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SMG 1410.503

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - ANIMAL DRUGS

ISSUANCE OF NOTICES, PROPOSALS, AND ORDERS RELATING TO NEW ANIMAL DRUGS AND MEDICATED FEED MILL LICENSE APPLICATIONS

Effective Date: 02/24/2011

[PDF Version]

1. AUTHORITIES DELEGATED AND TO WHOM DELEGATED.

A. The Director, the Deputy Director, and the Senior Advisor for Science Policy, Center for Veterinary Medicine (CVM), are authorized to:

1. issue notices of opportunity for a hearing on proposals to refuse approval or to withdraw approval of new animal drug applications, and supplements thereto, for drugs for animal use and proposals to refuse approval or to revoke approval of medicated feed mill license applications, and supplements thereto, submitted under Section 512(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(m)), as amended by the Animal Drug Availability Act of 1996 (Public Law 104-250);

2. issue notices refusing or withdrawing approval when opportunity for hearing has been waived; and

3. issue proposals and orders to revoke and amend regulations for new animal drugs for drugs for animal use and medicated feed mill licenses, corresponding to said act on such applications.

B. The Director, the Deputy Director, and the Senior Advisor for Science Policy, CVM, are authorized to issue notices of availability of Public Master Files containing data acceptable for use in applications for new animal drugs for drugs for animal use and feeds bearing or containing new animal drugs.

2. REDELEGATION.

These officials may not further redelegate these authorities.

3. EFFECTIVE DATE.

The Commissioner of Food and Drugs approved this delegation on February 24, 2011.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial02/24/2011N/aCVM/OMCommissioner of Food and Drugs