Centers For Disease Control And Prevention (CDC), Procurement & Grants Office, 2920 Brandywine Road, Atlanta, Georgia 30341-4146

A -- DEVELOPMENT AND PRODUCTION OF A NEW SMALLPOX VACCINE SOL 2000-N-00001 DUE 031300 POC Contact Charlotte L. Flitcraft, Contract Specialist at (404)488-3632 The United States Government requires a new smallpox vaccine to deal with the consequences if smallpox were used as a terrorist weapon against the civilian population. The Department of Health and Human Services (DHHS), Centers for Disease Control and Prevention (CDC) is seeking a contractor to (a) develop a candidate smallpox vaccine using vaccinia in cell culture; (b) produce the pilot lot production of the new vaccine; (c) conduct clinical trials; (d) obtain Food and Drug Administration (FDA) product licensure; (e) manufacture and ship or store initial stockpile of 40 million doses of the new vaccine; (f) manufacture and store or ship vaccines required to maintain the 40 million dose stockpile with in-date vaccines; (g) store a specified quantity of the initial 40 million dose stockpile at Contractor=s facility; (h) manufacture bifurcated needles for vaccine administration; and (i) formulate and produce diluent. The objective is to achieve FDA licensure and initiate large-scale production of a new vaccine in the shortest time possible. It is anticipated that the period of performance will be for approximately 240 months from the date of award. Product Specifications: The smallpox vaccine shall be partially purified vaccinia virus packaged in freeze-dried units of 100 doses per container when administered by bifurcated needle (multiple pressure or multiple puncture administration). Minimum vaccine potency should be not less than 100 million plaque forming units per milliliter (100 million infectious vaccinia viruses per ml). Product storage conditions should be maximized for longest possible retention of vaccine potency. Cell culture Substrate: The smallpox vaccine may be produced in primary chick embryo fibroblast cell culture or an equivalent cell culture substrate to be determined in consultation with the FDA. Vaccine Seed Stock: The New York City Department of Health Laboratory strain of vaccinia virus, derivatives of this strain, or comparable strains of known efficacy against smallpox virus shall be used. Seed Lot Analysis: The Contractor shall analyze the seed lot following standard assays to determine genomic integrity, absence of adventitious agents and other tests as appropriate as decided upon in consultation with FDA. Safety and Immunogenicity Testing: The Safety and Immunogenicity testing will be performed after consultation with FDA. Note: It is anticipated that human testing will be conducted by the Government under existing Government contracts. However, this may not be possible. Therefore, each offeror is required to submit a proposal to conduct the Safety and Immunogenicity testing in-house. Contract Procedures: Contract award will be based upon a best value analysis of all proposals including, at a minimum, the evaluation of each offeror=s price reasonableness, past performance, and technical competence. Complete evaluation criteria and order of precedence will be conveyed within the Request for Proposals (RFP). It is anticipated that item (a), (b), (c), and (d) above will be cost-plus-fixed-fee type line items, items (e), (f) and (g) will be ordered and funded under Indefinite Delivery Indefinite Quantity, fixed-price incentive (successive targets) type line items and items (h) and (i) will be ordered and funded under Indefinite Delivery Indefinite Quantity, firm-fixed-price type line items. The tentative date for issuance of RFP 2000-N-00001 is February 11, 2000. The tentative contract award date is July 1, 2000. Firms interested in receiving this solicitation should send a written request to Charlotte L. Flitcraft, either to the address listed above, by facsimile, (770) 488-2670, or by e-mail, CAF5@cdc.gov. No telephone request will be honored. The request must reference the solicitation (RFP) number, state the name of the company, mailing address of the firm, telephone number, fax number, e-mail address, and point of contact. Note: The contractor will not be limited to supplying this new smallpox vaccine to DHHS/CDC, but will be authorized to manufacture the vaccine for other institutions either within or outside the United States. See Numbered Note 26.***** Posted 01/25/00 (W-SN418844). (0025)

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