0910-AA49 201404 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 Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 20 21 CFR 201 and 207 21 CFR 314 and 330 21 CFR 514 to 516 21 CFR 601 and 607 21 CFR 610 21 CFR 1271 21 USC 321 and 331 21 USC 351 to 353 21 USC 355 to 356c 21 USC 360 and 360b 21 USC 360c to 360f 21 USC 360h to 360j 21 USC 371 and 374 21 USC 379e and 381 21 USC 393 15 USC 1451 to 1561 42 USC 262 and 264 42 USC 271 No NPRM 08/29/2006 71 FR 51276 NPRM Comment Period End 02/26/2007 Final Action 02/00/2015 No Businesses None No www.regulations.gov No Yes David Joy 0910 Food and Drug Administration FDA 301 796-2242 david.joy@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6254, Silver Spring MD 20993