Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Inlcuding Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; Final Rule

OMB 0910-0829

Latest Forms, Documents, and Supporting Material

Document Name
Reg and Listing Supporting Statement for Final Rule 2016.pdf Supporting Statement A
Reg and Listing FRIA 31 Aug 2016.pdf Supplementary Document
praedrlscm.doc Supplementary Document
Registration and Listing under 21 CFR Part 207
Registration and Listing under 21 CFR Part 1271
Registration and Listing under 21 CFR Part 607
Recordkeeping under Part 207