75N91023R00041 AMENDMENT 2.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

2. AMENDMENT/MODIFICATION NUMBER

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Mary Muir Contracting Officer

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this amendment is to

Offerors are required to acknowledge each Solicitation Amendment by including each Standard Form 30 (SF-30) signed by your organization’s signature authority and submitted with your proposal.

Proposal Due Date: July 3, 2023, 5:00PM EDT (Unchanged)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

N/A National Institutes of Health National Cancer Institute Office of Acquisitions 9609 Medical Center Dr., MSC 9705 Bethesda, MD 20892-9705

N/A

75N91023R00041

N/A

06/1 /2023

9B. DATED (SEE ITEM 11)

06/1 /2023

6/1 /2023

Mary E. Muir -S Digitally signed by Mary E. Muir -S Date: 2023.06.16 13:33:08 -04'00'

Solicitation 75N91023R00041 Amendment #2 – Solicitation Question and Responses 2

ARPA-H SBIR Solicitation 75N91023R00041 - Amendment #2

Solicitation Questions and Responses

Organizations are advised to carefully review the full solicitation to determine which opportunity of topics (starting on page 3 of the solicitation) would be the best fit for their proposed project. Organizations should carefully review the separate and unique research objectives, proposal preparation instructions, award decision factors/evaluation criteria, and eligibility criteria to identify if the idea is within scope. Also note, awards resulting from this solicitation will be contracts (not grants). Proposers that meet the submission criteria described in the solicitation for each topic are welcome to apply. Thank you for your interest in ARPA-H’s first SBIR solicitation!

Please see the following questions and answers:

1. The introductory language of the solicitation seems to invite any proposal that furthers the mission of ARPA-H, with the specific topics listed as examples of proposals ARPA-H would be very interested in funding. In the supporting documents, the language seems to limit the solicitation to only those proposals that meet the specific topics outlined. Please clarify. Will ARPA-H entertain novel proposals that carry out the goals of one of the focus areas listed on your website but not the specific topics outlined in the solicitation?

ANSWER: Proposals will only be considered for award if they are within the scope of the specific Topics set forth in this solicitation (75N91023R00041).

2. I submitted an abstract to the open BAA but haven’t heard back yet. If I am not notified of my abstract (either in invitation or not) by the SBIR submission deadline, am I able to submit an SBIR Phase II application in tandem with my abstract?

ANSWER: The ARPA-H Open BAA and SBIR solicitation are separate and distinct opportunities. It is permissible to submit a proposal in response to both solicitations;

however, organizations should carefully review the separate and unique research objectives, proposal preparation instructions, award decision factors/evaluation criteria, and, if applicable, eligibility criteria (for the SBIR program) for each. Note – an organization may not submit duplicative/essentially equivalent proposals to multiple SBIR solicitations for funding consideration within a Federal Agency at once; however, an organization may submit an essentially equivalent proposal to an SBIR and a non- SBIR solicitation at/around the same time.

3. Is a Phase II project that received Phase I SBIR funding from another agency eligible for consideration for this ARPA-H solicitation?

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Farpa-h.gov%2Fresearch%2F&data=05%7C01%7Csbir%40arpa-h.gov%7C0fe51474dce74099cc5608db660b8710%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638215971983218201%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=XWF4ONP6y%2FTUaAOBixYUBH9UeO353zoOBlOaAmUOaZk%3D&reserved=0

Amendment #2 – Solicitation Question and Responses 3

ANSWER: A Phase II project that received Phase I SBIR funding from another agency is eligible to submit an application and receive an award under this solicitation.

4. Will requesting funds to support the work of employees at a foreign branch of our Small Business reduce the likelihood of our project being funded or otherwise disadvantage it in terms of its evaluation relative to competing proposals?

ANSWER: All project work must be performed in the United States.

5. What are the anticipated timelines to receive proposal feedback and award funding?

ANSWER: The anticipated timelines to receive proposal feedback is August 2023 with contract awards made by September 30, 2023.

6. Please see the following questions for topic: ARPA-H 01 - Novel telehealth instruments for assessing pediatric well-being:

We have built an attachment to a phone that includes several devices which interface with a smart phone app.

Would we still qualify since we are not solely relying on cell phone capabilities but include a companion device that is provided to the patient?

ANSWER: An attachment to the phone is allowed as long as it remains inexpensive (i.e.

it can reasonably be assumed to be manufacturable for under $50).

We did a phase 1 equivalent study where we recorded patient usability and medical data in over 40 adult patients (lung sounds and throat and ear images). This was done through a state-funded grant and partially through an NIH-Phase 1 grant that is ongoing. The goals of the NIH study are broader and more-focused on COPD patients, but we've managed to collect data that is very relevant to this ARPA-H proposal and could be leveraged to accomplish Phase 2 objectives. Would this be an issue?

