41 CFR 102-117.325 - May my agency appear on its own behalf before a transportation regulatory body proceeding?

Code of Federal Regulations, 2010 CFR

2010-07-01

... its own behalf before a transportation regulatory body proceeding? 102-117.325 Section 102-117.325... Regulatory Body Proceedings § 102-117.325 May my agency appear on its own behalf before a transportation regulatory body proceeding? Generally, no executive agency may appear on its own behalf in any proceeding...

76 FR 60020 - Agency Information Collection Activities: Proposed Collection; Comment Request; Ambient Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-28

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2002-0091, FRL-9472-8] Agency Information Collection Activities: Proposed Collection; Comment Request; Ambient Air Quality Surveillance AGENCY: Environmental... . Fax: (202) 566-1741. Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC), Air and...

Inspector General, DoD, Oversight of the Air Force Audit Agency Audit of the FY 1996 Air Force Consolidated Financial Statements.

DTIC Science & Technology

1997-04-10

financial statements . We delegated the audit of the FY 1996 Air Force consolidated financial statements to the Air Force Audit Agency on May 17, 1996...This report provides our endorsement of the Air Force Audit Agency disclaimer of opinion on the Air Force consolidated financial statements for FY...1996, along with the Air Force Audit Agency Report of Audit, ’Opinion on Fiscal Year 1996 Air Force Consolidated Financial Statements .’

77 FR 12898 - Self-Regulatory Organizations; Midwest Securities Trust Company; Order Cancelling Clearing Agency...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-02

... the event any self-regulatory organization is no longer in existence or has ceased to do business in... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66461; File No. 600-7] Self-Regulatory Organizations; Midwest Securities Trust Company; Order Cancelling Clearing Agency Registration February 24, 2012...

Impacts of Climate Policy on Regional Air Quality, Health, and Air Quality Regulatory Procedures

NASA Astrophysics Data System (ADS)

Thompson, T. M.; Selin, N. E.

2011-12-01

Both the changing climate, and the policy implemented to address climate change can impact regional air quality. We evaluate the impacts of potential selected climate policies on modeled regional air quality with respect to national pollution standards, human health and the sensitivity of health uncertainty ranges. To assess changes in air quality due to climate policy, we couple output from a regional computable general equilibrium economic model (the US Regional Energy Policy [USREP] model), with a regional air quality model (the Comprehensive Air Quality Model with Extensions [CAMx]). USREP uses economic variables to determine how potential future U.S. climate policy would change emissions of regional pollutants (CO, VOC, NOx, SO2, NH3, black carbon, and organic carbon) from ten emissions-heavy sectors of the economy (electricity, coal, gas, crude oil, refined oil, energy intensive industry, other industry, service, agriculture, and transportation [light duty and heavy duty]). Changes in emissions are then modeled using CAMx to determine the impact on air quality in several cities in the Northeast US. We first calculate the impact of climate policy by using regulatory procedures used to show attainment with National Ambient Air Quality Standards (NAAQS) for ozone and particulate matter. Building on previous work, we compare those results with the calculated results and uncertainties associated with human health impacts due to climate policy. This work addresses a potential disconnect between NAAQS regulatory procedures and the cost/benefit analysis required for and by the Clean Air Act.

Re-evaluation of Non-regulatory Asbestos Group Minerals for Regulatory Agencies

NASA Astrophysics Data System (ADS)

Dogan, M.; Dogan, A.

2013-05-01

Agencies should oversea "positive" identification guidelines followed closely for non-regulatory asbestos group minerals.

78 FR 12052 - Agency Information Collection Activities: Proposed Collection; Comment Request; Ambient Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... pollution control agencies, and tribal entities which collect and report ambient air quality data for the..., documenting episodes and initiating episode controls, air quality trends assessment, and air pollution.... Although the state and local air pollution control agencies and tribal entities are responsible for the...

Air toxics regulatory issues facing urban settings.

PubMed Central

Olden, K; Guthrie, J

1996-01-01

Biomarker research does not exist in isolation. Its usefulness can only be realized when it is translated into prevention strategies to protect public health. In the context of air toxics, these prevention strategies begin with the development of regulatory standards derived from risk assessment schemes. The Clean Air Act Amendments of 1990 list 189 air toxics, including many volatile organics, metals, and pesticides. The National Institute of Environmental Health Sciences (NIEHS), through its affiliation with the National Toxicology Program, has generated toxicity and carcinogenicity data on more than 100 of these air toxics. The NIEHS extramural and intramural research portfolios support a variety of projects that develop and validate biomarkers for use in environmental health science and risk assessment. Biomarkers have a tremendous potential in the areas of regulating air toxics and protecting public health. Risk assessors need data provided by biomarkers of exposure, biomarkers of dose/pharmacokinetics, biomarkers of susceptibility or individual variability, and biomarkers of effects. The greatest benefit would be realized if biomarkers could be employed in four areas of primary and secondary prevention. The first is the use of biomarkers to enhance extrapolation of animal data to human exposure situations in establishing risk standards. The second is the use of biomarkers that assess noncancer, as well as cancer, end points. Important health end points include pulmonary dysfunction, immunotoxicity, and neurotoxicity. Third, biomarkers that serve as early waming signs to detect intermediate effects would enhance our ability to design timely and cost-effective intervention strategies. Finally, biomarkers used to evaluate the effectiveness of intervention strategies, both in clinical and regulatory settings, would enable us to ensure that programs designed to protect public health do, in fact, achieve the desired outcome. PMID:8933026

Regulatory Enforcement and Fiscal Impact in Local Health Agencies

PubMed Central

Rabarison, Kristina M.; Rabarison, Monika K.

2015-01-01

Objectives. We used a cross-sectional, retrospective study design to analyze the association between local health agency regulatory activities and revenues from nonclinical fees and fines (NFF). Methods. We extracted data from the 2010 National Association of County and City Health Officials (NACCHO) Profile Survey, the most recent report including NFF information, and used 2-part multivariable regression models to identify relationships between regulatory activities and revenue. We also interviewed LHD directors on access to revenue from fines. Results. NFFs generated substantial revenue for most LHDs, increasing in scope and amount with jurisdiction size for all but the largest municipalities. The greatest proportion of net revenue came from public pools, campgrounds and recreational vehicles, and solid waste disposal. For small and mid-sized LHDs, enforcement activities generated revenue in a dose–response pattern, with higher returns for increased activities. LHDs in decentralized governance states collected more NFF revenue than those in centralized states. States vary regarding LHD access to revenue from sanctions. Conclusions. The fiscal impact of changes in regulatory activity needs careful assessment to avoid unanticipated consequences of applicable law. PMID:25689178

Regulatory Considerations of Lower Cost Air Pollution Sensor Data Performance

EPA Science Inventory

Low-cost, portable air quality sensors could be the next generation of air monitoring, however, this nascent technology is not without risk. This article looks at how the U.S. Environmental Protection Agency (EPA) uses air monitoring data, the procedures followed to ensure and a...

The air quality and regional climate effects of widespread solar power generation under a changing regulatory environment

NASA Astrophysics Data System (ADS)

Millstein, D.; Zhai, P.; Menon, S.

2011-12-01

Over the past decade significant reductions of NOx and SOx emissions from coal burning power plants in the U.S. have been achieved due to regulatory action and substitution of new generation towards natural gas and wind power. Low natural gas prices, ever decreasing solar generation costs, and proposed regulatory changes, such as to the Cross State Air Pollution Rule, promise further long-run coal power plant emission reductions. Reduced power plant emissions have the potential to affect ozone and particulate air quality and influence regional climate through aerosol cloud interactions and visibility effects. Here we investigate, on a national scale, the effects on future (~2030) air quality and regional climate of power plant emission regulations in contrast to and combination with policies designed to aggressively promote solar electricity generation. A sophisticated, economic and engineering based, hourly power generation dispatch model is developed to explore the integration of significant solar generation resources (>10% on an energy basis) at various regions across the county, providing detailed estimates of substitution of solar generation for fossil fuel generation resources. Future air pollutant emissions from all sectors of the economy are scaled based on the U.S. Environmental Protection Agency's National Emission Inventory to account for activity changes based on population and economic projections derived from county level U.S. Census data and the Energy Information Administration's Annual Energy Outlook. Further adjustments are made for technological and regulatory changes applicable within various sectors, for example, emission intensity adjustments to on-road diesel trucking due to exhaust treatment and improved engine design. The future year 2030 is selected for the emissions scenarios to allow for the development of significant solar generation resources. A regional climate and air quality model (Weather Research and Forecasting, WRF model) is

On Regional Modeling to Support Air Quality Policies

EPA Science Inventory

We examine the use of the Community Multiscale Air Quality (CMAQ) model in simulating the changes in the extreme values of air quality that are of interest to the regulatory agencies. Year-to-year changes in ozone air quality are attributable to variations in the prevailing mete...

Inspector General, DOD, Oversight of the Air Force Audit Agency Audit of the FY 1995 Air Force Consolidated Financial Statements.

DTIC Science & Technology

1996-04-18

financial statements . We delegated the audit of the FY 1995 Air Force consolidated financial statements to the Air Force Audit Agency. On March 1...1996, the Air Force Audit Agency issued its "Report of Audit: Opinion on Fiscal Year 1995 Air Force Consolidated Financial Statements " (Project 94053001...disclaimer of opinion. The audit objective was to determine the accuracy and completeness of the audit of the FY 1995 Air Force consolidated financial statements conducted

Regulatory Agencies and Food Safety

PubMed Central

Chapman, R. A.; Morrison, A. B.

1966-01-01

Prior to Confederation, food control legislation in Canada consisted of only a few simple laws governing the quality, grading, packing and inspection of certain staple foods. The Inland Revenue Act of 1875 provided the first real control in Canada over adulteration of liquor, foods and drugs. Since then, food legislation has evolved in scope and complexity as the industries involved have developed, as consumers have become better informed, and as scientific advances have provided a sound basis for regulations. Present regulations under the Food and Drugs Act are intended to give consumers broad protection against health hazards and fraud in the production, manufacture, labelling, packaging, advertising, and sale of foods. This principle is well illustrated by present requirements for the control of pesticide residues, chemical additives, and the addition of vitamins to foods. In today's era of rapid technological change, application of current scientific knowledge to the food industry obviously involves the possibility of hazards to health. Regulatory agencies with responsibility for food safety must, therefore, fully utilize scientific knowledge in order to reduce the risks involved to a minimum. PMID:5905951

76 FR 67366 - Revisions to the California State Implementation Plan, Placer County Air Pollution Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-01

... Metro Air Quality Management District AGENCY: Environmental Protection Agency (EPA). ACTION: Direct... Pollution Control District (PCAPCD) and Sacramento Metro Air Quality Management District (SMAQMD) portions..., this action: Is not a ``significant regulatory action'' subject to review by the Office of Management...

40 CFR 63.13 - Addresses of State air pollution control agencies and EPA Regional Offices.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 10 2013-07-01 2013-07-01 false Addresses of State air pollution... PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES General Provisions § 63.13 Addresses of State air pollution control agencies...

40 CFR 63.13 - Addresses of State air pollution control agencies and EPA Regional Offices.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 10 2012-07-01 2012-07-01 false Addresses of State air pollution... PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES General Provisions § 63.13 Addresses of State air pollution control agencies...

40 CFR 63.13 - Addresses of State air pollution control agencies and EPA Regional Offices.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 10 2014-07-01 2014-07-01 false Addresses of State air pollution... PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES General Provisions § 63.13 Addresses of State air pollution control agencies...

The Role of Regulatory Agencies and Intellectual Property: Part I

PubMed Central

Noonan, Kevin E.

2015-01-01

The patent and regulatory regimes of different agencies of the federal government are not always in agreement, and although the concept of the “unified executive” holds that the executive branch speaks with one voice, that is not always the case.1 Some agencies, like the Food and Drug Administration, tend toward cooperation with government patent policies, whereas others, notably the Federal Trade Commission, are often at odds with the Patent Office, the patent system, or both. These skirmishes, when they arise, eventually come before federal courts and ultimately the Supreme Court, where balancing the differing policy objectives, as well as the will of Congress as embodied in its statutes, is subject to the vagaries of the politics of how the issues are framed by the courts, and the judges’ and justices’ own predilections and prejudices. Examples of these situations were prevalent in 2013 and the circumstances surrounding them illustrative of the tensions inherent between the various federal agencies. PMID:25775921

76 FR 76115 - Revisions to the California State Implementation Plan, Feather River Air Quality Management District

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-06

... the California State Implementation Plan, Feather River Air Quality Management District AGENCY... limited disapproval of revisions to the Feather River Air Quality Management District (FRAQMD) portion of..., Regulatory Planning and Review The Office of Management and Budget (OMB) has exempted this regulatory action...

The Environmental Protection Agency in the Early Trump Administration: Prelude to Regulatory Capture.

PubMed

Dillon, Lindsey; Sellers, Christopher; Underhill, Vivian; Shapiro, Nicholas; Ohayon, Jennifer Liss; Sullivan, Marianne; Brown, Phil; Harrison, Jill; Wylie, Sara

2018-04-01

We explore and contextualize changes at the Environmental Protection Agency (EPA) over the first 6 months of the Trump administration, arguing that its pro-business direction is enabling a form of regulatory capture. We draw on news articles, public documents, and a rapid response, multisited interview study of current and retired EPA employees to (1) document changes associated with the new administration, (2) contextualize and compare the current pro-business makeover with previous ones, and (3) publicly convey findings in a timely manner. The lengthy, combined experience of interviewees with previous Republican and Democratic administrations made them valuable analysts for assessing recent shifts at the Scott Pruitt-led EPA and the extent to which these shifts steer the EPA away from its stated mission to "protect human and environmental health." Considering the extent of its pro-business leanings in the absence of mitigating power from the legislative branch, we conclude that its regulatory capture has become likely-more so than at similar moments in the agency's 47-year history. The public and environmental health consequences of regulatory capture of the EPA will probably be severe and far-reaching.

41 CFR 102-80.25 - What are Federal agencies' responsibilities concerning the management of indoor air quality?

Code of Federal Regulations, 2010 CFR

2010-07-01

... agencies' responsibilities concerning the management of indoor air quality? 102-80.25 Section 102-80.25... Environmental Management Indoor Air Quality § 102-80.25 What are Federal agencies' responsibilities concerning the management of indoor air quality? Federal agencies must assess indoor air quality of buildings as...

41 CFR 102-80.25 - What are Federal agencies' responsibilities concerning the management of indoor air quality?

Code of Federal Regulations, 2011 CFR

2011-01-01

... agencies' responsibilities concerning the management of indoor air quality? 102-80.25 Section 102-80.25... Environmental Management Indoor Air Quality § 102-80.25 What are Federal agencies' responsibilities concerning the management of indoor air quality? Federal agencies must assess indoor air quality of buildings as...

On Regional Modeling to Support Air Quality Policies (book chapter)

EPA Science Inventory

We examine the use of the Community Multiscale Air Quality (CMAQ) model in simulating the changes in the extreme values of air quality that are of interest to the regulatory agencies. Year-to-year changes in ozone air quality are attributable to variations in the prevailing meteo...

76 FR 29156 - Outer Continental Shelf Air Regulations Consistency Update for California

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-20

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 55 [OAR-2004-0091; FRL-9304-4] Outer Continental Shelf Air Regulations Consistency Update for California AGENCY: Environmental Protection Agency (EPA... ``significant regulatory action'' subject to review by the Office of Management and Budget under Executive Order...

Towards the Next Generation Air Quality Modeling System: Current Progress on Implementing Chemistry into MPAS-A

EPA Science Inventory

The community multiscale air quality (CMAQ) model of the U.S. Environmental Protection Agency is one of the most widely used air quality model worldwide; it is employed for both research and regulatory applications at major universities and government agencies for improving under...

Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

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

MULKEY, C.H.

1999-07-06

This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through themore » DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants.« less

Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures-Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions.

PubMed

Wang, Ting; McAuslane, Neil; Liberti, Lawrence; Leufkens, Hubert; Hövels, Anke

2018-06-01

To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality of evidentiary requirements that could occur; and to identify strategic issues and trends of regulatory and HTA synergy. Two separate questionnaires were developed to assess stakeholders' perceptions on regulatory and HTA alignment, one for pharmaceutical companies and the other for regulatory and HTA agencies. The responses were analyzed using descriptive statistics. Seven regulatory and 8 HTA agencies from Australia, Canada, and Europe and 19 international companies developing innovative medicine responded to the survey. This study provided a snapshot of the current regulatory and HTA landscape. Changes made over the past 5 years were reflected in three main areas: there is an increasing interaction between regulatory and HTA agencies; current conditional regulatory approvals are not always linked with flexible HTA approaches; and companies are more supportive of joint scientific advice. Four types of evidentiary requirements were identified as building blocks for better alignment: acceptable primary end points, inclusion of an active comparator, use of patient-reported outcomes, and choice and use of surrogate end point. The study showed that the gap between regulatory and HTA requirements has narrowed over the past 5 years. All respondents supported synergy between regulatory and HTA stakeholders, and the study provided several recommendations on how to further improve evidentiary alignment including the provision of joint scientific advice, which was rated as a key strategy by both agencies and companies. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

40 CFR 97.87 - Change in regulatory status.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Change in regulatory status. 97.87 Section 97.87 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS Individual Unit Opt-ins...

Regulatory Impact Analysis for the Final Cross-State Air Pollution Rule

EPA Pesticide Factsheets

This Regulatory Impact Analysis (RIA) presents the health and welfare benefits, costs, and other impacts of the Transport Rule, also called the Cross-State Air Pollution Rule, focusing primarily on 2014.

40 CFR 68.215 - Permit content and air permitting authority or designated agency requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Permit content and air permitting authority or designated agency requirements. 68.215 Section 68.215 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CHEMICAL ACCIDENT PREVENTION PROVISIONS Other...

77 FR 35652 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

... Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency..., Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S... Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental...

77 FR 12896 - Self-Regulatory Organizations; Pacific Clearing Corporation; Order Cancelling Clearing Agency...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-02

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66459; File No. 600-11] Self-Regulatory Organizations; Pacific Clearing Corporation; Order Cancelling Clearing Agency Registration February 24, 2012. I..., 2006), 72 FR 814 (Jan. 8, 2007). Section 19(a)(3) of the Act \\14\\ provides that in the event any self...

NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

NASA Technical Reports Server (NTRS)

Duda, Kristen; Scroggins, Sharon

2008-01-01

NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage applications of certain materials. Such changes can result in NASA undertaking material replacement efforts. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross-Agency

NASA's Agency-wide Strategy for Environmental Regulatory Risk Analysis and Communication

NASA Technical Reports Server (NTRS)

Duda, Kristen; Scroggins. Sharon

2008-01-01

NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage aPi'iications of certain materials. Such changes can result in NASA undertaking material replacement efforts. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross-Agency

32 CFR 989.7 - Requests from Non-Air Force agencies or entities.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 6 2010-07-01 2010-07-01 false Requests from Non-Air Force agencies or entities. 989.7 Section 989.7 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE ENVIRONMENTAL PROTECTION ENVIRONMENTAL IMPACT ANALYSIS PROCESS (EIAP) § 989.7 Requests from Non-Air Force...

Status of acute systemic toxicity testing requirements and data uses by U.S. regulatory agencies.

PubMed

Strickland, Judy; Clippinger, Amy J; Brown, Jeffrey; Allen, David; Jacobs, Abigail; Matheson, Joanna; Lowit, Anna; Reinke, Emily N; Johnson, Mark S; Quinn, Michael J; Mattie, David; Fitzpatrick, Suzanne C; Ahir, Surender; Kleinstreuer, Nicole; Casey, Warren

2018-04-01

Acute systemic toxicity data are used by a number of U.S. federal agencies, most commonly for hazard classification and labeling and/or risk assessment for acute chemical exposures. To identify opportunities for the implementation of non-animal approaches to produce these data, the regulatory needs and uses for acute systemic toxicity information must first be clarified. Thus, we reviewed acute systemic toxicity testing requirements for six U.S. agencies (Consumer Product Safety Commission, Department of Defense, Department of Transportation, Environmental Protection Agency, Food and Drug Administration, Occupational Safety and Health Administration) and noted whether there is flexibility in satisfying data needs with methods that replace or reduce animal use. Understanding the current regulatory use and acceptance of non-animal data is a necessary starting point for future method development, optimization, and validation efforts. The current review will inform the development of a national strategy and roadmap for implementing non-animal approaches to assess potential hazards associated with acute exposures to industrial chemicals and medical products. The Acute Toxicity Workgroup of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), U.S. agencies, non-governmental organizations, and other stakeholders will work to execute this strategy. Copyright © 2018 Elsevier Inc. All rights reserved.

PM NAAQS Implementation Training and Assistance for State and Local Air Agencies

EPA Pesticide Factsheets

EPA offers training and assistance resources for air agencies in developing their state implementation plans (SIPs), as well as in reaching or maintaining attainment of the National Ambient Air Quality Standards (NAAQS) for particulate matter (PM).

41 CFR 102-117.340 - What other types of assistance may GSA provide agencies in dealing with regulatory bodies?

Code of Federal Regulations, 2011 CFR

2011-01-01

... assistance may GSA provide agencies in dealing with regulatory bodies? 102-117.340 Section 102-117.340 Public... MANAGEMENT REGULATION TRANSPORTATION 117-TRANSPORTATION MANAGEMENT Representation Before Regulatory Body... bodies? (a) GSA has oversight of all public utilities used by the Federal Government including...

41 CFR 102-117.340 - What other types of assistance may GSA provide agencies in dealing with regulatory bodies?

Code of Federal Regulations, 2010 CFR

2010-07-01

... assistance may GSA provide agencies in dealing with regulatory bodies? 102-117.340 Section 102-117.340 Public... MANAGEMENT REGULATION TRANSPORTATION 117-TRANSPORTATION MANAGEMENT Representation Before Regulatory Body... bodies? (a) GSA has oversight of all public utilities used by the Federal Government including...

40 CFR 63.13 - Addresses of State air pollution control agencies and EPA Regional Offices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 9 2011-07-01 2011-07-01 false Addresses of State air pollution control agencies and EPA Regional Offices. 63.13 Section 63.13 Protection of Environment ENVIRONMENTAL... POLLUTANTS FOR SOURCE CATEGORIES General Provisions § 63.13 Addresses of State air pollution control agencies...

40 CFR 63.13 - Addresses of State air pollution control agencies and EPA Regional Offices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 9 2010-07-01 2010-07-01 false Addresses of State air pollution control agencies and EPA Regional Offices. 63.13 Section 63.13 Protection of Environment ENVIRONMENTAL... POLLUTANTS FOR SOURCE CATEGORIES General Provisions § 63.13 Addresses of State air pollution control agencies...

Aflatoxin control--how a regulatory agency managed risk from an unavoidable natural toxicant in food and feed.

PubMed

Park, D L; Stoloff, L

1989-04-01

The control by the Food and Drug Administration (FDA) of aflatoxin, a relatively recently discovered, unavoidable natural contaminant produced by specific molds that invade a number of basic food and feedstuffs, provides an example of the varying forces that affect risk assessment and management by a regulatory Agency. This is the story of how the FDA responded to the initial discovery of a potential carcinogenic hazard to humans in a domestic commodity, to the developing information concerning the nature of the hazard, to the economic and political pressures that are created by the impact of natural forces on regulatory controls, and to the restraints of laws within which the Agency must work. This story covers four periods: the years of discovery and action decisions on the basis of meager knowledge and the fear of cancer; the years of tinkering on paper with the regulatory process, the years of digestion of the accumulating knowledge, and the application of that knowledge to actions forced by natural events; and an audit of the current status of knowledge about the hazard from aflatoxin, and proposals for regulatory control based on that knowledge.

Clearing the air and breathing freely: the health politics of air pollution and asthma.

PubMed

Brown, Phil; Mayer, Brian; Zavestoski, Stephen; Luebke, Theo; Mandelbaum, Joshua; McCormick, Sabrina

2004-01-01

This study examines the growing debate around environmental causes of asthma in the context of federal regulatory disputes, scientific controversy, and environmental justice activism. A multifaceted form of social discovery of the effect of air pollution on asthma has resulted from multipartner and multiorganizational approaches and from intersectoral policy that deals with social inequality and environmental justice. Scientists, activists, health voluntary organizations, and some government agencies and officials have identified various elements of the asthma and air pollution connection. To tackle these issues, they have worked through a variety of collaborations and across different sectors of environmental regulation, public health, health services, housing, transportation, and community development. The authors examine the role of activist groups in discovering the increased rates of asthma and framing it as a social and environmental issue; give an overview of the current knowledge base on air pollution and asthma, and the controversies within science; and situate that science in the regulatory debate, discussing the many challenges to the air quality researchers. They then examine the implications of the scientific and regulatory controversies over linking air pollution to increases in asthma. The article concludes with a discussion of how alliances between activists and scientists lead to new research strategies and innovations.

SO2 NAAQS Implementation Training and Assistance for State and Local Air Agencies

EPA Pesticide Factsheets

Presentations and training help air agencies understand the National Ambient Air Quality Standards (NAAQS) for sulfur dioxide, how to engage the public in local emissions reduction programs, successful state implementation plan (SIP) development, and more.

