47QFCA24R0036 Amendment 02_QA.pdf

Amendment 02 Draft

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

Will the Government please review (insert topic) and provide feedback on whether or not this is viable solution, would be deemed acceptable/responsive, fits, etc. Multiple vendors have requested the review of white papers, solution summaries, line cards, scenarios, etc. and/or have requested phone calls to discuss possible solutions.

The Government is not providing pre-submission feedback for this effort. The Government is not pre-evaluating Industry capability statements, approaches or methodologies received via email or other means for the competitive ARPA-H solicitation; no pre-evaluation or decisions will be provided. Industry should refer to the Solicitation for Topic Scope as a basis of their business decisions for proposal submission.

4.8 Please provide the Contractor POCs in Section 4.8. See Amendment 02 Section 4.8 for updates

6.1 / 3.4.1

Page 87 of the solicitation says that the proposal must be submitted with attachments in 2 parts: 1 PDF for the Technical Proposal and 1 PDF for the Business Proposal. Appendix A.1 and A.2 are required for every proposal, but page 39 of the solicitation says these Appendices must be EXCLUDED from the Technical proposal and submitted as a separate document. Can you please confirm it will be acceptable to submit the proposal in 3 parts then (1 PDF for the Technical Proposal, 1 PDF for the Business Proposal, and 1 PDF for Appendix A./ A.2)? Do you have a required file naming convention for Appendix A.1/A.2?

Proposals are to be submitted with attachments in two parts per Solicitation Section 6.1. Section

3.4.1 updated in amendment 2 to change from excluded to included. No additional naming convention for Appendix A.1/2 required.

3.4.1

Section 3.4 states “Offerors shall also submit the applicable Human Subjects and Clinical Trials appendices as part of the technical proposal submissions” but section 3.4.1.1 states that the “Human Subjects and Clinical Trials Information form and its attachments.. are to be submitted as a separate document from the Technical Proposal.” Could you please clarify how Appendices A.1/A.2 should be submitted (as part of or as a separate document from the Technical Proposal)? If submitted separately, could you please clarify if there are any special naming convention required for this document, similar to naming conventions provided in 6.3b?

Proposals are to be submitted with attachments in two parts per Solicitation Section 6.1. Section

3.4.1 updated in amendment 2 to change from excluded to included. No additional naming convention for Appendix A.1/2 required.

3.5.1.1

Can the formatting in Appendix A be modified (e.g. font size, font style, margins, etc.) from the template document, and if so, are there any restrictions on this? I was wondering if the font in the template can be changed and what size should be used for the font See Amendment 02 for updated information in Section 3.5.1.1

3.5.1.1 Are footnotes or endnotes permitted and, if so, are those counted towards the page limit? Can hyperlinks to references, websites, or portals be included? See Amendment 02 for updated information in Section 3.5.1.1

3.5.1.1 Are appendix materials allowed? Do these add to the page count?

It is at offeror's discretion, but must meet the guidelines found in 3.5.1.1 and required page limitations identified in the the Solicitation and Solicitation Appendix.

6.3

"1. There seem to be two different instructions regarding the subject line to use when submitting. On page 86 it says:

Proposals shall be submitted with the following subject line: {company name}_47QFCA24R0036_Proposal_Topic [insert].

On page 87 it says:

a. Your proposal submission shall be submitted with the following subject line: (1) the Phase the proposal is for; (2) the name of the Offeror; (3) 47QFCA24R0036 and (4) the Topic being proposed under.

Can you clarify which is correct?" See Amendment 02 which updates Section 6.3(a)

6.3

2. Similar question for naming files - On page 87, the examples for the technical and business proposals don't follow the same format. See Amendment 02 which updates section 6.3(b)

Appendix B/D

For GSA ASSIST required registration, Section 3.1.1 says that this certification should be included as part of the business proposal (Appendix B/D). Could you please clarify where and how in Appendix B this certification should be included? There does not appear to be any mention of ASSIST registration in Appendix B.

Amendment 02 updates Appendix B and D to include a request for a statement that GSA ASSIST is up to date

Appendix A.1/A.2

"Regarding the subject solicitation, I am unable to check boxes or attach files to the document APPENDIX A.2 HumanSubjectStudy_3_0-V3.0 Form H 5-23.pdf (attached). APPENDIX A.1 works just fine.

