[Federal Register Volume 76, Number 170 (Thursday, September 1, 2011)]
[Proposed Rules]
[Page 54408]
From the Federal Register Online via the Government Publishing 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: [email protected].
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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