ANSWER: There is no issue with using data collected in another study.

We have patient usability data in over 40 adult patients for our Phase 1. Is it expected for a company to have already developed preliminary algorithm development from Phase 1 work, or can this deliverable be the focus of the Phase II?

Amendment #2 – Solicitation Question and Responses 4

ANSWER: The 40 subject adult data can be used as preliminary data for the Phase II work proposed.

7. Who do I contact to submit a funding proposal?

ANSWER: Per the cover page of the solicitation, all proposals must be submitted using the electronic contract proposal submission (eCPS) website.

8. We have had an NIH STTR Phase I award that is ending soon. Our question is if we can use this as a basis for applying to the SBIR Direct Phase II mechanism, in response to the latest ARPA-H solicitation.

ANSWER: Yes.

9. The 10 page Research Plan seems to include 6 sub-sections that, for traditional NIH SBIR applications, would be described in separate multi-page documents. Are the following separate documents, typical for NIH applications, needed (outside of the 10-page Research Plan)?

a) Vertebrate Animals

b) NIH Biosketches for key personnel

c) Facilities and Other Resources

d) Equipment

e) Bibliography

f) Budget justification

g) Resource Sharing Plan

ANSWER: Please follow the Research Plan instructions outlined in Appendix A – Phase I Technical Proposal and Appendix C – Phase II Technical Proposal.

10. Can additional figures / bibliography be appended as an appendix, outside the 10-page limit of the Research Plan?

ANSWER: No. Please follow the page limits noted in the solicitation.

11. SBIR Phase II requires >50% of the effort by dollar amount to be done by the company. Does this apply to each individual year’s budget, or can it be applied more generally to the overall multi-year budget? For example, could we frontload costs outside of our company in Year 1 such that > 50% is expended outside the

Amendment #2 – Solicitation Question and Responses 5 company, while in the later 2 years expend more costs inside our company with overall 3-year effort by dollar amounts >50% from our company.

ANSWER: The total contract amount for entire period of performance (two years) cannot exceed 50% for all subcontractors and consultants proposed.

12. If a sensing scheme could detect a signal that is indigenous to a disease state, would a proposal based on this fit with "ARPA-H-Intra-Operative Contrast Agents?"

ANSWER: No, this call is intended for exogenous contrast agents.

13. We are currently preparing a Direct to Phase II SBIR proposal on an innovative prosthetic foot that we are developing for the ARPA-H 05 Scale Up topic. After looking at the Technical Proposal template, we are confused as to where we should provide a detailed problem background and outline the problem significance.

We noticed that the "Proposed Statement of Work" allows space for a "brief summary" of the needs. However, we are hoping to provide a more thorough description of the problem's significance and feel that it may be more appropriate to do that in the "Research Plan" section. However, the "Research Plan" begins with "Anticipated Results of the Phase I".

Should our description of the background and significance go in the "Proposed Statement of Work" section or the "Research Plan" section?

ANSWER: This may fit best under “2) Detailed Approach and Methodology” in the Research Plan. For Phase II applications, “1)” of the Research Plan is only meant for a discussion on the anticipated Results of the Phase I/ Phase I-like Effort.

14. What is the timeline for the evaluation process? When will ARPA - H announce the awardees?

ANSWER: The anticipated timelines to receive proposal feedback is August 2023 with awards made by September 30, 2023.

15. In addition to contract requirements specified in appendix F, are there any other regulatory standards that may need to be followed in the project?

ANSWER: No.

16. In Appendix c #4 Personnel - Do you need a list of all team members or the key team members with TBD for the rest. Some resources will be finalized based on when the grant is awarded.

Amendment #2 – Solicitation Question and Responses 6

ANSWER: Key team members.

17. Appendix E #6.4 - Will the PI for phase II be considered "primarily employed" with SBC if he/she is a contractor, as long as he/she spends more than half of his/her time with SBC?

ANSWER: Contractors may not be Principal Investigators.

18. Appendix F #7.15 Copyright - If the initiative is partly funded by the ARPA grant, and partly by external capital, does Federal government still get royalty free license?

ANSWER: Please refer to the Small Business Administration’s SBIR-STTR Policy Directive and its discussion of SBIR/STTR Data Rights for detailed discussion of data rights. It addresses how there is a protection period (unique to the SBIR/STTR program) of 20 years from date of contract award, after which time, the Government has a royalty-free license to use, and to authorize others to use on its behalf, data generated under the contract for Government Purposes.

19. Appendix F #7.15 Copyright - What areas can the Federal Government use the technology royalty free? Is it constrained to the market we have identified, or can it be used in other areas as well?

