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SMG 1410.502

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - ANIMAL DRUGS

APPROVAL OF NEW ANIMAL DRUG APPLICATIONS, MEDICATED FEED MILL LICENSE APPLICATIONS AND THEIR SUPPLEMENTS

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 perform all the functions of the Commissioner of Food and Drugs (Commissioner) with regard to the approval of new animal drug applications, and supplements thereto, for new animal drugs submitted under Section 512 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360b).

B. The following officials are authorized to perform all the functions of the Commissioner with regard to the approval of supplemental applications to approved new animal drugs submitted under Section 512 of the Act (21 U.S.C. 360b):

1. The Director, the Deputy Director for Administration, and the Deputy Director for Science Policy, Office of New Animal Drug Evaluation (ONADE), CVM

2. The Director and Deputy Director, Office of Surveillance and Compliance, CVM

C. The following officials are authorized to perform all the functions of the Commissioner with regard to the approval of supplemental applications to new animal drug applications that are described by Section 514.8(b) of Title 21, Code of Federal Regulations, Part 500.

1. The Director, Division of Manufacturing Technologies, Office of New Animal Drug Evaluation (ONADE), CVM

2. The Director, Division of Surveillance, Office of Surveillance and Compliance, CVM

D. The following officials are authorized to perform all the functions of the Commissioner with regard to the approval of supplemental applications to new animal drug applications that are described by Section 514.8(c)(3) of Title 21, Code of Federal Regulations, Part 500.

1. The Director, Division of Therapeutic Drugs for Non-food Animals, ONADE

2. The Director Division of Production Drugs, ONADE

3. The Director, Division of Therapeutic Drugs for Food Animals, ONADE

4. The Director, Division of Manufacturing Technologies, ONADE

5. The Leader, Generic Animal Drug Team, ONADE, CVM

E. The following officials are authorized to perform all the functions of the Commissioner with regard to the approval of medicated feed mill license applications for the manufacture of animal feeds containing new animal drugs under Section 512(m) of the Act (21 U.S.C. 360b(m), as amended by the Animal Drug Availability Act of 1996 (Public Law 104-250):

1. The Director, the Deputy Director, and the Senior Advisor for Science Policy, CVM

2. The Director, Division of Animal Feeds, Office of Surveillance and Compliance, CVM

3. The Leader, Medicated Feeds Team, Division of Animal Feeds, Office of Surveillance and Compliance, CVM

4. The Medicated Feeds Specialist, Medicated Feeds Team, Division of Animal Feeds, Office of Surveillance and Compliance, CVM

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