Opportunity Information: Apply for RFA NS 23 012
This funding opportunity, titled "Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)" (RFA-NS-23-012), is an NIH initiative led by the National Institute of Neurological Disorders and Stroke (NINDS) in partnership with the NIH Office of the Director. Its central goal is to support scientific research that uses data generated when patients with ALS receive investigational drugs or biological products through expanded access (EA), specifically under an "intermediate-size patient population" EA protocol. In practical terms, it is aimed at people living with ALS who cannot enroll in traditional clinical trials, while still allowing structured access to an investigational therapy and enabling researchers to learn from the resulting clinical data.
A key feature of the program is the requirement that expanded access activities must not disrupt, delay, or undermine the standard clinical development pathway. The FOA emphasizes that providing an investigational product via an intermediate EA protocol cannot interfere with the initiation, conduct, or completion of clinical investigations that could support FDA marketing approval. In other words, the expanded access effort has to be designed so it complements ongoing development rather than competes with or compromises pivotal trials, data integrity, enrollment feasibility, or the overall prospects for eventual product approval.
The eligible applicant pool is specialized. The primary intended applicants are clinical trial sites that are already participating in a Phase 3 clinical trial for an ALS investigational product, where that Phase 3 trial is supported by a U.S. small business concern, and that small business is also the FDA-designated sponsor of the ALS drug or biologic under an active Investigational New Drug (IND) application. This structure signals that NIH wants these expanded access research efforts tightly aligned with late-stage development programs and coordinated with the IND sponsor, likely to ensure regulatory consistency, appropriate safety oversight, and well-defined data capture.
The award mechanism is a U01 cooperative agreement, which generally means NIH expects substantial scientific and/or programmatic involvement during the project (for example, coordination around study conduct, milestones, data standards, and oversight). The opportunity is categorized under Health (CFDA 93.853) and is listed as a discretionary funding opportunity. While the full list of potentially eligible applicant types in the source data includes a wide range of domestic entities (such as state and local governments, public and private institutions of higher education, nonprofits with and without 501(c)(3) status, for-profit organizations other than small businesses, and small businesses), the narrative description makes clear that, for responsiveness, applicants should fit the specific scenario of being a Phase 3 ALS trial site linked to a U.S. small business that is the FDA-designated IND sponsor for the product being provided through expanded access.
The FOA also highlights inclusion of certain institution types and organizations that NIH often calls out for eligibility and participation, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. However, foreign participation is explicitly restricted: non-U.S. entities (foreign organizations/institutions) may not apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.
From an operational standpoint, the initiative is positioned as both an access and a research effort. Applicants are expected to conduct research using data that arise from the expanded access use of investigational ALS therapies in an intermediate-size patient population. The intent is to learn from real-world use in patients who are otherwise excluded from trials, while maintaining appropriate safeguards so that the expanded access program does not compromise the broader clinical evidence base needed for regulatory review. The original notice language indicates NIH provided early visibility so prospective teams could build collaborations and design projects; the source record lists an original closing date of 2023-05-01 and a creation date of 2023-01-09. The award ceiling and expected number of awards are not specified in the provided source text.Apply for RFA NS 23 012
- 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 2023-01-09.
- Applicants must submit their applications by 2023-05-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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.
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Frequently Asked Questions (FAQs)
What is the title and number of this funding opportunity?
The funding opportunity is titled "Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)" and is identified as RFA-NS-23-012.
Which agency is offering this opportunity?
This is an NIH funding opportunity led by the National Institute of Neurological Disorders and Stroke (NINDS) in partnership with the NIH Office of the Director.
What is the main purpose of this program?
The central goal is to support scientific research that uses data generated when people with ALS receive an investigational drug or biological product through expanded access (EA), specifically under an "intermediate-size patient population" expanded access protocol.
What does "expanded access" mean in the context provided?
Expanded access refers to providing patients access to an investigational drug or biologic outside a traditional clinical trial setting. In this FOA, the expanded access activity is tied to research use of the clinical data generated while patients receive the investigational product.
What does "intermediate-size patient population" expanded access refer to?
Based on the information provided, the FOA is focused on expanded access delivered under an intermediate-size patient population protocol, meaning it is intended to serve a group of patients (not just a single individual) who receive the investigational ALS therapy via expanded access.
Who is the program intended to help, in practical terms?
It is aimed at people living with ALS who cannot enroll in traditional clinical trials, while still enabling structured access to an investigational therapy and allowing researchers to learn from the resulting clinical data.
