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Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

ID: RFA-NS-28-009 • Type: Forecasted
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Description

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting the conduct of scientific research utilizing data from intermediate-size patient population expanded access protocols for ALS ("intermediate expanded access protocol for ALS", see Expanded Access Categories for Drugs (Including Biologics)). Eligible intermediate expanded access protocols for ALS should: 1) provide access to an investigational drug or biological product for people with ALS, and 2) generate data to support research on the prevention, diagnosis, mitigation, treatment, or cure of ALS. The scientific research goal(s) informed by these data could include the investigational drug's or biological product's effect on biomarkers related to the pathophysiology of ALS or target engagement, the collection of safety or outcome information, such as survival or other significant medical events (e.g., hospitalization or need for ventilatory support), or patient experience data that are not specifically tied to assessing efficacy.

Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop responsive projects.

Overview

Category of Funding
Health
Funding Instruments
Cooperative Agreement
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
On 9/23/26 the National Institutes of Health forecasted grant opportunity RFA-NS-28-009 for Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required). The grant will be issued under grant program 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.

Timing

Forecast Posted Date
Est. Application Posting Date
Est. Synopsis Response Date
Forecasted
Last Updated
Version
1

Eligibility

Eligible Applicants
Small businesses
Special district governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Native American tribal governments (Federally recognized)
Private institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
County governments
Public and State controlled institutions of higher education
For profit organizations other than small businesses
State governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Info
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 establish substantial evidence of effectiveness in support of a marketing application) supported by a U.S. based 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.

Contacts

Contact
ALS Program

Documents

Posted documents for RFA-NS-28-009

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