0910-AI68 202404 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs

FDA is amending its drug establishment registration and drug listing regulations via Direct Final Rule to extend the current exemption from drug establishment registration for certain manufacturers, repackers, relabelers, or salvagers of Type B or Type C medicated feeds to exempt all manufacturers, repackers, relabelers, or salvagers of Type B and C medicated feeds from drug establishment registration.  All manufacturers, repackers, relabelers, or salvagers of Type B or Type C medicated feeds are already exempt from the drug listing requirements.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Long-Term Actions No No 21 CFR 207.1 21 CFR 207.13 21 CFR 207.17 21 CFR 207.21 21 CFR 515.10 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360b 21 U.S.C. 371(a) 21 U.S.C. 374 No Direct Final Rule 09/00/2025 Undetermined Businesses None No No No No Isabel Pocurull W. Supervisory Consumer Safety Officer 0910 Food and Drug Administration FDA 240 402-5877 isabel.pocurull@fda.hhs.gov Center for Veterinary Medicine, 7500 Standish Place , MPN-2, HFV-221, Rockville MD 20855