Delegations of Authority and Organization; Issuance of Notices Relating to Debarment

Streszczenie

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to FDA officials in the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), and the Center for Biologics Evaluation and Research (CBER) by adding a new delegations section concerning the issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment. Additionally, FDA is amending the regulations regarding petitions so that certain officials of CDER, CVM, and CBER are authorized to respond to petitions concerning debarment and refusal to terminate debarment. This action will make the process of issuing such notices and responses to petitions more efficient.