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This is a Questions and Answers document addressing inquiries regarding the BARDA Accelerator Network 2.0 Diagnostics and Medical Devices Hub solicitation (26-BARDA-SOL-BAN_2_1). The document does not address specific products or services required but rather clarifies operational and structural aspects of the hub's establishment and management.

Key clarifications include: University Lab Partners currently operates the incumbent services under Other Transaction Agreement No. 75A50124C00007, with no transition period anticipated for the new hub operator. Development, Evaluation, and Validation (DEV) projects are intended to support approximately six months of work for awardees to demonstrate technology feasibility and validation, with flexibility for timeline extensions if necessary; the pre-award phase does not count toward the six-month execution period. The $500M agreement ceiling may support multiple hub activations simultaneously for Rapid Response scenarios. The base annual allocation ($1.5M for DEV Services with an average individual award of up to $200,000 per company) is designated for base operations only, with proposers independently assessing how many companies they can support within this budget. BARDA will provide standardized subaward structure templates consistent with current BAN Hubs and will share a draft Other Transaction Agreement with the selected proposer during award negotiations. No benchmark throughput data or minimum annual company support requirements have been provided, and no transition of prior hub portfolio companies is expected.

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BAN 2.0 – Supplemental Announcement to Fill Diagnostics and Medical Hub Q and A 4.6.2026

1. Is there an incumbent vendor performing these services? If so, can you provide the contract number and/or vendor name?

Yes, these services are currently being performed by University Lab Partners under Other Transaction Agreement No. 75A50124C00007.

2. Will other BAN 2.0 vacancies be coming soon?

We do not anticipate any further vacancies at this time.

3. Is there a preferred NIH or NSF-style resume required? Do all the resumes need to be in the same format?

There is no requirement for formatting of resumes, please ensure each resume does not exceed two pages.

4. Please clarify the following lines 426-427 in the solicitation:

"Timelines for the DEV support (outlined in Section III) to companies (individual projects are intended to conclude within 6 months of the start of the DEV awards)" Does this mean that all awarded projects through the Accelerator Hub must have a contracted award period (with associated milestones) that is no greater than a 6-month period? Is there any flexibility in this award period? I also want to confirm that any time an individual project spends in a solicitation funnel (pre-award) does not count towards the 6-month period.

DEV project funding is intended to support approximately 6 months of work for awardees to demonstrate feasibility and validation of their technology. The 6-month period begins at the time of award and reflects the expected duration of project execution. There is flexibility to extend the project timeline if needed to ensure successful completion of the work. Time spent in the pre-award phase (e.g., solicitation, review, selection) does not count toward the 6-month project period.

5. For DV subawards, does BARDA have a preference between structuring awards? Is there flexibility in subaward structure, or should proposers assume a specific mechanism?

BARDA plans to provide standardized templates to the Hub for structuring the project-milestone based awards; these templates are used in solicitations by the current BAN Hubs.

6. The agreement ceiling is $500M. For the Rapid Response capability, should proposers assume they would be the sole hub activated for diagnostics, or could multiple hubs be activated simultaneously for a single response scenario?

Multiple hubs could be activated based on the response requirements.

7. What is the expected level of coordination between the Diagnostics/Medical Devices Hub and the four existing BAN 2.0 hubs? Are there specific cross-hub processes or platforms that the new hub would be expected to adopt?

Each Hub is expected to maintain individual programming and processes that best support their individual efforts.

8. Dos BARDA anticipate a transition period from the previous Diagnostics/Medical Devices Hub? Specifically, should proposers plan to onboard or continue supporting any companies or projects from the prior hub's portfolio, or should proposals assume a clean start?

No, proposals should assume a clean start for Accelerator and DEV programming.

9. For steady-state operations, is the expectation that Rapid Response readiness costs (maintaining pre-qualified reviewer panels, surge staffing agreements, platform scaling infrastructure) be funded from the base annual allocation, or does BARDA envision a separate readiness funding mechanism?

The base annual allocation is for base operations only. Each hub must maintain an active Rapid Response Capability Activation Plan, as outlined in the Requirements section and Appendix A of the solicitation. If activated, the hub will be expected to ramp-up hub operations effectively based on the new funding which will be provided to the hub at that time.

10. Can BARDA provide any benchmark data on the throughput (number of companies served) and operational cost ratios achieved by the current BAN 2.0 hubs, to help proposers calibrate their staffing and budget proposals to BARDA's expectations?

No, the proposer’s understanding of its own capabilities and its ability to effectively propose associated costs is a key evaluation consideration.

11. For the purposes of budgeting and cost submission assumptions, does BARDA anticipate a minimum number of companies to be supported annually through the hub as part of the $1.5M Development, Evaluation, and Validation (DEV) Services?

No. The solicitation notes an average individual award amount of up to $200k for each company. So, BARDA is looking for the proposer to independently assess how many companies it can support within this provided budget. BARDA will consider this assessment as part of its evaluation.

12. What level of commitment is expected for partners or subs at the time of proposal submission (LoS, teaming agreements, etc)?

This is at the discretion of the proposer as informed by its own assessment of its capabilities.

13. Is BARDA able to share a sample Other Transaction Agreement that would allow us to review in advance of award specific articles, requirements, terms and conditions?

BARDA plans to share the draft OTA with the selected proposer at the beginning of award negotiations. The proposer will be given adequate time to review and discuss the proposed agreement before award finalization.

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