[Federal Register Volume 66, Number 120 (Thursday, June 21, 2001)]
[Notices]
[Pages 33255-33256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15602]


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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), 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 anti-
substance P antibodies and/or anti-substance P F(ab)'2 antibody 
fragments to prevent and/or treat an inflammatory response mediated by 
substance P associated with respiratory viral infection (particularly 
respiratory syncytial virus [RSV]). Anti-substance P antibody treatment 
would be used in combination with agents for anti-viral treatment 
(e.g., Ribavirin, palivizumab, and RSV fusion inhibitors) to ameliorate 
substance P-mediated inflammation and disease pathogenesis.
    Because CRADAs are designed to facilitate the development of 
scientific and technologic knowledge into useful, marketable products, 
a great deal of freedom is given to Federal agencies in

[[Page 33256]]

implementing collaborative research. 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 July 23, 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 Transfer Coordinator, National Center for Infectious 
Diseases, Centers for Disease Control and Prevention, 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, 1600 
Clifton Rd. NE., Mailstop G-09, Atlanta, GA 30333, telephone (404) 639-
3427.
Business: Lisa Blake-DiSpigna, Technology Transfer Coordinator, 
National Center for Infectious Diseases, Centers for Disease Control 
and Prevention, 1600 Clifton Rd. NE., Mailstop C-19, Atlanta, GA 30333, 
telephone (404) 639-3227.

SUPPLEMENTARY INFORMATION: The goal of this CRADA is to seek a partner 
for collaboration to examine the development and use of anti-substance 
P antibodies and/or anti-SP F(ab)'2 antibody fragments to prevent and/
or treat an inflammatory response mediated by substance P that is 
associated with respiratory viral infection (particularly RSV). The 
methods comprise the administration to the subject of a 
pharmaceutically effective amount of anti-SP antibodies or anti-SP 
F(ab)'2 antibody fragments to inhibit the activity of endogenous SP in 
the subject. Anti-SP antibody or anti-SP F(ab)'2 antibody treatment 
will be used in combination with anti-viral drugs and anti-viral 
reagents to inhibit the activity of endogenous SP in the subject so as 
to reduce the level of cytokine/chemokine-based inflammation and 
pulmonary cell infiltration and alter the disease course.
    Respondents should provide evidence of expertise in the development 
and evaluation of anti-viral drugs and anti-viral reagents, evidence of 
experience in animal models systems including non-human primate models, 
commercialization of anti-viral drugs and anti-viral reagents, 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 anti-viral drugs and 
anti-viral reagents;
    2. Expertise in evaluation of anti-viral drugs, reagents and anti-
viral treatments in animal model systems including non-human primates;
    3. Evidence of scientific credibility. The company has the 
capability of bringing the product to fruition, in part determined by 
past accomplishments with similar products, and/or that the company has 
published related studies in peer-reviewed journals;
    4. Evidence of commitment and ability to develop anti-substance P 
monoclonal antibodies for use with anti-viral drugs, anti-viral 
reagents or antiviral treatments; and
    5. Evidence of an existing infrastructure to commercialize 
successful technologies.
    This CRADA is proposed and implemented under the 1986 Federal 
Technology Transfer Act: Public Law 99-502.

    Dated: June 14, 2001.
Thena M. Durham,
Director, Executive Secretariat, Office of the Director, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 01-15602 Filed 6-20-01; 8:45 am]
BILLING CODE 4163-18-P