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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 Supervisory Regulatory Counsel Department of Health and Human Services Food and Drug Administration Room 15-61 (HF-23), Center for Food Safety and Applied Nutrition, 5001 Campus Drive, College Park, MD 20740 Phone:240 400-4053 Email: philip.chao@fda.hhs.gov