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HHS/FDA RIN: 0910-AA49 Publication ID: Fall 2003 
Title: Foreign and Domestic Establishment Registration and Listing Requirements for Drugs and Biologics 
Abstract: The proposed rule would amend FDA regulations on the registration of producers of drugs and the listing of drugs in commercial distribution. The proposed revisions would reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list drug or biologics regulated as drugs. The proposal describes when, how, and where to register and list, and what information must be submitted for registration and listing. The proposed regulations would also revise the requirements for the National Drug Code number and would require the electronic submission of most registration and listing information. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed 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 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 355    21 USC 360    21 USC 360b    21 USC 371    21 USC 374    42 USC 262    42 USC 264    42 USC 271   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2004    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Mary H. Keyes
Office of Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Reserach, 1451 Rockville Pike,
Rockville, MD 20852
Phone:301 594-2041
Fax:301 827-5562

 
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