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68 -- Therapeutics Applicable for the Treatment of Neutropenia Resulting from Exposure to Ionizing Radiation

Solicitation Number: DHHS-SOURCES-SOUGHT-ARS-MAY-2007
Agency: Department of Health and Human Services
Office: Office of the Secretary
Location: Acquisitions Management, Contracts, & Grants (AMCG)
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DHHS-SOURCES-SOUGHT-ARS-MAY-2007
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Sources Sought
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Added: May 30, 2007 Modified: May 31, 2007Track Changes
THE PURPOSE OF THIS AMENDMENT IS TO DELETE IN ITS ENTIRETY, THE PREVIOUS SOURCES SOUGHT NOTICE AND REPLACE IT WITH THE FOLLOWING:

THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL AND DOES NOT CONSTITUTE A COMMITMENT BY THE GOVERNMENT. The Government is currently conducting market research in accordance with Federal Acquisition Regulation, Part 10 to identify potential sources to provide the requirement and gather information on current capabilities within the market. All information submitted in response to this Sources Sought Notice (SSN) is voluntary and the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. Proprietary information submitted should be marked appropriately and will be controlled and secured. All submitted information shall remain with the U.S. Government and will not be returned.



The Department of Health & Human Services (HHS) anticipates pursuing the initial acquisition of one hundred thousand (100,000) treatment courses of a medical countermeasure for neutropenia arising as a consequence of acute radiation exposure (acute radiation syndrome, ARS). It is anticipated the product will be licensed/approved for ARS use by the U.S. Food and Drug Administration (FDA) and will be stable for at least 24 months. There will be options for up to an additional one hundred thousand (100,000) treatment courses to meet the USG requirement of at least 200,000 treatment courses. Potential respondents to this Sources Sought Notice (SSN) shall meet the following specific criteria:



1. An active FDA Investigational New Drug (IND) application, for any indication, filed and not currently on clinical hold, for the suggested product. Inclusion of the products Phase 1 and 2 clinical safety data, if completed, is desirable; this may represent safety data from a product already licensed for another indication.



2. The company shall demonstrate validated bulk drug substance (BDS) production for the suggested product and demonstrate manufacturing capability at the proposed commercial scale.



3. The respondent shall provide efficacy data for the product in appropriate animal models, with the goal of increased survival and improvement of peripheral circulating neutrophil counts, following administration of the product no earlier than 24 hours after whole body irradiation challenges in models sufficient to demonstrate lethality. Data sufficient to demonstrate a radiation dose modification factor is desirable.



It is anticipated that a Request for Proposal (RFP) will be announced in August 2007, with proposals due in November 2007. At that time, the offeror(s) shall have integrated into product development plans FDAs current thinking describing the minimum product information and data that shall be submitted to the FDA for review in order to potentially consider use of the product to treat ARS-induced neutropenia in a declared emergency under Emergency Use Authorization (EUA).



Respondents to this SSN may identify their interest by submitting a capability statement including an anticipated product delivery schedule and contact information for the primary contact at the organization (name, email, address, and telephone number) handling this SSN in the event that HHS has additional questions or requires clarification of the submitted information. Responses are limited to 10 pages. Data sets (e.g., tables, charts, graphs) and documents that are pertinent to the response can be submitted as appendices to the primary submission. Potential respondents are also requested to include whether or not they are a large or small business. All respondents and comments to this announcement shall reference DHHS-Sources Sought-ARS-May 2007 and be submitted to Linda Luczak, Contracting Officer, at Linda.Luczak@hhs.gov by COB on June 29, 2007.

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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
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Manufacturer's facility
20201
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Linda Luczak, Contracting Officer, Phone 202-260-0271, Fax 202-205-4520, Email linda.luczak@hhs.gov