Rules and Regulations. Notice; request for comment

Agency: Food and Drug Administration, HHS
Action: Notice; request for comment
Citation: FR Doc. 2024-13941 · Docket No. FDA-2024-N-2886

Summary

The Food and Drug Administration (FDA or Agency) is requesting comments on its “Information Technology (IT) Strategy” and “Customer Experience (CX) Strategy.” In accordance with the Agency's User Fee Program commitments and Omnibus Bill requirements, FDA must annually update and publish its IT Strategy by September 30. The initial strategy, released in September 2023, outlines the future direction of FDA's data and technology capabilities. A key objective of FDA's IT Strategy is to modernize enterprise services and capabilities to improve customer experience. The FDA CX Strategy was created to guide this effort. This comprehensive enterprise plan introduces the Agency's CX framework and considers the perspective of interested parties such as the public, employees, and industry.

Dates

Submit either electronic or written comments on the IT Strategy by July 31, 2024, to ensure that the Agency considers your comments for future iterations of the IT Strategy.

Supplementary Information

I. Background FDA is announcing the availability of a request for comment on its strategies entitled “FDA Information Technology Strategy” and “Customer Experience Strategy.” As part of FDA's fulfillment of requirements in section 3627 of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328), and commitments described in section IV.A.2. of the “PDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (PDUFA VII commitment letter), FDA is developing a comprehensive framework for guiding the Agency's work and allocating annual technology budgets and resources. The announcement of the availability of the first Agency-wide IT Strategy was published in the Federal Register on September 13, 2023 (88 FR 64435). As part of an annual strategic planning process, FDA reviewed the strategy and made minor updates to align with internal and external changes. FDA's 2024 refresh of the IT Strategy required no change to its IT goals and minimal changes listed below: • Updated 14 objectives to increase clarity; • Highlighted our commitment to working with global public health partners and advocating for global standards; • Clarified mission outcomes the IT Strategy aims to drive; and • Promoted alignment to relevant strategies, e.g., those of the Department of Health and Human Services. For additional context on how the IT Strategy will be executed, FDA suggests reading the IT Operating Plan, a companion document to the IT Strategy. The IT Operating Plan, published in February 2024, is a blueprint designed to guide FDA's technological growth and development in accordance with the IT strategic goals. It encompasses an IT strategic roadmap, governance, and organization construct as well as a performance measurement process designed to advance public health outcomes. One of FDA's IT strategic goals is to “Modernize Enterprise Services and Capabilities” which includes an objective to improve customer experience. This objective is focused on creating customer-centric solutions that enhance satisfaction by improving accessibility to IT solutions, streamlining processes, and easing adoption. The CX Strategy was developed to outline FDA's approach to make progress against this objective. The CX Strategy introduces the Agency's CX framework and is written with the perspective of interested parties from the public, employees, and industry in mind. The Agency continues to take a collaborative approach to strategy development by gathering input from numerous internal and external interested parties. This input is crucial for developing an updated comprehensive plan that best meets the needs and goals of industry and the Agency. Comments on the IT Strategy as well as the CX Strategy will be considered for future iterations. II. Requested Feedback Interested persons are invited to provide detailed comments to the Office of Digital Transformation (see ADDRESSES ) on the specific IT Strategy Goals and Objectives within FDA's Agency-wide IT Strategy as well as the CX Strategy. To facilitate comment, FDA has developed a series of questions in this section. The questions are not meant to be exhaustive, and FDA is also interested in any other pertinent information interested parties would like to share on this topic. FDA encourages interested parties to provide the specific rationale and basis for their comments, including any available supporting data and information. A. IT Strategy and Operating Plan This annual update to the IT Strategy contains minimal changes per the summary above. If you previously responded to the Agency's Federal Register notice published on September 13, 2023 (88 FR 64435), soliciting feedback, you will see some similar questions. You may choose to refer to your prior response or to provide additional feedback based on your experience since the first IT Strategy publication as well as context provided in our IT Operating Plan, a companion guide to the IT Strategy. 1. Which goals and objectives are most important to you? Why? 2. What are up to three outcomes the IT Strategy has helped or will help you achieve? Please provide examples. 3. What gaps do you see in the IT Strategy? 4. What challenges or risks do you foresee in executing the IT Strategy beyond those captured in the IT Operating Plan? 5. How have you leveraged the IT Strategy and/or IT Operating Plan since they were published in 2023? 6. How might FDA continue to communicate and engage interested parties in developing and implementing the strategy? B. Customer Experience Strategy 1. Which goals and objectives are most important to you? Why? 2. What gaps do you see in the CX Strategy's goals or objectives? 3. What has been your customer experience when interacting with FDA? 4. What is one thing FDA can do to improve your customer experience? III. Electronic Access Persons with access to the internet may obtain electronic versions of the IT Strategy and CX Strategy at https://www.regulations.gov and the IT Operating Plan at https://www.fda.gov/about-fda/office-digital-transformation/odt-reports . Dated: June 20, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-13941 Filed 6-25-24; 8:45 am]