02-31848. Proposed Research Protocol: Precursors to Diabetes in Japanese American Youth

AGENCY:

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

ACTION:

Notice.

SUMMARY:

On August 7, 2002, the Office of Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS), gave notice (67 FR 51283) that it was proposing to recommend approval of HHS support for the research protocol entitled “Precursors to Diabetes in Japanese American Youth,” subject to a stipulation that certain modifications be made to the protocol and consent forms. OHRP is reopening the period for public comment and is making available additional information regarding the protocol.

DATES:

To be considered, written or electronic comments must be received on or before January 17, 2003.

ADDRESSES:

Submit written comments to: Kelley Booher, Division of Policy, Planning, and Special Projects, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, The Tower Building, Rockville, MD 20852, telephone number [phone] (not a toll free number). Comments also may be sent via facsimile at [phone] (not a toll free number) or by e-mail to: [e-mail].

SUPPLEMENTARY INFORMATION:

On August 7, 2002, the Office for Human Research Protections published a notice in the Federal Register, 67 FR 51283 (http://frwebgate.access.gpo. gov/cgi-bin/getdoc.cgi?dbname=2002_ register&docid=02-19871-filed.pdf), soliciting comments on its proposal to recommend approval on HHS support for the research protocol entitled “Precursors to Diabetes in Japanese American Youth” (1 R01 DK59234-01). The comment period closed on August 21, 2002. OHRP hereby gives notice that the comment period is being reopened for 30 days, and additional information regarding the protocol is being made available.

OHRP received a number of comments in response to the August 7, 2002, notice. Several who commented stated that (1) the 14-day comment period was too short, and (2) the information about the research protocol that OHRP provided to the public was insufficient to allow for meaningful comment about whether the research was appropriate for HHS to support. In response to these comments, OHRP is reopening the public comment period for 30 days. OHRP also is making available additional information regarding the research protocol, namely: the protocol application reviewed by the Children's Hospital and Regional Medical Center (Seattle) IRB; the assent form; the consent form; and selected parts of the grant application, including the abstract, specific aims, background and significance, discussion of the involvement of human subjects, and literature cited. These materials are available for review on the OHRP Web page at (http://ohrp.osophs.dhhs.gov/​pdjay/​pdjayindex.htm). A paper copy of the information referenced here is available upon request.

FOR FURTHER INFORMATION CONTACT:

Requests for additional information about the research proposal may be submitted under the Freedom of Information Act (FOIA). Such requests should be directed to: Ms. Darlene Christian, PHS FOIA Office, Parklawn Building, Room 17A-46, 5600 Fishers Lane, Rockville, MD 20857; telephone [phone]; fax [phone].

Dated: December 12, 2002.

Eve E. Slater,

Assistant Secretary for Health.