Local Governments (Executive Offices) Sector (NAICS 921110)

EPA Pesticide Factsheets

EPA regulatory information for government executive offices, including state implementation plans (SIPs), local emergency planning under EPCRA, drinking water treatment, water supply security, and compliance assistance for boiler & combustion regulations.

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...

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...

78 FR 47574 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery Off the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-06

...-Grouper Fishery Off the Southern Atlantic States; Regulatory Amendment 18 AGENCY: National Marine... rule. SUMMARY: NMFS issues this final rule to implement Regulatory Amendment 18 to the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP) (Regulatory Amendment 18...

77 FR 14861 - Approval and Promulgation of Implementation Plans; State of Nevada; Revised Format for Materials...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-13

...EPA is revising the format for materials submitted by the State of Nevada that are incorporated by reference (IBR) into the Nevada State Implementation Plan (SIP). The regulations affected by this format change have all been previously submitted by the State of Nevada and approved by EPA. This format revision will primarily affect the ``Identification of plan'' section, as well as the format of the SIP materials that will be available for public inspection at the National Archives and Records Administration (NARA), the Air and Radiation Docket and Information Center located at EPA Headquarters in Washington, DC, and the EPA Regional Office. EPA is also adding a table in the ``Identification of plan'' section which summarizes the approval actions that EPA has taken on the non-regulatory and quasi-regulatory portions of the Nevada SIP.

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...

Systematic review of qualitative literature on occupational health and safety legislation and regulatory enforcement planning and implementation.

PubMed

MacEachen, Ellen; Kosny, Agnieszka; Ståhl, Christian; O'Hagan, Fergal; Redgrift, Lisa; Sanford, Sarah; Carrasco, Christine; Tompa, Emile; Mahood, Quenby

2016-01-01

The ability of occupational health and safety (OHS) legislation and regulatory enforcement to prevent workplace injuries and illnesses is contingent on political, economic, and organizational conditions. This systematic review of qualitative research articles considers how OHS legislation and regulatory enforcement are planned and implemented. A comprehensive search of peer-reviewed, English-language articles published between 1990 and 2013 yielded 11 947 articles. We identified 34 qualitative articles as relevant, 18 of which passed our quality assessment and proceeded to meta-ethnographic synthesis. The synthesis yielded four main themes: OHS regulation formation, regulation challenges, inspector organization, and worker representation in OHS. It illuminates how OHS legislation can be based on normative suppositions about worker and employer behavior and shaped by economic and political resources of parties. It also shows how implementation of OHS legislation is affected by "general duty" law, agency coordination, resourcing of inspectorates, and ability of workers to participate in the system. The review identifies methodological gaps and identifies promising areas for further research in "grey" zones of legislation implementation.

78 FR 22198 - Approval and Promulgation of Air Quality Implementation Plans; Charlotte, Raleigh/Durham and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-15

... CONTACT: Richard Wong, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics... organic compounds. Dated: April 3, 2013. A. Stanley Meiburg, Acting Regional Administrator, Region 4. 0...

Draft of the Martin Peña Initative Plan

EPA Pesticide Factsheets

This action plan is being developed so that EPA Region 2 can implement a strategy that focuses its programs and regulatory authorities in activities that comprehensively address the environmental issues affecting the Martin Pena communities.

40 CFR 256.22 - Recommendations for State regulatory powers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 25 2014-07-01 2014-07-01 false Recommendations for State regulatory powers. 256.22 Section 256.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...

40 CFR 256.22 - Recommendations for State regulatory powers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 26 2013-07-01 2013-07-01 false Recommendations for State regulatory powers. 256.22 Section 256.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...

40 CFR 256.21 - Requirements for State regulatory powers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 26 2013-07-01 2013-07-01 false Requirements for State regulatory powers. 256.21 Section 256.21 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...

40 CFR 256.21 - Requirements for State regulatory powers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Requirements for State regulatory powers. 256.21 Section 256.21 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...

40 CFR 256.21 - Requirements for State regulatory powers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 25 2014-07-01 2014-07-01 false Requirements for State regulatory powers. 256.21 Section 256.21 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...

40 CFR 256.22 - Recommendations for State regulatory powers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Recommendations for State regulatory powers. 256.22 Section 256.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...

78 FR 5794 - Occidental Chemical Corporation v. Midwest Independent Transmission System Operator, Inc.; Notice...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

..., violates the Public Utility Regulatory Policies Act of 1978 (PURPA) and the Commission's implementing... rights under PURPA and FERC's implementing regulations and find that the MISO QF Integration Plan is...

77 FR 77117 - Proposed Revision 0 on Access Authorization-Operational Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-31

...--Operational Program AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan-draft section revision... public comment on NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for... seeks comments on the new Section 13.6.4 of the Standard Review Plan (SRP) concerning implementation of...

Biomass Burning Emissions – The Importance of Reducing Uncertainties for Improved Regulatory Decision; an EPA Perspective

EPA Science Inventory

Biomass burning emissions from wildland and prescribed fires can have far reaching impacts in several of EPA’s regulatory programs under the Clean Air Act, ultimately affecting decisions on actions taken under State Implementation Plans (SIPs), and programs such as Visibility and...

78 FR 9073 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

.... Although the Limit Up-Limit Down Plan will be operational during the same time period as the proposed... implementation of the Plan is operational will help to protect against unanticipated consequences. To that end... in connection with the upcoming operation of the Plan to Address Extraordinary Market Volatility...

12 CFR 933.2 - Contents of plan.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Contents of plan. 933.2 Section 933.2 Banks and Banking FEDERAL HOUSING FINANCE BOARD FEDERAL HOME LOAN BANK RISK MANAGEMENT AND CAPITAL STANDARDS BANK... regulatory risk-based capital requirement after the plan is implemented. [66 FR 8310, Jan. 30, 2001, as...

12 CFR 933.2 - Contents of plan.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Contents of plan. 933.2 Section 933.2 Banks and Banking FEDERAL HOUSING FINANCE BOARD FEDERAL HOME LOAN BANK RISK MANAGEMENT AND CAPITAL STANDARDS BANK... regulatory risk-based capital requirement after the plan is implemented. [66 FR 8310, Jan. 30, 2001, as...

77 FR 42688 - Snapper-Grouper Fishery Off the Southern Atlantic States; Snapper-Grouper Management Measures

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... proposed rule to implement a regulatory amendment (Regulatory Amendment 12) to the Fishery Management Plan... can also attach additional files (up to 10MB) in Microsoft Word, Excel, WordPerfect, or Adobe PDF file... benefit to the nation, particularly with respect to providing food production and recreational...

76 FR 23876 - Clarifications to Indian Tribes' Clean Air Act Regulatory Requirements; Direct Final Amendments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-29

... Clarifications to Indian Tribes' Clean Air Act Regulatory Requirements; Direct Final Amendments AGENCY... to amend certain Clean Air Act regulations pertaining to Indian tribes. This action changes the title... Subpart L, which includes provisions specific to implementation plans for tribes located in EPA Region IX...

78 FR 9100 - Self-Regulatory Organizations; NASDAQ OMX BX Inc.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

... of investors and the public interest. Although the Limit Up-Limit Down Plan will be operational... pilot for at least through the phased implementation of the Plan is operational will help to protect... determine whether Rule 11890 is necessary once the Plan is operational and, if so, whether improvements can...

78 FR 9086 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

... of investors and the public interest. Although the Limit Up-Limit Down Plan will be operational... Pilot for at least through the phased implementation of the Plan is operational will help to protect... whether Rule 11.13 is necessary once the Plan is operational and, if so, whether improvements can be made...

78 FR 9076 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

... of investors and the public interest. Although the Limit Up-Limit Down Plan will be operational... pilot for at least through the phased implementation of the Plan is operational will help to protect... whether Rule 52.4 is necessary once the Plan is operational and, if so, whether improvements can be made...

78 FR 9081 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

...(b). \\11\\ 15 U.S.C. 78f(b)(5). Although the Limit Up-Limit Down Plan will be operational during the... at least through the phased implementation of the Plan is operational will help to protect against... 9083

Voluntary coordination as a strategy of plan implementation for health systems agencies.

PubMed

Berry, D E; Candia, G R

1979-10-01

Health planning agencies are faced with the difficult mission of guiding change within a large complex social system whose power is dispersed. Initial short- and long-range plans have been established as frameworks, and now the major focus is implementation. Regulation (non-voluntary coordination) and voluntary coordination are the major means of implementation. Voluntary coordination is a significant strategy for consideration by Health Systems Agencies (HSAs). It may interact with regulation as a competitor, substitute, or complement. Because of limited regulatory powers, HSAs are dependent upon voluntary coordination as a major means of influencing behavior. Conflict, a major feature of voluntary coordination, has the potential of being used as a constructive means for dialogue; negotiation and bargaining may become positive approaches to arriving at decisions. Legitimized community authority is the primary source of authority in a strategy dominated by voluntary coordination as contrasted to state or federal mandates in a regulatory strategy. Knowledge of the environment within which the HSA operates will assist HSA staff and board to arrive at rational and realistic decisions.

Urban family physician plan in Iran: challenges of implementation in Kerman.

PubMed

Dehnavieh, Reza; Kalantari, Ali Reza; Jafari Sirizi, Mohammad

2015-01-01

The Family Physician Plan has recently been implemented in three provinces of Iran on a pilot basis and is going to be implemented throughout Iran in the future. Through a qualitative design, this study aims to determine probable implementation challenges of Family Physician Plan in Kerman. This study was conducted in Kerman in 2013. Data were collected through interviews with 21 experts in the field. Sampling continued until data saturation level was achieved. All interviews were recorded and then analyzed, and main themes and subgroups were extracted from them based on a framework analysis model. most prevalent establishment challenges of Family Physician Plan were classified into policy-making, financial supply, laws and resources. The urban Family Physician Plan can be carried out more effectively by implementing this plan step by step, highlighting the relationships between the related organizations, using new payment mechanisms e.g Per Capita, DRG, make national commitment and proper educational programs for providers, development the health electronic Record, justifying providers and community about advantages of this plan, clarifying regulatory status about providers' Duties and most importantly considering a specific funding source.

40 CFR 96.287 - Change in regulatory status.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR SO2 Opt-in Units § 96.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in unit becomes a CAIR SO2 unit under § 96.204, then the CAIR designated representative shall notify in writing...

40 CFR 52.1960 - Original Identification of plan section.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., 1972. (Non-regulatory) (7) Sections 16.1, 16.3, and 16.5 of Regulation No. 16, “Control of Emissions of... plan revision designed to achieve the ozone standard in Tulsa County, including control strategy... Quality Control Implementation Plan” and all revisions submitted by Oklahoma that were federally approved...

40 CFR 52.1960 - Original Identification of plan section.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., 1972. (Non-regulatory) (7) Sections 16.1, 16.3, and 16.5 of Regulation No. 16, “Control of Emissions of... plan revision designed to achieve the ozone standard in Tulsa County, including control strategy... Quality Control Implementation Plan” and all revisions submitted by Oklahoma that were federally approved...

40 CFR 52.1960 - Original Identification of plan section.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., 1972. (Non-regulatory) (7) Sections 16.1, 16.3, and 16.5 of Regulation No. 16, “Control of Emissions of... plan revision designed to achieve the ozone standard in Tulsa County, including control strategy... Quality Control Implementation Plan” and all revisions submitted by Oklahoma that were federally approved...

40 CFR 52.1960 - Original Identification of plan section.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., 1972. (Non-regulatory) (7) Sections 16.1, 16.3, and 16.5 of Regulation No. 16, “Control of Emissions of... plan revision designed to achieve the ozone standard in Tulsa County, including control strategy... Quality Control Implementation Plan” and all revisions submitted by Oklahoma that were federally approved...

Characterization of cotton gin particulate matter emissions – project plan

USDA-ARS?s Scientific Manuscript database

In 2006, EPA implemented a more stringent standard for particulate matter with an effective diameter less than 2.5 microns (PM2.5). The implementation timeline for this standard will vary by state/district regulatory agency. For example, the San Joaquin Valley Air Pollution Control District, has pro...

Characterization of cotton gin particulate matter emissions - project plan

USDA-ARS?s Scientific Manuscript database

In 2006, EPA implemented a more stringent standard for particulate matter with an effective diameter less than 2.5 microns (PM2.5). The implementation time line for this standard will vary by state/district regulatory agency. For example, the San Joaquin Valley Air Pollution Control District has pro...

Environmental Implementation Plan

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

Not Available

1993-03-15

The purpose of the Environmental Implementation Plan (EIP) is to show the current and future (five years) environmental plans from individual site organizations and divisions, as well as site environmental programs and initiatives which are designed to protect the environment and meet or exceed changing environmental/regulatory requirements. Communicating with site organizations, departments, and committees is essential in making the site`s environmental-planning process work. The EIP gives the site the what, when, how, and why for environmental requirements. Through teamwork and proactive planning, a partnership for environmental excellence is formed to achieve the site vision for SRS to become the recognizedmore » model for Environmental Excellence in the Department of Energy`s Nuclear Weapons Complex.« less

Environmental Implementation Plan

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

Not Available

1993-03-15

The purpose of the Environmental Implementation Plan (EIP) is to show the current and future (five years) environmental plans from individual site organizations and divisions, as well as site environmental programs and initiatives which are designed to protect the environment and meet or exceed changing environmental/regulatory requirements. Communicating with site organizations, departments, and committees is essential in making the site's environmental-planning process work. The EIP gives the site the what, when, how, and why for environmental requirements. Through teamwork and proactive planning, a partnership for environmental excellence is formed to achieve the site vision for SRS to become the recognizedmore » model for Environmental Excellence in the Department of Energy's Nuclear Weapons Complex.« less

76 FR 25652 - Approval and Promulgation of Air Quality Implementation Plans; North Dakota; Revisions to the Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-05

...EPA is proposing to approve revisions to the North Dakota State Implementation Plan that the Governor of North Dakota submitted with a letter dated April 6, 2009. The revisions affect North Dakota's air pollution control rules regarding general provisions (including rules regarding shutdowns and malfunctions), ambient air quality standards, emissions of particulate matter, permitting, and fees. In addition, EPA is proposing administrative corrections to the regulatory text for North Dakota that will be codified in the Code of Federal Regulations; we made errors in the identification of plan table when we approved the North Dakota State Implementation Plan revisions for Interstate Transport of pollution, which the Governor also submitted on April 6, 2009. This action is being taken under section 110 of the Clean Air Act.

Underground storage tank management plan

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

NONE

1994-09-01

The Underground Storage Tank (UST) Management Program at the Oak Ridge Y-12 Plant was established to locate UST systems in operation at the facility, to ensure that all operating UST systems are free of leaks, and to establish a program for the removal of unnecessary UST systems and upgrade of UST systems that continue to be needed. The program implements an integrated approach to the management of UST systems, with each system evaluated against the same requirements and regulations. A common approach is employed, in accordance with Tennessee Department of Environment and Conservation (TDEC) regulations and guidance, when corrective actionmore » is mandated. This Management Plan outlines the compliance issues that must be addressed by the UST Management Program, reviews the current UST inventory and compliance approach, and presents the status and planned activities associated with each UST system. The UST Management Plan provides guidance for implementing TDEC regulations and guidelines for petroleum UST systems. (There are no underground radioactive waste UST systems located at Y-12.) The plan is divided into four major sections: (1) regulatory requirements, (2) implementation requirements, (3) Y-12 Plant UST Program inventory sites, and (4) UST waste management practices. These sections describe in detail the applicable regulatory drivers, the UST sites addressed under the Management Program, and the procedures and guidance used for compliance with applicable regulations.« less

76 FR 10544 - Approval and Promulgation of Air Quality Implementation Plans, State of Louisiana

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-25

..., were submitted by the State of Louisiana, and include formatting changes, regulatory wording changes... available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the Air Planning Section (6PD- L), Environmental Protection...

Urban family physician plan in Iran: challenges of implementation in Kerman

PubMed Central

Dehnavieh, Reza; Kalantari, Ali Reza; Jafari Sirizi, Mohammad

2015-01-01

Background: The Family Physician Plan has recently been implemented in three provinces of Iran on a pilot basis and is going to be implemented throughout Iran in the future. Through a qualitative design, this study aims to determine probable implementation challenges of Family Physician Plan in Kerman. Methods: This study was conducted in Kerman in 2013. Data were collected through interviews with 21 experts in the field. Sampling continued until data saturation level was achieved. All interviews were recorded and then analyzed, and main themes and subgroups were extracted from them based on a framework analysis model. Results: most prevalent establishment challenges of Family Physician Plan were classified into policy-making, financial supply, laws and resources. Conclusion: The urban Family Physician Plan can be carried out more effectively by implementing this plan step by step, highlighting the relationships between the related organizations, using new payment mechanisms e.g Per Capita, DRG, make national commitment and proper educational programs for providers, development the health electronic Record, justifying providers and community about advantages of this plan, clarifying regulatory status about providers' Duties and most importantly considering a specific funding source. PMID:26913266

DOE's Remote-Handled TRU Waste Characterization Program: Implementation Plan

EPA Pesticide Factsheets

Remote-handled (RH) transuranic (TRU) waste characterization, which involves obtaining chemical, radiological, and physical data, is a primary component of ensuring compliance of the Waste Isolation Pilot Plant (WIPP) with regulatory requirements.

Premise to Implement a Grading System to Evaluate the Sanitary Level in Food Service Establishments in Milan, Italy

PubMed Central

Razzini, Katia

2015-01-01

The regulatory framework of the official controls on food safety, the criteria and methods from the planning of interventions in the field of official control to the management of information flows, and the standards described in the operation manual of the local competent authorities drafted by the Lombardy Region (2011) were evaluated. A questionnaire consisting of n. 10 questions with multiple answers draft in partnership with EPAM (the Association of Provincial Public Retail and catering businesses in Milan) to n. 107 Food service establishments of Milan shows that 92% of managers approve the introduction of a grading system. The regulatory framework is planned to support the implementation of risk assignment, unfortunately the attribution of risk category of retail and catering businesses is still different among regions. PMID:27800403

Development of Physical Protection Regulations for Rosatom State Corporation Sites under the U.S.-Russian MPC&A Program

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

Izmaylov, Alexander; Babkin, Vladimir; Shemigon, Nikolai N.

2012-07-14

This paper describes issues related to upgrading the physical protection regulatory basis for Rosatom State Corporation sites. It is underlined that most of the regulatory and methodological documents for this subject area have been developed under the U.S.-Russian MPC&A Program. According to the joint management plan developed and agreed upon by the parties in 2005, nearly 50 physical protection documents were identified to be developed, approved and implemented at Rosatom sites by 2012. It is also noted that, on the whole, the plans have been fulfilled.

CINRG: Infrastructure for Clinical Trials in Duchenne Dystrophy

DTIC Science & Technology

2013-09-01

research centers sharing a common goal of improving the quality of life of neuromuscular disease patients by cooperative planning , implementation, analysis...discrepancies were noted surrounding the regulatory binder, consent process and data records. The site personnel have a scheduled plan with the CINRG CC...missing long term follow-up visits). The project manager also reviewed the study records to date while onsite. A high priority plan was developed with the

78 FR 54835 - Air Quality Implementation Plan; Alabama; Attainment Plan for the Troy Area 2008 Lead...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-06

... input options commensurate with the Regulatory Modeling Guidance. Perform current and post control.... Table 2--Post-Control Modeling Results \\4\\ Sanders lead facility Max 3-mth Background Total Year maximum...\\ (Facility MET data). The post-control analysis resulted in a predicted impact of 0.15 [mu]g/m\\3\\ (NWS MET...

78 FR 47259 - Approval and Promulgation of Implementation Plans; Washington: Thurston County Second 10-Year PM10

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-05

... Washington State Department of Ecology (Ecology) regulatory changes that strengthen the control measures... Standard (NAAQS) on August 7, 1987 (52 FR 29383). Ecology and ORCAA worked with the communities of Lacey... requirements imposed by the 1990 CAA Amendments, Ecology submitted a supplement to the attainment plan in...

Supporting the self-regulatory resource: does conscious self-regulation incidentally prime nonconscious support processes?

PubMed

Dorris, Derek C

2009-11-01

Ego-depletion (depletion of self-regulatory strength) can impair conscious efforts at self-regulation. Research into nonconscious self-regulation has demonstrated that preconscious automaticity and implementation intentions can automatically carry out regulatory tasks during times of ego-depletion. However, preconscious automaticity can only emerge during well-practiced tasks while implementation intentions can only support tasks that have been explicitly planned. Thus, when it comes to supporting the conscious self-regulation of nonroutine and unplanned behaviour during times of ego-depletion these processes should be ineffective. However, it is argued here that because the conscious self-regulation of nonroutine and unplanned behaviour can incidentally prime the underlying mental representations those primed representations can be postconsciously re-activated to support that behaviour during times of ego-depletion. Postconscious self-regulation might, therefore, support a type of self-regulatory behaviour that has, thus far, not been associated with any form of support.

NUTRIENT RESPONSE IN GREAT LAKES WETLANDS

EPA Science Inventory

The U.S. EPA National Health and Environmental Effects Laboratory's Aquatic Stressor Framework and associated Nutrient Implementation Plan define scientific and regulatory needs, and lay-out research goals too for a cross divisional program to investigate stressor-response relati...

Factors Influencing Acceptability and Perceived Impacts of a Mandatory ePortfolio Implemented by an Occupational Therapy Regulatory Organization.

PubMed

Vachon, Brigitte; Foucault, Marie-Lyse; Giguère, Charles-Édouard; Rochette, Annie; Thomas, Aliki; Morel, Martine

2018-01-01

The use of ePortfolios has been implemented in several regulatory organizations to encourage clinicians' engagement in continuing professional development (CPD). However, their use has achieved mixed success, and multiple personal and contextual factors can influence their impacts on practice change. The aim of this study was to identify which factors influence the acceptability and perceived impacts of an ePortfolio implemented by an occupational therapy regulatory organization in one Canadian province. A cross-sectional online survey design was used. The survey was sent to registered occupational therapists in Quebec. Multiple regression analyses were conducted to identify factors influencing acceptability and outcomes: ease of use, satisfaction, impact on implementation of the CPD plan, and competence improvement. The survey was fully completed by 546 participants. Factors significantly influencing the ePortfolio acceptability and perceived impacts were attitude toward and familiarity with the portfolio, confidence in reflective skills, engagement in the CPD plan, and desire for feedback. Time spent completing the ePortfolio and the fact of completing it in teams were negatively associated with the outcomes. Shaping more favorable user attitudes, helping users recognize and experience the tool's benefits for their practice, and fostering confidence in their reflective skills are important factors that can be addressed to improve ePortfolio acceptability and outcomes. Contextual factors, such as time spent completing the ePortfolio and completing it in teams, seem to reflect greater difficulty with using the tool. Study findings can contribute to improving ePortfolio implementation in the CPD context.

Technical approach to groundwater restoration. Final report

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

Not Available

1993-11-01

The Technical Approach to Groundwater Restoration (TAGR) provides general technical guidance to implement the groundwater restoration phase of the Uranium Mill Tailings Remedial Action (UMTRA) Project. The TAGR includes a brief overview of the surface remediation and groundwater restoration phases of the UMTRA Project and describes the regulatory requirements, the National Environmental Policy Act (NEPA) process, and regulatory compliance. A section on program strategy discusses program optimization, the role of risk assessment, the observational approach, strategies for meeting groundwater cleanup standards, and remedial action decision-making. A section on data requirements for groundwater restoration evaluates the data quality objectives (DQO) andmore » minimum data required to implement the options and comply with the standards. A section on sits implementation explores the development of a conceptual site model, approaches to site characterization, development of remedial action alternatives, selection of the groundwater restoration method, and remedial design and implementation in the context of site-specific documentation in the site observational work plan (SOWP) and the remedial action plan (RAP). Finally, the TAGR elaborates on groundwater monitoring necessary to evaluate compliance with the groundwater cleanup standards and protection of human health and the environment, and outlines licensing procedures.« less

78 FR 32131 - Revision to the Washington State Implementation Plan; Tacoma-Pierce County Nonattainment Area

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-29

... Particles in the Wapato Hills-Puyallup River Valley PM2.5 Nonattainment Area (the name formerly used for the...]. * * * * * * * * * * * * (e) * * * State of Washington Nonregulatory Provisions and Quasi-Regulatory Measures Applicable Name...

Regulation to Create Environments Conducive to Physical Activity: Understanding the Barriers and Facilitators at the Australian State Government Level

PubMed Central

Shill, Jane; Mavoa, Helen; Crammond, Brad; Loff, Bebe; Peeters, Anna; Lawrence, Mark; Allender, Steven; Sacks, Gary; Swinburn, Boyd A.

2012-01-01

Introduction Policy and regulatory interventions aimed at creating environments more conducive to physical activity (PA) are an important component of strategies to improve population levels of PA. However, many potentially effective policies are not being broadly implemented. This study sought to identify potential policy/regulatory interventions targeting PA environments, and barriers/facilitators to their implementation at the Australian state/territory government level. Methods In-depth interviews were conducted with senior representatives from state/territory governments, statutory authorities and non-government organisations (n = 40) to examine participants': 1) suggestions for regulatory interventions to create environments more conducive to PA; 2) support for preselected regulatory interventions derived from a literature review. Thematic and constant comparative analyses were conducted. Results Policy interventions most commonly suggested by participants fell into two areas: 1) urban planning and provision of infrastructure to promote active travel; 2) discouraging the use of private motorised vehicles. Of the eleven preselected interventions presented to participants, interventions relating to walkability/cycling and PA facilities received greatest support. Interventions involving subsidisation (of public transport, PA-equipment) and the provision of more public transport infrastructure received least support. These were perceived as not economically viable or unlikely to increase PA levels. Dominant barriers were: the powerful ‘road lobby’, weaknesses in the planning system and the cost of potential interventions. Facilitators were: the provision of evidence, collaboration across sectors, and synergies with climate change/environment agendas. Conclusion This study points to how difficult it will be to achieve policy change when there is a powerful ‘road lobby’ and government investment prioritises road infrastructure over PA-promoting infrastructure. It highlights the pivotal role of the planning and transport sectors in implementing PA-promoting policy, however suggests the need for clearer guidelines and responsibilities for state and local government levels in these areas. Health outcomes need to be given more direct consideration and greater priority within non-health sectors. PMID:23028434

OVERVIEW AND STATUS OF THE PM SUPERSITES PROGRAM

EPA Science Inventory

The PM Supersites program was first conceived as a set of special studies extending beyond the national regulatory networks for particulate matter (PM) to elucidate source-receptor relationships and atmospheric processes in support of State implementation plans (SIP's). The pr...

78 FR 41311 - Approval of Air Quality Implementation Plans; Indiana; Approval of “Infrastructure” SIP With...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-10

... Elements Required Under Sections 110(a)(1) and (2) for the 2006 24-Hour Fine Particle (PM 2.5 ) National... Indiana Nonregulatory and Quasi-Regulatory Provisions Title Indiana date EPA approval Explanation...

Goals, obstacles and effective strategies of wildfire mitigation programs in the Wildland-Urban Interface

Treesearch

Margaret A. Reams; Terry K. Haines; Cheryl R. Renner; Michael W. Wascom; Harish Kingre

2005-01-01

The dramatic expansion into the Wildland–Urban Interface (WUI) places property, natural assets, and human life at risk from wildfire destruction. The U.S. National Fire Plan encourages communities to implement laws and outreach programs for pre-fire planning to mitigate the risk to area residents. Starting in 2003, we surveyed the administrators of regulatory and...

Building hospital capacity planning mechanisms in Poland: The impact of 2016/2017 regulatory changes.

PubMed

Dubas-Jakóbczyk, Katarzyna; Sowada, Christoph; Domagała, Alicja; Więckowska, Barbara

2018-02-07

Capacity planning is a crucial component of modern health care governance. The aim of this paper is to analyze the requirements that need to be met to build effective hospital capacity planning mechanisms in Poland. In this context, the recent regulatory changes strongly influencing hospital sector functioning, including introduction of health care needs maps, capital investment assessment, and hospital network regulations, are analyzed. Some possible ways forward, based on review of international experiences in hospital capacity planning, are discussed. Applied methods include literature review and analysis of statistical data as well as desk analysis of key national regulations related to hospital sector. Results indicate that at the system level, the process of capacity planning involves 4 elements: capital investment in facilities, equipment, and technology; service delivery; allocation of staff; and financial resources. For hospital capacity planning to be effective, the strategic decision at the macrolevel must be complemented by appropriate management of individual hospitals. The major challenge of building hospital capacity planning mechanism in Poland is imbedding it into the overall health system strategy. Because of the lack of such a strategy, the practical implementation of the ad hoc changes, which have been introduced, shows some inconsistencies. The regulations implemented between 2016 and 2017 provided a basis for hospital capacity planning, yet still need evaluation and adjustments. Also, including a mechanism for human resources planning is of crucial importance. The regulations should provide incentives for reducing oversized hospital infrastructure with simultaneous development of the long-term and coordinated care models. Copyright © 2018 John Wiley & Sons, Ltd.

75 FR 79427 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing and Immediate Effectiveness of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... end of December 2010, it will work with the Commission to set a new target date for implementation as... new target date for implementation. The Exchange also has represented that it plans to file a proposed... made to the rules of New York Stock Exchange LLC. See SR-NYSE-2010- 79. \\6\\ See Securities Exchange Act...

78 FR 34310 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Queen Conch Fishery of Puerto...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-07

...NMFS proposes regulations to implement Regulatory Amendment 2 to the Fishery Management Plan (FMP) for the Queen Conch Resources of Puerto Rico and the U.S. Virgin Islands (USVI) (Regulatory Amendment 2), as prepared by the Caribbean Fishery Management Council (Council). If implemented, this rule would revise the commercial trip limit for queen conch in the Caribbean exclusive economic zone (EEZ) to be compatible with the trip limit in USVI territorial waters. The purpose of this proposed rule is to improve the compatibility of Federal and USVI territorial regulations for queen conch in order to facilitate enforcement efforts while ensuring the long-term health of the queen conch resource.

78 FR 26708 - Pacific Halibut Fisheries; Catch Sharing Plan; Correcting Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-08

... published on March 15, 2013, that implemented annual management measures governing the Pacific halibut... (78 FR 16423), included annual management measures for managing the harvest of Pacific halibut (Hippoglossus stenolepis) in the sport fishery in International Pacific Halibut Commission (IPHC) Regulatory...

Medical loss ratio as a potential regulatory tool in the Israeli healthcare system.

PubMed

Simon-Tuval, Tzahit; Horev, Tuvia; Kaplan, Giora

2015-01-01

The growth of the private health insurance sector in Western countries, which is characterized by information deficiencies and limited competition, necessitates the implementation of effective regulatory tools. One measure which is widely used is the medical loss ratio (MLR). Our objective was to analyze how MLR is applied as a regulatory measure in the Israeli voluntary health insurance (VHI) market in order to promote the protection of beneficiaries. The study will examine MLR values and the use of this tool by regulators of VHI in Israel. Descriptive analysis using 2005-2012 data from public reports of the Ministry of Health and the Ministry of Finance on VHI plans in three market segments: nonprofit health plans, group (collective) policies offered by commercial insurance companies and individual policies offered by commercial insurance companies. In 2012, 74% of the Israeli population owned VHI provided by nonprofit health plans and 43% owned VHI offered by for-profit commercial companies. At that time the MLRs of three nonprofit health plans were significantly lower than 80%, mostly in the upper layers of coverage. The MLR in the individual commercial segment was consistently low (38% in 2012). The use of MLR as a regulation tool was, and continues to be, relatively limited in all segments. The VHI in Israel covers several essential services that are not covered by the statutory benefits package as a result of budget constraints. Thus, due to the high penetration rate of VHI in Israel compared to European countries and the lower levels of MLR, in order to assure the protection of beneficiaries it may be warranted to increase the extent of regulation and adjust it to the nature of the services covered. This may include distinguishing between essential and nonessential coverages and implementation of the most suitable regulatory measures (such as an MLR threshold, limitation of services covered and adjusting the actuarial models to the beneficiaries' behavior), rather than focusing only on assuring solvency.

Developing a strategy and closure criteria for radioactive and mixed waste sites in the ORNL remedial action program: Regulatory interface

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

Trabalka, J.R.

1987-09-01

Some options for stabilization and treatment of contaminated sites can theoretically provide a once-and-for-all solution (e.g., removal or destruction of contaminants). Most realizable options, however, leave contaminants in place (in situ), potentially isolated by physical or chemical, but more typically, by hydrologic measures. As a result of the dynamic nature of the interactions between contaminants, remedial measures, and the environment, in situ stablization measures are likely to have limited life spans, and maintenance and monitoring of performance become an essential part of the scheme. The length of formal institutional control over the site and related questions about future uses ofmore » the land and waters are of paramount importance. Unique features of the ORNL site and environs appear to be key ingredients in achieving the very long term institutional control necessary for successful financing and implementation of in situ stabilization. Some formal regulatory interface is necessary to ensure that regulatory limitations and new guidance which can affect planning and implementation of the ORNL Remedial Action Program are communicated to ORNL staff and potential technical and financial limitations which can affect schedules or alternatives for achievement of long-term site stabilization and the capability to meet environmental regulations are provided to regulatory bodies as early as possible. Such an interface should allow decisions on closure criteria to be based primarily on technical merit and protection of human health and the environment. A plan for interfacing with federal and state regulatory authorities is described. 93 refs., 1 fig., 4 tabs.« less

Underground storage tank management plan, Oak Ridge Y-12 Plant, Oak Ridge, Tennessee

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

NONE

1997-09-01

The Underground Storage Tank (UST) Program at the Oak Ridge Y-12 Plant was established to locate UST systems at the facility and to ensure that all operating UST systems are free of leaks. UST systems have been removed or upgraded in accordance with Tennessee Department of Environment and Conservation (TDEC) regulations and guidance. With the closure of a significant portion of the USTs, the continuing mission of the UST Management Program is to manage the remaining active UST systems and continue corrective actions in a safe regulatory compliant manner. This Program outlines the compliance issues that must be addressed, reviewsmore » the current UST inventory and compliance approach, and presents the status and planned activities associated with each UST system. The UST Program provides guidance for implementing TDEC regulations and guidelines for petroleum UST systems. The plan is divided into three major sections: (1) regulatory requirements, (2) active UST sites, and (3) out-of-service UST sites. These sections describe in detail the applicable regulatory drivers, the UST sites addressed under the Program, and the procedures and guidance for compliance.« less

40 CFR 256.22 - Recommendations for State regulatory powers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste... prohibit new open dumps and close or upgrade all existing open dumps. (a) Solid waste disposal standards... solid waste disposal facility. These procedures should include identification of future land use or the...

40 CFR 256.23 - Requirements for closing or upgrading open dumps.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid... classification of existing solid waste disposal facilities according to the criteria. This classification shall... solid waste disposal facility; (2) The availability of State regulatory and enforcement powers; and (3...

40 CFR 256.22 - Recommendations for State regulatory powers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste... prohibit new open dumps and close or upgrade all existing open dumps. (a) Solid waste disposal standards... solid waste disposal facility. These procedures should include identification of future land use or the...

40 CFR 256.21 - Requirements for State regulatory powers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste... be adequate to enforce solid waste disposal standards which are equivalent to or more stringent than the criteria for classification of solid waste disposal facilities (40 CFR part 257). Such authority...

40 CFR 256.21 - Requirements for State regulatory powers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste... be adequate to enforce solid waste disposal standards which are equivalent to or more stringent than the criteria for classification of solid waste disposal facilities (40 CFR part 257). Such authority...

40 CFR 256.23 - Requirements for closing or upgrading open dumps.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid... classification of existing solid waste disposal facilities according to the criteria. This classification shall... solid waste disposal facility; (2) The availability of State regulatory and enforcement powers; and (3...

EPA Approved Nonregulatory Provisions and Quasi-Regulatory Measures in the New Jersey SIP

EPA Pesticide Factsheets

This section sets forth the applicable State Implementation Plan (SIP) for New Jersey under section 110 of the Clean Air Act, as amended, 42 U.S.C. 7401 et seq., and 40 CFR part 51 to meet National Ambient Air Quality Standards.

7 CFR 371.5 - Marketing and Regulatory Programs Business Services.

Code of Federal Regulations, 2011 CFR

2011-01-01

... implementation of policies and procedures and to assess the accomplishments of program objectives. (4) Evaluating... PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ORGANIZATION, FUNCTIONS, AND DELEGATIONS OF... Administration (GIPSA), and other APHIS, AMS, and GIPSA officials in the planning and formulation of MRP policies...

Comprehensive implementation plan for the DOE defense buried TRU- contaminated waste program

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

Everette, S.E.; Detamore, J.A.; Raudenbush, M.H.

1988-02-01

In 1970, the US Atomic Energy Commission established a transuranic'' (TRU) waste classification. Waste disposed of prior to the decision to retrievably store the waste and which may contain TRU contamination is referred to as buried transuranic-contaminated waste'' (BTW). The DOE reference plan for BTW, stated in the Defense Waste Management Plan, is to monitor it, to take such remedial actions as may be necessary, and to re-evaluate its safety as necessary or in about 10-year periods. Responsibility for management of radioactive waste and byproducts generated by DOE belongs to the Secretary of Energy. Regulatory control for these sites containingmore » mixed waste is exercised by both DOE (radionuclides) and EPA (hazardous constituents). Each DOE Operations Office is responsible for developing and implementing plans for long-term management of its radioactive and hazardous waste sites. This comprehensive plan includes site-by-site long-range plans, site characteristics, site costs, and schedules at each site. 13 figs., 15 tabs.« less

Planning Electric Transmission Lines: A Review of Recent Regional Transmission Plans

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

Eto, Joseph H.

The first Quadrennial Energy Review (QER) recommends that the U.S. Department of Energy (DOE) conduct a national review of transmission plans and assess the barriers and incentives to their implementation. DOE tasked Lawrence Berkeley National Laboratory (LBNL) to prepare two reports to support the agency’s response to this recommendation. This report reviews regional transmission plans and regional transmission planning processes that have been directed by Federal Energy Regulatory Commission (FERC) Order Nos. 890 and 1000. We focus on the most recent regional transmission plans (those issued in 2015 and through approximately mid-year 2016) and current regional transmission planning processes. Amore » companion report focuses on non-plan-related factors that affect transmission projects.« less

75 FR 4635 - Risk-Based Capital Guidelines; Capital Adequacy Guidelines; Capital Maintenance: Regulatory...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-28

... phase-in would unfairly penalize banking organizations given their already established businesses..., will aid banking organizations with capital planning as they implement FAS 166 and FAS 167 and adjust... assets a banking organization consolidates as a result of changes to U.S. generally accepted accounting...

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...

76 FR 38977 - Approval and Promulgation of Air Quality Implementation Plans, State of Louisiana

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-05

... submitted by the State of Louisiana, and include formatting changes, regulatory wording changes, substantive... other material, such as copyrighted material will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy...

78 FR 57073 - Approval and Promulgation of Implementation Plans; Washington: Puget Sound Clean Air Agency...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-17

... Washington State Department of Ecology on February 4, 2005 and August 2, 2006. The submissions contain... Department of Ecology (Ecology) submitted revisions to the Washington SIP to incorporate regulatory changes..., disproportionate human health or environmental effects, using practicable and legally permissible methods, under...

10 CFR 1.39 - Office of Human Resources.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Office of Human Resources. 1.39 Section 1.39 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Staff Offices § 1.39 Office of Human Resources. The Office of Human Resources— (a) Plans and implements NRC policies...

10 CFR 1.39 - Office of Human Resources.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Office of Human Resources. 1.39 Section 1.39 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Staff Offices § 1.39 Office of Human Resources. The Office of Human Resources— (a) Plans and implements NRC policies...

78 FR 62523 - Approval and Promulgation of Air Quality Implementation Plans; District of Columbia...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-22

..., regulatory structure, monitoring, modeling, legal authority, and adequate resources necessary to assure... the Agency views these as noncontroversial submittals and anticipates no adverse comments. A more... subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any...

76 FR 48093 - Hazardous Chemical Reporting: Revisions to the Emergency and Hazardous Chemical Inventory Forms...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

... provisions to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attn... information provided, unless the comment includes information claimed to be Confidential Business Information... EPA information about these programs and hazards in a risk management plan (RMP). The implementing...

78 FR 18849 - Disapproval of Implementation Plan Revisions; State of California; South Coast VMT Emissions...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-28

... significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal... business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section below. FOR FURTHER...

76 FR 64240 - Approval and Promulgation of Implementation Plans; North Carolina: Prevention of Significant...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-18

... and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the Regulatory... revision on May 17, 2011. In its final SIP revision, North Carolina made minor [[Page 64241

3 CFR 13610 - Executive Order 13610 of May 10, 2012. Identifying and Reducing Regulatory Burdens

Code of Federal Regulations, 2013 CFR

2013-01-01

..., welfare, safety, and our environment, but they can also impose significant burdens and costs. During... in light of changed circumstances, including the rise of new technologies. Executive Order 13563 of.... Significantly larger savings are anticipated as the plans are implemented and as action is taken on additional...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-10

... motor carrier of a scanned image of the original record; the driver would retain the original while the carrier maintains the electronic scanned electronic image along with any supporting documents. [[Page... plans to implement a new approach for receiving and processing RODS. Its drivers would complete their...

18 CFR 380.5 - Actions that require an environmental assessment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... REGULATORY COMMISSION, DEPARTMENT OF ENERGY REVISED GENERAL RULES REGULATIONS IMPLEMENTING THE NATIONAL... in §§ 380.4, 380.6 and 2.55 of this chapter, authorization for the site of new gas import/export... storage fields under section 7 of the Natural Gas Act. (5) New natural gas curtailment plans, or any...

75 FR 74673 - Approval and Promulgation of Implementation Plans; Georgia: Stage II Vapor Recovery

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-01

... includes multiple modifications to Georgia's Air Quality Rules found at Chapter 391-3-1. Previously, EPA...., Atlanta, Georgia 30303-8960. 5. Hand Delivery or Courier: Ms. Lynorae Benjamin, Regulatory Development... (404) 562-9029. Ms. Spann can also be reached via electronic mail at [email protected]epa.gov . SUPPLEMENTARY...

78 FR 56168 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; West Virginia's...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-12

... initial proposal on December 11, 2012. Principally, the supplemental NPR addressed the effects of the... behavior and prepare before the final rule takes effect. Today's rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect...

76 FR 29249 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-20

... collection; Title of Information Collection: State Plan Template to Implement Section 6062 of the Deficit Reduction Act; Form No.: CMS-10232 (OMB : 0938-1045); Use: The Deficit Reduction Act (DRA) provides States..., 2011. OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202...

78 FR 31614 - Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-24

... for Nuclear Power Plants,'' in support of NRC reviews of early site permit (ESP), standard design... NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants... License Applications for Nuclear Power Plants, (LWR Edition)'' (ML070630003) In addition, this ISG...

78 FR 42558 - Proposed Revision 0 to Fitness-for-Duty Standard Review Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-16

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0149] Proposed Revision 0 to Fitness-for-Duty Standard...: Section 13.7 ``Fitness-for-Duty,'' and Section 13.7.1 ``Fitness-for-Duty--Operational [[Page 42559...), concerning implementation of a Fitness-for- Duty (FFD) program. The current SRP does not contain guidance on...

