Synopsis: This is a Qualified/Capable Business Sources Sought Notice (SSN). This is NOT a solicitation for proposals, proposal abstracts, or quotations. This notice is published for market research purposes only. This notice is open to qualified business sources of all sizes. Information is sought regarding: (1) the availability and capability of all qualified business sources; (2) whether qualified business sources are small businesses, service-disabled, veteran-owned small businesses; (a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The NAICS Code for this proposed acquisition is 541711. Your responses to the information requested will assist the Government in determining the appropriate acquisition method for the development of medical countermeasures (MCMs). Background and Mission: The Transformational Medical Technologies (TMT) Project Office is seeking information related to the development of medical countermeasures (MCMs) using adaptable platform technologies for pre- and/or post-exposure prophylaxis and therapy of cases due to Emerging Infectious Diseases (EID), particularly pandemic influenza. The TMT mission is to better prepare and protect the warfighter and the nation from emerging, genetically engineered, and unknown biothreat agents. Purpose and Objectives: This proposed acquisition addresses development of novel MCMs for pandemic influenza indications discovered via an adaptable platform technology. Drugs or biologics that can be used as prophylaxis or treatment are included in this description. Excluded from this description are neuraminidase inhibitors, viral ion channel blockers (M2 proteins), and products intended solely for use prior to exposure. For this proposed acquisition, platform adaptability is the demonstrated ability of any technology or method that has been used to rapidly discover more than one antiviral MCM; traditional medicinal chemistry and Structure Activity Relationship are not considered adaptable platforms. The candidate MCM must have reached a stage of development in which an Investigative New Drug (IND) has been submitted to the FDA and is not on FDA Clinical Hold. The candidate IND must have already achieved a minimum Technical Readiness Level (TRL) 6b, as described in Memorandum, Department of the Army, SFAE-CBD, dated 17 December 2008, Subject: Integrated Medical Technology Readiness Levels. The scope of this proposed acquisition includes Phase 1 (post TRL 6b) through FDA approval or licensure. Candidate MCMs must show they are based on an adaptable platform and have data demonstrating post-exposure efficacy against one or more pathogens. Sources are encouraged to respond with state-of -the-art and innovative technological adaptable platform-based candidates. Definitions: Respondents to this SSN should define their platform technology and describe the characteristics and methods used therein. Requirements: Sources having the capability and/or concept to meet these requirements are invited to respond to this SSN. Responses should be limited to ten (10) pages for any given concept, not including the cover page, the cover letter and the table of contents. Any and all information submitted in response to this notice is strictly voluntary and in no way obligates the Government or otherwise to make a contract award. Submitted data and information will not be returned. Input on technical aspects of the responses may be solicited by JPEO-CBD (TMT) from non-government consultants/experts who are bound by appropriate non-disclosure requirements. For all responses, an additional, non proprietary cover page is also requested, identifying your company name, technical point of contact, and contact information. Respondents to this notice must provide, as part of their response, a statement regarding their capabilities. Respondents must include their DUNS number, organization name and address, point of contact, size and type of business. Submission Instructions: Respondents should provide responses: (1) using Microsoft Word or Adobe PDF (text searchable format) using single space, 12 point font and 8 x 11 size paper; (2) organizing material in such a manner that clearly identifies and addresses capability and concept statement; (3) including technical and administrative points of contact, with names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (4) not exceeding ten (10) single sided pages in total (not including cover page and cover letter) sent via email to:
[email protected] no later than Tuesday September 7, 2010 at 12:00 PM EST. Disclaimer and Important Notes: The Government will not pay for any information submitted in response hereto. This notice does not obligate the Government to issue a solicitation or to award a contract. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organizations qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, there may be a pre-solicitation synopsis and solicitation request published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation which may be published in the future. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Contracting Office Address: Defense Threat Reduction Agency Annex 8725 John J. Kingman Road , MSC 6201 Ft. Belvoir , Virginia 22060-6201 Point of Contact : Contracting Officer Email address:
[email protected] Place of Performance: TBD Complete View