Combined Synopsis.docx

Combined Synopsis/Solicitation – Notice of Intent to Sole Source Solicitation Number: 75F40125Q00438 Title: Multi-Channel Data Acquisition Platform for Photoacoustic Imaging (PAI) Applications

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 not being requested and a written solicitation will not be issued. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-06.

NOTICE: INTENT TO SOLICIT ONLY ONE SOURCE

The Food and Drug Administration (FDA), Department of Health and Human Services (HHS), intends to award a firm fixed-price sole source contract to:

PhotoSound Technologies, Inc, 9511 Town Park Dr, Houston, Texas, 77036, United States The proposed contract action is for supplies or services for which the Government is soliciting and negotiating with only one source under the authority of FAR 13.106-1(b)(1). This notice of intent is not a request for competitive proposals. However, the Government will consider all proposals received prior to the closing date and time of this solicitation.

2. Authority This acquisition is conducted under the authority of FAR Part 13.106-1(b)(1)(i) – soliciting from a single source, and FAR Subpart 13.5 (Simplified Procedures for Certain Commercial Products and Commercial Services).

3. NAICS & PSC

· NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing

· Size Standard: 1,000 employees

· PSC Code: 6640 – Laboratory Equipment and Supplies

4. Requirement The FDA requires the acquisition of one (1) multi-channel data acquisition platform specifically designed for photoacoustic imaging (PAI) applications. The required salient characteristics are listed in the attached Requirements Document.

5. Response Instructions This notice of intent is not a request for competitive proposals. However, interested parties may identify their capability to fulfill this requirement by submitting a capability statement in writing. The capability statement must contain material sufficient to demonstrate the party’s ability to provide equipment meeting FDA’s requirements.

Responses must be received by 09/16/2025 at 5:00 PM ET via email to Jennifer.mun@fda.hhs.gov

6. Evaluation of Responses The Government will review all responses received. If no responses are received that meet the requirements within the stated time, FDA will proceed with the sole source award to PhotoSound Technologies, Inc.

7. Clauses & Provisions The following FAR and HHSAR clauses apply:

· FAR 52.212-1 – Instructions to Offerors—Commercial Items

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

· FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items

· FAR 52.232-33 – Payment by Electronic Funds Transfer—System for Award Management

· HHSAR 352.232-71 – Electronic Submission of Payment Requests

· HHSAR 352.239-73 – Electronic and Information Technology Accessibility The following clause is listed in full text:

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.

· 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;

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

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

· 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;

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

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

· 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:

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

(c) 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 task 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.

8. Points of Contact Contracting Officer: Jennifer Mun (Jennifer.mun@fda.hhs.gov)

9. Attachments

1) Requirements Document

2) JEFO