78 FR 11984 - Approval and Promulgation of Implementation Plans; State of Hawaii; Update to Materials...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

...); Is not an economically significant regulatory action based on health or safety risks subject to... Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental... dust...... 11/29/1982 08/18/1983, 48 FR 37403 11-60-27 Incineration....... 11/29/1982 08/18/1983, 48 FR...

The OSHA Communication Standard and State Right-to-Know Laws.

ERIC Educational Resources Information Center

Roll, Michalene H.

1990-01-01

As a result of a 1988 federal appellate court mandate, schools and colleges in 24 states and 2 territories with OSHA-approved state plans must inform their employees about hazardous chemicals to which they may be exposed. School administrators should implement a responsible program meeting regulatory compliance, tort liability, and public…

Critical role of developing national strategic plans as a guide to strengthen laboratory health systems in resource-poor settings.

PubMed

Nkengasong, John N; Mesele, Tsehaynesh; Orloff, Sherry; Kebede, Yenew; Fonjungo, Peter N; Timperi, Ralph; Birx, Deborah

2009-06-01

Medical laboratory services are an essential, yet often neglected, component of health systems in developing countries. Their central role in public health, disease control and surveillance, and patient management is often poorly recognized by governments and donors. However, medical laboratory services in developing countries can be strengthened by leveraging funding from other sources of HIV/AIDS prevention, care, surveillance, and treatment programs. Strengthening these services will require coordinated efforts by national governments and partners and can be achieved by establishing and implementing national laboratory strategic plans and policies that integrate laboratory systems to combat major infectious diseases. These plans should take into account policy, legal, and regulatory frameworks; the administrative and technical management structure of the laboratories; human resources and retention strategies; laboratory quality management systems; monitoring and evaluation systems; procurement and maintenance of equipment; and laboratory infrastructure enhancement. Several countries have developed or are in the process of developing their laboratory plans, and others, such as Ethiopia, have implemented and evaluated their plan.

Better sorry than safe: Making a Plan B reduces effectiveness of implementation intentions in healthy eating goals.

PubMed

Vinkers, Charlotte D W; Adriaanse, Marieke A; Kroese, Floor M; de Ridder, Denise T D

2015-01-01

Implementation intentions (if-then plans) are helpful to health behaviour change. As these plans specify only one goal-directed behaviour for one specific situation, however, their effectiveness may be limited when a planned behaviour is impossible to execute in situ. The present research examines whether and how planning more than one goal-directed response for the same situation ('making a Plan B') affects successful self-regulation of eating behaviour. In Study 1, participants formulated either one or two plans, after which a lexical decision task was administered to assess association strength between the if-part and the then-part(s). In Study 2, the effect of making one, two or no plan(s) was assessed on actual eating behaviour, after which a Stroop task measured cognitive load as an additional explanatory mechanism. Study 1 revealed that making a Plan B disrupts the creation of strong if-then associations during plan formation. Study 2 showed that making a Plan B yields increased unhealthy food intake compared to making one or no plan, and induces greater cognitive load during plan enactment. Making a Plan B interferes with essential cognitive processes during different stages of planning, leading to an increased likelihood of self-regulatory failure.

Implementation Plan for Qualification of Sodium-Cooled Fast Reactor Technology Information

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

Moe, Wayne; Honma, George

This document identifies and discusses implementation elements that can be used to facilitate consistent and systematic evaluation processes relating to quality attributes of technical information (with focus on SFR technology) that will be used to support licensing of advanced reactor designs. Information may include, but is not limited to, design documents for SFRs, research-and-development (R&D) data and associated documents, test plans and associated protocols, operations and test data, international research data, technical reports, and information associated with past U.S. Nuclear Regulatory Commission (NRC) reviews of SFR designs. The approach for determining acceptability of test data, analysis, and/or other technical informationmore » is based on guidance provided in INL/EXT-15-35805, “Guidance on Evaluating Historic Technology Information for Use in Advanced Reactor Licensing.” The implementation plan can be adopted into a working procedure at each of the national laboratories performing data qualification, or by applicants seeking future license application for advanced reactor technology.« less

Safety Evaluation Report on Tennessee Valley Authority: Browns Ferry Nuclear Performance Plan: Browns Ferry Unit 2 restart

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

Not Available

1989-04-01

This safety evaluation report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Nuclear Performance Plan, through Revision 2, for the Browns Ferry Nuclear Power Station and in supporting documents has been prepared by the US Nuclear Regulatory Commission staff. The plan addresses the plant-specific concerns requiring resolution before startup of Unit 2. The staff will inspect implementation of those programs. Where systems are common to Units 1 and 2 or to Units 2 and 3, the staff safety evaluations of those systems are included herein. 3 refs.

A global regulatory science agenda for vaccines.

PubMed

Elmgren, Lindsay; Li, Xuguang; Wilson, Carolyn; Ball, Robert; Wang, Junzhi; Cichutek, Klaus; Pfleiderer, Michael; Kato, Atsushi; Cavaleri, Marco; Southern, James; Jivapaisarnpong, Teeranart; Minor, Philip; Griffiths, Elwyn; Sohn, Yeowon; Wood, David

2013-04-18

The Decade of Vaccines Collaboration and development of the Global Vaccine Action Plan provides a catalyst and unique opportunity for regulators worldwide to develop and propose a global regulatory science agenda for vaccines. Regulatory oversight is critical to allow access to vaccines that are safe, effective, and of assured quality. Methods used by regulators need to constantly evolve so that scientific and technological advances are applied to address challenges such as new products and technologies, and also to provide an increased understanding of benefits and risks of existing products. Regulatory science builds on high-quality basic research, and encompasses at least two broad categories. First, there is laboratory-based regulatory science. Illustrative examples include development of correlates of immunity; or correlates of safety; or of improved product characterization and potency assays. Included in such science would be tools to standardize assays used for regulatory purposes. Second, there is science to develop regulatory processes. Illustrative examples include adaptive clinical trial designs; or tools to analyze the benefit-risk decision-making process of regulators; or novel pharmacovigilance methodologies. Included in such science would be initiatives to standardize regulatory processes (e.g., definitions of terms for adverse events [AEs] following immunization). The aim of a global regulatory science agenda is to transform current national efforts, mainly by well-resourced regulatory agencies, into a coordinated action plan to support global immunization goals. This article provides examples of how regulatory science has, in the past, contributed to improved access to vaccines, and identifies gaps that could be addressed through a global regulatory science agenda. The article also identifies challenges to implementing a regulatory science agenda and proposes strategies and actions to fill these gaps. A global regulatory science agenda will enable regulators, academics, and other stakeholders to converge around transformative actions for innovation in the regulatory process to support global immunization goals. Copyright © 2012 Elsevier Ltd. All rights reserved.

Regional Transmission Planning: A review of practices following FERC Order Nos. 890 and 1000

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

Eto, Joseph H.; Gallo, Guilia

Federal Energy Regulatory Commission (FERC) Order Nos. 890 and 10001 established requirements that transmission planning regions must follow in regional transmission planning and allocating the costs of new transmission facilities. Order No. 890, issued in 2007, outlined general requirements for local as well as regional transmission planning practices and procedures. Order No. 1000, issued in 2011, laid out specific requirements for: (1) regional transmission planning; (2) consideration of transmission needs driven by public policy requirements; (3) non-incumbent transmission development; (4) interregional transmission coordination; and (5) cost allocation for transmission facilities that have been selected in a regional transmission plan formore » purposes of cost allocation. This report reviews how these FERC orders are being implemented by the 12 transmission planning regions recognized by FERC.« less

Environmental Implementation Plan

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

Not Available

1994-02-01

The Environmental Implementation Plan (EIP) is a dynamic long-range environmental-protection plan for SRS. The EIP communicates the current and future (five year) environmental plans from individual organizations and divisions as well as site environmental initiatives which are designed to protect the environment and meet or exceed compliance with changing environmental/ regulatory requirements. Communication with all site organizations is essential for making the site environmental planning process work. Demonstrating environmental excellence is a high priority embodied in DOE and WSRC policy. Because of your support and participation in the three EIP initiatives; Reflections, Sectional Revision, and Integrated Planning, improvements are beingmore » made to the EIP and SRS environmental protection programs. I appreciate the ``Partnership in Environmental Excellence`` formed by the environmental coordinators and professionals who work daily toward our goal of compliance and environmental excellence. I look forward to seeing continued success and improvement in our environmental protection programs through combined efforts of all site organizations to protect our employees, the public health, and the environment. Together, we will achieve our site vision for SRS to be the recognized model for Environmental Excellence in the DOE Nuclear Weapons Complex.« less

Hydropower Licensing as a Bridge between Climate Science and Applications: Creating Actionable Science for Regulatory Decisionmaking

NASA Astrophysics Data System (ADS)

Ray, A. J.; Barsugli, J. J.; Walker, S. H.

2016-12-01

The Integrated Licensing Process (ILP) of the US Federal Energy Regulatory Commission (FERC) is an example of an existing regulatory process that has the capacity to bridge the gap between science and decision making by clearly delineating existing science, the climate-regulatory nexus, and additional scientific work needed to inform licensing or relicensing of non-federal hydropower projects. In a parallel, but interacting set of legal and regulatory processes, NOAA's National Marine Fisheries Service (NMFS) must conduct analyses based on the best available science in order to implement the requirements of the Endangered Species Act (ESA), the Magnuson-Stevens Act, and NEPA, and to develop terms and conditions to protect fisheries for the 30-50 year term of the license and the longer life of the project itself. Therefore, NMFS must understand the combined effects of hydropower projects and climate change to fulfill its own mandates to protect anadromous fish, protected species and habitat. Federal Executive Order (EO) #13693 on climate change sustainability require use of climate risks in planning, also recommended in NOAA's own guidance on implementing ESA, and the Council on Environmental Quality (CEQ) guidance on implementing NEPA; however, as an independent agency FERC is not subject to that EO. In the past, FERC has consistently rejected NMFS' climate study requests, stating, among other reasons, that climate science is `too uncertain,' and therefore not actionable. Thus, in order for NMFS to get the information needed for its own decision process, NOAA must first persuade FERC that the science is actionable. This presentation will describe our experiences in a multi-year effort by an interdisciplinary team of climate and fishery scientists to develop acceptable climate study requests that address FERC's concerns about uncertainty, for the Susitna-Watana project on Alaska's Susitna River, the LaGrange Project on the Tuolumne R. in California, and the Hiram Project on the Saco R. in Maine. Furthermore, we document that climate studies are needed to meet FERC's own standard that study methodologies be "generally accepted practice" in the community, i.e., that water infrastructure planning and management has evolved to include use of climate risk assessments as best practices.

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 66699 - Lacey Act Implementation Plan; Definitions for Exempt and Regulated Articles

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-29

.../component/main?main=DocketDetail&d=APHIS-2009-0018 to submit or view comments and to view supporting and... comment to Docket No. APHIS-2009-0018, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8... Policy Analysis and Support, PPQ, APHIS, 4700 River Road Unit 60, Riverdale, MD 20737-1231; (301) 734...

76 FR 77701 - Approval and Promulgation of Implementation Plans; State of Missouri

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-14

... SIP amend 10 CSR 10-6.110 Submission of Emission Data, Emission Fees and Process Information to align... 10 CSR 10-6.110 Submission of Emission Data, Emission Fees and Process Information to align the State... not a ``significant regulatory action'' subject to review by the Office of Management and Budget under...

77 FR 36404 - Approval and Promulgation of Air Quality Implementation Plans; Massachusetts; Determination of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-19

... Environmental Protection recently performed a missing data analysis for this site in accordance with the regulatory requirements of 40 CFR Part 50, Appendix I, for both 2010 and 2011. The Massachusetts missing data... the missing days to decisively conclude that on the days with missing ozone data, the ozone levels, if...

77 FR 3220 - Approval and Promulgation of Air Quality Implementation Plans; Massachusetts; Determination of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-23

... of Environmental Protection performed a missing data analysis for this site in accordance with the regulatory requirements of 40 CFR part 50, Appendix I. The Massachusetts missing data analysis used a combination of meteorology and air quality data for ozone monitors near the Adams site for the missing days to...

77 FR 46129 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-02

... Volatility July 27, 2012. Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the ``Act... ``Trading Halts Due to Extraordinary Market Volatility.'' The text of the proposed rule change is available... implementation, on February 4, 2013, of the Plan to Address Extraordinary Market Volatility Pursuant to Rule 608...

78 FR 58249 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery Off the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-23

... rule. SUMMARY: NMFS issues this final rule to implement management measures for black sea bass described in Regulatory Amendment 19 to the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP), as prepared by the South Atlantic Fishery Management Council (Council...

75 FR 21169 - Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Revisions to New...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-23

... maintenance for carbon monoxide; and Removing the provision that allowed 8-hour ozone areas to use other tests..., 1999); Is not an economically significant regulatory action based on health or safety risks subject to...--Analysis in Serious, Severe, and Extreme Ozone Nonattainment Areas and Serious Carbon Monoxide Areas. 20.2...

78 FR 18280 - Approval and Promulgation of Air Quality Implementation Plans; Nevada; Regional Haze Federal...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... emission limits applicable to Units 1, 2, and 3 at RGGS by 18 months from January 1, 2015, to June 30, 2016.... Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order..., or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions...

Regional planning acceptance by residents of Northern New York, USA

NASA Astrophysics Data System (ADS)

Bobrow, Patricia; Gaige, Barbara; Harris, Glenn; Kennedy, Joyce; King, Leslie; Raymond, William; Werbitsky, Darrin

1984-01-01

This study compares the effectiveness of two regional planning agencies in terms of public support for various planning activities. The Adirondack Park Agency and the Temporary State Commission on Tug Hill have fundamentally different approaches to planning. The Adirondack Park Agency has implemented a restrictive regulatory program with little citizen participation by Adirondack residents. The Tug Hill Commission has implemented an advisory and coordinating program with an emphasis on public input. Residents of two towns in each region were surveyed to determine environmental concern and support for regional planning activities. Respondents from both regions favored a planning agency that incorporates citizen input; controls air, water, and toxic waste pollution; and develops recreation areas. They strongly opposed an agency that regulates private land-use. Basic demographic characteristics and levels of environmental concern were similar in all four towns, but receptivity to various planning activities was consistently greater among residents of the Tug Hill Region. Paired comparisons of the four towns demonstrated no differences between towns of the same region and significant differences between towns of different regions. Public support for regional planning is greater in the Tug Hill Region than in the Adirondack Park.

Soil Management Plan for the Oak Ridge Y-12 National Security Complex Oak Ridge, Tennessee

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

None

2005-03-02

This Soil Management Plan applies to all activities conducted under the auspices of the National Nuclear Security Administration (NNSA) Oak Ridge Y-12 National Security Complex (Y-12) that involve soil disturbance and potential management of waste soil. The plan was prepared under the direction of the Y-12 Environmental Compliance Department of the Environment, Safety, and Health Division. Soil disturbances related to maintenance activities, utility and building construction projects, or demolition projects fall within the purview of the plan. This Soil Management Plan represents an integrated, visually oriented, planning and information resource tool for decision making involving excavation or disturbance of soilmore » at Y-12. This Soil Management Plan addresses three primary elements. (1) Regulatory and programmatic requirements for management of soil based on the location of a soil disturbance project and/or the regulatory classification of any contaminants that may be present (Chap. 2). Five general regulatory or programmatic classifications of soil are recognized to be potentially present at Y-12; soil may fall under one or more these classifications: (a) Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) pursuant to the Oak Ridge Reservation (ORR) Federal Facilities Agreement; (b) Resource Conservation and Recovery Act (RCRA); (c) RCRA 3004(u) solid waste managements units pursuant to the RCRA Hazardous and Solid Waste Amendments Act of 1984 permit for the ORR; (d) Toxic Substances and Control Act-regulated soil containing polychlorinated biphenyls; and (e) Radiologically contaminated soil regulated under the Atomic Energy Act review process. (2) Information for project planners on current and future planned remedial actions (RAs), as prescribed by CERCLA decision documents (including the scope of the actions and remedial goals), land use controls implemented to support or maintain RAs, RCRA post-closure regulatory requirements for former waste management units, legacy contamination source areas and distribution of contamination in soils, and environmental infrastructure (e.g., caps, monitoring systems, etc.) that is in place or planned in association with RAs. (3) Regulatory considerations and processes for management and disposition of waste soil upon generation, including regulatory drivers, best management practices (BMPs), waste determination protocols, waste acceptance criteria, and existing waste management procedures and BMPs for Y-12. This Soil Management Plan provides information to project planners to better coordinate their activities with other organizations and programs with a vested interest in soil disturbance activities at Y-12. The information allows project managers and maintenance personnel to evaluate and anticipate potential contaminant levels that may be present at a proposed soil disturbance site prior to commencement of activities and allows a more accurate assessment of potential waste management requirements.« less

75 FR 48880 - Approval and Promulgation of Gila River Indian Community's Tribal Implementation Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-12

...The Environmental Protection Agency (EPA) proposes to approve the Gila River Indian Community's (GRIC or the Tribe) Tribal Implementation Plan (TIP) under the Clean Air Act (CAA) to regulate air pollution within the exterior boundaries of the Tribe's reservation. The proposed TIP is one of four CAA regulatory programs that comprise the Tribe's Air Quality Management Plan (AQMP). EPA approved the Tribe for treatment in the same manner as a State (Treatment as State or TAS) for purposes of administering the AQMP and other CAA authorities on October 21, 2009. In this action we propose to act only on those portions of the AQMP that constitute a TIP containing severable elements of an implementation plan under CAA section 110(a). The proposed TIP includes general and emergency authorities, ambient air quality standards, permitting requirements for minor sources of air pollution, enforcement authorities, procedures for administrative appeals and judicial review in Tribal court, requirements for area sources of fugitive dust and fugitive particulate matter, general prohibitory rules, and source category-specific emission limitations. The purpose of the proposed TIP is to implement, maintain, and enforce the National Ambient Air Quality Standards (NAAQS) in the GRIC reservation. The intended effect of today's proposed action is to make the GRIC TIP federally enforceable.

76 FR 68698 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revision to Nitrogen...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... regulatory language that inadvertently ended its nitrogen oxides (NO X ) budget at the end of the 2008 ozone... provide it in the body of your comment. If you send an email comment directly to EPA without going through... electronic comment, EPA recommends that you include your name and other contact information in the body of...

Agile Port and High Speed Ship Technologies

DTIC Science & Technology

2009-12-31

Alternative Shipboard Powering Systems for Naval and Regulatory Review • The Evaluation and Implementation Plan for Southern California Maglev ...Ackerman". CSULB Foundation Annual Report. CSULB Foundation, Long Beach, CA. December 2005. " Maglev Technology ’Conveys’ Port Transportation Solutions...34. Newsflash. College of Engineering, California State University, Long Beach. Cover page. Spring 2006 Hanson, Kristopher. "Engineers Tout Maglev at

Connection, regulation, and care plan innovation: a case study of four nursing homes.

PubMed

Colón-Emeric, Cathleen S; Lekan-Rutledge, Deborah; Utley-Smith, Queen; Ammarell, Natalie; Bailey, Donald; Piven, Mary L; Corazzini, Kirsten; Anderson, Ruth A

2006-01-01

We describe how connections among nursing home staff impact the care planning process using a complexity science framework. We completed six-month case studies of four nursing homes. Field observations (n = 274), shadowing encounters (n = 69), and in-depth interviews (n = 122) of 390 staff at all levels were conducted. Qualitative analysis produced a conceptual/thematic description and complexity science concepts were used to produce conceptual insights. We observed that greater levels of staff connection were associated with higher care plan specificity and innovation. Connection of the frontline nursing staff was crucial for (1) implementation of the formal care plan and (2) spontaneous informal care planning responsive to changing resident needs. Although regulations could theoretically improve cognitive diversity and information flow in care planning, we observed instances of regulatory oversight resulting in less specific care plans and abandonment of an effective care planning process. Interventions which improve staff connectedness may improve resident outcomes.

Expanded Access Programs

PubMed Central

Van Campen, Luann E.; Garnett, Timothy

2015-01-01

Expanded access is a regulatory mechanism by which an investigational drug can be made available outside of a clinical trial to treat patients with serious or life-threatening conditions for which there are no satisfactory treatment options. An expanded access program (EAP) is the formal plan under which preapproval access to an investigational drug can be provided to a group of patients. Although an EAP is a regulated program, the decision to authorize an EAP is the responsibility of the biopharmaceutical sponsor. Because of the significant impact an EAP can have on current patients, drug development, and future patients, we propose that a sponsor’s decision must be based not only on regulatory criteria but also on ethical and practical considerations regarding implementation of an EAP. Such an approach will help ensure that decisions and plans uphold ethical precepts such as fairness, promoting good, and minimizing risk of harm. PMID:29473010

Canadian development and commercialization of a North American mobile satellite service

NASA Technical Reports Server (NTRS)

Athanassiadis, Demetre

1990-01-01

Canada recognized early the value of mobile satellite communications, originally through the planning of a military system and subsequently through the development of the Canadian Mobile Satellite (MSAT) systems. Acting on behalf of the government, the Department of Communications (DOC) defined and carried out a complete plan for the implementation of Mobile Satellite Services (MSS). Based on an extensive dialogue between government, industry, and users and encompassing all technical, economic regulatory, and institutional aspects, this plan resulted in the completion by 1986 of a comprehensive business plan and a decision for commercial MSS delivery. The Canadian lead for a commercial system was quickly followed by others, and in particular the U.S., giving rise to the concept of North American MSS.

A qualitative study of the determinants of HIV guidelines implementation in two south-eastern districts of Tanzania

PubMed Central

Geubbels, Eveline; Wringe, Alison; Todd, Jim; Klatser, Paul; Dieleman, Marjolein

2017-01-01

Abstract Current HIV policies in Tanzania have adopted the three long-term impact results of zero new infections, zero HIV deaths and zero stigma and discrimination. Strategies to reach these results include scaling-up HIV Testing and Counselling (HTC); Preventing Mother-To-Child Transmission (PMTCT); and strengthening Care and Treatment Clinic (CTC) services. Previous studies showed that HIV policy and guideline recommendations were not always implemented in rural South Tanzania. This study aims to identify the determinants of HIV guideline implementation. A qualitative study of 23 semi-structured interviews with facility in-charges; healthcare workers; district, regional and national HIV coordinators was conducted. Five health facilities were purposively selected by level, ownership and proximity to district headquarters. Interviews were analysed according to Fleuren’s five determinants of innovation uptake related to: strategies used in guideline development and dissemination; guideline characteristics; the guideline implementing organization; guideline users; and the socio-cultural and regulatory context. None of the facilities had the HTC national guideline document. Non-involvement of providers in revisions and weak planning for guideline dissemination impeded their implementation. Lengthy guidelines and those written in English were under-used, and activities perceived to be complicated, like WHO-staging, were avoided. Availability of staff and lack of supplies like test kits and medication impeded implementation. Collaboration between facilities enhanced implementation, as did peer-support among providers. Provider characteristics including education level, knowledge of, and commitment to the guideline influenced implementation. According to providers, determinants of clients’ service use included gender norms, stigma, trust and perceived benefits. The regulatory context prohibited private hospitals from buying HIV supplies. Being tools for bringing policies to practice, national guidelines are crucial in the efforts towards the three zeros. Strategies to improve providers’ adherence to guidelines should include development of clearer guideline dissemination plans, strengthening of the health system, and possibly addressing of provider-perceived patient-level barriers to utilizing HIV services. PMID:28369374

Social Impact Management Plans: Innovation in corporate and public policy

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

Franks, Daniel M., E-mail: d.franks@uq.edu.au; Vanclay, Frank, E-mail: frank.vanclay@rug.nl

Social Impact Assessment (SIA) has traditionally been practiced as a predictive study for the regulatory approval of major projects, however, in recent years the drivers and domain of focus for SIA have shifted. This paper details the emergence of Social Impact Management Plans (SIMPs) and undertakes an analysis of innovations in corporate and public policy that have put in place ongoing processes – assessment, management and monitoring – to better identify the nature and scope of the social impacts that might occur during implementation and to proactively respond to change across the lifecycle of developments. Four leading practice examples aremore » analyzed. The International Finance Corporation (IFC) Performance Standards require the preparation of Environmental and Social Management Plans for all projects financed by the IFC identified as having significant environmental and social risks. Anglo American, a major resources company, has introduced a Socio-Economic Assessment Toolbox, which requires mine sites to undertake regular assessments and link these assessments with their internal management systems, monitoring activities and a Social Management Plan. In South Africa, Social and Labour Plans are submitted with an application for a mining or production right. In Queensland, Australia, Social Impact Management Plans were developed as part of an Environmental Impact Statement, which included assessment of social impacts. Collectively these initiatives, and others, are a practical realization of theoretical conceptions of SIA that include management and monitoring as core components of SIA. The paper concludes with an analysis of the implications for the practice of impact assessment including a summary of key criteria for the design and implementation of effective SIMPs. -- Highlights: • Social impact management plans are effective strategies to manage social issues. • They are developed in partnership with regulatory agencies, investors and community. • SIMPs link assessment to ongoing management and address social and community issues. • SIMPs clarify responsibilities in the management of impacts, opportunities and risks. • SIMPs demonstrate a shift to include management as a core component of SIA practice.« less

77 FR 7972 - Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... Prison Rape (Reg Plan Seq No. 85). References in boldface appear in The Regulatory Plan in part II of... 396. National Standards to Prevent, Detect, and Respond to Prison Rape Regulatory Plan: This entry is...

76 FR 20293 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-12

... January 19, 2010, EPA published a proposed rule to reconsider the 2008 8-hour ozone NAAQS (75 FR 2938) and... the Paperwork Reduction Act (44 U.S.C. 3501 et seq.); Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C...

76 FR 16718 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-25

... the 2008 8-hour ozone NAAQS (75 FR 2938) and to propose a revised ozone NAAQS. EPA has not yet made... provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.); Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C...

Global Access Programs: A Collaborative Approach for Effective Implementation and Management.

PubMed

Ainge, Debra; Aitken, Suzanne; Corbett, Mark; De-Keyzer, David

Global access programs (GAPs) provide access to medicinal products for patients with serious medical conditions and no commercially available treatment options. Providing early access to medicines can be challenging for a pharmaceutical company. The demand for a GAP often occurs at a time when other activities are the prime focus, such as delivery of pivotal clinical trials or gaining of marketing authorization. Furthermore, the skills, experience, and infrastructure necessary to implement and manage a successful GAP vary significantly from those required for regular clinical trial execution, and the regulatory environment presents its own challenges, with regulations often poorly defined and with considerable inter-country variation. This article considers the triggers for early access requests and examines the need for companies to develop a global strategy for GAPs in order to respond appropriately to requests for early access. It also provides a comprehensive overview of the processes for GAP set-up, implementation, management, and closure, along with the considerations affecting the type and scope of GAP, such as demand, regulatory feasibility, license status of the product, drug pricing structure, company strategy, costs, and product supply. Also discussed is the need for appropriate personnel to implement and manage the GAP, and when to consider collaboration with an external GAP provider. In summary, GAPs require careful and efficient planning and management, from set-up to closure. Well-run GAPs provide an ethical and regulatory-compliant pathway for access of new treatments to patients with serious conditions and an unmet medical need.

Defining and incorporating basic nursing care actions into the electronic health record.

PubMed

Englebright, Jane; Aldrich, Kelly; Taylor, Cathy R

2014-01-01

To develop a definition of basic nursing care for the hospitalized adult patient and drive uptake of that definition through the implementation of an electronic health record. A team of direct care nurses, assisted by subject matter experts, analyzed nursing theory and regulatory requirements related to basic nursing care. The resulting list of activities was coded using the Clinical Care Classification (CCC) system and incorporated into the electronic health record system of a 170-bed community hospital. Nine basic nursing care activities were identified as a result of analyzing nursing theory and regulatory requirements in the framework of a hypothetical "well" patient. One additional basic nursing care activity was identified following the pilot implementation in the electronic health record. The pilot hospital has successfully passed a post-implementation regulatory review with no recommendations related to the documentation of basic patient care. This project demonstrated that it is possible to define the concept of basic nursing care and to distinguish it from the interdisciplinary, problem-focused plan of care. The use of the electronic health record can help clarify, document, and communicate basic care elements and improve uptake among nurses. This project to define basic nursing care activities and incorporate into the electronic health record represents a first step in capturing meaningful data elements. When fully implemented, these data could be translated into knowledge for improving care outcomes and collaborative processes. © 2013 Sigma Theta Tau International.

Radio-ecological characterization and radiological assessment in support of regulatory supervision of legacy sites in northwest Russia.

PubMed

Sneve, M K; Kiselev, M; Shandala, N K

2014-05-01

The Norwegian Radiation Protection Authority has been implementing a regulatory cooperation program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective has been the enhancement of safety culture and includes a special focus on regulatory supervision of nuclear legacy sites. The initial project outputs included appropriate regulatory threat assessments, to determine the hazardous situations and activities which are most in need of enhanced regulatory supervision. In turn, this has led to the development of new and updated norms and standards, and related regulatory procedures, necessary to address the often abnormal conditions at legacy sites. This paper presents the experience gained within the above program with regard to radio-ecological characterization of Sites of Temporary Storage for spent nuclear fuel and radioactive waste at Andreeva Bay and Gremikha in the Kola Peninsula in northwest Russia. Such characterization is necessary to support assessments of the current radiological situation and to support prospective assessments of its evolution. Both types of assessments contribute to regulatory supervision of the sites. Accordingly, they include assessments to support development of regulatory standards and guidance concerning: control of radiation exposures to workers during remediation operations; emergency preparedness and response; planned radionuclide releases to the environment; development of site restoration plans, and waste treatment and disposal. Examples of characterization work are presented which relate to terrestrial and marine environments at Andreeva Bay. The use of this data in assessments is illustrated by means of the visualization and assessment tool (DATAMAP) developed as part of the regulatory cooperation program, specifically to help control radiation exposure in operations and to support regulatory analysis of management options. For assessments of the current radiological situation, the types of data needed include information about the distribution of radionuclides in environmental media. For prognostic assessments, additional data are needed about the landscape features, on-shore and off-shore hydrology, geochemical properties of soils and sediments, and possible continuing source terms from continuing operations and on-site disposal. It is anticipated that shared international experience in legacy site characterization can be useful in the next steps. Although the output has been designed to support regulatory evaluation of these particular sites in northwest Russia, the methods and techniques are considered useful examples for application elsewhere, as well as providing relevant input to the International Atomic Energy Agency's international Working Forum for the Regulatory Supervision of Legacy Sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

The Tasman Spirit oil spill: implications for regulatory change in Pakistan.

PubMed

Mian, Saima; Bennett, Suzan

2009-07-01

An oil spill in July 2003 from the tanker Tasman Spirit attracted considerable public and media attention in Pakistan. This paper focuses on the experience of a developing country such as Pakistan in dealing with a major oil spill and its impact on bringing about change in the national regulatory framework. A major outcome has been the ratification of the International Convention on Civil Liability for Oil Pollution Damage 1992, which came into force in March 2006 in Pakistan. The convention provides a compensation mechanism for victims incurring oil pollution damages from maritime casualties involving oil laden ships. Several additional changes are still required to improve the country's ability to cope with marine oil spills. These include the development of a comprehensive domestic regulatory framework, implementation of an effective contingency plan, and capacity building of all relevant agencies.

Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs.

PubMed

Mazzaglia, Giampiero; Straus, Sabine M J; Arlett, Peter; da Silva, Daniela; Janssen, Heidi; Raine, June; Alteri, Enrica

2018-02-01

Studies measuring the effectiveness of risk minimization measures (RMMs) submitted by pharmaceutical companies to the European Medicines Agency are part of the post-authorization regulatory requirements and represent an important source of data covering a range of medicinal products and safety-related issues. Their objectives, design, and the associated regulatory outcomes were reviewed, and conclusions were drawn that may support future progress in risk minimization evaluation. Information was obtained from risk management plans, study protocols, clinical study reports, and assessment reports of 157 medicinal products authorized for cardiovascular, endocrinology, and metabolic indications. We selected observational studies measuring, as outcomes of interest, the relationship between the RMMs in place and (1) implementation measures, such as clinical knowledge or physicians` compliance to recommendations contained in the RMMs; and (2) occurrence or reduced severity of the adverse drug reactions for which the RMMs were required. Of 59 eligible studies (24 completed, 35 ongoing), 44 assessed implementation measures, whereas only 15 assessed safety outcomes (1 study as a single endpoint and 14 studies with other endpoints). Fifty-one studies used non-experimental designs and 25 studies employed electronic healthcare databases for analysis. Of the 24 completed studies, 17 were considered satisfactory and supported immediate regulatory decision making, 6 were considered inconclusive and required new evaluations, and 1 was terminated early because new safety restrictions were required, thereby necessitating a new evaluation. Compliance with agreed deadlines was considered acceptable in 21 of 24 completed studies; the average time for a submission was 37 months (standard deviation ± 17), with differences observed by type of data source employed. Three important gaps in the evaluation plans of RMMs were identified: lack of early feedback on implementation, limited evaluation of safety outcomes, and inability to provide information on the effectiveness from an integrated measurement of different elements of a set of risk minimization tools. More robust evidence is needed to advance regulatory science and support more rapid adjustment of risk minimization strategies as needed.

77 FR 14047 - Guidance for Decommissioning Planning During Operations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-08

...)-4014, ``Decommissioning Planning During Operations.'' This action is necessary to correct the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2011-0286] Guidance for Decommissioning Planning During Operations AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; correction. SUMMARY: The U...

Small grant management in health and behavioral sciences: Lessons learned.

PubMed

Sakraida, Teresa J; D'Amico, Jessica; Thibault, Erica

2010-08-01

This article describes considerations in health and behavioral sciences small grant management and describes lessons learned during post-award implementation. Using the components by W. Sahlman [Sahlman, W. (1997). How to write a great business plan. Harvard Business Review, 75(4), 98-108] as a business framework, a plan was developed that included (a) building relationships with people in the research program and with external parties providing key resources, (b) establishing a perspective of opportunity for research advancement, (c) identifying the larger context of scientific culture and regulatory environment, and (d) anticipating problems with a flexible response and rewarding teamwork. Small grant management included developing a day-to-day system, building a grant/study program development plan, and initiating a marketing plan. Copyright 2010 Elsevier Inc. All rights reserved.

Country actions to meet UN commitments on non-communicable diseases: a stepwise approach.

PubMed

Bonita, Ruth; Magnusson, Roger; Bovet, Pascal; Zhao, Dong; Malta, Deborah C; Geneau, Robert; Suh, Il; Thankappan, Kavumpurathu Raman; McKee, Martin; Hospedales, James; de Courten, Maximilian; Capewell, Simon; Beaglehole, Robert

2013-02-16

Strong leadership from heads of state is needed to meet national commitments to the UN political declaration on non-communicable diseases (NCDs) and to achieve the goal of a 25% reduction in premature NCD mortality by 2025 (the 25 by 25 goal). A simple, phased, national response to the political declaration is suggested, with three key steps: planning, implementation, and accountability. Planning entails mobilisation of a multisectoral response to develop and support the national action plan, and to build human, financial, and regulatory capacity for change. Implementation of a few priority and feasible cost-effective interventions for the prevention and treatment of NCDs will achieve the 25 by 25 goal and will need only few additional financial resources. Accountability incorporates three dimensions: monitoring of progress, reviewing of progress, and appropriate responses to accelerate progress. A national NCD commission or equivalent, which is independent of government, is needed to ensure that all relevant stakeholders are held accountable for the UN commitments to NCDs. Copyright © 2013 Elsevier Ltd. All rights reserved.

[Food labeling in Ecuador: implementation, results, and pending actions].

PubMed

Díaz, Adrián Alberto; Veliz, Paula Mariana; Rivas-Mariño, Gabriela; Mafla, Carina Vance; Altamirano, Luz María Martínez; Jones, Cecilia Vaca

2017-06-08

Noncommunicable diseases are the world's leading cause of death, responsible for 38 million deaths in 2012. This epidemic is primarily associated with smoking, excessive alcohol consumption, sedentary lifestyle, and changes in dietary patterns, characterized by diets high in sugar and saturated fat, typical of processed foods and sugar-sweetened beverages, plus low intake of fruits and vegetables. Ecuador is no exception to this epidemiological profile or to changes in eating patterns. Thus, Ecuador's government designed and implemented an action plan aimed at changing the obesogenic environment, which includes six strategic lines. One of these is implementation of a traffic-light nutritional labeling system for processed foods, in late 2014, aimed at guaranteeing people's right to timely, clear, accurate, and non-deceptive information on the content and characteristics of these foods. This article analyzes implementation of processed food labeling and results to date, and proposes complementary measures needed to reach the goal in the National Plan for Good Living, in light of new scientific evidence and different agreements and regulatory frameworks in our Region. Methods included a literature and documentary review, key informant interviews, and analysis and processing of secondary sources.

LIMS user acceptance testing.

PubMed

Klein, Corbett S

2003-01-01

Laboratory Information Management Systems (LIMS) play a key role in the pharmaceutical industry. Thorough and accurate validation of such systems is critical and is a regulatory requirement. LIMS user acceptance testing is one aspect of this testing and enables the user to make a decision to accept or reject implementation of the system. This paper discusses key elements in facilitating the development and execution of a LIMS User Acceptance Test Plan (UATP).

Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation.

PubMed

de Wilde, Sofieke; Veltrop-Duits, Louise; Hoozemans-Strik, Merel; Ras, Thirza; Blom-Veenman, Janine; Guchelaar, Henk-Jan; Zandvliet, Maarten; Meij, Pauline

2016-06-01

Since the implementation of the European Union (EU) regulation for advanced therapy medicinal products (ATMPs) in 2009, only six ATMPs achieved marketing authorization approval in the EU. Recognizing the major developments in the ATMP field, starting mostly in academic institutions, we investigated which hurdles were experienced in the whole pathway of ATMP development towards clinical care. Quality interviews were executed with different stakeholders in The Netherlands involved in the ATMP development field, e.g. academic research groups, national authorities and patient organizations. Based on the hurdles mentioned in the interviews, questionnaires were subsequently sent to the academic principal investigators (PIs) and ATMP good manufacturing practice (GMP) facility managers to quantify these hurdles. Besides the familiar regulatory routes of marketing authorization (MA) and hospital exemption (HE), a part of the academic PIs perceived that ATMPs should become available by the Tissues and Cells Directive or did not anticipate on the next development steps towards implementation of their ATMP towards regular clinical care. The main hurdles identified were: inadequate financial support, rapidly evolving field, study-related problems, lacking regulatory knowledge, lack of collaborations and responsibility issues. Creating an academic environment stimulating and planning ATMP development and licensing as well as investing in expanding the relevant regulatory knowledge in academic institutions seems a prerequisite to develop ATMPs from bench to patient. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Guidelines for innovation in pediatric surgery.

PubMed

Kastenberg, Zachary; Dutta, Sanjeev

2011-05-01

Surgical innovation involves the conceptualization, research, and translation of a novel idea into a viable procedure or device. The technological advancements made within the field of pediatric surgery over the last century have led to major improvements in patient care and outcomes. There has, however, been a parallel increase in the complexity of the regulatory bodies governing research and device implementation. This article briefly outlines the history of innovation in pediatric surgery, describes the existing regulatory bodies governing surgical research and device development (i.e., Department of Health and Human Services, Food and Drug Administration), and offers a set of guidelines for the pediatric surgeon planning to incorporate a new procedure or device into clinical practice.

Corrective Action Decision Document/Corrective Action Plan for Corrective Action Unit 97: Yucca Flat/Climax Mine Nevada National Security Site, Nevada, Revision 1

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

Farnham, Irene

This corrective action decision document (CADD)/corrective action plan (CAP) has been prepared for Corrective Action Unit (CAU) 97, Yucca Flat/Climax Mine, Nevada National Security Site (NNSS), Nevada. The Yucca Flat/Climax Mine CAU is located in the northeastern portion of the NNSS and comprises 720 corrective action sites. A total of 747 underground nuclear detonations took place within this CAU between 1957 and 1992 and resulted in the release of radionuclides (RNs) in the subsurface in the vicinity of the test cavities. The CADD portion describes the Yucca Flat/Climax Mine CAU data-collection and modeling activities completed during the corrective action investigationmore » (CAI) stage, presents the corrective action objectives, and describes the actions recommended to meet the objectives. The CAP portion describes the corrective action implementation plan. The CAP presents CAU regulatory boundary objectives and initial use-restriction boundaries identified and negotiated by DOE and the Nevada Division of Environmental Protection (NDEP). The CAP also presents the model evaluation process designed to build confidence that the groundwater flow and contaminant transport modeling results can be used for the regulatory decisions required for CAU closure. The UGTA strategy assumes that active remediation of subsurface RN contamination is not feasible with current technology. As a result, the corrective action is based on a combination of characterization and modeling studies, monitoring, and institutional controls. The strategy is implemented through a four-stage approach that comprises the following: (1) corrective action investigation plan (CAIP), (2) CAI, (3) CADD/CAP, and (4) closure report (CR) stages.« less

Safety evaluation report on Tennessee Valley Authority: Browns Ferry nuclear performance plan

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

Not Available

1989-10-01

This safety evaluation report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Nuclear Performance Plan, through Revision 2, for the Browns Ferry Nuclear Plant and in supporting documents has been prepared by the US Nuclear Regulatory commission staff. The Browns Ferry Nuclear Plant consists of three boiling-water reactors at a site in Limestone County, Alabama. The plan addresses the plant-specific concerns requiring resolution before the startup of Unit 2. The staff will inspect implementation of those TVA programs that address these concerns. Where systems are common to Units 1 and 2 or to Units 2more » and 3, the staff safety evaluations of those systems are included herein. 85 refs.« less

Implementing sustainable drainage systems for urban surface water management within the regulatory framework in England and Wales.

PubMed

Ellis, J Bryan; Lundy, Lian

2016-12-01

The UK 2007 floods resulted in damages estimated to exceed over £4 billion. This triggered a national review of strategic flood risk management (Pitt, 2008) with its recommendations informing and implemented by the Flood and Water Management, Act (FWMA, 2010). Estimating that up to two-thirds of properties flooded in the 2007 event as a direct result of overloaded sewer systems, the FWMA set out an ambitious overhaul of flood risk management approaches including identifying bodies responsible for the management of local flood risk (local municipalities) and the development of over-arching Lead Local Flood Authorities (LLFAs) at a regional level. LLFAs duties include developing local flood risk management strategies and, aligned with this, many LLFAs and local municipalities produced sustainable drainage system (SUDS) guidance notes. In parallel, changes to the national planning policy framework (NPPF) in England give priority to the use of SUDS in new major developments, as does the related Town and Country Planning Order (2015). However, whilst all three pieces of legislation refer to the preferential use of SUDs, these requirements remain "economically proportionate" and thus the inclusion of SUDS within development controls remain desirable - but not mandatory - obligations. Within this dynamic policy context, reignited most recently by the December 2015 floods, this paper examines some of the challenges to the implementation of SUDS in England and Wales posed by the new regulatory frameworks. In particular, it examines how emerging organisational procedures and processes are likely to impact on future SUDS implementation, and highlights the need for further cross-sectoral working to ensure opportunities for cross-sectoral benefits- such as that accrued by reducing stormwater flows within combined sewer systems for water companies, property developers and environmental protection - are not lost. Copyright © 2016 Elsevier Ltd. All rights reserved.

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.

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

Metzler, D.; Gibb, J.P.; Glover, W.A.

