Trasis All in One radiosynthesizer and HPLC with installation and training.

Title: Trasis All in One radiosynthesizer and HPLC with installation and training.

Document Type: Sources Sought Notice
Solicitation Number: 75N91019Q00096
Posted Date: 06/27/2019
Response Date: 07/07/2019
Classification Code: 6640 - Laboratory Equipment and Supplies
NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing (1000 employees).

Contracting Office Address
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Bethesda, MD 20892.

Description
This is a sources-sought to determine the availability of potential sources having the skills and capabilities necessary to perform/provide the SPECIFIED REQUIREMENT. All interested vendors are invited to provide information to contribute to this market survey/sources sought synopsis only. Questions should be submitted by email to william.neal@nih.gov. Provide only the requested information below. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub-zone, 8(a), small, small disadvantage, woman-owned small business, or large business) relative to 334516 NAICS Code for Analytical Laboratory Instrument Manufacturing. Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources-sought synopsis, a solicitation announcement may be published on the FBO website. Responses to this sources-sought synopsis are not considered adequate responses to any future solicitation announcements. All interested offerors will have to respond to the solicitation announcement in addition to responding to this sources-sought announcement.

The National Cancer Institute (NCI) is seeking sources that can provide a Trasis All in One radiosynthesizer and HPLC. The requirement includes the instrument, installation and training. The equipment will be used for clinical PET radiolabeling doses for the clinical trial patients in the Molecular Imaging Program (MIP).

The mission of the Molecular Imaging Program (MIP) is to develop new imaging agents for cancer and translate them into human patients. The MIP conducts research in designing, developing and testing new novel targeted imaging agents for the detection and characterization of cancer. These imaging agents include tissue-specific MRI, Positron Emission Tomography (PET), radionuclide, and optical probes. The MIP focused on the clinical translation of targeted imaging agents for cancer imaging.

Over the past few years the regulatory standards for translation and good manufacturing practice (GMP) manufacture have become stricter. A major breakthrough in GMP production technology is the Trasis All in One box. Instead of manually setting up the synthesis this box enables "cassettes" custom designed for each probe. The cassettes include their own HPLC such that the box can almost immediately be reused thus dramatically improving the productivity of the lab. This will impact the MIP by allowing it to produce more of the probes already produced in PET and be able to introduce new agents more quickly into the clinic. This will enable MIP to fulfill its mission of bringing new imaging agents and potentially therapeutic agents to the clinic.

The following products are required to fulfill the NCI MIP requirement:

1. Trasis Product Number 7115
- All in One (AIO) 18: Synthesizer with 18 rotary actuators
2. Trasis Product Number 7561
- Upgrade from AIO 18 to AIO 24
3. Trasis Product Number 7565
- Option AIO: Built-in UV sensor with variable wavelength
4. Trasis Product Number 7564
- Built-in radio HPLC for AIO

Additionally, NCI MIP requires installation and remote training which includes:

- Onsite installation
- Factory Acceptance tests: IQ+OQ (Results will be used to accept the equipment)
- Calibration
- Remote training 2 hours before the installation and 2 hours after installation
- Training for daily operations with hot runs for one Ready to use tracer.

All responses and questions shall be emailed to William Neal, Contracting Officer, via electronic mail at william.neal@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through SAM.gov. Reference: 75N91019Q00096 on all correspondence.

This notice is not a request for competitive quotation. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received via electronic mail at william.neal@nih.gov by 12:00 PM EST, on July 07, 2019.

Responses should include both the STATEMENT OF CAPABILITY and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained below. This notice is to assist with determining sources only. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement.

REQUESTED INFORMATION: (1) STATEMENT OF CAPABILITY: Submit a brief description [ten (10) pages or less] that includes product specifications. Include past experience with performing this type of service for Government (Federal or State) agencies, or for a private medical facility. Please indicate your address (2) BUSINESS SIZE AND SOCIO-ECONOMIC STATUS: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub-zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB)(g) Include the DUNS number of your firm. (h) State whether your firm is registered with SAM System for Award Management www.sam.gov/. If not, please NOTE: any future solicitation can only be awarded to a contractor who is registered in SAM.

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