[Federal Register Volume 59, Number 200 (Tuesday, October 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25690]


[[Page Unknown]]

[Federal Register: October 18, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[CRADA 94-003]

 

Cooperative Research and Development Agreement

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 refinement and commercialization of a 
sensitive and specific assay for the detection of reverse transcriptase 
in a variety of sample types.
    It is anticipated that this 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 also 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

    Walid Heneine, Ph.D., or Thomas Folks, Ph.D., Retrovirus Diseases 
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-19, Atlanta, GA 30333, telephone 
(404) 639-1024.

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: To speed the research, development, and 
commercialization of this technology, CDC, National Center for 
Infectious Diseases is seeking an agreement with a biotechnology or 
pharmaceutical company in accordance with the regulations governing the 
transfer of government-developed agents for joint research, 
development, evaluation, and commercialization.
    CDC has developed a sensitive and specific reverse transcriptase 
assay which has a number of possible commercial uses, such as: (1) 
Sensitive detection of known and unknown retroviruses in supernatants 
from cell cultures of human or animal samples, (2) screening samples of 
serum/plasma, cerebrospinal fluid, or any other cells or tissues from a 
human or animal source for the presence of known or unknown 
retroviruses, (3) in vitro testing of antiretroviral drugs, (4) 
monitoring viral burden, such as in studies of the efficacy of 
antiviral drug therapy in HIV-infected patients, and (5) detection of 
RT-associated agents other than retroviruses.
    This developmental assay uses an in vitro transcribed 
heteropolymeric RNA sequence for the RT enzyme template, and gene 
amplification with Southern blot hybridization as the detection system 
for the cDNA product of the reaction. A comparative analysis using HIV-
1 found the assay to be 105 times more sensitive than standard RT, 
and from 10\2\ to 10\4\ times more sensitive than p24 antigen capture, 
branched DNA, and RT-PCR assays.
    The CRADA partner will refine the assay to make it more amenable 
for clinical laboratory use. Such refinements may include adapting it 
to a 96-well microtiter format and modifying the detection system to 
use a non-radioactive methodology, such as chemiluminescence. The 
collaborator will utilize its scientific expertise to explore 
additional applications of the assay, and its market research to 
evaluate the commercialization of the technology.
    Respondents should provide evidence of expertise in the development 
and evaluation of molecular 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 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 molecular biology;
2. Evidence of scientific credibility;
3. Evidence of commitment and ability to develop innovative molecular 
diagnostic assays;
4. Evidence of preparing non-radioactive detection systems for 
molecular probes or markers; 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 (15 U.S.C. 3710).
    The responses must be made to: 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.

    Dated: October 12, 1994.
Deborah L. Jones,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 94-25690 Filed 10-17-94; 8:45 am]
BILLING CODE 4163-18-P