SOLICITATION NOTICE
66 -- Two Automated Radiotracer Formulation Modules
- Notice Date
- 7/24/2014
- 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-14-496
- Archive Date
- 8/19/2014
- 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 Ecker & Ziegler Radiopharma, Inc. for two (2) automated radiotracer formulation modules 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. This acquisition is NOT 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 two (2) automated radiotracer formulation modules to be used by the National Institute of Mental Health (NIMH) Molecular Imaging Branch (MIB) for the preparation of doses for injection of radiotracers to human subjects under cGMP conditions. Period of Performance Delivery and installation shall be approximately 10 weeks after receipt of award. A firm fixed price purchase order is contemplated. Project Description The system must be a self-contained module capable of reliable and reproducible formulation of PET radioligands labeled with carbon-11 and fluorine-18 under cGMP production conditions. Two (2) complete systems are required. The system must possess the following features: 1. The formulation module must have the ability to purify crude reaction mixtures, collect the product fraction, and quickly and effectively remove solvents by solid phase extraction and/or evaporation 2. The formulation module must contain an internal vacuum pump at least one temperature controlled chamber with the ability to heat to 200 °C and cool rapidly to room temperature. 3. The formulation module must contain a nitrogen regulator for controlled evaporation of solvents. 4. The formulation module must be contained in a portable enclosure with dimensions of no more than 20 x 20 x 10 inches (W x H x D). 5. The system must be controlled by user-programmable software which allows for fully automated programmed time list operation as well as manual control of the hardware components. 6. The system must contain the ability to integrate with a radio-HPLC system, requiring a fraction collector valve and at least three four valve-operated chemical reservoirs in a closed-tubing system with solid-phase extraction with a capability of up to 100 mL of solvent and sterile filtration. 7. The software must be compliant with cGMP guidelines, including allowing tracking of vital process information such as system temperature and pressure, and provide process reports and a log of the process history. 8. After delivery of the system and preparation of a suitable installation location by the end user, the manufacturer must install and test the system to ensure it is fully operational. Acceptance testing documents must be supplied. 9. A minimum of two days of user training must be provided upon installation of the system. 10. The manufacturer may provide the option to purchase a service contract and/or as needed maintenance services, as well as replacement consumable parts. The system must, at minimum, be able to control collection of product fraction from an external HPLC system, accurately control evaporator temperatures from 25 - 200 °C, perform solid-phase extractions and sterile filtration, 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 Ecker & Ziegler Radiopharma, Inc. (Eckert & Ziegler) is capable of meeting the needs of this requirement due to the ability to replicate multiple existing systems already located at the NIMH PET Radiopharmacuetical Sciences Section (PRSS) of the Molecular Imaging Branch (MIB). The proposed purchase will serve to purigy and formulate PET radioligand under FDA-approved IND applications. The ReFORM lus is a widely used, fully contained system which satisfies cGMP production and doucmentiation requirements. Eckert & Ziegler is an established company which is expected to provide total and reliable support of the system for its entire period of us, which is critical to minimiaze production downtimie and therefore minimize waste of NIH resources which occurs when studies cannot be completed. The ReFORM Plus can accomplish several different formulation methods and as such will eliminate the need to purchase multiple system to establish cGMP production of all tracers currently in use. The intended source is: Eckert & Ziegler Radiopharma, Inc. 63 South Street Suite 140 Hopkinton, MA 01748 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-14-496/listing.html)
- Place of Performance
- Address: National Institute of Mental Health, PRSS Laboratory, 10 Center Drive Room B3C342, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03436566-W 20140726/140724235200-4dd3f4f4ce8dddd8db58def73a58688b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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