1) May 1 -- Comment period extended to June 12, 2023.
https://www.federalregister.gov/d/2023-09169
2) Apr 13 -- The Food and Drug Administration (FDA or Agency) is announcing a request for information and comments on the development of an FDA Data and Technology Strategic Plan. As part of our User Fee Program commitments and Omnibus Bill requirements, FDA will develop and publish an FDA Data and Technology Strategic Plan by September 30, 2023. This plan will define and shape the future course of FDA's data and technology capabilities, building on the existing FDA Modernization Framework. The plan will also integrate Agency and center strategies. 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 work on the final version of the strategy.
The Office of Digital Transformation (ODT) was established in September 2021 and reports directly to the Office of the Commissioner. ODT provides the vision and leadership in information technology, data, and cybersecurity needed to advance FDA's mission and strategic priorities. ODT has published a series of strategy documents known as the FDA Modernization Framework. The framework includes the Technology Modernization Action Plan, Data Modernization Action Plan, Enterprise Modernization Action Plan, Cybersecurity Modernization Action Plan, and the Leadership Modernization Action Plan. The FDA Modernization Framework aims to develop an integrated technology, data, cybersecurity, business, and leadership approach to advancing FDA's public health mission in collaboration with industry.
As part of the 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 VI commitment letter), FDA will work with industry as it develops a comprehensive framework for guiding the Agency's work and allocating annual technology budgets and resources. The FDA Data and Technology Strategic Plan, covering Fiscal Years 2024–2027, will define and shape the future course of FDA's data and technology capabilities as FDA transitions to the next phase of its journey. FDA will take an iterative approach to strategy development, starting with gathering input, then, sharing a draft of the strategic plan for comment and finally, considering inputs provided before publishing a final version of the strategic plan. FDA will focus on the outcomes to empower the Agency to meet its mission, building on the existing FDA Modernization Framework and integrating Agency and center strategies. FDA will engage internal and external stakeholders early and often throughout this process. FDA plans to incorporate stakeholder input as the Agency engages with internal and external stakeholders across the remainder of this fiscal year including through two Federal Register notices for information and comment (this one and a second one for comment on the draft strategy). Stakeholder input is crucial for developing a comprehensive plan that best meets the needs and goals of industry and the Agency. . . .
FRN:
https://www.federalregister.gov/d/2023-07766
