BREATHE Questions & Answers

Yes, an organization/company/individual can be on multiple proposals. There is no limit on the number of teams. 

Yes, UARCs can propose to the BREATHE solicitation as long as the UARC does not have specific non-compete verbiage within their sponsor agreement. 

Proposals may include multiple partners for each individual TA.

Each proposal must address all three technical areas. 

The draft Program Solicitation states that the prime performer can propose Government Entities as a sub-performer. Government Entities cannot be the prime performer. However, the final BREATHE solicitation, once posted, will limit Government entities' involvement to TA 3 ONLY. ARPA-H anticipates posting the final BREATHE solicitation in June, and it will be available on the BREATHE Program page. Please review the eligibility information section of the final BREATHE solicitation once posted.  

As stated in the draft Program Solicitation, ARPA-H will prioritize awards to entities (organization and/or individuals) that will conduct funded work in the United States. However, 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. See the Draft Program Solicitation, specifically the section on Eligibility Information, for additional details. 

There is a form that is provided/to be utilized for completing the teaming profile (see https://arpa-h.gov/research-and-funding/programs/breathe/teaming). 

ARPA-H will be responsible for outreach and will provide guidance to performers on messaging about BREATHE. Proposals do not need to include community engagement research or similar.

A performer can submit a Solution Summary and/or proposal as one organization if the entity can address all Phases and TAs as outlined in the BREATHE program solicitation.

Applicants are encouraged to present a Triple Bottom Line ROI analysis. Present the purely economic ROI showing profits from the point of view of the building owner, as well as ROI numbers that include the environmental and health effects. Health benefits should be monetized using QALY or DALY values, as described in either the HHS Guidelines for Regulatory Impact Analysis or the Reference Case Guidelines for Benefit-Cost Analysis. Disability weights for health conditions can be found here.

Costs should include all capital outlays, consumables, and energy costs, the expected net present value of lifecycle costs including disposal costs, the time cost of maintenance, and also the time cost to management of contracting, monitoring, and verification of performance. The social cost of carbon, including embodied carbon, should be included in the Environmental bottom line or ROI calculation. All costs imposed on third parties, such as the time cost of completing surveys if survey feedback is part of a verification or control system, should also be included in the Social bottom line.

Please visit the BREATHE website for the latest information on the program (https://arpa-h.gov/research-and-funding/programs/breathe). The BREATHE website provides publicly accessible program updates, events, materials (event recordings, slides, etc.) as they become available, Teaming Profiles, and Q&As.

It is up to the proposing team to decide on their team's structure. The director or project lead can be a lead on a Technical Area (TA), in which case the proposing team may submit their resume. If the director or project lead is not the lead on a TA, then their expertise may be summarized in the “Team Organization and Capabilities” section of the Solution Summary rather than submitting a resume.

Yes. Please see the BREATHE teaming profiles page (https://arpa-h.gov/research-and-funding/programs/breathe/teaming) to post information about your individual and/or organizational capabilities. You can also review information from other individuals and organizations. We also recommend reviewing the lightning talks from Proposers’ Day which will be posted to the BREATHE program web page. Two Matchmaking webinars were also hosted by the BREATHE Team on May 22nd and 29th to facilitate teaming through additional lightning talks. The webinars can be viewed on the BREATHE program webpage as they become available. 

Proposers may choose any building type, but as stated in the solicitation, the building type selected should allow exposure incidence to be statistically linked with in-building exposure to health outcomes. The solicitation notes that proposers should document any Government furnished information, equipment and/or facility assumptions within proposal submissions that would be helpful during the BREATHE period of performance.

No, the final solicitation is not anticipated to include this information. ARPA-H will coordinate with selected performers on IV&V-related requirements. 

ARPA-H anticipates that selection letters will be sent in early Fall 2024. Negotiations with selected Performers will then commence with awards targeted in February 2025. The period of performance will commence once negotiations have concluded, and Agreements have been awarded.

