Proposers Day Questions.pdf

Advanced Research Projects Agency for Health (ARPA-H) Broad Agency Announcement (BAA)

Proposer’s Day Questions Event Date: April 4, 2023

Rough Order of Magnitude (ROM):

1. What Rough Order of Magnitude (ROM) scale of grant ($1M, $10M, $100M) is possible? Is there a cap?

a. The Open BAA does not include a funding limit for individual awards. Abstracts will be evaluated based on the criteria laid out in the solicitation, one of which is cost realism.

Proposers are encouraged to suggest a budget that aligns with the scope of the proposed effort. ARPA-H is interested in funding holistic proof-of-concept efforts with multiple demonstrations and end-to-end solutions so proposers are encouraged to submit proposals at a scale that could result in transformational impact rather than funding smaller exploratory studies. The proposed budget should align with the technical scope.

2. Is funding available this fiscal year for approved projects?

a. Yes.

3. Estimating ROM cost-sharing is difficult for small businesses. Would it be sufficient to indicate an openness for significant cost sharing rather than estimating a split?

a. No. Cost sharing is not required; however, small business should clearly indicate if they plan to include cost-sharing or not. The amount of cost participation depends on the extent to which the Research and Development (R&D) effort/results are likely to enhance the contractor’s capability, expertise or competitive position, and the value of this enhancement to the contractor. Cost-sharing is a negotiable item. As such, the amount of cost-sharing will be proportional to the anticipated value of the contractor’s gain.

4. Could you provide additional information on what "Profit and Cost Sharing" means under the ROM estimate? Would you need a detailed breakdown of the work ROM for the abstract submission? Is there an Excel template to assist with the ROM?

a. A cost-sharing contract is a cost-reimbursement contract in which the contractor receives no fee and is reimbursed only for an agreed-upon portion of its allowable costs.

Only submission of the cost estimate for cost/profit sharing is required. The BAA includes a table that can be used for the ROM breakdown.

5. Are the indirect costs for funded projects equivalent to indirect costs of NIH?

a. No, ARPA-H is not required to follow NIH policies and procedures for indirect costs.

However, ARPA-H is required to follow federal law, regulation, executive orders, and other relevant federal policies, including internal HHS policies and procedures. ARPA-H must also follow the requirement from the Consolidated Appropriations Act 2023, “[I]n carrying out this section, the Director may (A) award grants and cooperative agreements, which shall include requirements to publicly report indirect facilities and administrative costs, broken out by fixed capital costs, administrative overhead, and labor costs.”

6. Should indirect costs (e.g., facilities and administrative costs) be included in the ROM?

a. Yes. Refer to BAA section titled ‘Rough Order of Magnitude (ROM).’

7. Can you provide a short summary of what is necessary for ROM on costs?

a. Refer to BAA section titled ‘Rough Order of Magnitude (ROM).’

Award Limits:

1. Are there general funding ranges attached to the award types (e.g., $10M for Other Transaction, $1M for cooperative agreement)?

a. No. The Open BAA does not include a funding limit for individual awards. Abstracts will be evaluated based on the criteria laid out in the solicitation, one of which is cost realism. Proposers are encouraged to indicate a budget that aligns with the scope of the proposed effort. ARPA-H is interested in funding holistic medium and larger scale proposals that could result in transformational impact rather than funding smaller exploratory studies. The proposed budget should align with the technical scope.

2. If the Other Transaction Authority mechanism is used, will the agency ensure that the mechanism will allow for participating academic institutions to maintain their fundamental research exemptions (e.g., allow academic institutions to publish and use results for internal teaching, research, and educational purposes)?

a. Yes. ARPA-H does not intend to place publication restrictions on “fundamental research” beyond any typical publication requirements of federally funded research.

3. Are organizations limited to only three active awards/agreements at any given time?

a. In some cases, yes, but not all. Refer to BAA section titled ‘Limitation on Number of

Awards’. Due to the ARPA-H statute, there is a limit on certain award types, but this limit only applies to Federal Acquisition Regulation (FAR)-based contracts.

4. Can equipment (e.g., high-performance liquid chromatography or liquid chromatography–mass spectrometry) be purchased with these awards?

a. Yes, but funding for equipment will be evaluated on a case-by-case basis. Refer to BAA sections titled ‘Rough Order of Magnitude (ROM)’ and ‘Cost Breakdown Information and Format.’

5. Are there expectations for add-on investments (e.g., infrastructure, equipment)?

a. Per the BAA, proposals directed towards policy changes, traditional education and training, or center coordination and construction of physical infrastructure are outside the scope of the ARPA-H mission and will be excluded. Funding for equipment will be considered on a case-by-case basis, and equipment purchase requests must be relevant to the research proposed.

6. If a technology is awarded to generate clinical data, will follow-on funding be available next year to complete clinical trials and gain registration in the U.S.?

a. Individual awards will be funded based on the quality and progress of the project and the availability of funds. Follow-on funding will be dependent on individual project success and funding appropriations by Congress.

7. How is the cooperative agreement different from ordinary funding (e.g., NIH funding)?

a. A cooperative agreement is a legally defined funding mechanism for supporting high-priority research areas that require substantial involvement from ARPA-H. Specifically, ARPA-H will work very closely with funding recipients to develop milestones and metrics and monitor research progress APRA-H will provide technical assistance, guidance, and oversight, including reviewing and approving the recipient's work plans, budget, and performance reports.

