BoSS Frequently Asked Questions (FAQs)

Not all foreign entities are eligible for ARPA-H funding. Awards will not be made to entities organized under the laws of a covered foreign country, defined in the National Security Act of 1947 (50 U.S.C. § 3059) as Russia, Iran, North Korea, and China. Individual solicitations may allow or restrict the participation of foreign entities to varying degrees. For more information, please visit ARPA-H’s International Affairs website and FAQs: https://arpa-h.gov/engage-and-connect/international.

Yes, academic and commercial entities are eligible to propose as the IV&V partner.

No, we encourage international partnerships. We are eager to see teaming with international partners as members and/or subject matter experts with consideration that culminating BoSS technologies are intended for domestic manufacturing. 

As stated in Section 4.2 of the BoSS ISO, FFRDCs and government entities are not allowed to participate in ARPA‑H R&D awards as a team member, except under special circumstances with an approved waiver. For example, if a potential Performer believes an FFRDC has a unique capability without which their solution is unachievable, they may provide documentation as part of their Solution Summary submission demonstrating they have exhausted all other options. ARPA-H will consider the documentation to determine if inclusion of the FFRDC as a team member necessary for the solution.

No. Monoclonal antibodies, proteins (e.g., recombinant, enzymes, hormones, growth factors, cytokines), peptides, and other non-cell demonstration systems are out of scope as a demonstration system for the BoSS program.

The BoSS program is not currently soliciting approaches that involve genetic modification. All genetic alterations—including any introduction of exogenous nucleic acids into cells—are out of scope for this program, in part due to safety risks associated with transient, permanent, heritable, or otherwise unintended genetic changes to cells.

Methods of payload delivery that can be adapted to deliver non-nucleic acid molecules are in scope.

At this time, BoSS is only seeking low-cost, rapid, and scalable methods that can induce reversible biostasis in cells used for biologics manufacturing and/or as drug products (e.g., cell therapies) and which have the potential to follow a relatively straightforward regulatory pathway. 

The government does not require ownership of all software, source code, or technical data developed under the BoSS program. Performer team members may retain ownership, including as trade secret or other proprietary IP, provided that the government receives license rights sufficient to:

• Use, operate, test, and evaluate the integrated BoSS system across relevant government users;
• Maintain, modify, and upgrade the system directly or through support contractors; and
• Support transition and potential follow‑on activities consistent with the program’s objectives.

In most cases, the government anticipates obtaining at least Government Purpose Rights in technical data and software developed under the program, so that the government can use the results for governmental purposes, including potential follow‑on competition and broader deployment, without being unduly restricted by proprietary claims.

Any proprietary or trade secret software or data must be appropriately marked and licensed on terms that do not impede deployment, sustainment, or further adoption of the BoSS system and associated products. Specific rights and licenses will be established in the award documents in accordance with applicable law and regulation.

Performers are not limited to using government-selected cells and are encouraged to demonstrate system generalizability by evaluating concepts on multiple cell types as early as in Phase 1.  

A commercially-relevant cell type specific for Phase 3 industry transition may be used as a demonstration cell type throughout the entire program, as long as the minimum requirements for end-of-phase demonstrations are also met.

To allow independent verification and validation (IV&V) of developed methods and approaches, at the end of Phase 1, Phase 2a, and Phase 2b, performers are expected to demonstrate on two government-selected cell types, but this is a minimum requirement, and other performer-selected cells may be used to demonstrate bioprocessing system performance.

At the end of Phase 2b, in addition to the IV&V evaluation on two government-selected cells, demonstration of a third performer-selected cell type is expected.

Table 2 on page 12 of the solicitation/ISO lists the government-selected cell types that will be used for end-of-phase demonstrations. The independent verification and validation (IV&V) partner will be selected in part based on their ability to supply adequate quantities of well-qualified cells to performers (see Section 2 of the ISO), thus the final cell types will be provided to performers as soon as the IV&V partner is selected and the contracting process is complete.

