PROSPR Frequently Asked Questions

You can find all of the relevant details on SAM.gov.

The budget submitted should be representative of the costs required to perform the work proposed. 

We support companies having IP, however we do expect data sharing for the overall gain of the program. For example, biomarkers would have to be shared as part of the program as this is a government-funded program that is meant to benefit all.

There is not a budget cap or expected range for each TA. Proposers are encouraged to submit their best ideas with a commensurate budget.  

We will award funding to the team/teams that present the best proposal and provide the most evidence they will be effective in accomplishing their goals independent of the number of teams. Multiple awards are anticipated to accomplish this, but one entity may propose to all TAs in accordance with the ISO. 

Yes, please see Section 6.1.2 of the Draft ISO.

Please see Section 5.1 of the Draft ISO. There is no limit on the size of teams, but each member should provide clear value and be managed by at least one Prime proposer. 

Yes.

Proposers are responsible for proposing a team capable of meeting all PROSPR Program requirements. CRO services will not be provided by the Government.

The Task tabs refer to specific Technical Areas (e.g., Task Tab 1 = TA 1).  Proposers must fill out the applicable Task tabs based on the number of TAs included in their proposal. The Phase tabs will be a roll-up of all proposed TAs (Task Tab costs). 

The fiscal years are the proposer’s fiscal years. Proposers may unhide columns as necessary if the Phase (base, option, etc.) extends beyond a single FY. 

No financial assistance will be issued as a result of the PROSPR solicitation. Proposers are encouraged to submit a budget that is reasonable and consistent with the technical approach.  Thus, budgets should include all reasonable costs (direct and indirect) with sufficient back-up information for the government to understand the basis of the budget. 

The DHHS salary cap will likely not apply to PROSPR awards because the government intends to award fixed amount Other Transaction Agreements and has requested only fully burdened labor rates in the Cost Proposal spreadsheet.

In terms of other ISOs, proposers are invited to search SAM.gov for other ARPA-H efforts or simply look on the ARPA-H page at https://arpa-h.gov/explore-funding/programs. In terms of past proposals, including budget submissions, the government will not release redacted past submissions. Please submit specific questions related to proposal submission (e.g. the Cost Proposal spreadsheet) to PROSPR@arpa-h.gov or submit a question through the PROSPR Program page.

No.

Proposers may use an assumed start date of 1 DEC 2025 as a start date in their submissions. During negotiations the government may provide an updated date.

While the government has the right to select portions of a proposal for award negotiations, the expectation is that proposals will include a technical solution that meets all TA/track requirements established in the ISO. Teaming is encouraged as/if appropriate. 

Yes, the Performer should propose the budget for in person assessments. Proposer budgets should account for all aspects of the proposer’s intended SOW.

Yes, proposer budgets should account for all aspects of the proposer’s intended SOW.

Yes, that is correct. .The budget template on SAM.Gov is for the full proposal.

Please refer to the Appendix B, Section F: Rough Order of Magnitude of the PROSPR ISO for ROM/BOE requirements. This section should be included with the other sections of the solution summary. 

In the provided template, direct labor is referring to the labor category. The labor hours  are the hours associated with the labor category. Please plan to report labor hours by labor category per phase. In places where the spreadsheet includes a cell for a Basis of Estimate, justifications may be included. Otherwise, support and rationale related to the spreadsheet should be included in the Cost and Pricing Data Support that is part of the Cost Proposal Volume.

See Appendix C, Volume II information (Section b. Cost Proposal Spreadsheet).

The Government will not direct proposers for how to assign roles and responsibilities within their own teams. The administrative point of contact is intended to be someone who is responsible for the non-technical aspects of the proposal. 

We provide funding in the form of contractual agreements for performers carrying out negotiated research and development work relevant to the program. 

Please see Section 5.1 of the Draft ISO.  

PROSPR is independent from the Mission Office ISOs, and the ARPA-H solutions portal will be used. Please see Section 4.2 of the Draft ISO for Solution Summary submission information. 

The OT Bundle of Attachments, which contains relevant templates, will be released no later than with the Final ISO. 

