Senior Regulatory Counsel

0910-AA49 201510 The Regulatory Plan and the 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

The rule will reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, including certain biological drugs, and animal drugs. These regulations contain information on when, how, and where to register drug establishments and list drugs, and what information must be submitted. They also address National Drug Codes.

]]> 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 514 21 CFR 515 21 CFR 601 21 CFR 607 21 CFR 1271 21 U.S.C. 321 and 331 21 U.S.C. 351 to 353 21 U.S.C. 355 to 356c 21 U.S.C. 360 and 360b 21 U.S.C. 360c to 360f 21 U.S.C. 360h to 360j 21 U.S.C. 371 and 374 21 U.S.C. 379e and 381 21 U.S.C. 393 15 U.S.C. 1451 to 1561 42 U.S.C. 262 and 264 42 U.S.C. 271 No NPRM 08/29/2006 71 FR 51276 NPRM Comment Period End 02/26/2007 Final Action 04/00/2016 Yes Businesses None No www.regulations.gov Yes Yes David Joy Senior Regulatory Counsel 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