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

Updated Oct 20, 2026

Cooperative agreement from the National Institutes of Health, open to small businesses. Closes Nov 10, 2026, 21 days left.

Opportunity number	RFA-NS-26-001
Agency	National Institutes of Health
Funding type	Cooperative agreement
Field	Health
Expected number of awards	4
Total program funding	$40.0 million
Cost sharing or matching	Not required
Assistance listing	93.853
Posted	May 4, 2026
Closes	Nov 10, 2026 (21 days left)
Add the deadline to	Google Calendar

Who can apply

State governments
County governments
City or township governments
Special district governments
Independent school districts
Public and state controlled institutions of higher education
Native American tribal governments (federally recognized)
Public housing authorities and Indian housing authorities
Native American tribal organizations (other than federally recognized tribal governments)
Nonprofits with 501(c)(3) status, other than institutions of higher education
Nonprofits without 501(c)(3) status, other than institutions of higher education
Private institutions of higher education
For-profit organizations other than small businesses
Small businesses
Others (see the eligibility notes)

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Eligible applicants must be clinical trial sites that participate in a phase 2/3 or phase 3 efficacy clinical trial (designed to provide pivotal data to support a marketing application) supported by a small business concern that is the FDA-designated sponsor of a drug or biological product which is the subject of an IND under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) to prevent, diagnose, mitigate, treat, or cure ALS. The definition of a small business concern can be found in section 3(a) of the Small Business Act (15 U.S.C. 632(a)).Foreign Organizations/International CollaborationsNon-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.

Description

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) for investigational drugs or biological products as described in section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb). These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not eligible for ongoing clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of ALS.

Full announcement and how to apply on Grants.gov

Health grants right now

There are 350 open federal grants in health that small businesses may apply for; 33 close within 30 days. The median award ceiling is $500,000. The agencies offering the most are National Institutes of Health, Centers for Disease Control and Prevention - ERA and Centers for Disease Control - NCBDDD. Grants in this field stay open a median of 1031 days; this one is open for 190 days.

Who has won this program before

University Of North Carolina AT Chapel Hill $977.0 million · from Jun 29, 2006
Mayo Clinic $102.2 million · from Sep 15, 2019
The General Hospital Corporation $75.4 million · from Sep 19, 2019
Research Triangle Institute $72.7 million · from Apr 1, 2018
Yale Univ $67.5 million · from Jul 1, 2015

The largest grants and cooperative agreements under assistance listing 93.853 with payments since Oct 1, 2025, from USAspending.gov. Amounts are each award's total.