Compliance with the mandate of the Uranium Mill Tailings Radiation Control Act (UMTRCA) at Uranium Mill Tailings Remedial Action (UMTRA) Project sites requires implementation of a groundwater remedial action plan that meets the requirements of Subpart B of the US Environmental Protection Agency`s proposed groundwater protection standards (40 CFR 192). The UMTRA Groundwater Project will ensure that unacceptable current risk or potential risk to the public health, safety and the environment resulting from the groundwater contamination attributable to the UMTRA sites, is mitigated in a timely and cost-efficient manner. For each UMTRA processing site and vicinity property where contamination exists,more » a groundwater remedial action plan must be developed that identifies hazardous constituents and establishes acceptable concentration limits for the hazardous constituents as either (a) alternate concentration limits (ACL), (b) maximum concentration limits (MCLs), (c) supplemental standards, or (d) background groundwater quality levels. Project optimization is a strategy that will aggressively work within the current regulatory framework using all available options to meet regulatory requirements. This strategy is outlined within.« less

Facility Decontamination and Decommissioning Program Surveillance and Maintenance Plan, Revision 2

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

Poderis, Reed J.; King, Rebecca A.

This Surveillance and Maintenance (S&M) Plan describes the activities performed between deactivation and final decommissioning of the following facilities located on the Nevada National Security Site, as documented in the Federal Facility Agreement and Consent Order under the Industrial Sites program as decontamination and decommissioning sites: ? Engine Maintenance, Assembly, and Disassembly (EMAD) Facility: o EMAD Building (Building 25-3900) o Locomotive Storage Shed (Building 25-3901) ? Test Cell C (TCC) Facility: o Equipment Building (Building 25-3220) o Motor Drive Building (Building 25-3230) o Pump Shop (Building 25-3231) o Cryogenic Lab (Building 25-3232) o Ancillary Structures (e.g., dewars, water tower, piping,more » tanks) These facilities have been declared excess and are in various stages of deactivation (low-risk, long-term stewardship disposition state). This S&M Plan establishes and implements a solid, cost-effective, and balanced S&M program consistent with federal, state, and regulatory requirements. A graded approach is used to plan and conduct S&M activities. The goal is to maintain the facilities in a safe condition in a cost-effective manner until their final end state is achieved. This plan accomplishes the following: ? Establishes S&M objectives and framework ? Identifies programmatic guidance for S&M activities to be conducted by National Security Technologies, LLC, for the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO) ? Provides present facility condition information and identifies hazards ? Identifies facility-specific S&M activities to be performed and their frequency ? Identifies regulatory drivers, NNSA/NFO policies and procedures, and best management practices that necessitate implementation of S&M activities ? Provides criteria and frequencies for revisions and updates ? Establishes the process for identifying and dispositioning a condition that has not been previously identified or documented ? Provides instructions for implementing annual S&M inspections and activities The following facilities that were included in Revision 1 of this plan have reached final disposition and are no longer in the S&M program: ? Reactor Maintenance, Assembly, and Disassembly Facility, Building 25-3110 ? Test Cell A Facility, Building 25-3113 ? TCC Facility, Building 25-3210 ? Pluto Disassembly Facility, Building 26-2201 ? Super Kukla Facility, Building 27-5400« less

A qualitative study of the determinants of HIV guidelines implementation in two south-eastern districts of Tanzania.

PubMed

Mwangome, Mary N; Geubbels, Eveline; Wringe, Alison; Todd, Jim; Klatser, Paul; Dieleman, Marjolein

2017-07-01

Current HIV policies in Tanzania have adopted the three long-term impact results of zero new infections, zero HIV deaths and zero stigma and discrimination. Strategies to reach these results include scaling-up HIV Testing and Counselling (HTC); Preventing Mother-To-Child Transmission (PMTCT); and strengthening Care and Treatment Clinic (CTC) services. Previous studies showed that HIV policy and guideline recommendations were not always implemented in rural South Tanzania. This study aims to identify the determinants of HIV guideline implementation. A qualitative study of 23 semi-structured interviews with facility in-charges; healthcare workers; district, regional and national HIV coordinators was conducted. Five health facilities were purposively selected by level, ownership and proximity to district headquarters. Interviews were analysed according to Fleuren's five determinants of innovation uptake related to: strategies used in guideline development and dissemination; guideline characteristics; the guideline implementing organization; guideline users; and the socio-cultural and regulatory context. None of the facilities had the HTC national guideline document. Non-involvement of providers in revisions and weak planning for guideline dissemination impeded their implementation. Lengthy guidelines and those written in English were under-used, and activities perceived to be complicated, like WHO-staging, were avoided. Availability of staff and lack of supplies like test kits and medication impeded implementation. Collaboration between facilities enhanced implementation, as did peer-support among providers. Provider characteristics including education level, knowledge of, and commitment to the guideline influenced implementation. According to providers, determinants of clients' service use included gender norms, stigma, trust and perceived benefits. The regulatory context prohibited private hospitals from buying HIV supplies. Being tools for bringing policies to practice, national guidelines are crucial in the efforts towards the three zeros. Strategies to improve providers' adherence to guidelines should include development of clearer guideline dissemination plans, strengthening of the health system, and possibly addressing of provider-perceived patient-level barriers to utilizing HIV services. © The Author 2017. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine.

An international review of the challenges associated with securing 'buy-in' for water safety plans within providers of drinking water supplies.

PubMed

Summerill, Corinna; Smith, Jen; Webster, James; Pollard, Simon

2010-06-01

Since publication of the 3rd Edition of the World Health Organisation (WHO) Drinking Water Quality guidelines, global adoption of water safety plans (WSPs) has been gathering momentum. Most guidance lists managerial commitment and 'buy-in' as critical to the success of WSP implementation; yet the detail on how to generate it is lacking. This commentary discusses aspects of managerial commitment to WSPs. We argue that the public health motivator should be clearer and a paramount objective and not lost among other, albeit legitimate, drivers such as political or regulatory pressures and financial efficiency.

Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products.

PubMed

Lucas-Samuel, Sophie; Ferry, Nicolas; Trouvin, Jean-Hugues

2015-01-01

Advanced therapy medicinal products, a new class of products with promising therapeutic effects, have been classified as medicinal products and as such should be developed according to a well-structured development plan, to establish their quality, safety and efficacy profile and conclude, at the time of the marketing authorisation evaluation, on a positive risk/benefit balance for patients. An important part of this development plan is achieved through clinical trials, which have also to be approved according to a well-established regulatory process, prior any initiation. This chapter is dedicated to describe the regulatory pathway to be followed in France, before initiating any clinical trial with those investigational advanced therapy medicinal products. In France, to get the final authorisation to initiate a clinical trial, the legislation imposes to run in parallel two independent but complementary authorisation procedures. The first procedure is aimed at assessing the ethical aspect of the biomedical research, while the second has to review the safety and regulatory aspects. A third procedure has to be envisaged where in case the investigational product consists or contains a genetically modified organism. The French system herein described is in line with the EU regulation on clinical trial and follows the respective deadlines for granting the final approval. The complexity of the procedure is in fact more due to the complexity of the products and protocols to be assessed than to the procedure itself which is now very close to the well-known procedure applied routinely for more conventional chemical or biological candidate medicinal products.

Integrated vector management: the Zambian experience.

PubMed

Chanda, Emmanuel; Masaninga, Fred; Coleman, Michael; Sikaala, Chadwick; Katebe, Cecilia; Macdonald, Michael; Baboo, Kumar S; Govere, John; Manga, Lucien

2008-08-27

The Zambian Malaria Control Programme with the Roll Back Malaria (RBM) partners have developed the current National Malaria Strategic Plan (NMSP 2006-2011) which focuses on prevention based on the Integrated Vector Management (IVM) strategy. The introduction and implementation of an IVM strategy was planned in accordance with the World Health Organization (WHO) steps towards IVM implementation namely Introduction Phase, Consolidation Phase and Expansion Phase. IVM has created commitment for Legal and Regulatory policy review, monitoring, Research and a strong stewardship by the chemical suppliers. It has also leveraged additional resources, improved inter-sectoral collaboration, capacity building and enhanced community participation which facilitated a steady scaling up in coverage and utilisation of key preventive interventions. Thus, markedly reducing malaria incidence and case fatalities in the country. Zambia has successfully introduced, consolidated and expanded IVM activities. Resulting in increased coverage and utilization of interventions and markedly reducing malaria-related morbidity and mortality while ensuring a better protection of the environment.

Direct broadcast satellite-radio market, legal, regulatory, and business considerations

NASA Technical Reports Server (NTRS)

Sood, Des R.

1991-01-01

A Direct Broadcast Satellite-Radio (DBS-R) System offers the prospect of delivering high quality audio broadcasts to large audiences at costs lower than or comparable to those incurred using the current means of broadcasting. The maturation of mobile communications technologies, and advances in microelectronics and digital signal processing now make it possible to bring this technology to the marketplace. Heightened consumer interest in improved audio quality coupled with the technological and economic feasibility of meeting this demand via DBS-R make it opportune to start planning for implementation of DBS-R Systems. NASA-Lewis and the Voice of America as part of their on-going efforts to improve the quality of international audio broadcasts, have undertaken a number of tasks to more clearly define the technical, marketing, organizational, legal, and regulatory issues underlying implementation of DBS-R Systems. The results and an assessment is presented of the business considerations underlying the construction, launch, and operation of DBS-R Systems.

Direct broadcast satellite-radio market, legal, regulatory, and business considerations

NASA Astrophysics Data System (ADS)

Sood, Des R.

1991-03-01

A Direct Broadcast Satellite-Radio (DBS-R) System offers the prospect of delivering high quality audio broadcasts to large audiences at costs lower than or comparable to those incurred using the current means of broadcasting. The maturation of mobile communications technologies, and advances in microelectronics and digital signal processing now make it possible to bring this technology to the marketplace. Heightened consumer interest in improved audio quality coupled with the technological and economic feasibility of meeting this demand via DBS-R make it opportune to start planning for implementation of DBS-R Systems. NASA-Lewis and the Voice of America as part of their on-going efforts to improve the quality of international audio broadcasts, have undertaken a number of tasks to more clearly define the technical, marketing, organizational, legal, and regulatory issues underlying implementation of DBS-R Systems. The results and an assessment is presented of the business considerations underlying the construction, launch, and operation of DBS-R Systems.

[Human resources for health in Ecuador's new model of care].

PubMed

Espinosa, Verónica; de la Torre, Daniel; Acuña, Cecilia; Cadena, Cristina

2017-06-08

Describe strategies implemented by Ecuador's Ministry of Public Health (MPH) to strengthen human resources for health leadership and respond to the new model of care, as a part of the reform process in the period 2012-2015. A documentary review was carried out of primary and secondary sources on development of human resources for health before and after the reform. In the study period, Ecuador developed a new institutional and regulatory framework for developing human resources for health to respond to the requirements of a model of care based on primary health care. The MPH consolidated its steering role by forging strategic partnerships, implementing human resources planning methods, and making an unprecedented investment in health worker training, hiring, and wage increases. These elements constitute the initial core for development of human resources for health policy and a health-services study program consistent with the reform's objectives. Within the framework of the reform carried out from 2012 to 2015, intersectoral work by the MPH has led to considerable achievements in development of human resources for health. Notable achievements include strengthening of the steering role, development and implementation of standards and regulatory instruments, creation of new professional profiles, and hiring of professionals to implement the comprehensive health care model, which helped to solve problems carried over from the years prior to the reform.

Disaster preparedness in biocontainment animal research facilities: developing and implementing an incident response plan (IRP).

PubMed

Swearengen, James R; Vargas, Karen J; Tate, Mallory K; Linde, N S

2010-01-01

Preparing for the wide variety of disasters that can occur is challenging for any animal research facility, but the level of concern for human and animal health rises significantly when infectious agents and toxins are part of the scenario. Federal regulations provide detailed requirements for the development of an incident response plan (IRP) when select agents and toxins (SATs) are used. In addition to the usual issues associated with disaster planning, the IRP must address concerns associated with the potential theft, loss, or release of SATs that may affect both institutional personnel and the surrounding community. The level of detail in the IRP and the intensity of training should be appropriate for the level of risk involved. Regulations describe certain basic requirements but do not address the risks of SAT-exposed animals, which have been the subject of additional guidance to help implement regulatory requirements. A 2008 joint publication of the Centers for Disease Control and Prevention and the Animal and Plant Health Inspection Service describes scenarios in which SAT-exposed animals are handled in the same manner as the agent or toxin itself for the purpose of reporting a SAT theft, loss, or release. Events that resulted from the impact of Hurricane Ike at the University of Texas Medical Branch in Galveston provide a valuable opportunity to evaluate the effectiveness of the federal regulations and to build on lessons learned from this disaster. These lessons can help to supplement the regulatory requirements and improve the safety and security of handling both SATs and animals exposed to them during and after an emergency situation.

ARM Unmanned Aerial Systems Implementation Plan

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

Schmid, Beat; Ivey, Mark

Recent advances in Unmanned Aerial Systems (UAS) coupled with changes in the regulatory environment for operations of UAS in the National Airspace increase the potential value of UAS to the U.S. Department of Energy (DOE) Atmospheric Radiation Measurement (ARM) Climate Research Facility. UAS include unmanned aerial vehicles (UAV) and tethered balloon systems (TBS). The roles UAVs and TBSs could play within the ARM Facility, particularly science questions they could help address, have been discussed in several workshops, reports, and vision documents, including: This document describes the implementation of a robust and vigorous program for use of UAV and TBS formore » the science missions ARM supports.« less

Knowledge Management Initiatives Used to Maintain Regulatory Expertise in Transportation and Storage of Radioactive Materials - 12177

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

Lindsay, Haile; Garcia-Santos, Norma; Saverot, Pierre

2012-07-01

The U.S. Nuclear Regulatory Commission (NRC) was established in 1974 with the mission to license and regulate the civilian use of nuclear materials for commercial, industrial, academic, and medical uses in order to protect public health and safety, and the environment, and promote the common defense and security. Currently, approximately half (∼49%) of the workforce at the NRC has been with the Agency for less than six years. As part of the Agency's mission, the NRC has partial responsibility for the oversight of the transportation and storage of radioactive materials. The NRC has experienced a significant level of expertise leavingmore » the Agency due to staff attrition. Factors that contribute to this attrition include retirement of the experienced nuclear workforce and mobility of staff within or outside the Agency. Several knowledge management (KM) initiatives have been implemented within the Agency, with one of them including the formation of a Division of Spent Fuel Storage and Transportation (SFST) KM team. The team, which was formed in the fall of 2008, facilitates capturing, transferring, and documenting regulatory knowledge for staff to effectively perform their safety oversight of transportation and storage of radioactive materials, regulated under Title 10 of the Code of Federal Regulations (10 CFR) Part 71 and Part 72. In terms of KM, the SFST goal is to share critical information among the staff to reduce the impact from staff's mobility and attrition. KM strategies in place to achieve this goal are: (1) development of communities of practice (CoP) (SFST Qualification Journal and the Packaging and Storing Radioactive Material) in the on-line NRC Knowledge Center (NKC); (2) implementation of a SFST seminar program where the seminars are recorded and placed in the Agency's repository, Agency-wide Documents Access and Management System (ADAMS); (3) meeting of technical discipline group programs to share knowledge within specialty areas; (4) development of written guidance to capture 'administrative and technical' knowledge (e.g., office instructions (OIs), generic communications (e.g., bulletins, generic letters, regulatory issue summary), standard review plans (SRPs), interim staff guidance (ISGs)); (5) use of mentoring strategies for experienced staff to train new staff members; (6) use of Microsoft SharePoint portals in capturing, transferring, and documenting knowledge for staff across the Division from Division management and administrative assistants to the project managers, inspectors, and technical reviewers; and (7) development and implementation of a Division KM Plan. A discussion and description of the successes and challenges of implementing these KM strategies at the NRC/SFST will be provided. (authors)« less

Quality assurance of HDR prostate plans: program implementation at a community hospital.

PubMed

Rush, Jennifer B; Thomas, Michael D

2005-01-01

Adenocarcinoma of the prostate is currently the most commonly diagnosed cancer in men in the United States, and the second leading cause of cancer mortality. The utilization of radiation therapy is regarded as the definitive local therapy of choice for intermediate- and high-risk disease, in which there is increased risk for extracapsular extension, seminal vesicle invasion, or regional node involvement. High-dose-rate (HDR) brachytherapy is a logical treatment modality to deliver the boost dose to an external beam radiation therapy (EBRT) treatment to increase local control rates. From a treatment perspective, the utilization of a complicated treatment delivery system, the compressed time frame in which the procedure is performed, and the small number of large dose fractions make the implementation of a comprehensive quality assurance (QA) program imperative. One aspect of this program is the QA of the HDR treatment plan. Review of regulatory and medical physics professional publications shows that substantial general guidance is available. We provide some insight to the implementation of an HDR prostate plan program at a community hospital. One aspect addressed is the utilization of the low-dose-rate (LDR) planning system and the use of existing ultrasound image sets to familiarize the radiation therapy team with respect to acceptable HDR implant geometries. Additionally, the use of the LDR treatment planning system provided a means to prospectively determine the relationship between the treated isodose volume and the product of activity and time for the department's planning protocol prior to the first HDR implant. For the first 12 HDR prostate implants, the root-mean-square (RMS) deviation was 3.05% between the predicted product of activity and time vs. the actual plan values. Retrospective re-evaluation of the actual implant data reduced the RMS deviation to 2.36%.

State Energy Conservation Program Measure Directory. Sourcebook: Volume 8. Part 2 of 2 books

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

Not Available

DOE prepared an 8-volume Sourcebook to provide useful information for states in development and implementation of their Energy Conservation Plans. The purpose of Vol. 8, a 2-book set, is to facilitate exchange of information among states concerning program measures of common interest. DOE/CS--0159/1, Vol. 8, Book 1, announced in EAPA 6: abst. 3475, covered states Alabama through Missouri; this report, Vol. 8, Book 2 begins with Montana and completes the alphabet. Information is summarized also for American Samoa, Guam, Northern Mariana Islands, Puerto Rico, and the Virgin Islands in the two books. Information on the various programs in each statemore » includes identification data; narrative description of program measure; program measure information; and annual energy savings reported. A cross-reference index is included for agriculture, industry, transportation, buildings, government, legislative/regulatory implementation strategies, general education implementation strategies, specific information implementation strategies, demonstration implementation strategies, administration implementation strategies, and renewable-resource implementation strategies.« less

SB 1082 -- Unified hazardous materials/waste program: Local implementation

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

Jones, W.

California Senate Bill 1082 was signed into law in the fall of 1993 because business and industry believed there were too many hazardous materials inspectors asking the same questions, looking at the same items and requiring similar information on several variations of the same form. Industry was not happy with the large diversity of programs, each with its own inspectors, permits and fees, essentially doing what industry believed was the same inspection. SB 1082 will allow local city and county agencies to apply to the California Environmental Protection Agency to become a Certified Unified Program Agency (CUPA) or work withmore » a CUPA as a Participating Agency (PA) to manage specific program elements. The CUPA will unify six regulatory programs including hazardous waste/tiered permitting, aboveground storage tanks, underground storage tanks, business and area plans/inventory or disclosure, acutely hazardous materials/risk management prevention and Uniform Fire Code programs related to hazardous materials inventory/plan requirements. The bill requires the CUPA to (1) implement a permit consolidation program; (2) implement a single fee system with a state surcharge; (3) consolidate, coordinate and make consistent any local or regional requirements or guidance documents; and (4) implement a single unified inspection and enforcement program.« less

Re-engineering the Federal planning process: A total Federal planning strategy, integrating NEPA with modern management tools

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

Eccleston, C.H.

1997-09-05

The National Environmental Policy Act (NEPA) of 1969 was established by Congress more than a quarter of a century ago, yet there is a surprising lack of specific tools, techniques, and methodologies for effectively implementing these regulatory requirements. Lack of professionally accepted techniques is a principal factor responsible for many inefficiencies. Often, decision makers do not fully appreciate or capitalize on the true potential which NEPA provides as a platform for planning future actions. New approaches and modem management tools must be adopted to fully achieve NEPA`s mandate. A new strategy, referred to as Total Federal Planning, is proposed formore » unifying large-scale federal planning efforts under a single, systematic, structured, and holistic process. Under this approach, the NEPA planning process provides a unifying framework for integrating all early environmental and nonenvironmental decision-making factors into a single comprehensive planning process. To promote effectiveness and efficiency, modem tools and principles from the disciplines of Value Engineering, Systems Engineering, and Total Quality Management are incorporated. Properly integrated and implemented, these planning tools provide the rigorous, structured, and disciplined framework essential in achieving effective planning. Ultimately, the goal of a Total Federal Planning strategy is to construct a unified and interdisciplinary framework that substantially improves decision-making, while reducing the time, cost, redundancy, and effort necessary to comply with environmental and other planning requirements. At a time when Congress is striving to re-engineer the governmental framework, apparatus, and process, a Total Federal Planning philosophy offers a systematic approach for uniting the disjointed and often convoluted planning process currently used by most federal agencies. Potentially this approach has widespread implications in the way federal planning is approached.« less

78 FR 663 - Decommissioning Planning During Operations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-04

...] Decommissioning Planning During Operations AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide..., ``Decommissioning Planning During Operations.'' The guide describes a method that the NRC staff considers acceptable for use by holders of licenses in complying with the NRC's Decommissioning Planning Rule (DPR) (76 FR...

Making habitat connectivity a reality.

PubMed

Keeley, Annika T H; Basson, Galli; Cameron, D Richard; Heller, Nicole E; Huber, Patrick R; Schloss, Carrie A; Thorne, James H; Merenlender, Adina M

2018-06-19

For over 40 years, habitat corridors have been a solution for sustaining wildlife in fragmented landscapes, and now are often suggested as a climate adaptation strategy. However, while a plethora of connectivity plans exist, protecting and restoring habitat connectivity through on-the-ground action has been slow. We identified implementation challenges and opportunities through a literature review of project implementation, a science-practice workshop, and interviews with conservation professionals. Our research indicates that connectivity challenges and solutions tend to be context-specific, dependent on land ownership patterns, socioeconomic factors, and the policy framework. We found evidence that developing and promoting a common vision shared by a diverse set of stakeholders including nontraditional conservation actors, such as water districts and recreation departments, and through communication among and between partners and the public is key to successful implementation. Other factors that lead to successful implementation include undertaking empirical studies to prioritize and validate corridors and the identification of related co-benefits of corridor projects. Engaging partners involved in land management and planning, such as non-governmental conservation organizations, public agencies, and private landowners is critical to effective strategy implementation. A clear regulatory framework including unambiguous connectivity conservation mandates would increase public resource allocation, and incentive programs are needed to promote private sector engagement. We argue that connectivity conservation must more rapidly move from planning to implementation and provide an evidence-based solution made up of key elements for successful on-the-ground connectivity implementation. The components of this new framework constitute the social processes necessary to advance habitat connectivity for biodiversity conservation and resilient landscapes under climate change. Three case studies serve to illustrate the application of the framework. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

The Individualized Quality Control Plan - Coming Soon to Clinical Microbiology Laboratories Everywhere!

PubMed

Anderson, Nancy

2015-11-15

As of January 1, 2016, microbiology laboratories can choose to adopt a new quality control option, the Individualized Quality Control Plan (IQCP), under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This voluntary approach increases flexibility for meeting regulatory requirements and provides laboratories the opportunity to customize QC for their testing in their unique environments and by their testing personnel. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process. It includes three main steps, (1) performing a risk assessment, (2) developing a QC plan, and (3) monitoring the plan through quality assessment. Resources are available from the Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, American Society for Microbiology, Clinical and Laboratory Standards Institute, and accrediting organizations, such as the College of American Pathologists and Joint Commission, to assist microbiology laboratories implementing IQCP.

Implementing business continuity management systems and sharing best practices at a European bank.

PubMed

Aronis, Stelios; Stratopoulos, Georgios

2016-01-01

This paper provides an overview of the methodology applied by the Alpha Bank Group in order to implement a business continuity management (BCM) programme to its parent company (Alpha Bank SA), as well as to its subsidiaries in Albania, Bulgaria, Cyprus, Former Yugoslav Republic of Macedonia, Greece, Romania, Serbia, UK and Ukraine. It also reviews the problems faced, how they were overcome and the lessons learned. When implementing a BCM programme in a large organisation, it is very important to follow the methodology described by BCM standard ISO 22301, otherwise the business continuity plan is unlikely to work efficiently or comply with the business recovery requirements, as well as with the requirements of other interested parties, such as customers, regulatory authorities, vendors, service providers, critical associates, etc.

What's the Regulatory Value of a Target Product Profile?

PubMed

Breder, Christopher D; Du, Wenny; Tyndall, Adria

2017-07-01

Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review times, perhaps as a result of increased planning or because the TPP promotes well-organized regulatory dialog. Published by Elsevier Ltd.

77 FR 61458 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-09

... Offer Members the Ability To Pay a Regulatory Fine Pursuant to an Installment Plan October 2, 2012... pay a regulatory fine pursuant to an installment plan, under certain conditions. The text of the... Action for Failure to Pay'' to offer members the ability to pay a regulatory fine pursuant to an...

77 FR 59439 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-27

... Proposed Rule Change To Offer Members the Ability To Pay a Regulatory Fine Pursuant to an Installment Plan... offer members the ability to pay a regulatory fine pursuant to an installment plan, under certain... Costs; Summary Action for Failure to Pay'' to offer members the ability to pay a regulatory fine...

Instrumentation and control upgrade plan for Browns Ferry nuclear plant

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

Belew, M.R.; Langley, D.T.; Torok, R.C.

1992-01-01

A comprehensive upgrade of the instrumentation and control (I C) systems at a power plant represents a formidable project for any utility. For a nuclear plant, the extra safety and reliability requirements along with regulatory constraints add further complications and cost. The need for the upgrade must, therefore, be very compelling, and the process must be well planned from the start. This paper describes the steps taken to initiate the I C upgrade process for Tennessee Valley Authority's (TVA's) Browns Ferry 2 nuclear plant. It explains the impetus for the upgrade, the expected benefits, and the process by which systemmore » upgrades will be selected and implemented.« less

Achieving built-environment and active living goals through Music City Moves.

PubMed

Omishakin, Adetokunbo A; Carlat, Jennifer L; Hornsby, Shannon; Buck, Tracy

2009-12-01

Nashville, Tennessee, formed Music City Moves (MCM), an interdisciplinary, countywide partnership to implement its vision for the community: a metropolitan region where routine physical activity is a fundamental part of daily life for all residents. Music City Moves' main focus was the pursuit of changes in community planning policies to help shape Nashville's built environment and facilitate walking and bicycling. To complement this focus, MCM developed a suite of health programs to support physical activity in high-risk populations and a countywide promotional campaign designed to increase awareness and get people active through event participation. Nashville made considerable strides in improving policies and regulations related to building and site design to improve the built environment for pedestrians and cyclists, including passage of (1) specific plan zoning; (2) revised subdivision regulations that introduced a "walkable subdivision" option for developers; and (3) a community-character manual that will guide future land-use planning. Programs and promotions have increased awareness and participation, and the Tour de Nash bike/walk event showcases yearly changes in the built environment. Political leadership has been critical to MCM's success. Leadership of the partnership by the planning department facilitated regulatory changes in planning policies. Music City Moves has accelerated Nashville's movement to improve the built environment and encourage active living. The beneficial impact of policy changes will continue to be manifested in coming years; however, ongoing political support and education of stakeholders in the planning process will be necessary to ensure that planning policies are fully implemented.

75 FR 29588 - Office of New Reactors: Proposed NUREG-0800; Standard Review Plan Section 13.6.6, Draft Revision...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-26

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0184] Office of New Reactors: Proposed NUREG-0800; Standard Review Plan Section 13.6.6, Draft Revision 0 on Cyber Security Plan AGENCY: Nuclear Regulatory... Plants,'' on a proposed Standard Review Plan (SRP) Section 13.6.6 on ``Cyber Security Plan'' (Agencywide...

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

The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.

PubMed

Tafuri, Giovanni; Lucas, Inês; Estevão, Steve; Moseley, Jane; d'Andon, Anne; Bruehl, Hannah; Gajraj, Elangovan; Garcia, Sonia; Hedberg, Niklas; Massari, Marco; Molina, Andrea; Obach, Mercè; Osipenko, Leeza; Petavy, Frank; Petschulies, Marco; Pontes, Caridad; Russo, Pierluigi; Schiel, Anja; Van de Casteele, Marc; Zebedin-Brandl, Eva-Maria; Rasi, Guido; Vamvakas, Spiros

2018-05-01

The parallel regulatory-health technology assessment scientific advice (PSA) procedure allows manufacturers to receive simultaneous feedback from both EU regulators and health technology assessment (HTA) bodies on development plans for new medicines. The primary objective of the present study is to investigate whether PSA is integrated in the clinical development programmes for which advice was sought. Contents of PSA provided by regulators and HTA bodies for each procedure between 2010 and 2015 were analysed. The development of all clinical studies for which PSA had been sought was tracked using three different databases. The rate of uptake of the advice provided by regulators and HTA bodies was assessed on two key variables: comparator/s and primary endpoint. In terms of uptake of comparator recommendations at the time of PSA in the actual development, our analysis showed that manufacturers implemented comparators to address both the needs of regulators and of at least one HTA body in 12 of 21 studies. For primary endpoints, in all included studies manufacturers addressed both the needs of the regulators and at least one HTA body. One of the key findings of this analysis is that manufacturers tend to implement changes to the development programme based on both regulatory and HTA advice with regards to the choice of primary endpoint and comparator. It also confirms the challenging choice of the study comparator, for which manufacturers seem to be more inclined to satisfy the regulatory advice. Continuous research efforts in this area are of paramount importance from a public health perspective. © 2018 The British Pharmacological Society.

New laws on population urged.

PubMed

1976-12-03

A workshop on ''Population and the Law'' sponsored by the Family Planning Organization of the Philippines and the International Planned Parenthood Federation recommended the following changes in Philippine law to implement family planning: legalization of abortion for women whose life or health are endangered by pregnancy and those who become pregnant despite contraceptives; delaying age of marriage to 18; extension of family planning incentives and maternity leave to women in government service; allow trained nurses and midwives to dispense contractives; legalize sterilization; include sterilization in medicare benefits; specify by law which contraceptive drugs may be dispensed by nonphysicians and nonpharmacists in rural areas; legalize premarital family planning counseling; declare family planning materials tax exempt; encourage reluctant doctors to practice sterilization through professional regulatory agencies; extend industrial family planning services to women living near the plant; launch massive information drives to advise young people of the hazards of premarital sex; strict enforcement of abortion laws in areas where illegal abortion still exists; grant women equal rights in area of consent for sterilization; and eliminate the stigma of illegitimacy for those born out of wedlock.

State-based Marketplaces using 'clearinghouse' plan management models are associated with lower premiums.

PubMed

Krinn, Kelly; Karaca-Mandic, Pinar; Blewett, Lynn A

2015-01-01

The state-based and federally facilitated health insurance Marketplaces, or exchanges, enrolled more than eight million people during the first open enrollment period, which ended March 31, 2014. There is significant variation in how states have designed and implemented their Marketplaces. We examined how premiums varied with states' involvement in the Marketplaces through governance, plan management authority, and strategy during the first year that the exchanges have been open. State-based Marketplaces using "clearinghouse" plan management models had significantly lower adjusted average premiums for all plans within each metal level compared to state-based Marketplaces using "active purchaser" models and the federally facilitated and partnership Marketplaces. Clearinghouse management models are those in which all health plans that meet published criteria are accepted. Active purchaser models are those in which states negotiate premiums, provider networks, number of plans, and benefits. Our baseline estimates provide valuable benchmarks for evaluating future performance of states' involvement in governance, plan management, and regulatory authority of the insurance Marketplaces. Project HOPE—The People-to-People Health Foundation, Inc.

76 FR 5224 - Joint Industry Plan; Notice of Filing of Amendment No. 25 to the Joint Self-Regulatory...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-28

... Collection, Consolidation and Dissemination of Quotation and Transaction Information for Nasdaq-Listed... Exchange, Inc., EDGX Exchange, Inc., Financial Industry Regulatory Authority, Inc., International... Joint Self-Regulatory Organization Plan Governing the Collection, Consolidation, and Dissemination of...

Forecasting PM10 in metropolitan areas: Efficacy of neural networks.

PubMed

Fernando, H J S; Mammarella, M C; Grandoni, G; Fedele, P; Di Marco, R; Dimitrova, R; Hyde, P

2012-04-01

Deterministic photochemical air quality models are commonly used for regulatory management and planning of urban airsheds. These models are complex, computer intensive, and hence are prohibitively expensive for routine air quality predictions. Stochastic methods are becoming increasingly popular as an alternative, which relegate decision making to artificial intelligence based on Neural Networks that are made of artificial neurons or 'nodes' capable of 'learning through training' via historic data. A Neural Network was used to predict particulate matter concentration at a regulatory monitoring site in Phoenix, Arizona; its development, efficacy as a predictive tool and performance vis-à-vis a commonly used regulatory photochemical model are described in this paper. It is concluded that Neural Networks are much easier, quicker and economical to implement without compromising the accuracy of predictions. Neural Networks can be used to develop rapid air quality warning systems based on a network of automated monitoring stations. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Scientific approaches to modernization of the regulatory framework in the field of hygiene of planning and building of settlements in Ukraine].

PubMed

Makhnyuk, V M

2014-01-01

In the paper there are investigated and analyzed the new laws and regulations of sanitary and town planning legislation, introduced in 2011-2012 which concern issues of planning and building of settlements. It is established that the functions of the State for Sanitary and Epidemiological Oversight have been given up and the necessity of incorporation in the Law of Ukraine "On ensuring sanitary and epidemiological welfare of the population" alterations which touch upon the implementation of a new approach to the State Sanitary and Epidemiological Oversight of the objects, namely for the placement of objects with low and moderate epidemic risk accordingly to hygienic declarations, objects with high risk--using an approach directed to the risk assessment of the impact of such facilities on public health.

Quality control in gastrointestinal surgery.

PubMed

Ramírez-Barba, Ector Jaime; Arenas-Moya, Diego; Vázquez-Guerrero, Arturo

2011-01-01

We analyzed the Mexican legal framework, identifying the vectors that characterize quality and control in gastrointestinal surgery. Quality is contemplated in the health protection rights determined according to the Mexican Constitution, established in the general health law and included as a specific goal in the actual National Development Plan and Health Sector Plan. Quality control implies planning, verification and application of corrective measures. Mexico has implemented several quality strategies such as certification of hospitals and regulatory agreements by the General Salubrity Council, creation of the National Health Quality Committee, generation of Clinical Practice Guidelines and the Certification of Medical Specialties, among others. Quality control in gastrointestinal surgery must begin at the time of medical education and continue during professional activities of surgeons, encouraging multidisciplinary teamwork, knowledge, abilities, attitudes, values and skills that promote homogeneous, safe and quality health services for the Mexican population.

Site observational work plan for the UMTRA Project site at Monument Valley, Arizona

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

NONE

1995-09-01

The site observational work plan (SOWP) for the Monument Valley, Arizona, US Department of Energy (DOE) Uranium Mill Tailings Remedial Action (UMTRA) Project site is one of the first site-specific documents developed to achieve ground water compliance at the site. This SOWP applies information about the Monument Valley site to a regulatory compliance framework that identifies strategies that could be used to meet ground water compliance. The compliance framework was developed in the UMTRA Ground Water programmatic environmental impact statement (DOE, 1995). The DOE`s goal is to implement a cost-effective site strategy that complies with the US Environmental Protection Agencymore » (EPA) ground water standards and protects human health and the environment. The compliance strategy that emerges in the final version of the SOWP will assess potential environmental impacts and provide stakeholder a forum for review and comment. When the compliance strategy is acceptable, it will be detailed in a remedial action plan that will be subject to review by the state and/or tribe and concurrence by the US Nuclear Regulatory Commission (NRC). Information available for the preparation of this SOWP indicates active remediation is the most likely compliance strategy for the Monument Valley site. Additional data are needed to determine the most effective remediation technology.« less

OEM Emergency Prevention and Mitigation Information

EPA Pesticide Factsheets

The Office of Emergency Management maintains information relevant to preventing emergencies before they occur, and/or mitigating the effects of emergency when they do occur. A principal element of this data asset is the information managed by the System for Risk Management Plans (SRMP), which compiles risk management plans submitted by facilities in accordance with the Clean Air Act, Section 112(r). Affected facilities are to develop risk management programs which will prevent and minimize consequences of accidental releases of certain hazardous chemicals that could harm public health and the environment.Another component of this data asset are the results generated by the Priority Assessment Model (PAM), which analyzes information concerning low-level chronic emissions from facilities and sets priorities (low, medium, high) for proactive controls on releases that do not necessarily pose imminent threats, but which may under adverse circumstances create unacceptable health or ecological risks.Also included are inspection records compiled by the Oil Inspection Program. Under the Clean Water Act Section 311, EPA regulates oil storage that meets a specific regulatory threshold. Facilities that store oil and meet the regulatory threshold need to prepare and implement a Spill Prevention, Control, and Countermeasures (SPCC) Plan which needs to be reviewed and approved by a professional engineer. Additionally, facilities with larger oil storage capacity may have to pre

To Prosecute or Not? Enforcement of Federal Criminal Regulatory Statutes. Revised Edition. A Student's Lesson Plan [and] A Teacher's Lesson Plan [and] A Lawyer's Lesson Plan.

ERIC Educational Resources Information Center

Howard, Estelle; And Others

One of a series of secondary level teaching units presenting case studies with pro and con analyses of particular legal problems, the document consists of a student's lesson plan, a teacher's lesson plan, and a lawyer's lesson plan for a unit about the enforcement of federal criminal regulatory statutes. The lesson plan presents an analysis of the…

76 FR 13442 - Joint Industry Plan; Order Approving Amendment No. 25 to the Joint Self-Regulatory Organization...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-11

..., Consolidation and Dissemination of Quotation and Transaction Information for Nasdaq-Listed Securities Traded on... Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange LLC...-Regulatory Organization Plan Governing the Collection, Consolidation, and Dissemination of Quotation and...

Strengthening TB infection control in specialized health facilities in Romania--using a participatory approach.

PubMed

Turusbekova, N; Popa, C; Dragos, M; van der Werf, M J; Dinca, I

2016-02-01

In 2012, the tuberculosis (TB) notification rate among Romanian TB facility doctors and nurses was 7.2 times higher than in the general population. This indicates that transmission is ongoing inside TB facilities and that TB infection control measures are insufficient. To help prevent nosocomial TB transmission a project was implemented that aimed at providing nationwide tailor-made technical assistance in TB infection control (TB-IC) in TB treatment facilities, including the development of TB infection control plans. The objective of the present article is to describe the implementation of the project and to discuss successes and challenges. The project was an implementation study using two methods of evaluation: (1) a cross sectional questionnaire study; and (2) collection of information, during the training, on challenges related to infection control and to the project implementation. The project team developed a TB facility infection control (TB-IC) plan template, together with the Romanian experts. The template was discussed and agreed upon with the experts at a meeting and thereafter distributed by email to all TB facilities. Afterwards, a training of trainers (TOT) seminar was organized which included the provision of information about different training methods, as well as information about TB-IC. The TOT was followed by training for key TB-IC providers. Information about use of the TB-IC template was gathered through a self-administered questionnaire sent to all participants of the expert meeting and the training (42 people). Additionally, non-systematized discussions were held on broader challenges in TB-IC implementation during the training. Within the project 42 key TB-IC service providers were trained in TB-IC, including 9 who were trained at a TOT seminar. The trainees were specialists working at the national level, such as country TB coordinators, or at the TB facility level: TB doctors, epidemiologists, laboratory specialists and maintenance engineers. Out of 42 key TB-IC service providers who were trained, only eighteen responded to the questionnaire (no reminders were sent). Out of these, 14 had used the TB-IC plan template after the project team disseminated it to them by email. The remaining four TB-IC service providers indicated that they were planning to use the template to develop or update their facility TB-IC plans. Related to the use of TB-IC plan template, the following broader challenges in TB-IC were identified: a lack of authority of the individuals responsible for TB-IC to implement the TB-IC measures, lack of training among facility epidemiologists on TB, underdeveloped system for reporting TB in healthcare workers, difficulties with triage of the TB suspects, and poor facility infrastructure hampering implementation of TB-IC measures. Implementing TB-IC plans in Romanian health care facilities proved to be challenging, mainly due to the fact that the national infection control plan for TB was not yet adopted at the time of project implementation, and therefore there was neither a regulatory framework to support TB facility-IC planning nor any related budget allocations for the implementation of the facilities' TB-IC plans. Nonetheless, most respondents who answered the questionnaire (18 of 42 responded) indicated that they had started using the TB-IC plan template, which represents a full package of infection control measures that, when implemented effectively and in its entirety, may be expected to reduce nosocomial transmission. The study's limitations are: very low survey response rate, thus there is a likelihood of responder bias. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Digital Architecture Planning Model

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

Oxstrand, Johanna Helene; Al Rashdan, Ahmad Yahya Mohammad; Bly, Aaron Douglas

As part of the U.S. Department of Energy’s Light Water Reactor Sustainability Program, the Digital Architecture (DA) Project focuses on providing a model that nuclear utilities can refer to when planning deployment of advanced technologies. The digital architecture planning model (DAPM) is the methodology for mapping power plant operational and support activities into a DA that unifies all data sources needed by the utilities to operate their plants. The DA is defined as a collection of information technology capabilities needed to support and integrate a wide spectrum of real-time digital capabilities for performance improvements of nuclear power plants. DA canmore » be thought of as integration of the separate instrumentation and control and information systems already in place in nuclear power plants, which are brought together for the purpose of creating new levels of automation in plant work activities. A major objective in DAPM development was to survey all key areas that needed to be reviewed in order for a utility to make knowledgeable decisions regarding needs and plans to implement a DA at the plant. The development was done in two steps. First, researchers surveyed the nuclear industry in order to learn their near-term plans for adopting new advanced capabilities and implementing a network (i.e., wireless and wire) infrastructure throughout the plant, including the power block. Secondly, a literature review covering regulatory documents, industry standards, and technical research reports and articles was conducted. The objective of the review was to identify key areas to be covered by the DAPM, which included the following: 1. The need for a DA and its benefits to the plant 2. Resources required to implement the DA 3. Challenges that need to be addressed and resolved to implement the DA 4. Roles and responsibilities of the DA implementation plan. The DAPM was developed based on results from the survey and the literature review. Model development, including the survey results and conclusions made about the key areas during the literature review, are described in this report.« less

Evolution of high-rise construction in Leningrad - Saint Petersburg in the middle of the 20th - Early 21st centuries: projects and Implementation

NASA Astrophysics Data System (ADS)

Vaytens, Andrey; Rusanov, Gennadiy; Skryabin, Pavel

2018-03-01

One of the most important issues in national urban planning is arrangement of high-rise buildings in the largest cities of Russia. This issue becomes especially acute in such cities as Saint Petersburg, which has unique architectural and urban-planning heritage preserved to a great extent. In this regard, it seems important to trace the evolution of high-rise construction development and arrangement in Leningrad - Saint Petersburg in the middle of the 20th — early 21st centuries. The goal of the article is to consider high-rise construction development regarding both public and residential buildings in comparison of project ideas and results of their implementation in the 1940s-2000s. Prerequisites and issues of high-rise construction of that period are considered. Particular attention is paid to changes in the official urban-planning policy, regulatory framework and attitude of city authorities to high-rise construction. The study was carried out with the consideration of the following historic periods differing in their urban-planning policy: the late 1940s-1950s; 1960s; 1970-1980s; 1990s; 2000s-2010s. Economical prerequisites of high-rise construction and their influence on the modern urban-planning policy during the post-Soviet period are considered. In conclusion, an attempt is made to determine tendencies of high-rise construction development in Saint Petersburg.

