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HHS/FDA RIN: 0910-AA49 Publication ID: Spring 2016 
Title: 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 
Abstract:

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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 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   
Legal Authority: 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    and sec 122    Pub. L. 105-115, 11 Stat. 2322 (21 U.S.C. 355 note)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/29/2006  71 FR 51276   
NPRM Comment Period End  02/26/2007    
Final Action  07/00/2016 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
Public Comment URL: www.regulations.gov  
RIN Data Printed in the FR: Yes 
Agency Contact:
David Joy
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6254,
Silver Spring, MD 20993
Phone:301 796-2242
Email: david.joy@fda.hhs.gov