance by primary-care physicians: LISREL analysis improves understanding. Prev Med 1997; 26: 29-36.) demonstrated that 'noticing patients' overweight and guidance of treatment' was directly and indirectly influenced by predisposing factors, driving forces and perceived barriers. This article defines and discusses the path analysis of the 2007 data (compared with 1997). This analysis shows both similarity and differences in working mechanism of determinants of noticing patients' overweight and guidance of treatment between 1997 and 2007. The backbone of the mechanism with four predisposing factors is the similarity. The number of driving forces and of paths through intermediary factors to the dependent variable constitutes the difference. The backbone of the working mechanism of determinants of the nutrition guidance practice: noticing patients' overweight and guidance of treatment by GPs was similar in 2007 and 1997. The influence of GPs task perception on noticing patients' overweight and guidance of treatment considerably increased in 2007 compared to 1997. The longitudinal character of this article gives a strong practice-based evidence for weight management by GPs.

43 CFR 4.422 - Documents.

Code of Federal Regulations, 2012 CFR

2012-10-01

... filing notice of the transfer or encumbrance in the proper land office, become entitled to receive and be... interest which is required to be given to a party to the proceeding. Every such notice of a transfer or... document is transmitted to the party, unless the serving party learns that it did not reach the party to be...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-03

... for Diagnostic and Interventional X-Ray Procedures AGENCY: Environmental Protection Agency (EPA... for Diagnostic and Interventional X-Ray Procedures. This document is Federal Guidance Report No. 14. It replaces Federal Guidance Report No. 9, ``Radiation Protection Guidance for Diagnostic X-rays...

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…

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.

Blended Homing Guidance Law Using Fuzzy Logic

DTIC Science & Technology

1998-01-01

President, Associate Fellow AIAA + Research Scientist Report Documentation Page Form ApprovedOMB No. 0704-0188 Public reporting burden for the collection...mixed-strategy guidance strategies discussed in References 3 and 4. According to that research , mixed strategy guidance strategies are found to be...for an advanced missile is the focus of present paper. The present research employs the missile  Copyright 1998 by Optimal Synthesis Inc. All Rights

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…

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.

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).

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

PubMed

2006-10-11

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

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

PubMed Central

2006-01-01

and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration- February 2006. PMID:17034633

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.

78 FR 49748 - Ameren Corporation; Notice of Filing

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-15

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AC11-46-000] Ameren Corporation; Notice of Filing Take notice that on July 22, 2013, Ameren Corporation (Ameren) submitted a... Refund Report and Providing Guidance, issued on June 13, 2013.\\1\\ \\1\\ Ameren Corporation, 143 FERC ] 61...

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).

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.

What does recovery mean in practice? A qualitative analysis of international recovery-oriented practice guidance.

PubMed

Le Boutillier, Clair; Leamy, Mary; Bird, Victoria J; Davidson, Larry; Williams, Julie; Slade, Mike

2011-12-01

Recovery is a multifaceted concept, and the need for operationalization in practice has been identified. Although guidance on recovery-oriented practice exists, it is from disparate sources and is difficult to apply. The aims of the study were to identify the key characteristics of recovery-oriented practice guidance on the basis of current international perspectives and to develop an overarching conceptual framework to aid the translation of recovery guidance into practice. A qualitative analysis of 30 international documents offering recovery-oriented practice guidance was conducted. Inductive, semantic-level, thematic analysis was used to identify dominant themes. Interpretive analysis was then undertaken to group the themes into practice domains. The guidance documents were diverse; from six countries-the United States, England, Scotland, Republic of Ireland, Denmark, and New Zealand-and varied in document type, categories of guidance, and level of service user involvement in guidance development. The emerging conceptual framework consists of 16 dominant themes, grouped into four practice domains: promoting citizenship, organizational commitment, supporting personally defined recovery, and working relationship. A key challenge for mental health services is the lack of clarity about what constitutes recovery-oriented practice. The conceptual framework contributes to this knowledge gap and provides a synthesis of recovery-oriented practice guidance.

International Conference on Harmonisation; guidance on Q9 Quality Risk Management; availability. Notice.

PubMed

2006-06-02

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q9 Quality Risk Management."' 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 principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The guidance is intended to enable regulators and industry to make more effective and consistent risk-based decisions.

Guidance on the Definition of Fuel Conversion Plants

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.

Implementation of the Revised Modeling Guidance for 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.

PSD and Title V Permitting Guidance for GHGs

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.

Guidance for Proposed Construction at Buckeye Cellulose Corporation

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.

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…

USDOT guidance summary for connected vehicle deployments : participant training and stakeholder education.

DOT National Transportation Integrated Search

2016-07-01

This document provides guidance material in regards to the Participant Training and Stakeholder Education Plan forthe CV Pilots Deployment Concept Development Phase. The guidance provides key requirements and references indeveloping the training plan...

December 6, 2000, Kentucky Notice of Deficiency

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.

November 30, 1998, Oregon Notice of Deficiency

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-18

...] Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability AGENCY: Food and... the availability of a guidance for industry entitled ``Electronic Source Data in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), clinical...

76 FR 43383 - Proposed Collection; Comment Request for Notice 2005-41

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

... Guidance Regarding Qualified Intellectual Property Contributions. DATES: Written comments should [email protected] . SUPPLEMENTARY INFORMATION: Title: Guidance Regarding Qualified Intellectual Property... governing charitable contributions of intellectual property made after June 3, 2004. The notice explains the...

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

... Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug... for 11 neurological and physical medicine devices. FDA is reopening the comment period to allow... announcing the availability of draft special controls guidance documents for 11 neurological and physical...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-06

...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. This draft guidance is not final nor is it in effect at this time.

75 FR 78705 - Issuance of Exposure Drafts on Implementation Guidance on the Accounting for the Disposal of G-PP...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-16

... FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD Issuance of Exposure Drafts on Implementation Guidance on the Accounting for the Disposal of G-PP&E and Implementation Guidance for Estimating the Historical Cost of G-PP&E AGENCY: Federal Accounting Standards Advisory Board. ACTION: Notice. Board Action...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-05

... Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION... controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft... stimulator device achieves ``aesthetic effects through physical change to the structure of the body'' as well...

A Guidance Document on Airport Noise Control.

DTIC Science & Technology

1980-08-01

airport . This Document is one of the tools designed to help airport operators and planners reach that goal. It should aid the reader in applying the...into the five major areas where airport noise control can be applied : airport plans, airport / airspace use, aircraft operation, land use, and noise...flights to another airport is just another form of rescheduling, though it need not apply only to night operations. The FAA is concerned about the

December 1990 EPA/Corps Enforcement Priorities Guidance

EPA Pesticide Factsheets

Document from 1990 providing guidance to EPA Regions and Army Corps of Engineers on enforcement priorities for unauthorized discharges of dredged or fill materials in violation of section 301 of the Clean Water Act (CWA).

Local Free-Space Mapping and Path Guidance for Mobile Robots.

DTIC Science & Technology

1988-03-01

CM a CD U 00 Technical Document 1227 March 1988 Local Free- Space Mapping o and Path Guidance for Mobile Robots o William T. Gex N’% Nancy L. Campbell...TITLE (inludvSeocutCl&sas~o*) Local Free- Space Mapping and Path Guidance for Mobile Robots 12. PERSONAL AUTHOR(S) William T. Gex and Nancy L...Description of Robot System... 2 Free- Space Mapping ... 4 Map Construction ... 4 . ,12pping Examplk... 5 ’ft Sensor Unreliability... 8 % Path Guidance

77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...

Environmental Guidance Program Reference Book: American Indian Religious Freedom Act

DOE Office of Scientific and Technical Information (OSTI.GOV)

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.

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

...: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy; Availability AGENCY...-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).'' This guidance document describes a means by which non-powered suction apparatus devices intended for NPWT may comply with...

Asset Management Plans, Appraisal Guidance for 2003-04.

