Sources Sought Notice.docx

U.S. FOOD AND DRUG ADMINISTRATION

Office of Facilities, Engineering and Mission Support

SOURCES SOUGHT NOTICE

Large-Area 2D X-Ray Flat Panel Detector for CBCT and Fluoroscopy Imaging

1. Purpose and Background This is a Sources Sought Notice (SSN) issued by the U.S. Food and Drug Administration (FDA) for market research purposes only. This notice does NOT constitute a Request for Proposal (RFP), Request for Quotation (RFQ), or any commitment by the Government to issue a solicitation or award a contract. No award will be made from this notice, and no reimbursement will be made for any costs associated with the preparation of a response.

The FDA is conducting market research to identify potential sources capable of providing one (1) large-area 2D X-ray flat panel detector suitable for laboratory cone-beam CT (CBCT) and fluoroscopy imaging. The detector will support human-sized phantom development, testing, and validation of imaging evaluation methods.

Brand name or equal products may be proposed provided all minimum technical requirements described herein are met or exceeded. The Government intends to use the information gathered from this notice to determine the appropriate acquisition strategy, including small business set-aside potential.

2. Minimum Technical Requirements Responses must address the ability to provide a detector meeting or exceeding all of the following minimum requirements:

3. Requested Information Interested parties are requested to submit a capability statement addressing ALL of the following items. Incomplete responses may not be considered in the market research assessment.

3.1 Company Information

1. Company name, address, and website

1. Unique Entity Identifier (UEI) and CAGE code

1. Point of contact: name, title, telephone number, and email address

1. Business size and socioeconomic status under NAICS 334510 (e.g., Small Business, 8(a), HUBZone, WOSB, SDVOSB, or Other Than Small Business)

1. Confirmation of active SAM.gov registration

3.2 Technical Capability

1. Identification of the specific product(s) offered, including manufacturer name, model number(s), and product line

1. Confirmation of whether the proposed product(s) meet or exceed each minimum requirement listed in Section 2. Provide a compliance matrix or equivalent narrative addressing each parameter individually

1. Description of any deviations, exceptions, or areas where the proposed product exceeds the stated minimums

1. Identification of whether the product is available as a commercial off-the-shelf (COTS) item or requires customization

3.3 Delivery and Support Capability

1. Estimated lead time from award to complete operational delivery

1. Description of warranty coverage offered

1. Description of remote and/or onsite technical support capabilities

1. Identification of any teaming arrangements or authorized reseller relationships, if applicable

3.4 Past Performance (Optional but Encouraged)

1. Description of prior or current contracts for similar equipment, including agency/customer name, contract number (if releasable), and a brief description of the work performed

3.5 Pricing Information (Optional)

1. Rough order of magnitude (ROM) pricing for the proposed product, including all components required for complete operational delivery, for market research purposes only. This pricing will not be used for evaluation in any subsequent solicitation

4. Submission Instructions Responses to this Sources Sought Notice shall be submitted electronically to the Point of Contact identified above no later than the response deadline specified in the notice information table.

1. File format: PDF or Microsoft Word (.docx)

1. Subject line: "Sources Sought Response – Large-Area X-Ray Flat Panel Detector – [Company Name]"

1. Page limit: 10 pages maximum (not including attachments or product data sheets)

1. Product data sheets, technical specifications, and compliance matrices may be submitted as attachments and are not counted toward the page limit

Questions regarding this notice may be directed to the Point of Contact listed above. Questions and answers of general interest may be shared with all respondents to the extent practicable.

5. Disclaimers and Important Notices

1. This Sources Sought Notice is issued for market research purposes ONLY and does not constitute a solicitation, Request for Proposal, or Request for Quotation.

1. No funding is currently available or committed. This notice does not commit the Government to issue a solicitation or award a contract.

1. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract.

1. The Government will not reimburse respondents for any costs incurred in the preparation and submission of capability statements.

1. All information submitted in response to this notice is voluntary. Information submitted is for market research and planning purposes only.

1. Proprietary information, if included in the response, should be clearly marked. The Government will endeavor to protect such information to the extent permitted by law.

1. This notice may or may not result in the issuance of a future solicitation. If a solicitation is issued, it will be posted on SAM.gov.

End of Sources Sought Notice U.S. Food and Drug Administration • Office of Facilities, Engineering and Mission Support