2011-22341. 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.

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: [phone] or 1-866-447-4777; facsimile: 301-402-2071; e-mail: [e-mail].

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.