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HHS/FDA RIN: 0910-AI63 Publication ID: Fall 2022 
Title: Animal Cells, Tissues, and Cell- and Tissue-Based Products 
Abstract:

FDA is proposing to establish requirements specific to investigational animal cells, tissues, and cell- and tissue-based products (ACTPs) and current animal good tissue practice for ACTPs, including requirements for donor eligibility, for sponsors, firms, individuals, and establishments that investigate, manufacture, or market ACTPs that are regulated by the FDA.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 513   
Legal Authority: 21 U.S.C. 201    21 U.S.C. 301    21 U.S.C. 371(a)    21 U.S.C. 501    21 U.S.C. 502    21 U.S.C. 510    21 U.S.C. 512    21 U.S.C. 701    21 U.S.C. 704   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2024 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Lynne M. Boxer
Supervisory Veterinary Medical Officer
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, 7500 Standish Place, MPN2, HFV-109,
Rockville, MD 20855
Phone:240 402-0611
Email: lynne.boxer@fda.hhs.gov