SPECTRA: Frequently Asked Questions (FAQs)

No, there is not a Proposers' Day scheduled for this program. Instead, we will post a downloadable Overview Brief for each Technical Area (TA).

• What: TA Overview Briefs are supplemental resources to the solicitation documents (found on SAM.gov) to help answer questions.
• Where: Documents will be available for download directly from the SPECTRA program page, under the Solicitation Overview heading.
• When: Each new TA Overview Brief will be made available around the time the ARPA-H Solutions site opens for each TA. Please reference the key dates listed in the solicitation for the most up-to-date information.

Questions? If you have additional questions that aren't addressed in the briefs, the solicitation documents, or on this page, please submit them to the Ask a Question form (sign-in required).

A Technical Area Overview Brief is a supplemental resources to the solicitation documents to help answer proposer questions.

Yes, there will be a brief for each TA. Briefs will post to the SPECTRA program page around the time that the ARPA-H Solutions site opens for each TA. Look for them under the Solicitation Overview heading.

You can submit questions any time while the ISO remains open using the Ask A Question form (sign-in required) or the email provided in the solicitation documents. Responses will be posted publicly on this page. Please note, per SPECTRA ISO section 6.5, we will not answer questions about the following:

1. Which Technical Area a given team or concept should address 
2. Whether a specific idea or approach falls within SPECTRA's scope 
3. Preferred or recommended teaming arrangements 
4. Requests for ARPA-H's position on topics beyond the requirements of this solicitation
    

An individual can be named as a prime performer for one TA submission, and as a subperformer on as many submissions as desired. We heavily discourage redundancies across proposals and this will be negotiated out. Please ensure that a distinct submission is made to each TA, at the time each TA opens for submission. We will not accept submissions attempting to combine their proposed solutions for multiple TAs.

We cannot estimate the time commitment for developing a full proposal, this depends on the solution being proposed. ARPA-H has actively managed contracts and expects regular engagement and collaboration with the program manager and other teams. 

Attachment A can be found in the Attachments section at the bottom of the SPECTRA opportunity on SAM.gov. 

To find the attachments, click here to navigate to SAM.gov. Select the SPECTRA link, then scroll to the bottom of the page. Download the pdf titled "SPECTRA_Attachment_A1..."

We recommend following this opportunity to access the latest ISO and attachment documents. Note: You must be signed in to SAM to follow an opportunity. Reference the system's guidance material for more information.

A Principal Investigator (PI) may submit as the lead institution on one submission per TA. A PI may be a subperformer on multiple submissions per TA. We heavily discourage redundancies across proposals and this will be negotiated out. 

Please ensure that a distinct submission is made to each TA, at the time each TA opens for submission. We will not accept submissions attempting to combine their proposed solutions for multiple TAs.

At this time, we are unable to accommodate requests for meetings to discuss the program and solicitation requirements, nor are we able to provided specific feedback on any particular approach or technology, or provide specific guidance on forming teams. However, to help facilitate team formation, ARPA-H has created a Teaming Directory for proposers to share their profiles and learn about other interested parties. You must register or sign in to submit and view profiles.

Additionally, proposers may submit technical questions using the Ask A Question button at the top of this (or via the email provided in the Solicitation documents on SAM.gov). 

Please keep in mind, as per SPECTRA ISO section 6.5, we will not answer questions about whether a specific idea or approach falls within SPECTRA's scope. That said, the best way to receive feedback from a PM is to submit a solution summary. Each submission will be evaluated on the unique characteristics of the proposed technology.

The focus of a submission should be on the work being proposed under SPECTRA. A statement about current funding is acceptable if it provides relevant background information or is used to clearly discuss how duplication of work has been mitigated.

Between the Solution Summary and Full Proposal stages of submission, the Prime (lead organization) must remain the same as they are the responsible entity who is ultimately being encouraged or discouraged at the Solution Summary stage. Sub performers can be altered as long as capabilities remain largely the same (for example, not an entirely new concept is being proposed).

In addition to checking for the latest announcements on our News page, new research programs are launched frequently. Subscribe to our ARPA-H Vitals newsletter for updates delivered to your inbox.

Anyone from the organization can submit a submission on the Solutions Site as long as they are authorized by their entity to do so.

No, per Attachment A1- TA4 solution summary requirements, biosketches and CVs are not required at the Solution Summary stage.

