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HHS/OASH

RIN: 0937-AA02

Publication ID: Fall 2011

Title: ●Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators
Abstract: The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) issued an advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM solicited comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: First time 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	03/00/2012

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