Thermo Fisher Scientific TruScan RM instrument performance certification

The U.S. Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Criminal Investigations (OCI) is responsible for conducting and coordinating criminal investigations of violations of the Federal Food, Drug, and Cosmetic Act (FDCA), the Federal Anti-Tampering Act (FATA), other related acts, and applicable violations of Title 18 of the United States Code. 

Due to the increasing concern of fentanyl and related compounds entering the United States, OCI has increased efforts for analyzing drug samples at the point of entry (e.g. International Mailing Facilities (IMFs) and Express Courier Hubs (ECHs).  Analyzing samples at the point of entry allows for rapid detection of drug products.  The TruScan RM Handheld Raman Analyzer instruments are used by OCI Import Operations Program (IOP) Special Agents to conduct the analysis and are effective in analyzing a wide variety of forensic samples such as counterfeit drugs, unknown materials, counter-terrorism related samples and suspected tampering samples.

The preliminary screening results obtained by OCI IOP Special Agents using the TruScan RM instruments are then used for rapid enforcement actions.  Without the annual certification in place, all analyses conducted by these instruments would be considered uncertified and not useful in the enforcement process.  The annual performance certification of the TruScan RM instruments will provide OCI with the ability to continue to utilize the TruScan RM instruments and provide the FDA/OCI with rapid field analysis capabilities which will help support the FDA’s mission in protecting the public from harmful counterfeit pharmaceuticals, illegal medicines and illicit drug substances.  

It is critical to OCI’s mission to have the ability to conduct rapid field analysis.  Furthermore, this analysis assists OCI Special Agents with the ability to perform intelligent sampling which is critical to the efficiency and effectiveness of the screening process.

Minimum Technical Requirements:  

The Contractor shall provide the Thermo Fisher Scientific TruScan RM instrument performance certification and related products and support as delineated in the table below for 16 instruments, brand name or equal to.

Deliverables

See attached for deliverables

2.2         Salient Characteristics

The salient functional characteristics for the Thermo Fisher Scientific TruScan RM instrument performance certification and related products and support are the following:

• The annual performance certification shall validate that the TruScan RM instruments are functioning properly,
• The annual performance certification shall still allow the instrument user the flexibility to develop methods using a third-party software program and transfer the methods to multiple TruScan RM hand held Raman instruments,
• The annual performance certification of the TruScan RM hand held Raman instruments shall allow the user to adjust the laser power and scan time during sample analysis,
• The annual performance certification shall allow the user to collect and store spectra and transfer spectra and results to a computer network or standalone computer,
• The annual performance certification shall allow for the transfer of Raman spectral data in a format that can be uploaded easily into the Eigenvector Solo+Model Exporter v8.1 software without any additional data manipulation.
• The annual performance certification shall be valid for 12-months from date of certification.

2.3         Compatibility

• The annual performance certification shall be compatible with the existing Thermo Scientific TruScan RM.
• The annual performance certification shall be compatible with the Eigenvector Solo+Model Exporter v8.1 software and shall not require any additional data manipulation.
• The annual performance certification shall be compatible with the FDA environment which consists of Microsoft Windows servers and Microsoft Exchange Servers.

NOTE: To be considered an “or Equal” solution, any alternative solution proposed shall 1) be compatible with existing TruScan and FDA environment in its entirety; 2) include any necessary technical add-ons, additions, etc. that would be required to establish a similar configuration that can be achieved with the existing Thermo Fisher instruments.

(Please Note: FDA defines “compatible” as meaning there will be no communication, performance, or maintainability issues of solutions with differing brand names.)

Place of Performance

Forensic Chemistry Center

6751 Steger Drive

Cincinnati, OH 45237

Period of Performance

The anticipated Period of Performance is as follows:

Base Period    –  12/23/2020 – 12/22/2021

Option Year 1 – 12/23/2021 – 12/22/2022

Option Year 2 – 12/23/2022 – 12/22/2023

Option Year 3 – 12/23/2023 – 12/22/2024

Option Year 4 – 12/23/2024 – 12/22/2025

The information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Respondents shall specify and document that their NAICS code is 325120 and provide proof of their business size.

This is a request for information and shall not be construed as a solicitation or obligation on the part of the FDA for any future solicitation. Telephone inquiries will not be accepted.

All interested parties shall submit their capability statements via email to be received by November May 17, 2020, at 1:00 p.m Eastern Time, to the Contracting Office Address: Food and Drug Administration, Michael Gemmill, Contract Specialist, Michael.Gemmill@fda.hhs.gov