ANSWER: Upon expiration of the protection period for SBIR/STTR Data, the Federal Government has a royalty-free license to use, and to authorize others to use on its behalf, these data for Government Purposes, and is relieved of all disclosure prohibitions and assumes no liability for unauthorized use of these data by third parties. The Federal Government receives Unlimited Rights in Form Fit, and Function Data, OMIT Data, and all unmarked SBIR/STTR Data.

20. Are proposed cost elements to be reported as an aggregate across the entire project, or are budgets for individual periods of performance (i.e. years) expected?

ANSWER: Please submit a separate CONTRACT PRICING PROPOSAL for each year for Phase IIs.

21. For ARPA-H Topic-05 (Scale Up), reference is made to the services provided by PATIO. Are these services included in all awards and/or do budget allocations need to be set aside for PATIO services?

ANSWER: Budget allocations do not need to be set aside for the services.

Amendment #2 – Solicitation Question and Responses 7

22. Reference is made on page 41 in Appendix F CONTRACT REQUIREMENTS of a cost item for "up to $50,000 per Phase II project (across all years) for technical assistance as discussed and outlined in Section 4.16 of the solicitation." We didn't see a Section

4.16 in this solicitation, so could you clarify if this cap applies to this proposal? If so, what types of technical assistance is covered by this cap, and is the $50k cap calculated on a vendor by vendor basis?

ANSWER: Section 4.16 was referenced in error. Please refer to Section 6.14 State Assistance and Technical Assistance of APPENDIX E – PROPOSAL FUNDAMENTALS for more information.

23. Does the agency have specific scope on Health R&D Services, if yes, what are the scope, expected result, and measurement criteria?

ANSWER: Please refer to the List of Topics that begin on page 2 of the solicitation.

24. Can proposal be for R&D commercialization on health, wellness maintenance, proactive disease/sickness prevention and control with focus on human subject?

What information /result are you expecting for study record on human subjects?

Our project proposal is on human subject, and we intend to use award to carry out the R&D, are we still required to complete Appendix A.1 & A.2 forms?

ANSWER: If Human Subject work is anticipated in your study, please see the requirement under Section 4.2 Proposal Instructions of the solicitation.

25. If awarded, can funds be used for covering lease and operating expenses including labor wages?

ANSWER: For the purposes of determining that a proposal represents an overall fair and reasonable price to the Government, the Government will review budget details provided in the Contract Pricing Proposal template. Lease, operating expense and labor costs may be considered when putting together a total proposed price.

Providing details in your Contract Pricing Proposal template for all anticipated cost elements that comprise the total price will facilitate the Government’s analysis of whether the proposal represents a fair and reasonable price. A cost item should be necessary for conducting the work, reasonably priced for what is required, and either 100% allocable/attributable to this one contract project, or proposed in a ratio proportionate to how much of the cost is allocable to this one contract project.

If proposing indirect rates, do not propose a rate that exceeds 40 percent of total direct costs unless you have a negotiated indirect rate agreement with a Government auditing agency.

Amendment #2 – Solicitation Question and Responses 8

The total price of your proposal must not exceed the budget set forth in the solicitation for the Topic and Phase.

26. What is your keys evaluation criteria for measurement of proposal for strength?

ANSWER: Please refer to Section 3. Method of Evaluation in the solicitation.

27. The planned proposal does not include human subjects, but does include deidentified human specimens / data from a publicly available resource for which no company personnel has access to subject identifiers. Confidentiality of human specimens / data is protected by the resource administrators of each resource database. For ARPA-H SBIR, is it sufficient to attach APPENDIX A.1 — HUMAN SUBJECTS AND CLINICAL TRIALS INFORMATION FORM and answering YES to human specimens and NO to human subjects, along with an explanation for use of human specimens and/or data not considered to be human subjects research?

ANSWER: Yes, for ARPA-H SBIRs, is it sufficient to attach APPENDIX A.1 — HUMAN SUBJECTS AND CLINICAL TRIALS INFORMATION FORM and answering YES to human specimens and NO to human subjects, along with an explanation for use of human specimens and/or data not considered to be human subjects research.

28. What are the requirements for proposals regarding: font, font size, and margins?

ANSWER: There aren’t any specific requirements for font, font size, and margins.

However, there are page limit requirements for Phase I and II applications.

29. For the contract pricing proposal / business proposal what fee / profit percentage is allowable?

ANSWER: Profit/Fee of up to 7% is what is most commonly seen as reasonable for SBIR/STTR awards.

30. I have a question regarding ARPA-H01-Novel Telehealth instruments for assessing pediatric well-being. It states that proposals should rely solely on cell phone capabilities with minimal or no attachments.

