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

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J. (Editor)

2008-01-01

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

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...

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.

NAFTA II : California border zone land transportation issues

DOT National Transportation Integrated Search

2001-09-01

This report constitutes Phase II of a study of the impacts of the North American Free Trade Agreement (NAFTA) of 1992 on border areas and determines transportation infrastructure access. Reviews status of NAFTA impact issues; identifies new issues; d...

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.'

Additional Guidance for Evaluating and Calculating Degradation Kinetics in Environmental Media

EPA Pesticide Factsheets

EFED compiled examples where the PestDF (version 0.8.4), the tool used most commonly by USEPA to conduct kinetic analysis following the NAFTA guidance, results required additional interpretation. Here are some of these examples.

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...

NAFTA Effects on Income Inequality between 1998 and 2006: A Comparative Analysis

DTIC Science & Technology

2013-12-01

Labor Cooperation To advance a cooperative mechanism on labor matters among NAFTA members as well as to advance laws for domestic labor, a...million, the U.S with 304.1 million, and Mexico with 106.7 million constitutes the NAFTA population.94 3. NAFTA Languages Though various languages...discrimination, secret ballot voting and protection of contract and migrant workers. With the NAALC, local employment laws in all three NAFTA countries

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

NAFTA: The Mexican Economy, and Undocumented Migration

DTIC Science & Technology

2011-10-28

NAFTA contributed to modest increases in Mexican formal employment since 1994. Since employment constitutes one of the chief factors affecting poverty...any other provision of law , no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a...FINAL 3. DATES COVERED (From - To) 4. TITLE AND SUBTITLE NAFTA , the Mexican Economy, and Undocumented Migration 5a

NAFTA: The World's Largest Trading Zone Turns 20

ERIC Educational Resources Information Center

Ferrarini, Tawni Hunt; Day, Stephen

2014-01-01

Everyone under the age of 20 who has grown up in North America has lived in the common market created by NAFTA--the North American Free Trade Agreement. In a zone linking the United States, Canada, and Mexico, most goods and investments flow freely across borders to users, consumers, and investors. In 1994, NAFTA created the largest relatively…

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.

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.

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

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.

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

The NAFTA Effect -- Mexico’s Unfulfilled Dream

DTIC Science & Technology

2011-10-28

and reap the benefits of NAFTA , Mexico will need to become more aggressive in its enforcement of competition and anti-trust laws .30 Having...the courts and rule of law . Mexico’s courts are notoriously unhurried and corrupt. Disastrous to NAFTA aims, few cases end up in court, due to the...any other provision of law , no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a

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...

19 CFR 181.97 - Withdrawal of NAFTA advance ruling requests.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 19 Customs Duties 2 2010-04-01 2010-04-01 false Withdrawal of NAFTA advance ruling requests. 181...; DEPARTMENT OF THE TREASURY (CONTINUED) NORTH AMERICAN FREE TRADE AGREEMENT Advance Ruling Procedures § 181.97 Withdrawal of NAFTA advance ruling requests. Any request for an advance ruling may be withdrawn by the person...

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.

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).

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

19 CFR 181.99 - Issuance of NAFTA advance rulings or other advice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Procedures § 181.99 Issuance of NAFTA advance rulings or other advice. (a) NAFTA advance ruling letters—(1... advance ruling letter in the English language setting forth the position of Customs and the reasons... an information letter or, in those situations in which general information is likely to be of little...

75 FR 28276 - Agency Information Collection Activities: NAFTA Regulations and Certificate of Origin

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-20

... Review: Revision. Affected Public: Businesses. Form 434, NAFTA Certificate of Origin: Estimated Number of... Activities: NAFTA Regulations and Certificate of Origin AGENCY: U.S. Customs and Border Protection... Homeland Security has submitted the following information collection request to the Office of Management...

77 FR 72325 - North American Free-Trade Agreement, Article 1904 NAFTA Panel Reviews; Request for Panel Review

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-05

..., Article 1904 NAFTA Panel Reviews; Request for Panel Review AGENCY: NAFTA Secretariat, United States... Review with the Mexican Section of the NAFTA Secretariat pursuant to Article 1904 of the North American... that made the determination. Under Article 1904 of the Agreement, which came into force on January 1...

77 FR 66441 - North American Free Trade Agreement, Article 1904 NAFTA Panel Reviews; First Request for Panel...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-05

..., Article 1904 NAFTA Panel Reviews; First Request for Panel Review AGENCY: NAFTA Secretariat, United States... Panel Review with the United States Section of the NAFTA Secretariat pursuant to Article 1904 of the... antidumping or countervailing duty law of the country that made the determination. Under Article 1904 of the...

76 FR 16728 - North American Free Trade Agreement, Article 1904; NAFTA Panel Reviews; Request for Panel Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-25

..., Article 1904; NAFTA Panel Reviews; Request for Panel Review AGENCY: NAFTA Secretariat, United States... Review with the United States Section of the NAFTA Secretariat pursuant to Article 1904 of the North... law of the country that made the determination. Under Article 1904 of the Agreement, which came into...

75 FR 82376 - North American Free Trade Agreement, Article 1904 NAFTA Panel Reviews; Request for Panel Review

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

..., Article 1904 NAFTA Panel Reviews; Request for Panel Review AGENCY: NAFTA Secretariat, United States... Review with the United States Section of the NAFTA Secretariat pursuant to Article 1904 of the North... duty law of the country that made the determination. Under Article 1904 of the Agreement, which came...

76 FR 42115 - North American Free-Trade Agreement, Article 1904 NAFTA Panel Reviews; Request for Panel Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-18

..., Article 1904 NAFTA Panel Reviews; Request for Panel Review AGENCY: NAFTA Secretariat, United States... with the United States Section of the NAFTA Secretariat pursuant to Article 1904 of the North American... duty law of the country that made the determination. Under Article 1904 of the Agreement, which came...

77 FR 66798 - North American Free-Trade Agreement, Article 1904; NAFTA Panel Reviews; Request for Panel Review

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-07

..., Article 1904; NAFTA Panel Reviews; Request for Panel Review AGENCY: NAFTA Secretariat, United States... with the Mexican Section of the NAFTA Secretariat pursuant to Article 1904 of the North American Free... law of the country that made the determination. Under Article 1904 of the Agreement, which came into...

76 FR 72677 - North American Free-Trade Agreement, Article 1904 NAFTA Panel Reviews; Request for Panel Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-25

..., Article 1904 NAFTA Panel Reviews; Request for Panel Review AGENCY: NAFTA Secretariat, United States... with the Mexican Section of the NAFTA Secretariat pursuant to Article 1904 of the North American Free... Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of the United...

77 FR 26252 - North American Free Trade Agreement, Article 1904 NAFTA Panel Reviews; First Request for Panel...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-03

..., Article 1904 NAFTA Panel Reviews; First Request for Panel Review AGENCY: NAFTA Secretariat, United States... for Panel Review with the United States Section of the NAFTA Secretariat pursuant to Article 1904 of... law of the country that made the determination. Under Article 1904 of the Agreement, which came into...

77 FR 10479 - North American Free Trade Agreement, Article 1904; NAFTA Panel Reviews; First Request for Panel...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

..., Article 1904; NAFTA Panel Reviews; First Request for Panel Review AGENCY: NAFTA Secretariat, United States... Section of the NAFTA Secretariat pursuant to Article 1904 of the North American Free Trade Agreement... determination. Under Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of...

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...

77 FR 9954 - Agency Information Collection Activities: NAFTA Regulations and Certificate of Origin

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-21

... Activities: NAFTA Regulations and Certificate of Origin AGENCY: U.S. Customs and Border Protection... Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: NAFTA Regulations and Certificate of Origin. This is a proposed revision and extension of an information collection...

76 FR 76983 - Agency Information Collection Activities: NAFTA Regulations and Certificate of Origin

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-09

... Activities: NAFTA Regulations and Certificate of Origin AGENCY: U.S. Customs and Border Protection (CBP... requirement concerning the NAFTA Regulations and Certificate of Origin. This request for comment is being made... request for Office of Management and Budget (OMB) approval. All comments will become a matter of public...

77 FR 72325 - North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-05

... DEPARTMENT OF COMMERCE International Trade Administration North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... Order and Rule 80 of the Article 1904 Panel Rules, the Panel Review was completed and the panelists were...

78 FR 10600 - North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-14

... DEPARTMENT OF COMMERCE International Trade Administration North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... Order and Rule 80 of the Article 1904 Panel Rules, the Panel Review was completed and the panelists were...

78 FR 5778 - North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

... DEPARTMENT OF COMMERCE International Trade Administration North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... the Panel Order and Rule 80 of the Article 1904 Panel Rules, the Panel Review was completed and the...

78 FR 11627 - North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

... DEPARTMENT OF COMMERCE International Trade Administration North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... Order and Rule 80 of the Article 1904 Panel Rules, the Panel Review was completed and the panelists were...

76 FR 4633 - North American Free-Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-26

... (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... duty law of the country that made the determination. Under Article 1904 of the Agreement, which came... Government of Mexico established Rules of Procedure for Article 1904 Binational Panel Reviews (``Rules...

76 FR 56404 - North American Free-Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-13

... (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... law of the country that made the determination. Under Article 1904 of the Agreement, which came into... Government of Mexico established Rules of Procedure for Article 1904 Binational Panel Reviews (``Rules...

78 FR 17639 - North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-22

... DEPARTMENT OF COMMERCE International Trade Administration North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... Order and Rule 80 of the Article 1904 Panel Rules, the Panel Review was completed and the panelists were...

