Document ID: FDA-2011-S-0009-0002
Agency: fda
Document Type: Proposed Rule
Title: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators; Extension of Comment Period
Posted Date: 2011-09-01T04:00Z

[Federal Register Volume 76, Number 170 (Thursday, September 1, 2011)]
[Proposed Rules]
[Page 54408]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22341]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Parts 46, 160, and 164

Food and Drug Administration

21 CFR Parts 50 and 56

Human Subjects Research Protections: Enhancing Protections for 
Research Subjects and Reducing Burden, Delay, and Ambiguity for 
Investigators; Extension of Comment Period

AGENCIES: The Office of the Secretary, HHS, and the Food and Drug 
Administration, HHS.

ACTION: Advance notice of proposed rulemaking; extension of comment 
period.

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SUMMARY: 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) is extending the comment period for an advance 
notice of proposed rulemaking (ANPRM) requesting comment on how current 
regulations for protecting human subjects who participate in research 
might be modernized and revised to be more effective. That ANPRM was 
published in the Federal Register on July 26, 2011.

DATES: The comment period for the proposed rule published July 26, 
2011, at 76 FR 44512 is extended. Comments will be received through 
October 26, 2011.

ADDRESSES: You may submit comments, identified by docket ID number HHS-
OPHS-2011-0005, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Enter the above docket ID number in the ``Enter Keyword or ID'' field 
and click on ``Search.'' On the next web page, click on ``Submit a 
Comment'' action and follow the instructions.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions] to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton 
Parkway, Suite 200, Rockville, MD 20852.
    Comments received, including any personal information, will be 
posted without change to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Office for 
Human Research Protections (OHRP), Department of Health and Human 
Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; 
telephone: 240-453-6900 or 1-866-447-4777; facsimile: 301-402-2071; e-
mail: jerry.menikoff@hhs.gov.

SUPPLEMENTARY INFORMATION: The ANPRM was published in the Federal 
Register on July 26, 2011 (Volume 76, Number 143, page 44512) with a 
deadline for comments of September 26, 2011. The ANPRM requests 
comments on how current regulations for protecting human subjects who 
participate in research might be modernized and revised to be more 
effective and how to better protect human subjects who are involved in 
research, while facilitating valuable research and reducing burden, 
delay, and ambiguity for investigators. Since the ANPRM was published 
the Department has received requests to extend the comment period to 
allow sufficient time for a full review of the ANPRM. HHS and OSTP are 
committed to affording the public a meaningful opportunity to comment 
on the ANPRM and welcome comments.

     Dated: August 26, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011-22341 Filed 8-31-11; 8:45 am]
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