8. How does ARPA-H handle indirect costs?

a. ARPA-H is required to follow federal law, regulation, executive orders, etc., including internal HHS policies and procedures. ARPA-H must also follow the requirement from the Consolidated Appropriations Act 2023, “[I]n carrying out this section, the Director may (A) award grants and cooperative agreements, which shall include requirements to publicly report indirect facilities and administrative costs, broken out by fixed capital costs, administrative overhead, and labor costs.”

9. Can the shared cost be anticipated Venture Capital (VC) raised funds (i.e., money not available prior to submitting the proposal)?

a. No. This is generally not anticipated for cost-sharing. Any proposed cost share will be evaluated on an individual basis during negotiations. Proposers are invited to include any information they believe to be relevant and within their control.

10. If not via grants, how is funding provided?

a. Per the BAA, "types of instruments that may be awarded [include] cooperative agreements, other transactions (OTs), and procurement contracts."

11. How would ARPA-H structure funding for a proposal that has academia and industry partnerships?

a. The proposer is responsible for including team members on projects. ARPA-H does not establish or facilitate partnerships but encourages partnerships that will help foster project success. ARPA-H will provide feedback directly to applicants whose abstracts are selected for full proposals and that feature such partnerships.

12. Is there an ideal cost-share to propose?

a. No. Cost sharing is not required. Applicants should refer to Section IV.A.4 of the BAA for more information about how ARPA-H views the potential inclusion of cost share.

13. What are some general ranges for cost and period of performance of interest to ARPA-H for the

Open BAA?

a. The Open BAA does not include a funding limit for individual awards. Abstracts will be evaluated based on the criteria laid out in the solicitation, one of which is cost realism.

Proposers are encouraged to suggest a budget that aligns with the scope of the proposed effort. ARPA-H is interested in funding holistic proof-of-concept efforts with multiple demonstrations and end-to-end solution scale proposals that could result in transformational impact rather than funding smaller exploratory studies. The proposed budget should align with the technical scope.

14. It was stated during the webinar that proof of concept clinical studies will be funded to prove that an approach works but not clinical trials for product development. Can you give examples of study types that ARPA-H will and will not fund? For instance, would ARPA-H fund a proof-of-concept clinical trial, e.g., a 300-person study to test the implementation of a solution and to look at clinical differences compared to a no-treatment control group?

a. In general, a clinical trial is eligible to be funded as part of a project awarded through the Open BAA. However, ARPA-H will not fund projects that exclusively involve clinical trials of otherwise developed products. Instead, it is expected that the clinical trial would be proposed as part of a broader R&D effort that first includes development of a high-impact technology.

15. Could you clarify how ARPA-H funding works? What do “cooperative agreements”, “other transactions”, and “procurement contracts” mean in practice?

a. Cooperative agreements, other transactions, and procurement contracts are all legally defined funding mechanisms and ARPA-H encourages applicants to work with their internal technical staff to understand the specific details. Briefly:

b. A ‘cooperative agreement’ is a support mechanism for high-priority research areas that require substantial involvement from ARPA-H.

c. An ‘other transaction’ (OT) is a unique type of legal instrument other than a contract, grant, or cooperative agreement. Generally, this award instrument is not subject to the FAR or grant regulations unless otherwise noted for certain provisions in terms and conditions of award. OTs, however, are subject to the OT authority that governs the initiative as well as applicable legislative mandates.

d. A ‘procurement contract’ follows FAR and is a legal agreement binding parties that has defined requirements, specific deliverables, and a defined schedule.

16. Can you provide some idea on budget reasonableness? Ambitious, non-incremental, blue-sky ideas require large budgets. Does ARPA-H have a rough order of magnitude for a budget number that will be viewed as outside the limits of the agency?

a. The Open BAA does not include a funding limit for individual awards. Abstracts will be evaluated based on the criteria laid out in the solicitation, one of which is cost realism.

Proposers are encouraged to suggest a budget that aligns with the scope of the proposed effort. ARPA-H is interested in funding holistic medium and larger scale proposals that could result in transformational impact rather than funding smaller exploratory studies. The proposed budget should align with the technical scope.

17. Are ARPA-H awards subject to HHS salary limits?

a. Yes.

18. What is the average award or limit per project?

a. There is no average award or limit per project.

19. Does ARPA-H follow indirect rates of other federal institutions (e.g., NIH)?

a. ARPA-H is required to follow federal law, regulation, executive orders, etc., including internal HHS policies and procedures. ARPA-H must also follow the requirement from the Consolidated Appropriations Act 2023, “[I]n carrying out this section, the Director may (A) award grants and cooperative agreements, which shall include requirements to publicly report indirect facilities and administrative costs, broken out by fixed capital costs, administrative overhead, and labor costs.”

Institution Type:

1. Can principal investigators of federal government research labs apply for ARPA-H funds either individually or as part of a bigger team with industry or academia?

a. Yes.