Where performers conclude that Government involvement or support will be necessary to overcome certain barriers, proposers should identify, with as much specificity as possible, what support will be needed. To the extent the concern relates to the disclosure of information and data about the study and its location, such information, along with all data, will be controlled in accordance with the agreement and is negotiable. Health Data Protection and Privacy considerations and guidelines will be detailed in the final BREATHE solicitation. 

See the solution summary posting on SAM.gov, including the relevant attached documents, for solution summary formatting requirements (https://sam.gov/opp/c94bc3e5bcbe49f9b940e4fa0b268c12/view). See the solicitation posting on SAM.gov, including the relevant attached documents, for proposal formatting requirements (https://sam.gov/opp/df54fbac13dd4af88ef0ef2d4ce93d19/view). 

Yes.

Yes, you can update your teaming profile (if necessary) by emailing BREATHE@arpa-h.gov with the subject line: "Teaming Profile Update.”

Hardware developed for this program should comply with all federal requirements and must align with the BREATHE Program goals. However, the Build America Buy America Act is applicable to funding for infrastructure projects (e.g., roads, harbors, buildings), and the BREATHE program is not providing funding for infrastructure projects. 

No, the solicitation does not require performers to establish an advisory board. 

The team may be comprised of a Prime performer and various sub-awardees. The Prime performer/entity will be the one who enters into the Agreement with ARPA-H. The sub awardees all contribute towards the goals and objectives as stated in the scope document negotiated with ARPA-H once selected. However, all tasks are the responsibility of the Prime performer/entity. The Prime performer/entity will work to ensure that the BREATHE program metrics are met, collectively by the overall team. 

The BREATHE team has received a significant number of teaming profiles since the Proposers’ Day event on May 2nd. We are actively updating the teaming profiles periodically throughout the week.

In the interest of fairness to all proposers, the BREATHE team is unable to schedule any individual calls or meetings. Submitting a Solution Summary is also a mechanism to receive feedback on a proposed approach. 

Solution summaries do not need to include a description of resource sharing – see the Solution Summary Template provided within ARPA-H-SN-24-108. 

For proposals, please see the language on resource sharing included in Section 1.3.4 of the final Solicitation. 

As stated in the Solicitation (Section 1.3), the inclusion of resource sharing will factor into the Government’s option exercise decision at the conclusion of each Phase.

Organizations can be on multiple teams, and the same entity can submit more than one proposal (as the Prime lead performer) if the technical solutions are separate and distinct. If an entity is proposed on multiple proposers’ teams as a sub-awardee and is part of multiple successful teams (as potential awardees), ARPA-H will negotiate and award individual Agreements with the prime proposer, and sub-awardees will receive funding through their contractual sub-award with the prime, under each individual award. As a sub-awardee performing on multiple teams, you will receive funding based on the number of sub-awards that you have. Thus, you must be able to perform under each team that you are a part of. Ultimately, proposers must consider, when deciding how to team and propose, what makes the most sense from a technical and business standpoint. Proposers must consider the most cost-effective way to bring their expertise to the program.

Yes.

Total funding or anticipated size of each award will not be provided. As stated within the BREATHE Solicitation, multiple awards are anticipated. The number of awards selected will depend on the quality of proposals received and the availability of funds.

There is no specific template for the one-page resumes. Proposers are welcome to provide any detailed information on their resumes that will support their capabilities along with their solution summary and/or proposal submissions.

The submission of solution summaries and proposals should be done by the entity that will serve as the prime organization for the overall proposed effort. There is not a preference of the type of organization that should submit a solution summary or proposal. 

The cost estimates provided at the Solution Summary phase are top level estimates of the resources needed to complete the proposed technical approach. The budget will naturally be refined and adjusted as more detailed planning takes place in preparation for the final proposal. 

Proposers should propose a profit objective that is commensurate with the research effort from a technical risk/management perspective.

All signatures and certifications should be completed by the prime/lead institutions, however, please take note of the instructions. Several questions request information regarding both prime/sub-awardee(s). Please note although all signatures would be requested from the prime it would be the responsibility of the prime/lead institution to confirm their sub-awardee(s) have all necessary certifications in place prior to award. 

The PI and other key personnel should list both foreign and domestic affiliations and employment, including affiliations with foreign entities and governments. This includes titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).

