Amendment 0002_fully executed.pdf

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SOLICITATION 75N91024R00006

Amendment #2

ARPA-H SBIR SOLICITATION 75N91024R00006

Amendment #2 Questions and Answers

Please note questions are due by February 15, 2024 5:00 PM EST. Multiple question and answer amendments are anticipated prior to the solicitation closing date.

1. QUESTION: My company is interested in applying for SBIR: ARPA-H 04 - Personalized medicine platform for predicting response to immunotherapy.

We read the focus seems to be on immune checkpoint inhibitor treatments.

Are predictions of outcomes of cell therapies (i.e. CAR-T) also responsive to the call? In the case of cell therapies (third line treatments now, though evaluation of uses as second line and first line), predicting outcomes requires months of waiting, and with our technology we can predict at earlier timepoints by tracking where in the body the cells go.

ANSWER: Yes, predictions of cell therapies are considered responsive to the call. However, the following statement is included directly in the topic:

“Platform must be capable of providing response prediction prior to initial treatment – hence, not include any markers measured past treatment start.” Though tracking cell migration in vivo following treatment may enable assessment earlier than conventional “watch-and-wait” approaches, it still requires treatment to have already begun. Proposers are encouraged to include a sufficiently argued justification on behalf of their technology and addressing that their technology can enable prediction before treatment begins.

2. QUESTION: Can we also co-submit to the SBIR mechanism? Can we submit comparable work (reduced in scope due to the difference in funding levels) to both the BAA and SBIR mechanisms. Can we submit a scope of work that is not included in the BAA to the SBIR mechanism and if successful in our applications would we be eligible for both awards?

ANSWER: You are welcome to submit to both the open ARPA-H BAA (Open Broad Agency Announcement | ARPA-H) and this SBIR solicitation, but please ensure the application fits within the SBIR topic you are interested in and is within the budget threshold amounts listed for that topic. Please keep in mind ARPA-H will not fund duplicative applications across the agency.

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3. QUESTION: Is it permissible to have two different PIs for the Phase 1 and Phase 2 portions for the Fast track option (for topic ARPA H 003)?

ANSWER: Yes, it is permissible.

4. QUESTION: I had reviewed previously the link for the open Small Business Program solicitation but I was not entirely sure about the following:

1. My understanding from review of the ARPA-H website is the steps are to first submit an abstract and then if invited submit a full proposal. However, in the link below it does not list submitting an abstract it lists the deadline for the proposal is Feb. 22. Does this mean by us submitting this week our abstract that we are now invited to submit a proposal?

2. Is the Small Business track the track we should submit a proposal to as opposed to either the HEROES or PARADIGM? Or should we wait to hear back from the ARPA-H BAA Questions <BAAQuestions@arpa-h.gov> email recipient as well regarding the possibility of submitting through HEROES or PARADIGM?

ANSWER: Unlike the ARPA-H open BAA, the SBIR solicitation is only accepting full proposals, which are due by February 22, 2024, 5:00 PM EST.

5. QUESTION: I am reaching out to express my intention to apply for ARPA-H's Small Business Innovation Research (SBIR) grant, with a specific focus on the ARPA-H-02 LymphoLab Prodiscover Kit outlined in the attached solicitation. I understand that a critical requirement for the SBIR funding mechanism is the establishment of a startup company before the funding commencement date. In light of this prerequisite, I am eager to commence the process of establishing a startup in stealth mode at the earliest opportunity. However, I am seeking clarification on the potential deadline for completing the company spinout to ensure eligibility for the funding.

ANSWER: At the time of submitting your proposal, you will need to complete all the required SAM.gov registrations concerning your company. This includes registering your small business with the SBA (Refer to Section 4.2 of the solicitation). Please refer to Section 6.11 (pgs 26-27). A new entity registration

Amendment #2 prior to proposal submission is required in order to provide a UEI # in the proposal. This will ensure the entity is active prior to award.

