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  1. FDA Organization

Office of Policy

Leslie Kux, Associate Commissioner


We develop and coordinate the review and analysis of broad agency policy that furthers the FDA’s mission to protect and promote public health, ensure consistency in the development and content of agency policy, and ensure that regulations and other agency documents to be published in the Federal Register meet all applicable requirements.

Major Functions

Our office consists of two components: the Policy Development and Coordination Staff, and the Regulations, Policy and Management Staff. We advise the Commissioner, the Deputy Commissioner for Policy, Planning and Budget, and other key department or agency officials on matters relating to agency policy and regulations development. We act as the FDA’s focal point for developing broad agency policy and are the agency's liaison for intergovernmental policy development. We oversee, direct and coordinate the agency’s rulemaking activities and regulations development system, including editing, processing and preparing documents for publication in the Federal Register and initiate new systems and procedures to make the agency's rulemaking process more efficient.

Professional Expertise

The Office employs staff with a broad range of backgrounds and expertise, including healthcare practitioners, scientists, public health specialists, public policy specialists and attorneys

Contact the Office of Policy

Associate Commissioner for Policy: Leslie Kux
Phone: 301-796-4830 | Fax: 301-847-3541 | Email: leslie.kux@fda.hhs.gov

Policy Development and Coordination Staff: Catherine C. Lorraine, Director
Phone: 301-796-9206 | Email: catherine.lorraine@fda.hhs.gov

Regulations Policy and Management Staff: Kenneth Cohen, Director
Phone: 301-796-7001 | Email: kenneth.cohen@fda.hhs.gov

Director of Regulatory Policy: Jarilyn Dupont
Phone: 301-796-4716 | Email: jarilyn.dupont@fda.hhs.gov

Regulations Editorial Section: Lisa Granger, Section Chief
Phone: 301-796-9115 | Fax: 301-847-8608 | Email: Lisa.Granger@fda.hhs.gov