The integration of the risk in the governance of urban projects: a key issue for a resilient city

NASA Astrophysics Data System (ADS)

Moulin, E.; Deroubaix, J.-F.

2012-04-01

Despite a severe regulation concerning the building in flooding areas, 80% of these areas are already built in the Greater Paris (Paris, Val-de-Marne, Hauts-de-Seine and Seine-Saint-Denis). The land use in flooding area is presented as one of the main solutions to solve the ongoing real estate pressure. For instance some of the industrial wastelands located along the river are currently in redevelopment and residential buildings are planned. So landuse in the flooding areas is currently a key issue in the development of the Greater Paris area. Tools and measures, structural or non-structural such as warning systems, barriers, etc do exist and could be a smart way to improve the resilience of the new urbanised areas. The technical solutions are available and efficient, but we notice that these tools are not much implemented. There is a lack of flood risk concern among the stakeholders and the inhabitants1. How landuse stakeholders could integrate the flood risk in the decision making process throughout the implementation of the urban project? Which type of governance favours an efficient development of good flood risk policy including prevention, protection and the management of the crisis? What is the "good" governance of the urban project e.g. enabling to take into account or not to forget the flood risk and to empower the (future) inhabitants? This inhabitants' empowerment includes the improvement of awareness (i.e. inhabitants being aware that they live in a flooded area) and the improvement of concern (i.e. inhabitants adopting the "right" behaviour when the risk occurs). In order to investigate how flood risk is or could be integrated in the project governance, we interviewed stakeholders (elected representatives, architects, property developers, etc.) and observed the integration or the vanishing of the risk throughout the project. In order to develop this topic we rely on a case study. The "Ardoines" is a project aiming at redeveloping an industrial site (South-East Paris), into a project including residential and office buildings and other amenities. In order to elaborate the master plan, the urban planning authority brought together some flood risk experts. With the remarks of the experts, the architect in charge of the landuse elaborated the master plan taking into account the flood risk; reducing vulnerability of the area and improving the resilience in case of floods, towards a threshold plan. How the experts' recommendations appear in the execution phase? We will show how the project completes or departs from the regulatory policy concerning the drawing up and the implementation of the prevention/protection against flood risk in France. How the vulnerability reduction or the resilience improvement reproduce the regulatory fragmentation, i.e.; on one hand the risk prevention plan and on the other hand the crisis management? We will demonstrate how a resilient approach should mix the several regulatory segments and put the inhabitant in the middle of the urban project thanks to suitable urban forms.

Specialty Task Force: A Strategic Component to Electronic Health Record (EHR) Optimization.

PubMed

Romero, Mary Rachel; Staub, Allison

2016-01-01

Post-implementation stage comes after an electronic health record (EHR) deployment. Analyst and end users deal with the reality that some of the concepts and designs initially planned and created may not be complementary to the workflow; creating anxiety, dissatisfaction, and failure with early adoption of system. Problems encountered during deployment are numerous and can vary from simple to complex. Redundant ticket submission creates backlog for Information Technology personnel resulting in delays in resolving concerns with EHR system. The process of optimization allows for evaluation of system and reassessment of users' needs. A solid and well executed optimization infrastructure can help minimize unexpected end-user disruptions and help tailor the system to meet regulatory agency goals and practice standards. A well device plan to resolve problems during post implementation is necessary for cost containment and to streamline communication efforts. Creating a specialty specific collaborative task force is efficacious and expedites resolution of users' concerns through a more structured process.

Barred from better medicine? Reexamining regulatory barriers to the inclusion of prisoners in research.

PubMed

Huang, Elaine; Cauley, Jacqueline; Wagner, Jennifer K

2017-04-01

In 2015, President Obama announced plans for the Precision Medicine Initiative ® (PMI), an ambitious longitudinal project aimed at revolutionizing medicine. Integral to this Initiative is the recruitment of over one million Americans into a volunteer research cohort, the All of Us SM Research Program. The announcement has generated much excitement but absent is a discussion of how the All of Us Research Program-to be implemented within the context of social realities of mass incarcerations and racial disparities in criminal justice and healthcare-might excaberate health disparities. We examine how attainment of Initiative's stated goals of reflecting the diversity of the American population and including all who are interested in participating might be impeded by regulatory and administrative barriers to the involvement of participants who become incarcerated during longitudinal studies. Changes have been proposed to the federal policy for human subjects research protections, but current regulations and administrative policies-developed under a protectionist paradigm in response to scandalous research practices with confined populations-dramatically limit research involving prisoners. Our review provides rationale for the development of Initiative policies that anticipate recruitment and retention obstacles that might frustrate inclusivity and exacerbate health disparities. Furthermore, we question the effective ban on biomedical and behavioral research involving prisoners and advocate for regulatory reforms that restore participatory research rights of prisoners. Disparities in health and justice are intertwined, and without regulatory reforms to facilitate participatory research rights of prisoners and careful planning of viable and responsible recruitment, engagement, and retention strategies, Initiative could miss discovery opportunities, exacerbate health disparities, and increase levels of distrust in science.

Department of Transportation Agency Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] [Department of Transportation Agency Semiannual Regulatory Agenda ] Part XIII Department of Transportation Semiannual Regulatory Agenda [[Page 79812

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) the improvement of the model-based ozone-attainment demonstration process are presented to identify future directions in this area. Images Figure 7. Figure 7. Figure 7. Figure 8. Figure 9. PMID:7614934

Department of the Interior Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] [Department of the Interior Semiannual Regulatory Agenda] Part X Department of the Interior Semiannual Regulatory Agenda [[Page 79796

Starting a sleep center.

PubMed

Epstein, Lawrence J; Valentine, Paul S

2010-05-01

The demand for sleep medicine services has grown tremendously during the last decade and will likely continue. To date, growth in demand has been met by growth in the number of new sleep centers. The need for more new centers will be dependent on market drivers that include increasing regulatory requirements, personnel shortages, integration of home sleep testing, changes in reimbursement, a shift in emphasis from diagnostics to treatment, and an increased consumer focus on sleep. The decision to open a new center should be based on understanding the market dynamics, completing a market analysis, and developing a business plan. The business plan should include an overview of the facility, a personnel and organizational structure, an evaluation of the business environment, a financial plan, a description of services provided, and a strategy for obtaining, managing, and extending a referral base. Implementation of the business plan and successful operation require ongoing planning and monitoring of operational parameters. The need for new sleep centers will likely continue, but the shifting market dynamics indicate a greater need for understanding the marketplace and careful planning.

Extending Safety Culture Development through Communication - 12366

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

Sneve, M.K.; Kiselev, M.; Shandala, N.K.

2012-07-01

The Norwegian Radiation Protection Authority has been implementing a regulatory support program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective is the enhancement of safety culture. The project outputs have included appropriate regulatory threat assessments, to determine the hazardous activities which are most in need of enhanced regulatory supervision; and development of the norms, standards and regulatory procedures, necessary to address the often abnormal conditions at nuclear legacy sites. Project outputs have been prepared and subsequently confirmed asmore » official regulatory documents of the Russian Federation. The continuing program of work focuses on practical application of the enhanced regulatory framework as applied to legacy sites, including safe management of radioactive wastes arising in the process of site remediation. One of the lessons learnt from this practical application is the importance of effective communication at all levels: - between managers and shop workers; - between different operators - e.g. waste producers and waste disposal organisations; - between operators and regulators; - between nuclear safety regulators, radiation protection regulators and other pollution and safety regulators; - between scientists, policy makers and wider stakeholders; and - between all of those mentioned above. A key message from this work is that it is not just an issue of risk communication; rather all aspects of communication can contribute to safety culture enhancement to support effective and efficient risk management, including the role of regulatory supervision. (authors)« less

76 FR 5231 - Joint Industry Plan; Notice of Filing and Immediate Effectiveness of Amendment No. 23 to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-28

... Organization Plan Governing the Collection, Consolidation and Dissemination of Quotation and Transaction...., EDGA Exchange, Inc., EDGX Exchange, Inc., Financial Industry Regulatory Authority, Inc., International... Joint Self-Regulatory Organization Plan Governing the Collection, Consolidation, and Dissemination of...

Costs of Food Safety Investments in the Meat and Poultry Slaughter Industries.

PubMed

Viator, Catherine L; Muth, Mary K; Brophy, Jenna E; Noyes, Gary

2017-02-01

To develop regulations efficiently, federal agencies need to know the costs of implementing various regulatory alternatives. As the regulatory agency responsible for the safety of meat and poultry products, the U.S. Dept. of Agriculture's Food Safety and Inspection Service is interested in the costs borne by meat and poultry establishments. This study estimated the costs of developing, validating, and reassessing hazard analysis and critical control points (HACCP), sanitary standard operating procedures (SSOP), and sampling plans; food safety training for new employees; antimicrobial equipment and solutions; sanitizing equipment; third-party audits; and microbial tests. Using results from an in-person expert consultation, web searches, and contacts with vendors, we estimated capital equipment, labor, materials, and other costs associated with these investments. Results are presented by establishment size (small and large) and species (beef, pork, chicken, and turkey), when applicable. For example, the cost of developing food safety plans, such as HACCP, SSOP, and sampling plans, can range from approximately $6000 to $87000, depending on the type of plan and establishment size. Food safety training costs from approximately $120 to $2500 per employee, depending on the course and type of employee. The costs of third-party audits range from approximately $13000 to $24000 per audit, and establishments are often subject to multiple audits per year. Knowing the cost of these investments will allow researchers and regulators to better assess the effects of food safety regulations and evaluate cost-effective alternatives. © 2017 Institute of Food Technologists®.

Physical and organizational provision for installation, regulatory requirements and implementation of a simultaneous hybrid PET/MR-imaging system in an integrated research and clinical setting.

PubMed

Sattler, Bernhard; Jochimsen, Thies; Barthel, Henryk; Sommerfeld, Kerstin; Stumpp, Patrick; Hoffmann, Karl-Titus; Gutberlet, Matthias; Villringer, Arno; Kahn, Thomas; Sabri, Osama

2013-02-01

The implementation of hybrid imaging systems requires thorough and anticipatory planning at local and regional levels. For installation of combined positron emission and magnetic resonance imaging systems (PET/MRI), a number of physical and constructional provisions concerning shielding of electromagnetic fields (RF- and high-field) as well as handling of radionuclides have to be met, the latter of which includes shielding for the emitted 511 keV gamma rays. Based on our experiences with a SIEMENS Biograph mMR system, a step-by-step approach is required to allow a trouble-free installation. In this article, we present a proposal for a standardized step-by-step plan to accomplish the installation of a combined PET/MRI system. Moreover, guidelines for the smooth operation of combined PET/MRI in an integrated research and clinical setting will be proposed. Overall, the most important preconditions for the successful implementation of PET/MRI in an integrated research and clinical setting is the interdisciplinary target-oriented cooperation between nuclear medicine, radiology, and all referring and collaborating institutions at all levels of interaction (personnel, imaging protocols, reporting, selection of the data transfer and communication methods).

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

Fraley, John J.; Marotz, Brian L.; DosSantos, Joseph M.

In this document we present fisheries losses, mitigation alternatives, and recommendations to protect, mitigate, and enhance resident fish and aquatic habitat affected by the construction and operation of Hungry Horse Dam. This plan addresses six separate program measures in the 1987 Columbia Basin Fish and Wildlife Program. We designed the plan to be closely coordinated in terms of dam operations, funding, and activities with the Kerr Mitigation Plan presently before the Federal Energy Regulatory Commission. This document represents a mitigation plan for consideration by the Northwest Power Planning Council process; it is not an implementation plan. Flathead Lake is onemore » of the cleanest lakes of its size in the world. The exceptional water quality and unique native fisheries make the Flathead Lake/River system extremely valuable to the economy and quality of life in the basin. The recreational fishery in Flathead Lake has an estimated value of nearly eight million dollars annually. This mitigation process represents our best opportunity to reduce the impacts of hydropower in this valuable aquatic system and increase angling opportunity. We based loss estimates and mitigation alternatives on an extensive data base, agency reports, nationally and internationally peer-reviewed scientific articles, and an innovative biological model for Hungry Horse Reservoir and the Flathead River. We conducted an extensive, 14-month scoping and consultation process with agency representatives, representatives of citizen groups, and the general public. This consultation process helped identify issues, areas of agreement, areas of conflict, and advantages and disadvantages of mitigation alternatives. The results of the scoping and consultation process helped shape our mitigation plan. Our recommended plan is based firmly on principles of adaptive management and recognition of biological uncertainty. After we receive direction from the NPPC, we will add more detailed hypotheses and other features necessary for a long-term implementation plan.« less

Factors affecting electronic health record adoption in long-term care facilities.

PubMed

Cherry, Barbara; Carter, Michael; Owen, Donna; Lockhart, Carol

2008-01-01

Electronic health records (EHRs) hold the potential to significantly improve the quality of care in long-term care (LTC) facilities, yet limited research has been done on how facilities decide to adopt these records. This study was conducted to identify factors that hinder and facilitate EHR adoption in LTC facilities. Study participants were LTC nurses, administrators, and corporate executives. Primary barriers identified were costs, the need for training, and the culture change required to embrace technology. Primary facilitators were training programs, well-defined implementation plans, government assistance with implementation costs, evidence that EHRs will improve care outcomes, and support from state regulatory agencies. These results offer a framework of action for policy makers, LTC Leaders, and researchers.

76 FR 74630 - Making Changes to Emergency Plans for Nuclear Power Reactors

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-01

... NUCLEAR REGULATORY COMMISSION 10 CFR Parts 50 and 52 RIN 3150-AI10 [NRC-2008-0122] Making Changes to Emergency Plans for Nuclear Power Reactors AGENCY: Nuclear Regulatory Commission. ACTION... guide (RG) 1.219, ``Guidance on Making Changes to Emergency Plans for Nuclear Power Reactors.'' This...

76 FR 32133 - FAR Council's Plan for Retrospective Review Under Executive Order 13563-Preliminary Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-03

... (E.O.) 13563, ``Improving Regulation and Regulatory Review.'' The E.O. sets forth principles and... resources and regulatory priorities, under which the agency will periodically review its existing... retrospective analysis. The Council's plan has tentatively identified eight priority initiatives for new or...

Implementing a framework for goal setting in community based stroke rehabilitation: a process evaluation.

PubMed

Scobbie, Lesley; McLean, Donald; Dixon, Diane; Duncan, Edward; Wyke, Sally

2013-05-24

Goal setting is considered 'best practice' in stroke rehabilitation; however, there is no consensus regarding the key components of goal setting interventions or how they should be optimally delivered in practice. We developed a theory-based goal setting and action planning framework (G-AP) to guide goal setting practice. G-AP has 4 stages: goal negotiation, goal setting, action planning & coping planning and appraisal & feedback. All stages are recorded in a patient-held record. In this study we examined the implementation, acceptability and perceived benefits of G-AP in one community rehabilitation team with people recovering from stroke. G-AP was implemented for 6 months with 23 stroke patients. In-depth interviews with 8 patients and 8 health professionals were analysed thematically to investigate views of its implementation, acceptability and perceived benefits. Case notes of interviewed patients were analysed descriptively to assess the fidelity of G-AP implementation. G-AP was mostly implemented according to protocol with deviations noted at the planning and appraisal and feedback stages. Each stage was felt to make a useful contribution to the overall process; however, in practice, goal negotiation and goal setting merged into one stage and the appraisal and feedback stage included an explicit decision making component. Only two issues were raised regarding G-APs acceptability: (i) health professionals were concerned about the impact of goal non-attainment on patient's well-being (patients did not share their concerns), and (ii) some patients and health professionals found the patient-held record unhelpful. G-AP was felt to have a positive impact on patient goal attainment and professional goal setting practice. Collaborative partnerships between health professionals and patients were apparent throughout the process. G-AP has been perceived as both beneficial and broadly acceptable in one community rehabilitation team; however, implementation of novel aspects of the framework was inconsistent. The regulatory function of goal non-attainment and the importance of creating flexible partnerships with patients have been highlighted. Further development of the G-AP framework, training package and patient held record is required to address the specific issues highlighted by this process evaluation. Further evaluation of G-AP is required across diverse community rehabilitation settings.

76 FR 44155 - Pacific Halibut Fisheries; Catch Sharing Plan for Guided Sport and Commercial Fisheries in Alaska

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

...NMFS proposes regulations that would implement a catch sharing plan for the guided sport and commercial fisheries for Pacific halibut in waters of International Pacific Halibut Commission (IPHC) Regulatory Areas 2C (Southeast Alaska) and 3A (Central Gulf of Alaska). If approved, this catch sharing plan will change the annual process of allocating halibut between the guided sport and commercial fisheries in Area 2C and Area 3A, establish allocations for each sector, and specify harvest restrictions for guided sport anglers that are intended to limit harvest to the annual guided sport fishery catch limit. In order to provide flexibility for individual commercial and guided sport fishery participants, the proposed catch sharing plan also will authorize annual transfers of commercial halibut quota to charter halibut permit holders for harvest in the guided sport fishery. This action is necessary to achieve the halibut fishery management goals of the North Pacific Fishery Management Council.

78 FR 13712 - U.S. Nuclear Regulatory Commission Planned Monitoring Activities for F-Area Tank Farm at the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-28

... Monitoring Activities for F-Area Tank Farm at the Savannah River Site, Revision 0 AGENCY: Nuclear Regulatory... carrying out its responsibilities for monitoring DOE's waste disposal activities at the F-Area Tank Farm at... the availability of ``U.S. Nuclear Regulatory Commission Plan for Monitoring Disposal Actions Taken by...

Self-Regulatory Private Speech Relates to Children's Recall and Organization of Autobiographical Memories

ERIC Educational Resources Information Center

Al-Namlah, Abdulrahman S.; Meins, Elizabeth; Fernyhough, Charles

2012-01-01

We investigated relations between 4- and 7-year-olds' (N=58) autobiographical memory and their use of self-regulatory private speech in a non-mnemonic context (a cognitive planning task). Children's use of self-regulatory private speech during the planning task was associated with longer autobiographical narratives which included specific rather…

75 FR 26822 - Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for EDGX Exchange, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-12

... Commission adopted amendments to paragraph (c) of Rule 19d-1 to allow self-regulatory organizations (``SROs... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62036; File No. 4-594] Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for EDGX Exchange, Inc. May 5, 2010. On March 19, 2010...

75 FR 26827 - Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for EDGA Exchange, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-12

... Commission adopted amendments to paragraph (c) of Rule 19d-1 to allow self-regulatory organizations (``SROs... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62037; File No. 4-595] Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for EDGA Exchange, Inc. May 5, 2010. On March 19, 2010...

76 FR 61402 - Draft Nuclear Regulatory Commission Fiscal Year 2012-2016 Strategic Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-04

... waste. The draft Strategic Plan also describes the agency's Organizational Excellence Objectives of Openness, Regulatory Effectiveness, and Operational Excellence, which characterize the manner in which the...

Liberalization of the Spanish electricity sector: An advanced model

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

Unda, J.I.

1998-06-01

Spain`s electricity industry is being restructured to provide a competitive generation market, a regulated, open access transmission and distribution system, and phased-in customer choice. But while the reform is radical in its objectives, it will be gradual in its implementation. This article briefly describes the current state of affairs within the Spanish electricity sector and details the reform plans set out in the act, focusing on the adopted institutional design and the established transition period. It also offers an overview of the role that the regulatory authority will play throughout the process.

Prototype Input and Output Data Elements for the Occupational Health and Safety Information System

NASA Technical Reports Server (NTRS)

Whyte, A. A.

1980-01-01

The National Aeronautics and Space Administration plans to implement a NASA-wide computerized information system for occupational health and safety. The system is necessary to administer the occupational health and safety programs and to meet the legal and regulatory reporting, recordkeeping, and surveillance requirements. Some of the potential data elements that NASA will require as input and output for the new occupational health and safety information system are illustrated. The data elements are shown on sample forms that have been compiled from various sources, including NASA Centers and industry.

ALARA at nuclear power plants

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

Baum, J.W.

1990-01-01

Implementation of the As Low As Reasonably Achievable (ALARA) principle at nuclear power plants presents a continuing challenge for health physicists at utility corporate and plant levels, for plant designers, and for regulatory agencies. The relatively large collective doses at some plants are being addressed though a variety of dose reduction techniques. It is planned that this report will include material on historical aspects, management, valuation of dose reduction, quantitative and qualitative aspects of optimization, design, operational considerations, and training. The status of this work is summarized in this report. 30 refs., 1 fig., 6 tabs.

77 FR 45721 - Consolidated Audit Trail

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-01

...The Securities and Exchange Commission (``Commission'') is adopting Rule 613 under the Securities Exchange Act of 1934 (``Exchange Act'' or ``Act'') to require national securities exchanges and national securities associations (``self-regulatory organizations'' or ``SROs'') to submit a national market system (``NMS'') plan to create, implement, and maintain a consolidated order tracking system, or consolidated audit trail, with respect to the trading of NMS securities, that would capture customer and order event information for orders in NMS securities, across all markets, from the time of order inception through routing, cancellation, modification, or execution.

Radon gas: contractor liability for an indoor health hazard.

PubMed

Shuko, C M

1986-01-01

Many families throughout the United States have recently detected dangerously high concentrations of radon gas inside their homes. Radon, a carcinogenic gas produced from uranium, has been discovered in structures overlying uranium-bearing rock. This discovery may result in litigation to determine contractor liability for building upon radon-releasing rock sites. This Note examines the strengths and weaknesses of the various theories of contractor liability and considers potential statutory claims under the Clean Air Act. The Note suggests, as an alternative approach to recovery, a proposed regulatory scheme and implementation plan.

Exploring the relationship between planning and procurement in Western U.S. electric utilities

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

Carvallo Bodelon, Juan Pablo; Sanstad, Alan H.; Larsen, Peter H.

Integrated resource planning (IRP) is an important regulatory process used in many U.S. states to formulate and evaluate least-cost and risk-assessed portfolios to meet future load requirements for electric utilities. In principle, effective implementation of IRP seeks to assure regulators and the public that utility investment decisions, given uncertainty, are as cost-effective as possible. However, to date, there is no empirical assessment on the effectiveness of IRP implementation. In this analysis, we compare planning, procurement processes and actual decisions for a sample of twelve load serving entities (LSEs) across the Western U. S. from 2003-2014. The 2008/2009 recession provides amore » unique “stress test” to the planning process and offers an excellent opportunity to trace how procurement decisions responded to this largely unforeseen event. In aggregate, there is a general alignment between planned and procured supply-side capacity. However, there are significant differences in the choice of supply-side resources and type of ownership for individual LSEs. We develop case studies for three LSEs and find that subsequent plans differ significantly due to changes in the planning environment and that procurement decisions in some cases are impacted by factors that are not accounted for in the planning process. Our results reveal that a limited amount of information produced during the long-term planning process (e.g., forecasts, methods, and least cost/risk portfolios) are ultimately used during the procurement process, and that the latter process relies extensively on the most recent information available for decision making. These findings suggest that states' IRP rules and regulations mandating long-term planning horizons with the same analytical complexity throughout the planning period may not create useful information for the procurement process. The social value of a long-term planning process that departs from procurement and the balance between transparency and complexity of the planning and procurement processes is an open question.« less

Barred from better medicine? Reexamining regulatory barriers to the inclusion of prisoners in research

PubMed Central

Huang, Elaine; Cauley, Jacqueline

2017-01-01

Abstract In 2015, President Obama announced plans for the Precision Medicine Initiative® (PMI), an ambitious longitudinal project aimed at revolutionizing medicine. Integral to this Initiative is the recruitment of over one million Americans into a volunteer research cohort, the All of UsSM Research Program. The announcement has generated much excitement but absent is a discussion of how the All of Us Research Program—to be implemented within the context of social realities of mass incarcerations and racial disparities in criminal justice and healthcare—might excaberate health disparities. We examine how attainment of Initiative's stated goals of reflecting the diversity of the American population and including all who are interested in participating might be impeded by regulatory and administrative barriers to the involvement of participants who become incarcerated during longitudinal studies. Changes have been proposed to the federal policy for human subjects research protections, but current regulations and administrative policies—developed under a protectionist paradigm in response to scandalous research practices with confined populations—dramatically limit research involving prisoners. Our review provides rationale for the development of Initiative policies that anticipate recruitment and retention obstacles that might frustrate inclusivity and exacerbate health disparities. Furthermore, we question the effective ban on biomedical and behavioral research involving prisoners and advocate for regulatory reforms that restore participatory research rights of prisoners. Disparities in health and justice are intertwined, and without regulatory reforms to facilitate participatory research rights of prisoners and careful planning of viable and responsible recruitment, engagement, and retention strategies, Initiative could miss discovery opportunities, exacerbate health disparities, and increase levels of distrust in science. PMID:28852561

Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa.

PubMed

Slack, Catherine; Strode, Ann; Fleischer, Theodore; Gray, Glenda; Ranchod, Chitra

2007-05-13

South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research. This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics committees; and lobbying the National Regulatory Authority for guidance.

Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa

PubMed Central

Slack, Catherine; Strode, Ann; Fleischer, Theodore; Gray, Glenda; Ranchod, Chitra

2007-01-01

Background South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. Discussion This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research. Summary This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics commitees; and lobbying the National Regulatory Authority for guidance. PMID:17498316

Economic efficiency of high-rise construction in the Moscow program of renovation of housing stock

NASA Astrophysics Data System (ADS)

Misailovov, Andrey

2018-03-01

The article considers a new initiative of the regional authorities of updating the housing stock designated as the renovation of housing. Its main aspects are analyzed, including the nature of program, economic efficiency of its implementation due to high-rise construction and the regulatory and legislative framework, the procedure for implementing the program, and the time frame for its implementation. The role of the program for regions in which high depreciation of the housing stock is combined with a limited number of sites for a new housing construction is disclosed. The high-rise construction in the renovation program is presented as a variant of a successful solution not only of the tasks of renovating the housing stock, but also of filling the regional budget. The social and economic orientation of the high-rise construction and the involvement of residents in the process of making town-planning decisions in the field of high-rise construction at all stages of implementing the program are shown.

77 FR 64564 - Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

...-Basis Hurricane and Hurricane Missiles AGENCY: Nuclear Regulatory Commission. ACTION: Proposed interim...-ISG-024, ``Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles....221, ``Design-Basis Hurricane and Hurricane Missiles for Nuclear Power Plants.'' DATES: Submit...

The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

PubMed

Keyter, Andrea; Gouws, Joey; Salek, Sam; Walker, Stuart

2018-01-01

The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.

PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.

PubMed

Mor, Vincent; Volandes, Angelo E; Gutman, Roee; Gatsonis, Constantine; Mitchell, Susan L

2017-04-01

Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N = 119 intervention/N = 241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization prior to recruitment feasible with 100% participation of facilities randomized to the intervention arm. Critical regulatory issues included minimal risk determination, waiver of informed consent, and determination that nursing home providers were not engaged in human subjects research. Intervention training and implementation were initiated on 5 January 2016 using corporate infrastructures for new program roll-out guided by standardized training elements designed by the research team. Video Status Reports in facilities' electronic medical records permitted "real-time" adherence monitoring and corrective actions. The Centers for Medicare and Medicaid Services Virtual Research Data Center allowed for rapid outcomes ascertainment. Conclusion We must rigorously evaluate interventions to deliver more patient-focused care to an increasingly frail nursing home population. Video decision support is a practical approach to improve advance care planning. PRagmatic trial Of Video Education in Nursing homes has the potential to promote goal-directed care among millions of older Americans in nursing homes and establish a methodology for future pragmatic randomized controlled trials in this complex healthcare setting.

78 FR 9083 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

... FINRA to determine whether Rule 11892 is necessary once the Plan is operational and, if so, whether... in Connection With the Limit Up-Limit Down Plan February 1, 2013. Pursuant to Section 19(b)(1) of the... also proposes to adopt new supplementary material in connection with the upcoming operation of the Plan...

76 FR 39922 - Office of New Reactors; Proposed Revision 4 to Standard Review Plan Section 8.1 on Electric Power...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... the proposed Revision 4 to Standard Review Plan Section 8.1 on ``Electric Power-- Introduction.'' The... NUCLEAR REGULATORY COMMISSION [NRC-2011-0119] Office of New Reactors; Proposed Revision 4 to Standard Review Plan Section 8.1 on Electric Power--Introduction, Correction AGENCY: Nuclear Regulatory...

Not so sweet refrain: sugar-sweetened beverage taxes, industry opposition and harnessing the lessons learned from tobacco control legal challenges.

PubMed

George, Anita

2018-05-21

As a growing number of countries implement, or announce plans to introduce, a sugar-sweetened beverage (SSB) tax, this paper explores the public health rationale for such a tax and provides an overview of the international normative and policy instruments supporting the introduction of fiscal measures on sugary drinks. After examining parallels between the legal arguments raised by the food and beverage industry in opposition to SSB taxes and those raised by the tobacco industry in response to tobacco control measures, this paper draws four key lessons that will assist countries to design effective and robust SSB tax measures and counter food and beverage industry opposition: regulatory distinctions in tax coverage should be based on bona fide, evidence-based reasoning; evidence-based measures need to be tailored to a country's public health objectives as part of a comprehensive strategy to address unhealthy diet consumption; procedural requirements and due process should be observed in the drafting and implementation of the measure; and regulatory space exists within domestic constitutions, laws and international trade and investment agreements recognising the sovereign right of states to regulate in the interests of public health.

Identification of Challenges to the Availability and Accessibility of Opioids in Twelve European Countries: Conclusions from Two ATOME Six-Country Workshops.

PubMed

Linge-Dahl, Lisa; Vranken, Marjolein; Juenger, Saskia; North, Kate; Scholten, Willem; Payne, Sheila; Radbruch, Lukas

2015-12-01

Access to many controlled medicines is inadequate in a number of European countries. This leads to deficits in the treatment of moderate to severe pain as well as in opioid agonist therapy. The study objective was to elaborate the reasons for this inadequacy. The work plan of the Access to Opioid Medication in Europe (ATOME) project included two six-country workshops. These workshops comprised a national situational analysis, drafting tailor-made recommendations for improvement and developing action plans for their implementation. In total, 84 representatives of the national Ministries of Health, national controlled substances authorities, experts representing regulatory and law enforcement authorities, leading health care professionals, and patient representatives from 13 European countries participated in either one of the workshops. The delegates used breakout sessions to identify key common challenges. Content analysis was used for the evaluation of protocols and field notes. A number of challenges to opioid accessibility in the countries was identified in the domains of knowledge and educational, regulatory, legislative, as well as public awareness and training barriers that limit opioid prescription. In addition, short validity of prescriptions and bureaucratic practices resulting in overregulation impeded availability of some essential medicines. Stigmatization and criminalisation of people who use drugs remained the major impediment to increasing opioid agonist program coverage. The challenges identified during outcomes of the workshops were used as the basis for subsequent dissemination and implementation activities in the ATOME project, and in some countries the workshop proceedings already served as a stepping-stone for the first changes in regulations and legislation.

Bridging the gap between goal intentions and actions: a systematic review in patient populations.

PubMed

Kersten, Paula; McCambridge, Alana; M Kayes, Nicola; Theadom, Alice; McPherson, Kathryn M

2015-01-01

To evaluate the evidence for the effectiveness of if-then implementation intentions (if-then plans) in adult patient populations. Outcomes of interest included adherence, goal pursuit and physical health outcomes. Keywords were used to search electronic databases without date or language restrictions (up to 30 April 2014). Studies were included if they (1) concerned a patient population; (2) used if-then plans as a sole intervention or as part of treatment, therapy or rehabilitation; (3) if they were randomised controlled trials. The PEDro scale was used to evaluate study quality. Guidance as set out by the Cochrane Collaboration was used. Two reviewers independently extracted data, discrepancies were discussed and if required referred to a third reviewer. In total, 18 of the 2141 articles were identified as potentially relevant and four studies of people with epilepsy, chronic back pain, stroke and obesity met the inclusion criteria. People who form if-then plans achieved better outcomes on epilepsy and stroke medication adherence and physical capacity than controls. Of the four studies that used an if-then plan, only one (people with epilepsy) looked at the intervention as a stand-alone strategy. Further research needs to explore if this simple approach improves rehabilitation outcomes and is a helpful and feasible strategy for people experiencing disabilities. Implications for Rehabilitation Steps involved in achieving goals, such as doing exercises or completing other goal related tasks, can be compromised for people with chronic health conditions particularly resulting from difficulties in self-regulating behaviour. If-then plans are implementation intention tools aimed at supporting people to deal more effectively with self-regulatory problems that might undermine goal striving and goal attainment, and have been found to be effective in health promotion and health behaviour change. This systematic literature review identified four studies completed with patient populations, with three demonstrating effectiveness. If-then plans provide an opportunity for clinicians to develop better ways of implementing rehabilitation.

Vaccines: A review of immune-based interventions to prevent and treat disease.

PubMed

Alemayehu, Demissie; Utt, Eric; Knirsch, Charles

2015-03-01

The enormous gains made in public health during the 20th century, through the prevention and treatment of infectious disease, have contributed to dramatic improvements in the quality and length of the human lifespan. Continued advances in medicine are dependent on addressing several challenges including the increase in existing and new resistance to antibiotics, the decrease in productivity of the research and development (R&D) ecosystem, uncertain regulatory pathways, and an economic environment that rewards innovation for developing therapeutics that involve long cycle times from idea to a product. In this article, we consider important issues pertaining to the development of vaccines with particular emphasis on preclinical requirements, optimal dose selection, design, execution, and reporting of clinical trials for regulatory submission, planning and implementation of post-approval life-cycle programs, and emerging themes in therapeutic vaccines. © 2015, The American College of Clinical Pharmacology.

Automated personnel data base system specifications, Task V. Final report

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

Bartley, H.J.; Bocast, A.K.; Deppner, F.O.

1978-09-01

This document is the General Research Corporation report on Task V of a study for the Office of Inspection and Enforcement of the Nuclear Regulatory Commission (NRC/IE). The full title of this study is ''Development of Qualification Requirements, Training Programs, Career Plans, and Methodologies for Effective Management and Training of Inspection and Enforcement Personnel.'' Task V required the development of an automated personnel data base system for NRC/IE. This system is identified as the NRC/IE Personnel, Assignment, Qualifications, and Training System (PAQTS). This Task V report provides the documentation for PAQTS including the Functional Requirements Document (FRD), the Data Requirementsmore » Document (DRD), the Hardware and Software Capabilities Assessment, and the Detailed Implementation Schedule. Specific recommendations to facilitate implementation of PAQTS are also included.« less

Internship - practical education

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

Porell, A.L.; Bauman, H.F.

1989-01-01

The current emphasis on regulatory compliance with environmental laws has depleted the availability of experienced environmental scientists and engineers needed to initiate critical environmental projects. Further, projects of short duration and long-term commitments to employment situations are considered a high risk for both the employer and the employee. Martin Marietta Energy Systems, Inc., has met this challenge for federal agencies through the US Department of Energy's (DOE's) Hazardous Waste Remedial Actions Program (HAZWRAP). Through unique interdepartmental agency agreements between the DOE and the Department of Defense (DOD) and contractual arrangements between Energy Systems, DOE, and the University of Tennessee's (UT's)more » Waste Management Institute (WMI), an intern program was formulated. HAZWRAP is a DOE headquarters' program for addressing hazardous-waste issues at all DOE facilities. Energy Systems is the support contractor office responsible for developing policies and implementing plans for this program. Under this charter, HAZWRAP assembled a large staff of experienced project managers for developing remedial actions plans, while providing other federal agencies assistance in implementing their remedial actions programs. HAZWRAP project managers are currently managing remedial investigations and feasibility studies at 130 federal facilities located throughout the DOD.« less

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....

78 FR 1570 - Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... Transformers (energy efficiency standards) Residential clothes washers (energy efficiency standards... Distribution Transformers (Reg Plan Seq No. 32). 263 Test Procedures for 1904-AC76 Residential Refrigerators... Efficiency Standards for Distribution Transformers Regulatory Plan: This entry is Seq. No. 32 in part II of...

U-PLANT GEOGRAPHIC ZONE CLEANUP PROTOTYPE

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

ROMINE, L.D.

2006-02-01

The U Plant geographic zone (UPZ) occupies 0.83 square kilometers on the Hanford Site Central Plateau (200 Area). It encompasses the U Plant canyon (221-U Facility), ancillary facilities that supported the canyon, soil waste sites, and underground pipelines. The UPZ cleanup initiative coordinates the cleanup of the major facilities, ancillary facilities, waste sites, and contaminated pipelines (collectively identified as ''cleanup items'') within the geographic zone. The UPZ was selected as a geographic cleanup zone prototype for resolving regulatory, technical, and stakeholder issues and demonstrating cleanup methods for several reasons: most of the area is inactive, sufficient characterization information is availablemore » to support decisions, cleanup of the high-risk waste sites will help protect the groundwater, and the zone contains a representative cross-section of the types of cleanup actions that will be required in other geographic zones. The UPZ cleanup demonstrates the first of 22 integrated zone cleanup actions on the Hanford Site Central Plateau to address threats to groundwater, the environment, and human health. The UPZ contains more than 100 individual cleanup items. Cleanup actions in the zone will be undertaken using multiple regulatory processes and decision documents. Cleanup actions will include building demolition, waste site and pipeline excavation, and the construction of multiple, large engineered barriers. In some cases, different cleanup actions may be taken at item locations that are immediately adjacent to each other. The cleanup planning and field activities for each cleanup item must be undertaken in a coordinated and cohesive manner to ensure effective execution of the UPZ cleanup initiative. The UPZ zone cleanup implementation plan (ZCIP) was developed to address the need for a fundamental integration tool for UPZ cleanup. As UPZ cleanup planning and implementation moves forward, the ZCIP is intended to be a living document that will provide a focal point for integrating UPZ actions, including field cleanup activities, waste staging and handling, and post-cleanup monitoring and institutional controls.« less

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...

The Evolving Purposes of Medical Revalidation in the United Kingdom: A Qualitative Study of Professional and Regulatory Narratives.

PubMed

Tazzyman, Abigail; Ferguson, Jane; Walshe, Kieran; Boyd, Alan; Tredinnick-Rowe, John; Hillier, Charlotte; Regan De Bere, Samantha; Archer, Julian

2017-11-07

Previous research found professionalism and regulation to be competing discourses when plans for medical revalidation in the United Kingdom were being developed in 2011. The purpose of this study was to explore how these competing discourses developed and how the perceived purposes of revalidation evolved as the policy was implemented. Seventy-one interviews with 60 UK policy makers and senior health care leaders were conducted during the development and implementation of revalidation: 31 in 2011, 26 in 2013, and 14 in 2015. Interviewees were selected using purposeful sampling. Across all interviews, questions focused around three areas: individual roles in relation to revalidation; interviewees' understanding of revalidation, its purpose, and aims; and predictions or experiences of revalidation's impact. The first two interview sets also included questions about measurement and evaluation of revalidation. Data were analyzed using the constant comparative method to understand changes and continuities. Two main discourses regarding the purpose of revalidation were present across the implementation period: professionalism and regulation. The nature of the relationship between these two purposes and how they were described changed over time, with the separate discourses converging, and early concerns about actual or potential conflict being replaced by perceptions of coexistence or codependency. The changing nature of the discourse about revalidation suggests that early concerns about adverse consequences were not borne out as organizations and professionals engaged with implementation and experienced the realities of revalidation in practice. Reconciling professional and regulatory narratives was arguably necessary to the effective implementation of revalidation.This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Developing a culturally competent health network: a planning framework and guide.

PubMed

Gertner, Eric J; Sabino, Judith N; Mahady, Erica; Deitrich, Lynn M; Patton, Jarret R; Grim, Mary Kay; Geiger, James F; Salas-Lopez, Debbie

2010-01-01

The number of cultural competency initiatives in healthcare is increasing due to many factors, including changing demographics, quality improvement and regulatory requirements, equitable care missions, and accreditation standards. To facilitate organization-wide transformation, a hospital or healthcare system must establish strategic goals, objectives, and implementation tasks for culturally competent provision of care. This article reports the largely successful results of a cultural competency program instituted at a large system in eastern Pennsylvania. Prior to the development of its cultural competency initiative, Lehigh Valley Health Network, Allentown, Pennsylvania, saw isolated activities producing innovative solutions to diversity and culture issues in the provision of equitable care. But it took a transformational event to support an organization-wide program in cultural competency by strengthening leadership buy-in and providing a sense of urgency, excitement, and shared vision among multiple stakeholders. A multidisciplinary task force, including senior leaders and a diverse group of employees, was created with the authority and responsibility to enact changes. Through a well-organized strategic planning process, existing patient and community demographic data were reviewed to describe existing disparities, a baseline assessment was completed, a mission statement was created, and clear metrics were developed. The strategic plan, which focused on five key areas (demographics, language-appropriate services, employees, training, and education/communication), was approved by the network's chief executive officer and senior managers to demonstrate commitment prior to implementation. Strategic plan implementation proceeded through a project structure consisting of subproject teams charged with achieving the following specific objectives: develop a cultural material repository, enhance employee recruitment/retention, establish a baseline assessment, standardize data collection, provide language-appropriate services, and develop an education program. Change management and project management methodologies; defined roles and responsibilities; and specific, measurable, attainable, realistic, and time-bound goals were used in the implementation. This process has supported organizational change, thereby promoting high-quality, safe, and equitable care through widespread expectations of culturally competent care delivery across the entire network. Using this "ecologic approach" will ensure long-term success.

77 FR 74063 - Amendments to the Abandoned Plan Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-12

... forth below in Section G of this preamble, entitled ``Regulatory Impact Analysis.'' B. Background On... detailed Regulatory Impact Analysis. For purposes of readability, the proposed rulemaking republishes the... sponsor's delinquent contribution debts to the plan and to collect these delinquencies (or to notify the...

Implementing a framework for goal setting in community based stroke rehabilitation: a process evaluation

PubMed Central

2013-01-01

Background Goal setting is considered ‘best practice’ in stroke rehabilitation; however, there is no consensus regarding the key components of goal setting interventions or how they should be optimally delivered in practice. We developed a theory-based goal setting and action planning framework (G-AP) to guide goal setting practice. G-AP has 4 stages: goal negotiation, goal setting, action planning & coping planning and appraisal & feedback. All stages are recorded in a patient-held record. In this study we examined the implementation, acceptability and perceived benefits of G-AP in one community rehabilitation team with people recovering from stroke. Methods G-AP was implemented for 6 months with 23 stroke patients. In-depth interviews with 8 patients and 8 health professionals were analysed thematically to investigate views of its implementation, acceptability and perceived benefits. Case notes of interviewed patients were analysed descriptively to assess the fidelity of G-AP implementation. Results G-AP was mostly implemented according to protocol with deviations noted at the planning and appraisal and feedback stages. Each stage was felt to make a useful contribution to the overall process; however, in practice, goal negotiation and goal setting merged into one stage and the appraisal and feedback stage included an explicit decision making component. Only two issues were raised regarding G-APs acceptability: (i) health professionals were concerned about the impact of goal non-attainment on patient’s well-being (patients did not share their concerns), and (ii) some patients and health professionals found the patient-held record unhelpful. G-AP was felt to have a positive impact on patient goal attainment and professional goal setting practice. Collaborative partnerships between health professionals and patients were apparent throughout the process. Conclusions G-AP has been perceived as both beneficial and broadly acceptable in one community rehabilitation team; however, implementation of novel aspects of the framework was inconsistent. The regulatory function of goal non-attainment and the importance of creating flexible partnerships with patients have been highlighted. Further development of the G-AP framework, training package and patient held record is required to address the specific issues highlighted by this process evaluation. Further evaluation of G-AP is required across diverse community rehabilitation settings. PMID:23705824

Advanced Reactor Technologies - Regulatory Technology Development Plan (RTDP)

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

Moe, Wayne L.

