SOW_Raman Spectrometer.doc

STATEMENT OF WORK

REQUIREMENT TITLE

Handheld Raman Spectrometer

BACKGROUND

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Enforcement’s Health Fraud Branch (HFB) requires the purchase of a handheld Raman spectrometer system in support of the FDA’s mission to protect the public health by rapidly screening health fraud related items to provide a preliminary indication on tainted products, i.e. products with undeclared active pharmaceutical ingredients, compounds or controlled substances.

PURPOSE

HFB serves as the ORA lead on tainted products having identified nearly a thousand of these products over the past decade. These products are typically marketed for weight loss, bodybuilding, pain management, sexual performance and as sleep aids. Many of these products are marketed online, including on popular e-commerce platforms, as well as in retail locations like gas stations, convenience stores and specialty shops. In December 2020, FDA warned consumers about dozens of tainted products purchased and tested from two prominent marketplaces.

ORA’s Forensic Chemistry Center (FCC) has found that the Progeny ResQ is effective for detecting APIs in the substandard drug products. Using these devices as part of HFB’s online surveillance and investigations will allow users to determine the composition of suspect products before having to send these products to a laboratory. The FCC has evaluated handheld Raman systems and has determined that this system is suitable for this purpose. One (1) unit is required to support the HFB analysis needs. The device will be maintained at the HFB office location in the Element Building in Rockville, MD. In addition, four (4) units are required to support the Office of Pharmaceutical Quality Operations (OPQO) analysis needs.

SCOPE

FDA/ORA require purchase of five (5) handheld Raman spectrometer. The system must meet or exceed the following requirements:

I. Minimum Performance Requirements/Salient Characteristics

All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the HFB.

· The system shall include a handheld analyzer based on Raman spectrometry that is capable of detecting narcotics, including fentanyl, fentanyl analogs, and other narcotics and be capable of analyzing powders, liquids, and tablets.

· The system shall include the ability to analyze various size and shape tablets and vials.

· The system shall include an integrated barcode scanner.

· The system shall include a touch screen display.

· The system shall include a carrying case and docking station.

· The system excluding docking station shall not weigh more than 4 lbs.

· The system excluding docking station shall not be larger than 12’’x 4’’x 3”.

· The system shall be able to operate using both rechargeable batteries and with an external power supply (110V, 50/60Hz).

· The system shall be able to send results and data via WiFi or USB from the instrument without the need to transfer the results or data to an external computer.

· The system shall include software to operate the system, a standard library of at least 10,000 compounds including narcotics, precursors and simulants embedded in the instrument software, and shall include library updates available from the vendor during its lifecycle at no additional charge.

· The system shall be able to allow users to create libraries that can be shared with other device users.

· The system shall allow users to add and remove library spectra using the device itself without having to use an external computer.

· The system shall employ a high wavelength laser (outside the visible range) in order to minimize sample fluorescence.

· The system shall include a laser with a user-adjustable power with at least 10 possible settings between 50 and 450 mW.

· The system shall include a laser with a user-adjustable exposure time with at least 10 possible settings between 10 ms and 5 s.

· The system shall include a laser with a user-adjustable focus nose cone accessory.

· The system shall be able to capture digital photographs.

· The embedded instrument software shall be able to generate a PDF of the results including the camera images.

· The system shall be capable of acquiring Raman data in the range 250 – 2500 cm-1.

· The system shall provide maximum spectral resolution not greater than of 11 cm-1.

· The system’s grating shall not require periodic alignment.

II. Trade and Service Specifications

· The system must be newly manufactured unit, not used and refurbished or previously used for demonstration. The Government must be able to expect routine customer service and technical support to be available from the vendor during its lifecycle.

· A minimum of a one-year warranty is required with the purchase and shall include at a minimum: coverage on all non-consumable items and parts supplied including the base instrument and any sampling accessories.

Records and Reports

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA Project Officer and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

Deliverables

Shipping Destination

System to be shipped to the following office:

US Food & Drug Administration

Health Fraud Branch 12420 Parklawn Drive Room 4041 Rockville, MD 20857

Point of contact (POC): CDR Shannon Aldrich Email: shannon.aldrich@fda.hhs.gov Phone: 240-402-8876

Period of Performance

Equipment shall be delivered by April 2022. The period of performance begins on the date of formal government acceptance and continues through the end of the manufacturer’s warranty period.

Packaging, Marking and Shipping All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. Electronic delivery of usernames and passwords may be acceptable.

Inspection and Acceptance The Government shall have ten (10) business days from delivery to formally accept the product. The contractor shall have ten (10) business days to remedy any deficiencies identified. If the contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the Technical POC of the reason for the delay and provide a proposed corrective action plan within three (3) business days.

Deliveries and Place of Performance The contractor shall contact the Government Technical POC at least 48 hours prior to delivery or service. Unless otherwise specified, deliveries, installation and trainings shall occur at the place of performance specified above. Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:00 p.m. in accordance of the delivery location time zone. Supplies or services scheduled for delivery on a Federal Holiday shall be made the next business day.

Government Points of Contact Technical Representative:

Contracting Officer (CO):

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