The cost proposal spreadsheet and narrative are due with your Solution Pitch submission through the portal, not at the time of the oral presentation itself. Your pitch will only be scheduled after ARPA-H receives a complete and conforming Solution Pitch package, which includes the cost proposal narrative (Attachment 3) and cost spreadsheet (Attachment 4).

BoSS does not have a preference for the cell demonstration systems used to assess the performance of developed biostabilization technologies as long as they are therapeutically relevant. Demonstrating generalizability of the proposed solution (i.e., demonstrations on multiple cell types) is a goal of the program. At the end of Phase 1, Phase 2a, and Phase 2b, at a minimum performers are required to demonstrate performance of their proposed solution on two government-selected cell types, but performers may choose to assess more cell types.  Demonstration on a performer-selected therapeutically-relevant cell type is required for Phase 3 but this cell type may be used for comprehensive demonstration throughout the entire program, as long as other requirements for phase-end demonstrations are met.  

The goal for the BoSS program is aimed at developing biostabilization technologies that enable shelf-life stability at room temperature. Solutions that require cold storage of biologic medicines are considered out of scope for this program. Please refer to section 3.3 Program Metrics of the BoSS Innovative Solution Opening for milestones and metrics used to assess the stabilized cell products including shelf-life stability at ambient room temperature and bioprocessing system performance.

The BoSS program does not expect or require manufacturing in a cGMP-compliant facility or submission of an IND. The program requires commercialization plans that strategically align biostabilization technology development with GMP standards and compliance to ensure that after the program concludes, the culminating biostabilization technologies and bioprocessing systems are commercially viable and adoptable.

Advancement will be determined by a number of factors, including how well each team’s solution meets the milestones and phase-end metrics, and is subject to available funding. Performance across different cell types may vary within a given solution; these variations will be integrated into the overall assessment of the solution’s performance at the end of each phase.

The biological function or potency refers to cell attribute(s) that are correlative to a proposed therapeutic efficacy or mechanism of action of a particular cell type when metabolically active (before biostabilization or after re-animation). Re-animation refers to the approach used to reverse biostabilization which will be assessed by the ability to return stabilized cells to their metabolically active state and the time it take for this reversal. For government-selected cell types, benchmarks of the metabolically active counterpart (fresh cells post-manufacturing and post-thaw following cryopreservation) of the cell types used for biostabilization will be established and provided by the IV&V partner. For performer-selected cell types, potency and other characterization assay benchmarks should align with anticipated regulatory review following the conclusion of the program.

The IV&V partner will provide a limited amount of 2 government-selected cell types that may include primary cells, cell lines, or other cell types, and these costs will be covered by the government.  All other demonstration cell costs should be included in the proposed budget.

Please refer to Table 3 in the BoSS ISO that lists a minimum set of assays that will be used to assess cellular attributes using standard characterization assays appropriate for all cells (e.g., viability, apoptosis, metabolic activity) and those that are specific to each cell type (e.g., identity, functional assays). It is recommended to include additional assays to comprehensively characterize the cells used in demonstrations to enable the assessment of the proposed preservation solution's performance. 

Yes, this is an acceptable assay to measure viability.

The BoSS program emphasizes efforts of translation to commercial adoption, especially with the milestones outlined in Phase 2 for scale-up and Phase 3 for commercial transition. Articulating a  plan to achieve commercial success is highly recommended in proposals.

Downselections will be based on each approach's progress towards achieving the specified phase-end metrics. It is possible that more than one approach might advance through the program's phases provided that the metrics and milestones are achieved.

Demonstration products for the BoSS program are cell-based biologics intended to be used to demonstrate the performance of a developed bioprocessing system for biostabilization, thus non-cell cell-derived products including organelles and secretome are out of scope. 

Performers are expected to submit a monthly status report (MSR) which describes progress made towards the metrics and milestones of the associated phase and virtually attend monthly meetings with the Program Management Team to review the MSR in order to release funds ties to each milestone. At the end of each phase, leadership from each Performer team is expected to meet with the Program Management Team. Please review section 3.4 Programmatic Deliverables of the BoSS Innovative Solution Opening for details.

