[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