Per the final program solicitation for BREATHE, resource sharing is no longer required in Phase II and III of the program, but resource sharing is strongly encouraged. There are no specific recommendations for resource share percentages in the final program solicitation (See Section 1.3.4 and 4.3 (b) of the BREATHE solicitation). 

Yes, the HHS salary cap applies to all proposals submitted to the BREATHE solicitation. 

See the instructions provided within Attachment 1, Volume 2, Price spreadsheet, specifically within the General Tab regarding fully burdened costs (visibility into indirect/costs, as applicable is not needed or requested). Please note that the proposed profit should not be included in the fully burdened rate. 

The total proposed amount should align with the proposed technical approach and the Price Volume template (Attachment 1, Volume 2) requests narrative descriptions to support the proposed costs detailed within the price spreadsheet. It is up to the Proposer to propose an amount commensurate with the technical solution put forth.

ARPA-H is not involved in creating or implementing policy or regulations, nor is ARPA-H specifically affiliated with standards organizations. However, data generated during the BREATHE program may help inform standards development organizations.

Only one resume per key personnel per TA should be included in addition to the resume of the principal investigator, meaning 4 resumes in total should be submitted (see Technical and Management Template, Attachment 1, Volume 1 to the BREATHE Solicitation).

The allocation of resources for functional roles that cross all TAs is at the discretion of the proposers. Note that only 4 resumes in total should be submitted – one resume per key personnel per TA in addition to the resume of the principal investigator. Cross-cutting functional roles may be highlighted in any of these resumes depending on the personnel's expertise.

As stated within Attachment 1, Volume 3, Administrative & National Policy Requirements, paragraph 3, Individual Conflict of Interest and Conflict of Commitment Disclosure, paragraph (a)(iv)  current and pending support/Other support should be provided for PIs and other senior/key personnel that will serve as prime and sub-awardees. Please review 3(a)(iv).

No, Volume 3 was not amended. Only Volume 1: Technical and Management was amended. See Amendment 2 to ARPA-H-SOL-24-107 which clarified this (posted on August 2, 2024).

Subawardee and subcontractor are used interchangeably. 

Yes, a subawardee to the Prime performer may contract with another organization to contribute to the project. Each proposed subawardee, and all tiers of subawardees, should prepare price volume documentation at the same level of detail as required by the prime proposer.

The term “price proposal” refers to the Volume 2: Price Volume written narrative and the price spreadsheet.

Site leads that are “service providers” should not be considered key personnel.

For Volume 3 Team Member Identification, the term “Non-U.S. Individual” is referring to whether the individual is a U.S. citizen or not.  Please check "Yes" if the individual is not a U.S. citizen, and "No" if they are a citizen.

Yes. The Experimental Design element listed in the solicitation under TA2 can be described under TA3 instead if that increases the clarity/ cohesiveness of the proposal. If this approach is used, we recommend referencing the TA2 requirements in the TA3 section. 

No, the BREATHE team will not be setting up meetings to review written solution summary feedback. 

Please review Section 3.1.1 of the BREATHE Solicitation. If a prime is partnering with a Government entity to be a sub-performer in TA3, then the prime Proposer is first responsible for determining if the Government entity is eligible to participate. Costs for eligible Government entities should then be included in the Prime price proposal, and Government entities must provide the same level of detail required of all subs regarding price (see Attachment 1, Volume 2, Price Volume Template). All costs associated with the sub/Government entity’s involvement in the proposed effort should be included; the appropriate level of effort for their involvement should be justified within the proposal submission. 

The high-level goal is for biosensors to be adaptable and capable of detecting a wide range of bioaerosols.  Biosensors should be designed to detect viruses, bacteria, and a third bioaerosol “type” (fungi or allergens).  The 'or' is meant to provide flexibility, enabling performers to tailor the biosensor according to specific applications or user preferences.

Biological targets should be strategically selected to achieve BREATHE metrics and milestones.  As one example of defining “different biological targets,” distinct viral variants and/or strains can each be considered a 'unique target' due to their genetic differences and potential implications for disease transmission, virulence, and vaccine efficacy.