2. Is it important to bring at least some of the right stakeholders into the project? Relatedly, will

Program Managers assist funded teams with identification of additional teaming partners?

a. The proposer is responsible for including team members on projects. ARPA-H does not establish or facilitate partnerships but encourages partnerships that will help foster project success. We encourage teaming and collaboration since these can make for successful submissions. We also have a technology transfer office and the Project Acceleration Transition Innovation Office (PATIO) to support these types of engagements in funded projects.

3. How does ARPA-H do small business contracts? Can funding go towards business development alongside product development and research?

a. We are targeting novel proposals irrespective of company size. Program Managers may work with small businesses to scope business development work.

4. Is there a small business set aside within ARPA-H?

a. No, there is no small business set aside under the Open BAA.

5. Could ARPA-H work with independent inventors on software capable of accelerating genomics by computing diagnostic and treatment response phenotypes in chronic disorders?

a. Yes, Section III.A.2 of the BAA includes a category for “Other Applicants” specifically mentioning that individuals are eligible for awards.

6. Can an academic entity partner with a government agency that has needed expertise or patient population?

a. ARPA-H will evaluate each submission based on the specifics of that proposal without creating any additional restrictions beyond legal, regulatory, or policy requirements for an HHS agency.

7. Are hospitals eligible to submit BAA abstracts/proposals?

a. Yes, hospitals are eligible.

8. Will the indirect costs policy be the same as for NIH?

a. No, ARPA-H is not required to follow NIH policies and procedures for indirect costs.

However, ARPA-H is required to follow federal law, regulation, executive orders, and other relevant federal policies, including internal HHS policies and procedures. ARPA-H must also follow the requirement from the Consolidated Appropriations Act 2023, “[I]n carrying out this section, the Director may (A) award grants and cooperative agreements, which shall include requirements to publicly report indirect facilities and administrative costs, broken out by fixed capital costs, administrative overhead, and labor costs.”

9. Can you explain the difference between ARPA-H BAA and the NIH Small Business Innovation Research (SBIR) program?

a. The ARPA-H BAA is soliciting abstracts from all businesses to support the objective outlined in the Open BAA. The SBIR program is a U.S. government funding program, which is coordinated by the Small Business Administration, intended to help certain small businesses conduct R&D.

Submission Documents and Templates:

1. Do applicants submit directly on SAM.gov?

a. No, abstract submissions should be through https://ecps.nih.gov in accordance with the instructions outlined in the BAA.

2. Our company has four 3-page white papers, each containing new technology medical breakthroughs. How should these papers be submitted? When can we expect a subsequent meeting to discuss our technologies?

a. Each abstract should be submitted individually through the Open BAA and ARPA-H does not have a restriction on the number of abstracts each applicant may submit. ARPA-H cannot guarantee a 1:1 meeting due to the volume of submissions but will provide feedback for abstracts that are selected for full proposals.

3. Who reviews the Open BAA submissions?

a. Reviews will be conducted by a team of government technical experts within ARPA-H and other USG entities. Ultimately, the ARPA-H government employees will be the https://ecps.nih.gov/ decision makers with subject matter experts providing recommendations. Note that the process at ARPA-H does not include committee or consensus-based reviews.

4. After an abstract is submitted in electronic Client Proposal Submission (eCPS), do applicants then submit the full application via Grants.Gov? What should be done if we are requesting a cooperative agreement?

a. Grants.gov is not being used for abstract submissions. Further submission instructions will be provided when full proposals are requested. Per the BAA, the "types of instruments that may be awarded [include] cooperative agreements, other transactions (OTs), and procurement contracts."

5. Can an entity make multiple submissions?

a. Yes.

6. Where can applicants find instructions for submission (e.g., forms, dates, requirements)?

a. Refer to Section III.D.4 of the BAA titled "Submission Information".

7. What is the likely percentage of abstracts that will convert to Full Proposal?

a. ARPA-H cannot predict the percentage of abstracts received from the BAA that will result in interested parties receiving requests for full proposals. ARPA-H will leverage its team of technical experts to evaluate abstracts and determine whether it is appropriate to extend a request for full proposal.

8. For abstract formatting, the BAA indicates font size (12 pt) but not margins. Will 0.5" margins be acceptable as for the NIH?

a. No, please use standard one-inch margins.

9. Does ARPA-H require preliminary data?

a. No. Proposers are welcome to include data to provide evidence for the feasibility of their approach.

10. Can you elaborate or provide further instructions on the format expected for the 3-page abstract submissions?

a. Refer to Section III.D of the BAA titled "Content and Form" for instructions.

11. How much technical detail must be provided for the abstract submission? Is it sufficient to frame the problem and approach in broad strokes?

a. Refer to Section D.1. “Abstract Format”.

12. If an abstract results in an invitation to submit a full proposal, will there be an opportunity to speak with a Program Manager prior to preparing a full proposal?

a. A Program Manager (PM) may choose to accommodate a meeting to discuss an abstract that results in an invitation to submit a full proposal. This decision, however, will be at the PM’s discretion based on availability and necessity. ARPA-H will provide detailed feedback on the abstract as part of the invitation to submit a full proposal.

13. How should a proposing team demonstrate that Organizational Conflict of Interest (OCI) has been avoided, neutralized, or mitigated when a researcher employed by a consortium member submits a proposal as a performer.

a. ARPA-H cannot speak to this hypothetical since each potential OCI will be evaluated on the unique characteristics involved.

