REQUEST FOR QUOTE

SODIUM IODIDE DETECTOR FOR THYROID COUNTING

BRAND NAME OR EQUAL

Request for Quote (RFQ) 75F40126Q00375 for Sodium Iodide Detector for Thyroid Counting and Support. This will be a single Firm Fixed Price (FFP) award and will be solicited as a Total Small Business set-aside under NAICS code 334516 - Analytical Laboratory Equipment Manufacturing, with a Small Business Size Standard of 1,000 employees.

This solicitation incorporates provisions and clauses by reference. Full text of provisions and clauses may be accessed electronically at:

https://www.acquisition.gov/far/

The Government is not obligated to make an award, nor shall it be liable for any costs incurred by an offeror in preparing and submitting a quotation.

1. PURPOSE

The purpose of this requirement is to acquire a Specialized Sodium Iodide Detector for Thyroid Counting

2. BACKGROUND

The FDA Winchester Engineering and Analytical Center (WEAC) thyroid counting system currently utilizes Sodium Iodide detectors that are more than 20 years old. One detector is exhibiting signs of failure.

Maintaining a functional thyroid detector system is required under the Office of Compliance and Safety (OCS) U.S. Nuclear Regulatory Commission (NRC) License No. 20-08361-01.

The thyroid counting system serves as a safety resource available to multiple FDA offices.

3.SALIENT CHARACTERISTICS

The equipment offered shall meet or exceed all requirements listed below.

Detector Characteristics

• 3”X 3” NaI(Tl) LED Stabilized Scintillation Detector

• Energy Range 30 keV to 3 MeV

• Resolution >7% https://www.acquisition.gov/far/

• Available with generic efficiency characterization

• OPERATING HUMIDITY – 85% non-condensing

• OPERATING TEMPERATURE – -20 to +50 °C (-4 to 122 °F).

• Must be compatible and seamlessly compatible with Apex InVivo Software and

Mirion Osprey Multichannel Digital Analyzer

• Diameter less than 3.5”

• Weight < 6 lbs

Multi-Channel Digital Analyzer Characteristics

• Includes HVPS, Preamplifier and Digital MCA

• Gain Coarse Gain: x1, x2, x4, x8 software programmable

• Fine Gain: x1 – x5 software programmable

• Total Gain: Product of Fine Gain and Coarse Gain, x1 – x40

• ADC: ADC 14-Bit 20 MHz Sampling

• ULD/LLD ULD: 0% to 100% of Full Scale software programmable

• LLD: 0% to 100% of Full Scale software programmable

• Detector Voltage: HVPS 0 to +1300 V dc: 100 V/s ramping on power up and down

• Shaping DSP Based Trapezoidal shaping filter operating at 80 MHz

• Rise Time: 0.2 μs – 5 μs in 200 ns steps. Default: 1 μs for NaI probe

• Flat Top: 0 to 3 μs in 100 ns steps. Default: 1 μs for NaI probe

• Digital Spectrum Stabilization

• Automatic Baseline Restore

• Automatic Fast Discriminator threshold

• Seamlessly compatible with Apex InVivo Software

• USB 2.0 and Ethernet 10/100BaseTX Output

• 14 pin and 8 pin PMT socket compatible

• Diameter less than 3.5”

• Weight < 6 lbs

• ACQUISITION MODES

• PHA PHA Channels: 256 to 2048 Channels, supports two memory groups of up to 2048 channels each

• Preset: ROI Counts (Integral), Real or Live Time timers

• Real and Live Time Resolution: 0.01 s

• Preset Time: 0 to >4 x 107 s

• Control: Internal or External Start/Stop control

• LTC accuracy: 5% (3% typical) up to 50 kcps

• MCS

• MCS Dwell range: 1 μs to 999 seconds in 1 μs steps

• Sweep range: 1 to 232 -1

• Preset Sweep Counter: 0 to 232 -1 Sweeps (0 implies "Forever")

• MCS input selection: PHA ROI, external TTL or Fast Discriminator

• Dwell selection: internal or external

• MCS Channels: 256 to 2048 Channels, supports two memory groups of up to 2048 channels each

• 8192 Channels Configurable as two groups of 2048, 1024, 512 or 256 channels for PHA and MCS with 32 bits per channel

• Integral Non-linearity: ±0.025% of full scale over the top 99% of the selected range

• Differential Non-linearity: ±1% over the top 99% of the range including the effects from integral non-linearity

• Gain Drift: <75 ppm/°C after 15 minutes of operation

• Incoming Count Rate (ICR): >250 K cps ICR if not limited by probe/detector

• Short Circuit Protection

• High Voltage Power Supply

• OUTPUT: 0-1300 V at 50 μA max

• RIPPLE: 1 mV — ACCURACY: 3% Full Scale

• SETTING RESOLUTION: 14-bit (1/16 384)

4. WARRANTY AND SUPPORT

The Contractor must provide a minimum 12-calendar-month warranty covering all parts and labor.

