CIRCLE Frequently Asked Questions (FAQs)

The only entity that needs to be registered in SAM is the entity that will be awarded the contract from ARPA-H, in other words, the prime awardee.

No. Solution Summaries must be submitted by March 30th at 1pm ET. Late submissions will not be considered for the CIRCLE program.

This is a misreading of the ISO. CIRCLE TA teams may be comprised of as many individuals and entities as are needed to meet all of the program's technical objectives. Teams must include effort to individually address and collectively integrate the three distinct technical areas (TAs) of the program.

The Project Lead (PL) on CIRCLE funded efforts is intended to serve in the role traditionally referred to as "PI" and techncial point of contact (POC) for the funded team. The CIRCLE ISO states that the Team Integrator component of each TA team "must be led by the performing teams’ Project Leads (PLs)". Thus, the Team Integrator component may be a team of individuals, but whether it is the PL alone or a team including the PL, the PL must be the leader and party to whom the ARPA-H Program Manager can contact with regard to the progress the team is making towards milestones and metrics.

Registration in SAM is not required for submission of a solution summary. However, an active SAM registration is required at the time of full proposal submission.

Yes, alterations in the composition of the proposing team between the Solution Summary and the final submitted proposal are allowed, and even encouraged if they strengthen the proposal team and/or are in response to feedback received in an "encourage" feedback letter.

Since organization A and B in this scenario are each writing Type A proposals, the fact that Organization B includes one individual who is from Organization A is immaterial. There is no restriction limiting individuals from one organization from being a member of a team led by a different organization for Type A proposals.

The restrictions on individuals "contributing" to more than one Type A (TA) proposal (CIRCLE ISO section 1.6.1) are not meant to restrict institutions from submitting multiple Type A proposals if they are staffed by different teams. Additionally, as stated in the same section, to avoid conflicts of interest, no institution will be allowed to participate in both a Type A and a Type B award. If an institution submits proposals of both types, ARPA-H will not fund both - both proposals will be reviewed.

Individuals may contribute to more than one Solution Summary. If multiple Solution Summaries including an individual are encouraged, and if such individuals remain on the teams of multiple proposals that ARPA-H wishes to fund, ARPA-H will carefully consider (a) whether such an individual is potentially billing more than 100% effort across the several proposals, (b) whether the work being performed by that individual is duplicative or distinct (ARPA-H will not pay twice for duplicative efforts), and (c) whether the roles of the individual constitute any type of conflict of interest. Individuals from an institution that will be funded to perform as an AP performer (Type B proposal), may be regarded as having a conflict of interest if they are a component of a Technical Area performer team (Type A proposal) led by a separate institution.

We encourage all interested parties to register on the CIRCLE Teaming page, and to look there to see who else may be interested in the CIRCLE program. You may be able to leverage internal communications within your organization to announce your interest in submitting a CIRCLE proposal to find willing collaborators, and to see who else is interested.

It is allowed for distinct teams to implement the same existing sensor devices or assays in their proposals. However, ARPA-H has both an interest in funding a diversity of approaches, and funding efforts that will pursue technological breakthroughs. Thus, separate proposals that both use the same technology and are not developing new advances are less likely to both be funded.

ARPA-H policy for submissions from international proposers is detailed in Section 3.3 of the ISO: "Non-U.S. entities may participate to the extent that such participants comply with any necessary nondisclosure agreements, security regulations, export control laws, and other governing statutes applicable under the circumstances. However, non-U.S. entities are encouraged to collaborate with domestic U.S. entities. In no case will awards be made to entities organized under the laws of a covered foreign country (as defined in section 119C of the National Security Act of 1947 (50 U.S.C. § 3059)); a foreign entity of concern meeting any of the criteria in section 10638(3) of the CHIPS and Science Act of 2022; or an individual that is party to a Malign Foreign Talent Recruitment Program (MFTRP), as defined in Section 10638(4) of the CHIPS and Science Act of 2022. "

Additionally, in Section 1.6.5 of the CIRCLE ISO, covering Commercial Transition, it is mentioned that, "Throughout the program, performers are expected to work towards the goal of transitioning their technological advances into the marketplace for the purpose of delivering improved critical care to the American public". Similarly, in section 5.1 covering evaluation criteria for TA proposals, "The degree to which commercialization plans are complete, realistic and give confidence that the ARPA-H investment will result in transition to publicly available technology for the benefit of American patients." Proposers would thus be wise to justify how their efforts would directly impact American patients. Although not required, one way to address this criterion would be to include American partner or partners in the proposing team.

