Purchase of Automated Radiosynthesis Module for Fluorine-18

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.

This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

Description:
The National Institute of Mental Health (NIMH), Molecular Imaging Branch, PET Radiopharmaceutical Sciences Section requires an automated radiosynthesis module for nucleophilic substitution of PET radioligands using fluorine-18.

Background:
The PET Radiopharmacuetical 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.

Purpose and Objectives:
The purpose of this acquisition is to replace one of our two obsolete Tracerlab systems. The purchased item will be used for development and production of radioligands for currently ongoing and future clinical Positron Emission Tomography (PET) brain imaging studies within the Molecular Imaging Branch of NIMH. And, will NIMH to continue producing current radioligands without concern of downtime and cancellations due to equipment failure and expand the range of work which may be performed in the updated system.

Project requirements:

1. The synthesis module must have the ability to reproducibly dry up to 1.2 mL of cyclotron-produced fluorine-18.
2. The synthesis module must contain at least two reaction chambers with the ability to heat to 200 ºC and cool rapidly to room temperature, and direct transfer between the two chambers.
3. The synthesis module must be contained in a portable enclosure with dimensions of no more than 20 x 20 x 20 inches (W x H x D).
4. 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.
5. The system must contain an integrated radio-HPLC system which consists of, at minimum, an injection valve, radioactivity detector, UV detector, and fraction collector valve.
6. The system must contain the ability to formulate the collected product into a dose suitable for injection into human subjects, consisting of a closed-tubing system with solid-phase extraction capability.
7. The software must be compliant with cGMP guidelines, including allowing tracking of vital process information such as reactor 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. The manufacturer must provide the option to purchase a service contract and/or as-needed maintenance services, as well as replacement consumable parts.

Anticipated period of performance:
The system shall be delivered within 60 days after receipt of order.

Other important considerations:
Delivery must be FOB Destination and must include inside installation. The equipment shall be delivered and installed between the hours of 8:00am and 5:00pm, Bethesda, MD local prevailing time, Monday through Friday. Inspection and acceptance will be performed at: NIMH, the specific location will be identified at award.

Capability statement /information sought. This is not a solicitation for competitive quotations. However, if any interested party especially a small business, believes they can meet the above requirement, may submit a quote and statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow NINDS to determine if it can meet the above unique specifications described herein. All questions, quote, and the capability statement must be received electronically (via email) to Ms. Gwennifer Epps, Contracting Officer, eppsg@mail.nih.gov in in MS Word or Adobe Portable Document Format (PDF) by August 17, 2016 no later than 11:00 AM EST. No telephone calls or facsimiles will be accepted. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA), through sam.gov. No collect calls will be accepted. Please reference solicitation number HHS-NIH-NIDA-SSSA-2016-675 on all correspondence.

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

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