Office of Biostatistics Cytel Software
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $25,000 to $250,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 519130 Internet Publishing and Broadcasting and Web Search Portals
- Points of contact
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
- tbd@fda.hhs.gov (301) 827-3742
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration's Office of Biostatistics is seeking Cytel Software to support review work involving power and sample size calculations, adaptive designs using EAST software, and exact statistical calculations through StatXact. The procurement encompasses biostatistical software solutions required for FDA regulatory review processes, with cost increases attributed to enhanced StatXact procedures integrated with SAS and SARGE functionality. The solicitation is expected to be released on May 1, 2026, with an estimated contract award date of September 1, 2026.
The estimated award value ranges from $25,000 to $250,000, reflecting the software licensing and associated costs for the FDA's biostatistical operations. This new requirement is classified under NAICS code 519130 (Internet Publishing and Broadcasting and Web Search Portals) and will be performed by the FDA. Interested parties should direct inquiries to the FDA's Acquisition Liaison at cderacquisitions@fda.hhs.gov or the general mailbox contact at tbd@fda.hhs.gov for additional information regarding this opportunity.
Forecast text
Office of Biostatistics Cytel Software Required for review work, specifically power and sample size calculations, adaptive designs (EAST), exact statistical calculations (StatXact). Increased cost driven in part by additional cost due to increase in costs of StatXact Procs with SARGE (SAS).
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