Opportunity Information: Apply for RFA NS 25 024
This funding opportunity (RFA-NS-25-024) is a National Institutes of Health (NIH) cooperative agreement (U01) led by the National Institute of Neurological Disorders and Stroke (NINDS) in partnership with the NIH Office of the Director. Its core purpose is to support research that uses data generated through expanded access (EA) to investigational drugs or biologics for people living with amyotrophic lateral sclerosis (ALS). The emphasis is specifically on an "intermediate-size" patient population: individuals who do not qualify for traditional clinical trials, but who may be able to receive an investigational product through an intermediate expanded access protocol. In practical terms, the program is trying to create a structured, research-ready way to learn from expanded access use in ALS, rather than treating EA as purely compassionate use with limited systematic data collection.
A central requirement of the program is that providing an investigational drug or biologic under this intermediate EA approach must not disrupt or slow down the clinical development pathway that could lead to FDA marketing approval. NIH is signaling that expanded access must be conducted in a way that does not interfere with initiation, enrollment, conduct, or completion of the pivotal trials (or other studies) needed to establish safety and effectiveness. The goal is to strike a balance: broaden access for patients who lack trial options while protecting the integrity and feasibility of the clinical investigations that ultimately determine whether a therapy becomes widely available.
Eligibility is relatively specific. The intended applicants are clinical trial sites that are already participating in a Phase 3 clinical trial for an ALS investigational product. That Phase 3 trial must be supported by a U.S. small business, and that small business must also be the FDA-designated sponsor of the investigational drug or biologic and hold the relevant Investigational New Drug (IND) application. This structure effectively ties the expanded access research to a product that is already in late-stage testing and to an established sponsor responsible for regulatory oversight, safety reporting, and IND obligations. The notice also indicates NIH wanted to give potential applicants time to build meaningful collaborations, which matters here because these projects require close coordination among clinical sites, the product sponsor, regulatory teams, and data management groups.
The mechanism is a U01 cooperative agreement, which typically means NIH expects substantial scientific and programmatic involvement during the project, not just a hands-off grant. While the text does not spell out the full set of required activities, the intent is clear: applicants would be expected to implement or operate an intermediate expanded access protocol for ALS and simultaneously conduct scientific research using the data produced through that access. That often implies more formalized data collection than is typical in ad hoc compassionate use, such as consistent clinical outcome measures, safety monitoring, standardized case report forms, and plans for data quality and analysis that can produce interpretable evidence (while still recognizing that EA is not the same as a randomized controlled trial).
From an applicant-type standpoint, the opportunity is listed under NIH with a health focus (CFDA 93.853) and is categorized as discretionary funding using a cooperative agreement instrument. The eligibility list in the source data is broad and includes many domestic entity types, such as state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including but not limited to small businesses), public housing authorities, and Native American tribal governments and organizations. It also explicitly mentions certain institution types (for example, HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISISs), as well as faith-based and community-based organizations and U.S. territories or possessions. However, foreign organizations are not eligible to apply, and foreign components of U.S. organizations are not allowed, consistent with NIH restrictions stated in the notice.
Key administrative details from the listing include the funding opportunity title "Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)," the funding opportunity number RFA-NS-25-024, and the NIH as the issuing agency. The original closing date in the provided source data is 2025-01-24, and the record shows a creation date of 2024-09-26. The award ceiling and expected number of awards are not specified in the excerpt you provided, so applicants would need to consult the full FOA package for budget limits, project period expectations, and the anticipated number of funded sites or awards.
Overall, this opportunity is aimed at building a careful bridge between patient need and product development in ALS: enabling access for patients who cannot join trials, while producing usable, responsibly collected data and ensuring expanded access does not undermine the clinical trials needed for eventual regulatory approval.Apply for RFA NS 25 024
- 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 2024-09-26.
- Applicants must submit their applications by 2025-01-24. (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)
1) What is the funding opportunity number and title?
The funding opportunity number is RFA-NS-25-024. The title is "Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)."
2) 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.
3) What type of award is this?
This opportunity uses a cooperative agreement (U01) mechanism, which generally means NIH expects substantial scientific and programmatic involvement during the project (not a fully hands-off grant).
4) What is the main purpose of this program?
The core purpose is to support research that uses data generated through expanded access (EA) to investigational drugs or biologics for people living with amyotrophic lateral sclerosis (ALS). The program is designed to make expanded access more structured and research-ready, rather than treating EA as purely compassionate use with limited systematic data collection.