Section 4.2 of the CIRCLE ISO includes, "All solution summaries submitted in response to this ISO must comply with the content, page, and formatting requirements outlined in Attachment A." Section 4.3 details the requirements for full proposals, including Volume I (Attachments B and C), and Volume 2 (Attachment D), and Volume 3 (Attachments E and F). All attachment instructions, forms and templates can be found on the same SAM.gov page as the CIRCLE ISO.

The CIRCLE ISO does not specify a minimum effort for the Project Lead (PL). However, the allocation of effort among the proposed team to perform the necessary tasks is used in evaluating the proposals. In particular, each Technical Area proposal team is required to include a Team Integrator component (see ISO section 1.5.1), which states, "The Team Integrator component of the CIRCLE program represents and highlights the overarching focus on integrated delivery of both research & development as well as commercialization/transition inherent to the CIRCLE program; this component is expected to play a management role and thus must be led by the performing teams’ Program Leads (PLs)." Thus, in addition to any other activities of the PL, the PL must include explicit effort for leading this Team Integrator activity, and including insufficient overall PL effort might be regarded as a weakness in a proposal.

This policy is detailed in Section 3.2 of the CIRCLE ISO, and incudes, "FFRDCs and U.S. Government entities, including federal Government employees, are not permitted to respond to this ISO as a prime or sub-performer on a proposed performer team."

As indicated in section 1.5.1 of the CIRCLE ISO, the Team Integrator is a component of the TA performer team. The Team integrator "must be led" by the performing teams' Program Leads (PLs). If the proposing team elects to have the Team Integrator component consist of only the PL, that is an option. They may alternatively opt to establish a larger group including and led by the PL.

The CIRCLE program expects to see proposals from complete teams with all the required technical expertise necessary to accomplish the proposed tasks and meet the program's goals. As detailed in section 1.6.1 of the CIRCLE ISO, proposals are expected to be led by one Program Lead under a single prime performer. The proposal may include whatever sub-performers are necessary to constitute a complete and effective team.

The CIRCLE program will fund performers who will develop and validate computational models and interventions that span the whole range of immuno-inflammatory dysregulation that characterizes critical illness. This gamut spans the intertwined innate and adaptive immune responses, and as such encompasses both hyper-inflammation and immunosuppression as well as multiple other intermediate immune states  (For a more complete discussion refer to the Proposers' Day video, beginning at 1:26:55)

The CIRCLE ISO goals include the "rapid and comprehensive assessments of patient immuno-inflammatory biomarkers." Note the use of "immuno-inflammatory." Although the use of existing EHR and real-time available ICU data is encouraged as a component of digital twin model inputs, these by themselves are likely insufficient to address the program's goals.

There is no need to contact the pharmaceutical/biotech company and have them listed as participants. Funds would need to be allocated for the purchase of the respective drugs if needed, or some other clearly stipulated arrangement that ensures access to these drugs is needed.

The CIRCLE program does not proscribe what assay type or types are needed to supply sufficient data for TA2 model success. Proposers should justify that the range of biomarkers they intend to probe will be sufficient to meet the goals of the program in the context of their models. 

The CIRCLE ISO contains this text (Section 1.3 Program Scope): "The primary focus of the CIRCLE program is on critical illness in adults. Due to the differences in the immuno-inflammatory mechanisms between adults and neonates or pediatric populations as well as the difficulty in obtaining sufficient data in these groups, proposers are strongly encouraged to focus on adult populations to strengthen the generalizability if CIRCLE therapeutic targets."

So no, focusing on pediatric populations is not strictly out of scope, but requires significant additional justification that the deliverables from the proposed effort will be generalizable to non-pediatric populations.

