Requirements Document.docx

Statement of Work

Color Multi-Mode Spectrophotometer Background The color additive analysis laboratories in ORA labs routinely use a standard mode UV-Vis spectrophotometer for regulatory analyses of foods and cosmetics. These instruments record full spectrum absorbance measurements for a solution based on light beams that pass through (in so-called "transmittance mode") a sample compared to reference beams that do not. This technology is robust and stable, has been in use for over 80 years, and is still commonly used in routine analyses. However, it requires that the samples to be analyzed are concentrated, free of undissolved particles, and completely dissolved in a solution.

Many approved color additives are not soluble in any common solvents, such as iron oxides, chromium hydroxide green, ultramarines, ferric ferrocyanide, etc., and thus, are not detectable with a transmittance mode UV-Vis spectrophotometer. New technology has been incorporated with traditional transmittance mode instruments to allow multi-mode analysis of color samples. Multi-mode spectrophotometers have the ability to also record reflectance mode measurements, which yield absorbance spectra for materials which cannot be dissolved in solution (such as those mentioned above).

Multi-mode instruments can take transmittance measurements with a beam that passes through a sample cuvette and they can also take reflectance measurements that are "bounced off" a powder or other material into a detector. The material to be analyzed is placed in a large or small petri dish topped with a target mask plate, or even placed directly on a target plate. Many of these instruments also have data collection and analysis software packages that allow the storing of reference spectral libraries and the deconvolution of colors in products with more than one colored component.

This technology would allow the detection and confirmation of color additives often used in cosmetic and food products that we are currently unable to analyze, thus adding to ORA's capacity to confirm that permitted color additives are used and properly declared.

Objectives Obtain a multi-mode color spectrophotometer that is capable of making reflectance-mode visible absorbance measurements on small and large volumes of dry or undissolved materials, as well as typical transmittance measurements on solutions with variable cell (path length) capabilities, along with data collection and analysis software.

Tasks System Requirements The instrument must be a visible light (minimum 360 - 720 nm) spectrophotometer capable of transmittance and reflectance-mode absorbance measurements using a diode array or similar simultaneous multi-wavelength technology (rather than a variable or scanning monochromator). (Preferable to also be capable of UV measurements down to 210 nm, but not a requirement.)

Must also meet the following requirements:

· System must allow the measurement of transmittance and reflectance mode visible spectra with rapid switching between measurement modes (i.e. should not require complete replacement of the sampling accessories, recalibration procedures, etc, between measurements), and allow the measurement of large (~8 x 8 x 8 cm) solids as well as powders and other materials, in reflectance mode. Prefer ability to place solid objects of sizes > 10 cm per side on a plate (not within a fixed chamber) to record reflectance measurements.

· Utilize a xenon flash or pulsed lamp or equivalent, with minimal (<=5 min) warm-up time

· Use a 110V AC (60 Hz) power source

· Capable of operation in standalone or workstation-controlled mode

· Benchtop footprint (not including computer) of no more than 20 (W) x 12(H) x 12 (D) inches

· Repeated transmittance and reflectance measurements within a standard deviation of <=0.1% (400-700 nm)

· Measurement time of approx. 5 sec or less per scan

· Capable of internal and/or automated/semi-automated functional verification capabilities (wavelength calibration, stray light measurement, baseline/noise tests).

Other required components/accessories:

· Transmittance mode measurement accessories: including 2, 10, and 20 mm glass or quartz cells/cuvettes, transmittance sample holders, zero and white calibration plates (if needed), transmittance mask (if needed) and any other required accessories to perform measurements.

· Reflectance mode measurement accessories: including large and small volume glass petri dish-type (or similar) sample holders for solid materials, matching large/small target masks (if needed), zero and white calibration solids (if needed), petri dish (or equivalent), calibration glass (if needed), specimen viewing mirror (if needed), and any other required accessories to perform measurements.

· Reference tile set (including at least red, yellow, and blue (and/or) green tiles) for periodic color calibration verification.

· Data analysis software (w/license) (used to collect and analyze data) must be Windows-10 compatible and be capable of collecting and storing analysis scans, as well as daily functional verification data and calibration parameters. It needs to be capable of providing basic spectral info such as a spectral plot (with overlay capability), determination of absorbance maxima, spectral annotation, printing to PDF files, and determination of colorimetric values, in both transmittance and reflectance modes. It is preferable to also be capable of building/storing a spectral reference library and preferably have the ability to deconvolute spectra into component colors based on reference library spectra.

· Installation, functional verification/qualification, calibration of instrument, minimum 1 year warranty, user familiarization and hardware/software training.

Records and Reports The Contractor shall, commensurate with the completion of installation, functional verification, calibration, and regulatory compliance checks (if any), provide the end-user of the equipment with a copy of the service report identifying the equipment name, manufacturer, model number, and serial number of the equipment being certified, and a detailed description of the work performed. This will include the name(s) and contact information of the engineer who performed the service.

508 Accessibility The following standards must be met:

· WCAG 2.0 A and AA

· E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

· E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

· E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

· E205 Electronic Content (Appendix A, Application and Scoping Requirements)

· E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

· Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

· 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

· Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/making-files-accessible/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

· E207 Software (Appendix A, Application and Scoping Requirements)

· Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

Deliverables

Delivery shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV. Federal holidays are as follows:

(Monday – Friday) between the times of 8:00 AM – 4:00 PM, excluding holidays as follows:

New Year’s Day Martin Luther King, Jr. Day Presidents Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

The Contractor shall provide the FDA Contracting Officer’s Representative (COR), and FDA Delivery Location Point of Contact with at least one (1) week’s written notice prior to delivery.

When vendor representatives arrive on site to deliver / install equipment, they will need to provide proper U.S. photo identification to check-in with the Federal Protective Service (FPS) Security Guards to enter the building. The vendor representatives will receive an “Escort Required” temporary badge, which must be worn always in the building and will remain escorted by lab personnel during their visit. If vendors need to enter the laboratory, safety glasses must be worn. When their work is complete, the vendor representatives will provide the lab personnel a work order or service receipt detailing the requirements of the visit. The vendor representatives will check-out with the same FPS Security Guards, turning in their temporary badge. Tobacco, of any form, and e-cigarettes are not permitted on Federal Property, in Federal Buildings or parking lots.

Period of Performance The equipment will be purchased so the Period of Performance runs from the date of contract award through the end of Fiscal Year 2023.

Equipment to be delivered no later than 90 days after contract award.

Place of Performance/Shipping Destination FDA Denver Laboratory (DENLHAF) 1 Denver Federal Center, Bldg 20 6th Ave & Kipling St Lakewood, CO 80225

POC: Lawrence Schaufler (303-231-2732) Lawrence.Schaufler@fda.hhs.gov

Inspection and acceptance

All items specified in this Requirements Statement to be delivered under this order are subject to final inspection and acceptance by an authorized representative for the Government. The authorized representative of the Government is the Government’s COR, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor. The COR will coordinate with the appropriate FDA representatives to verify that the software/hardware is functioning properly after the upgrade(s) are completed. The COR will inspect and verify that the software is operational, functional, and compatible with FDA networks and software. The COR will provide written notification of acceptance or rejection within 30 days of receipt. The Contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.