Is this opportunity focused on access, research, or both?
Both. The initiative is positioned as an access and a research effort: it supports expanded access use of an investigational ALS therapy while requiring research that uses the data arising from that expanded access experience.
What award mechanism is being used?
The award mechanism is a U01 cooperative agreement.
What does it mean that this is a U01 cooperative agreement?
A U01 cooperative agreement generally means NIH expects substantial scientific and/or programmatic involvement during the project. The FOA description indicates this may include coordination around study conduct, milestones, data standards, and oversight.
Does the FOA require a clinical trial?
Yes. The title includes "Clinical Trial Required," and the program description centers on expanded access under an intermediate-size patient population protocol with research use of the resulting data.
What is a key requirement about how expanded access must relate to traditional clinical development?
A key feature is that expanded access activities must not disrupt, delay, or undermine the standard clinical development pathway for the investigational product.
What does "must not disrupt, delay, or undermine" mean in this FOA?
The FOA emphasizes that providing the investigational product via intermediate-size expanded access cannot interfere with the initiation, conduct, or completion of clinical investigations that could support FDA marketing approval. The expanded access effort must complement ongoing development rather than compete with or compromise pivotal trials, data integrity, enrollment feasibility, or the overall prospects for eventual product approval.
Who are the primary intended applicants?
The primary intended applicants are clinical trial sites that are already participating in a Phase 3 clinical trial for an ALS investigational product, where that Phase 3 trial is supported by a U.S. small business concern, and where that small business is also the FDA-designated sponsor under an active IND for the ALS drug or biologic.
How is the small business involved, according to the FOA description?
The Phase 3 ALS trial site is expected to be linked to a U.S. small business concern that supports the Phase 3 trial and is also the FDA-designated sponsor of the investigational product under an active IND application.
Why does the FOA emphasize alignment with the IND sponsor and late-stage development?
The description indicates NIH wants expanded access research efforts tightly aligned with late-stage development programs and coordinated with the IND sponsor, likely to support regulatory consistency, appropriate safety oversight, and well-defined data capture while not compromising the pathway toward potential FDA marketing approval.
Does the FOA list broader categories of eligible applicants?
Yes. The provided source text notes that the full list of potentially eligible applicant types includes a wide range of domestic entities (such as state and local governments, public and private institutions of higher education, nonprofits with and without 501(c)(3) status, for-profit organizations other than small businesses, and small businesses).
If many entity types are listed as eligible, what determines whether an application is responsive?
Even though many domestic entity categories are listed, the narrative description makes clear that for responsiveness, applicants should fit the specific scenario described: a Phase 3 ALS trial site linked to a U.S. small business that is the FDA-designated IND sponsor for the product being provided via expanded access.
Are foreign organizations allowed to apply?
No. Foreign participation is explicitly restricted: non-U.S. entities may not apply.
Are non-U.S. components of U.S. organizations eligible?
No. The FOA information provided states that non-U.S. components of U.S. organizations are not eligible.
Are foreign components allowed under NIH policy for this opportunity?
No. The FOA information provided states that foreign components (as defined by NIH policy) are not allowed.
Does the FOA mention particular institution types encouraged or highlighted for eligibility and participation?
Yes. It highlights institution types and organizations NIH often calls out, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
What disease area and programmatic focus does this opportunity fall under?
It is focused on amyotrophic lateral sclerosis (ALS) and on generating research insights from investigational ALS therapies provided through expanded access to an intermediate-size patient population.
What is the CFDA number and category listed?
The opportunity is categorized under Health with CFDA 93.853 and is listed as a discretionary funding opportunity.
What kinds of products are covered (drug vs biologic)?
The description covers investigational drugs or biological products (biologics) for ALS.
What type of data is NIH expecting applicants to use?
Applicants are expected to conduct research using data that arise from the expanded access use of investigational ALS therapies in an intermediate-size patient population.
Is the funding opportunity designed to replace or serve as an alternative to pivotal clinical trials?
No. The FOA explicitly stresses that expanded access must not interfere with clinical investigations that could support FDA marketing approval. The expanded access effort must be designed to complement, not compromise, the development program.
Does the provided information specify an award ceiling or number of awards?
No. The award ceiling and expected number of awards are not specified in the provided source text.
What dates are provided for this opportunity?
The source record lists a creation date of 2023-01-09 and an original closing date of 2023-05-01.
Why did NIH provide early visibility about this opportunity?
The notice language indicates NIH provided early visibility so prospective teams could build collaborations and design projects aligned with the program requirements.
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