*CDER Informatics Enterprise Service and Operation and WFM New Contract
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $7,000,000 to $13,000,000
- 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's Center for Drug Evaluation and Research (CDER) is procuring informatics enterprise services and operations and maintenance support for the Informatics Enterprise Service Project (Inbound), with an estimated solicitation release date of August 1, 2026, and an estimated award date of January 1, 2027. The contractor will provide end-to-end ingestion of submission data for all application types (ANDA, NDA, BLA, IND) from the ASR system and route submissions to workflow management systems including Workfront and Appian based on submission metadata and eCTD backbone information. Services include launching and managing workflow processes across application review phases, capturing and triggering review decisions, archiving FDA review documents to the agency's record management system, expanding system integrations, document management services adhering to FDA record management policies, and operations and maintenance support for the Panorama review platform and other enterprise services that support GDUFA compliance and the Platform Operation Center capability.
The estimated award value ranges from $7 million to $13 million. Performance occurs across CDER's informatics systems and enterprise services supporting drug review workflows. The requirement is unrestricted and coded to NAICS 541519 (Other Computer Related Services). Inquiries should be directed to the FDA's CDER Acquisitions Liaison at cderacquisitions@fda.hhs.gov.
Forecast text
The Informatics Enterprise Service Project, commonly referred to as Inbound, provides CDER Informatic system with enterprise services and operation support (Panorama Platform, Panorama O&M, CDERNexus Application O&M, and CDER Informatics Platform Integration).Services include: Streamlined end-to-end solution to ingest submission data for all application types (ANDA, NDA, BLA, IND) from ASR and kicks off accurate workflow processes to the targeted workflow management systems such as Workfront and Appian based on the submission metadata (eCTD backbone + application form). - Launches workflow processes in the context of application/submission review phase, capture review decisions, trigger additional review process based on different decisions, and archive the FDA review documents to FDA's defined record management system. - Expands and improves integrations between systems. This is important to CDER because the review process involves several different systems that need to work in sync of one another. Without the integration services, CDER would not be able to complete their review processes. One service under this project is to expand and maintain services for document management. Proper document management is important because it must adhere to FDA record management policies, secures communication with industry is seamless, and less error prone. - Includes operations and maintenance (O&M) support to all enterprise services that are part of the project. - Covers the complete management, operations, and maintenance support of Panorama. Panorama is the review tool that houses the majority of the OGD, OPQ, OM, and a few other review process workflows. Panorama plays a major role ensuring GDUFA compliance. - Supports the Platform Operation Center (POC) capability to monitor and maintain production environments.
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