There is a preference in the CIRCLE program for the application of FDA approved therapies: (CIRCLE ISO, Section 1.3) "CIRCLE will focus initially on repurposing FDA-approved therapies that can effect immuno-inflammatory reprogramming, ideally with tissue-specific precision. If justified, CIRCLE will support the development of novel immune-modulating approaches as a means of validating specific predictions derived from digital twin models and/or as novel therapeutics." Additionally, Section 1.5.3, under TA3 states: "In the case of non-FDA approved therapies, TA3 performers may engage in activities advancing novel therapeutics to the pre-IND (investigational new drug/device) stage". While not explicitly mandated, any TA3 effort that can be connected to an existing or in-process IND would likely greatly strengthen a proposal.

CIRCLE is focused on critical illness secondary to infection, injury, or chronic disease exacerbation. Some iatrogenic modalities applied in the ICU, e.g., ECMO, while not generally considered causes of critical illness, can worsen organ injury. To the greatest degree possible, these interventions should be accounted for both in silico and in validation studies, though not as causes of critical illness per se.

Focusing on a single organ system is not necessarily out of scope for the CIRCLE program, so long as the effort addresses all of the goals delineated in the CIRCLE ISO. The approach must sense and model the evolving state of the immune system in individual patients, and seek to modulate that trajectory to avoid or mitigate organ damage. The progressive nature of critical illness is a hallmark of this disease, and cannot be ignored. An approach that spares a particular organ system while not mitigating the overall immune cascade that will cause other organs to fail would not be regarded as a suitable outcome for the program.

Proposals covering only one of the CIRCLE TAs are out of scope. TA1 sensor systems must be included within a comprehensive TA1-TA2-TA3 proposal that can produce a workable integrated Measure-Model-Modulate system by the indicated timepoints. The CIRCLE program is not proscriptive with respect to the types of technologies to be applied within complete TA (Type A) proposals, so long as the specific metrics and milestones listed in the CIRCLE ISO can be reached. Proposers with in-development technology should particularly reference the "Technological Readiness" metric.

TA2 is intended to cover the development of Digital Twins (computational models) that process repeated inputs of patient data, and deliver useful information directing therapeutic delivery. If an organ-on-a-chip/organoid can fill this role in an integrated TA proposal that can meet all of CIRCLE's metrics and milestones, than it would be in scope, but most likely in the context of TA3, not TA2.

The CIRCLE program does not proscribe any particular approach for obtaining patient data to feed the desired Digital Twin models, assay selection is entirely proposer-driven.

Proposers are free to include whatever evaluation studies are most cost, time and effort efficient to achieve the goals of the CIRCLE program. Evaluations in human subjects, or any non-human modality are allowable. Note that the CIRCLE ISO (section 1.4) states: " To the greatest extent practical, data should come from patients as opposed to animal models (although the use of clinically realistic animal models for verification and validation of model predictions, for the evaluation of therapeutics, and the safety and effectiveness of new sampling methods is appropriate, as are data obtained from other experimental systems if justified).", and "Proposed interventions should be tested under the most patient-realistic conditions practical, whether in simulations, large animal/non-human primate trials, and/or human studies." Section 1.5.2 states, for TA3, "If novel therapeutic approaches are used as a means of validating model predictions, performers will clearly establish the feasibility of the methods for testing their effectiveness and specificity for the desired target(s) through appropriate in vitro, ex vivo/micro-physiological devices, and/or animal studies. " Section 1.6 states that in Phase II of the program, "Validation of computational model simulations and predictions may involve either animal models or human subjects, or both." All studies in animals or humans must be supported by the appropriate ethical board certifications and follow accepted best-practices (see Section 6.3.4, and 6.3.5).

The CIRCLE ISO does not specify that proposals must address at least two causes of inflammation-mediated critical illness. Rather, the program requires that the focus not be "relevant to only one specific cause of critical illness, e.g., sepsis" (section 1.3). In other words, the solutions provided by CIRCLE performers are expected to be generalizable to multiple initiating causes, acting on the underlying immuno-inflammatory processes of critical illness, and not solely address specific initiating causes. Any validation in pre-clinical animal or other models in the context of TA3 should at the very minimum validate specific predictions or assumptions of the digital twin models with regards to the underlying immuno-inflammatory processes of critical illness. If the predictions of the models are specific to a particular initiating stimulus for critical illness then it is likely that the validation strategy would need to encompass multiple etiologies of critical illness to demonstrate model generalizability.