Responsibilities of regulatory agencies in the marketing of antimicrobials.

PubMed

Grein, K

2012-04-01

The regulatory agencies' main responsibility regarding the marketing of veterinary medicinal products is to ensure that the products have a marketing authorisation with specific conditions of use adequate to ensure the quality, safety and efficacy of the product under consideration. In addition, control and surveillance systems are necessary to allow monitoring of the product after it has been authorised. In respectto antimicrobials, specific consideration must be given to minimising resistance development and retaining the effectiveness of these drugs for the treatment of humans and animals. Surveillance programmes should be in place to follow trends in resistance development, as well as in the consumption of veterinary antimicrobials, in order to provide for science-based policy recommendations regarding public and animal health.

41 CFR 102-117.335 - How does my agency ask for a delegation to represent itself in a regulatory body proceeding?

Code of Federal Regulations, 2011 CFR

2011-01-01

... for a delegation to represent itself in a regulatory body proceeding? 102-117.335 Section 102-117.335... Regulatory Body Proceedings § 102-117.335 How does my agency ask for a delegation to represent itself in a regulatory body proceeding? You must send your request for delegation with enough detail to explain the...

41 CFR 102-117.335 - How does my agency ask for a delegation to represent itself in a regulatory body proceeding?

Code of Federal Regulations, 2010 CFR

2010-07-01

... for a delegation to represent itself in a regulatory body proceeding? 102-117.335 Section 102-117.335... Regulatory Body Proceedings § 102-117.335 How does my agency ask for a delegation to represent itself in a regulatory body proceeding? You must send your request for delegation with enough detail to explain the...

Enforcement of continuous compliance with air quality regulations

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

Harrington, C.W.

1985-01-01

The compliance of stationary air-pollution sources with air quality regulations is examined. Contrary to the predictions of economic models of enforcement, sources are generally in continuous compliance with the regulations. An alternative voluntary compliance model of enforcement is proposed, in which regulated sources are penalized not for violations, but for failing to return to compliance when a violation is discovered. It is argued that continuous compliance is a bargain struck between the source and the regulatory agency, in which the agency agrees to avoid use of penalties in return for the source's good faith attempts to maintain compliance.

Development of a novel regulatory pharmacovigilance prioritisation system: an evaluation of its performance at the UK Medicines and Healthcare products Regulatory Agency.

PubMed

Seabroke, Suzie; Wise, Lesley; Waller, Patrick

2013-10-01

The prioritisation of drug safety issues for further evaluation or regulatory action is critical to ensure that acceptable timelines and appropriate resource allocation are defined to meet public health and regulatory obligations. Our objective was to develop, pilot and implement a novel tool for prioritising pharmacovigilance issues within the Medicines and Healthcare products Regulatory Agency (MHRA). An initial system was developed empirically and then piloted over a 10-month period in the pharmacovigilance signal management meeting at the MHRA that discusses potential pharmacovigilance issues, and determines, through consensus, their priority and a timescale for action. The priority assigned by the tool was compared with the priority decided by collective judgement at the meeting. Once an acceptable level of concordance between the tool and the meeting had been achieved, the finalised tool was implemented into routine use at the MHRA, with an evaluation of its performance conducted after the first year. The Regulatory Pharmacovigilance Prioritisation System (RPPS) tool prioritises pharmacovigilance issues according to the following four broad categories, each with four inputs: strength of evidence, public health implications, agency regulatory obligations and public perceptions. A weighted scoring system links the inputs to a pre-defined number of points where if a threshold is reached then the points are awarded. The overall priority is determined by the sum of all points obtained from each of the inputs. The pilot study included a total of 73 pharmacovigilance issues during the 10-month study period, with an overall exact agreement between the RPPS priority and the collective judgement of the meeting of 60.3 %. Where exact agreement was not obtained, the RPPS generally prioritised the issues slightly higher than the meeting. Over the first year following implementation, the RPPS achieved an overall exact agreement of 82.2 %. Following the pilot study and

76 FR 50891 - Revisions to the California State Implementation Plan, South Coast Air Quality Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-17

... the California State Implementation Plan, South Coast Air Quality Management District (SCAQMD) AGENCY... sources, to achieve emissions reductions milestones, to attain and maintain ambient air quality standards... ``significant regulatory action'' subject to review by the Office of Management and Budget under Executive Order...

76 FR 50128 - Revisions to the California State Implementation Plan, South Coast Air Quality Management District

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-12

... the California State Implementation Plan, South Coast Air Quality Management District AGENCY... the South Coast Air Quality Management District (SCAQMD) portion of the California State... not a ``significant regulatory action'' subject to review by the Office of Management and Budget under...

78 FR 30768 - Revisions to the California State Implementation Plan, South Coast Air Quality Management District

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

... the California State Implementation Plan, South Coast Air Quality Management District AGENCY... the South Coast Air Quality Management District (SCAQMD) portion of the California State... ``significant regulatory action'' subject to review by the Office of Management and Budget under Executive Order...

77 FR 53773 - Revisions to the California State Implementation Plan, South Coast Air Quality Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-04

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2012-0236; FRL-9711-2] Revisions to the California State Implementation Plan, South Coast Air Quality Management District (SCAQMD) AGENCY... ``significant regulatory action'' subject to review by the Office of Management and Budget under Executive Order...

75 FR 46845 - Revisions to the California State Implementation Plan, South Coast Air Quality Management District

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-04

... the California State Implementation Plan, South Coast Air Quality Management District AGENCY... approve revisions to the South Coast Air Quality Management District (SCAQMD) portion of the California..., this action: Is not a ``significant regulatory action'' subject to review by the Office of Management...

Inspector General, DOD, Oversight of the Air Force Audit Agency Audit of the FY 1999 Air Force General Fund Financial Statements

DTIC Science & Technology

2000-02-14

Consolidated Financial Statements . Our objective was to determine the accuracy and completeness of the Air Force Audit Agency audit of the FY 1999 Air Force General Fund financial statements. See Appendix A for a discussion of the audit

Applying Knowledge-Based Methods to Design and Implement an Air Quality Workshop

Treesearch

Daniel L. Schmoldt; David L. Peterson

1991-01-01

In response to protection needs in class I wilderness areas, forest land managers of the USDA Forest Service must provide input to regulatory agencies regarding air pollutant impacts on air quality-related values. Regional workshops have been convened for land managers and scientists to discuss the aspects and extent of wilderness protection needs. Previous experience...

Air Emissions Damages from Municipal Drinking Water Treatment Under Current and Proposed Regulatory Standards.

PubMed

Gingerich, Daniel B; Mauter, Meagan S

2017-09-19

Water treatment processes present intersectoral and cross-media risk trade-offs that are not presently considered in Safe Drinking Water Act regulatory analyses. This paper develops a method for assessing the air emission implications of common municipal water treatment processes used to comply with recently promulgated and proposed regulatory standards, including concentration limits for, lead and copper, disinfection byproducts, chromium(VI), strontium, and PFOA/PFOS. Life-cycle models of electricity and chemical consumption for individual drinking water unit processes are used to estimate embedded NO x , SO 2 , PM 2.5 , and CO 2 emissions on a cubic meter basis. We estimate air emission damages from currently installed treatment processes at U.S. drinking water facilities to be on the order of $500 million USD annually. Fully complying with six promulgated and proposed rules would increase baseline air emission damages by approximately 50%, with three-quarters of these damages originating from chemical manufacturing. Despite the magnitude of these air emission damages, the net benefit of currently implemented rules remains positive. For some proposed rules, however, the promise of net benefits remains contingent on technology choice.

77 FR 32398 - Revisions to the California State Implementation Plan, South Coast Air Quality Management District

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

... the California State Implementation Plan, South Coast Air Quality Management District AGENCY... approve a revision to the South Coast Air Quality Management District (SCAQMD) portion of the California... action: Is not a ``significant regulatory action'' subject to review by the Office of Management and...

Regulatory and Non-regulatory Responses to Hydraulic Fracturing in Local Communities

NASA Astrophysics Data System (ADS)

Phartiyal, P.

2015-12-01

The practice of extracting oil and gas from tight rock formations using advances in technology, such as hydraulic fracturing and directional drilling, has expanded exponentially in states and localities across the country. As the scientific data collection and analysis catches up on the many potential impacts of this unconventional oil and gas development, communities are turning to their local officials to make decisions on whether and how fracking should proceed. While most regulatory authority on the issue rests with the state agencies, local officials have experimented with a wide range of regulatory, non-regulatory, and fiscal tools to manage the impacts of fracking. These impacts can occur on the local air, water, seismicity, soil, roads, schools, and affect residents, on-site workers, emergency and social services. Local officials' approaches are often influenced by their prior experience with minerals extraction in their localities. The speaker will present examples of the kinds of information sources, tools and approaches communities across the country are using, from noise barriers to setback requirements to information sharing in order to be able to balance the promise and perils of oil and gas development in their jurisdictions.

Reducing carcinogens in public schools: A non-regulatory approach by a regulatory agency

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

Roche, L.M.

1995-05-01

The New Jersey Public Employees` Occupational Safety and Health Program identified 318 public school districts that reported any of 10 selected carcinogens on their 1990 New Jersey Right to Know Survey of hazardous substances. After obtaining more information about the school districts` use of these carcinogens from a 10% random sample phone survey, a letter recommending substitution of less hazardous substances was sent to the 318 school districts. Individualized to reflect information provided by the schools in the 1990 survey, a form requesting additional information on the status of containers holding the carcinogens was also sent. There were 1,303 reportsmore » of the 10 carcinogens from the 272 (86%) school districts that completed the form. Most were disposed of (668, 51%), used completely (65, 5%), or were slated for disposal (287, 22%). This is an example of a successful project by a regulatory agency to reduce potential exposure to carcinogens in public schools. The 10 most reported carcinogens were arsenic, arsenic trioxide, asbestos, benzene, benzidine, lead chromate, sodium arsenate, sodium arsenite, sodium dichromate, and vinyl chloride.« less

The Environmental Protection Agency in the Early Trump Administration: Prelude to Regulatory Capture

PubMed Central

Sellers, Christopher; Underhill, Vivian; Shapiro, Nicholas; Ohayon, Jennifer Liss; Sullivan, Marianne; Brown, Phil; Harrison, Jill; Wylie, Sara

2018-01-01

We explore and contextualize changes at the Environmental Protection Agency (EPA) over the first 6 months of the Trump administration, arguing that its pro-business direction is enabling a form of regulatory capture. We draw on news articles, public documents, and a rapid response, multisited interview study of current and retired EPA employees to (1) document changes associated with the new administration, (2) contextualize and compare the current pro-business makeover with previous ones, and (3) publicly convey findings in a timely manner. The lengthy, combined experience of interviewees with previous Republican and Democratic administrations made them valuable analysts for assessing recent shifts at the Scott Pruitt–led EPA and the extent to which these shifts steer the EPA away from its stated mission to “protect human and environmental health.” Considering the extent of its pro-business leanings in the absence of mitigating power from the legislative branch, we conclude that its regulatory capture has become likely—more so than at similar moments in the agency’s 47-year history. The public and environmental health consequences of regulatory capture of the EPA will probably be severe and far-reaching. PMID:29698086

78 FR 23507 - Notice of Regulatory Review

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-19

.... 2013-N-06] Notice of Regulatory Review AGENCY: Federal Housing Finance Agency. ACTION: Request for comment. SUMMARY: The Federal Housing Finance Agency (FHFA) is issuing a notice of a regulatory review that will be conducted in accordance with the process set forth in the regulatory review plan published...

Modulation of redox regulatory molecules and electron transport chain activity in muscle of air breathing fish Heteropneustes fossilis under air exposure stress.

PubMed

Paital, Biswaranjan

2014-01-01

Responses of redox regulatory system to long-term survival (>18 h) of the catfish Heteropneustes fossilis in air are not yet understood. Lipid and protein oxidation level, oxidant (H2O2) generation, antioxidative status (levels of superoxide dismutase, catalase, glutathione peroxidase and reductase, ascorbic acid and non-protein sulfhydryl) and activities of respiratory complexes (I, II, III and IV) in mitochondria were investigated in muscle of H. fossilis under air exposure condition (0, 3, 6, 12 and 18 h at 25 °C). The increased levels of both H2O2 and tissue oxidation were observed due to the decreased activities of antioxidant enzymes in muscle under water deprivation condition. However, ascorbic acid and non-protein thiol groups were the highest at 18 h air exposure time. A linear increase in complex II activity with air exposure time and an increase up to 12 h followed by a decrease in activity of complex I at 18 h were observed. Negative correlation was observed for complex III and V activity with exposure time. Critical time to modulate the above parameters was found to be 3 h air exposure. Dehydration induced oxidative stress due to modulation of electron transport chain and redox metabolizing enzymes in muscle of H. fossilis was clearly observed. Possible contribution of redox regulatory system in muscle tissue of the fish for long-term survival in air is elucidated. Results of the present study may be useful to understand the redox metabolism in muscle of fishes those are exposed to air in general and air breathing fishes in particular.

75 FR 3760 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-22

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0018] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory...) is issuing for public comment a draft guide in the agency's ``Regulatory Guide'' series. This series...

75 FR 20645 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-20

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0158] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory... draft guide in the agency's ``Regulatory Guide'' series. This series was developed to describe and make...

76 FR 40150 - Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... Commission publishes its semiannual regulatory flexibility agenda. In addition, this document includes an...) requires each agency to publish twice each year a regulatory flexibility agenda containing a brief... 12866 requires each agency to publish twice each year a regulatory agenda of regulations under...

Regulatory Actions - Proposed Mercury and Air Toxics Standards (MATS) for Power Plants

EPA Pesticide Factsheets

The U.S. Environmental Protection Agency (EPA) has proposed Mercury and Air Toxics Standards (MATS) for power plants to limit mercury, acid gases and other toxic pollution from power plants. This page includes supporting documentation and

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2011 CFR

2011-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2014 CFR

2014-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2012 CFR

2012-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2013 CFR

2013-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2010 CFR

2010-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

Regulation by consensus: The expanded use of regulatory negotiation under the Clean Air Act

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

Claiborne, M.L.

This article discusses the consensus building approach, which stems from the more formal regulatory negotiation process under the Negotiated Rulemaking Act of 1990, for improving air quality. The article uses as examples the joint plan to improve air quality and visibility in the Grand Canyon and 15 other national parks and wilderness areas in the SW USA, and the Southern Appalachian Mountain initiative tackling more complex issues including visibility, ground ozone, acid deposition, etc.

77 FR 3019 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-20

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to Post-Trade Transparency for Agency Pass... 19b-4 thereunder,\\2\\ a proposed rule change related to post-trade transparency for agency pass-through...

Ten Years of Addressing Children’s Health through Regulatory Policy at the U.S. Environmental Protection Agency

PubMed Central

Payne-Sturges, Devon; Kemp, Debra

2008-01-01

Background Executive Order (EO) 13045, Protection of Children From Environmental Health Risks and Safety Risks, directs each federal agency to ensure that its policies, programs, activities, and standards address disproportionate environmental health and safety risks to children. Objectives We reviewed regulatory actions published by U.S. Environmental Protection Agency (EPA) in the Federal Register from April 1998 through December 2006 to evaluate applicability of EO 13045 to U.S. EPA actions and consideration of children’s health issues in U.S. EPA rulemakings. Discussion Although virtually all actions discussed EO 13045, fewer than two regulations per year, on average, were subject to the EO requirement to evaluate children’s environmental health risks. Nonetheless, U.S. EPA considered children’s environmental health in all actions addressing health or safety risks that may disproportionately affect children. Conclusion The EO does not apply to a broad enough set of regulatory actions to ensure protection of children’s health and safety risks, largely because of the small number of rules that are economically significant. However, given the large number of regulations that consider children’s health issues despite not being subject to the EO, other statutory requirements and agency policies reach a larger set of regulations to ensure protection of children’s environmental health. PMID:19079726

On the Control of Air Quality: Why the Laws Don't Work

ERIC Educational Resources Information Center

Goldstein, Paul; Ford, Robert

1973-01-01

Studied implementation of air quality management in two western New York counties by interviewing three enforcement agencies and 30 industrial firms. Concluded that critical problems existed in the transient nature of contaminant emissions and the control of regulatory power by industries. (CC)

Regulatory ozone modeling: status, directions, and research needs.

PubMed Central

Georgopoulos, P G

1995-01-01

The Clean Air Act Amendments (CAAA) of 1990 have established selected comprehensive, three-dimensional, Photochemical Air Quality Simulation Models (PAQSMs) as the required regulatory tools for analyzing the urban and regional problem of high ambient ozone levels across the United States. These models are currently applied to study and establish strategies for meeting the National Ambient Air Quality Standard (NAAQS) for ozone in nonattainment areas; State Implementation Plans (SIPs) resulting from these efforts must be submitted to the U.S. Environmental Protection Agency (U.S. EPA) in November 1994. The following presentation provides an overview and discussion of the regulatory ozone modeling process and its implications. First, the PAQSM-based ozone attainment demonstration process is summarized in the framework of the 1994 SIPs. Then, following a brief overview of the representation of physical and chemical processes in PAQSMs, the essential attributes of standard modeling systems currently in regulatory use are presented in a nonmathematical, self-contained format, intended to provide a basic understanding of both model capabilities and limitations. The types of air quality, emission, and meteorological data needed for applying and evaluating PAQSMs are discussed, as well as the sources, availability, and limitations of existing databases. The issue of evaluating a model's performance in order to accept it as a tool for policy making is discussed, and various methodologies for implementing this objective are summarized. Selected interim results from diagnostic analyses, which are performed as a component of the regulatory ozone modeling process for the Philadelphia-New Jersey region, are also presented to provide some specific examples related to the general issues discussed in this work. Finally, research needs related to a) the evaluation and refinement of regulatory ozone modeling, b) the characterization of uncertainty in photochemical modeling, and c

Providing Value to New Health Technology: The Early Contribution of Entrepreneurs, Investors, and Regulatory Agencies

PubMed Central

Lehoux, Pascale; Miller, Fiona A.; Daudelin, Geneviève; Denis, Jean-Louis

2017-01-01

Background: New technologies constitute an important cost-driver in healthcare, but the dynamics that lead to their emergence remains poorly understood from a health policy standpoint. The goal of this paper is to clarify how entrepreneurs, investors, and regulatory agencies influence the value of emerging health technologies. Methods: Our 5-year qualitative research program examined the processes through which new health technologies were envisioned, financed, developed and commercialized by entrepreneurial clinical teams operating in Quebec’s (Canada) publicly funded healthcare system. Results: Entrepreneurs have a direct influence over a new technology’s value proposition, but investors actively transform this value. Investors support a technology that can find a market, no matter its intrinsic value for clinical practice or healthcare systems. Regulatory agencies reinforce the "double" value of a new technology—as a health intervention and as an economic commodity—and provide economic worth to the venture that is bringing the technology to market. Conclusion: Policy-oriented initiatives such as early health technology assessment (HTA) and coverage with evidence may provide technology developers with useful input regarding the decisions they make at an early stage. But to foster technologies that bring more value to healthcare systems, policy-makers must actively support the consideration of health policy issues in innovation policy. PMID:28949463

Protect and enhance: Lowi's juridical democracy and the prevention of significant deterioration of air quality

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

Meiburg, A.S.

1986-01-01

The capture of Federal regulatory agencies by the groups they were supposed to be regulating has been a topic of concern in the traditional literature of public administration. In his influential book The End of Liberalism, Professor Theordore Lowi suggested that capture resulted in part from vauge delegations of authority of Congress to regulatory agencies. Lowi argued that democracy would be better served if Congress were more specific in drafting laws, if agencies made greater use of formal rulemaking in implementing them, and if the courts rejected statutes which contained excessively vague delegations of authority - a remedy which hemore » labeled juridicial democracy. This dissertation examines Lowi's theory in light of the experience of Congress and the Environmental Protection Agency (EPA) with the requirements of the Clean Air Act to prevent the significant deterioration of air quality in areas where air was already relatively clean. The history of the program to develop and carry out these requirements, known as PSD, is described in detail from its inception in the late 1960's through EPA's final regulations in 1980. Special attention is given to the actions taken by EPA after environmental groups successfully used the courts to force EPA to develop a PSD program in 1974, how Congress responded by amending the Clean Air Act in 1977, and the difficulties these amendments and subsequent additional court reviews caused for EPA.« less

Artemisinin-based combination therapy in the treatment of uncomplicated malaria: review of recent regulatory experience at the European Medicines Agency

PubMed Central

Pelfrene, Eric; Pinheiro, Marie-Hélène; Cavaleri, Marco

2015-01-01

Malaria remains a major public health challenge with almost half of the world's population exposed to the risk of contracting the illness. Prompt, effective and well tolerated treatment remains one of the cornerstones in the disease management, with artemisinin-based combination therapy the recommended option for non-severe malaria in endemic areas with predominant Plasmodium falciparum infections. Recent experience has been obtained at the European Medicines Agency with regulatory approval of two such antimalarial fixed combination products. For these cases, two different regulatory pathways were applied. As such, the present contribution describes this experience, emphasising main differences and applicability offered by these regulatory choices. PMID:25855638

76 FR 59066 - Notice of Regulatory Review Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-23

... [No. 2011-N-10] Notice of Regulatory Review Plan AGENCY: Federal Housing Finance Agency. ACTION... of and requesting comments on the FHFA interim regulatory review plan for review of existing... comments on all aspects of the interim regulatory review plan, including legal and policy considerations...

75 FR 61485 - Regulatory Training Session With Air Carriers, EPA Regional Partners and Other Interested Parties...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

... Regional Partners and Other Interested Parties for Implementation of the Aircraft Drinking Water Rule... Agency (EPA) will hold a two-day training session on the regulatory requirements of the Aircraft Drinking... water systems'' under the Safe Drinking Water Act (SDWA) must meet the first set of requirements of the...

Information, Understanding, and Influence: An Agency Theory Strategy for Air Base Communications and Cyberspace Support

DTIC Science & Technology

2014-05-01

DISTRIBUTION A. Approved for public release: distribution unlimited. INFORMATION, UNDERSTANDING, AND INFLUENCE: AN AGENCY THEORY STRATEGY ...Influence: An Agency Theory Strategy For Air Base Communications And Cyberspace Support 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER...present communications and cyberspace support organizations. Next, it introduces a strategy based on this analysis to bring information, understanding

COMPENDIUM OF METHODS FOR THE DETERMINATION OF TOXIC ORGANIC COMPOUNDS IN AMBIENT AIR--SECOND EDITION

EPA Science Inventory

This Second Edition of the Compendium has been prepared to provide regional, state and local environmental regulatory agencies with step-by-step sampling and analysis procedures for the determination of selected toxic organic pollutants in ambient air. It is designed to assist t...

Artemisinin-based combination therapy in the treatment of uncomplicated malaria: review of recent regulatory experience at the European Medicines Agency.

PubMed

Pelfrene, Eric; Pinheiro, Marie-Hélène; Cavaleri, Marco

2015-07-01

Malaria remains a major public health challenge with almost half of the world's population exposed to the risk of contracting the illness. Prompt, effective and well tolerated treatment remains one of the cornerstones in the disease management, with artemisinin-based combination therapy the recommended option for non-severe malaria in endemic areas with predominant Plasmodium falciparum infections.Recent experience has been obtained at the European Medicines Agency with regulatory approval of two such antimalarial fixed combination products. For these cases, two different regulatory pathways were applied. As such, the present contribution describes this experience, emphasising main differences and applicability offered by these regulatory choices. © The Author 2015. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.

Integrating Sensor Monitoring Technology into the Current Air Pollution Regulatory Support Paradigm: Practical Considerations

EPA Science Inventory

The US Environmental Protection Agency (EPA) along with state, local, and tribal governments operate Federal Reference Method (FRM) and Federal Equivalent Method (FEM) instruments to assess compliance with US air pollution standards designed to protect human and ecosystem health....

Hazardous waste management system--Environmental Protection Agency. Notice of regulatory reform actions; request for comments.

PubMed

1982-12-13

In response to Executive Order 12291 and the President's Task Force on Regulatory Relief, the Environmental Protection Agency is reviewing and reassessing the hazardous waste regulations developed under the Resource Conservation and Recovery Act (RCRA). A variety of activities are underway that will simplify procedures and reduce paperwork, modify existing regulations to make them more workable and cost effective, and control new wastes and new processes. The purpose of this notice is to inform the public of these activities and invite comments on the general approaches being taken.

Department of Defense Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... Register is mandated for the regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U... the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because... Flexibility Act. Printing of these entries is limited to fields that contain information required by the...

Development and Evaluation of an Air Quality Modeling Approach to Assess Near-Field Impacts of Lead Emissions from Piston-Engine Aircraft Operating on Leaded Aviation Gasoline

EPA Science Inventory

Since aviation gasoline is now the largest remaining source of lead (Pb) emissions to the air in the United States, there is increased interest by regulatory agencies and the public in assessing the impacts on residents living in close proximity to these sources. An air quality m...

