E7-25460. Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-Making Capacity

AGENCY:

Office for Human Research Protections, Office of Public Health and Science, Office of the Secretary, HHS.

ACTION:

Notice.

SUMMARY:

On September 5, 2007, the Office for Human Research Protections, Office of Public Health and Science, Office of the Secretary, Department of Health and Human Services (HHS) issued a notice in the Federal Register (Vol. 72, No. 171, pages 50966—50970) seeking information and comments about whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decision-making capacity who are potential subjects in research. A 90-day comment period was established upon publication of that notice.

The purpose of this notice is to inform all interested parties that the comment period originally identified in the September 5, 2007 Federal Register has been extended for forty one days, in order to maximize the opportunity for interested individuals and organizations to provide information and comments to HHS on this topic.

DATES:

The closing date for the comment period will now be January 14, 2008.

ADDRESSES:

Submit written comments to “Request for Information on Research That Involves Adult Individuals With Impaired Decision-Making Capacity”, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to [e-mail], or via facsimile at 301-402-2071. Comments received within the comment period, including any personal information provided, will be made available to the public upon request.

SUPPLEMENTARY INFORMATION:

A copy of the September 5, 2007 RFI can be accessed at: http://www.hhs.gov/​ohrp/​documents/​20070905.htm or http://www.hhs.gov/​ohrp/​documents/​20070905.pdf.

Dated: December 26, 2007.

Ivor A. Pritchard,

Acting Director, Office for Human Research Protections.