COMBINED Synopsis Solicitation 0814.pdf

75F40126Q00354

FDA OAGS | Supplies | Page 1 FSB Version 2.1 (June 14, 2026)

COMBINED SYNOPSIS/SOLICITATION

1. GENERAL INFORMATION

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 75F40126Q00354 is issued as a/an Request for Quote RFQ for two (2) Environmental Incubator Chamber that meet the requirements in the attached Statement of Work.

This acquisition [☐ is / ☒ is not] set-aside for small business concerns.

Set-Aside: ☒ None ☐ Total Small Business ☐ WOSB ☐ SDVOSB ☐ 8(a) ☐ HUBZone ☐ Other: [specify]

NAICS Code: 334516 Small Business Size Standard: 1,000 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 a ☒ quotation, which will be considered by the agency.

2. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance: U.S. Food and Drug Administration, Jamaica, NY 11433

FOB Point: [☒ Destination ☐ Origin] 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 no later than 30 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.

Base Period: 09/01/2026 through 12/01/2027

3. CONTRACT LINE ITEMS (CLINs)

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CLIN Description Qty Unit Unit Price Total Price

0001 Two (2) Environmental Incubator Chambers

Two (2)

Each

4. POINTS OF CONTACT

Contracting Officer:

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

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5. CONTRACT CLAUSES

5A. Clauses Incorporated by Reference

Appl. Clause/Prov.

No.

Title Date

REQ 52.212-4 Terms and Conditions—Commercial Products and Commercial Services

Nov 2025

REQ 52.203-17 Contractor Employee Whistleblower Rights Apr 2026

REQ 52.204-13 System for Award Management—Maintenance Nov 2025

REQ 52.204-91 Contractor Identification Nov 2025

REQ 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations

Nov 2025

REQ 52.219-28 Postaward Small Business Program Representation Nov 2025

REQ 52.222-3 Convict Labor Nov 2025

REQ 52.222-19 Child Labor—Cooperation with Authorities and Remedies Nov 2025

REQ 52.222-36 Equal Opportunity for Workers with Disabilities (or with Alt I)

Nov 2025

REQ 52.222-50 Combating Trafficking in Persons (or with Alt I) Nov 2025

REQ 52.222-90 Addressing DEI Discrimination by Federal Contractors Apr 2026

REQ 52.223-23 Sustainable Products and Services Nov 2025

REQ 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving

May 2024

REQ 52.232-33 Payment by Electronic Funds Transfer—System for Award Management

Oct 2018

REQ 52.232-40 Providing Accelerated Payments to Small Business Subcontractors

Mar 2023

REQ 52.233-3 Protest After Award Nov 2025

REQ 52.233-4 Applicable Law for Breach of Contract Claim Nov 2025

REQ 52.240-91 Security Prohibitions and Exclusions (or with Alt I) Nov 2025

REQ 52.244-6 Subcontracts for Commercial Products and Commercial Services

Nov 2025

REQ 52.225-1 Buy American—Supplies (or with Alt I) Nov 2025

REQ HHSAR

352.232-71

Electronic Submission of Payment Requests Apr 2026

5B. Clauses Incorporated by Full Text

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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)

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).

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

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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.

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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. SPECIFICATIONS

REQUIREMENT TITLE

Statement of Work

Environmental Incubator Chamber Instrument

Introduction and Background

The New York Medical Products Laboratory (NYMPL) requires a Environmental Incubator Chamber to replace multiple incubators that are currently inoperable.

Background NYMPL will be using this instrument to satisfy temperature requirements throughout four (4) different program areas during microbiological analytical testing in of USP Chapters <60> through <62> and <71>. The Environmental Incubation Chamber allows precise control over microbiological temperature depending on testing for cooling and heating which is needed to maintain continuity of operations throughout the week. This unique feature of the Environmental Incubator Chamber will increase analytical set up days from 2days per week to 5 days per week.