Prior to award, the entity must have an ACTIVE registration. Please register the entity on SAM.gov prior to proposal submission as a Unique Entity ID (UEI) will be required with the submission.

Also, note that eligibility will be verified at the time of award. Please refer to Section 10 General Definitions of the solicitation. There you can find what defines a Small Business Concern and eligibility under this requirement.

6. QUESTION: We are excited to submit for this ARPA-H/SBIR grant and were a bit confused about the instructions. The instruction sheet references a section 8.8 with required documents and we don't see it. Could you point us in the right direction about specific application instructions?

ANSWER: Please refer to the open solicitation for the Small Business Program published in SAM.Gov on Jan 23, 2024:

https://sam.gov/opp/a738f57f6f884dd49f3135c97b037d95/view.

The required attachments are listed here, along with Section 4 and 5 of the solicitation for Proposal Preparation and Instructions as well as Proposal Submission.

7. QUESTION: I am writing to seek clarification on the eligibility criteria for the Principal Investigator (PI) in SBIR projects.

As per my understanding, the PI for SBIR projects is required to dedicate a minimum of 50% of their time as an employee of the company. This stipulation creates challenges for many faculty members, rendering the pursuit of SBIR funds impractical unless a company PI meeting this criterion can be secured.

In light of this, I am inquiring about the possibility of having my graduate student assume the role of the company PI. The student is currently spearheading the project and is anticipated to graduate this May 2024, subsequently joining the company's workforce. Could you please provide guidance on whether this arrangement aligns with the eligibility requirements

Amendment #2 for the SBIR program?

ANSWER: See section 6.2. The PI who serves as the primary contact must be employed by the small business and meet the primary employment requirements as set by the SBA.

8. QUESTION: We are interested in applying to this ARPA-H grant as our company is working on a solution to one of the areas of interest. However I cannot find the link where to submit our proposal - could you please point me in the right direction?

ANSWER: Please be advised that any resultant award will be issued as a contract, not a grant as specified in the question. Please refer to Section 5 regarding Submission, which provides the website electronic Contract Proposal Submission.

9. QUESTION: We are considering applying for above mentioned contract opportunity. Is a company outside US (i.e. Italy), allowed to apply? If yes, which is the correct procedure to be followed?

ANSWER: For both Phase I and Phase II, all research or research and development work must be performed by the SBC and its subcontractors in the United States.

10. QUESTION: We are in the process of preparing two (2) Fast Track proposals in response to the subject solicitation. I just wanted to confirm that the Technical Proposal can be added under the Section that is Labeled Business Document since there is no button for the Technical Proposal.

ANSWER: As long as the Business and Technical proposals with attachments are clearly labeled, they can both be submitted through the Business Proposal link.

11. QUESTION: Can you please advise us on how to handle literature references in our Research Plan and Commercialization Plan. If we provide a separate list

Amendment #2 of references, would that count towards the 10 page limit in the Research Plan or the 4 page limit in the Commercial Plan?

(In NCI-SBIR applications, a separate list of references can be provided which does not count towards page limits – similar to letters of support)

ANSWER: A separate list of refences can be provided and will not count towards page limits.

12. QUESTION: We are in the process of drafting the proposal for ARPA-H 01 - Inexpensive Plant-Based Manufacturing of Viral Vectors for Gene Therapies. To ensure accuracy in our proposal, we seek confirmation on the following details listed on the first page of the technical proposal:

SOLICITATION NUMBER: Is it "Small Business Innovation Research (SBIR) Contract Solicitation"?

TOPIC NUMBER: Is it correctly identified as "ARPA-H 01"?

ANSWER: The solicitation number is 75N91024R00006 and the Topic Number is

ARPA-H 01.

13. QUESTION: Do we need to use the same margins for the Research Plan in the template (i.e. margin 1.25 inches), or can we use 0.5 inches margin from the end of the page on either side, as in NIH SBIR proposals? Also, we would like to confirm that we should use the font Poppins 10 in the template?

ANSWER: Please follow the defined margins from the applications. Otherwise, there are no specific requirements for font or margins.