14. If applicants are already having dialogue about their solution with the NIH, is it best to submit the same approach to ARPA-H or connect to ARPA-H separately through our current institute contacts?

a. Proposers should not submit to ARPA-H any proposal for the same work as submitted to another agency. In addition, ARPA-H reminds interested entities that ARPA-H's unique mission may mean a proposal suitable for one agency is not suitable for ARPA-H.

15. With regards to feasibility, can ARPA-H provide guidance for how to balance realism of timelines, personnel, and resources in light of high-risk, revolutionary goals?

a. It is up to each applicant to propose a reasonable project plan towards the development of their R&D concept. ARPA-H will evaluate the reasonableness of each abstract and proposal.

16. Will there be any incentive for prioritizing proposals from early career investigators or will teams be best served by having a more senior member with a longer track record leading the project?

a. ARPA-H does not have an inherent preference. Applicants should propose the team composition that best suits the specific project.

17. The 30-page full proposal sounds quite onerous, especially for brand new revolutionary ideas and approaches without much preliminary data. What is the actual technical/science portion in the full proposal?

a. The Summary of Proposal and Detailed Proposal Information shall be no more than 30 pages so shorter proposals are acceptable.

18. How do applicants make the proposal broad enough—i.e., not using x to treat specific y disease—without being too broad? Is it more like we have developed x that can be used across various fields so want to start exploring in one or two of those fields?

a. ARPA-H cannot speak to this hypothetical. Each abstract/proposal will be evaluated on the unique characteristics of the proposed technology.

19. Do Standard Form (SF) 4254 (Form 1 and Form 2) need to be submitted with the initial abstract—or does this occur once the abstract is reviewed and applicants are invited to provide a full proposal? Also, when is Attachment 4 used?

a. Forms 1 and 2 as well as Attachment 4 should be submitted with the requested full proposal.

20. Are there documents describing the standard roles of Principal Investigator (PI), Co-Principal Investigator (Co-PI), and Program Director in ARPA-H projects? For example, will each site usually have its own PI with other Key Personnel serving as Co-PIs? Are multiple site PIs considered to be Co-PIs with others who are not leading the site but given other roles such as Co-Investigator or Project Director of a particular project? If there are multiple site PIs, is a leadership plan requested? Is eRA Commons used for the agency login?

a. There are no standard roles for PIs (e.g., PI, Co-PI, multiple site PIs, etc.). Rather, proposers should propose the personnel and positions that will best support the proposed work. ARPA-H will not use eRA Commons.

21. Will actionable/constructive feedback be available for unsuccessful abstracts or full proposals to make realistic resubmissions?

a. ARPA-H will provide feedback to proposers.

22. Are submissions entered from the applicant’s institution/university or entered from the applicant?

a. Submissions should be entered from the university using the institution’s process for submitting to federal funding opportunities.

23. Where can applicants find detailed guidelines for the submission of abstracts (e.g., eligibility of the PIs and the institutions)?

a. The guidelines are listed on SAM.gov.

ARPA-H's response to abstract submissions:

1. Will decisions on submitted abstracts be rolling?

https://sam.gov/opp/caf109b75a0449418ead3630cef1915e/view

a. Yes, abstracts can be submitted and will be evaluated on a rolling basis. Abstract feedback is anticipated within 4-6 weeks of receipt. Depending on the volume of submissions received, ARPA-H may reserve the right to adjust the expected evaluation timelines to ensure integrity of the review process. If timelines need to be adjusted, updates will be posted on SAM.gov to provide transparency to applicants.

2. Will ARPA-H release all funding opportunities only through SAM.gov?

a. ARPA-H will use a platform(s) that provides the widest possible dissemination to relevant entities.

3. Does refusing to speak to applicants on the phone provide an unfair advantage to academics at universities with infinite job security and unfair to small businesses who are struggling to keep going every 6 months? (Specifically, certain applicants cannot spend weeks preparing a proposal and wait weeks more for a response just to find out the submission is not of interest.)

a. ARPA-H included the abstract phase as part of its proposal review process to minimize, to the greatest extent possible, the barrier to entry for receiving feedback on a potential technology concept.

4. Regarding scaling solutions, how will ARPA-H consider demonstrated feasibility? For example, is determining scalability within a Cancer Center’s service area for any given solution (e.g., cancer screening) considered large enough to demonstrate feasibility of scaling the solution?

a. ARPA-H cannot speak to this hypothetical since each abstract/proposal and associated proposed technology demonstrations will be evaluated on their unique characteristics.

5. Will abstract reviewers provide feedback on submissions? If so, would performers be able to improve on ideas and resubmit?

a. Yes, feedback will be provided on abstracts. The feedback should make clear whether it would make sense for the applicant to resubmit. In general, ARPA-H does not anticipate desiring resubmission of variations of the same core technology concept.

6. How often can performers expect to interface with Program Managers and how closely? If our team has a weekly lab meeting, would PMs attend every week or on a quarterly basis? Would PMs be around as we enroll patients and want to be involved that closely?

a. Level of involvement is at the discretion of the PM and based on their assessment of what is best for each individual project. Monthly status check meetings are typical.

7. Where can applicants find the ARPA-H BAA technical point of contact for the research topic/subtopic of interest?

a. Refer to Section VI “Agency Contacts”.

