Supervisory Regulatory Counsel

0910-AI35 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Phased Review of New Animal Drug Applications, Electronic Submission, and Master Files

FDA is proposing to amend its regulations to establish requirements for the phased review of new animal drug applications, the use of master files, the electronic submission of information to support those applications or files, and to clarify existing regulations governing the submission of new animal drug applications.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 12 21 CFR 20 21 CFR 58 21 CFR 201 21 CFR 225 21 CFR 226 21 CFR 500 21 CFR 510 21 CFR 511 21 CFR 514 21 CFR 516 21 CFR 558 21 U.S.C. 360b 21 U.S.C. 371(a) Pub. L. 115-234, sec. 301 No NPRM 12/00/2023 No Businesses None No No No No Urvi Desai Supervisory Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-0689 urvi.desai@fda.hhs.gov Center for Veterinary Medicine, 7500 Standish Place, MPN-2, HFV-101, Rockville MD 20855