NEW_Sources_Sought_SAM_Attachment_V1_1_260621.docx

Drafter legend (delete before posting): Yellow = mandatory fill-in. Cyan = optional language or a choice to make.

SOURCES SOUGHT NOTICE

Spectral Camera

WO62-3133, US FDA

Silver Spring, MD 20993

1.0 PURPOSE AND DISCLAIMERTHIS IS A SOURCES SOUGHT NOTICE ONLY, issued for market research under RFO Part 10. It is not a solicitation and does not commit the Government to issue one. The Government will not pay any costs incurred in responding. Responses will not be returned and respondents will not be notified of results. Not responding does not preclude participation in any future solicitation, which, if issued, will be posted to SAM.gov.

This notice has two purposes: (1) to identify sources of any business size capable of supplying domestic end products meeting this requirement, in support of the Government's obligations under the Buy American statute and RFO Part 25; and (2) to determine whether capable small business concerns, whether as manufacturer, OEM, authorized distributor, or reseller, exist in sufficient number to support a set-aside under RFO Part 19. Responses will inform the acquisition strategy, including the set-aside decision and any domestic availability determination, and may be summarized in market research documentation posted publicly with a proposed nonavailability waiver, if applicable. Do not submit proprietary pricing; mark any confidential business information clearly.

2.0 DESCRIPTION OF REQUIREMENTThe U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Imaging, Diagnostics and Software Reliability (DIDSR), is conducting market research to identify qualified sources capable of providing a portable hyperspectral camera for scientific research and laboratory testing. The required system will support FDA research activities by enabling the development of bench testing methods used to evaluate the safety and effectiveness of digital pathology devices. The Government seeks a commercially available portable hyperspectral imaging system capable of capturing high-resolution spectral imaging data for laboratory and research applications.

The anticipated requirement consists of one (1) portable hyperspectral camera and associated commercial accessories, software, documentation, warranty, and technical support necessary for full operation. At a minimum, the system shall be capable of meeting the following salient characteristics:

· The anticipated requirement consists of one (1) portable hyperspectral camera and associated commercial accessories, documentation, warranty, and technical support necessary for full operation. At a minimum, the system shall be capable of meeting the following salient characteristics:

· Operate over a spectral wavelength range of 400 nm to 800 nm.

· Provide 200 or more evenly distributed spectral bands.

· Provide a spectral bandwidth (FWHM) of 7 nm or less.

· Produce image output of at least 512 × 512 pixels.

· Provide a minimum spectral resolution of 12 bits per pixel.

· Focus on objects from approximately 15 centimeters to infinity.

· Operate as a standalone system with an integrated display and user interface without requiring an external computer for normal operation.

· Store collected data on portable media for transfer to external computers.

· Operate using an internal rechargeable battery.

· Utilize standard 120V, 60 Hz U.S. power for battery charging.

· Weigh no more than 2 kilograms.

· Include a minimum one-year manufacturer's warranty and technical support.

· Be delivered within approximately six (6) weeks after award.

· On-site installation is not required. Training is optional. Electronic or hard-copy user documentation shall be provided.

This Sources Sought Notice is issued solely for market research purposes in accordance with FAR Part 10 to determine the availability of capable small and large business concerns. It does not constitute a solicitation or a commitment by the Government to issue a solicitation or award a contract. Responses will be used to assess market capability, available sources, and potential small business participation.

3.0 INSTRUCTIONS TO RESPONDENTSResponses shall be submitted by email to the point of contact identified in the SAM.gov posting no later than the response due date, with subject line “Sources Sought Response - CDRH-2026-134060 - [COMPANY NAME].” A complete response consists of:

(a) The Vendor Response Form (Attachment 1), completed and returned in its NATIVE MICROSOFT EXCEL (.xlsx) FORMAT. Do not convert the form to PDF, scan it, or alter its structure. Name the file: CDRH-2026-134060_CompanyName.xlsx; and

(b) A capability statement not exceeding 10 pages in [SELECT: PDF / Microsoft Word] format providing narrative elaboration and supporting documentation as applicable (product literature, specification sheets, letters of supply or authorized distribution).

The Company Information fields in Section 4.0 and the questions in Sections 5.0 and 6.0 below are reproduced in the Vendor Response Form. The Government intends to consolidate and analyze market data directly from the returned forms; responses submitted without the completed form in native Excel format may not be fully considered in the Government’s analysis. Telephone inquiries will not be accepted.

4.0 COMPANY INFORMATION Company Name / Address:

UEI / CAGE Code:

Point of Contact (Name, Phone, Email):

Active SAM.gov Registration (Yes/No):

Business Size under the stated NAICS (Small / Other than Small):

Socioeconomic Categories (all that apply): 8(a); HUBZone; SDVOSB; VOSB; WOSB; EDWOSB; SDB; None

Existing Contract Vehicles (FSS/MAS, GWAC, IDIQ/BPA):

5.0 SMALL BUSINESS CAPABILITY QUESTIONS5.1. Identify your role for the required items: OEM, manufacturer, authorized distributor or dealer, reseller, or other (describe). If a distributor or reseller, identify the manufacturer(s) of the end items you would supply and provide evidence of authorized distribution, if available.

5.2. If you are a small business that is not the manufacturer of the end item, state whether you can supply end items manufactured by a small business concern in the United States, consistent with the nonmanufacturer rule (13 CFR 121.406), and identify that manufacturer if known. If you would supply the product of an other than small or foreign manufacturer, state this clearly.

5.3. Describe your capability and capacity to fulfill the full scope of this requirement, including the quantities and delivery timeframes in Section 2.0, and identify any portion you could not fulfill. Include relevant experience (up to three recent contracts or commercial sales) and any applicable quality or regulatory certifications. Federal experience is not required.

5.4. Describe any teaming, joint venture, or subcontracting arrangements you anticipate.

6.0 DOMESTIC MANUFACTURE AND AVAILABILITY QUESTIONSAll respondents shall answer, regardless of business size.

6.1. Identify the country (or countries) in which the offered end item is manufactured and the operations performed at each location.

6.2. If manufactured in the United States, state whether the item meets the domestic content threshold in effect under RFO 25.101 as of the anticipated award date, or the approximate domestic content percentage you can certify to. State whether the item is a commercially available off-the-shelf (COTS) item and whether it consists wholly or predominantly of iron or steel.

6.3. Identify the country of origin of any critical components or components for which no domestic source is known to you.

6.4. If you can supply a domestic end product, describe production capacity against the Section 2.0 quantities (sustainable output, available inventory, lead times). If you can satisfy the requirement only in part (insufficient quantity) or with deviations from the salient characteristics (insufficient quality), describe the shortfall specifically.

6.5. If you do not currently manufacture a domestic end product meeting this requirement, state whether and under what conditions you could establish or expand domestic production (estimated timeline, minimum quantities, or other commitments required).

6.6. Identify any alternative or substitute items manufactured in the United States that could satisfy the Section 2.0 characteristics, including items made by other firms, and any other known domestic manufacturers or supply chain constraints relevant to domestic availability.

[RETAIN IF FOREIGN OFFERS ARE ANTICIPATED OR THE ACTION MAY EXCEED A TRADE AGREEMENTS THRESHOLD] 6.7. If the offered item is not a domestic end product, identify its country of origin and, if known, whether it is a designated country end product under the Trade Agreements Act.