This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However,more » it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory importance of key DOE reactor research initiatives should be assessed early in the technology development process. Quality assurance requirements supportive of later licensing activities must also be attached to important research activities to ensure resulting data is usable in that context. Early regulatory analysis and licensing approach planning thus provides a significant benefit to the formulation of research plans and also enables the planning and development of a compatible AdvSMR licensing framework, should significant modification be required.« less

Advanced Reactor Technology -- Regulatory Technology Development Plan (RTDP)

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

Moe, Wayne Leland

This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However,more » it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory importance of key DOE reactor research initiatives should be assessed early in the technology development process. Quality assurance requirements supportive of later licensing activities must also be attached to important research activities to ensure resulting data is usable in that context. Early regulatory analysis and licensing approach planning thus provides a significant benefit to the formulation of research plans and also enables the planning and development of a compatible AdvSMR licensing framework, should significant modification be required.« less

Long-term surveillance plan for the Bodo Canyon Disposal Site, Durango, Colorado

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

Not Available

1994-03-01

This long-term surveillance plan (LTSP) for the Durango, Colorado, Uranium Mill Tailings Remedial Action (UMTRA) Project disposal site describes the surveillance activities for the Durango (Bodo Canyon) disposal site, which will be referred to as the disposal site throughout this document. The US Department of Energy (DOE) will carry out these activities to ensure that the disposal site continues to function as designed. This LTSP was prepared as a requirement for acceptance under the US Nuclear Regulatory Commission (NRC) general license for custody and long-term care of residual radioactive materials (RRM). RRMs include tailings and other uranium ore processing wastesmore » still at the site, which the DOE determines to be radioactive. This LTSP is based on the DOE`s Guidance for Implementing the UMTRA Project Long-term Surveillance Program (DOE, 1992).« less

Advancing drug availability-experiences from Africa.

PubMed

Powell, Richard A; Kaye, Richard Mugula; Ddungu, Henry; Mwangi-Powell, Faith

2010-07-01

International health and drug regulatory authorities acknowledge that analgesics (especially opioids) are insufficiently available for pain management in many countries. In Africa, reported morphine consumption is far below the global mean, with multiple factors hampering opioid supply. Since 2006, the African Palliative Care Association has hosted three regional drug availability workshops across the continent to address this issue. Using an interactive format, the workshops have identified country-specific barriers to opioid and other essential medication accessibility before supporting participants to develop action plans to address recognized impediments. Despite multiple challenges, a number of successes have arisen from the implementation of the plans. However, key issues remain, including the introduction of supportive policy environments, effective educational initiatives, and measures to address supply-chain obstacles impeding drug availability. Copyright 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Integrating Climate Change into Habitat Conservation Plans Under the U.S. Endangered Species Act

NASA Astrophysics Data System (ADS)

Bernazzani, Paola; Bradley, Bethany A.; Opperman, Jeffrey J.

2012-06-01

Habitat Conservation Plans (HCPs) under the Endangered Species Act (ESA) are an important mechanism for the acquisition of land and the management of terrestrial and aquatic ecosystems. HCPs have become a vital means of protecting endangered and threatened species and their habitats throughout the United States, particularly on private land. The scientific consensus that climate is changing and that these changes will impact the viability of species has not been incorporated into the conservation strategies of recent HCPs, rendering plans vulnerable biologically. In this paper we review the regulatory context for incorporating climate change into HCPs and analyze the extent to which climate change is linked to management actions in a subset of large HCPs. We conclude that most current plans do not incorporate climate change into conservation actions, and so we provide recommendations for integrating climate change into the process of HCP development and implementation. These recommendations are distilled from the published literature as well as the practice of conservation planning and are structured to the specific needs of HCP development and implementation. We offer nine recommendations for integrating climate change into the HCP process: (1) identify species at-risk from climate change, (2) explore new strategies for reserve design, (3) increase emphasis on corridors, linkages, and connectivity, (4) develop anticipatory adaptation measures, (5) manage for diversity, (6) consider assisted migration, (7) include climate change in scenarios of water management, (8) develop future-oriented management actions, and (9) increase linkages between the conservation strategy and adaptive management/monitoring programs.

Integrating climate change into habitat conservation plans under the U.S. endangered species act.

PubMed

Bernazzani, Paola; Bradley, Bethany A; Opperman, Jeffrey J

2012-06-01

Habitat Conservation Plans (HCPs) under the Endangered Species Act (ESA) are an important mechanism for the acquisition of land and the management of terrestrial and aquatic ecosystems. HCPs have become a vital means of protecting endangered and threatened species and their habitats throughout the United States, particularly on private land. The scientific consensus that climate is changing and that these changes will impact the viability of species has not been incorporated into the conservation strategies of recent HCPs, rendering plans vulnerable biologically. In this paper we review the regulatory context for incorporating climate change into HCPs and analyze the extent to which climate change is linked to management actions in a subset of large HCPs. We conclude that most current plans do not incorporate climate change into conservation actions, and so we provide recommendations for integrating climate change into the process of HCP development and implementation. These recommendations are distilled from the published literature as well as the practice of conservation planning and are structured to the specific needs of HCP development and implementation. We offer nine recommendations for integrating climate change into the HCP process: (1) identify species at-risk from climate change, (2) explore new strategies for reserve design, (3) increase emphasis on corridors, linkages, and connectivity, (4) develop anticipatory adaptation measures, (5) manage for diversity, (6) consider assisted migration, (7) include climate change in scenarios of water management, (8) develop future-oriented management actions, and (9) increase linkages between the conservation strategy and adaptive management/monitoring programs.

EU's new pharmacovigilance legislation: considerations for biosimilars.

PubMed

Calvo, Begoña; Zuñiga, Leyre

2014-01-01

Biosimilars are biological medicines, the active substances of which are highly similar to those of biologics that have already been authorized. As for any other medicine, the applicant of the biosimilar marketing authorization must submit a risk-management plan (RMP)/pharmacovigilance plan. The pharmacovigilance plan should take into account risks identified during product development, the potential risks and how those risks will be addressed after authorization of the product.Recently, new European Pharmacovigilance legislation has been implemented, ensuring proper risk management through the recording of suspected adverse drug reactions and data collection from all stakeholders. The new regulation entails a reduction of the administrative burden on companies and regulatory agencies, as obligations of the responsible parties are clearly established and duplication of effort avoided.This article analyzes the new European Pharmacovigilance System requirements, with special focus on those medicines requiring additional monitoring, such as biosimilars, which are priorities for pharmacovigilance. Further, it provides the new obligations to marketing authorization holders, such as the continuous benefit-risk assessment.

78 FR 49186 - Fisheries of the Northeastern United States; Tilefish Fishery Management Plan; Regulatory...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-13

... Plan; Regulatory Amendment, Corrections, and Clarifications AGENCY: National Marine Fisheries Service... October 10 of each fishing year; and (6) modifies the regulations governing the cost recovery fee... and efficient collection of the required cost-recovery fees. Additional detail and explanation...

Post-Closure Strategy for Use-Restricted Sites on the Nevada National Security Site, Nevada Test and Training Range, and Tonopah Test Range, Nevada

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

Silvas, A. J.

The purpose of this Post-Closure Strategy is to provide a consistent methodology for continual evaluation of post-closure requirements for use-restricted areas on the Nevada National Security Site (NNSS), Nevada Test and Training Range (NTTR), and Tonopah Test Range (TTR) to consolidate, modify, or streamline the program. In addition, this document stipulates the creation of a single consolidated Post-Closure Plan that will detail the current post-closure requirements for all active use restrictions (URs) and outlines its implementation and subsequent revision. This strategy will ensure effective management and control of the post-closure sites. There are currently over 200 URs located on themore » NNSS, NTTR, and TTR. Post-closure requirements were initially established in the Closure Report for each site. In some cases, changes to the post-closure requirements have been implemented through addenda, errata sheets, records of technical change, or letters. Post-closure requirements have been collected from these multiple sources and consolidated into several formats, such as summaries and databases. This structure increases the possibility of inconsistencies and uncertainty. As more URs are established and the post-closure program is expanded, the need for a comprehensive approach for managing the program will increase. Not only should the current requirements be obtainable from a single source that supersedes all previous requirements, but the strategy for modifying the requirements should be standardized. This will enable more effective management of the program into the future. This strategy document and the subsequent comprehensive plan are to be implemented under the assumption that the NNSS and outlying sites will be under the purview of the U.S. Department of Energy, National Nuclear Security Administration for the foreseeable future. This strategy was also developed assuming that regulatory control of the sites remains static. The comprehensive plan is not intended to be a permanent long-term stewardship plan. However, it is intended to clarify requirements and identify components to effectively manage the sites until regulatory requirements are met or management of the site changes. The Environmental Management Program is required to manage these sites until the NNSS Environmental Restoration program is completed, currently planned for 2030. Prior to completion of the Environmental Restoration program, additional planning will be conducted to ensure that long-term stewardship of the sites is maintained. A comprehensive post-closure plan can be transitioned effectively into any future site-wide long-term stewardship program that may be developed. Therefore, the post-closure plan will include current aspects of the post-closure program that are also important aspects of long-term stewardship, including the following: • Management of physical and engineering controls such as fences, signs, and soil covers • Management of institutional and administrative controls such as use restrictions and real estate systems • Management of monitoring and maintenance programs • Management of information related to the sites such as geographic information system data and related documentation The strategy will also allow for periodic review and modification of any aspect of the program to ensure continued effectiveness.« less

Bridging the goal intention-action gap in rehabilitation: a study of if-then implementation intentions in neurorehabilitation.

PubMed

Kersten, Paula; McPherson, Kathryn M; Kayes, Nicola M; Theadom, Alice; McCambridge, Alana

2015-01-01

To test the feasibility and acceptability of an implementation intention strategy (if-then plans) increasingly used in health psychology to bridge the goal intention-action gap in rehabilitation with people with neurological conditions who are experiencing difficulties with mobility. Twenty people with multiple sclerosis (MS) and stroke, randomised to an experimental and control group, set up to three mobility related goals with a physiotherapist. The experimental group also formulated if-then plans for every goal. Focus groups and interviews with participants and therapists; Patient Activation Measure (PAM), 10-m walk test, Rivermead Mobility Index, self-efficacy, subjective health status, quality of life. Qualitative data highlighted one main theme: Rehabilitation in context, encapsulating the usefulness of the if-then strategy in thinking about the patient in the context of complexity, the usefulness of home-based rehabilitation, and the perceived need for a few more sessions. Changes in walking speed were in the expected direction for both groups; PAM scores improved over 3 months in both groups. If-then plans were feasible and acceptable in bridging the goal intention-action gap in rehabilitation with people with MS and stroke, who are experiencing difficulties with mobility. This approach can now be adapted and trialled further in a definitive study. Goal planning in rehabilitation necessitates specific strategies that help people engage in goal-related tasks. If-then plans aim to support people to deal more effectively with self-regulatory problems that might undermine goal striving and have been found to be effective in health promotion and health behaviour change. This feasibility study with people with a stroke and multiple sclerosis has demonstrated that if-then plans are feasible and acceptable to patients and physiotherapists in supporting goal-directed behaviour.

Implementing national strategies on antimicrobial resistance in Thailand: potential challenges and solutions.

PubMed

Sommanustweechai, A; Tangcharoensathien, V; Malathum, K; Sumpradit, N; Kiatying-Angsulee, N; Janejai, N; Jaroenpoj, S

2018-04-01

Thailand has developed a national strategic plan on antimicrobial resistance (NSP-AMR) and endorsed by the Cabinet in August 2016. This study reviewed the main contents of the NSP-AMR and the mandates of relevant implementing agencies and identified challenges and recommends actions to mitigate implementation gaps. This study analysed the contents of NSP-AMR, reviewed institutional mandates and assessed the implementation gaps among agencies responsible for NSP-AMR. Two of six strategies are related to monitoring and surveillance of AMR and antimicrobial consumption in human and animal. Two other strategies aim to improve antibiotic stewardship and control the spread of AMR in both clinical and farm settings. The remaining two strategies aim to increase knowledge and public awareness on AMR and establish national governance for inter-sectoral actions. Strategies to overcome implementation challenges are sustaining cross-sectoral policy commitments, effective cross-sectoral coordination using One Health approach, generating evidence which guides policy implementation, and improving enforcement capacities in regulatory authorities. To address AMR, Thailand requires significant improvements in implementation capacities in two dimensions. First, technical capacities among implementing agencies are needed to translate policies into practice. Second, governance and organizational capacities enable effective multi-sectoral actions across human, animal, and environmental sectors. Copyright © 2018 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

ACHP | Alternatives for Implementing Section 106 of NHPA: An Assessment

Science.gov Websites

Historic Preservation Act: An Assessment: examines possible statutory, regulatory, and non-regulatory Preservation Act; considers the extent to which regulatory reforms already underway and new non-regulatory

Regulatory physiology discipline science plan

NASA Technical Reports Server (NTRS)

1991-01-01

The focus of the Regulatory Physiology discipline of the Space Physiology and Countermeasures Program is twofold. First, to determine and study how microgravity and associated factors of space flight affect the regulatory mechanisms by which humans adapt and achieve homeostasis and thereby regulate their ability to respond to internal and external signals; and, second, to study selected physiological systems that have been demonstrated to be influenced by gravity. The Regulatory Physiology discipline, as defined here, is composed of seven subdisciplines: (1) Circadian Rhythms, (2) Endocrinology, (3) Fluid and Electrolyte Regulation, (4) Hematology, (5) Immunology, (6) Metabolism and Nutrition, and (7) Temperature Regulation. The purpose of this Discipline Science Plan is to provide a conceptual strategy for NASA's Life Sciences Division research and development activities in the area of regulatory physiology. It covers the research areas critical to NASA's programmatic requirements for the Extended-Duration Orbiter, Space Station Freedom, and exploration mission science activities. These science activities include ground-based and flight; basic, applied, and operational; and animal and human research and development. This document summarizes the current status of the program, outlines available knowledge, establishes goals and objectives, identifies science priorities, and defines critical questions in regulatory physiology. It contains a general plan that will be used by both NASA Headquarters Program Offices and the field centers to review and plan basic, applied, and operational intramural and extramural research and development activities in this area.

[Evaluation of regulatory policies: the prevention of traffic accidents in Spain].

PubMed

Villalbí, Joan R; Pérez, Catherine

2006-03-01

Traffic accident injuries may be reduced with public policies. We review regulatory policies extending beyond the health sector by studying the case of traffic accident injuries. They have been the object of other analyses in Spain by both health professionals and professionals from other sectors, but we have not found a previous thorough review including regulatory aspects. We analyze the evolution of fatal victims of traffic accidents as collected by the Dirección General de Tráfico, stratifying for pedestrians, two-wheel vehicle occupants and occupants of other vehicles, and breaking down accidents between those occurring in roads and in urban settings. Despite the increase in exposure factors between 1970 and 2003, we observe a strong impact of regulatory policies in accident mortality. A favorable impact is seen for regulations and enforcement actions on motorcycle helmets, speed limits and the control of alcohol use, and a lower impact for safety belts, perhaps because its actual effective implementation was not equally sharp. The adoption of comprehensive plans or complex legislation packages seems to have had a positive impact, perhaps attributable to its triggering of more effective enforcement of already existing regulations. Although the existence of legal norms is not enough in itself, as its impact is low without active enforcement, compliance improves over time. In any case, the existence of specific initiatives to influence this field is important to obtain the best results of regulatory policies in public health.

The regulatory framework for safe decommissioning of nuclear power plants in Korea

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

Sangmyeon Ahn; Jungjoon Lee; Chanwoo Jeong

We are having 23 units of nuclear power plants in operation and 5 units of nuclear power plants under construction in Korea as of September 2012. However, we don't have any experience on shutdown permanently and decommissioning of nuclear power plants. There are only two research reactors being decommissioned since 1997. It is realized that improvement of the regulatory framework for decommissioning of nuclear facilities has been emphasized constantly from the point of view of IAEA's safety standards. It is also known that IAEA will prepare the safety requirement on decommissioning of facilities; its title is the Safe Decommissioning ofmore » Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission to Korea in 2011, it was recommended that the regulatory framework should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we focus on identifying the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. It is expected that if the things will go forward as planned, the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)« less

75 FR 62610 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Plant...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-12

...: Draft Regulatory Guide DG-1237, ``Guidance on Making Changes to Emergency Plans for Nuclear Power Reactors,'' Interim Staff Guidance (ISG) NSIR/DPR-ISG-01, ``Emergency Planning for Nuclear Power Plants... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS...

Equity Access Plans: A Regulatory and Educational State Response Model.

ERIC Educational Resources Information Center

DeLisle, James

1984-01-01

Introduces the basic notion of equity access plans as property-based solutions to the cash flow needs of elderly homeowners and then proposes a normative response model that states can adopt to help manage the risk exposures. The recommended model incorporates regulatory, information dissemination, and educational elements. (BH)

78 FR 66788 - Joint Industry Plan; Order Approving Amendment No. 30 to the Joint Self-Regulatory Organization...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-06

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70793; File No. S7-24-89] Joint Industry Plan..., Consolidation and Dissemination of Quotation and Transaction Information for Nasdaq-Listed Securities Traded on... Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange LLC...

Introduction to The Regulatory Plan and the Unified Agenda of Federal...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... Unified Agenda 79451 Published? III. How Are The Regulatory Plan and the Unified Agenda 79451 Organized? IV. What Information Appears for Each Entry? 79452 V. Abbreviations 79454 VI. How Can Users Get... Department of Defense 79504 Department of Education 79509 Department of Energy 79512 Department of Health and...

76 FR 15307 - Notice of Staff Attendance at Southwest Power Pool Strategic Planning Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-21

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Staff Attendance at Southwest Power Pool Strategic Planning Committee Meeting The Federal Energy Regulatory Commission hereby gives notice that members of its staff may attend the meeting of the Southwest Power Pool, Inc. (SPP) Strategic...

77 FR 24950 - Meeting Related to the Transmission Planning Activities of the Southwest Power Pool, Inc.; Notice...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-26

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Meeting Related to the Transmission Planning Activities of the Southwest Power Pool, Inc.; Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the...

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...

Access to essential drugs in Guyana: a public health challenge.

PubMed

Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa

2010-01-01

Guyana's pharmaceutical sector faces major challenges that limit access to essential drugs. This study analyzes Guyana's drug policy and regulation, public financing, and drug procurement and delivery. The study also identifies main barriers to drug access and proposes alternatives to strengthen the country's public health functions. Data were collected from the country's regulatory agencies, public procurement agency, pharmacies, wholesalers, and pharmaceutical companies. The information was supplemented with interviews with a convenient sample of Guyanese health authorities and stakeholders. Data were also compiled from scientific databases, and web pages of the country's Ministries of Health, Commerce and Finance, the Bureau of Statistics, and international organizations. Major barriers to drug access include: (1) lack of national drug policy and regulation, and limited role of the regulatory authority; (2) inefficient drug selection and irrational drug use; (3) insufficient financial resources and lack of drug pricing policy; (4) inefficient planning and managing public supply system; (5) deficient epidemiological and information systems; and (6) inadequate infrastructures and human resources shortage. Improving drug access in Guyana requires the strengthening of the country's public health functions and the implementation of a national drug policy and pricing policy, streamlining the drug financing, procurement, and planning and managing drug supply; and adequate infrastructures and human resources. Copyright 2008 John Wiley & Sons, Ltd.

Application of Incident Command Structure to clinical trial management in the academic setting: principles and lessons learned.

PubMed

Reynolds, Penny S; Michael, Mary J; Spiess, Bruce D

2017-02-09

Clinical trial success depends on appropriate management, but practical guidance to trial organisation and planning is lacking. The Incident Command System (ICS) is the 'gold standard' management system developed for managing diverse operations in major incident and public health arenas. It enables effective and flexible management through integration of personnel, procedures, resources, and communications within a common hierarchical organisational structure. Conventional ICS organisation consists of five function modules: Command, Planning, Operations, Logistics, and Finance/Administration. Large clinical trials will require a separate Regulatory Administrative arm, and an Information arm, consisting of dedicated data management and information technology staff. We applied ICS principles to organisation and management of the Prehospital Use of Plasma in Traumatic Haemorrhage (PUPTH) trial. This trial was a multidepartmental, multiagency, randomised clinical trial investigating prehospital administration of thawed plasma on mortality and coagulation response in severely injured trauma patients. We describe the ICS system as it would apply to large clinical trials in general, and the benefits, barriers, and lessons learned in utilising ICS principles to reorganise and coordinate the PUPTH trial. Without a formal trial management structure, early stages of the trial were characterised by inertia and organisational confusion. Implementing ICS improved organisation, coordination, and communication between multiple agencies and service groups, and greatly streamlined regulatory compliance administration. However, unfamiliarity of clinicians with ICS culture, conflicting resource allocation priorities, and communication bottlenecks were significant barriers. ICS is a flexible and powerful organisational tool for managing large complex clinical trials. However, for successful implementation the cultural, psychological, and social environment of trial participants must be accounted for, and personnel need to be educated in the basics of ICS. ClinicalTrials.gov, NCT02303964 . Registered on 28 November 2014.

A systematic policy approach to changing the food system and physical activity environments to prevent obesity.

PubMed

Sacks, Gary; Swinburn, Boyd A; Lawrence, Mark A

2008-06-05

As obesity prevention becomes an increasing health priority in many countries, including Australia and New Zealand, the challenge that governments are now facing is how to adopt a systematic policy approach to increase healthy eating and regular physical activity. This article sets out a structure for systematically identifying areas for obesity prevention policy action across the food system and full range of physical activity environments. Areas amenable to policy intervention can be systematically identified by considering policy opportunities for each level of governance (local, state, national, international and organisational) in each sector of the food system (primary production, food processing, distribution, marketing, retail, catering and food service) and each sector that influences physical activity environments (infrastructure and planning, education, employment, transport, sport and recreation). Analysis grids are used to illustrate, in a structured fashion, the broad array of areas amenable to legal and regulatory intervention across all levels of governance and all relevant sectors. In the Australian context, potential regulatory policy intervention areas are widespread throughout the food system, e.g., land-use zoning (primary production within local government), food safety (food processing within state government), food labelling (retail within national government). Policy areas for influencing physical activity are predominantly local and state government responsibilities including, for example, walking and cycling environments (infrastructure and planning sector) and physical activity education in schools (education sector). The analysis structure presented in this article provides a tool to systematically identify policy gaps, barriers and opportunities for obesity prevention, as part of the process of developing and implementing a comprehensive obesity prevention strategy. It also serves to highlight the need for a coordinated approach to policy development and implementation across all levels of government in order to ensure complementary policy action.

A harmonized and efficient clinical research environment would benefit patients and enhance European competitiveness. Commentary.

PubMed

Amato, Antonino; Aringhieri, Eugenio; Boccia, Stefania; Buccella, Filippo; Gorini, Barbara; Gramaglia, Donatella; Masetti, Riccardo; Rossi, Paolo; Pelicci, Pier Giuseppe

2017-01-01

The forthcoming implementation of the European Clinical Trial Regulation (Regulation (EU) No. 536/2014), which is expected to facilitate the conduct of clinical trials across the European Union, will require National Authorities to create the best conditions for the implementation of the new Regulation through national guidelines, so that sponsors may reconsider Europe as a prime location for planning clinical trials. During a meeting titled "Innovation in Clinical Research", an expert panel discussed potential local advances fostering competitiveness of European clinical research with representatives of the pharmaceutical industry, patient organisations and Italian regulatory agency in view of the forthcoming implementation of (EU) No. 536/2014 on clinical trials of medicinal products. In this article we summarise the findings of the meeting, describe features characterising clinical research patterns and offer some suggestions on the possible involvement of all stakeholders in order to foster research innovation and allow the timely access to novel medicines for patients.

Method to determine transcriptional regulation pathways in organisms

DOEpatents

Gardner, Timothy S.; Collins, James J.; Hayete, Boris; Faith, Jeremiah

2012-11-06

The invention relates to computer-implemented methods and systems for identifying regulatory relationships between expressed regulating polypeptides and targets of the regulatory activities of such regulating polypeptides. More specifically, the invention provides a new method for identifying regulatory dependencies between biochemical species in a cell. In particular embodiments, provided are computer-implemented methods for identifying a regulatory interaction between a transcription factor and a gene target of the transcription factor, or between a transcription factor and a set of gene targets of the transcription factor. Further provided are genome-scale methods for predicting regulatory interactions between a set of transcription factors and a corresponding set of transcriptional target substrates thereof.

Considerations that will determine if competency-based assessment is a sustainable innovation.

PubMed

Dauphinee, W Dale; Boulet, John R; Norcini, John J

2018-05-18

Educational assessment for the health professions has seen a major attempt to introduce competency based frameworks. As high level policy developments, the changes were intended to improve outcomes by supporting learning and skills development. However, we argue that previous experiences with major innovations in assessment offer an important road map for developing and refining assessment innovations, including careful piloting and analyses of their measurement qualities and impacts. Based on the literature, numerous assessment workshops, personal interactions with potential users, and our 40 years of experience in implementing assessment change, we lament the lack of a coordinated approach to clarify and improve measurement qualities and functionality of competency based assessment (CBA). To address this worrisome situation, we offer two roadmaps to guide CBA's further development. Initially, reframe and address CBA as a measurement development opportunity. Secondly, using a roadmap adapted from the management literature on sustainable innovation, the medical assessment community needs to initiate an integrated plan to implement CBA as a sustainable innovation within existing educational programs and self-regulatory enterprises. Further examples of down-stream opportunities to refocus CBA at the implementation level within faculties and within the regulatory framework of the profession are offered. In closing, we challenge the broader assessment community in medicine to step forward and own the challenge and opportunities to reframe CBA as an innovation to improve the quality of the clinical educational experience. The goal is to optimize assessment in health education and ultimately improve the public's health.

A Qualitative Assessment of Current CCF Guidance Based on a Review of Safety System Digital Implementation Changes with Evolving Technology

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

Korsah, Kofi; Muhlheim, Michael David; Wood, Richard

The US Nuclear Regulatory Commission (NRC) is initiating a new rulemaking project to develop a digital system common-cause failure (CCF) rule. This rulemaking will review and modify or affirm the NRC's current digital system CCF policy as discussed in the Staff Requirements Memorandum to the Secretary of the Commission, Office of the NRC (SECY) 93-087, Policy, Technical, and Licensing Issues Pertaining to Evolutionary and Advanced Light Water Reactor (ALWR) Designs, and Branch Technical Position (BTP) 7-19, Guidance on Evaluation of Defense-in-Depth and Diversity in Digital Computer-Based Instrumentation and Control Systems, as well as Chapter 7, Instrumentation and Controls, in NRCmore » Regulatory Guide (NUREG)-0800, Standard Review Plan for Review of Safety Analysis Reports for Nuclear Power Plants (ML033580677). The Oak Ridge National Laboratory (ORNL) is providing technical support to the NRC staff on the CCF rulemaking, and this report is one of several providing the technical basis to inform NRC staff members. For the task described in this report, ORNL examined instrumentation and controls (I&C) technology implementations in nuclear power plants in the light of current CCF guidance. The intent was to assess whether the current position on CCF is adequate given the evolutions in digital safety system implementations and, if gaps in the guidance were found, to provide recommendations as to how these gaps could be closed.« less

The European and American use of exploratory approaches for first-in-human studies.

PubMed

Silva-Lima, Beatriz; Carlson, David; Jones, David R; Laurie, David; Stahl, Elke; Maria, Vasco; Janssens, Walter; Robinson, William T

2010-02-01

Exploratory approaches for first-in-human clinical studies have evolved over the last few years and have stimulated the issuance of national regulatory guidances in some European countries as well as the United States. With the increasing implementation of these approaches and the recent preparation of a multiregional regulatory guidance (ICH M3 rev2), an exchange of experiences on the opportunities and challenges of exploratory clinical trials was desirable; thus, a workshop focusing on the use of this clinical approach was planned and conducted in Lisbon, Portugal, March 18-19, 2009 sponsored by the Portuguese Health Authority (INFARMED) and DIA. The structure of the workshop focused in three main areas. Regulatory representatives from Portugal, Belgium, Germany, the United Kingdom and the United States formally reviewed their experiences. This was followed by a discussion on issues from an ethics review perspective as well as an insight to the opportunities in the area of biologics. The industry perspective was presented by representatives from Merck, Pfizer, J&J, Novartis, Speedel, AstraZeneca, GSK, and Roche. Finally, through break out sessions, issues were identified to be addressed moving forward. It is the purpose of this paper to report on the outcome of this workshop.

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.

Recovery Audit Contractor medical necessity readiness: one health system's journey.

PubMed

Scott, Judith A; Camden, Mindy

2011-01-01

To develop a sustainable approach to Recovery Audit Contractor medical necessity readiness that mitigates the regulatory and financial risks of the organization. Acute care hospitals. Utilizing the model for improvement and plan-do-study-act methodology, this health system designed and implemented a medical necessity case management program. We focused on 3 areas for improvement: medical necessity review accuracy, review timeliness, and physician adviser participation for secondary reviews. Over several months, we improved accuracy and timeliness of our medical necessity reviews while also generating additional inpatient revenue for the health system. We successfully enhanced regulatory compliance and reduced our financial risks associated with Recovery Audit Contractor medical necessity audits. A successful medical necessity case management program can not only enhance regulatory compliance and reduce the amount of payments recouped by Medicare, but also generate additional inpatient revenue for your organization. With health care reform and accountable care organizations on the horizon, hospitals must find ways to protect and enhance revenue in order to carry out their missions. This is one way for case managers to help in that cause, to advocate for the care of their patients, and to bring value to the organization.

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...

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...

Application of an uncertainty analysis approach to strategic environmental assessment for urban planning.

PubMed

Liu, Yi; Chen, Jining; He, Weiqi; Tong, Qingyuan; Li, Wangfeng

2010-04-15

Urban planning has been widely applied as a regulatory measure to guide a city's construction and management. It represents official expectations on future population and economic growth and land use over the urban area. No doubt, significant variations often occur between planning schemes and actual development; in particular in China, the world's largest developing country experiencing rapid urbanization and industrialization. This in turn leads to difficulty in estimating the environmental consequences of the urban plan. Aiming to quantitatively analyze the uncertain environmental impacts of the urban plan's implementation, this article developed an integrated methodology combining a scenario analysis approach and a stochastic simulation technique for strategic environmental assessment (SEA). Based on industrial development scenarios, Monte Carlo sampling is applied to generate all possibilities of the spatial distribution of newly emerged industries. All related environmental consequences can be further estimated given the industrial distributions as input to environmental quality models. By applying a HSY algorithm, environmentally unacceptable urban growth, regarding both economic development and land use spatial layout, can be systematically identified, providing valuable information to urban planners and decision makers. A case study in Dalian Municipality, Northeast China, is used to illustrate applicability of this methodology. The impacts of Urban Development Plan for Dalian Municipality (2003-2020) (UDP) on atmospheric environment are also discussed in this article.

Strengthening the regulatory system through the implementation and use of a quality management system.

PubMed

Eisner, Reinhold; Patel, Rakeshkumar

2017-04-20

Quality management systems (QMS), based on ISO 9001 requirements, are applicable to government service organizations such as Health Canada's Biologics and Genetic Therapies Directorate (BGTD). This communication presents the process that the BGTD followed since the early 2000s to implement a quality management system and describes how the regulatory system was improved as a result of this project. BGTD undertook the implementation of a quality management system based on ISO 9001 and containing aspects of ISO 17025 with the goal of strengthening the regulatory system through improvements in the people, processes, and services of the organization. We discuss the strategy used by BGTD to implement the QMS and the benefits that were realized from the various stages of implementation. The eight quality principals upon which the QMS standards of the ISO 9000 series are based were used by senior management as a framework to guide QMS implementation.

The Effectiveness of Self-regulatory Speech Training for Planning and Problem Solving in Children with Specific Language Impairment.

PubMed

Abdul Aziz, Safiyyah; Fletcher, Janet; Bayliss, Donna M

2016-08-01

Self-regulatory speech has been shown to be important for the planning and problem solving of children. Our intervention study, including comparisons to both wait-list and typically developing controls, examined the effectiveness of a training programme designed to improve self-regulatory speech, and consequently, the planning and problem solving performance of 87 (60 males, 27 females) children aged 4-7 years with Specific Language Impairment (SLI) who were delayed in their self-regulatory speech development. The self-regulatory speech and Tower of London (TOL) performance of children with SLI who received the intervention initially or after a waiting period was compared with that of 80 (48 male, 32 female) typically developing children who did not receive any intervention. Children were tested at three time points: Time 1- prior to intervention; Time 2 - after the first SLI group had received training and the second SLI group provided a wait-list control; and Time 3 - when the second SLI group had received training. At Time 1 children with SLI produced less self-regulatory speech and were impaired on the TOL relative to the typically developing children. At Time 2, the TOL performance of children with SLI in the first training group improved significantly, whereas there was no improvement for the second training group (the wait-list group). At Time 3, the second training group improved their TOL performance and the first group maintained their performance. No significant differences in TOL performance were evident between typically developing children and those with SLI at Time 3. Moreover, decreases in social speech and increases in inaudible muttering following self-regulatory speech training were associated with improvements in TOL performance. Together, the results show that self-regulatory speech training was effective in increasing self-regulatory speech and in improving planning and problem solving performance in children with SLI.

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...

75 FR 79755 - Unified Agenda of Federal Regulatory and Deregulatory Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... planned action is likely to have significant economic impact on a substantial number of small entities as... regarding the planned action. In accordance with ED's Principles for Regulating listed in its regulatory... Principles for Regulating. Members of the public are also invited to comment on any regulations listed in...

76 FR 49764 - Notice of FERC Staff Attendance at the Entergy ICT Transmission Planning Summit and Entegry...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-11

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of FERC Staff Attendance at the Entergy ICT Transmission Planning Summit and Entegry Regional State Committee Meeting The Federal Energy Regulatory Commission hereby gives notice that members of its staff may attend the meetings noted below...

Involvement of Individuals in the Development of Technical Solutions and Rules of Management for Building Renovation Projects: A Case Study of Latvia

NASA Astrophysics Data System (ADS)

Pukite, I.; Grekis, A.; Geipele, I.; Zeltins, N.

2017-08-01

In March 2016, the Latvian government approved a new support program for increasing energy efficiency in residential apartment buildings. For the support of renovation of apartment buildings in the period from 2016 to 2023, 166 470 588 EUR will be available. Different persons, such as energy auditors, designers, architects, project managers and builders, will be involved in the process of planning, development and implementation of building renovation. At the development stage of the building renovation project, special attention should be devoted to the first stage - energy audit and technical project development. The problem arises due to the fact that each of these individuals, during the development of technical building documentation, does not work as a completely unified system. The implementation of construction project planning and organisational management system is one of the most important factors to guarantee that the quality of building renovation project is ensured in accordance with the laws and regulatory standards. The paper studies mutual cooperation, professionalism and the role of information feedback of personnel involved in the planning stage of building renovation, which is an essential prerequisite for the renovation process in order to achieve high quality of work and reduce the energy performance indicator. The present research includes the analysis of different technical solutions and their impact on energy efficiency. Mutual harmonisation of technical specifications is also investigated.

Implementing a voluntary, nonregulatory approach to nitrogen management in Tampa Bay, FL: a public/private partnership.

PubMed

Greening, H; DeGrove, B D

2001-11-14

Participants in the Tampa Bay Estuary Program have agreed to adopt nitrogen-loading targets for Tampa Bay based on the water-quality and related light requirements of underwater seagrasses. Based on modeling results, it appears that light levels can be maintained at necessary levels by "holding the line" at existing nitrogen loadings; however, this goal may be difficult to achieve given the 20% increase in the watershed"s human population and associated 7% increase in nitrogen loading that are projected to occur over the next 20 years. To address the long-term management of nitrogen sources, a nitrogen management consortium of local electric utilities, industries, and agricultural interests, as well as local governments and regulatory agency representatives, has developed a consortium action plan to address the target load reduction needed to "hold the line" at 1992 to 1994 levels. To date, implemented and planned projects collated in the Consortium Action Plan meet and exceed the agreed-upon nitrogen-loading reduction goal. An example of the success of the private partnership aspect of this program can be seen in three phosphate fertilizer mining and manufacturing companies with facilities located on Tampa Bay. These companies are participants in the Estuary Program and the Nitrogen Management Consortium to provide support and input for a program that advocates voluntary, nonregulatory cooperation to reach environmental goals.

Designing a low-cost pollution prevention plan to pay off at the University of Houston.

PubMed

Bialowas, Yurika Diaz; Sullivan, Emmett C; Schneller, Robert D

2006-09-01

The University of Houston is located just south of downtown Houston, TX. Many different chemical substances are used in scientific research and teaching activities throughout the campus. These activities generate a significant amount of waste materials that must be discarded as regulated hazardous waste per U.S. Environmental Protection Agency (EPA) rules. The Texas Commission on Environmental Quality (TCEQ) is the state regulatory agency that has enforcement authority for EPA hazardous waste rules in Texas. Currently, the University is classified as a large quantity generator and generates >1000 kg per month of hazardous waste. In addition, the University has experienced a major surge in research activities during the past several years, and overall the quantity of the hazardous waste generated has increased. The TCEQ requires large quantity generators to prepare a 5-yr Pollution Prevention (P2) Plan, which describes efforts to eliminate or minimize the amount of hazardous waste generated. This paper addresses the design and development of a low-cost P2 plan with minimal implementation obstacles and strong payoff potentials for the University. The projects identified can be implemented with existing University staff resources. This benefits the University by enhancing its environmental compliance efforts, and the disposal cost savings can be used for other purposes. Other educational institutions may benefit by undertaking a similar process.

The Civil Aviation Sector in Lebanon. Part 1; Institutional Reforms

NASA Technical Reports Server (NTRS)

Baaj, M. Hadi

2002-01-01

Civil aviation is one of the key contributors to a successful economic system. This has been recognized within Lebanon, which is undertaking developing a new civil aviation strategy encompassing a program of organizational reform, coordinated internationally, to meet the challenges of the new century. Such strategy is vital, as it will provide a coherent vision for the sector, compliment the extensive investments deployed by Lebanon in its aviation infrastructure, and guide future planning and investments. The proposed Civil Aviation Strategy for Lebanon has two major components: (1) institutional reform aiming at creating effective overall legal and regulatory frameworks in-line with current international best practice; and (2) implementation of liberalization measures and open skies policy. This paper aims to: (1) present Lebanon's current institutional arrangements; (2) review the institutional arrangements in key select countries (in order to define current trends in best institutional practice); (3) discuss the proposed institutional reform (which are at the basis of Lebanon's Draft Civil Aviation Reform Law) while showing that they conform with the identified best institutional trends; and (4) outline an implementation plan. The Draft Law has been approved by the Council of Ministers and now awaits Parliamentary endorsement.

Technology Implementation Plan: Irradiation Testing and Qualification for Nuclear Thermal Propulsion Fuel

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

Harrison, Thomas J.; Howard, Richard H.; Rader, Jordan D.

This document is a notional technology implementation plan (TIP) for the development, testing, and qualification of a prototypic fuel element to support design and construction of a nuclear thermal propulsion (NTP) engine, specifically its pre-flight ground test. This TIP outlines a generic methodology for the progression from non-nuclear out-of-pile (OOP) testing through nuclear in-pile (IP) testing, at operational temperatures, flows, and specific powers, of an NTP fuel element in an existing test reactor. Subsequent post-irradiation examination (PIE) will occur in existing radiological facilities. Further, the methodology is intended to be nonspecific with respect to fuel types and irradiation or examinationmore » facilities. The goals of OOP and IP testing are to provide confidence in the operational performance of fuel system concepts and provide data to program leadership for system optimization and fuel down-selection. The test methodology, parameters, collected data, and analytical results from OOP, IP, and PIE will be documented for reference by the NTP operator and the appropriate regulatory and oversight authorities. Final full-scale integrated testing would be performed separately by the reactor operator as part of the preflight ground test.« less

U.S. regulatory research program for implementation of burnup credit in transport casks

DOT National Transportation Integrated Search

2001-09-10

In 1999 the U.S. Nuclear Regulatory Commission (U.S. NRC) initiated a research program to : support the development of technical bases and guidance that would facilitate the implementation of : burnup credit into licensing activities for transport an...

Financial Incentives to Enable Clean Energy Deployment: Policy Overview and Good Practices

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

Cox, Sadie

Financial incentives have been widely implemented by governments around the world to support scaled up deployment of renewable energy and energy efficiency technologies and practices. As of 2015, at least 48 countries have adopted financial incentives to support renewable energy and energy efficiency deployment. Broader clean energy strategies and plans provide a crucial foundation for financial incentives that often complement regulatory policies such as renewable energy targets, standards, and other mandates. This policy brief provides a primer on key financial incentive design elements, lessons from different country experiences, and curated support resources for more detailed and country-specific financial incentive designmore » information.« less

Long-term surveillance plan for the Green River, Utah, disposal site

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

NONE

1997-06-01

The long-term surveillance plan (LTSP) for the Green River, Utah, Uranium Mill Tailings Remedial Action (UMTRA) Project disposal site describes the surveillance activities for the Green River disposal cell. The U.S. Department of Energy (DOE) will carry out these activities to ensure that the disposal cell continues to function as designed. This final LTSP was prepared as a requirement for acceptance under the U.S. Nuclear Regulatory Commission (NRC) general license for custody and long-term care of residual radioactive materials (RRM). This LTSP documents whether the land and interests are owned by the United States or an Indian tribe and detailsmore » how the long-term care of the disposal site will be carried out. The Green River, Utah, LTSP is based on the DOE`s Guidance for Implementing the UMTRA Project Long-term Surveillance Program (DOE, 1992a).« less

Pharmaceutical market access in emerging markets: concepts, components, and future.

PubMed

Kumar, Anuj; Juluru, Karthaveerya; Thimmaraju, Phani Kishore; Reddy, Jayachandra; Patil, Anand

2014-01-01

This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders. There is an increasing need to establish market access functions, especially in emerging markets, where the complex, dynamic healthcare landscape confounds product approval and uptake. Moreover, emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical companies. To address the challenges posed by regulatory agencies and diverse stakeholders, a customized market access strategy is the need of the hour. A market access framework with specific tools and tactics will help companies to plan, implement, and monitor stakeholder engagement activities.

New partnership for health? Business groups on health and health systems agencies.

