Automated radiosynthesis module for fluorine-18

HHS-NIH-NIDA-SSSA-CSS-2017-688 Title: Automated radiosynthesis module for fluorine-18 (i) 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 separate written solicitation will not be issued. (ii) The solicitation number is HHS-NIH-NIDA-SSSA-CSS-2017-688 and the solicitation is issued as a Request for Quotation (RFQ) on an unrestricted basis. A purchase order award is contemplated for this requirement. 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. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-94,2005-95 / 01-19-2017. (iv) The North American Industry Classification System (334510) code for this procurement is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing with associated small business size standard of 1,250 employees. (v) Background: The National Institute of Mental Health (NIMH), Molecular Imaging Branch (MIB) currently has two GE TracerLab FX N modules for fluorine-18 radiochemistry research, development and production of new radioligands for animal and human studies. One system was replaced with the newer model FX2 N in 2016; the other system is nearly 15 years old and now obsolete - some components are no longer available and the newer model has significant improvements over the current system in functionality. This purchase will replace the remaining obsolete Tracerlab system, which will allow MIB to continue producing current radioligands to meet its current demand without concern of downtime and cancellations due to equipment failure, and to expand the range of work which may be performed in the updated system. Purpose and Objective: The purpose of this purchase order is to provide MIB with one automated radiosynthesis module for fluorine-18 for the purpose of producing PET radiopharmaceuticals for use in imaging studies and for supporting research and development work. Project Requirements: Please see the attached Purchase Description for further details. Period of performance: 90 days after receipt of order. Contracting Officer's Representative: The Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract and will be specified at time of award. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Government may unilaterally change the COR designation at any time throughout the performance period of this contract. (vii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (viii) The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. The following is provided as an addendum to clause 52.212-2: The following evaluation factors are used when reviewing the technical proposals: - Lowest price technically acceptable (ix) The provision at FAR Clause 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition. (x) The provision at FAR Clause 52.212-4 Alternate I, Contract Terms and Conditions-Commercial Items, applies to this acquisition. (xi) The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items, applies to this acquisition. 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. Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. Responses to this solicitation must include clear and convincing evidence of the Offeror's capability of fulfilling the requirement as it relates to the government requirements stated in this solicitation. The Offeror's technical approach shall indicate compliance with the Scope of Work, and describe an essential understanding of the requirements involved in accomplishing the work. Offerors MUST include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer, OR provide a copy of the valid certifications registrations and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror's cover sheet. 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 responses must be received no later than the date and time specified in this announcement. Late responses will not be accepted. All responses must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-2017-688. Responses must be submitted electronically to zenab.chowdhry@nih.gov. Facsimile responses will not be accepted. For information regarding this solicitation, please contact Zenab Chowdhry by email at zenab.chowdhry@nih.gov or by phone at 301-827-6909.