[Federal Register Volume 63, Number 51 (Tuesday, March 17, 1998)]
[Notices]
[Pages 13057-13058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6788]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Deafness and Other Communication Disorders 
(NIDCD); Opportunity for a Cooperative Research and Development 
Agreement (CRADA) for the Development of a Vaccine Against Moraxella 
Catarrhalis Mediated Otitis Media

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: Moraxella catarrhalis is the third most common pathogen for 
otitis media, the most common cause of illness requiring medical 
treatment in children. The NIDCD is investigating candidate vaccines 
based on detoxified lipooligosaccharide-protein conjugates prepared 
from surface antigens of Moraxella catarrhalis.
    The NIDCD, NIH, is seeking capability statements from parties 
interested in entering into a CRADA for the development of a candidate 
vaccine with the goal of conducting a Phase I clinical trial to 
determine the safety for most promising candidates. This project is 
with the Section on Experimental Immunology, Laboratory of Immunology, 
National Institute on Deafness and Other Communication Disorders, NIH. 
The goals are to use the respective strengths of both parties to 
achieve one or more of the following: (1) Establish an animal model to 
test experimental vaccines to provide protection against Moraxella 
catarrhalis mediated otitis media; (2) screen experimental vaccines for 
their relative efficacy; (3) determine the efficacy of the most 
promising vaccines; (4) prepare a sufficient quantity of vaccine to 
gain IND approval from the FDA and to conduct a Phase I clinical trial. 
Additional investigations may be undertaken when the efficacy of the 
candidate vaccines has been determined in an animal model and safety in 
humans has been assured.
    It is anticipated that the commercial collaborator(s) will 
participate in

[[Page 13058]]

ongoing studies involving the determination of the efficacy and 
identification of most promising vaccines, preparing the vaccine for a 
clinical trial, and assisting in the conduct of such a trial. The 
collaborator may also be expected to contribute financial support under 
this CRADA for personnel, supplies, travel and equipment to support 
these projects.
    CRADA capability statements should be submitted to Ms. Lili 
Portilla, Technology Transfer Manager, National Heart, Lung, and Blood 
Institute (NHLBI), Technology Transfer Service Center, 31 Center Drive 
MSC 2490, Building 31/Room 1B30, Bethesda, MD 20892-2490, Phone: (301) 
402-5579, Fax: (301) 594-3080, E-mail address 
. Capability statements must be received by 
the NHLBI on or before May 1, 1998.
    The NIDCD has applied for patents claiming the core of the 
technology. Non-exclusive and/or exclusive licenses for these patents 
covering core aspects of this project are available to interested 
parties.
    Licensing inquiries regarding this technology should be referred to 
Ms. Elaine Gese, M.B.A., Licensing Specialist, NIH Office of Technology 
Transfer, Suite 325, 6011 Executive Blvd., Suite 325, Rockville, MD 
20852, Phone: (301) 496-7735, Ext. 282, Fax: (301) 402-0220, E-mail 
address<[email protected]>

    Dated: March 5, 1998.
Sheila E. Merritt,
Executive Officer, NHLBI.
[FR Doc. 98-6788 Filed 3-16-98; 8:45 am]
BILLING CODE 4140-01-M