The National Institutes of Health (NIH), specifically the National Institute of Neurological Disorders and Stroke (NINDS), has announced the Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) funding opportunity, identified by RFA-NS-24-029. This initiative aims to support scientific research utilizing data from expanded access to investigational drugs or biological products for ALS, targeting intermediate size populations of ALS patients who are not eligible for clinical trials. The program’s primary focus is on the diagnosis, mitigation, treatment, or cure of ALS.
The eligibility for this funding opportunity extends to various entities, including private and public educational institutions, government bodies at different levels, non-profit organizations, small businesses, and more. The program seeks to ensure that providing investigational drugs or biological products under this initiative does not interfere with ongoing clinical investigations that could support marketing approval. This initiative represents a crucial step towards advancing ALS research and treatment options, providing a platform for collaborations and projects that can significantly impact the lives of individuals living with ALS.
Opportunity ID: 351077
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-24-029 |
| 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: | |
| CFDA Number(s): | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 21, 2023 |
| Last Updated Date: | Nov 21, 2023 |
| Original Closing Date for Applications: | Feb 22, 2024 |
| Current Closing Date for Applications: | Feb 22, 2024 |
| Archive Date: | Mar 29, 2024 |
| Estimated Total Program Funding: | |
| Award Ceiling: | $ |
| Award Floor: | $ |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Private institutions of higher education County governments For profit organizations other than small businesses Independent school districts Native American tribal governments (Federally recognized) City or township governments Public housing authorities/Indian housing authorities Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not otherwise eligible for clinical trials for the diagnosis, mitigation, treatment, or cure of ALS (“intermediate EA protocol for ALS”). Providing the investigational drug or biological product under an intermediate EA protocol for ALS must not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval, or otherwise compromise the potential development of medical products for the diagnosis, mitigation, treatment, or cure of ALS. Eligible applicants are clinical trial sites that participate in a phase 3 clinical trial supported by a United States (U.S.) small business concern (as defined in section 3(a) of the Small Business Act (15 U.S. C. 623(a)) that is also the U.S. Food and Drug Administration (FDA) designated sponsor of a drug or biological product for ALS that is the subject of an Investigational New Drug Application (IND). This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in May 2022 with an expected application due date in June 2022. This FOA will utilize the U01 activity code. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-029.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact: NIH Grants Information
grantsinfo@nih.gov |