[Federal Register Volume 59, Number 128 (Wednesday, July 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16281]


[[Page Unknown]]

[Federal Register: July 6, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

 

Cooperative Research and Development Agreement

[CRADA 94-001]
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), National 
Center for Infectious Diseases, announces the opportunity for potential 
collaborators to enter into a Cooperative Research and Development 
Agreement (CRADA) for the further development, refinement, and 
validation of three interrelated technologies: (1) The Exchangeable 
Template Reaction (ETR), a method to assemble synthetic genes, (2) the 
construction of hepatitis C virus (HCV) specific ``mosaic'' proteins 
composed of immunodominant antigenic epitopes, and (3) differential HCV 
diagnostic tests. It is anticipated that these and any new technologies 
or inventions which may arise from this CRADA will be licensed to the 
collaborator with whom the CRADA is made.
    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: Howard A. Fields, Ph.D., 
Hepatitis Branch, Division of Viral and Rickettsial Diseases, National 
Center for Infectious Diseases, Centers for Disease Control and 
Prevention (CDC), 1600 Clifton Road, NE., Mailstop G-14, Atlanta, GA 
30333, telephone (404) 639-2335.
    Business: Lisa Blake-DiSpigna, Technology Transfer Representative, 
National Center for Infectious Diseases, Centers for Disease Control 
and Prevention (CDC), 1600 Clifton Road, NE., Mailstop C-19, Atlanta, 
GA 30333, telephone (404) 639-3227.

SUPPLEMENTARY INFORMATION: The goal of this CRADA is to bring to market 
HCV-specific technologies that will improve public health. CDC will 
provide intellectual insight and experimental design protocols to: (1) 
Improve the efficiency of ETR, (2) construct ``mosaic'' proteins for 
HCV that have immunodiagnostic and potential vaccine relevance, and (3) 
evaluate synthetic peptides containing antigenic epitopes as reagents 
to discriminate recent from late infections or that may predict outcome 
of HCV infection. CDC will design and conduct feasibility experiments 
for each of the project areas and will contribute in the preparation of 
serologic panels to validate various test formats. The CRADA partner 
will prepare all synthetic peptides and oligonucleotides as necessary 
for each project area, prepare monospecific and monoclonal antibodies 
whenever appropriate, and purify antigens from recombinant lysates as 
needed. The collaborator will utilize its expertise in market research 
to evaluate the commercialization of the technologies.
    Respondents should provide evidence of expertise in the development 
and evaluation of diagnostic assays, evidence of experience in 
commercialization of diagnostics products, 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 diagnostic virolgoy;
    2. Evidence of scientific credibility;
    3. Evidence of commitment and ability to develop innovative designs 
for diagnostic assays and/or vaccines;
    4. Evidence of preparing synthetic peptides and oligonucleotides;
    5. Evidence of a strong engineering department to design automated 
equipment; and,
    6. Evidence of an existing infrastructure to commercialize on 
successful technologies.
    This CRADA is proposed and implemented under the 1986 Federal 
Technology Transfer Act, Public Law 99-502 (15 U.S.C. 3710).
    The responses must be made to: Lisa Blake-Despigna, Technology 
Transfer Coordinator, National Center for Infectious Diseases, Centers 
for Disease Control and Prevention (CDC), 1600 Clifton Road, NE., 
Mailstop C-19, Atlanta, GA 30333.

    Dated: June 29, 1994.
Arthur C. Jackson,
Associate Director for Management and Operations, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 94-16281 Filed 7-5-94; 8:45 am]
BILLING CODE 4163-18-P