47QFCA24R0036 Amendment 0001 QA.pdf

47QFCA24R0036 Amendment 01 Q&A

Question Official Government Response for Q&A Amendment:

Are grants being awarded resulting from this solicitation?

Industry's attention is drawn to Page 2, "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 companies able to submit multiple proposals, i.e. one proposal each for two separate focus areas? Yes, offerors may submit multiple proposals. ie one proposal each for two separate topic areas

Is this a new Contract action or is there an incumbent performing these services? These are new SBIR/STTR topics in direct support of ARPA-H requirements

What is the meaning of ‘…miniaturized cell sorting and isolation devices that simultaneously perform CAR-T transformation, activation, and reintroduction.’ Could you clarify whether this device needs to be connected to the body at all times?

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.

1) I want to confirm that the July 26th, 2024 deadline is the full proposal NOT a pre-proposal?

2) Where can I find or can you send the Technical Proposal (Appendix A) and Business Proposal (Appendix B)?

1. The offer due date is 11:00Am ET on July 26, 2024 in response to the solicitation. 2. Appendix A and B are found on with the solicitation, under the Attachments/Link Section of the posting.

Could you please let me know how to access appendices A, B, C, and D, and other related templates

Please clarify the subject line for Questions to be submitted

Updated in Amendment 01 Section 6.2: Questions shall be submitted with the following subject line:

[Insert company name] _47QFCA24R0036_Topic [Insert #]_Questions

1. There is an incorrect reference in Section 4.3 that states 2.2; I believe this should reference Section 1.4 2. Section 5.10 needs the word "General" removed before Definitions Updated in Amendment 01. Refer to sections 4.3 and 5.10

1. Does ARPA-H SBIR/STTR offer Technical and Business Assistance (TABA) funding ($6,500 for Phase I and $50,000 for Phase II) Please refer to Section 3.5.2 of the Solicitation which discusses TABA funding

Please provide resources or mentorship on how to best develop a research plan for the SBIR deadline and instruction on how to craft the approach and other needed sections for a competitive proposal.

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.

Is there any restriction on our pursuit of other SBIR/STTR awards in parallel? (outside of this 47QFCA24R0036 ARPA-H solicitation)

Offerors may pursue other SBIR/STTR awards in parallel but AAS will not make awards that duplicate research funded by or anticipated to be funded by other agencies. It is important to note potential topic overlap on the cover page of your proposal. If a proposer fails to disclose that another Federal Agency has received this proposal (or an equivalent or overlapping proposal) on the proposal cover page, the proposer could be liable for administrative, civil, or criminal sanctions.

Are we allowed to apply as a 501(c)(3) nonprofit

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. A non-profit organization cannot directly receive an SBIR or STTR award. Non-profits may be a minority investor or subcontractor or sub-grantee on a project. Additional eligibility requirements can be found at:

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.

I am wondering if the SBIRs are being managed under FAR or OTA, and if whether Federal income taxes can be billed to the contract.

This is a Procurement contract. Regulations under FAR Part 31 - Contract Cost Principles and Procedures will apply to this procurement.

The document in SAM website is still in draft state, with no information like submission deadline, start date, etc. When will they be updated? The final RFP was posted to June 26, 2024. Please refer to for posting

47QFCA-24-R-0036 Solicitation.

Does Fee-For-Service work done through a vendor under the proposed grant considered a sub-contract and therefore counted towards the 33% max that can be subcontracted out for an

SBIR?

This solicitation will result in contract awards, not grants. Per SBIR/STTR Policy Directive Dated May 3, 2023: (nn) Subcontract. Any agreement, other than one involving an employer-employee relationship, entered into by an Awardee of a Funding Agreement calling for supplies or services for the performance of the original Funding Agreement.

Per NIH, A fee for Service provider provides goods or services within normal business operations and operates in a competitive environment providing similar goods and services to a variety of customers. Fee for Service providers not operating in the capacity as a subaward or subrecipient may not be calculated in the total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort.

There is no preference

This subject (solution/approach) falls outside of current posted topics. Is there an avenue for my company to apply for ARPA-H SBIR funding (multiple questions)

Proposals shall be submitted for the Topics as outlined in Section 9 of the Solicitation. Industry should monitor and ARPA-H websites (or other Participating Agency websites) for other funding opportunities.

SAM.gov https://www.sbir.gov/faqs/eligibility-requirements

SAM.gov SAM.gov

SBIR.gov

Appendices are found on SAM.gov with the solicitation, under the Attachments/Link Section of the posting.