76 FR 14917 - North American Free-Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

... (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... that made the determination. Under Article 1904 of the Agreement, which came into force on January 1... established Rules of Procedure for Article 1904 Binational Panel Reviews (``Rules''). These Rules were...

77 FR 74174 - North American Free-Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-13

... (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... duty law of the country that made the determination. Under Article 1904 of the Agreement, which came... Government of Mexico established Rules of Procedure for Article 1904 Binational Panel Reviews (``Rules...

75 FR 74686 - North American Free-Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-01

... (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... determination. Under Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of... Procedure for Article 1904 Binational Panel Reviews (``Rules''). These Rules were published in the Federal...

77 FR 29965 - North American Free-Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... determination. Under Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of... Procedure for Article 1904 Binational Panel Reviews (``Rules''). These Rules were published in the Federal...

78 FR 51708 - North American Free-Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-21

... (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... determination. Under Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of... Procedure for Article 1904 Binational Panel Reviews (``Rules''). These Rules were published in the Federal...

78 FR 66899 - International Trade Administration, North American Free-Trade Agreement (NAFTA), Article 1904...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-07

... (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of the United States, the Government of Canada and the Government of Mexico established Rules of Procedure for Article...

75 FR 20567 - North American Free-Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-20

... (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of the United States, the Government of Canada and the Government of Mexico established Rules of Procedure for Article...

76 FR 56156 - North American Free-Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-12

... (NAFTA), Article 1904 Binational Panel Reviews AGENCY: NAFTA Secretariat, United States Section... Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of the United States, the Government of Canada and the Government of Mexico established Rules of Procedure for Article...

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

76 FR 77777 - North American Free Trade Agreement (NAFTA), Article 1904; Binational Panel Reviews: Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-14

... (NAFTA), Article 1904; Binational Panel Reviews: Notice of Completion of Panel Review AGENCY: NAFTA... Rule 71(3) of the Rules of Procedure for Article 1904 Binational Panel Review, ``A panel review is...

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...

The impacts of NAFTA on U.S. and Canadian forest product exports to Mexico

Treesearch

Jeffrey P. Prestemon; Joseph Buongiorno

1996-01-01

The North American Free Trade Agreement (NAFTA) will lower barriers to trade and investment across the continent. This paper presents predictions of the effects of NAFTA on Mexico's imports of intermediate wood products, scrap and waste paper, pulp, and newsprint from the United States and Canada. Predictions were made with a partial equilibrium model. Model...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... Document for Fuel Cycle Facilities AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability..., Division of Fuel Cycle Safety and Safeguards, Office of Nuclear Material Safety and Safeguards, U.S... Commission (NRC) prepares and issues Interim Staff Guidance (ISG) documents for fuel cycle facilities. These...

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...

76 FR 23286 - North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews: Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-26

... DEPARTMENT OF COMMERCE International Trade Administration North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews: Notice of Completion of Panel Review AGENCY: NAFTA... Rule 80 of the Article 1904 Panel Rules, the Panel Review was completed and the panelists were...

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...

76 FR 62364 - North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-07

... DEPARTMENT OF COMMERCE International Trade Administration North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews; Notice of Completion of Panel Review AGENCY: NAFTA... of the Panel Order and Rule 80 of the Article 1904 Panel Rules, the Panel Review was completed and...

75 FR 54594 - North American Free Trade Agreement (NAFTA), Article 1904; Binational Panel Reviews: Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-08

... DEPARTMENT OF COMMERCE International Trade Administration North American Free Trade Agreement (NAFTA), Article 1904; Binational Panel Reviews: Notice of Completion of Panel Review AGENCY: NAFTA... was filed. Therefore, on the basis of the Panel Order and Rule 80 of the Article 1904 Panel Rules, the...

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...

77 FR 49781 - North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews: Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-17

... (NAFTA), Article 1904 Binational Panel Reviews: Notice of Termination of Panel Review AGENCY: NAFTA...) of the Rules of Procedure for Article 1904 Binational Panel Review, this panel review is terminated... that made the determination. Under Article 1904 of the Agreement, which came into force on January 1...

76 FR 77777 - North American Free Trade Agreement (NAFTA), Article 1904; Binational Panel Reviews: Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-14

... (NAFTA), Article 1904; Binational Panel Reviews: Notice of Termination of Panel Review AGENCY: NAFTA... Article 1904 Binational Panel Review, this panel review is terminated. FOR FURTHER INFORMATION CONTACT... Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of the United...

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0600] Guidance for Industry on Tobacco Health Document Submission; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a...

78 FR 45181 - North American Free Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews: Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-26

... (NAFTA), Article 1904 Binational Panel Reviews: Notice of Termination of Panel Review AGENCY: NAFTA... Article 1904 Binational Panel Review, the panel review is terminated as of July 3, 2013. A panel has not... antidumping or countervailing duty law of the country that made the determination. Under Article 1904 of 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

How Was President Clinton Able to Build a Winning Political Coalition on NAFTA?

DTIC Science & Technology

1997-01-01

The pro-NAFTA forces used economic arguments in support of free trade They asserted Increased trade wrth Mexrco would boost U S exports and growth...S exports , or more than $40 bilhon Moreover, since U S ta.rnYFs averaged only 4 percent, whrle Mexico’s were closer to 20 percent, a free trade pact...high wage export Jobs by 1995 Finally, the NAFTA met key U S forergn pohcy objectives of keeping Mexico on a democratic, free market I I path A

Economics and Migration: NAFTA’s Impact on Mexico

DTIC Science & Technology

2011-10-28

immigrants to the U.S. 1 No nation was ever ruined by trade, even seemingly the most disadvantageous . -Benjamin...NAFTA forced rural farmers to cultivate marginal land due to lost income caused by falling commodity prices, leading to extensive deforestation in

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-28

... evaluate results from the battery of Tier 1 screening assays along with other scientific and technical... guidance document that requested additional detail and clarification of the following: 1. Tier 1 battery of...

The Effect of George Bush's NAFTA on American Workers: Ladder Up or Ladder Down? Briefing Paper.

ERIC Educational Resources Information Center

Faux, Jeff; Lee, Thea

The proposed North American Free Trade Agreement (NAFTA) will result in lower wages, fewer jobs, and generally reduced living standards for the majority of U.S. workers. Substantial costs to the U.S. economy will occur in job and income loss and few off-setting benefits for most workers. Proponents argue that NAFTA will create upward mobility for…

76 FR 10005 - North American Free Trade Agreement, Article 1904 NAFTA Panel Reviews; Request for Panel Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-23

..., Article 1904 NAFTA Panel Reviews; Request for Panel Review AGENCY: NAFTA Secretariat, United States... Secretariat pursuant to Article 1904 of the North American Free Trade Agreement. Panel Review was requested of... countervailing duty law of the country that made the determination. Under Article 1904 of the Agreement, which...

75 FR 13494 - North American Free-Trade Agreement, Article 1904; NAFTA Panel Reviews; Request for Panel Review

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-22

..., Article 1904; NAFTA Panel Reviews; Request for Panel Review AGENCY: NAFTA Secretariat, United States... Secretariat pursuant to Article 1904 of the North American Free Trade Agreement. Panel Review was requested of... Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of the United...

75 FR 82375 - North American Free Trade Agreement, Article 1904 NAFTA Panel Reviews; Request for Panel Review

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

..., Article 1904 NAFTA Panel Reviews; Request for Panel Review AGENCY: NAFTA Secretariat, United States... to Article 1904 of the North American Free Trade Agreement. Second and Third Requests for Panel... Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of the United...

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...

Assessing the potential for Gulf Coast NAFTA maritime trade corridors.

DOT National Transportation Integrated Search

2015-12-01

The North American Free Trade Agreement (NAFTA) was enacted in 1994 with the expressed intent of : reducing barriers to trade. Since that time, however, transborder congestion and delays between the United : States (US) and Mexico threaten achievemen...

Identification of NAFTA-induced opportunities for Louisiana's ports and waterways.

DOT National Transportation Integrated Search

1996-06-01

The implementation of the North American Free Trade Agreement (NAFTA) on January 1, 1994, created a trading region extending from the Yucatan Peninsula in Mexico to the Yukon region of Alaska with trade between the United States, Canada, and Mexico t...

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

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

EPA Pesticide Factsheets

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

Identification of NAFTA-induced opportunities for Louisiana's ports and waterways : technical summary.

DOT National Transportation Integrated Search

1996-11-01

This study identifies NAFTA-induced market opportunities for Louisianas maritime sector and to help define the strategies, maritime services, and port infrastructure requirements necessary to exploit these opportunities. Identification of current ...

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 and Higher Education: The Cultural and Educational Dimensions of Trade.

ERIC Educational Resources Information Center

Altbach, Philip G.

1994-01-01

The North American Free Trade Agreement (NAFTA), which promises closer economic relations between Canada, the United States, and Mexico, has implications for higher education. These include the need for better understanding of the different educational systems, more educational and cultural exchange, and expanded area studies and language…

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...

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.

Debate over NAFTA's effect on health care a sign medicare will be dominant election issue

PubMed Central

Gray, Charlotte

1996-01-01

Does the North American Free Trade Agreement (NAFTA) pose a threat to Canada's medicare system? There was a flurry of political activity in March over concerns that US health care companies were eagerly eyeing the Canadian market because NAFTA had opened it to them. The issue disappeared almost as quickly as it arrived, but it caught the attention of federal politicians, who hastened to negotiate to protect all existing health and social services. The rapidity with which the question grabbed the headlines was another reminder that health care remains one of the key political issues in Canada, and politicians will ignore it at their peril.

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.

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.

