[Federal Register Volume 67, Number 243 (Wednesday, December 18, 2002)]
[Notices]
[Pages 77495-77496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31848]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 (301) 402-5942 (not a toll free
number). Comments also may be sent via facsimile at (301) 402-2071 (not
a toll free number) or by e-mail to: [email protected].
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/
[[Page 77496]]
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 (301) 443-5252; fax
(301) 443-0925.
Dated: December 12, 2002.
Eve E. Slater,
Assistant Secretary for Health.
[FR Doc. 02-31848 Filed 12-17-02; 8:45 am]
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