The warranty period must begin on the date of formal Government acceptance.

Warranty service must include repair or replacement of defective components necessary to maintain operation of the delivered system.

5.DELIVERABLES

Table 1. Deliverables / Schedule

Deliverable Quantity Unit Price

3X3 LED Temperature stabilized Sodium Iodide Probe compatible with Mirion Osprey Multi Channel Analyzer

Delivery Date: 9/15/2026 1 Each

Digital Tube Based Multichannel Analyzer with USB and Ethernet output

Delivery Date: 09/15/2026 1 Each

6. Shipping Address (FOB Destination) *In-Side Delivery_______________________________

The instrument system, installation, training, and warranty support shall be delivered and performed at:

Attn Elon Malkin

FDA WEAC

109 HOLTON ST

WINCHESTER MA 01890

Delivery, installation, and training shall occur during normal Government business hours:

Monday–Friday, 8:00 AM–4:00 PM, excluding Federal holidays and Government closures.

The Contractor shall coordinate delivery and installation with the Government Point of Contact prior to shipment.

All shipping, handling, freight, and delivery charges must be included in the Firm-Fixed-Price quotation.

The Contractor must not schedule deliveries, installations, or services during Federal holidays or Federal closures.

Federal holidays include:

• New Year's Day

• Martin Luther King Jr.'s Birthday

• Washington's Birthday

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

7. PERIOD OF PERFORMANCE

The period of performance must begin upon award.

Delivery, installation, and acceptance must be completed no later than 90 calendar days after award.

The warranty period must begin upon formal Government acceptance and must remain in effect for twelve (12) calendar months.

8. ACCEPTANCE

Acceptance: Supplies and/or services delivered hereunder must be inspected and accepted at destination by the Governments Contracting Officer Representative (COR) specified at award. If the supplies or services are acceptable, the COR must promptly forward a report of inspection and acceptance to the paying office.

If the supplies or services are not acceptable, the COR must document the nonconforming items/services and immediately notify the Contracting Officer.

9. CONTRACT TYPE____________________________________________________________

This requirement will result in a Firm-Fixed-Price (FFP) contract.

10. CONTRACT ADMINISTRATION_______________________________________________

Contracting Officer (CO):

Lilibeth Deato

Email: lilibeth.deato@fda.hhs.gov

Contracting Officer’s Representative (COR):

(To be entered at time of award)

11. CONTRACTING OFFICER’S AUTHORITY __________________________________

The Contracting Officer (CO) 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 RFQ; (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. No statement, whether oral or written, by anyone other than the Contracting Officer, must be interpreted as modifying the terms and conditions of this award. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the award. The Government will not reimburse the Contractor for any work not authorized by the Contracting Officer, including work outside the scope of the award.

The Contracting Officer’s Representative (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 contract 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.

12. IPP INVOICING INSTRUCTIONS_______________________________________________

(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 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) 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.

(1) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. or phone (866)

973-3131. 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.

(2) 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.

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

mailto:IPPCustomerSupport@fiscal.treasury.gov

(4) If the Contractors 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.

(1) At a minimum the following cost information must 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 Indirect)-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 must 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 FAR52.216-8 if applicable.

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

(1) list of all invoices submitted to date under the subject award, including the following: invoice number, amount, & date submitted-corresponding payment amount &date received -totalamountofallpaymentsreceivedtodateunderthesubjectcontractororder-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 must 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 must not be paid, or must 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.

13. PAYMENT TERMS___________________________________________________________

Net 30 days following Government acceptance of a proper invoice. Invoices for post-warranty, preventive maintenance, or certification services must be submitted no more frequently than monthly, and strictly in arrears. No advance payments will be made.

14. FAR / HHSAR Clauses_________________________________________________________

FAR 52.252-2 – Clauses Incorporated by Reference (Feb 1998) This purchase order 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 following FAR and HHSAR provisions and clauses, incorporated by reference, apply to this acquisition and can be obtained in full text at:

and http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.203-19 – Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 52.209-10 – Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015) 52.212-4 - Contract Terms and Conditions-Commercial Products and Commercial Services (Nov 2023) 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) 52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) 52.240-90 - Security Prohibitions and Exclusions Representations and Certifications (April 2026) 52.240-91 – Security Prohibitions and Exclusions (Dec 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 identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) 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.

http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

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

(d) 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)

HHSAR 352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

(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 electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at https://www.hhs.gov/web/508 . The complete text of Section 508 Final Provisions can be accessed at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements) Chapter 2 (Scoping Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria.