19 CFR 181.92 - Definitions and general NAFTA advance ruling practice.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 19 Customs Duties 2 2014-04-01 2014-04-01 false Definitions and general NAFTA advance ruling practice. 181.92 Section 181.92 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND... National Commodity Specialist Division or by such other office as designated by the Commissioner of Customs...

19 CFR 181.92 - Definitions and general NAFTA advance ruling practice.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 19 Customs Duties 2 2013-04-01 2013-04-01 false Definitions and general NAFTA advance ruling practice. 181.92 Section 181.92 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND... National Commodity Specialist Division or by such other office as designated by the Commissioner of Customs...

19 CFR 181.92 - Definitions and general NAFTA advance ruling practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... undertaken but has not resulted in any arrival or in the filing of any entry or entry summary or other... arrival, entry or otherwise will be resolved by that office in accordance with the principles and... consideration. (3) Completed NAFTA transactions. A question arising in connection with an entry of merchandise...

19 CFR 181.92 - Definitions and general NAFTA advance ruling practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... undertaken but has not resulted in any arrival or in the filing of any entry or entry summary or other... arrival, entry or otherwise will be resolved by that office in accordance with the principles and... consideration. (3) Completed NAFTA transactions. A question arising in connection with an entry of merchandise...

19 CFR 181.92 - Definitions and general NAFTA advance ruling practice.

Code of Federal Regulations, 2012 CFR

2012-04-01

... undertaken but has not resulted in any arrival or in the filing of any entry or entry summary or other... arrival, entry or otherwise will be resolved by that office in accordance with the principles and... consideration. (3) Completed NAFTA transactions. A question arising in connection with an entry of merchandise...

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.

The North American Free Trade Agreement (NAFTA) and Mexican Nursing

PubMed Central

2011-01-01

In the context of nurse migration, experts view trade agreements as either vehicles for facilitating migration or as contributing to brain-drain phenomena. Using a case study design, this study explored the effects of the North American Free Trade Agreement (NAFTA) on the development of Mexican nursing. Drawing results from a general thematic analysis of 48 interviews with Mexican nurses and 410 primary and secondary sources, findings show that NAFTA changed the relationship between the State and Mexican nursing. The changed relationship improved the infrastructure capable of producing and monitoring nursing human resources in Mexico. It did not lead to the mass migration of Mexican nurses to the United States and Canada. At the same time, the economic instability provoked by the peso crisis of 1995 slowed the implementation of planned advances. Subsequent neoliberal reforms decreased nurses’ security as workers by minimizing access to full-time positions with benefits, and decreased wages. This article discusses the linkages of these events and the effects on Mexican nurses and the development of the profession. The findings have implications for nursing human resources policy-making and trade in services. PMID:20595330

The North American Free Trade Agreement (NAFTA) and Mexican nursing.

PubMed

Squires, Allison

2011-03-01

In the context of nurse migration, experts view trade agreements as either vehicles for facilitating migration or as contributing to brain-drain phenomena. Using a case study design, this study explored the effects of the North American Free Trade Agreement (NAFTA) on the development of Mexican nursing. Drawing results from a general thematic analysis of 48 interviews with Mexican nurses and 410 primary and secondary sources, findings show that NAFTA changed the relationship between the State and Mexican nursing. The changed relationship improved the infrastructure capable of producing and monitoring nursing human resources in Mexico. It did not lead to the mass migration of Mexican nurses to the United States and Canada. At the same time, the economic instability provoked by the peso crisis of 1995 slowed the implementation of planned advances. Subsequent neoliberal reforms decreased nurses' security as workers by minimizing access to full-time positions with benefits, and decreased wages. This article discusses the linkages of these events and the effects on Mexican nurses and the development of the profession. The findings have implications for nursing human resources policy-making and trade in services.

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.

76 FR 63988 - Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-14

...-0097] Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits AGENCY: Federal Motor... public comment on data and information concerning the Pre-Authorization Safety Audits (PASAs) for two motor carriers that applied to participate in the Agency's long-haul pilot program to test and...

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...

77 FR 65864 - North American Free-Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-31

..., respecting Carbon and Certain Alloy Steel Wire Rod from Canada, NAFTA Secretariat File Number USA-CDA-2008... cases. (Dongbu Steel Co. Ltd. v. United States, 635 F3d 1363 (Fed Cir. 2011); and JTEKT Corp. v. United...

Pharmaceutical patents and some international trade issues: Canada, the United States, and NAFTA.

PubMed

Tancer, R S

1993-01-01

This paper traces the evolution of a more aggressive US policy for the protection of the intellectual property rights of its citizens, individual and corporate, who do business aborad. It focuses on the pharmaceutical industry and, in particular, the harmonization of conflicting US and Canadian policies. In reconciling these policy differences, the United States unilaterally applied relatively new procedures authorized under section 301 and Special 301 of its trade laws. It also utilized the bilateral dispute mechanism mandating cooperation "in the Uruguay Round ... to improve protection of intellectual property," as provided in the Canada-United States Free Trade Agreement. These efforts were successful; Canada amended its patent law in 1993 to conform to current international practices. These changes were incorporated into the North American Free Trade Agreement (NAFTA), making it a state-of-the-art example of the protection of intellectual property rights. The intellectual property chapter of NAFTA will serve as the model for US intellectual property rights negotiations for the foreseeable future.

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.

75 FR 5100 - Agency Information Collection Activities: NAFTA Regulations and Certificate of Origin

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-01

... Activities: NAFTA Regulations and Certificate of Origin AGENCY: U.S. Customs and Border Protection... Origin. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L... Office of Management and Budget (OMB) approval. All comments will become a matter of public record. In...

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...

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.

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 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...

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.

19 CFR 181.98 - Situations in which no NAFTA advance ruling may be issued.

Code of Federal Regulations, 2010 CFR

2010-04-01

... subpart. No advance ruling letter will be issued in regard to a completed transaction. (b) Pending matters... issue the requested advance ruling. In addition, no NAFTA advance ruling letter will be issued with... other court will not preclude the issuance of an advance ruling letter, provided neither Customs nor any...

19 CFR 181.98 - Situations in which no NAFTA advance ruling may be issued.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 19 Customs Duties 2 2013-04-01 2013-04-01 false Situations in which no NAFTA advance ruling may be issued. 181.98 Section 181.98 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND... subpart. No advance ruling letter will be issued in regard to a completed transaction. (b) Pending matters...

19 CFR 181.98 - Situations in which no NAFTA advance ruling may be issued.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 19 Customs Duties 2 2012-04-01 2012-04-01 false Situations in which no NAFTA advance ruling may be issued. 181.98 Section 181.98 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND... subpart. No advance ruling letter will be issued in regard to a completed transaction. (b) Pending matters...

19 CFR 181.98 - Situations in which no NAFTA advance ruling may be issued.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 19 Customs Duties 2 2011-04-01 2011-04-01 false Situations in which no NAFTA advance ruling may be issued. 181.98 Section 181.98 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND... subpart. No advance ruling letter will be issued in regard to a completed transaction. (b) Pending matters...

19 CFR 181.98 - Situations in which no NAFTA advance ruling may be issued.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 19 Customs Duties 2 2014-04-01 2014-04-01 false Situations in which no NAFTA advance ruling may be issued. 181.98 Section 181.98 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND... subpart. No advance ruling letter will be issued in regard to a completed transaction. (b) Pending matters...

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

NAFTA: A Partial Solution Not a Savior to Mexico’s Economic Woes

DTIC Science & Technology

2011-10-28

Mexico .” Economia Mexicana. 15 January 2004. http://www.economiamexicana.cide.edu/num_anteriores/XIV-2/LILIANA_MEZA.pdf (accessed: 28 October 2011... Mexico .” Economia Mexicana. 15 January 2004. http://www.economiamexicana.cide.edu/num_anteriores/XIV-2/LILIANA_MEZA.pdf (accessed: 28 October 2011...Trade Agreement, NAFTA, Mexico Economy, Trade Liberalization 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a

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...

The effects of NAFTA and an FTAA on U.S. exports of hardwood forest products

Treesearch

Jeffrey P. Prestemon

1998-01-01

The North American Free Trade Agreement (NAFTA) took effect on January 1, 1994, beginning what might result in a restructuring of trade in the hemisphere, especially between the United States and Mexico. This restructuring and expected welfare gains are intended outcomes of the kind of freer trade among countries that has been sweeping the hemisphere for at least ten...

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

Mexico's New Braceros: How NAFTA Promotes Child Labor and Truancy in the Onion Fields of Mexicali.

ERIC Educational Resources Information Center

Bacon, David

1997-01-01

Although NAFTA has proven profitable for U.S. growers who have relocated agricultural production to Mexico, it has helped create an economic crisis that has forced thousands of Mexican children to leave school in order to work and supplement their parents' shrinking income. In Mexicali Valley (Baja California), approximately a fourth of the…

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

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...

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.

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

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...

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 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...

"Will the US Take Mexico for Granted Too?": Pointers on Doing Business with Our New NAFTA Neighbor.

ERIC Educational Resources Information Center

Julian, Kerry E.; Peterson, Roger A.

This paper reviews the conduct of United States-based businesses and their executives in foreign countries, and views Americans as ill-prepared to integrate their business with Mexican culture. The economic importance of Mexico is analyzed in view of the North American Free Trade Agreement (NAFTA), and expansion of Japanese and European companies…

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...

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...

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.

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.

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...

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…

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.

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…

Patient perspectives: Tijuana cancer clinics in the post-NAFTA era.

