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 -- MALARIA VACCINE PRODUCTION AND SUPPORT SERVICES SOL RFI-00-18 DUE 071399 POC Mr. Phil Hastings, Contract Specialist, 301-496-0194 The purpose of this Request for Information/Sources Sought Notice is to identify potential sources capable of providing services and facilities to support the malaria vaccine development efforts of the Division of Parasitology and International Programs Branch of the Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). This 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]; synthetic peptides; 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. This Request for Information/Sources Sought Notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. In theevent an RFP is issued, Standard Industrialization Classification (SIC) Code 8731 is being considered. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked. 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. Interested firms should submit 3 copies of their capability statements addressing the 4 items above no later than 4:00pm local time on Tuesday, July 13, 1999 to Phil Hastings, Contract Specialist, Contract Management Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 6700-B Rockledge Drive, Room 2230, MSC 7612, Bethesda, MD 20892-7612. For overnight delivery, please use 6700-B Rockledge Drive, Room 2230, Rockville, MD 20817. You may also submit facsimile responses not exceeding 15 pages to (301) 480-5253. E-mail responses sent to ph23k@nih.gov will also be accepted. Posted 06/25/99 (W-SN347403). (0176)

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