Combined Synopsis Solicitation- CDER-2026-133117- Final - SAM Posting 06.16.2026.pdf

Request for Quotation: FDA-RFQ-CDER-2026-133117 BioProfile FLEX2 Parts and Components-Brand Name or Equal

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Notice of Combined Synopsis/Solicitation. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

Part-A Fundamental Contract Information

The solicitation number is FDA-RFQ-CDER-2026-133117 and is issued as a Request for Quotations (RFQ) for BioProfile Flex 2 Parts and Components-Brand Name and Equal (BNE). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2026-01.

1. Contract Type - The Government intends to award a Firm Fixed-Price (FFP) Purchase

FOrder to procure the requested items/system/services.

2. NAICS - This requirement is being solicited as an unrestricted, full and open competition requirement.

a. The NAICS for this requirement is: 334516

b. The SB size standard for the NAICS code is: 1000 Employees. The full table of size standards can be found at: https://www.sba.gov/document/support-table-size-standards

3. Background – The Center for Drug Evaluation and Research (CDER) requires operational parts and consumables for three (3) currently owned Nova BioProfile Flex 2 instruments.

To meet the purpose and objective of this requirement, a single Contractor shall provide the parts and components listed in the Statement of Work (SOW) that must be compatible with the corresponding three (3) NOVA BioProfile Flex 2 instruments:

Main FLEX2 instrument 1: Serial Number- T262230070C Main FLEX2 instrument 2: Serial Number- T26817050C External sampling module for instrument 2: T2761720PC Main FLEX2 instrument 3: Serial Number- T26A200050C

Please note Main FLEX2 instrument 2 has two serial numbers because it has an additional module added which has its own Serial Number. The offeror is also expected to adhere to the:

the established delivery times as expressed in Section 5.1 below to the fullest extent practicable.

4. Purpose - The Center for Drug Evaluation and Research (CDER) require a consistent supply of operational parts and consumables to maintain three Nova BioProfile Flex-2 instruments. These instruments are essential for ongoing Process Analytical Technology (PAT) initiatives, which focus on optimizing the integration of automated sampling analyzers with bioreactor systems. To ensure high accuracy amongst a heavy workload, operational components must be routinely replaced, necessitating a reliable source of supplies to keep them in a constant state of readiness.

https://www.sba.gov/document/support-table-size-https://www.sba.gov/document/support-table-size-

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4.1 General Requirement Guidance for Salient Characteristics.- The Contractor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement. The Contractor shall demonstrate how the requested items or services, “MEET” or “DO NO MEET” the salient/functional characteristics and specifications listed here-below.

The Contractor shall annotate each salient/functional characteristics and specifications with the following: Meets (if it meets the specification) or Does not meet (if it fails to meet the specification).

4.2 Grey market or refurbished products will not be accepted.//

4.3 .The Vendor shall indicate if non-domestic items are included in the quote.

4.4 The Vendor shall provide all, of the items listed within each delivery schedule phase, or none.

If the Contractor fails to deliver all requested supplies within its designated delivery phase, the Contractor shall pay, as fixed, and agreed liquidated damages, a reasonable sum identified by the Government for each calendar delay until delivery is complete.

4.5 The Vendor shall meet all technical/salient/functional, operational characteristics and specifications listed, and if not the manufacturer, shall be able to provide the required service with OEM certified technicians and parts or show proof that they are an authorized third party re seller/provider.

4.6 Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine).

Document submissions required throughout the award period(s) shall not have macro-enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

5. Specifications/Salient Characteristics- Compatibility is needed for three currently owned

Nova BioProfile Flex 2 instruments as described in this Section (Section 5). The Contractor shall identify the following salient characteristics for BioProfile Flex-2 commercial parts and consumables or equal :

Instrument identity: Manufacturer (Nova Biomedical), instrument name and model

(BioProfile FLEX 2), and all three serial numbers of the government-owned instruments

Instrument function: Automated bioanalysis system for cell culture monitoring, measuring parameters such as pH, dissolved gases, metabolites, osmolality, and cell density

Compatibility requirement: All parts and consumables supplied must be fully compatible with and functional in the Nova BioProfile FLEX 2 as configured at the FDA facility, without modification to the instrument

Quality standard: All items must be new, unused, and free from defects; grey market and refurbished products are unacceptable

