RFQ_75F40125Q00280_pdf.pdf

REQUEST FOR QUOTE

Molecular Dynamics Modeling Simulation

Platform software

FDA-RFQ - 75F40125Q00280

DATE POSTED: August 14, 2025

RESPONSE DATE: August 22, 2025, by 1:00PM EST

CLASSIFICATION CODE: 7A20 – IT and Telecom-Application Development Software

NAICS CODE: 513210 – Software Publishers

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. It is the Government's intent to issue a Firm Fixed Priced Purchase Order in accordance with FAR Part 13.

The solicitation number is FDA-SOL-75F40125Q00280. This solicitation is issued as a Request for Quote (RFQ).

This is a Full and Open Competition.

The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular 2025-03, effective 01 January 2025. FAR and HHSAR provisions and clauses referenced in this RFQ can be found on the following website: https://www.acquisition.gov/browse/index/far

1. Statement of Need _______________________________________________________________ The Food and Drug Administration’s (FDA) Office of Product Quality and Research (OPQR) conducts research to advance the adoption of emerging technologies for pharmaceutical manufacturing and support the regulatory review, inspection of FDA regulated products. OPQR uses artificial intelligence (AI) and machine learning (ML) based advanced molecular dynamic simulation tools for assessing the impact of manufacturing process parameters, material attributes and end user handling on the quality and performance of complex drug products and biologics. These studies include but are not limited to atomic and molecular level modeling and simulation of protein-excipient interaction in liquid, frozen and dried products, drug-interface interaction, liposome and nanomaterials structural dynamics, drug-excipient interactions, etc. To this end OPQR needs a molecular simulation platform or comparable platform and associated technical support to support ongoing research.

2. Supplies or Services and Price/Cost__________________________________________________

Item No

Description Qty Unit Price https://www.acquisition.gov/browse/index/far

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3. Technical Requirement____________________________________________________________ The Contractor shall provide brand name or equal software license. The salient characteristics as follows:

The required technical features of molecular dynamic simulation software package are:

• Shall be a high-performance molecular dynamics simulations platform capable of designing, modeling and simulating biological interactions, antisense oligonucleotides, protein-excipient and protein-ice interactions, protein-ligand complexes, viral capsid and macromolecular complexes with high throughput and scientific accuracy.

• Shall have a validated, proven, stable and robust framework for the calculation of energies and forces for atomistic force field models.

• Shall describe interactions between atoms in system using modern force fields with comprehensive coverage of chemical space for small molecules, biologics and materials science applications.

• Shall be a professionally managed software that is broadly available and used by the pharmaceutical industry to facilitate knowledge transfer from and to the FDA.

• Shall leverage machine learning to accurately and rapidly predict the aqueous phase pKa values and protonation state distributions of monoclonal antibodies and globular proteins.

• Shall employ supervised machine learning (ML) for predicting molecular properties based on chemical structure.

• The supervised learning platform shall be easy to implement by novice and experienced users.

• Shall be a user-friendly machine learning tool for relating properties derived from molecular simulations to key experimental properties.

• Shall predict quantitative structure activity/property relationship models.

• Shall offer a robust workflow for data management, storage, and computing resource management to streamline simulation projects.

• Shall manage and stores large volumes of image and quantitative data efficiently.

• Shall perform stability and reactivity analysis and facilitates the study of biologics and small molecule drug stability and reactivity under various conditions.

• Shall be a fast, general-purpose computing on graphics processing units (GPGPU) enabled molecular dynamics simulation program.

• Shall simulate systematic temperature variation and the progressive removal of water from a complex model system.

• Shall include well validated workflows for protein structure preparation including homology modeling particularly for antibodies, protein loop sampling, structural relaxation and protonation state assignment.

001 Molecular dynamic simulation software package

1 12 months

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• Shall simulate and analyzes protein-excipient combination and identify excipient hotspots near protein surfaces in solutions and freeze-dried products.

• Shall simulate protein excipient interactions of not less than 70000 atoms over a simulation duration of not less than 270 ns

• Shall support three dimensional visualization of reactions and analysis.

• Shall include analysis tools for protein structures sampled during simulations of protein containing systems such as secondary structure analysis, protein patch analysis.

• Shall be capable of constructing systems containing a mixture of proteins with complex composition of non-biological components.

