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HHS/FDA RIN: 0910-AA49 Publication ID: Spring 2010 
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 at 21 CFR part 207 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 for initial registration and listing and for changes to registration and listing. Consistent with amended statutory requirements, the rule will require that this information be submitted electronically. The rule will also make certain changes to the National Drug Code (NDC) system and would require that the appropriate human-readable NDC number appear on labels for drugs subject to the listing requirement. 
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 330    21 CFR 514    21 CFR 515    21 CFR 516    21 CFR 601    21 CFR 607    21 CFR 610    21 CFR 1271   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351    21 USC 352    21 USC 353    21 USC 355    21 USC 356    21 USC 356a    21 USC 356b    21 USC 356c    21 USC 360    21 USC 360b    21 USC 360c-360f    21 USC 360h-360j    21 USC 371    21 USC 374    21 USC 379e    21 USC 381    21 USC 393    15 USC 1451-1561    42 USC 262    42 USC 264    42 USC 271   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/29/2006  71 FR 51276   
NPRM Comment Period End  02/26/2007    
Final Action  03/00/2011    
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: www.regulations.gov  
RIN Data Printed in the FR: No 
Agency Contact:
Paula S. McKeever
Senior Scientific Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45,
Rockville, MD 20857-0001
Phone:301 827-1520
Fax:301 443-9718
Email: paula.mckeever@fda.hhs.gov