§ 5.78 - Issuance, amendment, or repeal of regulations pertaining to antibiotic drugs.

(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs under section 507 of the Federal Food, Drug, and Cosmetic Act (the act) regarding the issuance, amendment, or repeal of regulations pertaining to antibiotic drugs for human use:

(1) The Director, Deputy Center Director for Review Management, and Deputy Center Director for Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).

(2) The Director, Office of Drug Evaluation I, Office of Review Management, CDER.

(3) The Director, Office of Drug Evaluation IV, Office of Review Management, CDER.

(4) The Director and Deputy Director, Division of Oncologic Drug Products, Office of Drug Evaluation I, Office of Review Management, CDER.

(5) The Director and Deputy Director, Division of Anti-Infective Drug Products, Office of Drug Evaluation IV, Office of Review Management, CDER.

(6) The Director and Deputy Director, Division of Anti-Viral Drug Products, Office of Drug Evaluation IV, Office of Review Management, CDER.

(7) The Director and Deputy Director, Office of Compliance, CDER.

(b) The Director and Deputy Directors, Center for Devices and Radiological Health, are authorized to perform all the functions of the Commissioner of Food and Drugs under section 507 of the act regarding the issuance, amendment, or repeal of regulations pertaining to antibiotic drugs for human use contained in medical devices.