It is possible to submit to both, however, awarded work cannot have overlapping scope. It is recommended to submit to the Program ISO if that is a fit for your proposed work.

The scope for PROPSR is provided in the ISO. Publicly traded companies are eligible to apply for the award.

April 25, 2025.

The program will be available for submissions upon publication of the final Innovative Solutions Opening (ISO). 

Each proposal will consist of at least one prime entity and could also be composed of several sub-prime entities that will perform subsets of the work described in the proposal. If you join a team, you should decide who will be the prime on the proposal. Only one proposal per prime can be submitted, however an entity could be a subprime on multiple proposals submitted to the PROSPR program. See Section 5.1 of the Draft ISO. 

Proposers will first submit a Solution Summary. These will be reviewed by the PROSPR team and a subset will be encouraged to submit a full proposal. Please see the Innovative Solutions Opening on the PROSPR program website for full details, including page limits, due dates, submission website, and required content. 

The number of awards will be based on the number that is required to fulfill the goals of the program. Since we allow performers to form teams or submit proposals on single TAs, we will not predetermine the number of teams awarded. 

A prime can submit a proposal that covers a single or multiple TAs. 

The Team Organization and Capabilities section should be within the 5-page Proposed work section. 

The font size should be no smaller than 11-point. 

Solution Summaries and proposals are considered Selection Sensitive and not shared publicly. Submissions are only shared internally to the extent required to fulfill the Scientific Review process. Those who require access are either federal employees or support contractors who have signed appropriate Non-Disclosure Agreements. 

The Government will review Solution Summaries and provide feedback as quickly as possible. The specific timeframe for feedback is dependent on the number of submissions received.

The graphical and written abstract must be on a single page. 

See Section 2.3.1 Approach by Technical Area (TA). Proposers can submit to a single TA or single track. 

As listed in the General Instructions of Appendix B, any references provided are outside of the 5-page limit.

The requirement to have a UEI and active SAM registration applies at the full proposal stage.

A proposing team may revise its teaming structure between Solution Summary submission and the full proposal submission. Note that the Government’s review and recommendations at the Solution Summary stage are based on information available within the Solution Summary.

No.

The submission limit applies to full proposals only. Each institution is allowed to submit one full proposal to the PROSPR program as prime regardless of the number of TAs included in the full proposal. 

Anyone may upload the solution summary on behalf of a team

The sheet is no longer required.

Proposers have access to all full proposal templates. See appendix C of the ISO, the Model OT (e.g., SOW format), and the Cost Proposal spreadsheet uploaded with the ISO. 

See Sections 4 and 5 of the ISO for information related to the submission and evaluation process. 

It is a proposer’s responsibility how it substantiates its capability to meet the requirements of its proposed technical approach.  

One proposal is sufficient regardless of which TAs you choose, please clarify which TAs your proposal will cover in the solution summary and final proposal. Please see Section 2.3.2 of the Draft ISO.

Please see the timeline in the Draft ISO.

Yes, the improved IC score should include all five components of IC, but can include other physiological and biochemical parameters providing they improve the accuracy of 20 year health outcomes. Omics as well as routine lab work can be considered as the additional biochemical measures, please see section 2.3.1 of the draft ISO for more details.

Please see section 3.3.3 in the program draft ISO for more information. For TA3, it will likely be difficult to demonstrate that the target has a high reward potential without strong preliminary data of some kind, particularly in mammalian models.

Please see the Innovative Solutions Opening for in-scope and out-of-scope methods. Any method that is not out-of-scope will be considered, however these should be supported with a clear plan or evidence of previous success. We are not able to comment on suitability until the full details are submitted in the Solution Summary. 

The performers will be responsible for storing their own data as the ARPA-H data repository is being built. There is an anticipated change coming to the ISO that will remove reference to the data repository. The program itself is not able to partner with any organizations, but you are welcome to form teams at your discretion to provide such services. However, TA1 proposers can propose to coordinate and collaborate on the construction of a shared repository with other selected teams. 

In general, we will not allow proxies of IC physiological components. 

