Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)
Status: Forecasted
Posted date: September 22, 2025
Archive date: August 25, 2028
Close date: July 20, 2028
Opportunity ID: 359645
Opportunity number: PAR-25-450
Opportunity category: Discretionary
Agency name: National Institutes of Health
Agency code: HHS-NIH11
Award floor: $0
Award ceiling: $0
Cost sharing required: No
Funding Instrument Types
- Grant
Category of Funding Activity
- Health
- Income Security and Social Services
Eligible Applicants
- 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 tribal governments)
- Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of 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
Categories (use these for quoted searches)
- agency_code:hhs_nih11
- category_of_funding_activity:health
- category_of_funding_activity:income_security_and_social_services
- cost_sharing_or_matching_requirement:false
- eligible_applicants:city_or_township_governments
- eligible_applicants:county_governments
- eligible_applicants:for_profit_organizations_other_than_small_businesses
- eligible_applicants:independent_school_districts
- eligible_applicants:native_american_tribal_governments_federally_recognized
- eligible_applicants:native_american_tribal_organizations_other_than_federally_recognized_tribal_governments
- eligible_applicants:nonprofits_having_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
- eligible_applicants:nonprofits_that_do_not_have_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
- eligible_applicants:others
- eligible_applicants:private_institutions_of_higher_education
- eligible_applicants:public_and_state_controlled_institutions_of_higher_education
- eligible_applicants:public_housing_authoritiesindian_housing_authorities
- eligible_applicants:small_businesses
- eligible_applicants:special_district_governments
- eligible_applicants:state_governments
- funding_instrument_type:grant
- opportunity_category:discretionary
- status:forecasted
This Notice of Funding Opportunity (NOFO) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare diseases research by enabling efficient and effective movement of candidate therapeutics or diagnostics toward clinical trials, and to increase their likelihood of success. This could be through the development and testing of rigorous biomarkers and clinical outcome assessment measures, or by defining the presentation and course of a rare disease to enable the design of upcoming clinical trials.