Please submit a new submission on the Solutions Site with the correct documents. 

Then, please go to https://solutions.arpa-h.gov/Ask-A-Question, log in, select "SPECTRA" under Program Initiative and "SPECTRA- Submissions" and confirm the date and time of the submission that is the correct version. 

Please ensure you are still complying with all solution summary and proposal requirements as outlined in the ISO's Attachment As and Bs.

As of the ISO amendment posted on October 14, TA4 Solution Summaries are due Wednesday, October 21 by 3 PM ET. TA1 and 2 Solution Summaries are due Wednesday, December 2 at 3 PM ET, and TA3 Solution Summaries are due Tuesday, January 19 at 3 PM ET. 

For the latest due dates, please check SAM.gov. 
 

We prefer standard 1 inch margins but there are no formal requirements.

No, the SPECTRA program will not grant any extensions to the Solution Summary or proposal deadlines listed in the ISO and its attachments.

Yes, per ISO section 4.1, ARPA-H is primarily interested in proposals from:

• commercial performers, 
• academic institutions, 
• and non-profit organizations. 

Note: Federally Funded Research and Development Centers (FFRDCs) and government entities, including federal employees, are not permitted to respond to this ISO as a prime or sub-performer.

A non-U.S. citizen can apply as a PI or team member so long as the PI or team member complies with federal law relating to working with, or if applicable, in the United States. For more information on international affairs, see the International Affairs FAQs.

Yes. ARPA-H solicitations are generally open to all responsible sources that can meet the Government's needs, and that includes individuals who can carry out research and/or development. 

Individual proposers must meet the same requirements as any other proposer. That includes submitting a mandatory Solution Summary using Attachment A1 and being able to carry out the proposed work under an Other Transaction agreement. Individuals who want to join a team can use the SPECTRA Teaming Directory to find other interested parties.

Per ISO Section 4.1, Federally Funded Research and Development Centers (FFRDCs) and government entities, including federal employees, are not permitted to respond to this ISO as a prime, sub-performer or listed personnel.

Any and all justifiable assessment modalities of the person’s biological state are allowed.

No. Sensory sensitivities are real, and they differ from person to person. SPECTRA is deliberately technology-agnostic. We are pursuing the full range of assessment approaches, which includes contact-based options like wearables for people who are comfortable with them, and contactless options such as AI-based video, audio, and ambient sensing for those who are not. 

Participant comfort and choice are design requirements for the program, not afterthoughts. The aim is assessment that fits into everyday life without asking anyone to tolerate something they find distressing, and any technology developed under SPECTRA will need to show that the people who would actually use it find it acceptable.

At this time, we are unable to accommodate requests for meetings to discuss the program and solicitation requirements, nor are we able to provided specific feedback on any particular approach or technology. 

Proposers may submit technical questions via the ARPA-H Solutions site or to the email provided in the ISO. All responses will be posted publicly on the SPECTRA FAQ. 

However, per SPECTRA ISO section 6.5, we will not answer questions about whether a specific idea or approach falls within SPECTRA's scope. That said, the best way to receive feedback from a PM is to submit a solution summary. Each submission will be evaluated on the unique characteristics of the proposed technology.

The goal of this program is to fund original or additional research, not scale existing programs.

This is an important topic but out of scope for this program.

The phenotype characterization is focused on humans.

TA4 develops technologies that generate assessment data as a byproduct of everyday use and validates them in real-world use. It is not a clinical trial; controlled intervention testing sits in TA3. There is no fixed volume of preliminary data required. Preliminary data should be sufficient to establish feasibility and to make your predicted performance and adoption targets credible. Performers propose the numeric targets, and they are fixed at award.

Solution summaries should include discussion of how sustained use will be evaluated on the specific platforms they are proposing.

A prospective feasibility phase is within scope of the solicitation since we are seeking new and innovative approaches.

Start dates will be after project negotiation and depend on numerous factors. We are not able to provide an accurate date range at this time.

Yes.

Commitments are preferred, but not required at the solution summary stage.

Consultation with the autism community is required for all stages, but particularly for TA4 submissions where co-design is required. At the Solution Summary stage, submissions should show how they plan to integrate this into their proposed solution. 