As outlined in the BREATHE solicitation, the sensors should operate continuously in real-time, and the turnaround time from sample to result should be 45 minutes or less. In emergency conditions, such as the rapid emergence of a new pathogen, BREATHE systems must be able to update and adapt (e.g. samples can be sent to a centralized lab for genomic sequencing).

During Phase I, teams are allowed to explore more than one type of biosensor technology. Prior to the Chamber Studies in Phase II, teams are required to commit to one specific type of biosensor. Chamber testing in Phase II then necessitates the use of three identical prototype devices to validate reproducible performance of the chosen biosensor. 

Proposers are welcome to utilize and propose existing technologies, including commercially available multi-sensor IEQ management systems, provided they fulfill the objectives of the program. If a team already owns or licenses such a system that integrates the tasks required for detecting a variety of particulate matter and chemical threats, and can assess and respond to these threats effectively, they may propose to enhance this system by adding sensors for airborne bioaerosols. There is no requirement to propose a standalone system exclusively for bioaerosol monitoring if an existing system can be adapted to meet all the specified needs of the project.

In the draft solicitation, some terms, such as “biosensor devices” and “biosensor prototypes,” were used interchangeably. ARPA-H will provide necessary clarifying edits to this terminology in the final solicitation.

The solicitation notes that the following is considered out of scope for the BREATHE program: proposals to advance sensor technologies for monitoring non-biological air pollutants (e.g., particular matter, ozone, CO2, volatile organic compounds, and radon). However, performers may consider coupling biosensors with more conventional sensors, including those that measure VOCs, to inform aspects of the BREATHE program such as the risk models or return on investment (ROI) calculations. 

Performers must build and test indoor air biosensor prototypes capable of continuously quantifying a total of 25 unique biological targets across the three broad categories simultaneously. Binary detection with a single detection signal that indicates the presence of any of the targets, but does not differentiate among them, is not sufficient. Performers will work with the IV&V teams to ensure adequate testing capabilities are available in the chamber studies.

As stated in the solicitation, proposers must develop a viable R&D path for expanding biosensor coverage to at least the 100-plex scale (i.e., to monitor for at least 100 unique biological targets in parallel) as part of their proposed technology for TA1.  The BREATHE Program will require at least 25-plex capabilities in a real-world setting by Phase II chamber studies, and proof-of-concept for 100-plex capabilities in a lab setting by program completion. 

There is no specific preference mandated for the frequency of testing events within a designated time period; it is up to proposers to determine the optimal testing routine. This approach allows proposers to tailor their testing frequency based on their selected application and built environment type. The 45-minute detection window was chosen based on an a priori technical feasibility assessment; performers are encouraged to innovate and deliver a more rapid turnaround time.  Proposers are required to explain the rationale for how they will determine exposure thresholds and detail plans to minimize false positives and negatives. These plans should consider factors such as building type, target occupants, and specific pathogens, as outlined in the solicitation.

The purpose of the metrics is to articulate a set of criteria that will be used to evaluate performer and program success.  All biosensor metrics outlined in the solicitation have been deemed important. Biosensor design approaches are to be determined by proposers and should account for the metrics and milestones outlined in the program solicitation. 

The solicitation does not include preferred comparator methods. Proposers should explain and justify comparator methods in their proposal submission. 

No, the “Turnaround Time” metric does not include the sample collection time in the total 45 minute detection period. The metric for “Turnaround Time” is a 45 minute detection period that starts at the end of collecting air within a room to the completion of the biosensing method.

Biosensors are not constrained to only nucleic acid or antigen-based detection approaches. Other approaches can be applied, but biosensors must be able to detect bioaerosols at a performance capability and level that is outlined in the BREATHE Program Solicitation. Biosensors are required to detect viruses, bacteria, and fungi or allergens. 

This program requires performers to develop biosensors that can measure specific biological targets. However, per the Solicitation, proposers should also provide a plan to demonstrate rapid adaptation of biological targets for detection of novel pathogen variants (in less than 3-weeks following the publication of a novel variant). In such a plan, it is encouraged that prototype devices have a capability to effectively capture novel strains through bioaerosol capture components, which can then be sent to a genomic sequencing facility for follow-up bio-surveillance procedures.

