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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.