Per ISO section 2.2.2, "a program-wide engagement and co-design resource will connect the program to the full stakeholder community... The resource reinforces the co-design expectations in individual technical areas, notably TA2 governance and TA4 technology development, and provides shared methods so community priorities and privacy expectations are reflected consistently across the program.

Per SPECTRA ISO Section 6.5, we are unable to confirm whether a specific data source or approach — including the use of CMS claims data alongside primary data collection — falls within the scope of a given Technical Area. That said, the best way to receive feedback from a PM is to submit a solution summary. Each submission will be evaluated on the unique characteristics of the proposed technology, and all approaches will be evaluated for safety, privacy, ethics and impact.

Yes, a TA4 Overview Brief is available for download directly from the SPECTRA program page, under the Solicitation Overview heading.

Instructional technology, such as tutoring systems and other tools that teach academic content or drive academic achievement, is out of scope for TA4. Classroom measurement of behavior, occupational and daily-living skills, and communication is in scope, especially around IEP goals and plans.

Once contracts are awarded, TA-4 performers will work with TA-2 to integrate their data streams into the new frameworks.

No. A single proposed solution does not need to be applicable to all ages. Proposed solutions may target a defined age range or life stage for their technology, provided they justify that scope and state where on the developmental continuum the approach applies.

On the target, dimensional identification of elevated autistic characteristics is acceptable and is often the more appropriate objective in infancy, where a categorical diagnosis is not yet stable. TA4 Early Identification is not limited to predicting diagnostic threshold-crossing. Proposals should tie their dimensional measure to a meaningful later outcome, such as subsequent diagnostic status or functional trajectory, so the signal reflects something consequential. On the sample, a selected high-familial-likelihood sample is acceptable for early validation. As a tool moves toward real-world screening use, performance should also be shown in a more representative sample, because predictive accuracy depends on how common autism is in the population tested. The validation sample should match the intended use.

TA4 is focused on embedded assessment, meaning technologies that assess communication and function continuously and ecologically as a byproduct of ordinary use. A blood-based diagnostic is a point-in-time laboratory test, not an assessment of function in everyday life, so it is not a fit for TA4.

Consultation with the autism community is required for all stages, but particularly for TA4 submissions where co-design is required. At the Solution Summary stage, submissions should show how they plan to integrate this into their proposed solution. 

Per ISO section 2.2.2, "a program-wide engagement and co-design resource will connect the program to the full stakeholder community... The resource reinforces the co-design expectations in individual technical areas, notably TA2 governance and TA4 technology development, and provides shared methods so community priorities and privacy expectations are reflected consistently across the program.

Gate 3 in TA4 at Month 48 is the final gate determining successful completion of the project. The performance period for TA4 is for 4 years (48 months) total.

No, TA4 doesn't favor any particular technology. Solutions may target assessment in any relevant area, such as behavior, motor, physiology, sleep, sensory, cognition, daily functioning, and/or communication. Speech recognition and language modeling is one area in which ARPA-H will accept submissions. Submissions that include it should meet the speech-specific expectations: open models that run on the device, a consented and shareable speech corpus, a public benchmark, and plans for consent and data governance.

TA4 isn't a clinical trial. It develops technologies and validates their measurements in real-world use, and controlled testing of interventions belongs in TA3. In-home, IRB-approved studies that validate measurement are a good fit. Note that a TA4 technology must also be useful enough that people keep using it. In-home trials don't have to start on day one. An early prospective feasibility or controlled lab phase is allowed if it's justified. However, lab performance alone isn't enough. Your plan should show how you'll collect real-world pilot data in your target population in time for the Gate 1 (Month 12) metrics, and to deliver validated real-world measures to TA1/TA2 starting in Year 2. Co-design with autistic people and families is expected from the earliest stage.

For pilots and early testing, TA4 performers should recruit and budget for all of their own participants. Later stages will be coordinated with the other TAs. Once you've validated your measures in real-world pilots, you'll work with TA1, TA2, and TA3 performers on combined deployment and data collection, including measuring how well TA3 interventions work in real-world settings. Proposals should show how the pilot cohort supports the early milestones and how the technology will be ready to integrate with other TAs in later stages.

