75F40126Q134073 Sol.pdf

75F40126Q134073

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 75F40126Q134073. This solicitation is issued as a Request for Quote (RFQ).

The associated North American Industry Classification System (NAICS) code for this acquisition is 325413 – In-Vitro Diagnostic Substance Manufacturing; with a Small Business Size Standard of 1,250 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.

Ite m

Description QTY Unit of Measure

Unit Price Extended Price

Microsphere, Avidin MagPlex Bead 16, 1ml, Part #MA-C016-01 or equal

4 Ea $___________ $___________

2 Avidin MagPlex Bead 17, 1ml, Part #MA-C017-01 or equal 4 Ea $___________ $___________

3 Carboxylated MagPlex Bead 12, 1ml, Part # MC10012-01 or equal 4 Ea $___________ $___________

4 Carboxylated MagPlex Bead 13, 1ml, Part # MC10013-01 or equal 2 Ea $___________ $___________

5 Carboxylated MagPlex Bead 18, 1ml, Part # MC10018-01 or equal 1 Ea $___________ $___________

6 Carboxylated MagPlex Bead 19, 1ml, Part # MC10019-01 or equal 4 Ea $___________ $___________

7 Carboxylated MagPlex Bead 20, 1ml, Part # MC10020-01 or equal 1 Ea $___________ $___________

8 Carboxylated MagPlex Bead 21, 1ml, Part # MC10021-01 or equal 4 Ea $___________ $___________

9 Carboxylated MagPlex Bead 22, 1ml, Part # MC10022-01 or equal 4 Ea $___________ $___________

Carboxylated MagPlex Bead 23, 1ml, FM3D Only, Part # MC10023-01 or equal

4 Ea $___________ $___________

Carboxylated MagPlex Bead 24, 1ml, FM3D Only, Part # MC10024-01 or equal

4 Ea $___________ $___________

12 Carboxylated MagPlex Bead 25, 1ml, Part # MC10025-01 or equal 1 Ea $___________ $___________

13 Carboxylated MagPlex Bead 26, 1ml, Part # MC10026-01 or equal 1 Ea $___________ $___________

14 Carboxylated MagPlex Bead 27, 1ml, Part # MC10027-01 or equal 1 Ea $___________ $___________

15 Carboxylated MagPlex Bead 28, 1ml, Part # MC10028-01 or equal 1 Ea $___________ $___________

16 Carboxylated MagPlex Bead 29, 1ml, Part # MC10029-01 or equal 1 Ea $___________ $___________

17 Carboxylated MagPlex Bead 30, 1ml, Part # MC10030-01 or equal 2 Ea $___________ $___________

Carboxylated MagPlex Bead 31, 1ml, FM3D Only, Part # MC10031-01 or equal

4 Ea $___________ $___________

Carboxylated MagPlex Bead 32, 1ml, FM3D Only, Part # MC10032-01 or equal

4 Ea $___________ $___________

20 Carboxylated MagPlex Bead 33, 1ml, Part # MC10033-01 or equal 1 Ea $___________ $___________

21 Carboxylated MagPlex Bead 34, 1ml, Part # MC10034-01 or equal 1 Ea $___________ $___________

22 Carboxylated MagPlex Bead 35, 1ml, Part # MC10035-01 or equal 1 Ea $___________ $___________

23 Carboxylated MagPlex Bead 36, 1ml, Part # MC10036-01 or equal 1 Ea $___________ $___________

24 Carboxylated MagPlex Bead 37, 1ml, Part # MC10037-01 or equal 1 Ea $___________ $___________

25 Carboxylated MagPlex Bead 38, 1ml, Part # MC10038-01 or equal 2 Ea $___________ $___________

Carboxylated MagPlex Bead 40, 1ml, FM3D Only, Part # MC10040-01 or equal

4 Ea $___________ $___________

Carboxylated MagPlex Bead 41, 1ml, FM3D Only, Part # MC10041-01 or equal

4 Ea $___________ $___________

28 Carboxylated MagPlex Bead 42, 1ml, Part # MC10042-01 or equal 1 Ea $___________ $___________

29 Carboxylated MagPlex Bead 43, 1ml, Part # MC10043-01 or equal 1 Ea $___________ $___________

30 Carboxylated MagPlex Bead 44, 1ml, Part # MC10044-01 or equal 1 Ea $___________ $___________

31 Carboxylated MagPlex Bead 45, 1ml, Part # MC10045-01 or equal 1 Ea $___________ $___________

32 Carboxylated MagPlex Bead 46, 1ml, Part # MC10046-01 or equal 1 Ea $___________ $___________

33 Carboxylated MagPlex Bead 51, 1ml, Part # MC10051-01 or equal 1 Ea $___________ $___________

34 Carboxylated MagPlex Bead 52, 1ml, Part # MC10052-01 or equal 1 Ea $___________ $___________

35 Carboxylated MagPlex Bead 53, 1ml, Part # MC10053-01 or equal 1 Ea $___________ $___________

36 Carboxylated MagPlex Bead 54, 1ml, Part # MC10054-01 or equal 1 Ea $___________ $___________

37 Carboxylated MagPlex Bead 55, 1ml, Part # MC10055-01 or equal 1 Ea $___________ $___________

38 Carboxylated MagPlex Bead 61, 1ml, Part # MC10061-01 or equal 2 Ea $___________ $___________

39 Carboxylated MagPlex Bead 62, 1ml, Part # MC10062-01 or equal 1 Ea $___________ $___________

40 Carboxylated MagPlex Bead 63, 1ml, Part # MC10063-01 or equal 1 Ea $___________ $___________

41 Carboxylated MagPlex Bead 64, 1ml, Part # MC10064-01 or equal 1 Ea $___________ $___________

42 Carboxylated MagPlex Bead 65, 1ml, Part # MC10065-01 or equal 1 Ea $___________ $___________

Grand Total (Items 1-42):