PubMed

Bradbury, R C

1983-01-01

The experience of the Central Massachusetts Health Systems Agency (CMHSA) and the Central Massachusetts Business Group on Health (CMBGH) demonstrates the feasibility of cooperation between HSAs and BGHs. Objectives and strategies of the two groups in carrying out community health planning and working for health systems change are compared. Nearly two decades of government-sponsored community health planning programs, first through comprehensive health planning agencies and then through HSAs, have had less impact than many had anticipated because neither the technical nor political basis for such planning was sufficiently established. The CMHSA experience is typical, although it is credited with developing a hospital systems plan that is based on sound planning methods and statistical data. It is in the implementation of plans that the CMHSA has made slow progress, reflecting its inadequate community power base. The CMBGH, 1 of more than 90 groups that have developed recently across the country to attack high health care costs, was formed in 1981 by business leaders to address these rising costs. The principal strategy adopted by the CMBGH involves fostering a competitive health care market by creating a critical number of competing health plans. The providers in each plan will then have incentives to provide effective care in an efficient manner to keep the premium competitive and attract enrollees. Cooperation between the CMBGH and CMHSA is based on each organization's emphasizing its strengths. The CMHSA's data base and analyses have been the primary resources used by the CMBGH to identify problems. Each organization has developed its own set of goals and objectives, while keeping in mind those of the other organization. The CMBGH adopted a subset of theCMHSA's goals-those that focus on hospital capacity and utilization. Although the CMHSA's regulatory strategies differ greatly from the CMBGH's competition strategies, they do not necessarily conflict.Actually, each organization is supporting the other's strategies without deemphasizing its own.The CMBGH currently has a decisive advantage over the CMHSA in implementing activities because the business leaders are an integral part of the community power structure. Also, their companies' willingness to offer additional health plans to their employees is the prime incentive to develop such plans.

Evaluating brief motivational and self-regulatory hand hygiene interventions: a cross-over longitudinal design.

PubMed

Lhakhang, Pempa; Lippke, Sonia; Knoll, Nina; Schwarzer, Ralf

2015-02-04

Frequent handwashing can prevent infections, but non-compliance to hand hygiene is pervasive. Few theory- and evidence-based interventions to improve regular handwashing are available. Therefore, two intervention modules, a motivational and a self-regulatory one, were designed and evaluated. In a longitudinal study, 205 young adults, aged 18 to 26 years, were randomized into two intervention groups. The Mot-SelfR group received first a motivational intervention (Mot; risk perception and outcome expectancies) followed by a self-regulatory intervention (SelfR; perceived self-efficacy and planning) 17 days later. The SelfR-Mot group received the same two intervention modules in the opposite order. Follow-up data were assessed 17 and 34 days after the baseline. Both intervention sequences led to an increase in handwashing frequency, intention, self-efficacy, and planning. Also, overall gains were found for the self-regulatory module (increased planning and self-efficacy levels) and the motivational module (intention). Within groups, the self-regulatory module appeared to be more effective than the motivational module, independent of sequence. Self-regulatory interventions can help individuals to exhibit more handwashing. Sequencing may be important as a motivation module (Mot) first helps to set the goal and a self-regulatory module (SelfR) then helps to translate this goal into actual behavior, but further research is needed to evaluate mechanisms.

78 FR 16792 - Designation of Areas for Air Quality Planning Purposes; State of California; Imperial Valley...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-19

... (see, e.g., the PM 10 area designations in 40 CFR 81.305 for Coso Junction planning area, Owens Valley..., this action: Is not ``significant regulatory actions'' subject to review by the Office of Management..., 1999); Is not economically significant regulatory actions based on health or safety risks subject to...

77 FR 7960 - Unified Agenda of Federal Regulatory and Deregulatory Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... Identifier No. 373 Secure Handling of 1601-AA52 Ammonium Nitrate Program (Reg Plan Seq No. 53). 374 Homeland...) Proposed Rule Stage 373. Secure Handling of Ammonium Nitrate Program Regulatory Plan: This entry is Seq. No... performance standards to 33 CFR part 151, subparts C and D, for discharges of ballast water. It supports the...

76 FR 2291 - TRICARE Reimbursement Revisions

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-13

..., Medical Benefits and Reimbursement Systems, telephone (303) 676-3803. SUPPLEMENTARY INFORMATION: I... the descriptive terminology. Regulatory Procedures Executive Order 12866, ``Regulatory Planning and...

Public Utility Commission manual for Section 210 of PURPA for Vermont

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

Not Available

The Public Utility Regulatory Policies Act of 1978 (PURPA) places obligations on both electric utilities and state regulatory commissions. PURPA requires every electric utility to purchase all energy and capacity made available to it, by a qualifying facility, and to sell energy and capacity to a qualifying facility upon the qualifying facility's request. State regulatory commissions must implement and administer these utility obligations and other requirements that were implemented by the Federal Energy Regulatory Commission's (FERC) final rules, which became effective March 20, 1981, and must set fair rates for electric power purchases and sales between utilities and small powermore » producers. This manual provides a concise, annotated explanation of the final FERC rules, a description of federal and state statutory authorizations, court challenges to these authorizations, analysis of the relationship between federal and state laws, analysis of Vermont's implementation of section 210 of PURPA and for comparison, annotations of selected state regulatory authority decisions.« less

Public Utility Commission manual for Section 210 of PURPA for Montana

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

Not Available

The Public Utility Regulatory Policies Act of 1978 (PURPA) places obligations on both electric utilities and state regulatory commissions. PURPA requires every electric utility to purchase all energy and capacity made available to it, by a qualifying facility, and to sell energy and capacity to a qualifying facility upon the qualifying facility's request. State regulatory commissions must implement and administer these utility obligations and other requirements that were implemented by the Federal Energy Regulatory Commission's (FERC) final rules, which became effective March 20, 1981; and must set fair rates for electric power purchases and sales between utilities and small powermore » producers. This manual provides a concise, annotated explanation of the final FERC rules, a description of federal and state statutory authorizations, court challenges to these authorizations analysis of the relationship between federal and state laws, analysis of Montana's implementation of section 210 of PURPA and for comparison, annotations of selected state regulatory authority decisions.« less

Public Utility Commission manual for Section 210 of PURPA for Arkansas

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

Not Available

The Public Utility Regulatory Policies Act of 1978 (PURPA) places obligations on both electric utilities and state regulatory commissions. PURPA requires every electric utility to purchase all energy and capacity made available to it, by a qualifying facility, and to sell energy and capacity to a qualifying facility upon the qualifying facility's request. State regulatory commissions must implement and administer these utility obligations and other requirements that were implemented by the Federal Energy Regulatory Commission's (FERC) final rules, which became effective March 20, 1981; and must set fair rates for electric power purchases and sales between utilities and small powermore » producers. This manual provides a concise, annotated explanation of the final FERC rules, a description of federal and state statutory authorizations, court challenges to these authorizations, analysis of the relationship between federal and state laws, analysis of Arkansas' implementation of section 210 of PURPA and for comparison, annotations of selected state regulatory authority decisions.« less

78 FR 28776 - Approval and Promulgation of Implementation Plans; Georgia; State Implementation Plan...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... Section of this Federal Register, EPA is approving the State's implementation plan revision as a direct... Promulgation of Implementation Plans; Georgia; State Implementation Plan Miscellaneous Revisions AGENCY... State Implementation Plan (SIP) submitted by the Georgia Environmental Protection Division to EPA in...

78 FR 59982 - Revisions to Radiation Protection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-30

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0268] Revisions to Radiation Protection AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan section; issuance. SUMMARY: The U.S. Nuclear Regulatory... for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition'': Section 12.1...

77 FR 66650 - Proposed Revisions to Radiation Protection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-06

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0268] Proposed Revisions to Radiation Protection AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan-draft section revision; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) is revising the following sections...

COUNCIL FOR REGULATORY ENVIRONMENTAL MODELING (CREM) PILOT WATER QUALITY MODEL SELECTION TOOL

EPA Science Inventory

EPA's Council for Regulatory Environmental Modeling (CREM) is currently supporting the development of a pilot model selection tool that is intended to help the states and the regions implement the total maximum daily load (TMDL) program. This tool will be implemented within the ...

Revised ground-water monitoring compliance plan for the 300 area process trenches

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

Schalla, R.; Aaberg, R.L.; Bates, D.J.

1988-09-01

This document contains ground-water monitoring plans for process-water disposal trenches located on the Hanford Site. These trenches, designated the 300 Area Process Trenches, have been used since 1973 for disposal of water that contains small quantities of both chemicals and radionuclides. The ground-water monitoring plans contained herein represent revision and expansion of an effort initiated in June 1985. At that time, a facility-specific monitoring program was implemented at the 300 Area Process Trenches as part of a regulatory compliance effort for hazardous chemicals being conducted on the Hanford Site. This monitoring program was based on the ground-water monitoring requirements formore » interim-status facilities, which are those facilities that do not yet have final permits, but are authorized to continue interim operations while engaged in the permitting process. The applicable monitoring requirements are described in the Resource Conservation and Recovery Act (RCRA), 40 CFR 265.90 of the federal regulations, and in WAC 173-303-400 of Washington State's regulations (Washington State Department of Ecology 1986). The program implemented for the process trenches was designed to be an alternate program, which is required instead of the standard detection program when a facility is known or suspected to have contaminated the ground water in the uppermost aquifer. The plans for the program, contained in a document prepared by the US Department of Energy (USDOE) in 1985, called for monthly sampling of 14 of the 37 existing monitoring wells at the 300 Area plus the installation and sampling of 2 new wells. 27 refs., 25 figs., 15 tabs.« less

Reading the Tea Leaves: How Utilities in the West Are Managing Carbon Regulatory Risk in their Resource Plans

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

Barbose, Galen; Wiser, Ryan; Phadke, Amol

2008-02-01

The long economic lifetime and development lead-time of many electric infrastructure investments requires that utility resource planning consider potential costs and risks over a lengthy time horizon. One long-term -- and potentially far-reaching -- risk currently facing the electricity industry is the uncertain cost of future carbon dioxide (CO2) regulations. Recognizing the importance of this issue, many utilities (sometimes spurred by state regulatory requirements) are beginning to actively assess carbon regulatory risk within their resource planning processes, and to evaluate options for mitigating that risk. However, given the relatively recent emergence of this issue and the rapidly changing political landscape,more » methods and assumptions used to analyze carbon regulatory risk, and the impact of this analysis on the selection of a preferred resource portfolio, vary considerably across utilities. In this study, we examine the treatment of carbon regulatory risk in utility resource planning, through a comparison of the most-recent resource plans filed by fifteen investor-owned and publicly-owned utilities in the Western U.S. Together, these utilities account for approximately 60percent of retail electricity sales in the West, and cover nine of eleven Western states. This report has two related elements. First, we compare and assess utilities' approaches to addressing key analytical issues that arise when considering the risk of future carbon regulations. Second, we summarize the composition and carbon intensity of the preferred resource portfolios selected by these fifteen utilities and compare them to potential CO2 emission benchmark levels.« less

77 FR 61460 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-09

... Change To Offer Members and Member Organizations the Ability To Pay a Regulatory Fine Pursuant to an... and member organizations the ability to pay a regulatory fine pursuant to an installment plan, under... and Other Charges'' to offer members and member organizations the ability to pay a regulatory fine...

Regulatory Information by Topic: Emergency Management

EPA Pesticide Factsheets

Regulatory information about emergencies, including chemical accident prevention, risk management plans (RMPs), chemical reporting, community right to know, and oil spills and hazardous substances releases.

Self-Regulatory Speech during Planning and Problem-Solving in Children with SLI and Their Typically Developing Peers

ERIC Educational Resources Information Center

Abdul Aziz, Safiyyah; Fletcher, Janet; Bayliss, Donna M.

2017-01-01

Background: Past research with children with specific language impairment (SLI) has shown them to have poorer planning and problem-solving ability, and delayed self-regulatory speech (SRS) relative to their typically developing (TD) peers. However, the studies are few in number and are restricted in terms of the number and age range of…

76 FR 62055 - Wabash Gas Storage, LLC; Notice of Intent To Prepare an Environmental Assessment for the Planned...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-06

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PF11-6-000] Wabash Gas Storage, LLC; Notice of Intent To Prepare an Environmental Assessment for the Planned Wabash Gas Storage Project, Request for Comments on Environmental Issues, and Notice of Public Scoping Meeting The staff of the Federal Energy Regulatory Commission ...

78 FR 79688 - Paiute Pipeline Company; Notice of Intent To Prepare an Environmental Assessment for the Planned...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-31

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PF14-4-000] Paiute Pipeline Company; Notice of Intent To Prepare an Environmental Assessment for the Planned 2015 Elko Area Expansion Project, Request for Comments on Environmental Issues, and Notice of Public Scoping Meeting The staff of the Federal Energy Regulatory...

75 FR 26220 - Notice of Intent to Prepare an Environmental Assessment for the Planned Leader One Gas Storage...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Leader One Energy, LLC] Notice of Intent to Prepare an Environmental Assessment for the Planned Leader One Gas Storage Project, Request for Comments on Environmental Issues, and Notice of a Site Visit April 30, 2010. The staff of the Federal Energy Regulatory Commission (FERC or...

75 FR 56089 - Equitrans, L.P.; Notice of Intent To Prepare an Environmental Assessment for the Planned Sunrise...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-15

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PF10-19-000] Equitrans, L.P.; Notice of Intent To Prepare an Environmental Assessment for the Planned Sunrise Pipeline Project, Request for Comments on Environmental Issues, and Notice of Public Scoping Meeting September 3, 2010. The staff of the Federal Energy Regulatory...

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.

Radiation safety role in institutional disaster planning.

PubMed

Classic, K L; Knutson, A H; Smith, G D

2000-05-01

United States Nuclear Regulatory Commission (NRC) materials license applicants (non-nuclear power) must submit spill procedures with their application. While our counterparts in the nuclear power industry historically have concerned themselves with disaster drills and evacuation plans as a result of fire, explosion, or an act of terrorism, other licensees are looking only at minor spills of unsealed radioactive material and only at tile radiation hazard. Beyond NRC regulations, various oversight and accrediting organizations require, or at a minimum encourage, a written disaster plan outlining actions to be taken for events likely to occur in the region of the institution. Some of these organizations require drills to practice implementation of the written plan. On 5 May 1999, Mayo Clinic performed a wide-scale disaster drill involving Rochester City and Olmsted County response organizations, and several Mayo Clinic departments. Planning took several months; the drill took approximately three hours. Participants gathered at several meetings post-drill for "debriefing" sessions to discuss successes, areas for improvement, and lessons learned. There were three overriding lessons learned: critical responders need special identification to allow access to the disaster site; initial victim surveys are for gross contamination only; and access to the potentially contaminated disaster site might take weeks or months following a real event.

A cost effective bioremediation strategy using low technology resources for reclamation of dry land hydrocarbon contamination: A case study

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

Robb, A.J. III; Hoggatt, P.R.

Hydrocarbon containing soil was bioremediated at a combination wastewater and slop oil skim evaporation pond utilizing cost effective low technology resources. Fluids and sludge from the football field-sized pond were extraction procedure toxicity and purgeable organics tested, and total petroleum hydrocarbon (TPH) concentrations determined. An impact risk analysis was performed, and a corrective action plan developed and implemented. The three year project was closely coordinated with the Kansas Corporation Commission (KCC) and the Kansas Department of Health and Environment (KDHE) who established the closure level. The impacted soils at the pond were completely excavated and closure was immediately granted bymore » KDHE for the excavated area. The 24,000 cubic yards of excavated soil were then surface spread on adjacent Mobil property. A nutrient and microbial base was applied to bioaugment the soil. The preapplication land surface and the subsequently land farmed soil was periodically disced and chiseled. A job safety plan including industrial hygiene measures to eliminate workforce exposure was developed and implemented. The final remediation cost analysis amounts to $1.48 per cubic yard compared to the $30 to $150 per cubic yard industry o estimates for similar projects. Several factors were critical in ailing costs to remain so low: (1) assessment and implementation by local in-house staff, (2) conservative remedial action plan and sampling strategy; (3) local contractors; (4) locally available soil amendment; and (5) effective regulatory coordination. The methods described can be used to cost effectively characterize and bioremediate other sites where hydrocarbon-impacted soils exist in similar dry-land environments.« less

Safeguards-by-Design:Guidance for High Temperature Gas Reactors (HTGRs) With Prismatic Fuel

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

Mark Schanfein; Casey Durst

2012-11-01

Introduction and Purpose The following is a guidance document from a series prepared for the U.S. Department of Energy (DOE) National Nuclear Security Administration (NNSA), under the Next Generation Safeguards Initiative (NGSI), to assist facility designers and operators in implementing international Safeguards-by-Design (SBD). SBD has two main objectives: (1) to avoid costly and time consuming redesign work or retrofits of new nuclear fuel cycle facilities and (2) to make the implementation of international safeguards more effective and efficient at such facilities. In the long term, the attainment of these goals would save industry and the International Atomic Energy Agency (IAEA)more » time, money, and resources and be mutually beneficial. This particular safeguards guidance document focuses on prismatic fuel high temperature gas reactors (HTGR). The purpose of the IAEA safeguards system is to provide credible assurance to the international community that nuclear material and other specified items are not diverted from peaceful nuclear uses. The safeguards system consists of the IAEA’s statutory authority to establish safeguards; safeguards rights and obligations in safeguards agreements and additional protocols; and technical measures implemented pursuant to those agreements. Of foremost importance is the international safeguards agreement between the country and the IAEA, concluded pursuant to the Treaty on the Non-Proliferation of Nuclear Weapons (NPT). According to a 1992 IAEA Board of Governors decision, countries must: notify the IAEA of a decision to construct a new nuclear facility as soon as such decision is taken; provide design information on such facilities as the designs develop; and provide detailed design information based on construction plans at least 180 days prior to the start of construction, and on "as-built" designs at least 180 days before the first receipt of nuclear material. Ultimately, the design information will be captured in an IAEA Design Information Questionnaire (DIQ), prepared by the facility operator, typically with the support of the facility designer. The IAEA will verify design information over the life of the project. This design information is an important IAEA safeguards tool. Since the main interlocutor with the IAEA in each country is the State Regulatory Authority/SSAC (or Regional Regulatory Authority, e.g. EURATOM), the responsibility for conveying this design information to the IAEA falls to the State Regulatory Authority/SSAC. For the nuclear industry to reap the benefits of SBD (i.e. avoid cost overruns and construction schedule slippages), nuclear facility designers and operators should work closely with the State Regulatory Authority and IAEA as soon as a decision is taken to build a new nuclear facility. Ideally, this interaction should begin during the conceptual design phase and continue throughout construction and start-up of a nuclear facility. Such early coordination and planning could influence decisions on the design of the nuclear material processing flow-sheet, material storage and handling arrangements, and facility layout (including safeguards equipment), etc.« less

50 CFR 600.1008 - Implementation plan and implementation regulations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 50 Wildlife and Fisheries 8 2010-10-01 2010-10-01 false Implementation plan and implementation... Capacity Reduction Framework § 600.1008 Implementation plan and implementation regulations. (a) As soon as... period, a proposed implementation plan and implementation regulations. During the public comment period...

Implications of Modeling Uncertainty for Water Quality Decision Making

NASA Astrophysics Data System (ADS)

Shabman, L.

2002-05-01

The report, National Academy of Sciences report, "Assessing the TMDL Approach to Water Quality Management" endorsed the "watershed" and "ambient water quality focused" approach" to water quality management called for in the TMDL program. The committee felt that available data and models were adequate to move such a program forward, if the EPA and all stakeholders better understood the nature of the scientific enterprise and its application to the TMDL program. Specifically, the report called for a greater acknowledgement of model prediction uncertinaity in making and implementing TMDL plans. To assure that such uncertinaity was addressed in water quality decision making the committee called for a commitment to "adaptive implementation" of water quality management plans. The committee found that the number and complexity of the interactions of multiple stressors, combined with model prediction uncertinaity means that we need to avoid the temptation to make assurances that specific actions will result in attainment of particular water quality standards. Until the work on solving a water quality problem begins, analysts and decision makers cannot be sure what the correct solutions are, or even what water quality goals a community should be seeking. In complex systems we need to act in order to learn; adaptive implementation is a concurrent process of action and learning. Learning requires (1) continued monitoring of the waterbody to determine how it responds to the actions taken and (2) carefully designed experiments in the watershed. If we do not design learning into what we attempt we are not doing adaptive implementation. Therefore, there needs to be an increased commitment to monitoring and experiments in watersheds that will lead to learning. This presentation will 1) explain the logic for adaptive implementation; 2) discuss the ways that water quality modelers could characterize and explain model uncertinaity to decision makers; 3) speculate on the implications of the adaptive implementation for setting of water quality standards, for design of watershed monitoring programs and for the regulatory rules governing the TMDL program implementation.

75 FR 64771 - Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for BATS Y-Exchange, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-20

... provisions of Rule 19d-1(c)(1) of the Act \\4\\ requiring that a self-regulatory organization promptly file... Commission adopted amendments to paragraph (c) of Rule 19d-1 to allow self-regulatory organizations (``SROs... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63113; File No. 4-616] Self-Regulatory...

Accelerating the Whiteshell Laboratories Decommissioning Through the Implementation of a Projectized and Delivery-Focused Organization - 13074

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

Wilcox, Brian; Mellor, Russ; Michaluk, Craig

2013-07-01

Whiteshell Laboratories (WL) is a nuclear research site in Canada that was commissioned in 1964 by Atomic Energy of Canada Limited. It covers a total area of approximately 4,375 hectares (10,800 acres) and includes the main campus site, the Waste Management Area (WMA) and outer areas of land identified as not used for or impacted by nuclear development or operations. The WL site employed up to 1100 staff. Site activities included the successful operation of a 60 MW organic liquid-cooled research reactor from 1965 to 1985, and various research programs including reactor safety research, small reactor development, fuel development, biophysicsmore » and radiation applications, as well as work under the Canadian Nuclear Fuel Waste Management Program. In 1997, AECL made a business decision to discontinue research programs and operations at WL, and obtained government concurrence in 1998. The Nuclear Legacy Liabilities Program (NLLP) was established in 2006 by the Canadian Government to remediate nuclear legacy liabilities in a safe and cost effective manner, including the WL site. The NLLP is being implemented by AECL under the governance of a Natural Resources Canada (NRCan)/AECL Joint Oversight Committee (JOC). Significant progress has since been made, and the WL site currently holds the only Canadian Nuclear Safety Commission (CNSC) nuclear research site decommissioning license in Canada. The current decommissioning license is in place until the end of 2018. The present schedule planned for main campus decommissioning is 30 years (to 2037), followed by institutional control of the WMA until a National plan is implemented for the long-term management of nuclear waste. There is an impetus to advance work and complete decommissioning sooner. To accomplish this, AECL has added significant resources, reorganized and moved to a projectized environment. This presentation outlines changes made to the organization, the tools implemented to foster projectization, and the benefits and positive impacts on schedule and delivery. A revised organizational structure was implemented in two phases, starting 2011 April 1, to align WL staff with the common goal of decommissioning the site through the direction of the WL Decommissioning Project General Manager. On 2011 September 1, the second phase of the reorganization was implemented and WL Decommissioning staff was organized under five Divisions: Programs and Regulatory Compliance, General Site Services, Decommissioning Strategic Planning, Nuclear Facilities and Project Delivery. A new Mission, Vision and Objectives were developed for the project, and several productivity enhancements are being implemented. These include the use of an integrated and fully re-sourced Site Wide Schedule that is updated and reviewed at Plan-of-the-Week meetings, improved work distribution throughout the year, eliminating scheduling 'push' mentality, project scoreboards, work planning implementation, lean practices and various process improvement initiatives. A revised Strategic Plan is under development that reflects the improved project delivery capabilities. As a result of these initiatives, and a culture change towards a projectized approach, the decommissioning schedule will be advanced by approximately 10 years. (authors)« less

Clinical Trial of a Comprehensive Treatment for High Functioning Children with ASD

DTIC Science & Technology

2017-07-01

and completion of the regulatory review; (2) implementation of the treatment for sampling wave 2; (3) completion of pretest , posttest , and follow-up...implementation of the treatment for sampling wave 3; (7) completion of pretest , posttest , and follow-up measures for sampling wave 3; (8) enrollment of...of the regulatory review; (2) implementation of the treatment for sampling wave 2; (3) completion of pretest , posttest , and follow-up measures for

Parental supervision for their children's toothbrushing: Mediating effects of planning, self-efficacy, and action control.

PubMed

Hamilton, Kyra; Cornish, Stephen; Kirkpatrick, Aaron; Kroon, Jeroen; Schwarzer, Ralf

2018-05-01

With 60-90% of children worldwide reportedly experiencing dental caries, poor oral health in the younger years is a major public health issue. As parents are important to children's oral hygiene practices, we examined the key self-regulatory behaviours of parents for supervising their children's toothbrushing using the health action process approach. Participants (N = 281, 197 mothers) comprised Australian parents of 2- to 5-year-olds. A longitudinal design was used to investigate the sequential mediation chain for the effect of intention (Time 1) on parental supervision for their youngest child's toothbrushing (Time 3), via self-efficacy and planning (Time 2), and action control (Time 3). A latent-variable structural equation model, controlling for baseline behaviour and habit, revealed significant indirect effects from intention via self-efficacy and action control and intention via planning and action control, on parental supervision behaviour. The model was a good fit to the data, explaining 74% of the variance in parents' supervising behaviour for their children's toothbrushing. While national recommendations are provided to guide parents in promoting good oral hygiene practices with their children, current results show the importance of going beyond simple knowledge transmission to support parents' intentions to supervise their children's toothbrushing actually materialize. Current findings make a significant contribution to the cumulative empirical evidence regarding self-regulatory components in health behaviour change and can inform intervention development to increase parents' participation in childhood oral hygiene practices, thus helping to curb rising oral health conditions and diseases. Statement of contribution What is already known on this subject? Self-regulatory skills are important to translate intentions into behaviour. Self-efficacy, planning, and action control are key self-regulatory skills for behaviour change. What does this study add? Self-regulatory skills are needed for parents to supervise their children's toothbrushings. Self-efficacy, planning, and action control are important self-regulatory skills in this context. Future interventions should map these self-regulatory predictors onto behaviour change techniques. © 2018 The British Psychological Society.

Gaining Regulator Acceptance of Natural Attenuation as a Remediation Tool

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

Hughes, M.B.

Monitored natural attenuation (MNA) makes use of biological degradation, chemical reactions with natural materials, and other processes to clean up contaminated soils and groundwater. In the past, the regulatory community has been slow to accept natural attenuation due to a misperception that natural attenuation is a ''do nothing'' approach. Recently however, regulators have been more open to considering MNA as part of an overall clean-up plan that includes active treatment technologies to remove or contain the source of contamination at a site. MNA is currently being implemented at the Savannah River Site for remediation of selected contaminants. The South Carolinamore » Department of Health and Environmental Control, who has regulatory authority over these actions, has accepted this process. Significant overall cost savings are forecast. Additionally, there will be less disruption to the ecosystem, compared with engineered technologies. This paper describes the monitored natural attenuation concept as well as the process of constructive engagement with the regulators to achieve acceptance. Application to DOE, DOD, and commercial sites, as well as acceptability to other regulatory bodies, will be discussed with an emphasis on strategies to prevent false starts in the negotiation process and inventing options that result in mutual gains for all parties.« less

The European and American Use of Exploratory Approaches for First‐in‐Human Studies*

PubMed Central

Silva‐Lima, Beatriz; Carlson, David; Jones, David R.; Laurie, David; Stahl, Elke; Maria, Vasco; Janssens, Walter; Robinson, William T.

2010-01-01

Abstract Exploratory approaches for first‐in‐human clinical studies have evolved over the last few years and have stimulated the issuance of national regulatory guidances in some European countries as well as the United States. With the increasing implementation of these approaches and the recent preparation of a multiregional regulatory guidance (ICH M3 rev2), an exchange of experiences on the opportunities and challenges of exploratory clinical trials was desirable; thus, a workshop focusing on the use of this clinical approach was planned and conducted in Lisbon, Portugal, March 18–19, 2009 sponsored by the Portuguese Health Authority (INFARMED) and DIA. The structure of the workshop focused in three main areas. Regulatory representatives from Portugal, Belgium, Germany, the United Kingdom and the United States formally reviewed their experiences. This was followed by a discussion on issues from an ethics review perspective as well as an insight to the opportunities in the area of biologics. The industry perspective was presented by representatives from Merck, Pfizer, J&J, Novartis, Speedel, AstraZeneca, GSK, and Roche. Finally, through break out sessions, issues were identified to be addressed moving forward. It is the purpose of this paper to report on the outcome of this workshop. Clin Trans Sci 2010; Volume #: 1–4 PMID:20443952

Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop.

PubMed

Hurst, Frank P; Chianchiano, Dolph; Upchurch, Linda; Fisher, Benjamin R; Flythe, Jennifer E; Castillo Lee, Celeste; Hill, Terri; Neuland, Carolyn Y

2017-10-01

New technologies challenge current dialysis treatment paradigms as devices become smaller, more portable, and increasingly used outside the dialysis clinic. It is unclear how patients will view this care transition, and it will be important to consider patient and care partner perspectives during all aspects of development for novel dialysis therapies, from design and clinical trials to regulatory approval. To gain insight into this area, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, the US Food and Drug Administration, and nearly 80 member organizations and companies dedicated to enhancing patient safety and fostering innovation in kidney disease, convened a workshop of patients, care partners, and other kidney community stakeholders. The workshop included background presentations followed by focused small group discussions in 3 areas (device design, clinical trials, and regulatory approval). Participants explored how to involve patients throughout the life cycle of a medical device, including discussions of how patients can influence device design, assist in the planning and implementation of clinical trials, and provide input to affect regulatory decisions. Patients were engaged in the workshop discussion and interested in sharing their perspectives, but they recommended additional efforts around education, communication, and outreach in these areas. Published by Elsevier Inc.

Climate change adaptation in regulated water utilities

NASA Astrophysics Data System (ADS)

Vicuna, S.; Melo, O.; Harou, J. J.; Characklis, G. W.; Ricalde, I.

2017-12-01

Concern about climate change impacts on water supply systems has grown in recent years. However, there are still few examples of pro-active interventions (e.g. infrastructure investment or policy changes) meant to address plausible future changes. Deep uncertainty associated with climate impacts, future demands, and regulatory constraints might explain why utility planning in a range of contexts doesn't explicitly consider climate change scenarios and potential adaptive responses. Given the importance of water supplies for economic development and the cost and longevity of many water infrastructure investments, large urban water supply systems could suffer from lack of pro-active climate change adaptation. Water utilities need to balance the potential for high regret stranded assets on the one side, with insufficient supplies leading to potentially severe socio-economic, political and environmental failures on the other, and need to deal with a range of interests and constraints. This work presents initial findings from a project looking at how cities in Chile, the US and the UK are developing regulatory frameworks that incorporate utility planning under uncertainty. Considering for example the city of Santiago, Chile, recent studies have shown that although high scarcity cost scenarios are plausible, pre-emptive investment to guard from possible water supply failures is still remote and not accommodated by current planning practice. A first goal of the project is to compare and contrast regulatory approaches to utility risks considering climate change adaptation measures. Subsequently we plan to develop and propose a custom approach for the city of Santiago based on lessons learned from other contexts. The methodological approach combines institutional assessment of water supply regulatory frameworks with simulation-based decision-making under uncertainty approaches. Here we present initial work comparing the regulatory frameworks in Chile, UK and USA evaluating their ability to incorporate uncertain climate and other changes into long-term infrastructure investment planning. The potential for regulatory and financial adaptive measures is explored in addition to a discussion on evaluating their appropriateness via various modelling-based intervention decision-making approaches.

THE CLEAN ENERGY-ENVIRONMENT GUIDE TO ACTION ...

EPA Pesticide Factsheets

The Guide to Action identifies and describes sixteen clean energy policies and strategies that are delivering economic and environmental results for states. For each policy, the Guide describes: Objectives and benefits of the policy; Examples of states that have implemented the policy; Responsibilities of key players at the state level, including typical roles of the main stakeholders; Opportunities to coordinate implementation with other federal and state policies, partnerships and technical assistance resources; Best practices for policy design, implementation, and evaluation, including state examples; Action steps for states to take when adopting or modifying their clean energy policies, based on existing state experiences; Resources for additional information on individual state policies, legislative and regulatory language, and analytical tools and methods. States participating in the Clean Energy-Environment State Partnership Program will use the Guide to Action to: Develop their own Clean Energy-Environment Action Plan that is appropriate to their state; Identify the roles and responsibilities of key decision-makers, such as environmental regulators, state legislatures, public utility commissioners, and state energy offices; Access and apply technical assistance resources, models, and tools available for state-specific analyses and program implementation; and Learn from each other as they develop their own clean energy programs and policies.

The US Food and Drug Administration's tentative approval process and the global fight against HIV.

PubMed

Chahal, Harinder Singh; Murray, Jeffrey S; Shimer, Martin; Capella, Peter; Presto, Ryan; Valdez, Mary Lou; Lurie, Peter G

2017-12-01

In 2004, the US government began to utilize the Food and Drug Administration's (USFDA) tentative approval process (tFDA) as a basis to determine which HIV drugs are appropriate to be purchased and used in resource-constrained settings. This process permits products that are not approved for marketing in the US, including medicines with active patents or marketing restrictions in the US, to be purchased and distributed in resource-constrained settings. Although the tFDA was originally intended to support the United States' President's Emergency Plan for AIDS Relief (PEPFAR), the USFDA list has become a cornerstone of international HIV programmes that support procurement of ARVs, such as the World Health Organization and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Our objective in this article is to help the global HIV policy makers and implementers of HIV programmes better understand the benefits and limitations of the tFDA by providing an in-depth review of the relevant legal and regulatory processes. USFDA's dedicated tFDA process for ARVs used by the PEPFAR programme has a wide impact globally; however, the implementation and the regulatory processes governing the programme have not been thoroughly described in the medical literature. This paper seeks to help stakeholders better understand the legal and regulatory aspects associated with review of ARVs under the tFDA by describing the following: (1) the tFDA and its importance to global ARV procurement; (2) the regulatory pathways for applications under tFDA for the PEPFAR programme, including modifications to applications, review timelines and costs; (3) the role of US patents, US marketing exclusivity rights, and the Medicines Patents Pool in tFDA; and (4) an overview of how applications for PEPFAR programme are processed through the USFDA. We also provide a case study of a new ARV, tenofovir alafenamide fumarate (TAF), not yet reviewed by USFDA for PEPFAR use. In this paper, we describe the importance and implementation of USFDA's tentative approval process to review ARVs for resource-constrained settings. We also highlight the impact of patents and exclusivities on review of HIV drugs under tFDA and illustrate the concepts using a new HIV drug as an example. © 2017 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.

78 FR 5522 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

... the orderly coordination and implementation of technological and other changes to facilitate... change, at least five business days prior to the date on which FINRA filed the proposed rule change... Effectiveness of Proposed Rule Change To Delay the Implementation Date of FINRA Rule 5350 (Stop Orders) January...

Why don't Practitioners use Reservoir Optimization Methods? Results from a Survey of UK Water Managers

NASA Astrophysics Data System (ADS)

Dobson, B.; Pianosi, F.; Wagener, T.

2016-12-01

Extensive scientific literature exists on the study of how operation decisions in water resource systems can be made more effectively through the use of optimization methods. However, to the best of the authors' knowledge, there is little in the literature on the implementation of these optimization methods by practitioners. We have performed a survey among UK reservoir operators to assess the current state of method implementation in practice. We also ask questions to assess the potential for implementation of operation optimization. This will help academics to target industry in their current research, identify any misconceptions in industry about the area and open new branches of research for which there is an unsatisfied demand. The UK is a good case study because the regulatory framework is changing to impose "no build" solutions for supply issues, as well as planning across entire water resource systems rather than individual components. Additionally there is a high appetite for efficiency due to the water industry's privatization and most operators are part of companies that control multiple water resources, increasing the potential for cooperation and coordination.

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...

76 FR 8674 - Notice of a Public Meeting: Environmental Justice Considerations for Drinking Water Regulatory...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-15

... perchlorate and carcinogenic volatile organic compounds (VOCs). While the Agency is in the very preliminary stages of developing the regulatory efforts for perchlorate and carcinogenic VOCs, EPA plans to discuss..., Regulatory Determinations 3, perchlorate, and carcinogenic VOCs rulemaking efforts. Date and Location: The...

44 CFR 351.21 - The Nuclear Regulatory Commission.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true The Nuclear Regulatory... Assignments § 351.21 The Nuclear Regulatory Commission. (a) Assess NRC nuclear facility (e.g., commercial... protect the health and safety of the public. (b) Verify that nuclear facility licensee emergency plans can...

44 CFR 351.21 - The Nuclear Regulatory Commission.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false The Nuclear Regulatory... Assignments § 351.21 The Nuclear Regulatory Commission. (a) Assess NRC nuclear facility (e.g., commercial... protect the health and safety of the public. (b) Verify that nuclear facility licensee emergency plans can...

44 CFR 351.21 - The Nuclear Regulatory Commission.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false The Nuclear Regulatory... Assignments § 351.21 The Nuclear Regulatory Commission. (a) Assess NRC nuclear facility (e.g., commercial... protect the health and safety of the public. (b) Verify that nuclear facility licensee emergency plans can...

44 CFR 351.21 - The Nuclear Regulatory Commission.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false The Nuclear Regulatory... Assignments § 351.21 The Nuclear Regulatory Commission. (a) Assess NRC nuclear facility (e.g., commercial... protect the health and safety of the public. (b) Verify that nuclear facility licensee emergency plans can...

Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states.

PubMed

Preston, Charles; Chahal, Harinder S; Porrás, Analia; Cargill, Lucette; Hinds, Maryam; Olowokure, Babatunde; Cummings, Rudolph; Hospedales, James

2016-05-01

Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. "Regionalization"-an approach in which countries with common histories, cultural values, languages, and economic conditions work together to establish more efficient systems-may be one answer. This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. The initiative's concept and design includes a number of features and steps intended to enhance sustainability in resource-constrained contexts. The latter include 1) leveraging existing platforms for centralized cooperation, governance, and infrastructure; 2) strengthening regulatory capacities with the largest potential public health impact; 3) incorporating policies that promote reliance on reference authorities; 4) changing the system to encourage industry to market their products in CARICOM (e.g., using a centralized portal of entry to reduce regulatory burdens); and 5) building human resource capacity. If implemented properly, the CRS will be self-sustaining through user fees. The experience and lessons learned thus far in implementing this initiative, described in this report, can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments.

77 FR 33788 - Proposed Post Office Structure Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-07

... Plan AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing a recently-filed Postal Service request for an advisory opinion regarding its Post Office Structure Plan... Commission for an advisory opinion under 39 U.S.C. 3661 regarding its Post Office Structure Plan (POStPlan...

The Regulatory Challenges of Decommissioning Nuclear Power Plants in Korea - 13101

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

Lee, Jungjoon; Ahn, Sangmyeon; Choi, Kyungwoo

As of 2012, 23 units of nuclear power plants are in operation, but there is no experience of permanent shutdown and decommissioning of nuclear power plant in Korea. It is realized that, since late 1990's, improvement of the regulatory framework for decommissioning has been emphasized constantly from the point of view of International Atomic Energy Agency (IAEA)'s safety standards. And it is known that now IAEA prepare the safety requirement on decommissioning of facilities, its title is the Safe Decommissioning of Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission tomore » Korea in 2011, it was recommended that the regulatory framework for decommissioning should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became also important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we identify the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is to be established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. After dealing with it, it is expected that the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)« less

77 FR 43205 - Notice of Data Availability for Approval, Disapproval and Promulgation of Implementation Plans...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-24

... Haze State Implementation Plan; Federal Implementation Plan for Regional Haze AGENCY: Environmental... (SIP) revision submitted by the State of Wyoming on January 12, 2011, that addresses regional haze...; Regional Haze State Implementation Plan; Federal Implementation Plan for Regional Haze; Proposed Rule (77...

78 FR 28775 - Approval and Promulgation of Implementation Plans; North Carolina; State Implementation Plan...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... Promulgation of Implementation Plans; North Carolina; State Implementation Plan Miscellaneous Revisions AGENCY... a revision to the North Carolina State Implementation Plan submitted on February 3, 2010, through... particulate matter found in the Code of Federal Regulations. In the Final Rules Section of this Federal...

Actual operation and regulatory activities on steam generator replacement in Japan

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

Saeki, Hitoshi

1997-02-01

This paper summarizes the operating reactors in Japan, and the status of the steam generators in these plants. It reviews plans for replacement of existing steam generators, and then goes into more detail on the planning and regulatory steps which must be addressed in the process of accomplishing this maintenance. The paper also reviews the typical steps involved in the process of removal and replacement of steam generators.

Development and implementation of energy efficiency standards and labeling programs in China: Progress and challenges

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

Zhou, Nan; Khanna, Nina Zheng; Fridley, David

Over the last twenty years, with growing policy emphasis on improving energy efficiency and reducing environmental pollution and carbon emissions, China has implemented a series of new minimum energy performance standards (MEPS) and mandatory and voluntary energy labels to improve appliance energy efficiency. As China begins planning for the next phase of standards and labeling (S&L) program development under the 12th Five Year Plan, an evaluation of recent program developments and future directions is needed to identify gaps that still exist when compared with international best practices. The review of China’s S&L program development and implementation in comparison with majormore » findings from international experiences reveal that there are still areas of improvement, particularly when compared to success factors observed across leading international S&L program. China currently lacks a formalized regulatory process for standard-setting and do not have any legal or regulatory guidance on elements of S&L development such as stakeholder participation or the issue of legal precedence between conflicting national, industrial and local standards. Consequently, China’s laws regarding standard-setting and management of the mandatory energy label program could be updated, as they have not been amended or revised recently and no longer reflects the current situation. While China uses similar principles for choosing target products as the U.S., Australia, EU and Japan, including high energy-consumption, mature industry and testing procedure and stakeholder support, recent MEPS revisions have generally aimed at only eliminating the bottom 20% efficiency of the market. Setting a firm principle based on maximizing energy savings that are technically feasible and economically justified may help improve the stringency of China’s MEPS program and reduce the need for frequent revisions. China also lacks robust survey data and relies primarily on market research data in relatively simple techno-economic analyses used to determine its efficiency standards levels rather than the specific sets of analyses and tools used internationally. Based on international experiences, inclusion of more detailed energy consumption surveys in the Chinese national census surveys and statistical reporting systems could help provide the necessary data for more comprehensive standard-setting analyses. In terms of stakeholder participation in the standards development process, stakeholder participation in China is limited to membership on technical committees responsible for developing or revising standards and generally do not include environmental groups, consumer associations, utilities and other NGOs. Increasing stakeholder involvement to broader interest groups could help garner more support and feedback in the S&L implementation process. China has emerged as a leader in a national verification testing scheme with complementary pilot checktesting projects, but it still faces challenges with insufficient funding, low local awareness amongst some regulatory agencies and resistance to check-testing by some manufacturers, limited product sampling scope, and testing inconsistency and incomparability of results. Thus, further financial and staff resources and capacity building will be needed to overcome these remaining challenges and to expand impacts evaluations to assess the actual effectiveness of implementation and enforcement.« less

Investigation of Service Quality of Measurement Reference Points for the Internet Services on Mobile Networks

NASA Astrophysics Data System (ADS)

Lipenbergs, E.; Bobrovs, Vj.; Ivanovs, G.

