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HHS/FDA RIN: 0910-AA49 Publication ID: Fall 2013 
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, 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 and associated labeling. 
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 and 207    21 CFR 314 and 330    21 CFR 514 to 516    21 CFR 601 and 607    21 CFR 610    21 CFR 1271   
Legal Authority: 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   
Legal Deadline:  None
Action Date FR Cite
NPRM  08/29/2006  71 FR 51276   
NPRM Comment Period End  02/26/2007    
Final Action  05/00/2014 
Regulatory Flexibility Analysis Required: No  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:  
RIN Data Printed in the FR: No 
Agency Contact:
David Joy
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
WO 51, Room 6254, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-2242

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