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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
Abstract: 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

Timetable:

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 Email: daniel.barry@hhs.gov