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HHS/FDA RIN: 0910-AG11 Publication ID: Spring 2009 
Title: Revision of the Requirements for Publication of License Revocation 
Abstract: The Food and Drug Administration (FDA) is amending the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license. We are taking this action as part of our continuing effort to eliminate or modify those regulations that are outdated or otherwise in need of reform without diminishing public health protection. 
Agency: Department of Health and Human Services(HHS)  Priority: Info./Admin./Other 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 601.8   
Legal Authority: 15 USC 1451 to 1561    21 USC 321    21 USC 351 to 353    21 USC 355    21 USC 356b    21 USC 360    21 USC 360c to 360f    21 USC 360h to 360j    21 USC 371    21 USC 374    21 USC 379e    21 USC 381    42 USC 216    42 USC 241    42 USC 262 and 263    42 USC 264, sec 122    PL 105-115, 111 Stat. 2322 (21 USC 355 note)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM-Companion to Direct Final Rule  06/00/2009    
Direct Final Rule  06/00/2009    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Paul E. Levine Jr.
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike,
Rockville, MD 20852
Phone:301 827-6210