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HHS/OASH

RIN: 0937-AA02

Publication ID: Spring 2017

Title: Federal Policy for the Protection of Human Subjects; Final Rules
Abstract: The final rules would revise current human subjects regulations in order to strengthen protections for research subjects while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.
Agency: Department of Health and Human Services(HHS)	Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: Yes	Unfunded Mandates: Private Sector
CFR Citation: 45 CFR 46
Legal Authority: 21 U.S.C. 289

Legal Deadline: None

Timetable:

Action	Date	FR Cite
ANPRM	07/26/2011	76 FR 44512
ANPRM Comment Period End	10/26/2011
NPRM	09/08/2015	80 FR 53931
NPRM Comment Period End	01/06/2017
Final Action	01/19/2017	82 FR 7149
Final Action Effective	01/19/2018

Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Federalism: No
Included in the Regulatory Plan: Yes
RIN Data Printed in the FR: No
Agency Contact: Jerry Menikoff Director, Office for Human Research Protections Department of Health and Human Services Office of Assistant Secretary for Health 1101 Wootton Parkway, Suite 200, Rockville, MD 20852 Phone:240 453-6900 Email: jerry.menikoff@hhs.gov