ERIC Educational Resources Information Center

Department for Education and Skills, London (England).

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

A review of Grey and academic literature of evaluation guidance relevant to public health interventions.

PubMed

Denford, Sarah; Abraham, Charles; Callaghan, Margaret; Aighton, Peter; De Vocht, Frank; Arris, Steven

2017-09-12

Public Health evaluation is essential to understanding what does and does not work, and robust demonstration of effectiveness may be crucial to securing future funding. Despite this, programs are often implemented with poor, incomplete or no evaluation. Public health practitioners are frequently required to provide evidence for the effectiveness of their services; thus, there is a growing need for evaluation guidance on how to evaluate public health programs. The aim of this study is to identify accessible high-quality, evaluation guidance, available to researchers and practitioners and to catalogue, summarise and categorise the content of a subset of accessible, quality guides to evaluation. We systematically reviewed grey and academic literature for documents providing support for evaluation of complex health interventions. Searches were conducted January to March 2015, and included academic databases, internet search engines, and consultations with academic and practicing public health experts. Data were extracted by two authors and sent to the authors of the guidance documents for comments. Our initial search identified 402 unique documents that were screened to identify those that were (1) developed by or for a national or international organization (2) freely available to all (3) published during or after 2000 (4) specific to public health. This yielded 98 documents from 43 organisations. Of these, 48 were reviewed in detail. This generated a detailed catalogue of quality evaluation guidance. The content included in documents covers 37 facets of evaluation. A wide range of guidance on evaluation of public health initiatives is available. Time and knowledge constraints may mean that busy practitioners find it challenging to access the most, up-to-date, relevant and useful guidance. This review presents links to and reviews of 48 quality guides to evaluation as well as categorising their content. This facilitates quick and each access to multiple selected

Implementation Guidance on Annual Compliance Certification Reporting and Statement of Basis Requirements for Title V Operating Permits

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.

Guidance on Major Modification Provisions of PSD Rules as Applied to Re-Permitting at Acme Steel Co.

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.

Guidance for State Rules for Optional Federally-Enforceable Emissions Limits Based on Volatile Organic Compound (VOC) Use

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.

Reissuance of Guidance on Agency Review of State Fee Schedules for Operating Permits Program Under Title V

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.

76 FR 80980 - Notice of Acceptance for Docketing of the Application, Notice of Opportunity for Hearing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... Agencywide Documents Access and Management System (ADAMS) Public Electronic Reading Room online in the NRC... of the document. The E-Filing system also distributes an email notice that provides access to the... Docketing of the Application, Notice of Opportunity for Hearing, Regarding Renewal of Facility Operating...

78 FR 57685 - Guidance Regarding Deduction and Capitalization of Expenditures Related to Tangible Property

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-19

...This document contains final regulations that provide guidance on the application of sections 162(a) and 263(a) of the Internal Revenue Code (Code) to amounts paid to acquire, produce, or improve tangible property. The final regulations clarify and expand the standards in the current regulations under sections 162(a) and 263(a). These final regulations replace and remove temporary regulations under sections 162(a) and 263(a) and withdraw proposed regulations that cross referenced the text of those temporary regulations. This document also contains final regulations under section 167 regarding accounting for and retirement of depreciable property and final regulations under section 168 regarding accounting for property under the Modified Accelerated Cost Recovery System (MACRS) other than general asset accounts. The final regulations will affect all taxpayers that acquire, produce, or improve tangible property. These final regulations do not finalize or remove the 2011 temporary regulations under section 168 regarding general asset accounts and disposition of property subject to section 168, which are addressed in the notice of proposed rulemaking on this subject in the Proposed Rules section in this issue of the Federal Register.

Notice of Deficiency for Washington's Operating Permit Program

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.

Notice of Deficiency for Texas' Operating Permit Program

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.

Notice of Deficiency for Indiana's Operating Permit Program

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.

Notice of Deficiency for Michigan's Operating Permit Program

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.

Notice of Deficiency for Missouri's Operating Permit Program

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.

Notice of Deficiency for Hawaii's Operating Permits Program

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.

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

...] Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Electronic Source Data in Clinical... in Clinical Investigations.'' This revised draft document provides guidance to sponsors, contract...

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.

Clarification of Guidance for Calculating Actual or Potential Emissions

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.

Additional Guidance on Prevention of Significant Deterioration (PSD) Regulations

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.

Supplemental Guidance on Implementing the North County PSD Remand

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.

Potential to Emit (PTE) Guidance for Specific Source Categories

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.

Guidance on PSD Applicability for Refuse-to-Energy Facilities

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-18

... editorial changes were made to improve clarity. Some terminology was changed to harmonize terminology within.../MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm , or http://www.regulations.gov...

76 FR 66925 - Guidance for 1-Hour SO2

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-28

... making decisions concerning each document. The draft of the guidance document is available online at http... instructions for submitting comments. Email: [email protected] . Attention Docket ID No. EPA-HQ-OAR-2010-1059. Fax: (202) 566-9744. Attention Docket ID No. EPA-HQ-OAR- 2010-1059. Mail: Air Docket, Attention...

14 CFR 16.13 - Filing of documents.

Code of Federal Regulations, 2010 CFR

2010-01-01

... knowledge, information, and belief, the document is— (1) Consistent with this part; (2) Warranted by... proceeding. If any of these items change during the proceeding, the person shall promptly file notice of the change with the FAA Part 16 Airport Proceedings Docket and the hearing officer and shall serve the notice...

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.

ADM guidance-Ceramics: all-ceramic multilayer interfaces in dentistry.

PubMed

Lohbauer, Ulrich; Scherrer, Susanne S; Della Bona, Alvaro; Tholey, Michael; van Noort, Richard; Vichi, Alessandro; Kelly, J Robert; Cesar, Paulo F

2017-06-01

This guidance document describes the specific issues involved in dental multilayer ceramic systems. The material interactions with regard to specific thermal and mechanical properties are reviewed and the characteristics of dental tooth-shaped processing parameters (sintering, geometry, thickness ratio, etc.) are discussed. Several techniques for the measurement of bond quality and residual stresses are presented with a detailed discussion of advantages and disadvantages. In essence no single technique is able to describe adequately the all-ceramic interface. Invasive or semi-invasive methods have been shown to distort the information regarding the residual stress state while non-invasive methods are limited due to resolution, field of focus or working depth. This guidance document has endeavored to provide a scientific basis for future research aimed at characterizing the ceramic interface of dental restorations. Along with the methodological discussion it is seeking to provide an introduction and guidance to relatively inexperienced researchers. Copyright © 2017 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-04

...] Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability AGENCY: Food and Drug... availability of a document entitled ``Guidance for Industry: Cellular Therapy for Cardiac Disease'' dated... treatment of cardiac disease with recommendations on the design of preclinical and clinical studies and on...

Planning guidance for the Chemical Stockpile Emergency Preparedness Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Shumpert, B.L.; Watson, A.P.; Sorensen, J.H.

1995-02-01

This planning guide was developed under the direction of the U.S. Army and the Federal Emergency Management Agency (FEMA) which jointly coordinate and direct the development of the Chemical Stockpile Emergency Preparedness Program (CSEPP). It was produced to assist state, local, and Army installation planners in formulating and coordinating plans for chemical events that may occur at the chemical agent stockpile storage locations in the continental United States. This document provides broad planning guidance for use by both on-post and off-post agencies and organizations in the development of a coordinated plan for responding to chemical events. It contains checklists tomore » assist in assuring that all important aspects are included in the plans and procedures developed at each Chemical Stockpile Disposal Program (CSDP) location. The checklists are supplemented by planning guidelines in the appendices which provide more detailed guidance regarding some issues. The planning guidance contained in this document will help ensure that adequate coordination between on-post and off-post planners occurs during the planning process. This planning guide broadly describes an adequate emergency planning base that assures that critical planning decisions will be made consistently at every chemical agent stockpile location. This planning guide includes material drawn from other documents developed by the FEMA, the Army, and other federal agencies with emergency preparedness program responsibilities. Some of this material has been developed specifically to meet the unique requirements of the CSEPP. In addition to this guidance, other location-specific documents, technical studies, and support studies should be used as needed to assist in the planning at each of the chemical agent stockpile locations to address the specific hazards and conditions at each location.« less

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.