GSA Contract Number: __________________ (if applicable)

Requirement

The US FDA, Center for Biologics Evaluation and Research (CBER) requires magnetic carboxylated microsphere beads for use in fluorescent magnetic immunoassays (FMIA) to support the viral research and review program. These microspheres are essential components for evaluating antigen-specific immune responses in multiplex assay formats pertaining to post-vaccination and post-infection immunity for all current circulating and emerging strains of RSV, influenza and other viruses. The microspheres will be used for conjugation of antigens of interest via amine coupling chemistry and subsequent evaluation in multiplex immunoassays using flow cytometry platforms. Utilization of FMIA enhances throughput versus evaluation of antigen specific immune response using a technique such as ELISA. Multiple antigens can be tested in one well. Luminex MagPlex microspheres are functional in general flow cytometry systems. The flexibility of these microspheres to be used in multi-laser flow cytometers allows for increased throughput with the same sample as binding of multiple antigen specific antibodies can be evaluated in the same well. The supplies and instruments we currently possess necessitate the use of carboxylated magnetic microspheres so that crucial experiments can continue.

Minimum Requirements/Specifications for the magnetic carboxylated microsphere beads:

Physical and Chemical Properties:

1. Surface Chemistry: Carboxylated (COOH functional groups)

2. Magnetic Properties: Superparamagnetic or paramagnetic properties suitable for magnetic separation

Functional Requirements

1. Conjugation Capability: Suitable for amine coupling chemistry (EDC/NHS or equivalent)

2. Unique Identification: Each bead set must have distinct fluorescent signatures identifiable by flow cytometry

3. Variety: Minimum of 20 distinct bead regions/sets available for multiplex applications

4. Flow Cytometry Compatibility: Functional in multi-laser flow cytometry systems (minimum 2-laser systems)

5. Stability: Minimum 6-month shelf life from date of delivery when stored per manufacturer’s recommendations

6. Must not be expired.

Quality Standards

1. Lot-to-lot consistency in fluorescent intensity and magnetic properties

2. Free from microbial contamination

3. Free from aggregation or clumping

Delivery: Delivery is expected within 60 days of contract award to the below address:

Place of Delivery

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

US FDA/CBER

10903 New Hampshire Ave.

Bldg 52/72, Room 1230 Silver Spring MD 20993

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 https://www.acquisition.gov/far-overhaul 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) 52.209-6, 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) 52.222-3, Convict Labor (DEVIATION)(RFO Nov 2025) 52.222-36, Equal Opportunity for Workers with Disabilities (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) 52.225-3, Buy American- Free Trade Agreements-Israeli Trade Act (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) 52.232-36, Payment by Third Party (DEVIATION) (RFO Apr 2026) 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 (Apr 2026)(RFO DEVIATION)

(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.

http://www.ipp.gov/

(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, 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.

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

(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 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 product(s) have been delivered 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 mailto:suzanne.martella@fda.hhs.gov

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S.

Department of Treasury’s Invoice Processing Platform System (IPP).

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

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

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

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

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

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

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov

• 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 mailto:ERIC@fda.hhs.gov 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 52.203-18 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) 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)

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 52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate (DEVIATION) (RFO Nov 2025), Alternate II (Jan 2025) (a)

(1) The Offeror certifies that each end product, except those listed in paragraph (b) or (c)(1) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c)(2) of this provision contains a critical component.

(2) The terms "Bahraini, Moroccan, Omani, Panamanian, or Peruvian end product," "commercially available off-the-shelf (COTS) item," "critical component," "domestic end product," "end product," https://www.acquisition.gov/far-overhaul

"foreign end product," "Free Trade Agreement country," "Free Trade Agreement country end product," "Israeli end product," and "United States" are defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act."

(b) The Offeror certifies that the following supplies are Korean end products or Israeli end products as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act”.

Korean End Products or Israeli End Products:

Line Item No. Country of origin

[List as necessary] (c)

(1) The Offeror shall list those supplies that are foreign end products (other than those listed in paragraph (b) of this provision) as defined in the clause of this solicitation entitled "Buy American- Free Trade Agreements-Israeli Trade Act."

Other Foreign End Products:

Line Item No. Country of origin

[List as necessary]

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

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)

The provision at FAR 52.212-1 Instructions to Offerors - Commercial Products and Commercial Services (DEVIATION)(RFO Aug 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 http://www.itic.org/policy/accessibility

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 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 Aug 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 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.

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

All responsible sources may submit a quote, which if timely received, shall be considered. The quote must reference solicitation number 75F40126Q134073. Quotes are due by email only to Suzanne Martella at suzanne.martella@fda.hhs.gov on or before June 16, 2026, 3:30PM Central Time.

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