*** BACKGROUND *** The Federal Response Plan of the Department of Homeland Security designates the Department of Health and Human Services (HHS) as the lead agency for public health and medical response to man-made or natural disasters. In 2002, HHS established the Office of the Assistant Secretary for Public Health Emergency Preparedness (OASPHEP). This office holds responsibility for implementation of a comprehensive HHS strategy to protect from, and be prepared to respond to, acts of bioterrorism and other public health emergencies threatening the civilian population. The Office of Research and Development Coordination (ORDC) in OASPHEP has the responsibility within HHS to contract with industry for large-scale manufacturing and delivery of licensable products to the Strategic National Stockpile in preparation for response to a public health emergency. An example of such a product is Anthrax Recombinant Protective Antigen (rPA) vaccine. *** DESCRIPTION *** This is a Request for Information (RFI) only. It is not a request for proposal and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the Government and will not be returned. Bacillus anthracis is considered among the most-likely biological agent threat confronting the national security of the United States. B. anthracis is particularly effective in inducing disease when spores are released as an aerosol. The primary mortality and morbidity of B. anthracis is mediated through a toxemia. Antibiotics target the vegetative B. anthracis bacteria but antitoxins are necessary to neutralize the effects of the toxins and ensure a more successful therapeutic outcome. DHHS is seeking to be advised of the availability of commercial products, or products in advanced development, for immunotherapeutic or immunoprophylactic antitoxin treatments, or small molecular entity treatments (such as, but not limited to, mutant toxins, therapeutic proteins, enzymes, lysins, and protease inhibitors) for anthrax toxemia. Specifically these may include monoclonal and polyclonal antibody toxin inhibitors and inhibitors of intracellular anthrax toxin function, as well as inhibitors of the effects of toxins. Data obtained from this RFI will be used by DHHS in making recommendations and decisions on the development of an appropriate procurement strategy to meet the Nation’s bioterrorism defense needs. Interested organizations that have candidate products are invited to submit a capability statement to the DHHS. Submitted information should include: a) a description of the product including relevant chemical, physical chemical or immunological characteristics; b) a description of the mechanism of action of the product; c) a description of the proposed formulation, dosage and route of administration; d) a statement of the proposed indications for use (e.g. pre or post exposure prophylaxis or treatment); e) a statement of the proposed production process and the current state of validation or GMP compliance; f) an estimate of production capacity and timelines, and estimated cost; g) a product development plan for GMP production, animal and human studies; and h) the overall stage of product development including the current status of preclinical and clinical safety and efficacy studies. All information submitted to DHHS will be kept confidential as allowed by relevant federal law, including the Freedom of Information Act (5 USC 552) and the Trade Secrets Act (18 USC 1905). Information must be submitted by May 1, 2004. Responses should be limited to 25 pages and are preferred in electronic format and can be e-mailed to the attention of the technical contact person: Marissa A. Miller, DVM, MPH, ORDC, Phone 202/690-6013, email
[email protected] Please ensure that at least TWO (2) COPIES of all responses are submitted: one to the technical contact person, Marissa A. Miller, and one to the primary contracting point of contact, Vivian Hubbs.