Scope

• The Contractor shall provide Environmental Incubator Chamber that meets specifications below:

Minimum Technical Requirements:

• Capacity requirements should be equal to 750L

• Overall instrument must fit within laboratory space, not be greater than 49inches width, 93inches high, and 46 inches depth.

• Refrigerated incubator to include auto-programmable heating and cooling between 0°C–

70°C range.

• High Uniformity Temperature throughout the chamber ≤ ±0.5°C @ 20°C to 37°C

• Temperature stability range ≤ ±0.1°C @ 20°C to 37°C

• Temperature control that includes a programmable microprocessor.

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• Energy-efficient Peltier technology supports temperature stability and uniformity with lower energy usage

• Intuitive touchscreen interface with easy programmability of temperature cycles and process duration.

• Two access ports for independent data capture, and internal documentation of set and actual parameter values, along with event log to meet 21 CFR Part 11 requirements for process documentation.

• Data retrieval via USB stick, Ethernet connection.

• Sample and process protection: Assign personalized access with user IDs or restrict access with standard door lock. An option for an automated door lock

• Capability to alarm to avoid process issues.

• Adjustable shelving to help prevent cross-contamination.

• The unit shall be delivered with all necessary supplies and accessories required for installation and start-up.

• Upon installation, the system must meet or exceed all performance specifications which have been included in the vendor’s response and/or used are evaluation criteria for award.

The unit shall not be accepted until those performance specifications have been met.

Deliverables

Table 1. Deliverables / Schedule

Description Qty Due Date

Environmental Incubator Chamber Two (2) 30 days after contract award

Security

Check in with Security at front entrance. Deliveries are accepted on weekdays from 8:00 AM ET to 4:30 PM ET.

Delivery Location

Delivery must be coordinated with ORA/NYLMP at least 48 hours in advance:

U. S. FDA New York Laboratory-Medical Products Attn: POC to be identified at time of award.

158-15 Liberty Ave Jamaica, NY 11433

Place of Performance:

U.S. FDA New York Laboratory-Medical Products

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158-15 Liberty Ave, Jamaica NY 11433

Period of Performance:

The Contractor shall furnish, deliver, and successfully install all required equipment no later than 30 calendar days after the date of contract award. Installation shall include all activities necessary to ensure the equipment is fully operational according to the original equipment manufacturer specifications and ready for Government use. The equipment shall be covered by a one-year warranty beginning on the date of formal Government acceptance. The Period of Performance begins the date of contract award execution and continues for one year from the date of formal government acceptance.

-The Redacted Brand Name Justification is attached.

Period of Performance

Equipment shall be delivered no later than 30 days after contract award. The Period of Performance begins on the date of formal government acceptance and continues through the end of the one (1) year manufacturer’s warranty period.

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A. SOLICITATION PROVISIONS

A1. Provisions Incorporated by Reference

Appl. Clause/Prov.

No.

Title Date

REQ 52.204-7 System for Award Management—Registration Nov 2025

REQ 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services

Nov 2025

REQ 52.212-2 Evaluation—Commercial Products and Commercial Services (if applicable)

Nov 2025

REQ 52.219-1 Small Business Program Representations Nov 2025

REQ

52.203-18 Prohibition on Contracting with Entities that Require

Certain Internal Confidentiality Agreements— Representation

Jan 2017

REQ 52.225-2 Buy American Certificate Oct 2022

REQ 52.240-90 Security Prohibitions and Exclusions—Representations and Certifications

Nov 2025

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.]

B. OFFER SUBMISSION

Offers Due: Offers are due no later than 08/14/2026, 3:00 PM, ET via email to Jennifer.mun@fda.hhs.gov.

Preferred File Format: Searchable PDF and Excel Page Limit (if applicable): N/A

Offerors Shall Submit:

• Technical quotation

• Price quotation

• Warranty terms

• UEI and confirmation of active SAM.gov registration

• Lead time for delivery

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• Country of origin for all items

Points of Contact As listed on the SAM.gov notice.

C. 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.

Table 1. Deliverables / Schedule