Paradise, Jordan; Wolf, Susan M; Kuzma, Jennifer; Kuzhabekova, Aliya; Tisdale, Alison W; Kokkoli, Efrosini; Ramachandran, Gurumurthy
2009-01-01
The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Department of Agriculture (USDA), Occupational Safety and Health Administration (OSHA), and National Institutes of Health (NIH). All can learn from assessment of the successes and failures of past oversight efforts aimed at emerging technologies. This article reports on work funded by the National Science Foundation (NSF) aimed at learning the lessons of past oversight efforts. The article offers insights that emerge from comparing five oversight case studies that examine oversight of genetically engineered organisms (GEOs) in the food supply, pharmaceuticals, medical devices, chemicals in the workplace, and gene therapy. Using quantitative and qualitative analysis, the authors present a new way of evaluating oversight.
13 CFR 120.1005 - Bureau of PCLP Oversight.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Bureau of PCLP Oversight. 120.1005 Section 120.1005 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Risk-Based Lender Oversight Supervision § 120.1005 Bureau of PCLP Oversight. SBA's Bureau of PCLP Oversight within...
Gene therapy oversight: lessons for nanobiotechnology.
Wolf, Susan M; Gupta, Rishi; Kohlhepp, Peter
2009-01-01
Oversight of human gene transfer research ("gene therapy") presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution (by the Institutional Review Board and, for some research, the Institutional Biosafety Committee) and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology.
12 CFR 1273.4 - FHFA oversight.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 12 Banks and Banking 9 2013-01-01 2013-01-01 false FHFA oversight. 1273.4 Section 1273.4 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS OFFICE OF FINANCE § 1273.4 FHFA oversight. (a) Oversight and enforcement actions. FHFA shall have such oversight authority over the OF, the OF...
12 CFR 1273.4 - FHFA oversight.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 12 Banks and Banking 9 2012-01-01 2012-01-01 false FHFA oversight. 1273.4 Section 1273.4 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS OFFICE OF FINANCE § 1273.4 FHFA oversight. (a) Oversight and enforcement actions. FHFA shall have such oversight authority over the OF, the OF...
12 CFR 985.4 - Finance Board oversight.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Finance Board oversight. 985.4 Section 985.4 Banks and Banking FEDERAL HOUSING FINANCE BOARD OFFICE OF FINANCE THE OFFICE OF FINANCE § 985.4 Finance Board oversight. (a) Oversight and enforcement actions. The Finance Board shall have the same regulatory oversight authority and enforcement powers...
Memorandum providing additional information in support of Superfund's administrative reform on PRP oversight. Superfund program managers should consider RCRA's Results-Based Guidance when developing oversight plans with PRPs.
20 CFR 637.305 - Federal monitoring and oversight.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 20 Employees' Benefits 3 2012-04-01 2012-04-01 false Federal monitoring and oversight. 637.305... Procedures § 637.305 Federal monitoring and oversight. The Secretary shall conduct oversight of the programs and activities conducted in accordance with this part. ...
20 CFR 637.305 - Federal monitoring and oversight.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Federal monitoring and oversight. 637.305... Procedures § 637.305 Federal monitoring and oversight. The Secretary shall conduct oversight of the programs and activities conducted in accordance with this part. ...
20 CFR 637.305 - Federal monitoring and oversight.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false Federal monitoring and oversight. 637.305... Procedures § 637.305 Federal monitoring and oversight. The Secretary shall conduct oversight of the programs and activities conducted in accordance with this part. ...
32 CFR 2700.51 - Information Security Oversight Committee.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 32 National Defense 6 2011-07-01 2011-07-01 false Information Security Oversight Committee. 2700... MICRONESIAN STATUS NEGOTIATIONS SECURITY INFORMATION REGULATIONS Implementation and Review § 2700.51 Information Security Oversight Committee. The OMSN Information Security Oversight Committee shall be chaired...
77 FR 12623 - National Industrial Security Program Policy Advisory Committee (NISPPAC)
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-01
... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National... Information Security Oversight Office no later than Friday, March 16, 2012. The Information Security Oversight... FURTHER INFORMATION CONTACT: David O. Best, Senior Program Analyst, The Information Security Oversight...
32 CFR 2700.51 - Information Security Oversight Committee.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 32 National Defense 6 2010-07-01 2010-07-01 false Information Security Oversight Committee. 2700... MICRONESIAN STATUS NEGOTIATIONS SECURITY INFORMATION REGULATIONS Implementation and Review § 2700.51 Information Security Oversight Committee. The OMSN Information Security Oversight Committee shall be chaired...
49 CFR 633.19 - Financing the PMO program.
Code of Federal Regulations, 2010 CFR
2010-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.19... or entity to provide a project management oversight service in connection with a major capital... project management oversight services under this part will provide for the payment by FTA of 100 percent...
32 CFR 2103.51 - Information Security Oversight Committee.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 32 National Defense 6 2011-07-01 2011-07-01 false Information Security Oversight Committee. 2103... BE DECLASSIFIED Implementation and Review § 2103.51 Information Security Oversight Committee. The NCS Information Security Oversight Committee shall be chaired by the Staff Counsel of the National Security...
44 CFR 209.12 - Oversight and results.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Oversight and results. 209.12... Oversight and results. (a) FEMA oversight. Our Regional Administrators are responsible for overseeing this... they deem appropriate. (c) Program results. The State will review the effectiveness of approved...
44 CFR 209.12 - Oversight and results.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false Oversight and results. 209.12... Oversight and results. (a) FEMA oversight. Our Regional Administrators are responsible for overseeing this... they deem appropriate. (c) Program results. The State will review the effectiveness of approved...
44 CFR 209.12 - Oversight and results.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true Oversight and results. 209.12... Oversight and results. (a) FEMA oversight. Our Regional Administrators are responsible for overseeing this... they deem appropriate. (c) Program results. The State will review the effectiveness of approved...
44 CFR 209.12 - Oversight and results.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false Oversight and results. 209.12... Oversight and results. (a) FEMA oversight. Our Regional Administrators are responsible for overseeing this... they deem appropriate. (c) Program results. The State will review the effectiveness of approved...
44 CFR 209.12 - Oversight and results.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false Oversight and results. 209.12... Oversight and results. (a) FEMA oversight. Our Regional Administrators are responsible for overseeing this... they deem appropriate. (c) Program results. The State will review the effectiveness of approved...
32 CFR 2103.51 - Information Security Oversight Committee.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 32 National Defense 6 2010-07-01 2010-07-01 false Information Security Oversight Committee. 2103... BE DECLASSIFIED Implementation and Review § 2103.51 Information Security Oversight Committee. The NCS Information Security Oversight Committee shall be chaired by the Staff Counsel of the National Security...
76 FR 71081 - Public Aircraft Oversight Safety Forum
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-16
... NATIONAL TRANSPORTATION SAFETY BOARD Public Aircraft Oversight Safety Forum The National Transportation Safety Board (NTSB) will convene a Public Aircraft Oversight Safety Forum which will begin at 9 a... ``Public Aircraft Oversight Forum: Ensuring Safety for Critical Missions'', are to (1) raise awareness of...
49 CFR 633.19 - Financing the PMO program.
Code of Federal Regulations, 2014 CFR
2014-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.19... or entity to provide a project management oversight service in connection with a major capital... project management oversight services under this part will provide for the payment by FTA of 100 percent...
49 CFR 633.19 - Financing the PMO program.
Code of Federal Regulations, 2013 CFR
2013-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.19... or entity to provide a project management oversight service in connection with a major capital... project management oversight services under this part will provide for the payment by FTA of 100 percent...
49 CFR 633.19 - Financing the PMO program.
Code of Federal Regulations, 2011 CFR
2011-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.19... or entity to provide a project management oversight service in connection with a major capital... project management oversight services under this part will provide for the payment by FTA of 100 percent...
49 CFR 633.19 - Financing the PMO program.
Code of Federal Regulations, 2012 CFR
2012-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.19... or entity to provide a project management oversight service in connection with a major capital... project management oversight services under this part will provide for the payment by FTA of 100 percent...
7 CFR 3565.15 - Oversight and monitoring.
Code of Federal Regulations, 2011 CFR
2011-01-01
... any other oversight or monitoring activities. If the Agency implements a requirement for an electronic... 7 Agriculture 15 2011-01-01 2011-01-01 false Oversight and monitoring. 3565.15 Section 3565.15... AGRICULTURE GUARANTEED RURAL RENTAL HOUSING PROGRAM General Provisions § 3565.15 Oversight and monitoring. The...
7 CFR 3565.15 - Oversight and monitoring.
Code of Federal Regulations, 2014 CFR
2014-01-01
... any other oversight or monitoring activities. If the Agency implements a requirement for an electronic... 7 Agriculture 15 2014-01-01 2014-01-01 false Oversight and monitoring. 3565.15 Section 3565.15... AGRICULTURE GUARANTEED RURAL RENTAL HOUSING PROGRAM General Provisions § 3565.15 Oversight and monitoring. The...
7 CFR 3565.15 - Oversight and monitoring.
Code of Federal Regulations, 2012 CFR
2012-01-01
... any other oversight or monitoring activities. If the Agency implements a requirement for an electronic... 7 Agriculture 15 2012-01-01 2012-01-01 false Oversight and monitoring. 3565.15 Section 3565.15... AGRICULTURE GUARANTEED RURAL RENTAL HOUSING PROGRAM General Provisions § 3565.15 Oversight and monitoring. The...
7 CFR 3565.15 - Oversight and monitoring.
Code of Federal Regulations, 2013 CFR
2013-01-01
... any other oversight or monitoring activities. If the Agency implements a requirement for an electronic... 7 Agriculture 15 2013-01-01 2013-01-01 false Oversight and monitoring. 3565.15 Section 3565.15... AGRICULTURE GUARANTEED RURAL RENTAL HOUSING PROGRAM General Provisions § 3565.15 Oversight and monitoring. The...
7 CFR 3565.15 - Oversight and monitoring.
Code of Federal Regulations, 2010 CFR
2010-01-01
... any other oversight or monitoring activities. If the Agency implements a requirement for an electronic... 7 Agriculture 15 2010-01-01 2010-01-01 false Oversight and monitoring. 3565.15 Section 3565.15... AGRICULTURE GUARANTEED RURAL RENTAL HOUSING PROGRAM General Provisions § 3565.15 Oversight and monitoring. The...
The Politics of Legislative Evaluations: Benefits to "Fire-Alarm" Oversight.
ERIC Educational Resources Information Center
Wohlstetter, Priscilla
Evaluation practices used by state legislatures to monitor educational reform are analyzed in this paper, which focuses on the link between politics and choice of oversight strategies and evaluation methods. Two oversight strategies are compared--"police-patrol" and "fire-alarm.""Fire-alarm" oversight involves…
76 FR 54258 - Request for Comments-Fiscal Oversight Task Force Report and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-31
... LEGAL SERVICES CORPORATION Request for Comments--Fiscal Oversight Task Force Report and... Fiscal Oversight Task Force, which reviewed and made recommendations regarding how LSC conducts fiscal... territories. By Resolution adopted on July 21, 2010, the Board established the Fiscal Oversight Task Force...
13 CFR 120.1000 - Risk-Based Lender Oversight.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Risk-Based Lender Oversight. 120.1000 Section 120.1000 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Risk-Based Lender Oversight Supervision § 120.1000 Risk-Based Lender Oversight. (a) Risk-Based Lender...
Kuzma, Jennifer; Najmaie, Pouya; Larson, Joel
2009-01-01
The U.S. oversight system for genetically engineered organisms (GEOs) was evaluated to develop hypotheses and derive lessons for oversight of other emerging technologies, such as nanotechnology. Evaluation was based upon quantitative expert elicitation, semi-standardized interviews, and historical literature analysis. Through an interdisciplinary policy analysis approach, blending legal, ethical, risk analysis, and policy sciences viewpoints, criteria were used to identify strengths and weaknesses of GEOs oversight and explore correlations among its attributes and outcomes. From the three sources of data, hypotheses and broader conclusions for oversight were developed. Our analysis suggests several lessons for oversight of emerging technologies: the importance of reducing complexity and uncertainty in oversight for minimizing financial burdens on small product developers; consolidating multi-agency jurisdictions to avoid gaps and redundancies in safety reviews; consumer benefits for advancing acceptance of GEO products; rigorous and independent pre- and post-market assessment for environmental safety; early public input and transparency for ensuring public confidence; and the positive role of public input in system development, informed consent, capacity, compliance, incentives, and data requirements and stringency in promoting health and environmental safety outcomes, as well as the equitable distribution of health impacts. Our integrated approach is instructive for more comprehensive analyses of oversight systems, developing hypotheses for how features of oversight systems affect outcomes, and formulating policy options for oversight of future technological products, especially nanotechnology products.
20 CFR 631.31 - Monitoring and oversight.
Code of Federal Regulations, 2010 CFR
2010-04-01
... TITLE III OF THE JOB TRAINING PARTNERSHIP ACT State Administration § 631.31 Monitoring and oversight. The Governor is responsible for monitoring and oversight of all State and substate grantee activities... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Monitoring and oversight. 631.31 Section 631...
20 CFR 631.31 - Monitoring and oversight.
Code of Federal Regulations, 2011 CFR
2011-04-01
... TITLE III OF THE JOB TRAINING PARTNERSHIP ACT State Administration § 631.31 Monitoring and oversight. The Governor is responsible for monitoring and oversight of all State and substate grantee activities... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false Monitoring and oversight. 631.31 Section 631...
20 CFR 631.31 - Monitoring and oversight.
Code of Federal Regulations, 2012 CFR
2012-04-01
... TITLE III OF THE JOB TRAINING PARTNERSHIP ACT State Administration § 631.31 Monitoring and oversight. The Governor is responsible for monitoring and oversight of all State and substate grantee activities... 20 Employees' Benefits 3 2012-04-01 2012-04-01 false Monitoring and oversight. 631.31 Section 631...
Department of Defense Senior Intelligence Oversight Official
Skip to main content (Press Enter). Toggle navigation Department of Defense Senior Intelligence Intelligence Oversight Official Department of Defense Senior Intelligence Oversight Official Home About DOD Defense Senior Intelligence Oversight Official Website Michael T. Mahar, DoD SIOO Click here for DoD SIOO
13 CFR 120.1070 - Lender oversight fees.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Lender oversight fees. 120.1070 Section 120.1070 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Risk-Based Lender Oversight Supervision § 120.1070 Lender oversight fees. Lenders are required to pay to SBA fees to...
The Politics of Legislative Evaluations: Fire-Alarm and Police Patrol as Oversight Procedures.
ERIC Educational Resources Information Center
Wohlstetter, Priscilla
1990-01-01
Means by which state legislatures practice evaluation are examined by analyzing oversight strategies for monitoring recent educational reforms in Arizona, California, Florida, Georgia, Minnesota, and Pennsylvania. Focus is on the inextricable link between politics and oversight; the oversight strategy and methods for policy evaluation are largely…
14 CFR 1203b.108 - Management oversight.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Management oversight. 1203b.108 Section... AUTHORITY AND USE OF FORCE BY NASA SECURITY FORCE PERSONNEL § 1203b.108 Management oversight. (a) The Administrator shall establish a committee to exercise management oversight over the implementation of arrest...
20 CFR 667.410 - What are the oversight roles and responsibilities of recipients and subrecipients?
Code of Federal Regulations, 2010 CFR
2010-04-01
... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false What are the oversight roles and... INVESTMENT ACT Oversight and Monitoring § 667.410 What are the oversight roles and responsibilities of recipients and subrecipients? (a) Roles and responsibilities for all recipients and subrecipients of funds...
NASA Astrophysics Data System (ADS)
Ramachandran, Gurumurthy; Wolf, Susan M.; Paradise, Jordan; Kuzma, Jennifer; Hall, Ralph; Kokkoli, Efrosini; Fatehi, Leili
2011-04-01
Federal oversight of nanobiotechnology in the U.S. has been fragmented and incremental. The prevailing approach has been to use existing laws and other administrative mechanisms for oversight. However, this "stay-the-course" approach will be inadequate for such a complex and convergent technology and may indeed undermine its promise. The technology demands a new, more dynamic approach to oversight. The authors are proposing a new oversight framework with three essential features: (a) the oversight trajectory needs to be able to move dynamically between "soft" and "hard" approaches as information and nano-products evolve; (b) it needs to integrate inputs from all stakeholders, with strong public engagement in decision-making to assure adequate analysis and transparency; and (c) it should include an overarching coordinating entity to assure strong inter-agency coordination and communication that can meet the challenge posed by the convergent nature of nanobiotechnology. The proposed framework arises from a detailed case analysis of several key oversight regimes relevant to nanobiotechnology and is informed by inputs from experts in academia, industry, NGOs, and government.
Wolf, Susan M.; Jones, Cortney
2012-01-01
The basic procedures and rules for oversight of U.S. human subjects research have been in place since 1981. Certain types of human subjects research, however, have provoked creation of additional mechanisms and rules beyond the Department of Health & Human Services (DHHS) Common Rule and Food and Drug Administration (FDA) equivalent. Now another emerging domain of human subjects research—nanomedicine—is prompting calls for extra oversight. However, in 30 years of overseeing research on human beings, we have yet to specify what makes a domain of scientific research warrant extra oversight. This failure to systematically evaluate the need for extra measures, the type of extra measures appropriate for different challenges, and the usefulness of those measures hampers efforts to respond appropriately to emerging science such as nanomedicine. This article evaluates the history of extra oversight, extracting lessons for oversight of nanomedicine research in human beings. We argue that a confluence of factors supports the need for extra oversight, including heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant. We suggest the essential elements of the extra oversight needed. PMID:23226969
NASA Astrophysics Data System (ADS)
Wolf, Susan M.; Jones, Cortney M.
2011-04-01
The basic procedures and rules for oversight of U.S. human subjects research have been in place since 1981. Certain types of human subjects research, however, have provoked creation of additional mechanisms and rules beyond the Department of Health & Human Services (DHHS) Common Rule and Food and Drug Administration (FDA) equivalent. Now another emerging domain of human subjects research—nanomedicine—is prompting calls for extra oversight. However, in 30 years of overseeing research on human beings, we have yet to specify what makes a domain of scientific research warrant extra oversight. This failure to systematically evaluate the need for extra measures, the type of extra measures appropriate for different challenges, and the usefulness of those measures hampers efforts to respond appropriately to emerging science such as nanomedicine. This article evaluates the history of extra oversight, extracting lessons for oversight of nanomedicine research in human beings. We argue that a confluence of factors supports the need for extra oversight, including heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant. We suggest the essential elements of the extra oversight needed.
NASA Astrophysics Data System (ADS)
Sheehan, Bryan G.
The purpose of this qualitative phenomenological study was to examine the phenomenon of enhanced, risk-based Federal Aviation Administration (FAA) oversight of Part 145 repair stations that performed aircraft maintenance for Part 121 air carriers between 2007 and 2014 in Oklahoma. Specifically, this research was utilized to explore what operational changes have occurred in the domestic Part 145 repair station industry such as variations in management or hiring practices, training, recordkeeping and technical data, inventory and aircraft parts supply-chain logistics, equipment, and facilities. After interviewing 12 managers from Part 145 repair stations in Oklahoma, six major theme codes emerged from the data: quality of oversight before 2007, quality of oversight after 2007, advantages of oversight, disadvantages of oversight, status quo of oversight, and process improvement . Of those six major theme codes, 17 subthemes appeared from the data that were used to explain the phenomenon of enhanced oversight in the Part 145 repair station industry. Forty-two percent of the participants indicated a weak FAA oversight system that has hindered the continuous process improvement program in their repair stations. Some of them were financially burdened after hiring additional full-time quality assurance inspectors to specifically manage enhanced FAA oversight. Notwithstanding, the participants of the study indicated that the FAA must apply its surveillance on a more standardized and consistent basis. They want to see this standardization in how FAA inspectors interpret regulations and practice the same quality of oversight for all repair stations, particularly those that are repeat violators and fail to comply with federal aviation regulations. They believed that when the FAA enforces standardization on a consistent basis, repair stations can become more efficient and safer in the performance of their scope of work for the U.S. commercial air transportation industry.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 12 Banks and Banking 5 2012-01-01 2012-01-01 false What are the FDIC's oversight and monitoring....5 What are the FDIC's oversight and monitoring responsibilities in administering this program? (a... outreach oversight, which includes, but is not limited to, the monitoring, review and interpretation of...
Code of Federal Regulations, 2011 CFR
2011-01-01
... 12 Banks and Banking 4 2011-01-01 2011-01-01 false What are the FDIC's oversight and monitoring....5 What are the FDIC's oversight and monitoring responsibilities in administering this program? (a... outreach oversight, which includes, but is not limited to, the monitoring, review and interpretation of...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-26
..., including oversight of spot markets and derivative markets. The members of the interagency group are the... transparent carbon market, including oversight of spot markets and derivative markets.'' In carrying out this... in a carbon market that would have an effect on market oversight provisions--e.g., the basic...
Code of Federal Regulations, 2010 CFR
2010-04-01
... Accounting Oversight Board of disapproval of registration or of disciplinary action. (a) Definitions—(1) Board means the Public Company Accounting Oversight Board. (2) Public accounting firm shall have the... Accounting Oversight Board of disapproval of registration or of disciplinary action. 240.19d-4 Section 240...
Review of the OSHA framework for oversight of occupational environments.
Choi, Jae-Young; Ramachandran, Gurumurthy
2009-01-01
The OSHA system for oversight of chemicals in the workplace was evaluated to derive lessons for oversight of nanotechnology. Criteria relating to the development, attributes, evolution, and outcomes of the system were used for evaluation that was based upon quantitative expert elicitation and historical literature analysis. The oversight system had inadequate resources in terms of finances, expertise, and personnel, and insufficient incentive for compliance. The system showed a lack of flexibility in novel situations. There were minimal requirements on companies for data on health and safety of their products. These factors have a strong influence on public confidence and health and safety. The oversight system also scored low on attributes such as public input, transparency, empirical basis, conflict of interest, and informed consent. The experts in our sample tend to believe that the current oversight system for chemicals in the workplace is neither adequate nor effective. It is very likely that the performance of the OSHA oversight system for nanomaterials will be equally inadequate.
Code of Federal Regulations, 2010 CFR
2010-10-01
... TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.13... oversight agency must oversee the execution of these practices and procedures, to ensure compliance with the...
Oversight of fare collection practices : summary report
DOT National Transportation Integrated Search
1997-11-01
This report document an oversight study of fare collection practices in the transit industry. The oversight was designed as an investigation of practices currently used in the transit industry to evaluate the impact of farebox revenue collection and ...
Code of Federal Regulations, 2010 CFR
2010-01-01
... PLACEMENT (GENERAL) Interagency Career Transition Assistance Plan for Displaced Employees § 330.711 Oversight. OPM is responsible for oversight of the Interagency Career Transition Assistance Plan for Displaced Employees and may conduct reviews of agency activity at any time. ...
State Safety Oversight Program : annual report for 2003
DOT National Transportation Integrated Search
2004-10-01
The Federal Transit Administration (FTA) State Safety Oversight Rule (49 CFR Part 659) requires oversight of all rail transit agencies in revenue operation after January 1, 1997. This report summarizes activities performed to implement the State Safe...
State safety oversight program : annual report for 1999
DOT National Transportation Integrated Search
2000-09-01
The Federal Transit Administration (FTA) State Safety Oversight Rule (49 CFR Part 659) requires oversight for all rail transit agencies in revenue operation after January 1, 1997. This report summarizes activities performed to implement the State Saf...
49 CFR 633.11 - Covered projects.
Code of Federal Regulations, 2010 CFR
2010-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.11 Covered projects. The Administrator may contract for project management oversight services when the... 49 Transportation 7 2010-10-01 2010-10-01 false Covered projects. 633.11 Section 633.11...
75 FR 1566 - National Industrial Security Program Directive No. 1
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-12
... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office 32 CFR Part...: Information Security Oversight Office, NARA. ACTION: Proposed rule; correction. SUMMARY: This document... Management System (FDMS) number to the proposed rule for Information Security Oversight Office (ISOO...
75 FR 65526 - National Industrial Security Program Policy Advisory Committee (NISPPAC)
Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-25
... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: Information Security Oversight Office... planning to attend must be submitted to the Information Security Oversight Office (ISOO) no later than...
76 FR 6636 - National Industrial Security Program Policy Advisory Committee (NISPPAC)
Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-07
... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: Information Security Oversight Office... planning to attend must be submitted to the Information Security Oversight Office (ISOO) no later than...
76 FR 67484 - National Industrial Security Program Policy Advisory Committee (NISPPAC)
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-01
... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: Information Security Oversight Office... must be submitted to the Information Security Oversight Office (ISOO) no later than Friday, November 11...
76 FR 28099 - National Industrial Security Program Policy Advisory Committee (NISPPAC)
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-13
... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: Information Security Oversight Office... telephone number of individuals planning to attend must be submitted to the Information Security Oversight...
75 FR 39582 - National Industrial Security Program Policy Advisory Committee (NISPPAC)
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-09
... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: Information Security Oversight Office... telephone number of individuals planning to attend must be submitted to the Information Security Oversight...
49 CFR 633.11 - Covered projects.
Code of Federal Regulations, 2012 CFR
2012-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.11 Covered projects. The Administrator may contract for project management oversight services when the... 49 Transportation 7 2012-10-01 2012-10-01 false Covered projects. 633.11 Section 633.11...
49 CFR 633.11 - Covered projects.
Code of Federal Regulations, 2013 CFR
2013-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.11 Covered projects. The Administrator may contract for project management oversight services when the... 49 Transportation 7 2013-10-01 2013-10-01 false Covered projects. 633.11 Section 633.11...
49 CFR 633.11 - Covered projects.
Code of Federal Regulations, 2014 CFR
2014-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.11 Covered projects. The Administrator may contract for project management oversight services when the... 49 Transportation 7 2014-10-01 2014-10-01 false Covered projects. 633.11 Section 633.11...
49 CFR 633.11 - Covered projects.
Code of Federal Regulations, 2011 CFR
2011-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.11 Covered projects. The Administrator may contract for project management oversight services when the... 49 Transportation 7 2011-10-01 2011-10-01 false Covered projects. 633.11 Section 633.11...
Report: Additional Efforts Needed to Improve EPA’s Oversight of Assistance Agreements
Report #2002-P-00018, September 30, 2002. Although EPA developed corrective actions to improve oversight controls for assistance agreements, a number of EPA OIG, Agency, and GAO reviews determined that oversight continued to be a weakness.
The role of physician oversight on advanced practice nurses' professional autonomy and empowerment.
Petersen, Polly A; Way, Sandra M
2017-05-01
Little is known about the effects of physician oversight on advanced practice registered nurses (APRNs). Examination of these relationships provides insight into the strength of independent practice. The purpose of this study was to examine whether APRNs' perceptions of autonomy and empowerment varied according to type of physician oversight, whether facilitative or restrictive. A cross-sectional survey design was used to examine whether APRNs' perceptions of autonomy and empowerment varied according to physician oversight, geographical location, and practice setting. Five hundred questionnaires were mailed in March 2013 with 274 returned. Participants were asked about autonomy, empowerment, demographics, physician oversight, geographical location, and practice setting. Among surveyed respondents, physician oversight was related to increased empowerment, regardless of whether the oversight was defined in facilitative or restrictive terms; both had similar positive effects on empowerment. If APRNs are to be part of the solution to the growing problem of healthcare access, it is important to study factors that contribute to their success. We speculate that increasing opportunities for collaboration and interaction with physicians, and possibly other healthcare professionals, could facilitate APRN empowerment, optimizing their contribution. ©2017 American Association of Nurse Practitioners.
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-08
... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office; National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: National Archives and Records... individuals planning to attend must be submitted to the Information Security Oversight Office (ISOO) no later...
5 CFR 300.507 - Documentation and oversight.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Documentation and oversight. 300.507 Section 300.507 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS EMPLOYMENT (GENERAL) Use of Private Sector Temporaries § 300.507 Documentation and oversight. Agencies are...
