Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Supports clinical-trial-site research using expanded access data for investigational ALS drugs or biologics in intermediate-sized ALS patient populations not eligible for ongoing efficacy trials.
RESTRICTED TO: SMALL BUSINESS SBIR STTR
⚑ Applicant must be a clinical trial site participating in a phase 2/3 or phase 3 efficacy trial supported by a small business concern that is the FDA-designated sponsor of the ALS product. · Foreign organizations, non-domestic components, and foreign components are not allowed. · U01 cooperative agreement; clinical trial required.
Unit fits — one characterization, each unit's own rules
| Tom Love Innovation Hub | 75 strong | SBIR/STTR — core Hub pipeline (faculty founders + small-business partners); funds applied research; deep-tech content |
| Physical Sciences & Engineering (demo) | 65 good | technical depth: substantial; funds applied research |
| IPPRA | 50 partial | peripheral portfolio topic: public_health; social/behavioral work is minor; funds applied research; university can only partner, not lead; biomedical core — IPPRA health lane is communication/crisis/policy (capped); clinical-trial/biomedical core — IPPRA angle is policy/community (capped) |
Description
The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) for investigational drugs or biological products as described in section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb). These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not eligible for ongoing clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of ALS.
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on 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 support a marketing application) supported by a 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.
Apply
View on Grants.gov → CONTACT: National Institutes of Health <NINDSALSMailbox@mail.nih.gov>
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