Solicitation .pdf

Request for Quote 133983

Title: Quantitative Decision Reliability of AI-Accelerated Computational Modeling and Simulation for Cardiovascular Devices

DESCRIPTION

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov. The solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular

(FAC 2026-01).

• NAICS Code: 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

• Type of Contract: Firm Fixed Price (FFP)

• Acquisition Method: FAR Part 12– Acquisition of Commercial Products and Commercial

Services

SUPPLIES OR SERVICES AND PRICES/COSTS

PRICE SCHEDULE

DESCRIPTION PRICE

Quantitative Decision Reliability of AI- Accelerated Computational Modeling and Simulation for Cardiovascular Devices

BACKGROUND

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Office of Science and Engineering Laboratories (OSEL) conducts regulatory science research to develop scientific evidence, standards, and tools needed to assess the safety and effectiveness of medical devices.

Computational modeling and simulation (CM&S), defined as mathematical models based on mechanistic or physics-based governing equations, is increasingly used in medical device regulatory submissions, for virtual device testing, as device software functions, and for in silico clinical trials. Artificial intelligence (AI) methods can accelerate CM&S using machine learning-based surrogate models trained on CM&S output. This combination of CM&S and AI is increasingly being adopted in cardiovascular device submissions and has the potential to massively reduce computational costs, enabling real-time patient simulation and comprehensive virtual testing.

However, no standardized regulatory tools exist to assess whether AI-introduced error is small enough to preserve the integrity of regulatory or clinical decisions. Existing CM&S guidance excludes AI and data-driven models, and no current regulatory science tools address this critical gap. This project will develop methods for evaluating the reliability of AI-accelerated computational evidence in cardiovascular device regulatory submissions.

CONTRACT TYPE

This contract will be a Firm Fixed Price type contract.

OBJECTIVE

The objective of this contract is to develop surrogate models of computational fluid dynamics and demonstrate a method for assessing if surrogate model errors could alter the final decision compared to the baseline simulation model.

SCOPE

The Contractor shall provide research services to perform the tasks described in Section 4. All work shall be performed at the Contractor's facilities. No access to FDA systems, data, or facilities is required.

REQUIREMENTS/TASKS

TASKS

The Contractor shall perform the following tasks over a 12-month period of performance:

Task 1: Review of Surrogate Modeling for Cardiovascular Device Applications

The Contractor shall conduct a literature review of surrogate modeling methods used in cardiovascular devices applications. This should encompass surrogate modeling of CM&S in device evaluation, device software functions and in silico clinical trials. The review should collect information on the modeling field used, the context of use of the model, the surrogate approach used, and quantitative data on surrogate model accuracy when provided in the underlying documents.

SPECIFIC REQUIREMENTS

• The contractor shall conduct a systematic review of the literature using PubMed (https://pubmed.ncbi.nlm.nih.gov/), using pre-specified and documented search terms related to CM&S and surrogate models.

• The sponsor shall identify a minimum of 10 publications that use surrogate models for CM&S with cardiovascular applications, or, if not possible, review a minimum of 40 publications from the systematic search for potential surrogate use.

DELIVERABLES

• Literature review summary table: The sponsor shall deliver a summary table in CSV format, with one row per publication and the following fields at the minimum: device type, model field, context of use type (device evaluation, device software function, in silico clinical trial, other), context of use summary, surrogate approach, parameters varied, training and test dataset sizes, output quantities of interest, surrogate evaluation approach, surrogate evaluation quantitative metrics, computational cost reduction achieved.

• Literature review summary document: The sponsor shall deliver a document summarizing the methods, results and conclusions of the literature review (minimum 3 pages).

Task 2: Computational fluid dynamics and Surrogate Model Development and Evaluation

The Contractor shall select a cardiovascular computational fluid dynamics benchmark problem representative of regulatory submissions, generate a simulation dataset, develop a range of three or more surrogate models including at least one neural network based surrogate model, fit the surrogate model to the computational fluid dynamics simulation dataset, and evaluate the fit using established methods.

• Recommended benchmark problem: the FDA nozzle benchmark (https://cdrh-rst.fda.gov/benchmark-dataset-validating-computational-fluid-dynamic-cfd-simulation-blood-flow-through) using the publicly available simulation configuration information and experimental validation dataset. If an alternative problem is used, the contractor shall provide a written justification (minimum 2 pages), explaining how chosen problem is not inferior to FDA benchmark in terms of computational complexity and relevance to medical devices.

