Announcing a Request for Information and Comment to Reimagine the Future of Digital Transformation at the FDA

The U.S. Food and Drug Administration (FDA) is a data-driven organization, and technology enables every aspect of our work. The FDA's Office of Digital Transformation (ODT) has embarked on an ambitious journey to develop an FDA Data and Technology Modernization Strategy. We have made significant progress since the publication of the Technology Modernization Action Plan in September 2019. ODT is increasingly partnering with Centers and Offices across the Agency to use technology and data for improved public health and business outcomes. Effective strategy, planning, and collaborative governance are the critical underpinnings of this work. We are eager to take more of an "All FDA" approach to maximize our technology investments and better leverage each program's strengths and capabilities.

ODT recently announced a request for information and comment on the development of an FDA Data and Technology Modernization Strategic Plan. This plan will define and shape the future course of the FDA's digital transformation journey. We will build on the existing FDA Modernization Framework in action today and integrate center-level strategies. The plan will also reflect the FDA's User Fee Program commitments and FY23 Omnibus Bill requirements. It will be published by September 30, 2023.

Broad stakeholder engagement and collaboration are needed to develop a comprehensive strategy to advance the FDA's public health mission. We encourage wide-ranging ideas and feedback related to the following guiding questions:

• What are up to three outcomes the FDA Data and Technology Strategic Plan can help you achieve, e.g., speed to market?
• What are up to three challenges you are facing while trying to achieve these outcomes?
• What data and technical capabilities could FDA strengthen to help support its public health mission?
• What opportunities or risks do you foresee for the FDA Data and Technology Strategic Plan?
• What changes or trends in your industry could impact the FDA Data and Technology Strategic Plan? and
• How might FDA best communicate and engage stakeholders in developing and implementing the strategy?

The Agency Docket Number is Docket No. FDA-2023-N-1052 and additional information are available on the Federal Register Notice. Please submit either electronic or written comments on the request for information and comments by May 15, 2023, to ensure that the Agency considers your comments before it begins to work on the final version of the strategy. For additional information, please contact Casi Alexander, Office of Digital Transformation, Food and Drug Administration, FDA Library, 5630 Fishers Lane, Rm. 1087, Rockville, MD 20857, (240) 402–5171, email: Casi.Alexander@fda.hhs.gov