Notice Number: NOT-AI-05-007
Release Date: October 29, 2004
Response Due Date: December 20, 2004
Department of Health and Human Services,
Office of the Secretary,
Office of Public Health Emergency Preparedness,
Office of Research and Development Coordination
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. The Acute Radiation Syndrome (ARS), also referred to as radiation sickness, is an acute illness caused by irradiation of the entire or a significant portion of the body by a high dose of penetrating radiation in a relatively short time period (minutes). This exposure results in the depletion of hematopoetic stem cells and progenitors, resulting in severe neutropenia and thrombocytopenia. Severe neutropenia can significantly increase an individual's susceptibility to lethal infections, while thrombocytopenia increases the risk of hemorrhage. Currently there are no approved therapeutics to mitigate ARS. The Government has an interest in identifying sources of therapeutics likely to be effective in preventing or reducing the development of neutropenia and/or thrombocytopenia when administered at times after acute exposure to radiation. The Government is particularly interested in identifying therapeutics that are effective when given several hours to days after exposure. 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) 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. Information must be submitted by December 20, 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 Marissa.Miller@hhs.gov. 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, D. Andre Early.
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).
Point of Contact
Darrick Early, Contract Specialist,
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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