Mass Casualty Decontamination Guidance and Psychosocial Aspects of CBRN Incident Management: A Review and Synthesis

PubMed Central

Carter, Holly; Amlôt, Richard

2016-01-01

Introduction: Mass casualty decontamination is an intervention employed by first responders at the scene of an incident involving noxious contaminants.  Many countries have sought to address the challenge of decontaminating large numbers of affected casualties through the provision of rapidly deployable temporary showering structures, with accompanying decontamination protocols.  In this paper we review decontamination guidance for emergency responders and associated research evidence, in order to establish to what extent psychosocial aspects of casualty management have been considered within these documents. The review focuses on five psychosocial aspects of incident management: likely public behaviour; responder management style; communication strategy; privacy/ modesty concerns; and vulnerable groups. Methods: Two structured literature reviews were carried out; one to identify decontamination guidance documents for first responders, and another to identify evidence which is relevant to the understanding of the psychosocial aspects of mass decontamination.  The guidance documents and relevant research were reviewed to identify whether the guidance documents contain information relating to psychosocial issues and where it exists, that the guidance is consistent with the existing evidence-base. Results: Psychosocial aspects of incident management receive limited attention in current decontamination guidance.  In addition, our review has identified a number of gaps and inconsistencies between guidance and research evidence.  For each of the five areas we identify: what is currently presented in guidance documents, to what extent this is consistent with the existing research evidence and where it diverges.  We present a series of evidence-based recommendations for updating decontamination guidance to address the psychosocial aspects of mass decontamination. Conclusions: Effective communication and respect for casualties’ needs are critical in ensuring

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

...] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Implanted Blood... blood access devices may comply with the requirement of special controls for class II devices. This...

Technical Guidance for Assessing Environmental Justice in ...

EPA Pesticide Factsheets

The Technical Guidance for Assessing Environmental Justice in Regulatory Analysis (also referred to as the Environmental Justice Technical Guidance or EJTG) is intended for use by Agency analysts, including risk assessors, economists, and other analytic staff that conduct analyses to evaluate EJ concerns in the context of regulatory actions. Senior EPA managers and decision makers also may find this document useful to understand analytic expectations and to ensure that EJ concerns are appropriately considered in the development of analyses to support regulatory actions under EPA’s action development process. Specifically, the document outlines approaches and methods to help Agency analysts evaluate EJ concerns. The document provides overarching direction to analysts by outlining a series of questions that will ensure the decision maker has appropriate information about baseline risks across population groups, and how those risks are distributed under the options being considered. In addition, the document provides a set of recommendations and requirements as well as best practices for use in analyzing and reporting results from consideration of EJ concerns. These principles will help ensure consistency, quality, and transparency across regulatory actions, while allowing for flexibility needed across different regulatory actions. The purpose of the EJTG is ensure consistency, quality, and transparency in considering environmental justice, while allowing f

EPA Determination Regarding the Consistency of the Elmendorf ENVVEST/XL Project Proposal and EPA's Guidance for Military Installations

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.

Guidance on Enforceability Requirements for Limiting Potential to Emit Through SIP and Section 112 Rules and General Permits

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.

HER2 testing of gastro-oesophageal adenocarcinoma: a commentary and guidance document from the Association of Clinical Pathologists Molecular Pathology and Diagnostics Committee.

PubMed

Wong, Newton A C S; Amary, Fernanda; Butler, Rachel; Byers, Richard; Gonzalez, David; Haynes, Harry R; Ilyas, Mohammad; Salto-Tellez, Manuel; Taniere, Philippe

2018-05-01

The use of biologics targeted to the human epidermal growth factor receptor 2 (HER2) protein is the latest addition to the armamentarium used to fight advanced gastric or gastro-oesophageal junction adenocarcinoma. The decision to treat with the biologic trastuzumab is completely dependent on HER2 testing of tumour tissue. In 2017, the College of American Pathologists, American Society for Clinical Pathology and the American Society of Clinical Oncology jointly published guidelines for HER2 testing and clinical decision making in gastro-oesophageal adenocarcinoma. The Association of Clinical Pathologists Molecular Pathology and Diagnostics Committee has issued the following document as a commentary of these guidelines and, in parallel, to provide guidance on HER2 testing in National Health Service pathology departments within the UK. This guidance covers issues related to case selection, preanalytical aspects, analysis and interpretation of such HER2 testing. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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…

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)

77 FR 23809 - Proposed Collection; Comment Request for Notice 2005-64

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-20

... Notice 2005-64, Foreign Tax Credit and Other Guidance under Section 965. DATES: Written comments should be received on or before June 19, 2012 to be assured of consideration. ADDRESSES: Direct all [email protected] . SUPPLEMENTARY INFORMATION: Title: Foreign Tax Credit and Other Guidance under Section...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-20

... Polysulfate Sodium Capsule; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... entitled ``Bioequivalence Recommendations for Pentosan Polysulfate Sodium.'' The recommendations provide... (ANDAs) for pentosan polysulfate sodium capsule. DATES: Although you can comment on any guidance at any...

[International trend of guidance for nanomaterial risk assessment].

PubMed

Hirose, Akihiko

2013-01-01

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

ITS deployment guidance for transit systems : technical edition

DOT National Transportation Integrated Search

1997-04-01

This document provides guidance for the transit community on developing and implementing Intelligent Transportation Systems (ITS) and using the National ITS Architecture. It is written specifically for the transit community and focuses on transit app...

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

... DEPARTMENT OF VETERANS AFFAIRS Meeting the Challenge of Pandemic Influenza: Ethical Guidance for... its National Center for Ethics in Health Care (NCEHC) invites interested parties to comment on a guidance document entitled ``Meeting the Challenge of Pandemic Influenza: Ethical Guidance for Leaders and...

77 FR 58997 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-25

... Detection of Specific Novel Influenza A Viruses AGENCY: Food and Drug Administration, HHS. ACTION: Notice... reagents for detection of specific novel influenza A viruses. DATES: Submit either electronic or written... of information technology. Guidance on Reagents for Detection of Specific Novel Influenza A Viruses...

76 FR 26996 - Notice of Intent To Prepare an Environmental Impact Statement for New Corporate Average Fuel...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-10

...Pursuant to the National Environmental Policy Act (NEPA), NHTSA plans to prepare an Environmental Impact Statement (EIS) to analyze the potential environmental impacts of the agency's Corporate Average Fuel Economy program for passenger automobiles (referred to herein as ``passenger cars'') and non-passenger automobiles (referred to herein as ``light trucks''). The EIS will consider the potential environmental impacts of new fuel economy standards for model years 2017-2025 passenger cars and light trucks that NHTSA will be proposing pursuant to the Energy Independence and Security Act of 2007. This notice initiates the NEPA scoping process by inviting comments from Federal, State, and local agencies, Indian tribes, and the public to help identify the environmental issues and reasonable alternatives to be examined in the EIS. This notice also provides guidance for participating in the scoping process and additional information about the alternatives NHTSA expects to consider in its NEPA analysis. In preparing this notice, NHTSA has shared the document with the Council on Environmental Quality (CEQ), the Environmental Protection Agency (EPA), and the Department of Energy (DOE).

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... Pesticide Registrants on Antimicrobial Pesticide Products With Mold-Related Label Claims; Notice of... Register issue of December 12, 2012, requesting comments on Guidance for Antimicrobial Pesticide Products... CONTACT: Melba S. Morrow, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-14

... Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal...

Guidance on Mobile Energy Services Company Burning Tire Derived Fuel

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.

Operational Guidance on Control Technology for New and Modified MWC's

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.

Guidance on Limiting Potential to Emit in New Source Permitting

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.

Guidance on Implementing the Nitrogen Dioxide (NO2) PSD Increments

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.

Guidance on Extension of Prevention of Significant Deterioration (PSD) Permits

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.

Request for Guidance on PSD Applicability Determinations for Boiler Emissions

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.

Clarification of PSD Guidance For Modeling Class 1 Area Impacts

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.

National Guidance on Interpretation of the New Source Performance Standards - Subpart Y (Standards of Performance for Coal Preparation Plants)

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

...] Draft Guidance for Industry: Bar Code Label Requirements-- Questions and Answers (Question 12 Update... Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Bar... guidance provides you, manufacturers of a licensed vaccine, with advice concerning compliance with the bar...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-31

..., including Source Plasma, with recommendations intended to assist with determining which reporting mechanism... final version of the guidance, submit either electronic or written comments on the draft guidance by... INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the...

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…

21 CFR 10.115 - Good guidance practices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... understanding, or other communications directed to individual persons or firms. (c) What other terms have a... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... communication that are excluded from the definition of guidance document to informally communicate new or...

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...

Quality assurance and quality control in mammography: a review of available guidance worldwide.

PubMed

Reis, Cláudia; Pascoal, Ana; Sakellaris, Taxiarchis; Koutalonis, Manthos

2013-10-01

Review available guidance for quality assurance (QA) in mammography and discuss its contribution to harmonise practices worldwide. Literature search was performed on different sources to identify guidance documents for QA in mammography available worldwide in international bodies, healthcare providers, professional/scientific associations. The guidance documents identified were reviewed and a selection was compared for type of guidance (clinical/technical), technology and proposed QA methodologies focusing on dose and image quality (IQ) performance assessment. Fourteen protocols (targeted at conventional and digital mammography) were reviewed. All included recommendations for testing acquisition, processing and display systems associated with mammographic equipment. All guidance reviewed highlighted the importance of dose assessment and testing the Automatic Exposure Control (AEC) system. Recommended tests for assessment of IQ showed variations in the proposed methodologies. Recommended testing focused on assessment of low-contrast detection, spatial resolution and noise. QC of image display is recommended following the American Association of Physicists in Medicine guidelines. The existing QA guidance for mammography is derived from key documents (American College of Radiology and European Union guidelines) and proposes similar tests despite the variations in detail and methodologies. Studies reported on QA data should provide detail on experimental technique to allow robust data comparison. Countries aiming to implement a mammography/QA program may select/prioritise the tests depending on available technology and resources. •An effective QA program should be practical to implement in a clinical setting. •QA should address the various stages of the imaging chain: acquisition, processing and display. •AEC system QC testing is simple to implement and provides information on equipment performance.

76 FR 68768 - Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... provides recommendations for the design of clinical trials for cancer vaccines conducted under an IND to... in this notice finalizes the draft guidance of the same title dated September 2009. DATES: Submit...), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike...

Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers

PubMed Central

Calvert, Melanie; Kyte, Derek; Duffy, Helen; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; Ives, Jonathan; Draper, Heather; Brundage, Michael; Blazeby, Jane; King, Madeleine

2014-01-01

Background Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers. Methods and Findings We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3%) recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency. Conclusions PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-08

... Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

... Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-22

... Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of...

Interim Consequence Management Guidance for a Wide-Area Biological Attack

DOE Office of Scientific and Technical Information (OSTI.GOV)

Raber, Ellen; Kirvel, Robert; MacQueen, Don

2011-05-17

The Interagency Biological Restoration Demonstration (IBRD) program is a collaborative, interagency effort co-chaired by the Department of Homeland Security and Department of Defense aimed at improving the nation‘s ability to respond to and recover from a large-scale, wide-area, domestic attack involving the release of an environmentally persistent biological warfare agent. The program is focused on understanding interactions between the civilian and military sectors, and in building mutual support to carry out such remediations. This Interim Consequence Management Guidance document provides guidance for decisionmakers in executing activities required to respond to and recover from a biological incident affecting a wide urbanmore » area insofar as information is currently available. The spore-forming bacterium Bacillus anthracis is discussed as the biological agent of primary concern because it is the most difficult of known bioterrorism agents to inactivate and is considered to be one of the key threat agents. Most other biological threat agents are much easier to remediate, and in many cases, inactivation would occur naturally within days as a result of environmental exposure; however, the framework and operational questions that need to be addressed are expected to remain the same. The guidance in this document is applicable to (1) enclosed facilities, such as commercial, residential, and continental U.S. military facilities; (2) semi-enclosed facilities, such as subways and public transit facilities; (3) outdoor areas (both localized and wide area), such as building exteriors, streets, parks, and other open spaces; (4) drinking water facilities; and (5) drinking water sources. This document follows an interagency framework [Planning Guidance for Recovery Following Biological Incidents (DHS and EPA 2009)]—which considered Raber et al. (2002) in its development—but takes the framework to a more operational level and provides guidance at key action and

2 CFR 180.975 - Notice.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 2 Grants and Agreements 1 2010-01-01 2010-01-01 false Notice. 180.975 Section 180.975 Grants and Agreements OFFICE OF MANAGEMENT AND BUDGET GOVERNMENTWIDE GUIDANCE FOR GRANTS AND AGREEMENTS Reserved OMB GUIDELINES TO AGENCIES ON GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 180.975...

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.

77 FR 10506 - Locational Exchanges of Wholesale Electric Power; Notice Terminating Proceeding

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... Exchanges of Wholesale Electric Power; Notice Terminating Proceeding 1. On February 17, 2011, the Commission issued a Notice of Inquiry (NOI) concerning the regulatory treatment of locational exchanges of wholesale electric power. The Commission sought guidance as to the circumstances under which locational exchanges of...

75 FR 54627 - Best Management Practices for Unused Pharmaceuticals at Health Care Facilities

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-08

... at Health Care Facilities AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA... Unused Pharmaceuticals at Health Care Facilities. The guidance is targeted at hospitals, medical clinics... drafted a guidance document for health care facilities, which describes: Techniques for reducing or...

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

... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2011-1106] Dynamic Positioning... ``Mobile Offshore Drilling Unit Dynamic Positioning Guidance''. The notice recommended owners and operators of Mobile Offshore Drilling Units (MODUs) follow Marine Technology Society (MTS) Dynamic Positioning...

Notice of Deficiency for District of Columbia's Operating Permit Program

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.

Variable & Recode Definitions - SEER Documentation

Cancer.gov

Resources that define variables and provide documentation for reporting using SEER and related datasets. Choose from SEER coding and staging manuals plus instructions for recoding behavior, site, stage, cause of death, insurance, and several additional topics. Also guidance on months survived, calculating Hispanic mortality, and site-specific surgery.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

...The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. The Agency is taking this action to allow interested persons additional time to submit comments.

Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: A scoping review.

PubMed

Samuel, Gbeminiyi O; Hoffmann, Sebastian; Wright, Robert A; Lalu, Manoj Mathew; Patlewicz, Grace; Becker, Richard A; DeGeorge, George L; Fergusson, Dean; Hartung, Thomas; Lewis, R Jeffrey; Stephens, Martin L

2016-01-01

Assessments of methodological and reporting quality are critical to adequately judging the credibility of a study's conclusions and to gauging its potential reproducibility. To aid those seeking to assess the methodological or reporting quality of studies relevant to toxicology, we conducted a scoping review of the available guidance with respect to four types of studies: in vivo and in vitro, (quantitative) structure-activity relationships ([Q]SARs), physico-chemical, and human observational studies. Our aims were to identify the available guidance in this diverse literature, briefly summarize each document, and distill the common elements of these documents for each study type. In general, we found considerable guidance for in vivo and human studies, but only one paper addressed in vitro studies exclusively. The guidance for (Q)SAR studies and physico-chemical studies was scant but authoritative. There was substantial overlap across guidance documents in the proposed criteria for both methodological and reporting quality. Some guidance documents address toxicology research directly, whereas others address preclinical research generally or clinical research and therefore may not be fully applicable to the toxicology context without some translation. Another challenge is the degree to which assessments of methodological quality in toxicology should focus on risk of bias - as in clinical medicine and healthcare - or be broadened to include other quality measures, such as confirming the identity of test substances prior to exposure. Our review is intended primarily for those in toxicology and risk assessment seeking an entry point into the extensive and diverse literature on methodological and reporting quality applicable to their work. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

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.

