68 -- Acquisition of Therapeutic Products for Treatment of Inhalational Anthrax Disease for the Strategic National Stockpile

The Department of Health and Human Services is preparing to release a Request for Proposals for the acquisition and maintenance of therapeutic products to treat inhalational anthrax disease as part of the Strategic National Stockpile. This solicitation seeks initial procurement of between 10,000 and 70,000 treatment courses, comprising various therapeutic types such as immunotherapeutic antitoxins (including monoclonal and polyclonal antibodies), human immune globulin, mutated toxins, and small molecule treatments like protease inhibitors. These products are intended to be used alongside antibiotics for symptomatic patients exposed to anthrax. The contracting office plans to award single or multiple contracts and anticipates issuing further requirements annually over the next two years, contingent upon funding availability. Potential offerors must have submitted an Investigational New Drug application to the FDA for their product and have FDA allowance to continue under IND at contract award. They are required to pursue full FDA licensure or approval aggressively, with all lots purchased expected to qualify for regulatory approval. The solicitation encourages competition, including subcontracting with small businesses, and mandates that proposals meet specific eligibility criteria such as having proof-of-concept data in small animals and a complete IND in compliance with FDA regulations. The anticipated contract period is five years, and the solicitation will be released around August 18, 2004, with requests for the solicitation only accepted in writing or via email referencing the solicitation number and firm details. The procurement falls under the NAICS code for Biological Product Manufacturing.