ENVIRONMENTAL PROTECTION AGENCY INDOOR AIR QUALITY AND WORKENVIRONMENT STUDY: HEALTH SYMPTOMS AND COMFORT CONCERNS

EPA Science Inventory

In recent years, employees at the three headquarters buildings ofthe U.S. Environmental Protection Agency (EPA) in the Washington,DC, area have expressed concerns about air quality and workenvironment discomforts. n February 1989, a two-stage study ofhealth and comfort concerns a...

Department of Defense Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

... regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U.S.C. 602), the Department of Defense's printed agenda entries include only: (1) Rules that are in the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because they are likely to have a significant...

Providing Value to New Health Technology: The Early Contribution of Entrepreneurs, Investors, and Regulatory Agencies.

PubMed

Lehoux, Pascale; Miller, Fiona A; Daudelin, Geneviève; Denis, Jean-Louis

2017-01-25

New technologies constitute an important cost-driver in healthcare, but the dynamics that lead to their emergence remains poorly understood from a health policy standpoint. The goal of this paper is to clarify how entrepreneurs, investors, and regulatory agencies influence the value of emerging health technologies. Our 5-year qualitative research program examined the processes through which new health technologies were envisioned, financed, developed and commercialized by entrepreneurial clinical teams operating in Quebec's (Canada) publicly funded healthcare system. Entrepreneurs have a direct influence over a new technology's value proposition, but investors actively transform this value. Investors support a technology that can find a market, no matter its intrinsic value for clinical practice or healthcare systems. Regulatory agencies reinforce the "double" value of a new technology-as a health intervention and as an economic commodity-and provide economic worth to the venture that is bringing the technology to market. Policy-oriented initiatives such as early health technology assessment (HTA) and coverage with evidence may provide technology developers with useful input regarding the decisions they make at an early stage. But to foster technologies that bring more value to healthcare systems, policy-makers must actively support the consideration of health policy issues in innovation policy. © 2017 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

17 CFR 240.17a-22 - Supplemental material of registered clearing agencies.

Code of Federal Regulations, 2010 CFR

2010-04-01

... a significant relationship, such as pledgees, transfer agents, or self-regulatory organizations, any... clearing agency for which the Commission is not the appropriate regulatory agency shall at the same time file one copy of such material with its appropriate regulatory agency. [45 FR 73914, Nov. 7, 1980] ...

Using aircraft and satellite observations to improve regulatory air quality models

NASA Astrophysics Data System (ADS)

Canty, T. P.; Vinciguerra, T.; Anderson, D. C.; Carpenter, S. F.; Goldberg, D. L.; Hembeck, L.; Montgomery, L.; Liu, X.; Salawitch, R. J.; Dickerson, R. R.

2014-12-01

Federal and state agencies rely on EPA approved models to develop attainment strategies that will bring states into compliance with the National Ambient Air Quality Standards (NAAQS). We will describe modifications to the Community Multi-Scale Air Quality (CMAQ) model and Comprehensive Air Quality Model with Extensions (CAMx) frameworks motivated by analysis of NASA satellite and aircraft measurements. Observations of tropospheric column NO2 from OMI have already led to the identification of an important deficiency in the chemical mechanisms used by models; data collected during the DISCOVER-AQ field campaign has been instrumental in devising an improved representation of the chemistry of nitrogen species. Our recent work has focused on the use of: OMI observations of tropospheric O3 to assess and improve the representation of boundary conditions used by AQ models, OMI NO2 to derive a top down NOx emission inventory from commercial shipping vessels that affect air quality in the Eastern U.S., and OMI HCHO to assess the C5H8 emission inventories provided by bioegenic emissions models. We will describe how these OMI-driven model improvements are being incorporated into the State Implementation Plans (SIPs) being prepared for submission to EPA in summer 2015 and how future modeling efforts may be impacted by our findings.

77 FR 32703 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

... organization consents, the Commission shall either approve the proposed rule change, disapprove the proposed...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to Post-Trade Transparency for Agency Pass...

76 FR 189 - Final Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-03

.../reading-rm/doc-collections/ . In addition, regulatory guides are available for inspection at the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2010-0265] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 3...

ICH: an exclusive club of drug regulatory agencies and drug companies imposing its rules on the rest of the world.

PubMed

2010-08-01

Under the pretext of harmonising regulatory requirements for marketing authorisation of new drugs, the drug regulatory agencies of the world's wealthiest countries and three pharmaceutical industry trade associations, joined together since 1990 in the ICH, are promoting their own interests by imposing their criteria for evaluating drugs on the whole world. The toxicity standards advocated by ICH sometimes promote faster, cheaper drug development over patient protection. The drug quality standards advocated by ICH sometimes increase manufacturing costs without providing any public health benefit. It would be preferable if the World Health Organization were in charge of setting standards for drug development, focusing on patients' interests.

77 FR 6827 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-09

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0280] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC action to... public comment. SUMMARY: The Nuclear Regulatory Commission (NRC) invites public comment about our...

75 FR 18241 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-09

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0148] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the...

75 FR 45166 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-02

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0265] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the...

Human agency in social cognitive theory.

PubMed

Bandura, A

1989-09-01

The present article examines the nature and function of human agency within the conceptual model of triadic reciprocal causation. In analyzing the operation of human agency in this interactional causal structure, social cognitive theory accords a central role to cognitive, vicarious, self-reflective, and self-regulatory processes. The issues addressed concern the psychological mechanisms through which personal agency is exercised, the hierarchical structure of self-regulatory systems, eschewal of the dichotomous construal of self as agent and self as object, and the properties of a nondualistic but nonreductional conception of human agency. The relation of agent causality to the fundamental issues of freedom and determinism is also analyzed.

77 FR 5279 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-02

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0009] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The Nuclear Regulatory Commission (NRC) invites public comment about...

75 FR 52996 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-30

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0287] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of issuance and availability of Draft Regulatory Guide, DG-8035, ``Administrative Practices in Radiation Surveys and Monitoring.'' FOR FURTHER...

Towards the Next Generation Air Quality Modeling System ...

EPA Pesticide Factsheets

The community multiscale air quality (CMAQ) model of the U.S. Environmental Protection Agency is one of the most widely used air quality model worldwide; it is employed for both research and regulatory applications at major universities and government agencies for improving understanding of the formation and transport of air pollutants. It is noted, however, that air quality issues and climate change assessments need to be addressed globally recognizing the linkages and interactions between meteorology and atmospheric chemistry across a wide range of scales. Therefore, an effort is currently underway to develop the next generation air quality modeling system (NGAQM) that will be based on a global integrated meteorology and chemistry system. The model for prediction across scales-atmosphere (MPAS-A), a global fully compressible non-hydrostatic model with seamlessly refined centroidal Voronoi grids, has been chosen as the meteorological driver of this modeling system. The initial step of adapting MPAS-A for the NGAQM was to implement and test the physics parameterizations and options that are preferred for retrospective air quality simulations (see the work presented by R. Gilliam, R. Bullock, and J. Herwehe at this workshop). The next step, presented herein, would be to link the chemistry from CMAQ to MPAS-A to build a prototype for the NGAQM. Furthermore, the techniques to harmonize transport processes between CMAQ and MPAS-A, methodologies to connect the chemis

Meeting Regulatory Needs.

PubMed

Weber, Michael Fred

2017-02-01

The world is experiencing change at an unprecedented pace, as reflected in social, cultural, economic, political, and technological advances around the globe. Regulatory agencies, like the U.S. Nuclear Regulatory Commission (NRC), must also transform in response to and in preparation for these changes. In 2014, the NRC staff commenced Project Aim 2020 to transform the agency by enhancing efficiency, agility, and responsiveness, while accomplishing NRC's safety and security mission. Following Commission review and approval in 2015, the NRC began implementing the approved strategies, including strategic workforce planning to provide confidence that NRC will have employees with the right skills and talents at the right time to accomplish the agency's mission. Based on the work conducted so far, ensuring an adequate pipeline of radiation protection professionals is a significant need that NRC shares with states and other government agencies, private industry, academia, as well as international counterparts. NRC is working to ensure that sufficient radiation protection professionals will be available to fulfill its safety and security mission and leverage the work of the National Council on Radiation Protection and Measurements, the Conference of Radiation Control Program Directors, the Health Physics Society, the Organization of Agreement States, the International Atomic Energy Agency, the Nuclear Energy Agency, and others.

77 FR 70192 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-23

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0263] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

76 FR 72982 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0271] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

77 FR 69661 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-20

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0230] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

78 FR 70353 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0248] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

77 FR 21813 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0058] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

77 FR 58872 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-24

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0198] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

78 FR 66078 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-04

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0238] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

78 FR 42112 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-15

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0116] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

77 FR 45697 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-01

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0149] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending U.S. Nuclear... Budget and solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites...

77 FR 63893 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-17

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0228] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) invites...

78 FR 28244 - Agency Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-14

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0085] Agency Information Collection Activities; Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

77 FR 44289 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-27

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0150] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

76 FR 72983 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0250] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

77 FR 54617 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-05

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0184] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

77 FR 29697 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-18

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0066] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending U.S. Nuclear... Budget and solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites...

76 FR 33788 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-09

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0009] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... (OMB) and solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites...

78 FR 79500 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0279] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

77 FR 44290 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-27

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0155] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

77 FR 48555 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-14

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0172] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

77 FR 7663 - Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

...The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Executive Order 12866 ``Regulatory Planning and Review,'' signed September 30, 1993 (58 FR 51735), and Office of Management and Budget memoranda implementing section 4 of that Order establish minimum standards for agencies' agendas, including specific types of information for each entry. The Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) helps agencies fulfill these requirements. All Federal regulatory agencies have chosen to publish their regulatory agendas as part of the Unified Agenda. Editions of the Unified Agenda prior to fall 2007 were printed in their entirety in the Federal Register. Beginning with the fall 2007 edition, the Internet is the basic means for conveying regulatory agenda information to the maximum extent legally permissible. The complete Unified Agenda for fall 2011, which contains the regulatory agendas for 59 Federal agencies, is available to the public at http:// reginfo.gov. The fall 2011 Unified Agenda publication appearing in the Federal Register consists of agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act.

Toxicogenomics and the Regulatory Framework

EPA Science Inventory

Toxicogenomics presents regulatory agencies with the opportunity to revolutionize their analyses by enabling the collection of information on a broader range of responses than currently considered in traditional regulatory decision making. Analyses of genomic responses are expec...

76 FR 6085 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-03

...-2011-0014] RIN 3150-AI49 Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice Availability of Draft Regulatory Guide. SUMMARY: The U.S. Nuclear Regulatory Commission (Commission or NRC) is issuing for public comment Draft Regulatory Guide, DG-5019, ``Reporting and...

14 CFR 158.11 - Public agency request not to require collection of PFC's by a class of air carriers or foreign...

Code of Federal Regulations, 2012 CFR

2012-01-01

... collection of PFC's by a class of air carriers or foreign air carriers or for service to isolated communities... TRANSPORTATION (CONTINUED) AIRPORTS PASSENGER FACILITY CHARGES (PFC'S) General § 158.11 Public agency request not to require collection of PFC's by a class of air carriers or foreign air carriers or for service to...

14 CFR 158.11 - Public agency request not to require collection of PFC's by a class of air carriers or foreign...

Code of Federal Regulations, 2014 CFR

2014-01-01

... collection of PFC's by a class of air carriers or foreign air carriers or for service to isolated communities... TRANSPORTATION (CONTINUED) AIRPORTS PASSENGER FACILITY CHARGES (PFC'S) General § 158.11 Public agency request not to require collection of PFC's by a class of air carriers or foreign air carriers or for service to...

14 CFR 158.11 - Public agency request not to require collection of PFC's by a class of air carriers or foreign...

Code of Federal Regulations, 2010 CFR

2010-01-01

... collection of PFC's by a class of air carriers or foreign air carriers or for service to isolated communities... TRANSPORTATION (CONTINUED) AIRPORTS PASSENGER FACILITY CHARGES (PFC'S) General § 158.11 Public agency request not to require collection of PFC's by a class of air carriers or foreign air carriers or for service to...

14 CFR 158.11 - Public agency request not to require collection of PFC's by a class of air carriers or foreign...

Code of Federal Regulations, 2013 CFR

2013-01-01

... collection of PFC's by a class of air carriers or foreign air carriers or for service to isolated communities... TRANSPORTATION (CONTINUED) AIRPORTS PASSENGER FACILITY CHARGES (PFC'S) General § 158.11 Public agency request not to require collection of PFC's by a class of air carriers or foreign air carriers or for service to...

14 CFR 158.11 - Public agency request not to require collection of PFC's by a class of air carriers or foreign...

Code of Federal Regulations, 2011 CFR

2011-01-01

... collection of PFC's by a class of air carriers or foreign air carriers or for service to isolated communities... TRANSPORTATION (CONTINUED) AIRPORTS PASSENGER FACILITY CHARGES (PFC'S) General § 158.11 Public agency request not to require collection of PFC's by a class of air carriers or foreign air carriers or for service to...

General Services Administration Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

... regulatory plan. FOR FURTHER INFORMATION CONTACT: Hada Flowers, Supervisor, Regulatory Secretariat Branch, at... Required: Yes Agency Contact: Hada Flowers, Supervisor, Regulatory Secretariat Branch, Office of...: 202 501-4755 Fax: 202 501-4067 Email: hada.flowers@gsa.gov RIN: 3090-AI32 276. GSAR CASE 2008-G517...

3 CFR - Regulatory Compliance

Code of Federal Regulations, 2012 CFR

2012-01-01

... 3 The President 1 2012-01-01 2012-01-01 false Regulatory Compliance Presidential Documents Other Presidential Documents Memorandum of January 18, 2011 Regulatory Compliance Memorandum for the Heads of Executive Departments and Agencies My Administration is committed to enhancing effectiveness and efficiency in Government. Pursuant to the...

California's program: Indoor air problems aren't amenable to regulation

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

Wesolowski, J.

In 1982, California's legislature established an Indoor Air Quality Program (CIAQP) in the Department of Health Services to carry out research on the nature and extent of the indoor air problem (excluding industrial worksites), to find appropriate mitigation measures, and to promote and coordinate the efforts of other state agencies. Since indoor air problems usually are not amenable to regulatory solutions, regulatory authority was not included in the mandate. The program conducts research into a wide range of contaminants--radon, asbestos, formaldehyde, carbon monoxide, volatile organic compounds, environmental tobacco smoke (ETS), as well as into biological aerosols that cause such diseasesmore » as Legionnaires disease, tuberculosis, allergies, and asthma. Studies are also carried out to better understand the Sick Building Syndrome. The research includes field surveys to determine the exposure of the population to specific contaminants and experiments in the laboratory to develop protocols for reducing exposures. The research emphasizes measurement of exposure--concentration multiplied by the time a person is exposed--as opposed to measurement of concentration only.« less

75 FR 1830 - Final Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-13

... review of applications for permits and licenses. RG 5.71, ``Cyber Security Programs for Nuclear... NUCLEAR REGULATORY COMMISSION [NRC-2010-0009] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide...

OAR Regulatory Reform

EPA Pesticide Factsheets

The U.S. EPA's Office of Air and Radiation is hosting a public teleconference to solicit input on specific air and radiation actions that should be considered for “repeal, replacement, or modification” to reduce regulatory burden consistent with EO 13777.

76 FR 3825 - Regulatory Compliance

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-21

... Compliance Memorandum for the Heads of Executive Departments and Agencies My Administration is committed to... regulatory compliance and enforcement activities, such as information with respect to administrative... compliance information fosters fair and consistent enforcement of important regulatory obligations. Such...

Environmental Assessment Addressing the Defense Language Institute English Language Center (DLIELC), and the Inter-American Air Forces Academy (IAAFA) Area Development Plan at Lackland Air Force Base, Texas

DTIC Science & Technology

2012-01-01

Heat island” refers to built up areas that have hotter surface and air temperatures than nearby rural areas. Heat island effect occurs when...Summary of Environmental Effects The public and regulatory agency scoping process focused the analysis on the following environmental resources... effects of implementing the DLIELC and IAAFA ADP are not significant, that preparation of an Environmental Impact Statement is unnecessary, and that a

77 FR 8028 - Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... provides summary descriptions of regulations being developed by the Civilian Agency Acquisition Council and... Analysis Required: Yes. Agency Contact: Karlos Morgan, Procurement Analyst, DOD/GSA/NASA (FAR), 1275 First... 05/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: William Clark, Procurement...

78 FR 44399 - Semiannual Regulatory Flexibility Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-23

... of Basel III, Minimum Regulatory Capital Ratios, Capital Adequacy, and Transition Provisions. (Docket... Further Action........ 12/00/13 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Dena... Regulatory Capital Ratios, Capital Adequacy, and Transition Provisions. (Docket No. R-1442) Legal Authority...

76 FR 6086 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-03

... NUCLEAR REGULATORY COMMISSION 10 CFR Part 73 [NRC-2011-0015] RIN 3150-AI49 Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Availability of Draft... comment Draft Regulatory Guide, DG-5020, ``Applying for Enhanced Weapons Authority, Applying for...

77 FR 52791 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Minimum Regulatory...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

...The Office of the Comptroller of the Currency (OCC), Board of Governors of the Federal Reserve System (Board), and the Federal Deposit Insurance Corporation (FDIC) (collectively, the agencies) are seeking comment on three Notices of Proposed Rulemaking (NPR) that would revise and replace the agencies' current capital rules. In this NPR, the agencies are proposing to revise their risk-based and leverage capital requirements consistent with agreements reached by the Basel Committee on Banking Supervision (BCBS) in ``Basel III: A Global Regulatory Framework for More Resilient Banks and Banking Systems'' (Basel III). The proposed revisions would include implementation of a new common equity tier 1 minimum capital requirement, a higher minimum tier 1 capital requirement, and, for banking organizations subject to the advanced approaches capital rules, a supplementary leverage ratio that incorporates a broader set of exposures in the denominator measure. Additionally, consistent with Basel III, the agencies are proposing to apply limits on a banking organization's capital distributions and certain discretionary bonus payments if the banking organization does not hold a specified amount of common equity tier 1 capital in addition to the amount necessary to meet its minimum risk- based capital requirements. This NPR also would establish more conservative standards for including an instrument in regulatory capital. As discussed in the proposal, the revisions set forth in this NPR are consistent with section 171 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), which requires the agencies to establish minimum risk-based and leverage capital requirements. In connection with the proposed changes to the agencies' capital rules in this NPR, the agencies are also seeking comment on the two related NPRs published elsewhere in today's Federal Register. The two related NPRs are discussed further in the SUPPLEMENTARY INFORMATION.

76 FR 38212 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0275] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Revision 1 of Regulatory Guide (RG) 1.179, ``Standard Format [[Page 38213

An inventory of ambulance service regulatory programs in California.

PubMed

Narad, R A

1998-01-01

Ambulance regulation in California is the responsibility of numerous agencies on the state and local levels. By identifying and analyzing the variety of programs used in one state, this study establishes a framework for evaluation of state and local regulatory programs elsewhere. This study surveyed all California local EMS agencies (LEMSAs: California's equivalent of regional EMS organizations) to identify the types of regulatory programs used, the foci of these programs (e.g., equipment and personnel), and their application (e.g., public and private providers). All data acquired were analyzed using population parameters rather than inferential statistics. A response rate of 100% was obtained. Among the regulatory tools used are ordinances, contracts, and franchises. Regulatory standards vary widely as do their applications. Large counties and those that operate their own LEMSA have more extensive regulatory programs than do smaller counties and those who participate in multicounty agencies. Many of the enforcement mechanisms available are weak. This study suggests several policy implications for California and other states. The wide variation in the types of regulatory programs and the standards that are used suggest that the purpose and impact of regulatory programs should be studied further. The decentralization of the ambulance regulatory program and the lack of integration of ambulance regulations into EMS system planning also raise policy questions. In addition, the role of multicounty EMS agencies, as it relates to regulation of ambulance services, should be reviewed.

75 FR 48382 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-10

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0275] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-1228, ``Standard Format and Content of License Termination Plans for Nuclear Power Reactors.'' FOR FURTHER INFORMATION CONTACT: James C....

75 FR 28073 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-19

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0181] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-3039, ``Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities.'' FOR FURTHER INFORMATION CONTACT: Kevin M....

76 FR 24539 - Final Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-02

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0181] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide (RG) 3.67, ``Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities.'' FOR FURTHER INFORMATION CONTACT: Kevin M. Ramse...

76 FR 32379 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-06

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0114] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of pending...: Applications for licenses are [[Page 32380

76 FR 31382 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0287] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 8.2, Revision 1, ``Administrative Practices in Radiation Surveys and Monitoring.'' FOR FURTHER INFORMATION...

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

PubMed

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

75 FR 12804 - Withdrawal of Regulatory Guide 8.6

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-17

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0103] Withdrawal of Regulatory Guide 8.6 AGENCY: Nuclear...[uuml]ller Counters.'' FOR FURTHER INFORMATION CONTACT: Harriet Karagiannis, U.S. Nuclear Regulatory... . SUPPLEMENTARY INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is withdrawing...

Expert Views on Regulatory Preparedness for Managing the Risks of Nanotechnologies

PubMed Central

Beaudrie, Christian E. H.; Satterfield, Terre; Kandlikar, Milind; Harthorn, Barbara H.

2013-01-01

The potential and promise of nanotechnologies depends in large part on the ability for regulatory systems to assess and manage their benefits and risks. However, considerable uncertainty persists regarding the health and environmental implications of nanomaterials, hence the capacity for existing regulations to meet this challenge has been widely questioned. Here we draw from a survey (N=254) of US-based nano-scientists and engineers, environmental health and safety scientists, and regulatory scientists and decision-makers, to ask whether nano experts regard regulatory agencies as prepared for managing nanomaterial risks. We find that all three expert groups view regulatory agencies as unprepared. The effect is strongest for regulators themselves, and less so for scientists conducting basic, applied, or health and safety work on nanomaterials. Those who see nanotechnology risks as novel, uncertain, and difficult to assess are particularly likely to see agencies as unprepared. Trust in regulatory agencies, views of stakeholder responsibility regarding the management of risks, and socio-political values were also found to be small but significant drivers of perceived agency preparedness. These results underscore the need for new tools and methods to enable the assessment of nanomaterial risks, and to renew confidence in regulatory agencies’ ability to oversee their growing use and application in society. PMID:24244662

76 FR 32878 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-07

...-0129] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-1253, ``Preoperational Testing of Emergency Core Cooling Systems for Pressurized-Water Reactors''. FOR FURTHER INFORMATION CONTACT: Mekonen M...

75 FR 34962 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-154-FOR; OSM 2010-0002] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... the Pennsylvania regulatory program (the ``Pennsylvania program'') under the Surface Mining Control...

14 CFR 296.5 - Agency relationships.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF TRANSPORTATION (AVIATION PROCEEDINGS) ECONOMIC REGULATIONS INDIRECT AIR TRANSPORTATION OF PROPERTY General § 296.5 Agency relationships. An indirect cargo air carrier may act as agent of a shipper, or of a direct air carrier that has authorized such agency...

Data Integrity-A Study of Current Regulatory Thinking and Action.

PubMed

Shafiei, Nader; De Montardy, Regis; Rivera-Martinez, Edwin

2015-01-01

In reaction to breaches of data integrity in the pharmaceutical industry, regulatory authorities have introduced inspection approaches or initiatives with the aim of reducing occurrences of data integrity problems. This review article-based on study of 65 cases of regulatory action from 2002 to 2014-provides an overview of current regulatory thinking and action on breaches of data integrity affecting GxP (health-related regulations) processes supporting non-clinical studies, clinical studies, laboratory controls, and production controls. These case studies largely represent position of the U.S. Food and Drug Administration and the regulatory agencies affiliated with the European Medicines Agency. Also discussed is the role of human factors as a potential source of data integrity problems. The article concludes by recommending some remedial controls that could be established to avoid or reduce occurrences of data integrity problems.Lay Abstract: In fulfilling their mission to protect public health, regulatory agencies (e.g., U.S. Food and Drug Administration, European Medicines Agency) must establish confidence that medical products they approve are fit for their intended use. In so doing they rely on scientific and operational data generated during research, development, manufacturing, sales, marketing, distribution, and post-marketing surveillance activities. The level of confidence they build is directly proportional to the scientific validity and integrity of data presented to them by the sponsors of medical products. In this article we present analysis of 65 case studies that document regulatory action taken by various regulatory agencies on breach of data integrity between 2002 and 2014. The ensuing discussion on current trends largely represents position of the U.S. Food and Drug Administration and European Medicines Agency. The article concludes by proposing some remedial controls that could be established by pharmaceutical companies to avoid or reduce

77 FR 55893 - Agency Requests for Renewal of a Previously Approved Information Collection: Exemptions for Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-11

... Previously Approved Information Collection: Exemptions for Air Taxi Operations AGENCY: Office of the... public comments about our intention to request the Office of Management and Budget (OMB)'s approval to..., (202) 366-9721, Office of Aviation Analysis, Office of the Secretary, U.S. Department of Transportation...

Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit

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

Levine, Aaron L

Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit presentation from the WPTO FY14-FY16 Peer Review. The toolkit is aimed at regulatory agencies, consultants, project developers, the public, and any other party interested in learning more about the hydropower regulatory process.

