[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