RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > FDA Looking to Revamp its IT Portfolio With Focus on Capabilities

FDA Looking to Revamp its IT Portfolio With Focus on Capabilities

Posted 02 June 2014 | By Alexander Gaffney, RAC

FDA Looking to Revamp its IT Portfolio With Focus on Capabilities

The US Food and Drug Administration (FDA) says it's looking for some outside help with what it says will be a restructuring of its information technology (IT) portfolio meant to help it increase the transparency of its operations and improve the value it obtains from its IT spending.

In a "Request for Information/Sources Sought" notice posted to its website on 28 May 2014, FDA said it's looking for a company to create a framework by which it can better manage its strategic IT portfolio.

"Currently, there is no formal, consistent IT Strategic Portfolio Management framework and integrated operational governance process to strategically improve cross-agency IT decisions that maximize resources and improve IT operations over time," FDA wrote in its RFI. The agency current lacks a "well-developed, structured IT portfolio management process to ensure that FDA investments in IT products and services are clearly and explicitly aligned with the agency’s mission and business capability goals," it said.

Under the new plan, the agency says it wants to transition from an IT portfolio which is organizationally-focused to one which is capability-focused, it continued. Under such a plan, similar systems—regardless of which regulatory center they fall under—might be grouped together.

The massive plan covers at least two years, and calls for the outside contractor to work with FDA to develop integrated models of management and governance, methods of prioritization, portfolio selection, performance analysis, budgets, annual work plans, oversight, and more.

No budget for the project has yet been proposed.

The proposal comes just as technology is becoming an increasing part of FDA's budget. Under the recent Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Act (GDUFA), for example, FDA is required to make substantial improvements to its IT systems that support regulatory operations.


FDA Contract Notice

Regulatory Focus newsletters

All the biggest regulatory news and happenings.