Nitric Oxide Delivery System

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION: SOLE SOURCE ACQUISITION OF NITRIC OXIDE DELIVERY SYSTEM 1. Contracting Organization: The contracting organization responsible for this action is the 60TH Contracting Squadron, Travis Air Force Base, and California. 2. Description of Action: This action will be to award a purchase order for Nitric Oxide delivery systems/service used for direct care of critically ill patients. 3. Description of Services: The purpose of this requirement is to provide Nitric Oxide for inhalation portable cylinders delivery system. Nitric Oxide would be used to wean patients off by-pass, as a diagnostic procedure during a right heart catheterization and lastly it would also be used for Intensive Care patients to treat Hypoxic Respiratory failure and or Pulmonary Hypertension. David Grant Medical Center must have the nitric oxide available at all times to provide for patient needs. 4. Authority: The statutory authority permitting the sole sourcing of services is Far 6.302-1, 10 USC 2304 ( c ) (1), "Only one responsible source and no other supplies or services will satisfy agency requirements". 5. Applicability of Authority: The Nitric Oxide delivery system is used for treating Hypoxic Respiratory Failure (HRF) in patients. HRF means that the patient isn't getting enough oxygen into his or her blood. Patients with this form of respiratory failure are unable to breathe on their own and have high blood pressure in the blood vessels of lungs, which is known as pulmonary hypertension. This is the only known product used for treatment which is Food and Drug Administration (FDA) approved for use on near-term infant and newborns. This is the only known FDA approved Nitric Oxide delivery system available in our area. Without this product/service critically ill patients would and can potentially lose their lives. 6. Efforts to Obtain Competition: In accordance with FAR 6.302-1(b)(2), the distributor is the only authorized source to provide the Nitric Oxide delivery system. The Government will continue to conduct market research to determine whether or not other FDA approved drugs become available in the future. 7. Fair and Reasonable: The Contracting Officer will determine the price fair and reasonable with comparison to previous purchases made by the Department of Defense and the United States Air Force specifically. 8. Market Survey: The Food and Drug Administration (FDA) indicates on its website that INOMAX is the only FDA approved inhaled medication for patient use, exclusively for near-term and newborns. 9. Other Facts: 10. Interested Sources: INO Therapeutics, LLC 11. Further Competition: We will re-evaluate the competition in the next few years. Most FDA submissions are cleared within 6 months. We feel that 2 years will allow other companies to develop and will enable stronger competition. 12. Technical Requirements / Personnel Certification: As evidenced by their signatures on the Coordination and Approval Document, the technical and/or requirements personnel have certified that any supporting data contained herein, which is their responsibility, is both accurate and complete (FAR 6.303-2(c)). We hereby certify that the technical requirements and certifications are accurate. 13. Contracting Officers Certification: The contracting officer's signature on the Coordination and Approval Document evidences that he/she has determined this document to be both accurate and complete to the best of his/her knowledge and belief (FAR 6.303-2(b)(12)).