The 21st Century Cures Act - Provide Recoommendations

Please provide your recommendations for reforming animal research regulations!!

“Reducing Regulatory Burden”

How are Federal Laws Changed (i.e., reformed)?

Background (in brief)

  • Law: Federal statutes (i.e., laws) are collections of Acts of Congress approved by the president and codified as a federal regulation.
  • Act: A statue consists exclusively of “Acts” that were passed by Congress and signed into law by the President, or passed by Congress after a presidential veto.
  • Federal Register (Federal Register) is the official daily publication for rules, proposed rules, and notices of Federal agencies
    and organizations, as well as executive orders and other presidential documents.
  • Proposed Rules Section of the Federal Registry: is used to publicly announce proposed changes to regulations. It gives interested persons an opportunity to participate in the rule making prior to the adoption of the final rules by public comment or ideas regarding suggested changes.

      Proposed Changes to Animal Research Regulations

      1. The animal care and use research community calls for regulatory reform.

      Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden, 2017, Report of an April 17, 2017 workshop organized by Federation of American
      Societies for Experimental Biology (FASEB), the Association of American Medical Colleges, and the Council on Governmental Relations, with support from the National Association for
      Biomedical Research. FASEB-Report October 2017.

      Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century, 2016, National Academies. National Academies 2016

      Reducing Investigators' Administrative Workload for Federally Funded Research, 2014, National Science Board, National Science Foundation. National Science Board Report 2014

      2012 Faculty Workload Survey Research Report, 2014, Federal Demonstration Partnership (FDP). FDP Report 2014

      Findings of the FASEB Survey on Administrative Burden, 2013, FASEB. 2013 FASEB Report

      2. The 21st Century Cures Act, Section 2034(d) was signed into law on December 13, 2016, which
      requires regulating agencies (e.g., OLAW and the USDA) to review animal research regulations and make revisions that would result in reduce administrative burden for investigators.

      3. On February 24, 2017, President Trump issued an Executive order: (139 - Executive Order 13777) to
      enforce the Regulatory Reform Agenda.

      4. Upon completing their assessment of the animal research regulations, on March 14, 2018, federal regulators offered ideas for proposed changes through the Federal Register (Federal Registry Announcement).

      5. Through the federal register (Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 (83 FR 11221) Information from the animal research community is request.

      Submitting your Comments

      1. Comments will only be accepted from March 14, 2018 through June 12, 2018, and can be made by an individual or on behalf of an institution.

      2. Note: Comments must be suggested refinements in regulations that will reduce administrative burden for investigators.

      3. Comments must be submitted electronically at Submit Comments

      Point 3 under the “Tools and Resources” section of the 3/14/18 NIH Notice references the repository of best practices developed through The IACUC Administrators Association based on the engagement of IACUC Administrators at the annual IACUC Administrators Best Practice Meetings. As you prepare to comment on whether the IAA is a useful resource for reducing regulatory burden; consider visiting the IAA website (IAA) tab that offers summaries of best practices for conducting procedures such as: 1) Establishing an Emergency Disaster Plan; Developing an OHSP ; Investigating Whistle Blower Reports; Evaluating the Effectiveness of a training program; and 5) Prescreening an IACUC Protocol.