Accelerating Rare disease Cures Program

Past New Requirement Updated

Agency
Solicitation expected
Estimated value
$700,000 to $1,500,000
Set-aside
No set-aside

Forecast facts

Anticipated award
NAICS code
541690 Other Scientific and Technical Consulting Services
Points of contact

Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.

About this forecast

The Food and Drug Administration (FDA) is forecasting a new requirement for the Accelerating Rare Disease Cures Program, which will procure scientific and technical consulting services to support the FDA's Office of New Drugs (OND) in advancing rare disease treatment development. The contract will leverage both Budget Authority (BA) and Prescription Drug User Fee Act (PDUFA) funding to facilitate the acceleration of cure development for rare diseases. The solicitation is estimated to be released on August 1, 2025, with an anticipated award date of January 1, 2026.

The contract award value is estimated between $700,000 and $1,500,000, classified under NAICS code 541690 (Other Scientific and Technical Consulting Services). This procurement does not include a small business set-aside. Interested vendors should direct inquiries to the FDA's acquisition liaison at cderacquisitions@fda.hhs.gov for additional information regarding this forecasted opportunity.

Forecast text

Rare Disease Funding - BA and PDUFA for OND's Advancing Rare Disease Cures Program

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