Sol_QR_75F40126Q00351.pdf

Sol#: 75F40126Q00351

Solicitation Questions and Responses

KEY: All questions will be in a BOLD font.

All answers will be highlighted.

1. Are there any potential challenges to having a Canadian-based university lead the effort? In particular, any anti-DEI policies that may be hard for us to honour?

Any other important implications that we, as a Canadian organization, need to be sensitive to in case we are awarded?

This solicitation is unrestricted, meaning it is open to both U.S. and foreign vendors from countries that have trade agreements with the United States. However, there is a strong preference for U.S.-based performance — custom software development and outsourced operations must be located in the U.S. to the maximum extent practicable. If any work is proposed to be performed outside the continental United States, the vendor must disclose where those services will be provided and submit a detailed Information System Security Plan addressing the associated risks. Additionally, if cloud services are used, all data must be stored within the continental United States.

2. We would like to know if this is a brand-new contract OR if there is (was) an incumbent performing these services. If not brand new, could you please provide the current / previous contract number?

This is a brand-new contract.

3. Contractor Qualification Requirements: May the minimum qualification requirements identified in the Statement of Work be satisfied collectively through the proposed prime contractor, subcontractors, key personnel, and/or collaborating organizations, or must the prime contractor independently satisfy each qualification requirement?

Collectively satisfying the qualification requirements is acceptable, provided that each contributing entity is qualified in at least one or more key requirements for the completion of the project. In other words, each collaborating organization should be demonstrably capable of contributing to one or more parts of the project.

4. Principal Investigator / Co-Investigator Requirement: May the individual satisfying the requirement for participation in at least two completed TUS simulation research projects, or significant contribution to an open-source TUS simulation tool, be proposed through a subcontractor or collaborating organization?

Potentially, yes, however, the technical merit of the proposal will still depend heavily on the primary contractor’s expertise in the core research topic.

5. Peer-reviewed Publication Requirement: May the required peer-reviewed publications be those of the proposed key personnel and technical team members, including subcontractor personnel, or must the publications be directly attributable to the prime contractor organization?

Same answer as above - potentially, yes to the former, however, the technical merit of the proposal will still depend heavily on the primary contractor’s expertise in the core research topic.

6. Single- vs. Dual-Technique Approach: Does FDA have a preference between the single-technique and dual-technique RST development approaches, or will either approach be considered equally acceptable provided the proposed solution meets all technical and performance requirements?

There is a preference for the dual-technique RST development approach. However, a technically stronger proposal for the single-technique RST would still be considered.

7. Pricing Workbook Structure: The pricing attachment appears to include Base and Option Year columns, while the solicitation identifies a 12month period of performance with quarterly deliverables. Please confirm whether offerors should modify or adapt the pricing workbook to reflect the four quarterly phases, price only the applicable 12-month base period, or complete the option columns as provided.

There are no option years associated with this contract. There is strictly one base period of 12 months.

8. Deliverable-Level Pricing: Does FDA require a separate unit price for each of the 15 identified deliverables, or may offerors price at the Task/Quarter level provided all deliverables are clearly identified within the pricing proposal?

Offerors should use the pricing sheet attachment from the solicitation. Feel free to provide any pricing information/justification for the deliverables within your pricing proposal.

9. Budget / Funding Guidance: Is there an anticipated funding range, independent Government cost estimate, or other budgetary guidance available that offerors should consider when determining whether to propose the single-technique or dual-technique approach?

This is Simplified Acquisition Procurement which is not to exceed the Simplified acquisition threshold of $350,000.00.

10. Validation Data and Resources: Will FDA provide any existing ex-vivo skull datasets, CT/MRI datasets, hydrophone measurement data, tissue property data, or other validation resources for contract performance, or should offerors assume responsibility for obtaining and pricing all such validation datasets and resources?

The FDA hopes to provide such datasets in a collaborative effort – however, the availability and public sharability of such datasets is an unknown at this point. Therefore, offerors should assume responsibility for obtaining all required resources for meeting the core requirements of this project.

11. Computational Resources: Because the Statement of Work indicates that FDA may provide access to cloud computational resources subject to availability, should offerors price their proposals assuming that all required computational infrastructure will be contractor-furnished?

Same answer as above - offerors should assume responsibility for obtaining all required resources for meeting the core requirements of this project.

12. Intellectual Property / Background Technology: Please confirm that the public-domain requirements apply to work products developed specifically under this contract and do not require an offeror or subcontractor to relinquish ownership of pre-existing background intellectual property, software, algorithms, or other technology incorporated into the solution, subject to applicable licensing requirements.

That is correct - public-domain requirements apply to work products developed specifically under this contract.

13. Human or Animal Subject Requirements: Does FDA anticipate that performance of this requirement will involve activities requiring human-subjects or animal-subjects approvals, or are the associated HHSAR provisions included as standard/precautionary requirements?

FDA anticipates bench-testing only for tool validation and does not anticipate requiring human or animal subject testing.

14. Proposal Submission: Please confirm the email address, portal, or other electronic method to be used for submission of the separate technical and pricing proposals due August 31, 2026.

Both Proposals are due August 31st and are to be sent to ryan.alexander@fda.hhs.gov.

15. Qualifications — team vs. prime. May the mandatory Contractor Qualification Requirements be satisfied by the combined capabilities of the prime contractor and a proposed subcontractor, or must the prime contractor independently meet each minimum qualification?