Shelf life: All items must arrive with at least 75% to 80% of their total shelf life remaining upon delivery

Cold chain: Items requiring refrigeration or classified as flammable must be shipped

P a g e 3 | 29 and delivered in accordance with manufacturer specifications and applicable DOT/IATA regulations

Authorization: Offeror must be the manufacturer or an authorized reseller of the items quoted

5.1 Pricing Schedule - Prices shall be inclusive of shipping and handling and shall be firm fixed through one (1) year after award. Pricing shall include all applicable fees;

any charges presented after contract award shall not be considered/acceptable:

Phase 1 -The following items identified in the Phase 1 chart below must be provided within 7 days of Award:

Contract Line Item

(CLIN)

Description Quantity Unit Unit Price Extended Price

1 59209 BioProfile

FLEX 2 ESM

External Tubing

Set

1 each

1 57510 BioProfile

FLEX 2 pH/Gas MicroSensor™ Card LV (125 samples or 21 days)

10 each

1 57512 BioProfile

FLEX 2

Chemistry MicroSensor™ Card LV (150 samples or 21 days)

10 each

1 57467 BioProfile

FLEX 2 pH/Gas Reference

Sensor

1 each

1 57466 BioProfile

FLEX 2

Chemistry Reference

Sensor

1 each

1 58102 BioProfile

FLEX 2 pH/Gas Calibrator

8 each

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Cartridge MV

1 58101 BioProfile

FLEX 2

Chemistry Calibrator and

Reagent Cartridges MV

10 each

1 55297 BioProfile

FLEX 2 CDV

Reagent

Cartridges

11 each

1 42437 OSM20

50 mOsm/kg Calibration Standard 10/box

1 each

1 42439 OSM20

290 mOsm/kg

Reference Solution 10/box

1 each

1 59859 OSM48

Micro tubes BioProfile

FLEX2 500/box

1 each

1 56073 BioProfile

FLEX 2

pH/Gas Auto QC Cartridge

5 each

1 57035 BioProfile

FLEX 2

Chemistry Auto QC Cartridge

7 each

1 55288 BioProfile

FLEX 2 S-Line Probe Assembly

2 each

1 60608 FLEX2

pH/Gas

Shutdown Cartridge

2 each

1 60610 FLEX2

Chemistry

Module Shutdown Cartridge

2 each

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1 60611 FLEX2

CDV Module

Shutdown Cartridge

2 each

1 60612 FLEX2

ESM Shutdown

Cartridge

1 each

1 66287 BioProfile

FLEX2

Flowpath

Troubleshooting Kit

1 each

1 63940 FLEX2

CDV Module

Advanced Cleaning Solution

1 each

1 60613 FLEX2

pH/Gas Auto QC Shutdown

Cartridge

2 each

1 56227 BioProfile

FLEX 2 ESM

Reagent

Cartridge (200 samples)

2 each

TOTAL

Phase 2 - The following items identified in the Phase 2 chart below must be provided 90-120 Days After Contract Award

Contract Line Item

(CLIN)

Description Quantity Unit Unit Price

Extended Price

1 57510 BioProfile

FLEX 2 pH/Gas MicroSensor™

Card LV (125

10 each

P a g e 6 | 29 samples or 21 days)

1 57512 BioProfile

FLEX 2

Chemistry MicroSensor™ Card LV (150 samples or 21 days)

