0910-AI63 202404 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Animal Cells, Tissues, and Cell- and Tissue-Based Products

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 FDA.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Long-Term Actions No No 21 CFR 513 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 No NPRM 09/00/2025 No None No No No Lynne Boxer M. Supervisory Veterinary Medical Officer 0910 Food and Drug Administration FDA 240 402-0611 lynne.boxer@fda.hhs.gov Center for Veterinary Medicine, 7500 Standish Place, MPN2, HFV-109, Rockville MD 20855