PubMed

Moss, Ralph W

2005-03-01

This article contains observations and historical considerations on cancer and complementary and alternative medicine (CAM) in the Tijuana, Mexico, area. There are approximately 2 dozen such clinics in Tijuana, some of which have been treating international cancer patients since 1963. Among the first clinics to be established were the Bio-Medical Center (Hoxsey therapy), Oasis of Hope (a Laetrile-oriented clinic), and a series of clinics affiliated with the Gerson diet therapy. These original clinics were established mainly by American citizens in response to increased regulation of nonstandard therapies in the United States, particularly after passage of the Kefauver-Harris Amendments to the Food, Drug and Cosmetics Act in 1962. In the 1970s, the Tijuana clinics proliferated with the upsurge of interest in Laetrile (amygdalin). By 1978, 70,000 US cancer patients had taken Laetrile for cancer treatment, and many of those had gone to Tijuana to receive it. The popularity of the Tijuana clinics peaked in the mid-1980s. Although many new clinics opened after then, a dozen have folded in the past 10 years alone. The turning point for the clinics came with passage of the North American Free Trade Agreement (NAFTA), which facilitated greater cooperation among the antifraud authorities of Canada, the United States, and Mexico. In 1994, the tripartite members of NAFTA formed the Mexico-United States-Canada Health Fraud Work Group, or MUCH, whose brief is to strengthen the 3 countries' ability to prevent cross-border health fraud. Under the auspices of MUCH and its members, regulatory crackdowns began in earnest early in 2001. The clinics were also badly affected by the general downturn in travel after 9/11. If these trends continue, many Tijuana clinics are unlikely to survive. Some suggestions are made for how the Tijuana clinics could be reorganized and reformed to minimize the likelihood of governmental actions and to maximize public support. Such reforms center on 5

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...

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.

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

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...

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...

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

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 ...

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...

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...

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...

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...

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.

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...

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…

Integration and consolidation of border freight transportation data for planning applications and characterization of NAFTA truck loads for aiding in transportation infrastructure management : second year.

DOT National Transportation Integrated Search

2008-07-01

Average Daily Truck Traffic (ADTT) increased dramatically in Texas in the 1990s partly because of the : implementation of the North American Free Trade Agreement (NAFTA). Accurate information on truck : volumes and truck characteristics is critical t...

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...

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).

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…

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.

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.

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...

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...

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...

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 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

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...

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.

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...

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

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)

[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...

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.

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

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

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.

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

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.

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.

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...

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.

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."

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.

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

Environmental risk, precaution, and scientific rationality in the context of WTO/NAFTA trade rules.

PubMed

Crawford-Brown, Douglas; Pauwelyn, Joost; Smith, Kelly

2004-04-01

This article considers the role of scientific rationality in understanding statements of risk produced by a scientific community. An argument is advanced that, while scientific rationality does impose constraints on valid scientific justifications for restrictions on products and practices, it also provides flexibility in the judgments needed to both develop and apply characterizations of risk. The implications of this flexibility for the understanding of risk estimates in WTO and NAFTA deliberations are explored, with the goal of finding an intermediate ground between the view that science unambiguously justifies or rejects a policy, and the view that science is yet another cultural tool that can be manipulated in support of any decision. The result is a proposal for a dialogical view of scientific rationality in which risk estimates are depicted as confidence distributions that follow from a structured dialogue of scientific panels focused on judgments of evidence, evidential reasoning, and epistemic analysis.

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...

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...

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...

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.

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

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.

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.

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

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...

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.

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.

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...

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…

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...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

... availability of the draft guidance document entitled ``Factors to Consider When Making Benefit-Risk... versus its probable risk. This draft guidance sets out the factors FDA considers when making this... factors to consider when making benefit-risk determinations in medical device premarket review. It does...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-02

..., choosing a study population, using a control group and blinding, dose selection, treatment plans...] Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular... document entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-05

... electronic or written comments on the draft guidance by April 5, 2011. ADDRESSES: Submit written requests for... INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the..., plasma, and blood. These devices are used to aid in the diagnosis of Lyme disease. This document does not...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-03

... all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationand...),'' from CDRH you may either send an e-mail request to [email protected] to receive an electronic copy of... guidance describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics...

45 CFR 73.735-806 - Documentation and publication of opinions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... and accurate documentation of the formal advice and guidance given. (b) From time to time, the..., deleting, as necessary, any personal identifiers or other information which may give rise to an unwarranted...

45 CFR 73.735-806 - Documentation and publication of opinions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... and accurate documentation of the formal advice and guidance given. (b) From time to time, the..., deleting, as necessary, any personal identifiers or other information which may give rise to an unwarranted...

What guidance is available for researchers conducting overviews of reviews of healthcare interventions? A scoping review and qualitative metasummary.

PubMed

Pollock, Michelle; Fernandes, Ricardo M; Becker, Lorne A; Featherstone, Robin; Hartling, Lisa

2016-11-14

Overviews of reviews (overviews) compile data from multiple systematic reviews to provide a single synthesis of relevant evidence for decision-making. Despite their increasing popularity, there is limited methodological guidance available for researchers wishing to conduct overviews. The objective of this scoping review is to identify and collate all published and unpublished documents containing guidance for conducting overviews examining the efficacy, effectiveness, and/or safety of healthcare interventions. Our aims were to provide a map of existing guidance documents; identify similarities, differences, and gaps in the guidance contained within these documents; and identify common challenges involved in conducting overviews. We conducted an iterative and extensive search to ensure breadth and comprehensiveness of coverage. The search involved reference tracking, database and web searches (MEDLINE, EMBASE, DARE, Scopus, Cochrane Methods Studies Database, Google Scholar), handsearching of websites and conference proceedings, and contacting overview producers. Relevant guidance statements and challenges encountered were extracted, edited, grouped, abstracted, and presented using a qualitative metasummary approach. We identified 52 guidance documents produced by 19 research groups. Relatively consistent guidance was available for the first stages of the overview process (deciding when and why to conduct an overview, specifying the scope, and searching for and including systematic reviews). In contrast, there was limited or conflicting guidance for the latter stages of the overview process (quality assessment of systematic reviews and their primary studies, collecting and analyzing data, and assessing quality of evidence), and many of the challenges identified were also related to these stages. An additional, overarching challenge identified was that overviews are limited by the methods, reporting, and coverage of their included systematic reviews. This compilation

Safeguards-by-Design: Guidance for Independent Spent Fuel Dry Storage Installations (ISFSI)

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

Trond Bjornard; Philip C. Durst

2012-05-01

This document summarizes the requirements and best practices for implementing international nuclear safeguards at independent spent fuel storage installations (ISFSIs), also known as Away-from- Reactor (AFR) storage facilities. These installations may provide wet or dry storage of spent fuel, although the safeguards guidance herein focuses on dry storage facilities. In principle, the safeguards guidance applies to both wet and dry storage. The reason for focusing on dry independent spent fuel storage installations is that this is one of the fastest growing nuclear installations worldwide. Independent spent fuel storage installations are typically outside of the safeguards nuclear material balance area (MBA)more » of the reactor. They may be located on the reactor site, but are generally considered by the International Atomic Energy Agency (IAEA) and the State Regulator/SSAC to be a separate facility. The need for this guidance is becoming increasingly urgent as more and more nuclear power plants move their spent fuel from resident spent fuel ponds to independent spent fuel storage installations. The safeguards requirements and best practices described herein are also relevant to the design and construction of regional independent spent fuel storage installations that nuclear power plant operators are starting to consider in the absence of a national long-term geological spent fuel repository. The following document has been prepared in support of two of the three foundational pillars for implementing Safeguards-by-Design (SBD). These are: i) defining the relevant safeguards requirements, and ii) defining the best practices for meeting the requirements. This document was prepared with the design of the latest independent dry spent fuel storage installations in mind and was prepared specifically as an aid for designers of commercial nuclear facilities to help them understand the relevant international requirements that follow from a country’s safeguards agreement

Response to Request for Guidance Concerning Installation of Nitrogen Oxides Continuous Emissions Monitoring Systems

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 the Appropriate Injunctive Relief for Violations of Major New Source Review Requirements

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 Guidance, 40 CFR 52.21 (b)(2)(d) - Definition of Capable of Accommodating

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.

75 FR 14445 - Guidance for Industry on Submitting a Report for Multiple Facilities to the Reportable Food...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0260] Guidance for Industry on Submitting a Report for Multiple Facilities to the Reportable Food Electronic... Act of 2007.'' The document provides guidance to the industry in complying with the Reportable Food...

Human factors engineering in oil and gas--a review of industry guidance.

PubMed

Robb, Martin; Miller, Gerald

2012-01-01

Oil and gas exploration and production activities are carried out in hazardous environments in many parts of the world. Recent events in the Gulf of Mexico highlight those risks and underline the importance of considering human factors during facility design. Ergonomic factors such as machinery design, facility and accommodation layout and the organization of work activities have been systematically considered over the past twenty years on a limited number of offshore facility design projects to a) minimize the occupational risks to personnel, b) support operations and maintenance tasks and c) improve personnel wellbeing. During this period, several regulators and industry bodies such as the American Bureau of Shipping (ABS), the American Society of Testing and Materials (ASTM), the UK's Health and Safety Executive (HSE), Oil and Gas Producers (OGP), and Norway's Petroleum Safety Authority (PSA) have developed specific HFE design standards and guidance documents for the application of Human Factors Engineering (HFE) to the design and operation of Oil and Gas projects. However, despite the existence of these guidance and recommended design practise documents, and documented proof of their value in enhancing crew safety and efficiency, HFE is still not well understood across the industry and application across projects is inconsistent. This paper summarizes the key Oil and Gas industry bodies' HFE guidance documents, identifies recurring themes and current trends in the use of these standards, provides examples of where and how these HFE standards have been used on past major offshore facility design projects, and suggests criteria for selecting the appropriate HFE strategy and tasks for future major oil and gas projects. It also provides a short history of the application of HFE to the offshore industry, beginning with the use of ASTM F 1166 to a major operator's Deepwater Gulf of Mexico facility in 1990 and the application of HFE to diverse world regions. This

HANDBOOK: GUIDANCE ON SETTING PERMIT CONDITIONS AND REPORTING TRIAL BURN RESULTS

EPA Science Inventory

This Handbook provides guidance for establishing operational conditions for incinerators. he document provides a means for state and local agencies to achieve a level of consistency in setting permit conditions that will result in establishment of more uniform permit conditions n...