Code of Federal Regulations, 2010 CFR
2010-01-01
... LIQUIDITY GUARANTEE PROGRAM § 370.10 Oversight. (a) Participating entities are subject to the FDIC's oversight regarding compliance with the terms of the temporary liquidity guarantee program. (b) A..., for the duration of the temporary liquidity guarantee program, to be subject to the FDIC's authority...
Code of Federal Regulations, 2010 CFR
2010-01-01
... PLACEMENT (GENERAL) Agency Career Transition Assistance Plans (CTAP) for Local Surplus and Displaced Employees § 330.611 Oversight. OPM provides advice and assistance to agencies in implementing their Career Transition Assistance Programs. OPM is also responsible for oversight of agency CTAPs and may conduct reviews...
76 FR 31416 - Federal Acquisition Regulation; Oversight of Contractor Ethics Programs
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-31
...-AL92 Federal Acquisition Regulation; Oversight of Contractor Ethics Programs AGENCY: Department of... that contractors have implemented the mandatory contractor business ethics program requirements. DATES... to Improve DoD's Oversight of Contractor Ethics Programs. The ethics program requirement flows from...
78 FR 35056 - Effectiveness of the Reactor Oversight Process Baseline Inspection Program
Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-11
... NUCLEAR REGULATORY COMMISSION [NRC-2013-0125] Effectiveness of the Reactor Oversight Process... the effectiveness of the reactor oversight process (ROP) baseline inspection program with members of... Nuclear Reactor Regulations, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301...
49 CFR 633.17 - PMO contractor eligibility.
Code of Federal Regulations, 2010 CFR
2010-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.17 PMO contractor eligibility. (a) Any person or entity may provide project management oversight services in connection with a major capital project, with the following exceptions: (1) An entity may not provide PMO...
17 CFR 1.16 - Qualifications and reports of accountants.
Code of Federal Regulations, 2014 CFR
2014-04-01
... a futures commission merchant must be registered with the Public Company Accounting Oversight Board and must have undergone an examination by the Public Company Accounting Oversight Board, and may not... Accounting Oversight Board disciplinary hearing. (2) The Commission will not recognize any certified public...
49 CFR 633.17 - PMO contractor eligibility.
Code of Federal Regulations, 2013 CFR
2013-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.17 PMO contractor eligibility. (a) Any person or entity may provide project management oversight services in connection with a major capital project, with the following exceptions: (1) An entity may not provide PMO...
49 CFR 633.17 - PMO contractor eligibility.
Code of Federal Regulations, 2014 CFR
2014-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.17 PMO contractor eligibility. (a) Any person or entity may provide project management oversight services in connection with a major capital project, with the following exceptions: (1) An entity may not provide PMO...
49 CFR 633.17 - PMO contractor eligibility.
Code of Federal Regulations, 2011 CFR
2011-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.17 PMO contractor eligibility. (a) Any person or entity may provide project management oversight services in connection with a major capital project, with the following exceptions: (1) An entity may not provide PMO...
49 CFR 633.17 - PMO contractor eligibility.
Code of Federal Regulations, 2012 CFR
2012-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.17 PMO contractor eligibility. (a) Any person or entity may provide project management oversight services in connection with a major capital project, with the following exceptions: (1) An entity may not provide PMO...
78 FR 40778 - Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-08
... PRIVACY AND CIVIL LIBERTIES OVERSIGHT BOARD [Notice--PCLOB-2013-04; Docket No. 2013-0004; Sequence No. 4] Notice of Meeting AGENCY: Privacy and Civil Liberties Oversight Board. ACTION: Notice of a meeting. SUMMARY: The Privacy and Civil Liberties Oversight Board will conduct a public workshop with...
78 FR 39021 - Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-28
... PRIVACY AND CIVIL LIBERTIES OVERSIGHT BOARD [Notice-PCLOB-2013-04; Docket No. 2013-0004; Sequence No. 4] Notice of Meeting AGENCY: Privacy and Civil Liberties Oversight Board. ACTION: Notice of a meeting. SUMMARY: The Privacy and Civil Liberties Oversight Board will conduct a public workshop with...
48 CFR 36.518 - Work oversight in cost-reimbursement construction contracts.
Code of Federal Regulations, 2010 CFR
2010-10-01
...-reimbursement construction contracts. 36.518 Section 36.518 Federal Acquisition Regulations System FEDERAL... Contract Clauses 36.518 Work oversight in cost-reimbursement construction contracts. The contracting officer shall insert the clause at 52.236-18, Work Oversight in Cost-Reimbursement Construction Contracts...
Paradise, Jordan; Tisdale, Alison W; Hall, Ralph F; Kokkoli, Efrosini
2009-01-01
This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight.
22 CFR 96.103 - Oversight by accrediting entities.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Oversight by accrediting entities. 96.103... Relating to Temporary Accreditation § 96.103 Oversight by accrediting entities. (a) The accrediting entity... agency's application for full accreditation when it is filed. The accrediting entity must also...
22 CFR 96.103 - Oversight by accrediting entities.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Oversight by accrediting entities. 96.103... Relating to Temporary Accreditation § 96.103 Oversight by accrediting entities. (a) The accrediting entity... agency's application for full accreditation when it is filed. The accrediting entity must also...
Report: EPA Should Bill Superfund Oversight Costs More Timely
Report #11-P-0697, September 22, 2011. Based on our audit of oversight billings for nine sites in Regions 1, 5, and 9, we found that Region 5 did not timely bill or did not bill approximately $8.6 million in oversight costs for two sites.
14 CFR 1203b.108 - Management oversight.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Management oversight. 1203b.108 Section 1203b.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SECURITY PROGRAMS; ARREST AUTHORITY AND USE OF FORCE BY NASA SECURITY FORCE PERSONNEL § 1203b.108 Management oversight. (a) The...
14 CFR 1203b.108 - Management oversight.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Management oversight. 1203b.108 Section 1203b.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SECURITY PROGRAMS; ARREST AUTHORITY AND USE OF FORCE BY NASA SECURITY FORCE PERSONNEL § 1203b.108 Management oversight. (a) The...
Trends in United States Biological Materials Oversight and Institutional Biosafety Committees
ERIC Educational Resources Information Center
Jenkins, Chris
2014-01-01
Biological materials oversight in life sciences research in the United States is a challenging endeavor for institutions and the scientific, regulatory compliance, and federal communities. In order to assess biological materials oversight at Institutional Biosafety Committees (IBCs) registered with the United States National Institutes of Health,…
10 CFR 440.23 - Oversight, training, and technical assistance.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 3 2010-01-01 2010-01-01 false Oversight, training, and technical assistance. 440.23... PERSONS § 440.23 Oversight, training, and technical assistance. (a) The Secretary and the appropriate..., directly or indirectly, training and technical assistance to any grantee or subgrantee. Such training and...
Code of Federal Regulations, 2011 CFR
2011-07-01
... Relating to National Defense INFORMATION SECURITY OVERSIGHT OFFICE, NATIONAL ARCHIVES AND RECORDS... Responsibilities of the Director, Information Security Oversight Office (ISOO) [102(b)]. 1 1 Bracketed references... 32 National Defense 6 2011-07-01 2011-07-01 false Responsibilities of the Director, Information...
17 CFR 202.190 - Public Company Accounting Oversight Board budget approval process.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 17 Commodity and Securities Exchanges 2 2011-04-01 2011-04-01 false Public Company Accounting... SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES Public Company Accounting Oversight Board (Regulation P) § 202.190 Public Company Accounting Oversight Board budget approval process. (a) Purpose. These...
17 CFR 202.190 - Public Company Accounting Oversight Board budget approval process.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 17 Commodity and Securities Exchanges 2 2012-04-01 2012-04-01 false Public Company Accounting... SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES Public Company Accounting Oversight Board (Regulation P) § 202.190 Public Company Accounting Oversight Board budget approval process. (a) Purpose. These...
Code of Federal Regulations, 2010 CFR
2010-07-01
... Relating to National Defense INFORMATION SECURITY OVERSIGHT OFFICE, NATIONAL ARCHIVES AND RECORDS... Responsibilities of the Director, Information Security Oversight Office (ISOO) [102(b)]. 1 1 Bracketed references... 32 National Defense 6 2010-07-01 2010-07-01 false Responsibilities of the Director, Information...
48 CFR 52.236-24 - Work Oversight in Architect-Engineer Contracts.
Code of Federal Regulations, 2012 CFR
2012-10-01
... Architect-Engineer Contracts. 52.236-24 Section 52.236-24 Federal Acquisition Regulations System FEDERAL... Provisions and Clauses 52.236-24 Work Oversight in Architect-Engineer Contracts. As prescribed in 36.609-3, insert the following clause: Work Oversight in Architect-Engineer Contracts (APR 1984) The extent and...
48 CFR 52.236-24 - Work Oversight in Architect-Engineer Contracts.
Code of Federal Regulations, 2014 CFR
2014-10-01
... Architect-Engineer Contracts. 52.236-24 Section 52.236-24 Federal Acquisition Regulations System FEDERAL... Provisions and Clauses 52.236-24 Work Oversight in Architect-Engineer Contracts. As prescribed in 36.609-3, insert the following clause: Work Oversight in Architect-Engineer Contracts (APR 1984) The extent and...
48 CFR 52.236-24 - Work Oversight in Architect-Engineer Contracts.
Code of Federal Regulations, 2010 CFR
2010-10-01
... Architect-Engineer Contracts. 52.236-24 Section 52.236-24 Federal Acquisition Regulations System FEDERAL... Provisions and Clauses 52.236-24 Work Oversight in Architect-Engineer Contracts. As prescribed in 36.609-3, insert the following clause: Work Oversight in Architect-Engineer Contracts (APR 1984) The extent and...
48 CFR 52.236-24 - Work Oversight in Architect-Engineer Contracts.
Code of Federal Regulations, 2011 CFR
2011-10-01
... Architect-Engineer Contracts. 52.236-24 Section 52.236-24 Federal Acquisition Regulations System FEDERAL... Provisions and Clauses 52.236-24 Work Oversight in Architect-Engineer Contracts. As prescribed in 36.609-3, insert the following clause: Work Oversight in Architect-Engineer Contracts (APR 1984) The extent and...
48 CFR 52.236-24 - Work Oversight in Architect-Engineer Contracts.
Code of Federal Regulations, 2013 CFR
2013-10-01
... Architect-Engineer Contracts. 52.236-24 Section 52.236-24 Federal Acquisition Regulations System FEDERAL... Provisions and Clauses 52.236-24 Work Oversight in Architect-Engineer Contracts. As prescribed in 36.609-3, insert the following clause: Work Oversight in Architect-Engineer Contracts (APR 1984) The extent and...
17 CFR 202.11 - Public Company Accounting Oversight Board budget approval process.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Public Company Accounting Oversight Board budget approval process. 202.11 Section 202.11 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES § 202.11 Public Company Accounting Oversight...
49 CFR 659.43 - Certification of compliance.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 7 2010-10-01 2010-10-01 false Certification of compliance. 659.43 Section 659.43..., DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.43 Certification of compliance. (a) Annually, the oversight agency must certify to the FTA...
17 CFR 201.440 - Appeal of determinations by the Public Company Accounting Oversight Board.
Code of Federal Regulations, 2010 CFR
2010-04-01
... and Commission Review § 201.440 Appeal of determinations by the Public Company Accounting Oversight... for registration of a public accounting firm, may file an application for review. (b) Procedure. An... the Public Company Accounting Oversight Board. 201.440 Section 201.440 Commodity and Securities...
78 FR 19246 - Privacy Act of 1974; System of Records
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-29
... the system have been updated to include use in law enforcement, audits and oversight activities, and..., organization, or individual for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function. (4...
2016-09-30
Improvements Needed in Managing Scope Changes and Oversight of Construction Projects at Camp Lemonnier, Djibouti S E P T E M B E R 3 0 , 2 0 1 6 Report...Improvements Needed in Managing Scope Changes and Oversight of Construction Projects at Camp Lemonnier, Djibouti Visit us at www.dodig.mil Objective We...Findings (cont’d) ii │ DODIG-2016-141 (Project No. D2014-D000RE-0157.000) Results in Brief Improvements Needed in Managing Scope Changes and Oversight
Morain, Stephanie R; Joffe, Steven; Campbell, Eric G; Mello, Michelle M
2015-01-01
The conflicts of interest that may arise in relationships between academic researchers and industry continue to prompt controversy. The bulk of attention has focused on financial aspects of these relationships, but conflicts may also arise in the legal obligations that faculty acquire through consulting contracts. However, oversight of faculty members' consulting agreements is far less vigorous than for financial conflicts, creating the potential for faculty to knowingly or unwittingly contract away important rights and freedoms. Increased regulation could prevent this, but it is unclear what forms of oversight universities view as feasible and effective. In this article, we report on a Delphi study to evaluate several approaches for oversight of consulting agreements by medical schools. The panel was comprised of 11 senior administrators with responsibility for oversight of faculty consulting relationships. We found broad agreement among panelists regarding the importance of institutional oversight to protect universities' interests. There was strong support for two specific approaches: providing educational resources to faculty and submitting consulting agreements for institutional review. Notwithstanding the complexities of asserting authority to regulate private consulting agreements between faculty members and companies, medical school administrators reached consensus that several approaches to improving institutional oversight are feasible and useful. © 2015 American Society of Law, Medicine & Ethics, Inc.
Daykin, Anne; Selman, Lucy E; Cramer, Helen; McCann, Sharon; Shorter, Gillian W; Sydes, Matthew R; Gamble, Carrol; Macefield, Rhiannon; Lane, J Athene; Shaw, Alison
2017-12-22
The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder and sponsor. We aimed to examine how the relationships between these stakeholders affect the trial oversight process and its rigour, to inform future revision of Good Clinical Practice guidelines. Using an ethnographic study design, we observed the oversight processes of eight trials and conducted semi-structured interviews with members of the trials' TSCs and TMGs, plus other relevant informants, including sponsors and funders of trials. Data were analysed thematically, and findings triangulated and integrated to give a multi-perspective account of current oversight practices in the UK. Eight TSC and six TMG meetings from eight trials were observed and audio-recorded, and 66 semi-structured interviews conducted with 52 purposively sampled key informants. Five themes are presented: (1) Collaboration within the TMG and role of the CTU; (2) Collaboration and conflict between oversight committees; (3) Priorities; (4) Communication between trial oversight groups and (5) Power and accountability. There was evidence of collaborative relationships, based on mutual respect, between CTUs, TMGs and TSCs, but also evidence of conflict. Relationships between trial oversight committees were influenced by stakeholders' priorities, both organisational and individual. Good communication following specific, recognised routes played a central role in ensuring that relationships were productive and trial oversight efficient. Participants described the possession of power over trials as a shifting political landscape, and there was lack of clarity regarding the roles and accountability of each committee, the sponsor and funder. Stakeholders' perceptions of their own power over a trial, and the power of others, influenced relationships between those involved in trial oversight. Recent developments in trial design and conduct have been accompanied by changes in roles and relationships between trial oversight groups. Recognising and respecting the value of differing priorities among those involved in running trials is key to successful relationships between committees, funders and sponsors. Clarity regarding appropriate lines of communication, roles and accountability is needed. We present 10 evidence-based recommendations to inform updates to international trial guidance, particularly the Medical Research Council guidelines.
Weiss, W
2012-01-01
The report of International Commission on Radiological Protection (ICRP) Task Group 80 entitled 'Radiological protection in geological disposal of long-lived solid radioactive waste' updates and consolidates previous ICRP recommendations related to solid waste disposal (ICRP Publications 46, 77, and 81). The recommendations given in this report apply specifically to geological disposal of long-lived solid radioactive waste. The report explains how the 2007 system of radiological protection, described in ICRP Publication 103, can be applied in the context of the geological disposal of long-lived solid radioactive waste. The report is written as a self-standing document. It describes the different stages in the lifetime of a geological disposal facility, and addresses the application of relevant radiological protection principles for each stage depending on the various exposure situations that can be encountered. In particular, the crucial factor that influences application of the protection system over the different phases in the lifetime of a disposal facility is the level of oversight that is present. The level of oversight affects the capability to reduce or avoid exposures. Three main time frames have to be considered for the purpose of radiological protection: time of direct oversight when the disposal facility is being implemented and active oversight is taking place; time of indirect oversight when the disposal facility is sealed and indirect oversight is being exercised to provide additional assurance on behalf of the population; and time of no oversight when oversight is no longer exercised because memory is lost. Copyright © 2012. Published by Elsevier Ltd.
14 CFR § 1203b.108 - Management oversight.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Management oversight. § 1203b.108 Section § 1203b.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SECURITY PROGRAMS; ARREST AUTHORITY AND USE OF FORCE BY NASA SECURITY FORCE PERSONNEL § 1203b.108 Management oversight. (a...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-07
...] Guidance for Industry on Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring... Administration (FDA) is announcing the availability of a guidance for industry entitled ``Oversight of Clinical... monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and...
ERIC Educational Resources Information Center
Naylor, Michael W.; Davidson, Christine V.; Ortega-Piron, D. Jean; Bass, Arin; Gutierrez, Alice; Hall, Angela
2007-01-01
The use of psychotropic medications in youth with emotional disturbances in state custody is increasing and presents unique challenges concerning consent and oversight. We examine various means that state child welfare agencies use to provide consent for and oversight of psychotropic medications for children in state custody and describe benefits…
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-28
... Operated and Oriented Plan (CO-OP) Advisory Board; Office of Consumer Information and Insurance Oversight... and Insurance Oversight (OCIIO) on the Department's strategy to foster the creation of qualified... and Insurance Oversight (OCIIO) on the Department's strategy to foster the creation of qualified...
1988-05-01
This report discusses authority, mission, and responsibilities of the audit organizations that perform oversight of Air Force operations. A...the discussion of the major audit organizations. The audit oversight function is here to stay. Auditors and audit organizations can be beneficial to Air
Private Security Contractors: The Other Force
2011-03-22
improving PSC oversight. This paper will not address private contractors conducting Police force training , governmental use of PSCs outside of Iraq...theater entry requirements, conduct mandatory training , conduct weapons training and qualification and conduct security verification and criminal...an effective oversight program including contractor deployment tracking, limited contract oversight personnel, and untrained Contract Officer
DOT National Transportation Integrated Search
2010-03-04
The Federal Transit Administration (FTA) conducted an on-site audit of the safety program implemented by the Washington Metropolitan Area Transit Authority (WMATA) and overseen by the Tri-State Oversight Committee (TOC) between December 14 and 17, 20...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-22
... Oversight of Life Sciences Dual Use Research of Concern AGENCY: Office of Science and Technology Policy... comments on the proposed United States Government Policy for Institutional Oversight of Life Sciences Dual... requirements for certain categories of life sciences research at institutions that accept Federal funding for...
Charter School Oversight: The New Frontier
ERIC Educational Resources Information Center
Farland, Stephanie Medrano
2011-01-01
Some areas of charter school oversight are easy to overlook. This article provides a few practical tips for ensuring that legal and moral obligations are met and charter schools are "delivering the goods." Effective charter oversight takes time and diligence. As many districts know, closing or not renewing a charter school can be painful…
75 FR 39954 - Oversight of Laboratory Developed Tests; Public Meeting; Change of Meeting Location
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-13
...] Oversight of Laboratory Developed Tests; Public Meeting; Change of Meeting Location AGENCY: Food and Drug... location for the upcoming public meeting entitled ``Oversight of Laboratory Developed Tests.'' A new... the public meeting, FDA is announcing in this notice a new location for the public meeting. II. New...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-21
... Accounting Oversight Board; Order Approving Proposed Rules on Auditing Standard No. 7, Engagement Quality... Accounting Oversight Board (the ``Board'' or the ``PCAOB'') filed with the Securities and Exchange Commission... standards for public company audits, including a requirement for each registered public accounting firm to...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-24
... Accounting Oversight Board; Order Approving Proposed Board Funding Final Rules for Allocation of the Board's Accounting Support Fee Among Issuers, Brokers, and Dealers, and Other Amendments to the Board's Funding Rules August 18, 2011. I. Introduction On June 21, 2011, the Public Company Accounting Oversight Board (the...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-10
... Accounting Oversight Board; Order Approving Proposed Amendment to Board Rules Relating to Inspections March 4, 2010. I. Introduction On July 2, 2009, the Public Company Accounting Oversight Board (the ``Board'' or...'') relating to the Board's rules governing inspections of registered public accounting firms. Notice of the...
The Spider Web of Oversight: An Analysis of External Oversight of Higher Education
ERIC Educational Resources Information Center
Lane, Jason E.
2007-01-01
Over the past several decades, state officials and various interest groups and civic organizations have increased their level of direct involvement in the affairs of public higher education. The increase in external attention toward the academy would likely be accompanied by the development of oversight mechanisms to ensure that societal…
Board oversight of community benefit: an ethical imperative.
Magill, Gerard; Prybil, Lawrence D
2011-03-01
Board oversight of community benefit responsibility in tax-exempt organizations in the nonprofit health care sector is attracting considerable attention. Scrutiny by the IRS and other official bodies has led to stricter measures of compliance with the community benefit standard. But stricter compliance does not sufficiently engage the underlying ethical imperative for boards to provide effective oversight--an imperative that recent research suggests has not been sufficiently honored. This analysis considers why there is a distinctively ethical imperative for board oversight, the organizational nature of the imperative involved, and practical ways to fulfill its obligations. We adopt an organizational ethics paradigm to illuminate the constituent components of the ethical imperative and to clarify emerging benchmarks as flexible guidelines. As these emerging benchmarks enhance board oversight of community benefit they also can shed light on what it means to be a virtuous organization.
2001-04-12
Comparison of Oversight Models in Managed Care 1 Running Head: Comparison of Oversight Models in Managed Care A Comparison of the Audit and...TITLE AND SUBTITLE A Comparison of the Audit and Accreditation Tools Used By The Health Care Financing Administration, The Texas Department of...Comparison of Oversight Models in Managed Care 5 A Comparison of the Audit and Accreditation Tools Used By The Health Care Financing
2015-05-01
WHISTLEBLOWER PROTECTION DOD Needs to Enhance Oversight of Military Whistleblower Reprisal Investigations Report...00-2015 to 00-00-2015 4. TITLE AND SUBTITLE Whistleblower Protection: DOD Needs to Enhance Oversight of Military Whistleblower Reprisal...Government Accountability Office Highlights of GAO-15-477, a report to congressional requesters May 2015 WHISTLEBLOWER PROTECTION DOD
Creating a Learning Organization in Law Enforcement: Maturity Levels for Police Oversight Agencies
ERIC Educational Resources Information Center
Filstad, Cathrine; Gottschalk, Petter
2010-01-01
Purpose: The purpose of this paper is to conceptualize a stage model for maturity levels for police oversight agencies. Design/methodology/approach: The paper is based on a literature review covering police oversight organizations and stages of growth models. Findings: As a conceptual paper, the main findings are related to the appropriateness of…
Fatehi, Leili; Wolf, Susan M.; McCullough, Jeffrey; Hall, Ralph; Lawrenz, Frances; Kahn, Jeffrey P.; Jones, Cortney; Campbell, Stephen A.; Dresser, Rebecca S.; Erdman, Arthur G.; Haynes, Christy L.; Hoerr, Robert A.; Hogle, Linda F.; Keane, Moira A.; Khushf, George; King, Nancy M.P.; Kokkoli, Efrosini; Marchant, Gary; Maynard, Andrew D.; Philbert, Martin; Ramachandran, Gurumurthy; Siegel, Ronald A.; Wickline, Samuel
2015-01-01
The nanomedicine field is fast evolving toward complex, “active,” and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a science-based and ethically informed approach to HSR issues in nanomedicine, and integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human Subjects Research in Nanomedicine (HSR/N) Working Group and a Secretary’s Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern. PMID:23289677
Improvement of force health protection through preventive medicine oversight of contractor support.
Mower, Scott A
2009-01-01
Unprecedented numbers of contractors are used throughout the Iraq theater of operations to alleviate military manpower shortages. At virtually every major forward operating base, US-based contractors perform the preponderance of essential life support services. At more remote sites, local national contractors are increasingly relied upon to maintain chemical latrines, remove trash, deliver bulk water, and execute other janitorial functions. Vigorous oversight of contractor performance is essential to ensure services are delivered according to specified standards. Poor oversight can increase the risk of criminal activities, permit substandard performance, elevate disease and nonbattle injury rates, degrade morale, and diminish Soldier readiness. As the principal force health protection proponents in the Department of Defense, preventive medicine units must be tightly integrated into the oversight processes. This article defines the force health protection implications associated with service contracts and provide recommendations for strengthening preventive medicine's oversight role.
Alexander, Jeffrey A; Lee, Shoou-Yih D; Wang, Virginia; Margolin, Frances S
2009-04-01
Despite the legal and practical importance of monitoring and oversight of management by hospital governing boards, there is little empirical evidence of how hospital boards fulfill these roles and the extent to which these practices have changed over time. We utilize data from three national surveys of hospital governance to examine how oversight and monitoring practices in public and private not-for-profit (NFP) hospital boards have changed over time. Findings suggest that board relations with CEOs in NFP hospitals display important but potentially contradictory patterns. On the one hand, NFP hospital boards appear to be exercising more stringent oversight of management and hospital performance. On the other hand, management is more actively involved with governance matters with less separation of board and management. This general pattern varies by the dimension of oversight and monitoring practice and by specific characteristics of NFP hospitals.
2013-06-01
forensic pathology, forensic anthropology, and forensic toxicology . 13DOD’s forensic directive defines DOD components as the Office of the...DEFENSE FORENSICS Additional Planning and Oversight Needed to Establish an Enduring Expeditionary Forensic ...COVERED 00-00-2013 to 00-00-2013 4. TITLE AND SUBTITLE Defense Forensics : Additional Planning and Oversight Needed to Establish an Enduring
Foerster, Christopher R; Tavares, Walter; Virkkunen, Ilkka; Kämäräinen, Antti
2018-03-01
Paramedicine is often dependent on physician medical directors and their associated programs for direction and oversight. A positive relationship between paramedics and their oversight physicians promotes safety and quality care while a strained or ineffective one may threaten these goals. The objective of this study was to explore and understand the professional relationship between paramedics and physician medical oversight as viewed by front-line paramedics. All active front-line paramedics from four municipal paramedic services involving three medical oversight groups in Ontario were invited to complete an online survey. Five hundred and four paramedics were invited to participate in the study, with 242 completing the survey (48% response rate); 66% male, 76% primary care paramedics with an average of 13 (SD=9) years of experience. Paramedics had neutral or positive perceptions regarding their autonomy, opportunities to interact with their medical director, and medical director understanding of the prehospital setting. Paramedics perceived medical directives as rigid and ambiguous. A significant amount of respondents reported a perception of having provided suboptimal patient care due to fear of legal or disciplinary consequences. Issues of a lack of support for critical thinking and a lack of trust between paramedics and medical oversight groups were often raised. Paramedic perceptions of physician medical oversight were mixed. Concerning areas identified were perceptions of ambiguous written directives and concerns related to the level of trust and support for critical thinking. These perceptions may have implications for the system of care and should be explored further.
