Director, Office for Human Research Protections

0937-AA08 201904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0937 Office of Assistant Secretary for Health OASH 0900 Department of Health and Human Services HHS HHS Policy for the Protection of Human Research Subjects: Update to Subpart E (IRB Registration)

This rule would amend subpart E of 45 CFR part 46 (Institutional Review Board (IRB) Registration) to align subpart E with recent amendments to the basic HHS Policy for the Protection of Human Subjects (subpart A of 45 CFR part 46, also known as the Common Rule) and to give effect to one of the policy goals of the subpart A revision (i.e., eliminating unnecessary administrative burden on IRBs and institutions regulated under 45 CFR part 46). The general compliance date of amendments to subpart A of 45 CFR part 46 was January 21, 2019.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage No No Not subject to, not significant 45 CFR 46 5 U.S.C. 301 42 U.S.C. 289(a) 42 U.S.C. 300v-1(b) No NPRM 05/00/2019 No No Undetermined No No No 0937-AA02 Related to 0937-AA05 Related to Jerry Menikoff Director, Office for Human Research Protections 0937 Office of Assistant Secretary for Health OASH 240 453-6900 jerry.menikoff@hhs.gov 1101 Wootton Parkway, Suite 200, Rockville MD 20852