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Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

Food and Drug Administration · RFA-FD-25-017 · Deadline: February 8, 2028 · Advertised ceiling: $600k

Program-level history — this opportunity doesn't publish per-opportunity awards, so these numbers describe its parent program (CFDA 93.103, Food and Drug Administration Research), not this competition alone. Labeled that way on purpose.

Draw-down reality (program)

Across 205 completed awards in this program (FY2021+ sample, USAspending outlay records), grantees ultimately drew a median 100% of obligated funds. A median well under 100% means underspend or early closure is common here — worth knowing before promising a spend-down timeline.

Listing summary

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.

Eligibility: Others · Categories: Agriculture, Consumer Protection, Food and Nutrition · official listing ↗

Sources: NIH RePORTER (opportunity-exact) and USAspending (program-level), labeled per section. GrantsDue computes summaries only; verify anything critical against the originals. Methodology.