10 each

1 57467 BioProfile

FLEX 2 pH/Gas Reference

Sensor

1 each

1 57466 BioProfile

FLEX 2

Chemistry Reference

Sensor

1 each

1 58102 BioProfile

FLEX 2 pH/Gas Calibrator

Cartridge MV

8 each

1 58101 BioProfile

FLEX 2

Chemistry Calibrator and

Reagent Cartridges MV

10 each

1 55297 BioProfile

FLEX 2 CDV

Reagent

Cartridges

11 each

1 42437 OSM20

50 mOsm/kg Calibration

Standard 10/box

1 each

1 42439 OSM20

290 mOsm/kg

Reference Solution 10/box

1 each

1 59859 OSM48

Micro tubes BioProfile

FLEX2 500/box

1 each

P a g e 7 | 29

1 56073 BioProfile

FLEX 2 pH/Gas Auto QC Cartridge

5 each

1 57035 BioProfile

FLEX 2

Chemistry Auto QC Cartridge

7 each

1 55288 BioProfile

FLEX 2 S-Line Probe Assembly

2 each

1 60608 FLEX2

pH/Gas

Shutdown Cartridge

2 each

1 60610 FLEX2

Chemistry

Module Shutdown Cartridge

2 each

1 60611 FLEX2

CDV Module

Shutdown Cartridge

2 each

1 66287 BioProfile

FLEX2

Flowpath

Troubleshooting Kit

1 each

1 63940 FLEX2

CDV Module

Advanced Cleaning Solution

1 each

1 60613 FLEX2

pH/Gas Auto QC Shutdown

Cartridge

2 each

1 56227 BioProfile

FLEX 2 ESM

Reagent

Cartridge (200 samples)

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Phase 3 - The following items identified in the Phase 3 chart below must be provided 180-210 Days After Contract Award

(CLIN)

Description Quantity Unit Unit Price

Extended Price

1 57510 BioProfile

FLEX 2 pH/Gas MicroSensor™ Card LV (125 samples or 21 days)

10 each

1 57512 BioProfile

FLEX 2

Chemistry MicroSensor™ Card LV (150 samples or 21 days)

10 each

1 57467 BioProfile

FLEX 2 pH/Gas Reference

Sensor

1 each

1 57466 BioProfile

FLEX 2

Chemistry Reference

Sensor

1 each

1 58102 BioProfile

FLEX 2 pH/Gas Calibrator

Cartridge MV

8 each

1 58101 BioProfile

FLEX 2

Chemistry Calibrator and

Reagent

10 each

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Cartridges MV

1 55297 BioProfile

FLEX 2 CDV

Reagent

Cartridges

11 each

1 42437 OSM20

50 mOsm/kg Calibration

Standard 10/box

1 each

1 42439 OSM20

290 mOsm/kg

Reference Solution 10/box

1 each

1 59859 OSM48

Micro tubes BioProfile

FLEX2 500/box

1 each

1 56073 BioProfile

FLEX 2 pH/Gas Auto QC Cartridge

5 each

1 57035 BioProfile

FLEX 2

Chemistry Auto QC Cartridge

7 each

1 55288 BioProfile

FLEX 2 S-Line Probe Assembly

2 each

1 60608 FLEX2

pH/Gas

Shutdown Cartridge

2 each

1 60610 FLEX2

Chemistry

Module Shutdown Cartridge

2 each

1 60611 FLEX2

CDV Module

Shutdown Cartridge

2 each

1 60612 FLEX2

ESM Shutdown

Cartridge

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1 66287 BioProfile

FLEX2

Flowpath

Troubleshooting Kit

1 each

1 63940 FLEX2

CDV Module

Advanced Cleaning Solution

1 each

1 60613 FLEX2

pH/Gas Auto QC Shutdown

Cartridge

2 each

1 56227 BioProfile

FLEX 2 ESM

Reagent

Cartridge (200 samples)

2 each

1 59209 BioProfile

FLEX 2 ESM

External Tubing

Set

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Phase 4 - The following items reflected in the Phase 4 chart below must be provided 270-300 Days After Contract Award:

(CLIN)

Description Quantity Unit Unit Price Extended Price

1 57510 BioProfile

FLEX 2 pH/Gas MicroSensor™ Card LV (125 samples or 21 days)

10 each

1 57512 BioProfile

FLEX 2

Chemistry MicroSensor™ Card LV (150 samples or 21 days)

