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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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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. - PowerPoint PPT Presentation

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Page 1: FDA’s Framework for Reviewing Regulations

1

FDA’s Framework for Reviewing Regulations

Leslie KuxActing Assistant Commissioner for Policy

U.S. Food and Drug AdministrationMarch 10, 2011

Page 2: FDA’s Framework for Reviewing Regulations

2

Backdrop

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

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

Page 3: FDA’s Framework for Reviewing Regulations

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

Page 4: FDA’s Framework for Reviewing Regulations

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

Page 5: FDA’s Framework for Reviewing Regulations

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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