[Federal Register Volume 63, Number 200 (Friday, October 16, 1998)]
[Notices]
[Page 55632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Child Health and Human Development; 
Availability of a Panel of HIV-1 Subtypes for Commercial Production and 
Distribution

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: The National Institute of Child Health and Human Development 
(NICHD), National Institutes of Health (NIH), in cooperation with the 
Department of Defense (DoD) and the European Network for Viral 
Assessment, would like to make available to a qualified recipient a 
panel of HIV-1 subtypes for commercial production. The panel will 
consist of approximately 10-12 virus seed stocks representing clades 
A,B,C,D,E,F,G,H, and O. These isolates are an invaluable resource to 
the HIV-1 research community for development of assays for the 
detection of various subtypes of HIV-1 and for use as standards in 
quality assuring the performance of these assays. A qualified 
manufacturer must demonstrate a well-established history in the 
acquisition, production and provision of quality assurance reagents. 
The manufacturer must be willing to provide the commercially produced 
reagents at cost to non-profit representatives and under specific 
stipulations which will be set forth in a Transfer Agreement with the 
collaborating groups. These materials will be transferred to the 
qualified manufacturer at no cost other than the costs associated with 
the packaging and shipping of the materials from the current 
repository. A panel consisting of representatives from the 
collaborating groups will evaluate the proposals received. It is 
anticipated that the collection will be transferred to one or more 
manufacturers but NICHD will be under no obligation to make this 
collection available in this manner.

DATES: Only written proposals for acquisition of these materials which 
are received by NICHD on or before December 15, 1998 in the Federal 
Register will be considered.

ADDRESSES: Requests for further information about these materials and 
applications should be directed to: Patricia S. Reichelderfer, Ph.D., 
Center for Population Research, National Institute of Child Health and 
Human Development, 6100 Executive Boulevard, Room 8B13F, Rockville, MD 
20892; telephone (301) 496-1661; facsimile (301) 480-1972.

    Dated: October 7, 1998.
Yvonne T. Maddox,
Deputy Director, National Institute of Child Health and Human 
Development.
[FR Doc. 98-27750 Filed 10-15-98; 8:45 am]
BILLING CODE 4140-01-M