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

Active

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The PDUFA VII Data IT Modernization - IR Requests (IR) Foundations contract with the Food and Drug Administration focuses on providing operational support and streamlining inbound submission analysis. The primary scope of work involves responding to and triaging sponsor and internal emails across several specific inboxes, including eSub, CDERDirect, CDEReFacility, and ACA6004. Successful execution of these tasks requires specialized technical knowledge of the eCTD and SPL standards, as well as proficiency in internal FDA tracking systems such as DARRTS and DQCP. The project is categorized under NAICS code 541519 and is currently listed as a forecast for the agency.

General Info

FDA contract for operational support, email triage, and submission analysis using eCTD standards.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541519 - Other Computer Related Services

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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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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