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OpenResearch announcementOpportunity RFA-NS-26-001

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 an open federal cooperative agreement opportunity from the National Institutes of Health (Department of Health and Human Services). Applications are due November 10, 2026. Total estimated funding is $40M across about 4 awards. Applicant types listed as eligible include state governments, county governments, city or township governments, special district governments, independent school districts and 10 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

  1. May 4, 2026Posted
  2. Nov 10, 2026Application deadlinenext date
  3. Sep 1, 2026 (est.)Est. award date
  4. Jan 10, 2027Archived
Posted
May 4, 2026
Close date
Nov 10, 2026
Archive date
Jan 10, 2027
Est. award date
Sep 1, 2026
Award floor
Not specified
Award ceiling
Not specified
Est. total funding
$40,000,000
Implied average award
$10,000,000 calculated
Expected awards
4
Cost sharing
Not required
Funding instrument
Cooperative Agreement
Opportunity category
Discretionary

Typical awards for this program (SAM.gov listing for ALN 93.853, not this notice): Research grants: $22,709 to $7,753,905; $585,282. National Research Service Awards: Institutional $34,076 to $692,757; $193,304. Individual: $5,495 to $90,284; $46,239. SBIR/STTR: Phase 1 not to exceed $150,000; Phase II not to exceed $1,000,000; however with appropriate justification, budget caps for Phase I and Phase II are $225,000 and $1,500,00 respectively

Implied average = estimated total funding ÷ expected number of awards, calculated by GrantsJunction. Actual awards vary.

Who can apply

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public colleges & universities
  • Federally recognized tribal governments
  • Public & Indian housing authorities
  • 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)

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.

A quick check against the listed applicant types — other requirements in the notice still apply.

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 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.

Full announcement & documents

The full announcement has the complete rules — page limits, required attachments, evaluation criteria and any letter-of-intent dates. Files download directly from Grants.gov.

How to apply

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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.

Who was funded under ALN 93.853

Historical data · not a prediction

Since October 1, 2023, 10,021 grant awards had funding actions under Extramural Research Programs in the Neurosciences and Neurological Disorders, with 5,577 sub-awards passed on to other organizations. These are program-wide awards, not awards from this specific notice.

  1. THE GENERAL HOSPITAL CORPORATION$203M
  2. REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE$173M
  3. THE JOHNS HOPKINS UNIVERSITY$167M
  4. REGENTS OF THE UNIVERSITY OF MICHIGAN$155M
  5. THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK$141M
Recipients, states, recent awards and sub-awards →Source: USAspending.gov.

Agency contact (as published)

National Institutes of Health
NINDSALSMailbox@mail.nih.gov
301-402-2541

Quick answers

When is the deadline for this opportunity?

According to the official notice, applications are due November 10, 2026. Confirm the deadline and submission time on Grants.gov before applying.

Who is eligible to apply for this opportunity?

The official notice names these applicant types as eligible: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public colleges & universities, Federally recognized tribal governments, Public & Indian housing authorities, Native American tribal organizations, 501(c)(3) nonprofits, Nonprofits without 501(c)(3) status, Private colleges & universities and 3 more. Additional restrictions may apply; review the full notice.

How much funding is available through this opportunity?

Per the notice, total estimated program funding is $40,000,000 and the agency expects to make about 4 awards.

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-26-001), 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.