See answer to Q3 above.

16. Subcontractor documentation at quote stage. Where an offeror proposes a subcontractor to lead part of the effort, what documentation is required for that organization or individual at quote stage (e.g., CV, publication list, software-access confirmation, examples of prior work, letter of commitment), and is any particular format required?

There is no particular format. All of the listed examples above and more, that help to establish the credibility of the subcontractor, will help to strengthen the technical merit of the proposal.

17. SAM.gov / UEI for a subcontractor. Is a proposed subcontractor required to have its own SAM.gov registration and/or Unique Entity Identifier (UEI) at the time of quote or award, or is a UEI required only for subaward reporting (FFATA/FSRS)?

The solicitation only explicitly requires SAM/UEI information from the offeror (prime).

18. Consent to subcontract. Is the Contracting Officer's consent to subcontract required under FAR 52.244-6 for this acquisition, and should the scope and estimated value of any proposed subcontract be disclosed in the quote?

mailto:ryan.alexander@fda.hhs.gov

This acquisition does not carry a standing CO-consent-to-subcontract requirement. Offerors shall identify allocation of development responsibilities among the prime contractor, subcontractors, or collaborating organizations and shall describe relevant organizational qualifications and the integration plan.

19. Security flow-down. For a subcontractor performing within the United States on this Low-impact, No-PII effort, is flow-down of the HHSAR 352.204-71 information-security requirements (NDA, training, Rules of Behavior, personnel roster, incident reporting) sufficient, or are additional security requirements expected of subcontractors?

The Contractor must include the substance of the clause in subcontracts "of any amount" where subcontractor employees will have access to HHS information or systems. So, flowing down the NDA, training, Rules of Behavior, roster, and incident-reporting obligations from 352.204-71 to a U.S.-based subcontractor is exactly what the clause contemplates and requires.

20. Split place of performance. Where one portion of the work is performed within the United States and another portion is performed outside the continental United States, does U.S.-based performance of that portion satisfy the U.S.-performance preference for it, and is documenting the split of performance locations in the Information System Security Plan sufficient to meet the foreign-performance disclosure requirement?

The preference is that custom software development and outsourced operations be located in the U.S. "to the maximum extent practicable.”

If any services are proposed to be performed outside the continental United States, the contractor/subcontractor "must state in its proposal where all non-U.S. services are provided."

"At a minimum, the Contractor/subcontractor must include a detailed Information System Security Plan, for review and approval by the Contracting Officer, specifically to address mitigation of the resulting problems of communication, control, and data protection.

21. Representations and certifications. Are the Section K representations and certifications required only from the prime contractor, or are any certifications also required from a proposed subcontractor?

The majority of the certifications are required by the prime.

That said, some of these certifications may require the prime to certify on behalf of, or account for, its supply chain/subcontractors in substance even though the subcontractor doesn't sign anything itself.

22. Validation data provenance. If a subcontractor or collaborator provides medical imaging or ex-vivo skull data for benchmark validation, what are the Government's de-identification and data-provenance requirements, and does the Government confirm that such data may be released openly together with the public-domain RST?

Yes. Data provided by subcontractors or collaborators for benchmark validation must be appropriately de-identified before submission or use in the project, with de-identification sufficient to prevent identification or re-identification of individual subjects. The contractor should also maintain and provide adequate data-provenance documentation, including the source of the data, relevant acquisition and processing information, and confirmation that the provider has the necessary rights and permissions for the Government to use and publicly release the data.

Subject to confirmation of satisfactory de-identification and the absence of applicable legal, consent, licensing, proprietary, or other restrictions, benchmark data are intended to be released openly together with the public-domain RST.

23. Organizational conflict of interest. Are there any organizational-conflict-of-interest considerations that offerors proposing subcontractor or teaming arrangements should address?

The solicitation contains no dedicated organizational-conflict-of-interest clause or disclosure requirement.

There is no mandatory OCI certification or mitigation plan offerors must submit; however, given the SOW's structural features, OCI risk is still worth proactively addressing in a teaming arrangement. If a proposed subcontractor or teaming partner has a TUS device before FDA, commercial ties to device developers, or an existing FDA-collaborator relationship, offerors should proactively disclose that relationship and explain why it doesn't create bias or unfair advantage, since an evaluator could still raise it during review even without an explicit clause requiring it.

24. Pricing sheet structure and indirect rates. For a quote that includes a prime contractor and a subcontractor, should pricing be submitted as separate pricing sheets for each organization, or as a single consolidated sheet? If a single sheet is used, should each organization's own indirect (overhead) rate be applied to its respective portion of the cost — producing a blended effective overhead rate across the total — or does the Government require a specific approach? An illustrative calculation is shown below.

Organization Direct subtotal Overhead rate Overhead cost Institutional total

Prime 100 0.40 40 140

Subcontractor 60 0.80 48 108

Total 160 — 88 248

Blended effective overhead ratio = combined overhead ÷ (total − combined overhead) = 88 ÷ (248 − 88) = 88 ÷ 160 = 0.55.

You all shall only submit one collective quote that does not distinguish between prime and sub.

25. Additional requirements. Are there any additional submission requirements specific to prime/subcontractor teaming arrangements that offerors should address?

Not currently. If any arise, we will be sure to inform you.