TOPIC CALL 4 Q and A_Ph II.pdf

Questions Answers Q01: For pricing and DevSecOps purposes, would the government prefer the proposal solely discuss solutions that use data at unclassified and CUI levels?

A01: The data may be at unclassifed and CUI levels; however, we encourage solutions that incorporate DevSecOps practices to enhance software security.

Q02: Will CBA-03 require ML/AI/DL modeling and algorithm training under classified conditions by A02: Contractor is anticipated to have full capability of conducting the Q03: Is the government requesting unlimited rights to the awardee's background IP underlying algorithms, code and other aspects of the program, or Government Purpose Rights?

A03: We prefer unlimited rights but, at minimum, request Government Purpose Rights.

Q04: For CBA-03, are the intended end-users DoD laboratory personnel, warfighters, or technical persons trained minimally on the software? Or a combination thereof?

A04: Warfighters and technical persons with limited experience with the software are the main end-users.

Q05: Is there a preferred font, and font size, for the Phase II proposal? A05: There is no specific requirement; the offeror should use the font/size they deem appropriate.

Q06: Is the PM volume considered a part of the 25 pages of the technical proposal page limit? A06: Yes, the Project Management Plan is considered a part of the 25 page technical proposal page limit.

Q07: Do the references for the technical volume count toward the 25 pages of the technical volume

A07: Yes

Q08: Is there a small business goal, or small business set-aside for this proposal? Specifically for

CBA-03.

A08: There are no specific goals or set-asides however small business utilization is encouraged. Please reference the BAA for a link to small business program goals.

Q09: Is the desire for SOW to be 3-5 page limits as indicated in Attachment 2 SOW template (the BAA states no page limit)?

A09: The Statement of Work (SOW) template is a guide. There is no page limit for the SOW.

Q10: Are tables, charts and figures required to be searchable? A10: No Q11: For partnering with DOE laboratories, is a finalized set of documents required, or is an in-process (non-final) document sufficient?

A11: A finalized document is required.

Q12: For costing purposes and availability of resources, would the government provide an anticipated start date?

A12: Awards are estimated to occur in Government Fiscal Year 2025, 3rd quarter.

Q13: Are there any required DTRA project updates, meetings, or conferences that we should plan to travel to attend in-person?

A13: There is no requirement of travel for any specific events.

However, the awardee may be required to travel at least once a year for attending meetings with stakeholders and sponsors, e.g. Program Review, and/or conferences, e.g. DTRA CBD S&T Conference.

Q14: Are there particular pathogen, emerging pathogens, or classes of pathogens of interest? (BSL level or exposure route).

A14: No particular pathogen or class of pathogens is required. The solution should be pathogen agnostic and able to handle several types of data.

Q15: Are there any budget requirements or restrictions for subcontractors? A15: The offeror should submit a budget they deem appropriate for the successful completion of the effort.

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Q16: What metrics are of specific interest to DTRA to define the ability for an MPS to replicate the microbiome?

A16: Must contain a representative human core microbiome that can be justified based on characterization studies.

Q17: Do you have any constraints on the manner in which the MPS can operate? A17: As long as the system meets the general description of microphysiological systems (ie contains human primary cells with a microfluidic component) there are no constraints.

Q18: Our team includes a DoD laboratory. Would DTRA prefer to send money directly to that organization? If yes, could you please advise how we should prepare our cost volume?

A18: The offeror should propose the sub-contractor(s) they deem appropriate for the successful completion of the effort and include those costs in the cost volume.

Q19: Are the BOEs provided expected to be standalone narratives, or can we incorporate them into the costing spreadsheet provided?

A19: The BOEs are part of the technical volume. Please refer to the BAA for additional information.

Q20: Can we get clarification on the reviewer’s comments of our Phase I proposal? A20: Additional feedback on individual proposals is not provided.

Q21: Does CBA Medical Diagnostics have a preference between a singular representative microbiome MPS for the skin and/or oral cavity (i.e., a core microbiome) versus a modifiable representative microbiome MPS that could be tailored and/or tuned to represent microbiomes from different geographical regions, genders, races, environmental factors, etc. (i.e., a flexible core microbiome)?

Note: This question stems from the following statements in the BAA:

* “While diversity exists in the microbiome between individuals, there is a shared core microbiome that can be exploited for diagnostic purposes (8).”

* “Establish a standardized microbiome representative of the core microbial community in the human oral and skin niches.”

A21: While a modifiable microbiome is of interest, the intent is to use this technology to assess diagnostic markers that would be broadly representative for microbiomes across population groups, therefore, a single core microbiome should be prioritized.

Q22: Is the scope for this BAA focused on a healthy microbiome, or would any diseased state microbiomes also fall within scope?

Note: This question stems from the fact that more than 25% of adults in the US have untreated tooth decay and therefore, have oral cavity microbiomes containing both healthy and disease state microorganisms AND the fact that more than 20% of adults are colonized by potential disease causing microorganisms, such as S. aureus, on their skin. Thus, the influence of these disease agents in these oral and skin microbiomes will likely manifest in microbiome changes compared to healthy microbiomes where these organisms are not present.

A22: The consensus is that warfighters are generally young and healthy, therefore, initial focus should be on microbiomes that represent this population.

Q23: Is the machine learning element solely focused on streamlining analysis from future clinical samples or does CBA Medical Diagnostics desire any type of predictive modeling capability from the ML component?

A23: We have an interest in both approaches, however, predictive modeling capability will require large datasets which will likely not be available from these studies initially.

Q24: If changes are made in the experimental design based on feedback received on Phase I proposal, is it acceptable to increase the budget of the invited Phase II proposal?

A24: The offeror should submit a budget they deem appropriate for the successful completion of the effort.

CALL04 QA