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HHS/FDA RIN: 0910-AI86 Publication ID: Fall 2023 
Title: Recalls of Products Subject to the Jurisdiction of the Food and Drug Administration 

The Food and Drug Administration (FDA or the Agency) is issuing an advance notice of proposed rulemaking (ANPRM) to obtain information related to recalls of products subject to the jurisdiction of the FDA and to invite comments that may inform FDA’s intention to revise the Agency’s guidance on policy, procedures, and industry responsibilities for recalls (including product corrections) (FDA’s recall regulation).  Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 7   
Legal Authority: 21 U.S.C. 371(a)    21 U.S.C. 321 to 393    42 U.S.C. 241    42 U.S.C. 262    42 U.S.C. 263 to 263n    42 U.S.C. 264   
Legal Deadline:  None
Action Date FR Cite
ANPRM  11/00/2023 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Christopher Henderson
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
12420 Parklawn Drive,
Rockville, MD 20857
Phone:240 402-8186