Carbon-11 Methyl Iodide Synthesis System

Competitive Combined Synopsis/Solicitation HHS-NIH-NIDA-SSSA-CSS-2017-702 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. The solicitation number is HHS-NIH-NIDA-SSSA-SBSS-2017-702 and the solicitation is issued as a request for quotation (RFQ). ACQUISITION AUTHORITY 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 solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-94/95, dated January 19, 2017. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 334516 Analytical Laboratory Instrument Manufacturing and the small business size standard 1000 employees. DESCRIPTION OF REQUIREMENT Background The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The National Institute of Mental Health (NIMH), Molecular Imaging Branch (MIB) requires one Carbon-11 Methyl Iodide (MeI) Synthesis System for the purpose of producing [11C]MeI for radiolabeling of PET radiopharmaceuticals and supporting research and development work. NIMH currently has an existing system (MeI MicroLab) manufactured by GE that has been in use for fifteen years and has been discontinued over five years ago, so support and replacement parts are no longer available. The MeI synthesis system is critical to our primary mission of developing and investigating novel PET radioligands, from the early research stage to developing processes for producing these radioligands for clinical studies in human subjects. The existing system is used nearly every day, often multiple times per day, for a wide variety of project applications, so a failure of this system would have an extremely detrimental effect on our research. Purpose and Objective: The purpose of requirement is to procure a Carbon-11 Methyl Iodide Synthesis System (brand name or equal). Feature Requirements: Qty. 1 1. S9150JT - TRACERlab FX2 MeI system that includes all of the following parts: a. TRACERlab FX2 MeI synthesis module b. Control unit c. Control and supervision computers 2. P5450DD - 2 Day Onsite Application Training 3. Salient characteristics a. The synthesis system shall have the capability to trap either C-11 carbon dioxide or C-11 methane b. The system shall have the integrated capability to convert either starting material to either C-11 methyl iodide or C-11 methyl triflate c. The system shall reliably convert C-11 carbon dioxide to C-11 methyl iodide in greater than 50% decay-corrected yield d. The system shall be fully sealed against room air e. The system shall have a physical size footprint equal to or smaller than 12" W x 15" D f. Delivery and Installation shall be performed by the offeror. Upon delivery the vendor shall install the equipment and perform an equipment function test in the presence of a NIMH radiochemist to ensure the equipment is fully functional. g. The offeror shall provide equipment training for two days, including software operation, to NIMH radiochemists. h. Systems shall be covered under a 1-year warranty to include service and replacement parts. Period of Performance 30 days following placement of purchase request Place of Performance 10 Center Drive Bldg. 10 Rm. B3C342 9000 Rockville Pike Bethesda, MD 20892 Contract Type The Government intends to issue a firm fixed price commercial items purchase order for this requirement. Invoicing shall be on a NET30 basis and payment shall be made via Electronic Funds Transfer (EFT). There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. APPLICABLE CLAUSES AND PROVISIONS The following FAR clauses and provisions shall apply to this solicitation: 1. All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (JAN 2017), applies to this acquisition. 3. FAR clause 52.212-2, Evaluation - Commercial Items (October 2014) applies to this acquisition. 4. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (JAN 2017), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 5. FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (JAN 2017) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (JAN 2017) apply to this acquisition. 6. 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Jan 2017) must be attached or the specific clauses listed in the CSS. Please see attached clause with fill-ins completed. RESPONSE FORMAT 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. Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria and a price proposal. Respondents that believe that they are manufacturers or authorized resellers of the BRAND-NAME product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order.