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

Code of Federal Regulations, 2014 CFR

2014-10-01

... judicially noticed by the courts, or of technical or scientific facts within the general knowledge of the... a material fact not appearing in the evidence in the record, the fact of official notice shall be so... official report, decision, opinion, or published scientific or economic statistical data issued by any of...

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

Code of Federal Regulations, 2012 CFR

2012-10-01

... judicially noticed by the courts, or of technical or scientific facts within the general knowledge of the... a material fact not appearing in the evidence in the record, the fact of official notice shall be so... official report, decision, opinion, or published scientific or economic statistical data issued by any of...

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

Code of Federal Regulations, 2010 CFR

2010-10-01

... judicially noticed by the courts, or of technical or scientific facts within the general knowledge of the... a material fact not appearing in the evidence in the record, the fact of official notice shall be so... official report, decision, opinion, or published scientific or economic statistical data issued by any of...

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

Code of Federal Regulations, 2013 CFR

2013-10-01

... judicially noticed by the courts, or of technical or scientific facts within the general knowledge of the... a material fact not appearing in the evidence in the record, the fact of official notice shall be so... official report, decision, opinion, or published scientific or economic statistical data issued by any of...

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

Code of Federal Regulations, 2011 CFR

2011-10-01

... judicially noticed by the courts, or of technical or scientific facts within the general knowledge of the... a material fact not appearing in the evidence in the record, the fact of official notice shall be so... official report, decision, opinion, or published scientific or economic statistical data issued by any of...

USDOT guidance summary for connected vehicle deployments evaluation support.

DOT National Transportation Integrated Search

2016-07-01

The document provides guidance to Pilot Deployers in the timely and successful completion of Concept DevelopmentPhase deliverables, specifically in developing the Performance Measurement and Evaluation Support Plan in Task 5,identifying evaluation-su...

USDOT guidance summary for connected vehicle deployments : data sharing.

DOT National Transportation Integrated Search

2016-07-01

AbstractThe document provides guidance to Pilot Deployers in the timely and successful completion of Concept Development Phase deliverables, specifically in developing the Data Sharing Framework portion of the Performance Measurement and Evaluation S...

USDOT guidance summary for connected vehicle deployments : application deployment.

DOT National Transportation Integrated Search

2016-07-01

This document provides guidance material in regards to the Application Deployment Plan for the CV Pilots DeploymentConcept Development Phase. Methods for application deployment are discussed with definitions for the successfulmanagement of each aspec...

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…

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...

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.

Applicability of NSR Review Circumvention Guidance to 3M - Maplewood, Minnesota

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.

Guidance on Whether Replacing the Refractory Brick Constitutes a Major Modification

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.

Guidance On Enforcement of PSD Requirements Under the Clean Air Act

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0800... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-29

... comments concerning Notice 2007-46 (NOT-146367-06), Guidance Regarding Heavy Hybrid Vehicles. DATES... [email protected].gov . SUPPLEMENTARY INFORMATION: Title: Guidance Regarding Heavy Hybrid Vehicles... a process that allows taxpayers who purchase medium-duty and heavy-duty hybrid vehicles to rely on...

78 FR 46416 - Proposed Collection; Comment Request for Notice 2007-46 (NOT-146367-06)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

... comments concerning Notice 2007-46 (NOT-146367-06), Guidance Regarding Heavy Hybrid Vehicles. DATES... [email protected] . SUPPLEMENTARY INFORMATION: Title: Guidance Regarding Heavy Hybrid Vehicles. OMB... process that allows taxpayers who purchase medium-duty and heavy-duty hybrid vehicles to rely on domestic...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0081] Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Notice To Airmen (NOTAMS) For Airport Operators

DOT National Transportation Integrated Search

1996-06-20

This advisory circular (AC) provides guidance for use of the Notice to Airmen : (NOTAM) system in airport condition reporting. This material is intended : primarily for airport operators, or their agents, who monitor and manage the : day-to-day opera...

75 FR 39263 - Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-08

..., and Consumer Assistance (DSMICA), Center for Devices and Radiological Health (CDRH), Food and Drug... label to assist that office in processing your request, or fax your request to CDRH at 301-847-8149. The... the guidance you are requesting. A search capability for all CDRH guidance documents is available at...

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

Shuttle program. MCC Level C formulation requirements: Entry guidance and entry autopilot

NASA Technical Reports Server (NTRS)

Harpold, J. C.; Hill, O.

1980-01-01

A set of preliminary entry guidance and autopilot software formulations is presented for use in the Mission Control Center (MCC) entry processor. These software formulations meet all level B requirements. Revision 2 incorporates the modifications required to functionally simulate optimal TAEM targeting capability (OTT). Implementation of this logic in the MCC must be coordinated with flight software OTT implementation and MCC TAEM guidance OTT. The entry guidance logic is based on the Orbiter avionics entry guidance software. This MCC requirements document contains a definition of coordinate systems, a list of parameter definitions for the software formulations, a description of the entry guidance detailed formulation requirements, a description of the detailed autopilot formulation requirements, a description of the targeting routine, and a set of formulation flow charts.

49 CFR 1503.429 - Filing of documents with the Enforcement Docket Clerk.

Code of Federal Regulations, 2010 CFR

2010-10-01

... INVESTIGATIVE AND ENFORCEMENT PROCEDURES Assessment of Civil Penalties by TSA § 1503.429 Filing of documents.... If this e-mail address changes, TSA will provide notice of the change by notice in the Federal Register. (3) By facsimile transmission, to 410-962-1746. If this number changes, TSA will provide notice...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-23

... COUNCIL ON ENVIRONMENTAL QUALITY National Environmental Policy Act (NEPA) Draft Guidance, ``NEPA Mitigation and Monitoring.'' AGENCY: Council On Environmental Quality. ACTION: Notice of Availability, Draft... Quality (CEQ) announced four steps to modernize, reinvigorate, and ease the use and increase the...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-14

... Nanotechnology; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... ``Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology''. This guidance is... nanomaterials or otherwise involve the application of nanotechnology. The points to consider are intended to be...

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1086] 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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0258] Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0339] 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...

28 CFR 68.41 - Official notice.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ALIENS, UNFAIR IMMIGRATION-RELATED EMPLOYMENT PRACTICES, AND DOCUMENT FRAUD § 68.41 Official notice... so noticed, and shall be given adequate opportunity to show the contrary. [54 FR 48596, Nov. 24, 1989...

78 FR 68463 - Notice of Emergency Approval of an Information Collection: Regional Analysis of Impediments...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-14

... Approval of an Information Collection: Regional Analysis of Impediments Guidance for Sustainable Communities Grantees AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY: In... Budget (OMB) emergency approval of the information collection described in this notice. DATES: Comments...

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.

78 FR 18353 - Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

...; (Formerly FDA-2007D-0393)] Guidance for Industry: Blood Establishment Computer System Validation in the User... Industry: Blood Establishment Computer System Validation in the User's Facility'' dated April 2013. The... document entitled ``Guidance for Industry: Blood Establishment Computer System Validation in the User's...

US EPA GLOBAL POSITIONING SYSTEMS - TECHNICAL IMPLEMENTATION GUIDANCE

EPA Science Inventory

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

How Should We Treat the Vulnerable?: Qualitative Study of Authoritative Ethics Documents.

