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

Key facts

Copied from the official Grants.gov record. Last verified October 29, 2026.

Program name

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

Issuing agency

National Institutes of Health (Department of Health and Human Services)

Opportunity number

RFA-NS-28-009

Funding type

Cooperative Agreement

Funding purpose

Health

Status

Forecasted

Application deadline

Forecasted · estimated close May 25, 2027 (agency estimate)

Agency estimates

Estimated posting: March 1, 2027. Estimated award date: April 1, 2028. Estimates can change.

Published award range

Not published by the agency

Cost sharing or match required

No

Eligible applicants (official categories)

• State governments
• County governments
• City or township governments
• Special district governments
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Native American tribal organizations (other than Federally recognized tribal governments)
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• Private institutions of higher education
• For profit organizations other than small businesses
• Small businesses
• Others (see Additional Information on Eligibility)

Relevant to

Businesses and NonprofitsHow we determined this: Grants.gov eligibility includes small businesses or for-profit organizations. Grants.gov eligibility includes nonprofit organizations.

Geographic restrictions

None stated in structured data (federal opportunities are often nationwide). Check the eligibility details and full announcement for any limits.

Assistance Listing (CFDA)

93.853

Official source

View on Grants.gov ↗

Application URL

www.grants.gov/search-results-detail/363926 ↗Apply through Grants.gov (Workspace) using the application package on the official listing, unless the full announcement names a different submission system.

Source identifier

Grants.gov opportunity ID 363926 · Funding opportunity number RFA-NS-28-009

Posted

September 23, 2026 · Source last updated September 23, 2026

Last verified

October 29, 2026 (against Grants.gov)

Data completeness

92% of key fields published by the sourceNot published: published funding range.

Record confidence

mediumforecast — dates and amounts are agency estimates.

Eligibility details (from the agency)

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 establish substantial evidence of effectiveness in support of a marketing application) supported by a U.S. based 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 (from the official listing)

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting the conduct of scientific research utilizing data from intermediate-size patient population expanded access protocols for ALS ("intermediate expanded access protocol for ALS", see Expanded Access Categories for Drugs (Including Biologics)). Eligible intermediate expanded access protocols for ALS should: 1) provide access to an investigational drug or biological product for people with ALS, and 2) generate data to support research on the prevention, diagnosis, mitigation, treatment, or cure of ALS. The scientific research goal(s) informed by these data could include the investigational drug's or biological product's effect on biomarkers related to the pathophysiology of ALS or target engagement, the collection of safety or outcome information, such as survival or other significant medical events (e.g., hospitalization or need for ventilatory support), or patient experience data that are not specifically tied to assessing efficacy. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop responsive projects.

Agency contact

ALS Program
NINDSALSMailbox@mail.nih.gov