8. Are ARPA-H hubs being established to support the BAA applications regionally? Will these hubs also act as funding agencies?

a. Hubs are being established to support ARPA-H PM’s projects and programs. Note that the hubs will not act as funding agencies.

9. How is ARPA-H coordinating with other agencies to realize synergies and avoid duplication?

a. ARPA-H actively engages with other federal government agencies to collaborate and prevent duplicative work efforts where possible. Additionally, ARPA-H conducts thorough market analysis for all acquisitions to identify if other federal government agencies are performing similar work efforts.

10. ARPA-H mentioned not supporting productization efforts for a specific indication. How does that reconcile against the call for proposal ideas to include concept to commercialization efforts?

a. In general, productization efforts are eligible to be funded as part of a project awarded through the Open BAA. However, ARPA-H will not fund projects that exclusively involve productization of otherwise developed technologies. Instead, the productization effort would be proposed as part of a broader R&D effort that first includes development of a high-impact technology, assuming that the productization effort still involves substantial enough technical risk such that it could not be funded through traditional sources.

11. The BAA states that "non-US entities are encouraged to collaborate with domestic U.S. entities."

Are there particular qualities sought in a foreign-domestic collaboration?

a. A collaboration between non-US entities and domestic U.S. entities should involve high-potential, high-impact biomedical and health research.

12. Will any other BAAs be coming out?

a. Release of additional BAAs is to be determined. Although ARPA-H expects the current

BAA to be open for 1 year, there is potential for modifying the current BAA, extend the current BAA beyond 1 year, or publish separate BAAs with a different focus.

13. Can you explain the role of the Project Accelerator and at what stage of a program is this involved? Are applications submitted directly to the Project Accelerator?

a. The ARPA-H Project Accelerator Innovation Office (PATIO) provides a wide variety of transition and commercialization services to ARPA-H Program Managers and ARPA-H performers (i.e., applicants who are awarded ARPA-H cooperative agreements, other transactions, or procurement contracts). PATIO’s process and involvement, which is centered around the idea of enhancing commercial potential, occurs early and often from pre-concept development to project graduation. PATIO is not accepting direct applications for the BAA effort. However, interested parties may email the PATIO office at engagement@arpa-h.gov if they want to connect with PATIO and identify potential opportunities for collaboration.

14. Can we apply for the BAA if already have or intend to apply for an NIH grant?

a. Yes, but not with the same proposal or for the same work.

15. What aspects of the applications become publicly available?

a. Only information provided in applications that is minimally required would be made publicly available. The nature and extent of publicly available information may depend on proposed award type. For example, a Project Abstract Summary may be required for a cooperative agreement award. Otherwise, ARPA-H intends to handle all proposals in accordance with the Freedom of Information Act, the Privacy Act, the Procurement Integrity Act, HHS regulations and procedures, etc., and the attendant protections for proprietary, confidential, and other protected information.

16. Many institutes of higher education (IHEs) interested in ARPA-H programming have not historically fit the work of other ARPAs; therefore, the cost proposal concept is quite new for these campuses. Will training or detailed guidance on these rather complex cost proposal submissions from ARPA-H be available? Other than hiring consultants, is there any further advice ARPA-H can offer in this area?

a. Yes, a cost proposal template will be provided if a full proposal is requested based on the submitted abstract.

17. Will ARPA-H have SBIR calls or just BAAs?

a. ARPA-H does not currently participate in the SBIR program and, accordingly, is not yet making SBIR awards. It is possible that ARPA-H may participate in the SBIR program in the future.

18. Will abstracts that are not accepted to proceed to full proposal be kept confidential?

a. Yes, all submissions will be treated as source selection information. Refer to Section

III.B.2 of the BAA.

19. Has a Scalable Solutions technical point of contact been assigned? If so, is it possible to share that person’s contact information?

mailto:engagement@arpa-h.gov

a. At this time, technical points of contact have not been assigned. Please submit all inquiries to baaquestions@arpa-h.gov.

20. Is "revolutionary" referencing the technological or conceptual advancement? Would a "simple" idea with a transformative impact meet ARPA-H’s definition of "revolutionary?"

a. ARPA-H cannot speak to this hypothetical as each abstract/proposal and the associated technology concept will be evaluated on its unique characteristics.

21. Do the Program Managers take office visits like those from Defense Advanced Research Projects Agency (DARPA) or the Intelligence Advanced Research Projects Activity (IARPA)?

a. Yes, ARPA-H anticipates that its PMs will perform site visits as part of managing programs as is common in other ARPA organizations. The need for site visits will be at discretion of the PM for each project.

22. Is there a way to post our collaboration requests somewhere in ARPA-H’s ecosystem?

a. ARPA-H is developing a voluntary website to help connect potential teaming partners.

23. Can you explain eligibility of Department of Energy (DOE) National Labs to apply? Specifically, could you elaborate on the BAA asking for a letter confirming the Federally Funded Research and Development Center’s (FFRDC) eligibility to compete with industry?

a. FFRDCs are eligible to propose. Refer to BAA sections titled ‘Eligibility Information.’

FFRDCs should consider applicable federal laws and regulations as well as specifics of the FFRDC O&M contract for potential eligibility requirements.