The BoSS Innovative Solutions Opening (ISO) provides metrics that are minimum requirements to assess the measureable performance of biostabilization technologies. Additional metrics, including those specific to the cell demonstration products are highly recommended in order to generate sufficient data that can be used to support the development of stabilized therapeutic products including through regulatory pathway reviews.

Performance will be assessed based on phase end metrics on all cell demonstrations. IV&V will assess the performance of the government-selected cell types used for Phase 1 and 2 demonstrations but not the performer-selected cell types that are required for demonstrations into Phase 3.

Demonstration on a performer-selected therapeutically-relevant cell type is required for Phase 3 but this cell type(s) may be used for demonstrations throughout the entire program types, as long as other requirements for phase-end demonstrations are met. Performers will be provided with two government-selected cell types that will be required to be used for end of phase demonstrations. Performers are not limited to using government-selected cells and are encouraged to demonstrate system generalizability by evaluating concepts on multiple cell types, as early as Phase 1. 

The Solution Summary for Technical Performers should include strategies to mitigate risks given the high-risk nature of the program. Risk mitigation plans may include approaches that confer an ability to pivot or otherwise continue to advance an overall approach's progress towards feasibility, development of a bioprocessing system, and commercial transition.

Proposals can include additional metrics that would support the goal of patient access to advanced biologics following commercial adoption of the biostabilization technology.  

No, the BoSS program's goal is to develop bioprocessing systems that stabilize therapeutically relevant cells at ambient temperatures.

The production speed refers to the time it takes for the biostabilization process to produce cells stabilized ambient room temperature.

The commercial manufacturer’s suggested retail price (MSRP) of the bioprocessing system should not exceed $200,000, in support of broad, equitable access and affordability following the completion of the program.

If an internalized biostabilizing molecule prevents biostasis reversal and/or precludes eventual translation to use in humans, the process for removal must also be included as part of the TA1 solution under this program.

The Basis of Estimate is included in the 4 page limit. 

Performers are expected to provide biostabilization technologies, stabilized cells, and standard operating procedures for re-animation to the IV&V partner at the end of each phase for performance assessment. After assessments are complete, technologies will be returned to performers. If shipment would unreasonably compromise a technology’s performance or if equipment is otherwise not amenable to shipping, the IV&V partner may instead conduct on-site visits to operate and assess the system at the performer’s facility.  

Performers are expected to develop and refine commercialization plans throughout the program with a transition partner identified by the end of Phase 2a.  Ideal transitional partners for Performers are organizations equipped with established distribution networks to seamlessly integrate the developed bioprocessing system into their existing biomanufacturing pipelines for cell biologics, accelerating the path from innovation to implementation.

Preliminary results are not required, but are strongly encouraged when available, as relevant supporting evidence can strengthen the proposed solutions. Preliminary data or prior work can help support the feasibility of the approach, the capability of the team, and a credible path to meeting the program’s technical milestones.

Other Transactions (OTs) are legally binding but flexible contracting instruments that are not procurement contracts, grants, or cooperative agreements and are also not subject to acquisition laws and regulations. For more information, please visit ARPA-H's Other Transaction Community. 

All team members must sign an internal binding agreement (Articles of Collaboration) that, among other things, defines roles and responsibilities of team members and binds members to the team. Although the OT award will be between the Government and the team, only the lead agent/member appointed by the team need sign the OT on behalf of the team. This arrangement allows the Government privity of contract with all team members, even though only the agent signs the OT agreement. Reference: Section 4.6 of the ISO.

Under the OTA team structure (not prime/sub), the lead (team agent) receives payment from the Government and then distributes funds to team members according to the terms outlined in the internal team agreement (Article of Collaboration or Multi-Party Teaming Agreement). Each team member does not invoice the Government directly; instead, the agent manages payments based on the team’s agreed-upon process.

Reference: See Section 4.6 of the BoSS ISO.