76 FR 16714 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-25

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-160-FOR; OSM 2010-0019] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... Pennsylvania regulatory program (the ``Pennsylvania program'') under the Surface Mining Control and Reclamation...

75 FR 21899 - Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

....regulations.gov. FOR FURTHER INFORMATION CONTACT: Hada Flowers, Supervisor, Regulatory Secretariat Branch... Flexibility Analysis Required: Yes Agency Contact: Hada Flowers, Supervisor, Regulatory Secretariat, DOD/ GSA... Email: hada.flowers@gsa.gov RIN: 9000-AK92 301. FAR CASE 2006-005, HUBZONE PROGRAM REVISIONS Legal...

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).

PubMed

Ackermann, Brad; Neubert, Hendrik; Hughes, Nicola; Garofolo, Fabio; Abberley, Lee; Alley, Stephen C; Brown-Augsburger, Patricia; Bustard, Mark; Chen, Lin-Zhi; Heinrich, Julia; Katori, Noriko; Kaur, Surinder; Kirkovsky, Leo; Laterza, Omar F; Le Blaye, Olivier; Lévesque, Ann; Santos, Gustavo Mendes Lima; Olah, Timothy; Savoie, Natasha; Skelly, Michael; Spitz, Susan; Szapacs, Matthew; Tampal, Nilufer; Wang, Jian; Welink, Jan; Wieling, Jaap; Haidar, Sam; Vinter, Stephen; Whale, Emma; Witte, Bärbel

2015-12-01

The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. It is once again a 5-day week long event - a full immersion bioanalytical week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations that emerged from the extensive discussions held during the workshop, and is aimed at providing the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to advance scientific excellence, improve quality and deliver better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 2 covers the recommendations for hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in volume 7 of Bioanalysis, issues 22 and 24, respectively.

Using satellite observations in performance evaluation for regulatory air quality modeling: Comparison with ground-level measurements

NASA Astrophysics Data System (ADS)

Odman, M. T.; Hu, Y.; Russell, A.; Chai, T.; Lee, P.; Shankar, U.; Boylan, J.

2012-12-01

Regulatory air quality modeling, such as State Implementation Plan (SIP) modeling, requires that model performance meets recommended criteria in the base-year simulations using period-specific, estimated emissions. The goal of the performance evaluation is to assure that the base-year modeling accurately captures the observed chemical reality of the lower troposphere. Any significant deficiencies found in the performance evaluation must be corrected before any base-case (with typical emissions) and future-year modeling is conducted. Corrections are usually made to model inputs such as emission-rate estimates or meteorology and/or to the air quality model itself, in modules that describe specific processes. Use of ground-level measurements that follow approved protocols is recommended for evaluating model performance. However, ground-level monitoring networks are spatially sparse, especially for particulate matter. Satellite retrievals of atmospheric chemical properties such as aerosol optical depth (AOD) provide spatial coverage that can compensate for the sparseness of ground-level measurements. Satellite retrievals can also help diagnose potential model or data problems in the upper troposphere. It is possible to achieve good model performance near the ground, but have, for example, erroneous sources or sinks in the upper troposphere that may result in misleading and unrealistic responses to emission reductions. Despite these advantages, satellite retrievals are rarely used in model performance evaluation, especially for regulatory modeling purposes, due to the high uncertainty in retrievals associated with various contaminations, for example by clouds. In this study, 2007 was selected as the base year for SIP modeling in the southeastern U.S. Performance of the Community Multiscale Air Quality (CMAQ) model, at a 12-km horizontal resolution, for this annual simulation is evaluated using both recommended ground-level measurements and non-traditional satellite

76 FR 2726 - Withdrawal of Regulatory Guide 1.154

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-14

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0010] Withdrawal of Regulatory Guide 1.154 AGENCY: Nuclear Regulatory Commission. ACTION: Withdrawal of Regulatory Guide 1.154, ``Format and Content of Plant-Specific Pressurized Thermal Shock Safety Analysis Reports for Pressurized Water Reactors.'' FOR FURTHER INFORMATION CONTACT: Mekonen M. Bayssie,...

NASA/Air Force/Environmental Protection Agency Interagency Depainting Study

NASA Technical Reports Server (NTRS)

Clark-Ingram, Marceia

1998-01-01

Many popular and widely used paint stripping products have traditionally contained methylene chloride as their main active ingredient. However, the Environmental Protection Agency (EPA) has critically curved the allowable use of methylene chloride under the National Emission Standard for Hazardous Air Pollutants regulating Aerospace Manufacturing and Rework Facilities . Compliance with this rule was mandatory by September 1998 for affected facilities. An effort is underway to identify and evaluate alternative depainting technologies emphasizing those believed both effective and environmentally benign. On behalf of the EPA and in cooperation with the United States Air Force, the National Aeronautics and Space Administration is conducting a technical assessment of several alternative technologies ( i.e. : chemical stripping, two CO2 blasting processes, CO2 xenon lamp coating removal, CO2 Laser stripping, plastic media blasting, sodium bicarbonate wet stripping, high pressure water stripping, and wheat starch blasting). These depainting processes represent five removal method categories, namely abrasive, impact, cryogenic, thermal, and/or molecular bonding dissociation. This paper discusses the test plan and parameters for this interagency study. Several thicknesses of clad and non-clad aluminum substrates were used to prepare test specimens. Each depainting process has been assigned a specimen lot, all of which have completed three to five stripping cycles. Numerous metallurgical evaluations are underway to assess the impact of these alternative depainting processes upon the structural integrity of the substrate.

2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).

PubMed

Neubert, Hendrik; Song, An; Lee, Anita; Wei, Cong; Duggan, Jeff; Xu, Keyang; Woolf, Eric; Evans, Chris; Palandra, Joe; Laterza, Omar; Amur, Shashi; Berger, Isabella; Bustard, Mark; Cancilla, Mark; Chen, Shang-Chiung; Cho, Seongeun Julia; Ciccimaro, Eugene; Cludts, Isabelle; Cocea, Laurent; D'Arienzo, Celia; Danan-Leon, Lieza; Donato, Lorella Di; Garofolo, Fabio; Haidar, Sam; Ishii-Watabe, Akiko; Jiang, Hao; Kadavil, John; Kassim, Sean; Kurki, Pekka; Blaye, Olivier Le; Liu, Kai; Mathews, Rod; Lima Santos, Gustavo Mendes; Niwa, Makoto; Pedras-Vasconcelos, João; Qian, Mark; Rago, Brian; Saad, Ola; Saito, Yoshiro; Savoie, Natasha; Su, Dian; Szapacs, Matthew; Tampal, Nilufer; Vinter, Stephen; Wang, Jian; Welink, Jan; Whale, Emma; Wilson, Amanda; Xue, Y-J

2017-12-01

The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid ligand binding assay (LBA)/LCMS and LBA approaches. This 2017 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for biotherapeutics, biomarkers and immunogenicity assays using hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (LCMS for small molecules, peptides and small molecule biomarkers) and Part 3 (LBA: immunogenicity, biomarkers and pharmacokinetic assays) are published in Volume 9 of Bioanalysis, issues 22 and 24 (2017), respectively.

The absence of ion-regulatory suppression in the gills of the aquatic air-breathing fish Trichogaster lalius during oxygen stress.

PubMed

Huang, Chun-Yen; Lin, Hsueh-Hsi; Lin, Cheng-Huang; Lin, Hui-Chen

2015-01-01

The strategy for most teleost to survive in hypoxic or anoxic conditions is to conserve energy expenditure, which can be achieved by suppressing energy-consuming activities such as ion regulation. However, an air-breathing fish can cope with hypoxic stress using a similar adjustment or by enhancing gas exchange ability, both behaviorally and physiologically. This study examined Trichogaster lalius, an air-breathing fish without apparent gill modification, for their gill ion-regulatory abilities and glycogen utilization under a hypoxic treatment. We recorded air-breathing frequency, branchial morphology, and the expression of ion-regulatory proteins (Na(+)/K(+)-ATPase and vacuolar-type H(+)-ATPase) in the 1(st) and 4(th) gills and labyrinth organ (LO), and the expression of glycogen utilization (GP, glycogen phosphorylase protein expression and glycogen content) and other protein responses (catalase, CAT; carbonic anhydrase II, CAII; heat shock protein 70, HSP70; hypoxia-inducible factor-1α, HIF-1α; proliferating cell nuclear antigen, PCNA; superoxidase dismutase, SOD) in the gills of T. lalius after 3 days in hypoxic and restricted conditions. No morphological modification of the 1(st) and 4(th) gills was observed. The air-breathing behavior of the fish and CAII protein expression both increased under hypoxia. Ion-regulatory abilities were not suppressed in the hypoxic or restricted groups, but glycogen utilization was enhanced within the groups. The expression of HIF-1α, HSP70 and PCNA did not vary among the treatments. Regarding the antioxidant system, decreased CAT enzyme activity was observed among the groups. In conclusion, during hypoxic stress, T. lalius did not significantly reduce energy consumption but enhanced gas exchange ability and glycogen expenditure. Copyright © 2014 Elsevier Inc. All rights reserved.

75 FR 44816 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-29

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0263] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of pending NRC... individual monitoring for occupational radiation exposure during a monitoring (one calendar year) period to...

75 FR 39054 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-07

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0234] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of pending NRC..., or wishing to participate in a license application review for the potential geologic repository. 5...

75 FR 17438 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0141] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of... new Agreement State applications. Annually for participation by Agreement States in the IMPEP reviews...

75 FR 9444 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-02

... applications for licenses and amendments thereto to construct and operate nuclear power plants, preliminary or... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0063] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of...

76 FR 23628 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0056] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of pending...: Applications for licenses are submitted once. Other reports are submitted annually or as other events require...

77 FR 31486 - Virginia Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-29

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 946 [VA-126-FOR; OSM-2008-0012] Virginia Regulatory Program AGENCY: Office of Surface Mining Reclamation... an amendment to the Virginia regulatory program under the Surface Mining Control and Reclamation Act...

Environmental Regulatory Update Table, October 1991

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

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-11-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, December 1991

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

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1992-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, September 1991

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

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-10-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, November 1991

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

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-12-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Air Force Historical Research Agency

Science.gov Websites

Command Capt Joseph J Merhar Jr collection Early Wright Brothers Flying Machines History of the 3rd Organizations Wings and Groups Squadrons and Flights Studies Documents Personal Papers Oral History Catalogue S. Fairchild Research Information Center Military Sites Air Force Link DefenseLINK Air Force History

76 FR 52698 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-23

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0181] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of pending... administration of the byproduct material or the radiation there from to human beings or animals. Possession of...

75 FR 63866 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-18

... special nuclear material. The information in the applications, reports, and records is used by NRC to make... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0322] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of pending...

76 FR 39906 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... collection is required: There is a one-time application for any licensee wishing to renew its nuclear power... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0130] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of pending...

75 FR 45676 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0235] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of...: Applications for new licenses and amendments may be submitted at any time. Applications for renewal are...

78 FR 67204 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-08

... special nuclear material. The information in the applications, reports, and records is used by NRC to make... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0239] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC...

75 FR 37841 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0214] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of... the collection is required: Applications for new licenses and amendments may be submitted at any time...

75 FR 60375 - Utah Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-30

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 944 [SATS No. UT-047-FOR; Docket ID OSM-2010-0012] Utah Regulatory Program AGENCY: Office of Surface Mining... amendment to the Utah regulatory program (hereinafter, the ``Utah program'') under the Surface Mining...

Potential Air Pollutant Emissions and Permitting Classifications for Two Biorefinery Process Designs in the United States

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

Eberle, Annika; Bhatt, Arpit; Zhang, Yimin

Advanced biofuel production facilities (biorefineries), such as those envisioned by the United States (U.S.) Renewable Fuel Standard and U.S. Department of Energy's research and development programs, often lack historical air pollutant emissions data, which can pose challenges for obtaining air emission permits that are required for construction and operation. To help fill this knowledge gap, we perform a thorough regulatory analysis and use engineering process designs to assess the applicability of federal air regulations and quantify air pollutant emissions for two feasibility-level biorefinery designs. We find that without additional emission-control technologies both biorefineries would likely be required to obtain majormore » source permits under the Clean Air Act's New Source Review program. The permitting classification (so-called 'major' or 'minor') has implications for the time and effort required for permitting and therefore affects the cost of capital and the fuel selling price. Consequently, we explore additional technically feasible emission-control technologies and process modifications that have the potential to reduce emissions to achieve a minor source permitting classification. Finally, our analysis of air pollutant emissions and controls can assist biorefinery developers with the air permitting process and inform regulatory agencies about potential permitting pathways for novel biorefinery designs.« less

Potential Air Pollutant Emissions and Permitting Classifications for Two Biorefinery Process Designs in the United States

DOE PAGES

Eberle, Annika; Bhatt, Arpit; Zhang, Yimin; ...

2017-04-26

Advanced biofuel production facilities (biorefineries), such as those envisioned by the United States (U.S.) Renewable Fuel Standard and U.S. Department of Energy's research and development programs, often lack historical air pollutant emissions data, which can pose challenges for obtaining air emission permits that are required for construction and operation. To help fill this knowledge gap, we perform a thorough regulatory analysis and use engineering process designs to assess the applicability of federal air regulations and quantify air pollutant emissions for two feasibility-level biorefinery designs. We find that without additional emission-control technologies both biorefineries would likely be required to obtain majormore » source permits under the Clean Air Act's New Source Review program. The permitting classification (so-called 'major' or 'minor') has implications for the time and effort required for permitting and therefore affects the cost of capital and the fuel selling price. Consequently, we explore additional technically feasible emission-control technologies and process modifications that have the potential to reduce emissions to achieve a minor source permitting classification. Finally, our analysis of air pollutant emissions and controls can assist biorefinery developers with the air permitting process and inform regulatory agencies about potential permitting pathways for novel biorefinery designs.« less

Potential Air Pollutant Emissions and Permitting Classifications for Two Biorefinery Process Designs in the United States.

PubMed

Eberle, Annika; Bhatt, Arpit; Zhang, Yimin; Heath, Garvin

2017-06-06

Advanced biofuel production facilities (biorefineries), such as those envisioned by the United States (U.S.) Renewable Fuel Standard and U.S. Department of Energy's research and development programs, often lack historical air pollutant emissions data, which can pose challenges for obtaining air emission permits that are required for construction and operation. To help fill this knowledge gap, we perform a thorough regulatory analysis and use engineering process designs to assess the applicability of federal air regulations and quantify air pollutant emissions for two feasibility-level biorefinery designs. We find that without additional emission-control technologies both biorefineries would likely be required to obtain major source permits under the Clean Air Act's New Source Review program. The permitting classification (so-called "major" or "minor") has implications for the time and effort required for permitting and therefore affects the cost of capital and the fuel selling price. Consequently, we explore additional technically feasible emission-control technologies and process modifications that have the potential to reduce emissions to achieve a minor source permitting classification. Our analysis of air pollutant emissions and controls can assist biorefinery developers with the air permitting process and inform regulatory agencies about potential permitting pathways for novel biorefinery designs.

21 CFR 312.86 - Focused FDA regulatory research.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

21 CFR 312.86 - Focused FDA regulatory research.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

21 CFR 312.86 - Focused FDA regulatory research.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

21 CFR 312.86 - Focused FDA regulatory research.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

21 CFR 312.86 - Focused FDA regulatory research.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

75 FR 39585 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-09

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0236] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of pending NRC... licensees to ascertain compliance with the provisions of the Atomic Energy Act of 1954, as amended, Title II...

Environmental Regulatory Update Table, August 1991

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

Houlberg, L.M., Hawkins, G.T.; Salk, M.S.

1991-09-01

This Environmental Regulatory Update Table (August 1991) provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

77 FR 8185 - Ohio Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 935 [SATS No. OH-252-FOR; Docket ID OSM 2011-0003] Ohio Regulatory Program AGENCY: Office of Surface Mining... amendment to the Ohio regulatory program (the ``Ohio program'') under the Surface Mining Control and...

76 FR 28102 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-13

... Analysis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555... agency's ``Regulatory Guide'' series. This series was developed to describe and make available to the... guide. Licensees should identify how chosen approaches and methods (whether they are quantitative or...

78 FR 12267 - Revision of Air Quality Implementation Plan; California; Placer County Air Pollution Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-22

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2013-0094; FRL-9783-2] Revision of Air Quality Implementation Plan; California; Placer County Air Pollution Control District and Feather River Air Quality Management District; Stationary Source Permits AGENCY: Environmental Protection Agency...

Environmental Regulatory Update Table, January/February 1995

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

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

1995-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives impacting environmental, health, and safety management responsibilities. the table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

33 CFR 334.1280 - Bristol Bay, Alaska; air-to-air weapon range, Alaskan Air Command, U.S. Air Force.

Code of Federal Regulations, 2012 CFR

2012-07-01

... weapon range, Alaskan Air Command, U.S. Air Force. 334.1280 Section 334.1280 Navigation and Navigable... REGULATIONS § 334.1280 Bristol Bay, Alaska; air-to-air weapon range, Alaskan Air Command, U.S. Air Force. (a... enforced by the Commander, Alaskan Air Command, U.S. Air Force, Seattle, Washington, or such agencies as he...

33 CFR 334.1280 - Bristol Bay, Alaska; air-to-air weapon range, Alaskan Air Command, U.S. Air Force.

Code of Federal Regulations, 2013 CFR

2013-07-01

... weapon range, Alaskan Air Command, U.S. Air Force. 334.1280 Section 334.1280 Navigation and Navigable... REGULATIONS § 334.1280 Bristol Bay, Alaska; air-to-air weapon range, Alaskan Air Command, U.S. Air Force. (a... enforced by the Commander, Alaskan Air Command, U.S. Air Force, Seattle, Washington, or such agencies as he...

33 CFR 334.1280 - Bristol Bay, Alaska; air-to-air weapon range, Alaskan Air Command, U.S. Air Force.

Code of Federal Regulations, 2014 CFR

2014-07-01

... weapon range, Alaskan Air Command, U.S. Air Force. 334.1280 Section 334.1280 Navigation and Navigable... REGULATIONS § 334.1280 Bristol Bay, Alaska; air-to-air weapon range, Alaskan Air Command, U.S. Air Force. (a... enforced by the Commander, Alaskan Air Command, U.S. Air Force, Seattle, Washington, or such agencies as he...

33 CFR 334.1280 - Bristol Bay, Alaska; air-to-air weapon range, Alaskan Air Command, U.S. Air Force.

Code of Federal Regulations, 2010 CFR

2010-07-01

... weapon range, Alaskan Air Command, U.S. Air Force. 334.1280 Section 334.1280 Navigation and Navigable... REGULATIONS § 334.1280 Bristol Bay, Alaska; air-to-air weapon range, Alaskan Air Command, U.S. Air Force. (a... enforced by the Commander, Alaskan Air Command, U.S. Air Force, Seattle, Washington, or such agencies as he...

33 CFR 334.1280 - Bristol Bay, Alaska; air-to-air weapon range, Alaskan Air Command, U.S. Air Force.

Code of Federal Regulations, 2011 CFR

2011-07-01

... weapon range, Alaskan Air Command, U.S. Air Force. 334.1280 Section 334.1280 Navigation and Navigable... REGULATIONS § 334.1280 Bristol Bay, Alaska; air-to-air weapon range, Alaskan Air Command, U.S. Air Force. (a... enforced by the Commander, Alaskan Air Command, U.S. Air Force, Seattle, Washington, or such agencies as he...

78 FR 63911 - Montana Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926...; S2D2SSS08011000 SX066A00033 F13XS501520] Montana Regulatory Program AGENCY: Office of Surface Mining Reclamation... regulatory program (hereinafter, the ``Montana program'') under the Surface Mining Control and Reclamation...

Public Perceptions of Regulatory Costs, Their Uncertainty and Interindividual Distribution.

PubMed

Johnson, Branden B; Finkel, Adam M

2016-06-01

Public perceptions of both risks and regulatory costs shape rational regulatory choices. Despite decades of risk perception studies, this article is the first on regulatory cost perceptions. A survey of 744 U.S. residents probed: (1) How knowledgeable are laypeople about regulatory costs incurred to reduce risks? (2) Do laypeople see official estimates of cost and benefit (lives saved) as accurate? (3) (How) do preferences for hypothetical regulations change when mean-preserving spreads of uncertainty replace certain cost or benefit? and (4) (How) do preferences change when unequal interindividual distributions of hypothetical regulatory costs replace equal distributions? Respondents overestimated costs of regulatory compliance, while assuming agencies underestimate costs. Most assumed agency estimates of benefits are accurate; a third believed both cost and benefit estimates are accurate. Cost and benefit estimates presented without uncertainty were slightly preferred to those surrounded by "narrow uncertainty" (a range of costs or lives entirely within a personally-calibrated zone without clear acceptance or rejection of tradeoffs). Certain estimates were more preferred than "wide uncertainty" (a range of agency estimates extending beyond these personal bounds, thus posing a gamble between favored and unacceptable tradeoffs), particularly for costs as opposed to benefits (but even for costs a quarter of respondents preferred wide uncertainty to certainty). Agency-acknowledged uncertainty in general elicited mixed judgments of honesty and trustworthiness. People preferred egalitarian distributions of regulatory costs, despite skewed actual cost distributions, and preferred progressive cost distributions (the rich pay a greater than proportional share) to regressive ones. Efficient and socially responsive regulations require disclosure of much more information about regulatory costs and risks. © 2016 Society for Risk Analysis.

7 CFR 1700.32 - Program Accounting and Regulatory Analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 11 2014-01-01 2014-01-01 false Program Accounting and Regulatory Analysis. 1700.32... SERVICE, DEPARTMENT OF AGRICULTURE GENERAL INFORMATION Agency Organization and Functions § 1700.32 Program Accounting and Regulatory Analysis. RUS, through Program Accounting and Regulatory Analysis, monitors and...

7 CFR 1700.32 - Program Accounting and Regulatory Analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 11 2013-01-01 2013-01-01 false Program Accounting and Regulatory Analysis. 1700.32... SERVICE, DEPARTMENT OF AGRICULTURE GENERAL INFORMATION Agency Organization and Functions § 1700.32 Program Accounting and Regulatory Analysis. RUS, through Program Accounting and Regulatory Analysis, monitors and...

Drug Development for Pediatric Populations: Regulatory Aspects

PubMed Central

Zisowsky, Jochen; Krause, Andreas; Dingemanse, Jasper

2010-01-01

Pediatric aspects are nowadays integrated early in the development process of a new drug. The stronger enforcement to obtain pediatric information by the regulatory agencies in recent years resulted in an increased number of trials in children. Specific guidelines and requirements from, in particular, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) form the regulatory framework. This review summarizes the regulatory requirements and strategies for pediatric drug development from an industry perspective. It covers pediatric study planning and conduct, considerations for first dose in children, appropriate sampling strategies, and different methods for data generation and analysis to generate knowledge about the pharmacokinetics (PK) and pharmacodynamics (PD) of a drug in children. The role of Modeling and Simulation (M&S) in pediatrics is highlighted—including the regulatory basis—and examples of the use of M&S are illustrated to support pediatric drug development. PMID:27721363

Clean Air Markets - Facility Attributes and Contacts Query Wizard

EPA Pesticide Factsheets

The Facility Attributes and Contacts Query Wizard is part of a suite of Clean Air Markets-related tools that are accessible at http://camddataandmaps.epa.gov/gdm/index.cfm. The Facility Attributes and Contact module gives the user access to current and historical facility, owner, and representative data using custom queries, via the Facility Attributes Query Wizard, or Quick Reports. In addition, data regarding EPA, State, and local agency staff are also available. The Query Wizard can be used to search for data about a facility or facilities by identifying characteristics such as associated programs, owners, representatives, locations, and unit characteristics, facility inventories, and classifications.EPA's Clean Air Markets Division (CAMD) includes several market-based regulatory programs designed to improve air quality and ecosystems. The most well-known of these programs are EPA's Acid Rain Program and the NOx Programs, which reduce emissions of sulfur dioxide (SO2) and nitrogen oxides (NOx)-compounds that adversely affect air quality, the environment, and public health. CAMD also plays an integral role in the development and implementation of the Clean Air Interstate Rule (CAIR).

Clean Air Markets

EPA Pesticide Factsheets

Clean Air Markets implements regulatory programs such as the Acid Rain Program and the Cross-State Air Pollution Rule to reduce air pollution from the power sector that contributes to human health and environmental issues.

48 CFR 41.402 - Rate changes and regulatory intervention.

Code of Federal Regulations, 2014 CFR

2014-10-01

... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...

48 CFR 41.402 - Rate changes and regulatory intervention.

Code of Federal Regulations, 2010 CFR

2010-10-01

... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...

48 CFR 41.402 - Rate changes and regulatory intervention.

Code of Federal Regulations, 2013 CFR

2013-10-01

... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...

48 CFR 41.402 - Rate changes and regulatory intervention.

Code of Federal Regulations, 2012 CFR

2012-10-01

... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...

48 CFR 41.402 - Rate changes and regulatory intervention.

Code of Federal Regulations, 2011 CFR

2011-10-01

... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...