• Shall characterize complex mixtures of components including radial distribution functions, spatial density analysis, glass transition temperatures and diffusion rates.

• Shall conduct simulations in NPT or NP𝝻𝝻T ensembles (constant temperature and pressure), with typical temperatures of 233.15 K and 300 K, or other mutually agreed-upon values.

• Shall simulate interactions between formulations and lipid-based systems, liposomes, or other nanomaterials.

• Shall analyzes the 3D distribution of components within lyophilized formulations, including small and complex molecules.

• Shall include parameter analysis including but not limited to trajectories, root mean square deviation (RMSD), energy profiles, and other critical data from simulation systems.

• The MD simulation platform shall have a user accessible script-based automation of complex modeling workflows.

• The above features shall be available in a single, integrated suite of software with a well-developed graphical user interface for visualizing molecular systems, enable interpretation of results and facile interoperability of the protein-focused and materials science-focused capabilities for molecular dynamics and machine learning.

• Shall be deployable on DPQR network. and compatible with hardware in OPQR Precision 7920 Tower:

o Memory: 128GB o GPU: Dual Nvidia RTX A5000 (8192 CUDA cores each), 24GB o Operation System: Ubuntu o CPU: Intel Xeon Gold 5220R 2.2GHz (24 cores) o Storage: 512GB

• Shall accelerate performance of above Graphics processing unit (GPU) or comparable by at least 60%

• Alternatively, the vendor may supply software with compatible government approved hardware, GPUs or high-performance computing platform.

• The platform and the vendor’s scientists shall be well published and have a proven track record on solving pharmaceutical and regulatory science challenges involving MD simulation.

• Shall provide technical support and perform simulation parallel to FDA’s projects at client requests.

• Shall including packages, license, and libraries for:

o Machine learning-based predictive modeling.

o Molecular visualization and chemical informatics.

o Conformational sampling.

o Scaffold replacement for novel molecule design.

P a g e 4 | 14 o pKa and protonation state prediction tool.

o 3D-QSAR modeling.

o Ligand-receptor docking.

o Ligand preparation and stereochemical variation.

o Molecular mechanics simulations.

o Predicts drug permeability across membranes and interfaces.

o Protein structure prediction and refinement.

o Quantum mechanics and Molecular mechanics simulations for reactions of proteins and ligands.

o Binding site identification for proteins.

o Design, characterization, and optimization of drug formulations and delivery systems at the molecular level.

o Biologics modeling (e.g., antibodies).

o KNIME, Maestro, and OPLtS Access Licenses: Data workflows, GUI, and force field support

• Shall be compatible with the current DPQR software such as GROMACS.

4. Delivery Locations ________________________________________________________________ The Contractor shall provide the following deliverables for the base period to the Contract Officer’s Representative (COR). The vendor will cover all costs associated with the following:

• System software, shipping, and delivery.

• Full system installation in person or screen sharing support on FDA OPQR in house high-performance workstation with the help of client’s IT professional.

• Provide all necessary training to run the projects on simulating, analyzing and visualizing the formulations, molecular interactions, and manufacturing of complex drugs.

• All necessary training and technical support to execute associated projects on simulating, analyzing and visualizing of formulations, interfacial and molecular interactions, and manufacturing of complex drugs.

• Shall offer a minimum of 10 days of full time employee hours for comprehensive support, services for constructing protein formulation structures and simulation with their resources parallel to FDA OPQR Precision 7920 Tower at FDA OPQR requests.

• Shall execute and analyze protein-excipient combinations (with 3 replicates) equilibrium simulations in the initial liquid, frozen and solid state

• Comprehensive modeling support including documentation, rapid response to queries and knowledge transfer to the FDA, The molecular modeling and simulation platform will be delivered to the following location:

ATTN:

Food and Drug Administration 10903 New Hampshire Ave Building 64, Room 1016 Silver Spring, MD 20993

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5. Period of performance_________________________________________________________ The Period of Performance is a base period, which includes a 12-month subscription.

6. Contract Type_____________________________________________________________________ This order is a firm-fixed-price order.

