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SMG 1410.306

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - FOOD AND COSMETICS

DETERMINATIONS RELATED TO RECORDS ACCESS FOR HUMAN AND ANIMAL FOODS UNDER SECTION 414 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

Effective Date: 12/15/2010

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1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The following officials are authorized to determine, under Section 414(a) and 704(a) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 350c(a)), 374(a) that there is a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals:

1. The Director and Deputy Directors, Center for Food Safety and Applied Nutrition (CFSAN)

2. The Director and Deputy Director, of the Office of Compliance (CFSAN)

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

4. The Director of the Office of Surveillance and Compliance (CVM)

5. The Director of the Division of Compliance (CVM)

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

The Commissioner of Food and Drugs approved this delegation, via memorandum, on December 15, 2010.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial12/15/2010N/aCFSAN/OMSMargaret A. Hamburg, M.D., Commissioner of Food and Drugs