Services to study if evidence that beet root juice supplementation can improve nitric oxide delivery into the human eye

INTRODUCTION 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 National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to MEDSTAR RESEARCH INSTITUTE INC for services to study if evidence that beet root juice supplementation can improve nitric oxide delivery into the human eye. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 with a Size Standard of $16.50. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2020-07 effective August 31, 2020. This acquisition is conducted under the procedures as prescribed in FAR subpart 13'Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of the 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. BACKGROUND The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports research on many of the most serious diseases affecting public health. The Institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines. The Institute's Division of Intramural Research encompasses the broad spectrum of metabolic diseases such as diabetes, obesity, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive and liver diseases, nutrition, urology and renal disease, and hematology. Basic research studies include biochemistry, biophysics, nutrition, pathology, histochemistry, bioorganic chemistry, physical chemistry, chemical and molecular biology, and pharmacology. NIDDK extramural research is organized into 4 divisions: Diabetes, Endocrinology, and Metabolic Diseases; Digestive Diseases and Nutrition; Kidney, Urologic, and Hematologic Diseases; and Extramural Activities. The Institute supports basic and clinical research through investigator-initiated grants, program project and center grants, and career development and training awards. The Institute also supports research and development projects and large-scale clinical trials through contracts. ? PURPOSE AND OBJECTIVES Glaucoma is one of the leading causes of blindness in world. Decreased outflow of aqueous humor (liquid filling the eyeball, that is continuously excreting inside of the eye) is one of the main causes of glaucoma, leading to increased intraocular pressure, leading to possible optical nerve damage and loss of the sight. Eye drops containing prostaglandins (hormone-like substances), are one of the most common treatments of this disease. Recently, FDA approved a new compound from this group for glaucoma treatment, latanoprosten bunod. In this compound, nitric oxide (NO), the most potent vasodilator and relaxant of smooth muscle, likely acts through relaxation of trabecular meshwork and Schlemm canal, allowing the increased outflow of aqueous humor out of the eye and decrease or normalization of intraocular (eye) pressure. Nitric oxide in its pure form is a short-lived radical (generally half-life is less than a minute), so efforts had been concentrated to the use of its precursor or storage molecules, nitrite and nitrate, respectively. Recently we showed presence of these molecules in eye and also confirmed that eye tissue is able to convert them into nitric oxide. The proposed project is a further development of this hypothesis. Independently, and not as an agent of the Government, the contractor shall provide equipment and services to upgrade to the current 500, 800 and 900 MHz NMR spectrometers for the NIDDK Laboratory of Chemical Physics and Laboratory of Bioorganic Chemistry. This requirement is for an organization or institution to provide the NIDDK with services to investigate if nitrate dietary supplementation in form of beet root juice influences intraocular pressure in swine model and what is the mechanism of this action spectrometers. The purchase of these services is necessary to maintain the high quality of our research. Specifically, the NIDDK requires the following: SALIENT / REQUIRED FEATURES AND SPECIFICATIONS: - Physiological measurements and samples needed to be done and collected at precise time points after the dietary intervention. - Specific handling procedures for samples (such as addition of preserving solution, as an example) in order to assure the highest quality of data. - Samples will be submerged into nitrite preserving solution after dissection for measuring nitrate and nitrite and also separate samples will be collected without preserving solution for Western blotting and nitrate reductase activity measurements. - MedStar facilities must be in proximity (within 40mi) to NIH Bethesda Headquarters. - MedStar personnel must be well trained to handle large animals and familiar with procedures we require for this project in accordance with this SOW. - MedStar personnel must have extensive experience in order to assist in the accomplishment our goal; test the hypothesis if nitrate dietary intervention is a viable way to develop a support therapy in glaucoma treatment. Task Area 1 - Animals Purchased by MedStar and housed at MedStar animal facility according to a previously agreed timeline with NIH investigators. Task Area 2 - Samples - After dietary treatment, pigs will be anesthetized either 3 or 24 hours after receiving the treatment. Once anesthetized, blood pressure and IOP will be measured in all groups, eye surface swabbed for sample of microbiome, followed by eye lavage with saline collected from both eyes. Samples of microbiome will be collected also from mouth, nose and gut (anal swab). Blood samples, both arterial and venous, will also be collected. Additionally, while under deep anesthesia 2-3 units of blood will be removed before animal is euthanized. Once euthanized, body with be perfused with heparinized saline to eliminate as much blood as possible from all tissues. Tissue samples will immediately be taken from tissues listed below, eyes and eye muscles will be dissected, as well as samples collected from following tissues/organs for detailed comparison: lacrimal and salivary glands, skeletal muscle, heart, liver, brain, vena cava, aorta, bladder, urine. Eyes will be dissected into eye parts immediately after collection. All samples will be frozen on dry ice shortly after collection. - Repeated nitrate bolus arm will receive their dietary treatment in the mornings for 5 consecutive day. In the termination day, morning bolus will be distributed, and animals will be anesthetized 3 hours after its ingestion. The same process as for single bolus groups will be followed. All samples will be collected into separate tubes with clear statement what the sample is, from which pig it is and when it was collected. Task Area 3 - Delivery - Freshly collected samples will be picked up and delivered to NIH by designated NIH investigators as needed. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION 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. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined MEDSTAR RESEARCH INSTITUTE INC to be the only reasonably available source to provide the services to study if evidence that beet root juice supplementation can improve nitric oxide delivery into the human eye the NIDDK requires. MEDSTAR RESEARCH INSTITUTE INC provided similar tissues as a research gift and analysis of these led to a research paper currently submitted into a peer-reviewed scientific journal. Results obtained from any other facilities cannot be compared to previous data because of the different animal housing and care protocol. PERIOD OF PERFORMANCE 9/25/2020 - 3/24/2021 Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 10 Center Drive Bethesda MD 20814 CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. - All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Tuesday, September 15, 2020 to the Contract Specialist, Amber Harris, at contact@example.gov . Assessment of Capability Lowest Price Technically Acceptable