United Nations: Progress on Management Reform Efforts has Varied
2007-11-01
this review, GAO was asked to (1) determine the progress of UN management reform initiatives in five key areas—ethics, oversight , procurement... oversight , procurement, management operations of the Secretariat, and review of programs and activities (known as mandates). To determine the...forms. Member states made some progress in improving oversight at the UN when they created an Independent Audit Advisory Committee, which is expected
Patriot Modernization: Oversight Mechanism Needed to Track Progress and Provide Accountability
2016-08-01
PATRIOT MODERNIZATION Oversight Mechanism Needed to Track Progress and Provide Accountability Report to...Highlights of GAO-16-488, a report to congressional committees. August 2016 PATRIOT MODERNIZATION Oversight Mechanism Needed to Track Progress and...with PDB-8 and PDB-8.1. DOD partially concurred, focusing its response on plans to track other MDAPs, but did not clarify how or if it would
2016-09-01
unneeded to support U.S. forces in the CENTCOM area of responsibility and in future contingencies worldwide. View GAO-16-406. For more information...DEFENSE INFRASTRUCTURE Actions Needed to Enhance Oversight of Construction Projects Supporting Military Contingency ...Actions Needed to Enhance Oversight of Construction Projects Supporting Military Contingency Operations Why GAO Did This Study For about 15 years, DOD
Defense Contract Management Agency Santa Ana Quality Assurance Oversight Needs lmprovement
2013-04-19
Management Agency Santa Ana Quality Assurance Oversight Needs Improvement What We Did We determined whether the Defense Contract Management Agency (DCMA...for critical safety items (CSIs). For this audit, we reviewed QA oversight of four contracts valued at about $278 million. What We Found The DCMA...limited assurance that 18,507 critical safety items, consisting of T-11 parachutes, oxygen masks, drone parachutes, and breathing apparatuses met
Ideal Police Oversight and Review: The Next Piece of the Community Policing Puzzle
2015-12-01
oversight. Included in that malpractice are instances of perceived physical and verbal abuse , perceived harassment, failure to take appropriate action...a kid from south Stockton. 1 I. INTRODUCTION A. PROBLEM STATEMENT—BACKGROUND Independent oversight boards are asked to make the complaint...communities with inclusion and investigative transparency when filing complaints of police misconduct and abuse of police powers. In his article “Race
Millar, Ross; Freeman, Tim; Mannion, Russell
2015-06-16
Hospital boards, those executive members charged with developing appropriate organisational strategies and cultures, have an important role to play in safeguarding the care provided by their organisation. However, recent concerns have been raised over boards' ability to enact their duty to ensure the quality and safety of care. This paper offers critical reflection on the relationship between hospital board oversight and patient safety. In doing so it highlights new perspectives and suggestions for developing this area of study. The article draws on 10 interviews with key informants and policy actors who form part of the 'issue network' interested in the promotion of patient safety in the English National Health Service. The interviews surfaced a series of narratives regarding hospital board oversight of patient safety. These elaborated on the role of trust and intelligence in highlighting the potential dangers and limitations of approaches to hospital board oversight which have been narrowly focused on a risk-based view of organisational performance. In response, a need to engage with the development of trust based organisational relationships is identified, in which effective board oversight is built on 'trust' characterised by styles of leadership and behaviours that are attentive to the needs and concerns of both staff and patients. Effective board oversight also requires the gathering and triangulating of 'intelligence' generated from both national and local information sources. We call for a re-imagination of hospital board oversight in the light of these different perspectives and articulate an emerging research agenda in this area.
2011-07-30
contractor purchasing system review of Anham. Management Comments and Audit Response The Defense Contract Mangement Agency and the U.S. Central... Introduction 1 Background 1 Government Agency Roles and Oversight Responsibilities 4 Objectives 7 Weak Government Oversight Resulted in Significant...Subcontracting Procedures Allowed Questionable Costs To Go Undetected SIGIR 11-022 July 30, 2011 Introduction Since 2003, the United States Government
2015-03-04
H 4 , 2 0 1 5 Delinquent Medical Service Accounts at Naval Medical Center Portsmouth Need Additional Management Oversight Report No. DODIG-2015...04 MAR 2015 2. REPORT TYPE 3. DATES COVERED 00-00-2015 to 00-00-2015 4. TITLE AND SUBTITLE Delinquent Medical Service Accounts at Naval...i Results in Brief Delinquent Medical Service Accounts at Naval Medical Center Portsmouth Need Additional Management Oversight Visit us at
5 CFR 2500.11 - Implementation and review.
Code of Federal Regulations, 2011 CFR
2011-01-01
... INFORMATION SECURITY REGULATION § 2500.11 Implementation and review. The Information Security Oversight... information security program. The chairperson shall also be responsible for conducting an active oversight...
Oversight: Space Telescope, 1982
NASA Astrophysics Data System (ADS)
The oversight hearing of the House subcommittee on Space Science and Applications concerning the development of the Space Telescope is presented. Plans for future utilization of the telescope are discussed.
5 CFR 2500.11 - Implementation and review.
Code of Federal Regulations, 2010 CFR
2010-01-01
... INFORMATION SECURITY REGULATION § 2500.11 Implementation and review. The Information Security Oversight... information security program. The chairperson shall also be responsible for conducting an active oversight...
Hennig, Michael; Hundt, Ferdinand; Busta, Susanne; Mikus, Stefan; Sanden, Per-Holger; Sörgel, Andrea; Ruppert, Thorsten
2017-01-01
In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight's evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial.
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Government Reform and Oversight.
This congressional hearing continues the House's oversight of the Department of Labor's (DOL's) Job Corps program, focusing on the fourth element of successful job training, maintaining a vocational curriculum that reflects current and future job opportunities. It reviews findings of a General Accounting Office (GAO) study that found the program…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. Senate Select Committee on Indian Affairs.
The July 24, 1980, Indian education oversight hearings focused on four issues: the proposed closing of the Fort Sill and Stewart Indian Boarding Schools; the furloughing of Bureau of Indian Affairs (BIA) teachers; contract schools' problems with indirect costs and operations and maintenance funding; and a study of Johnson O'Malley support for…
2008-03-11
guidance dealing with contractors who support deployed forces in October 2005. However, as we recently testified , DOD’s leadership needs to ensure...GAO-08-572T may be “ borderline inherently governmental.”14 We have also found problems with contractors having too much control at other...contract oversight personnel, lessons learned, and training of military commanders and contract oversight personnel. More recently, we testified that DOD’s
49 CFR 633.15 - Access to information.
Code of Federal Regulations, 2010 CFR
2010-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.15 Access to information. A recipient of FTA funds for a major capital project shall provide the...
49 CFR 633.15 - Access to information.
Code of Federal Regulations, 2013 CFR
2013-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.15 Access to information. A recipient of FTA funds for a major capital project shall provide the...
49 CFR 633.15 - Access to information.
Code of Federal Regulations, 2011 CFR
2011-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.15 Access to information. A recipient of FTA funds for a major capital project shall provide the...
49 CFR 633.15 - Access to information.
Code of Federal Regulations, 2014 CFR
2014-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.15 Access to information. A recipient of FTA funds for a major capital project shall provide the...
49 CFR 633.15 - Access to information.
Code of Federal Regulations, 2012 CFR
2012-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.15 Access to information. A recipient of FTA funds for a major capital project shall provide the...
Preventive medicine oversight of splash pads on military installations.
Hardcastle, Lisa Raysby; Perry, Matthew; Browne, Ashley
2015-01-01
Over the past several years, an increasing number of military installations have installed splash pads that provide fun, recreational water entertainment for Soldiers and their families. The addition of splash pads brings added responsibilities for medical treatment facility preventive medicine oversight and installation facilities maintenance to ensure a safe and healthy environment. Currently, there are no consistent standards or detailed guidance for military installations to follow when installing and maintaining splash pads. The central issues associated with splash pads on military installations are water quality and risk for waterborne illnesses, responsibility for safety and health oversight, and federal energy and water sustainability mandates. This article examines the importance of implementing a standard for design and oversight to ensure the health and safety of Soldiers and their families.
Biosafety Oversight and Compliance: What do you Mean, I have to Fill Out Another Form?!
Petrella, Brenda L
2015-11-03
This unit is an overview of biosafety compliance and oversight in the United States. Specific attention is given to the oversight of the Institutional Biosafety Committee (IBC) and how the purview of the IBC may overlap with other local committees, such as the Institutional Animal Care and Use Committee (IACUC) for animal research and the Institutional Review Board (IRB) for research on human subjects. Requirements for the Federal Select Agent Program and Dual Use Research of Concern (DURC) are also briefly reviewed for those working with materials and experiments covered under these regulations. This unit serves as a guide for new and established investigators who are navigating the regulatory world and how regulatory oversight applies to their research. Copyright © 2015 John Wiley & Sons, Inc.
Biological Select Agents and Toxins: Risk-Based Assessment Management and Oversight.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Burnett, LouAnn Crawford; Brodsky, Benjamin H.
Sandia National Laboratories' International Biological and Chemical Threat Reduction (SNL/IBCTR) conducted, on behalf of the Federal Select Agent Program (FSAP), a review of risk assessment in modern select agent laboratories. This review and analysis consisted of literature review, interviews of FSAP staff, entities regulated by FSAP, and deliberations of an expert panel. Additionally, SNL/IBCTR reviewed oversight mechanisms used by industries, US agencies, and other countries for high-consequence risks (e.g, nuclear, chemical, or biological materials, aviation, off-shore drilling, etc.) to determine if alternate oversight mechanisms existed that might be applicable to FSAP oversight of biological select agents and toxins. This reportmore » contains five findings, based on these reviews and analyses, with recommendations and suggested actions for FSAP to consider.« less
1980-03-01
Subcommittee on General Oversight and Minority Enterprise, Committee on Small Business March 3, 1980 -- I ’zm golng:to providesa structural overview of the key...Industry Newspaper firms are small businesses . To illustrate, the median circulation for the 1580 daily newspapers publishing in 1977 was 12,000. During...UNCLASSIFIEO RAN/P-6502 NL " ’~~~- Iililii111118 iTESTIMONY BEFORE THE SUBCOMMITTEE ON GENERAL.OVERSIGHT AND MINORITY ENTERPRISE, COMMITTEE ON SMALL BWTSINESS
Defense Logistical Support Contracts in Iraq and Afghanistan: Issues for Congress
2010-04-28
and oversight of DOD’s procurement of goods and services. The bill was amended by the HASC on April 21, 2010, discharged by the House Oversight and...continued) 21, 2010, discharged by the House Oversight and Government Reform Committee on April 23, 2010, and reported favorably in a HASC vote of 56...Contracting in Iraq and Afghanistan; • Section 852 calls for the Army Audit Agency, the Navy Audit Services, and the Air Force Audit Agency to each conduct
32 CFR 2004.11 - Agency Implementing Regulations, Internal Rules, or Guidelines [102(b)(3)].
Code of Federal Regulations, 2010 CFR
2010-07-01
... National Defense INFORMATION SECURITY OVERSIGHT OFFICE, NATIONAL ARCHIVES AND RECORDS ADMINISTRATION NATIONAL INDUSTRIAL SECURITY PROGRAM DIRECTIVE NO. 1 Implementation and Oversight § 2004.11 Agency...
ERIC Educational Resources Information Center
Erlichson, Herman
1995-01-01
Discusses Newton's apparent oversight of the role of energy considerations in collisions between two spherical bodies related to the third corollary of his "Laws of Motion." Investigates several theories that provide solutions to the mysterious oversight. (LZ)
42 CFR 460.71 - Oversight of direct participant care.
Code of Federal Regulations, 2011 CFR
2011-10-01
... SERVICES (CONTINUED) PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) PACE Administrative Requirements § 460.71 Oversight of direct participant care...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-06
... Practice; Interim Commission Review of Public Company Accounting Oversight Board Inspection Reports and... facilitate interim Commission review of Public Company Accounting Oversight Board [[Page 47445
Upstream oversight assessment for agrifood nanotechnology: a case studies approach.
Kuzma, Jennifer; Romanchek, James; Kokotovich, Adam
2008-08-01
Although nanotechnology is broadly receiving attention in public and academic circles, oversight issues associated with applications for agriculture and food remain largely unexplored. Agrifood nanotechnology is at a critical stage in which informed analysis can help shape funding priorities, risk assessment, and oversight activities. This analysis is designed to help society and policymakers anticipate and prepare for challenges posed by complicated, convergent applications of agrifood nanotechnology. The goal is to identify data, risk assessment, regulatory policy, and engagement needs for overseeing these products so they can be addressed prior to market entry. Our approach, termed upstream oversight assessment (UOA), has potential as a key element of anticipatory governance. It relies on distinct case studies of proposed applications of agrifood nanotechnology to highlight areas that need study and attention. As a tool for preparation, UOA anticipates the types and features of emerging applications; their endpoints of use in society; the extent to which users, workers, ecosystems, or consumers will be exposed; the nature of the material and its safety; whether and where the technologies might fit into current regulatory system(s); the strengths and weaknesses of the system(s) in light of these novel applications; and the possible social concerns related to oversight for them.
46 CFR 503.53 - Oversight Committee.
Code of Federal Regulations, 2011 CFR
2011-10-01
... FEDERAL MARITIME COMMISSION GENERAL AND ADMINISTRATIVE PROVISIONS PUBLIC INFORMATION Information Security... provisions of Executive Order 13526 and directives of the Information Security Oversight Office. The program... and complaints concerning the Commission's information security program; (d) Recommend appropriate...
46 CFR 503.53 - Oversight Committee.
Code of Federal Regulations, 2010 CFR
2010-10-01
... FEDERAL MARITIME COMMISSION GENERAL AND ADMINISTRATIVE PROVISIONS PUBLIC INFORMATION Information Security... provisions of Executive Order 12958 and directives of the Information Security Oversight Office. The program... and complaints concerning the Commission's information security program; (d) Recommend appropriate...
Report: EPA's Financial Oversight of Superfund State Contracts Needs Improvement
Report #16-P-0217, June 27, 2016. With improved financial oversight, the EPA may manage SSCs more effectively, report results more accurately, and increase the availability of funds for cleanups protecting public health.
Controls Over Project Management Oversight Program
DOT National Transportation Integrated Search
1997-12-08
This is the final report on Federal Transit Administration's (FTA) controls over its Project Management Oversight (PMO) Program. This report reflects Office of Inspector General's (OIG) consideration of information provided in FTA's May 29, 1997, rep...
ERIC Educational Resources Information Center
US House of Representatives, 2005
2005-01-01
The purpose of this hearing was to examine the Federal Communications Commission's management and oversight of the E-Rate program. This subcommittee has done much to expose for Congress a range of problems in the E-Rate program management--problems that raise questions about the program's effectiveness and whether the Nation's taxpayers can be…
Statement of Janet Kasper Director, Contracts and Assistance Agreement Audits Office of Inspector General EPA Before the House Oversight and Government Reform Committee, Subcommittee on Government Operations U.S. House of Representatives
Advisory Memorandum on Oversight for Pilot Training Programs
DOT National Transportation Integrated Search
1997-01-14
This advisory memorandum presents the results of our audit of Federal : Aviation Administration (FAA) oversight for pilot training programs operated : by air carriers under Part 121 of the Federal Aviation Regulations. The : objective of our audit wa...
Congressional Testimony: EPA Oversight - Unimplemented Inspector General and GAO Recommendations
September 6, 2017. Statement of Alan S. Larsen Counsel to the Inspector General U.S. Environmental Protection Agency before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce U.S. House of Representatives.
77 FR 24714 - Meeting of the National Toxicology Program (NTP) Board of Scientific Counselors
Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-25
... public and private sectors that provides primary scientific oversight to the NTP and evaluates the... private sectors that provides primary scientific oversight to the NTP. Specifically, the BSC advises the...
76 FR 68461 - Meeting of the National Toxicology Program (NTP) Board of Scientific Counselors
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-04
... public and private sectors that provides primary scientific oversight to the NTP and evaluates the... private sectors that provides primary scientific oversight to the NTP. Specifically, the BSC advises the...
Aviation Safety: FAA Oversight of Repair Stations Needs Improvement
DOT National Transportation Integrated Search
1997-10-24
This report by the General Accounting Office examines the Federal Aviation : Administration's (FAA) oversight of the aviation repair station industry. : Specifically, this report addresses the following questions: (1) What is the : nature and scope o...
Compliance guidelines for states with new starts projects
DOT National Transportation Integrated Search
2000-06-01
The Federal Transit Administration's (FTA) State Safety Oversight Rule (49 CFR Part 659) requires oversight for all rail transit agencies in revenue operation after January 1, 1997. States with "New Start" systems, funded through FTA's discretionary ...
Notification: EPA Oversight of Delegated State Resource Conservation and Recovery Act Programs
Project #OPE-FY16-0033, September 19, 2016. The EPA OIG plans to begin preliminary research on the EPA's oversight of authorized state hazardous waste programs that fall under the Resource Conservation and Recovery Act.
Notification: Oversight of Superfund State Contracts for Remedial Activities
Project #OA-FY15-0054, December 30, 2014. The Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) is beginning an audit of the EPA's oversight of Superfund State Contracts (SSCs) for remedial activities.
Compliance with Aerospace Quality Assurance Standard AS9100
NASA Technical Reports Server (NTRS)
Hughitt, Brian
2009-01-01
The contents include: 1) United States Federal Acquisition Regulations (FAR) Part 46, Quality Assurance; 2) NASA Quality Roadmap; 3) AS9003 Inspection and Test Quality Management System; 4) Government Oversight Responsibilities; and 5) Third Party vs Second Party Oversight.
Notification: Evaluation of EPA Oversight of Disaster Debris Management
Project #OPE-FY15-0012, November 24, 2014. The Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) plans to begin preliminary research on EPA's oversight of disaster debris management in December 2014.
Notification: Preliminary Research on the Adequacy of EPA's Oversight of State FIFRA Programs
Project #OPE-FY14-4013, November 06, 2013. The EPA OIG plans to begin preliminary research on the adequacy of the EPA’s oversight of states’ Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) programs.
Implementation Guidelines for State Safety Oversight of Rail Fixed Guideway Systems
DOT National Transportation Integrated Search
1996-06-01
These guidelines will assist states, oversight agencies, and rail transit agencies in developing safety and security programs to satisfy the requirements of the Federal Transit Administration (FTA). These requirements were published in the Federal Re...
Report #2007-P-00023, May 14, 2007. EPA did not provide effective enforcement oversight of major facilities with National Pollutant Discharge Elimination System permits in long-term significant noncompliance.
78 FR 22546 - Hearing Procedures
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-16
... FINANCIAL STABILITY OVERSIGHT COUNCIL Hearing Procedures AGENCY: Financial Stability Oversight... Council (Council) has adopted amendments to its hearing procedures (Council Hearing Procedures) for hearings conducted by the Council under Title I and Title VIII of the Dodd-Frank Wall Street Reform and...
78 FR 4145 - Proposed Recommendations Regarding Money Market Mutual Fund Reform
Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-18
... FINANCIAL STABILITY OVERSIGHT COUNCIL Proposed Recommendations Regarding Money Market Mutual Fund Reform AGENCY: Financial Stability Oversight Council. ACTION: Proposed recommendation; extension of...'') published in the Federal Register proposed recommendations regarding money market mutual funds (``MMFs...
Notification: Evaluation of EPA Oversight of Hazardous Waste Imports
Project #OPE-FY14-0036, March 26, 2014. The Office of Inspector General for the U.S. Environmental Protection Agency plans to begin preliminary research on the EPA oversight of hazardous waste imports on April 14, 2014.
Notification: Oversight of Clean Water State Revolving Loan Funds
Project #OA-FY15-0153, April 6, 2015. The Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) is beginning preliminary research on the EPA oversight of the Clean Water State Revolving Fund (CWSRF).
75 FR 5844 - Agency Information Collection Activity Seeking OMB Approval
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-04
..., vol. 74, no. 199, page 53315. This rule set safety and oversight rules for a broad variety of...: An estimated 30,320.6 hours annually. Abstract: This rule set safety and oversight rules for a broad...
Notification: Audit of the EPA's Oversight of Smokestack Emissions Testing and Reporting
Project #OA&E-FY18-0186, April 10, 2018. The OIG plans to begin preliminary research for an audit of the EPA's oversight of smokestack emissions testing and reporting, with an initial emphasis on EPA Region 10.
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. Senate Committee on Labor and Human Resources.
The document contains proceedings from oversight hearings on the problems and difficulties of implementing P.L. 94-142, the Education for All Handicapped Children Act. Testimonies cover such issues as the failure to carry out effective and proper physical education programs, improper student placement, misapplication of the mainstreaming concept,…
13 CFR 130.800 - Oversight of the SBDC program.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Oversight of the SBDC program. 130.800 Section 130.800 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS... funds for the benefit of the small business community. ...
13 CFR 130.800 - Oversight of the SBDC program.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Oversight of the SBDC program. 130.800 Section 130.800 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS... funds for the benefit of the small business community. ...
Notification: Audit of EPA Region 2's Oversight of Puerto Rico Assistance Agreements
Project #OA-FY17-0001, October 3, 2016. The Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) plans to begin preliminary research of the EPA’s oversight of Puerto Rico assistance agreements.
22 CFR 96.32 - Internal structure and oversight.
Code of Federal Regulations, 2010 CFR
2010-04-01
... official who is qualified by education, adoption service experience, and management credentials to ensure... has authority and responsibility for management and oversight of the staff and any supervised..., budget, and programs; provides leadership to secure the resources needed to support its programs...
Code of Federal Regulations, 2010 CFR
2010-10-01
... TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT General Provisions § 633.1 Purpose. This part implements section 324... receiving assistance from the agency. First, subpart B discusses project management oversight, designed..., subpart C discusses the project management plan (PMP) required of all major capital projects. The PMP is...
Report #16-P-0164, May 3, 2016. Accurate enforcement databases and updated CMS plans promote effective and efficient EPA oversight of compliance programs, and help to protect the public from harmful air pollutants.
78 FR 64024 - National Industrial Security Program Policy Advisory Committee (NISPPAC)
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-25
... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office [NARA-2014-001] National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: National Archives and... submitted to the Information Security Oversight Office (ISOO) no later than Friday, November 8, 2013. ISOO...
78 FR 64037 - Notice of Hearing
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-25
... No. 7] Notice of Hearing AGENCY: Privacy and Civil Liberties Oversight Board (PCLOB). ACTION: Notice of a hearing. SUMMARY: The Privacy and Civil Liberties Oversight Board (PCLOB) will conduct a public hearing with current and former government officials and others to address the activities and...
5 CFR 831.911 - Oversight of coverage determinations.
Code of Federal Regulations, 2013 CFR
2013-01-01
....911 Section 831.911 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) RETIREMENT Law Enforcement Officers and Firefighters § 831.911 Oversight of coverage determinations. (a) Upon deciding that a position is a law enforcement officer or firefighter position, each...
5 CFR 831.911 - Oversight of coverage determinations.
Code of Federal Regulations, 2011 CFR
2011-01-01
....911 Section 831.911 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) RETIREMENT Law Enforcement Officers and Firefighters § 831.911 Oversight of coverage determinations. (a) Upon deciding that a position is a law enforcement officer or firefighter position, each...
5 CFR 831.911 - Oversight of coverage determinations.
Code of Federal Regulations, 2014 CFR
2014-01-01
....911 Section 831.911 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) RETIREMENT Law Enforcement Officers and Firefighters § 831.911 Oversight of coverage determinations. (a) Upon deciding that a position is a law enforcement officer or firefighter position, each...
5 CFR 831.911 - Oversight of coverage determinations.
Code of Federal Regulations, 2012 CFR
2012-01-01
....911 Section 831.911 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) RETIREMENT Law Enforcement Officers and Firefighters § 831.911 Oversight of coverage determinations. (a) Upon deciding that a position is a law enforcement officer or firefighter position, each...
7 CFR 1703.107 - Reporting and oversight requirements.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 7 Agriculture 11 2010-01-01 2010-01-01 false Reporting and oversight requirements. 1703.107 Section 1703.107 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE RURAL DEVELOPMENT Distance Learning and Telemedicine Loan and Grant...
Report: Region 6 Needs to Improve Oversight Practices
Report #10-P-0100, April 14, 2010. Region 6’s documentation of its oversight was not sufficient to determine whether CANM’s allegations had merit or whether NMED’s actions and decisions with regard to the MWL monitoring wells were technically sound.
Code of Federal Regulations, 2012 CFR
2012-10-01
... TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT General Provisions § 633.1 Purpose. This part implements section 324... receiving assistance from the agency. First, subpart B discusses project management oversight, designed..., subpart C discusses the project management plan (PMP) required of all major capital projects. The PMP is...
Code of Federal Regulations, 2011 CFR
2011-10-01
... TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT General Provisions § 633.1 Purpose. This part implements section 324... receiving assistance from the agency. First, subpart B discusses project management oversight, designed..., subpart C discusses the project management plan (PMP) required of all major capital projects. The PMP is...
Code of Federal Regulations, 2013 CFR
2013-10-01
... TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT General Provisions § 633.1 Purpose. This part implements section 324... receiving assistance from the agency. First, subpart B discusses project management oversight, designed..., subpart C discusses the project management plan (PMP) required of all major capital projects. The PMP is...
Code of Federal Regulations, 2014 CFR
2014-10-01
... TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT General Provisions § 633.1 Purpose. This part implements section 324... receiving assistance from the agency. First, subpart B discusses project management oversight, designed..., subpart C discusses the project management plan (PMP) required of all major capital projects. The PMP is...
20 CFR 634.5 - Federal oversight.
Code of Federal Regulations, 2010 CFR
2010-04-01
... Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR LABOR MARKET INFORMATION PROGRAMS UNDER TITLE IV, PART E OF THE JOB TRAINING PARTNERSHIP ACT Comprehensive Labor Market Information System § 634.5 Federal oversight. The Secretary shall take such action as necessary to ensure...
Report #16-P-0207, June 20, 2016. More than $58 million in consolidated cooperative agreement funds is not being administered efficiently and effectively due to inadequate oversight and a lack of internal controls.
7 CFR 1703.107 - Reporting and oversight requirements.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 7 Agriculture 11 2011-01-01 2011-01-01 false Reporting and oversight requirements. 1703.107 Section 1703.107 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE RURAL DEVELOPMENT Distance Learning and Telemedicine Loan and Grant...
7 CFR 1703.107 - Reporting and oversight requirements.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 7 Agriculture 11 2014-01-01 2014-01-01 false Reporting and oversight requirements. 1703.107 Section 1703.107 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE RURAL DEVELOPMENT Distance Learning and Telemedicine Loan and Grant...
7 CFR 1703.107 - Reporting and oversight requirements.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 7 Agriculture 11 2013-01-01 2013-01-01 false Reporting and oversight requirements. 1703.107 Section 1703.107 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE RURAL DEVELOPMENT Distance Learning and Telemedicine Loan and Grant...
7 CFR 1703.107 - Reporting and oversight requirements.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 7 Agriculture 11 2012-01-01 2012-01-01 false Reporting and oversight requirements. 1703.107 Section 1703.107 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE RURAL DEVELOPMENT Distance Learning and Telemedicine Loan and Grant...
Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System.
Lee, Sandra Soo-Jin; Kelley, Maureen; Cho, Mildred K; Kraft, Stephanie Alessi; James, Cyan; Constantine, Melissa; Meyer, Adrienne N; Diekema, Douglas; Capron, Alexander M; Wilfond, Benjamin S; Magnus, David
2016-01-01
Human subjects protection in healthcare contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called "research on medical practice" (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research. We conducted six semi-structured, open-ended focus group discussions with IRB members to understand their experiences and perspectives on ethical oversight of ROMP, including randomization of patients to standard treatments. Our study revealed that IRB members are unclear or divided on the central questions at stake in the current policy debate over ethical oversight of ROMP: IRB members struggle to make a clear distinction between clinical research and medical practice improvement, lack consensus on when ROMP requires IRB review and oversight, and are uncertain about what constitutes incremental risk when patients are randomized to different treatments, any of which may be offered in usual care. They characterized the central challenge as a balancing act, between, on the one hand, making information fully transparent to patients and providing adequate oversight, and on the other hand, avoiding a chilling effect on the research process or harming the physician-patient relationship. Evidence-based guidance that supports IRB members in providing adequate and effective oversight of ROMP without impeding the research process or harming the physician-patient relationship is necessary to realize the full benefits of the learning health system.
Hennig, Michael; Hundt, Ferdinand; Busta, Susanne; Mikus, Stefan; Sanden, Per-Holger; Sörgel, Andrea; Ruppert, Thorsten
2017-01-01
In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight’s evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial. PMID:28163667
Statement of Nikki L. Tinsley Inspector General U.S. Environmental Protection Agency Before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce U.S. House of Representatives
Project #OPE-FY14-0007, June 19, 2014. Our updated objective is to determine how the EPA's state oversight ensures the quality of state-performed Worker Protection Standard inspections and Certification and Training inspections.
46 CFR 160.001-5 - Production oversight.
Code of Federal Regulations, 2011 CFR
2011-10-01
...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...
46 CFR 160.001-5 - Production oversight.
Code of Federal Regulations, 2012 CFR
2012-10-01
...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...
46 CFR 160.001-5 - Production oversight.
Code of Federal Regulations, 2013 CFR
2013-10-01
...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...