Environmental Regulatory Update Table, May--June 1994

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

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

1994-07-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, January--February 1993

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

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1993-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, March--April 1994

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

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

1994-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, September--October 1992

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

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

1992-11-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, September/October 1993

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

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1993-11-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operation and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, January--February 1994

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

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1994-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations ad contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table November--December 1994

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

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

1995-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, November--December 1992

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

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

1993-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly wit information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, July--August 1992

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

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

1992-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table July/August 1993

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

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1993-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, March/April 1993

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

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1993-05-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, July/August 1994

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

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

1994-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, November--December 1993

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

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1994-01-01

The Environmental Regulatory Update Table provides information on regulatory of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, May/June 1993

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

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1993-07-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-04

... Concerning Electronic Signatures and Documents AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: FMCSA issues regulatory guidance concerning the... regulatory guidance concerning the use of electronic signatures and documents to comply with FMCSA...

77 FR 40817 - Low-Level Radioactive Waste Regulatory Management Issues

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-11

...-2011-0012] RIN-3150-AI92 Low-Level Radioactive Waste Regulatory Management Issues AGENCY: Nuclear... Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555... State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington...

NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

NASA Technical Reports Server (NTRS)

Scroggins, Sharon; Duda, Kristen

2008-01-01

This viewgraph presentation gives an overview of NASA's risk analysis communication programs associated with changing environmental policies. The topics include: 1) NASA Program Transition; 2) Principal Center for Regulatory Risk Analysis and Communication (RRAC PC); and 3) Regulatory Tracking and Communication Process.

Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.

PubMed

Eichler, Hans-Georg; Bloechl-Daum, Brigitte; Abadie, Eric; Barnett, David; König, Franz; Pearson, Steven

2010-04-01

Drug regulatory agencies have traditionally assessed the quality, safety and efficacy of drugs, and the current paradigm dictates that a new drug should be licensed when the benefits outweigh the risks. By contrast, third-party payers base their reimbursement decisions predominantly on the health benefits of the drug relative to existing treatment options (termed relative efficacy; RE). Over the past decade, the role of payers has become more prominent, and time-to-market no longer means time-to-licensing but time-to-reimbursement. Companies now have to satisfy the sometimes divergent needs of both regulators and payers, and to address RE during the pre-marketing stages. This article describes the current political background to the RE debate and presents the scientific and methodological challenges as they relate to RE assessment. In addition, we explain the impact of RE on drug development, and speculate on future developments and actions that are likely to be required from key players.

Toward a functional definition of a "rare disease" for regulatory authorities and funding agencies.

PubMed

Clarke, Joe T R; Coyle, Doug; Evans, Gerald; Martin, Janet; Winquist, Eric

2014-12-01

The designation of a disease as "rare" is associated with some substantial benefits for companies involved in new drug development, including expedited review by regulatory authorities and relaxed criteria for reimbursement. How "rare disease" is defined therefore has major financial implications, both for pharmaceutical companies and for insurers or public drug reimbursement programs. All existing definitions are based, somewhat arbitrarily, on disease incidence or prevalence. What is proposed here is a functional definition of rare based on an assessment of the feasibility of measuring the efficacy of a new treatment in conventional randomized controlled trials, to inform regulatory authorities and funding agencies charged with assessing new therapies being considered for public funding. It involves a five-step process, involving significant negotiations between patient advocacy groups, pharmaceutical companies, physicians, and public drug reimbursement programs, designed to establish the feasibility of carrying out a randomized controlled trial with sufficient statistical power to show a clinically significant treatment effect. The steps are as follows: 1) identification of a specific disease, including appropriate genetic definition; 2) identification of clinically relevant outcomes to evaluate efficacy; 3) establishment of the inherent variability of measurements of clinically relevant outcomes; 4) calculation of the sample size required to assess the efficacy of a new treatment with acceptable statistical power; and 5) estimation of the difficulty of recruiting an adequate sample size given the estimated prevalence or incidence of the disorder in the population and the inclusion criteria to be used. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

77 FR 28467 - Identifying and Reducing Regulatory Burdens

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-14

... online wherever practicable. Sec. 3. Setting Priorities. In implementing and improving their... regulatory priorities, to promote public participation in retrospective review, to modernize our regulatory..., agencies shall give priority, consistent with law, to those initiatives that will produce significant...

78 FR 11686 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0230] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

78 FR 11686 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0263] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

76 FR 77560 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-13

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0181] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

77 FR 15398 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-15

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0271] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

77 FR 12624 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0263] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

77 FR 69662 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-20

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0172] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

77 FR 69663 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-20

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0155] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

75 FR 20783 - Approval and Promulgation of Implementation Plans: Tennessee; Visibility Impairment Prevention...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-21

...-2010-0150,'' Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management... Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency... at the Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management...

A novel principal component analysis for spatially misaligned multivariate air pollution data.

PubMed

Jandarov, Roman A; Sheppard, Lianne A; Sampson, Paul D; Szpiro, Adam A

2017-01-01

We propose novel methods for predictive (sparse) PCA with spatially misaligned data. These methods identify principal component loading vectors that explain as much variability in the observed data as possible, while also ensuring the corresponding principal component scores can be predicted accurately by means of spatial statistics at locations where air pollution measurements are not available. This will make it possible to identify important mixtures of air pollutants and to quantify their health effects in cohort studies, where currently available methods cannot be used. We demonstrate the utility of predictive (sparse) PCA in simulated data and apply the approach to annual averages of particulate matter speciation data from national Environmental Protection Agency (EPA) regulatory monitors.

77 FR 4461 - New Mexico Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-30

... [SATS No. NM-048-FOR; Docket ID OSM-2010-0014] New Mexico Regulatory Program AGENCY: Office of Surface... approving an amendment to the New Mexico regulatory program (the ``New Mexico program'') under the Surface Mining Control and Reclamation Act of 1977 (``SMCRA'' or ``the Act''). New Mexico proposed non...

7 CFR 371.5 - Marketing and Regulatory Programs Business Services.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 5 2010-01-01 2010-01-01 false Marketing and Regulatory Programs Business Services... AUTHORITY § 371.5 Marketing and Regulatory Programs Business Services. (a) General statement. Marketing and Regulatory Programs Business Services (MRPBS) plans and provides for the agency's human, financial, and...

76 FR 40118 - Spring 2011 Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... Protection Agency (EPA) publishes the semiannual regulatory agenda online (the e-Agenda) at http://www... that, until 2007, was published in the Federal Register but that now is only available through an... publish it in the Federal Register because that is what is required by the Regulatory Flexibility Act of...

77 FR 15090 - Proposed Agency Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-14

... DEPARTMENT OF ENERGY Proposed Agency Information Collection AGENCY: U.S. Department of Energy, DOE... collection of information under the provisions of the Paperwork Reduction Act of 1995. The proposed...: Written comments should be sent to the: DOE Desk Officer, Office of Information and Regulatory Affairs...

48 CFR 2003.101-3 - Agency regulations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Agency regulations. 2003.101-3 Section 2003.101-3 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST Safeguards 2003.101-3 Agency regulations...

48 CFR 2003.101-3 - Agency regulations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Agency regulations. 2003.101-3 Section 2003.101-3 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST Safeguards 2003.101-3 Agency regulations...

14 CFR 399.73 - Definition of small business for Regulatory Flexibility Act.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Definition of small business for Regulatory... Rulemaking Proceedings § 399.73 Definition of small business for Regulatory Flexibility Act. For the purposes... Flexibility Act), a direct air carrier or foreign air carrier is a small business if it provides air...

US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars.

PubMed

McHughen, Alan; Smyth, Stuart

2008-01-01

This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy.

77 FR 19276 - Proposed Agency Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-30

... DEPARTMENT OF ENERGY Proposed Agency Information Collection AGENCY: U.S. Department of Energy, DOE... and Budget (OMB) for clearance, a proposal for collection of information under the provisions of the... should be sent to the DOE Desk Officer, Office of Information and Regulatory Affairs, Office of...

The Emerging Role of Outdoor and Indoor Air Pollution in Cardiovascular Disease

PubMed Central

Uzoigwe, Jacinta C.; Prum, Thavaleak; Bresnahan, Eric; Garelnabi, Mahdi

2013-01-01

Outdoor and indoor air pollution poses a significant cardiovascular risk, and has been associated with atherosclerosis, the main underlying pathology in many cardiovascular diseases. Although, it is well known that exposure to air pollution causes pulmonary disease, recent studies have shown that cardiovascular health consequences of air pollution generally equal or exceed those due to pulmonary diseases. The objective of this article is to evaluate the current evidence on the emerging role of environmental air pollutions in cardiovascular disease, with specific focus on the types of air pollutants and mechanisms of air pollution-induced cardiotoxicity. Published literature on pollution was systematically reviewed and cited in this article. It is hoped that this review will provide a better understanding of the harmful cardiovascular effects induced by air pollution exposure. This will help to bring a better understanding on the possible preventive health measures and will also serve regulatory agencies and researchers. In addition, elucidating the biological mechanisms underlying the link between air pollution and cardiovascular disease is an essential target in developing novel pharmacological strategies aimed at decreasing adverse effects of air pollution on cardiovascular system. PMID:24083218

76 FR 23845 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-28

... draft guide in the agency's ``Regulatory Guide'' series. This series was developed to describe and make... approach that the staff of the NRC considers acceptable for use in developing an appropriate surveillance... steel. The recommendations described in this draft regulatory guide are an approach acceptable to the...

77 FR 8902 - Draft Regulatory Guide: Issuance, Availability Decommissioning of Nuclear Power Reactors

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-15

... Decommissioning of Nuclear Power Reactors AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide... draft regulatory guide (DG) DG-1271 ``Decommissioning of Nuclear Power Reactors.'' This guide describes... Regulatory Guide 1.184, ``Decommissioning of Nuclear Power Reactors,'' dated July 2000. This proposed...

76 FR 39991 - Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... Deregulatory Actions. SUMMARY: The Regulatory Flexibility Act requires that agencies publish semiannual... agencies have chosen to publish their regulatory agendas as part of the Unified Agenda. Editions of the... Published? III. How Is the Unified Agenda Organized? IV. What Information Appears for Each Entry? V...

77 FR 21785 - Medical Countermeasures Initiative Regulatory Science Symposium

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Medical Countermeasures Initiative Regulatory Science Symposium AGENCY: Food and Drug Administration, HHS...: Medical Countermeasures Initiative Regulatory Science Symposium. The symposium is intended to provide a...

Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices

PubMed Central

Rowe, Laura A; Vossenaar, Marieke; Garrett, Greg S

2015-01-01

While fortification of staple foods and condiments has gained enormous global traction, poor performance persists throughout many aspects of implementation, most notably around the critical element of regulatory monitoring, which is essential for ensuring foods meet national fortification standards. Where coverage of fortified foods is high, limited nutritional impact of fortification programs largely exists due to regulatory monitoring that insufficiently identifies and holds producers accountable for underfortified products. Based on quality assurance data from 20 national fortification programs in 12 countries, we estimate that less than half of the samples are adequately fortified against relevant national standards. In this paper, we outline key findings from a literature review, key informant interviews with 11 fortification experts, and semi-quantitative surveys with 39 individuals from regulatory agencies and the food fortification industry in 17 countries on the perceived effectiveness of regulatory monitoring systems and barriers to compliance against national fortification standards. Findings highlight that regulatory agencies and industry disagree on the value that enforcement mechanisms have in ensuring compliance against standards. Perceived political risk of enforcement and poorly resourced inspectorate capacity appear to adversely reinforce each other within an environment of unclear legislation to create a major hurdle for improving overall compliance of fortification programs against national standards. Budget constraints affect the ability of regulatory agencies to create a well-trained inspector cadre and improve the detection and enforcement of non-compliant and underfortified products. Recommendations to improve fortification compliance include improving technical capacity; ensuring sustained leadership, accountability, and funding in both the private and the public sectors; and removing political barriers to ensure consistent detection of

40 CFR 40.115-3 - Interstate agency.

Code of Federal Regulations, 2010 CFR

2010-07-01

... RESEARCH AND DEMONSTRATION GRANTS § 40.115-3 Interstate agency. (a) Under the Clean Air Act, an agency... substantial powers or duties pertaining to the prevention and control of air pollution. (b) Under the Federal... powers or duties pertaining to the control of pollution of waters. (c) Under the Resource Conservation...

Validation of the digital opacity compliance system under regulatory enforcement conditions.

PubMed

McFarland, Michael J; Rasmussen, Steve L; Stone, Daniel A; Palmer, Glenn R; Wander, Joseph D

2006-09-01

U.S. Environmental Protection Agency (EPA) Emission Measurement Center in conjunction with EPA Regions VI and VIII, the state of Utah, and the U.S. Department of Defense have conducted a series of long-term pilot and field tests to determine the accuracy and reliability of a visible opacity monitoring system consisting of a conventional digital camera and a separate computer software application for plume opacity determination. This technology, known as the Digital Opacity Compliance System (DOCS), has been successfully demonstrated at EPA-sponsored Method-9 "smoke schools", as well as at a number of government and commercially operated industrial facilities. Results from the current DOCS regulatory pilot study demonstrated that, under regulatory enforcement conditions, the average difference in opacity measurement between the DOCS technology and EPA Reference Method 9 (Method 9) was 1.12%. This opacity difference, which was computed from the evaluation of 241 regulated air sources, was found to be statistically significant at the 99% confidence level. In evaluating only those sources for which a nonzero visible opacity level was recorded, the

77 FR 59702 - Promoting U.S. EC Regulatory Compatibility

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-28

... TRADE REPRESENTATIVE Promoting U.S. EC Regulatory Compatibility AGENCY: Office of the United... and European Commission (EC) share the goal of reducing excessive regulatory costs, unjustified..., safety, welfare, and the environment. Promoting this goal will help businesses to grow, create jobs, and...

75 FR 21885 - Unified Agenda of Federal Regulatory and Deregulatory Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

... regulatory plan. FOR FURTHER INFORMATION CONTACT: Hada Flowers, Supervisor, Regulatory Secretariat Branch, at... Required: Yes Agency Contact: Hada Flowers, Supervisor, Regulatory Secretariat Branch, Office of...: 202 501-4755 Fax: 202 501-4067 Email: hada.flowers@gsa.gov RIN: 3090-AI32 276. GSAR CASE 2008-G517...

76 FR 40208 - Regulatory Flexibility Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

.... ACTION: Semiannual regulatory agenda. SUMMARY: The Securities and Exchange Commission is publishing an... INFORMATION: The RFA requires each Federal agency, during April and October of each year, to publish in the...

FEDERAL RULEMAKING: Procedural and Analytical Requirements at OSHA and Other Agencies

DTIC Science & Technology

2001-06-14

informal rulemaking. Formal rulemaking is used in ratemaking proceedings and in certain other cases when rules are required by statute to be made “on...crosscutting statutory requirements that I have just listed are by no means the only statutory requirements that guide agency rulemaking. Regulations generally...directives designed to guide the federal rulemaking process, often with the goal of reducing regulatory burden. Although independent regulatory agencies are

Environmental Regulatory Update Table, March/April 1993. Revision 1

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

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1993-05-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Air quality and urban form in U.S. urban areas: evidence from regulatory monitors.

PubMed

Clark, Lara P; Millet, Dylan B; Marshall, Julian D

2011-08-15

The layout of an urban area can impact air pollution via changes in emissions and their spatial distribution. Here, we explore relationships between air quality and urban form based on cross-sectional observations for 111 U.S. urban areas. We employ stepwise linear regression to quantify how long-term population-weighted outdoor concentrations of ozone, fine particulate matter (PM(2.5)), and other criteria pollutants measured by the U.S. Environmental Protection Agency depend on urban form, climate, transportation, city size, income, and region. Aspects of urban form evaluated here include city shape, road density, jobs-housing imbalance, population density, and population centrality. We find that population density is associated with higher population-weighted PM(2.5) concentrations (p < 0.01); population centrality is associated with lower population-weighted ozone and PM(2.5) concentrations (p < 0.01); and transit supply is associated with lower population-weighted PM(2.5) concentrations (p < 0.1). Among pollutants, interquartile range changes in urban form variables are associated with 4%-12% changes in population-weighted concentrations-amounts comparable, for example, to changes in climatic factors. Our empirical findings are consistent with prior modeling research and suggest that urban form could potentially play a modest but important role in achieving (or not achieving) long-term air quality goals.

78 FR 20664 - 2013 Medical Countermeasures Initiative Regulatory Science Symposium

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] 2013 Medical Countermeasures Initiative Regulatory Science Symposium AGENCY: Food and Drug... following meeting: 2013 Medical Countermeasures initiative (MCMi) Regulatory Science Symposium. The...

78 FR 54517 - Water Quality Standards Regulatory Clarifications

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-04

... 131 Water Quality Standards Regulatory Clarifications; Proposed Rule #0;#0;Federal Register / Vol. 78... AGENCY 40 CFR Part 131 [EPA-HQ-OW-2010-0606; FRL-9839-7] RIN 2040-AF 16 Water Quality Standards... Environmental Protection Agency (EPA) is proposing changes to the federal water quality standards (WQS...

Validation and Verification of Operational Land Analysis Activities at the Air Force Weather Agency

NASA Technical Reports Server (NTRS)

Shaw, Michael; Kumar, Sujay V.; Peters-Lidard, Christa D.; Cetola, Jeffrey

2011-01-01

The NASA developed Land Information System (LIS) is the Air Force Weather Agency's (AFWA) operational Land Data Assimilation System (LDAS) combining real time precipitation observations and analyses, global forecast model data, vegetation, terrain, and soil parameters with the community Noah land surface model, along with other hydrology module options, to generate profile analyses of global soil moisture, soil temperature, and other important land surface characteristics. (1) A range of satellite data products and surface observations used to generate the land analysis products (2) Global, 1/4 deg spatial resolution (3) Model analysis generated at 3 hours

78 FR 70905 - Extension of Comment Period for the Water Quality Standards Regulatory Clarifications Proposed Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-27

... Comment Period for the Water Quality Standards Regulatory Clarifications Proposed Rule AGENCY... Environmental Protection Agency (EPA) is extending the comment period for the proposed rule ``Water Quality... published the proposed rule ``Water Quality Standards Regulatory Clarifications'' in the Federal Register...

75 FR 39056 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-07

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0113] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: U.S. Nuclear Regulatory... byproduct, source, or special nuclear material that are ceasing licensed activities and terminating the...

Estimating Air-Manganese Exposures in Two Ohio Towns ...

EPA Pesticide Factsheets

Manganese (Mn), a nutrient required for normal metabolic function, is also a persistent air pollutant and a known neurotoxin at high concentrations. Elevated exposures can result in a number of motor and cognitive deficits. Quantifying chronic personal exposures in residential populations studied by environmental epidemiologists can be time-consuming and expensive. We developed an approach for quantifying chronic exposures for two towns (Marietta and East Liverpool, Ohio) with elevated air Mn concentrations (air-Mn) related to ambient emissions from industrial processes. This was accomplished through the use of measured and modeled data in the communities studied. A novel approach was developed because one of the facilities lacked emissions data for the purposes of modeling. A unit emission rate was assumed over the surface area of both source facilities, and offsite concentrations at receptor residences and air monitoring sites were estimated with the American Meteorological Society/Environmental Protection Agency Regulatory Model (AERMOD). Ratios of all modeled receptor points were created, and a long-running air monitor was identified as a reference location. All ratios were normalized to the reference location. Long-term averages at all residential receptor points were calculated using modeled ratios and data from the reference monitoring location. Modeled five-year average air-Mn exposures ranged from 0.03-1.61 µg/m3 in Marietta and 0.01-6.32 µg/m3 in E

Framework for assessing causality of air pollution-related health effects for reviews of the National Ambient Air Quality Standards.

PubMed

Owens, Elizabeth Oesterling; Patel, Molini M; Kirrane, Ellen; Long, Thomas C; Brown, James; Cote, Ila; Ross, Mary A; Dutton, Steven J

2017-08-01

To inform regulatory decisions on the risk due to exposure to ambient air pollution, consistent and transparent communication of the scientific evidence is essential. The United States Environmental Protection Agency (U.S. EPA) develops the Integrated Science Assessment (ISA), which contains evaluations of the policy-relevant science on the effects of criteria air pollutants and conveys critical science judgments to inform decisions on the National Ambient Air Quality Standards. This article discusses the approach and causal framework used in the ISAs to evaluate and integrate various lines of scientific evidence and draw conclusions about the causal nature of air pollution-induced health effects. The framework has been applied to diverse pollutants and cancer and noncancer effects. To demonstrate its flexibility, we provide examples of causality judgments on relationships between health effects and pollutant exposures, drawing from recent ISAs for ozone, lead, carbon monoxide, and oxides of nitrogen. U.S. EPA's causal framework has increased transparency by establishing a structured process for evaluating and integrating various lines of evidence and uniform approach for determining causality. The framework brings consistency and specificity to the conclusions in the ISA, and the flexibility of the framework makes it relevant for evaluations of evidence across media and health effects. Published by Elsevier Inc.

77 FR 59023 - Preoperational Testing of Instrument and Control Air Systems

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-25

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0065] Preoperational Testing of Instrument and Control Air..., ``Preoperational Testing of Instrument and Control Air Systems.'' This regulatory guide is being revised to address... instrument and control air systems (ICAS) to meet seismic requirement, ICAS air- dryer testing to meet dew...

Improving AirNow Air Quality Products with NASA Near-Real-Time Remote Sensing Data (Invited)

NASA Astrophysics Data System (ADS)

Dye, T.; Pasch, A. N.; DeWinter, J. L.; Haderman, M.; Szykman, J.; White, J. E.; van Donkelaar, A.; Martin, R.

2013-12-01

The U.S. Environmental Protection Agency's (EPA) AirNow program provides the public with real-time and forecasted air quality conditions. Millions of people each day use it to protect their health. The AirNow program (http://www.airnow.gov), reports ground-level ozone (O3) and fine particulate matter (PM2.5) in a standardized index called the Air Quality Index (AQI). AirNow aggregates information from over 130 state, local, and federal air quality agencies and provides tools for over 2,000 agency staff responsible for monitoring, forecasting, and communicating local air quality. Each hour, AirNow systems generate thousands of maps and products. This presentation will describe how AirNow is benefiting from NASA's remote sensing data. We will describe two applications of NASA near-real-time remote sensing data within AirNow through case studies, focusing specifically on days when large spatial gradients in AQI and wildfire smoke impacts were observed. The first case study will show how AirNow is merging satellite-estimated PM2.5 concentrations into the AQI maps via the AirNow Satellite Data Processor (ASDP). AirNow derives these satellite estimates using NASA/NOAA satellite aerosol optical depth (AOD) retrievals and GEOS-Chem modeled ratios of surface PM2.5 concentrations to AOD. The second case study will show how NASA's Global Image Browse Services (GIBS) provides a near-real-time satellite product in AirNow-Tech for agency users to quickly identify smoke plumes and access air quality conditions in data-sparse areas during wildland fires.

75 FR 21773 - Improving Government Regulations; Unified Agenda of Federal Regulatory and Deregulatory Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

... Register is mandated for the regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U... the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because... Flexibility Act. Printing of these entries is limited to fields that contain information required by the...

Australians are not equally protected from industrial air pollution

NASA Astrophysics Data System (ADS)

Dobbie, B.; Green, D.

2015-05-01

Australian air pollution standards are set at national and state levels for a number of chemicals harmful to human health. However, these standards do not need to be met when ad hoc pollution licences are issued by state environment agencies. This situation results in a highly unequal distribution of air pollution between towns and cities, and across the country. This paper examines these pollution regulations through two case studies, specifically considering the ability of the regulatory regime to protect human health from lead and sulphur dioxide pollution in the communities located around smelters. It also considers how the proposed National Clean Air Agreement, once enacted, might serve to reduce this pollution equity problem. Through the case studies we show that there are at least three discrete concerns relating to the current licencing system. They are: non-onerous emission thresholds for polluting industry; temporal averaging thresholds masking emission spikes; and ineffective penalties for breaching licence agreements. In conclusion, we propose a set of new, legally-binding national minimum standards for industrial air pollutants must be developed and enforced, which can only be modified by more (not less) stringent state licence arrangements.

75 FR 18142 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Control of Air Pollution...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-09

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2006-0988; FRL-9135-5] Approval and Promulgation of Air Quality Implementation Plans; Texas; Control of Air Pollution From Motor Vehicles AGENCY... (TAC), Chapter 114, Control of Air Pollution from Motor Vehicles. The State submitted these revisions...

BCI federal legislative & regulatory update

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

NONE

1995-02-01

Several updates on recent government actions that affect the battery industry are outlined. The National Highway Traffic Safety Administration is requesting public comments on how to regulate electric vehicles (EV) with respect to battery electrolyte spillage and electric shock hazard during crashes or rollovers, as well as during repair or maintenance. The Environmental Protection Agency (EPA) was mentioned in two actions: the monitoring rule regarding major sources of air pollution and the reccomendation of reasearch concerning hazardous air pollutants from small stationary sources. OSHA will develop a new standards planning process to ensure that the agency`s limited resources are usedmore » appropriately. This includes a list of fifty workplace hazards or issues that would warrant OSHA action.« less

75 FR 66394 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-28

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0262] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... 10. Abstract: NRC Form 4 is used to record the summary of a radiation worker's cumulative...