Is it allowable to submit a single PDF for APPENDIX A.2 that includes the required documents, e.g., Inclusion of Individuals Across the Lifespan?"

This is an acceptable approach. Please ensure if these documents are pulled out separately to submit as a PDF due to technical issues, that they follow a similar naming convention as identified in section 6.3(b)

I am writing to inquire about the upcoming deadlines for the submission of proposals for the ARPA-H SBIR program. Additionally, I would like to know if there is a recording of the webinar available.

The offer due date is 11:00Am ET on July 26, 2024 in response to the solicitation. The Webinar is posted within this amendment as well as on the following sites: SAM.gov Special notice 47QFCA-24-ARPA; SAM.gov 47QFCA-24-R-0036. The direct link to the webinar is https://www.youtube.com/watch?v=nWclERJy5t8

We are doing preliminary interviews with stakeholders including pediatricians, educators, and professional advocates for neurodivergent persons, which have yielded key insights that will inform our proposal and our product design. We are also pursuing partnerships with closely aligned business interests and non-profit organizations, but we may not have MOUs with those organizations signed before the submission deadline. May we still submit letters of interest from these SMEs and organizations after the July 26 due date?

No, complete proposals have to be received by the Solicitation response date and time as stated in the Solicitation. Offers are due by 11:00AM ET, July 26, 2024.

We lost administrative access to our SAM account when the authentication system was changed back in March, and we have been working on restoring it for several months in an effort to renew or registration . We will proceed with the fix but there is a risk that the renewal will be pending at the submission deadline. It would be helpful to understand if there will be any latitude with our submission if this scenario materializes.

No exemptions apply under FAR 4.1102(a) therefore Offerors are required to be registered in SAM at the time the offer is submitted to comply with the annual representations and certification requirements.

Is a technology that does not involve a device suitable for this call? (ARPA-H_05 ) This topic area is inclusive of technologies in addition to devices, however its focus is novel brain targeting technology.

Should applications address all three target areas (i.e., hardware, mobile app, and web server with database) or a single target area (ARPA-H_01)

We strongly encourage proposals to address all target areas, but, with justification, we will consider proposals that address 1 or 2 target areas.

1. Non-Invasive Administration Routes: Could you please provide detailed information on what administration routes are covered under the term "non-invasive" as referenced in the solicitation? 2.

Anticipated Award Dates: Could you also provide insight into the anticipated award dates and the earliest possible start date for the projects? Understanding this timeline will assist us in our planning and proposal preparation.

1. For the purpose of this topic area, non-invasive is defined as administration without direct injection into the peripheral or central nervous system. 2. Anticipated Award Dates: End of September 2024

The slide mentions that you are only accepting Phase 1 proposals. We are interested in submitting a Fast-track application for ARPA H-06. Is that a possibility?

The Government is only accepting proposals for the respective Phases identified in Section 9 of the Solicitation for the specific Topic(s). Proposals for phases outside of what is Solicited will not be evaluated. Per Section 9, ARPA-H 06: NutriTech: Revolutionizing Personalized Food as Medicine Only Phase I proposals will be accepted. This topic is open to SBIR or STTR.

(2) Topic "ARPA-H 04: Wearable Cell sorting and Gene Delivery Systems" explicitly includes "wearable" in the title, however the goal of the solicitation topic is also stated as to "enable administration of the gene delivery in a hospital setting." How is 'wearable' defined exactly, given that such a device may require venous access in order to collect the tens or hundreds of millions of cells that are typically required for a cellular (e.g. CAR-T) therapy?

The device does not need to be connected to the body. The intention of the noted sentence was to enable isolation of the target cells, transformation/transduction, and reintroduction into the patient in a closed “vein-to-vein” format.`

Imaging Specifications: How strict are the resolution requirements (sub10 μm isotropic resolution for invasive and better than 100 μm x 100 μm x 100 μm for non-invasive approaches)? Will ARPA H allow for some flexibility? (ARPA-H_07) There is some flexibility around spatial resolution/ depending on the applications received.

Could you please let me know if the proposal must address both goal areas, or if it can concentrate on just one of the two goal areas?

The current outlined goal areas are for this research topic solicitation are:

Goal Area 1: Advanced in-line or at-line process analytical technologies informing on critical process parameters.