46 CFR 160.001-5 - Production oversight.
Code of Federal Regulations, 2014 CFR
2014-10-01
...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...
46 CFR 160.001-5 - Production oversight.
Code of Federal Regulations, 2010 CFR
2010-10-01
...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...
Management, Security, and Congressional Oversight. Federal Government Information Technology.
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. Office of Technology Assessment.
This report considers the management, use, and congressional oversight of information technology in the Federal Government as rapid advances in technology--e.g., microcomputers, computer networking, computer modeling, videoconferencing, and electronic information exchange--are generating many new applications, opportunities, and issues which are…
49 CFR 633.13 - Initiation of PMO services.
Code of Federal Regulations, 2010 CFR
2010-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.13... engineering phase of the project. However, consistent with other provisions in this part, the Administrator may determine that a project is a “major capital project” at any point during its implementation...
NASA Technical Reports Server (NTRS)
Malone, Roy W., Jr.
2010-01-01
The presentation slides examine: The Journey, Current Safety and Mission Assurance (S and MA) Oversight/Insight, The Change, The Issue, Potential NASA relationship with Commercial Partners, and Commercial "X" FRR - Are you Go.
41 CFR 105-53.133 - Information Security Oversight Office.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Information Security Oversight Office. 105-53.133 Section 105-53.133 Public Contracts and Property Management Federal Property Management Regulations System (Continued) GENERAL SERVICES ADMINISTRATION 53-STATEMENT OF ORGANIZATION AND...
41 CFR 105-53.133 - Information Security Oversight Office.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false Information Security Oversight Office. 105-53.133 Section 105-53.133 Public Contracts and Property Management Federal Property Management Regulations System (Continued) GENERAL SERVICES ADMINISTRATION 53-STATEMENT OF ORGANIZATION AND...
20 CFR 416.919t - Consultative examination oversight.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Consultative examination oversight. 416.919t Section 416.919t Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE... will also perform ongoing special management studies of the quality of consultative examinations...
20 CFR 416.919t - Consultative examination oversight.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Consultative examination oversight. 416.919t Section 416.919t Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE... will also perform ongoing special management studies of the quality of consultative examinations...
20 CFR 416.919t - Consultative examination oversight.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Consultative examination oversight. 416.919t Section 416.919t Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE... will also perform ongoing special management studies of the quality of consultative examinations...
20 CFR 416.919t - Consultative examination oversight.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Consultative examination oversight. 416.919t Section 416.919t Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE... will also perform ongoing special management studies of the quality of consultative examinations...
20 CFR 404.1519t - Consultative examination oversight.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Consultative examination oversight. 404.1519t Section 404.1519t Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND... will also perform ongoing special management studies of the quality of consultative examinations...
20 CFR 404.1519t - Consultative examination oversight.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false Consultative examination oversight. 404.1519t Section 404.1519t Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND... will also perform ongoing special management studies of the quality of consultative examinations...
20 CFR 416.919t - Consultative examination oversight.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false Consultative examination oversight. 416.919t Section 416.919t Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE... will also perform ongoing special management studies of the quality of consultative examinations...
20 CFR 404.1519t - Consultative examination oversight.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Consultative examination oversight. 404.1519t Section 404.1519t Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND... will also perform ongoing special management studies of the quality of consultative examinations...
20 CFR 404.1519t - Consultative examination oversight.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Consultative examination oversight. 404.1519t Section 404.1519t Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND... will also perform ongoing special management studies of the quality of consultative examinations...
20 CFR 404.1519t - Consultative examination oversight.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Consultative examination oversight. 404.1519t Section 404.1519t Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND... will also perform ongoing special management studies of the quality of consultative examinations...
78 FR 38077 - National Industrial Security Program Policy Advisory Committee (NISPPAC)
Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-25
... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office [NARA-13-0030] National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: National Archives and... submitted to the Information Security Oversight Office (ISOO) no later than Friday, July 12, 2013. ISOO will...
Project #OA-FY17-0382, August 28, 2017. The EPA OIG plans to begin preliminary research on the EPA’s adherence to policies, procedures and oversight controls pertaining to the Administrator’s travel to Oklahoma.
48 CFR 36.609-3 - Work oversight in architect-engineer contracts.
Code of Federal Regulations, 2012 CFR
2012-10-01
... architect-engineer contracts. 36.609-3 Section 36.609-3 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SPECIAL CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 36.609-3 Work oversight in architect-engineer contracts. The contracting officer...
48 CFR 36.609-3 - Work oversight in architect-engineer contracts.
Code of Federal Regulations, 2013 CFR
2013-10-01
... architect-engineer contracts. 36.609-3 Section 36.609-3 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SPECIAL CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 36.609-3 Work oversight in architect-engineer contracts. The contracting officer...
48 CFR 36.609-3 - Work oversight in architect-engineer contracts.
Code of Federal Regulations, 2010 CFR
2010-10-01
... architect-engineer contracts. 36.609-3 Section 36.609-3 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SPECIAL CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 36.609-3 Work oversight in architect-engineer contracts. The contracting officer...
48 CFR 36.609-3 - Work oversight in architect-engineer contracts.
Code of Federal Regulations, 2014 CFR
2014-10-01
... architect-engineer contracts. 36.609-3 Section 36.609-3 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SPECIAL CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 36.609-3 Work oversight in architect-engineer contracts. The contracting officer...
48 CFR 36.609-3 - Work oversight in architect-engineer contracts.
Code of Federal Regulations, 2011 CFR
2011-10-01
... architect-engineer contracts. 36.609-3 Section 36.609-3 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SPECIAL CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 36.609-3 Work oversight in architect-engineer contracts. The contracting officer...
49 CFR 633.13 - Initiation of PMO services.
Code of Federal Regulations, 2014 CFR
2014-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.13... engineering phase of the project. However, consistent with other provisions in this part, the Administrator may determine that a project is a “major capital project” at any point during its implementation...
49 CFR 633.13 - Initiation of PMO services.
Code of Federal Regulations, 2011 CFR
2011-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.13... engineering phase of the project. However, consistent with other provisions in this part, the Administrator may determine that a project is a “major capital project” at any point during its implementation...
49 CFR 633.13 - Initiation of PMO services.
Code of Federal Regulations, 2012 CFR
2012-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.13... engineering phase of the project. However, consistent with other provisions in this part, the Administrator may determine that a project is a “major capital project” at any point during its implementation...
49 CFR 633.13 - Initiation of PMO services.
Code of Federal Regulations, 2013 CFR
2013-10-01
..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.13... engineering phase of the project. However, consistent with other provisions in this part, the Administrator may determine that a project is a “major capital project” at any point during its implementation...
Project #OPE-FYI7-0018, May 5, 2017. The EPA OIG plans to begin preliminary research to determine whether EPA oversight has ensured that vehicle inspection and maintenance programs are effective and efficient in reducing vehicle emissions.
44 CFR 207.8 - Management cost funding oversight.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false Management cost funding oversight. 207.8 Section 207.8 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY DISASTER ASSISTANCE MANAGEMENT COSTS § 207.8 Management cost funding...
44 CFR 207.8 - Management cost funding oversight.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Management cost funding oversight. 207.8 Section 207.8 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY DISASTER ASSISTANCE MANAGEMENT COSTS § 207.8 Management cost funding...
44 CFR 207.8 - Management cost funding oversight.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false Management cost funding oversight. 207.8 Section 207.8 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY DISASTER ASSISTANCE MANAGEMENT COSTS § 207.8 Management cost funding...
Kim, Mi-Kyung
2009-01-01
We examine whether the current regulatory regime instituted in South Korea and the United States would have prevented Hwang's potential transgressions in oocyte procurement for somatic cell nuclear transfer, we compare the general aspects and oversight framework of the Bioethics and Biosafety Act in South Korea and the US National Academies' Guidelines for Human Embryonic Stem Cell Research, and apply the relevant provisions and recommendations to each transgression. We conclude that the Act would institute centralized oversight under governmental auspices while the Guidelines recommend politically-independent, decentralized oversight bodies including a special review body for human embryonic stem cell research at an institutional level and that the Guidelines would have provided more vigorous protection for the women who had undergone oocyte procurement for Hwang's research than the Act. We also suggest additional regulations to protect those who provide oocytes for research in South Korea.
Howard, Larry L
2014-01-01
Gains in life expectancy around the world have increasingly placed pressure on governments to ensure that the elderly receive assistance with activities of daily living. This research examines the impact of government oversight of Medicaid payment policies on access to nursing home care services in the United States. Variation in price levels induced by a federal policy shift in 1997 is used to identify the effect of Medicaid reimbursements on the number of nursing homes and beds available. Court rulings prior to the policy change are used to categorically define a range of oversight treatments at the state level. Difference-in-differences estimates indicate a significant decline in access to nursing home care services for individuals living in states in which courts consistently ruled that Medicaid reimbursements did not meet the minimum standard implied by federal law. The findings suggest that nursing home care services were made more accessible through a combination of legislative and judicial oversight of Medicaid payment policies. © The Author(s) 2014.
Protection of health research participants in the United States: a review of two cases.
Douglass, Alison; Crampton, Peter
2004-06-01
Two research-related deaths and controversies in the United States during recent years have raised public concern over the safety of research participants. This paper explores the reasons why, in two studies, there was a failure of ethical oversight. The issues exposed by these failures have international relevance as they could possibly occur anywhere where human health research is carried out. Five factors that contributed to these failures are highlighted: 1. failure to support and resource research ethics committees; 2. failure of the research oversight process to adequately assess the risks and benefits of research, while giving undue emphasis to informed consent; 3. conflicts of interest arising from financial relationships and research ethics committee membership; 4. lack of consistent oversight of privately funded research; and 5. incompetent or intentional failure to adhere by ethical guidelines. There is considerable headway to be made in the United States, as in other countries, in the fostering and maintenance of robust systems of human research oversight.
2014-01-01
Gains in life expectancy around the world have increasingly placed pressure on governments to ensure that the elderly receive assistance with activities of daily living. This research examines the impact of government oversight of Medicaid payment policies on access to nursing home care services in the United States. Variation in price levels induced by a federal policy shift in 1997 is used to identify the effect of Medicaid reimbursements on the number of nursing homes and beds available. Court rulings prior to the policy change are used to categorically define a range of oversight treatments at the state level. Difference-in-differences estimates indicate a significant decline in access to nursing home care services for individuals living in states in which courts consistently ruled that Medicaid reimbursements did not meet the minimum standard implied by federal law. The findings suggest that nursing home care services were made more accessible through a combination of legislative and judicial oversight of Medicaid payment policies. PMID:25526725
Chung, Rick
2012-06-01
Patient empowerment has increased the demand for direct to consumer (DTC) laboratory testing. Multiple professional societies and advocacy groups have raised concerns over how DTC laboratory testing is being offered to consumers without proper physician oversight. Physician telehealth services can properly oversee DTC laboratory testing in a safe and medically sound manner. Using telehealth protocols and standards established by professional health organizations and state regulators, physician telehealth oversight in DTC laboratory test ordering can be effective to increase patient access to healthcare services. With proper physician oversight in test interpretation, post-test counseling, and information collaboration, DTC laboratory testing can remain a reliable and convenient option for consumers. Working within the channel of distribution of most DTC laboratory testing, physician telehealth services can properly oversee DTC laboratory testing in a safe and medically sound manner to ensure that proper test interpretation, counseling, and information collaboration are achieved. Physician telehealth services can properly oversee DTC laboratory testing to ensure that proper test interpretation, counseling, and information collaboration are achieved.
Institutional Oversight of Occupational Health and Safety for Research Programs Involving Biohazards
Dyson, Melissa C; Carpenter, Calvin B; Colby, Lesley A
2017-01-01
Research with hazardous biologic materials (biohazards) is essential to the progress of medicine and science. The field of microbiology has rapidly advanced over the years, partially due to the development of new scientific methods such as recombinant DNA technology, synthetic biology, viral vectors, and the use of genetically modified animals. This research poses a potential risk to personnel as well as the public and the environment. Institutions must have appropriate oversight and take appropriate steps to mitigate the risks of working with these biologic hazards. This article will review responsibilities for institutional oversight of occupational health and safety for research involving biologic hazards. PMID:28662748
Xiong, Yongliang
2016-04-16
Here, Gautier et al. (2014) recently published their determination of hydromagnesite solubility constant and hydromagnesite growth kinetics. Although their raw data appear to be of high quality, there is an oversight in their calculations of the hydromagnesite solubility constants given the solution compositions in their experiments. The oversight lies in the fact that they did not consider the constraint of simultaneous equilibrium with brucite. This oversight causes their newly calculated equilibrium constant for hydromagnesite to be discordant with the literature values (Königsberger et al., 1992 and Xiong, 2011).
Dyson, Melissa C; Carpenter, Calvin B; Colby, Lesley A
2017-06-01
Research with hazardous biologic materials (biohazards) is essential to the progress of medicine and science. The field of microbiology has rapidly advanced over the years, partially due to the development of new scientific methods such as recombinant DNA technology, synthetic biology, viral vectors, and the use of genetically modified animals. This research poses a potential risk to personnel as well as the public and the environment. Institutions must have appropriate oversight and take appropriate steps to mitigate the risks of working with these biologic hazards. This article will review responsibilities for institutional oversight of occupational health and safety for research involving biologic hazards.
Transparency and Oversight in Local Wellness Policies
ERIC Educational Resources Information Center
Chriqui, Jamie F.; Chaloupka, Frank J.
2011-01-01
Background: Advocates have called for increased wellness policy transparency and oversight through the use of health advisory councils. This study examines (1) wellness policy transparency, (2) advisory council requirements, (3) factors associated with each, and (4) whether transparency or advisory council requirements are indicative of a stronger…
DOT National Transportation Integrated Search
2002-01-01
The FMCSA is proposing to revise its regulatory oversight of Mexico-domiciled Commercial Motor Carriers (CMC) through a series of four rulemakings. The purpose of the four proposed rules is to protect the health and safety of the general public, by e...
14 CFR 26.23 - Extended limit of validity.
Code of Federal Regulations, 2011 CFR
2011-01-01
... revision or supplement, as applicable, to the Airworthiness Limitations section (ALS) of the Instructions... Oversight Office for approval. The revised ALS or supplement to the ALS must include the applicable extended... documented as airworthiness limitation items in the ALS and submitted to the FAA Oversight Office for...
14 CFR 26.23 - Extended limit of validity.
Code of Federal Regulations, 2014 CFR
2014-01-01
... revision or supplement, as applicable, to the Airworthiness Limitations section (ALS) of the Instructions... Oversight Office for approval. The revised ALS or supplement to the ALS must include the applicable extended... documented as airworthiness limitation items in the ALS and submitted to the FAA Oversight Office for...
14 CFR 26.23 - Extended limit of validity.
Code of Federal Regulations, 2013 CFR
2013-01-01
... revision or supplement, as applicable, to the Airworthiness Limitations section (ALS) of the Instructions... Oversight Office for approval. The revised ALS or supplement to the ALS must include the applicable extended... documented as airworthiness limitation items in the ALS and submitted to the FAA Oversight Office for...
14 CFR 26.23 - Extended limit of validity.
Code of Federal Regulations, 2012 CFR
2012-01-01
... revision or supplement, as applicable, to the Airworthiness Limitations section (ALS) of the Instructions... Oversight Office for approval. The revised ALS or supplement to the ALS must include the applicable extended... documented as airworthiness limitation items in the ALS and submitted to the FAA Oversight Office for...
77 FR 50091 - Privacy Act of 1974; System of Records
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-20
..., prosecution, or oversight of violations of administrative, civil, or criminal law or regulation. This system... oversight of violations of administrative, civil, or criminal law or regulation, if that information is... necessary information and to coordinate with other law enforcement agencies as appropriate. DATES: The...
76 FR 2805 - Delegation of Authority to the Chief Accountant
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-18
... respect to proposed rule changes of the Public Company Accounting Oversight Board pursuant to Section 107... effectiveness and efficiency of the Commission's PCAOB proposed rule filing process. DATES: Effective Date...''),\\1\\ proposed rules of the Public Company Accounting Oversight Board (``PCAOB'') are governed by...
49 CFR 659.15 - System safety program standard.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 7 2010-10-01 2010-10-01 false System safety program standard. 659.15 Section 659... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.15 System safety program standard. (a) General requirement. Each state...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-26
... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office; State, Local, Tribal, and Private Sector Policy Advisory Committee (SLTPS-PAC) AGENCY: National Archives and Records....m. to 12:00 noon. ADDRESSES: National Archives and Records Administration, 700 Pennsylvania Avenue...
Report: Enhanced EPA Oversight Needed to Address Risks From Declining Clean Air Act Title V Revenues
Report #15-P-0006, October 20, 2014. Weaknesses in the EPA's oversight of Title V revenues and expenditures jeopardize program implementation and, in turn, compliance with air regulations for many of the nation's largest sources of air pollution.
Report #2003-P-00002, November 4, 2002. Although some remediation progress has been made, Region 10 needs to further improve its oversight of Superfund remedial activities pertaining to Hanford’s 100-K Area.
15 CFR 2008.18 - Information Security Oversight Committee.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Information Security Oversight Committee. 2008.18 Section 2008.18 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE REGULATIONS TO IMPLEMENT E.O. 12065; OFFICE OF...
15 CFR 2008.18 - Information Security Oversight Committee.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 15 Commerce and Foreign Trade 3 2012-01-01 2012-01-01 false Information Security Oversight Committee. 2008.18 Section 2008.18 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE REGULATIONS TO IMPLEMENT E.O. 12065; OFFICE OF...
15 CFR 2008.18 - Information Security Oversight Committee.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 15 Commerce and Foreign Trade 3 2014-01-01 2014-01-01 false Information Security Oversight Committee. 2008.18 Section 2008.18 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE REGULATIONS TO IMPLEMENT E.O. 12065; OFFICE OF...
15 CFR 2008.18 - Information Security Oversight Committee.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 15 Commerce and Foreign Trade 3 2013-01-01 2013-01-01 false Information Security Oversight Committee. 2008.18 Section 2008.18 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE REGULATIONS TO IMPLEMENT E.O. 12065; OFFICE OF...
15 CFR 2008.18 - Information Security Oversight Committee.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 15 Commerce and Foreign Trade 3 2011-01-01 2011-01-01 false Information Security Oversight Committee. 2008.18 Section 2008.18 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE REGULATIONS TO IMPLEMENT E.O. 12065; OFFICE OF...
Taymour, Rekar K; Abir, Mahshid; Chamberlin, Margaret; Dunne, Robert B; Lowell, Mark; Wahl, Kathy; Scott, Jacqueline
2018-02-01
Introduction In a 2015 report, the Institute of Medicine (IOM; Washington, DC USA), now the National Academy of Medicine (NAM; Washington, DC USA), stated that the field of Emergency Medical Services (EMS) exhibits signs of fragmentation; an absence of system-wide coordination and planning; and a lack of federal, state, and local accountability. The NAM recommended clarifying what roles the federal government, state governments, and local communities play in the oversight and evaluation of EMS system performance, and how they may better work together to improve care. This systematic literature review and environmental scan addresses NAM's recommendations by answering two research questions: (1) what aspects of EMS systems are most measured in the peer-reviewed and grey literatures, and (2) what do these measures and studies suggest for high-quality EMS oversight? To answer these questions, a systematic literature review was conducted in the PubMed (National Center for Biotechnology Information, National Institutes of Health; Bethesda, Maryland USA), Web of Science (Thomson Reuters; New York, New York USA), SCOPUS (Elsevier; Amsterdam, Netherlands), and EMBASE (Elsevier; Amsterdam, Netherlands) databases for peer-reviewed literature and for grey literature; targeted web searches of 10 EMS-related government agencies and professional organizations were performed. Inclusion criteria required peer-reviewed literature to be published between 1966-2016 and grey literature to be published between 1996-2016. A total of 1,476 peer-reviewed titles were reviewed, 76 were retrieved for full-text review, and 58 were retained and coded in the qualitative software Dedoose (Manhattan Beach, California USA) using a codebook of themes. Categorizations of measure type and level of application were assigned to the extracted data. Targeted websites were systematically reviewed and 115 relevant grey literature documents were retrieved. A total of 58 peer-reviewed articles met inclusion criteria; 46 included process, 36 outcomes, and 18 structural measures. Most studies applied quality measures at the personnel level (40), followed by the agency (28) and system of care (28), and few at the oversight level (5). Numerous grey literature articles provided principles for high-quality EMS oversight. Limited quality measurement at the oversight level is an important gap in the peer-reviewed literature. The grey literature is ahead in this realm and can guide the policy and research agenda for EMS oversight quality measurement. Taymour RK , Abir M , Chamberlin M , Dunne RB , Lowell M , Wahl K , Scott J . Policy, practice, and research agenda for Emergency Medical Services oversight: a systematic review and environmental scan. Prehosp Disaster Med. 2018;33(1):89-97.
49 CFR 1.33 - Assistant Secretary for Budget and Programs and Chief Financial Officer.
Code of Federal Regulations, 2012 CFR
2012-10-01
... Programs and CFO, in consultation with the Chief Information Officer, may designate any information technology system as a financial management system under the CFO's policy and oversight area of... oversight and policy guidance for all budget, financial management, program performance, and internal...
49 CFR 1.33 - Assistant Secretary for Budget and Programs and Chief Financial Officer.
Code of Federal Regulations, 2014 CFR
2014-10-01
... Programs and CFO, in consultation with the Chief Information Officer, may designate any information technology system as a financial management system under the CFO's policy and oversight area of... oversight and policy guidance for all budget, financial management, program performance, and internal...
49 CFR 1.33 - Assistant Secretary for Budget and Programs and Chief Financial Officer.
Code of Federal Regulations, 2013 CFR
2013-10-01
... Programs and CFO, in consultation with the Chief Information Officer, may designate any information technology system as a financial management system under the CFO's policy and oversight area of... oversight and policy guidance for all budget, financial management, program performance, and internal...
31 CFR 205.29 - What are the State oversight and compliance responsibilities?
Code of Federal Regulations, 2010 CFR
2010-07-01
... 31 Money and Finance: Treasury 2 2010-07-01 2010-07-01 false What are the State oversight and compliance responsibilities? 205.29 Section 205.29 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) FISCAL SERVICE, DEPARTMENT OF THE TREASURY FINANCIAL MANAGEMENT SERVICE RULES...
Getting a Handle on Academic Quality
ERIC Educational Resources Information Center
Massy, William F.; Graham, Steven W.; Short, Paula Myrick
2007-01-01
The quality of teaching, more than ever, is seen as the all-important results area for colleges and universities. Few board members would dispute the importance of teaching or their responsibility for exercising oversight over its quality and continuous improvement. Yet there is little consensus about how to accomplish such oversight. Few board…
Report #11-P-0706, September 26, 2011. As a support agency to the Coast Guard, EPA’s oversight of the Gulf Coast oil spill waste management activities provided assurance that oil-contaminated waste was disposed of properly.
California Charter Oversight: Key Elements and Actual Costs. CRB Briefly Stated
ERIC Educational Resources Information Center
Blanton, Rebecca E.
2012-01-01
The Legislature mandated the California Research Bureau (CRB) explore known best practices for charter school authorizers and survey California authorizers about their practices and costs. Additionally, the Legislature mandated CRB provide an analysis of current reimbursement for charter school oversight and include suggestions for improving…
Security Clearance Oversight and Reform Enhancement Act
Sen. Tester, Jon [D-MT
2013-07-10
House - 10/11/2013 Referred to the House Committee on Oversight and Government Reform. (All Actions) Notes: For further action, see H.R.2860, which became Public Law 113-80 on 2/12/2014. Tracker: This bill has the status Passed SenateHere are the steps for Status of Legislation:
42 CFR 495.366 - Financial oversight and monitoring of expenditures.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 42 Public Health 5 2014-10-01 2014-10-01 false Financial oversight and monitoring of expenditures. 495.366 Section 495.366 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH... are not hospital-based including the determination that substantially all health care services are not...
42 CFR 495.366 - Financial oversight and monitoring of expenditures.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 42 Public Health 5 2013-10-01 2013-10-01 false Financial oversight and monitoring of expenditures. 495.366 Section 495.366 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH... are not hospital-based including the determination that substantially all health care services are not...
42 CFR 495.366 - Financial oversight and monitoring of expenditures.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 42 Public Health 5 2010-10-01 2010-10-01 false Financial oversight and monitoring of expenditures. 495.366 Section 495.366 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH... are not hospital-based including the determination that substantially all health care services are not...
42 CFR 495.366 - Financial oversight and monitoring of expenditures.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 42 Public Health 5 2011-10-01 2011-10-01 false Financial oversight and monitoring of expenditures. 495.366 Section 495.366 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH... are not hospital-based including the determination that substantially all health care services are not...
42 CFR 495.366 - Financial oversight and monitoring of expenditures.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 42 Public Health 5 2012-10-01 2012-10-01 false Financial oversight and monitoring of expenditures. 495.366 Section 495.366 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH... are not hospital-based including the determination that substantially all health care services are not...
49 CFR 659.23 - System security plan: contents.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 49 Transportation 7 2014-10-01 2014-10-01 false System security plan: contents. 659.23 Section 659.23 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.23 System security...
14 CFR 1203b.108 - Management oversight.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Management oversight. 1203b.108 Section 1203b.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SECURITY PROGRAMS; ARREST...) Demonstrate knowledge and skill in the use of unarmed defense techniques and their assigned firearms. (d) The...
Management and Capability ot the Major Range and Test Facility Bases
1995-07-27
The audit objective was to evaluate management oversight provided to the test ranges and determine whether management oversight could be streamlined... The audit also evaluated whether program managers were procuring test resources that already existed at the test ranges. Management controls related to the objectives were also evaluated.
2001-02-28
statements and to report on the adequacy of internal controls and compliance with laws and regulations. We contracted the audit of the FY 2000 Military...performed on the oversight of the audit of the FY 2000 Military Retirement Fund Financial Statements.
45 CFR 153.260 - General oversight requirements for State-operated reinsurance programs.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 45 Public Welfare 1 2014-10-01 2014-10-01 false General oversight requirements for State-operated reinsurance programs. 153.260 Section 153.260 Public Welfare Department of Health and Human Services REQUIREMENTS RELATING TO HEALTH CARE ACCESS STANDARDS RELATED TO REINSURANCE, RISK CORRIDORS, AND RISK...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-16
...; Securities Exchange Act of 1934 Release No. 63526/December 10, 2010] Order Approving Public Company... Company Accounting Oversight Board (the ``PCAOB'') to oversee the audits of companies and related matters..., subject to approval by the Commission, auditing and related attestation, quality control, ethics, and...
Budgeting for Higher Education and the Legislative Oversight Process.
ERIC Educational Resources Information Center
Southern Regional Education Board, Atlanta, GA.
Five papers are presented from a legislative seminar on budgeting for higher education and the legislative oversight process. In "Budgeting: A University Perspective," Jack K. Williams addresses the preparation of an institutional budget, what legislators should know about budgets, plans for no-growth or retrenchment, and the importance…
42 CFR 54a.9 - Oversight of the Charitable Choice requirements.
Code of Federal Regulations, 2012 CFR
2012-10-01
...., FOR SUBSTANCE ABUSE PREVENTION AND TREATMENT SERVICES § 54a.9 Oversight of the Charitable Choice requirements. In order to ensure that program funds are used in compliance with the SAMHSA Charitable Choice provisions, applicants for funds under applicable programs are required, as part of their applications for...
42 CFR 54a.9 - Oversight of the Charitable Choice requirements.
Code of Federal Regulations, 2014 CFR
2014-10-01
...., FOR SUBSTANCE ABUSE PREVENTION AND TREATMENT SERVICES § 54a.9 Oversight of the Charitable Choice requirements. In order to ensure that program funds are used in compliance with the SAMHSA Charitable Choice provisions, applicants for funds under applicable programs are required, as part of their applications for...
42 CFR 54a.9 - Oversight of the Charitable Choice requirements.
Code of Federal Regulations, 2011 CFR
2011-10-01
...., FOR SUBSTANCE ABUSE PREVENTION AND TREATMENT SERVICES § 54a.9 Oversight of the Charitable Choice requirements. In order to ensure that program funds are used in compliance with the SAMHSA Charitable Choice provisions, applicants for funds under applicable programs are required, as part of their applications for...