No, biosensor research, innovation, and development beyond applications of indoor air detection of bioaerosols are out-of-scope of the BREATHE Program. However, proposals to develop indoor air biosensors by adapting commercially available outdoor air or wastewater sensors would be within scope of the BREATHE Program.

Sensor schedules can be determined by the proposers and are not mandated by the BREATHE solicitation. 

Proposals should include all 25 targets during the manual sample collection phase of the program, as the data will inform TA1 biosensor development and TA2 risk assessment model development. 

Biosensors will need to be capable of detecting at 25-plex by the end of Phase I as per section 1.3.5 in the BREATHE Program Solicitation. 

Teams may develop multiple biosensors for tiered-sensing approaches that can be implemented after the end of Phase I (e.g. low-tier and high-tier risk threat biosensors; tiered spatial resolution at the building and room level). However, each individual biosensor will require significant justification based on performance, the unique or complementary information that it will collect, and the strategy for deployment to support the TA1 biosensing metrics. See Amendment 2 to ARPA-H-SOL-24-107 which clarified this (posted on August 2, 2024).

Proposers must clearly articulate and demonstrate the statistical validity of their experimental designs within the proposal.  The rationale for selecting specific experimental design and data analytics methods will be a factor in evaluation. 

Yes.

Human challenge studies can be included if they are required to achieve BREATHE milestones. If human challenge studies data is available through federal funding or other funding mechanisms, we encourage performers to leverage that data. As stated in the solicitation, the BREATHE program requires assessing risk in the facilities selected by performer teams.  

As stated in the solicitation, the BREATHE program includes monitoring and assessing bioaerosol exposure risk, with bioaerosols broadly categorized as airborne bacteria, viruses, fungi (including molds) and allergens.  Occupant immune response is an acceptable health outcome to include in the program.

No, performers should select and justify the baseline they are proposing to use to assess bioaerosol exposure risk. 

The proposing teams can determine who will be in charge of the overall monitoring of IAQ for data collection purposes. The IAQ data collected will be used and integrated by TA2 for risk assessment. 

Proposers may choose any building type, such as residential facilities, but as stated in the solicitation, the building type selected should allow exposure incidence to be statistically linked with in-building exposure to health outcomes.  

According to the solicitation, TA3 performers are responsible for choosing a single building type to focus on for the duration of the BREATHE program (for example hospitals or schools, but not both). The field studies must include facilities located in at least three U.S. cities across three distinct climate zones. This geographic diversity is essential to provide a varied real-world context for the research, development, and demonstration of BREATHE technologies. These cities can be rural, suburban, or urban. The proposal should include an outline that details the type, location, and number of buildings to be included in field studies, along with evidence of buy-in from building owners and operators. Performers will have the first six months of Phase I to finalize their selection of buildings.

The phrase “exposure incidence can be statistically linked with in-building exposure” refers to the requirement for a robust experimental design and statistical approach for associating occupant outcomes with bioaerosol exposure in the field trial facilities.  

We encourage proposers to select facilities where the final outcomes can be achieved – 25% reduction in disease prevalence and 10% ROI.  ROI can be calculated as a function of operational costs and impact (e.g. value of lives saved due to infection prevention or school attendance).

Yes, energy efficiency is an important metric for the proposed solutions and should be quantified to the cost savings of operating those solutions. Climate/carbon costs can be included in the ROI.

Proposals should focus on a building type where exposure incidence can be statistically linked to in-building exposure.  Example facilities where this is likely achievable include but are not limited to non-ambulatory care sites (e.g. nursing homes and facilities, assisted living, inpatient hospice, convalescent homes, and group homes with nursing care), single family homes, military facilities, schools, and ambulatory care sites such as hospitals. We do not want to constrain innovation; proposers are welcome to make a case for how data from airplanes, airports or other transportation hubs could be leveraged to meet BREATHE program metrics and milestones. 