I am developing a multi-function kit - ear, nose, throat, skin imaging and stethoscope for lungs and heart. To accomplish this we are creating 5 attachments that attach to a small "pod" 2"x1"x0.5" that sends the diagnostic data wirelessly to a mobile device. I strongly believe that this configuration is required for sufficient ease of use, reliability and quality of diagnostic data when used by a consumer. Our

Amendment #2 – Solicitation Question and Responses 9 physician advisors say that there is no comparison between existing consumer products or their own tools - as one pediatrician state - "every pediatrician should have one of these)

I have resource and time constraints and do not want to take those up creating a proposal if it is not likely. However, if after reviewing the attached information you feel that there could be a good chance of approval, I will move forward.

We are looking at a kit cost of 175-199 for all components and inclusive of AI auto-diagnosis. In the beginning, we are creating a high kit for $299

Here is our Executive Summary which is also attached

Here is a high resolution Demo Video Compilation with a low resolution version attached.

Please advise on potential acceptance of this configuration or if it is definitely outside the scope of acceptable proposals.

ANSWER: We will accept proposals having attachments for the cell phone that can be foreseeably manufactured for under $50. We have specifically asked for diagnosis of 3 conditions- if your attachments for those conditions could be manufactured for under $50, then you are welcome to apply.

31. Would we need to incorporate our small business prior to the application submission or can we do this step after the application submission but before the award allocation in case we are awarded the funding?

ANSWER: As stated in Appendix E of the solicitation, an organization must be registered with the SBA Company Registry prior to proposal submission and attach proof of registration in its business proposal. An organization must also be registered in the System for Award Management (SAM) prior to proposal submission. Please begin working on these registrations immediately to verify what requirements they entail and ensure that your proposal could be considered for award.

32. I am assisting with a proposal to solicitation 75N91023R00041. Appendix F Contract Requirements includes the below language regarding salary rate limitations. I wanted to confirm we are allowed to use the level II rate effective January 2023 of $212,100 in the budget.

ANSWER: Effective January 1, 2023, the Executive Level II salary cap level is $212,100.

Estimated cost for the total annual salary paid per individual proposed on the contract shall not exceed $212,100. Please ensure that all salaries proposed for your organization and any proposed subcontractors and Consultants comply with this salary rate limitation for the duration of the study.

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.dropbox.com%2Fs%2Fdea3l5kh0qhn5jq%2FZipline%2520Executive%2520Summary%2520-%25203.5M.pdf%3Fdl%3D0&data=05%7C01%7Csbir%40arpa-h.gov%7C2337e03f3db64a9c2c3508db6b870d67%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638222001202963268%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ExIHTiMUqVN%2BF1qJEaPIWcI2fWWRjVFpDcPwWlpy78M%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.dropbox.com%2Fs%2Fbkdtlf91marzury%2FZipline%2520Health%2520Demo%2520Video%2520Compilation.mp4%3Fdl%3D0&data=05%7C01%7Csbir%40arpa-h.gov%7C2337e03f3db64a9c2c3508db6b870d67%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638222001202963268%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ug7wfAGhxf4Yz8mhlA2Ri5aGd3np64tIk3OUOVTr9Xg%3D&reserved=0 https://www.sbir.gov/registration

Amendment #2 – Solicitation Question and Responses 10

33. Regarding acknowledgement of the solicitation amendment(s), where should each completed Standard Form 30 (SF-30) be attached in the proposal - the technical proposal, business proposal, or elsewhere?

ANSWER: The signed SF30 can be attached to the Technical proposal and will not count towards the page limit.

34. When will the next SBIR be released and will the same topics appear or are they one-time opportunities?

ANSWER: It is anticipated for the next ARPA-H SBIR solicitation to be posted next year. A synopsis will be posted in advance on SAM.gov. Topics are selected based on the needs of the agency.

35. Can you please provide the names and titles of the individuals who will review applications or if not, the type of individuals and their academic and work backgrounds, for example, M.D. and NIH scientist?

ANSWER: This information will not be provided. Please refer to Section 3 METHOD OF EVALUATION of the solicitation for information on how proposals will be evaluated.

36. When teaming with another entity, is it sufficient to have a letter of support from the individual collaborator at the entity or is it necessary to also have an institutional letter of support?

ANSWER: Please refer to the required elements of the Research Plan, which explains appropriate letters for subcontractors/consultants.

37. For our initial application submission, is it necessary to fill out all of these appendices (SAM.gov) or just the two related to Phase 1 (Appendix A and B)?

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fsam.gov%2Fopp%2Fad4bb5fcd9ad424381f30b35bdb92a09%2Fview%23contact&data=05%7C01%7Csbir%40arpa-h.gov%7C14357e62a5d54663912808db6b99b755%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638222080194030667%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=yDLJRdJHh1bGtFou9qh81ECyLY2AJyyeJAyH%2Bi0Dolc%3D&reserved=0

Amendment #2 – Solicitation Question and Responses 11

ANSWER: All the topics listed in the solicitation are Direct to Phase II and will require Appendix C and D. Topics 03 and 04 allow for Fast-Track proposals, therefore both Phase I (Appendix A and B) and Phase II (Appendix C and D) applications will be required. Please refer to section 2 PROGRAM DESCRIPTION of the solicitation, 2.2 Direct to Phase II Proposals and 2.3 Fast Track Proposals for more information.

