COMBINED SYNOPSIS SOLICITATION.docx

COMBINED SYNOPSIS/SOLICITATION

Notice Type: Combined Synopsis/Solicitation Solicitation Number: 75F40125Q00423 Response Date: 09/16/2025 at 12:00 PM ET Set Aside: Full and Open Competition NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing PSC Code: 6650 – Optical Instruments, Test Equipment, Components

1. DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation will not be issued.

This solicitation is issued as a Request for Quotation (RFQ) under FAR Parts 12 and 13.

2. REQUIREMENT SUMMARY

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), requires one (1) specialized visible range spectrometer with 1 MHz line scan camera to support regulatory science work related to optical coherence tomography (OCT) imaging technologies. This procurement will directly support retinal oximetry validation and ophthalmic imaging research.

The system must include a fully integrated camera, spectrometer, frame grabbers, software, and support services as outlined in the attached Requirements Document.

See Attachment 1 – Requirements Document for full technical specifications.

3. DELIVERY

Delivery Due Date: Within 60 calendar days after award FOB: Destination Delivery Address:

FDA CDRH DBP

10903 New Hampshire Avenue

WO62 RM 1132

Silver Spring, MD 20993

4. SUBMISSION INSTRUCTIONS

Quote Due Date: 09/16/2025 at 12:00 PM ET Submission Email: Jennifer.mun@fda.hhs.gov Subject Line: Quote Submission – 75F40125Q00423 – Visible Range Spectrometer Vendors shall include the following in their quote:

· Company name, DUNS/UEI number, CAGE code, small business size

· Technical description or spec sheet confirming compliance with all minimum requirements

· Pricing (Firm Fixed Price)

· Delivery timeline

· Warranty terms

· Completed FAR 52.212-3 (Reps & Certs) or confirmation of registration in SAM.gov

· Point of contact information All quotes must be emailed to Jennifer.mun@fda.hhs.gov by the due date.

5. EVALUATION CRITERIA

Award will be made to the responsible offeror whose quotation is technically acceptable and offers the lowest price. The Government reserves the right to verify technical acceptability through market research or clarifications.

6. CONTRACT TYPE

This will be a Firm-Fixed Price (FFP) purchase order.

7. CLAUSES AND PROVISIONS

The following FAR provisions and clauses apply to this acquisition:

FAR PROVISIONS:

· 52.212-1 – Instructions to Offerors – Commercial Items

· 52.212-2 – Evaluation – Commercial Items (Filled in above)

· 52.212-3 – Offeror Representations and Certifications—Commercial Items

FAR CLAUSES:

· 52.212-4 – Contract Terms and Conditions—Commercial Items

· 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (applicable clauses checked below):

Under FAR 52.212-5, the following apply:

· 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards

· 52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

· 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns

· 52.219-28 Post Award Small Business Program Representation

· 52.222-3 Convict Labor

· 52.222-19 Child Labor—Cooperation with Authorities and Remedies

· 52.222-21 Prohibition of Segregated Facilities

· 52.222-26 Equal Opportunity

· 52.222-36 Equal Opportunity for Workers with Disabilities

· 52.225-1 Buy American—Supplies

· 52.225-13 Restrictions on Certain Foreign Purchases

· 52.232-33 Payment by Electronic Funds Transfer—System for Award Management Additional Clauses:

· 52.204-7 System for Award Management

· 52.204-13 SAM Maintenance

· 52.232-40 Providing Accelerated Payments to Small Business Subcontractors

8. PRICE SCHEDULE

9. ATTACHMENTS

· Attachment 1 – Requirements Document