Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements

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As part of the implementation of Executive Order 13771 entitled, "Reducing Regulation and Controlling Regulatory Costs," and Executive Order 13777 entitled, "Enforcing the Regulatory Reform Agenda," the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Drug Evaluation and Research (CDER).