Yes, a range of participants ages will be permitted. Clarification of this will be available in the final Innovative Solutions Opening. 

Yes, this is permitted for consideration.

The biochemical components can be measured at regular intervals of your choosing, providing you adequately justify the timing in your proposal. 

Yes, you should read IDE instead of IND when applying for TA3 with a medical device.  

Yes, it is expected that you propose primary endpoints for TA2b in addition to the PROSPR IC. These endpoints should be supported by strong scientific rationale and evidence.

Yes.

Demonstration of improvement of age-induced health outcomes of any kind are permitted. However, considering the current literature, we anticipate there will be interventions proposed with evidence of lifespan or healthspan improvements, frailty, or multiple system improvements in adult or aged animals. Many of these studies show promising effects, but might only test in male rodents or assess physiology while omitting cognitive function, they might have low sample size or short duration. The first phase of TA3 will be a much more comprehensive, longer duration preclinical study that most currently published, using intrinsic capacity as a measure of general health.  

If you have two drugs, you may propose both in one proposal and please let the budget reflect your intention to test two, rather than a single, drug. 

The proposed interventions are not required to be pharmacological. A goal of the PROSPR program is build a healthspan therapeutic industry, therefore we require TA2 and TA3 to seek FDA approval for their interventions. Lifestyle interventions are suitable for TA1. 

Currently, the only mechanism for obtaining a label change is through the original NDA holder submitting data to the FDA. ARPA-H is not aware of any officially approved alternatives that allow non-manufacturers to seek a label change independently. 

Yes we are interested in brain health and encourage proposals that aim to prevent cognitive decline as a component. That said, we believe brain health is one of several important aspects of general health and the best outcome will be those that influence multiple Intrinsic Capacity components such that the overall IC score is improved.  

Yes, this is acceptable and encouraged where the optimal dose in unknown. 

Proposers should recruit the number of participants such that at the end of the study, you are sufficiently powered, taking into consideration participant attrition or exclusion throughout the study.

The intention of the clinic visits is to ensure that the in-home measures accurately reflect Intrinsic Capacity measures taken in the clinic or by a medical professional. Sending a professional to the home could replace clinic visits, but we find it unlikely this could be a fully virtual approach. 

For TA3, please ensure that the Solution Summary contains all of the in-vivo data available for your intervention, particularly data that demonstrates preserved health in aged animals or other in-vivo justification to perform such studies. The remaining studies should be part of the proposed preclinical studies. 

Yes, you are permitted to include any analysis that would demonstrate preserved health over time in your Solution Summary/Proposal provided IC is also included. If selected, ARPA-H will negotiate the terms with the proposer, including which assays will be allowed as part of the ARPA-H contract. 

You do not need to collaborate with any teams in order to submit a proposal and you are permitted to propose to a single TA. That said, you will be required to collaborate with the team selected by ARPA-H for TA1, and will be required to incorporate the factors important for human IC score generation. TA3 success will be measured by Intrinsic capacity, though you are permitted to propose other assays in addition to this. If selected, ARPA-H will negotiate which non-IC assays will be funded as part of the final award. 

We agree that IRB approval must occur before patients are recruited. The ISO expects performers to apply for IRB in Phase I and to have received approval early in Phase II. However, proposers should propose the timeline they believe will ensure the success of their Solution (e.g., beginning the process sooner).  If selected as most advantageous, ARPA-H will negotiate the final terms, including timelines, milestones, and deliverables. 

The trial begins at the start of year 3 of the program.

We are in discussions with JAX on this issue. Proposers shall assume the issue will be resolved when submitting solutions. 

Regardless of its current classification, if the food supplement will be used to treat an indication (in our case low IC), it will be treated by the FDA as a drug, and will be subject to all requirements that apply to drugs. Therefore these are allowable for inclusion in the PROSPR program.

We agree that the IC score is likely to need alterations to be the most predictive of healthspan and this is the focus of TA1. Performers are allowed to include most components at their discretion into the tested elements to identify which will be included in the final PROSPR IC score. This could include medical history, but also may not.  

