75F40126Q135669.pdf

75F40126Q135669

This is a notice of intent for a sole-source award of a commercial product and commercial services prepared in accordance with the Federal Acquisition Regulation (FAR) RFO Part 12, as supplemented with additional information included in this notice. This announcement constitutes the only notice;

quotes are NOT being requested and a competitive written solicitation will not be issued. The solicitation number is 75F40126Q135669. This notice is issued as an Intent to Sole Source. The Government intends to award a firm-fixed-price contract to TissUse GmbH for the purchase of a factory-certified refurbished HUMIMIC starter kit control unit.

This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul.

The associated North American Industry Classification System (NAICS) code for this acquisition is 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees. This requirement is being solicited as a sole-source procurement directly to TissUse GmbH; competitive quotes are not being sought, and submissions from other sources will not be evaluated.

The FDA intends to award a brand name, sole-source, firm-fixed-price purchase order to TissUse GmbH, Oudenarder Str. 16, Berlin, 13347 Germany, pursuant to FAR RFO 12.102(a). FDA has documented that only one source is available and the basis for that decision. The requirement is for the purchase of a factory-certified refurbished HUMIMIC Starter Kit Control Unit (Product Code:

D01-B), including mandatory OEM factory recertification and technical services tied to Serial Number 68517 (or an OEM-designated equivalent refurbished unit), and an OEM-configured HUMIMIC Starter M2.SSD replacement part loaded with proprietary system firmware. No other source is available to satisfy the requirement because TissUse GmbH is the Original Equipment Manufacturer (OEM), sole developer, and patent-holder of the HUMIMIC technology platform, and no other commercial source possesses the proprietary software source codes, diagnostic calibration fixtures, or engineering data necessary to execute the required factory recertification and maintenance for this specific hardware. All responsible sources may submit capability information or a quote, as appropriate, which will be considered by the agency by the response date identified in this notice.

Schedule of Supplies or Services and Prices/Costs. Prices quoted shall be all-inclusive, including delivery to the final government destination under Incoterms: Delivered Duty Paid (DDP).

Item

Description Est.

QTY

Unit of Measure Unit Price Extended

Price

HUMIMIC Starter Kit, Product code:

D01-B (Control Unit for optimal operation of the on-chip pumps of HUMIMIC Chips)

1 Ea $___________ $___________

HUMIMIC Care, Mandatory recertification and technical service (one-off commercial transfer HUMIMIC Starter SN: 68517 or OEM-designated equivalent refurbished unit)

1 Ea $___________ $___________ https://www.acquisition.gov/far-overhaul

HUMIMIC Starter M2.SSD replacement part (hard drive replacement)

1 Ea $0.00 $0.00

Shared On-Site Travel and Service Expenses (Covers planned factory service visit for both newly acquired unit and existing FDA operational unit on-site)

1 Job $0.00 $0.00

Grand Total:

GSA Contract Number: __________________ (if applicable)

Requirement/Background

Scientists in the Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), Office of Cellular Therapy and Human Tissue CMC, Division of Cell Therapy 1 (DCT1), Cellular and Tissue Therapy Branch (CTTB) take a significant and growing interest in utilizing multi-organ-on-a-chip microphysiological systems (MPS) for the safety, efficacy, and toxicological evaluation of advanced biological products.

As the regulatory oversight body for innovative, novel therapies—including cultured allogeneic cell-based products, stem cell derivatives, tissue-engineered combination products, and advanced cellular immunotherapies—CTTB is at the forefront of advancing regulatory science and applying non-animal testing methodologies. Traditional 2D cell cultures and animal models inherently limited in their ability to replicate the complex 3D architecture, extracellular matrix features, and dynamic inter-organ crosstalk of the human body, thereby limiting their predictive value for clinical safety and efficacy. Implementing multi-organ-on-a-chip systems provides more physiologically relevant, vascularized, and predictive in-vitro human models to assess product safety and accelerate clinical translation.