Goal Area 2: Rapid, automated, walk-up-enabled product quality testing. (ARPA-H_03) One goal area would meet the solicitation requirement

Is it possible for our proposal to cover only one phase, specifically Phase I (ARPA-H_03)

ARPA-H 03: Cell and Gene Therapy Process Analytical Technology (PAT) and Quality Control (QC) Testing is for: Phase I or Direct to Phase II proposals will only be accepted. This topic is open to SBIR only.

ARPA-H 01 topic, "Ambulatory Edema Monitor." Specifically, we would like to clarify whether this topic is limited to peripheral edema monitoring only. No, it is not limited to peripheral edeme monitoring only.

The slide also mentions FDA regulation. Typically, Food-as-Medicine Recommendations are not regulated by the FDA as long as they involve the use of food and GRAS. What exactly are you looking for in terms of FDA regulations? (ARPA-H_6)

For Diagnostics and Digital Health tools that prescribe food as medicine, the FDA typically evaluates the dietary management of disease and conditions based on risk, intended use and evidence-based recommendations. It would be expected that the technology would comply with appropriate FDA regulations.

1. For the submission does an offeror need to prepare the grant as a regular SBIR from Specific aims, project descriptions etc. all the way to the budget or does the offeror just need to fill the form posted under the following link:

https://sam.gov/opp/2879e06cc538421d9a2eb2c871a9537b/view ?

2. Would you please provide the link where I can find the guidelines to prepare the SBIR grant?

1. The offeror shall follow the proposal instructions contained within the solicitation. Sections 3 and 6 specifically address proposal preparation, however other sections contain information that is also associated to proposal preparation. Additionally the offeror's attention is drawn to Page 2, I have a question about eligibility for DARPA-H grants under your SBIR program. My question is how this would work with the current structure of this company.

I would like to know if this company is eligible to apply under its current structure, and if not, what would need to be done to secure eligibility.

Grants are not being awarded resulting from this Solicitation. Procurement contracts are being awarded. To receive a SBIR or STTR award, the awardee must qualify as a Small Business Concern as defined by SBA regulations at 13 C.F.R. §§701-705. Only United States small business concerns (SBCs) are eligible to submit SBIR and STTR applications. A small business concern is one that, at the time of award for both Phase I and Phase II awards, meets all the eligibility criteria.

Information would be set forth in the offeror's proposal, certifications and/or appendixes for Government consideration. Eligibility and Certification requirements are set forth in the Small Business Act, SBA regulations (13 CFR part 121), the SBIR/STTR Policy Directive and also any statutory and regulatory provisions referenced in those authorities. Further information may be obtained by contacting the Small Business Administration Size District Office.

Are Biosketch for key personnel required?

Biosketch are not included as an element of the Solicitation. The Appendix requires "Senior/Key Personnel and Bibliography of Directly Related Work."

Reference Letters: Could you please confirm if such a requirement exists and, if so, how many letters are needed?

If you don't require the letters, could we add them to support our project?

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

Letters of Support 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.

In the technical proposal, can we attach supporting letters, reference list, etc that helps in the review?

Do they count as ten page limits?

Letters of Support 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.

In Section 7 of the research plan for the Phase 1 proposal, "Potential Commercial Applications," can we include letters of support from companies we collaborate with who would be potential purchasers of our technology solution and not have that count in the 8 page limit? Currently, we partner with the Mayo Clinic, USC Keck Medical, Midland Health to name a few.

Letters of Support 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.

We have letters of support for our proposal. Does ARPA-H accept these letters? If yes, how should we submit them with our proposal?

Letters of Support 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.

Can we provide Letters of Support from future Commercial Channel Partners, Distributors, Suppliers, Investors, or R&D Partners? If so, would those Letters of Support be counted towards the page limit?

Letters of Support 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.

Do applicants need to submit an SBIR/STTR application and the ARPA-H appendices? Or is the whole of the application the ARPA-H appendices?

Please refer to Section 3 Proposal Preparation and Instructions. The NIH SBIR/STTR process is not being utilized for this Solicitation. Offerors should ensure they are following the guidance provided in the Solicitation for the anticipated procurement contract awards.

Please refer to the Solicitation for specific proposal submission requirements and required Appendices.

"Only Procurement contracts will be awarded resulting from this solicitation; Grants will not be awarded. The attached forms reference “Grants” throughout the documentation and should be replaced with the term “Contract.” This solicitation is only for the award of procurement contracts and not grants, however the applicable NIH/HHS/ARPA-H forms may not account for this difference.

