Opportunity Information: Apply for RFA NS 26 001
This funding opportunity, titled "Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)" (RFA-NS-26-001), is an NIH Notice of Funding Opportunity that supports research built around expanded access (EA) use of investigational drugs or biological products for ALS. The central idea is to generate scientifically useful data from real-world treatment under expanded access, specifically for an intermediate-sized group of ALS patients who cannot enroll in existing clinical trials. Expanded access here refers to the pathway in Section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb), which allows patients with serious or immediately life-threatening diseases to obtain investigational therapies outside of traditional trials when certain conditions are met. The NOFO focuses on ALS patients who are excluded from ongoing trials and aims to use data collected during expanded access treatment to advance evidence on prevention, diagnosis, mitigation, treatment, or cure of ALS.
The award mechanism is a U01 cooperative agreement, which generally means the NIH expects substantial scientific or programmatic involvement during the project rather than a hands-off grant. The NOFO is explicitly marked "Clinical Trial Required," signaling that the funded work must include a clinical trial component, even though the research is organized around expanded access rather than standard randomized enrollment. In practice, applicants should expect to propose structured protocols for treatment and data collection that allow the expanded access experience to yield interpretable outcomes and safety information, while still operating within the regulatory and ethical constraints of expanded access.
Eligibility is specialized and tied to active late-stage ALS drug development. Applicants must be clinical trial sites that are already participating in a phase 2/3 or phase 3 efficacy clinical trial intended to generate pivotal data in support of a marketing application. In addition, that pivotal trial must be supported by a small business concern that is the FDA-designated sponsor of the investigational drug or biological product, and the therapy must be under an active Investigational New Drug (IND) application under Section 505(i) of the FD&C Act (21 U.S.C. 355(i)). The NOFO points to the Small Business Act definition of a small business concern (15 U.S.C. 632(a)), making it clear that this is meant to connect expanded access research with products being developed by qualifying small businesses that hold sponsor responsibilities with the FDA.
While the general NIH applicant categories listed in the opportunity include a wide range of domestic entities (state and local governments, public and private institutions of higher education, tribal governments and organizations, nonprofits with and without 501(c)(3) status, for-profits, and small businesses), the practical eligibility gate is the requirement that the applicant be a clinical trial site participating in the relevant pivotal phase 2/3 or phase 3 ALS study tied to an FDA-designated small business sponsor. In other words, many organization types could theoretically apply, but only those that meet the specific clinical trial site and sponsor-linked conditions described in the NOFO will be considered eligible.
The opportunity does not allow foreign participation on the applicant side. Non-U.S. entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by the NIH Grants Policy Statement are not allowed. This means the proposed expanded access activities, oversight, and data collection need to be entirely U.S.-based without foreign subcomponents.
Administratively, the opportunity is categorized as discretionary funding and falls under the health activity category, with CFDA number 93.853. The posting indicates an original application closing date of 2026-11-10 and anticipates making about four awards. No award ceiling is provided in the text you supplied, suggesting applicants would need to consult the full NOFO for budget constraints, allowed costs, and any caps or modular budget requirements.
Overall, the program is designed to bridge a common gap in ALS research: patients who are not eligible for traditional clinical trials still seek access to investigational therapies, and the NIH is using this cooperative agreement to ensure that expanded access use is paired with deliberate, rigorous data collection that can inform the broader evidence base for late-stage ALS product development.Apply for RFA NS 26 001
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
- This funding opportunity was created on 2026-05-04.
- Applicants must submit their applications by 2026-11-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
FAQs: Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) - RFA-NS-26-001
What is this funding opportunity?
This is an NIH Notice of Funding Opportunity (NOFO) titled "Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)" with opportunity number RFA-NS-26-001. It supports research that uses expanded access (EA) to investigational drugs or biological products for ALS and is designed to produce scientifically useful data from real-world treatment delivered through expanded access.
What is the main purpose of the program?