The HUMIMIC platform, manufactured by TissUse GmbH, is an established and validated system for building multi-organ models with controlled fluidics, and it is the only platform that meets the specific technical requirements for the research projects in CTTB. The HUMIMIC Starter Control Unit features a proprietary network of 24 pre-calibrated pneumatic connectors capable of driving fluidic flow profiles across up to 8 distinct microfluidic circuits simultaneously. This specific automated pressure/vacuum system allows the branch to recreate critical physiological mechanical forces, adjust fluid flow velocity and direction dynamically, and establish continuous inter-organ communication (e.g., gut-liver or liver-kidney barriers) in a human-relevant context. Alternative microfluidic configurations lack the proprietary pneumatic actuation profiles, integrated digital monitoring framework, and dynamic software settings required to perform the complex, multi-organ research planned by CTTB. Consequently, procuring this factory-refurbished and calibrated unit from the OEM is vital to achieving these research capabilities, while providing a significant cost savings of 50% off the standard list price to ensure the most efficient and responsible use of taxpayer funds.

Scope

The scope of this procurement is to obtain the following commercial goods from TissUse GmbH:

1. One (1) Certified HUMIMIC Starter System, including all necessary components for operation (Serial Number: 68517, or an OEM-designated equivalent refurbished unit).

2. Incidental mandatory recertification and technical service for the newly acquired unit executed by the OEM prior to delivery.

3. One (1) OEM-configured internal HUMIMIC Starter M2.SSD replacement part loaded with proprietary system firmware .

4. Coordinated on-site technical deployment and shared installation service covering both the newly acquired unit and the existing FDA operational unit currently on-site.

This RFQ is for a Brand Name solution. Equipment and accompanying services need to meet all the technical requirements and salient characteristics listed below to be deemed technically acceptable:

Technical Requirements for Refurbished HUMIMIC Starter System:

1. Equipment shall be a genuine HUMIMIC Starter Control Unit (Product Code: D01-B), or factory-refurbished equivalent, engineered and certified directly by the Original Equipment Manufacturer (OEM), TissUse GmbH.

2. The physical asset provided shall be Serial Number: 68517, or an OEM-certified substitute factory-refurbished unit of identical make, model, and configuration.

3. Control unit shall feature a pre-calibrated internal network capable of controlling up to 24 distinct pneumatic actors simultaneously.

4. System shall feature fully adjustable fluidic flow parameters, with software-driven controls capable of dynamically modifying both flow velocity (speed) and direction.

5. Unit shall support both optional internal vacuum generation or integration with an external laboratory vacuum supply line.

6. Shall utilize digital precision controls for independent multi-channel pressure and vacuum regulation.

7. Shall feature an integrated, high-resolution capacitive touchscreen display for real-time protocol management, data logging, and automated user-setting reports.

8. System shall arrive as a complete functional kit, including all necessary integrated pump tubing, connection ports, and power supply.

9. Unit shall be fully validated, refurbished, and updated by the OEM with the latest compatible system software, to include the installation of a compatible HUMIMIC Starter M2.SSD Replacement Part loaded with proprietary system firmware.

10. System hardware shall be officially CE-certified.

11. System shall include a comprehensive 1-year manufacturer warranty.

Work Requirements for Service

The OEM shall perform the following services for the newly acquired unit prior to commercial transfer to ensure automated laboratory compliance, and execute a shared on-site technical visit at the FDA facility:

• Mandatory one-off recertification and technical service.

• This includes visual inspection of internal lines, function testing, digital calibration of pressure/vacuum controllers, software updates, and electrical safety testing.

• Provide a full-service and calibration report upon completion.

• Shared Technical Deployment: The contractor shall provide factory-certified service personnel to execute a coordinated on-site service visit that simultaneously covers the start-up start-up optimization of the newly acquired unit and the planned technical maintenance of the existing FDA operational unit currently on-sit.

System Requirements, Documentation, and Warranty:

1. Offered systems shall be a turn-key solution i.e., the Contractor shall be responsible for providing all hardware, components, instruments, internal storage (M2.SSD), software, and services otherwise required to meet these specifications and the FDA’s stated need.

2. The system shall be delivered to the final destination with all necessary supplies, accessories, and standard connection kits required for rapid laboratory start-up and immediate operational deployment.

3. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format.

4. Systems shall be warranted for a minimum of one (1) year from FDA acceptance of the system. Warranty shall be included with the equipment and not separately priced. Warranty services shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system firmware improvements and updates. Phone and email technical support shall be included at no additional cost for a minimum of one (1) year.