Are letters of support allowed and/or recommended?

Is a Solution Summary Required for proposal submission

1. Regarding Appendix B for the Business proposal, what is the purpose of p. 6 labeled General Information? What information is required here and what is meant by "replies questions II to V above"?

Where are these questions?

1. Page 6 General Information provides instructions 1-4 as well as a "continuation page" that links directly to questions II through V on the previous page 5 for additional spaces, where it stats to idnetify on seperate page)

2. On p.9 of Appendix B, can you explain table c and what information is meant to be provided?

2. Page 9 table c: The following specific information must be provided by the offeror pertaining to the Project Director, Principal Investigator, and each of any other proposed key professional individuals designated for performance under any resulting contract. "c" specifically relates to the LOE of dedicated resultant contract awarded.

3. Where are we supposed to provide quotes for equipment (>$5,000)? Do we attach them at the end of the Business proposal PDF or are they not required?

3. Per the Business Proposal Page 4 "Item Description" For Equipment, Supplies, and Other costs:

provide itemized list with quantity and unit prices, indicate planned sources, and state how price was determined to be reasonable (e.g, market research, competitions, etc.).

Can you possibly direct me to the proper email address so that I can submit my summary, along with any other necessary requirements

The Government is only accepting proposals in response the the Topics contained within the Solicitation. Industry should monitor SBIR.gov as well as ARPA-H website https://arpa-h.gov/news-and-events/arpa-h-announces-small-business-funding-opportunity and other agency websites for additional SBIR/STTR topic opportunities outside what is currently solicited in

47QFCA-24-R-0036

"The question concerns the requirement that PI(s) must be “primarily employed with a small business at the time of the award and during of the project.” If Selection applies for and receives an ARPA-H contract, we will of course hire one or more scientists and will be able to satisfy this requirement. But as of now, all of our technical people are employed at academic institutions.

Is there any way that we can make this “work”? For example, I could become an “employee” (albeit at no salary yet!), but I'm not a scientist. Or we could look to quickly bring on a scientist employee should we learn that we will in fact be receiving the contract."

For both SBIR Phase I and II - the principal investigator must be primarily employed with the SBC at the time of award and for the duration of the award. The strategy or approach utilized by the offeror is at their discretion, however must meet the requirements set forth by the Small Business Act, SBA regulations (13 CFR part 121), the SBIR/STTR Policy Directive and also any statutory and regulatory provisions referenced in those authorities as well as the Solicitation, to include technical approach and certifications.

To respond to this Solicitation two companies are combining knowledge and expertise to respond to the Topic. Each company will have a PI. We will respond with a combined proposal with a single point of contact. Is this acceptable?

Refer to 1.4.3 Eligible Individuals (PD/PI) of the Solicitation. "For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide."

Correct, both pages 58 and 74 state, Cost sharing is permitted for proposals under this solicitation;

however, cost sharing is not required, nor will it be an evaluation factor in the consideration of a Phase I proposal.

Do all personnel, including contractors and sub-contractors, need to be specifically identified prior to starting the project? Under our proposed scope of work, we envision we will need to hire personnel and/or identify additional specific contractors, but will not be able to specifically name them all in advance of the proposal deadline.

Per Section 3.5.1 List all key personnel by name as well as by number of hours dedicated to the project as direct labor. Additionally, refer to Appendix B and D for "Direct Labor" and "Subcontractors/Consultant" pricing requirements.

The template Contract Pricing Proposal has separate cost elements for “Overhead” and “General and Administrative Expenses.” Is it a requirement to break down indirect costs into these two separate categories, or may we just propose one cost element titled “Indirect Costs”?

Per Appendix B and D, this form provides a standard format for the offeror to submit a summary of estimated costs (and attached supporting information suitable for detailed review and analysis.)

2. Offerors should use indirect rates consistent with their own accounting system, even if different from the rate categories shown on page 1 of this Appendix.

What guidelines does ARPA-H have on indirect cost rate rates for the contractor and any subcontractors? What about an added fee (e.g., 7%) for profit?

The Solicitation in conjunction with Appendix B and D provide guidance. For example 3.5.1 states Threshold for Negotiation of General and Administrative (G&A)/Indirect Costs (IDC) Rates for SBIR proposals – SBIR offerors who propose a G&A/IDC rate of 40 percent of total direct costs or less will not be required to negotiate Final Indirect Rates with the AAS Contracting Officer, or other cognizant auditing agency.... It also states Profit: Offerors shall not exceed a Profit of 7%. The business proposal has additional instructions on the tops of pages 4 (Item Description) and 6 (General Information). See Solicitation documents.

