Archived

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

Federal funding opportunity RFA-NS-25-024 from National Institutes of Health (Department of Health and Human Services).

Posted: September 26, 2024
Closed: January 24, 2025
Cost sharing: No
Instrument: Cooperative Agreement
Assistance listing: 93.853
Category: Health
Archives: March 1, 2025

Program funding history

Awards made under Assistance Listing 93.853 across FY2025–FY2027, from public federal spending records.

FY2025 obligated: $1.8B
FY2026 obligated: $2B
FY2027 (to date) obligated: $0
Awards in window: 8,124

Top recipients: The General Hospital Corporation, Regents of the University of California, San Francisco, the, The Johns Hopkins University, Regents of the University of Michigan, Washington University, the

Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →

This opportunity is archived. Applications are no longer accepted. Similar grants are listed below, and the free Tuesday digest carries the next ones like it.

Synopsis

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.

Who can apply

Private institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
County governments
Public and State controlled institutions of higher education
Public housing authorities/Indian housing authorities
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Native American tribal organizations (other than Federally recognized tribal governments)
Native American tribal governments (Federally recognized)
City or township governments
For profit organizations other than small businesses
Small businesses
State governments
Independent school districts
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education

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.

The official record

Grants.gov published the official terms and dates of this opportunity; this page keeps them as they were listed.

View on Grants.gov Full announcement

Agency contact: National Institutes of Health · [email protected] · 301-402-2541

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