Combined Synopsis.docx

Combined Synopsis/Solicitation Notice Type: Combined Synopsis/Solicitation Solicitation Number: 75F40125Q00414 Issued by: U.S. Food and Drug Administration (FDA) Title: Deformable Mirror (DM) for Adaptive Optics System Response Due Date: 09/12/2025 at 3:00 PM ET NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing PSC Code: 6650 – Optical Instruments, Test Equipment, Components, and Accessories Size Standard: 1,000 Employees Set-Aside: Total Small Business Set-Aside Acquisition Type: Simplified Acquisition (FAR Part 13) Contract Type: Firm Fixed Price (FFP)

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 separate written solicitation will not be issued.

This solicitation is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) FAC 2025‑04.

The U.S. Food and Drug Administration (FDA), under the Center for Devices and Radiological Health (CDRH), requires a Deformable Mirror (DM) for use in an adaptive optics (AO) system supporting regulatory science investigations into ophthalmic devices.

2. Statement of Work (SOW) Please see Attachment 1 – Statement of Work (SOW) for full technical specifications and performance requirements.

3. Contract Line Item (CLIN)

4. Place of Performance / Delivery Delivery Address:

TBD

Silver Spring, MD 20993

Place of Performance: Contractor's facility for manufacturing and testing.

5. Period of Performance 30 calendar days from date of contract award for delivery and acceptance.

6. Instructions to Offerors Submission Deadline: 09/12/2025 at 3:00 PM ET Submit all quotes electronically via email to:

Jennifer Mun Email: Jennifer.mun@fda.hhs.gov

Quote Format:

Offerors shall submit the following documents:

1. Technical Quote – Demonstrating conformance to all SOW requirements.

2. Price Quote – Firm fixed price including all shipping, handling, insurance, and customs clearance costs.

3. Completed Representations and Certifications – FAR 52.212-3 or confirmation they are updated in SAM.gov.

4. SAM.gov Registration – Offeror must be active in SAM (https://sam.gov) at time of award.

7. Basis for Award Award will be made to the Lowest Price Technically Acceptable (LPTA) offeror, in accordance with FAR 15.101-2.

Only quotes that meet all technical requirements will be evaluated for price. The Government intends to award a single purchase order.

8. Evaluation Criteria Technical Acceptability A quote is technically acceptable if it meets or exceeds all requirements in the SOW, including:

· Number of actuators (>90)

· Circular actuator layout

· Zernike order correction (up to 10)

· Coating reflectivity >95% (silver)

· Effective diameter (15 mm)

· Surface quality <10 nm RMS

· Stroke (±50 µm)

· AR coated protective window

· USB3 interface or equivalent without external hardware

· One-year warranty (incl. shipping)

· User manual included

· Delivery within 30 days Price Evaluation Price will be evaluated for reasonableness. Award will be made to the lowest-priced, technically acceptable offer.

9. Applicable FAR Provisions and Clauses The following provisions and clauses apply:

FAR Provisions (incorporated by reference):

· 52.212-1 – Instructions to Offerors—Commercial Items

· 52.212-3 – Offeror Representations and Certifications—Commercial Items FAR Clauses (incorporated by reference):

· 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, including:

· 52.204-10 – Reporting Executive Compensation

· 52.219-6 – Notice of Total Small Business Set-Aside

· 52.222-3 – Convict Labor

· 52.222-19 – Child Labor—Cooperation with Authorities

· 52.222-21 – Prohibition of Segregated Facilities

· 52.222-26 – Equal Opportunity

· 52.225-1 – Buy American—Supplies

· 52.232-33 – Payment by Electronic Funds Transfer—SAM

10. Full Text of FAR 52.212-5 Clause (JUN 2024)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law applicable to acquisitions of commercial products and commercial services:

(1) 52.203-6, Restrictions on Subcontractor Sales to the Government (SEP 2021)

(2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020)

(3) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUL 2024)

(4) 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (JUN 2023)

(5) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (JUN 2020)

(6) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2021)

(7) 52.222-3, Convict Labor (JUN 2003)

(8) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (JUN 2020)

(9) 52.222-21, Prohibition of Segregated Facilities (APR 2015)

(10) 52.222-26, Equal Opportunity (SEP 2016)

(11) 52.222-50, Combating Trafficking in Persons (JAN 2023)

(12) 52.225-1, Buy American—Supplies (MAY 2020)

(13) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (JUL 2024)

(b) If the Contractor becomes aware of any inconsistency between the terms of this contract and applicable law or regulation, the Contractor shall immediately bring the inconsistency to the attention of the Contracting Officer.

(c) The Contractor shall comply with other applicable clauses prescribed by agency acquisition regulations or other law, including clauses in solicitations and contracts at FAR 52.212-4.

(d) The Contractor shall include the substance of this clause, including this paragraph (d), in subcontracts for commercial products and commercial services.

10. Attachments

· Attachment 1 – Requirements Document