Notice of Intent to Extend Contract #200-2004-09985 for One (1) Year

THIS NOTICE OF INTENT IS NOT REQUEST FOR PROPOSAL. The Center for Disease Control and Prevention (CDC), National Center for Environmental Health, Division of Laboratory Sciences (DLS) intends to modify an existing contract number 200-2004-09985 by adding twelve (12) additional months to this cost-plus-fixed-fee contract in accordance with FAR Part 15 - Contracting by Negotiation, to University of Missouri Columbia, 310 Jesse Hall, Columbia, MO 65211. University of Missouri Columbia is the only vendor to establish and maintain a GHB standardization program following the American Association of Clinical Chemistry (AACC) Standards Committee's protocol. CDC anticipates soliciting and negotiating with only one source under the statutory authority 10 U.S.C. 2304(c)(1) permitting other than full and open competition in accordance with Federal Acquisition Regulation (FAR) Part 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements. The purpose of this acquisition is to (1) establish and maintain the Diabetes Control and Complications Trial (DCCT) primary reference method, (2) establish a network of reference laboratories, all of which maintain reference methods or precise methods traceable to the reference method, (3) monitor Network Laboratories monthly to meet monitoring criteria, (4) Through the Network, to interact with manufacturers of GHB methods, providing assistance in standardizing their methods and then providing comparison data for certification of traceability to the DCCT, (5) the effort shall provide assessment of effectiveness of the program through evaluation of independent Proficiency Testing data from College of American Pathologists (CAP). (6) To provide data and reference materials to assist CDC in the development of definitive reference method. (7) The Contractor shall establish and maintain a C-peptide standardization program for select laboratories following guidelines. The scope of work involves furnishing all the necessary labor, materials, facilities, and equipment necessary to establish and maintain a GHB standardization program following the American Association of Clinical Chemistry (AACC) Standards Committee's protocol. The program shall establish and monitor a voluntary network of reference laboratories for GHB testing, which, in turn, interact with manufacturers of GHB methods to (1) assist in standardizing their methods; and (2) provide comparison data for certification of traceability to DCCT primary reference method. Two elements are key in the design of the program: (1) an Administrative Center to coordinate certification processes, analyze certification and monitoring data, and issue certificates of traceability; and (2) a Central Primary Reference Laboratory that analyzes GHB by high performance liquid chromatography (HPLC) using Bio-Rex 70 resin, sets the initial calibration based on the "set-point" used in the DCCT, and administers a monitoring program for all certified laboratories. CDC believes that University of Missouri Columbia is the only source available to provide this product that meets mission critical requirements. CDC posted a sources sought synopsis on April 10, 2007 identifying University of Missouri as the only known, responsible source capable of satisfying the requirement. The CDC responded to one inquiry to the April 10, 2007 synopsis, however, at that time no interested offeror successfully demonstrated a capability to meet the minimum requirements identified in the statement of work (copy attached). Accordingly, the CDC awarded 200-2004-09985 to University of Missouri dated September 01, 2004 for $1,692,305. Presently, the CDC requires additional services from University of Missouri (see attached modified Statement of Work) and thus intends to negotiate a bi-lateral modification to the contract with University of Missouri for the additional services and extend the period of from September 30, 2009 to September 30, 2010. THIS NOTICE OF INTENT IS NOT REQUEST FOR PROPOSAL. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. This procurement is not set-aside for small business. The NAICS Code for this requirement is 541380 -- Testing Laboratories. Interested parties who believe they possess the capability to satisfy this requirement should submit a capability statement demonstrating their ability to meet this requirement. All responses must be sent in writing to Mr. Michael E. Allen via email to MEAllen@cdc.gov including the reference number "200-2004-09985" in the subject line, no-later-than 2:30 PM, Eastern Standard Time, on July 17, 2009.