*PDUFA VII Data IT Modernization - IR Requests (IR) Foundations New Contract
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
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring other computer-related services to respond to and triage sponsor and internal emails across multiple submission inboxes (eSub, CDERDirect, CDEReFacility, and ACA6004), with solicitation estimated for release on 2026-10-01 and award targeted for 2027-03-01. The contractor must demonstrate proficiency in eCTD and SPL standards and operational knowledge of internal FDA systems including DARRTS and DQCP that track submissions. Work encompasses two primary tasks: operational support and streamlining inbound submission and analysis.
The estimated award value ranges from $1.5 million to $3 million under NAICS 541519 (Other Computer Related Services). Inquiries should be directed to the FDA's Acquisition Liaison at cderacquisitions@fda.hhs.gov.
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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