• An established computational fluid dynamics solver shall be used, e.g., Ansys Fluent, OpenFOAM or other established solver supported by multiple peer reviewed journal publications.

• The computational fluid dynamics solver, version, and simulation settings shall be documented to the extent required to reproduce the simulations.

• The parameter ranges and sampling strategy shall be documented.

• Mesh convergence analysis shall be performed to estimate numerical errors in the outputs the surrogates will be fitted to, for at least 5 points in the parameter space.

https://cdrh-rst.fda.gov/benchmark-dataset-validating-computational-fluid-dynamic-cfd-simulation-blood-flow-through https://cdrh-rst.fda.gov/benchmark-dataset-validating-computational-fluid-dynamic-cfd-simulation-blood-flow-through https://cdrh-rst.fda.gov/benchmark-dataset-validating-computational-fluid-dynamic-cfd-simulation-blood-flow-through

• The sponsor shall sample the parameter space and solve the computational fluid dynamics problem at those points. A minimum 100 points should be used, or a written justification provided for why less simulations are sufficient for training the surrogates with acceptable surrogate errors.

• The contractor shall allocate a maximum of 80% of the simulation dataset as training data, with the remainder as hold-out test data, and fit at least three surrogate models to the training dataset (one Gaussian process surrogate and at least one neural network-based surrogate).

• The contractor shall evaluate each surrogate model on the hold-out test dataset, using the following metrics: root mean squared error (RSME), R², maximum absolute error, and any other metrics of the contractor’s choice as appropriate.

• The contractor shall evaluate the speedup achieved by each surrogate.

DELIVERABLES

• Computational Fluid Dynamics and Surrogate Summary Document: The sponsor shall deliver a document describing the problem solved and methods used (including computational fluid dynamics solver, version, and simulation settings) in sufficient detail to reproduce the simulations, the surrogate model architectures and training strategy in sufficient detail to reproduce the surrogate models, and the results of the surrogate evaluation metrics on the training and test datasets.

• Computational fluid dynamics simulation dataset: The sponsor shall also deliver a dataset in an appropriate format such as HDF5 or CSV containing simulation inputs and outputs used for training the surrogate models.

• Surrogate Models: The sponsor shall also deliver python code for reproducing surrogate training and running the surrogate models, including explicitly providing all parameters or weights, and all other data required for reproducing surrogate training and inference, together with appropriate metadata.

Task 3: Decision Reliability Assessment

The Contractor shall assess the likelihood that using the surrogate model in place of the reference computational fluid dynamics model leads to a different binary decision (i.e., “decision reliability”), where the decision is defined in terms of scalar model output being above a pre-specified threshold. The sponsor shall develop a python Jupyter notebook assessing decision reliability using three surrogate models from Task 2.

• The Contractor shall define a mathematical procedure to estimate total error that combines surrogate approximation error, numerical error from mesh convergence results, and model-comparator discrepancy from validation. The method used to combine these quantities shall be explicitly justified with reference to ASME V&V20 and V&V40 Standards, the verification, validation and uncertainty quantification

(VVUQ) literature and statistical literature. The procedure should be defined in a manner that does not assume the parameter values used for surrogate training points, mesh convergence, and validation coincide.

• The total model form error shall be used to estimate the likelihood that use of a surrogate model in place of the reference computational fluid dynamics model leads to a different binary decision, where the decision is defined in terms of scalar model output being above a pre-specified threshold.

• The procedure shall be implemented in a python Jupyter notebook and explicitly demonstrated using the computational fluid dynamics simulation results and three surrogate models from Task 2.

DELIVERABLE

• Decision Reliability Assessment Jupyter notebook: The sponsor shall deliver a Jupyter notebook which computes decision reliability according to the above specifications for the three surrogate models.

Task 4: Reporting and Publication

The Contractor shall develop a journal publication documenting all work performed under this contract. The Contractor may continue collaboration with FDA staff on a voluntary, unfunded basis following the completion of the contract period.

• The Contractor shall virtually meet with FDA bi-weekly.

