[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]
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