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FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - ANIMAL DRUGS

SMG 1410.505 - ISSUANCE OF WRITTEN NOTICES CONCERNING PATENT INFORMATION, CURRENT GOOD MANUFACTURING PRACTICES AND FALSE OR MISLEADING LABELING OF NEW ANIMAL DRUGS AND FEEDS BEARING OR CONTAINING NEW ANIMAL DRUGS

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) under sections 512(e) and 512 (m)(4)(B)(ii) and (m)(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(e), (m)(4)(B)(ii), and (m)(4)(B)(iii)) regarding the issuance of written notices:

1. The Director and Deputy Director, Center for Veterinary Medicine (CVM).

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

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

4. Regional Food and Drug Directors.

5. District Directors.

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

The Acting Principal Deputy Commissioner approved this delegation on April 2, 2001 (Via Memorandum from the Acting Senior Associate Commissioner for Management and Services to the Acting Principal Deputy Commissioner, Subject: Comprehensive Update to 21 CFR Part 5, Delegations of Authority and Organization - ACTION, dated April 2, 2001, and Tab C - Delegations of Authority Statement signed by the Acting Principal Deputy Commissioner, dated April 2, 2001). This information was previously published in the June 8, 2001, Final Rule, 66 Federal Register 30992-31025.

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