24. Can other government agencies submit proposals? If not, can they collaborate with a separate eligible entity?

a. ARPA-H is not seeking submissions from other federal government agencies as BAAs are not the intended solicitation vehicle or mechanism to allow such agencies to collaborate.

25. When posting BAA amendments, will ARPA-H provide a summary or highlight the changes made?

a. ARPA-H aims to ensure that BAA amendments are as clear as possible when posted to SAM.gov. Interested parties can also “Follow” ARPA-H’s BAA opportunity by clicking the hyperlink on SAM.gov.

Timelines

1. Is there any reason or advantage to submitting abstracts sooner rather than later? Could the money run out mid-year or will all awards be made by March 2024?

a. Starting immediately, submissions and awards will be made on a rolling basis. For applicants who provide a successful abstract, ARPA-H will indicate a due date for the full proposal. Early submissions are encouraged.

2. In looking at the bench to bedside map, how far along should a typical proposal progress in the near term? What would count as near term—1 or 5 years?

a. ARPA-H cannot speak to this hypothetical as each abstract/proposal and the R&D plan/timeline will be evaluated on the unique characteristics of the proposed technology. There is also not a predetermined definition of exactly how many years constitute near term.

3. What is the expected turnaround time to get a go/no-go decision for an abstract submission?

a. Abstracts can be submitted and will be evaluated on a rolling basis. Abstract feedback is anticipated within 4-6 weeks of receipt. Depending on the volume of submissions, mailto:baaquestions@arpa-h.gov

ARPA-H may reserve the right to adjust the expected evaluation timelines to ensure integrity of the review process. If the timelines need to be adjusted, updates will be posted on SAM.gov to provide transparency for the process.

4. When does the BAA close?

a. The BAA will close on March 14, 2024, at 11:59pm ET and up until then, submissions will be received on a rolling basis. Although ARPA-H expects the current BAA to be open for 1 year, there is potential for extending the current BAA beyond March 14, 2024.

5. What is the timeline post-submission? When will applicants receive feedback and start dates?

a. Abstracts can be submitted and will be evaluated on a rolling basis with abstract feedback anticipated within 4-6 weeks. Depending on the volume of submissions received, ARPA-H may reserve the right to adjust expected evaluation timelines to ensure integrity of the review process. If the timelines need to be adjusted, updates will be posted on SAM.gov to provide transparency. Following the abstract submission, certain applicants will be notified of ARPA-H's interest in the team submitting a full proposal.

6. What is ARPA-H’s time horizon for revolutionary health outcomes to be realized from a 1-, 2-, or 3-year project?

a. ARPA-H cannot speak to this hypothetical as each abstract/proposal and R&D plan/timeline will be evaluated on its unique characteristics.

7. Are there any budget constraints for a BAA response? Can you outline the suggested timeline for a project?

a. The Open BAA does not include a funding limit for individual awards. Abstracts will be evaluated based on the criteria laid out in the solicitation, one of which is cost realism.

Proposers are encouraged to indicate a budget that aligns with the effort’s scope. ARPA- H is interested in funding holistic medium and larger scale proposals that could result in transformational impact rather than funding smaller exploratory studies. The proposed budget should align with the technical scope.

Similarly, the Open BAA does not include a limit or range for the period of performance for individual awards. Proposers are encouraged to list a period of performance that aligns with the effort’s scope.

8. The list of Program Managers, deadlines, and proposal format instructions is difficult to find, and many links were non-functional/broken. Could ARPA-H clarify the exact dates and contacts as well as provide a link to the forms and website via which to submit?

a. Refer to Section VI titled “Agency Contacts”. If you are experiencing broken links, please notify baaquestions@arpa-h.gov.

9. Is there a general timeline for an ARPA-H grant?

a. Although there is no general timeline, ARPA-H expects to take 4-6 weeks for abstract review. ARPA-H does not issue grants but, per the BAA, the "types of instruments that may be awarded [include] cooperative agreements, other transactions (OTs), and procurement contracts".

10. Will most projects have a 2- to 3-year funding period?

a. The Open BAA does not include a limit or range for the period of performance of individual awards. Proposers are encouraged to suggest a period of performance that aligns with the scope of the proposed effort.

11. How much time will ARPA-H give applicants to prepare the full proposal following invitation to submit?

mailto:baaquestions@arpa-h.gov

a. The exact timing depends on the nature of the proposal and the resources ARPA-H has to complete a full proposal evaluation. In general, ARPA-H anticipating providing at least 30 days.

12. Since a lot of time and resources are required to put together even a 3-page high quality proposal, there must be a faster, more efficient way to get project feedback. How long will ARPA-H need to review the proposal?

a. ARPA-H aims to undertake as streamlined of a process as possible for timely and effectively evaluation of BAA abstracts and proposals given the established evaluation criteria as well as other legal and regulatory constraints. The typical timeframe for abstract review is 4-6 weeks.

13. Does ARPA-H anticipate always having an Open BAA that can capture ideas that wouldn't necessarily be reflected in other current topical BAAs?

a. This is to be determined. Although the current BAA is planned to be open for 1 year, there is potential that ARPA-H could modify the current BAA, extend the current BAA beyond 1 year, or publish separate BAAs with a different focus.