5. Delivery shall be executed under Delivered Duty Paid (DDP) Incoterms to the final government destination. The Contractor shall finalize factory recertification, clear customs, and deliver the functional system to the FDA laboratory within sixty (60) calendar days after receipt of order (ARO). “Ex Works” (EXW) delivery terms or open-ended delivery windows extending beyond 60 days are technically unacceptable.

Service Records and Reports (Initial and Warranty): The Contractor shall, commensurate with the completion of the initial factory recertification service and any subsequent service calls or repairs executed during the 1-year warranty period, provide the end-user with a copy of a detailed service report. This report must explicitly identify the equipment name, manufacturer, model number, and serial number of the equipment being serviced, a detailed description of the diagnostic or repair work performed, the test instruments used, the name(s) and contact information of the technician who performed the service, and a list of any parts or components replaced. For warranty claims requiring hardware return to the manufacturer’s facility, a comprehensive diagnostic and repair log must accompany the returned unit.

Delivery: Delivery shall be completed within 60 days of contract award at the below address:

Place of Delivery

The instrument shall be delivered to the Center for Biologics Evaluation and Research (CBER) at:

FDA/CBER

10903 New Hampshire Avenue Building 52/72, Room 3248 Silver Spring, MD 20993-0002

POC: will be appointed and contact information will be given upon contract award Deliveries shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Labor Day Birthday of Martin Luther King, Jr. Columbus Day Washington’s Birthday Veterans Day Memorial Day Thanksgiving Day Juneteenth National Independence Day Christmas Day Independence Day

Contract Type: Commercial Product - Firm fixed price

Contract Clauses:

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://www.acquisition.gov/far-overhaul and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR Clauses Required:

52.212-4, Contract Terms and Conditions-Commercial Items (DEVIATION)(RFO Nov 2025)

Applicable:

52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 52.204-13, System for Award Management Maintenance (DEVIATION)(RFO Nov 2025) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (DEVIATION)(RFO Nov 2025) 52.222-3, Convict Labor (DEVIATION)(RFO Nov 2025) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (DEVIATION)(RFO Nov 2025) https://www.acquisition.gov/far-overhaul https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.222-50, Combating Trafficking in Persons (DEVIATION)(RFO Nov 2025) 52.222-90 Addressing DEI Discrimination by Federal Contractors (DEVIATION)(RFO April 2026) 52.223-23, Sustainable Products (DEVIATION)(RFO Nov 2025) 52.225-1, Buy American-Supplies (DEVIATION)(RFO Nov 2025) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) 52.233-3, Protest After Award (DEVIATION)(RFO Nov 2025) 52.233-4, Applicable Law for Breach of Contract Claim (DEVIATION)(RFO Nov 2025) 52.240-91, Security Prohibitions and Exclusions (DEVIATION)(RFO Nov 2025) 52.244-6, Subcontracts for Commercial Products and Commercial Services (DEVIATION)(RFO Nov 2025)

HHSAR Clauses

352.232-71 Electronic Submission of Payment Requests (RFO DEVIATION) (Apr 2026)

(a) Definitions. As used in this clause-

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements in FAR 32.905(b) and the applicable payment clause included in this contract.

(b) Submission instructions. Except as provided in paragraph (c) of this clause, the Contractor must submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) Alternate submission procedures. The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing.

(d) Submission of alternate payment procedures authorization. If alternate payment procedures are authorized, the Contractor must include a copy of the Contracting Officer’s written authorization with each payment request.

(End of clause)

352.239-79 Information and Communication Technology Accessibility (Feb 2024) (DEVIATION)

[(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services http://www.ipp.gov/ https://www.hhs.gov/web/section-508/index.html support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of Clause)

Contract Administration

Contracting Officer

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

or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer is:

Name: Suzanne Martella / Email: suzanne.martella@fda.hhs.gov / Phone: (301) 796-2383 https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat https://www.hhs.gov/web/section-508/accessibility-checklists/index.html mailto:suzanne.martella@fda.hhs.gov

Contracting Officer’s Representative (COR)

The COR is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The following Contracting Officer’s Representative (COR) will represent the Government for this contract (the information below will be provided upon contract award):

Name: / Email: / Phone:

Acceptance

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the COR specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

Payment Terms. Net 30 days after government acceptance of a proper invoice which shall only be submitted after products have been delivered and accepted at the destination point.

