ARPA-H-SOL-26-165_COSMOS_QA_Set_2_2026-09-25.pdf

Comprehensive Organ System Modeling in Outer Space (COSMOS)

ARPA-H-SOL-26-165

Questions and Answers: 9/25/2026

Disclaimer: This Q&A is provided for informational purposes only and does not amend the solicitation.

QUESTION

NUMBER

Question Answer

1 What is ARPA-H's expectation regarding proposal coordination and award between technical performer teams and CSP providers?

We are only answering questions about technical performers solicited by the

COSMOS ISO. Work proposed specific to CSP tasks are out of scope for this ISO.

2 What is the process and expected timeline for selecting the CSPs?

We are only answering questions about technical performers solicited by the

COSMOS ISO. Work proposed specific to CSP tasks are out of scope for this ISO.

3 Will there be a Proposers' Day? There is no Proposers' Day for COSMOS.

The full proposal deadline is October 7, 2026 at 2pm ET.

4 Is there a Not to Exceed Value

(NTE) for awards? What is the expected award range per performer team?

Proposers should submit a cost proposal that reflects funds needed to achieve the technical goals and objectives of the solicitation. The language ('program'

'initiative' etc) should not be interpreted as an inferred budgetary bracket or limit.

5 What is the Admin and National Policy Document expected submission date?

The Admin and National Policy Document expected submission date coincides with the full proposal date, which is October 7, 2026 at 2pm ET.

6 This looks like a lot of work for one lab and my team is focused on other diseases of these organs. How can I apply?

In keeping with the ARPA-H model, we anticipate that many proposers will need to team with other researchers, teams, entities, companies, etc. to propose. Even if your focus is on a different set of diseases, it is more than feasible to propose to COSMOS if you are the expert in manufacturing a given MPS set from healthy donors relevant to the Program.

7 Do we need to propose MPS and organoids for Phase I, Phase II or both?

It is strongly recommended that you read and carefully review the ISO in its entirety. It contains all mission parameters required for COSMOS. Requirements for MPSs and organoids across Phase I and Phase II are clearly spelled out in the technical sections of the ISO.

8 Are we allowed to submit multiple proposals per institution?

Yes. There is no limit to proposals per institution. However, a PI can only be the lead PI on a single proposal to a given funding initiative, and must have 15-20% LOE to support any project where they are the prime proposer 9 Our PI cannot commit more than 15-20% effort to this project. Are we still able to submit a proposal? Can we instead have multiple Co-PIs leading a team rather than one PI? Should our Project Manager be at 100% FTE?

Yes. While 0.5 FTE is ideal, ARPA-H will accept 15-20% FTE for the lead PI provided there's a clear justification and plan demonstrating the PI's direct, committed involvement in the project. It is also expected that a 100% FTE Project Manager is on staff as a member of the key personnel for each proposing team. ARPA-

H prefers to have two direct lines of responsibility on each proposed project: a

PI and a Project Manager. This structure allows direct accountability and alignment with the ARPA-H team. ARPA-H will not accept a plan with multiple Co-PIs or a senior scientist serving in lieu of a PI.

10 Should technical teams collaborate with commercial service providers (hardware or flight) for the proposal?

No. Work proposed specific to CSP tasks (hardware or flight) are out of scope for this

ISO. Proposers to this ISO must only propose work specific to the technical metrics and milestones proposed in the

ISO.

11 Our prior efforts typically included graduate students. Are we allowed to have graduate students working on this project?

No. ARPA-H does not fund training grants.

12 1. Is there flexibility in the mandatory experimental design requirements with regard to MPS, donor, or organoid number?

2. What is the required timing for the number of prepared chips/organoids for a given launch?

3. What are the imaging parameters for the Terrestrial/LEO Twin Study?

4. How long will the autonomous organoids/MPS in LEO need to run without human interaction?

5. Does CSP-hardware require a specific chip design or manufacturer for fluidic interface?

1. The Required experimental design is laid out in the ISO. No fewer than 50 is acceptable for the Terrestrial-Only Study.

No fewer than 32 human donors are acceptable for the Terrestrial/LEO Twin Study.

2. Simultaneous preparation of 50% of the total experimentally-required

MPSs/organoids is required in order to deliver and load them into spacecraft for launch per the ISO schedule.

3. Imaging via optically clear MPS/organoid carriers is intended to be used to track visual indicators of the health of the

MPSs/organoids throughout both the Terrestrial and LEO arms of the Twin study.

However, the Hardware CSP is primarily responsible for engineering the imaging aspects of the Twin study in collaboration with awarded technical teams.

4. Final logistics will be resolved in collaboration with the selected CSPs.

Performers should plan for 4 weeks of autonomous flight and may opt to add a few additional days as a logistical buffer before and after flight.

5. At this point, all options will be considered provided there is sufficient justification

13 Is the project using the current NIH salary cap of $228,000?

The Cost Proposal Template and the ISO do not stipulate a salary cap. Proposals will be evaluated to determine the reasonableness or value of the proposed price/cost to accomplish the work in the Technical Description Document (TDD).

14 1. Is 60 ±2 years or 65 ±2 years the correct age bracket?