38. When submitting our application, do we fill out and upload "Appendix A" (above, in question 1) as document (1) below ("Technical PDF") and "Appendix B" (above, in question 1) as document (3) below ("Business PDF")?

ANSWER: Yes.

39. I'm trying to open the relevant PDF for "PHS Human Subjects & Clinical Trials PDF" whose link I found in an Appendix but am getting this error message. I'm just wondering if you'd mind emailing me a copy, please? Just to confirm - is it the PDF in question (when I manage to open it!) that we need to fill out and upload as document (2) above, "PHS Human Subjects & Clinical Trials PDF"?

Amendment #2 – Solicitation Question and Responses 12

ANSWER: Yes. Please ensure the latest version of Adobe is updated on your computer.

Also, as stated in the solicitation, “Due to large file size, Appendix A.1 and Appendix A.2.

can only be opened in Internet Explorer. However, you may download them from any browser, then view them once you have saved them onto your computer.”

40. Is there any Appendix/template that we should fill out as the "Business Excel" document?

ANSWER: No, please follow the specific Appendices for Phase I and II applications.

41. Are you looking for projects that take an existing technology and make it better, meaning more accessible, more scalable, better integrated, easier to use, etc., or are you looking for projects that expand a platform’s scope into new indications so its functionality is broader?

ANSWER: For topic 05, we are looking for existing revolutionary technologies that need support in bridging the gap to commercialization.

42. The NAICS code listed is 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). No other codes are listed. Does this mean that companies with the NAICS code - 541714

- Research and Development in Biotechnology (except Nanobiotechnology) - are excluded from submitting to this opportunity?

ANSWER: Potential Offerors are not excluded for submitting a proposal, but will be asked to update their SAM registration to include NAICS Code 541715 should they be considered for an award.

43. For topic “ARPA-H 05 – Scale-Up: Transition disruptive technologies from proof-of-concept prototypes to commercially scalable and deployable technologies.” Since this is a Direct to Phase II that has only anticipated 2 awards we were hoping you could give us more details on the following 3 questions:

Amendment #2 – Solicitation Question and Responses 13

• If we get it funded, when is the funding timing/start date of the proposal?

ANSWER: Contract awards are anticipated to be made in September 2023.

• Can the award money be used for legal fees or general fees for patent applications or conversions?

ANSWER:: Legal fees will not be considered as reasonable costs to include in the Contract Pricing Proposal for awards under this solicitation, with two caveats – a percentage of profit/fee may be proposed, which could be used for legal fees at the awardee’s discretion, and/or the organization may include a line in their pricing proposal for Technical and Business Assistance (TABA), as described in Section 6.14 in Appendix E of this solicitation.

Technical and Business Assistance (TABA) costs may NOT cause the total proposed price (inclusive of all costs) to exceed the budget set forth for the Topic in the solicitation.

When requesting Technical and Business Assistance, in your Pricing Proposal:

include a planned vendor/s you will work with, a detailed description of the technical or business assistance that your vendor/s will provide, and the expected benefits and results of the technical or business assistance provided. A letter of support from the vendor describing their qualifications and services to be provided is recommended.

• Do the same award and budget rules apply for the ARPA-H proposals as they do for standard NIH SBIR proposals?

ANSWER: Please refer to the solicitation or Appendix E and F for more information.

• What is the percentage of indirect costs that can be used standard? Is it greater than 40%

ANSWER: There is no standard Indirect Rates for SBIRs; rather, a potential Offeror should calculate the Indirect Rate that are reasonable for the scope of work proposed. If indirect rate(s) have been negotiated with HHS, DCAA or other agency, please submit a copy of the active agreement. If you do not have a negotiated indirect rate agreement, please provide the basis and your calculations arriving at your proposed indirect rates. Indirect rates should not

Amendment #2 – Solicitation Question and Responses 14 exceed 40%, unless your organization has a negotiated indirect rate agreement with a Government auditing agency.

Solicitation 75N91023R000041 Amendment 2 – Solicitation Questions and Answers

APPENDIX C

PHASE II TECHNICAL PROPOSAL

NAME, ADDRESS, AND TELEPHONE:

TITLE OF PROJECT:

SOLCITATION NUMBER:

TOPIC NUMBER:

FAST-TRACK PROPOSAL: ☐ Yes ☐ No

ATTACHMENT CHECKLIST

Appendix A.1 — Human Subjects & Clinical Trials Form (If your proposal does not involve Human Subjects or Clinical Trials, you must still note this on the form and submit the form.)

