42 U.S.C. § 3501: Establishment of Department; effective date

The provisions of Reorganization Plan Numbered 1 of 1953, submitted to the Congress on March 12, 1953 , shall take effect ten days after April 1, 1953 , and its approval by the President, notwithstanding the provisions of the Reorganization Act of 1949, as amended, except that section 9 of such Act shall apply to such reorganization plan and to the reorganization made thereby. lead a review by research funding agencies of all regulations and policies related to the disclosure of financial conflicts of interest, including the minimum threshold for reporting financial conflicts of interest; make revisions, as appropriate, to harmonize existing policies and reduce administrative burden on researchers while maintaining the integrity and credibility of research findings and protections of human participants; and confer with the Office of the Inspector General about the activities of such office related to financial conflicts of interest involving research funding agencies. modifying the timelines for the reporting of financial conflicts of interest to just-in-time information by institutions receiving grant or cooperative agreement funding from the National Institutes of Health; ensuring that financial interest disclosure reporting requirements are appropriate for, and relevant to, awards that will directly fund research, which may include modification of the definition of the term ‘investigator’ for purposes of the regulations and policies described in subparagraphs (A) and (B) of paragraph (1); and updating any applicable training modules of the National Institutes of Health related to Federal financial interest disclosure. the subrecipient is subject to Federal audit requirements pursuant to the Uniform Guidance of the Office of Management and Budget; the primary awardee conducts, pursuant to guidance of the National Institutes of Health, a pre-award evaluation of each subrecipient’s risk of noncompliance with Federal statutes and regulations, the conditions of the subaward, and any recurring audit findings; and such exemption does not absolve the primary awardee of liability for misconduct by subrecipients; and the implementation of alternative grant structures that obviate the need for subrecipient monitoring, which may include collaborative grant models allowing for multiple primary awardees. The Secretary, in consultation with the Director of National Institutes of Health, shall evaluate financial expenditure reporting procedures and requirements for recipients of funding from the National Institutes of Health and take action, as appropriate, to avoid duplication between department and agency procedures and requirements and minimize burden to funding recipients. identify ways to ensure such regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative, including with respect to inspection and review requirements by Federal agencies and accrediting associations; take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals. The Secretary shall clarify the applicability of the requirements under the Office of Management and Budget Uniform Guidance for management and certification systems adopted by entities receiving Federal research grants through the Department of Health and Human Services regarding documentation of personnel expenses, including clarification of the extent to which any flexibility to such requirements specified in such Uniform Guidance applies to entities receiving grants through the Department of Health and Human Services. Not later than 1 year after the date of enactment of this Act [ Dec. 13, 2016 ], the Director of the Office of Management and Budget shall establish an advisory committee, to be known as the ‘Research Policy Board’ (referred to in this subsection as the ‘Board’), to provide Federal Government officials with information on the effects of regulations related to Federal research requirements. The Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget. The Director of the Office of Science and Technology Policy. The Secretary of Health and Human Services. The Director of the National Science Foundation. The secretaries and directors of other departments and agencies that support or regulate scientific research, as determined by the Director of the Office of Management and Budget. nomination by members of the nonprofit scientific research community, including academic research institutions; and procedures to fill membership positions vacated before the end of a member’s term. providing thorough and informed analysis of regulations and policies; identifying negative or adverse consequences of existing policies and making actionable recommendations regarding possible improvement of such policies; making recommendations with respect to efforts within the Federal Government to improve coordination of regulation and policy related to research; creating a forum for the discussion of research policy or regulatory gaps, challenges, clarification, or harmonization of such policies or regulation, and best practices; and conducting ongoing assessment and evaluation of regulatory burden, including development of metrics, periodic measurement, and identification of process improvements and policy changes. The Board may form temporary expert subcommittees, as appropriate, to develop timely analysis on pressing issues and assist the Board in anticipating future regulatory challenges, including challenges emerging from new scientific advances. Not later than 2 years after the date of enactment of this Act, and once thereafter, the Board shall submit a report to the Director of the Office of Management and Budget, the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget, the Director of the Office of Science and Technology Policy, the heads of relevant Federal departments and agencies, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives containing formal recommendations on the conceptualization, development, harmonization, and reconsideration of scientific research policy, including the regulatory benefits and burdens. The Board shall terminate on September 30, 2021 . Not later than 4 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct an independent evaluation of the activities carried out by the Board pursuant to this subsection and submit to the appropriate committees of Congress a report regarding the results of the independent evaluation. Such report shall review and assess the Board’s activities with respect to the responsibilities described in paragraph (3).” The National Academy of Sciences shall conduct a comprehensive study of the Department of Health and Human Services’ data collection systems and practices, and any data collection or reporting systems required under any of the programs or activities of the Department, relating to the collection of data on race or ethnicity, including other Federal data collection systems (such as the Social Security Administration) with which the Department interacts to collect relevant data on race and ethnicity. identifies the data needed to support efforts to evaluate the effects of socioeconomic status, race and ethnicity on access to health care and other services and on disparity in health and other social outcomes and the data needed to enforce existing protections for equal access to health care; examines the effectiveness of the systems and practices of the Department of Health and Human Services described in subsection (a), including pilot and demonstration projects of the Department, and the effectiveness of selected systems and practices of other Federal, State, and tribal agencies and the private sector, in collecting and analyzing such data; contains recommendations for ensuring that the Department of Health and Human Services, in administering its entire array of programs and activities, collects, or causes to be collected, reliable and complete information relating to race and ethnicity; and includes projections about the costs associated with the implementation of the recommendations described in paragraph (3), and the possible effects of the costs on program operations. For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for fiscal year 2001.”