5) Who is the program trying to help (what is the "intermediate-size" patient population)?
The focus is on an "intermediate-size" patient population: individuals with ALS who do not qualify for traditional clinical trials, but who may be able to receive an investigational product through an intermediate expanded access protocol.
6) What does "expanded access" mean in this context?
In this opportunity, expanded access refers to providing an investigational drug or biologic to certain patients with ALS outside of a traditional clinical trial, while also collecting data in a systematic way so that the experience can contribute to research understanding.
7) Why is NIH emphasizing research-quality data collection from expanded access?
The emphasis is to create a structured way to learn from expanded access use in ALS. The intent is that data generated through intermediate EA can be collected more consistently (for example, with standardized outcomes and monitoring) so it is more usable for scientific analysis, recognizing that EA is still different from a randomized controlled trial.
8) What is a central requirement regarding clinical development and FDA approval?
A central requirement is that providing an investigational drug or biologic under this intermediate EA approach must not disrupt or slow down the clinical development pathway that could lead to FDA marketing approval.
9) What does it mean to "not disrupt" clinical development?
NIH is signaling that expanded access must be conducted in a way that does not interfere with the initiation, enrollment, conduct, or completion of pivotal trials (or other studies) needed to establish safety and effectiveness for regulatory decision-making.
10) Who is intended to apply for this opportunity?
The intended applicants are clinical trial sites that are already participating in a Phase 3 clinical trial for an ALS investigational product, under the specific sponsor and IND structure described in the notice.
11) What Phase of clinical trial must be involved?
The relevant clinical trial is a Phase 3 clinical trial for an ALS investigational product.
12) What are the requirements related to the product sponsor?
The Phase 3 trial must be supported by a U.S. small business, and that small business must also be the FDA-designated sponsor of the investigational drug or biologic and hold the relevant Investigational New Drug (IND) application.
13) Why does the opportunity tie eligibility to a U.S. small business sponsor holding the IND?
Based on the description provided, this structure connects the expanded access research to a product already in late-stage testing and to an established sponsor responsible for regulatory oversight, safety reporting, and IND obligations.
14) What kinds of activities are applicants expected to carry out?
While the full set of required activities is not spelled out in the excerpt, the intent is that awardees would implement or operate an intermediate expanded access protocol for ALS and simultaneously conduct scientific research using data produced through that expanded access.
15) What kinds of data collection practices are implied for this expanded access research?
The opportunity implies more formalized data collection than typical ad hoc compassionate use. Examples described include: consistent clinical outcome measures, safety monitoring, standardized case report forms, and plans for data quality and analysis aimed at producing interpretable evidence.
16) Is expanded access treated as the same as a randomized controlled trial under this program?
No. The description recognizes that expanded access is not the same as a randomized controlled trial, even though the program aims for systematic and interpretable data collection.
17) What organizations are eligible to apply?
The listing includes a broad set of domestic entity types, including (as described): state and local governments; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit organizations (including small businesses); public housing authorities; Native American tribal governments and organizations; and U.S. territories or possessions. It also explicitly mentions certain institution types (for example, HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISISs), as well as faith-based and community-based organizations.
18) Are foreign organizations eligible to apply?
No. Foreign organizations are not eligible to apply under this opportunity.
19) Are foreign components of U.S. organizations allowed?
No. The notice states that foreign components of U.S. organizations are not allowed, consistent with NIH restrictions referenced in the description.
20) What is the CFDA number and general category of funding?
The opportunity is listed under NIH with a health focus and includes CFDA 93.853. It is categorized as discretionary funding using a cooperative agreement instrument.
21) What is the application deadline (closing date) shown in the listing?
The original closing date shown in the provided source data is 2025-01-24.
22) When was this record created?
The record shows a creation date of 2024-09-26.
23) Are award ceiling amounts or the expected number of awards provided here?
No. The excerpt provided does not specify the award ceiling or the expected number of awards. Applicants would need to consult the full FOA package for budget limits, project period expectations, and the anticipated number of funded sites or awards.
24) What is the overall program goal in plain terms?
The overall goal is to build a careful bridge between patient need and product development in ALS: expand access for patients who cannot join trials, collect responsibly structured data from that use, and ensure the expanded access effort does not undermine the clinical trials needed for eventual regulatory approval.
25) Why does collaboration matter for these projects?
The description indicates NIH wanted to give potential applicants time to build meaningful collaborations, because these projects require close coordination among clinical sites, the product sponsor, regulatory teams, and data management groups.
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