• The Contractor shall develop a journal publication (drafted and ready for submission to a journal to be chosen in collaboration by the Contractor and FDA) documenting all work performed under this contract. The draft publication shall summarize the methods and results of Tasks 1-3.

DELIVERABLE

• Draft Publication: PDF format, 25-40 pages

DELIVERY

The following deliverables are required for performance of this SOW.

Task Reference

Title See Section 4 for descriptions. Quantity

Due Date (relative to contract start date)

1 1 Literature review summary table. 1 3 months 2 1 Literature review summary document.

1 3 months

3 2 Computational fluid dynamics and surrogate summary Document:

1 9 months

4 2 Computational fluid dynamics simulation dataset

1 9 months

5 2 Surrogate Model 1 9 months 6 3 Decision Reliability Assessment

Jupyter notebook 1 12 months

7 4 Draft Publication 1 12 months

Deliverables shall be submitted to the Division of Applied Mechanics, OSEL, CDRH, FDA.

The Contractor shall deliver all items virtually to the following:

• Pras Pathmanathan, CDRH/OSEL/DAM, pras.pathmanathan@fda.hhs.gov

• Prasanna Hariharan, CDRH/OSEL/DAM, prasanna.hariharan@fda.hhs.gov.

GOVERNMENT FURNISHED PROPERTY

No Government-furnished property, material, equipment, or information will be provided under this contract.

SECURITY

This contract does not involve access to FDA systems, databases, or facilities. The Contractor will not require a PIV badge. The Contractor will not handle sensitive information, personally identifiable information (PII), or Privacy Act records.

TRAVEL

No travel is required or authorized under this contract.

SPECIAL MATERIAL REQUIREMENTS

None

OTHER UNIQUE REQUIREMENTS AND CONDITIONS

mailto:pras.pathmanathan@fda.hhs.gov mailto:prasanna.hariharan@fda.hhs.gov

Computational Resources: The Contractor must provide computational resources necessary for computational fluid dynamics simulations and surrogate model development.

Contractor Qualifications: The Contractor must demonstrate:

• Proven track record in cardiovascular computational fluid dynamics, with history of peer reviewed publications

• Experience with medical device applications and regulatory science

• Expertise in surrogate modeling approaches

• Understanding of regulatory evaluation frameworks and decision-making processes for medical devices

PLACE OF PERFORMANCE

All work shall be performed at the Contractor's facility. The Contractor's address will be specified at contract award.

PERIOD OF PERFORMANCE

The period of performance for this contract is 12 months from the date of contract award.

CONTRACT ADMINISTRATION

The contact information for the FDA Contracting Officer’s Representative (COR) is the following: TBD

The contact information for the FDA Contracting Officer (CO) is the following: TBD

The contact information for the FDA Contract Specialist (CS) is the following: TBD

The contact information for the Contractor (KTR) is the following: TBD

CONTRACT CLAUSES

1. CLAUSES AND PROVISIONS

Federal Acquisition Regulation (FAR) Clauses and Provisions

52.212-4 Terms and Conditions—Commercial Products and Commercial Services (Nov 2025)

(DEVIATION)

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 (Nov 2025) (DEVIATION)

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (Nov 2025) (DEVIATION)

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (Nov 2025)

(DEVIATION)

52.222-3 Convict Labor (Jun 2003)

52.222-19 Child Labor—Cooperation with Authorities and Remedies (Nov 2025)

(DEVIATION)

52.222-35 Equal Opportunity for Veterans (Nov 2025) (DEVIATION)

52.222-36 Equal Opportunity for Workers with Disabilities (Nov 2025) (DEVIATION)

52.222-37 Employment Reports on Veterans (Nov 2025) (DEVIATION)

52.222-41 Service Contract Labor Standards (Aug 2018)

52.222-42 Statement of Equivalent Rates for Federal Hires (May 2014)

52.222-43 Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018)

52.222-50 Combating Trafficking in Persons (Nov 2025) (DEVIATION)

52.222-54 Employment Eligibility Verification (Nov 2025) (DEVIATION)

52.222-62 Paid Sick Leave Under Executive Order 13706 (Jan 2022)

52.224-3 Privacy Training (Jan 2017)

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)

52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013)

52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Mar 2023)

52.233-3 Protest After Award (Nov 2025) (DEVIATION)

52.233-4 Applicable Law for Breach of Contract Claim (Nov 2025) (DEVIATION)

52.240-91 Security Prohibitions and Exclusions (Nov 2025) (DEVIATION)

52.240-92 Security Requirements (Nov 2025)

52.240-93 Basic Safeguarding of Covered Contractor Information Systems (Nov 2025)

52.217-9 Option to Extend the Term of the Contract (Mar 2000)

The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires; provided that the Government The total duration of this contract, including the exercise of any options under this clause, must not exceed the identified period of performance, inclusive of any options if exercised. Gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension. If the Government exercises this option, the extended contract must be considered to include this option clause.

