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SMG 1410.509

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - ANIMAL DRUGS

IMPORT TOLERANCES UNDER SECTION 512(a) OF THE FEDERAL FOOD, DRUG AND COSMETIC ACT

Effective Date: 02/24/2011

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1. AUTHORITY DELEGATED AND TO WHOM DELEGATED AND REDELEGATION.

A. The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under Section 512(a) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360(b)(a), as added by the ADAA regarding import tolerances of drug residues found in the edible tissue of imported food products of animal origin:

1. Director, the Deputy Director, and the Senior Advisor for Science Policy, Center for Veterinary Medicine (CVM)

2. Director and Deputy Director, Office of Surveillance and Compliance, CVM, the same authority under Section 512(a) of the act regarding import tolerances of drug residues found in the edible tissue of imported food products of animal origin. Specifically, the authority to:

a. Establish tolerances of drug residues of animal drugs that are not approved in the United States that are found in the edible tissue of imported food products of animal origin

b. Revoke tolerances if information demonstrates that the use of the new animal drug under actual use conditions results in food being imported into the United States with residues exceeding the tolerance or if scientific evidence shows the tolerance to be unsafe

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