10 each

1 57467 BioProfile

FLEX 2 pH/Gas Reference

Sensor

1 each

1 57466 BioProfile

FLEX 2

Chemistry Reference

Sensor

1 each

1 58102 BioProfile

FLEX 2 pH/Gas Calibrator

Cartridge MV

8 each

1 58101 BioProfile

FLEX 2

Chemistry Calibrator and

Reagent Cartridges MV

10 each

1 55297 BioProfile

FLEX 2 CDV

Reagent

Cartridges

11 each

P a g e 12 | 29

1 42437 OSM20

50 mOsm/kg Calibration

Standard 10/box

1 each

1 42439 OSM20

290 mOsm/kg

Reference Solution 10/box

1 each

1 59859 OSM48

Micro tubes BioProfile

FLEX2 500/box

1 each

1 56073 BioProfile FLEX 2 pH/Gas Auto QC Cartridge

5 each

1 57035 BioProfile

FLEX 2

Chemistry Auto QC Cartridge

7 each

1 55288 BioProfile

FLEX 2 S-Line Probe Assembly

2 each

1 60608 FLEX2

pH/Gas

Shutdown Cartridge

2 each

1 60610 FLEX2

Chemistry

Module Shutdown Cartridge

2 each

1 60611 FLEX2

CDV Module

Shutdown Cartridge

2 each

1 66287 BioProfile

FLEX2

Flowpath

Troubleshooting Kit

1 each

1 63940 FLEX2

CDV Module

Advanced

P a g e 13 | 29

Cleaning Solution

1 60613 FLEX2

pH/Gas Auto QC Shutdown

Cartridge

2 each

1 56227 BioProfile

FLEX 2 ESM

Reagent

Cartridge (200 samples)

5.2 Extended Warranty

At least (1) year extended warranty from the date of Customers first use of the products(s) against defects in workmanship and component failure. A full (1) year manufacturer warranty shall be included. The entire system shall be warranted for parts and labor for twelve (12) months from the date of installation and acceptance. Warranty coverage shall commence upon Government acceptance.

5.3 Holidays and Government Closures

The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday, Government closure, or shut-down for the Washington, D.C. area:

New Year's Day January 1

Martin Luther King's Birthday Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19

American Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in October Veteran's Day November 11 Thanksgiving Day Fourth Thursday in November Christmas Day December 25

5.4 Period of Performance (POP)- The period of performance will span over the course of four (4) delivery windows, spanning approximately 300 days. The POP does not include the warranty period.

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5.5 Points of Contact:

Contracting Officer Name:

Brandon Rafus Email: brandon.rafus@fda.hhs.gov

Contract Specialist:

Name: Brandon Rafus Email: brandon.rafus@fda.hhs.gov

Contracting Officer’ Representative: Name: Erica Berilla Email: erica.berilla@fda.hhs.gov

6. Contracting Officer’s Authority

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of the statement of work. In the event the Contractor effects any changes at the direction of any person other than the CO or the TPOC the changes shall be considered to have been made without authority, and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract and modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds.

The Contracting Officer is the only person with authority to act as agent of the Government under the Contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of the Contract; or (5) otherwise change any terms and conditions of the Contract.

Part-B Contract Clauses

1. FAR 52.212-4 - Contract Terms and Conditions – Commercial – Items (Nov 2021).

2. FAR 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 these addresses:

https://www.acquisition.gov/far/part-52 https://www.acquisition.gov/far-overhaul https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses mailto:brandon.rafus@fda.hhs.gov mailto:erica.berilla@fda.hhs.gov https://www.acquisition.gov/far/part-52 https://www.acquisition.gov/far-overhaul https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

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Required and applicable Clauses

Clause Number

Clause Title

X 52.203-6 w/Alt I

Restrictions on Subcontractor Sales to the Government (JUN 2020)

X 52.203-17 Contractor Employee Whistleblower Rights (NOV 2023) X 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

(JAN 2017)

X 52.204-9 Personal Identity Verification of Contractor Personnel (JAN 2011) X 52.204-91 Contractor Identification (NOV 2025) X 52.204-13 System for Award Management—Maintenance (NOV 2025) X 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (NOV 2025)

Required 52.212-4 Contract Terms and Conditions-Commercial Products and Commercial Services

(NOV 2023)

X 52.219-14 Limitations on Subcontracting Plan X 52.219-33 Nonmanufacturer Rule (NOV 2025) X 52.222-3 Convict Labor (NOV 2025) X 52.222-19 Child Labor—Cooperation with Authorities and Remedies (NOV 2025) X 52.222-50 Combating Trafficking in Persons (or with Alt I) (NOV 2025)

X 52.222-90 Addressing DEI Discrimination by Federal Contractors (Executive Order of MARCH

2026) X 52.225-1 Buy American—Supplies (or with Alt I) (NOV 2025)

X 52.226-8 Encouraging Contractor Policies to Ban Text Messaging (MAY 2024) X 52.233.3 Protest After Award (NOV 2025) X 52.244-6 Subcontracts for Commercial Products and Commercial Services (NOV 2025)

X 52.243-1 52.243-1 Changes-Fixed-Price (DEVIATION) (RFO JUN 2025) X Contractor Personal Security and Agency Access (DEVIATION (FEB 2024 X 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

Health and Human Services Acquisition Regulation (HHSAR) Clauses can be viewed in full text at: https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-cont53ract-clauses/index.html

3.) 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.

https://www.hhs.gov/grants-contracts/contracts/contract-policies-https://www.hhs.gov/grants-contracts/contracts/contract-policies-http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

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(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).Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

(1) 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.