As described in the solicitation, interventions proposed should be suitable for the buildings under study and available to the performer team. These approaches may include minor modifications to existing infrastructure, such as adding variable air exchange rates or filtration to existing HVAC systems, or commercial-off-the-shelf capabilities such as UV sanitization, however the program will not provide funding for buildings to retrofit or install new intervention systems. Mitigations may also include changes in operations (individual testing, social distancing, work from home) or personal protective equipment (masking).

If you believe that your solution does not fall within BREATHE’s scope, please visit the Mission Office–specific Innovative Solutions Opening (ISO) webpage https://arpa-h.gov/research-and-funding/mission-office-iso to learn more about other funding opportunities. However, proposers should NOT submit the same proposal to multiple ARPA-H solicitations.

Yes, performers under this solicitation should focus on evaluating the actual health consequences of a built system. Not all health outcome data will be equally informative.  For example, routine nasal swab data from occupants will likely be a more powerful health indicator in comparison to absenteeism data; both sources of data could be used in risk assessment models. Ultimately, the systems developed for the BREATHE Program are expected to reduce facility-related indoor respiratory illness incidence by at least 25% relative to baseline health data while achieving a ≥10% return on investment from indoor air quality interventions.

As described in the BREATHE metrics table in the solicitation, BREATHE performers are required to measure the incidence of RI in facilities during the baseline data collection period in Phases I and II of the program, as well as during Phase III before and after interventions. While point prevalence data collection is also recommended when the respiratory illness studied is chronic, this should complement the incidence data to provide a fuller epidemiological snapshot.

The answer to the first question is yes.  While technologies that are capable of distinguishing between RI caused by indoor bioaerosols (like airborne bacteria and viruses or bio-allergens such as pollen and dander) and RI caused by non-biological indoor air stressors (such as air temperature, humidity, particulate matter, CO2 and various chemical pollutants) are not required, this distinction has the potential to strengthen the risk model’s  accuracy and influence the intervention measure. In such cases, proposers are encouraged to use data from off-the-shelf or minimally modified commercially available technologies. 

The answer to the second question is no, but the suggested approach is encouraged.  It is not necessary for teams to determine the etiology of each RI case fully; however, an assessment is encouraged. For example, if bioaerosol and bio-allergen levels are low during a period of increased RI, while non-biological particulates or gases are elevated, proposers may consider these non-biological factors as potential primary causes of the RI spike. Ultimately, proposers are encouraged to use a robust analytical approach that considers multiple potential factors from the multiple data streams to better understand and measure causality.

Solutions will be evaluated on their ability to consider both based on their specific application and context. 

The Solicitation does not specify a specific number of buildings or total square footage, which may be different for teams working with homes than large hospitals, for example. There must be enough statistical power for the teams to demonstrate the outcome at the end of the program – a 25% reduction in respiratory illness with a 10% return on investment. 

Please review the solution summaries template that is linked to the BREATHE program page.  The template asks that you provide any letters of intent, executed partnership agreements, or similar items indicating current buy-in from building owners and operators which indicates permission to perform all tasks relevant to TA3 of the program at the specified location.

As stated in the Solicitation, to provide real-world context for research, development, and demonstration of BREATHE technologies, buildings must be located in at least three U.S. cities. 

No, simulant releases are not required as a part of TA3. We are open to considering proposals that provide a rationale for why simulant releases would be helpful for achieving the goals of TA3, but the efficacy trials are generally intended to be based on natural conditions. 

Proposers should clearly identify any proposal assumptions for ARPA-H to consider, if selected, during the negotiation process. This could include the desire to keep building owners’/operators’ identities private. Sharing of any program information will be controlled in accordance with the negotiated terms of the resulting Agreement. 

The LOIs, partnership agreements or similar items do not count toward the solution summary 6 page limit.

Far UV technologies as an intervention type are within the scope of the BREATHE program. However, proposers should note that interventions must involve only minor modifications to existing infrastructure, such as adjusting air exchange rates or adding filtration to existing HVAC systems or using commercial off-the-shelf capabilities like germicidal UV sanitization.