47QFCA24R0036 Amendment 03 QA.pdf

Amendment 03 Final

Solicitation Section Updated Question Official Government Response for Q&A Amendment:

4.2

In which way will the Fast Track proposals be evaluated. In section 1.3 it mentions Phase I and Phase II will be separately evaluated, but in section 4.2 it mentions Phase I and Phase II will receive a combined review.

See Amendment 03 for clarification. When submitting a fast track proposal, the Phase I and Phase II proposals will be reviewed separately but as a single proposal submission.

We would like to determine if we should apply for a Direct to Phase 2 or a Phase 1. Our concern is how much, and what form of commercialization analysis we will need to present in support of a D2P2 application given that there is currently nothing to compare with. (ARPA-H_03)

Offerors should submit proposals in accordance with the criteria set forth in the Solicitation. It is the offerors business decision based on their supporting data whether or not a Direct to Phase II or Phase I is proposed.

For the TABA funding, for Phase I we can request $6,500. Does this need to be included under the $600,000 limit for Topic 3 or is it OK to add in addition to that limit?

Yes, the request for TABA funds must be within the stated budget limits for the SBIR/STTR mechanism.

The budget limitations provide for up to $6,500 per year for a Phase I and up to $50,000 per Phase II project (across all years) for technical assistance. If we use this funding to enlist our own qualified technical and business assistant, are we still eligible to be partnered with an “Entrepreneur In Residence” provided by ARPA-H, if our work is funded?

Applicants proposing TABA funds may also be eligible for the EIR program. If both programs are considered, there can be no duplication of services between TABA and the ARPA-H EIR program.

ARPA-H_06 General Overview of Topic:

- Scope of Technology: Is the primary focus of Topic 6 to design a proof of concept for new technology that assesses nutrition intake, such as an AI-enabled photo food log or the integration of CGM data with food tracking?

PM response: The primary focus of Topic 6 is on the correlation of inputs to outputs (assessing a personalized nutritional need with a direct improvement in health outcome through a nutritional intervention) .

ARPA-H_07 Acquisition Time: Will ARPA H allow for some flexibility with regard to the one hour time limit for acquisition time?

No. We are looking for a practical solution that can make a difference in the clinic. Acquisition times beyond one hour are impractical and difficult to tolerate for patients.

ARPA-H_08 Novel Technology vs. Novel Approach: Is the solicitation focused solely on funding novel technologies, or is there also the possibility of funding more established technologies if they involve a novel approach?

PM Response: Applying existing technologies in a new way or a new application is still innovation. The primary consideration is achieving gold standard performance (as currently provided by FDA cleared pressure cuff devices).

ARPA-H_08 We would like to understand the requirement for the Cost of Goods Sold (COGS) being less than $20. COGS sometimes includes not just the material used in manufacturing but also labor and overhead. We assume the definition of COGS in this case is restricted to the cost of materials and not labor or overhead. Furthermore, the target wearable may have additional components, such as a screen, battery, CPUs, and additional sensors. Can we assume the COGS is limited to the additional components necessary to add blood pressure monitoring to an existing wearable

The intention stated in the topic is for a technology that can be integrated into other multifunctional devices – as a Component, at scale, the ESTIMATED COGS (including all usual elements of COGS) should be targeted to $20. We don't expect $20 be to demonstrated in the SBIR Phase 1 other than feasibility through engineering analysis.

As a stand-alone (presumably single function) device that has other components (battery, screen etc.)

the COGS can be higher but a stand alone device.

During the webinar, it was indicated that funding would be awarded by end of fiscal year, or around end of September 2024. For a project that is already in progress, when should the project budget initiate the SBIR funded expenses? Can the SBIR funded project expenses in the budget start in this fiscal year?

Should the subcontract budget for SBIR funded expenses be treated differently in terms of the start of budgeting?

SBIR funded expenses would not start until after the SBIR award, once the funding is obligated and placed on contract.

We plan to build an high-resolution CT scanner (50 micrometer spatial resolution) for the topic using latest technology breakthrough in X-ray detectors and sources. The detectors and sources can be costly, e.g., 200k for a X-ray tube. Should I classify main components like X-ray photon-counting detectors, X-ray tubes as equipment in our budget?

