SOLICITATION NOTICE
66 -- Dual-Channel non-invasive tissue oximeter - Attachment A
- Notice Date
- 9/12/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-2016-PSOL-759
- Archive Date
- 10/4/2016
- Point of Contact
- Andrea McGee, Phone: 3014358781
- E-Mail Address
-
amcgee@nida.nih.gov
(amcgee@nida.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Additional Specs Dual-Channel non-invasive tissue oximeter HHS-NIH-NIDA-SSSA-2016-PSOL-759 INTRODUCTION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12--Acquisition of Commercial Items. The solicitation number is HHS-NIH-NIDA-SSSA-2016-PSOL-759 and the solicitation is issued as a PRE-SOLICITATION, NOTICE OF INTENT, to award a contract on a noncompetitive basis to I.S.S. (USA) Inc, 1602 Newton Drive, Champaign, IL 61822. ACQUISITION AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13--Simplified Acquisition Procedures and Subpart 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements, 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 non-competitive determination is based upon the market research conducted as prescribed in FAR Part 10--Market Research, specifically the results of market research concluded no other source of supply has the ability to provide the Dual-Channel non-invasive tissue oximeter due to the importance of consistency of the results and data, as well as the protocols and procedures that have been developed for certain particular on-going projects that this requirement would support; there are no other sources besides the proposed Contractor, who can provide the requested systems. These systems are currently in use by NINDS and to maintain consistency and continuity of science, the same exact systems must be procured as they will support the same projects. CONTRACT TYPE The Government intends to award a firm fixed price purchase order for this requirement. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-89 dated August 15, 2016. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The associated NAICS code for this requirement is 334516, with a size standard 1000 Employees. BACKGROUND The research program of the Neuroimmunological Diseases Unit of the NINDS focuses on precision medicine care of patients with neuroimmunological diseases, especially multiple sclerosis (MS). Evidence of brain hypoxia has been seen in pathology material of some, but not all patients with MS. It is believed that brain hypoxia in MS is driven by two mechanisms: mitochondrial dysfunction and tissue hypoperfusion. However, thus far this type of subclinical brain hypoxia could not be reliably determined in living human subjects (e.g. HIF-1b, a marker used on post-mortem pathology studies is not detectable in human cerebrospinal fluid [CSF]). Neuroimmunological Diseases Unit has several ongoing clinical protocols (09-N-0197, 13-N-0088 and 09-N- 0032) where identification of patients with brain cortical microvascular tissue hypoxia is desired research/clinical goal. Using frequency-domain near-infrared spectroscopy, researchers recently confirmed reduced cortical microvascular oxygenation in MS in a blinded, case-controlled study1. Our goal is to use this technology to 1. Independently validate the observation of decreased cortical microvascular oxygenation in MS, 2. Evaluate within the context of currently ongoing open-label clinical trial of idebenone (protocol 13-N-0088), a compound which tested for its ability to enhance mitochondrial function in MS, whether idebenone enhances cortical microvascular tissue oxygenation and whether this effect correlates with the efficacy on clinical biomarkers; and finally 3. Whether subgroup of MS patients with reduced cortical microvascular tissue oxygenation differ in other aspects of disease phenotype from those patients who have brain tissue oxygenation within physiological limits. We expect that this methodology may pre-select patients who may uniquely benefit from idebenone or other tissue-oxygenation-promoting therapeutic strategies. There is currently only a single company producing frequency-domain near infrared oximeter: OxiplexTS from ISS medical. Other companies (Artinis, Vioptix, Hutchinson, Covidien) produce continuous wave near-infrared oximeters, which do not measure optical properties of the tissue in individual patients, but instead make assumptions of the optical properties of tissue based on cohort averages. Therefore, this methodology disregards individualized aspects of tissue properties and as such it introduces non-biological noise to the measurement. This technology is therefore not suitable for precision-medicine type applications. PROJECT REQUIREMENTS The following on-going projects utilizes these systems and require the same systems to be used in order to ensure the continuity of science: Specifically the Contractor shall provide a Dual-Channel non-invasive tissue oximeter, with, but not limited to, the following specifications (see Attachment A): 0101 Dual Channel OxiplexTS 0220.2 Adult Size Lowe profile flexible sensors 0460 Auxiliary Input Interface System 0461 Auxiliary Output System 0722.a 2.26 GHz Portable Personal Computer Place of Performance 9000 Rockville Pike 10 Center Drive Bethesda, MD 20892 Anticipated Period of Performance 16 weeks ARO The subject matter contractor is the only source of supply or service who can provide these systems and its associated specifications due to the importance of maintaining consistency of the results and data for the aforementioned on-going projects that already currently have in use these systems. This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. 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. Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. The following FAR provisions shall apply to this solicitation: 52.212-1, Instructions to Offerors--Commercial Items, 52.212-2, Evaluation--Commercial Items. Evaluation factors that will be used to evaluate the offer most advantageous to the Government, price and other factors considered, include ability to meet the technical requirements stated in this pre-solicitation and on basis of best value to the government. Offerors must include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer. The Clause at 52.212-4, Contract Terms and Conditions Commercial Items, applies to this acquisition and the Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items applies to this acquisition. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. All responses must be received by September 19, 2016 at 12:00 pm, Eastern Standard Time (EST) and must reference solicitation number HHS-NIH-NIDA-SSSA-PSOL-2016-759. Responses may be submitted electronically to amcgee@mail.nih.gov and to NIDASSSAPurchaseRequ@mail.nih.gov or by U.S. mail to the National Institute of Drug Abuse (NIDA), Station Support / Simplified Acquisition Branch (SS/SA), 31 Center Drive, Building 31, Room 1B59, Bethesda, Maryland 20892-2080, Attention: Andrea McGee. Fax responses will be accepted at (301) 480-1358. For information regarding this solicitation, contact Andrea McGee by email at amcgee@mail.nih.gov or by phone at (301) 480-2449.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-2016-PSOL-759/listing.html)
- Place of Performance
- Address: 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04267967-W 20160914/160912235921-23bef8259ec5904360c0bc18b92ccdc2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |