# 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

Source: https://welltoldgrants.com/grants/rfa-fd-23-030-systematic-review-of-clinical-outcome-assessments-coas-for/  
Official notice: https://www.grants.gov/search-results-detail/346898

> Food and Drug Administration offered grants of up to $500,000 (at least $200,000) to the applicants described in the notice. Applications closed on May 24, 2023.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-23-030 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | May 24, 2023 |
| Award ceiling | $500,000 |
| Award floor | $200,000 |
| Expected awards | not stated |
| Total funding | not stated |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- Others (see text field entitled "Additional Information on Eligibility" for clarification)

1. Eligible ApplicantsEligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)Local GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions)

## What the grant funds

The purpose of this funding opportunity is to solicit applications for UH2/UH3 cooperative agreements to support and inform the future development and use of COAs for cBCIs in patients with amyotrophic lateral sclerosis (ALS). The UH2/UH3 cooperative agreement involves two milestone driven phases: 1) the UH2 Phase will include a systematic landscape analysis of the available literature, relevant data sources, and interviews with key opinion leaders (KOLs) to document COAs for cBCIs used clinically and identify gaps between current COAs used in cBCI studies and other outcome measures that could demonstrate functional benefits for ALS patients with severe communication limitations; 2) the UH3 phase will consist of patient and caregiver focus groups to collect information about symptoms, functional status, and perceived benefits/risks of cBCIs. Each phase will have a limit of 1 year for a total award period of 2 years. The UH2/UH3 application must be submitted as a single application, and applicants should note specific instructions for each phase in this FOA.

## Questions people ask

### Is RFA-FD-23-030 still open?

No. It closed on May 24, 2023. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for 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?

Food and Drug Administration accepted applications from the applicants described in the notice. The notice adds further conditions, so read its eligibility section.

### What is the deadline for 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?

Closed May 24, 2023. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### How much funding is available?

Awards of up to $500,000 each.

### Who has won Food and Drug Administration Research grants before?

The largest recipients over five fiscal years were The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials. The program made 940 awards worth $1.2 billion in that time.