Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
Applications close Feb 8, 2028
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- Agency
- Stephanie Bogan Grantor
- Opportunity number
- RFA-FD-25-017
- Posted
- Jul 11, 2025
- Closes
- Feb 8, 2028
- Award ceiling
- $600,000
- Cost sharing required
- false
About this opportunity
The purpose of this notice of funding opportunity (NOFO) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.
Who can apply
Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationNonprofits 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)Local GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)Federal Governments 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 Organizations)Foreign OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
How to apply
- 1Register your organization
Applications are submitted by your institution, not individuals. Make sure your organization has an active SAM.gov registration (with a UEI) and a Grants.gov account with an Authorized Organization Representative.
- 2Read the full notice
Open the official notice for the complete eligibility rules, review criteria, page limits, and required forms. Applications close Feb 8, 2028.
- 3Download the application package
From the Grants.gov opportunity page, download the package (or apply via your agency's system where required) and prepare each component.
- 4Build and submit
Prepare the budget and narrative, route for institutional sign-off, and submit before the deadline: GrantsManager can track every step for you.
Agency contact: Stephanie Bogan Grantor · Kimberly.Pendleton@fda.hhs.gov
Details are pulled from Grants.gov and can change, always confirm against the official notice. GrantsManager isn't affiliated with these agencies.
Resources for applying
- Proposal submission checklist
A pre-submission checklist for research proposals: solicitation review, internal routing, budget, compliance, and sponsor-system steps to hit the deadline cleanly.
- Direct vs. indirect costs
The difference between direct and indirect costs on research grants, with examples of each, the gray areas like administrative salaries, and how indirect costs are calculated from your F&A rate.
- Reading your Notice of Award
The parts of a Notice of Award that determine what you can spend, when, and what needs prior approval, plus the terms that cause disallowed costs if missed.
- Grant Budget Template
A five-year research grant budget in Excel that calculates fringe, the NIH salary cap, the MTDC base, and F&A automatically.
- Budget Justification Template
A free budget justification (budget narrative) template for research grants, organized by the federal R&R budget categories, with example language for personnel, fringe, equipment, travel, other direct costs, subawards, and F&A.
- Grant Letter of Intent Template
A free grant letter of intent (LOI) template with two versions: the short NIH letter of intent requested in many funding opportunities, and a foundation LOI that pitches the project before a full proposal.
- Letter of Support Template for Grant Applications
A free letter of support template for NIH and other research grant applications, with collaborator and consultant versions, what NIH asks letters to include, and how NIH's move to letters of collaboration affects them.
- F&A & MTDC calculator
Build the Modified Total Direct Cost base, apply your F&A rate, and see total direct costs, indirect costs, and the full award total, with the usual MTDC exclusions handled.
- Grant burn rate
Compare the share of a grant spent and encumbered with the share of the award period elapsed, see the average monthly burn, the monthly spend needed to finish on budget, and the projected run-out date.
Manage this from draft to award
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