[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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