Questions.pdf

1. HL7 Reference Information Model Under Evaluation Factor 1 (Understanding of Requirement), the solicitation states that the Government will evaluate an offeror's "experience and expertise with HL7 Reference Information Model." The Statement of Work, however, addresses computational fluid dynamics, surrogate modeling, and decision reliability, and does not reference HL7 or health-information interchange.

Could the Government clarify whether the HL7 Reference Information Model requirement applies to this acquisition, and if so, how it relates to the Statement of Work?

Response: This was an error, please ignore reference to HL7.

2. Management Plan evaluation The Evaluation Factors identify four technical factors:

• Understanding of Requirement

• Management Plan

• Key Personnel

• Relevant Experience

However, evaluation criteria are provided only for Factors 1, 3, 4, and 5.

Could the Government provide the evaluation criteria and expected content for the Management Plan factor?

Response: This was an error, please ignore

3. Key Personnel cross-reference Factor 3 states that Key Personnel will be evaluated against the "knowledge and experience requirements listed in the proposal instructions for Factor 3." We were unable to locate those requirements within the Instructions to Offerors.

Should offerors instead rely on the Contractor Qualifications section of the Statement of Work as the governing criteria for Key Personnel? Yes

4. "Sponsor" versus "Contractor" Several activities and deliverables within Tasks 1–3 are written as responsibilities of "the sponsor" rather than "the Contractor," including:

• literature review deliverables,

• parameter-space sampling,

• simulation dataset generation,

• surrogate model delivery, and

• the decision-reliability notebook.

Could the Government confirm that these are intended to be Contractor responsibilities? Yes

B. Proposal preparation

5. Technical proposal format The solicitation does not specify a page limit, font, margin requirements, or required proposal structure.

Could the Government advise whether any formatting requirements apply? In addition, are PDF files acceptable for both the technical and price submissions?

Response: There are no formatting requirements, and pdf is acceptable.

6. Price submission format Factor 5 states that price will be evaluated based on the fairness and reasonableness of proposed labor rates, while the Price Schedule contains a single firm-fixed-price line item.

Could the Government specify the expected level of pricing detail—for example, labor categories, labor rates, hours by task, or simply a total firm-fixed price?

Response: Simple Total Price is fine for me.

7. Payment schedule The Price Schedule contains one contract line item, while the Statement of Work identifies seven deliverables at approximately 3, 9, and 12 months.

Does the Government prefer offerors to propose milestone-based payments tied to those deliverables, or a single payment upon completion?

Response: Single payment upon completion - please propose the total cost for the project

8. UEI in place of DUNS The Cover Page requests a Dun & Bradstreet (DUNS) number. Since DUNS has been replaced by the Unique Entity Identifier (UEI) for Federal awards, is the UEI acceptable in its place?

Response: YES

9. FAR 52.212-3 representations The Cover Page references representations and certifications under FAR 52.212-3, although that provision does not appear in the solicitation's list of incorporated provisions and clauses.

Please confirm whether offerors are expected to submit or update FAR 52.212-3 representations for this acquisition.

Response: YES

10. Responses to questions Could the Government indicate how responses to offeror questions will be issued (for example, by amendment to the SAM.gov notice), so that offerors may ensure any amendments are acknowledged in their quotations?

Response: by amendment to the SAM.gov notice

C. Technical scope

11. Validation comparison in Task 3 Task 3 requires combining surrogate approximation error, mesh-convergence error, and model-comparator discrepancy from validation.

However, Task 2 appears to require generation of CFD results, surrogate models, and hold-out evaluation, without explicitly including comparison against the experimental validation dataset.

Could the Government clarify whether performing the CFD-versus-experimental validation comparison is within the scope of this contract, and if so, under which task?

Response: Performing experiments is outside the scope of the project, which is entirely computational. If a benchmark problem such as the recommended FDA nozzle benchmark is used, which includes an experimental dataset, then comparing the simulation results with the experimental results is within the scope of Task 3.

12. Quantity of interest and parameter space Task 3 defines the regulatory decision as whether a scalar model output exceeds a pre-specified threshold.

Could the Government indicate whether the quantity of interest and decision threshold will be provided, or whether they are expected to be proposed by the offeror?

Response: The offeror should choose the quantity of interest and the decision threshold as part of Task 3.

Similarly, could the Government indicate the intended dimensionality of the parameter space to be sampled in Task 2, or confirm that this is left to the offeror's technical approach?

Response: This is left to the offeror to decide.

D. Contract administration

13. Contractor Qualifications and Key Personnel The solicitation incorporates HHSAR 352.237-75 (Key Personnel), and Evaluation Factor 3 references the qualifications described in the Statement of Work.

Is it the Government's intent that the Contractor Qualifications—including cardiovascular CFD expertise, peer-reviewed publications, regulatory-science experience, surrogate-modeling expertise, and familiarity with regulatory evaluation frameworks—be demonstrated through the qualifications of the proposed Key Personnel, including any subcontractor or consultant personnel?

Response: Yes

14. Service Contract Labor Standards The solicitation incorporates FAR 52.222-41, 52.222-42, 52.222-43, and 52.222-62. However, no Department of Labor wage determination is attached, and FAR 52.222-42 is not completed.

Could the Government clarify whether the Service Contract Labor Standards apply to this acquisition? If so, would the applicable wage determination and covered labor classifications be provided?

Response: It does not, please disregard

15. Option periods The solicitation incorporates FAR 52.217-5 (Evaluation of Options), although no option line items or option periods appear in the Price Schedule or the stated twelve-month period of performance. Please confirm whether any option periods are contemplated under this acquisition.

Response: There are no option period