42 CFR 54a.9 - Oversight of the Charitable Choice requirements.
Code of Federal Regulations, 2010 CFR
2010-10-01
...., FOR SUBSTANCE ABUSE PREVENTION AND TREATMENT SERVICES § 54a.9 Oversight of the Charitable Choice requirements. In order to ensure that program funds are used in compliance with the SAMHSA Charitable Choice provisions, applicants for funds under applicable programs are required, as part of their applications for...
42 CFR 54a.9 - Oversight of the Charitable Choice requirements.
Code of Federal Regulations, 2013 CFR
2013-10-01
...., FOR SUBSTANCE ABUSE PREVENTION AND TREATMENT SERVICES § 54a.9 Oversight of the Charitable Choice requirements. In order to ensure that program funds are used in compliance with the SAMHSA Charitable Choice provisions, applicants for funds under applicable programs are required, as part of their applications for...
Project #OPE-FY12-0009, February 14, 2013. The U.S. Environmental Protection Agency’s Office of Inspector General plans to begin the fieldwork phase of an evaluation of EPA’s Oversight of Clean Air Act Title V Emissions Fees.
49 CFR 659.19 - System safety program plan: contents.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 49 Transportation 7 2012-10-01 2012-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...
49 CFR 659.19 - System safety program plan: contents.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 7 2011-10-01 2011-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...
49 CFR 659.19 - System safety program plan: contents.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 49 Transportation 7 2013-10-01 2013-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...
49 CFR 659.19 - System safety program plan: contents.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 49 Transportation 7 2014-10-01 2014-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-13
... and physical environment of the reserve, research to date and research gaps. Reserves revise their... Collection; Comment Request; Management and Oversight of the National Estuarine Research Reserve System... estuarine research reserves representative of various regions and estuarine types in the United States to...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-28
... describe the biological and physical environment of the reserve, research to date and research gaps. A... Collection; Comment Request; Management and Oversight of the National Estuarine Research Reserve System....) provides for the designation of estuarine research reserves representative of various regions and estuarine...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-14
...: Doreen Solomon, Assistant Director for Oversight on (202) 307-2829 (not a toll-free number), Wendy Tien, Deputy Assistant Director for Oversight on (202) 307-3698 (not a toll- free number), or Larry Wahlquist, Office of the General [[Page 16160
Project #OA-FY17-0382, October 6, 2017 - The EPA OIG plans to expand the scope of preliminary research on the EPA’s adherence to policies, procedures and oversight controls pertaining to the Administrator’s travel.
49 CFR 659.19 - System safety program plan: contents.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 7 2010-10-01 2010-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...
48 CFR 936.609-3 - Work oversight in architect-engineer contracts.
Code of Federal Regulations, 2012 CFR
2012-10-01
... architect-engineer contracts. 936.609-3 Section 936.609-3 Federal Acquisition Regulations System DEPARTMENT OF ENERGY SPECIAL CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 936.609-3 Work oversight in architect-engineer contracts. In addition to the clause at 48...
48 CFR 936.609-3 - Work oversight in architect-engineer contracts.
Code of Federal Regulations, 2014 CFR
2014-10-01
... architect-engineer contracts. 936.609-3 Section 936.609-3 Federal Acquisition Regulations System DEPARTMENT OF ENERGY SPECIAL CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 936.609-3 Work oversight in architect-engineer contracts. In addition to the clause at 48...
48 CFR 936.609-3 - Work oversight in architect-engineer contracts.
Code of Federal Regulations, 2013 CFR
2013-10-01
... architect-engineer contracts. 936.609-3 Section 936.609-3 Federal Acquisition Regulations System DEPARTMENT OF ENERGY SPECIAL CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 936.609-3 Work oversight in architect-engineer contracts. In addition to the clause at 48...
48 CFR 936.609-3 - Work oversight in architect-engineer contracts.
Code of Federal Regulations, 2011 CFR
2011-10-01
... architect-engineer contracts. 936.609-3 Section 936.609-3 Federal Acquisition Regulations System DEPARTMENT OF ENERGY SPECIAL CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 936.609-3 Work oversight in architect-engineer contracts. In addition to the clause at 48...
48 CFR 936.609-3 - Work oversight in architect-engineer contracts.
Code of Federal Regulations, 2010 CFR
2010-10-01
... architect-engineer contracts. 936.609-3 Section 936.609-3 Federal Acquisition Regulations System DEPARTMENT OF ENERGY SPECIAL CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 936.609-3 Work oversight in architect-engineer contracts. In addition to the clause at 48...
49 CFR 659.21 - System security plan: general requirements.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 7 2010-10-01 2010-10-01 false System security plan: general requirements. 659.21... State Oversight Agency § 659.21 System security plan: general requirements. (a) The oversight agency shall require the rail transit agency to implement a system security plan that, at a minimum, complies...
78 FR 78864 - Comparability Determination for Australia: Certain Entity-Level Requirements
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-27
... authority to support and enforce its oversight of the registrant. In this context, comparable does not... enforce its oversight of the registrant.\\18\\ \\18\\ 78 FR 45343. In making a comparability determination... effective systemic risk management for the overall swaps market. In making its comparability determination...
78 FR 12802 - Sunshine Act Meetings
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-25
... PRIVACY AND CIVIL LIBERTIES OVERSIGHT BOARD [Notice-PCLOB-2013-02; Docket No. 2013-0004; Sequence... public. The rest of the meeting will be closed to the public. MATTERS TO BE CONSIDERED: The Privacy and... 21, 2013. Claire McKenna, Legal Counsel, Privacy and Civil Liberties Oversight Board. [FR Doc. 2013...
48 CFR 52.236-18 - Work Oversight in Cost-Reimbursement Construction Contracts.
Code of Federal Regulations, 2010 CFR
2010-10-01
...-Reimbursement Construction Contracts. 52.236-18 Section 52.236-18 Federal Acquisition Regulations System FEDERAL... Provisions and Clauses 52.236-18 Work Oversight in Cost-Reimbursement Construction Contracts. As prescribed in 36.518, insert the following clause in solicitations and contracts when cost-reimbursement...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-28
... Accounting Oversight Board Budget and Annual Accounting Support Fee for Calendar Year 2011 The Sarbanes-Oxley Act of 2002, as amended (the ``Sarbanes-Oxley Act''), established the Public Company Accounting... through registration of public accounting firms and standard setting, inspection, and disciplinary...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-20
... Accounting Oversight Board Budget and Annual Accounting Support Fee for Calendar Year 2013 The Sarbanes-Oxley Act of 2002, as amended (the ``Sarbanes-Oxley Act''),\\1\\ established the Public Company Accounting... through registration of public accounting firms and standard setting, inspection, and disciplinary...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-18
... Accounting Oversight Board Budget and Annual Accounting Support Fee for Calendar Year 2012 The Sarbanes-Oxley Act of 2002, as amended (the ``Sarbanes-Oxley Act''),\\1\\ established the Public Company Accounting... through registration of public accounting firms and standard setting, inspection, and disciplinary...
Report #15-P-0204, July 16, 2015. Enhanced EPA oversight of the permitting process for diesel fuel use during hydraulic fracturing can further EPA efforts to protect water resources, and establishment of a plan for determining whether to propose a chemical
20 CFR 411.595 - What oversight procedures are planned for the EN payment systems?
Code of Federal Regulations, 2013 CFR
2013-04-01
... EN payment systems? 411.595 Section 411.595 Employees' Benefits SOCIAL SECURITY ADMINISTRATION THE TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM Employment Network Payment Systems § 411.595 What oversight... activities to identify areas for improvement. Internal reviews of our systems security controls are regularly...
20 CFR 411.595 - What oversight procedures are planned for the EN payment systems?
Code of Federal Regulations, 2012 CFR
2012-04-01
... EN payment systems? 411.595 Section 411.595 Employees' Benefits SOCIAL SECURITY ADMINISTRATION THE TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM Employment Network Payment Systems § 411.595 What oversight... activities to identify areas for improvement. Internal reviews of our systems security controls are regularly...
20 CFR 411.595 - What oversight procedures are planned for the EN payment systems?
Code of Federal Regulations, 2014 CFR
2014-04-01
... EN payment systems? 411.595 Section 411.595 Employees' Benefits SOCIAL SECURITY ADMINISTRATION THE TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM Employment Network Payment Systems § 411.595 What oversight... activities to identify areas for improvement. Internal reviews of our systems security controls are regularly...
20 CFR 411.595 - What oversight procedures are planned for the EN payment systems?
Code of Federal Regulations, 2010 CFR
2010-04-01
... EN payment systems? 411.595 Section 411.595 Employees' Benefits SOCIAL SECURITY ADMINISTRATION THE TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM Employment Network Payment Systems § 411.595 What oversight... activities to identify areas for improvement. Internal reviews of our systems security controls are regularly...
20 CFR 411.595 - What oversight procedures are planned for the EN payment systems?
Code of Federal Regulations, 2011 CFR
2011-04-01
... EN payment systems? 411.595 Section 411.595 Employees' Benefits SOCIAL SECURITY ADMINISTRATION THE TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM Employment Network Payment Systems § 411.595 What oversight... activities to identify areas for improvement. Internal reviews of our systems security controls are regularly...
20 CFR 603.5 - What are the exceptions to the confidentiality requirement?
Code of Federal Regulations, 2010 CFR
2010-04-01
... determinations on coverage of employers, employment, and wages, is permissible provided all social security... Oversight and Audits. The confidentiality requirement does not apply to any disclosure to a Federal official for purposes of UC program oversight and audits, including disclosures under 20 CFR part 601 and 29...
20 CFR 603.5 - What are the exceptions to the confidentiality requirement?
Code of Federal Regulations, 2011 CFR
2011-04-01
... determinations on coverage of employers, employment, and wages, is permissible provided all social security... Oversight and Audits. The confidentiality requirement does not apply to any disclosure to a Federal official for purposes of UC program oversight and audits, including disclosures under 20 CFR part 601 and 29...
49 CFR 659.39 - Oversight agency reporting to the Federal Transit Administration.
Code of Federal Regulations, 2010 CFR
2010-10-01
..., must make its initial submission to FTA by May 1, 2006. In states with rail fixed guideway systems... must make a new initial submission to FTA within thirty (30) days of the designation. (b) An initial... must submit the following to FTA: (1) A publicly available annual report summarizing its oversight...
49 CFR 659.9 - Designation of oversight agency.
Code of Federal Regulations, 2010 CFR
2010-10-01
... to review by FTA. (b) Exception. States which have designated oversight agencies for purposes of this part before May 31, 2005 are not required to re-designate to FTA. (c) Timing. The state designation of... project between FTA and a rail transit agency within the state's jurisdiction; or (2) Occur before the...
Oversight of Department of Defense Reconstruction Projects in Afghanistan
2016-03-16
had to reschedule some of our site visits multiple times due to security conditions. As an alternative means for conducting oversight, due to a limited...employed less than 20 percent of the staff it was expected to employ. According to the doctors and nurses on site during our inspection, the limited
AGB Statement on Board Responsibility for the Oversight of Educational Quality
ERIC Educational Resources Information Center
Association of Governing Boards of Universities and Colleges, 2011
2011-01-01
This "Statement on Board Responsibility for the Oversight of Educational Quality," approved by the Board of Directors of the Association of Governing Boards (AGB) in March 2011, urges institutional administrators and governing boards to engage fully in this area of board responsibility. The seven principles in this statement offer suggestions to…
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-30
... Standards Board (``ASB'') of the American Institute of Certified Public Accountants); and observations from... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63606; File No. PCAOB 2010-01] Public Company.... Introduction On September 15, 2010, the Public Company Accounting Oversight Board (the ``Board'' or the ``PCAOB...
Report #13-P-0264, May 23, 2013. Since the 1980s, EPA has had an oversight process, known as Permit Quality Reviews (PQRs), to promote permit quality and ensure a reasonable degree of national consistency with regard to core program requirements.
A Voice Crying in the Wilderness: Legislative Oversight Agencies' Efforts to Achieve Utilization
ERIC Educational Resources Information Center
VanLandingham, Gary R.
2006-01-01
While legislative oversight offices, like many evaluation and policy analysis units, face substantial challenges in promoting use of their work by policymakers, they often have not taken steps to overcome these challenges by adopting the strategies suggested by the evaluation literature. Although the offices seek utilization, they have not fully…
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-28
..., Department of Labor; Office of Consumer Information and Insurance Oversight, Department of Health and Human... group health plans and health insurance issuers can employ value-based insurance design in the coverage... Insurance Oversight, Department of Health and Human Services, Attention: HHS-OS- 2010-002, Room 445-G...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-29
... risk-based approach to the oversight of clinical investigations. It does not create or confer any... a range of approaches to monitoring. FDA currently has OMB approval for the information collection... Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or...
ERIC Educational Resources Information Center
O'Regan, Katherine; Oster, Sharon
2002-01-01
Government contracting has raised a collection of issues with respect to adequate oversight and accountability. This paper explores one avenue through which contracting agencies may achieve these tasks: through the governance practices of the contractor's board. Oversight and monitoring are a board's key responsibilities, and influencing a board's…
42 CFR 460.71 - Oversight of direct participant care.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 42 Public Health 4 2014-10-01 2014-10-01 false Oversight of direct participant care. 460.71 Section 460.71 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... plan, ethics, the PACE benefit, and any policies related to the job duties of specific staff. (2) The...
42 CFR 460.71 - Oversight of direct participant care.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 42 Public Health 4 2012-10-01 2012-10-01 false Oversight of direct participant care. 460.71 Section 460.71 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... plan, ethics, the PACE benefit, and any policies related to the job duties of specific staff. (2) The...
49 CFR 659.41 - Conflict of interest.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 7 2010-10-01 2010-10-01 false Conflict of interest. 659.41 Section 659.41... Agency § 659.41 Conflict of interest. The oversight agency shall prohibit a party or entity from providing services to both the oversight agency and rail transit agency when there is a conflict of interest...
9 CFR 92.2 - Application for recognition of the animal health status of a region.
Code of Federal Regulations, 2013 CFR
2013-01-01
... being requested. (2) Veterinary control and oversight. (3) Disease history and vaccination practices. (4.... (2) Veterinary control and oversight. (3) Disease history and vaccination practices (4) Disease... in English and must be sent to the Administrator, c/o National Center for Import and Export, VS...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0274] Oversight of Laboratory Developed Tests; Public Meeting; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of the comment period. SUMMARY: The Food and Drug...
78 FR 78923 - Comparability Determination for the European Union: Certain Entity-Level Requirements
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-27
... authority to support and enforce its oversight of the registrant. In this context, comparable does not... jurisdiction's authority to support and enforce its oversight of the registrant.\\23\\ \\23\\ 78 FR 45343. In... with respect to their swaps activities,\\41\\ which is critical to effective systemic risk management for...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-30
... Parts 30 and 3400 SAFE Mortgage Licensing Act: Minimum Licensing Standards and Oversight... No. FR-5271-F-03] RIN 2502-A170 SAFE Mortgage Licensing Act: Minimum Licensing Standards and... pursuant to the Secure and Fair Enforcement Mortgage Licensing Act of 2008 (SAFE Act or Act), to ensure...
Designated Medical Directors for Emergency Medical Services: Recruitment and Roles
ERIC Educational Resources Information Center
Slifkin, Rebecca T.; Freeman, Victoria A.; Patterson, P. Daniel
2009-01-01
Context: Emergency medical services (EMS) agencies rely on medical oversight to support Emergency Medical Technicians (EMTs) in the provision of prehospital care. Most states require EMS agencies to have a designated medical director (DMD), who typically is responsible for the many activities of medical oversight. Purpose: To assess rural-urban…
Code of Federal Regulations, 2010 CFR
2010-10-01
... compliance of health and safety codes during construction projects being performed by a Self-Governance Tribe... SERVICES TRIBAL SELF-GOVERNANCE Construction Roles of the Secretary in Establishing and Implementing Construction Project Agreements § 137.368 Is the Secretary responsible for oversight and compliance of health...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-07
... Microbiological Effects on Bacteria of Human Health Concern'' ( http://www.fda.gov/AnimalVeterinary/Guidance... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1046] Veterinary Oversight of Antimicrobial Use in Livestock: Impact on Stakeholders; Public Meetings; Request for...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0080... and Drug Administration (FDA) is announcing the availability of a guidance entitled ``FDA Oversight of... nearly all aspects of the FDA approval and surveillance processes, including application submission...
14 CFR 158.71 - Federal oversight.
Code of Federal Regulations, 2013 CFR
2013-01-01
... PASSENGER FACILITY CHARGES (PFC'S) Reporting, Recordkeeping and Audits § 158.71 Federal oversight. (a) The Administrator may periodically audit and/or review the use of PFC revenue by a public agency. The purpose of the... records pertinent to PFC's [Doc. No. 26385, 56 FR 24278, May 29, 1991, as amended by Amdt. 158-2, 65 FR...
14 CFR 158.71 - Federal oversight.
Code of Federal Regulations, 2014 CFR
2014-01-01
... PASSENGER FACILITY CHARGES (PFC'S) Reporting, Recordkeeping and Audits § 158.71 Federal oversight. (a) The Administrator may periodically audit and/or review the use of PFC revenue by a public agency. The purpose of the... records pertinent to PFC's [Doc. No. 26385, 56 FR 24278, May 29, 1991, as amended by Amdt. 158-2, 65 FR...
14 CFR 158.71 - Federal oversight.
Code of Federal Regulations, 2010 CFR
2010-01-01
... PASSENGER FACILITY CHARGES (PFC'S) Reporting, Recordkeeping and Audits § 158.71 Federal oversight. (a) The Administrator may periodically audit and/or review the use of PFC revenue by a public agency. The purpose of the... records pertinent to PFC's [Doc. No. 26385, 56 FR 24278, May 29, 1991, as amended by Amdt. 158-2, 65 FR...
14 CFR 158.71 - Federal oversight.
Code of Federal Regulations, 2011 CFR
2011-01-01
... PASSENGER FACILITY CHARGES (PFC'S) Reporting, Recordkeeping and Audits § 158.71 Federal oversight. (a) The Administrator may periodically audit and/or review the use of PFC revenue by a public agency. The purpose of the... records pertinent to PFC's [Doc. No. 26385, 56 FR 24278, May 29, 1991, as amended by Amdt. 158-2, 65 FR...
14 CFR 158.71 - Federal oversight.
Code of Federal Regulations, 2012 CFR
2012-01-01
... PASSENGER FACILITY CHARGES (PFC'S) Reporting, Recordkeeping and Audits § 158.71 Federal oversight. (a) The Administrator may periodically audit and/or review the use of PFC revenue by a public agency. The purpose of the... records pertinent to PFC's [Doc. No. 26385, 56 FR 24278, May 29, 1991, as amended by Amdt. 158-2, 65 FR...
Sikes, Robert S; Bryan, John A
2016-01-01
Ethical and effective oversight of the use of wildlife species in research and education requires consideration of issues and methods not relevant to work with traditional laboratory or domesticated animals, just as the effective oversight of biomedical research requires consideration of issues and methods not germane to wildlife research. Institutional Animal Care and Use Committees or other institutional review committees can meet their responsibilities in these disparate types of animal activities only by using resources tailored to the animals and situations encountered. Here we review the issues and the resources that facilitate effective oversight of such activities in the wildlife research arena available to researchers, institutional review committees, regulatory bodies, and accrediting bodies. Issues covered include an understanding of the fundamental differences between wildlife research and biomedical research; the profound differences between wildlife species and traditional laboratory subjects, most of which are domesticated animals; and the unique issues presented when the research subjects are members of wild populations and communities. We review the resources available for effective oversight of wildlife projects and emphasize that competent oversight of wildlife research demands the use of appropriate resources. These resources include guidelines designed for the use of wild species (taxon-specific guidelines) and protocol forms tailored for the species and situations encountered. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.
Verghese, Abraham; Charlton, Blake; Kassirer, Jerome P; Ramsey, Meghan; Ioannidis, John P A
2015-12-01
Oversights in the physical examination are a type of medical error not easily studied by chart review. They may be a major contributor to missed or delayed diagnosis, unnecessary exposure to contrast and radiation, incorrect treatment, and other adverse consequences. Our purpose was to collect vignettes of physical examination oversights and to capture the diversity of their characteristics and consequences. A cross-sectional study using an 11-question qualitative survey for physicians was distributed electronically, with data collected from February to June of 2011. The participants were all physicians responding to e-mail or social media invitations to complete the survey. There were no limitations on geography, specialty, or practice setting. Of the 208 reported vignettes that met inclusion criteria, the oversight was caused by a failure to perform the physical examination in 63%; 14% reported that the correct physical examination sign was elicited but misinterpreted, whereas 11% reported that the relevant sign was missed or not sought. Consequence of the physical examination inadequacy included missed or delayed diagnosis in 76% of cases, incorrect diagnosis in 27%, unnecessary treatment in 18%, no or delayed treatment in 42%, unnecessary diagnostic cost in 25%, unnecessary exposure to radiation or contrast in 17%, and complications caused by treatments in 4%. The mode of the number of physicians missing the finding was 2, but many oversights were missed by many physicians. Most oversights took up to 5 days to identify, but 66 took longer. Special attention and skill in examining the skin and its appendages, as well as the abdomen, groin, and genitourinary area could reduce the reported oversights by half. Physical examination inadequacies are a preventable source of medical error, and adverse events are caused mostly by failure to perform the relevant examination. Copyright © 2015 Elsevier Inc. All rights reserved.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 12 Banks and Banking 4 2010-01-01 2010-01-01 false What are the FDIC's oversight and monitoring responsibilities in administering this program? 361.5 Section 361.5 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION REGULATIONS AND STATEMENTS OF GENERAL POLICY MINORITY AND WOMEN OUTREACH PROGRAM CONTRACTING § 361...
Project Manager Performance and the Decision to Backsource the Project Management Office
ERIC Educational Resources Information Center
Lively, William R.
2014-01-01
This paper reviews a management decision of an Information Technology Outsource (ITO) provider to backshore the management oversight of its Project Management Office (PMO) after only one year of offshore operations. Governance is a term used in project management to refer to management oversight. The review is a quantitative analysis of existing…
Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-28
... requests or appeals on behalf of other persons or entities; individuals who are the subjects of FOIA or PA... number) information, and proof of identification; names and other information about persons who are the... oversight function. E. To appropriate agencies, entities, and persons when: 1. The Board suspects or has...
Code of Federal Regulations, 2011 CFR
2011-04-01
... of Market Oversight or, in his or her absence, each Deputy Director of the Division of Market Oversight, the Director of the Market Surveillance Section, the Director of the Division of Clearing and... jurisdiction, provided that the Commission official making the disclosure is satisfied that the information...
77 FR 6411 - Training, Qualification, and Oversight for Safety-Related Railroad Employees
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-07
... equipment is in a service that constitutes a train movement under part 232 of this chapter; [and] (6... Administration 49 CFR Parts 214, 232, and 243 Training, Qualification, and Oversight for Safety-Related Railroad..., 232, and 243 [Docket No. FRA-2009-0033, Notice No. 1] RIN 2130-AC06 Training, Qualification, and...
2007-11-30
Affairs Dr. Michael J. Kussman , in U.S. Congress, House Committee on Veterans’ Affairs Subcommittee on Oversight and Investigations, hearing on...Health, Department of Veterans Affairs, Michael Kussman , in U.S. Congress, House Committee on Appropriations, Subcommittee on Military Construction...Department of Veterans Affairs Dr. Michael J. Kussman , in U.S. Congress, House Committee on Veterans’ Affairs Subcommittee on Oversight and
ERIC Educational Resources Information Center
Jung, Steven M.; Proffitt, John
Perspectives on an American Institutes for Research (AIR) study of state oversight in postsecondary education, conducted for the U.S. Office of Education (USOE), are offered by researcher Steven M. Jung. In addition, a list of recommendations by the General Accounting Office concerning USOE's eligibility process and responses by John Proffitt, on…
ERIC Educational Resources Information Center
Smith-Boydston, Julianne M.; Holtzman, Rochelle J.; Roberts, Michael C.
2014-01-01
Background: Multisystemic therapy (MST) has been shown to be effective in treating delinquent behavior in youth. However, some community agencies with MST programs are unable to afford the ongoing costs of licensure and quality assurance oversight provided by MST services. Objective: The present study utilized retrospective archival analyses of…
Best Practices for Audit and Financial Advisory Committees Within the Department of Defense
2007-12-06
oversight of an organization’s annual financial statement audit, risk management plan, internal control framework, and compliance with external...is generally responsible for providing independent oversight of an organization’s annual financial statement audit, risk management plan, internal...achieving financial management objectives and identify areas of risk or concern. 40 11.2. Systems of Internal Controls
2012-10-01
earlier, LEMV experienced schedule delays of at least 10 months, largely rooted in technical, design, and engineering problems in scaling up the airship ...had informal coordination with the Blue Devil Block 2 effort in the past. For example, originally both airships had several diesel engine ...DEFENSE ACQUISITIONS Future Aerostat and Airship Investment Decisions Drive Oversight and Coordination Needs
ERIC Educational Resources Information Center
O'Malley, Michael P.; Roseboro, Donyell L.; Hunt, John
2012-01-01
This instrumental case study reviews the 1994-2004 period of state financial oversight in East St. Louis, Illinois School District 189, with a secondary review of the initial years of NCLB implementation. Although the oversight panel's fiscal management did generate financial stability, case findings indicate that its accountability processes did…
U.S. Army Acquisition Workforce: Reflecting Modern Structural Changes
2009-06-01
provisions ensuring oversight over a massive infusion of contracts, state grants and other measures. Interviews with acquisition workforce specialists... telecommuting .”3 Incentives for retaining qualified acquisition workforce members are discussed. Surveys were analyzed primarily for contextual...and the players who now have a voice in this expanded system. One major change was the use of the Joint Requirements Oversight Council (JROC
Accounting Profession: Oversight, Auditor Independence, and Financial Reporting Issues
2002-05-03
oversight of the accounting profession, auditor independence, and selected financial reporting matters. The sudden and largely unexpected bankruptcy of the...Enron Corporation (Enron) and other large corporations financial reporting restatements have raised questions about the soundness of the current self...regulatory and financial reporting systems and resulted in substantial losses to employees, shareholders, and other investors. These events have also
2016-05-01
DOD ADVERTISING Better Coordination, Performance Measurement, and Oversight Needed to Help Meet Recruitment Goals...Accountability Office Highlights of GAO-16-396, a report to congressional committees May 2016 DOD ADVERTISING Better Coordination, Performance...the military, DOD requested almost $575 million in fiscal year 2017 to conduct advertising intended to increase awareness of military service and
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-12
... Accounting Oversight Board; Notice of Filing of Proposed Board Funding Final Rules for Allocation of the...'' means the portion of the accounting support fee established by the Board that is to be allocated among... support fee'' means the portion of the accounting support fee established by the Board that is to be...
California Charter Oversight: Key Elements and Actual Costs. CRB 12-001
ERIC Educational Resources Information Center
Blanton, Rebecca E.
2012-01-01
This study was mandated by SB537 (Simitian, Chapter 650, Stats. of 2007, codified at Ed. Code Section 47613), which requires the California Research Bureau (CRB) to prepare and submit to the Legislature a report on the key elements and actual costs of charter school oversight. Charter schools are public schools that are operated by entities other…
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-17
... Vol. 77 Monday, No. 180 September 17, 2012 Part IV Securities and Exchange Commission Public Company Accounting Oversight Board; Notice of Filing of Proposed Rules on Auditing Standard No. 16, Communications With Audit Committees and Related and Transitional Amendments to PCAOB Standards; Notice #0;#0;Federal Register / Vol. 77, No. 180 / Monday,...
ERIC Educational Resources Information Center
Jacobs, Frederic; Zonnenberg, Arina
2004-01-01
This article (1) examines the overall structure of regulatory research oversight in the United States; (2) details the origins and evolution of federal legislation pertaining to the protection of human subjects in biomedical and behavioral treatment and research; and (3) describes the expansion of oversight regulation from biomedical and…
Governing nanobiotechnology: lessons from agricultural biotechnology regulation
NASA Astrophysics Data System (ADS)
Johnson, Robbin S.
