Delegations of Authority and Organization

The Food and Drug Administration (FDA) is amending regulations for delegations of authority to allow the Director of the Center for Drug Evaluation and Research (CDER) and the Director of the Office of Compliance, CDER, to grant or deny a request, submitted in the form of a citizen petition under its pertinent regulations, for an exception or alternative to applicable current good manufacturing practice (CGMP) requirements for positron emission tomography (PET) drug products. This action is necessary to allow CDER to be able to grant an exception or alternative to applicable CGMP requirements for PET drug products when the request is made in a citizen petition.