Systematic Review of Clinical Outcome Assessments (COAs) for Communication Brain-Computer Interface Devices (cBCIs) in Amyotrophic Lateral Sclerosis (ALS) (UH2/UH3) Clinical Trials Not Allowed | RFA FD 23 030

Opportunity Information: Apply for RFA FD 23 030

This Food and Drug Administration (FDA) funding opportunity (RFA-FD-23-030) supports a two-phase, milestone-driven UH2/UH3 cooperative agreement focused on improving how clinical benefits are measured for communication brain-computer interface devices (cBCIs) used by people with amyotrophic lateral sclerosis (ALS), especially those with severe speech and communication limitations. The core aim is not to run a clinical trial, but to build a strong evidence base and patient-centered understanding that can guide the future development, selection, and use of clinical outcome assessments (COAs) for evaluating cBCIs in ALS. In other words, the work is meant to clarify what outcomes are currently being measured, what is missing, and what patients and caregivers consider meaningful changes when using these devices.

The award is structured as a two-stage project spanning up to two years total, with each phase limited to one year. Applicants must submit a single combined UH2/UH3 application, but they need to clearly lay out plans, methods, and milestones for both phases. Because this is a cooperative agreement, the FDA is expected to have substantial programmatic involvement compared with a typical grant, and progress from the UH2 phase to the UH3 phase depends on meeting the predefined milestones.

The UH2 phase is essentially a systematic landscape analysis meant to map the current state of measurement in the field. It includes a systematic review of available literature and other relevant data sources, along with interviews of key opinion leaders (KOLs). The goal is to document which COAs have been used in clinical contexts or studies involving cBCIs, and to identify gaps between those existing COAs and other outcome measures that might better capture functional benefits for ALS patients who have profound communication impairments. A practical deliverable of this phase is a clear inventory and critique of existing measures: what they assess (for example, communication speed, accuracy, usability, independence, quality of life), where they fall short (such as limited relevance to late-stage ALS communication needs), and what measurement concepts may need to be added or refined.

The UH3 phase shifts from literature and expert perspectives to direct input from the people most affected: ALS patients and their caregivers. This phase centers on conducting focus groups to gather detailed qualitative information about symptoms, functional status, day-to-day communication challenges, and the benefits and risks patients and caregivers perceive with cBCIs. The intent is to ensure that future COAs reflect outcomes that matter in real life, such as the ability to reliably express needs, participate in family decisions, communicate in emergencies, maintain social connection, reduce caregiver burden, or preserve autonomy. This patient- and caregiver-informed work is meant to complement the UH2 landscape findings and help prioritize which outcomes should be measured and how those outcomes should be framed so they are clinically meaningful.

Several administrative details define the opportunity. The funding instrument is a cooperative agreement, the activity category is research and development (science and technology), and clinical trials are explicitly not allowed under this announcement. The opportunity lists an award ceiling of $500,000. The CFDA number associated with this program is 93.103. The FDA is the sponsoring agency, the opportunity was created on March 16, 2023, and the original closing date was May 24, 2023.

Eligibility is broad and includes a wide range of domestic and non-domestic entities. Eligible applicants include public and private institutions of higher education (with encouragement for institutions such as HBCUs, HSIs, TCCUs, Alaska Native and Native Hawaiian-serving institutions, and AANAPISIs), nonprofit organizations with or without 501(c)(3) status, for-profit organizations (including small businesses and other for-profits), and many government and community-based entities (state, local, tribal governments, U.S. territories or possessions, public housing authorities, independent school districts, regional organizations, and faith-based or community-based organizations). Foreign (non-U.S.) entities are also listed as eligible.

Overall, the opportunity is aimed at strengthening the measurement foundation needed to evaluate cBCIs for ALS in a way that regulators, clinicians, researchers, and technology developers can use, while keeping the focus on outcomes that reflect meaningful communication ability and real-world function for people living with advanced ALS. By pairing a rigorous evidence and expert landscape (UH2) with lived-experience input from patients and caregivers (UH3), the project is designed to clarify what should be measured, why it matters, and where current COAs may not adequately capture the benefits and tradeoffs of cBCI technologies.

• The Food and Drug Administration in the science and technology and other research and development sector is offering a public funding opportunity titled "Systematic Review of Clinical Outcome Assessments (COAs) for Communication Brain-Computer Interface Devices (cBCIs) in Amyotrophic Lateral Sclerosis (ALS) (UH2/UH3) Clinical Trials Not Allowed" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
• This funding opportunity was created on 2023-03-16.
• Applicants must submit their applications by 2023-05-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• Eligible applicants include: Others.

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