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

Eligibility

Nonprofits are listed as eligible applicants.

• Native American tribal organizations (other than Federally recognized tribal governments)
• Others (see text field entitled "Additional Information on Eligibility" for clarification)
• City or township governments
• Public and state controlled institutions of higher education
• Private institutions of higher education
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• Small businesses
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• State governments
• Special district governments
• County governments
• For profit organizations other than small businesses
• Native American tribal governments (Federally recognized)

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.