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HHS/FDA | RIN: 0910-AC17 | Publication ID: Fall 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 |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
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 |