RFQ-FDA-133666.docx

ALP: CDRH-2026-133666

Ophthalmic Adaptive Optics Retinal Imaging System

COMBINED SYNOPSIS/SOLICITATION

1. INTRODUCTION

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

Solicitation number RFQ-FDA-133666 is issued as an RFQ for purchase of an Ophthalmic Adaptive Optics.

This acquisition is 100% set-aside for small business concerns.

Set-Aside: Total Small Business

NAICS Code: 334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing Small Business Size Standard: 1,250 employees This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at: https://acquisition.gov/ | https://acquisition.gov/far-overhaul | https://acquisition.gov/hhsar

All responsible sources may submit quotation, which will be considered by the agency.

2. DESCRIPTION OF REQUIREMENTS

The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP) is seeking sources capable of providing one (1) Adaptive Optics (AO) Retinal Imaging System, including all associated hardware, software, delivery, installation, and operator training. The system will be deployed in the Optical Diagnostic Devices Laboratory at the FDA White Oak Campus, Silver Spring, Maryland, in support of an ophthalmic research program focused on AO biomarker development, retinal phantom development, and regulatory science tool advancement for cellular-level ophthalmic imaging devices.

The system must be capable of pupillary reflectance imaging and non-contact transscleral flood illumination, with a lateral optical resolution of 2–3 µm in tissue, pixel pitch of 1 µm, and live cellular-level imaging capability, along with analytic software tool to enable automatic quantification of cellular features in the images obtained by the system. Key physical requirements include a maximum footprint of 65 cm x 65 cm x 65 cm and weight not to exceed 60 kg.

Technical Specification: Hardware

3.2 Software Features

3.3 Electrical and Physical Specifications

3.4 Warranty

The contractor shall provide a minimum one (1) year full warranty after Government acceptance of the delivered system. The warranty shall cover all hardware components and software. Any defects identified during the warranty period shall be remediated by the contractor at no additional cost to the Government.

3.5 The contractor shall provide:

NOTE to Contractor/Vendor: Before the contract is awarded, we FDA program office isare required to get Pre-Approval of all the IT Hardware and/or Software-Firmware-Freeware from the FDA Chief Information Officer (CIO). For IT Hardware, this includes any device that process or stores data or controlled by data (computers/data switches, etc..) but does not include passive hardware (rack, network cables, power supplies/cords). This will require the applicable contractor to provide a complete list of Hardware and/or Software-Firmware-Freeware that the contractor will use in fulfilling this contract.

This list will need to include: IT hardware: Manufacture, nomenclature and model number Software (all types): Manufacture, nomenclature and version number Item(s) rejected by the CIO will need to be changed and the replacement item(s) would need to go through the same approval process.

3. LINE ITEMS

4. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance: U.S. Food and Drug Administration CDRH/OSEL/DBP, 10903 New Hampshire Avenue, WO62, Room G101, Silver Spring, MD 20993 FOB Point: Destination Inspection and Acceptance: Inspection and acceptance shall be performed at the delivery location in accordance with the terms of clause 52.212-4.

Period of Performance Supplies: Delivery Timeframe + Warranty Delivery shall be completed within 120 days of award. The delivered items shall include a [one (1)] year warranty. The warranty period begins on the date of Government acceptance under the inspection and acceptance clause(s) of this contract.

Following Government acceptance, the Contracting Officer will issue an administrative modification under RFO 43.203(b)(1) and 43.201 to memorialize the period of performance dates, anchored to the Government acceptance date. The modification does not change scope, price, or any other substantive term. The Contractor's written confirmation of the installation completion date supports inspection and acceptance scheduling; it does not establish the period of performance.

5. CONTRACT CLAUSES

5A. Clauses Incorporated by Reference

5B. Clauses Incorporated by Full Text

52.252-2, Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://acquisition.gov https://acquisition.gov/far-overhaul https://acquisition.gov/hhsar (End of clause)

52.217-8, Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor at any time before contract completion.

(End of clause)

FDA Electronic Invoicing and Payment Requirements — Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

(2) total amount of all payments received to date under the subject contract or order

(3) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the Delivery Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

(End of clause)

6. SOLICITATION PROVISIONS

6A. Provisions Incorporated by Reference

Basis for Award Lowest Price Technically Acceptable (LPTA): Award will be made to the lowest-priced offeror whose offer is determined technically acceptable. Technical acceptability will be determined on a pass/fail basis against the salient characteristics and minimum requirements of the requirement. Offers that do not meet all salient characteristics will be determined technically unacceptable and will not be considered for award. Price will be evaluated for reasonableness.

6B. Addenda to 52.212-1

Offer Paragraph (b) of the provision is hereby amended to extend the period for acceptance of offers from 60 calendar days to 120 calendar days from the date specified for receipt of offers.

7. OFFER SUBMISSION AND POINTS OF CONTACT

Questions Due: Questions regarding this solicitation shall be submitted in writing to the Primary POC identified in the SAM.gov notice June 10, 2026, 10:00 AM EASTERN TIME.

Offers Due: As listed on the SAM.gov notice.

Submission Method: Email to the POCs listed in the SAM.gov posting.

Preferred File Format: Searchable PDF and Excel Page Limit: 10

Offerors Shall Submit:

1. Technical quotation

1. Price quotation

1. Warranty terms

1. UEI and confirmation of active SAM.gov registration

1. Lead time for delivery

1. Country of origin for all items Points of Contact As listed on the SAM.gov notice.

8. ADDITIONAL INFORMATION

Amendments:

Any amendments to this solicitation will be posted to SAM.gov. It is the offeror's responsibility to monitor SAM.gov for any amendments.

FDA OAGS — Supplies | Page 1