Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required

Federal funding opportunity RFA-FD-23-001 from Food and Drug Administration (Department of Health and Human Services).

Program funding history

Synopsis

Who can apply

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

Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions)Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

The official record

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