NMDE: RWE Premarket BAA Pathway
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $3,000,000 to $7,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541990 All Other Professional, Scientific, and Technical Services
- Points of contact
-
- Joshua Holliday joshua.holliday@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Department of Health and Human Services Food and Drug Administration is forecasting a new requirement contract through the Broad Agency Announcement (BAA) pathway, focused on professional, scientific, and technical services. The contract is estimated to have a solicitation release date of May 1, 2026, with an anticipated award date of July 1, 2026, targeting the NAICS 541990 category for All Other Professional, Scientific, and Technical Services. The procurement appears to involve research and work related to medical device innovation and active surveillance.
For fiscal year 2025, the total contract value is projected at $5 million, with $4.5 million sourced from MDUFA (Medical Device User Fee Amendments) funding - specifically $2.5 million for work currently performed by MDIC and $2 million for work by Aetion, and an additional $0.5 million from MDE funds allocated to MDIC as a convener of Active Surveillance. The primary point of contact is Joshua Holliday from the FDA, who can be reached at joshua.holliday@fda.hhs.gov, and the contract does not appear to have a specific set-aside designation.
Forecast text
This is going through the BAA pathway. The dollar amount for FY25 will be $5M and $4.5 of that will come from MDUFA funding ($2.5M for work currently being done by MDIC and $2M for work currently being done by Aetion) and $0.5M will come from MDE funds to MDIC as convener of Active Surveillance
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