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| HHS/FDA | RIN: 0910-AC17 | Publication ID: Fall 2003 |
| Title: Institutional Review Boards: Registration Requirements | |
| Abstract: The proposed 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 proposed 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: Proposed 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 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
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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 |
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