Guidance for Human Subjects Research in the National Exposure Research Laboratory

EPA Science Inventory

This document provides guidance to investigators and managers associated with the U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD)’s National Exposure Research Laboratory (NERL) on the ethical conduct, regulatory review, and approval of all huma...

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...

ISS Crew Transportation and Services Requirements Document

NASA Technical Reports Server (NTRS)

Lueders, Kathryn L. (Compiler)

2015-01-01

Under the guidance of processes provided by Crew Transportation Plan (CCT-PLN-1100), this document with its sister documents, Crew Transportation Technical Management Processes (CCT-PLN-1120), Crew Transportation Technical Standards and Design Evaluation Criteria (CCT-STD-1140), and Crew Transportation Operations Standards (CCT-STD-1150), and International Space Station (ISS) to Commercial Orbital Transportation Services Interface Requirements Document (SSP 50808), provides the basis for a National Aeronautics and Space Administration (NASA) certification for services to the ISS for the Commercial Provider. When NASA Crew Transportation System (CTS) certification is achieved for ISS transportation, the Commercial Provider will be eligible to provide services to and from the ISS during the services phase of the NASA Commercial Crew Program (CCP).

Revisions to US EPA Superfund Risk and Dose Assessment Models and Guidance - 13403

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

Walker, Stuart A.

2013-07-01

The U.S. Environmental Protection Agency (EPA) Superfund program's six Preliminary Remediation Goal (PRG) and Dose Compliance Concentration (DCC) internet based calculators for risk and dose assessment at Superfund sites are being revised to reflect better science, revisions to existing exposure scenarios and new scenarios, and changes to match up more closely with the EPA chemical regional screening level calculator. A revised version of the 1999 guidance document that provides an overview for the Superfund risk assessment process at radioactively contaminated sites, 'Radiation Risk Assessment At CERCLA Sites: Q and A', is being completed that will reflect Superfund recommended guidance andmore » other technical documents issued over the past 13 years. EPA is also issuing a series of fact sheets in the document 'Superfund Radiation Risk Assessment: A Community Tool-kit'. This presentation would go over those changes that are expected to be finished by this spring. (authors)« less

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

... the Draft Guidance of Applying Quantitative Data To Develop Data-Derived Extrapolation Factors for.... SUMMARY: EPA is announcing that Eastern Research Group, Inc. (ERG), a contractor to the EPA, will convene an independent panel of experts to review the draft document, ``Guidance for Applying Quantitative...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-20

...-847-8149 to receive a hard copy. Please use the document number (1607). CDRH maintains an entry on the... personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device... capability for all CDRH guidance documents is available at http://www.fda.gov/medicaldevices...

GUIDANCE COUNSELOR INSTITUTE FOR HEALTH CAREERS (JULY 7-22, 1966).

ERIC Educational Resources Information Center

MORGAN, PHILIP W.

THE INSTITUTE, SPONSORED BY A FEDERATED CHARITY REPRESENTING 78 NONPROFIT VOLUNTARY HOSPITALS IN NEW YORK CITY, WAS ATTENDED BY 48 HIGH SCHOOL AND EMPLOYMENT SERVICE COUNSELORS. THE NEED FOR SUCH INSTITUTES WAS DOCUMENTED BY A PRE-INSTITUTE QUESTIONNAIRE TO LICENSED GUIDANCE COUNSELORS. TO EVALUATE THE INSTITUTE, THE PROFESSIONAL EXAMINATION…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-05

...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),'' dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The recommendations in this guidance, when finalized, will supersede those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated August 2007.

Glossary of CERCLA, RCRA and TSCA related terms and acronyms. Environmental Guidance

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

Not Available

1993-10-01

This glossary contains CERCLA, RCRA and TSCA related terms that are most often encountered in the US Department of Energy (DOE) Environmental Restoration and Emergency Preparedness activities. Detailed definitions are included for key terms. The CERCLA definitions included in this glossary are taken from the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), as amended and related federal rulemakings. The RCRA definitions included in this glossary are taken from the Resource Conservation and Recovery Act (RCRA) and related federal rulemakings. The TSCA definitions included in this glossary are taken from the Toxic Substances and Control Act (TSCA) and related federalmore » rulemakings. Definitions related to TSCA are limited to those sections in the statute and regulations concerning PCBs and asbestos.Other sources for definitions include additional federal rulemakings, assorted guidance documents prepared by the US Environmental Protection Agency (EPA), guidance and informational documents prepared by the US Department of Energy (DOE), and DOE Orders. The source of each term is noted beside the term. Terms presented in this document reflect revised and new definitions published before July 1, 1993.« less

Additional Clarification of Guidance for Implementation of the 1-hour NO2 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.

Request for Clarification of EPA Guidance on the Alternative Fuels Exemption under the PSD 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 Concerning the Implementation of the 1-hour NO2 NAAQS for the PSD 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.

Reliability history of the Apollo guidance computer

NASA Technical Reports Server (NTRS)

Hall, E. C.

1972-01-01

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

Patterns for Effectively Documenting Frameworks

NASA Astrophysics Data System (ADS)

Aguiar, Ademar; David, Gabriel

Good design and implementation are necessary but not sufficient pre-requisites for successfully reusing object-oriented frameworks. Although not always recognized, good documentation is crucial for effective framework reuse, and often hard, costly, and tiresome, coming with many issues, especially when we are not aware of the key problems and respective ways of addressing them. Based on existing literature, case studies and lessons learned, the authors have been mining proven solutions to recurrent problems of documenting object-oriented frameworks, and writing them in pattern form, as patterns are a very effective way of communicating expertise and best practices. This paper presents a small set of patterns addressing problems related to the framework documentation itself, here seen as an autonomous and tangible product independent of the process used to create it. The patterns aim at helping non-experts on cost-effectively documenting object-oriented frameworks. In concrete, these patterns provide guidance on choosing the kinds of documents to produce, how to relate them, and which contents to include. Although the focus is more on the documents themselves, rather than on the process and tools to produce them, some guidelines are also presented in the paper to help on applying the patterns to a specific framework.

Opening All Options. Proceedings of the Ohio Middle School and Junior High School Career Guidance Conference (Columbus, Ohio, June 24-26, 1987).

ERIC Educational Resources Information Center

Ohio State Dept. of Education, Columbus.

This document presents the conference proceedings of a career guidance conference which focused attention on the need to develop a comprehensive career guidance program in Ohio middle and junior high schools. Papers include: (1) "Competency-Based Guidance Programs: A Model of the Future" (C. D. Johnson and Sharon Johnson); (2) "How…

Guidance on validation and qualification of processes and operations involving radiopharmaceuticals.

PubMed

Todde, S; Peitl, P Kolenc; Elsinga, P; Koziorowski, J; Ferrari, V; Ocak, E M; Hjelstuen, O; Patt, M; Mindt, T L; Behe, M

2017-01-01

Validation and qualification activities are nowadays an integral part of the day by day routine work in a radiopharmacy. This document is meant as an Appendix of Part B of the EANM "Guidelines on Good Radiopharmacy Practice (GRPP)" issued by the Radiopharmacy Committee of the EANM, covering the qualification and validation aspects related to the small-scale "in house" preparation of radiopharmaceuticals. The aim is to provide more detailed and practice-oriented guidance to those who are involved in the small-scale preparation of radiopharmaceuticals which are not intended for commercial purposes or distribution. The present guideline covers the validation and qualification activities following the well-known "validation chain", that begins with editing the general Validation Master Plan document, includes all the required documentation (e.g. User Requirement Specification, Qualification protocols, etc.), and leads to the qualification of the equipment used in the preparation and quality control of radiopharmaceuticals, until the final step of Process Validation. A specific guidance to the qualification and validation activities specifically addressed to small-scale hospital/academia radiopharmacies is here provided. Additional information, including practical examples, are also available.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes approaches to developing process and drug substance understanding and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The draft 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.

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

EPA Pesticide Factsheets

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

Addressing incontinence for people with dementia living at home: a documentary analysis of local English community nursing service continence policies and clinical guidance.

PubMed

Drennan, Vari M; Norrie, Caroline; Cole, Laura; Donovan, Sheila

2013-02-01

To establish whether the problems and issues experienced by people with dementia living at home and their carers were addressed in the clinical guidance for continence management for community nursing services in England. Internationally, the numbers of people with dementia are rising. Managing incontinence is a significant issue as the presence of incontinence is one of the triggers for people with dementia to move their residence to a care home. People with dementia living at home and their family carers report difficulties in accessing knowledgeable professionals and acceptable continence products. A review by documentary analysis of clinical policies and guidance from a sample of community nursing services in all Strategic Health Authority regions of England. A sample of clinical policy and guidance documents for continence assessment and management from up to four community nursing services in each of the ten Strategic Health Authority regions in England was sought. Documentary analysis was undertaken on the relevance of the documents identified for people with dementia living at home. Ninety-eight documents from 38 local community nursing services spread across ten Strategic Health Authority areas were obtained and analysed. Only in the documents of three services were nurses offered detailed guidance about the management of incontinence for people with dementia at home. In the documentation of only one service were people with dementia identified as a special case which warranted the provision of additional continence products. Clinical guidance on continence assessment and management for community nurses in many parts of England does not address the specific needs of people with dementia living at home or their carers. Nurses working in community settings and those providing clinical leadership in continence care should review their clinical guidance and policies to ensure relevance for people with dementia living at home and their family carers. © 2012

Communication Services and Supports for Individuals With Severe Disabilities: Guidance for Assessment and Intervention.

