Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)

This program funds clinical projects that improve readiness for future clinical trials in rare diseases by validating biomarkers or clinical outcome measures, or by defining disease natural history and patient characteristics needed for trial design. It does not fund clinical trials, biomarker discovery, assay characterization, standalone patient registries, new trial networks, or intervention studies focused on safety, pharmacokinetics, efficacy, or effectiveness. Eligible applicants include U.S. higher education institutions, nonprofits, for-profits, governments, tribal organizations, faith-based or community-based organizations, and foreign organizations are not eligible; foreign components are not allowed. Awards may request up to $275,000 in direct costs for a 2-year project period, with no more than $200,000 in direct costs in any single year, and cost sharing is not required.

✳ AI-generated summary — verify against the announcement

• Health
• Income Security and Social Services
• Research & Discovery
• Patients & People with Health Conditions
• Researchers & Scholars
• Biomedical & Disease Research

• ✓ City or township governments
• ✓ County governments
• ✓ For-profit organizations other than small businesses
• ✓ Independent school districts
• ✓ Native American tribal governments (Federally recognized)
• ✓ Native American tribal organizations (other than Federally recognized)
• ✓ Nonprofits with 501(c)(3) status (other than higher education)
• ✓ Nonprofits without 501(c)(3) status (other than higher education)
• ✓ Others
• ✓ Private institutions of higher education
• ✓ Public and State controlled institutions of higher education
• ✓ Public housing authorities / Indian housing authorities
• ✓ Small businesses
• ✓ Special district governments
• ✓ State governments