The Food and Drug Administration (FDA or Agency) is announcing the availability of an information technology (IT) strategic plan entitled the "FDA Information Technology Strategy" and a request for comment on this IT Strategy. 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 29, 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. Comments are due OCTOBER 30.
Use the link below to review the entire document, background materials, and to submit a comment. Please consider identifying yourself as an INFORMS member in your comment.
Food and Drug Administration Information Technology Strategy; Request for Comments
| Federal Register |
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| Food and Drug Administration Information Technology Strategy; Request for Comments |
| The Food and Drug Administration (FDA or Agency) is announcing the availability of an information technology (IT) strategic plan entitled the ``FDA Information Technology Strategy'' and a request for comment on this IT Strategy. As part of our User Fee Program commitments and Omnibus Bill... |
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Requested Feedback
Interested persons are invited to provide detailed comments to ODT (see ADDRESSES ) on the specific IT Strategy Goals and Objectives within FDA's Agency-wide IT 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 stakeholders would like to share on this topic. FDA encourages stakeholders to provide the specific rationale and basis for their comments, including any available supporting data and information.
1. Which goals and objectives are most important to you? Why?
2. Describe up to five ways the FDA IT Strategy will impact your industry?
3. What gaps do you see in the FDA IT Strategy's goals or objectives?
4. What challenges or risks do you foresee in executing the FDA IT Strategy?
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Kara Morgan
Principal
Quant Policy Strategies, LLC
Dublin OH
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