In accordance with the “Advance Payment Statute” at 31 U.S.C § 3324: Advance payments will not be made.

Invoice Submission

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.

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

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 mailto:ipp.noreply@mail.eroc.twai.gov

(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.

Solicitation Provisions This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquisition.gov/far-overhaul and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR Provisions 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (Jan 2017) 52.204-7 System for Award Management—Registration (DEVIATION) (RFO Nov 2025) mailto:ERIC@fda.hhs.gov https://www.acquisition.gov/far-overhaul

52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products (Feb 2021) 52.240-90 Security Prohibitions and Exclusions Representations and Certifications (DEVIATION)(RFO Nov 2025)

Full Text Provisions 52.225-2 Buy American-Supplies (DEVIATION) (RFO Nov 2025) (a)

(1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c) of this provision contains a critical component.

(2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select “no”.

(3) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

(4) The terms “commercially available off-the-shelf (COTS) item,” “critical component,” “domestic end product,” “end product,” and “foreign end product” are defined in the clause of this solicitation entitled “Buy American-Supplies.”

(b) Foreign End Products:

Line Item No. Country of origin Exceeds 55% domestic content (yes/no)

(b)[List as necessary]

(c) Domestic end products containing a critical component:

Line Item No. ___ [List as necessary]

(d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation.

(End of provision)

HHSAR Provisions 352.239-78 Information and Communication Technology Accessibility Notice (Feb 2024)

(DEVIATION)

(a) Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

https://www.hhs.gov/web/section-508/index.html

(b) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-79 Information and Communication Technology Accessibility. In order to facilitate the Government’s determination whether proposed ICT supplies, products, platforms, information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions.

The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

(c) If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies, products, platforms, information, documentation, or services support delivered do not conform to the described accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available at https://Section508.gov/.

(e) In order to facilitate the Government’s determination whether proposed ICT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the ICT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(f) Respondents to this solicitation must identify any inability to conform to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(g) Items delivered as electronic content must be accessible to HHS acceptance criteria.

Checklist for various formats are available at https://Section508.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer’s Representative. - (End of provision) -https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat https://section508.gov/ https://section508.gov/

The provision at FAR 52.212-1 Instructions to Offerors - Commercial Products and Commercial Services (DEVIATION)(RFO Nov 2025) applies to this solicitation. The following addenda apply:

Brand Name Limitation & Technical Acceptability:

This requirement is restricted exclusively to a Brand Name solution for the HUMIMIC Starter Kit platform manufactured by the Original Equipment Manufacturer (OEM), TissUse GmbH. This notice is an Intent to Sole Source; competitive quotes are not being requested and “or equal” products will not be accepted or evaluated.

Technical Acceptability: To be deemed technically acceptable, the respondent must provide conclusive, documented technical evidence demonstrating that they are the OEM (TissUse GmbH) or a factory-certified entity possessing the proprietary factory-diagnostic fixtures, source-code firmware, and legal authorization necessary to perform technical calibration, maintenance, and mandatory recertification on physical hardware Serial Number: 68517 (or an OEM-designated equivalent refurbished unit).

Section 508 Accessibility Requirements:

The Quoter shall submit a written Accessibility Conformance Report (ACR) for each item not in compliance with 508 standards identified in clause 352.239-79 (DEVIATION), describing how the item(s) will fully address the accessibility requirements outlined in the solicitation; and a description of the evaluation methods the offeror will use to validate for conformance to the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).

For this requirement, it is explicitly defined that the Section 508 requirement is only applicable to commercial invoices, initial factory service records, and subsequent 1-year warranty service reports/tickets.

NOTE: Submission of the ACR is required for documentation purposes. In accordance with agency purchasing procedures, solutions which do not conform fully to the applicable 508 standards may still be purchased by FDA if the FDA Requiring Office obtains the appropriate approval. In order to obtain approval, the FDA must have an ACR from the vendor documenting the level of conformance of the items being purchased.