☐ Yes ☐ No

Appendix A.2 — Study Record to Human Subjects & Clinical Trials Form (If applicable, Appendix A.2. – Study Record must be attached to Appendix A.1)

☐Yes ☐ No

ABSTRACT OF RESEARCH PLAN: State the proposal’s long-term objectives and specific aims referring to the health-relatedness of the project. Describe concisely the research design and methods for achieving these goals and discuss the potential of the research for technological innovation. Summarize the results that are expected. Avoid summaries of past accomplishments and the use of the first person. This abstract is meant to serve as a succinct and accurate description of the proposed work when separated from the application. If the proposal is funded, this description, as is, will become public information.

Therefore, don’t include proprietary/confidential information. DO NOT EXCEED 200 WORDS.

Provide key words (8 maximum) to identify the research or technology.

Provide a brief summary of the potential impact of the research. DO NOT EXCEED 50 WORDS.

Provide a brief summary of the potential commercial applications of the research. DO NOT

EXCEED 50 WORDS.

PERSONNEL SHEET

TITLE OF PROJECT:

TOPIC NUMBER:

OFFEROR PERSONNEL ENGAGED ON PROJECT

Name (First, Middle, Last) Degree(s) Position Title

SUBCONTRACTOR ORGANIZATIONS

(If more than one, list each organization and its personnel separately)

COLLABORATORS OR CONSULTANTS

PROPOSED STATEMENT OF WORK

Please limit the proposed Statement of Work to no more than 5 pages. The Statement of Work will be attached to the award document. Please do not include confidential or propriety information.

TITLE: [Normally carries the same title as Phase I but may be changed if the previous title no longer accurately describes the project.]

BACKGROUND: Provide a general, brief summary of what needs the research on this contract will be addressing.

Information from the Topic description may be useful to include for context.

SCOPE: Provide a one to two sentence statement of what is expected to be accomplished under the contract.

OBJECTIVES: State the specific objectives and anticipated end results of the proposed Phase II effort. Limit responses to 250 words.

SERVICES TO BE PERFORMED:

Begin this section with the following language: “The contractor shall independently perform all work and furnish all labor, materials, supplies, equipment, and services to perform the following services:”

1. Specific Requirements – List all tasks in a logical sequence, in an outline format, to precisely describe what is expected of the contractor in performance of the work. Tasks should contain enough detail to establish parameters for the project and keep the effort focused on meeting the objectives. Do not include any proprietary information.

2. If the research plan includes the use of human subjects or animals, briefly describe the parameters of this use.

REPORTS & DELIVERABLES: Describe end products and deliverables and describe periodic/final reports required to monitor work progress under the contract in a milestone format (i.e. a kick-off, midterm, and final).

RESEARCH PLAN FOR PHASE II PROPOSALS (including Direct to Phase II Proposals and the Phase II Proposal of a Fast Track submission)

Consider whether a list describing abbreviations or providing significant definitions would be helpful to reviewers, and if so, include such a list at the beginning of your Research Plan. Please limit the Research Plan to no more than 10 pages.

Discuss the following elements in the order indicated:

1) Anticipated Results of the Phase I/ Phase I-like Effort –

For Fast Track proposals: Briefly discuss and summarize the objectives of the Phase I effort, the research activities to be carried out, and the anticipated results.

For Direct to Phase II: Summarize the specific aims of the preliminary work that forms the basis for this Direct Phase II proposal, quantitative milestones (a quantitative definition of success) for each aim, the importance of the findings, and emphasize the progress made toward their achievement. Describe the technology developed, its intended use and who will use it. Provide data or evidence of the capability, completeness of design, and efficacy along with the rationale for selection of the criteria used to validate the technology, prototype, or method Describe the current status of the product (e.g., under development, commercialized, in use, discontinued). If applicable, describe the status of FDA approval for the product, process, or service (e.g., continuing pre-IND studies, filed on IND, in Phase I (or II or III) clinical trials, applied for approval, review ongoing, approved, not approved). List the generic and/or commercial names of products.

2) Detailed Approach and Methodology - Provide an explicit detailed description of the Phase II approach. This section should be the major portion of the proposal and must clearly show advancement in the project appropriate for Phase II. Indicate not only what is planned, but also how and where the work will be carried out. List all tasks in a logical sequence to precisely describe what is expected of the contractor in performance of the work. Tasks should contain detail to (1) establish parameters for the project; (2) keep the effort focused on meeting the objectives; (3) describe end products and deliverables; and (4) describe periodic/final reports required to monitor work progress under the contract.

• If a project involves vertebrate animals, include a Vertebrate Animals Section, as discussed in

APPENDIX F – CONTRACT REQUIREMENTS, Section 8.107.21 Research Involving Vertebrate Animals.

