Inactive

PRE-SOLICITATION NOTICE **NOTICE OF INTENT TO SOLE SOURCE NOI-NIAID-24-2231509 NAICS – 334516 This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious D... PRE-SOLICITATION NOTICE **NOTICE OF INTENT TO SOLE SOURCE NOI-NIAID-24-2231509 NAICS – 334516 This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Moor Instruments Inc to purchase upgrade/add-on equipment, a 4-Channel Laser Doppler Flowmetry System, for use with an existing Moor Instruments near-infrared spectroscopy (NIRS) system in use by the Laboratory of Malaria Research Vaccine Research (LMRV). The mission of the LMRV is to develop production processes for vaccine candidates as they pertain specifically to Malaria. Malaria is associated with disturbances in microvascular blood flow that lead to coma, lactic acidosis, and kidney injury. Some of the mechanisms of blood flow disturbance include adherence of infected red blood cells to the vascular endothelium, excessive clotting of blood in small vessels, and disruption of signaling by nitric oxide, which is an endogenous short-acting vasodilator. LMVR has identified that human vascular endothelial cells use hemoglobin to control the release of nitric oxide. They found that some of the genetic mutations in the alpha and beta globin genes that encode for hemoglobin are associated with differences in endothelial hemoglobin expression and differences in the extent of nitric oxide-dependent vasodilation. This raises the possibility that some of the hemoglobin variants that protect against severe malaria such as hemoglobin S (also known as sickle cell trait) or hemoglobin C, may confer protection by enhancing the release of nitric oxide from endothelial cells. The original studies were performed on human arteries that were surgically removed from patients and then studied under controlled laboratory conditions. To further elucidate how hemoglobin variants affect human arterial vasoreactivity, LMVR needs to perform non-invasive studies in people. To do this, the lab needs to acquire a laser Doppler flowmetry system that measures blood flow in small vessels of the skin. Then they can use this laser Doppler system to compare cutaneous blood flow in people with hemoglobin genetic variants against blood flow measured in people with normal hemoglobin genes. To fully characterize blood flow, researchers will measure blood flow at rest as well as during exposure to temperature changes, occlusion-reperfusion maneuvers, and drug treatments. Together, these studies will elucidate the impact of hemoglobin gene variants on human vasoregulation and may identify a new mechanism by which the gene mutations protect against severe malaria. This knowledge will help LMVR to design a new therapy that improves blood circulation during severe malaria. To characterize microcirculatory function in human patients with hemoglobin variants, LMVR will measure cutaneous (i.e., skin) blood flow using a high-powered multi-fiber laser Doppler flowmeter. Blood flow will be measured at baseline and after exposure to heat, which causes two phases of vasodilation, one neuronal and another based on endothelial nitric oxide release. This approach requires a skin heating unit that is integrated into the laser Doppler probe. Researchers will also measure cutaneous blood flow in response to an ischemia-reperfusion maneuver which also stimulates release of nitric oxide. This approach will be facilitated by use of an integrated cuff inflator which can inflate a pneumatic cuff on the upper arm to transiently stop blood flow to the lower arm. The lab will also monitor cutaneous blood flow before and after hand grip exercises, a stimulus that triggers vasoconstriction that is opposed by nitric oxide. Researchers will also monitor blood flow before and after exposure to cold temperature, another vasoconstrictive stimulus. Finally, LMVR will apply vasoconstricting and vasodilating drugs (e.g., phenylephrine and acetylcholine) and measure the cutaneous blood flow responses. This approach requires the use of iontophoretic drug delivery, a technique that employs a small electrical current to deliver the drug into the skin from the surface. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement. All required documents must be submitted via the NIAID electronic Simplified Acquisition Submission System (eSASS) website at https://esass.nih.gov by July 25, 2024 at 5:00 pm ET. All vendors must register in the eSASS system to submit their documentation. Instructions on how to register /submit documents are included on the website. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.