Supply Chain Integrity & Authorized OEM Sourcing To ensure strict regulatory compliance, technical calibration consistency, and biological data integrity for advanced cellular microphysiological research, the Government will only accept hardware and services sourced directly from the Original Equipment Manufacturer (OEM), TissUse GmbH (Berlin, Germany). Grey-market distributors, unauthorized international resellers, or secondary-market brokers are non-responsive to this requirement. Submissions from any entity unable to verify direct factory chain-of-custody from the OEM manufacturing facility will be deemed technically unacceptable and will not be evaluated.

Price: The price(s) proposed must be detailed and shall represent the quoter’s response to the schedule of supplies/services above. Quoters are also encouraged to submit a vendor quote with this document.

Include the firm’s Unique Entity ID (UEI) number with quote. Proprietary and/or confidential information shall be clearly marked.

https://www.itic.org/policy/accessibility/vpat http://www.itic.org/policy/accessibility

The government is not responsible for locating or securing any information which is not identified in the quote; the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government.

Period for Acceptance of Offers. The offeror agrees to hold the prices in its quote firm through September 30, 2026.

Buy American Act and Executive Order 14005 Respondent shall provide the exact place (country) of product/service manufacture or performance and any other applicable information to enable review and analysis pertaining to the requirements under the Buy American Act and requirements relating to Executive Order 14005. This information is vital to support the active Nonavailability Waiver request being processed through the Made in America Office (MIAO) Digital Waiver Portal.

Microsoft Suite Documents Containing Macros 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 responsibility to ensure all electronic documents are submitted without the use of macros.

The provision at 52.212-2 Evaluation-Commercial Items (DEVIATION)(RFO Nov 2025) is applicable to this solicitation.

The following subparagraph (a) factors apply:

(a) The Government intends to award a firm-fixed-price commercial contract resulting from this notice of intent to sole source to the Original Equipment Manufacturer (OEM), TissUse GmbH, whose quote, conforming to the solicitation, will be most advantageous to the Government, price and other factors considered. Quotes/capability statements will be evaluated strictly on a Pass/Fail basis on their ability to meet the explicit OEM brand name requirements provided herein.

Technical acceptability will be determined by a comprehensive review of information submitted by the quoter. The respondent must provide sufficient technical information necessary for the Government to conclusively determine that the quoted products meet or exceed the technical requirements identified herein. To be deemed technically acceptable, the submission must unequivocally demonstrate that the entity is the OEM or an OEM-authorized facility possessing the proprietary testing fixtures, software source codes, and legal clearance required to perform factory recertification and maintenance on physical hardware Serial Number: 68517 (or an OEM-designated equivalent refurbished unit). Uninvited submissions from unauthorized third-party brokers unable to verify direct factory chain-of-custody will be determined technically unacceptable and will not be evaluated.

The Government’s determination of technical acceptability in no way relinquishes the Awardee’s contractual obligation to ensure the quoted products meet the FDA’s stated need.

(b) Options. Not applicable.

(c) A written notice of award or acceptance of a quote, mailed or otherwise furnished to the successful quoter within the time for acceptance specified in the quote, shall result in a binding contract without further action by either party. Before the quoter’s specified expiration time, the Government may accept a quote (or part of a quote), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

Notice to Offerors or Quoters:

- System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in this solicitation. Contracting officers will rely on representations from offers based on provisions in the solicitation. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

One or more of the items under this acquisition is subject to the Buy American Statute.

It is the quoter’s responsibility to monitor the Government Point of Entry (GPE) (sam.gov) for information relevant to this solicitation, e.g., questions and answers, amendments, etc. An official authorized to bind the quoter must sign the terms and conditions of the quote. quoters that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation may be excluded from consideration.

Notice Regarding the Use of Macros in Submitted Documents

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.

All responsible sources may submit a quote, which if timely received, shall be considered. The quote must reference solicitation number 75F40126Q135669. Quotes are due by email only to Suzanne Martella at suzanne.martella@fda.hhs.gov on or before Augist 1, 2026, 1:00PM Central Time.

mailto:suzanne.martella@fda.hhs.gov