This script search US Code. View Rule
Menu Item - Home
Menu Item - Agenda Main page
Menu Item - Historical Agenda
Menu Item - Historical Agenda
Menu Item - Agenda Search
Menu Item - EO Dashboard
Menu Item - Reg Review
Menu Item - EO Agency lists
Menu Item - EO Search
Menu Item - EO Historical Reports
Menu Item - Review Counts
Menu Item - OIRA Letters
Menu Item - EOM 12866 Search
Menu Item - EO XML Reports
Menu Item - ICR Dashboard page
Menu Item - ICR Main page
Menu Item - ICR Search
Menu Item - ICR XML Reports
Menu Item - FAQ
Menu Item - Additional Resources
Menu Item - Contact Us
Search: Agenda Reg Review ICR
       Search

View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AC17 Publication ID: Spring 2008 
Title: Institutional Review Boards: Registration Requirements 
Abstract: The final rule would require institutional review boards (IRB) to register with the Department of Health and Human Services. 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 number of active protocols 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 to 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
Timetable:
Action Date FR Cite
NPRM  07/06/2004  69 FR 40556 
NPRM Comment Period End  10/04/2004   
Final Action  12/00/2008   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Philip L. Chao
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Room 15-61 (HF-23), Office of Policy and Planning (HF-23), Room 14C-17, 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 827-0587
Fax:301 827-4774
Email: philip.chao@fda.hhs.gov

 
About Us   Vertical Spacer Spacer Related Resources   Vertical Spacer Spacer Disclosure   Vertical Spacer Spacer Accessibility   Vertical Spacer Spacer Privacy Policy   Vertical Spacer Spacer Contact Us