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HHS/FDA RIN: 0910-AA49 Publication ID: Fall 2006 
Title: Foreign and Domestic Establishment Registration and Listing Requirements 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. The rule will 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 rule will also require that the NDC number appear on certain drug labels. In addition, FDA will 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: 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 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  08/29/2006  71 FR 51276   
NPRM Comment Period End  11/27/2006    
Final Action  09/00/2007    
Regulatory Flexibility Analysis Required: Undetermined  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
Email: howard.mullerjr@fda.hhs.gov