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HHS/OASH RIN: 0937-AA02 Publication ID: Fall 2015 
Title: Federal Policy for the Protection of Human Subjects 
Abstract:

The proposed rule 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: Proposed Rule Stage 
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  12/07/2015 
Final Action  09/00/2016 
Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: No 
Included in the Regulatory Plan: No 
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