75F40126Q131715

This is a combined synopsis/solicitation for commercial items 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 solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is 75F40126Q131715. This solicitation is issued as a Request for Quote (RFQ).

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 solicited full and open, any sized business under the applicable NAICS may submit a quote.

Schedule of Supplies or Services and Prices/Costs. Prices shall be inclusive of shipping and installation.

Item

Description Est.

QTY

Unit of Measure Unit Price Extended

Price

ConsiGma Standalone PAT Laboratory Test Rig (Basic Equipment) or equivalent instrument.

Ea

Grand Total:

GSA Contract Number: __________________ (if applicable)

Background

The US FDA, Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR) supports the modernization of pharmaceutical manufacturing by conducting regulatory science research on emerging technologies. Continuous manufacturing (CM) of oral solids has been recognized as an emerging technology by the FDA. Continuous process monitoring and manufacturing process control are critical for establishment of a robust CM process that can consistently produce product of desired quality while identifying and mitigating manufacturing risks.

Currently, OPQR possesses an integration platform that combines multiple powder feeders and a continuous blender. The integration platform is used to produce powder blend samples under specified experimental conditions. However, the existing platform lacks the capability to monitor the properties of the powder blend as it exits the blender. This package will expand the platform's capabilities to permit in-line property measurements of the resulting powder blend, as well as enable easier and more consistent blend sampling.

Requirement

The Center/Office/Program (COP) has a requirement for a GEA North America LLC ConsiGma standalone Process Analytical Technology (PAT) Rig, or an equivalent product. The PAT rig will enable smooth, controlled flow of the powder blend over a near infrared (NIR) probe for consistent measurement of NIR spectra. The PAT rig will be adaptable to CM operation, including options for seamless integration of upstream and downstream unit operations. The NIR spectra of the flowing powder blend, measured in real time, will be analyzed to assess various properties of the blend. This equipment will be essential in supporting the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) review processes for CM applications.

Minimum Requirements/Specifications:

The Process Analytical Technology (PAT) Rig shall:

1. Be constructed from stainless steel product contact metal surfaces with pharmaceutical grade metal finish.

2. Be constructed from FDA-compliant materials for all non-metal product contact equipment parts.

3. Have passed factory acceptance testing and site commissioning prior to shipping.

4. Be calibrated prior to shipping.

5. Undergo installation and operational qualification after installation, including recalibration if required.

6. Be portable with casters and brakes.

7. Consist of a vertical tube or chute through which pharmaceutical powders can flow with minimal to no mixing or turbulence.

8. Contain a sealable insertion point in the vertical tube or chute into which an NIR measurement probe between 10–20 mm in diameter can be inserted into the flowing powder with minimal to no disruption to powder flow.

9. Permit continuously adjustable speed at which powder exits the bottom of the vertical tube or chute to match the flow rate of the incoming powder.

10. Permit flow of cohesive powder through the tube or chute without impacting the accuracy or precision of an NIR spectrometer.

11. Be adaptable to continuous manufacturing operation which includes options for the seamless integration of upstream and downstream unit operations.

12. Include a minimum of one (1) year parts and labor with warranty from date of installation/commissioning.

Delivery, Installation, Training and Additional System Requirements:

1. The components and equipment shall be newly manufactured, not used and refurbished or previously used for demonstration.

2. Offered systems shall be a turn-key solution i.e., the Contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.

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

4. Installation shall be conducted by factory-certified service personnel, who shall demonstrate that all modules start up properly, are correctly installed and connected.

5. 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.

6. The Contractor shall provide all labor, travel, and tools to install, qualify, and recalibrate the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications.

7. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization for at least two (2) attendees. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures.

8. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. 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, immediate access to system improvements and updates, labor and travel costs. Phone and email technical support shall be included for a minimum of one (1) year.

Deliverables: Service Records and Reports: The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service call), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Delivery Terms: Delivery, installation, qualification, and training are expected to be completed within 280 days of contract award at the below address:

Food and Drug Administration Center for Drug Evaluation and Research (CDER) 5901 Ammendale Road, Suite D Beltsville MD 20705

POC: will be appointed and contact information will be given upon contract award.

Delivery 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 IndependenceDay 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 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020) Alternate I (Nov 2021) 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) 52.209-6, Protecting the Government’s Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (DEVIATION)(RFO Nov 2025) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (DEVIATION)(RFO Nov 2025) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (DEVIATION)(RFO Nov 2025) 52.219-8, Utilization of Small Business Concerns (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) 52.222-35, Equal Opportunity for Veterans (DEVIATION)(RFO Nov 2025) 52.222-36, Equal Opportunity for Workers with Disabilities (DEVIATION)(RFO Nov 2025) 52.222-37, Employment Reports on Veterans (DEVIATION)(RFO Nov 2025) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEVIATION) (RFO Nov 2025) 52.222-50, Combating Trafficking in Persons (DEVIATION)(RFO Nov 2025) 52.222-90 Addressing DEI Discrimination by Federal Contractors (DEVIATION)(RFO Apr 2026) 52.223-23, Sustainable Products (DEVIATION)(RFO Nov 2025) 52.225-5, Trade Agreements (Nov 2023) 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) https://www.acquisition.gov/far-overhaul https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

