0910-AI48 202010 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Amendments to Good Guidance Practices Regulation

The Food and Drug Administration seeks to develop a proposed rule that would amend its current Good Guidance Practices (GGP) regulation (21 CFR. 10.115). This action is intended to implement Executive Order 13891, "Promoting the Rule of Law Through Improved Agency Guidance Documents." The Executive Order requires that agency regulations address certain issues related to guidance documents by 8/27/2020.  The amendments to the GGP regulation would address the issues in the EO that are not currently addressed by 21 CFR 10.115. 

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No Fully or Partially Exempt 21 CFR 10.115 21 U.S.C. 371(h) 21 U.S.C. 371(a) No NPRM 02/00/2021 No No None No No No No Brian Pendleton L. Senior Policy Advisor 0910 Food and Drug Administration FDA 301 796-4614 301 847-3541 brian.pendleton@fda.hhs.gov Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002