Non-public data utilized by AP2 for the purposes of evaluation (IV&V) of TA performer models need not be made public during or after the program. Such data may need to be provided to TA performers for the purposes of refining their models, but like all such data, sharing and use outside the program will be governed by ARPA-H, contractual, and inter-performer (Associate Performer Agreement, APA) restrictions. 

AP1 will incorporate whatever data is generated by the TA teams into a common CIRCLE database for the use by all TA teams. AP3 will organize and facilitate platform clinical trials. These trials will generate data, but the collection of those data and their provision to the AP1 performer is the responsibility of the TA teams. From the perspective of the TA teams, TA1 will develop the methods and carry out studies that generate data for the training, calibration, and developement of TA2 digital twin models. These TA1-developed methods (including near-real-time data streams) will be incorporated into TA3-led and AP3-administered clinical trials.

Biomarker assessment will be necessary for the development of the digital twins in Phase 1 of the CIRCLE program, so any new biomarkers, or other means of obtaining the biomarkers in question need to be ready in a timely fashion so as to meet the required milestones. It is up to the proposer team to assess the feasibility of incorporating novel biomarkers in that context. (For a more complete discussion refer to the Proposers' Day video, beginning at 1:09:42). 

TA1 is expected to obtain data that are of the appropriate scope for the needs of the TA2 digital twin models. ARPA-H will not be paying for broad data set collection that is not directly connected to the needs of the modeling to be done under the CIRCLE program. (For a more complete discussion refer to the Proposers' Day video, beginning at 1:18:24)

No, this is not a requirement. However, teams are advised to make and justify the strongest case possible that all program milestones can be met. Teams that have no preliminary data, systems, devices, models, etc. will have to make a stronger case that they will be successful relative to teams that have such preliminary achievements.

CIRCLE is focused on the ICU time period, but data available across the whole of patients' journey before, during and after an ICU admission are relevant to the modeling efforts of the CIRCLE program. TA1 data collection should therefore be primarily focused on the ICU time frame, but data on pre- and post-ICU time periods can be used to train models in order to gain insights into means of reducing the incidence of critical illness and to predict the impact of therapies administered in the ICU at later time points post-discharge.

The TRL metrics indicated in Table 2 of the CIRCLE ISO are minimum levels. TA1 technologies that surpass these metrics  will be better positioned to serve data to the TA2 modeling efforts. No matter what the stage of technological development of these sensors, successful proposals will detail how data will be collected/generated to achieve the early stages of Digital Twin development (such as calibration). Complete reliance on a technology that is not sufficiently developed to generate useful data to meet the TA2 milestones is not advisable.

The CIRCLE program does not require the application of any specific type of mechanistic modeling approach or framework. Any approach that captures, for example, the biological relationships, mechanisms, pathways, interactions, dynamics, kinetics, etc. of real biological systems in order to achieve the stated goals of the CIRCLE program will be preferred to methods that are solely data-driven.

CIRCLE is focused on the use of immune system digital twins that are mechanistic in nature and calibrated to data, but not based only on correlations among data elements. The use of machine learning (ML) methods is not prohibited if it supports the generation or use of those mechanistic digital twins.  Proposals that are limited to the use of ML methods alone will be deemed out of scope.

The question seems to conflate the distinct roles of TA3 and AP3. TA3 is tasked with validation of TA2 digital twin predictions, and may do so using a clinical study of any sort (or using appropriate pre-clinical experimental paradigms). AP3 will focus solely on platform/adaptive clinical trials to both validate any studies by TA3 and also to compare therapeutic and/or diagnostic strategies among TA teams. During the first three months, and throughout the period of performance, TA teams will work closely with the AP3 performer to work out the details of clinical trials to maximize the effectiveness of that effort. 

The milestones for the CIRCLE program are indicated in Table 1 (and elaborated in Appendix A) of the ISO. These include completion of a platform trial assessment of selected control point modulations and initiating a first-in-human adaptive clinical trial of the [performer's] integrated CIRCLE system, in concert with the AP3 performer, by 4.5 years after award.