2011-04-01
This article uses lessons from biotechnology to help inform the design of oversight for nanobiotechnology. Those lessons suggest the following: first, oversight needs to be broadly defined, encompassing not just regulatory findings around safety and efficacy, but also public understanding and acceptance of the technology and its products. Second, the intensity of scrutiny and review should reflect not just risks but also perceptions of risk. Finally, a global marketplace argues for uniform standards or commercially practical solutions to differences in standards. One way of designing oversight to achieve these purposes is to think about it in three phases—precaution, prudence, and promotion. Precaution comes early in the technology or product's development and reflects real and perceived uncertainties. Prudence governs when risks and hazards have been identified, containment approaches established, and benefits broadly defined. Transparency and public participation rise to the fore. The promotional phase moves toward shaping public understanding and acceptance and involves marketing issues rather than safety ones. This flexible, three-phase approach to oversight would have avoided some of the early regulatory problems with agricultural biotechnology. It also would have led to a more risk-adjusted pathway to regulatory approval. Furthermore, it would avoid some of the arbitrary, disruptive marketing issues that have arisen.
Bhat, S B; Hegde, T T
2006-09-01
International health-related research on human subjects entails unique ethical responsibilities and difficulties. Often, these difficulties are augmented by the lack of a local ethical review infrastructure. In a recent cross-national study conducted by us, three critical components of ethical regulation were identified--external oversight, local oversight and subject involvement--and integrated into the study design. These three concepts are outlined and established as an important aspect of ensuring ethical coherence in the local context, particularly when reviews by the local institutional review boards cannot practically be obtained. The three levels of ethical oversight identified are suggested to be the framework within which future field studies on human subjects are developed and a standard for maintaining ethical rigorousness in research on humans.
Weiss, W; Larsson, C-M; McKenney, C; Minon, J-P; Mobbs, S; Schneider, T; Umeki, H; Hilden, W; Pescatore, C; Vesterlind, M
2013-06-01
This report updates and consolidates previous recommendations of the International Commission on Radiological Protection (ICRP) related to solid waste disposal (ICRP, 1985, 1997b, 1998). The recommendations given apply specifically to geological disposal of long-lived solid radioactive waste. The report explains how the ICRP system of radiological protection described in Publication 103 (ICRP, 2007) can be applied in the context of the geological disposal of long-lived solid radioactive waste. Although the report is written as a standalone document, previous ICRP recommendations not dealt with in depth in the report are still valid. The 2007 ICRP system of radiological protection evolves from the previous process-based protection approach relying on the distinction between practices and interventions by moving to an approach based on the distinction between three types of exposure situation: planned, emergency and existing. The Recommendations maintains the Commission's three fundamental principles of radiological protection namely: justification, optimisation of protection and the application of dose limits. They also maintain the current individual dose limits for effective dose and equivalent dose from all regulated sources in planned exposure situations. They re-enforce the principle of optimisation of radiological protection, which applies in a similar way to all exposure situations, subject to restrictions on individual doses: constraints for planned exposure situations, and reference levels for emergency and existing exposure situations. The Recommendations also include an approach for developing a framework to demonstrate radiological protection of the environment. This report describes the different stages in the life time of a geological disposal facility, and addresses the application of relevant radiological protection principles for each stage depending on the various exposure situations that can be encountered. In particular, the crucial factor that influences the application of the protection system over the different phases in the life time of a disposal facility is the level of oversight or 'watchful care' that is present. The level of oversight affects the capability to control the source, i.e. the waste and the repository, and to avoid or reduce potential exposures. Three main time frames are considered: time of direct oversight, when the disposal facility is being implemented and is under active supervision; time of indirect oversight, when the disposal facility is sealed and oversight is being exercised by regulators or special administrative bodies or society at large to provide additional assurance on behalf of society; and time of no oversight, when oversight is no longer exercised in case memory of the disposal facility is lost. Copyright © 2013. Published by Elsevier Ltd.
2013-10-01
Support and Oversight: 1a. Provide oversight of the overall Consortium budget including auditing for allowable expenses, managing re- budget requests... budgeted for the first year did not occur due to a much less expensive alternative to the originally proposed protocol and data management system...Identification of cost savings and efficiencies in year 1 and year 2 allowed for an increase in the budget available to fund research projects for the
Joint Strategic Oversight Plan for Afghanistan Reconstruction FY13
2012-07-01
programs within its ministries and made progress in deterring corruption by investi gating, prosecuting, sanctioning or removing corrupt officials from...within its ministries and made progress in deterring corruption by investigat ing, prosecuting, sanctioning or removing corrupt officials from office...of oversight and Lodin’s credibility. • Department of Justice and the Justice Sector Support Program continued their suspension of training the
An Analysis of Army Contract Administration With Regard to Contracting Officers Representatives
2016-09-01
education/ training , communication, staff levels, oversight, and leadership support by comparing and contrasting Army COR contract administration...processes from a CONUS and OCONUS perspective. The results inform Army Contracting leadership about differences and discrepancies that exist in the training ...five common COR issues that need to be addressed: education/ training , communication, staff Levels, oversight, and leadership support. We found that
2003-04-01
Charlottesville, Virginia. Member of the bars of Nebraska and the Court of Appeals for the Armed Forces. This article was submitted in partial completion of the...Oversight of Panel-Member Selection Process ................................. 34 1. 1789 to 1916: A Period of Limited Oversight...Code of Military Justice: New Statutory Limitations on Convening Authority Discretion
2015-04-01
suggestions for reducing this burden, to Washington Headquarters Services , Directorate for Information Operations and Reports, 1215 Jefferson Davis Highway... Service Auditors General to coordinate their oversight and avoid duplication of effort. Section 8L provides a new mandate for the three Lead IG...SUMMARY 7 • Medical Support Service in Iraq (DoS OIG). DoS OIG issued a manage- ment assistance report on concerns with oversight of medical support
Small Business Contracting in the United States and Europe: A Comparative Assessment
2010-03-01
Counsel for procurement, innovation, and oversight matters at the US Senate Committee on Small Business & Entrepreneurship , then chaired by Senator Olympia... Entrepreneurship , then chaired by Senator Olympia J. Snowe (R-ME), the author‘s responsibilities included oversight of Federal small business...authorities on both sides of the Atlantic use the demand created by government contracts to stimulate competitive private entrepreneurship and greater
Code of Federal Regulations, 2012 CFR
2012-07-01
... land by non-Army entities (AR 385-10). 655.10 Section 655.10 National Defense Department of Defense... Oversight of radiation sources brought on Army land by non-Army entities (AR 385-10). (a) As used in this... possession of ionizing radiation sources by non-Army entities (including their civilian contractors) on an...
Code of Federal Regulations, 2011 CFR
2011-07-01
... land by non-Army entities (AR 385-10). 655.10 Section 655.10 National Defense Department of Defense... Oversight of radiation sources brought on Army land by non-Army entities (AR 385-10). (a) As used in this... possession of ionizing radiation sources by non-Army entities (including their civilian contractors) on an...
Code of Federal Regulations, 2013 CFR
2013-07-01
... land by non-Army entities (AR 385-10). 655.10 Section 655.10 National Defense Department of Defense... Oversight of radiation sources brought on Army land by non-Army entities (AR 385-10). (a) As used in this... possession of ionizing radiation sources by non-Army entities (including their civilian contractors) on an...
Code of Federal Regulations, 2014 CFR
2014-07-01
... land by non-Army entities (AR 385-10). 655.10 Section 655.10 National Defense Department of Defense... Oversight of radiation sources brought on Army land by non-Army entities (AR 385-10). (a) As used in this... possession of ionizing radiation sources by non-Army entities (including their civilian contractors) on an...
Congressional Oversight of Intelligence: Current Structure and Alternatives
2012-03-14
Intelligence Information, by Richard A. Best Jr.; CRS Report RL33639, Sources of Systemic Risk in Large Value Interbank Payment Systems, by Edward V. Murphy...Numerous initiatives to change Congress’s oversight structure have materialized in the meantime, including, most importantly, the creation of parallel... Risk : Report, available at http://www.preventionwmd.gov/report, p. 9. 12 Kay King, Congress and National Security, Council on Foreign Relations
Ethics committees and the changed clinical research environment in India in 2016: A perspective!
Davis, Sanish; Sule, Poonam; Bughediwala, Murtuza; Pandya, Vrunda; Sinha, Shilpi
2017-01-01
Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013-2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism. The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs. Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies. Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC. Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.
Oversight of human participants research: identifying problems to evaluate reform proposals.
Emanuel, Ezekiel J; Wood, Anne; Fleischman, Alan; Bowen, Angela; Getz, Kenneth A; Grady, Christine; Levine, Carol; Hammerschmidt, Dale E; Faden, Ruth; Eckenwiler, Lisa; Muse, Carianne Tucker; Sugarman, Jeremy
2004-08-17
The oversight of research involving human participants is widely believed to be inadequate. The U.S. Congress, national commissions, the Department of Health and Human Services, the Institute of Medicine, numerous professional societies, and others are proposing remedies based on the assumption that the main problems are researchers' conflict of interest, lack of institutional review board (IRB) resources, and the volume and complexity of clinical research. Developing appropriate reform proposals requires carefully delineating the problems of the current system to know what reforms are needed. To stimulate a more informed and meaningful debate, we delineate 15 current problems into 3 broad categories. First, structural problems encompass 8 specific problems related to the way the research oversight system is organized. Second, procedural problems constitute 5 specific problems related to the operations of IRB review. Finally, performance assessment problems include 2 problems related to absence of systematic assessment of the outcomes of the oversight system. We critically assess proposed reforms, such as accreditation and central IRBs, according to how well they address these 15 problems. None of the reforms addresses all 15 problems. Indeed, most focus on the procedural problems, failing to address either the structure or the performance assessment problems. Finally, on the basis of the delineation of problems, we outline components of a more effective reform proposal, including bringing all research under federal oversight, a permanent advisory committee to address recurrent ethical issues in clinical research, mandatory single-time review for multicenter research protocols, additional financial support for IRB functions, and a standardized system for collecting and disseminating data on both adverse events and the performance assessment of IRBs.
Millar, Ross; Mannion, Russell; Freeman, Tim; Davies, Huw TO
2013-01-01
Context Recurring problems with patient safety have led to a growing interest in helping hospitals’ governing bodies provide more effective oversight of the quality and safety of their services. National directives and initiatives emphasize the importance of action by boards, but the empirical basis for informing effective hospital board oversight has yet to receive full and careful review. Methods This article presents a narrative review of empirical research to inform the debate about hospital boards’ oversight of quality and patient safety. A systematic and comprehensive search identified 122 papers for detailed review. Much of the empirical work appeared in the last ten years, is from the United States, and employs cross-sectional survey methods. Findings Recent empirical studies linking board composition and processes with patient outcomes have found clear differences between high- and low-performing hospitals, highlighting the importance of strong and committed leadership that prioritizes quality and safety and sets clear and measurable goals for improvement. Effective oversight is also associated with well-informed and skilled board members. External factors (such as regulatory regimes and the publication of performance data) might also have a role in influencing boards, but detailed empirical work on these is scant. Conclusions Health policy debates recognize the important role of hospital boards in overseeing patient quality and safety, and a growing body of empirical research has sought to elucidate that role. This review finds a number of areas of guidance that have some empirical support, but it also exposes the relatively inchoate nature of the field. Greater theoretical and methodological development is required if we are to secure more evidence-informed governance systems and practices that can contribute to safer care. PMID:24320168
Clinical Oversight: Conceptualizing the Relationship Between Supervision and Safety
Lingard, Lorelei; Baker, G. Ross; Kitchen, Lisa; Regehr, Glenn
2007-01-01
Background Concern about the link between clinical supervision and safe, quality health care has led to widespread increases in the supervision of medical trainees. The effects of increased supervision on patient care and trainee education are not known, primarily because the current multifacted and poorly operationalized concept of clinical supervision limits the potential for evaluation. Objective To develop a conceptual model of clinical supervision to inform and guide policy and research. Design, Setting, and Participants Observational fieldwork and interviews were conducted in the Emergency Department and General Internal Medicine in-patient teaching wards of two academic health sciences centers associated with an urban Canadian medical school. Members of 12 Internal Medicine and Emergency Medicine teaching teams (n = 88) were observed during regular clinical activities (216 hours). Sixty-five participants (12 physicians, 28 residents, 17 medical students, 8 nurses) also completed interviews about supervision. Field notes and interview transcripts were analyzed for emergent themes using grounded theory methodology. Results The term “clinical oversight” was developed to describe patient care activities performed by supervisors to ensure quality of care. “Routine oversight” (preplanned monitoring of trainees’ clinical work) can expose supervisors to concerns that trigger “responsive oversight” (a double-check or elaboration of trainees’ clinical work). Supervisors sometimes engage in “backstage oversight” (oversight of which the trainee is not directly aware). When supervisors encounter a situation that exceeds a trainee’s competence, they move beyond clinical oversight to “direct patient care”. Conclusions This study elaborates a typology of clinical oversight activities including routine, responsive, and backstage oversight. This new typology provides a framework for clinical supervision policy and for research to evaluate the relationship between supervision and safety. PMID:17557190
Beinecke, R H
1999-01-01
An expanded range of oversight mechanisms is being adopted to hold public human service programs more accountable to funding sources as well as consumers, family members, and providers. Most of these approaches are hierarchical in nature. Some involve negotiated agreements and each is designed to meet certain goals and functions. Each utilizes different forms of decision-making. Stakeholders prefer to be part of a shared decision-making process. Understanding these underlying premises can help to assess the strengths and weaknesses of each method and can suggest how to most effectively utilize combinations of approaches to improve program performance. Whether we will move toward a new paradigm emphasizing participation and collaboration rather than more formal structural approaches is yet undetermined but will greatly affect how programs are monitored and evaluated in the future.
DeMets, David L; Fleming, Thomas R; Geller, Gail; Ransohoff, David F
2017-08-01
When there have been substantial failures by institutional leadership in their oversight responsibility to protect research integrity, the public should demand that these be recognized and addressed by the institution itself, or the funding bodies. This commentary discusses a case of research failures in developing genomic predictors for cancer risk assessment and treatment at a leading university. In its review of this case, the Office of Research Integrity, an agency within the US Department of Health and Human Services, focused their report entirely on one individual faculty member and made no comment on the institution's responsibility and its failure to provide adequate oversight and investigation. These actions missed an important opportunity to emphasize the institution's critical responsibilities in oversight of research integrity and the importance of institutional transparency and accountability.
Corporate social responsibility for nanotechnology oversight.
Kuzma, Jennifer; Kuzhabekova, Aliya
2011-11-01
Growing public concern and uncertainties surrounding emerging technologies suggest the need for socially-responsible behavior of companies in the development and implementation of oversight systems for them. In this paper, we argue that corporate social responsibility (CSR) is an important aspect of nanotechnology oversight given the role of trust in shaping public attitudes about nanotechnology and the lack of data about the health and environmental risks of nanoproducts. We argue that CSR is strengthened by the adoption of stakeholder-driven models and attention to moral principles in policies and programs. In this context, we examine drivers of CSR, contextual and leadership factors that influence CSR, and strategies for CSR. To illustrate these concepts, we discuss existing cases of CSR-like behavior in nanotechnology companies, and then provide examples of how companies producing nanomedicines can exhibit morally-driven CSR behavior.
2010-01-01
management , and program evaluation specific to the readiness of the force, including those affecting the recruiting force. In establishing oversight...Government Performance and Results Act, GAO/GGD-96-118 (Washington, D.C.: June 1996); and GAO, Managing for Results: Enhancing Agency Use of Performance...Information for Management Decision Making, GAO-05-927 (Washington, D.C.: September 9, 2005). Page 6 GAO-10-254 Military Recruiting
Therapeutic cloning research and ethical oversight.
Spriggs, M
2003-08-01
Cloning Trevor, a story about therapeutic cloning research, appeared in the June issue of The Atlantic Monthly. The story gives a human face to the people whom therapeutic cloning could benefit. It presents an argument for government funding and it puts the usual calls for a moratorium on embryonic stem cell research to allow for more debate, in a less favourable light. The story also highlights some problems with ethical oversight.
The Army’s Approach to Property Accountability: A Strategic Assessment
2012-02-07
can formalize the process of “paying attention” to a problem and reinforce the idea that the Army leaders really share a concern for the problem.34...budgetary constriction, strategic decisions related to force deployments and training sets, leader development, and congressional oversight. This paper...training sets, leader development, and congressional oversight. This paper examines the effectiveness of the Army’s strategic message in the context of
ERIC Educational Resources Information Center
Government Accountability Office, 2008
2008-01-01
In February 2005, the U.S. Government Accountability Office (GAO) issued a report that raised concerns about the effectiveness of the Department of Health and Human Services (HHS) Administration for Children and Families' (ACF) oversight of about 1,600 local organizations that receive nearly $7 billion in Head Start grants. GAO was asked to report…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. Senate Committee on Indian Affairs.
The Senate Committee on Indian Affairs received testimony from representatives of federal agencies as to how the U.S. government might better address the needs of American Indian youth through the development of federal laws, programs, and policies. The hearing was a followup to an oversight hearing 1 month earlier in which American Indian young…
F-35 Joint Strike Fighter: Development of New Capabilities Requires Continued Oversight
2016-04-26
Expected at 10:00 a.m. ET Tuesday, April 26, 2016 GAO-16-634T United States Government Accountability Office Letter Page 1 GAO-16-634T F-35...difficult for Congress to hold it accountable for achieving its cost, schedule, and performance requirements. Given that congressional oversight... Accountability Office, the audit, evaluation, and investigative arm of Congress, exists to support Congress in meeting its constitutional
Management process invaded Ames as the Center shifted from NACA to NASA oversight. Ames constructed
NASA Technical Reports Server (NTRS)
1968-01-01
Management process invaded Ames as the Center shifted from NACA to NASA oversight. Ames constructed a review room in its headquarters building where, in the graphical style that prevailed in the 1960's, Ames leadership could review progress against schedule, budget and performance measures. Shown, in October 1965 is Merrill Mead chief of Ames' program and resources office. (for H Julian Allen Retirement album)
ERIC Educational Resources Information Center
Scott, George A.
2007-01-01
Concerns have been raised about the Department of Education's (Education) role in overseeing the lenders and schools that participate in the largest of the federal government's student loan programs, the Federal Family Education Loan Program (FFELP). GAO was asked to analyze Education's use of its oversight, guidance, and enforcement authorities…
2016-09-07
investigations and overseeing investigations conducted by the military services —took steps to better track and analyze timeliness data by developing a guide...recommendation by reporting timeliness information to Congress biannually. DODIG has strengthened its oversight of military service reprisal...conducted by someone outside the military service chain of command. In response, DODIG directed the service IGs to certify investigators
Goldenberg, Neil A.; Spyropoulos, Alex C.; Halperin, Jonathan L.; Kessler, Craig M.; Schulman, Sam; Turpie, Alexander G. G.; Skene, Allan M.; Cutler, Neal R.
2011-01-01
Standards for clinical trial design, execution, and publication have increased in recent years. However, the current structure for interaction among the pharmaceutical sponsor funding a drug or device development program, the contract research organization (CRO) that typically assists in executing the trial, regulatory agencies, and academicians, provides inadequate leadership and oversight of the development process. Conventional academic steering committees are not provided with the independent infrastructure by which to verify statistical analyses and conclusions regarding safety and efficacy. We propose an alternative approach centered on partnerships between CROs and university-based academic research organizations (AROs). In this model, the ARO takes responsibility for processes that address journal requirements and regulatory expectations for independent academic oversight (including oversight of Steering Committee and Data and Safety Monitoring Board activities), whereas the CRO provides infrastructure for efficient trial execution, site monitoring, and data management. The ARO engages academic experts throughout the trial process and minimizes conflicts of interest in individual industry relationships via diversification of sponsors, agents, and therapeutic areas. Although numerous models can be entertained, the ARO-CRO model is uniquely structured to meet the demand for greater assurance of integrity in clinical trials and the needs of each stakeholder in the process. PMID:21068436
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Congress of the U.S., Washington, DC. Senate Committee on Agriculture, Nutrition, and Forestry.
The Federal government's oversight of its food and nutrition programs is discussed in this transcript of a Senate hearing. Testimony is presented regarding food stamps, the school lunch program, problems of targeting the needy, the Special Supplemental Food Program for Women, Infants, and Children (WIC), commodity distribution, surplus dairy…
2008-05-01
Subcommittee on Oversight of Government Management, the Federal Workforce, and the District of Columbia Committee on Homeland Security and...allows flex-time, telecommuting , or alternative work schedules. Page 17 GAO-08-596 Corps of Engineers Table 1: Examples of Human Capital...programs and policies; and provides analyses, recommendations, and other assistance to help Congress make informed oversight , policy, and funding
United States Special Operations Command (USSOCOM): Construction Management Handbook
2010-02-11
installation B-Hut Road Work Sea-Hut Water Well and Pump House Brick and Mortar billets D. Oversight Program Oversight of contracts is critical to the...often asked to fulfill construction requirements in austere locations with little or no training in construction terminology, concepts, and protocols...contracting arm of SOAL is the Director of Procurement (also known as SOAL-K), located within the USSOCOM Headquarters on MacDill AFB, Florida. SOAL-K
2011-06-01
Coast Guard Academies Have Taken Steps to Address Incidents of Sexual Harassment and Assault, but Greater Federal Oversight Is Needed, GAO-08-296...provided through multiple sources and vary annually relative to other programmatic priorities. According to the Army Sexual Harassment /Assault...2.1 million it received from the Army’s Sexual Harassment /Assault Response and Prevention program in fiscal year 2010 for the improvement of sexual
2016-07-27
effectively respond to these threats has increased the importance of focused leadership in national security space. In Senate Report 114-49 accompanying...review the effectiveness of the current DOD space acquisition and oversight model and to evaluate what changes, if any, could be considered to... effectively consolidate space leadership. Some of these responsibilities include reviewing all service budgets for conformity with national security
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Education and Labor.
Oversight hearings on the Student Loan Marketing Association (Sallie Mae) are presented. Sallie Mae was established by the Education Amendments of 1972 to provide liquidity for Guaranteed Student Loan (GSL) lenders by purchasing GSL portfolios from lenders or making loans on GSL loans held by lenders. In 1982, Sallie Mae had total cumulative…
Fiscal Year 2011 Comprehensive Oversight Plan for Southwest Asia and Surrounding Areas
2011-03-31
NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND...ADDRESS(ES) Department of Defense Inspector General,400 Army Navy Drive,Arlington,VA,22202-4704 8. PERFORMING ORGANIZATION REPORT NUMBER 9...Southwest Asia in Appendix B. The FY 2011 edition is organized by primary oversight countries: Afghanistan, Iraq, Pakistan, Kuwait, Qatar, and all
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Congress of the U.S., Washington, DC. House Committee on Government Reform and Oversight.
The Subcommittee on Human Resources and Intergovernmental Relations of the House of Representatives Committee on Government Reform and Oversight met to consider the causes of and solutions to teen pregnancy and the role of community organizations in prevention efforts. Opening remarks by Representative Christopher Shays were followed by statements…
Reflections on governance models for the clinical translation of stem cells.
Sugarman, Jeremy
2010-01-01
Governance models for the oversight of human embryonic stem cell research have been proposed which mirror in large part familiar oversight mechanisms for research with human subjects and non-human animals. While such models are in principle readily endorsable, there are a set of concerns related to their implementation--such as ensuring that an elaborated informed consent process and conducting long-term monitoring of research subjects are tenable--which suggest areas where gathering data may facilitate more appropriate oversight. In addition, it is unclear whether a new governance model based at individual institutions are sufficient to address the ethical issues inherent to this research. Regardless, some of the concerns that have arisen in considering the appropriate governance of stem cell research, particularly the important translational pathway of innovation in contrast to staged research, transparency and publication, and social justice, may be useful in science and translational research more broadly.
Yang, Y Tony; Silverman, Ross D
2014-02-01
Mobile health (mHealth) technology has facilitated the transition of care beyond the traditional hospital setting to the homes of patients. Yet few studies have evaluated the legal implications of the expansion of mHealth applications, or "apps." Such apps are affected by a patchwork of policies related to medical licensure, privacy and security protection, and malpractice liability. For example, the privacy protections of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 may apply to only some uses of the apps. Similarly, it is not clear what a doctor's malpractice liability would be if he or she injured a patient as the result of inaccurate information supplied by the patient's self-monitoring health app. This article examines the legal issues related to the oversight of health apps, discusses current federal regulations, and suggests strategies to improve the oversight of these apps.
Enhancing Brigade Combat Team Adaptability
2010-06-11
S3 DUTIES AND RESPONSIBILITIES S3 SGM S3 Operations Fires and EffectsS3 Training S3 Plans CYCLIC TNG GUIDANCE UNIT ASSESSMENT APPROVE DTU TOC/TAC SET...UP TEAM LEADER COURSE BOC MTT Requests/Tracking MTT OVERSIGHT TMPs RECLAMAS LOE OVERSIGHT MONITOR DIV O&I DTU /Task Management TOP 5 CALENDAR...referenced in Chapter 5 to this thesis. SLIDE: 1FOR OFFICIAL USE ONLY OPERATIONAL TASKS/SYSTEMS BOC Shift Change MONITOR DIV O&I DTU SDO BRIEFING
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Congress of the U.S., Washington, DC. House Committee on Education and Labor.
The text of an oversight hearing on Drug Abuse Resistance Education (DARE) programs is presented in this document. Introductory statements by Representatives Jolene Unsoeld and Dale E. Kildee are presented. Testimony by these witnesses is included: (1) Roy Bondurant, student, and Roy "Skip" Bondurant, parent, Tenino, Washington; (2) Paul…
2009-05-27
Representatives Subject: Financial Management: DOD Needs to Clarify Its General Gift Fund Policies to Provide for Effective Oversight From fiscal...year 2005 through fiscal year 2008, the military services received about $295 million in monetary and nonmonetary gifts from individuals and...organizations wishing to donate gifts to the Department of Defense (DOD).1 Section 2601(a) of Title 10, U.S. Code is a long-standing authority under which
2013-06-25
test Waste Water Treatment Plant” because no testing kit was onsite. The COR additionally stated he identified failed equipment and the contractor...Officer ( PCO ) confirmed with the previous ACC-Rl PCO and neither recall ever making this statement. The previous PCO recalls discussing that a QASP...performance surveillance and have access to all contract documents. Adequate contract oversight is always a concern of the PCO , in part due to the
2009-01-14
ORGANIZATION NAME(S) AND ADDRESS(ES) Office of the Special Inspector General for Iraq Reconstruction,400 Army Navy Drive,Arlington,VA,22202-4704 8...Congressional concerns about the adequacy of oversight given to private security contractors (PSCs) in Iraq increased after an incident involving Blackwater ...that resulted in the deaths of 17 Iraqi civilians. Blackwater is under contract with the Department of State. Responding to a congressional mandate
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Congress of the U.S., Washington, DC. House Committee on Education and Labor.
Congress has the authority to return rules and regulations to the Commissioner of Education if those rules and regulations violate the Commissioner's statutory authority. These oversight committee hearings were held to hear agency and public comments about rules which the Commissioner proposed to put into effect to deal with the new formulas that…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Education and Labor.
This volume presents a transcript of discussion and statements presented at an oversight hearing before the House Subcommittee on Employment Opportunities. The hearing reviewed new enforcement policies of the Equal Employment Opportunity Commission (EEOC), which had the stated intent of increasing the litigation of individual cases of unlawful…
Political Organizations: Data Disclosure and IRS’s Oversight of Organizations Should Be Improved
2002-07-01
444 Report Documentation Page Report Date 00Jul2002 Report Type N/A Dates Covered (from... to) - Title and Subtitle POLITICAL ORGANIZATIONS...users of the Web site who also represent public interest groups. Our scope and methodology are discussed in more detail in a separate section of...any penalties because it has not performed the oversight to uncover noncompliance, even when IRS’s data on filed forms indicate that thousands of
2013-10-30
SIGAR produced four audits, four inspections, and one alert letter this quarter. Three of the audits assessed pro - grams to build and evaluate the ANSF...SIGAR produced a series of oversight access maps pro - jecting that no more than 21% of Afghanistan will be accessible to U.S. civilian oversight...those involved in the production, trafficking or trade of illicit drugs.”2 Crimes like theft, bribery, kickbacks, and money laundering deprive pro
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Agriculture.