52.212-1 Instructions to Offerors — Commercial Products and Commercial Services (Nov 2025)

(DEVIATION)

52.212-2 Evaluation — Commercial Products and Commercial Services (Nov 2025) (DEVIATION)52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sep 2024)

52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (Jan 2017)

52.204-7 System for Award Management (Nov 2025) (DEVIATION)

52.217-5 Evaluation of Options (Nov 2025) (DEVIATION)

52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications JUN 2020

52.240-90 Security Prohibitions and Exclusions Representations and Certifications (Nov 2025)

(DEVIATION

Health and Human Services Acquisition Regulation (HHSAR) Clauses

352.224-70 Notification of System of Records Notice (Feb 2024) (DEVIATION)

352.224-71 Confidential Information (Feb 2024) (DEVIATION)

352.227-70 Publications and Publicity (Dec 2015)

352.237-75 Key Personnel (Dec 2015)

352.232-71 Electronic submission of payment requests (FEB 2022)

(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.

(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)

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 FAR 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 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 Indirects)-show rate, base and total amount;

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

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs 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 FAR 52.216-8 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:

(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 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.

INSTRUCTIONS TO OFFERORS

COVER PAGE

Offeror shall include a cover page which shall include a point of contact (name, telephone number, and email address). Dun and Bradstreet (DUNS) number, country of manufacturing of equipment, and certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current (to include updated representations and certifications in accordance with FAR 52.212-3).

The technical proposal shall be submitted electronically via email to the Contract Specialist Telisha Wilson, at telisha.wilson@fda.hhs.gov and ensure the solicitation number is visible in the subject of the email transmission of their proposal.

The proposal submitted shall describe in detail a full understanding on the evaluation factors listed below.

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 offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

EVALUATION FACTORS

The Government will evaluate offerors for technical acceptability in the following four technical factors (Understanding of Requirement; Management Plan; Key Personnel; Relevant Experience). For these factors, Offerors will be evaluated as either technically acceptable or unacceptable. Price will be evaluated for fairness and reasonableness.

Factor 1-Understanding of Requirement

The Government will evaluate the extent to which the offeror’s proposal demonstrates a cohesive understanding of the requirements and demonstrates experience and expertise with HL7 Reference Information Model. Specifically, the Government will evaluate the extent to which the offeror’s proposal addresses the following questions:

• Did the offeror demonstrate by explanation a general, but thorough, understanding of the tasks within the SOW.

• Did the offeror document their experience.

• Did the offeror provide documentation which reports three years of experience related to the successful development and implementation of items in factor four.

FACTOR 3: KEY PERSONNEL

Offerors will be evaluated on the extent to which their proposal demonstrates that the proposed personnel meet or exceed the knowledge and experience requirements listing in the proposal instructions for Factor 3 and the criteria provided in the Statement of Work.

FACTOR 4: RELEVANT EXPERIENCE

The Government will evaluate the extent to which the offeror has demonstrated recent experience providing similar services in size and scope to that of this requirement.

FACTOR 5: COST/PRICE

The FDA will be evaluated for fairness and price reasonableness of the proposed labor rates.

BASIS FOR AWARD

Award shall be made to a single responsible party with the lowest priced technically acceptable offer. More specifically, the Government intends to evaluate only the lowest priced proposals until the point at which it determines that a technically acceptable proposal has been received, and at that point, no further technical evaluations will be conducted.

OFFERORS RESPONSE DATE AND TIME

All quotes shall be submitted via email to Telisha.Wilson@fda.hhs.gov with the subject titled

“ALP-133983”.

Questions are due by 10AM EST on 07/31/2026.

Responses are due by 10AM EST on 08/07/2026.

Quotes must be valid through September 30, 2026.