PubMed

Zagorac, Ivana

2016-01-01

The aim of this study is to explore what actual guidance is provided by authoritative ethics documents regarding the recognition and protection of the vulnerable. The documents included in this analysis are the Belmont Report, the Declaration of Helsinki, The Council for International Organizations of Medical Sciences (CIOMS) Guidelines, and the UNESCO Universal Declaration on Bioethics and Human Rights, including its supplementary report on vulnerability. A qualitative analysis of these documents was conducted in light of three questions: what is vulnerability, who are the vulnerable, and how should the vulnerable be protected? The results show significant differences among the documents regarding the first two questions. None of the documents provides any guidance on the third question (how to protect the vulnerable). These results suggest a great discrepancy between the acknowledged importance of the concept of vulnerability and a general understanding of the scope, content, and practical implications of vulnerability.

75 FR 18872 - Ginnie Mae Multiclass Securities Program Documents

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-13

... Securities Program Documents AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY... with the Multiclass Securities Program. The intent of the Multiclass Securities program is to increase... Securities Program Documents. OMB Approval Number: 2503-0030. Form Numbers: None. Description of the Need for...

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

... pesticides registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Material... the information collection activities and related burden estimates associated with the guidance provided in PR Notice 2012-1. DATES: Comments on the Agency's information collection activities and related...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0490] Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

77 FR 14473 - Final Guidance on Improving the Process for Preparing Efficient and Timely Environmental Reviews...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-12

... COUNCIL ON ENVIRONMENTAL QUALITY 40 CFR Parts 1500, 1501, 1502, 1503, 1505, 1506, 1507, and 1508 Final Guidance on Improving the Process for Preparing Efficient and Timely Environmental Reviews Under the National Environmental Policy Act AGENCY: Council on Environmental Quality. ACTION: Notice of...

76 FR 21752 - Guidance for Industry on How To Write a Request for Designation; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0214] Guidance for Industry on How To Write a Request for Designation; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

78 FR 15956 - Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0595... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug...

Guidance on Early Delegation of Authority for the NO2 Increments 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.

Guidance for Determining BACT for Reducing CO2 Emissions from Bioenergy Production

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.

Guidance for Implementation of the 1-hour SO2 NAAQS 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.

Data Assessment and Reporting-Supplement to Section 106 Tribal Guidance

EPA Pesticide Factsheets

This document is intended to complement the Tribal 106 Guidance and provide additional detail to tribes concerning the reporting information requested by EPA. It addresses the water quality assessment component of a Tribal Assessment Report.

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.

Remedial Investigation/Feasibility Study (RI/FS) process, elements and techniques guidance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

This manual provides detailed guidance on Remedial Investigation/Feasibility Studies (RI/FSs) conducted pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) at Department of Energy (DOE) facilities. The purpose of the RI/FS, to assess the risk posed by a hazardous waste site and to determine the best way to reduce that risk, and its structure (site characterization, risk assessment, screening and detailed analysis of alternatives, etc.) is defined in the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) and further explained in the Environmental Protection Agency`s (EPA`s) Guidance for Conducting Remedial Investigations and Feasibility Studies Under CERCLA (Interimmore » Final) 540/G-89/004, OSWER Directive 9355.3-01, October 1988. Though issued in 1988, the EPA guidance remains an excellent source of information on the conduct and structure of an RI/FS. This document makes use of supplemental RI/FS-related guidance that EPA has developed since its initial document was issued in 1988, incorporates practical lessons learned in more than 12 years of experience in CERCLA hazardous site remediation, and drawing on those lessons, introduces the Streamlined Approach For Environmental Restoration (SAFER), developed by DOE as a way to proceed quickly and efficiently through the RI/FS process at DOE facilities. Thus as its title implies, this guidance is intended to describe in detail the process and component elements of an RI/FS, as well as techniques to manage the RI/FS effectively.« less

78 FR 22349 - Guidance on the Treatment of Uncertainties Associated With PRA in Risk-Informed Decisionmaking

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-15

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0066] Guidance on the Treatment of Uncertainties Associated With PRA in Risk-Informed Decisionmaking AGENCY: Nuclear Regulatory Commission. ACTION... issued for public comment a document entitled: NUREG-1855, Revision 1, ``Guidance on the Treatment of...

77 FR 28602 - Agency Information Collection Activities; Proposed Collection; Comment Request; Early Food Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-15

.... Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in... electronically via the Electronic Submission Gateway (ESG); and the guidance document entitled, ``Recommendations... to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed...

75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0590] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0305] Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

Waste treatability guidance program. User`s guide. Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Toth, C.

1995-12-21

DOE sites across the country generate and manage radioactive, hazardous, mixed, and sanitary wastes. It is necessary for each site to find the technologies and associated capacities required to manage its waste. One role of DOE HQ Office of Environmental Restoration and Waste Management is to facilitate the integration of the site- specific plans into coherent national plans. DOE has developed a standard methodology for defining and categorizing waste streams into treatability groups based on characteristic parameters that influence waste management technology needs. This Waste Treatability Guidance Program automates the Guidance Document for the categorization of waste information into treatabilitymore » groups; this application provides a consistent implementation of the methodology across the National TRU Program. This User`s Guide provides instructions on how to use the program, including installations instructions and program operation. This document satisfies the requirements of the Software Quality Assurance Plan.« less

Guidance To States On Authority Necessary To Implement The Operating Permits Program In Title V Of The Clean Air Act Amendments of 1990

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-24

... Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and... Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access)'' (the draft guidance). The document provides guidance to egg producers on...

Towards a standardised approach for evaluating guidelines and guidance documents on palliative sedation: study protocol

PubMed Central

2014-01-01

Background Sedation in palliative care has received growing attention in recent years; and so have guidelines, position statements, and related literature that provide recommendations for its practice. Yet little is known collectively about the content, scope and methodological quality of these materials. According to research, there are large variations in palliative sedation practice, depending on the definition and methodology used. However, a standardised approach to comparing and contrasting related documents, across countries, associations and governmental bodies is lacking. This paper reports on a protocol designed to enable thorough and systematic comparison of guidelines and guidance documents on palliative sedation. Methods and design A multidisciplinary and international group of palliative care researchers, identified themes and clinical issues on palliative sedation based on expert consultations and evidence drawn from the EAPC (European Association of Palliative Care) framework for palliative sedation and AGREE II (Appraisal Guideline Research and Evaluation) instrument for guideline assessment. The most relevant themes were selected and built into a comprehensive checklist. This was tested on people working closely with practitioners and patients, for user-friendliness and comprehensibility, and modified where necessary. Next, a systematic search was conducted for guidelines in English, Dutch, Flemish, or Italian. The search was performed in multiple databases (PubMed, CancerLit, CNAHL, Cochrane Library, NHS Evidence and Google Scholar), and via other Internet resources. Hereafter, the final version of the checklist will be used to extract data from selected literature, and the same will be compiled, entered into SPSS, cleaned and analysed systematically for publication. Discussion We have together developed a comprehensive checklist in a scientifically rigorous manner to allow standardised and systematic comparison. The protocol is applicable to all

Towards a standardised approach for evaluating guidelines and guidance documents on palliative sedation: study protocol.

