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.
Response Date	Nov 10, 2026 12:00:00 AM EST
Posting Date	May 04, 2026 12:00:00 AM EDT
Archive Date	Jan 10, 2027 12:00:00 AM EST
Award Ceiling	N/a
Award Floor	N/a
Cost Sharing	No

Eligibility

Eligible Applicants

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

Additional Info on Eligibility:

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.

Additional Information

Agency Name	National Institutes of Health
Link to Additional Information:	N/a
Grantor Contact Information:	If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk Phone: 301-402-2541

CFDA Program(s)

• 93.853: Extramural Research Programs in the Neurosciences and Neurological Disorders