• If APPENDIX F – CONTRACT REQUIREMENTS, Section 8.117.22 Dual Use Research of Concern is applicable to your project, address it here.

3) Innovation - Discuss how the end product or technology being developed would offer significant advantages over existing approaches, methodologies, instrumentation, or interventions on the market currently being utilized in research or clinical practice, such as meaningful improvements in quality, capability, cost, speed, efficiency, etc.

4) Key Personnel - List by name, title, department and organization, the extent of commitment to this Phase II effort, and detail each person’s qualifications and role in the project. Provide resumes for all key staff members, describing directly related education, experience, and relevant publications. Describe in detail any involvement of subcontractors or consultants, and provide resumes for all key subcontractor staff. Also, include letters of commitment with proposed consultants confirming the extent of involvement and hourly/daily rate.

5) Subcontractors/Consultants. Identify all investigator/collaborators by name and organization.

Involvement of a university or other subcontractors or consultants in the project may be appropriate and is permitted. If such involvement is intended, it should be described in detail and identified in the business proposal. In addition, supported by appropriate letters from each individual confirming his/her role in the project must be included (letters are excluded from the research plan page limit).

6) Resources - List/describe all equipment, facilities and other resources available for this project, including the offeror’s clinical, computer and office facilities/equipment at any other performance site that will be involved in this project. Briefly state their capacities, relative proximity and extent of availability to this effort. (Any equipment specifically proposed as a cost to the contract must be justified in this section as well as detailed in the budget. Equipment and products purchased with Government funds shall be American-made, to the extent possible. Title to the equipment will vest in the Government.)

7) Commercialization Plan – Limited to 4 pages (this is in addition to the 10-page limit for the Research Plan elements above). The Phase II portion of Fast-Track proposals and all Direct Phase II proposals must include a Commercialization Plan. Be succinct. There is no requirement for offerors to use the maximum allowable pages allotted to the Commercialization Plan. Provide a description in each of the following areas:

a) Value of the SBIR Project, Expected Outcomes, and Impact. Describe, in layperson's terms, the proposed project and its key technology objectives. Clarify the need addressed, specifying weaknesses in the current approaches to meet this need. In addition, describe the commercial applications of the research and the innovation inherent in this proposal. Be sure to also specify the potential societal, educational, and scientific benefits of this work. Explain the non-commercial impacts to the overall significance of the project. Explain how the SBIR project integrates with the overall business plan of the company.

b) Company. Give a brief description of your company including corporate objectives, core competencies, present size (annual sales level and number and types of employees), history of previous Federal and non-Federal funding, regulatory experience, and subsequent commercialization, and any current products/services that have significant sales. Include a short description of the origins of the company. Indicate your vision for the future, how you will grow/maintain a sustainable business entity, and how you will meet critical management functions as your company evolves from a small technology R&D business to a successful commercial entity.

c) Market, Customer, and Competition. Describe the market and/or market segments you are targeting and provide a brief profile of the potential customer. Tell what significant advantages your innovation will bring to the market, e.g., better performance, lower cost, faster, more efficient or effective, new capability. Explain the hurdles you will have to overcome in order to gain market/customer acceptance of your innovation.

Describe any strategic alliances, partnerships, or licensing agreements you have in place to get FDA approval (if required) and to market and sell your product

Briefly describe your marketing and sales strategy. Give an overview of the current competitive landscape and any potential competitors over the next several years. (It is very important that you understand and know the competition.)

d) Intellectual Property (IP) Protection. Describe how you are going to protect the IP that results from your innovation. Also note other actions you may consider taking that will constitute at least a temporal barrier to others aiming to provide a solution similar to yours.

e) Finance Plan. Describe the necessary financing you will require, and when it will be required, as well as your plans to raise the requisite financing to launch your innovation into commercialization and begin the revenue stream. Plans for this financing stage may be demonstrated in one or more of the following ways:

i) Letter of commitment of funding.

ii) Letter of intent or evidence of negotiations to provide funding, should the Phase II project be successful and the market need still exist.

iii) Letter of support for the project and/or some in-kind commitment, e.g., to test or evaluate the innovation.

iv) Specific steps you are going to take to secure non-SBIR follow-on funding.

f) Production and Marketing Plan. Describe how the production of your product/service will occur (e.g., in-house manufacturing, contract manufacturing). Describe the steps you will take to market and sell your product/service. For example, explain plans for licensing, internet sales, etc.

g) Revenue Stream. Explain how you plan to generate a revenue stream for your company should this project be a success. Examples of revenue stream generation include, but are not limited to, manufacture and direct sales, sales through value added resellers or other distributors, joint venture, licensing, service. Describe how your staffing will change to meet your revenue expectations.

