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

Source: https://welltoldgrants.com/grants/rfa-ns-28-009-amyotrophic-lateral-sclerosis-als-intermediate-patient/  
Official notice: https://www.grants.gov/search-results-detail/363926

> National Institutes of Health plans to offer grants to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It is a forecast: the notice is expected around March 1, 2027, with applications due around May 25, 2027.

| Field | Value |
|---|---|
| Opportunity number | RFA-NS-28-009 |
| Agency | National Institutes of Health |
| Status | Forecast |
| Deadline | expected May 25, 2027 |
| Award ceiling | not stated |
| Award floor | not stated |
| Expected awards | not stated |
| Total funding | not stated |
| Cost sharing | not required |
| Assistance Listings | 93.853 |

## Who can apply

- 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 text field entitled "Additional Information on Eligibility" for clarification)

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.

## What the grant funds

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.

## Questions people ask

### Who can apply for Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)?

National Institutes of Health accepts applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.

### What is the deadline for Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)?

Expected deadline May 25, 2027. Confirm the date and time in the official notice on Grants.gov.