The detailed description of this metric is given in Appendix A (CIRCLE ISO, p.56): "Performers will collect biomarker data following the successful modulation of control points for comparison with levels predicted by TA2 models. The biomarkers to be tracked will be the set of those modeled in TA2. AP2 and AP3 will develop success criteria for these validation studies. Studies will be carried out in a series of experimental systems of increasing clinical relevance." The intent of this metric is ensure that the performers are progressing towards the overall goal of the program of reducing ICU stay duration. In the ideal case this would be shown directly in ICU-realistic animal models at Y4, but potentially, extrapolation of observed effects on surrogate animal model biomarkers through modeling or simulation may be acceptable. In short, the metric is appropriately named "Control Point Validation", not "ICU stay reduction"; studies that provide the desired validation are acceptable. Furthermore, during the first three months of the program, all performers will collaborate in a "Metrics Preparation Report" (see CIRCLE ISO, Appendix A, p.49) that may result in the revision of metrics parameters.

The commercialization plan of Type A (TA) proposals will of necessity have to be written without the benefit of any AP performer input. Following initiation of funding, the AP performers may provide some consultative support, but as they are tasked with IV&V functions as well as accelerating the performance of all TA performers, they will not have a direct role in commercialization planning by each TA team.

The Regulatory Submission milestone at 4.5 years is described in Appendix A as, "Performer teams will make documentary submissions to regulatory bodies appropriate to the level of development for each TA technology product, and each combined partial and complete integrated system instance." The level of technological development must be sufficient to achieve other milestones, such as those for carrying out Platform Trials on specific interventions, and the integrated system.

AP1's primary role is in providing a database for the use of the TA2 model builders, assessing and verifying data quality, and incorporating datasets into that database. TA performers are responsible for all software and hardware infrastructure for handling the streaming of the patient data they are generating into the digital twin models when they are implemented as integrated systems. TA performers are responsible for delivering datasets to AP1 for incorporation into the database. 

There will be only three AP performers total in the CIRCLE program, one each for AP1, AP2 and AP3. Each AP performer will work with all TA performers, focusing on the corresponding TA. Thus, each TA performer will work will all three AP performers. 

TA1 is the primary entity within each TA team that is charged with obtaining data of relevance to TA2 models. The role of AP1 is to compile and make accessible a compilation of data useful for all of the TA2 digital twin modeling efforts, which includes validation and incorporation of TA performer data. The choice of data to be input into TA performers' digital twins in entirely up to those TA performers, and can include any appropriate external data source. Proposers are advised to consult the relevant section (1.7.3) of the CIRCLE ISO on Data Collection and Sharing Requirements.

Proposers may submit separate proposals for different APs (AP1, AP2, or AP3), but those propsals should be separate, complete solutions encompassing all of the required components of each of those APs. If you have data products to offer that complement an AP1 proposal, but do not have the database expertise to propose a stand-alone AP1 proposal yourself, you might want to consider teaming with another AP1 proposer. (For a more complete discussion refer to the Proposers' Day video, beginning at 1:30:07)

In the case of AP3 performers who are providing access to platform clinical trials through consortia, consortium members (who are not the prime performer for the AP3 effort) may still be TA performers (via Type A proposals), so long as they do not participate in CIRCLE AP3-related consortium trials. This language has been added to the ISO and will appear in Amendment 2.

The inclusion of the phrase, "foundation/large language models" was part of a list of examples of possible data products AP1 might provide "for performer use to enhance their research productivity" and also potentially to the broader critical illness community. AP1 proposals may offer any type of data product that would provide this capability. As such, AP1 proposers may choose to leverage existing foundation models that are further trained on CIRCLE datasets or generate new models, but must justify their choices in the context of AP1 milestones and deliverables. 

AP1's primary role, as detailed in section 1.6.4 of the CIRCLE ISO, is to compile data from the TA performers and from external sources into a common database, and provide access to that database to all TA performers. AP1 will have no role in conducting clinical data collection.

