Learning and Education to ADvance and Empower Rare Disease Drug Devel (LEADER 3D
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541990 All Other Professional, Scientific, and Technical Services
- Points of contact
-
- Christopher Scott christopher.scott@fda.hhs.gov
- tbd@fda.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration (FDA) is seeking a contractor to support the Accelerating Rare Disease Cures (ARC) Program through the Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. The primary objective is to develop educational materials that enhance understanding of regulatory drug development for rare diseases, including videos and case studies for both external stakeholders and FDA review staff. The estimated solicitation release date is June 1, 2026, with an anticipated contract award date of August 1, 2026.
The contract falls under the NAICS category 541990 for All Other Professional, Scientific, and Technical Services, with Christopher Scott (christopher.scott@fda.hhs.gov) serving as the primary point of contact. While specific award values are not disclosed, the initiative aims to continue its work of creating educational resources that have already been viewed by thousands of individuals and received positive press coverage. The program is critical for addressing unmet medical needs in rare disease drug development and ensuring continued regulatory support for rare disease product development.
Forecast text
Accelerating Rare disease Cures (ARC) Program inaugurated the Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) initiative to better understand and address the unique challenges in bringing rare disease products regulated by FDA CDER to the market. emphasizes a deeper understanding of regulatory policies, and engages with rare disease community to achieve this goal. LEADER 3D develops educational materials to enhance understanding of regulatory drug development for rare diseases. Materials generated include videos and case studies for both external stakeholders and FDA review staff involved in the development of rare disease drugs. The materials have been viewed by thousands of individuals and have garnered positive press reports on their rigor and usefulness.If the contract were not renewed, these positive contributions to the design, conduct and review of rare disease drug development programs will be impeded drug development for rare diseases, contributing to the ongoing unmet medical need.
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