Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period

In a final rule published on January 19, 2017, a number of federal departments and agencies revised to the Federal Policy for the Protection of Human Subjects (often referred to as the "Common Rule"), which each department and agency adopted into regulations in its part of the Code of Federal Regulations (CFR). The Consumer Product Safety Commission (CPSC) adopted the same changes in a final rule published on September 18, 2017. The revised Common Rule was scheduled to become effective on January 19, 2018, with a general compliance date of the same date. By an interim final rule issued on January 17, 2018 and published in the Federal Register on January 22, 2018, federal departments and agencies delayed the effective date and the general compliance date for the revised Common Rule for a 6-month period, until July 19, 2018. The Department of Housing and Urban Development (HUD) published an interim final rule adopting the same regulatory changes on January 26, 2018. The revised Common Rule, including technical amendments made by the January 22, 2018 interim final rule, is referred to here as the "2018 Requirements." On April 20, 2018, the federal departments and agencies listed here published a notice of proposed rulemaking (NPRM) proposing and seeking comments as to whether the general compliance date for the 2018 Requirements should be delayed for an additional 6-month period. The NPRM also proposed and sought comments on whether to allow regulated entities to implement certain burden-reducing provisions of the 2018 Requirements in specified circumstances during such continued delay period. Through this final rule, we are adopting the proposals described in the April 20, 2018 NPRM. This rule delays the general compliance date for the 2018 Requirements for an additional 6-month period, until January 21, 2019. As a result of this delay, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Fe