Health Policy Analyst

0910-AI07 201810 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 Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards

This proposed rule would amend several sections of FDA’s regulations for the Protection of Human Subjects and Institutional Review Boards to harmonize with the recently revised final HHS Common Rule (45 CFR 46, subpart A). This rule would add definitions, conform wording, and other changes to FDA regulations to harmonize with the Common Rule. The rule also makes minor technical amendments unrelated to the harmonization efforts.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No Deregulatory 21 CFR 50 21 CFR 56 21 U.S.C. 321 21 U.S.C. 343 21 U.S.C. 346 21 U.S.C. 346a 21 U.S.C. 348 21 U.S.C. 350a to 350b 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360c to 360f 21 U.S.C. 360h to 360j 21 U.S.C. 360hh to 360ss 21 U.S.C. 371 21 U.S.C. 379e 21 U.S.C. 381 42 U.S.C. 216 42 U.S.C. 262 Statutory NPRM 12/13/2019 Section 3023 of the 21st Century Cures Act No NPRM 06/00/2019 Undetermined None No No No No Sheila Brown Health Policy Analyst 0910 Food and Drug Administration FDA 301 796-6563 sheila.brown@fda.hhs.gov Office of Clinical Policy, 10903 New Hampshire Avenue, WO 32, Room 5103, Silver Spring MD 20993