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  1. Doing Business With FDA

FDA Business Investments

FDA Business Investments

  Investment Description Overall PoP Value Range Target RFTOP Release
OIM-10-DOS-ELMS-RAM-081 Enterprise Business Objects - Business Objects Support Help Desk, Application and Business Objects Administration support 36 Months $1-$5M Q3
OIM-10-DOS-ELMS-ORADSS-097 Regulatory Business Information Systems (RBIS) - New contract to support operations, maintenance, and new development for the systems that comprise the RBIS Investment 60 months >$10M Q3
OIM-10-DOS-ELMS-CDRH-074 CDRH CeSub - CeSUB is comprised of the Image 2000 Document Management System. It is the central repository for document-management activities for Pre and Post Market data. It includes development and implementation of the Center's electronic submissions program.  There are several sub systems that comprise the CeSub suite of applications - includes Documentum with Custom Front End to Access/View Files/Documents, Electronic submission, review and archive systems and APEX based applications. 60 months >$10M Q3
OIM-10-DOS-ELMS-CDER-073 CDER Steady State Support - This task order will cover Operations and Maintenance support for the Center for Drug Evaluation and Research (CDER) Information Technology Applications currently in use. This shall include support for ongoing maintenance, technical software and hardware refreshes, maintenance software releases, Tier II help desk support and system integration into the FDA enterprise architecture. The CDER IT applications that will be supported by this task order include 14 Legacy Refresh (LX) applications, Electronic Document Room (EDR/ASR), Substance Registration and Ingredient Dictionary (SRS/ID), Time Reporting System (TRS) and the Special Product Online Tracking System (SPOTS) system. 48 months $1-$5M Q3

FURLS TO to replace existing O&M Contract. Contractor will provide ongoing O&M, new development enhancements, defect fixes to existing FURLS app modules, maintain the system, and collaborate with other app services and systems. The subsystems listed below comprise the modules that are currently included within FURLS, which first became operational on October 16, 2003.

Account Management (OAA) – Implemented in 2003, this subsystem is used to maintain account information. All other modules require that the user log into the system and the system authenticate the account to determine which modules the account can access.

Food Facility Registration Module (FFRM) – Implemented in 2003, this module is used to register facilities that manufacture, process or hold food items that are sold for consumption in the United States. This includes foreign facilities that export food items to the US.

Drug Facility Registration Module (DFRM) – Implemented in 2006, this module is used to register facilities that manufacture drugs to be sold in the US; this includes foreign facilities. The requirements for this module are the requirements as defined for the FFRM module.

Devices Registration and Listing Module (DRLM) – Implemented in 2007, this module is used to register facilities that manufacture medical devices, and to list the products manufactured at these facilities.

Alert Module (Alert) – Implemented in 2007, this module is used to send mass notifications to selected facilities. (The initial version of the Module supports FFRM. Other modules can be modified to enable this Alert capability).

Shell Egg Producer Registration Module (SEPRM) - Currently in implementation - this module is used to register facilities with hens that lay eggs that are destined for for consumption in the United States.

- FURLS has an underlying Oracle Relational Database Management System (RDBMS) to hold operational and functional FURLS data.
- Reports are generated using Business Objects.

60 months >$10M Q3
OIM-10-DOS-ELMS-CVM-085 CVM IT SDLC TO. Center for Veterinary Medicine (CVM) IT SDLC. Procure IT full lifecycle development support services for CVM ITIRB approved IT DME and O&M activities. 60 months >$10M Q3

ALM Lab Communication ELEXNET O&M/DME
The primary focus of this Task Order is Operations and Maintenance (O & M) and Development, Modernization, to continue support of the eLEXNET system, infrastructure, and program support.

  • O & M Activities include:
  • Managing third party hosting services
  • Hardware, Software, and database maintenance
  • Providing Help Desk support
  • Providing emergency fixes
  • Project management
  • Program support
  • Maintaining the NEIS interface
  • Maintaining the NEIS application
  • Maintaining contributing Laboratory interfaces
  • DME Activities include:
  • Providing a web service
  • Providing a common log on
  • Expanding the existing eLEXNET data field
  • Build a content management system
  • Upgrading the browser
  • Facilitating outreach activities
60 months >$10M Q3


Firm Management Services (FMS) - Firm Management System (FMS) provides two primary functions which are firm search and firm maintenance. The firm search is intended to provide fast and efficient searches in multiple ORA repositories. Firm Management System allows users with specific roles to add, update, merge and unmerge firms in the MARCS database 60 months Q3
OIM-10-DOS-ELMS-EMC-083 Installed Products Support (EMC, Documentum, Captiva, Center Stage) Contract to provide Division of System under FDA's OIM ability to migrate data from existing document libraries to the Documentum libraries, create and implement disaster recovery strategies, create overall system administration and upgrades along with risk mitigation strategies and their associated implementation plans. 60 months $5-$10M Q3
OIM-10-DOS-ELMS-AWQA-110 Agency Wide Quality Assurance Support Contract to provide Division of System under FDA's OIM ability to define, create, standardarize Quality Assurance and related practicies for critical project leading to an improved overall application quality. Implementation strategies and plans for a comprehensive CMMi and overall Metrics plan 60 months $5-$10M Q3
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