7. Conformance with Applicable Laws, Regulations, Policies, and Standards__________________ Contractor Compliance

The Contractor shall be responsible for knowledge of, and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov/. HHS documents are found at: http://www.hhs.gov/oirm/

Section 508 Standard Compliance Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this order must comply with the “Electronic and Information Technology Accessibility Provisions” 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 http://www.section508.gov/. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm

Special Notice and Agreement Regarding Software EULA/TOS

Computer software and services are often subject to license agreements, referred to as End User License Agreements (EULA), Terms of Service (TOS), or other similar legal instruments or agreements. Many of these agreements contain indemnification clauses that are inconsistent with Federal law and unenforceable, but which could create a violation of the Anti-Deficiency Act (31 U.S.C. 1341) if agreed to by the Government.

Therefore, by submitting a quotation the all offeror shall agree that the inclusion of any Limitation of Liability, Indemnification, and any other clauses that conflict with Federal law or regulation in any EULA or TOS are NULL AND VOID. The offeror agrees that any EULA/TOS clauses conflicting with Federal law or regulation and are not agreed to by the Government if included with the submission of a quotation. Additionally, by submission of the quotation the offeror shall agree to the inclusion of FAR 52.232-39 Unenforceability of Unauthorized Obligations in any resulting contract or order, if awarded.

http://www.cio.gov/ http://www.hhs.gov/oirm/ http://www.section508.gov/ http://www.access-board.gov/sec508/provisions.htm

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8.Inspection and Acceptance________________________________________________________

The Contracting Officer’s Representative (COR) will verify that the software is functioning properly. The Government shall have 10 working days to inspect and verify that the software is operational, functional, and compatible with FDA server and software.

The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within 10 days when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

9. Contract Administration_____________________________________________________________

Contracting Officer (CO):

Roosevelt Walker Email: roosevelt.walker@fda.hhs.gov

Contracting Officer’s Representative (COR): (To be entered at time of award)

10. 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, shall 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.

11. 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 mailto:roosevelt.walker@fda.hhs.gov

P a g e 7 | 14 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.

(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 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 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 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– amountasallowableinaccordancewiththeScheduleandFAR52.216-8ifapplicable.

(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:

(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.

mailto:IPPCustomerSupport@fiscal.treasury.gov

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(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.

12. Payment terms_____________________________________________________________________ Payment terms Net 30 days after government acceptance of the supply item/service. Payments shall not be made more frequently than monthly in arrears. Advance payments will not be made.

13. Inspection & Acceptance_____________________________________________________________ Inspection and acceptance will be at destination in accordance with FAR clause 52.212-4(a). In accordance with FAR 52.212-4(a), the Government has the right either to reject or to require correction of nonconforming supplies.

Supplies are nonconforming when they are defective in material or workmanship or are otherwise not in conformity with contract requirements. The Government may reject nonconforming supplies with or without disposition instructions.

The COR will perform inspection and acceptance of all products and services. The performance criteria for these products shall be timely delivery and closure of all activities and deliverables listed above and within the established Period of Performance.

Inspection and acceptance will occur at the place of delivery. Inspection will include verifying all parts were received and warranties and services are in place. The Government will accept goods and services only if they conform to all terms and conditions of this order. The Government will provide written notification of acceptance or rejection within ten (10) business days of receiving the delivery.

The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR or technical POC of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

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All quoter’s shall be Authorized reseller and/or servicing agent shall identify and/or provide documentation to confirm their claim as an authorized reseller and/or servicing agent.

All Offerors quote shall clearly state license number, product description, quantity, price, and period of performance for each product. The quotation shall include and match license number, product description, quantity, and period of performance. Offerors are advised that should their quotation conflict with or does not clearly reflect the specified product and requirement of this solicitation, their quotation may be deemed as technically unacceptable and may not be considered for award.

Price: Provide detailed price quote for each item proposed to meet the Schedule of Items. Include the firm’s Unique Entity Identifier (UEI) number with quote. The option year periods will not be funded at time of award.

If exercised, funding will be obligated individually each year for the option period exercised via contract modification; the option periods shall be priced accordingly.

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of macros. If the offeror or applicant submits documents that contain macros 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 offerors or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

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

The provision at 52.212-2 Evaluation-Commercial Items (OCT 2014) is applicable to this solicitation. The following addenda apply:

The government intends to award a firm‐fixed‐price order resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be best value to the Government as Lowest Price Technically Acceptable (LPTA).