14. Is it possible or encouraged to reach out to the ARPA-H technical team before submitting an abstract to discuss a potential project?

a. No, ARPA-H is requesting that proposers submit their abstracts for formal review and feedback without prior outreach to the Program Manager or technical team.

15. Given that there are only two PMs at ARPA-H, how will BAAs be selected and who will manage the project? Will the number of PMs slow down selection?

a. Proposals will be selected based on the evaluation criteria specified in the BAA by existing staff and ARPA-H does not anticipate any delay in selection.

16. If the abstract deadline is March 2024, what is the actual full proposal deadline? How much time do proposers have between the abstract acceptance and full proposal submission?

a. The March 14, 2024, deadline is only the deadline for submission of abstracts. ARPA-H aims to undertake as streamlined of a process as possible for timely and effective evaluation. Further submission instructions and detailed feedback on the abstract will be provided as part of the invitation to submit a full proposal.

17. What is the anticipated review time for the concept paper? Will feedback be given on the concepts?

a. ARPA-H accepts abstracts in response to the BAA, which includes a concept summary.

Abstracts can be submitted and will be evaluated on a rolling basis with abstract feedback anticipated within 4-6 weeks of receipt. Depending on the volume of submissions, ARPA-H may reserve the right to adjust the expected evaluation timelines to ensure integrity of the review process. If timelines need to be adjusted, updates will be posted on SAM.gov to provide transparency into the process.

18. What does it mean to transition a project? What are the hopes and expectations about how that works?

a. Each project will have unique milestones and expectations for transition. ARPA-H defines transitioning of a project as the completion of the initial phases of project sufficient to be moved to a subsequent stage of development (e.g., transitioned from proof of concept to early-stage commercial development]. ARPA-H has established the ARPA-H Project Accelerator Transition Innovation Office (PATIO) that is responsible for providing a wide variety of transition and commercialization services to ARPA-H performers. For more information on PATIO, visit: https://arpa-h.gov/engage/patio/.

19. What percent of abstracts is expected to be invited for submitting full proposals?

https://arpa-h.gov/engage/patio/

a. There is no set percentage of abstracts that will be invited to submit full proposals. The number will depend on the quality, quantity, and nature of abstracts received.

20. Is there a timeline for program announcements? Will these announcements be posted as a separate solicitation from the Open BAA?

a. ARPA-H does not have preordained timelines for program announcements. Any ARPA-H program-specific BAAs will likely be posted as separate solicitations from the BAA.

21. Will there be an opportunity to renew or extend the 2- to 4-year project duration?

a. ARPA-H efforts will have a period of performance that is determined by the proposal and statement of work. These efforts are finite and will not generally be considered for extension.

Eligibility

1. Are ARPA-H’s funding opportunities more suitable for basic or clinical research?

a. ARPA-H will have a balanced portfolio including both basic research and clinical aspects.

2. Can green card holders be proposers?

a. Refer to Section III.A.2, which describes the eligibility requirements.

3. We submitted an abstract but have refined our focus. Should we resubmit or can an abstract be modified after submission?

a. You may resubmit but please send an e-mail to baaquestions@arpa-h.gov officially requesting to withdraw your previous submission and notifying ARPA-H of the replacement.

4. Please elaborate on what ARPA-H is looking for with respect to ethical, legal, and social implications (ELSI). Could you provide an example?

a. ARPA-H will intentionally design programs to ensure the highest standards related to ethical, legal, and societal implications. As such, ARPA-H is seeking innovative approaches to establishing an ELSI program within the agency that aligns with the agency high-risk, high-reward health outcomes mission focus. Applicants are encouraged to understand existing ELSI programs within NIH, DARPA, and other federal agencies, but to recognize ARPA-H has a unique mission need for an agency-appropriate ELSI program.

5. Does a project need to fit into one focus area only or can a project span several focus areas?

a. Projects can span multiple focus areas.

6. Is ARPA-H interested in revolutionary approaches to acquiring and using data to discover novel effective individual-, community-, and population-level (non-clinical) interventions that have the potential to dramatically improve health outcomes?

a. To receive feedback from ARPA-H on your concept, please submit an abstract.

7. Does the BAA allow multi-PI proposals?

a. Yes.

8. What are the limitations/policies with respect to international collaborations and subcontracts, specifically with academic colleagues in non-restricted countries (e.g., EU, UK, Canada, Australia)?

a. Refer to Section III.A.2.

9. Will ARPA-H consider diversity, equity, and inclusion (DEI) requirements and/or community impact requirements when evaluating submissions?

a. Please see the evaluation criteria specified in the BAA.

10. In the Proposers’ Day presentation, ARPA-H mentioned that proposed projects should be "complete". Does that mean the solution must reach the market by the project’s end?

a. No, proposed projects do not need to reach the market by the end of the project.

‘Complete projects’ references having all the technical teams and collaborators required finalize the proposed work.

11. When a full proposal is requested, will the proposer be notified of being considered for an other transaction (OT)?

a. Applicants should indicate their preferred award type when submitting a full proposal.

12. Is there a restriction on contracts with foreign entities?

a. Refer to Section III.A.2.

13. Can we submit the same idea to both the ARPA-H DASH and the Open BAA?

a. Yes, but please note the difference in information required for submissions to the Open BAA vs the DASH.

