RIN Data

HHS/OASH RIN: 0937-AA02 Publication ID: Spring 2016 
Title: Federal Policy for the Protection of Human Subjects; Final Rules 

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: Final Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 45 CFR 46   
Legal Authority: 21 U.S.C. 289   
Legal Deadline:  None
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