78 FR 63249 - OMB Agency Information Collection Activities: Submission for the Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0116] OMB Agency Information Collection Activities: Submission for the Office of Management and Budget Review; Comment Request AGENCY: Nuclear... comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review...

77 FR 75451 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-20

... upgraded licenses or license renewals to operate the controls at a nuclear reactor facility. This... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0184] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory...

33 CFR 334.1300 - Blying Sound area, Gulf of Alaska, Alaska; air-to-air gunnery practice area, Alaskan Air Command...

Code of Federal Regulations, 2014 CFR

2014-07-01

..., Alaska; air-to-air gunnery practice area, Alaskan Air Command, U.S. Air Force. 334.1300 Section 334.1300... gunnery practice area, Alaskan Air Command, U.S. Air Force. (a) The danger zone. A rhomboidal area... Air Command, U.S. Air Force, Anchorage, Alaska, or such agencies as he may designate. (Sec. 7, 40 Stat...

33 CFR 334.1300 - Blying Sound area, Gulf of Alaska, Alaska; air-to-air gunnery practice area, Alaskan Air Command...

Code of Federal Regulations, 2011 CFR

2011-07-01

..., Alaska; air-to-air gunnery practice area, Alaskan Air Command, U.S. Air Force. 334.1300 Section 334.1300... gunnery practice area, Alaskan Air Command, U.S. Air Force. (a) The danger zone. A rhomboidal area... Air Command, U.S. Air Force, Anchorage, Alaska, or such agencies as he may designate. (Sec. 7, 40 Stat...

33 CFR 334.1300 - Blying Sound area, Gulf of Alaska, Alaska; air-to-air gunnery practice area, Alaskan Air Command...

Code of Federal Regulations, 2013 CFR

2013-07-01

..., Alaska; air-to-air gunnery practice area, Alaskan Air Command, U.S. Air Force. 334.1300 Section 334.1300... gunnery practice area, Alaskan Air Command, U.S. Air Force. (a) The danger zone. A rhomboidal area... Air Command, U.S. Air Force, Anchorage, Alaska, or such agencies as he may designate. (Sec. 7, 40 Stat...

33 CFR 334.1300 - Blying Sound area, Gulf of Alaska, Alaska; air-to-air gunnery practice area, Alaskan Air Command...

Code of Federal Regulations, 2012 CFR

2012-07-01

..., Alaska; air-to-air gunnery practice area, Alaskan Air Command, U.S. Air Force. 334.1300 Section 334.1300... gunnery practice area, Alaskan Air Command, U.S. Air Force. (a) The danger zone. A rhomboidal area... Air Command, U.S. Air Force, Anchorage, Alaska, or such agencies as he may designate. (Sec. 7, 40 Stat...

33 CFR 334.1300 - Blying Sound area, Gulf of Alaska, Alaska; air-to-air gunnery practice area, Alaskan Air Command...

Code of Federal Regulations, 2010 CFR

2010-07-01

..., Alaska; air-to-air gunnery practice area, Alaskan Air Command, U.S. Air Force. 334.1300 Section 334.1300... gunnery practice area, Alaskan Air Command, U.S. Air Force. (a) The danger zone. A rhomboidal area... Air Command, U.S. Air Force, Anchorage, Alaska, or such agencies as he may designate. (Sec. 7, 40 Stat...

Air Quality Management Process Cycle

EPA Pesticide Factsheets

Air quality management are activities a regulatory authority undertakes to protect human health and the environment from the harmful effects of air pollution. The process of managing air quality can be illustrated as a cycle of inter-related elements.

Characterization of the evolution of the pharmaceutical regulatory environment.

PubMed

Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

2013-01-01

This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main

10 CFR 76.53 - Consultation with Environmental Protection Agency.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Consultation with Environmental Protection Agency. 76.53 Section 76.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.53 Consultation with Environmental Protection Agency. In reviewing an application for a...

10 CFR 76.53 - Consultation with Environmental Protection Agency.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Consultation with Environmental Protection Agency. 76.53 Section 76.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.53 Consultation with Environmental Protection Agency. In reviewing an application for a...

10 CFR 76.53 - Consultation with Environmental Protection Agency.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Consultation with Environmental Protection Agency. 76.53 Section 76.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.53 Consultation with Environmental Protection Agency. In reviewing an application for a...

10 CFR 76.53 - Consultation with Environmental Protection Agency.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Consultation with Environmental Protection Agency. 76.53 Section 76.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.53 Consultation with Environmental Protection Agency. In reviewing an application for a...

10 CFR 76.53 - Consultation with Environmental Protection Agency.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Consultation with Environmental Protection Agency. 76.53 Section 76.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.53 Consultation with Environmental Protection Agency. In reviewing an application for a...

77 FR 61596 - Illinois Electric Agency; Notice of Filing

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-10

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL13-2-000] Illinois Electric Agency; Notice of Filing Take notice that on October 1, 2012, Illinois Electric Agency filed its Revised and Superseding Proposed Revenue Requirement for reactive supply service under Midwest Independent...

75 FR 63866 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-18

... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0236] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory... compliance with the provisions of the Atomic Energy Act of 1954, as amended. Title II of the Energy...

Monitoring air quality in mountains: Designing an effective network

USGS Publications Warehouse

Peterson, D.L.

2000-01-01

A quantitatively robust yet parsimonious air-quality monitoring network in mountainous regions requires special attention to relevant spatial and temporal scales of measurement and inference. The design of monitoring networks should focus on the objectives required by public agencies, namely: 1) determine if some threshold has been exceeded (e.g., for regulatory purposes), and 2) identify spatial patterns and temporal trends (e.g., to protect natural resources). A short-term, multi-scale assessment to quantify spatial variability in air quality is a valuable asset in designing a network, in conjunction with an evaluation of existing data and simulation-model output. A recent assessment in Washington state (USA) quantified spatial variability in tropospheric ozone distribution ranging from a single watershed to the western third of the state. Spatial and temporal coherence in ozone exposure modified by predictable elevational relationships ( 1.3 ppbv ozone per 100 m elevation gain) extends from urban areas to the crest of the Cascade Range. This suggests that a sparse network of permanent analyzers is sufficient at all spatial scales, with the option of periodic intensive measurements to validate network design. It is imperative that agencies cooperate in the design of monitoring networks in mountainous regions to optimize data collection and financial efficiencies.

Current Regulations and Regulatory Actions

EPA Pesticide Factsheets

This site will provide basic information on clean air permitting under the title V operating permits program, provide access to state and regional permitting programs, and maintain access to proposed and final regulatory requirements.

75 FR 79751 - Improving Government Regulations; Unified Agenda of Federal Regulatory and Deregulatory Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U.S.C. 602), the Department of Defense's printed agenda entries include only: (1) Rules that are in the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because they are likely to have a significant...

How health technology assessment agencies address the issue of unpublished data.

PubMed

Kreis, Julia; Panteli, Dimitra; Busse, Reinhard

2014-01-01

Reporting bias potentially threatens the validity of results in health technology assessment (HTA) reports. Our study aimed to explore policies and practices of HTA agencies regarding strategies to include previously unpublished data in their assessments, focusing on requests to industry for unpublished data. We included international HTA agencies with publicly available methods papers as well as HTA reports. From the methods papers and recent reports we extracted information on requests to industry and on searches in trial registries, regulatory authority Web sites and for conference abstracts. Eighteen HTA agencies and seventy-three reports were included. Agencies' methods papers showed variability regarding requests to industry (requests are routinely carried out in seven cases, not mentioned in six, at the discretion of HTA authors in three, and based on manufacturer applications in two), which were reflected in the reports investigated. As reporting of requests was limited, it often remained unclear whether unpublished data had been received. Searches in trial registries, at regulatory authorities or for conference abstracts are described as a routine or optional part of the search strategy in the methods papers of 9, 11, and 8 included agencies, respectively. A total of 52 percent, 39 percent, and 16 percent of reports described searches in trial registries, at regulatory agencies, and hand searching of conference proceedings. International HTA agencies currently differ considerably in their efforts to address the issue of unpublished data. Requests to industry may constitute one strategy to access and include unpublished data, while agencies can learn from each other concerning successful practice.

Air Quality and Heart Health: Managing an Emerging ...

EPA Pesticide Factsheets

Dr. Cascio will share with a broad range of federal agencies current understanding of the links between air quality and cardiovascular health. The key facts include that air pollution contributes a high attributable health burden. That certain well-defined vulnerable subpopulations are at higher risk. At-risk populations include those with heart disease, lung disease and diabetes, older adults, children and individuals living in low socioeconomic neighborhoods. There is no established threshold level for safe long-term exposure to air particle pollution, and some of the basic biological mechanisms that account for adverse health effects are now known. This knowledge is giving us insight into how we might mitigate the effects apart from the regulatory efforts to improve overall air quality. Moreover, the work that each State has done to improve air quality has resulted in improved health outcomes including cardiovascular outcomes, and longer lives. The presentation will address: 1) What do we know? 2) Who are the at-risk populations? 3) What can communities do to reduce risk? 4) What can healthcare professionals do to reduce risk of the at-risk population? And 5) What tools are available to help healthcare professionals and their patients reduce exposure and risk from air pollutants? The talk will feature a description of the Air Quality Index and associated EPA tools and health information that can be used by health care providers to educate their at-ris

77 FR 25872 - Oklahoma Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

... air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq.) or the Clean Air Act (42 U.S.C. 7401 et seq.). None of the revisions that Oklahoma proposed to... regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Oklahoma...

75 FR 44781 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-29

...; File No. 265-26] Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Commodity... Meeting of Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues. SUMMARY: The Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues will hold a public meeting on August 11, 2010, from 9 a.m...

75 FR 66362 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-28

...; File No. 265-26] Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Commodity... meeting of Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues. SUMMARY: The Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues will hold a public meeting on November 5, 2010, from 9 a.m...

Ambient Air Quality Data Inventory

EPA Pesticide Factsheets

The Office of Air and Radiation's (OAR) Ambient Air Quality Data (Current) contains ambient air pollution data collected by EPA, other federal agencies, as well as state, local, and tribal air pollution control agencies. Its component data sets have been collected over the years from approximately 10,000 monitoring sites, of which approximately 5,000 are currently active. OAR's Office of Air Quality Planning and Standards (OAQPS) and other internal and external users, rely on this data to assess air quality, assist in Attainment/Non-Attainment designations, evaluate State Implementation Plans for Non-Attainment Areas, perform modeling for permit review analysis, and other air quality management functions. Air quality information is also used to prepare reports for Congress as mandated by the Clean Air Act. This data covers air quality data collected after 1980, when the Clean Air Act requirements for monitoring were significantly modified. Air quality data from the Agency's early years (1970s) remains available (see OAR PRIMARY DATA ASSET: Ambient Air Quality Data -- Historical), but because of technical and definitional differences the two data assets are not directly comparable. The Clean Air Act of 1970 provided initial authority for monitoring air quality for Conventional Air Pollutants (CAPs) for which EPA has promulgated National Ambient Air Quality Standards (NAAQS). Requirements for monitoring visibility-related parameters were added in 1977. Requiremen

40 CFR 63.851 - Regulatory authority review procedures.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 11 2014-07-01 2014-07-01 false Regulatory authority review procedures... PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Primary Aluminum Reduction Plants...

40 CFR 63.851 - Regulatory authority review procedures.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 10 2011-07-01 2011-07-01 false Regulatory authority review procedures... PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Primary Aluminum Reduction Plants...

40 CFR 63.851 - Regulatory authority review procedures.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 11 2013-07-01 2013-07-01 false Regulatory authority review procedures... PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Primary Aluminum Reduction Plants...

40 CFR 63.851 - Regulatory authority review procedures.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 11 2012-07-01 2012-07-01 false Regulatory authority review procedures... PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Primary Aluminum Reduction Plants...

Air pollution and cardiovascular disease: a statement for healthcare professionals from the Expert Panel on Population and Prevention Science of the American Heart Association.

PubMed

Brook, Robert D; Franklin, Barry; Cascio, Wayne; Hong, Yuling; Howard, George; Lipsett, Michael; Luepker, Russell; Mittleman, Murray; Samet, Jonathan; Smith, Sidney C; Tager, Ira

2004-06-01

Air pollution is a heterogeneous, complex mixture of gases, liquids, and particulate matter. Epidemiological studies have demonstrated a consistent increased risk for cardiovascular events in relation to both short- and long-term exposure to present-day concentrations of ambient particulate matter. Several plausible mechanistic pathways have been described, including enhanced coagulation/thrombosis, a propensity for arrhythmias, acute arterial vasoconstriction, systemic inflammatory responses, and the chronic promotion of atherosclerosis. The purpose of this statement is to provide healthcare professionals and regulatory agencies with a comprehensive review of the literature on air pollution and cardiovascular disease. In addition, the implications of these findings in relation to public health and regulatory policies are addressed. Practical recommendations for healthcare providers and their patients are outlined. In the final section, suggestions for future research are made to address a number of remaining scientific questions.

EPA's control technology approach to assisting states and regions with air toxics problems: Five case studies

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

Nolen, S.L.; Dimmick, W.F.

1990-10-01

The Environmental Protection Agency (EPA) announced in June 1985 a new strategy to reduce public exposure to toxic air pollutants in the ambient air. Over the next 5-8 years, the strategy called for State and Local authorities to take on more of the lead regulatory role, with the Agency providing technical and financial assistance to their efforts. The shift in emphasis and responsibility from the Federal level to State and Local air toxics programs and the need to transfer expertise from the Federal level to the appropriate State or Local level prompted EPA's Office of Research and Development (ORD) andmore » EPA's Office of Air Quality Planning and Standards (OAQPS) to develop and implement an innovative technical assistance program. This program is called the Control Technology Center (CTC). It has since been expanded to include technical assistance in the area of control of air toxics, particulate matter, and volatile organic compounds (VOCs); emission measurements; and other areas where expertise is available to ORD and OAQPS. During the CTC's first year of operation, operating guidelines were developed and three categories of technical assistance were established. These categories are telephone HOTLINE calls, direct engineering assistance, and technical guidance projects. The CTC HOTLINE is a special telephone number which State and Local Agencies can call for easy access to EPA personnel who can provide prompt assistance in a variety of ways including discussions, references to pertinent literature, and referrals to other EPA personnel. In some cases, a HOTLINE call will require more in-depth engineering analysis indicating a need for direct engineering assistance.« less

Environmental Regulatory Update Table, May/June 1992

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

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

1992-07-01

This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number_sign}.

Environmental Regulatory Update Table, May/June 1992

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

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

1992-07-01

This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number sign}.

77 FR 47060 - Illinois Municipal Electric Agency; Notice of Filing

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-07

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL12-93-000] Illinois Municipal Electric Agency; Notice of Filing Take notice that on July 30, 2012, Illinois Municipal Electric Agency filed a Proposed Revenue Requirement for reactive supply service under Midwest Independent...

78 FR 1646 - Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... provides summary descriptions of regulations being developed by the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council in compliance with Executive Order 12866 ``Regulatory... issuance of changes published in the Federal Register and produced electronically as Federal Acquisition...

Sharing regulatory data as tools for strengthening health systems in the Region of the Americas.

PubMed

Sousa, Varley Dias; Ramalho, Pedro I; Silveira, Dâmaris

2016-05-01

Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the process of building an open government is still fragile and fragmented across various Health Regulatory Agencies (HRAs) and Regional Reference Authorities (RRAs). This study assessed the transparency status of RRAs, focusing on various medicine life-cycle documents (the Medicine Dossier, Clinical Trial Report, and Inspection Report) as tools for strengthening health systems. Based on a narrative (nonsystematic) review of RRA regulatory transparency, transparency status was classified as one of two types: public disclosure of information (intra-agency data) and data- and work-sharing (inter-agency data). The risks/benefits of public disclosure of medicine-related information were assessed, taking into account 1) the involvement and roles of multiple stakeholders (health care professionals, regulators, industry, community, and academics) and 2) the protection of commercial and personal confidential data. Inter-agency data- and work-sharing was evaluated in the context of harmonization and cooperation projects that focus on regulatory convergence. Technical and practical steps for establishing an openness directive for the pharmaceutical regulatory environment are proposed to improve and strengthen health systems in the Americas. Addressing these challenges requires leadership from entities such as the Pan American Health Organization to steer and support collaborative regional alliances that advance the development and establishment of a trustworthy regulatory environment and a sustainable public health system in the Americas, using international successful initiatives as reference and taking into account the domestic characteristics and experiences of each individual country.

Low-Cost Air Quality Monitoring Tools: From Research to Practice (A Workshop Summary)

PubMed Central

Griswold, William G.; RS, Abhijit; Johnston, Jill E.; Herting, Megan M.; Thorson, Jacob; Collier-Oxandale, Ashley; Hannigan, Michael

2017-01-01

In May 2017, a two-day workshop was held in Los Angeles (California, U.S.A.) to gather practitioners who work with low-cost sensors used to make air quality measurements. The community of practice included individuals from academia, industry, non-profit groups, community-based organizations, and regulatory agencies. The group gathered to share knowledge developed from a variety of pilot projects in hopes of advancing the collective knowledge about how best to use low-cost air quality sensors. Panel discussion topics included: (1) best practices for deployment and calibration of low-cost sensor systems, (2) data standardization efforts and database design, (3) advances in sensor calibration, data management, and data analysis and visualization, and (4) lessons learned from research/community partnerships to encourage purposeful use of sensors and create change/action. Panel discussions summarized knowledge advances and project successes while also highlighting the questions, unresolved issues, and technological limitations that still remain within the low-cost air quality sensor arena. PMID:29143775

77 FR 47062 - Kentucky Municipal Power Agency; Notice of Filing

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-07

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL12-94-000] Kentucky Municipal Power Agency; Notice of Filing Take notice that on July 30, 2012, Kentucky Municipal Power Agency filed a Proposed Revenue Requirement for reactive supply service under Midwest Independent Transmission...

77 FR 47060 - Indiana Municipal Power Agency; Notice of Filing

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-07

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL12-97-000] Indiana Municipal Power Agency; Notice of Filing Take notice that on July 30, 2012, Indiana Municipal Power Agency filed a Proposed Revenue Requirement for reactive supply service under Midwest Independent Transmission...

77 FR 61595 - Kentucky Municipal Power Agency; Notice of Filing

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-10

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL13-3-000] Kentucky Municipal Power Agency; Notice of Filing Take notice that on October 1, 2012, Kentucky Municipal Power Agency filed its Revised and Superseding Proposed Revenue Requirement for reactive supply service under...

77 FR 61594 - Indiana Municipal Power Agency; Notice of Filing

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-10

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL13-7-000] Indiana Municipal Power Agency; Notice of Filing Take notice that on October 1, 2012, Indiana Municipal Power Agency filed its Revised and Superseding Proposed Revenue Requirement for reactive supply service under Midwest...

78 FR 44341 - Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-23

... provides summary descriptions of regulations being developed by the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council in compliance with Executive Order 12866 ``Regulatory... Acquisition Circulars (FACs). The electronic version of the FAR, including changes, can be accessed on the FAR...

75 FR 46877 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-04

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-156-FOR; OSM 2010-0004] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... Pennsylvania program (the ``Pennsylvania program'') under the Surface Mining Control and Reclamation Act of...

Current european regulatory perspectives on insulin analogues.

PubMed

Enzmann, Harald G; Weise, Martina

2011-07-07

Insulin analogues are increasingly considered as an alternative to human insulin in the therapy of diabetes mellitus. Insulin analogues (IAs) are chemically different from human insulin and may have different pharmacokinetic or pharmacodynamic properties. The significance of the modifications of the insulin molecule for the safety profile of IAs must be considered. This review describes the regulatory procedure and the expectations for the scientific content of European marketing authorization applications for innovative IAs submitted to the European Medicines Agency. Particular consideration is given to a potential cancer hazard. Specific regulatory guidance on how to address a possible carcinogenic or tumor promoting effect of innovative IAs in non-clinical studies is available. After marketing authorization, the factual access of patients to the new product will be determined to great extent by health technology assessment bodies, reimbursement decisions and the price. Whereas the marketing authorization is a European decision, pricing and reimbursement are national or regional responsibilities. The assessment of benefit and risk by the European Medicines Agency is expected to influence future decisions on price and reimbursement on a national or regional level. Collaborations between regulatory agencies and health technology assessment bodies have been initiated on European and national level to facilitate the use of the European Medicines Agency's benefit risk assessment as basis on which to build the subsequent health technology assessment. The option for combined or joint scientific advice procedures with regulators and health technology assessment bodies on European level or on a national level in several European Member States may help applicants to optimize their development program and dossier preparation in regard of both European marketing authorization application and reimbursement decisions.

5 CFR 110.102 - What are Agency responsibilities?

Code of Federal Regulations, 2011 CFR

2011-01-01

... posting location that best fits their physical layout. Agencies may supplement these postings with... managers and employees of regulatory changes based upon office layout, geographic dispersion of employees...

5 CFR 110.102 - What are Agency responsibilities?

Code of Federal Regulations, 2010 CFR

2010-01-01

... posting location that best fits their physical layout. Agencies may supplement these postings with... managers and employees of regulatory changes based upon office layout, geographic dispersion of employees...

A site-specific screening comparison of modeled and monitored air dispersion and deposition for perfluorooctanoate.

PubMed

Barton, Catherine A; Zarzecki, Charles J; Russell, Mark H

2010-04-01

This work assessed the usefulness of a current air quality model (American Meteorological Society/Environmental Protection Agency Regulatory Model [AERMOD]) for predicting air concentrations and deposition of perfluorooctanoate (PFO) near a manufacturing facility. Air quality models play an important role in providing information for verifying permitting conditions and for exposure assessment purposes. It is important to ensure traditional modeling approaches are applicable to perfluorinated compounds, which are known to have unusual properties. Measured field data were compared with modeling predictions to show that AERMOD adequately located the maximum air concentration in the study area, provided representative or conservative air concentration estimates, and demonstrated bias and scatter not significantly different than that reported for other compounds. Surface soil/grass concentrations resulting from modeled deposition flux also showed acceptable bias and scatter compared with measured concentrations of PFO in soil/grass samples. Errors in predictions of air concentrations or deposition may be best explained by meteorological input uncertainty and conservatism in the PRIME algorithm used to account for building downwash. In general, AERMOD was found to be a useful screening tool for modeling the dispersion and deposition of PFO in air near a manufacturing facility.

U.S. ENVIRONMENTAL PROTECTION AGENCY'S PM SUPERSITES PROGRAM - A MAJOR SUCCESSFUL COLLABORATIVE AIR QUALITY PROGRAM SUPPORTING STATES AND REGIONAL ORGANIZATIONS IN THEIR APPROACHES TO REDUCE PM LEVELS IN AIR ON URBAN AND REGIONAL SCALES

EPA Science Inventory

The U.S. Environmental Protection Agency's Particulate Matter (PM) Supersites Program (Program) is a nationwide air quality methods, measurement, modeling, and data analysis program initiated through cooperative agreements with leading universities in the United States. The Progr...

Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments.

PubMed

Otsubo, Yasuto; Ishiguro, Akihiro; Uyama, Yoshiaki

2013-01-01

Pharmacogenomics-guided drug development has been implemented in practice in the last decade, resulting in increased labeling of drugs with pharmacogenomic information. However, there are still many challenges remaining in utilizing this process. Here, we describe such remaining challenges from the regulatory perspective, specifically focusing on sample collection, biomarker qualification, ethnic factors, codevelopment of companion diagnostics and means to provide drugs for off-target patients. To improve the situation, it is important to strengthen international harmonization and collaboration among academia, industries and regulatory agencies, followed by the establishment of an international guideline on this topic. Communication with a regulatory agency from an early stage of drug development is also a key to success.

78 FR 69100 - Agency Information Collection Activities: Proposed Collection; Comment Request; Request for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-18

... DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA-2013-0045... AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. SUMMARY: The Federal Emergency... written comments to Regulatory Affairs Division, Office of Chief Counsel, DHS/FEMA, 500 C Street SW., Room...

40 CFR 63.851 - Regulatory authority review procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... 63.851 Section 63.851 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Primary Aluminum Reduction Plants...

Pharmacogenomics: a new clinical or regulatory paradigm? European experiences of pharmacogenomics in drug regulation and regulatory initiatives.

PubMed

Prasad, Krishna; Breckenridge, Alasdair

2011-10-01

Are regulatory agencies and processes up to speed? This is an often asked question. Recent advances in science and the improved knowledge of the human genome have a considerable influence on drug development and their impact on the regulatory aspect is also significant for several reasons, including changing stakeholder expectations and treatment paradigms. One of the challenges faced by the regulators is the need to adapt regulatory processes to accommodate the newer methodologies and techniques while ensuring that the biomarkers, tests and/or diagnostics, and the clinical trials are appropriate and fit for purpose. The change in emphasis in pharmacological treatment from a phenotype-based approach to newer methods is attractive but is it ready for universal adoption? This paper details some of the regulatory responses to the developments in this area. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

Longitudinal effects of prenatal exposure to air pollutants on self-regulatory capacities and social competence.

