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HHS/FDA | RIN: 0910-AI78 | Publication ID: Fall 2024 |
Title: Requirements for Requesting Records in Advance of or in Lieu of an Inspection of an Establishment that Manufactures Certain HCT/Ps | |
Abstract:
Human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are regulated solely under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264) and the regulations in 21 CFR part 1271(361 HCT/Ps) are not regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). As a result, our statutory authority under section 704(a)(4) of the FD&C Act, under which persons are required to submit certain records or other information to FDA in response to a request from FDA in advance of or in lieu of a drug establishment inspection does not apply to these products. Currently, FDA can request that establishments that manufacture 361 HCT/Ps submit records voluntarily in advance of or in lieu of an inspection. The proposed amendment to the regulations at 21 CFR part 1271, subpart F would establish requirements for the submission of records or other information to FDA upon request, in advance of or in lieu of an inspection of establishments that manufacture 361 HCT/Ps. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 1271 | |
Legal Authority: 42 U.S.C. 264 42 U.S.C. 271 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Melissa Segal Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301, Silver Spring, MD 20993 Phone:240 402-7911 Email: melissa.segal@fda.hhs.gov |