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HHS/OASH RIN: 0937-AA02 Publication ID: 2012 
Title: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators 
Abstract: The Department is considering revisions to the current human subjects regulations in order to strengthen protections for research subjects. 
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: No  Unfunded Mandates: No 
CFR Citation: 45 CFR 160    45 CFR 164    21 CFR 56    21 CFR 50   
Legal Authority: 21 USC 321p    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 360    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM  07/26/2011  76 FR 44512   
ANPRM Comment Period End  09/26/2011    
NPRM  04/00/2013 
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