PubMed

Margolis, Amy E; Herbstman, Julie B; Davis, Katie S; Thomas, Valerie K; Tang, Deliang; Wang, Ya; Wang, Shuang; Perera, Frederica P; Peterson, Bradley S; Rauh, Virginia A

2016-07-01

We evaluated the influence of prenatal exposure to widespread urban air pollutants on the development of self-regulation and social competence in a longitudinal prospective cohort of children born to nonsmoking minority women in New York City. Air pollutant exposure was estimated categorically by level of polycyclic aromatic hydrocarbon (PAH)-DNA adducts in maternal blood collected at delivery, providing a biomarker of maternal exposure to PAH over a 2- to 3-month period. Deficient emotional self-regulation (DESR) was defined as moderate elevations on three specific scales of the child behavior checklist (anxious/depressed, aggressive behavior, and attention problems). We used generalized estimating equations to assess the influence of prenatal exposure to PAH on DESR in children at 3-5, 7, 9, and 11 years of age, adjusted for gender and race/ethnicity. Next, we assessed the association of prenatal exposure to PAH with social competence, as measured by the social responsiveness scale (SRS), the association of impaired self-regulation with social competence, and whether impairment in self-regulation mediated the association of prenatal exposure to PAH with social competence. We detected a significant interaction (at p = .05) of exposure with time, in which the developmental trajectory of self-regulatory capacity was delayed in the exposed children. Multiple linear regression revealed a positive association between presence of PAH-DNA adducts and problems with social competence (p < .04), level of dysregulation and problems with social competence (p < .0001), and evidence that self-regulation mediates the association of prenatal exposure to PAH with social competence (p < .0007). These data suggest that prenatal exposure to PAH produces long-lasting effects on self-regulatory capacities across early and middle childhood, and that these deficits point to emerging social problems with real-world consequences for high-risk adolescent behaviors in this minority

Converting Constant Volume, Multizone Air Handling Systems to Energy Efficient Variable Air Volume Multizone Systems

DTIC Science & Technology

2017-10-26

30. Energy Information Agency Natural Gas Price Data ..................................................................................... 65 Figure...different market sectors (residential, commercial, and industrial). Figure 30. Energy Information Agency Natural Gas Price Data 7.2.3 AHU Size...1 FINAL REPORT Converting Constant Volume, Multizone Air Handling Systems to Energy Efficient Variable Air Volume Multizone

Recent regulatory experience of low-Btu coal gasification. Volume III. Supporting case studies

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

Ackerman, E.; Hart, D.; Lethi, M.

The MITRE Corporation conducted a five-month study for the Office of Resource Applications in the Department of Energy on the regulatory requirements of low-Btu coal gasification. During this study, MITRE interviewed representatives of five current low-Btu coal gasification projects and regulatory agencies in five states. From these interviews, MITRE has sought the experience of current low-Btu coal gasification users in order to recommend actions to improve the regulatory process. This report is the third of three volumes. It contains the results of interviews conducted for each of the case studies. Volume 1 of the report contains the analysis of themore » case studies and recommendations to potential industrial users of low-Btu coal gasification. Volume 2 contains recommendations to regulatory agencies.« less

78 FR 1704 - Unified Agenda of Federal Regulatory and Deregulatory Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... semiannual agenda on February 13, 2012 (77 FR 8078). Within each group, the rules are ordered according to... March 11, 2011, earthquake and tsunami. The NRC agenda lists all open rulemaking actions. Four rules... Regulatory Flexibility Analysis Required: Yes. Agency Contact: Solomon Sahle, Nuclear Regulatory Commission...

40 CFR 52.1535 - Original identification of plan section.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Pollution Control Agency. (2) Non-regulatory provisions for retention and availability of air quality data submitted on March 23, 1972, by the New Hampshire Air Pollution Control Agency. (3) Attainment dates of... Pollution Control Agency. (4) Revision of regulation No. 5, section 111.A, limiting sulfur content of fuels...

40 CFR 52.1535 - Original identification of plan section.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Pollution Control Agency. (2) Non-regulatory provisions for retention and availability of air quality data submitted on March 23, 1972, by the New Hampshire Air Pollution Control Agency. (3) Attainment dates of... Pollution Control Agency. (4) Revision of regulation No. 5, section 111.A, limiting sulfur content of fuels...

40 CFR 52.1535 - Original identification of plan section.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Pollution Control Agency. (2) Non-regulatory provisions for retention and availability of air quality data submitted on March 23, 1972, by the New Hampshire Air Pollution Control Agency. (3) Attainment dates of... Pollution Control Agency. (4) Revision of regulation No. 5, section 111.A, limiting sulfur content of fuels...

40 CFR 52.1535 - Original identification of plan section.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Pollution Control Agency. (2) Non-regulatory provisions for retention and availability of air quality data submitted on March 23, 1972, by the New Hampshire Air Pollution Control Agency. (3) Attainment dates of... Pollution Control Agency. (4) Revision of regulation No. 5, section 111.A, limiting sulfur content of fuels...

40 CFR 52.1535 - Original identification of plan section.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Pollution Control Agency. (2) Non-regulatory provisions for retention and availability of air quality data submitted on March 23, 1972, by the New Hampshire Air Pollution Control Agency. (3) Attainment dates of... Pollution Control Agency. (4) Revision of regulation No. 5, section 111.A, limiting sulfur content of fuels...

77 FR 34888 - Kentucky Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-12

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 917 [KY-255-FOR; OSM-2012-0004] Kentucky Regulatory Program AGENCY: Office of Surface Mining Reclamation... Program (hereinafter, the ``Kentucky program'') under the Surface Mining Control and Reclamation Act of...

75 FR 34960 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-155-FOR; OSM 2010-0003] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... ``Pennsylvania program'') under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act...

76 FR 50436 - Kentucky Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 917 [KY-254-FOR; OSM-2011-0005] Kentucky Regulatory Program AGENCY: Office of Surface Mining Reclamation... Program (hereinafter, the ``Kentucky program'') under the Surface Mining Control and Reclamation Act of...

78 FR 38053 - Regulatory Systems Strengthening

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-25

... Science Policy Analysis/Office of International Programs, HFG-1, Food and Drug Administration, 10903 New... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0010] Regulatory Systems Strengthening AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

75 FR 29699 - Approval and Promulgation of Air Quality Implementation Plans: Florida; Approval of Section 110(a...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

... Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental...: Lynorae Benjamin, Chief, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics... Bradley, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management...

THE PITTSBURGH AIR POLLUTION EPISODE OF NOVEMBER 17-21 1975: AIR QUALITY

EPA Science Inventory

In November 1975 a serious air stagnation problem developed over Western Pennsylvania, with extremely heavy air pollution in the Pittsburgh area. The U.S. Environmental Protection Agency's Health Effects Research Laboratory (HERL) mobilized a team of air monitoring and epidemiolo...

The International Agency for Research on Cancer (IARC) evaluation of the carcinogenicity of outdoor air pollution: focus on China.

PubMed

Loomis, Dana; Huang, Wei; Chen, Guosheng

2014-04-01

The International Agency for Research on Cancer (IARC) has classified outdoor air pollution and the particulate matter (PM) in outdoor air pollution as carcinogenic to humans, as based on sufficient evidence of carcinogenicity in humans and experimental animals and strong support by mechanistic studies. The data with important contributions to the evaluation are reviewed, highlighting the data with particular relevance to China, and implications of the evaluation with respect to China are discussed. The air pollution levels in Chinese cities are among the highest observed in the world today and frequently exceed health-based national and international guidelines. Data from high-quality epidemiologic studies in Asia, Europe, and North America consistently show positive associations between lung cancer and PM exposure and other indicators of air pollution, which persist after adjustment for important lung cancer risk factors, such as tobacco smoking. Epidemiologic data from China are limited but nevertheless indicate an increased risk of lung cancer associated with several air pollutants. Excess cancer risk is also observed in experimental animals exposed to polluted outdoor air or extracted PM. The exposure of several species to outdoor air pollution is associated with markers of genetic damage that have been linked to increased cancer risk in humans. Numerous studies from China, especially genetic biomarker studies in exposed populations, support that the polluted air in China is genotoxic and carcinogenic to humans. The evaluation by IARC indicates both the need for further research into the cancer risks associated with exposure to air pollution in China and the urgent need to act to reduce exposure to the population.

The limits of regulatory toxicology

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

Carrington, Clark D.; Bolger, P. Michael, E-mail: mike.bolger@fda.hhs.go

2010-03-01

The Acceptable Daily Intake (ADI) has been used by regulatory and public health organizations (e.g., the U.S. Food and Drug and Administration, and the World Health Organization) for chemicals for more than 50 years. The ADI concept was also initially employed at the U.S. Environmental Protection Agency at its inception in 1971, although with the adoption of newer terminology, it later became known as the Reference Dose (RfD). It is clear from the literature that both were first devised as instruments of regulatory policy. In the intervening years, it has become common to use language that implies that these standardsmore » are statements of scientific fact. Similarly, some of the discretionary or default values that are used to derive regulatory standards are represented as scientific assumptions when in fact they also represent regulatory policy. This confusion impedes both the best use of the available science and informed public participation in policy making. In addition, the misconception of the ADI or the RfD as statements of scientific fact may impede the consideration of alternative means to reduce exposure to chemicals that may be harmful, including regulatory measures that do not involve prescribing a regulatory concentration limit.« less

78 FR 1604 - Department Regulatory Agenda; Semiannual Summary

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... NPRM 06/00/13 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Stephen A Glowacki... 20591, Phone: 202-385-4898, Email: stephen.a.glowacki@faa.gov . RIN: 2120-AJ60 340. +Flight Crewmember...

77 FR 41914 - Approval and Promulgation of Air Quality Implementation Plans; Indiana

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-17

... Promulgation of Air Quality Implementation Plans; Indiana AGENCY: Environmental Protection Agency (EPA). ACTION..., Control Strategies Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West... Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard...

78 FR 27235 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

... Justice in Regulatory Analysis.'' The purpose of this guidance is to provide EPA analysts with technical...-566-2363. Mail: Technical Guidance for Assessing Environmental Justice in Regulatory Analysis... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2013-0320; FRL-9810-5] Technical Guidance for Assessing...

Regulatory accountability: Telecommunications and electricity agencies in the United Kingdom, France and Sweden

NASA Astrophysics Data System (ADS)

Rubinstein, Dorit

2007-12-01

This dissertation examines how administrative agencies deal with multiple and conflicting accountability pressures. Drawing on an empirical study of six agencies, the telecommunications and electricity regulators of the UK, France and Sweden, it describes how the agencies legitimized their behavior in relation to three major issues, network pricing, universal service and retail competition. I find that agencies use different forms of accountability in different circumstances, and suggest a classification of accountability strategies along two dimensions: internalizing v. externalizing authority, and the breadth of the target audience. What explains variations along these dimensions is the task characteristics of the issue an agency is dealing with, and specifically, its informational aspects and the degree of political controversy associated with it. The more an issue requires expertise, the more an agency will seek to rely on its professional judgment. The more an issue can be addressed only in terms of the values surrounding it, the more an agency will seek to externalize authority and defer to other actors. Also, the more politically controversial an issue, the broader the target audience before whom an agency will try to justify itself.

78 FR 62017 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Capital Adequacy...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-11

...The Office of the Comptroller of the Currency (OCC) and Board of Governors of the Federal Reserve System (Board), are adopting a final rule that revises their risk-based and leverage capital requirements for banking organizations. The final rule consolidates three separate notices of proposed rulemaking that the OCC, Board, and FDIC published in the Federal Register on August 30, 2012, with selected changes. The final rule implements a revised definition of regulatory capital, a new common equity tier 1 minimum capital requirement, a higher minimum tier 1 capital requirement, and, for banking organizations subject to the advanced approaches risk-based capital rules, a supplementary leverage ratio that incorporates a broader set of exposures in the denominator. The final rule incorporates these new requirements into the agencies' prompt corrective action (PCA) framework. In addition, the final rule establishes limits on a banking organization's capital distributions and certain discretionary bonus payments if the banking organization does not hold a specified amount of common equity tier 1 capital in addition to the amount necessary to meet its minimum risk-based capital requirements. Further, the final rule amends the methodologies for determining risk-weighted assets for all banking organizations, and introduces disclosure requirements that would apply to top-tier banking organizations domiciled in the United States with $50 billion or more in total assets. The final rule also adopts changes to the agencies' regulatory capital requirements that meet the requirements of section 171 and section 939A of the Dodd-Frank Wall Street Reform and Consumer Protection Act. The final rule also codifies the agencies' regulatory capital rules, which have previously resided in various appendices to their respective regulations, into a harmonized integrated regulatory framework. In addition, the OCC is amending the market risk capital rule (market risk rule) to apply to

5 CFR 792.105 - Agency responsibilities.

Code of Federal Regulations, 2010 CFR

2010-01-01

... (CONTINUED) FEDERAL EMPLOYEES' HEALTH AND COUNSELING PROGRAMS Regulatory Requirements for Alcoholism and Drug Abuse Programs and Services for Federal Civilian Employees § 792.105 Agency responsibilities. (a... counseling and referral services can offer and provide employees who have alcohol and/or drug problems short...

5 CFR 792.105 - Agency responsibilities.

Code of Federal Regulations, 2011 CFR

2011-01-01

... (CONTINUED) FEDERAL EMPLOYEES' HEALTH AND COUNSELING PROGRAMS Regulatory Requirements for Alcoholism and Drug Abuse Programs and Services for Federal Civilian Employees § 792.105 Agency responsibilities. (a... counseling and referral services can offer and provide employees who have alcohol and/or drug problems short...

5 CFR 792.105 - Agency responsibilities.

Code of Federal Regulations, 2012 CFR

2012-01-01

... (CONTINUED) FEDERAL EMPLOYEES' HEALTH AND COUNSELING PROGRAMS Regulatory Requirements for Alcoholism and Drug Abuse Programs and Services for Federal Civilian Employees § 792.105 Agency responsibilities. (a... counseling and referral services can offer and provide employees who have alcohol and/or drug problems short...

76 FR 6587 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-159-FOR; OSM 2010-0017] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). In response to a required...

76 FR 12849 - Kentucky Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

... (underground mining). The text of the Kentucky regulations can be found in the administrative record and online... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 917 [KY-252-FOR; OSM-2009-0011] Kentucky Regulatory Program AGENCY: Office of Surface Mining Reclamation...

77 FR 46346 - Ohio Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-03

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 935 [OH-254-FOR; Docket ID OSM-2012-0012] Ohio Regulatory Program AGENCY: Office of Surface Mining... under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Ohio's proposed...

76 FR 12920 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-157-FOR; OSM 2010-0011] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). In response to a required...

14 CFR 296.5 - Agency relationships.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Agency relationships. 296.5 Section 296.5 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF TRANSPORTATION (AVIATION PROCEEDINGS) ECONOMIC REGULATIONS INDIRECT AIR TRANSPORTATION OF PROPERTY General § 296.5 Agency relationships. An indirect cargo...

77 FR 72432 - Application of Boutique Air, Inc. for Commuter Air Carrier Authority

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-05

... Boutique Air, Inc. for Commuter Air Carrier Authority AGENCY: Department of Transportation. ACTION: Notice... interested persons to show cause why it should not issue an order finding Boutique Air, Inc., fit, willing, and able, and awarding it commuter air carrier authority to conduct scheduled commuter service. DATES...

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).

PubMed

Song, An; Lee, Anita; Garofolo, Fabio; Kaur, Surinder; Duggan, Jeff; Evans, Christopher; Palandra, Joe; Donato, Lorella Di; Xu, Keyang; Bauer, Ronald; Bustard, Mark; Chen, Linzhi; Cocea, Laurent; Croft, Stephanie; Galliccia, Fabrizio; Haidar, Sam; Hughes, Nicola; Ishii-Watabe, Akiko; Islam, Rafiqul; Jones, Barry; Kadavil, John; Krantz, Carsten; Lima Santos, Gustavo Mendes; Olah, Timothy; Pedras-Vasconcelos, João; Staelens, Ludovicus; Saito, Yoshiro; Savoie, Natasha; Scheibner, Kara; Spitz, Susan; Tampal, Nilufer; Thomas, Eric; Vinter, Stephen; Wakelin-Smith, Jason; Welink, Jan; Zeng, Jianing; Zhou, Shaolian

2016-12-01

The 2016 10th Workshop on Recent Issues in Bioanalysis (10 th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis including Biomarkers and Immunogenicity. As usual, it is specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecules involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity. This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This White Paper is published in 3 parts due to length. This part (Part 2) discusses the recommendations for Hybrid LBA/LCMS and regulatory inputs from major global health authorities. Parts 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) have been published in the Bioanalysis journal, issues 22 and 23, respectively.

75 FR 21729 - Semiannual Regulatory Agenda, Spring 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

...This agenda provides summary descriptions of significant and not significant regulations being developed in agencies of the U.S. Department of Agriculture (USDA) in conformance with Executive Order 12866 ``Regulatory Planning and Review.''

Indoor Air Pollution

MedlinePlus

... is known as sick building syndrome. Usually indoor air quality problems only cause discomfort. Most people feel better ... and getting rid of pollutants can improve the quality of your indoor air. Environmental Protection Agency

40 CFR 51.162 - Identification of responsible agency.

Code of Federal Regulations, 2014 CFR

2014-07-01

.... 51.162 Section 51.162 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Sources and Modifications § 51.162 Identification of responsible agency. Each plan must identify the State or local agency which will be responsible for meeting the requirements of this subpart in each area...

40 CFR 51.162 - Identification of responsible agency.

Code of Federal Regulations, 2013 CFR

2013-07-01

.... 51.162 Section 51.162 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Sources and Modifications § 51.162 Identification of responsible agency. Each plan must identify the State or local agency which will be responsible for meeting the requirements of this subpart in each area...

40 CFR 51.162 - Identification of responsible agency.

Code of Federal Regulations, 2012 CFR

2012-07-01

.... 51.162 Section 51.162 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Sources and Modifications § 51.162 Identification of responsible agency. Each plan must identify the State or local agency which will be responsible for meeting the requirements of this subpart in each area...

40 CFR 51.162 - Identification of responsible agency.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... 51.162 Section 51.162 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Sources and Modifications § 51.162 Identification of responsible agency. Each plan must identify the State or local agency which will be responsible for meeting the requirements of this subpart in each area...

40 CFR 51.162 - Identification of responsible agency.

Code of Federal Regulations, 2011 CFR

2011-07-01

.... 51.162 Section 51.162 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Sources and Modifications § 51.162 Identification of responsible agency. Each plan must identify the State or local agency which will be responsible for meeting the requirements of this subpart in each area...

THE USEPA'S LANDFILL RESEARCH AND REGULATORY STRATEGY

EPA Science Inventory

The priorities and initiatives of Environmental Protection Agency's landfill research and regulatory program over the next five years will be described. This will include municipal solid waste landfills as well as abandoned hazardous waste landfills.

Regarding municipals s...

44 CFR 352.21 - Participating Federal agencies.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Department of Defense; (3) Department of Energy; (4) Department of Health and Human Services; (5) Department...; (8) Environmental Protection Agency; (9) Federal Communications Commission; (10) General Services Administration; (11) National Communications System; (12) Nuclear Regulatory Commission; (13) United States...

The European Medicines Agency's strategies to meet the challenges of Alzheimer disease.

PubMed

Haas, Manuel; Mantua, Valentina; Haberkamp, Marion; Pani, Luca; Isaac, Maria; Butlen-Ducuing, Florence; Vamvakas, Spiros; Broich, Karl

2015-04-01

Regulatory agencies have a key role in facilitating the development of new drugs for Alzheimer disease, particularly given the challenges associated with early intervention. Here, we highlight the strategies of the European Medicines Agency to help address such challenges.

Moving new vaccines for tuberculosis through the regulatory process.

PubMed

Brennan, M J

2000-06-01

The development of novel vaccines for the prevention of tuberculosis is an area of intense interest for scientific researchers, public health agencies, and pharmaceutical manufacturers. Development of effective new vaccines directed against tuberculosis for use in target populations will require close cooperation among several different international organizations, including regulatory agencies responsible for evaluating the safety and effectiveness of new biologics for human use.

76 FR 64043 - Iowa Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-17

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 915 [Docket No. IA-016-FOR; Docket ID: OSM-2011-0014] Iowa Regulatory Program AGENCY: Office of Surface Mining.... SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are announcing receipt of a...

78 FR 63909 - Missouri Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 925... 08011000 SX066A00033 F13XS501520] Missouri Regulatory Program AGENCY: Office of Surface Mining Reclamation... hearing on proposed amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM...

The International Agency for Research on Cancer (IARC) evaluation of the carcinogenicity of outdoor air pollution: focus on China

PubMed Central

Loomis, Dana; Huang, Wei; Chen, Guosheng

2014-01-01

The International Agency for Research on Cancer (IARC) has classified outdoor air pollution and the particulate matter (PM) in outdoor air pollution as carcinogenic to humans, as based on sufficient evidence of carcinogenicity in humans and experimental animals and strong support by mechanistic studies. The data with important contributions to the evaluation are reviewed, highlighting the data with particular relevance to China, and implications of the evaluation with respect to China are discussed. The air pollution levels in Chinese cities are among the highest observed in the world today and frequently exceed health-based national and international guidelines. Data from high-quality epidemiologic studies in Asia, Europe, and North America consistently show positive associations between lung cancer and PM exposure and other indicators of air pollution, which persist after adjustment for important lung cancer risk factors, such as tobacco smoking. Epidemiologic data from China are limited but nevertheless indicate an increased risk of lung cancer associated with several air pollutants. Excess cancer risk is also observed in experimental animals exposed to polluted outdoor air or extracted PM. The exposure of several species to outdoor air pollution is associated with markers of genetic damage that have been linked to increased cancer risk in humans. Numerous studies from China, especially genetic biomarker studies in exposed populations, support that the polluted air in China is genotoxic and carcinogenic to humans. The evaluation by IARC indicates both the need for further research into the cancer risks associated with exposure to air pollution in China and the urgent need to act to reduce exposure to the population. PMID:24694836

76 FR 15859 - Reducing Regulatory Burden; Retrospective Review under E.O. 13563

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-22

... Management, at (202) 501- 1777. SUPPLEMENTARY INFORMATION: A. Background Executive Order 13563 directs each..., ineffective, insufficient, or excessively burdensome.'' The EO calls on every agency to develop ``a... modified, streamlined, expanded or repealed to make the agency's regulatory program more effective and or...

78 FR 30770 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Air Quality Standards...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

... Promulgation of Air Quality Implementation Plans; Illinois; Air Quality Standards Revision AGENCY... Illinois state implementation plan (SIP) to reflect current National Ambient Air Quality Standards (NAAQS... Implementation Plan at 35 Illinois Administrative Code part 243, which updates National Ambient Air Quality...

78 FR 29062 - 2006 Biennial Regulatory Review

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-17

... Regulatory Review AGENCY: Federal Communications Commission. ACTION: Correcting amendments. SUMMARY: The Federal Communications Commission published a document in the Federal Register on February 6, 2013 (78 FR... INFORMATION: The Federal Communications Commission published a rule on February 6, 2013 which became effective...

Cleaning up our Federal energy regulatory mess

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

Kennedy, R.T.

1978-08-01

The new Department of Energy is making much effort to cut back on overlaps of regulations in regard to energy. Several governmental agencies were absorbed into DOE, but many of the previous agencies' policies are still on the books. The Energy Reorganization Act of 1977 did not eliminate the problem of regulatory overlap and confusion, the author says. Also, our future national energy policy will have to rest on this very complex of laws and regulations, he says. The author, being a former deputy administrator of the FEA, uses the nuclear industry to discuss ''the confusion.'' He concludes that eachmore » of us ''has a responsibility to clean up the energy regulation situation. Broad national policy issues must be addressed by Congress and the President. The States must focus hard on ways to simplify and strengthen their processes; and Federal agencies must look to ways to improve their interface with the states and to reduce duplication both with the states and with each other. All regulatory agencies must, mindful of their role in the process, police themselves, and keep a close eye on how that process is working. Finally, each government official and citizen must do his part to bring problems and solutions to the attention of the appropriate officials. For you are the watchdogs in this process, the keystone upon which our system rests.'' (MCW)« less

77 FR 66219 - Clearing Agency Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-02

... operation of a registered clearing agency that identify minimum standards designed to enhance the regulatory...'', Securities Exchange Act Release No. 34-66868 (Apr. 27, 2012). Title VII was designed to provide greater... encourage the safe design and operation of entities that provide clearance and settlement services. The FMI...

Air Emissions Inventories

EPA Pesticide Factsheets

This site provides access to emissions data, regulations and guidance, electronic system access, resources and tools to support trends analysis, regional, and local scale air quality modeling, regulatory impact assessments.

77 FR 73966 - Utah Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-12

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 944 [SATS No. UT-049-FOR; Docket ID OSM-2012-0015] Utah Regulatory Program AGENCY: Office of Surface Mining... Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Utah proposes to revise references to...

76 FR 18165 - Request for Public Comments Concerning Regulatory Cooperation Activities That Would Help...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-01

... DEPARTMENT OF COMMERCE International Trade Administration Request for Public Comments Concerning Regulatory Cooperation Activities That Would Help Eliminate or Reduce Unnecessary Regulatory Divergences in North America That Disrupt U.S. Exports AGENCY: International Trade Administration, Commerce. ACTION...