Previous federal awards we've worked with have had specific limitations on what could be included in the base number for which indirect costs are applied. Traditional exclusions include: equipment, amounts over the first $25,000 of each subcontract, participant support costs, etc. Are these Uniform Guidance restrictions applicable here? If so, can this be made explicit (with links to the appropriate guidance) in the solicitation?

The Solicitation in conjunction with Appendix B and D provide guidance. For example 3.5.1 states Threshold for Negotiation of General and Administrative (G&A)/Indirect Costs (IDC) Rates for SBIR proposals – SBIR offerors who propose a G&A/IDC rate of 40 percent of total direct costs or less will not be required to negotiate Final Indirect Rates with the AAS Contracting Officer, or other cognizant auditing agency.... The business proposal has additional instructions on the tops of pages 4 (Item Description) and 6 (General Information)

Could you provide information about the selection criteria and point me to the relevant document? Section 4 of the Solicitation describes the Method of Selection and Evaluation Criteria We have a few concerns with entering into NDAs with external consultants for the purpose of proposal evaluation (we just want to make sure we're doing our due diligence to protect our ideas).

Will you review proposals that DO NOT have an NDA in place with either HIVE or MITRE? Or would not including an executed NDA disqualify our proposal for evaluation?

In accordance with Solicitation section 4.8, the offeror can "choose" to enter into a non-disclosure agreement with those listed companies. It is not a mandatory requirement of this Solicitation. Please see Federal Acquisition Regulations 9.505-4(b) for additional information related Solicitation Section 4.8.

Can we opt to enter into an NDA with just one of those recommended consultants - to indicate our preferred consultant to work with?

In accordance with Solicitation section 4.8, the offeror can "choose" to enter into a non-disclosure agreement with those listed companies. It is not a mandatory requirement of this Solicitation. Please see Federal Acquisition Regulations 9.505-4(b) for additional information related Solicitation Section 4.8.

Under what conditions would the proposal be sent to one of these groups for review? (Meaning, is there any way the proposal stays internal for evaluation, even if an executed NDA is included?)

It should be assumed that all three companies will play a part or have a roll in the review of all offerors' proposals.

Can you provide contact information for MITRE? The solicitation says it’s awaiting amendment, but we know these NDAs take time to execute… Please see updated RFP Section 4.8 in Amendment 02.

Would these consultants be used during award negotiations and contracting as well? Or are they only being used for proposal evaluation?

Related question – Is the intent to share the entire proposal with them (both the Technical and Business proposal)? Or just the Technical proposal? The Technical proposal may be shared as part of the evaluation.

Are there any example Phase I submissions available (for any related solicitation)? We're concerned about getting all the content right in conformance with the application instructions and therefore an example would be tremendously helpful.

The Government does not have example submittals of previous proposals. Some resources that may be able to provide assistance include, the Small Business Administration (SBA) provides financial, technical, and management assistance to help Industry start, run, and grow their businesses. Various levels of assistance, mentoring and guidance is available at SBA's website. As well as the APEX Accelerators program.

If responding to the solicitation for proposals which addressed two respective topics was allowed? Yes, offerors may submit multiple proposals. ie one proposal each for two separate topic areas

What are the conditions within which an offeror must complete and submit FAR Provisions 52.204-24 and 52.204-26 as part of the Small Business Proposal? In the case that this documentation is required, where can they be located?

Section 2.2.6 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment.

All offerors must complete and submit FAR Provisions 52.204-24 and 52.204-26 as part of your Business Proposal (Appendix B and D, see appendices for more detail).

Human testing: Will a proposal be considered non responsive if human testing is not included?

Yes, a proposal will be considered non-responsive without human testing. Per Section 3.3:

Appendix A.1. is required for every proposal submission. If your proposal does not involve Human Subjects or Clinical Trials, you must still note this on the form and submit the form. If applicable (i.e.

the proposal requires human subjects or clinical trials) Human subjects, Appendix A.2. – Study Record must be attached to Appendix A.1.

