[Federal Register Volume 63, Number 68 (Thursday, April 9, 1998)]
[Notices]
[Pages 17426-17427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9335]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[CRADA 98-001]
Cooperative Research and Development Agreement
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (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
collaborator(s) to enter into a Cooperative Research and Development
Agreement (CRADA) for the development of a worldwide sentinel
surveillance system to isolate, characterize, and monitor for the
emergence of new retroviruses and divergent HIV variants of public
health importance. The reagents generated from this project will be
used to validate the sensitivity and specificity of the current HIV
screening tests. This research effort is designed to further the
development of diagnostics to test for new HIV variants to ensure
protection of the blood supply.
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 May 11, 1998. Respondents may be
provided a longer period of time to furnish additional information if
CDC finds this necessary.
FOR FURTHER INFORMATION CONTACT:
Technical: Thomas M. Folks, Ph.D., Chief, HIV/Retrovirus Diseases
Branch, Division of AIDS, STD and TB Laboratory Research, National
Center for Infectious Diseases, Centers for Disease Control and
Prevention (CDC), 1600 Clifton Rd. NE., Mailstop G-19, Atlanta, GA
30333, telephone (404) 639-1010.
Business: Lisa Blake-DiSpigna, Technology Transfer Representative,
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, (E-Mail: [email protected]).
SUPPLEMENTARY INFORMATION: Efforts will be made to sample various
regions and risk groups in geographically dispersed countries. Where
possible, the optimal sample size will be sufficient to have a high
probability of detecting HIV variants present in these populations even
if their prevalence is low (<1%). Samples will be tested for antibodies
to HIV-1 and HIV-2; sero-reactive specimens will be further processed
for sera, plasma, and cells. Attempts will be made to target
populations attending STD clinics, counseling and testing centers,
antenatal clinics, and TB treatment centers. Asymtomatic individuals
reporting high risk behaviors and seronegative persons with elevated
reactivity in screening assays will be further investigated. In
addition, samples will be obtained whenever possible from sero-
discordant couples and symptomatic individuals who have remained
seronegative. Such samples will be evaluated using generic retroviral
testing to identify new or highly divergent viruses which lack common
epitopes with prototypic HIV strains. Specimen collection will be in
accordance with CDC Institutional Review Board (IRB) approved
protocols. An initial site assessment will be done to determine the
prevalence of HIV infection and the feasibility of collecting and
processing the requisite number of specimens.
Goals: The primary goal of this project is to collect isolates of
representative emerging retroviruses and divergent HIV strains from
persons with various transmission risk factors, representing different
regions worldwide to help in understanding the degree of genetic
diversity among emerging variants and what HIV strains predominate in
these populations. Special emphasis will be given to monitoring for the
presence of divergent HIV variants that are distinct from already
characterized HIV-\1/2\
[[Page 17427]]
subtypes and to define the extent of variability within recognized
subtypes. The secondary goal is to collect specimens representing these
variants and recognized subtypes (A-I) to prepare a panel of sera
collected from people whose infecting virus has been sequenced. The
panel will be used to evaluate the sensitivity and specificity of
existing and newly developed HIV antibody tests with regard to these
strains and to assist, if necessary, in modifying these tests to
broaden their sensitivity. Specimens will primarily be blood, but may
include urine or oral fluids to evaluate diagnostic tests using these
specimens. The research efforts in support of this CRADA are focused on
the combined use of molecular and epidemiologic data to examine the
question of whether certain HIV strains have distinctive patterns of
transmission and disease progression in infected individuals.
The CRADA partner will be expected to provide both financial as
well as scientific resources. Substantial involvement in specimen
testing including molecular and biochemical analysis of viruses and
viral components would be anticipated from the CRADA partner.
Respondents should provide evidence of expertise in the development
and marketing of clinical diagnostics (prior experience with HIV
preferred) and supporting data (e.g., publications, proficiency
testing, certifications, resumes, etc.) of qualifications for the
laboratory director and laboratory personnel who would be involved in
the CRADA. The respondent will develop the final research plan in
collaboration with CDC but should provide an outline of a research plan
for review by CDC in judging applications.
Applicant submissions will be judged according to the following
criteria:
1. Knowledge of molecular diagnostics including: epitope specific
and recombinant based immunoassays, rapid tests, and nucleic acid based
detection assays.
2. Working knowledge of nucleic acid sequencing, PCR, eukaryotic
expression of recombinant antigens, and the large scale production of
said products.
3. Operational experience in an international setting.
4. Procedural understanding of and experience in the development
and marketing of HIV diagnostics in the United States.
This CRADA is proposed and implemented under the 1986 Federal
Technology Transfer Act: Public Law 99-502, as amended.
The responses must be made to: Lisa Blake-DiSpigna, Program
Analyst, National Center for Infectious Diseases, Centers for Disease
Control and Prevention (CDC), 1600 Clifton Road, NE., Mailstop C-19,
Atlanta, GA 30333.
Dated: April 3, 1998.
Joseph R. Carter
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 98-9335 Filed 4-8-98; 8:45 am]
BILLING CODE 4160-18-P