0910-AA49 200904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 20 21 CFR 201 21 CFR 207 21 CFR 314 21 CFR 330 21 CFR 514 and 515 21 CFR 601 21 CFR 607 21 CFR 610 21 CFR 1271 21 USC 321 21 USC 331 21 USC 351 and 352 21 USC 355 21 USC 360 21 USC 360b 21 USC 371 21 USC 374 42 USC 262 42 USC 264 42 USC 271 No NPRM 08/29/2006 71 FR 51276 NPRM Comment Period End 02/26/2007 72 FR 5944 Final Action 12/00/2009 No Businesses None No No Yes Paula McKeever S. 0910 Food and Drug Administration FDA 301 827-1520 301 443-9718 paula.mckeever@fda.hhs.gov Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45, Rockville MD 20857-0001