This document is comprised of statements and materials submitted to a hearing on the school pesticide provision included in a Senate amendment to House Resolution 1 (H.R. 1), the Elementary and Secondary Education Act. The hearing was held July 18, 2001, before the Subcommittee on Department Operations, Oversight, Nutrition, and Forestry of the…
Millin, Michael G; Johnson, David E; Schimelpfenig, Tod; Conover, Keith; Sholl, Matthew; Busko, Jonnathan; Alter, Rachael; Smith, Will; Symonds, Jennifer; Taillac, Peter; Hawkins, Seth C
2017-01-01
A disparity exists between the skills needed to manage patients in wilderness EMS environments and the scopes of practice that are traditionally approved by state EMS regulators. In response, the National Association of EMS Physicians Wilderness EMS Committee led a project to define the educational core content supporting scopes of practice of wilderness EMS providers and the conditions when wilderness EMS providers should be required to have medical oversight. Using a Delphi process, a group of experts in wilderness EMS, representing educators, medical directors, and regulators, developed model educational core content. This core content is a foundation for wilderness EMS provider scopes of practice and builds on both the National EMS Education Standards and the National EMS Scope of Practice Model. These experts also identified the conditions when oversight is needed for wilderness EMS providers. By consensus, this group of experts identified the educational core content for four unique levels of wilderness EMS providers: Wilderness Emergency Medical Responder (WEMR), Wilderness Emergency Medical Technician (WEMT), Wilderness Advanced Emergency Medical Technician (WAEMT), and Wilderness Paramedic (WParamedic). These levels include specialized skills and techniques pertinent to the operational environment. The skills and techniques increase in complexity with more advanced certification levels, and address the unique circumstances of providing care to patients in the wilderness environment. Furthermore, this group identified that providers having a defined duty to act should be functioning with medical oversight. This group of experts defined the educational core content supporting the specific scopes of practice that each certification level of wilderness EMS provider should have when providing patient care in the wilderness setting. Wilderness EMS providers are, indeed, providing health care and should thus function within defined scopes of practice and with physician medical director oversight.
Zetterqvist, Anna V.; Mulinari, Shai
2013-01-01
Background The alleged efficacy of pharmaceutical industry self-regulation has been used to repudiate increased government oversight over promotional activity. European politicians and industry have cited Sweden as an excellent example of self-regulation based on an ethical code. This paper considers antidepressant advertising in Sweden to uncover the strengths and weaknesses of self-regulation. Methodology We analyzed all antidepressant advertisements in the Swedish Medical Journal, 1994–2003. The regulation of these advertisements was analyzed using case reports from self-regulatory bodies. The authors independently reviewed this material to investigate: (1) extent of violative advertising; (2) pattern of code breaches; (3) rate at which the system reacted to violative advertising; (4) prevalence of and oversight over claims regarding antidepressant efficacy and disease causality, and (5) costs for manufactures associated with violative advertising. Principal Findings Self-regulatory bodies identified numerous code breaches. Nonetheless, they failed to protect doctors from unreliable information on antidepressants, since as many as 247 of 722 (34%) advertisements breached the industry code. Self-regulatory bodies repeatedly failed to challenge inflated claims of antidepressant efficacy, lending evidence of lax oversight. On average, 15 weeks elapsed between printing and censure of a wrongful claim, and in 25% of cases 47 weeks or more elapsed. Industry paid roughly €108000 in fines for violative advertising, adding an estimated additional average cost of 11% to each purchased violative advertisement, or amounting to as little as 0.009% of total antidepressant sales of around €1.2 billion. Conclusions Lax oversight, combined with lags in the system and low fines for violations, may explain the Swedish system’s failure to pressure companies into providing reliable antidepressants information. If these shortcomings prove to be consistent across self-regulatory settings, and if appropriate measures are not taken to amend shortcomings, many countries may want to reconsider the current balance between self-regulation, and legislative control with government oversight. PMID:23650519
Zetterqvist, Anna V; Mulinari, Shai
2013-01-01
The alleged efficacy of pharmaceutical industry self-regulation has been used to repudiate increased government oversight over promotional activity. European politicians and industry have cited Sweden as an excellent example of self-regulation based on an ethical code. This paper considers antidepressant advertising in Sweden to uncover the strengths and weaknesses of self-regulation. We analyzed all antidepressant advertisements in the Swedish Medical Journal, 1994-2003. The regulation of these advertisements was analyzed using case reports from self-regulatory bodies. The authors independently reviewed this material to investigate: (1) extent of violative advertising; (2) pattern of code breaches; (3) rate at which the system reacted to violative advertising; (4) prevalence of and oversight over claims regarding antidepressant efficacy and disease causality, and (5) costs for manufactures associated with violative advertising. Self-regulatory bodies identified numerous code breaches. Nonetheless, they failed to protect doctors from unreliable information on antidepressants, since as many as 247 of 722 (34%) advertisements breached the industry code. Self-regulatory bodies repeatedly failed to challenge inflated claims of antidepressant efficacy, lending evidence of lax oversight. On average, 15 weeks elapsed between printing and censure of a wrongful claim, and in 25% of cases 47 weeks or more elapsed. Industry paid roughly €108000 in fines for violative advertising, adding an estimated additional average cost of 11% to each purchased violative advertisement, or amounting to as little as 0.009% of total antidepressant sales of around €1.2 billion. Lax oversight, combined with lags in the system and low fines for violations, may explain the Swedish system's failure to pressure companies into providing reliable antidepressants information. If these shortcomings prove to be consistent across self-regulatory settings, and if appropriate measures are not taken to amend shortcomings, many countries may want to reconsider the current balance between self-regulation, and legislative control with government oversight.
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Education and Labor.
The series of five extensive oversight hearings specifically focused on Johnson O'Malley funds; education functions; the bill's formula for distribution of education funds; the new education personnel system; the development of regulations relative to academic and living standards for Bureau of Indian Affairs (BIA) schools; the administration of…
2008-02-26
will no longer defer work from one block to another. Accountability should also be improved as MDA will for the first time estimate unit costs for... costs are no longer accounted for in the original block. In other words, if work planned and budgeted for Block 2006 was deferred to Block 2008, that...difficult to conduct oversight and hold the agency accountable for its planned outcomes and costs . As we reported in March 2007, MDA operates with
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Education and Labor.
These two congressional hearings are part of a series held by the Subcommittee in conjunction with its oversight of the Federal Government's enforcement of equal employment opportunity laws and affirmative action. The first hearing addresses what are perceived to be destructive rather than constructive policy initiatives and program changes in the…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on the District of Columbia.
The purpose of this oversight hearing on the District of Columbia public school system was to welcome the new superintendent, Franklin L. Smith, and to assess the general condition of the school system. Among the problems and issues assessed were the impact of boarder babies entering the school system, the impact on the system of children who were…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Education and Labor.
This document is a transcript of an oversight hearing on the Job Training Partnership Act (JTPA). It is the first in a series designed by the House Subcommittee on Employment Opportunities, Committee on Education and Labor, to evaluate the program. In his introduction, the subcommittee chairman voiced his concern about proposed budget cuts in…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. Senate Committee on Labor and Human Resources.
Oversight hearings were conducted on April 23, 1981 in reference to social service block grants for the Community Services Administration, child abuse prevention and treatment and adoption programs, and Native American Programs Act. Testimonies for support of block grants advocated ability of States to decide how program resources can best be…
Oversight of and Within the Department of Defense: Is It Becoming Counterproductive?
1991-09-01
impacts of producing at higher more economical rates and ID potential costs at various levels of production Chairman Committee on Appropriations ( S ...1988. Horngren , Charles T. and George Foster. Cost Accounti A Managerial Emphasis. Englewood Cliffs: Prentice-Hall, Inc., 1987. Marsh, Robert T...INSTITUTE OF TECHNOLOGY Wright-Patterson Air Force Base, Ohio 92 2 25 090’ " AF:T/GSM/LSG/91S-16 DTJC S ELECT- MAR0 3 1992 D OVERSIGHT OF AND WITHIN
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Ways and Means.
Proceedings are presented of hearings before the Subcommittee on Oversight of the Committee on Ways and Means in the House of Representatives. The purpose of the hearings was to review the Social Security student benefit program to determine whether the program is still necessary. Testimony was received from the General Accounting Office, which…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Government Reform and Oversight.
The relationships between improvements to facilities and accurate enrollment counts and an academic plan for the District of Columbia public schools were explored in a hearing that was part of a series on the D.C. public schools. Representative Thomas Davis (Virginia) spoke of the progress being made in improving the D.C. schools and the great…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Science, Space and Technology.
This document contains prepared remarks and testimony of the hearings before the subcommittee on science, research and technology regarding the oversight of the National Science Foundation (NSF) particularly the status of science education in the United States. The document includes the testimony and prepared statements of: (1) Hon. Sherwood…
ERIC Educational Resources Information Center
Scott, George A.
2011-01-01
This testimony discusses the Department of Defense's (DOD) oversight of its Military Tuition Assistance (TA) Program. In fiscal year 2010, the TA Program provided $531 million in tuition assistance to approximately 302,000 service members who elected to pursue off-duty postsecondary education. DOD offers these benefits to service members in order…
2014-08-13
No. DODIG-2014-101 A U G U S T 1 3 , 2 0 1 4 Delinquent Medical Service Accounts at Brooke Army Medical Center Need Additional Management...13 AUG 2014 2. REPORT TYPE 3. DATES COVERED 00-00-2014 to 00-00-2014 4. TITLE AND SUBTITLE Delinquent Medical Service Accounts at Brooke Army...Results in Brief Delinquent Medical Service Accounts at Brooke Army Medical Center Need Additional Management Oversight Visit us at www.dodig.mil
2007-06-12
up Northrop Grumman Ship Systems ( NGSS ). Table 2. FY2008-FY2013 Amphibious and MPF(F) Ship Procurement Plan (Ships fully funded in FY2006 shown for... Plan . . 13 Navy-Marine Corps Amphibious and Maritime Prepositioning Ship Programs: Background and Oversight Issues for Congress Introduction The...is whether to approve, modify, or reject the Navy’s plans for procuring amphibious and MPF(F) ships. Decisions that Congress makes on this CRS-2 1 The
2016-09-19
Effective Anti-Corruption Institution , SIGAR Audit 10-2, December 16, 2009. SIGAR-16-60-SP – Review: High Office of Oversight Page 3 We conducted...Donor Support to Become an Effective Anticorruption Institution , SIGAR Audit 10-2, December 16, 2009, pp. 2–3. 7 U.S. Embassy in Kabul...Significantly Strengthened Authority, Independence, and Donor Support to Become an Effective Anti-Corruption Institution , SIGAR Audit 10-2, December 16, 2009
ERIC Educational Resources Information Center
US House of Representatives, 2004
2004-01-01
The focus of this hearing is to review Federal and State oversight of child welfare programs and systems designed to prevent abuse and neglect of children, including those under State protection. The purpose being to provide subcommittee representatives the opportunity to learn what Federal, State, and local officials should be doing to ensure…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Energy and Commerce.
In connection with its jurisdiction over biomedical research and development at higher education institutions, the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations met a second time to hear testimony on abuses in the indirect cost recovery practices at universities for federal research grants and contracts. The…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Education and Labor.
This is a report of the oversight hearing held in Washington, D.C., on August 19, 1980, on the federal enforcement of equal employment opportunity laws (section 717 of the Civil Rights Act of 1964). It focuses on findings of the subcommittee's survey of forty-five selected Federal agencies which generally show underrepresentation of women and…
Information Systems: Opportunities Exist to Strengthen SEC’s Oversight of Capacity and Security
2001-07-01
Strengthen SEC’s Oversight of Capacity and Security 5 . FUNDING NUMBERS 6. AUTHOR(S) GAO 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING...ANSI Std. Z39-18 298-102 Page i GAO-01-863 Information Systems Letter 1 Results in Brief 2 Background 4 Scope and Methodology 5 SEC Uses a Wide Range...or external organizations to conduct the independent reviews. These internal audits are performed cyclically based on an annual risk analysis. SEC
ERIC Educational Resources Information Center
Congress of the U. S., Washington, DC. House Committee on Interstate and Foreign Commerce.
This report of the Subcommittee on Oversight and Investigation focuses on issues raised by the marketing of commercially prepared infant formulas that were nutritionally deficient. In this context, the report examines the scope of FDA authority to protect the public and the manner in which the FDA carries out its responsibilities with respect to…
2016-01-01
abuse. 62 The success of U.S. foreign policy in complex and high threat environments is dependent upon private contingency contractors for a number...Trafficking: Oversight of Contractors ’ Use of Foreign Workers in High -Risk Environments Needs to Be Strengthened,” November 2014, http://www.gao.gov...Congressional Committees, “GAO-15- 102 Human Trafficking: Oversight of Contractors ’ Use of Foreign Workers in High -Risk Environments Needs to Be
ERIC Educational Resources Information Center
Scott, George A.
2011-01-01
In fiscal year 2009, the Department of Defense's (DOD) Military Tuition Assistance (TA) Program provided $517 million in tuition assistance to approximately 377,000 service members. US Government Accountability Office (GAO) was asked to report on (1) DOD's oversight of schools receiving TA funds, and (2) the extent to which DOD coordinates with…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Education and the Workforce.
This document presents the transcript (and written statements) of a congressional hearing on the potential politicization of the National Assessment of Educational Progress (NAEP) and the trustworthiness of the scores that the states received during the 1998 reading assessment. It addresses whether Vice President Al Gore's "release" of…
Rady, Mohamed Y; Verheijde, Joseph L.
2017-01-01
Mr Justice Baker delivered the Oxford Shrieval Lecture ‘A Matter of Life and Death’ on 11 October 2016. The lecture created public controversies about who can authorise withdrawal of assisted nutrition and hydration (ANH) in disorders of consciousness (DOC). The law requires court permission in ‘best interests’ decisions before ANH withdrawal only in permanent vegetative state and minimally conscious state. Some clinicians favour abandoning the need for court approval on the basis that clinicians are already empowered to withdraw ANH in other common conditions of DOC (e.g. coma, neurological disorders, etc.) based on their best interests assessment without court oversight. We set out a rationale in support of court oversight of best interests decisions in ANH withdrawal intended to end life in any person with DOC (who will lack relevant decision-making capacity). This ensures the safety of the general public and the protection of vulnerable disabled persons in society. PMID:28368210
Ferreira-Gonzalez, Andrea; Teutsch, Steven; Williams, Marc S; Au, Sylvia M; Fitzgerald, Kevin T; Miller, Paul Steven; Fomous, Cathy
2008-09-01
As genetic testing technology is integrated into healthcare, increasingly detailed information about individual and population genetic variation is available to patients and providers. Health professionals use genetic testing to diagnose or assess the risk of disease in individuals, families and populations and to guide healthcare decisions. Consumers are beginning to explore personalized genomic services in an effort to learn more about their risk for common diseases. Scientific and technological advances in genetic testing, as with any newly introduced medical technology, present certain challenges to existing frameworks of oversight. In addition, the growing use of genetic testing will require a significant investment in evidence-based assessments to understand the validity and utility of these tests in clinical and personal decisionmaking. To optimize the use of genetic testing in healthcare, all sectors of the oversight system need to be strengthened and yet remain flexible in order to adapt to advances that will inevitably increase the range of genetic tests and methodologies.
Brown, Brandon; Kinsler, Janni; Folayan, Morenike O; Allen, Karen; Cáceres, Carlos F
2014-06-01
The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study's investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research regulatory structures, arranging a site visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide.
Disaster risk reduction capacity assessment for precarious settlements in Guatemala City.
Miles, Scott B; Green, Rebekah A; Svekla, Walter
2012-07-01
This study presents findings of an institutional capacity analysis of urban disaster risk reduction for informal settlements in the Guatemala Metropolitan Region. It uses a resource access perspective of vulnerability, actor-network theory, and qualitative data collection. The analysis reveals that there is interest in disaster risk reduction for the informal settlements; however, there is little in the way of direct financial or oversight relationships between informal settlement residents and all other actors. Respondents observed that informal settlements would probably remain inhabited; thus, there is a need for disaster risk reduction within these settlements. Disaster risk reduction capacity for informal settlements exists and can be further leveraged, as long as steps are taken to ensure appropriate access to and control of resources and oversight. Further, the nascent institutional arrangements should be strengthened through increased communication and coordination between actors, a decentralization of oversight and financial relationships, and mediation of identified resource conflicts. © 2012 The Author(s). Journal compilation © Overseas Development Institute, 2012.
The Case for Laboratory Developed Procedures
Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri; Benirschke, Robert; Carlow, Dean; Funke, Birgit H.; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Pessin, Melissa; Press, Richard D.; Thomson, Richard B.
2017-01-01
An explosion of knowledge and technology is revolutionizing medicine and patient care. Novel testing must be brought to the clinic with safety and accuracy, but also in a timely and cost-effective manner, so that patients can benefit and laboratories can offer testing consistent with current guidelines. Under the oversight provided by the Clinical Laboratory Improvement Amendments, laboratories have been able to develop and optimize laboratory procedures for use in-house. Quality improvement programs, interlaboratory comparisons, and the ability of laboratories to adjust assays as needed to improve results, utilize new sample types, or incorporate new mutations, information, or technologies are positive aspects of Clinical Laboratory Improvement Amendments oversight of laboratory-developed procedures. Laboratories have a long history of successful service to patients operating under Clinical Laboratory Improvement Amendments. A series of detailed clinical examples illustrating the quality and positive impact of laboratory-developed procedures on patient care is provided. These examples also demonstrate how Clinical Laboratory Improvement Amendments oversight ensures accurate, reliable, and reproducible testing in clinical laboratories. PMID:28815200
Ourso, André
2012-01-01
Currently, pharmaceutical companies' utilization of foreign clinical trial data is a ubiquitous and indispensable aspect of gaining approval to market drugs in the United States. Cost benefits, a larger pool of ready volunteer subjects, and greater efficiency in clinical testing are some of the reasons for conducting clinical trials overseas. Despite these advantages, lack of proper oversight may have serious public health implications regarding the integrity of clinical research, ethical treatment of human subjects, and drug safety. Due to the expansive global nature of foreign clinical trials, there are concerns with the FDA's ability to monitor and regulate these trials. This article examines the FDA's oversight of foreign clinical trials and the agency's limitations regulating these trials. In addition to looking at steps the FDA is taking to address these limitations, the article examines other potential regulatory and cooperative actions that can be taken to effectively monitor foreign clinical trials and to ensure data integrity and patient safety.
Still Human: A Call for Increased Focus on Ethical Standards in Cadaver Research.
Bach, Michelle C
2016-12-01
Research on human cadavers is an important mechanism of scientific progress and comprises a large industry in the United States. However, despite its importance and influence, there is little ethical or regulatory oversight of cadaver-based research. This lack of transparency raises important ethical questions. Thus, this paper serves as a call for ethicists and regulators to pay increased attention to cadaver research. I argue that cadaver research ought to be considered a subset of human subjects research and held accountable to higher ethical standards. After describing current practices, I argue that oversight of cadaver research as a form of human subjects research is appropriate because cadaver research is similar to other types of human research, participants in cadaver research incur risks of harm, and a current lack of oversight has allowed the cadaver industry to entice research participation through ethically questionable practices. This paper urges greater dialogue among human subjects research ethicists and regulators about what constitutes appropriate protections for participants in cadaver research.
Braver, Elisa R.; Dodd, Robert S.; Cheung, Ivan; Long, Lindsay O.
2012-01-01
Interstate motorcoach travel has been the fastest-growing transportation mode in recent years. To identify challenges to monitoring compliance with motorcoach safety regulations and to examine factors affecting safety, four focus groups with a total of 32 participants were conducted during 2011, one with federal safety investigators, one with state motor carrier inspectors, and two with motorcoach drivers. Investigators and inspectors expressed concern about falsified logbooks, inadequate sleep among motorcoach drivers, hazards from speeding motorcoaches, practices by motorcoach carriers to mask ownership and avoid oversight, and difficulties keeping up with rapid motorcoach industry growth. Drivers described problems with getting sufficient sleep, pressure to drive longer than permitted, and fears of motor carriers giving them less work if they turned down driving jobs. Drivers said that driving 72–74 mph was acceptable in light traffic. To help assess workload among personnel performing safety oversight, data on numbers of motor carriers, commercial motor vehicles, federal investigators, and state inspectors were obtained from the Federal Motor Carrier Safety Administration (FMCSA). The data suggested a heavy workload (2.13 inspectors per 1,000 commercial motor vehicles). The focus groups of inspectors, investigators, and drivers indicated the existence of serious motorcoach safety problems, provided insight about the multiple factors contributing to them, and described major obstacles to effective safety oversight. The qualitative nature of focus group research means that these notable findings will need to be measured using other methods such as surveys and observational studies. PMID:23169117
Paul, Ellen; Sikes, Robert S; Beaupre, Steven J; Wingfield, John C
2016-01-01
The use of vertebrate animals in research and education in the United States is subject to a number of regulations, policies, and guidelines under the immediate oversight of Institutional Animal Care and Use Committees (IACUCs), which are charged with ensuring the ethical and appropriate use of the animal subjects. In almost all instances, this regulatory and oversight landscape of animal use has been developed around domesticated animals in biomedical research environments. When the research activities involve wild species, especially in their natural habitat rather than a laboratory, oversight personnel and investigators alike struggle with determining what constitutes ethical and appropriate activities. These difficulties stem from fundamental differences in biology between wild and domesticated animals and from the differences in research objectives and methods in wildlife compared with biomedical research. Here we discuss the various policies, regulations, and guidance documents for animal use in the context of wildlife research. We compare the expectations of the various oversight agencies and how these expectations are met when working with wild vertebrates. We make recommendations for how IACUCs can use available resources to ensure that activities involving wild species are conducted in compliance with existing regulations and policies and in ways that are biologically appropriate for these nondomesticated species. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.
Braver, Elisa R; Dodd, Robert S; Cheung, Ivan; Long, Lindsay O
2012-01-01
Interstate motorcoach travel has been the fastest-growing transportation mode in recent years. To identify challenges to monitoring compliance with motorcoach safety regulations and to examine factors affecting safety, four focus groups with a total of 32 participants were conducted during 2011, one with federal safety investigators, one with state motor carrier inspectors, and two with motorcoach drivers. Investigators and inspectors expressed concern about falsified logbooks, inadequate sleep among motorcoach drivers, hazards from speeding motorcoaches, practices by motorcoach carriers to mask ownership and avoid oversight, and difficulties keeping up with rapid motorcoach industry growth. Drivers described problems with getting sufficient sleep, pressure to drive longer than permitted, and fears of motor carriers giving them less work if they turned down driving jobs. Drivers said that driving 72-74 mph was acceptable in light traffic. To help assess workload among personnel performing safety oversight, data on numbers of motor carriers, commercial motor vehicles, federal investigators, and state inspectors were obtained from the Federal Motor Carrier Safety Administration (FMCSA). The data suggested a heavy workload (2.13 inspectors per 1,000 commercial motor vehicles). The focus groups of inspectors, investigators, and drivers indicated the existence of serious motorcoach safety problems, provided insight about the multiple factors contributing to them, and described major obstacles to effective safety oversight. The qualitative nature of focus group research means that these notable findings will need to be measured using other methods such as surveys and observational studies.
American Society of Clinical Oncology policy statement: oversight of clinical research.
2003-06-15
Well-publicized lapses in the review or implementation of clinical research studies have raised public questions about the integrity of the clinical research process. Public trust in the integrity of research is critical not only for funding and participation in clinical trials but also for confidence in the treatments that result from the trials. The questions raised by these unfortunate cases pose an important opportunity to reassess the clinical trials oversight system to ensure the integrity of clinical research and the safety of those who enroll in clinical trials. Since its inception, the American Society of Clinical Oncology (ASCO) has worked for the advancement of cancer treatments through clinical research and to help patients gain prompt access to scientifically excellent and ethically unimpeachable clinical trials. As an extension of its mission, ASCO is affirming with this policy statement the critical importance of a robust review and oversight system to ensure that clinical trials participants give fully informed consent and that their safety is a top priority. Ensuring the integrity of research cannot be stressed enough because of its seminal connection to the advancement of clinical cancer treatment. The overall goal of this policy is to enhance public trust in the cancer clinical trials process. To achieve this, the following elements are essential: 1. Ensure safety precautions for clinical trial participants and their fully informed consent. 2. Ensure the validity and integrity of scientific research. 3. Enhance the educational training of clinical scientists and research staff to ensure the highest standards of research conduct. 4. Promote accountability and responsibility among all those involved in clinical research (not just those serving on institutional review boards [IRBs], but also institutional officials, researchers, sponsors, and participants) and ensure support for an effective oversight process. 5. Enhance the professional and public understanding of clinical research oversight. 6. Enhance the efficiency and cost-effectiveness of the clinical research oversight system. This policy statement makes recommendations in several areas that serve as principles to support an improved system of oversight for clinical research. ASCO will work with all parties involved in the clinical research system to develop the steps necessary to implement these recommendations. Centralized Trial Review: A large percentage of oncology clinical trials are coordinated through the National Cancer Institute's (NCI) system of cooperative groups, which already incorporates centralized scientific review. As such, there is a tremendous opportunity to employ a centralized mechanism to provide ethical review by highly trained IRB members, allowing local IRBs to take advantage of the financial and time efficiencies that central review provides. Centralized review boards (CRBs) would also contribute consistency and efficiency to the process. Once successfully completed, the review would represent an approval to open the protocol at all of the institutions that have subscribed to the centralized review system. Local IRBs would be able to devote time usually spent on initial review to ongoing monitoring of the trial taking place at their institution. Considering the enormous size and complexity of the clinical research enterprise, ASCO envisions multiple CRBs, which could be distributed as regional review boards. Central review will use a single protocol and consent form, and monitor and evaluate adverse events (AEs) on a global basis, eliminating many of the time-consuming steps for the local IRB. Global monitoring and assessment of AEs has real potential to enhance trial participants' safety by giving local institutions more information on the overall trial and enabling them to devote more time to ongoing review of the trial onsite. Use of a CRB also has real potential to reduce the costs of clinical trial oversight by allowing local IRBs to eliminate the costs of initial review. These efficiencies will likely lead to institutions redirecting funds toward monitoring ongoing trials. Although a CRB has potential to improve the efficiency of the process, a CRB could also have tremendous ability to delay valuable trials. Checks and balances must be included in the newly devised system to ensure timely review and appeals of CRB actions. ASCO proposes the advent of a new pilot program for centralizing review of clinical trials. It requires clear engagement of all stakeholders in planning the experiment, clear articulation of the goals, and assurance of federal regulatory protection for institutions choosing to participate. If successful, this CRB pilot project could be expanded to include multi-institutional industry-sponsored research. Education and Training:Education and training are critical to the ultimate success of an improved oversight system. All members of the research team should receive comprehensive education on conducting scientifically and ethically valid clinical research. The curriculum should also include information on the prevailing local and federal regulations that pertain to the clinical trials process. IRB members should also receive ongoing education and training in the review of clinical research protocols. IRB training should pay particular attention to nonscientific members to give them the tools necessary to speak on behalf of research participants. ASCO should develop a curriculum that focuses on the proper conduct of human research and emphasize ethically sound clinical research in the context of its Annual Meeting. Informed Consent: Investigators and review boards have specific roles to play in ensuring the education of trial participants through the informed consent process, both when they are considering trial enrollment and as they participate in the trial. Review boards and investigators should focus primarily on the informed consent process, rather than the informed consent documents. Federal Oversight: The federal government has an important role to play in the oversight of clinical research. This role should be expanded to cover all research, not just that which is funded by the federal government or conducted with the oversight of the Food and Drug Administration (FDA). The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the FDA should provide clear regulatory support and guidance for local institutions that choose to employ a CRB. In the case of the pilot CRB discussed in this policy statement, it should serve as the preferred option for the cancer cooperative group clinical trials. Ideally, the federal government should unify and streamline its regulations for the oversight of clinical research. Resources Supporting Clinical Research Infrastructure:An effective oversight process demands the highest quality scientific and ethical review and onsite monitoring of the safety of trial participants. This can only be accomplished by the involvement of an experienced IRB that receives funding, resources, and institutional support enabling it to fulfill its mandate. Critical to the integrity of research is the absence of bias in the process. ASCO strongly recommends the adoption of standards for the identification, management, and, where appropriate, elimination of conflicts of interests, whether they are actual, potential, or apparent.
