*PDUFA VII Data IT Modernization - IR Requests (IR) Foundations New Contract

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.

Estimated value

>= $1.5M and < $3M

Est. solicitation date

Oct 1, 2026

Anticipated award

Mar 1, 2027

• NAICS541519
• PSC541519