It is strongly recommended that multi-party teams submitting proposals as Technical Performers incorporate expertise to achieve program milestones and goals, including but not limited to regulatory affairs, commercialization, intellectual property management, and other relevant business analytics and strategic capabilities. Demonstrating that such expertise is represented within the team at the time of proposal submission will strengthen the overall quality and credibility of the proposal. These capabilities may also be added after program initiation, provided that appropriate roles and associated costs have been anticipated and budgeted in the original proposal.

No, we encourage international partnerships. We are eager to see teaming with international partners as members and/or subject matter experts with consideration that culminating BoSS technologies are intended for domestic manufacturing. 

A multi-party team is formed by having all team members sign a teaming agreement (also referred to as “articles of collaboration”), a contract which binds signing members together as a team and which identifies team members, roles, responsibilities, etc. The government is not a party to this teaming agreement and is not involved in the negotiation of the terms amongst the team members. This is a private arrangement amongst the team members with no government-dictated terms.

While one team member is usually elected to serve as the lead member, each member must be bound to a teaming agreement and must be a party to the resultant OT award with ARPA-H.

A multi-party team structure gives the government privity of contract with all team members, allowing the government insight and visibility into all levels of technical and management actions, providing for direct communication between all team members and the government, ensuring that all team members are responsible for successful performance, and enabling seamless leadership changes of the effort and/or addition of new team members (e.g. product sponsors), if necessary, as the program evolves.

Please review Section 4.6 Proposer Team Structure in the BoSS ISO for details.

• For the Solution Summary, ARPA-H expects a single, basis of estimate (BOE) that incorporates cost estimations for all phases of the entire program and the amount of federal funds requested, as well as the total project cost including resource sharing, if applicable. The BOE should also include a breakdown of the work by direct labor (fully-burdened), labor hours, materials, equipment, other direct costs (e.g., travel), profit, resource sharing (if any) and any other relevant costs. Please see Appendix A for a table that may be used as a template for the BOE on SAM.gov for the BoSS Innovative Solutions Opening (ARPA-H-SOL-26-136).
• For the Solution Pitch, ARPA-H expects a single, consolidated program budget. The costs for all parties should be substantiated by the details provided in the Solution Pitch and cost proposal (e.g., the type and number of labor hours proposed per task, the types and quantities of materials, equipment and fabrication costs, travel and any other applicable costs including the basis for the estimates). 

Please see Section 6.4.4 of the ISO for information on how ARPA-H will evaluate proposed cost/price and Attachments 3 and 4 for the cost proposal narrative and spreadsheet on SAM.gov related to the BoSS ISO (ARPA-H-SOL-26-136).

Overhead and indirect costs should be incorporated into proposed fully burdened rates and prices. If profit/fee is requested, it should not be incorporated into rates/costs/prices but broken out separately in the spreadsheet. Please note: Fee/profit should not be proposed when resource-sharing is also proposed.

The Government reserves the right to negotiate any/all proposed elements of costs/prices prior to award.

Each team should submit one consolidated budget for the entire multi-party team.

• For the Solution Summary, the budget is referred to as a basis of estimate (BOE) which will be submitted as part of Appendix A. Please refer to Appendix A of the BoSS ISO for details and instructions for the BOE. 
• For the Solution Pitch, the budget should be provided as Attachment 3 Cost Proposal Narrative and Attachment 4 Cost Proposal Spreadsheet. Please refer to these attachments in the BoSS ISO (ARPA-H-SOL-26-136) for details and instructions. 

ARPA-H issues a single OT award to the team, with the Lead member as the direct payee who receives funds from the government and distributes payment to the team members according to their established teaming agreement. 

Please refer to section 4.6 Proposer Team Structure of the BoSS ISO for more information. 

All team members are equally responsible for performance and compliance under the OT. 

Please refer to Section 4.6 Proposer Team Structure of the BoSS ISO for more information.  

Teaming agreements will be established among the team members and will not involve ARPA-H. ARPA-H does not prescribe or direct what is included in the teaming agreements; however, teams should ensure that teaming agreements, at a minimum, bind members to the team. 

