[Federal Register Volume 66, Number 218 (Friday, November 9, 2001)]
[Notices]
[Pages 56678-56679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28147]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Cooperative Research and Development Agreement (CRADA)

AGENCY: Centers for Disease Control and Prevention (CDC), Public Health 
Service, HHS.

ACTION: Notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) is 
seeking a CRADA partner(s) for collaboration to utilize the newly 
acquired knowledge that the CX3C chemokine region in the respiratory 
syncytial virus (RSV) G glycoprotein binds to the chemokine receptor 
CX3CR1 and this binding facilitates RSV infection of cells and induces 
chemokine-like responses to develop ways to treat or prevent RSV 
disease. The CRADA partner could be involved in all or part of studies 
examining (1) alteration of the CX3C region in the G glycoprotein of 
live viruses in such a way as prevent CX3C interaction with the CX3C 
receptor (CX3CR1) on cells and improve the safety and/or efficacy of a 
live virus vaccine; (2) alteration of the G glycoprotein to enhance 
induction of antibodies that block G glycoprotein binding to the CX3C 
chemokine receptor, CX3CR1, and treat or prevent RSV disease; (3) 
development of reagents (drugs, antibodies, peptides, polypeptides, 
etc.) that block interaction of the CX3C region in G glycoprotein with 
CX3CR1 on cells to treat or prevent RSV disease; (4) development of 
assays to detect blocking of G glycoprotein binding to the CX3C 
receptor, CX3CR1, or detect blocking of the biological activity 
initiated by G glycoprotein binding to CX3CR1 to identify reagents 
(drugs, antibodies, peptides, polypeptides, etc.) or evaluate candidate 
vaccines that might be used as prophylactic or therapeutic treatments 
for preventing RSV disease.
    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.

DATES: This opportunity is available until December 10, 2001. 
Respondents may be provided a longer period of time to furnish 
additional information if CDC finds this necessary.

ADDRESSES: 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.

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

[[Page 56679]]

Coordinator, National Center for Infectious Diseases, Centers for 
Disease Control and 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(s) for collaboration to develop studies examining (1) live RSV 
vaccines produced by modifying the RSV G glycoprotein CX3C region to 
render it nonfunctional for viral attachment to host cells, (2) 
producing live or non-live RSV vaccines, or improving existing live or 
non-live RSV vaccines by modifying the CX3C region or proximal regions 
thereof so that when administered, higher titers of antibodies are 
produced that block the biological activity of the CX3C region on the G 
glycoprotein of subsequently infecting RSV viruses, (3) treatment 
provided by administration to an RSV infected individual an effective 
amount of a drug, antibody, peptide, polypeptide, or other molecule 
that block interaction of the CX3C region in G glycoprotein with CX3CR1 
on host cells or the biological activity of the CX3C region in the G 
glycoprotein, and (4) development of assays to detect blocking of G 
glycoprotein binding to the CX3C receptor, CX3CR1, or detect blocking 
of the biological activity initiated by G glycoprotein binding to 
CX3CR1 to identify reagents (drugs, antibodies, peptides, polypeptides, 
etc.) that might be used as prophylactic or therapeutic treatments for 
preventing RSV disease.
    Respondents should provide evidence of expertise in all or one of 
the following areas including the development and evaluation of RSV 
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 principle 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 RSV vaccines;
    (2) Expertise in evaluation of RSV vaccines in animal model systems 
including non-human primates;
    (3) Evidence of scientific credibility;
    (4) Evidence of commitment and ability to produce RSV vaccines; and
    (5) Evidence of an existing infrastructure to commercialize 
successful technologies.

    With respect to Government 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.

    Dated: November 5, 2001.
Karen Groux,
Deputy Associate Director for Management and Operations, Centers for 
Disease Control and Prevention.
[FR Doc. 01-28147 Filed 11-8-01; 8:45 am]
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