United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2018_register executive 2018-01-23 article Rules and Regulations D09002ee1c7ed02b9 D09002ee1c7ed1907 United States Department of Homeland Security originator org United States Government Agency or Subagency United States Department of Agriculture originator org United States Government Agency or Subagency United States Department of Energy originator org United States Government Agency or Subagency United States National Aeronautics and Space Administration originator org United States Government Agency or Subagency United States Department of Commerce originator org United States Government Agency or Subagency United States Consumer Product Safety Commission originator org United States Government Agency or Subagency United States Social Security Administration originator org United States Government Agency or Subagency United States Agency for International Development originator org United States Government Agency or Subagency United States Department of Labor originator org United States Government Agency or Subagency United States Department of Defense originator org United States Government Agency or Subagency United States Department of Education originator org United States Government Agency or Subagency United States Department of Veterans Affairs originator org United States Government Agency or Subagency United States Environmental Protection Agency originator org United States Government Agency or Subagency United States Department of Health and Human Services originator org United States Government Agency or Subagency United States National Science Foundation originator org United States Government Agency or Subagency United States Department of Transportation originator org United States Government Agency or Subagency In a final rule published on January 19, 2017, federal departments and agencies listed in this document made revisions to the Federal Policy for the Protection of Human Subjects. The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The revised policy, reflected in both final rules, is described here as the "2018 Requirements." The 2018 Requirements are scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). This interim final rule delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements. The limited implementation delay accomplished by this interim final rule both provides additional time to regulated entities for the preparations necessary to implement the 2018 Requirements, and additional time for the departments and agencies listed in this document to seek input from interested stakeholders through a notice and comment rulemaking process that allows for public engagement on the proposal for a further implementation delay. 83 FR 2885 https://www.govinfo.gov/app/details/FR-2018-01-22/2018-00997 2018-00997 fr22ja18-1 RIN 0937-AA06 4150-36-P https://www.govinfo.gov/app/details/FR-2018-01-22/2018-00997 https://www.govinfo.gov/content/pkg/FR-2018-01-22/html/2018-00997.htm https://www.govinfo.gov/content/pkg/FR-2018-01-22/pdf/2018-00997.pdf Human Research Subjects Reporting and Record-Keeping Requirements Research 10 p. 2885 2894 83 FR 2885 Title 10 Part 745 10 CFR Part 745 Title 14 Part 1230 14 CFR Part 1230 Title 15 Part 27 15 CFR Part 27 Title 16 Part 1028 16 CFR Part 1028 Title 20 Part 431 20 CFR Part 431 Title 22 Part 225 22 CFR Part 225 Title 29 Part 21 29 CFR Part 21 Title 32 Part 219 32 CFR Part 219 Title 34 Part 97 34 CFR Part 97 Title 38 Part 16 38 CFR Part 16 Title 40 Part 26 40 CFR Part 26 Title 45 Part 46 45 CFR Part 46 Title 45 Part 690 45 CFR Part 690 Title 49 Part 11 49 CFR Part 11 Title 6 Part 46 6 CFR Part 46 Title 7 Part 1 7 CFR Part 1 RIN 0937-AA06 Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects; Federal Register Vol. 83, Issue RULE 2018-00997 DEPARTMENT OF HOMELAND SECURITY DEPARTMENT OF AGRICULTURE DEPARTMENT OF ENERGY NATIONAL AERONAUTICS AND SPACE ADMINISTRATION DEPARTMENT OF COMMERCE CONSUMER PRODUCT SAFETY COMMISSION SOCIAL SECURITY ADMINISTRATION AGENCY FOR INTERNATIONAL DEVELOPMENT DEPARTMENT OF LABOR DEPARTMENT OF DEFENSE DEPARTMENT OF EDUCATION DEPARTMENT OF VETERANS AFFAIRS ENVIRONMENTAL PROTECTION AGENCY DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL SCIENCE FOUNDATION DEPARTMENT OF TRANSPORTATION 2018-07-19 2018-03-19 4150-36-P 2018-00997 Interim final rule; delay of effective and compliance dates; request for comments.

In a final rule published on January 19, 2017, federal departments and agencies listed in this document made revisions to the Federal Policy for the Protection of Human Subjects. The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The revised policy, reflected in both final rules, is described here as the "2018 Requirements." The 2018 Requirements are scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). This interim final rule delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements. The limited implementation delay accomplished by this interim final rule both provides additional time to regulated entities for the preparations necessary to implement the 2018 Requirements, and additional time for the departments and agencies listed in this document to seek input from interested stakeholders through a notice and comment rulemaking process that allows for public engagement on the proposal for a further implementation delay.

This interim final rule is effective on July 19, 2018. This interim final rule delays until July 19, 2018, the effective date and general compliance date of the final rule published in the Federal Register (82 FR 7149, Jan. 19 2017) and of the final rule published by the Consumer Product Safety Commission in the Federal Register (82 FR 43459, Sept. 18, 2017). To be assured consideration, comments must be received at one of the addresses provided below, no later than 11:59 p.m. Eastern Standard Time on March 19, 2018. Jerry Menikoff, M.D., J.D., Office for Human Research Protections (OHRP), Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; telephone: 240-453-6900 or 1-866-447-4777; facsimile: 301-402-2071; email Jerry.Menikoff@hhs.gov. Human Research Subjects Reporting and Record-Keeping Requirements Research Federal Policy for the Protection of Human Subjects: Delay of Revisions to Federal Policy for Protection of Human Subjects , Jerry.Menikoff@hhs.gov http://www.cogr.edu/sites/default/files/AAMC_AAU_APLU_COGR%20Common%20Rule%20Delay%20Letter%206-21-2017.pdf http://www.regulations.gov https://www.amia.org/sites/default/files/AMIA%20Letter%20Regarding%20the%20Common%20Rule.pdf https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-a-august-2-2017/index.html https://www.hhs.gov/ohrp/sachrp-committee/recommendations/sachrp-recommendations/index.html https://www.regulations.gov/document?D=HHS-OPHS-2017-0001 Vol. 83, no. 14 Office of the Federal Register, National Archives and Records Administration 2018-01-22 continuing daily deposited born digital 184 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-01-22 P0b002ee19811bd2a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr22ja18 https://www.govinfo.gov/app/details/FR-2018-01-22 https://www.govinfo.gov/content/pkg/FR-2018-01-22/pdf/FR-2018-01-22.pdf https://www.govinfo.gov/content/pkg/FR-2018-01-22/xml/FR-2018-01-22.xml fdlp 2885 3058 DGPO 2018-01-23 2024-06-01 FR-2018-01-22 machine generated eng FR FR-2018-01-22 83 14