RFP ANNOUNCEMENT: DEVELOPMENT AND TESTING OF A MODIFIED VACCINIA ANKARA (MVA) VACCINE - NIH-NIAID-DMID-03-44 Release Date: August 14, 2002 NOTICE: NOT-AI-02-047 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) Receipt Date: September 30, 2002 DESCRIPTION The Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), NIH, has a requirement for the development and testing of a Modified Vaccinia Ankara (MVA) Vaccine. The purpose of this RFP is to provide resources for the initial development of MVA vaccine candidates. It is the intent of the Government to provide contract support for the development and stockpiling of MVA vaccines through the issuance of sequential RFPs. This current RFP (NIH-NIAID-DMID-03-44) is intended to provide resources for the initial development of MVA vaccine candidates. It is anticipated that one (1) or more cost reimbursement, completion type contracts will be awarded for a period of three (3) years, beginning approximately January 31, 2003. This RFP also includes a Part B to the Statement of Work as an Option provision under FAR 17.2 for the conduct of expanded Phase II clinical studies in healthy populations (i.e., adult and children) and Phase I and II studies in "at risk" (i.e., immuno-compromised) populations. RFP-NIH-NIAID-DMID-03-44 will be available electronically on or about August 15, 2002, and may be accessed through the NIAID Contract Management Branch (CMB) Home Page at http://www.niaid.nih.gov/contract, and will be posted on FedBizOpps at http://www.fedbizopps.gov/. Any responsible Offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. In addition, the Government intends to issue a second RFP entitled "Production and Acquisition of MVA Vaccine" on or about June 2003. The main objectives of the second RFP will be to: a) execute a plan to manufacture, formulate, fill and finish, and test, assuming 30 X 106 doses of MVA in accordance with cGMP regulations; b) deliver to the Government up to 30 million doses of vaccine to constitute a stockpile for emergency use under IND, and to maintain the stockpile as needed; and c) provide a licensure plan to include the conduct of expanded human safety studies required for licensure and the conduct of pivotal animal protection studies. Participation in RFP NIH-NIAID-DMID-03-44 will NOT be a pre-requisite for participation in the second RFP, "Production and Acquisition of MVA Vaccine"; the second RFP will be a full and open, competitive procurement. Contracting Office Address: National Institutes of Health National Institutes of Allergy and Infectious Diseases Contract Management Branch 6700-B Rockledge Drive Room 2230, MSC 7612 Bethesda, MD, 20892-7612 Point of Contact: Phil Hastings, Contracting Officer, Phone 301-496-0194, Fax 301-402-0972, E- mail ph23k@nih.gov Jacqueline Holden, Senior Contracting Officer, Phone 301-496-7119, Fax 301- 402-0972, E-mail jh55b@nih.gov
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