0910-AC17 200710 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Institutional Review Boards: Registration Requirements 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. Info./Admin./Other Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 56.106 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 No NPRM 07/06/2004 69 FR 40556 Final Action 03/00/2008 No None No Not Collected Philip Chao L. 0910 Food and Drug Administration FDA 301 827-0587 301 827-4774 philip.chao@fda.hhs.gov Room 15-61 (HF-23), Office of Policy and Planning (HF-23), Room 14C-17, 5600 Fishers Lane, Rockville MD 20857