Offerors are encouraged to seek commitment(s) of funds and/or resources from an investor or partner organization for commercialization of the product(s) or service(s) resulting from the SBIR contract. Your follow-on non-SBIR funding may be from any of a number of different sources including, but not limited to: SBIR firm itself;

private investors or “angels”; venture capital firms; investment companies; joint ventures; R&D limited partnerships; strategic alliances;

research contracts; sales of prototypes (built as part of this project);

public offering; state finance programs; non SBIR-funded R&D or production commitments from a Federal agency with the intention that the results will be used by the United States government; or other industrial firms.

Fast-Track proposals that do not contain all parts described above will be redirected for Phase I consideration only.

DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH PROPOSAL

SUMMARY AND DATA RECORD

RFP NUMBER/CONTRACT NUMBER:

PROJECT TITLE (Title of RFP or Contract Proposal):

LEGAL NAME AND ADDRESS OF OFFEROR:

PLACE OF PERFORMANCE (Full address including ZIP):

TYPE OF CONTRACT PROPOSED: Fixed Price

ESTIMATED TIME REQUIRED TO COMPLETE PROJECT:

PROPOSED STARTING DATE:

ESTIMATED DIRECT COSTS IN PROPOSED YEAR (From Budget):

DOES THIS PROPOSAL INCLUDE A SUBCONTRACT? ☐ Yes ☐ No (If yes, please furnish name and location of organization, description of services, basis for selection, responsible person employed by subcontractor and cost information.) (Use attachment if necessary.)

NAME AND TITLE OF PRINCIPAL INVESTIGATOR:

EST. HOURS WEEKLY:

AREA CODE/TEL. NO.:

NAME AND TITLE OF CO-INVESTIGATOR (Use attachment if necessary):

EST. HOURS WEEKLY:

AREA CODE/TEL. NO.:

NAME AND TITLE OF INDIVIDUAL(S) AUTHORIZED TO NEGOTIATE CONTRACTS:

NAME AND TITLE OF INDIVIDUAL(S) AUTHORIZED TO EXECUTE CONTRACTS:

DOES THIS PROPOSAL INVOLVE HUMAN SUBJECTS RESEARCH? ☐ Yes ☐ No

EXEMPTION NUMBER (IFAPPLICABLE):

If YES to Human Subjects, is the IRB review Pending? ☐ Yes ☐ No If IRB Review Not Pending, IRB Approval Date:

Human Subjects Assurance Number:

An example of the informed consent for this study is enclosed: ☐ Yes ☐ No ☐ N/A A Clinical Protocol is enclosed: ☐ Yes ☐ No ☐ N/A

Are Vertebrate Animals Used? ☐ Yes ☐ No

If YES to Vertebrate Animals, is the IACUC review Pending? ☐ Yes ☐ No If IACUC Review Not Pending, IRB Approval Date:

Animal Welfare Assurance Number:

OFFEROR’S ACKNOWLEDGEMENT OF AMENDMENTS TO THE RFP

(use attachment if necessary)

ERRATA NUMBER:

DATE:

ERRATA NUMBER:

DATE:

NAME, ADDRESS, AND PHONE NUMBER OF COGNIZANT GOVERNMENT AUDIT AGENCY:

NUMBER OF EMPLOYEES CURRENTLY EMPLOYED:

DOLLAR VOLUME OF BUSINESS PER ANNUM:

FOR THE INSTITUTION

SIGNATURE OF PRINCIPAL INVESTIGATOR:

TYPED NAME AND TITLE:

SIGNATURE OF BUSINESS REPRESENTATIVE:

TYPED NAME AND TITLE:

EMPLOYER IDENTIFICATION NUMBER:

DATE OF OFFER:

a. Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

b. The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR 2.1 2.11, or from a source that is exempt from licensing under those sections.

c. The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

d. If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c)above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with Animal Welfare Assurances.

Solicitation 75N91023R00041 - Amendment 2 - Solicitation Questions and Answers

APPENDIX F – CONTRACT REQUIREMENTS

7 CONTRACT REQUIREMENTS

Upon award of a contract, the contractor will be required to make certain legal commitments through acceptance of Government contract clauses. This Section discusses which clauses will be included in a contract resulting from this solicitation, if applicable to the project being proposed. For the purposes of this solicitation, ARPA-H will follow the polices noted within this Appendix.

7.2 CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015)

Note : The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (Email ace@aphis.usda.gov; Web site: ( http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare ). (End of clause)

7.3 Animal Welfare

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy).

The PHS Policy can be accessed at:

http://grants1.nih.gov/grants/olaw/references/phspol.htm .

In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the contractor's technical proposal, which is incorporated by reference.

7.4 PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015)

a. The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR part 46 and with the Contractor's current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

b. The Contractor shall bear full responsibility for the performance of all work and services…