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FDA’s Framework for Reviewing Regulations

FDA’s Framework for Reviewing Regulations. Leslie Kux Acting Assistant Commissioner for Policy U.S. Food and Drug Administration March 10, 2011. Backdrop. 1980's The Regulatory Flexibility Act EO 12291 1990's EO 12866 REGO FDA Modernization Act. Formal Review Mechanisms: Final Rules.

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FDA’s Framework for Reviewing Regulations

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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

  2. Backdrop • 1980's • The Regulatory Flexibility Act • EO 12291 • 1990's • EO 12866 • REGO • FDA Modernization Act

  3. 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

  4. 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

  5. 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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