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

This Notice is a re-submission of a Notice published on June 9, 2004. The purpose of this notice is to indicate that this RFP will be published on or about August 18, 2004. The Department of Health and Human Services has a requirement for the acquisition and maintenance of therapeutic products for the Strategic National Stockpile (SNS) to treat U.S. civilians with inhalational anthrax disease. The types of products that may be acquired under this solicitation include immunotherapeutic antitoxin treatments, such as monoclonal antibodies and polyclonal antibody toxin inhibitors, human immune globulin and other protein therapeutic products such as mutated toxins, or small molecular entity treatments such as protease inhibitors for anthrax toxemia. It is anticipated that these products would be used in conjunction with antibiotics in the treatment of symptomatic patients exposed to anthrax. This requirement is for the initial acquisition of between 10,000 and 70,000 therapeutic courses of treatment for inhalational anthrax disease, potentially from a variety of product types, based on the availability of funds. The government reserves the right to make single or multiple contract awards. It is anticipated that additional requirements for anthrax therapeutic products from a variety of product types will be released approximately annually over the next two years, based on the availability of funds. The Office of Research and Development Coordination (ORDC) in OASPHEP has the primary responsibility within HHS to contract with industry for large-scale manufacturing and delivery of licensable products to the SNS in preparation for response to a public health emergency. Potential Offerors are required to have submitted an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) by the time of proposal submission to be considered in response to this RFP. Potential Offerors' products must be allowed to proceed by FDA under IND at time of contract award. The requirement of the solicitation is that any successful Offeror will aggressively pursue FDA licensure or approval of their products. All lots of IND product purchased for the SNS through this acquisition are expected to qualify for licensure or product approval. This RFP is being issued on the basis of full and open competition. Subcontracting with small businesses is encouraged. All potential Offerors with a candidate product or products for the treatment of inhalational anthrax disease that meet the Absolute Criteria for Eligibility specified in the RFP are encouraged to submit a proposal in response to this solicitation. The Absolute Criteria for Eligibility will include: 1. A complete IND submitted to and received by the FDA for initiation of clinical trials. The IND must conform to the requirements as specified in 21 Code of Federal Regulations (CFR) 312. 2. Proof-of concept data in small animals. The acticipated period of performance will be for a total of five years or 60 months. Additional details and requirements will be described in the solicitation. The solicitation is scheduled to be released on or about August 18, 2004. Only written or email requests, directly from the requestor, for this solicitation will be accepted. No telephone requests will be accepted. Requests should reference the solicitation number, state the name of the firm, name of the requestor, mailing address, telephone number, fax number, and email address. The solicitation will also be posted to Fedbizopps. Requests should be mailed to the Contracting Office Address, ATTN: Lorenzo Falgiano. The applicable NAICS is 325414, Biological Product (except Diagnostic) Manufacturing, and the size standard is 500 employees.