Type A (Technical Area) proposals must be integrated, stand-alone TA1/TA2/TA3 teams that incorporate data collection, modeling and pre-clinical/clinical evaluation. These teams are expected to be capable of meeting all CIRCLE metrics and milestones. The AP1 performer is responsible for incorporating all data from the TA teams into a CIRCLE-wide database that is available to all performers. AP1 is responsible for providing additional datasets, which will be made available to performers for use. The CIRCLE program will not be requiring a unity of approach across different TA teams, nor will it specify any particular evaluation platforms.

AP2 will not be creating a specification to which TA2 performers must adhere. However AP2 performers are responsible for coordinating TA2 performer compliance with "standard ontologies and nomenclatures for objects in their models and [compliance] with relevant regulatory standards and best practices" as indicated in the CIRCLE ISO section 1.7.4. Ideally, the AP2 performer will have the capabilities to evaluate and test all TA2 products fairly within the AP2 performer's framework (which is also expected to ultimately be capable of supporting regulatory submissions based on digital twin models developed by TA2 performers), and thereby to compare them to each other to the greatest extent possible. Capabilities to integrate multiple TA2 products into a single system would be looked upon as a strength of an AP2 proposal. AP2 required tasks are detailed in the CIRCLE ISO, Section 1.6.4.

AP performers will only have access to TA performers work products for the expressed purposes of sharing data within the team, and testing, evaluating, validating and comparing work products. All access by AP providers to TA performers' data and work products are governed by the indicated text in Section 1.6.4. As indicated in Section 1.4, data generated by performers as part of the CIRCLE program will be incorporated (by the AP1 performer) into a common database "that will ultimately become a public resource". The AP2 performer will investigate the possibility of creating "meta" digital twins by integrating digital twin models from multiple CIRCLE performers. Policies and process for handling data and IP rights are discussed in section 1.7.3 and 1.7.6 of the CIRCLE ISO.

No, ARPA-H does adhere to the HHS salary cap limitations. Salaries should be proposed in accordance with the rate limitation.

The ROM Budget tables in the solution summary are meant to capture the roll up number. All the non-Prime team member costs should roll up into the sub proposer line.  Separating them in the table is not necessary.

For proposal purposes, assume a maximum of 6 TA teams.

No, AP performers are not required or expected to participate in commercialization activities directly, but will be supporting the TA teams in their efforts. It is permitted for AP teams to optionally include commercialization plans and ROM budget commercialization cost details if the proposer feels that this is relevant to the proposed work.

Donated devices may be included as a component of performers' share of funding. Proposers must make clear the source of such donations. To count towards the commercialization-related funding requirements, donated devices or other in-kind contributions must be contributed by commercialization partners, and have a commercialization-related purpose.

ARPA-H expects proposers to have a reasonable justification demonstrating that budget items in this category are genuinely commercialization-related. Reasonable examples of such activities include regulatory consulting, scale-up of research-grade devices for manufacturing, market planning, and end-user adoption studies. Research and Development activities should not  be included in the commercialization costs category.

Yes, the AP3 performer is responsible for the costs associated with the trial platform (the patients, the access, the overhead, the gereric SOPs, etc.), while the TA team is responsible for the specifications (the interventions, the specialized monitoring and staff, etc.)

The AP3 performer will provide access and expertise related to patient recruitment, and will be responsible for the costs of patient recruitment for adaptive platform clinical trials for the CIRCLE program as a whole. Regardless of whether ultimately this work is organized as a single overarching trial or separate parallel ones, the TA performer can expect the AP3 performer to defray the costs of the trial related to patient recruitment and overhead, but not the specific aspects of the TA performer's intervention (such as drug and/or device costs). 

For the Solution Summary ROM budget tables, only include actual commercialization-related activities for the entire proposing team. There is no need to break this down by the individual components within the team for this ROM table. During Phase 1, which is primarily focused on R&D activities, we would not expect significant commercialization activities, while during Phases 2 and 3, regulatory, manufacturing , scale-up and market research activities would be more likely to fall into the commercialization bucket. 

The point we are making is that CIRCLE is focused on those host immuno-inflammatory processes that manifest in critical illness regardless of initiating stimulus, since those are therapeutic targets likeliest to prove of benefit to the broadest set of critically ill patients. Any validation studies in animals should be established with that mindset. It is not necessary to have a completely separate second animal model to demonstrate a broad effect, one can bridge the gap with appropriate computational simulations, ex vivo data, data from the AP1 dataset, etc.

