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HHS/FDA RIN: 0910-AB29 Publication ID: Fall 1999 
Title: Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License 
Abstract: As a "Reinventing Government" initiative and to amend regulations to implement section 123 of the Food and Drug Administration Modernization Act of 1997, FDA is eliminating the requirement and use of establishment licenses and product licenses for biological products regulated under section 351 of the Public Health Service Act. In lieu of product licenses and establishment licenses, FDA will require submission and approval of a biologics license application in order to market these biologic products in interstate commerce. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 3    21 CFR 5    21 CFR 10    21 CFR 20    21 CFR 207    21 CFR 310    21 CFR 312    21 CFR 316    21 CFR 600    21 CFR 601    21 CFR 607    21 CFR 610    21 CFR 640    21 CFR 660   
Legal Authority: 42 USC 262    PL 105-115   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/31/1998  63 FR 40858   
Public Workshop  08/11/1998  63 FR 42773   
Final Rule  10/20/1999  64 FR 56441   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Included in the Regulatory Plan: No 
Agency Contact:
Robert A. Yetter
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-10), Center for Biologics Evaluation and Research, 1401 Rockville Pike,
Rockville, MD 20852-1448
Phone:301 827-0373