[Federal Register Volume 63, Number 88 (Thursday, May 7, 1998)]
[Notices]
[Page 25220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12109]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Aging: Opportunity for a Cooperative 
Research and Development Agreement (CRADA) To Develop a Vaccine for 
Pneumonia

AGENCY: National Institutes of Health (NIH), PHS, DHHSNIA, NIH, PHS, 
DHHS.

ACTION: Notice.

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SUMMARY: The National Institute on Aging (NIA) is seeking a 
Collaborator to participate in a Cooperative Research and Development 
Agreement (CRADA) to develop a vaccine for pneumonia. The term of the 
CRADA will be up to five (5) years.

ADDRESESS: Inquiries and proposals regarding this opportunity should be 
addressed to Bruce D. Goldstein, J.D., Technology Development and 
Commercialization Branch, National Cancer Institute, 6120 Executive 
Blvd., EPS Suite 450, Rockville, Maryland 20852, telephone number 301-
496-0477, FAX number 301-402-2117.

DATES: interested parties are advised to notify this office in writing 
of their intent to file a formal proposal no later than FIFTEEN (15) 
days from the date of this advertisement. Formal proposals must be 
submitted to this office no later than TWENTY (20) days from the date 
of this notice.

SUPPLEMENTARY INFORMATION: A CRADA is the anticipated joint agreement 
to be entered into by NIA pursuant to the Federal Technology Transfer 
Act of 1986, a amended by the National Technology Transfer Act (Pub. L. 
104-113 (Mar. 7, 1996)) and by Executive Order 12591 of April 10, 1987. 
The NCI owns U.S. Patent No. 4,455,032, concerning the use of 
phosphocholine hapten conjugates in vaccines, which presently is not 
licensed. NIA is now planning to develop a vaccine for pneumonia 
utilizing the invention in the NCI patent.
    Under the present proposal, the specific goals of the CRADA will be 
the development of the following technology:
     Development of one or more vaccines utilizing the 
phosphocholine-hapten technology;
     and preclinical evaluation of the candidate vaccines.

Party Contributions

    The role in NIA includes the following:
    (1) Develop, in cooperation with the Collaborator, candidate 
pneumonia vaccines;
    (2) Conduct preclinical trials of candidate vaccines in small 
mammal models;
    (3) Provide staff, expertise, & materials for the development and 
testing of promising vaccines, and provide work space and equipment for 
testing of the prototype vaccines; and
    (4) Jointly evaluate and publish the data generated with 
Collaborator.
    The role of the successful Collaborator will include the following:
    (1) Provide an adequate supply of at least one mutually agreeable, 
GMP-grade carrier system, and provide expertise and assistance in the 
development and use of its vaccine carrier system(s);
    (2) Provide resources, staff, expertise, and funding, as necessary, 
in support of the research goals; and
    (3) Develop and market any promising vaccines.

Selection Criteria

    Proposals submitted for consideration should fully address each of 
the following qualifications:
    (1) Expertise:
    A. Demonstrated expertise in developing and producing high quality 
pharamacuetical compositions;
    B. Demonstrated ability to secure national and/or international 
marketing and distribution of pharmaceutical compositions;
    C. Demonstrated intellectual ability to guide development of 
product line which addresses the requirements of NIA;
    (2) Reputation: The successful Collaborator must be recognized in 
the pharmaceutical industry for:
    A. Producing quality pharmaceutical products;
    B. Indications of satisfaction by industry experts with the 
Collaborator's products; and
    C. Commitment to the research and development of new 
pharmaceuticals.
    (3) Physical Resources:
    A. An established headquarters with offices, space, and equipment;
    B. Access to the organization during business hours by telephone, 
mail, e-mail, the Internet, and other evolving technologies; and
    C. Sufficient financial resources to support, at a minimum, the 
current activities of the CRADA to meet the needs of NIA.

    Dated: April 26, 1998.
Kathleen Sybert,
Acting Director, Technology Development & Commercialization Branch, 
National Cancer Institute, National Institutes of Health.
[FR Doc. 98-12109 Filed 5-6-98; 8:45 am]
BILLING CODE 4140-01-M