2016-10-01

To ensure that end-users and consumers have access to comprehensive, comparable and user-friendly information regarding the Internet access service quality, it is necessary to implement and regularly renew a set of legislative regulatory acts and to provide monitoring of the quality of Internet access services regarding the current European Regulatory Framework. The actual situation regarding the quality of service monitoring solutions in different European countries depends on national regulatory initiatives and public awareness. The service monitoring solutions are implemented using different measurement methodologies and tools. The paper investigates the practical implementations for developing a harmonising approach to quality monitoring in order to obtain objective information on the quality of Internet access services on mobile networks.

A Review of the Environmental Impacts for Marine and Hydrokinetic Projects to Inform Regulatory Permitting: Summary Findings from the 2015 Workshop on Marine and Hydrokinetic Technologies, Washington, D.C.

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

Baring-Gould, E. Ian; Christol, Corrie; LiVecchi, Al

In 2014 and 2015, the U.S. Department of Energy initiated efforts to develop and implement technology- and application-focused marine and hydrokinetic (MHK) workshops to share the global experience and knowledge base on evolving MHK technologies, observed and not-observed impacts, monitoring and measurement methods, and regulatory needs. The resulting MHK Regulator Workshops engaged resource managers and other decision makers at key regulatory organizations, scientists, researchers, facilitators, and technical experts and provided an opportunity to examine the risks of single-device and small-scale deployments, explore what can be learned and observed from single devices and small-scale arrays, and consider requirements for projects atmore » varying scales of deployment. Experts and stakeholders identified key remaining information gaps. Initial discussions focused on differentiating between monitoring required for single or small-scale deployments and MHK impact research that, although important, goes beyond what is feasible or should be needed to meet specific project regulatory requirements but is appropriate for broader research and development. Four areas of identified potential environmental impacts provided the focus for the workshop: acoustic output impacts, electromagnetic field (EMF) emissions, physical interactions, and environmental effects of MHK energy development on the physical environment. Discussions also focused on the regulatory process and experience, adaptive management, industry drivers, and lessons that can be learned from the wind energy industry. The discussion was set in the context of the types of MHK technologies that are currently proposed or planned in the United States. All presentations and the following discussions are summarized in this document.« less

77 FR 66947 - Magnuson-Stevens Act Provisions; Fisheries of the Northeastern United States; Northeast...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-08

... NMFS, copies of addenda to FY 2012 sector operations plans detailing industry-funded monitoring plans... from Federal fishing regulations through its annual operations plan (for more information on sector operations plans and regulatory exemptions, see the fishing year 2012 sector operations plan proposed rule...

A workshop on developing risk assessment methods for medical use of radioactive material. Volume 1: Summary

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

Tortorelli, J.P.

1995-08-01

A workshop was held at the Idaho National Engineering Laboratory, August 16--18, 1994 on the topic of risk assessment on medical devices that use radioactive isotopes. Its purpose was to review past efforts to develop a risk assessment methodology to evaluate these devices, and to develop a program plan and a scoping document for future methodology development. This report contains a summary of that workshop. Participants included experts in the fields of radiation oncology, medical physics, risk assessment, human-error analysis, and human factors. Staff from the US Nuclear Regulatory Commission (NRC) associated with the regulation of medical uses of radioactivemore » materials and with research into risk-assessment methods participated in the workshop. The workshop participants concurred in NRC`s intended use of risk assessment as an important technology in the development of regulations for the medical use of radioactive material and encouraged the NRC to proceed rapidly with a pilot study. Specific recommendations are included in the executive summary and the body of this report. An appendix contains the 8 papers presented at the conference: NRC proposed policy statement on the use of probabilistic risk assessment methods in nuclear regulatory activities; NRC proposed agency-wide implementation plan for probabilistic risk assessment; Risk evaluation of high dose rate remote afterloading brachytherapy at a large research/teaching institution; The pros and cons of using human reliability analysis techniques to analyze misadministration events; Review of medical misadministration event summaries and comparison of human error modeling; Preliminary examples of the development of error influences and effects diagrams to analyze medical misadministration events; Brachytherapy risk assessment program plan; and Principles of brachytherapy quality assurance.« less

Approved Air Quality Implementation Plans in Region 10

EPA Pesticide Factsheets

Landing page for information about EPA-approved air quality State Implementation Plans (SIPs), Tribal Implementation Plans (TIPs), and Federal Implementation Plans (FIPs) in Alaska, Idaho, Oregon, Washington.

76 FR 77431 - Decommissioning Planning During Operations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-13

... (DG) DG-4014, ``Decommissioning Planning During Operations.'' This guide describes a method that the.... The draft regulatory guide entitled, ``Decommissioning Planning During Operations,'' is temporarily..., 40, 50, 70, and 72 RIN 3150-AI55 [NRC-2011-0286; NRC-2008-0030] Decommissioning Planning During...

78 FR 21245 - Continuity of Operations Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-10

...; Order No. 778] Continuity of Operations Plan AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Final rule. SUMMARY: In this Final Rule the Commission revises its Continuity of Operations Plan... Commission's Continuity of Operations Plan (COOP) regulations to incorporate its regional offices into the...

78 FR 69625 - Approval and Promulgation of Implementation Plans; New York State Ozone Implementation Plan Revision

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

...] Approval and Promulgation of Implementation Plans; New York State Ozone Implementation Plan Revision AGENCY...) is proposing to approve a revision to the New York State Implementation Plan (SIP) for ozone... air quality standards for ozone. DATES: Comments must be received on or before December 20, 2013...

77 FR 13974 - Approval and Promulgation of Implementation Plans; New York State Ozone Implementation Plan Revision

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-08

... Promulgation of Implementation Plans; New York State Ozone Implementation Plan Revision AGENCY: Environmental... a proposed revision to the New York State Implementation Plan (SIP) for ozone concerning the control... national ambient air quality standards for ozone. DATES: Effective Date: This rule will be effective April...

An evaluation of public participation in UK river basin management planning

NASA Astrophysics Data System (ADS)

Schmid, M.; Benson, D.

2012-04-01

The EU Water Framework Directive is reshaping multi-level environmental governance structures in many Member States. One area where re-structuring should be highly visible is in regards to public participation in water management. The Directive legally mandates that implementing agencies should make information publicly available relating to river basin management planning, include the public in the planning process and encourage the active involvement of 'interested parties' both during and after the planning stage. Yet critical questions arise over the extent to which these requirements have actually been met in Member States and the outcomes of participatory processes on the ground. In this study, public participation was evaluated in England and Wales by conducting: a) a broad based quantitative survey of the implementation strategy undertaken across all 11 River Basin Districts (RBDs); and, b) an in-depth analysis of the Anglian RBD drawing on theoretical notions of social learning; a critical measure of participatory processes. Results from the survey showed all RBDs complied with the minimum regulatory requirements on public access to information and written consultation, and even went further with provisions for oral consultation and stakeholder engagement. But the focus was clearly on stakeholder groups with little public involvement beyond minimal legally mandated requirements. Analysis of case study data provided some evidence of social learning at every level (instrumental, communicative and transformative) and beyond the individual scale (wider community and organisational learning). Learning was however significantly limited by participant's high level of expertise and environmental awareness. Also apparent was the influence of other factors, operating at various institutional scales, in shaping learning. The paper then speculates on the implications of the findings for both future research and policy, particularly in light of the European Commission's upcoming review of EU water policy.

Gathering Information on Costs of Service: Some Basic Considerations for Implementation of PURPA,

DTIC Science & Technology

1979-10-01

UNCLASSFIED RAND/P-6b22 ML."’ II I I I ll6lllllUi GATHERING INFORMATION ON COSTS OF .SERVICE: SOME BASIC CONSIDERATIONS FOR IMPLEMENTATION OF PURPA ...CONSIDERATIONS FOR IMPLEMENTATION OF PURPA Jan Paul Acton, Frank Camm, Derek McKay P-6422 October 1979 4v, P ,. . • L .... .S -iii- PREFACE In the period following...the passage of the Public Utility Regulatory Policies Act of 1978( PURPA ) the Federal Energy Regulatory Commission was responsible for the generation

Proceedings of the Monterey Conference on Planning for Rotorcraft and Commuter Air Transportation

NASA Technical Reports Server (NTRS)

Stockwell, W. L.

1983-01-01

Planning and technological issues involved in rotorcraft and commuter fixed-wing air transportation are discussed. Subject areas include the future community environment, aircraft technology, community transportation planning, and regulatory perspectives.

Audio visual summary: Implementing PURPA in Mid-America

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

Not Available

The audio-visual presentation, Implementing PURPA in Mid-America, is a slide presentation designed to complement deliverable W-101-2, a booklet entitled Implementing PURPA in Mid-America: A Guide to the Public Utility Regulatory Policies Act. The presentation lasts 10 to 12 min and explains the major sections of PURPA, the rules promulgated by the Federal Energy Regulatory Commission to implement PURPA, and the implications of PURPA and its rules. It delineates the rights and responsibilities of citizens who want to sell electricity to utilities, explains the certification process, and discusses the rights and responsibilities of the utilities.

77 FR 7940 - Unified Agenda of Federal Regulatory and Deregulatory Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... economic impact on a substantial number of small entities as defined by the Regulatory Flexibility Act (5 U... with ED's Principles for Regulating listed in its regulatory plan, ED is committed to regulations that... not consistent with the Principles for Regulating. Members of the public are also invited to comment...

18 CFR 12.22 - Contents of emergency action plan.

Code of Federal Regulations, 2012 CFR

2012-04-01

... action plan. 12.22 Section 12.22 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... plans for notifying potentially affected persons, appropriate Federal, state, and local agencies... nuclear power plants—1) Radiological response plan. If the personnel operating any powerhouse or any...

18 CFR 12.22 - Contents of emergency action plan.

Code of Federal Regulations, 2011 CFR

2011-04-01

... action plan. 12.22 Section 12.22 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... plans for notifying potentially affected persons, appropriate Federal, state, and local agencies... nuclear power plants—1) Radiological response plan. If the personnel operating any powerhouse or any...

18 CFR 12.22 - Contents of emergency action plan.

Code of Federal Regulations, 2014 CFR

2014-04-01

... action plan. 12.22 Section 12.22 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... plans for notifying potentially affected persons, appropriate Federal, state, and local agencies... nuclear power plants—1) Radiological response plan. If the personnel operating any powerhouse or any...

18 CFR 12.22 - Contents of emergency action plan.

Code of Federal Regulations, 2013 CFR

2013-04-01

... action plan. 12.22 Section 12.22 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... plans for notifying potentially affected persons, appropriate Federal, state, and local agencies... nuclear power plants—1) Radiological response plan. If the personnel operating any powerhouse or any...

Biosimilar Products in the Modern U.S. Health Care and Regulatory Landscape.

PubMed

Peterson, Jesse; Budlong, Holly; Affeldt, Tim; Skiermont, Kyle; Kyllo, Gregg; Heaton, Al

2017-12-01

Biosimilars have the potential to greatly reduce medication costs in the United States. As of July 1, 2017, 5 biosimilars have been approved by the FDA, but only 2 are available for purchase. This commentary outlines the efforts of an integrated health system to ensure biosimilar accessibility and discusses the current challenges and future implications. We highlight the implementation of a health plan policy and how a health system's formulary committee can encourage use while considering provider perceptions and operational challenges. In addition, we provide our perspective on potential implications for pricing, site of care, and pharmacy dispensing practices based on our experience with regulatory hurdles and market trends. Overall, we believe biosimilars are a good thing for the health care system, but their expected benefit may not be realized for years to come. No outside funding supported this work. Affeldt reports advisory board membership with Janssen, and Skiermont reports membership with Amgen and McKesson. The other authors have nothing to disclose. Peterson and Budlong contributed the study concept and design and wrote the manuscript. Affeldt, Skiermont, Kyllo, and Heaton reviewed and revised the manuscript.

Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

PubMed Central

Tu, Pei-Weng; Wu, Shiow-Ing

2015-01-01

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development. PMID:26075255

Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan.

PubMed

Li, Tzu-Wei; Tu, Pei-Weng; Liu, Li-Ling; Wu, Shiow-Ing

2015-01-01

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.

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.''

Approved Air Quality Implementation Plans in The Virgin Islands

EPA Pesticide Factsheets

This site contains information about air quality regulations called State Implementation Plans (SIPs), Federal Implementation Plans (FIPs), and Tribal Implementation Plans (TIPs) approved by EPA within the U.S. Virgin Islands.

14 CFR 313.4 - Major regulatory actions.

Code of Federal Regulations, 2013 CFR

2013-01-01

...) PROCEDURAL REGULATIONS IMPLEMENTATION OF THE ENERGY POLICY AND CONSERVATION ACT § 313.4 Major regulatory... major regulatory action requiring an energy statement, if it: (1) May cause a near-term net annual... its precedential value, substantial controversy with respect to energy conservation and efficiency, or...

14 CFR 313.4 - Major regulatory actions.

Code of Federal Regulations, 2012 CFR

2012-01-01

...) PROCEDURAL REGULATIONS IMPLEMENTATION OF THE ENERGY POLICY AND CONSERVATION ACT § 313.4 Major regulatory... major regulatory action requiring an energy statement, if it: (1) May cause a near-term net annual... its precedential value, substantial controversy with respect to energy conservation and efficiency, or...

Lessons Learned from Emergency Response Vaccination Efforts for Cholera, Typhoid, Yellow Fever, and Ebola

PubMed Central

Date, Kashmira A.; Sreenivasan, Nandini; Harris, Jennifer B.; Hyde, Terri B.

2017-01-01

Countries must be prepared to respond to public health threats associated with emergencies, such as natural disasters, sociopolitical conflicts, or uncontrolled disease outbreaks. Rapid vaccination of populations vulnerable to epidemic-prone vaccine-preventable diseases is a major component of emergency response. Emergency vaccination planning presents challenges, including how to predict resource needs, expand vaccine availability during global shortages, and address regulatory barriers to deliver new products. The US Centers for Disease Control and Prevention supports countries to plan, implement, and evaluate emergency vaccination response. We describe work of the Centers for Disease Control and Prevention in collaboration with global partners to support emergency vaccination against cholera, typhoid, yellow fever, and Ebola, diseases for which a new vaccine or vaccine formulation has played a major role in response. Lessons learned will help countries prepare for future emergencies. Integration of vaccination with emergency response augments global health security through reducing disease burden, saving lives, and preventing spread across international borders. PMID:29155670

Physical Property Analysis and Report for Sediments at 100-BC-5 Operable Unit, Boreholes C7505, C7506, C7507, and C7665

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

Lindberg, Michael J.

2010-09-28

Between October 14, 2009 and February 22, 2010 sediment samples were received from 100-BC Decision Unit for geochemical studies. This is an analytical data report for sediments received from CHPRC at the 100 BC 5 OU. The analyses for this project were performed at the 325 building located in the 300 Area of the Hanford Site. The analyses were performed according to Pacific Northwest National Laboratory (PNNL) approved procedures and/or nationally recognized test procedures. The data sets include the sample identification numbers, analytical results, estimated quantification limits (EQL), and quality control data. The preparatory and analytical quality control requirements, calibrationmore » requirements, acceptance criteria, and failure actions are defined in the on-line QA plan 'Conducting Analytical Work in Support of Regulatory Programs' (CAW). This QA plan implements the Hanford Analytical Services Quality Assurance Requirements Documents (HASQARD) for PNNL.« less

Gene Therapy in Heart Failure.

PubMed

Fargnoli, Anthony S; Katz, Michael G; Bridges, Charles R; Hajjar, Roger J

2017-01-01

Heart failure is a significant burden to the global healthcare system and represents an underserved market for new pharmacologic strategies, especially therapies which can address root cause myocyte dysfunction. Modern drugs, surgeries, and state-of-the-art interventions are costly and do not improve survival outcome measures. Gene therapy is an attractive strategy, whereby selected gene targets and their associated regulatory mechanisms can be permanently managed therapeutically in a single treatment. This in theory could be sustainable for the patient's life. Despite the promise, however, gene therapy has numerous challenges that must be addressed together as a treatment plan comprising these key elements: myocyte physiologic target validation, gene target manipulation strategy, vector selection for the correct level of manipulation, and carefully utilizing an efficient delivery route that can be implemented in the clinic to efficiently transfer the therapy within safety limits. This chapter summarizes the key developments in cardiac gene therapy from the perspective of understanding each of these components of the treatment plan. The latest pharmacologic gene targets, gene therapy vectors, delivery routes, and strategies are reviewed.

Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals.

PubMed

Nasr, Moheb M; Krumme, Markus; Matsuda, Yoshihiro; Trout, Bernhardt L; Badman, Clive; Mascia, Salvatore; Cooney, Charles L; Jensen, Keith D; Florence, Alastair; Johnston, Craig; Konstantinov, Konstantin; Lee, Sau L

2017-11-01

Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is based on the 2nd International Symposium on the Continuous Manufacturing of Pharmaceuticals, describes not only the advances that have taken place since the first International Symposium on Continuous Manufacturing of Pharmaceuticals in 2014, but the regulatory landscape that exists today. Key regulatory concepts including quality risk management, batch definition, control strategy, process monitoring and control, real-time release testing, data processing and management, and process validation/verification are outlined. Support from regulatory agencies, particularly in the form of the harmonization of regulatory expectations, will be crucial to the successful implementation of continuous manufacturing. Collaborative efforts, among academia, industry, and regulatory agencies, are the optimal solution for ensuring a solid future for this promising manufacturing technology. Copyright © 2017 American Pharmacists Association®. All rights reserved.

Development and implementation of a Bayesian-based aquifer vulnerability assessment in Florida

USGS Publications Warehouse

Arthur, J.D.; Wood, H.A.R.; Baker, A.E.; Cichon, J.R.; Raines, G.L.

2007-01-01

The Florida Aquifer Vulnerability Assessment (FAVA) was designed to provide a tool for environmental, regulatory, resource management, and planning professionals to facilitate protection of groundwater resources from surface sources of contamination. The FAVA project implements weights-of-evidence (WofE), a data-driven, Bayesian-probabilistic model to generate a series of maps reflecting relative aquifer vulnerability of Florida's principal aquifer systems. The vulnerability assessment process, from project design to map implementation is described herein in reference to the Floridan aquifer system (FAS). The WofE model calculates weighted relationships between hydrogeologic data layers that influence aquifer vulnerability and ambient groundwater parameters in wells that reflect relative degrees of vulnerability. Statewide model input data layers (evidential themes) include soil hydraulic conductivity, density of karst features, thickness of aquifer confinement, and hydraulic head difference between the FAS and the watertable. Wells with median dissolved nitrogen concentrations exceeding statistically established thresholds serve as training points in the WofE model. The resulting vulnerability map (response theme) reflects classified posterior probabilities based on spatial relationships between the evidential themes and training points. The response theme is subjected to extensive sensitivity and validation testing. Among the model validation techniques is calculation of a response theme based on a different water-quality indicator of relative recharge or vulnerability: dissolved oxygen. Successful implementation of the FAVA maps was facilitated by the overall project design, which included a needs assessment and iterative technical advisory committee input and review. Ongoing programs to protect Florida's springsheds have led to development of larger-scale WofE-based vulnerability assessments. Additional applications of the maps include land-use planning amendments and prioritization of land purchases to protect groundwater resources. ?? International Association for Mathematical Geology 2007.

A Strategy to Establish a Quality Assurance/Quality Control Plan for the Application of Biosensors for the Detection of E. coli in Water.

PubMed

Hesari, Nikou; Kıratlı Yılmazçoban, Nursel; Elzein, Mohamad; Alum, Absar; Abbaszadegan, Morteza

2017-01-03

Rapid bacterial detection using biosensors is a novel approach for microbiological testing applications. Validation of such methods is an obstacle in the adoption of new bio-sensing technologies for water testing. Therefore, establishing a quality assurance and quality control (QA/QC) plan is essential to demonstrate accuracy and reliability of the biosensor method for the detection of E. coli in drinking water samples. In this study, different reagents and assay conditions including temperatures, holding time, E. coli strains and concentrations, dissolving agents, salinity and pH effects, quality of substrates of various suppliers of 4-methylumbelliferyl glucuronide (MUG), and environmental water samples were included in the QA/QC plan and used in the assay optimization and documentation. Furthermore, the procedural QA/QC for the monitoring of drinking water samples was established to validate the performance of the biosensor platform for the detection of E. coli using a culture-based standard technique. Implementing the developed QA/QC plan, the same level of precision and accuracy was achieved using both the standard and the biosensor methods. The established procedural QA/QC for the biosensor will provide a reliable tool for a near real-time monitoring of E. coli in drinking water samples to both industry and regulatory authorities.

A Strategy to Establish a Quality Assurance/Quality Control Plan for the Application of Biosensors for the Detection of E. coli in Water

PubMed Central

Hesari, Nikou; Kıratlı Yılmazçoban, Nursel; Elzein, Mohamad; Alum, Absar; Abbaszadegan, Morteza

2017-01-01

Rapid bacterial detection using biosensors is a novel approach for microbiological testing applications. Validation of such methods is an obstacle in the adoption of new bio-sensing technologies for water testing. Therefore, establishing a quality assurance and quality control (QA/QC) plan is essential to demonstrate accuracy and reliability of the biosensor method for the detection of E. coli in drinking water samples. In this study, different reagents and assay conditions including temperatures, holding time, E. coli strains and concentrations, dissolving agents, salinity and pH effects, quality of substrates of various suppliers of 4-methylumbelliferyl glucuronide (MUG), and environmental water samples were included in the QA/QC plan and used in the assay optimization and documentation. Furthermore, the procedural QA/QC for the monitoring of drinking water samples was established to validate the performance of the biosensor platform for the detection of E. coli using a culture-based standard technique. Implementing the developed QA/QC plan, the same level of precision and accuracy was achieved using both the standard and the biosensor methods. The established procedural QA/QC for the biosensor will provide a reliable tool for a near real-time monitoring of E. coli in drinking water samples to both industry and regulatory authorities. PMID:28054956

Future time perspective and health behaviors: temporal framing of self-regulatory processes in physical exercise and dietary behaviors.

PubMed

Gellert, Paul; Ziegelmann, Jochen P; Lippke, Sonia; Schwarzer, Ralf

2012-04-01

Limitations in perceived lifetime can undermine long-term goal striving. Planning is supposed to translate intentions into health behaviors and to operate as a compensatory strategy to overcome goal striving deficits associated with a limited time perspective. Two longitudinal studies were conducted examining the compensatory role of planning: an online survey on fruit and vegetable consumption (N = 909; 16-78 years; follow-up at 4 months) and a questionnaire study on physical exercise in older adults (N = 289; 60-95 years, over a half-year period). Intentions, planning, and behavior were measured in a behavior-specific, future time perspective in a generic manner. Planning mediated between intentions and both health behaviors. Time perspective operated as a moderator, indicating that in individuals with a more limited time perspective, a stronger effect of planning on health behaviors emerged. Planning as a self-regulatory strategy may compensate for a limited time perspective.

77 FR 48061 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Regional Haze State...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

... Promulgation of Air Quality Implementation Plans; Pennsylvania; Regional Haze State Implementation Plan...'s limited approval of Pennsylvania's Regional Haze State Implementation Plan (SIP). DATES: Effective... announcing our limited approval of Pennsylvania's Regional Haze SIP. In this document, we inadvertently...

10 CFR 76.91 - Emergency planning.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Emergency planning. 76.91 Section 76.91 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.91 Emergency planning. The Corporation shall establish, maintain, and be prepared to follow a written emergency plan. The...

10 CFR 76.91 - Emergency planning.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Emergency planning. 76.91 Section 76.91 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.91 Emergency planning. The Corporation shall establish, maintain, and be prepared to follow a written emergency plan. The...

10 CFR 76.91 - Emergency planning.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Emergency planning. 76.91 Section 76.91 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.91 Emergency planning. The Corporation shall establish, maintain, and be prepared to follow a written emergency plan. The...

Knowledge enabled plan of care and documentation prototype.

PubMed

DaDamio, Rebecca; Gugerty, Brian; Kennedy, Rosemary

2006-01-01

There exist significant challenges in integrating the plan of care into documentation and point of care operational processes. A plan of care is often a static artifact that meets regulatory standards with limited influence on supporting goal-directed care delivery processes. Although this prototype is applicable to many clinical disciplines, we will highlight nursing processes in demonstrating a knowledge-driven computerized solution that fully integrates the plan of care within documentation. The knowledge-driven solution reflects evidenced-based practice; is an effective tool for managing problems, orders/interventions, and the patient's progress towards expected outcomes; meets regulatory standards; and drives quality and process improvement. The knowledge infrastructure consists of fully represented terminology, structured clinical expressions utilizing the controlled terminology and clinical knowledge representing evidence-based practice.

76 FR 32331 - Preliminary Plan for Retrospective Review of Existing Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-06

... review. In addition, DHS launched an IdeaScale Web page; this social media tool provided an additional... agency's regulatory program more effective or less burdensome in achieving its regulatory objectives. DHS...

Land Development and Subdivision Regulations that Support Access Management

DOT National Transportation Integrated Search

1993-01-01

This report examines the role of the comprehensive plan in developing an access : management program, aspects of current regulatory practice that contribute to : access problems, and regulatory techniques that support access management : principles. ...

AFO Manure Management - Oregon: Plan Review and Public Notice of Substantial Changes

EPA Pesticide Factsheets

Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

75 FR 33588 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-14

.... SUMMARY: The Director, Information Collection Clearance Division, Regulatory Information Management... Management Services, Office of Management, publishes that notice containing proposed information collection... Clearance Division, Regulatory Information Management Services, Office of Management. Office of Planning...

30 CFR 701.2 - Objective.

Code of Federal Regulations, 2011 CFR

2011-07-01

... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

30 CFR 701.2 - Objective.

Code of Federal Regulations, 2014 CFR

2014-07-01

... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

30 CFR 701.2 - Objective.

Code of Federal Regulations, 2010 CFR

2010-07-01

... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

30 CFR 701.2 - Objective.

Code of Federal Regulations, 2013 CFR

2013-07-01

... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

30 CFR 701.2 - Objective.

Code of Federal Regulations, 2012 CFR

2012-07-01

... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

76 FR 14108 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

..., Revision 1, ``Control of Preheat Temperature for Welding of Low-Alloy Steel.'' FOR FURTHER INFORMATION... for Welding of Low-Alloy Steel,'' was issued with a temporary identification as Draft Regulatory Guide... implementing regulatory requirements related to the control of welding for low-alloy steel components during...

78 FR 52587 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-23

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70228; File No. 4-663] Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and Declaring Effective a Plan..., Inc. and the Topaz Exchange, LLC August 19, 2013. On July 2, 2013, the Financial Industry Regulatory...

78 FR 71689 - Self-Regulatory Organizations; Topaz Exchange, LLC; Notice of Filing of Proposed Minor Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

... of Rule 19d-1(c)(1) of the Act \\3\\ requiring that a self- regulatory organization (``SRO'') promptly... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70927; File No. 4-669] Self-Regulatory Organizations; Topaz Exchange, LLC; Notice of Filing of Proposed Minor Rule Violation Plan November 22, 2013...

77 FR 67722 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing of Proposed Minor Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-13

... Rule 19d-1(c)(1) of the Act \\3\\ requiring that a self- regulatory organization (``SRO'') promptly file... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68170; File No. 4-655] Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing of Proposed Minor Rule Violation Plan November 6, 2012...

Lessons from a Successful Implementation of a Computerized Provider Order Entry System

PubMed Central

Jacobs, Brian R.; Hallstrom, Craig K.; Hart, Kim Ward; Mahoney, Daniela; Lykowski, Gayle

2007-01-01

OBJECTIVES The electronic health record (EHR) can improve patient safety, care efficiency, cost effectiveness and regulatory compliance. Cincinnati Children's Hospital Medical Center (CCHMC) has successfully implemented an Integrating Clinical Information System (ICIS) that includes Computerized Provider Order Entry (CPOE). This review describes some of the unanticipated challenges and solutions identified during the implementation of ICIS. METHODS Data for this paper was derived from user-generated feedback within the ICIS. Feedback reports were reviewed and placed into categories based on root cause of the issue. Recurring issues or problems which led to potential or actual patient injury are included. RESULTS Nine distinct challenges were identified: 1) Deterioration in communication; 2) Excessive system alerts to users; 3) Unrecognized discontinuation of medications; 4) Unintended loss of orders; 5) Loss of orders during implementation; 6) Amplification of errors; 7) Unintentional generation of patient care orders by system analysts; 8) Persistence of specific patient care order instructions; 9) Verbal orders entered under the incorrect clinician. CONCLUSIONS Unanticipated challenges are expected when implementing EHRs. The implementation plan for any EHR should include methods to identify, evaluate and repair problems quickly. While continued challenges with this complex system are expected, we believe that the EHR will continue to facilitate improved patient care and safety. The lessons learned at CCHMC will permit other institutions to avoid some of these challenges and design robust processes to detect and respond to problems in a timely fashion to ensure implementation success. PMID:23055847

Bundled payment fails to gain a foothold In California: the experience of the IHA bundled payment demonstration.

PubMed

Ridgely, M Susan; de Vries, David; Bozic, Kevin J; Hussey, Peter S

2014-08-01

To determine whether bundled payment could be an effective payment model for California, the Integrated Healthcare Association convened a group of stakeholders (health plans, hospitals, ambulatory surgery centers, physician organizations, and vendors) to develop, through a consensus process, the methods and means of implementing bundled payment. In spite of a high level of enthusiasm and effort, the pilot did not succeed in its goal to implement bundled payment for orthopedic procedures across multiple payers and hospital-physician partners. An evaluation of the pilot documented a number of barriers, such as administrative burden, state regulatory uncertainty, and disagreements about bundle definition and assumption of risk. Ultimately, few contracts were signed, which resulted in insufficient volume to test hypotheses about the impact of bundled payment on quality and costs. Although bundled payment failed to gain a foothold in California, the evaluation provides lessons for future bundled payment initiatives. Project HOPE—The People-to-People Health Foundation, Inc.

State Performance-Based Regulation Using Multiyear Rate Plans for U.S. Electric Utilities

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

Lowry, Mark Newton; Makos, Matt; Deason, Jeff

Electric utilities today must contain costs at a time when many need to modernize aging systems and all face major changes in technologies, customer preferences and competitive pressures.Most U.S. electric utility facilities are investor-owned, subject to rate and service regulation by state public utility commissions. Regulatory systems under which these utilities operate affect their performance and ability to meet these challenges. In this business environment, multiyear rate plans have some advantages over traditional rate regulation.The report focuses on key design issues and provides case studies of the multiyear rate plan approach, applicable to both vertically integrated and restructured states. Markmore » Newton Lowry and Matt Makos of Pacific Energy Group Research and Jeff Deason of Berkeley Lab authored the report; Lisa Schwartz, Berkeley Lab, was project manager and technical editor.The report is aimed primarily at state utility regulators and stakeholders in the state regulatory process. The multiyear rate approach also provides ideas on how to streamline oversight of public power utilities and rural electric cooperatives for their governing boards.Two key provisions of multiyear rate plans strengthen cost containment incentives and streamline regulation: 1. Reducing frequency of rate cases, typically to every four or five years 2. Using an attrition relief mechanism to escalate rates or revenue between rate cases to address cost pressures such as inflation and growth in number of customers, independently of the utility’s own cost Better utility performance can be achieved under well-designed multiyear rate plans while achieving lower regulatory costs. Benefits can be shared between utilities and their customers. But plans can be complex and involve significant changes in the regulatory system. Designing plans that stimulate utility performance without undue risk and share benefits fairly can be challenging.This report discusses the rationale for multiyear rate plans and their usefulness under modern business conditions. It then explains critical plan design issues and challenges and presents results from numerical research that considers the extra incentive power achieved under different plan provisions. Next, the report presents several case studies of utilities that have operated under formal multiyear rate plans or, for various reasons, have stayed out of rate cases for more than a decade. These studies consider the effect of multiyear rate plans and rate case frequency on utility cost, reliability and other performance dimensions.« less

Baseline Evaluations to Support Control Room Modernization at Nuclear Power Plants

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

Boring, Ronald L.; Joe, Jeffrey C.

2015-02-01

For any major control room modernization activity at a commercial nuclear power plant (NPP) in the U.S., a utility should carefully follow the four phases prescribed by the U.S. Nuclear Regulatory Commission in NUREG-0711, Human Factors Engineering Program Review Model. These four phases include Planning and Analysis, Design, Verification and Validation, and Implementation and Operation. While NUREG-0711 is a useful guideline, it is written primarily from the perspective of regulatory review, and it therefore does not provide a nuanced account of many of the steps the utility might undertake as part of control room modernization. The guideline is largely summative—intendedmore » to catalog final products—rather than formative—intended to guide the overall modernization process. In this paper, we highlight two crucial formative sub-elements of the Planning and Analysis phase specific to control room modernization that are not covered in NUREG-0711. These two sub-elements are the usability and ergonomics baseline evaluations. A baseline evaluation entails evaluating the system as-built and currently in use. The usability baseline evaluation provides key insights into operator performance using the control system currently in place. The ergonomics baseline evaluation identifies possible deficiencies in the physical configuration of the control system. Both baseline evaluations feed into the design of the replacement system and subsequent summative benchmarking activities that help ensure that control room modernization represents a successful evolution of the control system.« less

Experiences and lessons learned for planning and supply of micronutrient powders interventions

PubMed Central

Schauer, Claudia; Sunley, Nigel; Nyhus Dhillon, Christina; Roca, Claudia; Tapia, Gustavo; Mathema, Pragya; Walton, Shelley; Situma, Ruth; Zlotkin, Stanley; DW Klemm, Rolf

2017-01-01

Abstract Realistic planning for a nutrition intervention is a critical component of implementation, yet effective approaches have been poorly documented. Under the auspices of “The Micronutrient Powders Consultation: Lessons Learned for Operational Guidance,” 3 working groups were formed to summarize experiences and lessons across countries regarding micronutrient powders (MNP) interventions for young children. This paper focuses on programmatic experiences in the planning stages of an MNP intervention, encompassing assessment, enabling environment and adaptation, as well as considerations for supply. Methods included a review of published and grey literature, key informant interviews, and deliberations throughout the consultation process. We found that assessments helped justify adopting an MNP intervention, but these assessments were often limited by their narrow scope and inadequate data. Establishing coordinating bodies and integrating MNP into existing policies and programmes have helped foster an enabling environment and support programme stability. Formative research and pilots have been used to adapt MNP interventions to specific contexts, but they have been insufficient to inform scale‐up. In terms of supply, most countries have opted to procure MNP through international suppliers, but this still requires understanding and navigating the local regulatory environment at the earliest stages of an intervention. Overall, these findings indicate that although some key planning and supply activities are generally undertaken, improvements are needed to plan for effective scale‐up. Much still needs to be learned on MNP planning, and we propose a set of research questions that require further investigation. PMID:28960875

18 CFR 5.12 - Comments on proposed study plan.

Code of Federal Regulations, 2010 CFR

2010-04-01

... study plan. 5.12 Section 5.12 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... PROCESS § 5.12 Comments on proposed study plan. Comments on the potential applicant's proposed study plan, including any revised information or study requests, must be filed within 90 days after the proposed study...

78 FR 48504 - Proposed Revisions to Maintenance Rule Standard Review Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-08

... Review Plan AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan-draft section revision... Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition,'' Section 17... and Management System (ADAMS): You may access publicly available documents online in the NRC Library...

Northrop TRIGA facility decommissioning plan versus actual results

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

Gardner, F.W.

1986-01-01

This paper compares the TRIGA facility decontamination and decommissioning (D and D) plan to the actual results and discusses key areas where operational activities were impacted by the final US Nuclear Regulatory Commission approved D and D plan. A discussion of fuel transport, release criteria, and release survey plans is included.

77 FR 5191 - Approval and Promulgation of Air Quality Implementation Plans; District of Columbia; Regional...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-02

... Promulgation of Air Quality Implementation Plans; District of Columbia; Regional Haze State Implementation Plan... of Columbia Regional Haze Plan, a revision to the District of Columbia State Implementation Plan (SIP... existing anthropogenic impairment of visibility in mandatory Class I areas through a regional haze program...

Utilisation of an electronic portfolio to engage rehabilitation professionals in continuing professional development: results of a provincial survey.

PubMed

Foucault, Marie-Lyse; Vachon, Brigitte; Thomas, Aliki; Rochette, Annie; Giguère, Charles-Édouard

2018-06-01

ePortfolios are frequently used to support continuing professional development (CPD) of rehabilitation professionals. Though this tool is now widely implemented in many professions by regulatory organisations, very few studies have investigated the use and impact among rehabilitation professionals. Implementation of comprehensive ePortfolios that are centred on the needs of rehabilitation professionals requires documenting their level of use and perceived outcomes. The objectives were to describe how occupational therapists use a mandatory ePortfolio that has been recently implemented by a regulatory organisation in Quebec (Canada) and the perceived outcomes of this requirement on continuing professional development and practice change. An online survey was sent to all registered occupational therapists in Quebec using the ePortfolio. The survey content was developed based on a literature review and expert consultation. Results were analysed using descriptive statistics. A total of 546 respondents completed the survey. Results show relatively high levels of ease and satisfaction with the tool, but a limited perception of the tool's impacts on the improvement of professional competencies and change in practices. Occupational therapists reported that use of the ePortfolio supports their engagement in CPD but has limited impact on practice. Promotion of work-based learning, team use and mentor support could increase its meaningfulness for professionals. Implications for Rehabilitation To improve attitudes and beliefs about benefits related to portfolio use, rehabilitation practitioners need a very clear understanding of the purpose and usefulness of a portfolio in clinical practice. Most of the respondents saw the ePortfolio as helping them develop and implement a continuing professional development plan and reflect on the changes needed in their practice. Portfolio use in teams and productive reflection should be promoted in order to target shared objectives for continuous practice improvement. Rehabilitation professionals trained in portfolio use during their entry-level studies have a slightly more positive attitude towards portfolio use and impact of this use compared with than clinicians who have not had this training.

Linkages between public and non-government sectors in healthcare: A case study from Uttar Pradesh, India.

PubMed

Srivastava, Aradhana; Bhattacharyya, Sanghita; Gautham, Meenakshi; Schellenberg, Joanna; Avan, Bilal I

2016-12-01

Effective utilisation of collaborative non-governmental organisation (NGO)-public health system linkages in pluralistic health systems of developing countries can substantially improve equity and quality of services. This study explores level and types of linkages between public health sector and NGOs in Uttar Pradesh (UP), an underprivileged state of India, using a social science model for the first time. It also identifies gaps and challenges for effective linkage. Two NGOs were selected as case studies. Data collection included semi-structured in-depth interviews with senior staff and review of records and reporting formats. Formal linkages of NGOs with the public health system related to registration, participation in district level meetings, workforce linkages and sharing information on government-supported programmes. Challenges included limited data sharing, participation in planning and limited monitoring of regulatory compliances. Linkage between public health system and NGOs in UP was moderate, marked by frequent interaction and some reciprocity in information and resource flows, but weak participation in policy and planning. The type of linkage could be described as 'complementarity', entailing information and resource sharing but not joint action. Stronger linkage is required for sustained and systematic collaboration, with joint planning, implementation and evaluation.

V&V Plan for FPGA-based ESF-CCS Using System Engineering Approach.

NASA Astrophysics Data System (ADS)

Maerani, Restu; Mayaka, Joyce; El Akrat, Mohamed; Cheon, Jung Jae

2018-02-01

Instrumentation and Control (I&C) systems play an important role in maintaining the safety of Nuclear Power Plant (NPP) operation. However, most current I&C safety systems are based on Programmable Logic Controller (PLC) hardware, which is difficult to verify and validate, and is susceptible to software common cause failure. Therefore, a plan for the replacement of the PLC-based safety systems, such as the Engineered Safety Feature - Component Control System (ESF-CCS), with Field Programmable Gate Arrays (FPGA) is needed. By using a systems engineering approach, which ensures traceability in every phase of the life cycle, from system requirements, design implementation to verification and validation, the system development is guaranteed to be in line with the regulatory requirements. The Verification process will ensure that the customer and stakeholder’s needs are satisfied in a high quality, trustworthy, cost efficient and schedule compliant manner throughout a system’s entire life cycle. The benefit of the V&V plan is to ensure that the FPGA based ESF-CCS is correctly built, and to ensure that the measurement of performance indicators has positive feedback that “do we do the right thing” during the re-engineering process of the FPGA based ESF-CCS.

Evaluation of evidence supporting the effectiveness of desert tortoise recovery actions

USGS Publications Warehouse

Boarman, William I.; Kristan, William B.

2006-01-01

As a federally threatened species, the desert tortoise's (Gopherus agassizii) recovery is required under the Endangered Species Act (ESA). According to the criteria established by the Desert Tortoise Recovery Plan (U.S. Fish and Wildlife Service 1994) for delisting the tortoise from ESA protection, the species as a whole will be considered recovered when tortoises have exhibited a statistically significant upward trend for at least one tortoise generation (25 years), enough habitat is protected to allow persistence, provisions are in place to maintain discrete population growth rates at or above 1.0, regulatory measures are in place to ensure continued management of tortoise habitat, and there is no longer reason to believe that the species will require ESA protection in the future. Just as species extinction can be thought of as the cumulative extinction of all populations, species recovery can be thought of as recovery of constituent populations; management efforts for recovery generally are implemented and assessed at the population level. A recent review of the Desert Tortoise Recovery Plan, including an exhaustive literature search, has been compiled by the Desert Tortoise Recovery Plan Assessment Committee (Tracy et al. 2004).

Computer validation in toxicology: historical review for FDA and EPA good laboratory practice.

PubMed

Brodish, D L

1998-01-01

The application of computer validation principles to Good Laboratory Practice is a fairly recent phenomenon. As automated data collection systems have become more common in toxicology facilities, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency have begun to focus inspections in this area. This historical review documents the development of regulatory guidance on computer validation in toxicology over the past several decades. An overview of the components of a computer life cycle is presented, including the development of systems descriptions, validation plans, validation testing, system maintenance, SOPs, change control, security considerations, and system retirement. Examples are provided for implementation of computer validation principles on laboratory computer systems in a toxicology facility.

Reduce costs and improve patient satisfaction with home pre-operative bowel preparations.

PubMed

Hearn, K; Dailey, M; Harris, M T; Bodian, C

2000-01-01

The results of a home-based preoperative bowel preparation, with and without the support of home care services, are compared with hospital-based preoperative bowel preparation. Length of stay, morbidity, and mortality rates; issues of patient satisfaction; and demographics are reported. The method and tools used in planning, implementing, and evaluating the home preoperative bowel preparation program are also shared. Other issues discussed are the healthcare market forces that promote an increased value of care. Economic and patient satisfaction considerations by employers, payers, and patients; the increasing influence of patient choice on healthcare provider selection and care setting preferences; the nursing workforce issues related to the impending shortage; and issues of regulatory and accrediting agencies are also discussed.

[Factors affecting the recovery in the intensive care unit].

PubMed

Turkov, P N; Nikitin, V V; Antsupova, M A; Podkopaev, V N; Panfilova, R P; Ivanova, I N; Nesterova, L I

2013-01-01

Urgency of the problem is defined by economical, regulatory and legislative acts, regional social and moral factors. There is critical situation in Russian Pediatric Healthcare system. This situation is due to inadequate funding, high medical technologies inaccessibility for some Russian children, their adverse health state. The article presents a retrospective analysis of intensive therapy and resuscitation outcomes with technical equipment and work environment assessment in the intensive care unit of Tushinskaya city pediatric clinic for the period from 2007 to 2011. Anaesthetic and emergency care quality and safety depend on several factors: permanent equipment improvement, comprehensive analysis of every fatal case and full implementation of "Anti-epidemic (prophylactic) actions plan" and "Program of monitoring compliance with the sanitary norms".

