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1 FDA’s Framework for Reviewing Regulations Leslie Kux Acting Assistant Commissioner for Policy U.S. Food and Drug Administration March 10, 2011

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Page 1: 1 FDA’s Framework for Reviewing Regulations Leslie Kux Acting Assistant Commissioner for Policy U.S. Food and Drug Administration March 10, 2011

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FDA’s Framework for Reviewing Regulations

Leslie KuxActing Assistant Commissioner for Policy

U.S. Food and Drug AdministrationMarch 10, 2011

Page 2: 1 FDA’s Framework for Reviewing Regulations Leslie Kux Acting Assistant Commissioner for Policy U.S. Food and Drug Administration March 10, 2011

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Backdrop

• 1980's– The Regulatory Flexibility Act – EO 12291

• 1990's– EO 12866– REGO– FDA Modernization Act

Page 3: 1 FDA’s Framework for Reviewing Regulations Leslie Kux Acting Assistant Commissioner for Policy U.S. Food and Drug Administration March 10, 2011

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Formal Review Mechanisms: Final Rules

• Retrospective Review of Selected Regulations– Usually due to changed circumstances, e.g., out-

dated, statutory revisions, harmonization

• Review When Revisions Made to Existing Rules– Is the specific regulation still valid, or should it be

updated to reflect new policies, data, or technology

Page 4: 1 FDA’s Framework for Reviewing Regulations Leslie Kux Acting Assistant Commissioner for Policy U.S. Food and Drug Administration March 10, 2011

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Formal Review Mechanisms: Final Rules

• Citizen Petition Process– 21 CFR 10.30

• 610(c) Review Required by RFA– FDA uses Unified Agenda to notify public of

upcoming reviews and solicit comment– Letters to Small Business Community

Page 5: 1 FDA’s Framework for Reviewing Regulations Leslie Kux Acting Assistant Commissioner for Policy U.S. Food and Drug Administration March 10, 2011

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Formal Review Mechanisms: NPRMs and ANPRMs

• Periodic Review to Determine if Withdrawal Appropriate– Current policy is every 5 years (2008;

2003;1994;1991)– Publish Notice in FR of candidate rules all

NPRMs and ANPRMs published more than 5 years ago


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