(e) 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:

- invoice number, amount, & date submitted

- corresponding payment amount & date received

- total amount of all payments received to date under the subject contract or order

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

(f) 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.

P a g e 17 | 29

(g) 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.

(h) 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.

(i) 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.

(j) . 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)

4. FAR 52.252-6 Authorized Deviations in Clauses (Nov 2020)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any Health and Human Services Acquisition Regulation clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of clause)

Part C- Solicitation Provisions

1. FAR 52.252-1. Solicitation Provisions Incorporated by Reference (Feb 1998)

Required and applicable Clauses

Clause Number Clause Title

Required 52.204-7 System for Award Management--Registration (NOV 2025) Required 52.212-1 Instructions to Offerors—Commercial Products and Commercial

Services (NOV 2025) X 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain

Federal Transactions (SEP 2024) X 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal

Confidentiality Agreements—Representation (JAN 2017) X 52.219-2 Equal Low Bids (NOV 2025)

P a g e 18 | 29

2. Inquiries and Notices:

All questions regarding this RFQ shall be submitted (by 06/22/2026, in writing to Brandon.Rafus@fda.hhs.gov. Phone or fax inquiries will not receive a response.

3. Response Dates and Time RFQ Due Date: All proposals shall be submitted electronically via email to Brandon.rafus@fda.hhs.gov before 12:00 pm Eastern Time on 06/26/2026.

4. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1 (f). Instructions to Offerors – Commercial Items (Nov 2021)

5. Proposal Preparation Instructions:

5.1 The vendor shall submit the following in their proposal:

a) The vendor should submit a proposal, which will be considered if received by the due date. The subject line shall read: Subject: Request for Quotations: Request for Quotation: FDA-RFQ-CDER-2026-133117, and a statement from the Offeror verifying that they are SAM.gov, including the UEI Number.

b) The Offeror’s current address and UEI Number shall be included in the quote.

c) Offerors that fail to submit all required documentation, or do not complete the required representations and certifications, or reject the terms and conditions of the solicitation, shall be excluded from consideration.

d) Quotes must include all quantities listed; all or none.

e) A complete proposal must consist of: i) Cover Letter, ii) Technical Proposal (which, in accordance with FAR 52.212-1 (b) (4)) must be a technical description of the items or services being offered in sufficient detail to evaluate compliance with the requirements in this RFQ). This may include product literature, or other documents, if necessary. Incomplete proposals shall be considered non- responsive and shall not be evaluated.

f) Digital Microsoft (MS) Word files and MS Excel files shall be compatible with MS Office Windows 10.

g) Proposal shall not consist of any lock or password-protect files (e.g. *.docx, *.pptx, *.xlsx,*.txt,*.msg).

h) The Offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the Offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents, and the submission will be considered non-responsive to the solicitation. No additional time will be given to an Offeror or applicant to correct the document submission, and the Government will not inform the Offeror or applicant that their submission is non-responsive prior to award. It is the Offeror’s or applicant’s

P a g e 19 | 29 responsibility to ensure all electronic documents are submitted without the use of macros.

5.2. Period for Acceptance of Offers:

Addenda to 52.212-1 Quote Acceptance Period (if applicable)

Offer Acceptance Period (if applicable):

Paragraph (b) of the provision is hereby amended to extend the period for acceptance of quotes from 60 calendar days to 90 calendar days from the date specified for receipt of offers.

Preparation Costs ***Note that this solicitation does not commit the Government to pay any cost for the preparation and submission of a proposal. Until formal notice of award is issued, no communication by the Government, either written or oral, shall be interpreted as a promise that an award will be made.

It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.

6. Request for Pricing. The Vendor shall complete the chart below, including any fees and charges. Any charges after contract award shall not be accepted.