14. QUESTION: We registered on sbir.gov/sbc and downloaded our SBC registration. However, our company profile is not verified with SAM.gov on the sbir portal, although the same EIN is used on both accounts and I've changed the email address to match the email address on record for one of the contacts in SAM. Will this pose a problem for our application?

Amendment #2

We have submitted a registration as of yesterday on SAM.gov . Given we are awaiting for our registration to be active, and currently do not have an "Active Registration" I want to be certain this does not pose an issue for our application before the deadline of Feb 22, 2024.

Lastly, we are in the process of writing our grant and wanted to confirm if there is a particular formatting you want us to use (Ex: spacing, margins, font size, etc.).

ANSWER: An active SAM registration is required prior to award. Please see question 5 above. Please follow the defined margins from the applications.

Otherwise, there are no specific requirements for font or margins. In addition, please be advised that any resultant award will be issued as a contract, not a grant as specified in the question.

15. QUESTION: What is the review period for the ARPA-H proposals? Is it 3 months after the submission deadline? We would like to provide an estimated start date for the work, but we could not find any details regarding the review period prior to award.

If one of our subcontractors (a university) cannot approve a finalized budget before the submission deadline, can we submit a budget estimate for this subcontractor? The subcontractor understands that their total costs cannot exceed the budget that we provided them.

ANSWER: We typically provide feedback on technical evaluations and award notification within a few months of application submission. Please note this timeline is subject to vary. The anticipated award date is on or before end of September 2024; therefore, you could assume this estimated start date for work. All costs submitted do not need to be final at the time of proposal submission. Please submit a full business proposal that includes a realistic estimate that does not exceed the topic ceiling.

16. QUESTION: We are trying to use the form titled “APPENDIX +A.2+HumanSubjectStudy_3_0-V3.0+Form+H+5-23.pdf, but it is locked. Can you send one that is unlocked so we can use it please?

Amendment #2

ANSWER: Please see attached template titled, “HumanSubjectStudy_3_0- V3.0 Form H 5-23.pdf.” There is a know issue with block 1.4.a being auto-filled. Until this can be fixed, please add a comment as to what the field should say based on your proposal.

17. QUESTION: For fast-track applications, I'd like to confirm the requirement to submit both Phase I and Phase II technical and business documents. Given the expected time gap between completing Phase I and initiating Phase II, I'm seeking clarification on how comprehensive and finalized the Phase II research plan and budget need to be at the time of submission. Specifically, I'm curious if adjustments to the details are permissible following the conclusion of Phase I.

ANSWER: The Phase II application and budget must be submitted in full and follow the defined budget guidelines for a Phase II. Since the awards will result in a firm-fixed price contract and Phase II will be included in the award as an option period, price and scope will be finalized at contract award. Adjustments may be made prior to award during the negotiation period.

18. QUESTION: Do subcontractors on the project need to be US based, or is it only a requirement that the work they do for the contract is performed in the US?

ANSWER: Please refer to Section 10 of the solicitation, which defines the requirements to be eligible for award of funding agreements in the SBA's Small Business Innovation Research (SBIR) program.

19. QUESTION: We are interested in applying ARPA-H SBIR funding opportunities (Notice ID: 75N91024R00006), and have a quick question. Is there any specific rule about the budget split between primary and subcontractors?

ANSWER: Yes, please refer to Solicitation Section 6.2 Offeror Eligibility and Performance Requirements where it states, "For Phase I, a minimum of two-thirds of the research or analytical effort must be performed by the AWARDEE.

For Phase II, a minimum of one-half of the research or analytical effort must be performed by the AWARDEE. The percentage of work will be measured by total award dollars." (The awardee is the Prime Contractor).

Amendment #2

20. QUESTION: For human subject documentation, where do we enter the information? For other grants, we have used ASSIST to enter the information.

For this solicitation, please let us know how to enter the information.

ANSWER: Please reference Appendices A 1 and 2 human subjects form.