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HHS/FDA RIN: 0910-AA49 Publication ID: Spring 2001 
Title: Establishment Registration and Product Listing for Drugs and Biologics 
Abstract: The proposed rule would revise the regulations under part 207 to clarify the requirements for registration and listing and to consolidate and reorganize the regulations. The proposal would also require the electronic submission of establishment registration and product 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: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 207   
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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/00/2001    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
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