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HHS/OS RIN: 0991-AC15 Publication ID: Spring 2020 
Title: Establishment of Safeguards and Program Integrity Requirements for HHS-Funded Extramural Research Involving Human Fetal Tissue 

On June 5, 2019, the Department of Health and Human Services issued a statement in which it announced the Administration’s policies with respect to research conducted or funded by the Department involving human fetal tissue derived from elective abortion.  Consistent with that announcement, the Department will propose changes to human subject protection regulations and its grants regulations in order to adopt and strengthen safeguards and program integrity requirements applicable to extramural research involving the use of human fetal tissue.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Regulatory 
CFR Citation: 45 CFR 46, subpart B    45 CFR 75     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 5 U.S.C. 301    31 U.S.C. 503(b)(2)(2)    41 U.S.C. Ch. 13    42 U.S.C. 216(b)    42 U.S.C. 289g-1 and 289g-2   
Legal Deadline:  None
Action Date FR Cite
NPRM  06/00/2020 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: State 
Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Daniel Barry
Deputy General Counsel
Department of Health and Human Services
Office of the Secretary
200 Independence Avenue SW,
Washington, DC 20201
Phone:202 690-6295