National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Solar Bldg., Room 3C07, 6003 Executive Blvd. MSC 7610, Bethesda, MD 20892-7610

A -- TARGETED HIV VACCINE AND RELATED BIOMEDICAL PREVENTION RESEARCH SOL NIH-NIAID-DAIDS-98-15 (DRAFT) DUE 091697 POC Kristiane Cooper, Contract Specialist, (301) 496-7288; Lawrence M. Butler, Contracting Officer, (301) 496-0192 The development of vaccines and other biomedical interventions to prevent the spread of HIV infection is a national goal of the highest priority. To help accomplish this goal, the Division of AIDS of the National Institute of Allergy and Infectious Diseases plans to select an organization(s) with experience in both: 1) vaccine development; and 2) research management skills. This group will manage a Master Contract for Targeted HIV Vaccine Development and Related Biomedical Prevention Research. The contract will provide the NIAID with two functions: 1) process development and cGMP production of pilot lots of candidate HIV vaccines; and, 2) a rapid response mechanism for funding high priority, targeted developmental research. The NIAID, in consultation with its advisory groups, will establish the priorities for all research and development. 1 -- PILOT LOT PRODUCTION The most important technical capacity of the contractor(s) is their expertise in vaccine development, especially biologicals. A Process Development Team will support vaccine candidates or concepts, identified by the NIAID, from the earliest stages of identification/discovery through the IND issuance process. 2 -- OTHER TARGETED RESEARCH The NIAID will also establish priorities for the other targeted research by directing the Contractor to provide specific systems and reagents (e.g. unique animal models, specialized assays, construction and characterization of challenge stocks, cell lines expressing particular co-receptor) for preclinical and clinical vaccine evaluation. To accomplish "Other Targeted Research," the Master Contractor will establish a peer review process, fund research through subcontracts to selected groups, receive data, and monitor technical and administrative progress of all work (e.g., to create novel reagents or utilize animal models for concept testing). Both vaccine development and other vaccine evaluation activities will require the Master Contractor to interact extensively with NIAID staff, provide and update timelines, manage data, and coordinate all activities, including those of subcontractors performing the targeted developmental research, in accordance with the projected schedules. Recognizing that the expertise to accomplish all work statement requirements may not exist within one organization, the Master Contractor may consist of one organization or a combination of organizations [e.g., prime contractor and subcontractor(s) who propose together]. The Master Contractor must have equal commitment to the development of specific vaccines and to the scientific management of vaccine evaluation projects. As provided for by the FAR we are issuing a presolicitation notice (Draft Work Statement) for this project which will be made available for review through the NIAID Internet Home Page. We are soliciting comments on our initial Draft Work Statement in hopes of making improvements, and avoiding obstacles, prior to issuing a solicitation. We are not soliciting proposals at this time. The DRAFT WORK STATEMENT will be available electronically on or about July 9, 1997, 15, and may be accessed through either the NIAID Contract Management (CMB) Home Page or the NIH Gopher by using the electronic addresses and instructions: 1) NIAID/CMB Home Page (via the World Wide Web): Access by using http://www.niaid.nih.gov/contract and select the "RFP" link. 2) To access the NIH Gopher: Point your gopher client to GOPHER.NIH.GOV.PORT70 (you should now be in the NIH Gopher). Select "Grants and Research Information," then select "R&D Request for Proposals (RFP)." Please note that the draft work statement can be found under NIH-NIAID-DAIDS-98-15. Please note that this announcement includes a DRAFT WORK STATEMENT FOR COMMENT ONLY; proposals are not being solicited at this time. Lawrence M. Butler 6003 Executive Boulevard Room 3C07 Bethesda, Maryland 20892-7610 FAX: (301) 402-0972 E Mail: lb13t@NIH.GOV (0183)

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