FDA Policy/General

FDA Resource Capacity Planning Capability

FDA says growth in its user fee programs in terms of scope of activities and the volume and complexity of submissions has increased operational demands on the agency. “To help ensure that the agency is making optimal use of its financial resources to maximize its ability to efficiently and effectively deliver on its commitments to the public,” says an FDA report on implementation of resource capacity planning and modernized time reporting, “the agency has committed to developing a resource capacity planning capability and to modernize its time reporting approach.”

The report says this approach will lead to more systematic, data-driven, and repeatable processes to better understand and anticipate its current and future resource demands.

The agency has engaged PriceWaterhouseCoopers (PWC) to support development of the implementation plan and to use that company’s Integrated Operations and Business Planning framework to inform design of the FDA plan. FDA says it worked with PWC to tailor the PWC framework to fit the agency’s current state and operational challenges.

“The tailored plan focuses first on modernizing FDA’s time reporting approach while also beginning development of its resource forecasting capability,” the report says. “It then includes designing the organization and support model for these capabilities, including the underlying business processes. Once the support model and initial time reporting and resource forecasting capabilities are in place, FDA will be able to begin comparing actual resource utilization to the forecasted resource utilization. This will enable FDA to improve its resource forecasts, prioritize its existing resources, and develop proactive plans to acquire the roles and skills it will likely require. The information will also help develop financial forecasts to better predict use of financial resources to support the user fee programs.”

The agency says it recognizes that success requires that it consider some significant factors including aligning the organization around the program vision and managing change to ensure successful adoption of new capabilities. It also necessitates acquisition of new information technology and the harmonization of data models and business processes. FDA says it will need to acquire and develop the staff necessary to build and manage its new capabilities.

It has committed to hosting annual public meetings, beginning in 2019, to engage the public in discussions about agency progress in developing its resource capacity planning and modernized time reporting capabilities.

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