MODIFICATION
65 -- Anthrax Therapeutics
- Notice Date
- 4/5/2005
- Notice Type
- Modification
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Office of Public Health Emergency Preparedness, Office of Research and Development Coordination 200 Independence Avenue, SW Room 636G, Washington, DC, 20201
- ZIP Code
- 20201
- Solicitation Number
- Reference-Number-RFI-ORDC-05-04
- Response Due
- 5/10/2005
- Archive Date
- 5/25/2005
- Description
- ***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 Public Health Emergency Preparedness (OPHEP). 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 OPHEP 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. ***DESCRIPTION*** This is a Request for Information (RFI) only. It is not a request for proposals 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 threats 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 therapeutic treatments, directed at anthrax toxemia. These products may include immunotherapeutics or small molecular entity treatments. Data obtained from this RFI will inform DHHS?s next round of procurements for anthrax therapeutics. Interested organizations that have candidate products are invited to submit a capability statement to the DHHS. New respondents should submit the following information about their product: 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 indication 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; and i) timeline for submitting IND package to FDA. Those who have responded previously need only supply updates. All information submitted to DHHS will be kept confidential as allowed by relevant federal law. Information must be submitted by May 10, 2005. Responses should be limited to 25 pages and are preferred in electronic format and should be e-mailed to the attention of Darrick A. Early, phone 202-401-3693, email darrick.early@hhs.gov. Under provisions laid out in the Project BioShield Act of 2004, future competition may be limited to sources responding to this request for information (Sec. 319F-2 (c)(7) (C)(vii) of the Public Health Service Act, 42 U.S.C. 274d-6b).
- Record
- SN00781943-W 20050407/050405211920 (fbodaily.com)
- Source
-
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