PDUFA VII Data IT Modernization - IR Requests (IR) Foundations
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $1,500,000 to $3,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541519 Other Computer Related Services
- Points of contact
-
- tbd@fda.gov
- Christopher Scott christopher.scott@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 seeking IT support services for PDUFA VII Data IT Modernization, specifically focused on email response and submission triage across multiple FDA systems (eSub, CDERDirect, CDEReFacility, and ACA6004). The contract involves two primary tasks: Operational Support and Streamlining Inbound Submission and Analysis, requiring expertise in eCTD and SPL standards, as well as familiarity with internal FDA tracking systems like DARRTS and DQCP. The estimated solicitation release date is July 1, 2026, with an anticipated contract award by September 1, 2026.
This opportunity is classified under NAICS code 541519 for Other Computer Related Services and does not have a specific set-aside designation. The primary point of contact is Christopher Scott (christopher.scott@fda.hhs.gov), representing the Food and Drug Administration. While specific award values and detailed performance location are not currently disclosed, the contract appears to be a comprehensive IT support service focused on managing and processing electronic submission inboxes for the FDA's regulatory processes.
Forecast text
Respond to and triage both sponsor and internal emails in the eSub, CDERDirect, CDEReFacility, and ACA6004 inboxes. Working in these inboxes requires knowledge of the eCTD standard, the SPL standard, and the internal FDA systems that these submissions are tracked in, including DARRTS and DQCP. Task #1. Operational Support, Task #2. Streamline Inbound Submission and Analysis.
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