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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  7. Regulations Policy and Management Staff
  1. Office of Policy

Regulations Policy and Management Staff

Kenneth Cohen, Director

Major Functions

  • Serves as the agency focal point for developing and maintaining communications, policies, and programs with regard to regulations development. Directs, manages, and coordinates the agency's rulemaking tracking, review and clearance process. Initiates new and more efficient systems or procedures to accomplish agency goals in the rulemaking process.
  • Serves as the agency's focal point with the Department of Health and Human Services, Office of Management and Budget, and other Federal agencies for policies and programs concerning regulations development.
  • Reviews proposed regulations, final regulations, and other agency documents to be published in the Federal Register. Ensures regulations are necessary; consistent with established agency policy; clearly written; enforceable; coordinated with other agency components, the Office of the General Counsel, and Federal, State, and local government agencies; appropriately responsive to public participation requirements and applicable executive orders; and responsive to any applicable requirements for assessment of economic and environmental effects.
  • Coordinates, with other Agency components, the evaluation of existing regulations to determine whether they are efficiently and/or effectively accomplishing their intended purpose. Identifies regulations that require revision to correspond with current standards and those that should be revoked due to obsolescence. Makes recommendations for disposition of these regulations.

Federal Register

Regulations Resources



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