14. ARPA-H stated that will not fund “traditional educational initiatives”; however, if a group has an innovative approach to education that meets one or more of the focus areas listed, would that be eligible for funding?

a. Please submit an abstract to receive feedback from ARPA-H on your concept.

15. Given the goal to demonstrate outcomes and feasibility in 1- to 2-year timeframes, would providing step-by-step assessment and contingency plans be essential in an abstract submission?

a. Refer to the “Content and Form of Application Submission” Section of the BAA.

16. Would a project that builds upon preliminary data previously supported by NIH grants (but no longer funded) be considered ‘revolutionary’ and therefore in scope for this BAA?

a. Previous NIH funding does not impact eligibility to submit an abstract. For more detailed evaluation of your concept, please submit an abstract to receive feedback from ARPA-H.

17. Please elaborate on the definition of ‘do-ability’ during the review process.

a. Refer to the “Evaluation Criteria for Procurement Contracts, Cooperative Agreements, and Other Transactions” Section of the BAA.

18. How is the likelihood of success determined?

a. Refer to the “Evaluation Criteria for Procurement Contracts, Cooperative Agreements, and Other Transactions” Section of the BAA.

19. Do subcontracts/subawards count toward the limit of 3 concurrent awards per entity?

a. The limit only applies to FAR procurement contracts and not subcontracts.

20. What would be considered proof that someone can handle the size of the project?

a. Refer to the “Evaluation Criteria for Procurement Contracts, Cooperative Agreements, and Other Transactions” Section of the BAA.

21. Can funding for a project be extended to meet a new set of target goals?

a. ARPA-H awards will be distinct, defined efforts with associated deliverables and milestones. Although new target goals could be envisioned in conjunction with the ARPA-H Program Manager, awards are not typically extended to achieve entirely new target goals.

Teaming:

1. Assuming teams will not be built out at the time of abstract submission, can applicants assume that ARPA-H will primarily evaluate the applicant’s demonstrated ability to hire and assemble a team?

a. Refer to the “Evaluation Criteria for Procurement Contracts, Cooperative Agreements, and Other Transactions” Section of the BAA. ARPA-H may choose to comment on the team’s capabilities as part of its feedback on an abstract.

2. Can the constitution of a team be modified after submitting an abstract?

a. Yes.

3. Are there effort requirements for team members?

a. No, applicants should propose the level of effort for each team member that is necessary to achieve the proposed goals.

4. If some entities or organizations do not have a technical partner for a critical innovative element, will ARPA-H help those entities/organization locate technical partners?

a. ARPA-H may provide feedback and suggestions regarding teaming during the abstract, full proposal, and/or negotiation phases. However, funded teams are responsible for making final decisions on involvement of specific team members.

5. Is there any guidance on the size and location differences of the team (e.g., residing within one large institution or assembled from groups at multiple intuitions across the country/world)?

a. There are no specific limitations on size and location of the team. Applicants should suggest a team that is necessary to achieve the proposed goals, which may mean spanning different institutions and/or countries.

6. Can government entities such as national labs participate on proposing teams? If not, are there other mechanisms for participation?

a. Refer to Section III.A.1.a. for eligibility of FFRDCs.

7. Are there any limitations for NIH National Eye Institute (NEI) employees or other government lab personnel as team members?

a. ARPA-H does not intend to make awards where another federal agency is the prime awardee. However, ARPA-H will consider the participation of federal employees on a case-by-case basis after considering any applicable federal laws and regulations.

Scope:

1. Is the concept of ARPA-H as an agency like DARPA?

a. Yes, ARPA-H has adopted many aspects of the DARPA business model for breakthroughs in health.

2. Is a single Program Manager taking responsibility for one project or multiple projects?

a. Each individual project will be managed by one Program Manager (PM). Each PM is expected to manage multiple projects.

3. Is ARPA-H looking for submissions just focused on clinical medicine, curing diseases, and projects highly focused on patients—or will public health, preventive health, and health promotion, also be considered?

a. All of the above are within scope of possible topics that ARPA-H will consider.

4. Are you looking for translational ideas, basic science, or both?

a. Both translational and basic science proposals are acceptable. As stated in Part II.I, "ARPA-H will foster innovations across the spectrum of technology readiness – from foundational science to the introduction of new prototypes into the marketplace."

5. What is ARPA-H's interest in biomanufacturing?

a. ARPA-H encourages potential applicants to review the Executive Order: Advancing

Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy (September 2022). In alignment with this EO, ARPA-H is interested in revolutionary ideas related to biomanufacturing innovation.

6. Does physical infrastructure include critical instrumentation for the project? What is ARPA-H’s policy on equipment purchases?

a. ARPA-H will consider critical instrumentation as part of a proposal.

7. Would you consider funding drug X (or an X class of drugs) that targets a common key aspect of many major diseases?

a. Please submit an abstract to receive feedback from ARPA-H on your concept.

8. Does the world's most unique small molecule library (not available from any other source) for drug discovery purposes fit an example of something ARPA-H would be able to fund?

a. Please submit an abstract to receive feedback from ARPA-H on your concept.

9. Are medical devices in scope of ARPA-H’s funding?

a. Yes.

10. Would the concept of "One Drug - Multiple Diseases" be a fit for ARPA-H?

a. Yes.

11. Is ARPA-H open to seedling proposals that…