Purchase of Automated Radiosynthesis Module for Fluorine-18

This is a Combined Synopsis/Solicitation Brand Name or Equal (COMPETITIVE) The National Institute of Mental Health (NIMH), Molecular Imaging Branch, PET Radiopharmaceutical Sciences Section, has the requirement to procure the following brand name item: General Electric Company, TRACElab, catalog #: S9150KF, TRACERLAB Fx2 N 115V, from: GE Healthcare, 3000 N. Grandview Blvd., Waukesha, WI 53188-1615, USA or EQUAL. 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; quotes are being requested and a written solicitation will not be issued. The combined synopsis/ solicitation number remains the same: HHS-NIH-NIDA-SSSA-2016-675. 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-Simplified Procedures 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 (FAC 20) 05-72, (January 2014) Simplified Procedures for a Commercial Item. The Government contemplates only one award of a Firm-Fixed Price contract. The Associated North America Industry Classification Code (NAICS) 334516 and the Business Size Standard is 1000. It has been determined there are no opportunities to acquire green products or services for this procurement. Background: The PET Radio-pharmaceutical Sciences Section (PRSS) of the Molecular Imaging Branch (MIB) of NIMH currently produces a variety of radiolabeled compounds for PET brain imaging of human subjects in ongoing NIH clinical trials, as well as for the supporting research and animal studies. The GE TracerLab FX-N Pro system is a widely used, highly efficient system which can be used for start-to-finish radiolabeling of compounds with [18F]F-, [18F]fluoromethyl bromide, and [18F]fluoroethyl bromide. NIMH currently have two GE TracerLab FX-N modules for fluorine-18 radiochemistry research, development and production of new radioligands for animal and human studies. The current systems are nearly 15 years old and now obsolete - some components are no longer available and the newer models have significant improvements over the in functionality. Project requirements: the contractor shall provide- A. Salient Purchase Description - Automated radiosynthesis module for fluorine-18 - The system must be a self-contained radiosynthesis module capable of reliable and reproducible nucleophilic substitution of radioligands with fluorine-18. - The system must possess the following features: 1) Two reaction chambers capable of heating to 200 - C and rapid cooling, and the ability to transfer directly between the two 2) An integrated vacuum pump and nitrogen regulator for controlled drying of target water 3) An integrated radio-HPLC system with, at minimum, an injection valve, UV detector, radioactivity detector, and fraction collection valve 4) A closed-tubing formulation system capable of solid-phase extraction of up to 100 mL of solvent and sterile filtration 5) A footprint of no larger than 20x20" - The system must, at minimum, be able to reproducibly dry up to 1.2 mL of cyclotron-produced fluorine-18, accurately control reactor temperatures from 25 - 200 - C, and perform HPLC chromatography and solid-phase extractions. - One complete system is required - Automated radiosynthesis module for fluorine-18 - GE TracerLab FX-N Pro - GE Healthcare - TracerLab FX-N Pro II. Delivery: Contractor(s) shall deliver the instrument within 60 days of receipt of award to: NIH/NIMH Bethesda, Maryland 20892. The Contractor that receives the award will be provided with the complete mailing address and point of contact. Upon delivery, the contractor must notify the NIMH Contracting Officer's Representative (COR) to schedule the delivery date and time. III. Installation: Installation will require that equipment is set up and all components work with existing equipment. IV. Payment: Payment shall be made after delivery, installation, and successful operation of equipment. Payment authorization requires submission and approval of invoice to the NIMH COR and NIH Commercial Accounts. BASIS FOR AWARD: Offerors must provide descriptive literature or other materials that demonstrate their offer meets the forgoing requirements. The contract will be awarded to the responsible offeror with the lowest price offer that fully meets the requirements of the solicitation. QUOTATIONS ARE DUE: All responses must be received by September 13, 2016 at 11:00 AM, EST. Please reference solicitation number HHS-NIH-NIDA-SSSA-2016-675 on all correspondence. NOTE: The vendor must submit a response/quote to this solicitation in order to be considered for an award. All questions, and quotes, must be received electronically (via email) to Gwennifer Epps, Contracts Specialist, eppsg@mail.nih.gov. in MS Word or Adobe Portable Document Format (PDF). No telephone calls or facsimiles will be accepted. NOTE: Respondents proposing on an equal product 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. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2006- 87-2, dated April 6, 2016. PROVISIONS AND CLAUSES: The following provisions and clauses will be incorporated by reference: 52.211-6 Brand Name or Equal (a) If an item in this solicitation is identified as quote mark brand name or equal, quote mark the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that quote mark equal quote mark products must meet are specified in the solicitation. (b) To be considered for award, offers of quote mark equal quote mark products; including quote mark equal quote mark products of the brand name manufacturer, must- (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; (2) Clearly identify the item by- (i) Brand name, if any; and (ii) Make or model number; (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification. (c) The Contracting Officer will evaluate quote mark equal quote mark products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. (d) Unless the offeror clearly indicates in its offer that the product being offered is an quote mark equal quote mark product, the offeror shall provide the brand name product referenced in the solicitation. (End of provision) 52.212-1 Instruction to Offerors Commercial Items 52.212-2, Evaluation Commercial Items: The purchase order will be awarded to the Lowest Price Technically Acceptable (LPTA). The award will be made on the basis of the lowest evaluated price of quotations meeting or exceeding the acceptability standards for the requirements/technical specifications stated above. The technical evaluation will be a determination based on information furnished by the vendor. The Government is not responsible for locating or securing any information which is not identified in the proposal. The Government reserves the right to make an award without discussions. 52.212-3 Offerors Representations and Certifications Commercial Items (November 2013) WITH DUNS NUMBER ADDENDUM (52.204-6 (July 2013): 52.212-4 Contract Terms and Conditions Commercial Items, applies to this acquisition. 52.212-5 Contract terms and Conditions Required to Implement Statutes or Executive Orders---Commercial Items (January 2014). The following additional FAR clauses cited in this clause are applicable: (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: 52.203-6, Restrictions on Subcontractor Sales to the Government, with Alternate I (41 U.S.C. 253g and 10 U.S .C. 2402) 52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards 52.209-6, Protecting the Government' Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment 52.222-3, Convict Labor 52.222-19 Child Labor Cooperation with Authorities and Remedies 52.222-21 Prohibition of Segregated Facilities 52.222-26 Equal Opportunity 52.222-35 Equal Opportunity for Veterans 52.222-36 Affirmative Action for Workers with Disabilities 52.222-40 Notification of Employee Rights Under the National Labor Relations Act 52.222-37 Employment Reports on Veterans 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving 52.225-1 Buy American Act - Supplies 52.225-13 Restrictions on Certain Foreign Purchase 52.232-33 Payment by Electronic Funds Transfer System for awards Management 52.246-2 Inspection of Supplies-Fixed Price No collect calls will be accepted. In order to receive an award, contractor must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representation and Certifications Applications (ORCA) through sam.gov.