Closed · RFA-NS-25-024 · CFDA 93.853 · Discretionary

Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

Federal grant opportunity posted by National Institutes of Health, cataloged on Grants.gov.

Varies
Award range
Closed
Status
January 24, 2025
Close date
-
Expected awards

The verdict

Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) is a closed discretionary listing from National Institutes of Health that offered Varies by applicant. Future funding cycles may be published under the same CFDA number.

Varies
award range
Closed
application status
93.853
CFDA program

Opportunity snapshot. This Grants.gov announcement - Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) - is cataloged under number RFA-NS-25-024 and tied to CFDA assistance listing 93.853, posted by National Institutes of Health. Grants.gov currently shows the opportunity as closed, first posted on September 26, 2024. The funding category is Discretionary, delivered as a cooperative agreement.

Award economics. The award range on file is Varies by applicant. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.

Deadline and action path. This opportunity closed on January 24, 2025. Future funding cycles may be published under the same CFDA number, so monitoring the parent program page is the most reliable way to catch re-announcements. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully, federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed, it helps clarify scope and scoring priorities. Before acting on the deadline or award figures above, verify them directly on the official Grants.gov listing, amendments can change dates and amounts after this page was last refreshed.

Award Range

Varies by applicant

Close Date

January 24, 2025

Posted

September 26, 2024

Instrument

Cooperative Agreement

Description

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.

Eligibility

Grants.gov lists this opportunity under eligibility category codes 00, 01, 02, 04, 05, 06, 07, 08, 11, 12, 13, 20, 22, 23, 25. These codes correspond to applicant types (state/local government, tribal organization, nonprofit, educational institution, individual, small business, etc.) defined in Grants.gov's own eligibility reference. See the current Grants.gov eligibility categories or check the official listing below for this opportunity's exact eligibility statement.

Official Listing on Grants.gov

View full details, application forms, and submission instructions.

View on Grants.gov

Agency Contact

NIH Grants Information grantsinfo@nih.gov

Key Dates

Posted September 26, 2024
Close Date January 24, 2025
Archive Date March 1, 2025
Last Updated September 26, 2024

Frequently Asked Questions

What is this grant opportunity?
This is a federal funding opportunity titled "Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)", offered by National Institutes of Health. It is associated with CFDA program 93.853. 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 Oppor...
Is this opportunity still open?
No, this opportunity is closed. It closed on January 24, 2025. Check the parent program page for future funding cycles.
How much funding is available?
The award range for this opportunity is Varies by applicant.
How do I apply?
Applications for federal grant opportunities are typically submitted through Grants.gov. Visit the official listing at grants.gov for application instructions, required documents, and submission deadlines.

Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.

Data sourced from the SAM.gov Assistance Listings and Grants.gov. See our methodology for details. Retrieved and formatted by PlainGrants