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  • Washington Highlights

    White House Spring Regulatory Agenda Includes Updates on FDA’s Human Subjects Research Protection Regulations

    Daria Grayer, Director, Regulation and Policy
    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel

    The Office of Information and Regulatory Affairs in the Office of Management and Budget May 9 released the Spring 2018 edition of the Unified Agenda of Federal Regulatory and Deregulatory Actions, a listing of the key regulatory priorities of federal agencies and the Administration. The priorities include plans for the Food and Drug Administration (FDA) to align its human subject protection regulations  (21 CFR Parts 50 and 56) with the revised Common Rule - which applies to the protection of all human subjects of research that is funded, conducted, or supported by federal agencies - as required by the 21st Century Cures Act (Pub. L. 114-255).

    The agenda indicates that the FDA intends to modify these regulations through a "direct final rule," a process which can be faster than the notice of proposed rulemaking. The direct final rule will be published in the Federal Register and go into effect as a final rule at the conclusion of a comment period unless substantive adverse comments are received. The agenda also includes the FDA’s plans to revise its rules related to cooperative research, perhaps to mirror the requirements of the revised Common Rule’s “single Institutional Review Board” provisions. While the publication of the agenda does not provide the regulated community with certainty about the timing of these actions or the content of the rules, it serves as a demonstration of the agency’s plans to move forward with harmonization.

    In a letter submitted Feb. 5 in response to the FDA’s request for comments on ways to identify regulations and related paperwork requirements that could be “modified, repealed, or replaced” under Presidential Executive Orders 13771 and 13777, the AAMC strongly urged the FDA to promptly align its human subject protections regulations with the Department of Health and Human Service’s revised Common Rule [see Washington Highlights Feb 9, 2018].

    The AAMC will post updates and resources on the Common Rule website as soon as they become available.