6.1 Pricing Chart

Contract Line Item

(CLIN)

Description Quantity Price

1 BioProfile Flex-2 commercial parts and consumables or equal (must include all applicable parts identified in phases 1- 4 above in Section 5.1 Pricing Schedule)

1 $

2 Delivery 1 $ 3 Installation 1 $

Total: (All Items FOBD) $

The offer shall be on a firm-fixed-price basis and include all quantities/services listed; all or none. Offerors shall provide documentation that they are an authorized dealer/reseller of the product that is being proposed, if they are not the manufacturer.

PART D: Packing, Marking, Delivering, and Shipping- The Contractor shall deliver the items and quantities ordered, all, or none. The deliverables required under this contract shall be

P a g e 20 | 29 packaged, marked, and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor’s name. All required materials shall be delivered in immediate new, usable, and acceptable condition, at the U.S.

Food and Drug Administration (FDA) facility address listed below:

Shipment Destination-

FDA Campus Point of Entry Address:

The equipment should be complete with all accessories and software necessary to work and to be delivered to:

U.S. Food and Drug Administration Attention: Erica Berilla 10903 New Hampshire Avenue White Oak Building 52/72 Room 2232 Silver Spring, MD 20903

Schedule: Phases of the Delivery Schedule shall be completed within each phased delivery timeframe identified in the chart above after contract award.

PART E- Inspection and Acceptance: Inspection and Criteria- Delivery and installation of the instrument and all components specified above shall be coordinated through the FDA Project Officer. Inspection and acceptance shall be performed at the delivery location in accordance with the terms of FAR Clause 52.212-4.

The FDA’s Technical Point of Contact (TPOC) will approve all tasks and deliverables.

The delivery of services shall be performed during regular business hours (Monday- Friday) during the times of 8:00 AM – 4:00 PM Eastern, excluding holidays.

The TPOC/COR will be responsible for determining the acceptance of the work that is completed. The Vendor shall contact the TPOC/COR by email or phone to schedule delivery. Deliveries shall be coordinated with the TPOC/COR prior to shipment. No deliveries will be accepted without prior authorization from the TPOC/COR. To meet the purpose and objective of this requirement, a single Contractor shall provide the parts and components that reflect saliant characteristics compatible with a NOVA BioProfile Flex 2 (SN T26817050C) and that meet the established delivery timeline above. Additionally, some of the components require refrigeration or are flammable, and must be shipped under appropriate conditions. The vendor must contact the COR prior to shipping the items to ensure the shipments can be received and must provide tracking numbers for the shipments

All goods should be delivered from the manufacturer intact with no shipping damage

P a g e 21 | 29 directly. Goods shall not be expired upon receipt. For items requiring cold shipping, goods should be shipped overnight for early morning delivery Monday through Friday to ensure goods are received and stored appropriately. The vendor must contact the Technical Point of Contact/COR prior to shipping the items to ensure the shipments can be received and must provide tracking numbers for the shipments.

All deliverables shall be marked as follows:

• Name and address of the Contractor,

• Contract Number

• Description of item contained therein; and

• Consignee’s name and address.

Travel and expenses shall be covered by the Contractor (in any manner causes an increase or decrease in the total contract price; or changes any of the expressed terms, conditions, or specifications of the contract.

A. All technical directions shall be issued in writing by the TPOC or shall be confirmed by him/her in writing within five (5) working days.

B. The Contractor shall proceed promptly with the performance of technical directions duly issued by the TPOC in the manner prescribed by this clause and within his/her authority under the provisions of this clause.

C. If, in the opinion of the Contractor, any instruction or direction issued by the TPOC is within one of the categories as defined in B. (1) through B. (4) above, the Contractor shall not proceed but shall notify the Contracting Officer, in writing, within five (5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the Contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor, in writing, that, in his/her opinion, the technical directions are within the scope of this clause and do not constitute a change under the "Changes" clause of the contract. The Contractor shall thereupon proceed immediately with the direction given.

Any failure of the parties to agree upon the nature of the instruction or direction, or upon the contract action to be taken with respect thereto, shall be subject to the provisions of the contract clause entitled "Disputes."

Part-F Evaluation of Commercial Items

FAR 52.212-2 Evaluation - Commercial Items (Nov 2021) applies to this acquisition.

The Government reserves the right to award a contract without discussions. Commercial Items (Oct 2014) applies to this acquisition. Only one award shall be made from this RFQ. The corresponding requirement will be awarded on the basis of identifying the quote deemed 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. Quotes that do not meet all salient characteristics will be determined technically unacceptable and will not be considered for award. Moreover, price will be evaluated for reasonableness.

