Therapeutics Discovery and Development for Rare Diseases (SBIR)

Therapeutics Discovery and Development for Rare Diseases (SBIR) is sponsored by National Center for Advancing Translational Sciences (NCATS/NIH). Funds small businesses advancing therapeutics via innovative delivery platforms like implants for rare diseases requiring precise dosing. This program should be reviewed carefully against your organization's mission, staffing capacity, timeline, and compliance readiness before you commit resources to a full application. Strong submissions usually translate sponsor priorities into concrete objectives, clear implementation milestones, and measurable public benefit.

For planning purposes, treat rolling deadlines or periodic funding windows as your working submission target unless the sponsor publishes an updated notice. A competitive project plan should include a documented need statement, implementation approach, evaluation framework, risk controls, and a realistic budget narrative. Even when a grant allows broad program design, reviewers still expect credible evidence that the proposed work can be executed within the grant period and with appropriate accountability.

Current published award information indicates $50,000 - $2,000,000 Organizations should verify the final funding range, matching requirements, and allowability rules directly in the official opportunity materials before preparing a budget. Finance and program teams should align early so direct costs, indirect costs, staffing assumptions, procurement timelines, and reporting obligations all remain consistent throughout drafting and post-award administration.

Eligibility guidance for this opportunity is: U.S. small businesses If your organization has partnerships, subrecipients, or collaborators, define responsibilities and compliance ownership before submission. Reviewers often look for implementation credibility, so letters of commitment, prior performance evidence, and a clear governance model can materially strengthen the application narrative and reduce concerns about delivery risk.

A practical approach is to begin with a focused readiness review, then build a workback schedule from the sponsor deadline. Confirm required attachments, registration dependencies, and internal approval checkpoints early. This reduces last-minute issues and improves submission quality. For the most accurate requirements, always rely on the official notice and primary source links associated with Therapeutics Discovery and Development for Rare Diseases (SBIR).

Funding Opportunities | National Center for Advancing Translational Sciences U. S. Department of Health & Human Services National Institutes of Health Read a recent letter to the N3C Community from Joni Rutter and Michael Kurilla on Dec.

10, 2025. Open Funding Opportunities Funding Policy & Operating Guidelines Challenges and Prize Competitions Challenges and Prize Competitions Winners Conference Grant Information Resources for Researchers Resources for Rare Disease Patients and Advocates About Translational Science We offer an array of funding opportunities that support our mission of turning research observations into health solutions through translational science.

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Notice of Change to Funding Opportunity Notice of Intent to Publish Notice of Special Interest Research-Related Programs Research Career Development Notice of Announcement of NIH Oligonucleotide Toxicity (OligoTox) Open Data Challenge Competition Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed) Notice of Extension for RFA-TR-23-018 "Miniaturization and Automation of Tissue Chip Systems (MATChS) (UT1/UT2 - Clinical Trial Not Allowed)" Notice of Change to Funding Opportunity Notice of Extension for RFA-TR-23-017 "Miniaturization and Automation of Tissue Chip Systems (MATChS) (U43/U44 Clinical Trial Not Allowed)" Notice of Change to Funding Opportunity Notice of Rare Diseases Clinical Research Network Alumni Site: Data Storage and Access Notice of Extension and Change for PAR-23-268 "Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) ...

Notice of Change to Funding Opportunity Notice of Extension for PAR-25-157 Awards Supporting Cutting-Edge Technologies for Translational Science (ASCETTS) (R21 Clinical Trials Not Allowed) Notice of Change to Funding Opportunity Showing Row 1 to 10 of 419 Last updated on February 19, 2025 9609 Medical Center Drive For language access assistance, contact the NCATS Public Information Officer HHS Vulnerability Disclosure