PubMed

Brady, Nancy C; Bruce, Susan; Goldman, Amy; Erickson, Karen; Mineo, Beth; Ogletree, Bill T; Paul, Diane; Romski, Mary Ann; Sevcik, Rose; Siegel, Ellin; Schoonover, Judith; Snell, Marti; Sylvester, Lorraine; Wilkinson, Krista

2016-03-01

The National Joint Committee for the Communication Needs of People With Severe Disabilities (NJC) reviewed literature regarding practices for people with severe disabilities in order to update guidance provided in documents originally published in 1992. Changes in laws, definitions, and policies that affect communication attainments by persons with severe disabilities are presented, along with guidance regarding assessment and intervention practices. A revised version of the Communication Bill of Rights, a powerful document that describes the communication rights of all individuals, including those with severe disabilities is included in this article. The information contained within this article is intended to be used by professionals, family members, and individuals with severe disabilities to inform and advocate for effective communication services and opportunities.

Communication Services and Supports for Individuals with Severe Disabilities: Guidance for Assessment and Intervention

PubMed Central

Brady, Nancy C.; Bruce, Susan; Goldman, Amy; Erickson, Karen; Mineo, Beth; Ogletree, Bill T.; Paul, Diane; Romski, Mary Ann; Sevcik, Rose; Siegel, Ellin; Schoonover, Judith; Snell, Marti; Sylvester, Lorraine; Wilkinson, Krista

2015-01-01

The National Joint Committee for the Communication Needs of People with Severe Disabilities (NJC) reviewed literature regarding practices for people with severe disabilities in order to update guidance provided in documents originally published in 1992. Changes in laws, definitions, and policies that affect communication attainments by persons with severe disabilities are presented, along with guidance regarding assessment and intervention practices. A revised version of the Communication Bill of Rights, a powerful document that describes the communication rights of all individuals, including those with severe disabilities is included in this article. The information contained within this article is intended to be used by professionals, family members, and individuals with severe disabilities to inform and advocate for effective communication services and opportunities. PMID:26914467

Rural Career Guidance: Abstracts of Current Research, Materials, and Practices.

ERIC Educational Resources Information Center

Far West Lab. for Educational Research and Development, San Francisco, CA.

The annotated bibliography provides a guide to the latest resource material, research findings, and/or developments in rural career guidance found in the ERIC system. Section I contains 158 citations and abstracts which have appeared in "Resources in Education" (RIE). RIE document resumes include the ERIC accession number, author(s), title,…

USDOT guidance for connected vehicle deployments : institutional and business models and financial sustainability.

DOT National Transportation Integrated Search

2016-07-01

This document provides guidance material in regards to Institutional and Business issues as well as Financial Sustainability for the CV Pilots Deployment Concept Development Phase. This material also provides part of the foundation for the Performanc...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-29

... office in processing your request, or fax your request to CDRH to 301-847-8149. See the SUPPLEMENTARY... guidance you are requesting. A search capability for all CDRH guidance documents is available at http://www... Response Responses Response Total Hours CDRH 110 1 110 12 1,320 CBER 4 1 4 12 48 Total 1,368 \\1\\ There are...

Vocational Guidance and Counselling for Young People and Adults in the European Community. Findings of a Conference (Berlin, West Germany, December 7-8, 1989).

ERIC Educational Resources Information Center

de Vries, Heinz J., Ed.

1990-01-01

This document reports on a conference centered around three topics: vocational guidance in the Member States of the European Community (EC), the "Europeanization" of vocational guidance, and approaches to cross-frontier vocational guidance. Among the recommendations of the conference participants are the following: the tasks of…

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

EPA Science Inventory

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

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

NASA Technical Reports Server (NTRS)

1973-01-01

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

Sampling and Analysis Plan - Guidance and Template v.4 - General Projects - 04/2014

EPA Pesticide Factsheets

This Sampling and Analysis Plan (SAP) guidance and template is intended to assist organizations in documenting the procedural and analytical requirements for one-time, or time-limited, projects involving the collection of water, soil, sediment, or other

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-25

... is requesting public comment on draft NUREG-1556, Volume 4, Revision 1, ``Consolidated Guidance About... sensitive information, and changes in regulatory policies and practices. This document is intended for use...-415- 4737, or by email to [email protected] . The draft NUREG-1556, Volume 4, Revision 1, is...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

... 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics... applicable to all devices reviewed through the 510(k) notification process in CDRH and CBER and have been... draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is...

77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-17

... Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver... request, or fax your request to CDRH at 301-847-8149. The draft guidance may also be obtained by mail by... using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda...

Transportation Equity Act for the 21st Century (TEA-21) Guidance (Federal Highway Administration)

EPA Pesticide Factsheets

This document from July 11, 2003 provides interagency guidance on applying the preference for wetlands mitigation banking mandated in TEA-21 to compensatory mitigation requirements under Section 404 of the Clean Water Act (CWA).

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

PubMed Central

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

2005-01-01

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

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

PubMed

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

2005-09-05

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

... document describes FDA's recommendations concerning 510(k) submissions for various types of in vitro.... SUPPLEMENTARY INFORMATION: I. Background This draft guidance includes recommendations concerning 510(k...

Final Documentation: Incident Management And Probabilities Courses of action Tool (IMPACT).

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

Edwards, Donna M.; Ray, Jaideep; Tucker, Mark D.

This report pulls together the documentation produced for the IMPACT tool, a software-based decision support tool that provides situational awareness, incident characterization, and guidance on public health and environmental response strategies for an unfolding bio-terrorism incident.

EMP Attachment 3 DOE-SC PNNL Site Dose Assessment Guidance

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

Snyder, Sandra F.

2011-12-21

This Dose Assessment Guidance (DAG) describes methods to use to determine the Maximally-Exposed Individual (MEI) location and to estimate dose impact to that individual under the U.S. Department of Energy Office of Science (DOE-SC) Pacific Northwest National Laboratory (PNNL) Site Environmental Monitoring Plan (EMP). This guidance applies to public dose from radioactive material releases to the air from PNNL Site operations. This document is an attachment to the Pacific Northwest National Laboratory (PNNL) Environmental Monitoring Plan (EMP) and describes dose assessment guidance for radiological air emissions. The impact of radiological air emissions from the U.S. Department of Energy Office ofmore » Science (DOE-SC) PNNL Site is indicated by dose estimates to a maximally exposed member of the public, referred to as the maximally exposed individual (MEI). Reporting requirements associated with dose to members of the public from radiological air emissions are in 40 CFR Part 61.94, WAC 246-247-080, and DOE Order 458.1. The DOE Order and state standards for dose from radioactive air emissions are consistent with U.S. Environmental Protection Agency (EPA) dose standards in 40 CFR 61.92 (i.e., 10 mrem/yr to a MEI). Despite the fact that the current Contract Requirements Document (CRD) for the DOE-SC PNNL Site operations does not include the requirement to meet DOE CRD 458.1, paragraph 2.b, public dose limits, the DOE dose limits would be met when EPA limits are met.« less

Public health economics: a systematic review of guidance for the economic evaluation of public health interventions and discussion of key methodological issues.

PubMed

Edwards, Rhiannon Tudor; Charles, Joanna Mary; Lloyd-Williams, Huw

2013-10-24

If Public Health is the science and art of how society collectively aims to improve health, and reduce inequalities in health, then Public Health Economics is the science and art of supporting decision making as to how society can use its available resources to best meet these objectives and minimise opportunity cost. A systematic review of published guidance for the economic evaluation of public health interventions within this broad public policy paradigm was conducted. Electronic databases and organisation websites were searched using a 22 year time horizon (1990-2012). References of papers were hand searched for additional papers for inclusion. Government reports or peer-reviewed published papers were included if they; referred to the methods of economic evaluation of public health interventions, identified key challenges of conducting economic evaluations of public health interventions or made recommendations for conducting economic evaluations of public health interventions. Guidance was divided into three categories UK guidance, international guidance and observations or guidance provided by individual commentators in the field of public health economics. An assessment of the theoretical frameworks underpinning the guidance was made and served as a rationale for categorising the papers. We identified 5 international guidance documents, 7 UK guidance documents and 4 documents by individual commentators. The papers reviewed identify the main methodological challenges that face analysts when conducting such evaluations. There is a consensus within the guidance that wider social and environmental costs and benefits should be looked at due to the complex nature of public health. This was reflected in the theoretical underpinning as the majority of guidance was categorised as extra-welfarist. In this novel review we argue that health economics may have come full circle from its roots in broad public policy economics. We may find it useful to think in this broader

Guidance for implementing the long-term surveillance program for UMTRA Project Title I Disposal Sites

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

NONE

1996-02-01

This guidance document has two purposes: it provides guidance for writing site-specific long-term surveillance plans (LTSP) and it describes site surveillance, monitoring, and long-term care techniques for Title I disposal sites of the Uranium Mill Tailings Radiation Control Act (UMTRCA) (42 USC Section 7901 et seq.). Long-term care includes monitoring, maintenance, and emergency measures needed to protect public health and safety and the environment after remedial action is completed. This document applies to the UMTRCA-designated Title I disposal sites. The requirements for long-term care of the Title I sites and the contents of the LTSPs are provided in U.S. Nuclearmore » Regulatory Commission (NRC) regulations (10 CFR Section 40.27) provided in Attachment 1.« less

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.

