Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Forecasted Federal grant Posted
- Opportunity number
- RFA-NS-28-009
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications expected due
- Award size
- Not on record
Opportunity facts
- Expected posting
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Private)
- Higher Education Inst. (Public)
- 501(c)(3) Nonprofits
- State Governments
- Tribal Organizations (Not Federally Recognized)
- Tribal Governments (Federally Recognized)
- County Governments
- Other
- For Profit Organizations
- City/Township Governments
- Small Businesses
- Special District Governments
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institute of Neurological Disorders and Stroke (NINDS) is forecasting support for scientific research utilizing data from intermediate-size patient population expanded access protocols for ALS, with a cooperative agreement mechanism and no current application due date. Eligible applicants must be clinical trial sites that participate in a phase 2/3 or phase 3 efficacy clinical trial sponsored by a U.S.-based small business concern that holds FDA designation as the sponsor of a drug or biological product under an IND to prevent, diagnose, mitigate, treat, or cure ALS. Foreign organizations and non-domestic components of U.S. organizations are ineligible.
Eligible applicant types include higher education institutions (public and private), 501(c)(3) and non-501(c)(3) nonprofits, state and tribal governments (federally and non-federally recognized), county and city/township governments, special district governments, for-profit organizations, and small businesses. No cost share requirement is specified.
Supported intermediate expanded access protocols for ALS must provide access to an investigational drug or biological product for people with ALS and generate data to support ALS research. Scientific research goals may include investigation of the investigational drug's or biological product's effect on biomarkers related to ALS pathophysiology or target engagement, collection of safety or outcome information (survival, hospitalization, or need for ventilatory support), or patient experience data not specifically tied to assessing efficacy.
Research grants requesting $500,000 or more in direct costs in any yearly budget period require prior NINDS agreement to submit. The opportunity is assigned to CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). Applications are not currently being solicited; this notice provides prospective applicants time to develop responsive projects.
Forecast synopsis
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.
Eligibility
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.
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