1. At a minimum, a proposing team must: 
   Not be a prime/sub-performer team. While a multi-party team may still choose to subcontract with commercial vendors and consultants not performing essential components of the program, entities that are performing substantive work should be members of the team, not sub-contractors.
2. Identify a team member to perform administrative functions and act as an agent or lead member for the team. The agent does not need to be the lead performing organization, but the agent should perform substantive technical work on the program beyond program management and administrative functions.
3. Execute, prior to award, a teaming agreement that details the team structure, roles, and responsibilities and which binds the team members to the agreement. All members of the team will be party to the OT agreement with the government. Whatever the team structure, the lead performing organization must be able to change during performance or between phases, if necessary. The teaming agreement must account for the full scope of the BoSS program. The government is not a party to and will not approve the teaming agreement, however ARPA-H will require evidence that the teaming agreement has been fully executed by all team members in order to make an award to the team.

Please refer to Section 4.6 Proposer Team Structure of the BoSS ISO for more information.

Budgets should include all phases, with higher resolution for Phase 1.  

During months 13–15, Performers are expected to continue work toward Phase 2a to improve the performance of their solutions, and proposed budgets should reflect this ongoing effort. Months 12-15 should be included in the budget because work should continue towards Phase 2a until informed otherwise to pivot towards close-out reports. 

Milestone payments are structured as fixed payments associated with the completion of defined milestones under the award.

As long as a team makes a good‑faith, technically sound effort and can document credible progress toward the agreed milestone objectives, ARPA‑H may approve the full milestone payment, even if the originally anticipated technical results are not fully achieved.

Any final decision regarding payment for a milestone will be made by the Agreements Officer, in consultation with the ARPA‑H Program Manager.

Teams may propose a milestone structure—including descriptions, objectives, and associated payment amounts—that is logically aligned with the program goals. During negotiation, ARPA‑H may refine, add, or adjust proposed milestones to ensure they are appropriate for payment and consistent with program needs. The final milestone structure and associated payments will be established in the negotiated award.

For the Solution Summary, ARPA-H expects a single, basis of estimate (BOE) that incorporates cost estimations for all phases of the entire program and the amount of federal funds requested, as well as the total project cost including resource sharing, if applicable. For the Solution Pitch, ARPA-H expects a single, consolidated program budget. The costs for all parties should be substantiated by the details provided in the Solution Pitch and cost proposal spreadsheet and narrative.

ARPA-H adheres to HHS salary cap limitations. Salaries should be proposed in accordance with the rate limitation, which may change annually.

Yes, this acceptable if all parties agree, and sponsored work is not duplicative.

Yes, ARPA-H adheres to HHS salary cap limitations. Salaries should be proposed in accordance with the rate limitation, which may change annually.

For the Solution Pitch, ARPA-H expects a single, consolidated program budget. The costs for all parties should be substantiated by the details provided in the cost proposal.

Yes. You are welcome to bring key team members to BoSS Proposers’ Day as long as all members are registered to attend.

The BoSS Proposers’ Day will be held on January 29, 2026, at The Warner Building, 1299 Pennsylvania Ave NW, Washington, DC 20004. The event is hybrid, with both in-person and virtual attendance options. The event is expected to run from 8:30 AM to 5:00 PM Eastern Time (ET). 

A formal agenda will be published prior to the meeting and made available to all registered participants.

• Morning: Registration and welcome, overview presentations by ARPA-H program staff
• Midday: Lunch
• Afternoon: Lightning talks, networking opportunities, and closing remarks
• Post-event: A no-host social gathering will be held at a nearby venue immediately following the conclusion of Proposers’ Day, providing additional opportunities for informal networking and team formation. 

Pre-scheduled sidebars with the BoSS Program Manager and team will also be available.

No hotel group rates have been secured for this event; attendees are responsible for making their own hotel reservations.

During registration for Proposers' Day (link opens in new window), you will be asked if you request to present a lightning talk. Upon request, you will receive a separate email with lightning talk instructions and the template.