Grants / Department of Health and Human Services / National Institutes of Health

RFA-NS-25-024: Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

Closed Closed January 24, 2025 Opportunity RFA-NS-25-024 ☆ Save

This grant is closed. A newer notice from the same program is open now: Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) (RFA-NS-26-001). Status: Closes November 10, 2026 (3 days left). It is in our archive of National Institutes of Health notices from 2024.

• Award amountsNot given on Grants.gov
• Cost sharingNot required
• Funding typeCooperative Agreement

Key dates

Who can apply

This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses.

Is this a realistic fit?

• Most of the program's money (76% over five years) went to colleges and universities.
• No cost sharing or match is required.

What the grant funds

The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not otherwise eligible for clinical trials for the diagnosis, mitigation, treatment, or cure of ALS ("intermediate EA protocol for ALS"). Providing the investigational drug or biological product under an intermediate EA protocol for ALS must not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval, or otherwise compromise the potential development of medical products for the diagnosis, mitigation, treatment, or cure of ALS. Eligible applicants are clinical trial sites that participate in a phase 3 clinical trial supported by a United States (U.S.) small business concern (as defined in section 3(a) of the Small Business Act (15 U.S. C. 623(a)) that is also the U.S. Food and Drug Administration (FDA) designated sponsor of a drug or biological product for ALS that is the subject of an Investigational New Drug Application (IND). This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in May 2022 with an expected application due date in June 2022. This FOA will utilize the U01 activity code.

Category: Health.

Applying now

This notice no longer takes applications. Apply under the newer notice, RFA-NS-26-001, which is open now.

The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.