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

Background
The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), are promoting a new initiative to solicit applications for scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. The initiative targets intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not eligible for ongoing clinical trials for the diagnosis, mitigation, treatment, or cure of ALS.

Grant Details
The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for the conduct of scientific research utilizing data from expanded access (EA) for investigational drugs or biological products. The applications will target EA for intermediate size populations of patients living with ALS who are not eligible for ongoing clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of ALS.
The FOA will utilize the U01 activity code. The FOA encourages studies that lead to findings applicable to all people affected by ALS. It requires a recruitment and retention plan designed to overcome obstacles to study participation and a Data and Safety Monitoring Plan (DSMP) following NINDS Guidelines for Data and Safety Monitoring in Clinical Trials.

Eligibility Requirements
Eligible applicants must be clinical trial sites that participate in a phase 3/efficacy clinical trial supported by a small business concern that is the FDA-designated sponsor of a drug or biological product which is the subject of an Investigational New Drug Application (IND). 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 Institutions are not eligible to apply.

Period of Performance
The FOA is expected to be published in May 2022 with an expected application due date in June 2022.
The project period can be up to 4 years with an earliest start date in May 2023.

Grant Value
NINDS intends to commit up to $75,000,000 in FY 2023 to fund 3-5 awards.