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 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, http://www.ipp.gov/ https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat 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

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 COR will represent the Government for this contract (the information below will be provided upon contract award):

Name:

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html mailto:suzanne.martella@fda.hhs.gov

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 shipment(s) have been delivered, installed, qualification tested/calibrated and accepted at the destination point. In accordance with the “Advance Payment Statute” at 31 U.S.C § 3324: Advance payments shall 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.

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 http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

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

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

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

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

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

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

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

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

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

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

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

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

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

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

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

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

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

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.

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 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sep 2024) 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

52.219-1, Small Business Program Representations (DEVIATION)(RFO Nov 2025) 52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products (Feb 2021) 52.229-11, Tax on Certain Foreign Procurements—Notice and Representation (DEVIATION)(RFO Nov 2025) 52.240-90 Security Prohibitions and Exclusions Representations and Certifications (DEVIATION)(RFO Nov 2025)

Notice to Offerors:

- 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.

Full Text Provisions 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:

Quoters shall provide sufficient technical information necessary for the government to conclusively determine that the offered service/equipment meets all the technical requirements herein, to include descriptive material, literature, brochures and other information corresponding to each minimum technical requirement which demonstrates the capabilities of the offered system. The Government is not responsible for locating or securing any information which is not identified in the quote; however, the Government reserves the right to obtain information for use in the evaluation from any sources including sources outside of the Government. The Government reserves the right to request additional information at any time.

Technical Acceptability: Quoter must provide sufficient technical information for the Government to conclusively determine that the quoted product meets or exceeds the minimum requirements identified above. In addition to identifying manufacturer, make, and model of quoted products, it is incumbent of quoters that they unequivocally demonstrate that quoted products meet the requirements herein through the submission of technical specifications, descriptive material, scientific literature, brochures, scientific publications where proposed solution has been used for same or similar purposes, and other information which demonstrates the capability of the quoted equipment. Quoters shall address the technical requirements identified above, as well as provide detailed information on the item(s) in the solicitation.

To be considered for award, quotes of “equal” products, including “equal” products of the sole source manufacturer shall meet the salient physical, functional, or performance characteristic specified in this solicitation; clearly identify the item by brand name, if any; and make or model number. “Equal” quotes shall include a narrative describing how the offer meets each salient characteristic as well as a demonstration of how each salient characteristic is fully met.

The Quoter shall submit a written Accessibility Conformance Report (ACR) for each item not in compliance with 508 standards identified in clause 352.239-74, 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 anticipated the 508 requirement will only be applicable to invoices and service records/reports.

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.

Letters of Supply (if applicable) Quoters who are authorized resellers of an item, and not the manufacturer, shall provide a copy of their letter of supply or other documentation substantiating their relationship as an authorized reseller of the proposed manufacturer’s product. The documentation shall be on the Original Equipment Manufacturer (OEM) letterhead and include contact information for the individual who has signed the letter.

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.

The government is not responsible for locating or securing any information which is not identified in the proposal; 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 If applicable, respondent shall provide 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 Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request submitted through the Made in America Office (MIAO) Digital Waiver Portal is required.

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 http://www.itic.org/policy/accessibility 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 contract resulting from this solicitation to the lowest priced technically acceptable responsible quoter/offeror whose quote, conforming to the solicitation, will be most advantageous to the Government, price and other factors considered. Quotes will be evaluated on their ability to meet the requirements provided herein. The lowest priced quote will be evaluated first. If the lowest priced quote is not technically acceptable, the next lowest priced quote will be evaluated and so on until a technically acceptable quote is determined.

Technical acceptability will be determined by review of information submitted by the quoter which must provide sufficient technical information necessary for the Government to conclusively determine that the quoted products meet or exceed the technical requirements identified herein.

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.

One or more of the items under this acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements.

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.

52.225-6 Trade Agreements Certificate (Feb 2021)

(a) The offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled "Trade Agreements."

(b) The offeror shall list as other end products those supplies that are not U.S.-made or designated country end products.

Other End Products:

Line item No. Country of origin

[List as necessary]

(c) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for those products are insufficient to fulfill the requirements of this solicitation.

(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.

(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.

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

(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.

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All responsible sources may submit a quote, which if timely received, shall be considered. The quote must reference solicitation number 75F40126Q134715. Quotes are due by email only to Suzanne Martella at suzanne.martella@fda.hhs.gov on or before June 17, 2026, 3:30PM Central Time.

https://section508.gov/ https://section508.gov/ mailto:suzanne.martella@fda.hhs.gov