Grant✓ Small businesses may apply
Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
National Institutes of Health
Program funding
$40,000,000
- Opportunity #
- RFA-NS-26-001
- Agency
- National Institutes of Health
- ALN (CFDA)
- 93.853
- Status
- posted
- Posted
- May 4, 2026
- Closes
- Nov 10, 2026
- Funding instrument
- Cooperative Agreement
- Category
- Health
- Cost sharing required
- No
Who can apply
- •City or township governments
- •Private institutions of higher education
- •Independent school districts
- •Special district governments
- •Small businesses
- •Native American tribal governments (Federally recognized)
- •Others (see text field entitled "Additional Information on Eligibility" for clarification)
- •State governments
- •Public and State controlled institutions of higher education
- •For profit organizations other than small businesses
- •Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- •County governments
- •Public housing authorities/Indian housing authorities
- •Native American tribal organizations (other than Federally recognized tribal governments)
- •Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
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.
Synopsis
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.
Contact
National Institutes of Health · NINDSALSMailbox@mail.nih.gov