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Energy and Commerce.
In connection with its jurisdiction over biomedical research and development at higher education institutions, the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations met twice to hear testimony on abuses in the indirect cost recovery practices at universities for Federal research grants and contracts. At the…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Education and Labor.
Oversight hearing held on two days in September and October of 1977 focused on school design and construction by the Bureau of Indian Affairs (BIA) and on the supplemental and basic support offered to Indian education by the Johnson O'Malley program. On both days Dr. William Demmert, Jr., Director of the Office of Indian Education Programs, BIA,…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Education and Labor.
This is a report of oversight hearings held in Washington, D.C., on January 23 and 24 and February 5, 6, and 7, 1980, to provide the House of Representatives Subcommittee on Elementary, Secondary, and Vocational Education of the Committee of Education and Labor, with a general picture of the current state of American secondary education. The focus…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. Senate Committee on Labor and Human Resources.
This Congressional report contains prepared statements presented at a hearing held in Mississippi to assess local and statewide implementation of the Job Training Partnership Act (JTPA). The focus of the hearing was on state-level administration and assessment of the program, strategies for linking education and training systems, and employers and…
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. Senate Committee on Governmental Affairs.
A hearing before the oversight committee for the District of Columbia (D.C.) public schools provided the opportunity for several senators and educators to comment on the progress of educational reform in the District's public schools. The hearing was held at a time when the opening of the city's public schools was delayed because of their many…
Goldstein, Cory E; Weijer, Charles; Brehaut, Jamie C; Fergusson, Dean A; Grimshaw, Jeremy M; Horn, Austin R; Taljaard, Monica
2018-02-27
Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs.
Poster - Thur Eve - 02: Regulatory oversight of the robotic radiosurgery facilities.
Broda, K
2012-07-01
Following a recent review of the Class II Nuclear Facilities and Prescribed Equipment Regulations and regulatory oversight of particle accelerators, the Canadian Nuclear Safety Commission (CNSC) has changed its policy concerning the regulation of particle accelerators. In November 2011, the CNSC began to exercise its regulatory authority with respect to all particle accelerators operating at a beam energy of 1 (one) MeV or greater. The CNSC already licences and inspects particle accelerators capable of operating at or above 10 MeV. The decision to now include low energy particle accelerators (i.e., those operating at or above 1 MeV) ensures adequate, uniform and consistent regulatory oversight for all Class II accelerators. The CNSC expects these facilities to comply with CNSC requirements by December 2013. Besides conventional linear accelerators of lower energy (6 MeV or below) typically found in cancer clinics, two types of equipment now fall under the CNSC's regulatory oversight as a result of the above change: robotic radiosurgery and tomotherapy equipment and facilities. A number of clinics in Canada already operates these types of equipment and facilities. The safety aspects of radiosurgery equipment differ slightly from those for conventional linear accelerators. This poster aims to present an approach taken by the CNSC to regulate robotic radiosurgery equipment and facilities. The presentation will explain how to meet regulatory requirements of the Class II Nuclear Facilities and Prescribed Equipment Regulations by licensees operating or planning to acquire these types of equipment and facilities. © 2012 American Association of Physicists in Medicine.
Centralized Oversight of Physician–Scientist Faculty Development at Vanderbilt: Early Outcomes
Brown, Abigail M.; Morrow, Jason D.; Limbird, Lee E.; Byrne, Daniel W.; Gabbe, Steven G.; Balser, Jeffrey R.; Brown, Nancy J.
2013-01-01
Purpose In 2000, faced with a national concern over the decreasing number of physician–scientists, Vanderbilt School of Medicine established the institutionally funded Vanderbilt Physician–Scientist Development (VPSD) program to provide centralized oversight and financial support for physician–scientist career development. In 2002, Vanderbilt developed the National Institutes of Health (NIH)-funded Vanderbilt Clinical Research Scholars (VCRS) program using a similar model of centralized oversight. The authors evaluate the impact of the VPSD and VCRS programs on early career outcomes of physician–scientists. Method Physician–scientists who entered the VPSD or VCRS programs from 2000 through 2006 were compared with Vanderbilt physician–scientists who received NIH career development funding during the same period without participating in the VPSD or VCRS programs. Results Seventy-five percent of VPSD and 60% of VCRS participants achieved individual career award funding at a younger age than the comparison cohort. This shift to career development award funding at a younger age among VPSD and VCRS scholars was accompanied by a 2.6-fold increase in the number of new K awards funded and a rate of growth in K-award dollars at Vanderbilt that outpaced the national rate of growth in K-award funding. Conclusions Analysis of the early outcomes of the VPSD and VCRS programs suggests that centralized oversight can catalyze growth in the number of funded physician–scientists at an institution. Investment in this model of career development for physician–scientists may have had an additive effect on the recruitment and retention of talented trainees and junior faculty. PMID:18820531
Children as research subjects: moral disputes, regulatory guidance, and recent court decisions.
Kopelman, Loretta M
2006-05-01
The millennium has ushered in a new era of oversight for pediatric research, with renewed moral and legal attention to the upper thresholds of potential harms to which children may be exposed in studies. Watershed events discussed include: First, the deaths of two research subjects, allegedly due to insufficient oversight by the investigators and their institutional review boards. Second, the courts expressed concerns about research policies for incompetent persons or children in two cases, T.D. v. N.Y. and Grimes v. Kennedy Krieger Institute, and reinforcement of the principle that the best interest standard must be used for incompetent persons even in research. Third, the Best Pharmaceutical for Children Act and the Pediatric Rule created incentives as well as uncertainty among Institutional Review Boards and researchers about conducting pediatric studies. Fourth, the Office of Human Research Protection signaled the start of more rigorous oversight with its public rebuke and suspension of a National Institute of Child Health and Human Development pediatric obesity study. Failure to clarify the meaning of the pediatric regulations has sometimes misled generally risk-averse institutions and dedicated investigators about what is permissible.
Race, Margaret S; Hammond, Edward
2008-03-01
Institutional biosafety committees (IBCs) have been charged with the oversight and review of biosafety at thousands of biocontainment labs nationwide, hundreds of which are high-level BSL-3 and BSL-4 labs. In light of the recent rapid proliferation of BSL-3 and BSL-4 facilities and the increases in research in the areas of biodefense, select agents, recombinant DNA, and synthetic biology and dual-use research, questions have been raised about whether IBCs are fulfilling their oversight responsibilities. This article reviews information on the responsibilities and expectations of IBCs as currently constituted and provides an analysis of IBC performance from survey data of hundreds of research institutions over the past several years. The findings highlight serious ongoing problems with IBCs' adherence to NIH Guidelines. This raises questions about the current voluntary governance framework as an effective system to monitor and oversee U.S. research facilities, including high-containment facilities, and their research activities. The findings strongly suggest the need for immediate improvement or replacement of the IBC system.
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on the District of Columbia.
This document contains the text of a Congressional oversight hearing on Public Law 98-621, the St. Elizabeths Hospital and District of Columbia Mental Health Services Act, which became law in November 1984 and which transferred St. Elizabeths Hospital from federal control to that of the government of the District of Columbia. The text of Public…
Examining the FDA's oversight of direct-to-consumer advertising.
Gahart, Martin T; Duhamel, Louise M; Dievler, Anne; Price, Roseanne
2003-01-01
Our analysis examined the effects of the Food and Drug Administration's (FDA's) 1997 draft guidance regarding advertisements for prescription drugs broadcast directly to consumers. We found that although direct-to-consumer (DTC) advertising spending by pharmaceutical companies has increased, more than 80 percent of their promotional spending is directed to physicians. DTC advertising appears to increase the use of prescription drugs among consumers. The FDA's oversight has not prevented companies from making misleading claims in subsequent advertisements, and a recent policy change has lengthened the FDA's review process, raising the possibility that some misleading campaigns could run their course before review.
ERIC Educational Resources Information Center
US Senate, 2004
2004-01-01
The Subcommittee conducted an oversight hearing on Section 529 College Savings Plans, State-sponsored investments that are designed to encourage families to save money for their children's college education. Section 529 refers to the Internal Revenue Code section that authorizes and confers special tax treatment on these entities. Section 529…
United States Food and Drug Administration Regulation of Gene and Cell Therapies.
Bailey, Alexander M; Arcidiacono, Judith; Benton, Kimberly A; Taraporewala, Zenobia; Winitsky, Steve
2015-01-01
The United States (US) Food and Drug Administration (FDA) is a regulatory agency that has oversight for a wide range of products entering the US market, including gene and cell therapies. The regulatory approach for these products is similar to other medical products within the United States and consists of a multitiered framework of statutes, regulations, and guidance documents. Within this framework, there is considerable flexibility which is necessary due to the biological and technical complexity of these products in general. This chapter provides an overview of the US FDA regulatory oversight of gene and cell therapy products.
2000-02-28
iIÄ»lllilil^» P «lMlii fport INSPECTOR GENERAL, DOD, OVERSIGHT OF THE ARMY AUDIT AGENCY AUDIT OF THE FY 1999 U.S. ARMY CORPS OF ENGINEERS, CIVIL...WORKS PROGRAM, FINANCIAL STATEMENTS Report No. D -2000-093 February 28, 2000 pnc QXIAUTY mm®™* i 0ffice Qf ±Q hispdCtor General Department of...Works Program, Financial Statements (Report No. D -2000-093) We are providing this audit report for your information and use and for transmittal to
NASA Technical Reports Server (NTRS)
Thomas, LeAnn; Doreswamy, Rajiv N.
2008-01-01
Systems Engineering and Integration (SE&I) is a critical discipline in developing new space systems. In 2005, NASA performed an internal study of 24 agency and Department of Defense (DoD) programs to evaluate methods of integrating SE&I practices and determine their effectiveness. The goal of the study was to determine the best SE&I implementation strategy for the Ares Projects Office. The study identified six SE&I organizational structures: 1. Lead systems integrator (LSI) with SE&I responsibility and government technical insight. 2a. Integration contractor with government SE&I responsibility (government insight). 2b. Integration contractor with government SE&I responsibility (government oversight). 3a. Prime contractor with SE&I responsibility (government insight). 3b. Prime contractor with SE&I responsibility (government oversight). 3c. Prime contractor with SE&I responsibility (government/industry partnership). 4a.Prime contractor with government SE&I responsibility (government insight). 4b. Prime contractor with government SE&I responsibility (government oversight). 4d.Prime contractors with total system performance responsibility (TSPR). 5. Prime contractor with government SE&I responsibility and integration products through a Federally Funded Research and Development Center (FFRDC). 6. Government/FFRDC in-house development with SE&I responsibility and function. The organizational structure used most often was number 4, using a prime contractor with government SE&I responsibility and government technical insight. However, data analyses did not establish a positive relationship between program development costs and specific SE&I organizational types, nor did it positively determine the relationship between successful programs or projects and their SE&I structure. The SE&I study reached the following conclusions: (1) Large, long-duration, technically complex programs or projects reach their technical goals, but rarely meet schedule or cost goals. NASA's recent successes have been smaller, short-duration development projects using heritage hardware/software, focused technology development, technical oversight and stable external factors. (2) Programs and projects have failed or been terminated due to lack of technical insight, relaxing of SE&I processes, and unstable external factors. (3) The study did not find a single, clear optimum SE&I organization type to fit all projects. However, while any organizational structure can be made to work, the fewer complexities in the program, the better the likelihood of success. (4) The most common successful SE&I organization structure type in the study was type 4b, where the government maintained integration responsibility, with the prime contractor providing SE&I products and the government providing technical oversight. This study was instrumental in helping the APO select organization structure 4, following the same SE&I and oversight process used during humanlund7s last voyages to the Moon.
Safety Oversight of Decommissioning Activities at DOE Nuclear Sites
DOE Office of Scientific and Technical Information (OSTI.GOV)
Zull, Lawrence M.; Yeniscavich, William
2008-01-15
The Defense Nuclear Facilities Safety Board (Board) is an independent federal agency established by Congress in 1988 to provide nuclear safety oversight of activities at U.S. Department of Energy (DOE) defense nuclear facilities. The activities under the Board's jurisdiction include the design, construction, startup, operation, and decommissioning of defense nuclear facilities at DOE sites. This paper reviews the Board's safety oversight of decommissioning activities at DOE sites, identifies the safety problems observed, and discusses Board initiatives to improve the safety of decommissioning activities at DOE sites. The decommissioning of former defense nuclear facilities has reduced the risk of radioactive materialmore » contamination and exposure to the public and site workers. In general, efforts to perform decommissioning work at DOE defense nuclear sites have been successful, and contractors performing decommissioning work have a good safety record. Decommissioning activities have recently been completed at sites identified for closure, including the Rocky Flats Environmental Technology Site, the Fernald Closure Project, and the Miamisburg Closure Project (the Mound site). The Rocky Flats and Fernald sites, which produced plutonium parts and uranium materials for defense needs (respectively), have been turned into wildlife refuges. The Mound site, which performed R and D activities on nuclear materials, has been converted into an industrial and technology park called the Mound Advanced Technology Center. The DOE Office of Legacy Management is responsible for the long term stewardship of these former EM sites. The Board has reviewed many decommissioning activities, and noted that there are valuable lessons learned that can benefit both DOE and the contractor. As part of its ongoing safety oversight responsibilities, the Board and its staff will continue to review the safety of DOE and contractor decommissioning activities at DOE defense nuclear sites.« less
NASA Technical Reports Server (NTRS)
Parks, Robert E.
1991-01-01
An investigation into when it was first recognized that there was a deficiency in NASA optical metrology oversight capability, why this deficiency existed unnoticed for so long, and a proposal for correcting the problem is presented. It is explained why this optical metrology oversight is so critical to program success and at the same time, why it is difficult to establish due to the nature of the technology. The solution proposed is the establishment of an Optics Metrology Group within the NASA/MSFC Optics Branch with a line of authority from NASA S & MA.
ERIC Educational Resources Information Center
1976
The full texts of all prepared statements and supplemental materials presented during five days of oversight hearings held on rehabilitation of the handicapped programs and implementation of these programs by agencies under the Rehabilitation Act of 1973 are contained in this document. Statements are made by (1) State and local directors and other…
Public accountability for health: new standards for health system performance.
Lansky, D; Purdy, S
1995-01-01
This article reviews the failure of contemporary quality oversight organizations to respond to the changing health care environment and suggests an overhaul of quality measurement and assurance functions. The authors examine the factors that have limited public accountability for health care, emphasizing the limited agreement that exists on the purpose of American health care, standards for evaluating care, or the appropriate locus of responsibility for quality of care. A five-part quality oversight system is proposed including development of quality measures, promulgation of national standards, validation and accreditation, use of data for purchasing and provider selection, and use of data for quality improvement.
Strategic opportunities in the oversight of the U.S. hospital accreditation system.
Moffett, Maurice L; Morgan, Robert O; Ashton, Carol M
2005-12-01
Hospital accreditation and state certification are the means that the Centers for Medicare & Medicaid Services (CMS) employs to meet quality of care requirements for medical care reimbursement. Hospitals can choose to use either a national accrediting agency or a state certification inspection in order to receive Medicare payments. Approximately, 80% of hospitals choose the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The purpose of this paper is to analyze and discuss improvements on the structure of the accreditation process in a Principal-Agent-Supervisor framework with a special emphasis on the oversight by the principal (CMS) of the supervisor (JCAHO).
Beaudrie, Christian E H; Kandlikar, Milind; Satterfield, Terre
2013-06-04
Engineered nanomaterials (ENMs) promise great benefits for society, yet our knowledge of potential risks and best practices for regulation are still in their infancy. Toward the end of better practices, this paper analyzes U.S. federal environmental, health, and safety (EHS) regulations using a life cycle framework. It evaluates their adequacy as applied to ENMs to identify gaps through which emerging nanomaterials may escape regulation from initial production to end-of-life. High scientific uncertainty, a lack of EHS and product data, inappropriately designed exemptions and thresholds, and limited agency resources are a challenge to both the applicability and adequacy of current regulations. The result is that some forms of engineered nanomaterials may escape federal oversight and rigorous risk review at one or more stages along their life cycle, with the largest gaps occurring at the postmarket stages, and at points of ENM release to the environment. Oversight can be improved through pending regulatory reforms, increased research and development for the monitoring, control, and analysis of environmental and end-of-life releases, introduction of periodic re-evaluation of ENM risks, and fostering a "bottom-up" stewardship approach to the responsible management of risks from engineered nanomaterials.
Nanotechnology, voluntary oversight, and corporate social performance: does company size matter?
NASA Astrophysics Data System (ADS)
Kuzma, Jennifer; Kuzhabekova, Aliya
2011-04-01
In this article, we examine voluntary oversight programs for nanotechnology in the context of corporate social performance (CSP) in order to better understand the drivers, barriers, and forms of company participation in such programs. At the theoretical level, we use the management framework of CSP to understand the voluntary behavior of companies. At the empirical level, we investigate nanotech industry participation in the Environmental Protection Agency's Nanoscale Materials Stewardship Program (NMSP) as an example of CSP, in order to examine the effects of company characteristics on CSP outcomes. The analysis demonstrates that, on the average, older and larger companies for which nanotech is one of the many business activities demonstrate greater CSP as judged by company actions, declarations, and self-evaluations. Such companies tended to submit more of the requested information to the NMSP, including specific information about health and safety, and to claim fewer of the submitted items as confidential business information. They were also more likely to have on-line statements of generic and nano-specific corporate social responsibility principles, policies, and achievements. The article suggests a need to encourage smaller and younger companies to participate in voluntary oversight programs for nanotechnology and presents options for better design of these programs.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Stenson, Ron; Howard, Don
2013-07-01
As Canada's nuclear regulator, the Canadian Nuclear Safety Commission (CNSC) is responsible for licensing all aspects of uranium mining, including remediation activities at legacy sites. Since these sites already existed when the current legislation came into force in 2000, and the previous legislation did not apply, they present a special case. The Nuclear Safety and Control Act (NSCA), was written with cradle-to- grave oversight in mind. Applying the NSCA at the end of a 'facilities' life-cycle poses some challenges to both the regulator and the proponent. When the proponent is the public sector, even more challenges can present themselves. Althoughmore » the licensing process for legacy sites is no different than for any other CNSC license, assuring regulatory compliance can be more complicated. To demonstrate how the CNSC has approached the oversight of legacy sites the history of the Commission's involvement with the Gunnar uranium mine and mill site provides a good case study. The lessons learned from the CNSC's experience regulating the Gunnar site will benefit those in the future who will need to regulate legacy sites under existing or new legislation. (authors)« less
NASA Technical Reports Server (NTRS)
Strand, Albert A.; Jackson, Darryl J.
1992-01-01
As the nation redefines priorities to deal with a rapidly changing world order, both government and industry require new approaches for oversight of management systems, particularly for high technology products. Declining defense budgets will lead to significant reductions in government contract management personnel. Concurrently, defense contractors are reducing administrative and overhead staffing to control costs. These combined pressures require bold approaches for the oversight of management systems. In the Spring of 1991, the DPRO and TRW created a Process Action Team (PAT) to jointly prepare a Performance Based Management (PBM) system titled Teamwork for Oversight of Processes and Systems (TOPS). The primary goal is implementation of a performance based management system based on objective data to review critical TRW processes with an emphasis on continuous improvement. The processes are: Finance and Business Systems, Engineering and Manufacturing Systems, Quality Assurance, and Software Systems. The team established a number of goals: delivery of quality products to contractual terms and conditions; ensure that TRW management systems meet government guidance and good business practices; use of objective data to measure critical processes; elimination of wasteful/duplicative reviews and audits; emphasis on teamwork--all efforts must be perceived to add value by both sides and decisions are made by consensus; and synergy and the creation of a strong working trust between TRW and the DPRO. TOPS permits the adjustment of oversight resources when conditions change or when TRW systems performance indicate either an increase or decrease in surveillance is appropriate. Monthly Contractor Performance Assessments (CPA) are derived from a summary of supporting system level and process-level ratings obtained from objective process-level data. Tiered, objective, data-driven metrics are highly successful in achieving a cooperative and effective method of measuring performance. The teamwork-based culture developed by TOPS proved an unequaled success in removing adversarial relationships and creating an atmosphere of continuous improvement in quality processes at TRW. The new working relationship does not decrease the responsibility or authority of the DPRO to ensure contract compliance and it permits both parties to work more effectively to improve total quality and reduce cost. By emphasizing teamwork in developing a stronger approach to efficient management of the defense industrial base TOPS is a singular success.
NASA Astrophysics Data System (ADS)
Strand, Albert A.; Jackson, Darryl J.
As the nation redefines priorities to deal with a rapidly changing world order, both government and industry require new approaches for oversight of management systems, particularly for high technology products. Declining defense budgets will lead to significant reductions in government contract management personnel. Concurrently, defense contractors are reducing administrative and overhead staffing to control costs. These combined pressures require bold approaches for the oversight of management systems. In the Spring of 1991, the DPRO and TRW created a Process Action Team (PAT) to jointly prepare a Performance Based Management (PBM) system titled Teamwork for Oversight of Processes and Systems (TOPS). The primary goal is implementation of a performance based management system based on objective data to review critical TRW processes with an emphasis on continuous improvement. The processes are: Finance and Business Systems, Engineering and Manufacturing Systems, Quality Assurance, and Software Systems. The team established a number of goals: delivery of quality products to contractual terms and conditions; ensure that TRW management systems meet government guidance and good business practices; use of objective data to measure critical processes; elimination of wasteful/duplicative reviews and audits; emphasis on teamwork--all efforts must be perceived to add value by both sides and decisions are made by consensus; and synergy and the creation of a strong working trust between TRW and the DPRO. TOPS permits the adjustment of oversight resources when conditions change or when TRW systems performance indicate either an increase or decrease in surveillance is appropriate. Monthly Contractor Performance Assessments (CPA) are derived from a summary of supporting system level and process-level ratings obtained from objective process-level data. Tiered, objective, data-driven metrics are highly successful in achieving a cooperative and effective method of measuring performance. The teamwork-based culture developed by TOPS proved an unequaled success in removing adversarial relationships and creating an atmosphere of continuous improvement in quality processes at TRW. The new working relationship does not decrease the responsibility or authority of the DPRO to ensure contract compliance and it permits both parties to work more effectively to improve total quality and reduce cost. By emphasizing teamwork in developing a stronger approach to efficient management of the defense industrial base TOPS is a singular success.
Strategic planning--a plan for excellence for South Haven Health System.
Urbanski, Joanne; Baskel, Maureen; Martelli, Mary
2011-01-01
South Haven Health System has developed an innovative approach to strategic planning. The key to success of this process has been the multidisciplinary involvement of all stakeholders from the first planning session through the final formation of a strategic plan with measurable objectives for each goal. The process utilizes a Conversation Café method for identifying opportunities and establishing goals, Strategic Oversight Teams to address each goal and a Champion for implementation of each objective. Progress is measured quarterly by Strategic Oversight Team report cards. Transparency of communication within the organization and the sharing of information move the plan forward. The feedback from participant evaluations has been overwhelmingly positive. They are involved and excited.
Understanding Research Misconduct: A Comparative Analysis of 120 Cases of Professional Wrongdoing
DuBois, James M.; Anderson, Emily E.; Chibnall, John; Carroll, Kelly; Gibb, Tyler; Ogbuka, Chiji; Rubbelke, Timothy
2013-01-01
We analyzed 40 cases of falsification, fabrication, or plagiarism (FFP), comparing them to other types of wrongdoing in research (n = 40) and medicine (n = 40). Fifty-one variables were coded from an average of 29 news or investigative reports per case. Financial incentives, oversight failures, and seniority correlate significantly with more serious instances of FFP. However, most environmental variables were nearly absent from cases of FFP and none were more strongly present in cases of FFP than in other types of wrongdoing. Qualitative data suggest FFP involves thinking errors, poor coping with research pressures, and inadequate oversight. We offer recommendations for education, institutional investigations, policy, and further research. PMID:24028480
NASA Astrophysics Data System (ADS)
Degnan, Frank
1993-12-01
The Comet Rendezvous Asteroid Flyby (CRAF)/Cassini program was first funded by the Congress in fiscal year 1990. Since then, it has encountered difficulties that resulted in the cancellation of CRAF, reduction of Cassini's original scientific capabilities, and extension of its launch date. At the request of the former Chairman of the Investigations and Oversight Subcommittee, House Committee on Science, Space, and Technology, GAO reviewed the program to identify the factors that led to the cancellation of the CRAF project and the prospects for continuation of the Cassini project.
2013-01-01
Abstract Intraoperative neurophysiological monitoring (IONM) is used as an adjunct for surgeries that pose risk to nervous system structures. IONM is performed by a technologist in the operating room and is overseen by a highly trained fellowship-trained physician clinical neurophysiologist. Telemedicine has allowed the professional oversight component to be done remotely, with reimbursement for multiple simultaneous cases. Recent changes to Current Procedure Terminology coding and Medicare reimbursement policies provide options only for exclusive 1:1 technologist:oversight physician billing. This policy change may create profound repercussions in the practice of telemedicine by actively discouraging the leveraging of highly specialized and scarce expertise through on-site physician extenders. PMID:23952785
Scientific Autonomy and Public Oversight
Resnik, David B.
2009-01-01
When scientific research collides with social values, science’s right to self-governance becomes an issue of paramount concern. In this article, I develop an account of scientific autonomy within a framework of public oversight. I argue that scientific autonomy is justified because it promotes the progress of science, which benefits society, but that restrictions on autonomy can also be justified to prevent harm to people, society, or the environment, and to encourage beneficial research. I also distinguish between different ways of limiting scientific autonomy, and I argue that government involvement in scientific decision-making should usually occur through policies that control the process of science, rather than policies that control the content of science. PMID:19777124
ERIC Educational Resources Information Center
Congress of the U.S., Washington, DC. House Committee on Education and Labor.
The oversight hearing at the second White House Conference on Library and Information Services (WHCLIS2) focuses on the role of the library in three major areas addressed by conference presenters: a literate work force; the productivity to compete in the international marketplace in the 21st century; and a populace fully equipped to participate in…
Standardized Testing Practices: Effect on Graduation and NCLEX® Pass Rates.
Randolph, Pamela K
The use standardized testing in pre-licensure nursing programs has been accompanied by conflicting reports of effective practices. The purpose of this project was to describe standardized testing practices in one states' nursing programs and discover if the use of a cut score or oversight of remediation had any effect on (a) first time NCLEX® pass rates, (b) on-time graduation (OTG) or (c) the combination of (a) and (b). Administrators of 38 nursing programs in one Southwest state were sent surveys; surveys were returned by 34 programs (89%). Survey responses were compared to each program's NCLEX pass rate and on-time graduation rate; t-tests were conducted for significant differences associated with a required minimum score (cut score) and oversight of remediation. There were no significant differences in NCLEX pass or on-time graduation rates related to establishment of a cut score. There was a significant difference when the NCLEX pass rate and on-time graduation rate were combined (Outcome Index "OI") with significantly higher program outcomes (P=.02.) for programs without cut-scores. There were no differences associated with faculty oversight of remediation. The results of this study do not support establishment of a cut-score when implementing a standardized testing. Copyright © 2016. Published by Elsevier Inc.
Real-time Responsiveness for Ethics Oversight During Disaster Research.
Eckenwiler, Lisa; Pringle, John; Boulanger, Renaud; Hunt, Matthew
2015-11-01
Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises--particularly in resource-poor settings--is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees (RECs). Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like--how it might be conceptualized and utilized--using the concept of real-time responsiveness (RTR). The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. © 2015 John Wiley & Sons Ltd.