Radiopharmecutical Drug

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. This is a pre-solicitation non-competitive (Notice of Intent) synopsis to award a Contract or Purchase Order without providing for full or open competition (Including Brand Name). The Clinical Center, Office of Purchasing and Contracts intends to award a Contract or Purchase Order without providing for full and open competition (Including Brand Name) to Cardinal Health Beltsville Nuclear Pharmacy, 7051 Muirkirk Meadows Drive, Beltsville, MD 20705 for the acquisition of radiopharmaceutical (FDA approved radioactive drug) - F-18FDG (Fluorine-18 Fluorodeoxyglucose) with tungsten shielding under the authority of 41.U.S.C 253 (c) (1) as set forth in Federal Acquisition Regulations FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5 - Test Program for Certain Commercial Items; and FAR Part 12 - Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. The intended procurement is classified under North American Industry Classification System code 424210 with a business size standard of 500 employees. The resultant award shall include all applicable provisions in effect through the Federal Acquisition Circular (FAC 2005-73) effective April 29, 2014. This acquisition is conducted under the authority of Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. The Department of Nuclear Medicine (NMD) resides with in the Mark O. Hatfield Clinical Research Center, a state of the art, 250-bed biomedical research hospital located on the campus of National Institutes of Health in Bethesda, Maryland. The Department of Nuclear Medicine Pharmacy Department requires the purchase of radiopharmaceutical (FDA approved radioactive drug) -F-18 FDG (Fluorine-18 Fluorodeoxyglucose)-with tungsten shielding and delivery. The government anticipates procuring 4000 units during the base period and 4000 units during each successive twelve (12) month option period. The total award shall not exceed 60 months. The radiopharmaceutical shall be used for clinical nuclear medicine procedures that are critical to the missions of the NIH Clinical Center. These radiopharmaceuticals are Food and Drug Administration (FDA) approved drugs for use in patients. They are also radioactive materials that are regulated by the United States Nuclear Regulatory Commission (US NRC) through the NIH radioactive material license (RAM) administered by the NIH Radiation Safety Office (RSO). Only RSO certified Nuclear Medicine personnel can order these radiopharmaceuticals directly for patient use. Each radiopharmaceutical must be properly compounded, dispensed, calibrated and delivered for a specific patient at a specific time on a specific date. F-18 FDG is not only a drug but, also radioactive material. In addition to meeting FDA Good Manufacturing Practice regulations, the manufacturer must also meet the US Nuclear Regulatory Commission requirements for safe handling of these radioactive drugs. Only Cardinal Health Nuclear Pharmacy offers a patented special shielding delivery system for each individual unit dose to minimize radiation exposure to the clinical staff and the public. The useful dose activity (radioactivity) of F-18 FDG decays away extremely fast (110 minutes) so it must be manufactured, compounded, dispensed, and delivered to the NIH Clinical Center at a specific required time and contains a specific required dose activity in order for the imaging/therapy study to be properly performed. For each specific patient study, the dose is unique and specific at a specific time. Since the radioactivity of this radiopharmaceutical decay away in minutes, F-18 FDG cannot be purchased in advance for storage. Each radioactive dose must be ordered on the day before the imaging study is scheduled. A specific patient dose (unit dose) of F-18 FDG is then delivered on the same day. Any delay in the ordering or shipping will jeopardize the life of the patient because the life-saving imaging/therapeutic study cannot be performed.Only Cardinal Health is able of provide this timely and dose specific service on demand on a daily basis to meet all of our requirements (quality, delivery, radiation safety). The purpose of this award is to procure F-18 FDG to assist in performing imaging and therapy procedures for all patients admitted to the NIH Clinical Center. These procedures are essential and necessary for the NIH clinical staff to save patients' lives and minimize their sufferings. These nuclear medicine procedures must use radiopharmaceuticals that are administered to the patients in order to produce the required images or therapeutic results. Radiopharmaceuticals are radioactive drugs that are regulated by both FDA and US NRC. Procurement and use of these radiopharmaceutical drugs must meet federal regulations from both of these agencies. Only qualified vendors that meet the FDA and US NRC regulations can provide these radiopharmaceuticals for compounding and dispensing at NIH Nuclear Pharmacy to NIH Clinical Center patients. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research. This is a notice of intent to award a sole source contract. All information submitted in response to this announcement is voluntary. The Government will not pay for any cost incurred in the preparation or submission of industry responses. Solicitations are not available at this time, and as such any requests for solicitations will not receive a response. This synopsis is not a request for proposals. However, interested parties may identify their interest and capability to satisfy the Government's requirement by submitting their capability statement with sufficient technical information documenting the products capabilities for evaluation. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement. Any information received will be considered for the purpose of conducting a competitive procurement. If not responses are received within ten calendar days after this notice is published, the National Institutes of Health will pursue a sole source contract with Cardinal Health. The Government shall consider all responses received prior to the closing date of this announcement. All responses must be considered no later than May 26, 2014 at 9:00AM, Eastern Standard Time. Please email Diania Robinson, Contract Specialist, at dmrobinson1@cc.nih.gov any technical questions or written responses pertaining to this notice. No phone calls will be accepted.