Notice of Intent

On August 13, 2004 The New Mexico VA Health Care System (NMVAHCS) VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (VACSPCRPCC) intends to negotiate with Medtronic, Inc., 800 53rd Avenue NE, Minneapolis, MN 55421-1200 for supplies required to complete an on going research project. Medtronic is the sole manufacturer with an FDA approved product for application in fully implantable, chronic, brain stimulation. This will be a firm fixed price Indefinite-Quantity Contract for additional quantities of FDA approved deep brain stimulator systems (DBS) consisting of quadripolar Kinetra Neuro-Stimulator Minimum quantity 15, with a patient programmer minimum quantity 15, with lead kits minimum quantity 30, and in-line extensions minimum quantity 30, (Maximums not to exceed 20% of each of these items). This system provides bilateral, continuous electrical stimulation to the one hemisphere of the brain to manage the symptoms of Parkinson's Disease for CSP #468. This trial is being conducted under Investigational Device Exemption (#G010287), which requires that only these devices from Medtronic, Inc. be used in the trial. No substitutions are allowed in this study. This research study was originally placed under station level contract V501P-2660 with the NMVAHCS in Albuquerque, New Mexico on September 28, 2001. On April 29, 2004 the Food and Drug Administration (FDA) approved an additional year follow-up for those patients who have DBS surgery as of October 31, 2004. This is why the additional quantities are required. The additional quantities requested exceed the quantities mentioned in the original contract. When the FDA approved an additional year in the study additional quantities were required. This request is a special competency that must meet the special needs of the research criteria. This request is abiding by guidelines contained in The Federal Acquisition Regulation (FAR) Chapter 35 and also references the following authorities: FAR 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. (a) Authority. (1) Citations: 10 U.S.C. 2304(c)(1) or 41 U.S.C. 253(c)(1), and FAR 6.302-3 -- Industrial Mobilization; Engineering, Developmental, or Research Capability; or Expert Services. (a) Authority. (1) Citations: 10 U.S.C. 2304(c)(3) or 41 U.S.C. 253(c)(3). The contracting officer for this request is Cesar Fausto , contact@example.gov and can be reached at +1 (555) 000-0000. The technical expert for this research project is William Gagne +1 (555) 000-0000. NAICS Code is 339113. The estimated value of this award is between $250,000.00 - $500,000.00.