SMG 1410.106

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - HUMAN DRUGS

ISSUANCE OF NOTICES RELATING TO PROPOSALS TO REFUSE APPROVAL OR TO WITHDRAW APPROVAL OF NEW DRUG APPLICATIONS AND THEIR SUPPLEMENTS

Effective Date: 06/04/2004

1. AUTHORITIES DELEGATED AND TO WHOM DELEGATED.

A. The Director, the Deputy Director, and the Directors, Office of New Drugs and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER), are authorized to issue notices of an opportunity for a hearing on proposals to refuse approval or to withdraw approval of new drug applications and abbreviated new drug applications and supplements thereto on drugs for human use, except for those drugs listed in 21 CFR, Part 300, Section 314.440(b), that have been submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) and subpart B of 21 CFR, Part 300, Section 314 and to issue notices refusing approval or withdrawing approval when opportunity for hearing has been waived.

B. The Director and Deputy Directors, Center for Biologics Evaluation and Research, for those drugs listed in 21 CFR, Part 300, section 314.440(b), are authorized to issue notices of an opportunity for a hearing on proposals to refuse approval or to withdraw approval of new drug applications and abbreviated new drug applications and supplements thereto on drugs for human use that have been submitted under section 505 of the act and subpart B of part 314 of 21 CFR and to issue notices refusing approval or withdrawing approval when opportunity for hearing has been waived.

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

The Acting Commissioner of Food and Drugs approved this revised delegation via memorandum on June 4, 2004 to reflect updated titles and additional CDER officials.