Comparing a motivational and a self-regulatory intervention to adopt an oral self-care regimen: a two-sequential randomized crossover trial.

PubMed

Lhakhang, Pempa; Gholami, Maryam; Knoll, Nina; Schwarzer, Ralf

2015-01-01

A sequential intervention to facilitate the adoption and maintenance of dental flossing was conducted among 205 students in India, aged 18-26 years. Two experimental groups received different treatment sequences and were observed at three assessment points, 34 days apart. One group received first a motivational intervention (intention, outcome expectancies, and risk perception, followed by a self-regulatory intervention (planning, self-efficacy, and action control). The second group received the same intervention in the opposite order. Both intervention sequences yielded gains in terms of flossing, planning, self-efficacy, and action control. However, at Time 2, those who had received the self-regulatory intervention first, were superior to their counterparts who had received the motivational intervention first. At Time 3, differences vanished as everyone had then received both interventions. Thus, findings highlight the benefits of a self-regulatory compared to a mere motivational intervention.

Visible, Durable, Enforceable Institutional Controls: Weldon Spring Site - A 10-Year Journey - 13190

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

Uhlmeyer, Terri; Thompson, Randy; Starr, Ken

2013-07-01

The DOE Office of Legacy Management's (LM's) mission is to manage the DOE's post-closure responsibilities and ensure the future protection of human health and the environment. LM has control and custody of legacy land, structures, and facilities and is responsible for maintaining them at levels suitable for their long-term use. This includes all engineered and institutional controls (ICs) designed as another level of assurance to prevent exposure to residual contamination and waste. The development and management of ICs has been, and continues to be, a critical component to the success of LM surveillance and maintenance activities. Many major federal laws,more » Executive Orders, regulations, and various other drivers influence the establishment and use of ICs at LM sites. LM uses a wide range of ICs to appropriately limit access to, or uses of, land, facilities, and other real and personal properties; protect the environment; maintain the physical safety and security of DOE facilities; and prevent or limit inadvertent human and environmental exposure to residual contaminants and other hazards. The ICs at the Weldon Spring, Missouri, Site were developed in close coordination with federal and state regulators. An Explanation of Significant Differences (ESD) was issued in February 2005, which clarified the use restrictions necessary for the remedial actions specified in the Records of Decision for the separate operable units to remain protective over the long-term. The operable units included the Chemical Plant Operable Unit, the Chemical Plant Groundwater Operable Unit, and the Quarry Residuals Operable Unit. The ESD clarified specific requirements for each site area that needed use restrictions and established how DOE would implement, maintain, and monitor the specific requirements. DOE developed the Long-Term Surveillance and Maintenance Plan for the U.S. Department of Energy Weldon Spring, Missouri, Site (LTS and M Plan) that addressed the full scope of the site management activities necessary to ensure that the Weldon Spring Site remains protective over the long-term. The LTS and M Plan is revised periodically to ensure its applicability to changing site, regulatory, or procedural conditions. In addition to addressing such activities as long-term groundwater monitoring and disposal cell maintenance, the LTS and M Plan was developed and issued to ensure that the use restrictions identified in the ESD were properly imposed and maintained. The LTS and M Plan included a detailed IC Implementation Plan, which includes a process for evaluating and identifying specific IC mechanisms that best accomplish the objectives set out in the ESD. Consistent with EPA guidance on selecting ICs, various IC mechanisms were evaluated, including government controls, proprietary controls, enforcement tools, and informational devices. Where appropriate, redundant mechanisms were employed to increase the effectiveness of the ICs. Information in the IC Implementation Plan includes: (1) a discussion of current site conditions (reflecting post-remedial action conditions for the Chemical Plant and Quarry Areas and the risk-basis for why use restrictions are needed); (2) the objectives of, or performance expectations for, the use restrictions; (3) specific ICs already in place and additional mechanisms identified for implementation; (4) a schedule for implementing additional ICs; (5) procedures for maintaining the ICs and for conducting periodic inspections; and (6) general provisions for the implementing ICs for the site. The actual agreements and documentation of the various ICs are included in an appendix of the LTS and M Plan. These documents are also available via the internet from the authorizing agencies (County, Missouri Department of Natural Resources, EPA, etc.) The Weldon Spring Site personnel have been successful in finalizing each of the ICs that were established for the site. The planning, establishment, and implementation of the ICs was a long and detailed process with several lessons-learned that were identified along the way. (authors)« less

COST EFFECTIVE REGULATORY APPROACHES TO ENHANCE DOMESTIC OIL & GAS PRODUCTION AND ENSURE THE PROTECTION OF THE ENVIRONMENT

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

Ben Grunewald; Paul Jehn; Tom Gillespie

The Environmental Information Management Suite/Risk Based Data Management System (EIMS/RBDMS) and Cost Effective Regulatory Approach (CERA) programs continue to be successful. All oil and gas state regulatory programs participate in these efforts. Significant accomplishments include: streamline regulatory approaches, enhancing environmental protection, and making oil and gas data available via the Internet. Oil and gas companies worldwide now have access to data on state web sites. This reduces the cost of exploration and enables companies to develop properties in areas that would have been cost prohibited for exploration. Early in project, GWPC and State Oil and Gas agencies developed the EIMSmore » and CERA strategic plan to prioritize long term development and implementation. The planning process identifies electronic commerce and coal bed methane as high priorities. The group has involved strategic partners in industry and government to develop a common data exchange process. Technical assistance to Alaska continues to improve their program management capabilities. New initiatives in Alaska include the development of an electronic permit tracking system. This system allows managers to expedite the permitting process. Nationwide, the RBDMS system is largely completed with 22 states and one Indian Nation now using this nationally accepted data management system. Additional remaining tasks include routine maintenance and the installation of the program upon request for the remaining oil and gas states. The GWPC in working with the BLM and MMS to develop an XML schema to facilitate electronic permitting and reporting (Appendix A, B, and C). This is a significant effort and, in years to come, will increase access to federal lands by reducing regulatory barriers. The new initiatives are coal bed methane and e-commerce. The e-commerce program will provide industry and BLM/MMS access to the millions of data points housed in the RBDMS system. E-commerce will streamline regulatory approaches and allow small operators to produce energy from areas that have become sub-economic for the major producers. The GWPC is working with states to develop a coal bed methane program, which will both manage the data and develop a public education program on the benefits of produced water. The CERA program benefits all oil and gas states by reducing the cost of regulatory compliance, increasing environmental protection, and providing industry and regulatory agencies a discussion forum. Activities included many small and large group forum settings for discussions of technical and policy issues as well as the ongoing State Class II UIC peer review effort. The accomplishments detailed in this report will be the basis for the next initiative which is RBDMS On-Line. RBDMS On-Line will combine data mining, electronic permitting and electronic reporting with .net technology. Industry, BLM, GWPC and all Oil and Gas states are partnering this effort.« less

Regulatory Technology Development Plan - Sodium Fast Reactor. Mechanistic Source Term - Trial Calculation. Work Plan

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

Grabaskas, David; Bucknor, Matthew; Jerden, James

2016-02-01

The overall objective of the SFR Regulatory Technology Development Plan (RTDP) effort is to identify and address potential impediments to the SFR regulatory licensing process. In FY14, an analysis by Argonne identified the development of an SFR-specific MST methodology as an existing licensing gap with high regulatory importance and a potentially long lead-time to closure. This work was followed by an initial examination of the current state-of-knowledge regarding SFR source term development (ANLART-3), which reported several potential gaps. Among these were the potential inadequacies of current computational tools to properly model and assess the transport and retention of radionuclides duringmore » a metal fuel pool-type SFR core damage incident. The objective of the current work is to determine the adequacy of existing computational tools, and the associated knowledge database, for the calculation of an SFR MST. To accomplish this task, a trial MST calculation will be performed using available computational tools to establish their limitations with regard to relevant radionuclide release/retention/transport phenomena. The application of existing modeling tools will provide a definitive test to assess their suitability for an SFR MST calculation, while also identifying potential gaps in the current knowledge base and providing insight into open issues regarding regulatory criteria/requirements. The findings of this analysis will assist in determining future research and development needs.« less

Emotional intensity influences pre-implementation and implementation of distraction and reappraisal

PubMed Central

Shafir, Roni; Schwartz, Naama; Blechert, Jens

2015-01-01

Although emotional intensity powerfully challenges regulatory strategies, its influence remains largely unexplored in affective-neuroscience. Accordingly, the present study addressed the moderating role of emotional intensity in two regulatory stages—implementation (during regulation) and pre-implementation (prior to regulation), of two major cognitive regulatory strategies—distraction and reappraisal. According to our framework, because distraction implementation involves early attentional disengagement from emotional information before it gathers force, in high-intensity it should be more effective in the short-term, relative to reappraisal, which modulates emotional processing only at a late semantic meaning phase. Supporting findings showed that in high (but not low) intensity, distraction implementation resulted in stronger modulation of negative experience, reduced neural emotional processing (centro-parietal late positive potential, LPP), with suggestive evidence for less cognitive effort (frontal-LPP), relative to reappraisal. Related pre-implementation findings confirmed that anticipating regulation of high-intensity stimuli resulted in distraction (over reappraisal) preference. In contrast, anticipating regulation of low-intensity stimuli resulted in reappraisal (over distraction) preference, which is most beneficial for long-term adaptation. Furthermore, anticipating cognitively demanding regulation, either in cases of regulating counter to these preferences or via the more effortful strategy of reappraisal, enhanced neural attentional resource allocation (Stimulus Preceding Negativity). Broad implications are discussed. PMID:25700568

Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

[Implementation of Italian guidelines on public health genomics in Italy: a challenging policy of the NHS].

PubMed

Boccia, Stefania; Federici, Antonio; Colotto, Marco; Villari, Paolo

2014-01-01

Genomics and related fields are becoming increasingly relevant in health care practice. Italy is the first European country that has a structured policy of Public Health Genomics. Nevertheless, what should be the role of genomics in a public health perspective and how public health professionals should engage with advances in genomics' knowledge and technology, is still not entirely clear. A description of the regulatory framework made-up by the Italian government in the last years is provided. In order to implement the national guidelines on Public Health Genomics published in 2013, key issues including the ethical, legal and social aspects within an evidence-based framework should be warranted and are herewith discussed. Genomics and predictive medicine are considered one of the main intervention areas by the National Prevention Plan 2010-2012, and dedicated guidelines were published in 2013. In order to implement such guidelines, we envisage a coordinated effort between stakeholders to guide development in genomic medicine, towards an impact on population health. There is also room to implement knowledge on how genomics can be integrated into health systems in an appropriate and sustainable way. Learning programs are needed to spread knowledge and awareness of genomics technology, in particular on genomic testing for complex diseases.

Promoting action control and coping planning to improve hand hygiene.

PubMed

Reyes Fernández, Benjamín; Lippke, Sonia; Knoll, Nina; Blanca Moya, Emanuel; Schwarzer, Ralf

2015-09-25

We examined a brief educational intervention addressing hand hygiene self-regulatory mechanisms, and evaluated which psychological mechanisms may lead to hand hygiene behaviours. Two hundred forty two students (mean age = 21 years, SD = 3.9) received either an experimental (n = 149) or a control condition on action control and planning (n = 93). Hand hygiene, coping planning, and action control were measured at baseline and six weeks later. By applying repeated measures ANOVA, we compared the experimental condition addressing planning to perform hand hygiene with a control condition. Additionally, working mechanisms were evaluated by means of mediation analysis. The intervention had an effect on action control, as reflected by a time by treatment interaction. The direct effect of the intervention on behaviour was, however, non-significant. Changes in action control led to changes in coping planning. These social-cognitive changes mediated the effect of intervention on behaviour, after controlling for gender, baseline behaviour, and classroom membership. In spite of the associations between the intervention and self-regulatory strategies, no direct effect was found of the intervention on behaviour. Further research on how to increase hand sanitizing, involving enviromental characteristics, is required. The intervention led only indirectly to an improvement of hand hygiene via changes in self-regulatory factors. Results indicate the importance of promoting action control and coping planning to initiate changes in hand hygienic behaviours.

75 FR 76758 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-09

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63430; File No. 4-618] Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and Declaring Effective a Plan for the Allocation of Regulatory Responsibilities Between BATS Exchange, Inc., BATS Y-Exchange, Inc., Chicago Board Options Exchange, Inc., Chicago...

The planning, construction, and operation of a radioactive waste storage facility for an Australian state radiation regulatory authority

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

Wallace, J.D.; Kleinschmidt, R.; Veevers, P.

1995-12-31

Radiation regulatory authorities have a responsibility for the management of radioactive waste. This, more often than not, includes the collection and safe storage of radioactive sources in disused radiation devices and devices seized by the regulatory authority following an accident, abandonment or unauthorised use. The public aversion to all things radioactive, regardless of the safety controls, together with the Not In My Back Yard (NIMBY) syndrome combine to make the establishment of a radioactive materials store a near impossible task, despite the fact that such a facility is a fundamental tool for regulatory authorities to provide for the radiation safetymore » of the public. In Queensland the successful completion and operational use of such a storage facility has taken a total of 8 years of concerted effort by the staff of the regulatory authority, the expenditure of over $2 million (AUS) not including regulatory staff costs and the cost of construction of an earlier separate facility. This paper is a summary of the major developments in the planning, construction and eventual operation of the facility including technical and administrative details, together with the lessons learned from the perspective of the overall project.« less

Implementation of a commercial-grade dedication program - Benefits and lessons learned

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

Harrington, M.; MacFarlane, I.

1991-01-01

The recent issuance of industry guidelines, the Nuclear Management and Resources Council procurement initiative, and a US Nuclear Regulatory Commission NRC generic letter on commercial-grade item dedication (CGD) has been viewed by many utility managers and executives as only adding to the existing burden of compliance with regulatory requirements. While the incorporation of these documents into existing CGD programs has created additional costs, the resulting enhanced dedication programs have also produced benefits beyond regulatory compliance, and some lessons have been learned. This paper discusses the benefits and the lessons learned during implementation of an enhanced CGD program at New Hampshiremore » Yankee's (NHY's) Seabrook nuclear plant. Based on NHY's experience, it is believed that the benefits described in this paper can be realized by other utilities implementing CGD programs.« less

24 CFR 598.605 - Implementation plan.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 3 2014-04-01 2013-04-01 true Implementation plan. 598.605 Section 598.605 Housing and Urban Development Regulations Relating to Housing and Urban Development (Continued... Grants § 598.605 Implementation plan. (a) Implementation plan content. An EZ must submit an...

77 FR 41279 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Regional Haze State...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... Promulgation of Air Quality Implementation Plans; Pennsylvania; Regional Haze State Implementation Plan AGENCY... the Regional Haze State Implementation Plan (SIP) (hereafter RH SIP) revision submitted by the... anthropogenic impairment of visibility in mandatory Class I areas [[Page 41280

76 FR 12945 - Instructions for Implementing Climate Change Adaptation Planning in Accordance With Executive...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

... COUNCIL ON ENVIRONMENTAL QUALITY Instructions for Implementing Climate Change Adaptation Planning... Availability of Climate Change Adaptation Planning Implementing Instructions. SUMMARY: The Chair of the Council... for Implementing Climate Change Adaptation Planning are now available at: http://www.whitehouse.gov...

77 FR 28478 - Privacy Act; Implementation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-15

... rule is not a significant regulatory action, and therefore, does not require a regulatory impact... Delinquency Investigations) Files. IRS 26.021 Transferee Files. IRS 34.037 IRS Audit Trail and Security...

Action planning as predictor of health protective and health risk behavior: an investigation of fruit and snack consumption

PubMed Central

van Osch, Liesbeth; Beenackers, Mariëlle; Reubsaet, Astrid; Lechner, Lilian; Candel, Math; de Vries, Hein

2009-01-01

Background Large discrepancies between people's intention to eat a healthy diet and actual dietary behavior indicate that motivation is not a sufficient instigator for healthy behavior. Research efforts to decrease this 'intention - behavior gap' have centered on aspects of self-regulation, most importantly self-regulatory planning. Most studies on the impact of self-regulatory planning in health and dietary behavior focus on the promotion of health protective behaviors. This study investigates and compares the predictive value of action planning in health protective behavior and the restriction of health risk behavior. Methods Two longitudinal observational studies were performed simultaneously, one focusing on fruit consumption (N = 572) and one on high-caloric snack consumption (N = 585) in Dutch adults. Structural equation modeling was used to investigate and compare the predictive value of action planning in both behaviors, correcting for demographics and the influence of motivational factors and past behavior. The nature of the influence of action planning was investigated by testing mediating and moderating effects. Results Action planning was a significant predictor of fruit consumption and restricted snack consumption beyond the influence of motivational factors and past behavior. The strength of the predictive value of action planning did not differ between the two behaviors. Evidence for mediation of the intention - behavior relationship was found for both behaviors. Positive moderating effects of action planning were demonstrated for fruit consumption, indicating that individuals who report high levels of action planning are significantly more likely to translate their intentions into actual behavior. Conclusion The results indicate that the planning of specific preparatory actions predicts the performance of healthy dietary behavior and support the application of self-regulatory planning in both health protective and health risk behaviors. Future interventions in dietary modification may turn these findings to advantage by incorporating one common planning protocol to increase the likelihood that good intentions are translated into healthy dietary behavior. PMID:19825172

Identifying and overcoming the constraints that prevent the full implementation of decommissioning and remediation programs in uranium mining sites.

PubMed

Franklin, Mariza Ramalho; Fernandes, Horst Monken

2013-05-01

Environmental remediation of radioactive contamination is about achieving appropriate reduction of exposures to ionizing radiation. This goal can be achieved by means of isolation or removal of the contamination source(s) or by breaking the exposure pathways. Ideally, environmental remediation is part of the planning phase of any industrial operation with the potential to cause environmental contamination. This concept is even more important in mining operations due to the significant impacts produced. This approach has not been considered in several operations developed in the past. Therefore many legacy sites face the challenge to implement appropriate remediation plans. One of the first barriers to remediation works is the lack of financial resources as environmental issues used to be taken in the past as marginal costs and were not included in the overall budget of the company. This paper analyses the situation of the former uranium production site of Poços de Caldas in Brazil. It is demonstrated that in addition to the lack of resources, other barriers such as the lack of information on site characteristics, appropriate regulatory framework, funding mechanisms, stakeholder involvement, policy and strategy, technical experience and mechanism for the appropriation of adequate technical expertise will play key roles in preventing the implementation of remediation programs. All these barriers are discussed and some solutions are suggested. It is expected that lessons learned from the Poços de Caldas legacy site may stimulate advancement of more sustainable options in the development of future uranium production centers. Copyright © 2011 Elsevier Ltd. All rights reserved.

78 FR 38313 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-26

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following joint stakeholder meeting related to the transmission planning...

78 FR 36770 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following stakeholder meeting related to the transmission planning...

78 FR 39728 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-02

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following joint stakeholder meeting related to the transmission planning...

40 CFR 52.672 - Approval of plans.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Idaho § 52.672 Approval of plans. (a) Carbon Monoxide. (1) EPA approves as a revision to the Idaho State Implementation Plan, the Limited Maintenance Plan for.... [Reserved] (e) Particulate Matter. (1) EPA approves as a revision to the Idaho State Implementation Plan...

78 FR 17835 - Approval and Promulgation of Federal Implementation Plan for Oil and Natural Gas Well Production...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-22

...The EPA is taking final action to promulgate a Reservation- specific Federal Implementation Plan in order to regulate emissions from oil and natural gas production facilities located on the Fort Berthold Indian Reservation in North Dakota. The Federal Implementation Plan includes basic air quality regulations for the protection of communities in and adjacent to the Fort Berthold Indian Reservation. The Federal Implementation Plan requires owners and operators of oil and natural gas production facilities to reduce emissions of volatile organic compounds emanating from well completions, recompletions, and production and storage operations. This Federal Implementation Plan will be implemented by the EPA, or a delegated tribal authority, until replaced by a Tribal Implementation Plan. The EPA proposed a Reservation-specific Federal Implementation Plan concurrently with an interim final rule on August 15, 2012. This final Federal Implementation Plan replaces the interim final rule in all intents and purposes on the effective date of the final rule. The EPA is taking this action pursuant to the Clean Air Act (CAA).

24 CFR 598.605 - Implementation plan.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 3 2012-04-01 2012-04-01 false Implementation plan. 598.605 Section 598.605 Housing and Urban Development Regulations Relating to Housing and Urban Development... Empowerment Zone Grants § 598.605 Implementation plan. (a) Implementation plan content. An EZ must submit an...

24 CFR 598.605 - Implementation plan.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 3 2013-04-01 2013-04-01 false Implementation plan. 598.605 Section 598.605 Housing and Urban Development Regulations Relating to Housing and Urban Development... Empowerment Zone Grants § 598.605 Implementation plan. (a) Implementation plan content. An EZ must submit an...

78 FR 68005 - Approval and Promulgation of Implementation Plans; Mississippi; Transportation Conformity SIP...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

... this Federal Register, EPA is approving the State's implementation plan revision as a direct final rule...] Approval and Promulgation of Implementation Plans; Mississippi; Transportation Conformity SIP--Memorandum... proposing to approve a State Implementation Plan revision submitted by the Mississippi Department of...

Effective protection of open space: does planning matter?

PubMed

Steelman, Toddi A; Hess, George R

2009-07-01

High quality plans are considered a crucial part of good land use planning and often used as a proxy measure for success in plan implementation and goal attainment. We explored the relationship of open space plan quality to the implementation of open space plans and attainment of open space protection goals in Research Triangle, North Carolina, USA. To measure plan quality, we used a standard plan evaluation matrix that we modified to focus on open space plans. We evaluated all open space plans in the region that contained a natural resource protection element. To measure plan implementation and open space protection, we developed an online survey and administered it to open space planners charged with implementing the plans. The survey elicited each planner's perspective on aspects of open space protection in his or her organization. The empirical results (1) indicate that success in implementation and attaining goals are not related to plan quality, (2) highlight the importance of when and how stakeholders are involved in planning and implementation processes, and (3) raise questions about the relationship of planning to implementation. These results suggest that a technically excellent plan does not guarantee the long-term relationships among local land owners, political and appointed officials, and other organizations that are crucial to meeting land protection goals. A greater balance of attention to the entire decision process and building relationships might lead to more success in protecting open space.

AFO Manure Management - California: Implementing TMDL Wasteload Allocations

EPA Pesticide Factsheets

Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

10 CFR 20.2105 - Records of planned special exposures.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Records of planned special exposures. 20.2105 Section 20.2105 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20.2105 Records of planned special exposures. (a) For each use of the provisions of § 20.1206 for planned special...

10 CFR 20.2105 - Records of planned special exposures.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Records of planned special exposures. 20.2105 Section 20.2105 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20.2105 Records of planned special exposures. (a) For each use of the provisions of § 20.1206 for planned special...

10 CFR 20.2105 - Records of planned special exposures.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Records of planned special exposures. 20.2105 Section 20.2105 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20.2105 Records of planned special exposures. (a) For each use of the provisions of § 20.1206 for planned special...

10 CFR 20.2105 - Records of planned special exposures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Records of planned special exposures. 20.2105 Section 20.2105 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20.2105 Records of planned special exposures. (a) For each use of the provisions of § 20.1206 for planned special...

10 CFR 20.2105 - Records of planned special exposures.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Records of planned special exposures. 20.2105 Section 20.2105 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20.2105 Records of planned special exposures. (a) For each use of the provisions of § 20.1206 for planned special...

75 FR 14648 - Self-Regulatory Organizations; Notice of Filing of Proposed Rule Change by NYSE Amex LLC Deleting...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-26

... (Business Continuity and Contingency Plans) and adopt new Rule 4370--NYSE Amex Equities (Business Continuity... Continuity and Contingency Plans) as substantively duplicative of NASD Rules 3510 (Business Continuity Plans... Equities (Business Continuity and Contingency Plans) to remove the existing text and incorporate NASD Rules...

Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods.

PubMed

Dozier, Samantha; Brown, Jeffrey; Currie, Alistair

2011-11-29

In recent years, technologically advanced high-throughput techniques have been developed that replace, reduce or refine animal use in vaccine quality control tests. Following validation, these tests are slowly being accepted for use by international regulatory authorities. Because regulatory acceptance itself has not guaranteed that approved humane methods are adopted by manufacturers, various organizations have sought to foster the preferential use of validated non-animal methods by interfacing with industry and regulatory authorities. After noticing this gap between regulation and uptake by industry, we began developing a paradigm that seeks to narrow the gap and quicken implementation of new replacement, refinement or reduction guidance. A systematic analysis of our experience in promoting the transparent implementation of validated non-animal vaccine potency assays has led to the refinement of our paradigmatic process, presented here, by which interested parties can assess the local regulatory acceptance of methods that reduce animal use and integrate them into quality control testing protocols, or ensure the elimination of peripheral barriers to their use, particularly for potency and other tests carried out on production batches.

Proposal for the creation of a national strategy for precision medicine in cancer: a position statement of SEOM, SEAP, and SEFH.

PubMed

Garrido, P; Aldaz, A; Vera, R; Calleja, M A; de Álava, E; Martín, M; Matías-Guiu, X; Palacios, J

2018-04-01

Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. Precision medicine is transforming clinical and biomedical research, as well as health care itself from a conceptual, as well as a methodological viewpoint, providing extraordinary opportunities to improve public health and lower the costs of the healthcare system. However, the implementation of precision medicine poses ethical-legal, regulatory, organizational, and knowledge-related challenges. Without a national strategy, precision medicine, which will be implemented one way or another, could take place without the appropriate planning that can guarantee technical quality, equal access of all citizens to the best practices, violating the rights of patients and professionals, and jeopardizing the solvency of the healthcare system. With this paper from the Spanish Societies of Medical Oncology, Pathology, and Hospital Pharmacy, we highlight the need to institute a consensual national strategy for the development of precision medicine in our country, review the national and international context, comment on the opportunities and challenges for implementing precision medicine, and outline the objectives of a national strategy on precision medicine in cancer.

Guidelines for Bacteriophage Product Certification.

PubMed

Fauconnier, Alan

2018-01-01

Following decades in the wilderness, bacteriophage therapy is now appearing as a credible antimicrobial strategy. However, this reemerging therapy does not rekindle without raising sensitive regulatory concerns. Indeed, whereas the European regulatory framework has been basically implemented to tackle ready-to-use pharmaceuticals produced on a large scale, bacteriophage therapy relies on a dynamic approach requiring a regulation on personalized medicine, nonexistent at present. Because of this, no guideline are currently available for addressing the scientific and regulatory issues specifically related to phage therapy medicinal products (PTMP).Pending to the implementation of an appropriate regulatory framework and to the development of ensuing guidelines, several avenues which might lead to PTMP regulatory compliance are explored here. Insights might come from the multi-strain dossier approach set up for particular animal vaccines, from the homologous group concept developed for the allergen products or from the licensing process for veterinary autogenous vaccines. Depending on national legislations, customized preparations prescribed as magistral formulas or to be used on a named-patient basis are possible regulatory approaches to be considered. However, these schemes are not optimal and should thus be regarded as transitional.

Evaluating the impact of farm scale innovation at catchment scale

NASA Astrophysics Data System (ADS)

van Breda, Phelia; De Clercq, Willem; Vlok, Pieter; Querner, Erik

2014-05-01

Hydrological modelling lends itself to other disciplines very well, normally as a process based system that acts as a catalogue of events taking place. These hydrological models are spatial-temporal in their design and are generally well suited for what-if situations in other disciplines. Scaling should therefore be a function of the purpose of the modelling. Process is always linked with scale or support but the temporal resolution can affect the results if the spatial scale is not suitable. The use of hydrological response units tends to lump area around physical features but disregards farm boundaries. Farm boundaries are often the more crucial uppermost resolution needed to gain more value from hydrological modelling. In the Letaba Catchment of South Africa, we find a generous portion of landuses, different models of ownership, different farming systems ranging from large commercial farms to small subsistence farming. All of these have the same basic right to water but water distribution in the catchment is somewhat of a problem. Since water quantity is also a problem, the water supply systems need to take into account that valuable production areas not be left without water. Clearly hydrological modelling should therefore be sensitive to specific landuse. As a measure of productivity, a system of small farmer production evaluation was designed. This activity presents a dynamic system outside hydrological modelling that is generally not being considered inside hydrological modelling but depends on hydrological modelling. For sustainable development, a number of important concepts needed to be aligned with activities in this region, and the regulatory actions also need to be adhered to. This study aimed at aligning the activities in a region to the vision and objectives of the regulatory authorities. South Africa's system of socio-economic development planning is complex and mostly ineffective. There are many regulatory authorities involved, often with unclear responsibilities and inadequate procedures of implementing objectives. Planning for development in South Africa needs to take various factors into account. Economic and green economic growth is pursued, while social imbalances are addressed and the environment is protected against unreasonable exploitation. The term Sustainable Development is a neutral concept in the vision of many of the regulating authorities; however, the implementation of sustainability is difficult. This study considers an approach which aligns activities in a specified region to the vision and objectives of the applicable regulatory authorities, as an alternative to achieving objectives strictly through enforcing regulations. It was determined whether objectives of development planning were realistic in terms of water availability. It was established that the position of a farm in the landscape is a determining factor of the impact it has on the catchment area's water supply. For this purpose, hydrological modelling (SWAT and SIMGRO) was done for the Letaba catchment of the Limpopo Province, on two scales to also accommodate small-scale farming communities more accurately. Parallel to the modelling, the National Development Plan (NDP), the National Framework for Sustainable Development (NFSD), the Integrated Sustainable Rural Development Strategy (ISRDS) and the principles of Water Allocation Reform (WAR) were regarded. For regional categorisation, the relevant municipal Integrated Development Plan (IDP), Spatial Development Framework (SDF), Local Economic Development (LED) plan and the applicable Catchment Management Strategy (CMS) were considered. The developed Integrated Evaluation Model combined all the visions and objectives of the mentioned strategic documents to specifically assess the contribution a small-scale farm makes. The evaluation results provided insight into the alignment of activities to the ideals of a region and can be useful when formulating actions to reach a common vision. Small-scale farms are well-aligned to the objectives of WAR, the CMS and ISRDS. The farms have a limited contribution to the ideals of the NDP and NFSD and results against the IDP, the SDF and the LED differ considerably for each farm. Furthermore, the results of the farms' alignment with regional objectives do not correspond to the hydrologically ideal locations. Therefore, the development of small-scale farming should take hydrological information into consideration. The Integrated Evaluation Model proves to be valuable, understandable and applicable to evaluate the alignment of small-scale farms to the visions of regulatory authorities. It is also foreseen that the Evaluation model be linked to the hydrological model. The work was also kindly supported and executed in the framework of the EU project EAU4Food.

78 FR 41731 - Source Specific Federal Implementation Plan for Implementing Best Available Retrofit Technology...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-11

... Federal Implementation Plan for Implementing Best Available Retrofit Technology for Four Corners Power... Implementation Plan (FIP) to implement the Best Available Retrofit Technology (BART) requirement of the Regional... given the uncertainties in the electrical market in Arizona, EPA is proposing to extend the date by...

Australian Food Safety Policy Changes from a "Command and Control" to an "Outcomes-Based" Approach: Reflection on the Effectiveness of Its Implementation.

PubMed

Smith, James; Ross, Kirstin; Whiley, Harriet

2016-12-08

Foodborne illness is a global public health burden. Over the past decade in Australia, despite advances in microbiological detection and control methods, there has been an increase in the incidence of foodborne illness. Therefore improvements in the regulation and implementation of food safety policy are crucial for protecting public health. In 2000, Australia established a national food safety regulatory system, which included the adoption of a mandatory set of food safety standards. These were in line with international standards and moved away from a "command and control" regulatory approach to an "outcomes-based" approach using risk assessment. The aim was to achieve national consistency and reduce foodborne illness without unnecessarily burdening businesses. Evidence demonstrates that a risk based approach provides better protection for consumers; however, sixteen years after the adoption of the new approach, the rates of food borne illness are still increasing. Currently, food businesses are responsible for producing safe food and regulatory bodies are responsible for ensuring legislative controls are met. Therefore there is co-regulatory responsibility and liability and implementation strategies need to reflect this. This analysis explores the challenges facing food regulation in Australia and explores the rationale and evidence in support of this new regulatory approach.

Australian Food Safety Policy Changes from a “Command and Control” to an “Outcomes-Based” Approach: Reflection on the Effectiveness of Its Implementation

PubMed Central

Smith, James; Ross, Kirstin; Whiley, Harriet

2016-01-01

Foodborne illness is a global public health burden. Over the past decade in Australia, despite advances in microbiological detection and control methods, there has been an increase in the incidence of foodborne illness. Therefore improvements in the regulation and implementation of food safety policy are crucial for protecting public health. In 2000, Australia established a national food safety regulatory system, which included the adoption of a mandatory set of food safety standards. These were in line with international standards and moved away from a “command and control” regulatory approach to an “outcomes-based” approach using risk assessment. The aim was to achieve national consistency and reduce foodborne illness without unnecessarily burdening businesses. Evidence demonstrates that a risk based approach provides better protection for consumers; however, sixteen years after the adoption of the new approach, the rates of food borne illness are still increasing. Currently, food businesses are responsible for producing safe food and regulatory bodies are responsible for ensuring legislative controls are met. Therefore there is co-regulatory responsibility and liability and implementation strategies need to reflect this. This analysis explores the challenges facing food regulation in Australia and explores the rationale and evidence in support of this new regulatory approach. PMID:27941657

State trends in ecological risk assessment and standard setting

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

Siegel, M R; Fowler, K M; Bilyard, G R

1993-02-01

The purposes of this paper are (1) to identify key states' activities and plans related to setting cleanup standards using the ecological risk assessment process, and (2) to discuss the impacts these actions may have on the US Department of Energy's (DOE's) environmental restoration program. This report is prepared as part of a larger task, the purpose of which is to identify and assess state regulatory trends and legal developments that may impact DOE's environmental restoration program. Results of this task are intended to provide DOE with advance notice of potentially significant regulatory developments so as to enhance DOE's abilitymore » to influence these developments and to incorporate possible regulatory and policy changes into its planning process.« less

78 FR 40654 - Approval, Disapproval and Promulgation of Implementation Plans; State of Wyoming; Regional Haze...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-08

..., Disapproval and Promulgation of Implementation Plans; State of Wyoming; Regional Haze State Implementation Plan; Federal Implementation Plan for Regional Haze; Notice of Public Hearings AGENCY: Environmental...) addressing regional haze under. We are making this change in response to letters submitted by the Governor of...

78 FR 78310 - Approval and Promulgation of Implementation Plans; North Carolina; Transportation Conformity...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-26

... Federal Register, EPA is approving the State's implementation plan revision as a direct final rule without...] Approval and Promulgation of Implementation Plans; North Carolina; Transportation Conformity Memorandum of... Implementation Plan submitted on July 12, 2013, through the North Carolina Department of Environment and Natural...

77 FR 58072 - Finding of Substantial Inadequacy of Implementation Plan; Call for California State...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-19

... Substantial Inadequacy of Implementation Plan; Call for California State Implementation Plan Revision; South Coast AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: In response to a... that the California State Implementation Plan (SIP) for the Los Angeles-South Coast Air Basin (South...

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...

Status and trends monitoring of the mainstem Columbia River: sample frame development and review of programs relevant to the development of an integrated approach to monitoring

USGS Publications Warehouse

Counihan, Timothy D.; Hardiman, Jill M.; Waste, Stephen

2013-01-01

Implementing an Integrated Status and Trends Monitoring program (ISTM) for the mainstem Columbia River will help identify trends in important natural resources and help us understand the long-term collective effects of management actions. In this report, we present progress towards the completion of a stepwise process that will facilitate the development of an ISTM for the mainstem Columbia River. We discuss planning and regulatory documents that can be used to identify monitoring goals and objectives and present existing monitoring and research activities that should be considered as the development of a Columbia River ISTM proceeds. We also report progress towards the development of sample frames for the Columbia and Snake Rivers and their floodplains. The sample frames were formulated using Digital Elevation Models (DEM’s) of the river channel and upland areas and a Generalized Random-Tessellation Stratified (GRTS) algorithm for an area based resource to generate “master sample(s).” Working with the Pacific Northwest Aquatic Monitoring Partnership (PNAMP) we facilitated the transfer of the sample frames to the PNAMP “Monitoring Sample Designer” tool. We then discuss aspects of response and survey designs as they pertain to the formulation of a mainstem Columbia River ISTM. As efforts to formulate an ISTM for the mainstem Columbia River proceed, practitioners should utilize the extensive literature describing the planning and implementation of fish and wildlife mitigation and recovery efforts in the Columbia River Basin. While we make progress towards establishing an ISTM framework, considerable work needs to be done to formulate an ISTM program for the mainstem Columbia River. Long-term monitoring programs have been established for other large rivers systems; scientists that have experience planning, implementing, and maintaining large river monitoring efforts such as those in the Colorado, Illinois, and Mississippi Rivers should be consulted and involved as efforts proceed.

77 FR 72296 - Public Meeting of the U.S.-Canada Regulatory Cooperation Council (RCC) Motor Vehicles Working Group

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-05

... February 4, 2011. After private sector consultations and bilateral negotiations, the RCC released the Joint... bilateral negotiations, the RCC released the Joint Action Plan on Regulatory Cooperation on December 7, 2011...

20 CFR 669.560 - Are there regulatory and/or statutory waiver provisions that apply to WIA section 167?

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADMINISTRATION, DEPARTMENT OF LABOR NATIONAL FARMWORKER JOBS PROGRAM UNDER TITLE I OF THE WORKFORCE INVESTMENT ACT Performance Accountability, Planning and Waiver Provision § 669.560 Are there regulatory and/or...

77 FR 36532 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-19

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the New York...

77 FR 75630 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meeting related to the transmission planning activities of ISO New England...

77 FR 73645 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-11

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the Midwest...

77 FR 50492 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-21

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the Midwest...

77 FR 75630 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the interregional transmission planning activities of the...

77 FR 11531 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-27

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meeting related to the transmission planning activities of the...

77 FR 24486 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-24

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the New York...

77 FR 38045 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meeting related to the transmission planning activities of ISO New England...

77 FR 38045 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the Midwest...

77 FR 24485 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-24

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the Midwest...

77 FR 40606 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-10

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the Midwest...

77 FR 30003 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the PJM...

77 FR 34034 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-08

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the Southwest...

78 FR 14783 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-07

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of ISO...

77 FR 37665 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-22

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meeting related to the transmission planning activities of the North Carolina...

77 FR 38046 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meeting related to the transmission planning activities of the Southern...

77 FR 34378 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-11

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the New York...

77 FR 30003 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meeting related to the transmission planning activities of the...

77 FR 73645 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-11

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meeting related to the transmission planning activities of the...

77 FR 3765 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-25

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the...

77 FR 65680 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-30

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the interregional transmission planning activities of the...

76 FR 60820 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meeting related to the transmission planning activities of the Midwest...

77 FR 42718 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the Southwest...

77 FR 42717 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meeting related to the transmission planning activities of the...

77 FR 60980 - Notice of Commission Staff Attendance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-05

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the Mid-Continent...

30 CFR 784.20 - Subsidence control plan.

Code of Federal Regulations, 2010 CFR

2010-07-01

... COAL MINING AND RECLAMATION OPERATIONS PERMITS AND COAL EXPLORATION SYSTEMS UNDER REGULATORY PROGRAMS UNDERGROUND MINING PERMIT APPLICATIONS-MINIMUM REQUIREMENTS FOR RECLAMATION AND OPERATION PLAN § 784.20... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Subsidence control plan. 784.20 Section 784.20...

U.S. Nuclear Regulatory Commission natural analogue research program

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

Kovach, L.A.; Ott, W.R.

1995-09-01

This article describes the natural analogue research program of the U.S. Nuclear Regulatory Commission (US NRC). It contains information on the regulatory context and organizational structure of the high-level radioactive waste research program plan. It also includes information on the conditions and processes constraining selection of natural analogues, describes initiatives of the US NRC, and describes the role of analogues in the licensing process.

Implementing the Synchronized Global Switch from Trivalent to Bivalent Oral Polio Vaccines-Lessons Learned From the Global Perspective.

PubMed

Ramirez Gonzalez, Alejandro; Farrell, Margaret; Menning, Lisa; Garon, Julie; Everts, Hans; Hampton, Lee M; Dolan, Samantha B; Shendale, Stephanie; Wanyoike, Sarah; Veira, Chantal Laroche; Châtellier, Gaël Maufras du; Kurji, Feyrouz; Rubin, Jennifer; Boualam, Liliane; Chang Blanc, Diana; Patel, Manish

2017-07-01

In 2015, the Global Commission for the Certification of Polio Eradication certified the eradication of type 2 wild poliovirus, 1 of 3 wild poliovirus serotypes causing paralytic polio since the beginning of recorded history. This milestone was one of the key criteria prompting the Global Polio Eradication Initiative to begin withdrawal of oral polio vaccines (OPV), beginning with the type 2 component (OPV2), through a globally synchronized initiative in April and May 2016 that called for all OPV using countries and territories to simultaneously switch from use of trivalent OPV (tOPV; containing types 1, 2, and 3 poliovirus) to bivalent OPV (bOPV; containing types 1 and 3 poliovirus), thus withdrawing OPV2. Before the switch, immunization programs globally had been using approximately 2 billion tOPV doses per year to immunize hundreds of millions of children. Thus, the globally synchronized withdrawal of tOPV was an unprecedented achievement in immunization and was part of a crucial strategy for containment of polioviruses. Successful implementation of the switch called for intense global coordination during 2015-2016 on an unprecedented scale among global public health technical agencies and donors, vaccine manufacturers, regulatory agencies, World Health Organization (WHO) and United Nations Children's Fund (UNICEF) regional offices, and national governments. Priority activities included cessation of tOPV production and shipment, national inventories of tOPV, detailed forecasting of tOPV needs, bOPV licensing, scaling up of bOPV production and procurement, developing national operational switch plans, securing funding, establishing oversight and implementation committees and teams, training logisticians and health workers, fostering advocacy and communications, establishing monitoring and validation structures, and implementing waste management strategies. The WHO received confirmation that, by mid May 2016, all 155 countries and territories that had used OPV in 2015 had successfully withdrawn OPV2 by ceasing use of tOPV in their national immunization programs. This article provides an overview of the global efforts and challenges in successfully implementing this unprecedented global initiative, including (1) coordination and tracking of key global planning milestones, (2) guidance facilitating development of country specific plans, (3) challenges for planning and implementing the switch at the global level, and (4) best practices and lessons learned in meeting aggressive switch timelines. Lessons from this monumental public health achievement by countries and partners will likely be drawn upon when bOPV is withdrawn after polio eradication but also could be relevant for other global health initiatives with similarly complex mandates and accelerated timelines. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

Regulatory and Quality Considerations for Continuous Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

40 CFR 52.1392 - Federal Implementation Plan for the Billings/Laurel Area.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 4 2013-07-01 2013-07-01 false Federal Implementation Plan for the Billings/Laurel Area. 52.1392 Section 52.1392 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Montana § 52.1392 Federal Implementation Plan for...

40 CFR 52.1392 - Federal Implementation Plan for the Billings/Laurel Area.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 4 2012-07-01 2012-07-01 false Federal Implementation Plan for the Billings/Laurel Area. 52.1392 Section 52.1392 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Montana § 52.1392 Federal Implementation Plan for...