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HHS/FDA RIN: 0910-AC17 Publication ID: Spring 2005 
Title: Institutional Review Boards: Registration Requirements 
Abstract: The final rule would require institutional review boards (IRB) to register with FDA. The registration information would include the name of the IRB, the name of the institution operating the IRB, and names, addresses, phone numbers, facsimile (fax) numbers, and electronic mail (e-mail) addresses of the senior officer of the institution and IRB chair or contact, the range of active protocols (small, medium, or large) involving FDA-regulated products reviewed in the previous calendar year, and a description of the types of FDA-regulated products reviewed. The final rule would make it easier for FDA to inspect IRBs and to convey information to IRBs. 
Agency: Department of Health and Human Services(HHS)  Priority: Info./Admin./Other 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 56.106   
Legal Authority: 21 USC 321    21 USC 346    21 USC 346a    21 USC 348    21 USC 351 to 353    21 USC 355    21 USC 360    21 USC 360c to 360f    21 USC 360h to 360j    21 USC 371    21 USC 379e    21 USC 381    42 USC 216    42 USC 241    42 USC 262    42 USC 263b to 263n   
Legal Deadline:  None
Action Date FR Cite
NPRM  07/06/2004  69 FR 40556   
Final Action  09/00/2005    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Darin Achilles
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
14-101-11, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring , MD 20993
Phone:877 287-1373
Fax:301 595-1426

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