75 FR 1088 - Notice of Availability of a Memorandum of Understanding Between the Nuclear Regulatory Commission...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-08

... NUCLEAR REGULATORY COMMISSION [NRC-2009-0578] Notice of Availability of a Memorandum of Understanding Between the Nuclear Regulatory Commission and the Bureau of Land Management AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Availability. FOR FURTHER INFORMATION CONTACT: Mr. Alan Bjornsen, Project Manager, Environmental Review Branch,...

76 FR 24846 - Approval and Promulgation of Air Quality Implementation Plans; Illinois

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-03

... Promulgation of Air Quality Implementation Plans; Illinois AGENCY: Environmental Protection Agency (EPA... Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. Hand Delivery: Douglas Aburano, Chief, Control Strategies Section, Air...

78 FR 30829 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Air Quality Standards...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

... Promulgation of Air Quality Implementation Plans; Illinois; Air Quality Standards Revision AGENCY... the Illinois State Implementation Plan (SIP) to reflect current national ambient air quality standards...) 692-2450. 4. Mail: Pamela Blakley, Chief, Control Strategies Section, Air Programs Branch (AR-18J), U...

10 CFR 9.62 - Records under control of another Government agency.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Records under control of another Government agency. 9.62 Section 9.62 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Privacy Act Regulations Nrc Procedures... requester with the name of the controlling Government agency, if known, within ten working days after...

10 CFR 9.62 - Records under control of another Government agency.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Records under control of another Government agency. 9.62 Section 9.62 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Privacy Act Regulations Nrc Procedures... requester with the name of the controlling Government agency, if known, within ten working days after...

10 CFR 9.62 - Records under control of another Government agency.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Records under control of another Government agency. 9.62 Section 9.62 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Privacy Act Regulations Nrc Procedures... requester with the name of the controlling Government agency, if known, within ten working days after...

10 CFR 9.62 - Records under control of another Government agency.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Records under control of another Government agency. 9.62 Section 9.62 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Privacy Act Regulations Nrc Procedures... requester with the name of the controlling Government agency, if known, within ten working days after...

10 CFR 9.62 - Records under control of another Government agency.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Records under control of another Government agency. 9.62 Section 9.62 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Privacy Act Regulations Nrc Procedures... requester with the name of the controlling Government agency, if known, within ten working days after...

Enabling Mobile Air Quality App Development with an AirNow API

NASA Astrophysics Data System (ADS)

Dye, T.; White, J. E.; Ludewig, S. A.; Dickerson, P.; Healy, A. N.; West, J. W.; Prince, L. A.

2013-12-01

The U.S. Environmental Protection Agency's (EPA) AirNow program works with over 130 participating state, local, and federal air quality agencies to obtain, quality control, and store real-time air quality observations and forecasts. From these data, the AirNow system generates thousands of maps and products each hour. Each day, information from AirNow is published online and in other media to assist the public in making health-based decisions related to air quality. However, an increasing number of people use mobile devices as their primary tool for obtaining information, and AirNow has responded to this trend by publishing an easy-to-use Web API that is useful for mobile app developers. This presentation will describe the various features of the AirNow application programming interface (API), including Representational State Transfer (REST)-type web services, file outputs, and RSS feeds. In addition, a web portal for the AirNow API will be shown, including documentation on use of the system, a query tool for configuring and running web services, and general information about the air quality data and forecasts available. Data published via the AirNow API includes corresponding Air Quality Index (AQI) levels for each pollutant. We will highlight examples of mobile apps that are using the AirNow API to provide location-based, real-time air quality information. Examples will include mobile apps developed for Minnesota ('Minnesota Air') and Washington, D.C. ('Clean Air Partners Air Quality'), and an app developed by EPA ('EPA AirNow').

Indoor Air Quality in Schools: Clean Air Is Good Business.

ERIC Educational Resources Information Center

Guarneiri, Michele A.

2003-01-01

Describes the effect of poor indoor air quality (IAQ) on student health, the cost of safeguarding good IAQ, the cause of poor IAQ in schools, how to tell whether a school has an IAQ problem, and how the U.S. Environmental Protection Agency can help schools improve indoor air quality though the use of their free "Indoor Air Quality Tools for…

76 FR 6589 - West Virginia Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 948 [WV-116-FOR; OSM-2009-0008] West Virginia Regulatory Program AGENCY: Office of Surface Mining... Mining Reclamation and Enforcement (OSM) characterized the change as non-substantive, and did not note...

Regulatory cross-cutting topics for fuel cycle facilities.

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

Denman, Matthew R.; Brown, Jason; Goldmann, Andrew Scott

This report overviews crosscutting regulatory topics for nuclear fuel cycle facilities for use in the Fuel Cycle Research & Development Nuclear Fuel Cycle Evaluation and Screening study. In particular, the regulatory infrastructure and analysis capability is assessed for the following topical areas: Fire Regulations (i.e., how applicable are current Nuclear Regulatory Commission (NRC) and/or International Atomic Energy Agency (IAEA) fire regulations to advance fuel cycle facilities) Consequence Assessment (i.e., how applicable are current radionuclide transportation tools to support risk-informed regulations and Level 2 and/or 3 PRA) While not addressed in detail, the following regulatory topic is also discussed: Integrated Security,more » Safeguard and Safety Requirement (i.e., how applicable are current Nuclear Regulatory Commission (NRC) regulations to future fuel cycle facilities which will likely be required to balance the sometimes conflicting Material Accountability, Security, and Safety requirements.)« less

78 FR 40013 - Approval and Promulgation of Air Quality Implementation Plans; Illinois

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-03

... Promulgation of Air Quality Implementation Plans; Illinois AGENCY: Environmental Protection Agency (EPA... Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. Hand Delivery: Pamela Blakley, Chief, Control Strategies Section, Air Programs...

75 FR 78646 - Approval and Promulgation of Air Quality Implementation Plans; Minnesota

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-16

... Promulgation of Air Quality Implementation Plans; Minnesota AGENCY: Environmental Protection Agency (EPA...: Douglas Aburano, Chief, Control Strategies Section, Air Programs Branch (AR-18J), U.S. Environmental..., Chief, Control Strategies Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency...

77 FR 61592 - Arkansas Electric Cooperative Corporation; Mississippi Delta Energy Agency; Clarksdale Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-10

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL12-110-000] Arkansas Electric Cooperative Corporation; Mississippi Delta Energy Agency; Clarksdale Public Utilities Commission.... 825(h), Arkansas Electric Cooperative Corporation, Mississippi Delta Energy Agency, and its two...

From molecule to market access: drug regulatory science as an upcoming discipline.

PubMed

Gispen-de Wied, Christine C; Leufkens, Hubertus G M

2013-11-05

Regulatory science as a discipline has evolved over the past years with the object to boost and promote scientific rationale behind benefit/risk and decision making by regulatory authorities. The European Medicines Agency, EMA, the Food and Drug Administration, FDA, and the Japanese Pharmaceutical and Medical Devices Agency, PMDA, highlighted in their distinct ways the importance of regulatory science as a basis of good quality assessment in their strategic plans. The Medicines Evaluation Board, MEB, states: 'regulatory science is the science of developing and validating new standards and tools to evaluate and assess the benefit/risk of medicinal products, facilitating sound and transparent regulatory decision making'. Through analysis of regulatory frameworks itself and their effectiveness, however, regulatory science can also advance knowledge of these systems in general. The comprehensive guidance that is issued to complete an application dossier for regulatory product approval has seldomly been scrutinized for its efficiency. Since it is the task of regulatory authorities to protect and promote public health, it is understood that they take a cautious approach in regulating drugs prior to market access. In general, the authorities are among the first to be blamed if dangerous or useless drugs were allowed to the market. Yet, building a regulatory framework that is not challenged continuously in terms of deliverables for public health and cost-effectiveness, might be counterproductive in the end. Regulatory science and research can help understand how and why regulatory decisions are made, and where renewed discussions may be warranted. The MEB supports regulatory science as an R&D activity to fuel primary regulatory processes on product evaluation and vigilance, but also invests in a 'looking into the mirror' approach. Along the line of the drug life-cycle, publicly available data are reviewed and their regulatory impact highlighted. If made explicit

Lean in Air Permitting Guide

EPA Pesticide Factsheets

The Lean in Air Permitting Guide is designed to help air program managers at public agencies better understand the potential value and results that can be achieved by applying Lean improvement methods to air permitting processes.

Measuring and Modeling the U.S. Regulatory Ecosystem

NASA Astrophysics Data System (ADS)

Bommarito, Michael J., II; Katz, Daniel Martin

2017-09-01

Over the last 23 years, the U.S. Securities and Exchange Commission has required over 34,000 companies to file over 165,000 annual reports. These reports, the so-called "Form 10-Ks," contain a characterization of a company's financial performance and its risks, including the regulatory environment in which a company operates. In this paper, we analyze over 4.5 million references to U.S. Federal Acts and Agencies contained within these reports to measure the regulatory ecosystem, in which companies are organisms inhabiting a regulatory environment. While individuals across the political, economic, and academic world frequently refer to trends in this regulatory ecosystem, far less attention has been paid to supporting such claims with large-scale, longitudinal data. In this paper, in addition to positing a model of regulatory ecosystems, we document an increase in the regulatory energy per filing, i.e., a warming "temperature." We also find that the diversity of the regulatory ecosystem has been increasing over the past two decades. These findings support the claim that regulatory activity and complexity are increasing, and this framework contributes an important step towards improving academic and policy discussions around legal complexity and regulation.

77 FR 12897 - Self-Regulatory Organizations; Pacific Securities Depository Trust Company; Order Cancelling...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-02

...(a)(3) of the Act \\14\\ provides that in the event any self-regulatory organization is no longer in... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66460; File No. 600-10] Self-Regulatory Organizations; Pacific Securities Depository Trust Company; Order Cancelling Clearing Agency Registration...

75 FR 18061 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Control of Air Pollution...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-09

... Promulgation of Air Quality Implementation Plans; Texas; Control of Air Pollution From Motor Vehicles AGENCY... Chapter 114, Control of Air Pollution from Motor Vehicles. These revisions consist of the new Rebate Grant... air pollution regulations and control strategies to ensure that air quality meets the National Ambient...

40 CFR 52.2233 - Significant deterioration of air quality.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., Nashville, Tennessee 37243-1531, or local agencies, Knox County Air Quality Management-Department of Public... quality. 52.2233 Section 52.2233 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Significant deterioration of air quality. (a)(1) Paragraph 1200-3-9-.01(4)-(0)-2. of Tennessee's regulations...

Finding of No Significant Impact: First Air Force Air Operations Center, First Air Force Headquarters/Air Force Forces Center, and Highway 98 Overpass at Tyndall Air Force Base, Florida

DTIC Science & Technology

2004-11-10

found at the following web address: <http://dep.state.fl.us/air/forms/asbestos.htm#asbestos>. The Air Force is advised to contact Sandra Veazey at...advised to contact Sandra Veazey at (850) 595·8300 for additional information on asbestos issues. http://tlhora6.dep.state.fl.us/clearinghouse/agency

SPATIAL PREDICTION OF AIR QUALITY DATA

EPA Science Inventory

Site-specific air quality monitoring data have been used extensively in both scientific and regulatory programs. As such, these data provide essential information to the public, environmental managers, and the atmospheric research community. Currently, air quality management prac...

32 CFR 728.58 - Federal Aviation Agency (FAA) beneficiaries.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 5 2011-07-01 2011-07-01 false Federal Aviation Agency (FAA) beneficiaries. 728.58 Section 728.58 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL... Federal Agencies § 728.58 Federal Aviation Agency (FAA) beneficiaries. (a) Beneficiaries. Air Traffic...

32 CFR 728.58 - Federal Aviation Agency (FAA) beneficiaries.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 5 2013-07-01 2013-07-01 false Federal Aviation Agency (FAA) beneficiaries. 728.58 Section 728.58 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL... Federal Agencies § 728.58 Federal Aviation Agency (FAA) beneficiaries. (a) Beneficiaries. Air Traffic...

32 CFR 728.58 - Federal Aviation Agency (FAA) beneficiaries.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 5 2010-07-01 2010-07-01 false Federal Aviation Agency (FAA) beneficiaries. 728.58 Section 728.58 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL... Federal Agencies § 728.58 Federal Aviation Agency (FAA) beneficiaries. (a) Beneficiaries. Air Traffic...

32 CFR 728.58 - Federal Aviation Agency (FAA) beneficiaries.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 5 2014-07-01 2014-07-01 false Federal Aviation Agency (FAA) beneficiaries. 728.58 Section 728.58 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL... Federal Agencies § 728.58 Federal Aviation Agency (FAA) beneficiaries. (a) Beneficiaries. Air Traffic...

32 CFR 728.58 - Federal Aviation Agency (FAA) beneficiaries.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 5 2012-07-01 2012-07-01 false Federal Aviation Agency (FAA) beneficiaries. 728.58 Section 728.58 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL... Federal Agencies § 728.58 Federal Aviation Agency (FAA) beneficiaries. (a) Beneficiaries. Air Traffic...

Other Agency Actions Related to Title V

EPA Pesticide Factsheets

This site will provide basic information on clean air permitting under the title V operating permits program, provide access to state and regional permitting programs, and maintain access to proposed and final regulatory requirements.

78 FR 23492 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Particulate Matter Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-19

... Promulgation of Air Quality Implementation Plans; Indiana; Particulate Matter Air Quality Standards AGENCY... submission contains the 24-hour fine particle (PM 2.5 ) National Ambient Air Quality Standards (NAAQS..., ``National primary and secondary ambient air quality standards for PM 2.5 .'' In the submission, IDEM has...

77 FR 11164 - Agency Information Collection Activities: Emergency Clearance Submission for the Office of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-24

... seven public meetings to gather stakeholder feedback. Further, the Nuclear Energy Institute provided... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0047] Agency Information Collection Activities...: Nuclear Regulatory Commission. ACTION: Notice of pending NRC action to submit an information collection...

24 CFR 266.505 - Regulatory agreement requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.505 Regulatory agreement requirements. (a) General. (1) The HFA... capital needs. (3) Maintain the project as affordable housing, as defined in § 266.5. (4) Continue to use...

24 CFR 266.505 - Regulatory agreement requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.505 Regulatory agreement requirements. (a) General. (1) The HFA... capital needs. (3) Maintain the project as affordable housing, as defined in § 266.5. (4) Continue to use...

24 CFR 266.505 - Regulatory agreement requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.505 Regulatory agreement requirements. (a) General. (1) The HFA... capital needs. (3) Maintain the project as affordable housing, as defined in § 266.5. (4) Continue to use...

24 CFR 266.505 - Regulatory agreement requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.505 Regulatory agreement requirements. (a) General. (1) The HFA... capital needs. (3) Maintain the project as affordable housing, as defined in § 266.5. (4) Continue to use...

24 CFR 266.505 - Regulatory agreement requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.505 Regulatory agreement requirements. (a) General. (1) The HFA... capital needs. (3) Maintain the project as affordable housing, as defined in § 266.5. (4) Continue to use...

75 FR 14438 - Agency Information Collection Activities; Proposed Collection; Comment Request; NOX

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-25

.... NO X is a prime ingredient in the formation of ground-level ozone (smog), a pervasive air pollution... X Budget Trading Program To Reduce the Regional Transport of Ozone AGENCY: Environmental Protection...) 566-1741. Mail: Air and Radiation Docket and Information Center, Environmental Protection Agency...

Micro-CT imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies - A workshop report.

PubMed

Solomon, Howard M; Makris, Susan L; Alsaid, Hasan; Bermudez, Oscar; Beyer, Bruce K; Chen, Antong; Chen, Connie L; Chen, Zhou; Chmielewski, Gary; DeLise, Anthony M; de Schaepdrijver, Luc; Dogdas, Belma; French, Julian; Harrouk, Wafa; Helfgott, Jonathan; Henkelman, R Mark; Hesterman, Jacob; Hew, Kok-Wah; Hoberman, Alan; Lo, Cecilia W; McDougal, Andrew; Minck, Daniel R; Scott, Lelia; Stewart, Jane; Sutherland, Vicki; Tatiparthi, Arun K; Winkelmann, Christopher T; Wise, L David; Wood, Sandra L; Ying, Xiaoyou

2016-06-01

During the past two decades the use and refinements of imaging modalities have markedly increased making it possible to image embryos and fetuses used in pivotal nonclinical studies submitted to regulatory agencies. Implementing these technologies into the Good Laboratory Practice environment requires rigorous testing, validation, and documentation to ensure the reproducibility of data. A workshop on current practices and regulatory requirements was held with the goal of defining minimal criteria for the proper implementation of these technologies and subsequent submission to regulatory agencies. Micro-computed tomography (micro-CT) is especially well suited for high-throughput evaluations, and is gaining popularity to evaluate fetal skeletons to assess the potential developmental toxicity of test agents. This workshop was convened to help scientists in the developmental toxicology field understand and apply micro-CT technology to nonclinical toxicology studies and facilitate the regulatory acceptance of imaging data. Presentations and workshop discussions covered: (1) principles of micro-CT fetal imaging; (2) concordance of findings with conventional skeletal evaluations; and (3) regulatory requirements for validating the system. Establishing these requirements for micro-CT examination can provide a path forward for laboratories considering implementing this technology and provide regulatory agencies with a basis to consider the acceptability of data generated via this technology. Published by Elsevier Inc.

75 FR 6070 - Notice of Public Meeting on the International Atomic Energy Agency Basic Safety Standards Version...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... Energy Agency Basic Safety Standards Version 3.0, Draft Safety Requirements DS379 AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Public Meeting on the International Atomic Energy Agency Basic... development of U.S. Government comments on this International Atomic Energy Agency (IAEA) draft General Safety...

75 FR 48895 - Approval and Promulgation of Air Quality Implementation Plans; MN

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-12

... Promulgation of Air Quality Implementation Plans; MN AGENCY: Environmental Protection Agency (EPA). ACTION..., Chief, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. Hand Delivery: Jay Bortzer, Chief, Air Programs Branch (AR-18J), U.S...

75 FR 45568 - Approval and Promulgation of Air Quality Implementation Plans; Minnesota

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... Promulgation of Air Quality Implementation Plans; Minnesota AGENCY: Environmental Protection Agency (EPA.... Fax: (312) 629-2054. 4. Mail: Jay Bortzer, Chief, Air Programs Branch (AR-18J), U.S. Environmental..., Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago...

76 FR 23196 - Approval and Promulgation of Air Quality Implementation Plans; IL

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-26

... Promulgation of Air Quality Implementation Plans; IL AGENCY: Environmental Protection Agency (EPA). ACTION... VOC for purposes of preparing SIPs to attain the national ambient air quality standard for ozone under... Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard...

75 FR 65572 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Ohio Ambient Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-26

... Promulgation of Air Quality Implementation Plans; Ohio; Ohio Ambient Air Quality Standards AGENCY... Ohio Administrative Code (OAC) relating to the consolidation of Ohio's Ambient Air Quality Standards... apply to Ohio's SIP. Incorporating the air quality standards into Ohio's SIP helps assure that...

78 FR 64397 - Mississippi Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... text of the program amendment available at www.regulations.gov . A. Mississippi Surface Coal Mining... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 924...; S2D2SSS08011000SX066A00033F13XS501520] Mississippi Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement...

78 FR 66671 - Oklahoma Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-06

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 936...; S2D2SSS08011000SX066A00033F13XS501520] Oklahoma Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement... amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are announcing...

Regulatory decision with EPA/NRC/DOE/State Session (Panel)

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

O`Donnell, E.

1995-12-31

This panel will cover the Nuclear Regulatory Commission`s (NRC) proposed radiation limits in the Branch Technical Position on Low-Level Radioactive Waste Performance Assessment and the Environmental Protection Agency`s (EPA) draft regulation in Part 193. Representatives from NRC and EPA will discuss the inconsistencies in these two regulations. DOE and state representatives will discuss their perspective on how these regulations will affect low-level radioactive waste performance assessments.

Air Force Research Laboratory, Edwards Air Force Base, CA

DTIC Science & Technology

2011-06-27

Air Force Research Laboratory (AFMC) AFRL /RZS 1 Ara Road Edwards AFB CA 93524-7013 AFRL -RZ-ED-VG-2011-269 9...SPONSORING / MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR’S ACRONYM(S) Air Force Research Laboratory (AFMC) AFRL /RZS 11. SPONSOR...Form 298 (Rev. 8-98) Prescribed by ANSI Std. 239.18 Air Force Research Laboratory Ed d Ai F B CA Col Mike Platt war s r orce

76 FR 31997 - Final Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the U.S...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0118] Final Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the U.S. Department of Homeland Security on Chemical Facility Anti-Terrorism Standards AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability. FOR FURTHER...

Air Quality System (AQS) Metadata

EPA Pesticide Factsheets

The U.S. Environmental Protection Agency compiles air quality monitoring data in the Air Quality System (AQS). Ambient air concentrations are measured at a national network of more than 4,000 monitoring stations and are reported by state, local, and tribal

15 CFR 923.47 - Designated State agency.

Code of Federal Regulations, 2011 CFR

2011-01-01

... MANAGEMENT COASTAL ZONE MANAGEMENT PROGRAM REGULATIONS Authorities and Organization § 923.47 Designated State... coordinate other State or local programs, plans and/or policies within the coastal zone; (ii) To what extent... management or regulatory authorities affecting the coastal zone presently are administered by the agency; and...

15 CFR 923.47 - Designated State agency.

Code of Federal Regulations, 2010 CFR

2010-01-01

... MANAGEMENT COASTAL ZONE MANAGEMENT PROGRAM REGULATIONS Authorities and Organization § 923.47 Designated State... coordinate other State or local programs, plans and/or policies within the coastal zone; (ii) To what extent... management or regulatory authorities affecting the coastal zone presently are administered by the agency; and...

Developing regulatory programs for the control of acid precipitation

Treesearch

Michael A. Berry; John D. Bachmann

1976-01-01

The U.S. Clean Air Act provides mechanisms by which the public welfare may be protected from "any known or anticipated adverse effects associated with the presence of (an) air pollutant in the ambient air." The history of the U.S. Environment Protection Agency's (EPA) efforts to establish and defend a secondary ambient air quality standard for sulfur...

Clean Air. It's Up to You, Too.

ERIC Educational Resources Information Center

Environmental Protection Agency, Washington, DC.

Opportunities for citizen participation in federal environmental decisions relative to air pollution and its control are assessed in this booklet. The Environmental Protection Agency (EPA), as the federal agency charged with enforcement of the Clean Air Act, offers guidelines for responsible citizen action. Designed for groups already organized…

77 FR 13589 - Seminole Electric Cooperative, Inc. and Florida Municipal Power Agency v.

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-07

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL12-39-000] Seminole Electric Cooperative, Inc. and Florida Municipal Power Agency v. Florida Power Corporation; Notice of... Cooperative, Inc. and Florida Municipal Power Agency (Complainants) filed a formal complaint against Florida...

75 FR 73026 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Clean Air Interstate Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

... Promulgation of Air Quality Implementation Plans; Indiana; Clean Air Interstate Rule AGENCY: Environmental... State Implementation Plan (SIP) under the Clean Air Act (CAA). The State has submitted amendments to the Indiana Administrative Code (IAC), which supplement Indiana's Clean Air Interstate Rule (CAIR), for which...

75 FR 65594 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Ohio Ambient Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-26

... Promulgation of Air Quality Implementation Plans; Ohio; Ohio Ambient Air Quality Standards AGENCY... the Ohio Administrative Code (OAC) relating to the consolidation of Ohio's Ambient Air Quality Standards (AAQS) into Ohio's State Implementation Plan (SIP) under the Clean Air Act. On April 8, 2009, and...

77 FR 12524 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Lead Ambient Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... Promulgation of Air Quality Implementation Plans; Indiana; Lead Ambient Air Quality Standards AGENCY... Indiana State Implementation Plan (SIP) for lead (Pb) under the Clean Air Act (CAA). This submittal incorporates the National Ambient Air Quality Standards (NAAQS) for Pb promulgated by EPA in 2008. DATES...

Regulatory Intermediation and Quality Assurance in Higher Education: The Case of the Auditors

ERIC Educational Resources Information Center

King, Roger; Griffiths, Paul; Williams, Ruth

2007-01-01

The paper takes the external quality assurance of English universities and colleges as an example of regulation in higher education as undertaken by the Quality Assurance Agency (QAA). Regulatory scholarship generally has been largely disinterested in higher education and the paper applies a "regulatory lens" to higher education quality…

75 FR 51968 - Outer Continental Shelf Air Regulations Consistency Update for Massachusetts

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-24

... comments to: Ida McDonnell, Air Permits, Toxics and Indoor Air Unit, Office of Ecosystem Protection, U.S... INFORMATION CONTACT: Ida E. McDonnell, Air Permits, Toxics and Indoor Air Unit, U.S. Environmental Protection... Continental Shelf Air Regulations Consistency Update for Massachusetts AGENCY: Environmental Protection Agency...

State government regulation of forestry practices applied to nonfederal forests: extent and intensity of agency involvement

Treesearch