As indicated in the CIRCLE ISO Milestones table for both TA3 and AP3, this milestone is a collaborative effort between the TA and AP3 performers. The AP3 performer is expected to provide the patients and framework for the platform trials, while the TA performer must provide all of the specific required equipment, materials and supplies, and whatever personnel are necessary. The expectation that the AP3 performer is responsible for budgeting for the platform trials (instead of just facilitating the TA performers' participation) is not explicit in the originally posted version of the CIRCLE ISO. This will be made explicit in the next Amendment.

No.  In addition to Federal Agencies being restricted from contributing to proposals as a prime or sub-performer (CIRCLE ISO, Section 3.2), funding received from other government awards is not an allowable as a cost share source. 

There are no specific budget ceilings or ranges per TA. Proposers should develop TDDs to accomplish all ISO requirements. Further, proposers should calculate budgets based on successfully accomplishing the TDD using the proposed technical approach; considering cost share as appropriate.

While the Government cannot tell you exactly how to price your proposal, it is important that your proposed budget is realistic and thorough, covering all aspects needed to achieve your technical and management goals. Your budget narrative should include enough explanation and supporting information to justify the costs listed in your budget spreadsheet.

ARPA-H will encourage or discourage Solution Summaries based on the whole proposing team, but may indicate that one or the other of the TAs are strong or weak components. ARPA-H will not be involved in match-making or reshuffling team composition. However, teams may voluntarily add, drop, or change components in the process of finalizing their proposals. (For a more complete discussion refer to the Proposers' Day video, beginning at 2:26:13) 

No, each Solution Summary will be evaluated on its own merit, and it will be left up to each proposing institution whether to pursue each encouraged Solution Summary with a full proposal. (For a more complete discussion refer to the Proposers' Day video, beginning at 2:29:50)

Solution Summary determinations to encourage or discourage proposals will not make comparisons among them at the level of individual team member composition. The feedback will not include direction on how to resolve potential conflicts should multiple full proposals be selected for funding. If the CIRCLE program desires to fund multiple proposals containing the same individuals or entities, deconfliction will occur at the point at which contracts are negotiated. The CIRCLE program has an expressed desire to fund a diversity of approaches, and may use overlaps and similarities of approach as a rationale for not offering funding to multiple proposals with noted similarity.

Section 4.2 of the CIRCLE ISO states, "ARPA-H will provide written feedback to all solution summary submissions. Feedback at a minimum will provide an encourage or discourage recommendation in submitting a proposal submission. Feedback will be sent to the administrative and technical points of contact noted on the solution summary cover sheet." Submitted full proposals will go directly to formal review. Proposals that are selected for potential funding will enter into a contract negotiations phase which will refine the final statement of work (Task Description Document).

Thank you for identifying that typo. You are correct that the TA2 metrics begin with "Model Response Time". This will be corrected in the next Amendment of the CIRCLE ISO.

We apologize for the poor separation of the text between columns in Table 1. The correct parsing of this Milestone is:
 Milestone: "Demonstrate the possibility of 15%, 25% reduction in ICU stay (directly in pre-clinical model and/or simulation)" 
 Deadline: "3.5, 4.5 years"
This means that we expect to see 15% reduction demonstrated at 3.5 years, and 25% reduction demonstrated by 4.5 years. "Directly" means in a real pre-clinical model, as opposed to a simulation, which we would regard in contrast as "Indirectly".

Unfortunately, we are unable to distribute a list of all the individuals who registered for or attended the CIRCLE Proposers' Day. However, all parties who are interested in sharing their contact information are encouraged to participate on the CIRCLE teaming profiles page. Very likely, the people you are looking for can be found there.

Learning about the CIRCLE program, asking questions and connecting with potential collaborators are the primary goals of the CIRCLE Proposers' Day. To learn more about the details of the Proposers' Day event, please consult the CIRCLE Proposers' Day Special Notice on SAM.gov

In-person participants have the opportunity to present a poster for other in-person participants to view, and all interested parties are encouraged to post a Teaming Profile to facilitate collaboration in crafting the best teams to respond to the CIRCLE ISO.

There will be no Sidebars at this event.