Use a description that most accurately describes the parts that you intend to purchase. Please ensure the data aligns the requirements set forth in the business proposal.

If we are doing a delayed onset for A.1, do we need to turn in A.2 as well indicating this?

A.2 is required, if applicable. Per Section 3.4.1.1 APPENDIX A.2. — STUDY RECORD, ATTACHMENT TO HUMAN SUBJECTS AND CLINICAL TRIALS INFORMATION FORM

If your project involves Human Subjects, even if the project is exempt from Federal Regulations, then completion of Appendix A.1. will also require Appendix A.2. – STUDY RECORD, which is an attachment to Appendix A.1. Instructions to complete this form can be found at:

https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.ht m

Budget/Business Appendices Clarification

Is there separate guidance in addressing the format of the business proposal? I reviewed the Solicitation Instructions but would appreciate guidance on sections that may further clarify items such as:

- What is the difference between estimated cost vs. total estimated cost? Will the total estimated cost include the 25% fringe benefits?

- Will you please verify the definitions or options of representing:

- X Base (Column Appendix B)

- Rate (Column Appendix B)

- Fee or Profit (Appendix B, line 6.)

For Travel, in addition to including purpose details, would it be possible to show the allocation of this for specific subcontractor organizations, or is it okay to share the details of the number of travelers, days, and address it as a one-line item and overall collaborative team description? Or do we need to separate each for each collaborator institution?

The Government encourages all offeror to seek professional assistance if the offeror is uncertain how to complete the Contract Pricing Proposal. Not all organizations allocate indirect cost in the same way.

It is important that you use the indirect rate structure applicable to your organization. As it relates to Appendices (B&D) Contract Pricing Proposal and the questions asked:

1) The difference between the estimated cost vs. the total estimated cost is that the estimated cost is specific to the individual line item whereas the total estimated cost is the sum of all line items within the specific cost elements. For example, in the direct labor element, the principal investigator would have an estimated cost specifically derived from the labor rate and hours estimated for the principal investigator. With the assumption that there will be more than one person working on a research area, additional labor categories and their respective estimated costs will roll up into one ""Total Estimated Cost"" specific to the Direct Labor element.

2) Fringe benefits will be factored into the ""Total Estimated Cost and Fee or Profit"" row at the bottom of the contract Pricing Proposal worksheet.

3) For Element 2, X Base = The Total Direct Labor Total Estimated Cost. For Element 3, X base = the Total Estimated Cost estimated from completing Element 2. For Element 4b. X Base can be a multitude of things from the amount ""hours"" to ""1 lot.""

Rate is defined as a fixed price paid or charged for something, especially goods or services

Fee is defined as a payment made to a professional person or to a professional or public body in exchange for advice or services.

Profit is defined as a financial gain, especially the difference between the amount earned and the amount spent in buying, operating, or producing something.

4) All Travel expense shall be included within one line item if using the Contract Price Proposal worksheet in the appendices.

Also, the guidance requests Letters of Direct Support to share agreements of daily or hourly rates, but the Business Proposal (Appendix B & D) indicates hourly rates. Would it be okay to show daily rates for some of the personnel?

Appendix A and C (Technical proposals) refer to Key personnel to include letters of commit with proposed consultants confirming the extent of involvement and hourly/daily rates. The Business proposal (Appendix B and D) is by Estimated hours at a Rate/Hour for direct labor and the rate for subcontractors/consultants. If the agreement with the subcontractor/consultant (whomever) is by a daily rate and is not proposed as an hourly rate, then the daily rate would be included in the contract pricing proposal.

My question is where I should put my references? In the template they lay out three page-limited sections and don't have a references section. I'm hoping I can avoid adding the references to my page count.

"References" are not explicitly required as part of the Solicitation. Any documents the Offeror submits would count toward the respective page limitations identified. The Solicitation references "letters" in the Technical Proposal Appendix, "Research Plan" Section under "Subcontractors/Consultants". If Offerors question falls within that requirement set forth in the Solicitation, then Offerors shall refer to the respective Appendix.