SOLICITATION NOTICE
66 -- Automated Radiosynthesis Module for Flourine-18
- Notice Date
- 8/13/2014
- Notice Type
- Presolicitation
- 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
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-NOI-14-588
- Archive Date
- 9/13/2014
- Point of Contact
- Megan Ault,
- E-Mail Address
-
megan.ault@nih.gov
(megan.ault@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This is a pre-solicitation non-competitive (notice of intent) synopsis to award a contract without providing for full or open competition (including brand-name). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institute on Drug Abuse (NIDA), Consolidated Station Support and Simplified Acquisitions (CSS/SA) Branch intends to negotiate and award a purchase order to General Electric Company, GE Healthcare Division for an automated radiosynthesis modulefor Flourine-18 without providing for full and open competition (including brand-name). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 334516 with a Size Standard of 500 Employees. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-72 dated January 30,2014. This acquisition is for a commercial item or service and is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures; FAR Subpart 13.5-Test Program for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items. This acquisition is expected to exceed the simplified acquisition threshold. STATUTORY AUTHORITY This acquisition is conducted under the authority of the authority of FAR Subpart 13.106-1. DESCRIPTION OF REQUIREMENT Purpose and Objectives The purpose of this requirement is acquisition of an automated radiosynthesis modulefor Flourine-18to be used by the National Institute of Mental Health (NIMH) PET Radiopharmaceutical Sciences Section (PRSS) Molecular Imaging Branch (MIB). This system will be used for production of radioligands for currently ongoing and future clinical studies. Period of Performance Delivery shall be approximately 60 days after receipt of award. A firm fixed price purchase order is contemplated. Project Description The system must be a self-contained radiosynthesis module capable of reliable and reproducible nucleophilic substitution of radioligands with fluorine-18 under cGMP production conditions. One complete system is required. The system must possess the following features: 1) Two reaction chambers capable of heating to 200 ºC 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; and 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 ºC, perform HPLC chromatography and solid-phase extractions, and be compliant with cGMP process and documentation standards. 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. Specifically, only General Electric Company, GE Healthcare Division (GEHD) is capable of meeting the needs of this requirement due to the comparability to the existing system already located at the NIMH MIB. The new automated radiosynthesis system will serve to replicate an existing system currently in use to produce PET radioligands under FDA-approved IND applications. The TracerLab FX-N is a fully self-contained, start-to-finish production module which satisfies cGMP production and documentation requirements, and General Electric is an established company which may be expected to provide total and reliable support of the system for its entire period of use, which is critical to minimize production downtime and therefore minimize waste of NIH resources which occurs when studies cannot be completed. Significant downtime would also result from an attempt to transfer the existing methods to a different synthesis apparatus from another manufacturer- each system has entirely unique hardware configurations and software processes, and the time delays required to redevelop methods, rewrite IND documentation, and wait for FDA approval of the new methods may all be avoided by purchasing the most comparable system, the TracerLab FX-N. The intended source is: General Electric Company, GE Healthcare Divison 3200 N. Grandview BLvd, Mail Code WT-897 Waukesha. WI 53188 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: unit price, list price, shipping and handling costs, the delivery period after contract award, 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 responses must be received by the closing date and time of this announcement and must reference the solicitation number. Responses may be submitted electronically to Megan Ault, Contract Specialist, at megan.ault@nih.gov. US Mail and Fax responses will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-NOI-14-588/listing.html)
- Place of Performance
- Address: NIMH/PRSS Laboratory, Building 10 Room B3C342, 10 Center Drive, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03463885-W 20140815/140814000214-dc5f362a36859d8daee1bf361e508ba0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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