66--Lateral Flow Immunoassays

This synopsis provides the opportunity to participate in a two-phased solicitation process for the acquisition of lateral flow Immunoassay (LFI) strips in support of the Department of Defense (DoD) Critical Reagents Program (CRP). The Government has decided to initiate a process following the principles of FAR 15.202--Advisory Multi-Step Process. Pursuant to FAR 15.202, a Product Demontration Model (PDM) is requested from prospective Respondents. Based on the information derived from the model submitted, Respondents will be advised on whether the company will be a viable competitor. All responses to this notice will be evaluated in accordance with the criteria referenced in this notice, and each Respondent will be advised in writing either that they will be invited to participate in the resultant RFP/acquisition or, based on the information submitted, that they are unlikely to be a viable competitor. Respondents not considered viable competitors will be informed of the general basis for that opinion. Notwithstanding the advice provided by the Government in response to the submitted PDM, a Respondent may elect to submit a proposal in response to the RFP or cease participation. Phase 1 of the selection process requires submission of Product Demonstration Models (PDMs). The Government will not pay for PDM development. The potential Respondents shall furnish all personnel, equipment, tools, materials, supervision, and all other items and services that are required to deliver PDMs for Government evaluation, except for the Government Furnished Material (GFM) listed in the PDM plan. PDM materials do not required Biosafety Level (BSL) 3 containment but it is recommended they are handled under BSL 2 conditions. The Government will document PDM performance in areas identified in the PDM Plan. Phase 1 participation requires Respondents to identify themselves through a formal request to participate and submit a signed Participation Agreement form which must be received by the Government by 17 July 2008. The PDM Plan and participation forms can be viewed, downloaded, and printed from the USASMDC website: http://www.smdc.army.mil/contracts/ontracts.html, under Solicitations. GFM will be shipped overnight to all eligible Respondents approximately four weeks post Pre-Solicitation release. The Government will consider PDM questions from Respondents beginning with the PDM Pre-Solicitation release date (3 July 2008) up to the date of GFM shipment (31 July 2008). Respondents will submit PDMs to a designated, third party Government-appointed Conformance Test Laboratory (CTL) such that PDMs are received by the CTL on the 60th calendar day post shipment of GFM. Each Respondent will be allowed to submit one set (n=300) of PDMs per antigen for testing and evaluation; no additional submissions will be accepted. The Government will notify Respondents in writing of PDM evaluation results approximately 90 days post receipt of PDM at the CTL. In Phase 2, the Government will issue a Request for Proposal(RFP)for the manufacture of LFI strips approximately one week after Respondents are informed of the Phase 1 evaluation results (on or about 9 January 2009). The prospective Contractor shall provide LFI strips for the detection of approximately 15-20 antigens and be responsible for shipping and delivery of LFI strips to a Government-designated location. The Government anticipates requiring manufacture of 1.7-6.6 million LFI strips per year for incorporation into multiple end item configurations. The will be a Best Value selection process. The Government will not issue a second Pre-Solicitation notice to announce posting of Phase 2 (RFP). Regardless of the Government's evaluation of the Respondent's PDMs in Phase 1, Offerors may submit formal proposals in response to the RFP. Offeror must have capability to receive GFM within five (5) business days after GFM shipment, the capacity to store specific GFM (i.e. antibody, antigen) at appropriate temperatures (-80 degrees and 2-8 degrees Celsius) and the capability to deliver LFI to a Government designated facility within five (5) business days from CRP request. The successful Offeror's facility and Key Personnel must be cleared for storage and use of classified information and materials. The LFI end product will be unclassified. The successful Offeror must have an existing Secret Level DoD Security Clearance or must be eligible to receive a DoD Secret Level Clearance that would be initiated at contract award in accordance with Defense Industrial Security Regulation, DOD 5220.22R-M. The successful Offeror must possess or be able to obtain Centers for Disease Control (CDC) and Prevention Office of Health and Safety Laboratory Select Agent Registration for toxins. Proposals will be due approximately 45 calendar days post RFP issuance. The contract type will be Indefinite Delivery, Indefinite Quantity, firm fixed price (with stepped quantities) with an initial ordering period of twelve months plus four additional one year optional ordering periods with an anticipated award date on or about September 2009. The North American Industrial Classification System (NAICS) code is 334519 with a size standard of 500 employees. In accordance with DFARS 252.204-7004, all interested contractors shall be registered in the Central Contractor Registration (CCR) database prior to contract award. CCR registration can be accomplished at the following website: http://www.ccr.gov. All interested parties can view download, and print a copy of the solicitation and any resulting amendments when released on or about January 2009 from the USASMDC website: http://www.smdc.army.mil/contracts/contracts.html, under Solicitations. No paper copies of the solicitation will be provided and no mailing list will be maintained because the acquisition will be posted on the above website. Questions or correspondence referencing solicitation W9113M-08-R-0010 should be directed to contact@example.gov