*PDUFA VII Data IT Modernization - IR Requests (IR) Foundations New Contract
Type: Forecast
Overview
Description
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.
Est. Value
Min: $1,500,000
Max: $3,000,000
Max: $3,000,000
Est. Award Date
27-Mar
Future Opp
Source Est. Solicitation Date
26-Oct
Set Aside
To be determined
Forecast Type
New
Place of Performance
USA
Forecast Source
Department of Health and Human Services
Center for Drug Evaluation and Research is forecasted to issue a new procurement for *PDUFA VII Data IT Modernization - IR Requests (IR) Foundations New Contract around 27-Mar worth up to $3,000,000.
Agency
Source Level 1 Agency
Department of Health and Human Services
Source Level 2 Agency
FDA
Source Level 3 Agency
CDER
Contacts
Potential Bidders and Partners
Similar Active Opportunities
Additional Detail
Date Published
11/6/26
Date Modified
11/7/26
Additional Notes
Program Office: 75F401; Contracting Office: 75F402