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ForecastedOpportunity RFA-NS-28-009

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

National Institutes of Health · Department of Health and Human Services

At a glance

Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) is a forecasted federal cooperative agreement opportunity from the National Institutes of Health (Department of Health and Human Services). The agency's forecast estimates an application due date of May 25, 2027; forecast dates can change. Applicant types listed as eligible include state governments, county governments, city or township governments, special district governments, public colleges & universities and 8 more. Cost sharing is not required. It is funded under Assistance Listing 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).

Summary assembled from the official notice's fields. The official notice governs.

Key facts

Posted
Sep 23, 2026
Est. close date
May 25, 2027
Est. award date
Apr 1, 2028
Award floor
Not specified
Award ceiling
Not specified
Est. total funding
Not specified
Expected awards
Not specified
Cost sharing
Not required
Funding instrument
Cooperative Agreement
Opportunity category
Discretionary
Fiscal year
FY2028

Who can apply

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Public colleges & universities
  • Federally recognized tribal governments
  • Native American tribal organizations
  • 501(c)(3) nonprofits
  • Nonprofits without 501(c)(3) status
  • Private colleges & universities
  • For-profit organizations (not small businesses)
  • Small businesses
  • Others (see notice)

Additional information on eligibility (from the notice)

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.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

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.

Assistance Listing

What is an ALN?

Reported obligations under ALN 93.853

Historical data · not a prediction
FY24$2.36B
FY25$2.35B
FY26— est.
Source: SAM.gov Assistance Listing 93.853. Program-wide totals, not awards from this specific opportunity.

Agency contact (as published)

ALS Program
NINDSALSMailbox@mail.nih.gov
Please contact via email.

Quick answers

Is this opportunity open for applications yet?

Not yet. It is a forecast — an agency's advance notice of an expected opportunity. The agency estimates posting the full notice around March 1, 2027. Forecast details and dates can change.

Who is eligible to apply for this opportunity?

The official notice lists these applicant types as eligible: State governments, County governments, City or township governments, Special district governments, Public colleges & universities, Federally recognized tribal governments, Native American tribal organizations, 501(c)(3) nonprofits, Nonprofits without 501(c)(3) status, Private colleges & universities, For-profit organizations (not small businesses), Small businesses and 1 more. Additional restrictions may apply; review the full notice.

How do I apply for this opportunity?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity RFA-NS-28-009), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.