IMPROVING INFORMATION TECHNOLOGY SYSTEMS OF THE FOOD AND DRUG ADMINISTRATION.

SEC. 3627. IMPROVING INFORMATION TECHNOLOGY SYSTEMS OF THE FOOD AND DRUG ADMINISTRATION.(a) FDA Strategic Information Technology Plan.—(1) In general.—Not later than September 30, 2023, and at least every 4 years thereafter, the Secretary shall develop and submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration, a coordinated information technology strategic plan to modernize the information technology systems of the Food and Drug Administration. Each such report shall be known as the “Food and Drug Administration Strategic Information Technology Plan”. The first such report may include the Data and Technology Modernization Strategy, as set forth in the letters described in section 1001(b) of the FDA User Fee Reauthorization Act of 2022 (division F of Public Law 117–180). (2) Content of strategic plan.—The Food and Drug Administration Strategic Information Technology Plan under paragraph (1) shall include—(A) agency-wide strategic goals and priorities for modernizing the information technology systems of the Food and Drug Administration to maximize the efficiency and effectiveness of such systems for enabling the Food and Drug Administration to fulfill its public health mission; (B) specific activities and strategies for achieving the goals and priorities identified under subparagraph (A), and specific milestones, metrics, and performance measures for assessing progress against such strategic goals and priorities; (C) specific activities and strategies for improving and streamlining internal coordination and communication within the Food and Drug Administration, including for activities and communications related to signals of potential public health concerns; (D) challenges and risks the Food and Drug Administration will face in meeting its strategic goals and priorities, and the activities the Food and Drug Administration will undertake to overcome those challenges and mitigate those risks; (E) the ways in which the Food and Drug Administration will use the Plan to guide and coordinate the projects and activities of the Food and Drug Administration across its offices and centers; and (F) a skills inventory, needs assessment, gap analysis, and initiatives to address skills gaps as part of a strategic approach to information technology human capital planning.136 STAT. 5889 (3) Evaluation of progress.—Each Food and Drug Administration Strategic Information Technology Plan issued pursuant to this subsection, with the exception of the first such Food and Drug Administration Strategic Information Technology Plan, shall include an evaluation of—(A) the progress the Secretary has made, based on the metrics, benchmarks, and other milestones that measure successful development and implementation of information technology systems; and (B) whether actions taken in response to the previous Plan improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities set forth in such previous Plans. (b) GAO Report.—(1) In general.—Not later than September 30, 2026, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the implementation of the Food and Drug Administration Strategic Information Technology Plan adopted pursuant to subsection (a). (2) Content of report.—The report required under paragraph (1) shall include an assessment of—(A) the development and implementation of the Food and Drug Administration Strategic Information Technology Plan, including the sufficiency of the plan, progress of the Food and Drug Administration in meeting the results-oriented goals, milestones, and performance measures identified in such plan and any gaps in such implementation; (B) the efficiency and effectiveness of the Food and Drug Administration’s expenditures on information technology systems over the preceding 10 fiscal years, including the implementation by the Food and Drug Administration of the Technology Modernization Action Plan and Data Modernization Action Plan; (C) challenges posed by the information technology systems of the Food and Drug Administration for carrying out the Food and Drug Administration’s public health mission, including on meeting user fee agreement performance goals, conducting inspections, responding to identified safety concerns, and keeping pace with new scientific and medical advances; and (D) recommendations for the Food and Drug Administration to address the identified challenges, improve its implementation of the Food and Drug Administration Strategic Information Technology Plan, and to otherwise improve the Food and Drug Administration’s information technology systems.