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Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access

National Institutes of Health

General Information

Document Type:	Grants Notice
Funding Opportunity Number:	RFA-NS-26-001
Funding Opportunity Title:	Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Opportunity Category:	Discretionary
Opportunity Category Explanation:
Funding Instrument Type:	Cooperative Agreement
Category of Funding Activity:	Health
Category Explanation:
Expected Number of Awards:	4
Assistance Listings:	93.853 -- Extramural Research Programs in the Neurosciences and Neurological Disorders
Cost Sharing or Matching Requirement:	No

Version:	Synopsis 1
Posted Date:	May 04, 2026
Last Updated Date:	May 04, 2026
Original Closing Date for Applications:	Nov 10, 2026
Current Closing Date for Applications:	Nov 10, 2026
Archive Date:	Jan 10, 2027
Estimated Total Program Funding:	$ 40,000,000
Award Ceiling:	$
Award Floor:	$

Additional Information

Agency Name:	National Institutes of Health
Description:	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.
Link to Additional Information:
Grantor Contact Information:	If you have difficulty accessing the full announcement electronically, please contact: ALS Program NINDSALSMailbox@mail.nih.gov

AI Based Application Success Predictor

1. Significance (Importance of the Research Question) (Highest Predictor ⭐⭐⭐⭐⭐)

This is one of NIH's core review criteria.

Competitive proposals should:

Address an important biomedical or public health problem.
Fill a significant knowledge gap.
Advance scientific understanding.
Improve prevention, diagnosis, treatment, or health outcomes.

Reviewers ask whether successful completion of the project will have a meaningful impact on the field.

2. Strong alignment with the Funding Opportunity Announcement (FOA) and Institute priorities (Highest Predictor ⭐⭐⭐⭐⭐)

Competitive applications closely match:

The objectives of the specific FOA.
The mission of the relevant NIH Institute or Center (e.g., NCI, NHLBI, NIDDK, NIAID, NHGRI).
The scientific priorities described in the funding announcement.

Even scientifically strong proposals are less competitive if they do not fit the FOA or Institute mission.

3. Innovation (Highest Predictor ⭐⭐⭐⭐⭐)

Innovation is a formal NIH review criterion.

Competitive proposals often include:

Novel hypotheses.
New technologies.
Innovative methodologies.
Creative experimental approaches.
New therapeutic or diagnostic strategies.
Artificial intelligence or advanced computational methods (when appropriate).

Projects should demonstrate how they advance beyond current knowledge rather than simply extending existing work.

4. Rigorous Approach and Methodology (Highest Predictor ⭐⭐⭐⭐⭐)

The Approach section is often the most heavily scrutinized part of an NIH application.

Competitive proposals include:

Well-defined hypotheses.
Strong preliminary rationale (especially for R01s).
Robust experimental design.
Appropriate statistical analyses.
Risk mitigation strategies.
Alternative approaches.
Realistic timelines and milestones.

A weak approach can prevent funding even for highly innovative ideas.

5. Investigator(s) and Team Expertise (Very High Predictor ⭐⭐⭐⭐⭐)

Reviewers evaluate whether the investigators have the expertise to complete the proposed work.

Competitive teams demonstrate:

Strong publication record.
Relevant scientific expertise.
Leadership experience.
Complementary multidisciplinary skills.
Successful collaboration.

For early-stage investigators, reviewers place greater emphasis on potential and mentorship.

6. Strong Research Environment (Very High Predictor ⭐⭐⭐⭐⭐)

The institutional environment should provide:

Appropriate laboratories and equipment.
Core facilities.
Clinical infrastructure (when applicable).
Biostatistical support.
Institutional commitment.
Collaborative opportunities.

A strong research environment increases confidence that the project can be successfully completed.

7. Scientific Rigor, Reproducibility, and Transparency (Very High Predictor ⭐⭐⭐⭐⭐)

NIH places strong emphasis on:

Scientific rigor.
Reproducibility.
Authentication of key biological resources.
Consideration of sex as a biological variable (when applicable).
Transparent reporting.
Data management and sharing.

Applications should clearly describe how rigor and reproducibility will be ensured throughout the study.

8. Strong Preliminary Data (especially for R01s) (High Predictor ⭐⭐⭐⭐☆)

For many NIH mechanisms—particularly R01—competitive applications often include preliminary data demonstrating:

Feasibility.
Technical capability.
Early proof of concept.
Supporting evidence for the central hypothesis.

Mechanisms such as R21 may place less emphasis on preliminary data, depending on the FOA.

9. Potential for Translation and Public Health Impact (High Predictor ⭐⭐⭐⭐☆)

Competitive proposals often describe how the research could lead to:

New diagnostics.
New therapeutics.
Clinical trials.
Precision medicine.
Public health interventions.
Improved healthcare delivery.

Even basic science applications benefit from articulating their long-term translational relevance.

10. Appropriate Budget, Data Sharing, and Compliance (High Predictor ⭐⭐⭐⭐☆)

Strong applications include:

Well-justified budgets.
Realistic resource requests.
Data Management and Sharing Plans (required for applicable applications).
Compliance with NIH policies on human subjects, vertebrate animals, inclusion, and research ethics.

Administrative completeness and compliance support a smoother review process.

Specialties

Neurosciences

Eligibility Requirements

Eligible Applicants:

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

Additional Information 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.

Eligible Countries:

United States

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Sponsor Type: Government/Federal

Address: 9000 Rockville Pike, Bethesda, MD 20892

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