P a g e 22 | 29

Part-G Offeror Representations and Certifications

FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2024) (DEVIATION FEB 2025) applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision— "Covered telecommunications equipment or services" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following:

ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

P a g e 23 | 29

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Reasonable inquiry has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended. "Sensitive technology"— Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3)of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

Service-disabled veteran-owned small business (SDVOSB) concern means a small business concern— (1)(i) Not less than 51 percent of which is owned and controlled by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or

P a g e 24 | 29 more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran; or

(2) A small business concern eligible under the SDVOSB Program in accordance with 13 CFR part 128 (see subpart 19.14).

(3) Service-disabled veteran, as used in this definition, means a veteran as defined in 38 U.S.C. 101(2), with a disability that is service connected, as defined in 38 U.S.C.

101(16), and who is registered in the Beneficiary Identification and Records Locator Subsystem, or successor system that is maintained by the Department of Veterans Affairs’ Veterans Benefits Administration, as a service-disabled veteran.

Service-disabled veteran-owned small business (SDVOSB) concern eligible under the SDVOSB Program means an SDVOSB concern that—

(1) Effective January 1, 2024, is designated in the System for Award Management (SAM) as certified by the Small Business Administration (SBA) in accordance with 13 CFR 128.300; or

(2) Has represented that it is an SDVOSB concern in SAM and submitted a complete application for certification to SBA on or before December 31, 2023.

Service-disabled veteran-owned small business (SDVOSB) Program means a program that authorizes contracting officers to limit competition, including award on a sole-source basis, to SDVOSB concerns eligible under the SDVOSB Program.

Small business concern—

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in its field of operation, and qualified as a small business under the criteria in 13 CFR part 121 and size standards in this solicitation.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

Small disadvantaged business concern, consistent with13 CFR 124.1001, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by—

(i) One or more socially disadvantaged (as defined at13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding the threshold at 13 CFR 124.104(c)(2) after taking into account the applicable exclusions set forth at 13 CFR124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

Subsidiary means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation Successor means an entity that has replaced a predecessor by acquiring the assets and

P a g e 25 | 29 carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term "successor" does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

Veteran-owned small business concern means a small business concern—

(1) Not less than 51 percent of which is owned and controlled by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

Women-owned small business concern means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States, and the concern is certified by SBA or an approved third-party certifier in accordance with 13

CFR 127.300.

(b)(1) Annual Representations and Certifications. Any changes provided by the Offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications in SAM

(2) The offeror has completed the annual representations and certifications electronically in SAM accessed through http://www.sam.gov. After reviewing SAM information, the Offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard(s) applicable to the NAICS code(s) referenced for this solicitation), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ______________.

[Offeror to identify the applicable paragraphs at (c) through (v) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on

SAM.]

(c) Offerors must complete the following representations when the resulting contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii). Check all that apply.

P a g e 26 | 29

(1) Small business concern. The offeror represents as part of its offer that it [ ] is, [ ] is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a veteran-owned small business concern.

(3) SDVOSB concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a service-disabled veteran-owned small business concern.

(4) SDVOSB concern joint venture eligible under the SDVOSB Program. The offeror represents that it [ ] is, [ ] is not an SDVOSB joint venture eligible under the SDVOSB Program that complies with the requirements of 13 CFR 128.402. [Complete only if the offeror represented itself as an SDVOSB concern in paragraph (c)(3) of this provision.] [The offeror shall enter the name and unique entity identifier of each party to the joint venture: ____________.]

(5) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, that it [ ] is, [ ] is not a small disadvantaged business concern as defined in 13 CFR 124.1001.

(6) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [ ] is, [ ] is not a women-owned small business concern.

(7) WOSB joint venture eligible under the WOSB Program. The offeror represents that it [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [ The offeror shall enter the name and unique entity identifier of each party to the joint venture: __.]

(8) Economically disadvantaged women-owned small business (EDWOSB) joint venture.

The offeror represents that it [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [ The offeror shall enter the name and unique entity identifier of each party to the joint venture: __.] Note to paragraphs (c)(9) and (10): Complete paragraphs (c)(9) and (10) only if this solicitation is expected to exceed the simplified acquisition threshold.

(9) Women-owned business concern (other than small business concern).