[Federal Register Volume 60, Number 54 (Tuesday, March 21, 1995)]
[Notices]
[Page 14957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6853]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Opportunity For a License: Live, Attenuated Bovine Parainfluenza 
Virus Type 3 (BPIV-3) for Use as a Vaccine to Protect Infants and 
Children Against Disease(s) Caused by Human Parainfluenza Virus Type 3 
(HPIV-3)

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

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH), Department of Health 
and Human Services (DHHS), seeks licensee(s) who can effectively pursue 
the clinical and commercial development of a live, attenuated BPIV-3 
vaccine. Several common childhood acute respiratory illnesses, 
including croup, pneumonia and bronchiolitis, are caused by HPIV-3 
viral infection. Briefly, the National Institute of Allergy and 
Infectious Diseases (NIAID) has supported the clinical research 
development of this experimental vaccine in a series of phase I trials 
and has evidence that this candidate live virus could be used as a safe 
and immunogenic pediatric vaccine against HPIV-3. The NIAID is 
interested in having these efforts utilized for the public good, as 
mandated by the Federal Technology Transfer Act (FTTA) of 1986, by 
transferring certain unpatented biological materials to a company. For 
consideration, prospective licensee(s) should be capable of further 
developing and eventually commercializing a live attenuated BPIV-3 
vaccine. Furthermore, the prospective industrial partner should have: 
An aggressive clinical development plan for BPIV-3; access to suitably 
equipped manufacturing facilities for large-scale production of the 
candidate vaccine; relevant experience in obtaining regulatory approval 
for other vaccines. NIAID scientists would provide the relevant BPIV-3 
viral strains as well as supply information and data from the completed 
phase I clinical studies. This information is available for 
confidential evaluation to interested parties following the acceptance 
of standard confidentiality terms. The deadline for submitting a 
license application will be 90 days from March 21, 1995.

ADDRESSES: Requests for a summary of the clinical trial results and 
additional scientific information about the BPIV-3 vaccine as well as 
other questions and comments concerning clinical aspects this 
technology should be directed to: Claire T. Driscoll, Technology 
Transfer Specialist, Technology Transfer Branch, NIAID, NIH, Building 
31, Room 7A32, 9000 Rockville Pike, Bethesda, MD 20892. Telephone (301) 
496-2644; E-mail: Claire D[email protected]; Fax (301) 
402-7123.
    Requests for a copy of the license application form, or other 
questions and comments concerning the licensing of this technology 
should be directed to: Steven M. Ferguson, Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804. 
Telephone (301) 496-7735 extension 266; E-mail: 
[email protected]; Fax (301) 402-0220.

    Dated: March 13, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-6853 Filed 3-20-95; 8:45 am]
BILLING CODE 4140-01-P