[Federal Register Volume 59, Number 58 (Friday, March 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7033]


[[Page Unknown]]

[Federal Register: March 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

 

National Institute of Allergy and Infectious Diseases; 
Opportunity for a Cooperative Research and Development Agreement 
(CRADA) for the Clinical Development of a Live, Attenuated Cold-Adapted 
Influenza Virus Vaccine(s)

AGENCY: National Institutes of Health, PHS, HHS.

ACTION: Notice.

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SUMMARY: The National Institute of Allergy and Infectious Diseases 
(NIAID) of the National Institutes of Health announces its intention to 
make available, to all interested and capable parties, information 
related to the clinical development of a live, attenuated cold-adapted 
influenza virus vaccine(s). Briefly, under IND 601 (Investigational New 
Drug #), the NIAID has supported the clinical research development of 
this experimental vaccine(s). The NIAID is interested in having these 
efforts utilized for the public good by transferring this information 
to a company with an interest in the development and licensure of the 
cold-adapted vaccine. The information in the IND 601 will be available 
for confidential evaluation to interested and capable parties for a 
period of 45 days. This information will be made available to 
representatives of companies at a site in Bethesda, Maryland, following 
the execution of a Confidentiality Agreement. Copies of the material 
may be made at this site, by company representatives, at a nominal fee 
to cover copying cost. Following this 45 day evaluation period, the 
NIAID will entertain proposals from any companies interested in 
pursuing the development of this product, for a period not to exceed 30 
days. Scheduling for review of documents will occur on a first come, 
first serve basis but only after receipt of an executed Confidentiality 
Agreement.

ADDRESSES: Proposals should be submitted to: Technology Transfer 
Branch, National Institute of Allergy & Infectious Diseases, National 
Institutes of Health, Bldg. 31, rm. 7A32, 9000 Rockville Pike, 
Bethesda, MD 20892. If you are interested in obtaining a copy of the 
Confidentiality Agreement and arranging for an appointment, please 
contact Dr. Carole Heilman, Chief, Respiratory Disease Branch, National 
Institute of Allergy & Infectious Diseases, National Institutes of 
Health, Solar Building, 6003 Executive Blvd., room 3B06, Rockville, 
Maryland, 20852, or telephone 301-496-5305.

DATES: Proposals must be submitted on or before April 25, 1994.

    Dated: March 7, 1994.
Donald P. Christoferson,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 94-7033 Filed 3-24-94; 8:45 am]
BILLING CODE 4140-01-M