PubMed

Abarshi, Ebun; Rietjens, Judith; Caraceni, Augusto; Payne, Sheila; Deliens, Luc; Van Den Block, Lieve

2014-01-01

Sedation in palliative care has received growing attention in recent years; and so have guidelines, position statements, and related literature that provide recommendations for its practice. Yet little is known collectively about the content, scope and methodological quality of these materials. According to research, there are large variations in palliative sedation practice, depending on the definition and methodology used. However, a standardised approach to comparing and contrasting related documents, across countries, associations and governmental bodies is lacking. This paper reports on a protocol designed to enable thorough and systematic comparison of guidelines and guidance documents on palliative sedation. A multidisciplinary and international group of palliative care researchers, identified themes and clinical issues on palliative sedation based on expert consultations and evidence drawn from the EAPC (European Association of Palliative Care) framework for palliative sedation and AGREE II (Appraisal Guideline Research and Evaluation) instrument for guideline assessment. The most relevant themes were selected and built into a comprehensive checklist. This was tested on people working closely with practitioners and patients, for user-friendliness and comprehensibility, and modified where necessary. Next, a systematic search was conducted for guidelines in English, Dutch, Flemish, or Italian. The search was performed in multiple databases (PubMed, CancerLit, CNAHL, Cochrane Library, NHS Evidence and Google Scholar), and via other Internet resources. Hereafter, the final version of the checklist will be used to extract data from selected literature, and the same will be compiled, entered into SPSS, cleaned and analysed systematically for publication. We have together developed a comprehensive checklist in a scientifically rigorous manner to allow standardised and systematic comparison. The protocol is applicable to all guidelines on palliative sedation, and

Expanded Guidance for NASA Systems Engineering. Volume 1: Systems Engineering Practices

NASA Technical Reports Server (NTRS)

Hirshorn, Steven R.

2016-01-01

This document is intended to provide general guidance and information on systems engineering that will be useful to the NASA community. It provides a generic description of Systems Engineering (SE) as it should be applied throughout NASA. A goal of the expanded guidance is to increase awareness and consistency across the Agency and advance the practice of SE. This guidance provides perspectives relevant to NASA and data particular to NASA. This expanded guidance should be used as a companion for implementing NPR 7123.1, Systems Engineering Processes and Requirements, the Rev 2 version of SP-6105, and the Center-specific handbooks and directives developed for implementing systems engineering at NASA. It provides a companion reference book for the various systems engineering-related training being offered under NASA's auspices.

78 FR 48457 - Correction of Document Revoking Customs Broker Licenses

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-08

... DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Correction of Document Revoking Customs Broker Licenses AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Correction of document revoking certain customs broker licenses. SUMMARY: In a notice published...

International Scavenging for First Responder Guidance and Tools: IAEA Products

DOE Office of Scientific and Technical Information (OSTI.GOV)

Stern, W.; Berthelot, L.; Bachner, K.

In fiscal years (FY) 2016 and 2017, with support from the U.S. Department of Homeland Security (DHS), Brookhaven National Laboratory (BNL) examined the International Atomic Energy Agency (IAEA) radiological emergency response and preparedness products (guidance and tools) to determine which of these products could be useful to U.S. first responders. The IAEA Incident and Emergency Centre (IEC), which is responsible for emergency preparedness and response, offers a range of tools and guidance documents for responders in recognizing, responding to, and recovering from radiation emergencies and incidents. In order to implement this project, BNL obtained all potentially relevant tools and productsmore » produced by the IAEA IEC and analyzed these materials to determine their relevance to first responders in the U.S. Subsequently, BNL organized and hosted a workshop at DHS National Urban Security Technology Laboratory (NUSTL) for U.S. first responders to examine and evaluate IAEA products to consider their applicability to the United States. This report documents and describes the First Responder Product Evaluation Workshop, and provides recommendations on potential steps the U.S. federal government could take to make IAEA guidance and tools useful to U.S. responders.« less

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-23

..., ``Consideration of the Effects of Climate Change and Greenhouse Gas Emissions.'' AGENCY: Council On Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``Consideration of the Effects of Climate Change... Effects of Climate Change and Greenhouse Gas Emissions'' should be submitted electronically to GCC...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0691... Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... manufacturing practice regulations for PET drugs. DATES: Although you can comment on any guidance at any time...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

... Forensic Science AGENCY: National Institute of Standards and Technology (NIST), United States Department of Commerce. ACTION: Notice, extension of comment period. SUMMARY: NIST is extending the deadline for... Guidance Groups for Forensic Science. Due to the lack of availability of information posted on the NIST Web...

WCATS: Waste Documentation, Course No. 8504

DOE Office of Scientific and Technical Information (OSTI.GOV)

Simpson, Sandy

2016-04-14

This course was developed for individuals at Los Alamos National Laboratory (LANL) who characterize and document waste streams in the Waste Compliance and Tracking System (WCATS) according to Environmental Protection Agency (EPA) Department of Transportation (DOT) regulations, Department of Energy Orders, and other applicable criteria. When you have completed this course, you will be able to recognize how waste documentation enables LANL to characterize and classify hazardous waste for compliant treatment, storage, and disposal, identify the purpose of the waste stream profile (WSP), identify the agencies that provide guidance for waste management, and more.

76 FR 4684 - Pesticides; Science Policies; Notice of Withdrawal and Notice of Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-26

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2010-0830; FRL-8854-2] Pesticides; Science Policies...: Notice. SUMMARY: EPA announces the withdrawal of two pesticide science policy documents that are no... of two updated pesticide science policy documents, entitled: ``The Development and Use of the Index...

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

... policy guidance will accompany the final rule for Major Capital Investment Projects published elsewhere... policy guidance on the review and evaluation process and criteria for major capital investment projects... capital investment program authorized at 49 U.S.C. 5309. Both the new regulation and the proposed policy...

Notice of Deficiency for 34 Clean Air Act Operating Permits Programs in California

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.

April 18, 2002 Notice of Deficiency for Ohio's Title V Operating Permit Program

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.

Ethics of clinician communication in a changing communication landscape: guidance from professional societies.

PubMed

Gollust, Sarah E; Dwyer, Anne M

2013-12-01

Cancer experts engage in public communication whenever they promote their research or practice, respond to media inquiries, or use social media. In a changing communication landscape characterized by new technologies and heightened attention to cancer controversies, these activities may pose ethical challenges. This study was designed to evaluate existing resources to help clinicians navigate their public communication activities. We conducted a systematic, qualitative content analysis of codes of ethics, policy statements, and similar documents disseminated by professional medical and nursing societies for their members. We examined these documents for four types of content related to public communication: communication via traditional media; communication via social media; other communication to the public, policy, and legal spheres; and nonspecific language regarding public communication. We identified 46 documents from 23 professional societies for analysis. Five societies had language about traditional news media communication, five had guidance about social media, 11 had guidance about other communication domains, and 15 societies offered general language about public communication. The limited existing guidance focused on ethical issues related to patients (such as privacy violations) or clinicians (such as accuracy and professional boundaries), with less attention to population or policy impact of communication. Cancer-related professional societies might consider establishing more specific guidance for clinicians concerning their communication activities in light of changes to the communication landscape. Additional research is warranted to understand the extent to which clinicians face ethical challenges in public communication.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-13

... document, which addresses safety achieved through drug product design, is the first in a series of planned...] Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication Errors... Considerations for Product Design to Minimize Medication Errors.'' The draft guidance provides sponsors of...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-24

... container labels and carton labeling design, is the second in a series of three planned guidance documents...] Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To... entitled ``Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...

78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-07

...] Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and... availability of a final guidance document entitled ``Technical Considerations for Pen, Jet, and Related... developing information to support a marketing application for a pen, jet, or related injector device intended...

77 FR 35689 - Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0146] Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment; Availability...). The document announced the availability of a guidance for industry entitled ``Irritable Bowel Syndrome...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-25

... (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD... brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: For devices regulated by CDRH... copy of the guidance may do so by using the Internet. A search capability for all CDRH guidance...

78 FR 2258 - Notice of Telephonic Prehearing Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-10

... CONSUMER PRODUCT SAFETY COMMISSION [CPSC Docket No. 13-1] Notice of Telephonic Prehearing Conference AGENCY: U.S. Consumer Product Safety Commission. ACTION: Notice. SUMMARY: Notice of telephonic..., regulations, and consumer product safety rules; (11) Disclosure of the names of witnesses and of documents or...

32 CFR 651.22 - Notice of intent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 4 2010-07-01 2010-07-01 true Notice of intent. 651.22 Section 651.22 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) ENVIRONMENTAL QUALITY ENVIRONMENTAL ANALYSIS OF ARMY ACTIONS (AR 200-2) Records and Documents § 651.22 Notice of intent. A Notice of...