• Accessibility checklists for various formats are available at the HHS site. Materials that are final items must be compliant with Section 508 at time of delivery, except upon approval of the Contracting Officer or Representative.

• E207 Software (Appendix A, Application and Scoping Requirements)

• Chapter 4 Hardware Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements) Chapter 6 Support Documentation

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website:

(https://www.hhs.gov/web/508 ). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at https://www.hhs.gov/web/508 . If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(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 must 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 must 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 https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/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.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat 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 must identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of Clause)]

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.

(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.

https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat https://section508.gov/

(g) Items delivered as electronic content must be accessible to HHS acceptance criteria. Checklists for various formats are available at http://508.hhs.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)

The Quoter must 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 2.5 (MS Word) provided by the Industry Technology Industry Council (ITIC).

For this requirement, only invoices and service records/reports are anticipated to be applicable to the 508 requirement.

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.

15. Instructions to Quoters_________________________________________________________ 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.

Microsoft Suite Documents Containing Macros. The offeror or applicant must 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.

Technical Acceptability. Offerors must provide sufficient technical information necessary for the government to conclusively determine that the offered service/equipment/product 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.

To be considered for award, quotes of “equal” products, including “equal” products of the manufacturer must 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 must include a narrative describing how the offered product(s) meet(s) each salient characteristic as well as a demonstration of how each salient characteristic is fully met.

http://508.hhs.gov/ https://www.itic.org/policy/accessibility/vpat http://www.itic.org/policy/accessibility http://www.itic.org/policy/accessibility

Price proposed must be detailed and must represent the offeror’s response to the schedule of supplies/services above. In Addition, all shipping and handles must be included in the price.

Authorized reseller and/or servicing agent must identify and/or provide documentation to confirm their claim as an authorized reseller and/or servicing agent.

Unique Entity Identifier (UEI). To be considered for an award the offeror must be registered and active in SAM (www.sam.gov) by the date and time set forth for receipt of quotes/proposals. Proprietary and/or confidential information must be clearly marked. Respondent’s SAM Unique Entity Identifier (UEI) number must be included with quote.

Buy American Act and Executive Order 14005.

If applicable, respondent must 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. If the respondent does not provide a response for a line item, or if the respondent’s SAM.gov online representation for FAR provision 52.225-4, Buy American-Free Trade Agreements-Israeli Trade Act Certificate, is not completed or is unclear, the Government will presume that the item is made in America.

Line Item No. Country of Origin

Period for Acceptance of Offerors. The offer agrees to hold the prices in its offer firm through September 30, 2026.

16. Evaluation Criteria____________________________________________________________ The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. In this case, the Government intends to award a Firm‐Fixed‐Price contract resulting from this Solicitation to the lowest-priced technically acceptable (LPTA) and responsible offeror. Offers will be evaluated on their ability to meet the requirements provided herein. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined.

The following evaluation factors apply:

(i) Technical Acceptability

(ii) Price

Technical Acceptability will be determined by review of information submitted by the offeror who must provide sufficient descriptive material to demonstrate the proposed meet all requirements and by addressing each technical requirement as stated above for the Government to conclusively determine the proposed will satisfy its requirement.

http://www.sam.gov/

A written notice of award or acceptance of an offer will be transmitted via email to the successful offeror within the time for acceptance specified in the offer, must result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

The Government is not responsible for locating or securing any information which is not identified in the proposal and reserves the right to request additional information or conduct discussions at any time.

The Government reserves the right to request additional information or conduct discussions at any time.

Once the Government determines the offeror that is the best-suited (i.e., the apparent successful offeror), the Government reserves the right to communicate with only that offeror to address any remaining issues, if necessary, and finalize a contract with that offeror. These issues may include technical, price or other issues.

The Government's determination of technical acceptability in no way relinquishes the Awardee's contractual obligation to ensure all equipment and/or services meet the FDA’s stated need.

NOTICE

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.

It is the offeror's responsibility to monitor sam.gov for the release of any information related to this acquisition, e.g., questions and answers, amendments, award notice, etc. Offerors that fail to complete the required representations and certifications or reject the terms and conditions of the solicitation may be excluded from consideration.

Offerors must submit quotes and supporting documents electronically No Later Than 2:00 pm EST on Monday, August 31, 2026.

(End of Solicitation)