PSI Frequently Asked Questions

The BAA is available at SAM.gov.

We welcome investigators at all stages in academia, industry, and other areas of the health ecosystem. The Precision Surgical Interventions (PSI) program anticipates teaming will be necessary to accomplish our program goals and metrics.

Abstracts are 4-page descriptions of the technical effort and will be due September 21, 2023. PSI will respond to in-scope, compliant abstracts by either inviting or not inviting submission of a full proposal. More information is available in the BAA.

The PSI project team is unable to discuss concepts that a potential applicant is considering submitting to the BAA. We will evaluate and provide feedback on technical concepts once they have been officially submitted. The PSI program anticipates that teaming will be necessary to accomplish our program goals and metrics. The PSI program anticipates considering a broad spectrum of applications across a range of development phases. Specifics about the PSI program, including technical details and details about the submission process, is in the BAA.

The PSI project team is unable to accommodate individual requests for calls or meetings to discuss concepts that a potential applicant is considering submitting to the BAA. We will evaluate and provide feedback on technical concepts once they have been officially submitted. Sidebar conversations at Proposers' Day serve as the opportunity to meet with the PSI team to answer any BAA-specific questions.

Participation in the PSI Proposers’ Day is not a requirement for submission of an abstract, full proposal, or selection for funding.

No. Teaming is at the discretion of proposers.

Teaming changes may be allowed at ARPA-H’s discretion and in response to new or different needs arising from the program’s progress. However, requests would be dealt with on a case-by-case basis.

No. If you believe you and/or your team can accomplish all program metrics, there is no requirement to team with other entities. However we believe teaming will be important to success and strongly recommend doing so.

ARPA-H does not conduct its own research. Instead, the agency funds research organizations such as universities and medical centers to conduct such work. If you have an interest in volunteering for studies, you could look for volunteer opportunities at hospitals, universities, or research institutions near you. For example, the National Institutes of Health (NIH) maintains a webpage with information on volunteering - https://clinicaltrials.gov/. Thank you again for your interest, and we encourage you to stay up to date on the current state of the program at https://arpa-h.gov/engage/programs/psi/.

You should submit an abstract to the Open BAA instead: https://arpa-h.gov/research-and-funding/open-baa/

The abstract and full proposal need to cover the efforts for the entire project (both Phase 1 and 2).

This depends on the number of abstracts that are submitted by potential proposers, but we hope to finish abstract review within 3 weeks.

No.

No.

No, we are not evaluating your ROM budget in the abstract stage.

You need to have a good idea of your team, but you can change team members/partners between the abstract and full proposer submission. The principal investigator needs to remain the same.

No.

You can and should show preliminary data in your abstract, where possible. If you claim you can already achieve a certain set of results, please substantiate that claim. If your data is from other cancers, that’s fine; just tell us why you think it’ll also work for the cancers we specify in the PSI BAA.

No, we will not give feedback early.

They are reviewed as a whole, but we may ask performers to modify some parts of a successful proposal.

Please detail them with a 3-month (quarter) granularity.

We aim to make multiple awards per TA.

No, the PSI program is a one-time opportunity. Those interested in ARPA-H funding outside of the PSI program may apply to the Open BAA program or may keep a look out for future programs.

The references/citations/bibliography do not count towards the page limit.  

No.

We require end-to-end solutions and will not be creating teams from partial solutions, nor can we create your team for you. Please use the teaming page or other folks in your network to find suitable collaborators. https://arpa-h.gov/engage/programs/psi/teaming/

Principal investigators (PI) cannot be changed, but Co-PIs and other team members can be changed, as long as initial capabilities remain or are expanded.

Yes, but they may be subject to additional scrutiny; see the BAA for the rules and regulations.

No, you do not. We will provide you with commercialization and transition assistance.

You do not; we recognize that cutting edge research happens in industry labs as well as academic labs.

There is no maximum but be aware that an increasing number of teams/people creates an increasing administrative, management, and communication burden.

For all aims, we are requesting a surgeon to be a co-Investigator. For TA1-A and TA1-B, there are additional requirements to interview at least ten surgeons; for TA2, at least five surgeons must be consulted (see the BAA for the specifics). These additional surgeons do not need to be Co-PI's; they may be consultants.

No; we will select the best ideas.

Every few days.

We understand that a lot can happen in 5 years, and we will need to approve the choice of new PI if they need to change.

You may be the prime on one (1) proposal and a sub-proposer on one other, or sub-proposer on two (2) proposals. You may not participate in research and development activities for more than two (2) proposals. You can provide an agent/device at cost for more than two (2) teams, as long as there are no development efforts for any teams past two (2).

If you do not do research and development activities under this program’s funds, you can be the supplier for any number of programs. You do not need to be a Co-PI or researcher in this case.

There are no hard rules, but it is difficult to believe that a PI who only commits 5% of their time to the project will be able to successfully carry out their duties.

Probably not. The program is a serious commitment of time and effort.

It is not our role to find partners for you, but if you do not have adequate partners to ensure translation, we will help you chart a path that will result in the solution being moved forward (which may mean help you establish a company, identify partners, etc.). 

There is no reason to have a partnership if you do not need one. We do not prefer any kind of institution of partnership structure over others —we will simply pick the most promising solutions. 