USDOT guidance summary for connected vehicle pilot site deployments: security operational concept : final report.

DOT National Transportation Integrated Search

2016-07-01

This document provides guidance material in regards to security for the CV Pilots Deployment Concept Development Phase. An approach for developing the security operational concept is presented based on identifying the impacts of security breaches reg...

New Source Review (NSR) Program Supplemental Transitional Guidance on Applicability of New Part D NSR Permit Requirements

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 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 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 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 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.

Interim Guidance on New Source Review (NSR) Questions Raised in Letters Dated September 9 and 24, 1992.

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.

Co-operation of employers in the area of personal monitoring: a commentary on BIR guidance on the UK regulatory situation.

PubMed

Rogers, Andy

2017-11-01

The requirement for organizations to co-operate regarding doses to staff who work across organizational boundaries is well established. However, in the field of personal dosimetry there is little guidance as to how to actually achieve legal compliance. Following improvement action in the UK by the regulator, The Health & Safety Executive, a guidance document was developed by the leading professional bodies in this area. This guidance was also commented on by the Health & Safety Executive Specialist Inspectorate (Radiation) enabling the published guidance to represent a compliant standard. This commentary describes the guidance and discusses the issues involved with developing systems for compliance in this area.

Selecting a Clinical Intervention Documentation System for an Academic Setting

PubMed Central

Andrus, Miranda; Hester, E. Kelly; Byrd, Debbie C.

2011-01-01

Pharmacists' clinical interventions have been the subject of a substantial body of literature that focuses on the process and outcomes of establishing an intervention documentation program within the acute care setting. Few reports describe intervention documentation as a component of doctor of pharmacy (PharmD) programs; none describe the process of selecting an intervention documentation application to support the complete array of pharmacy practice and experiential sites. The process that a school of pharmacy followed to select and implement a school-wide intervention system to document the clinical and financial impact of an experiential program is described. Goals included finding a tool that allowed documentation from all experiential sites and the ability to assign dollar savings (hard and soft) to all documented interventions. The paper provides guidance for other colleges and schools of pharmacy in selecting a clinical intervention documentation system for program-wide use. PMID:21519426

Selecting a clinical intervention documentation system for an academic setting.

PubMed

Fox, Brent I; Andrus, Miranda; Hester, E Kelly; Byrd, Debbie C

2011-03-10

Pharmacists' clinical interventions have been the subject of a substantial body of literature that focuses on the process and outcomes of establishing an intervention documentation program within the acute care setting. Few reports describe intervention documentation as a component of doctor of pharmacy (PharmD) programs; none describe the process of selecting an intervention documentation application to support the complete array of pharmacy practice and experiential sites. The process that a school of pharmacy followed to select and implement a school-wide intervention system to document the clinical and financial impact of an experiential program is described. Goals included finding a tool that allowed documentation from all experiential sites and the ability to assign dollar savings (hard and soft) to all documented interventions. The paper provides guidance for other colleges and schools of pharmacy in selecting a clinical intervention documentation system for program-wide use.

75 FR 13766 - Guidance for Industry on the Content and Format of the Dosage and Administration Section of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-23

...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is one of a series of guidance documents intended to assist applicants in drafting prescription drug labeling in which prescribing information is clear and accessible and in complying with the requirements in the final rule on the content and format of labeling for prescription drug and biological products. This guidance is intended to help applicants select information for inclusion in the ``Dosage and Administration'' section of labeling and to help them organize that information.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-20

..., adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and... documents in a digital format, which FDA strongly encourages in order to improve the management and...

36 CFR 1225.3 - What standards are used as guidance for this part?

Code of Federal Regulations, 2010 CFR

2010-07-01

... retain records), 9.10 (Documenting records management processes), 10 (Records management processes and... RECORDS ADMINISTRATION RECORDS MANAGEMENT SCHEDULING RECORDS § 1225.3 What standards are used as guidance... documentation—Records management. Paragraphs 4 (Benefits of records management), 6.3 (Responsibilities), 7.1...

Guidance on Cumulative Risk Assessment of Pesticide Chemicals that have a Common Mechanism of Toxicity

EPA Pesticide Factsheets

This document provides guidance to OPP scientists for evaluating and estimating the potential human risks associated with such multichemical and multipathway exposures to pesticides. This process is referred to as cumulative risk assessment.

75 FR 14602 - Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-26

... and 25, 2010, to discuss and debate issues contained in the published guidance document. The purpose... specific debate and discussion some controversial issues such as: Whether indications of cholestasis...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... and Radiological Health (CDRH) guidance documents is available at http://www.fda.gov/MedicalDevices... ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' from CDRH you may...

Applicability of the May 16, 1995 Memorandum Potential to Emit for MACT Standards - Guidance on Timing Issues for Subpart T Sources Who Become Non-major after the Compliance Date of the Standard

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 13629 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-14

...] Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information--Fermentation-Derived... Controls (CMC) Information-- Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products... documentation to submit to support the CMC information for fermentation-derived intermediates, drug substances...

NRC ARDC Guidance Support Status Report

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

Holbrook, Mark R.

This report provides a summary that reflects the progress and status of proposed regulatory design criteria for advanced non-light water reactor (LWR) designs in accordance with the Level 3 milestone M3AT-17IN2001013 in work package AT-17IN200101. These criteria have been designated as advanced reactor design criteria (ARDC) and they provide guidance to future applicants for addressing the general design criteria (GDC) that are currently applied specifically to LWR designs. This report provides a summary of Phase 2 activities related to the various tasks associated with ARDC development and the subsequent development of ARDC regulatory guidance for sodium fast reactor (SFR) andmore » modular high-temperature gas-cooled reactor (HTGR) designs. Status Report Organization: Section 2 discusses the origin of the GDC and their application to LWRs. Section 3 addresses the objective of this initiative and how it benefits the advanced non-LWR reactor vendors. Section 4 discusses the scope and structure of the initiative. Section 5 provides background on the U.S. Department of Energy (DOE) ARDC team’s original development of the proposed ARDC that were submitted to the NRC for consideration. Section 6 provides a summary of recent ARDC Phase 2 activities. Appendices A through E document the DOE ARDC team’s public comments on various sections of the NRC’s draft regulatory guide DG–1330, “Guidance for Developing Principal Design Criteria for Non-Light Water Reactors.”« less

GUIDANCE ON SELECTING AGE GROUPS FOR MONITORING AND ASSESSING CHILDHOOD EXPOSURES TO ENVIRONMENTAL CONTAMINANTS

EPA Science Inventory

This guidance document provides a set of early-lifestage age groups for Environmental Protection Agency scientists to consider when assessing children’s exposure to environmental contaminants and the resultant potential dose. These recommended age groups are based on current und...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

...] Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and... Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent... abbreviated donor history questionnaire and accompanying materials (aDHQ documents), version 1.3 dated August...

78 FR 26785 - Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-08

...] Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and... Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of... history questionnaire and accompanying materials (aDHQ documents), version 1.3 dated December 2012...

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 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 69634 - International Conference on Harmonisation; Guidance on Q11 Development and Manufacture of Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-20

... Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to... sections of the CTD. A summary of changes includes the following: (1) Revisions to the introduction and...

Technical Support Document: 50% Energy Savings Design Technology Packages for Highway Lodging Buildings

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

Jiang, Wei; Gowri, Krishnan; Lane, Michael D.

2009-09-28

This Technical Support Document (TSD) describes the process, methodology and assumptions for development of the 50% Energy Savings Design Technology Packages for Highway Lodging Buildings, a design guidance document intended to provide recommendations for achieving 50% energy savings in highway lodging properties over the energy-efficiency levels contained in ANSI/ASHRAE/IESNA Standard 90.1-2004, Energy Standard for Buildings Except Low-Rise Residential Buildings.

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

EPA Science Inventory

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

Public health economics: a systematic review of guidance for the economic evaluation of public health interventions and discussion of key methodological issues

PubMed Central

2013-01-01

Background If Public Health is the science and art of how society collectively aims to improve health, and reduce inequalities in health, then Public Health Economics is the science and art of supporting decision making as to how society can use its available resources to best meet these objectives and minimise opportunity cost. A systematic review of published guidance for the economic evaluation of public health interventions within this broad public policy paradigm was conducted. Methods Electronic databases and organisation websites were searched using a 22 year time horizon (1990–2012). References of papers were hand searched for additional papers for inclusion. Government reports or peer-reviewed published papers were included if they; referred to the methods of economic evaluation of public health interventions, identified key challenges of conducting economic evaluations of public health interventions or made recommendations for conducting economic evaluations of public health interventions. Guidance was divided into three categories UK guidance, international guidance and observations or guidance provided by individual commentators in the field of public health economics. An assessment of the theoretical frameworks underpinning the guidance was made and served as a rationale for categorising the papers. Results We identified 5 international guidance documents, 7 UK guidance documents and 4 documents by individual commentators. The papers reviewed identify the main methodological challenges that face analysts when conducting such evaluations. There is a consensus within the guidance that wider social and environmental costs and benefits should be looked at due to the complex nature of public health. This was reflected in the theoretical underpinning as the majority of guidance was categorised as extra-welfarist. Conclusions In this novel review we argue that health economics may have come full circle from its roots in broad public policy economics. We may

Higher Education's Responsiveness in Mexico and the United States to a New Economy and the Impacts of NAFTA. "Understanding the Differences": A Working Paper Series on Higher Education in the U.S. and Mexico. Working Paper Number 4.

