Supervisory Regulatory Counsel

0910-AI86 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Prerule Stage No No 21 CFR 7 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 No ANPRM 06/00/2023 No None No No No Christopher Henderson Supervisory Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-8186 christopher.henderson@fda.hhs.gov 12420 Parklawn Drive, Rockville MD 20857