Draft PSD Guidance for Impacts of the North County Resource Recovery PSD Remand

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.

Response to Request for Guidance in Defining Adjacent with Respect to Source Aggregation

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.

January 2004 Guidance on Using Locomotive and Truck Idling Emission Reductions for Offsets

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.

International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice.

PubMed

2001-07-13

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S7A Safety Pharmacology Studies for Human 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 provides a definition, general principles, and recommendations for the nonclinical safety pharmacology studies. The guidance is intended to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.

The Nature of the Planning Environment: And the Effects of Guidance, Organization and Authority

DTIC Science & Technology

2013-05-23

home reading the newspaper, and notice a small blurb buried beneath the fold in the back of ... THE NATURE OF THE PLANNING ENVIRONMENT: AND THE EFFECTS OF GUIDANCE, ORGANIZATION AND AUTHORITY A Monograph by Major...0704-0188 Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for

Guidance for Using Formal Methods in a Certification Context

NASA Technical Reports Server (NTRS)

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

2010-01-01

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

43 CFR 4.422 - Documents.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., upon filing notice of the transfer or encumbrance in the proper land office, become entitled to receive... transfer or encumbrance will be noted upon the records of the land office. Thereafter such transferee or... document is transmitted to the party, unless the serving party learns that it did not reach the party to be...

43 CFR 4.422 - Documents.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., upon filing notice of the transfer or encumbrance in the proper land office, become entitled to receive... transfer or encumbrance will be noted upon the records of the land office. Thereafter such transferee or... document is transmitted to the party, unless the serving party learns that it did not reach the party to be...

43 CFR 4.422 - Documents.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., upon filing notice of the transfer or encumbrance in the proper land office, become entitled to receive... transfer or encumbrance will be noted upon the records of the land office. Thereafter such transferee or... document is transmitted to the party, unless the serving party learns that it did not reach the party to be...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-15

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0585] Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

78 FR 15017 - Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0643... Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...

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

ERIC Educational Resources Information Center

Centers for Disease Control and Prevention, 2009

2009-01-01

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

Readings in Computer Based Guidance. The Bartlesville System.

ERIC Educational Resources Information Center

Bartlesville Public Schools, OK.

The document contains six papers which deal with the need for change in guidance and counseling due to the overwhelming amount of data which is insufficiently processed by conventional manual systems. Included in these papers are discussions on when these changes should occur and the nature of their alterations. The reports consider some of the…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-13

... for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave... INFORMATION CONTACT: For information concerning the guidance as it relates to devices regulated by CDRH: Mary... Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/Medical...

76 FR 67197 - Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-31

...The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 25, 2011 (76 FR 66074). The document announced the availability of a guidance for industry entitled ``Required Warnings for Cigarette Packages and Advertisements--Small Entity Compliance Guide'' for a final rule that published in the Federal Register of June 22, 2011 (76 FR 36628). The notice published with an incorrect docket number. This document corrects that error.

GUIDANCE FOR EVALUATING LANDFILL GAS EMISSIONS FROM CLOSED OR ABANDONED FACILITIES

EPA Science Inventory

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

Technical Document on Control of Nitrogen Oxides From Municipal Waste Combustors

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.

Scientific and Regulatory Policy Committee Review: Review of the Organisation for Economic Co-operation and Development (OECD) Guidance on the GLP Requirements for Peer Review of Histopathology.

PubMed

Fikes, James D; Patrick, Daniel J; Francke, Sabine; Frazier, Kendall S; Reindel, James F; Romeike, Annette; Spaet, Robert H; Tomlinson, Lindsay; Schafer, Kenneth A

2015-10-01

In 2014, the Organisation for Economic Co-operation and Development (OECD) issued guidance no. 16, Guidance on the GLP Requirements for Peer Review of Histopathology. The stated purpose of the guidance document is "to provide guidance to pathologists, test facility management, study directors and quality assurance personnel on how the peer review of histopathology should be planned, managed, documented, and reported in order to meet Good Laboratory Practice (GLP) expectations and requirements." On behalf of and in collaboration with the global societies of toxicologic pathology, the Society of Toxicologic Pathology initiated a review of OECD guidance no. 16. The objectives of this review are to provide a unified interpretation of the guidance, to recommend compliant processes for organizations to implement, and to avoid inconsistent process adaptations across the industry. This review of the guidance document is the product of a global collaboration with other societies of toxicologic pathology and provides a section-by-section international consensus view and interpretation of the OECD guidance on peer review. © 2015 by The Author(s).

New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process.

PubMed

Huang, Shiew-Mei; Strong, John M; Zhang, Lei; Reynolds, Kellie S; Nallani, Srikanth; Temple, Robert; Abraham, Sophia; Habet, Sayed Al; Baweja, Raman K; Burckart, Gilbert J; Chung, Sang; Colangelo, Philip; Frucht, David; Green, Martin D; Hepp, Paul; Karnaukhova, Elena; Ko, Hon-Sum; Lee, Jang-Ik; Marroum, Patrick J; Norden, Janet M; Qiu, Wei; Rahman, Atiqur; Sobel, Solomon; Stifano, Toni; Thummel, Kenneth; Wei, Xiao-Xiong; Yasuda, Sally; Zheng, Jenny H; Zhao, Hong; Lesko, Lawrence J

2008-06-01

Predicting clinically significant drug interactions during drug development is a challenge for the pharmaceutical industry and regulatory agencies. Since the publication of the US Food and Drug Administration's (FDA's) first in vitro and in vivo drug interaction guidance documents in 1997 and 1999, researchers and clinicians have gained a better understanding of drug interactions. This knowledge has enabled the FDA and the industry to progress and begin to overcome these challenges. The FDA has continued its efforts to evaluate methodologies to study drug interactions and communicate recommendations regarding the conduct of drug interaction studies, particularly for CYP-based and transporter-based drug interactions, to the pharmaceutical industry. A drug interaction Web site was established to document the FDA's current understanding of drug interactions (http://www.fda.gov/cder/drug/drugInteractions/default.htm). This report provides an overview of the evolution of the drug interaction guidances, includes a synopsis of the steps taken by the FDA to revise the original drug interaction guidance documents, and summarizes and highlights updated sections in the current guidance document, Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-04

... (Formerly 2007D-0252)] Pulse Oximeters--Premarket Notification Submissions [510(k)s]; Guidance for Industry... entitled ``Pulse Oximeters--Premarket Notification Submissions [510(k)s].'' This guidance document pertains to non-invasive pulse oximeters intended for prescription use to measure arterial blood oxygen...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

...] Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion... the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump--Premarket Notification... this issue of the Federal Register, FDA is announcing a public meeting regarding external infusion...

Mississippi Curriculum Framework for Child Care and Guidance Management and Services (Program CIP: 20.0201--Child Care & Guidance Workers and Managers). Secondary Programs.

ERIC Educational Resources Information Center

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

This document, which reflects Mississippi's statutory requirement that instructional programs be based on core curricula and performance-based assessment, contains outlines of the instructional units required in local instructional management plans and daily lesson plans for child care and guidance management and services I and II. Presented first…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

25 CFR 559.7 - May a tribe submit documents required by this part electronically?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 2 2013-04-01 2013-04-01 false May a tribe submit documents required by this part... NOTIFICATIONS AND SUBMISSIONS § 559.7 May a tribe submit documents required by this part electronically? Yes. Tribes wishing to submit documents electronically should contact the Commission for guidance on...

25 CFR 559.7 - May a tribe submit documents required by this part electronically?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 2 2014-04-01 2014-04-01 false May a tribe submit documents required by this part... NOTIFICATIONS AND SUBMISSIONS § 559.7 May a tribe submit documents required by this part electronically? Yes. Tribes wishing to submit documents electronically should contact the Commission for guidance on...

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 ...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-19

...] Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in... entitled ``Evaluation of Sex Differences in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences in medical device clinical trials, with a specific...

76 FR 50483 - Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When...