3041-AD54 201804 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 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 prepared a final rule briefing package for Commission consideration. The Commission voted to approve the package. At the request of the Office of the Federal Register, staff revised the rule to state the full regulatory text from 45 CFR 46. The final rule was published on September 18, 2017 with an effective date of January 19, 2018. 

On January 22, 2018, CPSC signed on with other agencies to an interim final rule (IFR) delaying the effective and compliance dates of the amended Common Rule was published. The IFR provided additional time for regulated entities to implement the 2018 Requirements. This IFR delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. CPSC, along with other agencies, is considering an NPRM that would extend the compliance date an additional six months.

 

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No Independent agency 16 CFR 1028 5 U.S.C. 301 42 U.S.C. 300v-1(b) No 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 08/02/2017 Commission Decision 08/08/2017 Staff Sends Revised Final Rule Briefing Package to Commission 09/06/2017 Commission Decision 09/12/2017 Final Rule 09/18/2017 82 FR 43459 Staff Sends IFR Briefing Package to Commission 01/03/2018 Commission Decision 01/04/2018 Interim Final Rule Published in the Federal Register 01/22/2018 83 FR 2885 NPRM 05/00/2018 Interim Final Rule Effective 07/19/2018 No 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