We understand that some TAs will have more comprehensive commercialization requirements than others. For example, TA2b commercialization plan could address how the data produced might be used by commercial entities or more support the commercialization goals of the PROSPR IC, or how a repurposed drug would enter the market.. 

At this time, we will focus on interventions that increase healthspan in the environment of natural aging and therefore will not allow genetically modified animals in the PROSPR program. 

Each proposer must exercise its professional judgment in terms of strategizing submission composition. However, the government notes if two full proposals are evaluated relatively equally against criteria 1-3, the government may consider teams that cover multiple tracks or TAs to be more advantageous. 

95% consistency applies to shared or comparable variables across datasets. While not all datasets are required to contain every IC subdomain, those variables that do appear in multiple datasets must be harmonized with 95% consistency. For example, if three datasets include cognitive function metrics but only two include gait speed, the 95% consistency requirement would apply independently to each subset of overlapping variables to predict the outcome. We expect the proposers to provide scientifically defendable metrics and validation methods to prove the harmonized dataset achieves this level of consistency.

At this time we are not considering proposals that propose accelerated aging models as study participants for any of the TAs. 

Please see amendment 1 to the ISO. Exceptions to the rodent model proposed may be considered in cases where preliminary data strongly suggests the therapeutic will extend healthspan in non-disease contexts and justification is provided for the use of another rodent model. Diseased or accelerated rodent models will not be considered.  

The metrics and milestones listed in the ISO are anticipated timelines. Please provide a timeline that makes sense for your team and provide the justification for your choices. 

While the government has the right to select portions of a proposal for award negotiations, the expectation is that proposals will include a technical solution that meets all TA/track requirements established in the ISO. Teaming is encouraged as/if appropriate.

Yes, this would be considered. Participants in the study should be in general good health, aged 60-65, without diagnosed diseases such as cardiovascular or diabetes, etc. 

This would not be excluded from consideration providing the endpoints are consistent without those outlined in the PROSPR ISO. 

The final cost of ~$100 should be a per use cost.

The goal should be for the cost to consumers to be less than $100, if part of the plan is to have insurance cover part of the cost of the device, this would be acceptable and should be included in the proposal.

The goal of the study should be to prevent a change in the anticipated IC score with the therapeutic intervention. When conducting a power analysis, please include the expected change in IC score in the timeframe of participants of similar age (based on published data) and power the study sufficiently such that the treatment group remains unchanged. Also, work within the effect size you anticipate based on your preclinical data.  

For TA2b, hybrid trials are permitted.

This would be acceptable, however you should maximize the changes of the drug being approved by the FDA for healthspan on its own by including a drug-only arm. Please also provide justification for the inclusion of the lifestyle intervention with the drug.  

Please see amendment 1 to the ISO. Exceptions to the rodent model proposed may be considered in cases where preliminary data strongly suggests the therapeutic will extend healthspan in non-disease contexts and justification is provided for the use of another rodent model. Diseased or accelerated rodent models will not be considered. 

Adding these measures to the IC score would not be out-of-scope.

TA2b performers will provide the assessment technology to the TA2b decentralized trial. 

No, TA3 performers must propose the entirety of TA3 from preclinical to clinical trial. Please feel free to form teams with other TA3 performers in advance, proposing multiple interventions if desired such that the team could carry out all the aims of TA3. 

The goal of the PROSPR program is to have low IC labeled as a condition that can be treated with interventions because now it is not possible to get treatment for age-induced loss of function despite the challenges it causes individuals. This approach allows clinical trials and FDA-approved therapeutics for losing function as we age, independent of disease.

There should be approximately 1000 participants in the observational trial, from which a subset should be used in the lifestyle intervention trial. Please propose the number of participants required based on a statistical power analysis. 

Yes.

Solution summaries should present what the proposing entity is currently capable of offering to allow accurate evaluation. Teaming is typically finalized by this point but the Prime proposer/awardee is ultimately responsible for ensuring any agreed upon work is carried out. 

Proposer’s Day will now consist of a pre-recorded video that contains the relevant information for proposers. The link to the video will be emailed to all registrants and posted on SAM.gov and the PROSPR webpage.