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HHS/FDA | RIN: 0910-AI86 | Publication ID: Spring 2023 |
Title: ●Recalls of Products Subject to the Jurisdiction of the Food and Drug Administration | |
Abstract:
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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: First time 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 |
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Timetable:
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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 Supervisory Regulatory Counsel Department of Health and Human Services Food and Drug Administration 12420 Parklawn Drive, Rockville, MD 20857 Phone:240 402-8186 Email: christopher.henderson@fda.hhs.gov |