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HHS/FDA RIN: 0910-AA49 Publication ID: Spring 2005 
Title: Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Certain Biological Drugs, and Animal Drugs 
Abstract: The proposed rule would 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. The proposed rule would require that this information be submitted via the Internet into the FDA registration and listing database, instead of the current requirement to submit the information to FDA on paper forms. The proposed rule would also require that the NDC number appear on drug labels. In addition, FDA would assign the NDC number to newly listed drugs and take other steps to minimize the use of inaccurate NDC numbers on drug labels. 
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
Action Date FR Cite
NPRM  09/00/2005   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Howard P. Muller
Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440

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