The program is built for data to move between TAs. TA2 provides a federated data network that keeps records where they are and uses a common data model. After award, TA4 performers will work with TA2 to connect their data streams. TA4 hands validated measures to TA1 and TA2 starting in Year 2, and TA1 publishes a yearly statement of the measurement gaps it most needs filled. TA4 data will also be used to measure how well TA3 interventions work, and federated learning across the cohort should improve the base models for new users. The specific mechanisms, such as data-use terms and any shared validation, will be worked out after award with the PM. Proposals should be able to stand on their own.

TA4 is about measurement in everyday life, so clinical settings don't count toward this requirement. Performance in a clinic alone isn't enough. Technologies must hold up in the ordinary, real-world places where people use them. A setting is one of those everyday places, such as home, school, community, or work. "Home and clinic" would not meet the two-setting requirement. "Home and school" would. An independent deployment site is a separate organization or location with its own participants, staff, and operations, so the results don't all come from one team or one group of people. Examples:

1. two school districts in different regions
2. home deployments with families recruited through two unaffiliated community organizations or regional partners
3. a school district plus an unaffiliated community program"

The program sets the direction of the metric: earlier validated identification, below the current 16-month floor and robust by 24 months. Proposers set the numeric thresholds and they may propose other metrics if they're technically justified. A G2 milestone that fits a prospective design is acceptable to propose, with the validated identification result delivered at Month 48. The G2 report should still include some interim evidence beyond procedures and the pipeline, for example enrollment and retention, agreement with concurrent structured assessments, or early results in an enriched (high-familial-likelihood) sample. Dimensional outcomes and enriched samples are acceptable for early validation.

For TA4 solution summaries, include a budget for 48 months (or 4 years). 

At this time, there are no plans to share budget information about the program. Please propose the most reasonable costs for your technical approach when submitting a solution.

Per Attachment A1- TA4 Solutions Summary Model Section 5, a Basis of Estimate (BOE) is required that encompasses all costs and resources for the entire proposed project team. The BOE should include direct labor, materials, supplies, equipment, travel, profit/fee, indirect costs, and any other relevant costs associated with the proposed project. See Attachment A1 for exact format and instructions for the BOE.

An in-person kickoff meeting will be held soon after the performers’ period of performance start date. Additionally, two annual program- wide in-person meetings and one annual TA-specific meeting will be held in each of the 4 years of the program. Proposers should plan for 2-day events at which, at the very minimum, the Project Lead (PL) and leads for each TA are expected to attend, alternating between Washington, DC and San Francisco, CA. 

Note, these locations are tentative and shared for budgeting purposes. All other program meetings will be held online.

Adhere to HHS guidelines for salary cap limitations. Salaries must be proposed below the rate limitation, which usually changes annually. 

Generally, no. However, a proposer may offer the use of an existing technology (e.g., software, platforms, or equipment) or its associated intellectual property during the period of performance as in-kind resource sharing.

To be considered, the contribution must: 1) be central to the proposed project; 2) be under the proposing team's control; 3) be reasonably valued, consistent with fair market value, and supported by verifiable data. The proposer is responsible for supporting the value. Resources developed with Federal Government funding should not be proposed as resource sharing. 

Resource sharing is encouraged but not required for SPECTRA. Any proposed resource sharing should appear in the Basis of Estimate (BOE) required by Attachment A1, Section 5. ARPA-H decides during award negotiation whether to accept a proposed contribution and at what value.

Resource sharing is encouraged for SPECTRA but is not required. All SPECTRA awards will be Other Transactions (OTs), and final resource-sharing terms are set during award negotiation.

(1) It depends on a number of specifics. If appropriate, submit in accordance with instructions in the ISO and it will be discussed during negotiations.

(2) ARPA-H does not require one specific valuation method. The proposer carries the burden of proof.

(3) Yes. Calculate the Government and Performer percentages against total project cost (ARPA-H funds requested plus the value of the performer's contribution). "Total Funds Requested From ARPA-H" should show only the Government share.

(4) Under Attachment A1, Section 5, the Solution Summary must include a Basis of Estimate (BOE) covering all costs and resources for the whole project team. Proposers offering in-kind resource sharing should briefly identify in the BOE the type of resource, how it will be used, its estimated value, and the valuation method. Detailed supporting documentation is not expected at this stage. If invited to submit a full proposal, or selected for negotiation, you will need to provide verifiable data supporting the valuation.

Yes, that is correct.