ERIC Educational Resources Information Center

Santillanez, Elizabeth J.

This working paper discusses the critical role that higher education in the United States and Mexico must play since the implementation of the North American Free Trade Agreement (NAFTA). The paper gives an overview of recent transformations in areas of economic development and business needs which require that higher education better prepare…

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

ERIC Educational Resources Information Center

Roberts, Tommy L.; And Others

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

Human Systems Integration: Unmanned Aircraft Control Station Certification Plan Guidance

NASA Technical Reports Server (NTRS)

2005-01-01

This document provides guidance to the FAA on important human factors considerations that can be used to support the certification of a UAS Aircraft Control Station (ACS). This document provides a synopsis of the human factors analysis, design and test activities to be performed to provide a basis for FAA certification. The data from these analyses, design activities, and tests, along with data from certification/qualification tests of other key components should be used to establish the ACS certification basis. It is expected that this information will be useful to manufacturers in developing the ACS Certification Plan,, and in supporting the design of their ACS.

Guidance for 1-Hour Sulfur Dioxide (SO2) Nonattainment Area State Implementation Plans (SIP) Submissions

EPA Pesticide Factsheets

The document is intended to provide guidance and recommendations to state, local and tribal governments for the development of SIPs and tribal implementation plans (TIPs) under the 2010 1-hour primary NAAQS for Sulfur Dioxide (SO2).

Age-related references in national public health, technology appraisal and clinical guidelines and guidance: documentary analysis.

PubMed

Forrest, Lynne F; Adams, Jean; Ben-Shlomo, Yoav; Buckner, Stefanie; Payne, Nick; Rimmer, Melanie; Salway, Sarah; Sowden, Sarah; Walters, Kate; White, Martin

2017-05-01

older people may be less likely to receive interventions than younger people. Age bias in national guidance may influence entire public health and health care systems. We examined how English National Institute for Health & Care Excellence (NICE) guidance and guidelines consider age. we undertook a documentary analysis of NICE public health (n = 33) and clinical (n = 114) guidelines and technology appraisals (n = 212). We systematically searched for age-related terms, and conducted thematic analysis of the paragraphs in which these occurred ('age-extracts'). Quantitative analysis explored frequency of age-extracts between and within document types. Illustrative quotes were used to elaborate and explain quantitative findings. 2,314 age-extracts were identified within three themes: age documented as an a-priori consideration at scope-setting (518 age-extracts, 22.4%); documentation of differential effectiveness, cost-effectiveness or other outcomes by age (937 age-extracts, 40.5%); and documentation of age-specific recommendations (859 age-extracts, 37.1%). Public health guidelines considered age most comprehensively. There were clear examples of older-age being considered in both evidence searching and in making recommendations, suggesting that this can be achieved within current processes. we found inconsistencies in how age is considered in NICE guidance and guidelines. More effort may be required to ensure age is consistently considered. Future NICE committees should search for and document evidence of age-related differences in receipt of interventions. Where evidence relating to effectiveness and cost-effectiveness in older populations is available, more explicit age-related recommendations should be made. Where there is a lack of evidence, it should be stated what new research is needed. © The Author 2016. Published by Oxford University Press on behalf of the British Geriatrics Society.

78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-07

... assessment. In some cases, a PMA may include multiple studies designed to answer different scientific... designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles...

Guidance documents: Continued support to improve operations of fish hatcheries and field sites to reduce the impact or prevent establishment of New Zealand Mudsnails and other invasive mollusks

USGS Publications Warehouse

Moffitt, Christine M.

2017-01-01

This project tested and revised a risk assessment/management tool authored by Moffitt and Stockton designed to provide hatchery biologists and others a structure to measure risk and provide tools to control, prevent or eliminate invasive New Zealand mudsnails (NZMS) and other invasive mollusks in fish hatcheries and hatchery operations. The document has two parts: the risk assessment tool, and an appendix that summarizes options for control or management.The framework of the guidance document for risk assessment/hatchery tool combines approaches used by the Hazard Analysis and Critical Control Points (HACCP) process with those developed by the Commission for Environmental Cooperation (CEC), of Canada, Mexico, and the United States, in the Tri-National Risk Assessment Guidelines for Aquatic Alien Invasive Species. The framework approach for this attached first document assesses risk potential with two activities: probability of infestation and consequences of infestation. Each activity is treated equally to determine the risk potential. These two activities are divided into seven basic elements that utilize scientific, technical, and other relevant information in the process of the risk assessment. To determine the probability of infestation four steps are used that have scores reported or determined and averaged. This assessment follows a familiar HACCP process to assess pathways of entry, entry potential, colonization potential, spread potential. The economic, environmental and social consequences are considered as economic impact, environmental impact, and social and cultural influences.To test this document, the Principal Investigator worked to identify interested hatchery managers through contacts at regional aquaculture meetings, fish health meetings, and through the network of invasive species managers and scientists participating in the Western Regional Panel on Aquatic Nuisance Species and the 100th Meridian Initiative's Columbia River Basin Team, and the

Federal Transit Administration's noise and vibration Guidance Manual: Updates after 10 years of experience

NASA Astrophysics Data System (ADS)

Hanson, Carl E.

2005-09-01

In April 1995, the Federal Transit Administration of the U.S. Department of Transportation issued its guidance manual, ``Transit Noise and Vibration Impact Assessment.'' The manual was written to provide direction for the preparation of noise and vibration sections of environmental documents for public transportation projects in the interest of promoting quality and uniformity in assessments. In the 10 years since its release, the guidance manual has been used as the basis of noise and vibration assessments in over 80 environmental documents and has been used worldwide as a standard method for performing transit noise analyses. An updated version has recently been prepared that takes account of improvements in tools, changes in the environmental assessment procedures, modifications of impact criteria, and experience with mitigation measures. These factors, and other background information, will be discussed to provide insight regarding the revisions in the new edition.

Project C.H.A.N.G.E.: Concepts of Handicaps and Attitudes Need Guidance and Education. Media Assessment List.

ERIC Educational Resources Information Center

Smith, M. Sherry; And Others

The document contains a compilation of materials recommended for use in Project CHANGE (Concepts of Handicaps and Attitudes Need Guidance and Education), a comprehensive curriculum designed to improve children's attitudes toward the disabled. The major portion of the document consists of forms describing required and supplemental student materials…

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

PubMed

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

2016-08-01

In 2009 the first European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guideline for diagnosing Clostridium difficile infection (CDI) was launched. Since then newer tests for diagnosing CDI have become available, especially nucleic acid amplification tests. The main objectives of this update of the guidance document are to summarize the currently available evidence concerning laboratory diagnosis of CDI and to formulate and revise recommendations to optimize CDI testing. This update is essential to improve the diagnosis of CDI and to improve uniformity in CDI diagnosis for surveillance purposes among Europe. An electronic search for literature concerning the laboratory diagnosis of CDI was performed. Studies evaluating a commercial laboratory test compared to a reference test were also included in a meta-analysis. The commercial tests that were evaluated included enzyme immunoassays (EIAs) detecting glutamate dehydrogenase, EIAs detecting toxins A and B and nucleic acid amplification tests. Recommendations were formulated by an executive committee, and the strength of recommendations and quality of evidence were graded using the Grades of Recommendation Assessment, Development and Evaluation (GRADE) system. No single commercial test can be used as a stand-alone test for diagnosing CDI as a result of inadequate positive predictive values at low CDI prevalence. Therefore, the use of a two-step algorithm is recommended. Samples without free toxin detected by toxins A and B EIA but with positive glutamate dehydrogenase EIA, nucleic acid amplification test or toxigenic culture results need clinical evaluation to discern CDI from asymptomatic carriage. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-05

... Methicillin-Resistant Staphylococcus aureus and Staphylococcus aureus; Availability AGENCY: Food and Drug...-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA).'' The draft guidance document... and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus...

Response to Request for Guidance on PSD Definition Referencing Cogeneration Gas Turbines that are Separated by One-Half Mile

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 Determining Applicability of New Major Source Regulations in the Granting of Construction Permits to Sources of Air 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.

Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry.

PubMed

Siegfried, Elaine C; Jaworski, Jennifer C; Eichenfield, Lawrence F; Paller, Amy; Hebert, Adelaide A; Simpson, Eric L; Altman, Emily; Arena, Charles; Blauvelt, Andrew; Block, Julie; Boguniewicz, Mark; Chen, Suephy; Cordoro, Kelly; Hanna, Diane; Horii, Kimberly; Hultsch, Thomas; Lee, James; Leung, Donald Y; Lio, Peter; Milner, Joshua; Omachi, Theodore; Schneider, Christine; Schneider, Lynda; Sidbury, Robert; Smith, Timothy; Sugarman, Jeffrey; Taha, Sharif; Tofte, Susan; Tollefson, Megha; Tom, Wynnis L; West, Dennis P; Whitney, Lucinda; Zane, Lee

2018-05-01

Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for "the Agency's current thinking on a particular subject." Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices). © 2018 Wiley Periodicals, Inc.

Guidance for Considering and Using Open Literature Toxicity Studies to Support Human Health Risk Assessment

EPA Pesticide Factsheets

This guidance was developed to assist OPP scientists and is intended for use in OPP’s risk assessments. It is intended to ensure consistent consideration, use, and documentation of information in the open literature by OPP scientists and risk assessors.

Development of comprehensive guidance on obtaining service consumed data for NTD : final report, January 2009.

DOT National Transportation Integrated Search