The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (DEC 2019), applies to this acquisition.

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (OCT 2018). The following addenda apply:

FAR Provision:

FAR 52.204-7 System for Award Management (Oct 2018)

FAR 52.204-16 Commercial and Government Entity Code Reporting (Jul 2016)

FAR 52.204-27 Prohibition on a ByteDance Covered Application (Jun 2023)

FAR 52.211-6 Brand Name or Equal (Aug 1999) https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

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HHSAR Provision:

HHSAR 352.239-73 Electronic and Information Technology Accessibility (Dec 2015)

FAR Clause:

FAR 52.204-13 System for Award Management and Maintenance (Oct 2018)

FAR 52.204-18 Commercial and Government Entity Code Maintenance (Jul 2016)

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

FAR 52.217-7 Option for Increased Quantity-Separately Priced Line Item (Mar 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor at any time before the contract expires. Delivery of added items shall continue at the same rate that like items are called for under the contract unless the parties otherwise agree.

HHSAR Clause:

HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

HHSAR 352.232-71 Electronic Submission of Payment Requests

(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 shall 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) 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 shall 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.

https://www.hhs.gov/web/508 https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards

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(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 for historic materials that are not within contractor control otherwise the following standard below is applicable:

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

(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.

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(End of Clause)

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items. (JAN 2025)

a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (Aug 1996) ( 31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

____X_____ 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) ( 31 U.S.C. 6101 note).

____X_____ 52.219-28, Post Award Small Business Program Representation (Jan 2025) (15 U.S.C.

632(a)(2)).(ii) Alternate I (MAR 2020) of 52.219-28.

_____X____ 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_____X____ 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Dec 2022) (E.O.13126).

_____X____ 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) ( 29 U.S.C. 793).

_____X____ 52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

_____X____ 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

______X___ 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 22 U.S.C. chapter 78 and E.O.

13627).

_____X____ 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving ( Driving (Jun 2020) (E.O. 13513).

https://www.acquisition.gov/far/part-52#FAR_52_203_19 https://www.acquisition.gov/far/part-52#FAR_52_204_23 https://www.acquisition.gov/far/part-52#FAR_52_204_25 https://www.acquisition.gov/far/part-52#FAR_52_209_10 https://www.acquisition.gov/far/part-52#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_233_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_209_6 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_3 https://www.acquisition.gov/far/part-52#FAR_52_222_19 https://www.acquisition.gov/far/part-52#FAR_52_222_36 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_37 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_40 https://www.acquisition.gov/far/part-52#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_223_18

P a g e 13 | 14

_______X___ 52.225-1, Buy American-Supplies (Oct 2022) ( 41 U.S.C. chapter 83).

_____X________ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) ( 31 U.S.C. 3332).

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1), in a subcontract for commercial products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(2) While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of clause)

14. Evaluation Criteria Clauses___________________________________________________________ The basis for award is Lowest Price Technically Acceptable (LPTA). The government intends to award this order without clarification or discussions with Vendors, so each Vendor is encouraged to submit its best and final quote. Additional Federal discounts are highly encouraged.

The government will evaluate quotes for technical acceptability based on the requirements specified in https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-52#FAR_52_232_33 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3332&num=0&edition=prelim https://www.acquisition.gov/far/part-2#FAR_2_101 https://www.acquisition.gov/far/part-52#FAR_52_215_2 https://www.acquisition.gov/far/part-4#FAR_Subpart_4_7

P a g e 14 | 14 this RFQ. Quotes not meeting the requirements of this RFQ will be rated as unacceptable. Note: This is a brand name or equal requirement.

The government will evaluate overall price and will verify that the prices are accurate and in line with published GSA MAS Contract price lists. Additional federal discounts are highly encouraged. The Government will verify the mathematical accuracy of the total price computation.

The Government will award based on the lowest evaluated price quote meeting the acceptability standards for items and services identified in this RFQ.

15. Evaluation Criteria__________________________________________________________________

All contractor responding to this solicitation should submitted a quote on or before August 22, 2025, by 1:00 pm Washington DC Local Time. All questions shall be submitted via email to Roosevelt Walker, Contracting Officer, roosevelt.walker@fda.hhs.gov.

mailto:roosevelt.walker@fda.hhs.gov

REQUEST FOR QUOTE