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

Agency: Food and Drug Administration

93.103 -- Food and Drug Administration Research

Archived opportunityLast Updated: May 13, 2026

Description

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.

Eligibility

Eligible applicants

Miscellaneous

Other

Additional information

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)

Grantor contact information

Description

Shashi Malhotra Grants Management Specialist Phone 2404027592

Email

shashi.malhotra@fda.hhs.gov

Documents

No documents are currently available.

Link to additional information

FULL ANNOUNCEMENT

Archived: June 23, 2023

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$--

Program Funding

Expected awards

$200,000

Award Minimum

$500,000

Award Maximum

Funding opportunity number:

RFA-FD-23-030

Cost sharing or matching requirement:

Funding instrument type:

Cooperative agreement

Opportunity Category:

Discretionary

Opportunity Category Explanation:

Category of Funding Activity:

Science technology and other research and development

Category Explanation:

History

Version:

Posted date:

March 16, 2023

Archive date:

June 23, 2023