SOURCES SOUGHT
A -- Seeking Sources in the advanced development of Medical Radiation Countermeasures
- Notice Date
- 12/28/2005
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- W9113M-06-S-0002
- Response Due
- 1/31/2006
- Archive Date
- 4/1/2006
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought Notice. The purpose of this announcement is to identify companies that believe they have viable candidate drugs that can be expeditiously developed and will provide a safe and effective countermeasure against radiation injur y. The Department of Defense (DoD), through the Chemical Biological Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) Joint Product Management Office is seeking Prime Contractor(s) for the advanced development activities associated with prophylactic and/or therapeutic products to prevent/treat acute radiation syndrome. Specifically, it is anticipated that the products will mitigate the hematopoetic (especially neutropenia and/or thrombocytopenia) syndrome and/or gastrointestinal sy ndrome. A Prime Contractor will be responsible for conducting the advanced development activities and selecting and managing subcontractors capable of conducting various activities associated with drug development in manners that are consistent with event ual approval by the U.S. Food and Drug Administration (FDA). Depending on the technical maturity of the proposed technology, activities may include process development and related tasks, current Good Manufacturing Practices-compliant small-scale manufactu ring and testing of the product, Good Laboratory Practices-compliant acute toxicology testing in animals, filing of an Investigational New Drug application, conduct of Phase 1 clinical studies in accordance with FDA regulations and guidelines, follow-on c linical studies, and definitive animal studies (assumes use of the FDA animal rule ) and appropriate non-clinical studies leading to eventual FDA approval of the product. MITS anticipates that the Prime Contractor will file the New Drug Application and h old the license for the product. These prophylactic/therapeutic products are being developed in response to a requirement to mitigate the effectiveness of nuclear or radiological attacks against U.S. Forces. Prospective products should have initial in-viv o safety and efficacy data that clearly demonstrate the potential for further development into a FDA-approved drug. This is not a request for competitive proposals, but parties interested in responding must furnish in writing, a 1-2 page synopsis of their candidate and related data that clearly supports its prophylactic or therapeutic potential. Any information received in response to this Sources Sought Notice that is marked proprietary will be handled accordingly. This information may be submitted via m ail, e-mail, or fax. All responses are to be submitted by no later than January 31, 2006 by 4:00 pm EST in order to be accepted for review. All paperwork must be sent to U.S. Army Space and Missile Defense Command, ATTN: Shelley Marken, 64 Thomas Johnson Drive, Frederick, MD 21702, Fax (301)619-5069 or by e-mail to Shelley.marken@det.amedd.army.mil. The NAICS code is 541710. This notice should not be construed as a request for proposal or an obligation on the part of the U.S. Government and cannot be ac cepted by the Government to form a binding contract.
- Place of Performance
- Address: US Army Space and Missile Defense Command, Deputy Commander ATTN SMDC-CM-AP, P.O. Box 1500 Huntsville AL
- Zip Code: 35807-3801
- Country: US
- Zip Code: 35807-3801
- Record
- SN00959091-W 20051230/051228211936 (fbodaily.com)
- Source
-
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