3041-AD54 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 3041 Consumer Product Safety Commission CPSC Protection of Human Subjects: Common Rule

On September 18, 2015, the Commission voted (4-1) to amend the Commission's regulations at 16 CFR part 1028, Protection of Human Subjects, in a notice of proposed rulemaking (NPRM). The NPRM would adopt the Federal Policy for the Protection of Human Subjects, (referred to as the Common Rule), as proposed to be amended by the U.S. Department of Health and Human Services (HHS), through cross-reference to HHS's regulations at 45 CFR part 46, subpart A. Staff will prepare a final rule briefing package for Commission consideration.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage Undetermined Undetermined 16 CFR 1028 5 U.S.C. 301 42 U.S.C. 300v-1(b) No Staff Sends NPRM Briefing Package to Commission 09/14/2015 Commission Decision 09/18/2015 NPRM Published in the Federal Register 09/24/2015 80 FR 57548 Extension of Comment Period Published in Federal Register 12/01/2015 80 FR 75020 NPRM Comment Period End 01/06/2016 Staff Sends Final Rule Briefing Package to Commission 11/00/2016 Undetermined None No No No Alice Thaler Project Manager, Directorate for Health Sciences 3041 301 987-2240 athaler@cpsc.gov National Product Testing and Evaluation Center, 5 Research Place, Rockville MD 20850