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SMG 1410.504

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - ANIMAL DRUGS

SUBMISSION OF AND EFFECTIVE APPROVAL DATES FOR ABBREVIATED NEW ANIMAL DRUG APPLICATIONS AND CERTAIN NEW ANIMAL DRUG APPLICATIONS

Effective Date: 02/24/2011

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1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) with regard to decisions made under Section 512(c)(2)(D)(iv) and (c)(2)(F) of the Federal, Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360b(c)(2)(D)(iv) and (c)(2)(F) concerning the date of submission and the date of effective approval of abbreviated new animal drug applications including supplements thereto, submitted under Section 512(b)(2) of the Act (21 U.S.C. 360b(b)(2)), and of new animal drug applications including supplements thereto, submitted under Section 512(b)(1) of the Act (21 U.S.C. 360b(b)(1)):

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

2. The Director and Deputy Director, Office of New Animal Drug Evaluation, CVM

2. REDELEGATION.

These officials may not further redelegate this authority.

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