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Reducing Regulatory Burden

Evidenced-Based Policymaking

In the last few years, the number of new and proposed regulations and policies have increased dramatically, placing significant stress on researchers and academic institutions. In 2016, the National Academies of Sciences, Engineering, and Medicine ("the Academies") and the Government Accountability Office, (GAO) published reports identifying a need for federal agencies to harmonize regulations, reduce workload and costs, and consider evidence-based regulatory approaches. Both reports cite AAMC’s Conflict of Interest (COI) Metrics Project as an example of an existing effort to quantify the impact and burden of research regulations on academic institutions.

Adding to the efforts of the Academies and GAO, on March 30, 2016, the Commission on Evidence Based-Policymaking was created by the Evidence-Based Commission Act of 2016 (P.L. 114-140).The Commission was charged with examining ways to increase the use and availability of evidence to inform policy and regulatory decisions as well as how to best incorporate evaluation in program design. The Commission released a final report on September 7, 2017.

The Foundations of Evidence-Based Policymaking Act, bipartisan legislation introduced by Speaker Paul Ryan (R-Wis) and Patty Murry (D-WA), was passed in the House on November 15, 2017 and is currently awaiting vote in the Senate. The legislation draws significantly on the recommendations in the Commission on Evidence-Based Policymaking's final report. Specifically, the bill requires the establishment of Chief Evaluation Officers to make continual assessments of agency activities and for federal agencies to create evidence-building plans, as well as the creation of an advisory committee to study the Commission's recommendation for the creation of a National Secure Data Service.

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21st Century Cures Act and Regulatory Burden

The 21st Century Cures Act (H.R. 34) was signed into law by President Barack Obama on December 13, 2016 and provides significant funding for research initiatives at the National Institutes of Health (NIH) and Food and Drug Administration (FDA) to aid the acceleration of safe and effective new drugs and devices and enhance state opioid response. The Act also implements many of the recommendations in Part 1 of the Academies' report, Optimizing the Nation’s Investment in Academic Research, such as the creation of a research policy board (Section 2034(f)), tasked with making recommendations on modifying and harmonizing policies and regulations across research funding agencies to reduce administrative burden.

The Act also requires the director of the National Institutes of Health (NIH) in coordination with the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) to review and revise regulations and policies governing the care and use of laboratory animals to reduce administrative burden. On October 24, 2017, the Federation of American Societies for Experimental Biology (FASEB), AAMC, the Council on Governmental Relations (COGR), and the National Association of Biomedical Research (NABR) released a report on Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden.

On March 14, 2018, the NIH announced a Request for Information (RFI) "to improve the coordination of regulations and policies with respect to research with laboratory animals as required by the 21st Century Cures Act, Section 2034(d)." Responses to this RFI must be submitted by June 12, 2018.

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Executive Orders and Memoranda

Since January 20, 2017, the White House has issued several executive orders and memoranda on reducing regulation and controlling regulatory cost.

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For questions, contact Heather Pierce, JD, MPH, Senior Director, Science Policy and Regulatory Counsel at hpierce@aamc.org or (202) 478-9926. You may follow Heather on Twitter at @HeatherHPierce

Last Updated: March 30, 2018