Is there a funding preference for SBIR v STTR

47QFCA24R0036 Amendment 01 Q&A

Question Official Government Response for Q&A Amendment:

Requesting approval for foreign company and for some of the technical work to place place in Europe

For both Phase I and Phase II work, the R/R&D work must be performed in the United States. However based on a rare and unique circumstance, agencies may approve a particular portion of the R/R&D work to be performed or obtained in a country outside of the united States, for example, if a supply or material or other item or project requirement is not available in the united States. Information would be set forth in the offeror's proposal, certifications and/or appendixes for Government consideration. Certification requirements Eligibility 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.

Request for webinar Link and slide deck (multiple questions)

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

The slide deck can be directly downloaded here

For both Phase I and Phase II work, the R/R&D work must be performed in the United States. However based on a rare and unique circumstance, agencies may approve a particular portion of the R/R&D work to be performed or obtained in a country outside of the United States, for example, if a supply or material or other item or project requirement is not available in the United States. 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.

How do I find the RFP?

There are various links to the Solicitation to include (47QFCA-24-R-0036 Solicitation); as well as ARPA-H website

Is it possible to submit two grants to the same SBIR topic area if they are completely different solutions? If so, would they need to have different PIs and CO-Is?

This solicitation will result in procurement contracts, not grants. Interested parties may submit multiple proposals for a single SBIR topic so long the technical approach/methodology/idea/concept is different. PIs must meet the eligibility and Certification criteria 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.

1. Could you please provide more information about the specific requirements for subcontractors . Is it possible to submit the proposal without the subcontractor’s documents initially and provide those documents after the deadline.

Please refer to the solicitation and SBIR/STTR Policy Directives, SBA regulations (13 CFR part 121) for subcontract involvement. Complete proposals shall be submitted by July 26, 2024 11:00AM, to include both prime and subcontractor documentation as outlined in the Solicitation (Sections 3.3, 3.5.5 and 4.1).

What age-range and what stage of autism spectrum are the target users of the AAC tool technology?

It is usually more severe autism -- when there are difficulties with language acquisition.The ideal age to introduce AAC is pre-K or elementary school -- but, depending on needs -- can be used into adulthood as well.

The current AAC systems have a limited useful range and vocabulary, and are not useful in cases of mild impairment, nor do they promote improvement of speech and language abilities beyond that limited range.

Are there specific salary range guidelines for the PI and supporting staff?

Per Section 3.5.1 Salary Rate Limitation - None of the funds appropriated shall be used to pay the direct annual salary of an individual at a rate in excess of Executive Schedule, Level II of the Federal Executive Pay Scale. Effective January 1, 2023, Executive Schedule, Level II of the Federal Executive Pay Scale is $212,100.

1. We have made significant progress in a technology. Given our progress, could we apply for Phase II funding directly?

2. Does the grant solicitation require solutions to address both cell and gene therapy challenges, or is it acceptable to focus only on cell therapy?

This solicitation will result in procurement contract awards, not grants. 1. The Government is not providing pre-submission feedback for this effort. It is at Industry discretion which Phase is proposed, based on the Solicitatio (i.e. see Solicitation Section 9 and specific topic). 2. A solution that focuses only on cell therapy is certainly welcomed, they do not need to focus on both.

While our company is based in Germany, we have a C-Corporation subsidiary in the USA. I would like to know if it is possible to apply for the funding through our US subsidiary? Otherwise, we do comply with all the SBC requirements.

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?

Support letters are not explicitly required as part of the Solicitation. Any documents the Offeror submits would count within the 8 page limitation.

Research Topic 3: Cell and Gene Therapy Process Analytical Technology and Quality Control Testing: The solicitation states, “Phase I or Direct to Phase II proposals will only be accepted. This topic is open to SBIR only.” Since Fast-track proposals include both Phase 1 and Direct to Phase II components, are Fast-tracks allowed under Research Topic 3?

Per Section 9 of the Solicitation: ARPA-H 03: Cell and Gene Therapy Process Analytical Technology (PAT) and Quality Control (QC) Testing Phase I or Direct to Phase II proposals will only be accepted. This topic is open to SBIR only.

Fast-Track is not being accepted for this topic.

Per 1.4.1 Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. To receive SBIR or STTR funds, each awardee of a SBIR/STTR Phase I or Phase II award must qualify as a small business concern (SBC) at the time of award and at any other time set forth in SBA's regulations at 13 CFR 121.701-121.705. Eligibility 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.

https://www.youtube.com/watch?v=nWclERJy5t8.

https://investorcatalysthub.org/wp-content/uploads/2024/07/FY24-SBIR-STTR-Solicitation-Webinar_Final.pdf

SAM.gov SBIR.gov https://arpa-h.gov/news-and-events/arpa-h-announces-small-business-funding-opportunity

Will the Firm-Fixed Price contract be FAR based or an OTA type contract?

Can we include an international expert as a subcontractor?

This is a Procurement contract and follows the regulations under FAR.

Can we subcontract with an FFRDC? Yes, FFRDCs and federal labs are eligible to be subawardees.