National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Room 2230, 6700-B Rockledge Drive, MSC 7612, Bethesda, MD 20892-7612

A -- MALARIA VACCINE PRODUCTION AND SUPPORT SERVICES SOL RFP-NIH-NIAID-DMID-00-18 DUE 011400 POC Nancy Hershey, Contracting Officer, (301) 496-0193 The Division of Parasitology and International Programs Branch (PIPB) of the Division of Microbiology and Infectious Diseases (DMID), and the Laboratory of Parasitic Diseases (LPD) of the Division of Intramural Research, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) has a requirement to provide services and facilities to support the malaria vaccine development efforts of the Institute. The purpose of this Request for Proposal is to seek responsible offerors for providing services and facilities to support malaria vaccine development efforts which includes: 1) project management to provide oversight for the transition of lead vaccine candidates through development and production to clinical evaluation; 2) process development in a variety of systems (potentially: recombinant proteins expressed in prokaryotic systems [e.g. E. coli]; recombinant proteins expressed in eukaryotic systems [e.g. baculovirus, Pichia, Saccharomyces, mammalian cells]; syntheticpeptides; vector-based vaccines in bacterial [e.g. BCG, Salmonella] or viral [e.g. adenovirus, vaccinia] systems; and DNA vaccines) to identify optimal production and purification strategies for clinical-grade immunogens; 3) production of pilot lots of antigens within the same systems and formulation of candidate vaccines under GMP-compliant conditions; and, 4) regulatory support for compiling documentation necessary for FDA approval of clinical trials. Potential Offerors must be able to document access to all of these services and facilities within a timeframe specified by NIAID, as dictated by development needs for any particular vaccine candidate. It is anticipated that one (1) cost-reimbursement, completion type contract will be awarded for a period of seven years, beginning approximately September 15, 2000. RFP-NIH-NIAID-DMID-00-18 will be available electronically on or about September 15, 1999, and may be accessed through the NIAID Contract Management Branch (CMB) Home Page by using the following electronic address and instructions: NIAID/CMB Home Page (via the World Wide Web): Access by using http://www.niaid.nih.gov/contract and select the "RFPs" link and then select "RFP-NIH-NIAID-DMID-00-18." Please note that the RFP for this acquisition has been revised to include only the Statement of Work, deliverable and reporting requirements, special requirements and mandatory qualifications, if any, the Technical Evaluation Criteria, and the proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due January 14, 2000. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. All respondents are asked to indicate the type and size of your business organization, e.g., Large Business, Small Business, Hubzone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization. We plan to conduct a pre-proposal conference for the purpose of providing information concerning this acquisition and for answering questions you may have regarding this acquisition or the proposal preparation, evaluation and award process. The date for the pre-proposal conference will be Friday, October 22, 1999, in Bethesda, Maryland. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. Point of Contact: Nancy Hershey, Contracting Officer Electronic mail address: nh11x@nih.gov Telephone: (301) 496-0193 Fax: (301) 480-5253 Posted 08/31/99 (W-SN374749). (0243)

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