Section 1.4.3.1 mentions all PD/PI must have an NIH ASSIST account, but subsequent sections (3.1.1 and 3.5) mention required registration in GSA ASSIST. Could you please clarify if registration in just one or both of these are required for proposal submission?

1. GSA ASSIST is required prior to proposal submission. Per Section 3.1.1 (and 3.5) Registration in GSA’s ASSIST – Required Prior to Proposal Submission Contractor Registration: The offeror shall provide a statement that it has been registered in ASSIST and that all information in ASSIST is up to date

2. NIH ASSIST registration will be required Post-Award for PD/PI information

Is an NIH Assist Account required to be created before submitting the proposal? NIH ASSIST registration will be required Post-Award for PD/PI information Topic 1 is straight to Phase II. Would you still like separate Phase I Technical and Phase I Business Proposals? May Phase I and Phase II be combined into Phase II Technical and Phase II Business Proposals?

Per Section 3.3 Contents of a Complete Proposal of the Solicitation; the Appendices required state:

2. A SBIR/STTR Phase II proposal consists of a Technical Proposal (Appendix C) and a Business Proposal (Appendix D).

On page 74 of the solicitation, it says that cost sharing is permitted under this solicitation; however, cost sharing is not required, nor will it be an evaluation factor in the consideration of a Phase I proposal. Can you confirm that cost sharing is not required, nor will it be an evaluation factor in the consideration of a Direct to Phase II proposal as well?

I had a question regarding the reviewers. Do these applications go to NIH study sections? What does the composition of the reviewers look like

Per Section 4.2 Peer Review - No peer reviews will be conducted as part of the evaluation of proposals.

The applications received for ARPA-H's SBIR/STTR solicitations do not go through any NIH peer review processes. The ARPA-H SBIR/STTR topics are developed and evaluated by an ARPA-H Program Manager.

We are very new (just incorporating) but have research capabilities to execute programs through academic partners and CROs, is it possible to submit even if the incorporation is not completed (but very close)?

The application can be submitted if not fully incorporated yet but companies must be fully incorporated prior to award.

Our subcontractor usually requires advanced payments. Can we get paid in advance or on a monthly basis or is milestone based payments the only option?

Correct, milestone payments will be allowed under the contract as outlined in the Solicitation, if proposed by the offeror.

Do we need to register for the clinical trial before submitting the proposal?

Clinical trials do not need to be registered before submitting the proposal if referring to registering for a clinical trial on the CT.gov website. If a clinical trial is planned, then please follow institutional policies in getting the trial approved and following human subjects requirements.

When are Phase II invitations after a Phase 1 contract award generally sent? On a rolling basis? Or should we structure our proposed work plan to align with certain timelines (i.e. to complete Phase I aims by a certain date at which all Phase I awardees will be evaluated)?

Phase II requirements following a Phase I would be solicited via a separate Solicitation at the Government's discretion. Industry should monitor ARPA-H websites, SBIR.gov and SAM.gov for any additional requirements outside the Topics solicited in 47QFCA-24-R-0036

We would like to include a subset of the vocabulary corpus, evaluation questionnaires, and other sample materials to illustrate our approach. Are appendices allowed in addition to the 11 pages for Phase I and the 19 pages for Phase II?

All proposals and contents of the proposal shall fit into the specified page/word limitation found within the Solicitation and Solicitation Appendices

Attachment Clarification

Will you please clarify if our plan for attaching submission files is correct? From reading your appendices, we understand we will submit a FAST Track of at least two attachments:

1. Phase 1 (appendices A, B)

2. Phase 2 (appendices C, D)

A SBIR/STTR Fast-Track proposal consists of both a complete Phase I (Appendix A and B) proposal and a separate, complete Phase II (Appendix C and D) proposal.

Is it best to combine appendices A.1 and A.2 with Phase 1 appendices, or do you prefer these as separate attachments?

Appendix A.1 and A.2 are addressed under Amendment 02 and shall be submitted as part of the technical proposal.

We assume each phase would be combined with letters of support and resumes, but please clarify if we can refer to this in appropriate sections and create an independent section for this with business appendices.

Letters of Support 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. Offerors shall follow Solicitation and Solicitation Appendix requirements

Could you please clarify who should fill out the “Department of Health and Human Services National Institutes of Health Proposal Summary and Data Record” and “For the Institution” sections in Appendix A? It seems like we should fill out the former, but leave the latter blank? This should all be completed by the applicant.