2. Table 1 and Figure 2 disagree. Please clarify the experimental design requirements for each team regarding the Terrestrial Only Study and the Terrestrial/LEO

Twin Study.

3. How does ARPA-H define a single MPS versus a single organoid? If organoids provide part of a more complex, multi-cellular structure, is the final product considered an organoid or an MPS?

4. May each independently addressable well or tissue chamber within a multiwell microfluidic platform count as one MPS, or must each MPS be housed in a separate device with independent fluidic control?

5. Can multiple donor-specific

MPSs be incorprated into a single autonomous, flight compatible array?

1. 60 +/- 2 years is correct

2. See Amendment 02 - The figure and tables have been corrected and reconciled (Table 1, Figure 2, Sections 3.2, 4.1 (4.1.2, 4.1.3, 4.1.4).

3. We recognize that the term MPS can encompass a broad range of complex multicellular cell culture models.

For COSMOS, "MPS" refers to an "organ on a chip" - a complex biological system growing in a biomechanical environment which includes a required microfluidics component and leverages microfabricated device components. These may include scaffolds or cells to form membranes, mechanical pressure/stretching, etc., to guide cells into a specific 3D architecture.

"MPS" should recapitulate active fluid passage through or across the organized cells in a way that recapitulates some part of the organ's function. The organ-function components of an MPS must be derived from a donor fitting into a specific age bracket.

Any other complex multicellular cell collective, including those that grow on an artificial scaffold to achieve a specific 3D shape, that does NOT require microfluidics and/or microfabricated device components will be considered organoids.

4. For COSMOS "MPS" refers to an "organ on a chip" - a complex biological system growing in a biomechanical environment which includes a required microfluidics component and leverages microfabricated device components. These may include scaffolds or cells to form membranes, mechanical pressure/stretching, etc., to guide cells into a specific 3D architecture.

"MPS" should recapitulate active fluid passage through or across the organized cells in a way that recapitulates some part of the organ's function. If this definition can be achieved in mutiple chambers on a single carrier, that could be acceptable provided sufficient justification is provided.

5. Yes, provided each MPS meets the

COSMOS definition of an MPS, as above.

15 Add to Q14 question as component 4, 5

Must each MPS be housed in an individual 'chip' or other microfuidically isolated carrier, or can each individual adressable well/tissue chamber on a multiwell platform be counted as individual MPS?

Can multiple donor-specific MPS be incorprated into a single autonomous, flight compatible array?

Answered in Q14

16 May the 32 donors per age bracket used in the LEO or terrestrial twin study be a subset of the 51 donors per age bracket used in the supplemental terrestrial-only study, or must these two cohorts consist of independent donors?

The 32 donors may be a subset, provided that a sufficient numer of full MPS can be derived froma tissue sample. If employing this overlap model, any individual donor sample would need sufficient viable cells to generate six full "organ on a chip" type MPS. However, ARPA-H recommends individual donor pools.

17 How does ARPA-H define healthy tissue? Are tissues collected by surgical resection for a benign condition or pathology eligible?

For COSMOS, healthy tissue is that free of defect or pathology, including benign pathology. If a proposer disagrees with the definition provided, substantial and compelling justification must be included.

18 May performers use appropriately consented, previously collected tissue, cryopreserved primary cells, or established patient-derived organoid and stromal-cell banks, provided that donor age at collection, clinical metadata, tissue histology, and sample provenance are documented and the resulting MPS meets all required fidelity and functional criteria?

Yes. Please provide sufficient substantiation to clearly demonstrate all protocols achieve the goals of the ISO and comply with HSR guidelines.

19 I represent a Hardware CSP, and proposer teams have reached out to inquire about my company acting as the

COSMOS CSP. How should I advise them?

Work proposed specific to CSP tasks are out of scope for this ISO.We are only answering questions about technical performers solicited by the COSMOS ISO.

20 Can a Principle Investigator submit a full proposal? If the PI can submit, do they need to be registered individually with SAM.gov, or is that only required of their home institution?

All responsible sources capable of satisfying the Government’s needs may submit a proposal to this ISO. Proposers are encouraged to carefully read Section 8.3, "System for Award Management (SAM)", for details.

21 Which parties to the proposal must submit biosketches, in what format and where should they be included?

Biosketches, Current & Pending Support, and Collaborators & Other Affiliations

(COA) materials must all be submitted and included under Attachment E. See

Sections 1 and 4 of Attachment E for specific guidance.

22 Must all Key Peronnel (KP) be named at the time of proposal?

It is acceptable to list 'to be named' personnel at the time of proposal.

However, due to the requirement for research security review as outlined in

Attachment E_COSMOS Administrative and National Policy Requirements.docx , no

KP may begin work until screening is complete and ARPA-H has accepted the individual.

23 Are a Phase II technical and management plan and a Phase II cost proposal required at the time of submission?

Proposals should include a high level description of how the proposer would approach Phase II based on the requirements oulined in the ISO. The same level of technical detail is NOT required for Phase II as is required for Phase I. Phase II budget estimate is required.

24 Are teams required to submit solution summaries? When are full proposals due?

There will be no solution summaries for COSMOS. The full proposal deadline is

October 7, 2026 at 2pm ET.