The goal is to generate interpretable evidence (including safety and outcome information) from expanded access treatment in ALS patients who cannot enroll in existing clinical trials. The intent is to advance knowledge relevant to the prevention, diagnosis, mitigation, treatment, or cure of ALS, using structured data collection during expanded access use.
What does "expanded access" mean in this NOFO?
Expanded access refers to the pathway described in Section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb). It allows patients with serious or immediately life-threatening diseases to obtain investigational therapies outside of traditional clinical trials when certain conditions are met.
Who is the target patient population?
The focus is on an intermediate-sized group of ALS patients who are excluded from ongoing ALS clinical trials and therefore cannot enroll in those trials. The NOFO is aimed at enabling access for these patients while also collecting structured research data.
Is this opportunity focused on traditional clinical trials or expanded access?
The research is organized around expanded access use rather than standard randomized enrollment, but it is still labeled "Clinical Trial Required." Applicants should expect to include a clinical trial component and propose structured protocols for treatment and data collection that fit within expanded access regulatory and ethical constraints.
What award mechanism is used?
The mechanism is a U01 cooperative agreement. This generally indicates the NIH expects substantial scientific or programmatic involvement during the project rather than a fully hands-off approach.
What does "Clinical Trial Required" imply for applicants?
It signals that the funded work must include a clinical trial component. Even though the activity centers on expanded access, applicants should plan for structured protocols that allow the expanded access experience to yield interpretable outcomes and safety information.
Who is eligible to apply in practice?
Eligibility is specialized. Applicants must be clinical trial sites that are already participating in a phase 2/3 or phase 3 efficacy clinical trial intended to generate pivotal data in support of a marketing application for an ALS investigational drug or biological product.
Are there additional eligibility requirements tied to the drug sponsor?
Yes. The pivotal phase 2/3 or phase 3 efficacy trial must be supported by a small business concern that is the FDA-designated sponsor of the investigational drug or biological product. The therapy must also be under an active Investigational New Drug (IND) application under Section 505(i) of the FD&C Act (21 U.S.C. 355(i)).
How is "small business concern" defined for this program?
The NOFO points to the Small Business Act definition of a small business concern (15 U.S.C. 632(a)). The description indicates the program is meant to connect expanded access research with products being developed by qualifying small businesses that hold FDA sponsor responsibilities.
The NIH applicant categories list many organization types. Does that mean any of them can apply?
While the general NIH applicant categories include a wide range of domestic entities, the practical eligibility gate described in the NOFO is that the applicant must be a clinical trial site participating in the relevant pivotal phase 2/3 or phase 3 ALS study tied to an FDA-designated small business sponsor. Many organization types could theoretically apply, but only those meeting these specific conditions would be eligible.
Are foreign organizations allowed to apply?
No. Non-U.S. entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed.
Can a U.S. organization include foreign components or non-U.S. subcomponents?
No. The information provided states that non-U.S. components of U.S. organizations are not eligible and that foreign components are not allowed. The expanded access activities, oversight, and data collection would need to be entirely U.S.-based without foreign subcomponents.
What kinds of investigational products are in scope?
The opportunity supports expanded access use of investigational drugs or biological products for ALS that are in active late-stage development and tied to a pivotal phase 2/3 or phase 3 efficacy trial, with the product under an active IND.
What stage of clinical development is required for the linked trial?
The applicant must be participating in a phase 2/3 or phase 3 efficacy clinical trial intended to generate pivotal data in support of a marketing application.
What is the relationship between expanded access activities and the pivotal trial?
The expanded access research is meant to be built around an investigational therapy that is already being studied in a pivotal phase 2/3 or phase 3 trial. The expanded access effort targets ALS patients who cannot enroll in that or other ongoing trials, while capturing structured data that can add to the evidence base.
How many awards does NIH expect to make?
The posting anticipates about four awards.
What is the application due date listed in the posting?
The information provided indicates an original application closing date of 2026-11-10.
Is an award budget ceiling provided in the information given?
No award ceiling is provided in the text supplied. Applicants would need to consult the full NOFO for budget constraints, allowable costs, and any caps or modular budget requirements.
What is the CFDA number and activity category?
