[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 Driscoll@d31.niaid.pc.niaid.nih.gov; 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:
fergusos@od6100m1.od.nih.gov; 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
