SOLICITATION NOTICE
Q -- Advanced Therapeutics for Treating Neutropenia Resulting from Acute Exposure to Ionizing Radiation
- Notice Date
- 2/29/2008
- Notice Type
- Solicitation Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority 330 Independence Avenue, SW, Rm G640, Washington, DC, 20201, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- HHS-BARDA-08-10
- Archive Date
- 3/15/2008
- Point of Contact
- Jeannett Jackman, Contract Specialist, Phone 202-205-1625, Fax 202-205-0613, - Linda Luczak, Contracting Officer, Phone 202-260-0271, Fax 202-205-4520
- E-Mail Address
-
jeannett.jackman@hhs.gov, linda.luczak@hhs.gov
- Description
- THIS IS A FORMAL SYNOPSIS OF PROPOSED CONTRACT ACTION NOTICE IN ACCORDANCE WITH FAR 5.2. The Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) is seeking to acquire medical countermeasures (MCM) that will support an effective public health emergency response to a radiological or nuclear event. The United States Government (USG) contemplates a five year Firm Fixed Price single award contract for MCMs that can specifically treat the neutropenia component of Acute Radiation Syndrome. Neutropenia is defined as the depression of neutrophils which occurs as a component of the hematologic pathologies arising following sufficient exposure to ionizing radiation (h-ARS). It is the goal of the RFP to obtain advanced development products, i.e., at a development level, as classified by the Food and Drug Administration (FDA), which are in no less than Phase 2 of the Investigational New Drug (IND) stage as well as those products which already have approved therapeutic indications. Prior to the submission of the proposal, the offeror must have met with the appropriate review division at the FDA to consult on the appropriate path for approval of their respective therapeutic for use in pathologies known to be associated with, or as components of, Acute Radiation Syndrome (ARS). It is the goal of BARDA to place in the Strategic National Stockpile (SNS) a Final Drug Product (FDP) which may be used for therapy of neutropenia in human subjects associated with whole body acute exposure to ionizing radiation exceeding 2 Gy.
- Record
- SN01520604-W 20080302/080229223817 (fbodaily.com)
- Source
-
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