The opportunity is in the health activity category and lists CFDA number 93.853.
What does it mean that the opportunity is categorized as discretionary funding?
The posting categorizes it as discretionary funding. The provided text does not add further details beyond that classification.
Why is NIH focusing on expanded access for ALS in this program?
The program is designed to address a gap where ALS patients who are not eligible for traditional clinical trials still seek access to investigational therapies. NIH is using a cooperative agreement approach to ensure expanded access use is paired with deliberate, rigorous data collection that can inform late-stage ALS product development.
Browse more opportunities from the same category: Health
Next opportunity: DoW Vision, Mentored Clinical Research Award
Previous opportunity: Notice of Intent (NOI) DE-FOA-0003607, is to Issue Notice of Funding Opportunity (NOFO) No. DE-FOA-0003606, titled, "Improving Efficiency, Reliability, and Flexibility of Coal-Based Power Plants"
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA NS 26 001
Applicants also applied for:
Applicants who have applied for this opportunity (RFA NS 26 001) also looked into and applied for these:
| Funding Opportunity |
|---|
| Bioengineering Research Grants (BRG) (R01 Clinical Trial Optional) Apply for PAR 27 072 Funding Number: PAR 27 072 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Maximizing Investigators’ Research Award (MIRA) for Early Stage Investigators (ESI) Apply for PAR 27 032 Funding Number: PAR 27 032 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| INCLUDE Project: Exploratory/Developmental Research Awards for Down syndrome (R21 Clinical Trial Not Allowed) Apply for RFA OD 27 003 Funding Number: RFA OD 27 003 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required) Apply for RFA OD 27 005 Funding Number: RFA OD 27 005 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| INCLUDE Project: Transformative Research Awards for Down syndrome (R01 Clinical Trial Not Allowed) Apply for RFA OD 27 004 Funding Number: RFA OD 27 004 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Discovery of in vivo Chemical Probes for the Nervous System (R01 Clinical Trial Not Allowed) Apply for PAR 27 081 Funding Number: PAR 27 081 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21) Apply for RFA OH 26 015 Funding Number: RFA OH 26 015 Agency: Centers for Disease Control and Prevention - ERA Category: Health Funding Amount: $365,000 |
| Coccidioidomycosis Collaborative Research Centers (P01 Clinical Trial Not Allowed) Apply for RFA AI 27 012 Funding Number: RFA AI 27 012 Agency: National Institutes of Health Category: Health Funding Amount: $1,200,000 |
| Garrett Lee Smith State/Tribal Youth Suicide Prevention and Early Intervention Program Apply for SM 26 010 Funding Number: SM 26 010 Agency: Substance Abuse and Mental Health Services Adminis Category: Health Funding Amount: $735,000 |
| Community Programs for Youth and Young Adults at Clinical High Risk for Psychosis Apply for SM 26 012 Funding Number: SM 26 012 Agency: Substance Abuse and Mental Health Services Adminis Category: Health Funding Amount: $650,000 |
| Enhancing Understanding of and Preparedness for Public Health Threats Through Research in Kenya Apply for RFA JG 26 034 Funding Number: RFA JG 26 034 Agency: Centers for Disease Control and Prevention - ERA Category: Health Funding Amount: $6,000,000 |
| Tuberculosis Research Advancement Centers (TRACs) (P30 Clinical Trial Not Allowed) Apply for RFA AI 27 016 Funding Number: RFA AI 27 016 Agency: National Institutes of Health Category: Health Funding Amount: $600,000 |
| Providers Clinical Support System – Substance Use Disorder Treatment (PCSS-SUD Treatment) Apply for TI 26 002 Funding Number: TI 26 002 Agency: Substance Abuse and Mental Health Services Adminis Category: Health Funding Amount: $3,000,000 |
| Disaster Distress Helpline (Short Title: DDH) Apply for SM 26 011 Funding Number: SM 26 011 Agency: Substance Abuse and Mental Health Services Adminis Category: Health Funding Amount: $1,953,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA NS 26 001", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.