[Federal Register Volume 66, Number 45 (Wednesday, March 7, 2001)]
[Notices]
[Pages 13744-13745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5503]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Centers for Disease Control and Prevention

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) is 
seeking a CRADA partner for collaboration to examine the use of CD40L 
as a molecular adjuvant to enhance the humoral and cellular immune 
responses to Respiratory Syncytial Virus (RSV) and other viral 
vaccines. The methods comprise expression of the immune-enhancing CD40L 
molecule with viral antigens in vaccines or addition of CD40L to viral 
antigens in vaccines to augment the antibody and cellular immune 
responses to the vaccine antigens. RSV is one example of a viral agent 
for which vaccines are sought and for which CD40L might prove to be a 
safe and effective adjuvant.
    Because CRADAs are designed to facilitate the development of 
scientific and technological knowledge into useful, marketable 
products, a great deal of freedom is given to Federal agencies in 
implementing collaborative research. The CDC may accept staff, 
facilities, equipment, supplies, and money from the other participants 
in a CRADA; CDC may provide staff, facilities, equipment, and supplies 
to the project. There is a single restriction in this exchange: CDC MAY 
NOT PROVIDE FUNDS to the other participants in a CRADA. This 
opportunity is available until 30 days after publication of this 
notice. Respondents may be provided a longer period of time to furnish 
additional information if CDC finds this necessary.

FOR FURTHER INFORMATION CONTACT:
    Technical: Ralph A. Tripp, Ph.D., Respiratory and Enteric Viruses, 
Division of Viral and Rickettsial Diseases, National Center for 
Infectious Diseases, Centers for Disease Control and Prevention (CDC), 
1600 Clifton Rd. NE., Mailstop G-09, Atlanta, GA 30333, telephone (404) 
639-3427.
    Business: Lisa Blake-DiSpigna, Technology Development Coordinator, 
National Center for Infectious Diseases, Centers for Disease Control 
and

[[Page 13745]]

Prevention (CDC), 1600 Clifton Rd. NE., Mailstop C-19, Atlanta, GA 
30333, telephone (404) 639-3227 or by E-Mail at [email protected].

SUPPLEMENTARY INFORMATION: The goal of this CRADA is to seek a partner 
for collaboration to examine development of research animal models 
(particularly for non-human primates) to study both the safety and 
efficacy of CD40L as a vaccine adjuvant. These animal model systems and 
vaccines will be used to study the ability of CD40L to enhance the 
immune response to (RSV) vaccine antigens. These studies will focus on 
humoral immune responses (eg. viral titers), cellular immune responses 
(eg. cytotoxicity), cytokines and chemokine expression, quantification 
of cell subsets at the site of infection (i.e. the pulmonary cell 
infiltrate) and quantification of viral replication in the lungs. 
Respondents should provide evidence of expertise in the development and 
evaluation of anti-viral vaccines and vaccine agents, evidence of 
experience in animal models systems including non-human primate models, 
commercialization of vaccines and vaccine agents, and supporting data 
(e.g., publications, proficiency testing, certifications, resumes, 
etc.) of qualifications for the principal investigator who would be 
involved in the CRADA. The respondent will develop the final research 
plan in collaboration with CDC.
    Applicant submissions will be judged according to the following 
criteria:
    1. Expertise in development and evaluation of anti-viral (RSV) 
vaccines;
    2. Expertise in evaluation of anti-viral (RSV) vaccines in animal 
model systems including non-human primates;
    3. Evidence of scientific credibility;
    4. Evidence of commitment and ability to anti-viral (RSV) vaccines 
and;
    5. Evidence of an existing infrastructure to commercialize 
successful technologies.
    With respect to Government Intellectual Property (IP) rights to any 
invention not made solely by a CRADA partner's employees for which a 
patent or other IP application is filed, CDC has the authority to grant 
to the CRADA partner an exclusive option to elect an exclusive or 
nonexclusive commercialization license. This option does not apply to 
inventions conceived prior to the effective date of a CRADA that are 
reduced to practice under the CRADA, if prior to that reduction to 
practice, CDC has filed a patent application on the invention and has 
licensed it or offered to license it to a third party. This CRADA is 
proposed and implemented under the 1986 Federal Technology Transfer 
Act: Public Law 99-502, as amended.
    The responses must be made to: Lisa Blake-DiSpigna, Technology 
Development Coordinator, National Center for Infectious Diseases, 
Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd. NE., 
Mailstop C-19, Atlanta, GA 30333.

    Dated: March 1, 2001.
Joseph R. Carter,
Associate Director for Management and Operations, Centers for Disease 
Control and Prevention.
[FR Doc. 01-5503 Filed 3-6-01; 8:45 am]
BILLING CODE 4163-18-P