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HHS/FDA RIN: 0910-AI48 Publication ID: Fall 2020 
Title: 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. 

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 21 CFR 10.115   
Legal Authority: 21 U.S.C. 371(h)    21 U.S.C. 371(a)   
Legal Deadline:  None
Action Date FR Cite
NPRM  02/00/2021 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Brian L. Pendleton
Senior Policy Advisor
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-4614
Fax:301 847-3541