You should propose a new accelerated timeline and milestones that apply to your program. The new proposed timeline can include clinical trials. Should you decide to propose a new timeline, you need to demonstrate (at the beginning of the program) that you meet the deliverables for year 1, 2 or 3 (depending on how many you need to skip) set forth in the initial BAA.

No, this is out of scope for the PSI program.

No, but we may take your prototype from you for a month for evaluation at the end of Phase I.

You can do TA-1B and TA2 together if your technology for both substantially overlaps. You cannot do any other combination. Also, you can be prime on one proposal with one TA and sub on another proposal with another TA.

If clinical trials are required, we may be able to help you with logistics through the ARPA-H Hub and Spoke.

Prior IP remains entirely with the company. IP developed during the period of performance will be negotiated with ARPA-H on a case-by-case basis, depending on the award type. Please review the BAA for more detail.

We expect every team to try to achieve the metrics in the PSI BAA. Do not propose a solution that does not aim to reach them.

We mean we want to see or otherwise clearly distinguish single cells, such that you can make a pathology determination as to whether even one cancer cell is in the image. We know a scalpel doesn’t cut with the precision of a single cell; however, we’re asking you to visualize that single cell.

Cell level. If your agent labels Her2 (e.g.), but only 20% of the tumor cells overexpress Her 2, there will be a lot of tumor cells undetected if labeling at the tumor level.

No, we are strictly adhering to the 10-minute timeframe (with an additional 5 minutes for cavity or sample preparation), given that longer reads may disrupt the surgical workflow.

High-resolution imaging takes time and mechanical stability, and we do not want the surgeon (or anyone else) to have to stand for 10 minutes holding a device in place. Handheld solutions that do not interfere with the surgical workflow and meet the technical requirements of the BAA will be considered- as long as imaging is very quick (<30 seconds)/ROI.

Yes; please do not reinvent the wheel.

No, we intend to provide funding that can accelerate a nascent solution into a functional prototype.

Our goal is to help you meet FDA regulatory requirements and test your device in a realistic configuration. Choose the animal model(s) that make sense.

There are no strict SWaP requirements, but the device must be usable in operating rooms in both well-resourced and under-resourced hospitals.

It is at the margin level.

No, you need to convey a 3D understanding to the surgeon. This may mean a sensing solution without a full visualization component (e.g. a tool that knows its distance to a nerve).

Probably not for this effort.

You may but be aware that the program has exacting requirements and additional efforts may make it more difficult to achieve success.

Yes, provided the surgical robot is reasonably advanced and could realistically be used in the operating room.

Anatomy shifts around between presurgical imaging and resection. In addition, how would you know how much tissue the surgeon has removed with only pre-operative imaging? If you think you can achieve the level of accuracy required by the program, please justify how that will happen.

Yes, you can use a low resolution approach for wide field of view imaging and down select to ROIs for high resolution imaging. The ROIs must be selected in a deterministic way (not just guessing/eyeballing).

Brain cancer can be the second cancer you demonstrate your device in, but not your first. Be aware that the unique anatomy and physiology of the brain make it less likely that a solution developed for brain cancer can be successfully applied to many cancers, and we would like devices to be usable in as wide a selection of cancers as possible.

No, it means that the device has to be able to fit a 10 x 10 x 10 cm sample in the case that it is medically required to image a sample that large. The test samples can be any size, although you might want to make an effort to find a large sample for demonstration purposes. Maximum imaging time specified will apply to the largest tumor imaged, some of which need to be very close to the specified limit.

No, the NAICS number is just a categorization to help proposers search SAM.gov. Nanoparticle solutions are in scope.

The reason behind asking for one (1) cocktail is to ensure wide applicability to multiple cancers. Unfortunately, prior tests and assays would mean that a wide array of agents would need to be passed through the FDA. This is not practical, and the assays would make the entire solution more expensive. 

Yes. It is the case that TA-1B is mostly for laparoscopic surgery; however, as per the BAA, we allow for breast surgery, which is open. You could choose prostate and breast as your 2 cancers, and engineer a platform for closed surgeries which you then modify to also work in open surgeries. Usually what works for closed will also work for open; the reverse is not necessarily true.  

Yes, you can use cell lines instead of homogeneous organoids and tissue instead of heterogeneous organoids. 

We are anticipating a budget start date in March 2024.

We will not give a budget limit for the individual proposal or the full program. Please propose the budget necessary to do the technical work proposed, without resorting to cost-saving strategies such as proposing excessive amounts of junior staff.

No limits on how you subcontract. You can choose the type of contract for your subcontractors.

Yes, we expect universities to propose Facilities and Administrative (F&A) rates in accordance with the negotiated agreement for forward pricing and billing purposes.

No, we will be providing that to you. However, you will still need to budget for CRO’s performing the IND/IDE work.

No, performers will not be reimbursed for previous work.

The principal investigator’s institution receives the funds and distributes them to the co-investigators.

Price analysis will be performed on each proposal to ensure the reasonableness of the overall price. In addition, cost realism analysis may be performed to ensure proposed costs are realistic for the technical and management approach, accurately reflect the technical goals and objectives of this BAA, are consistent with the proposer's SOW, and reflect a sufficient understanding of the costs and level of effort needed to successfully accomplish the proposed technical approach.