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SMG 1410.507

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - ANIMAL DRUGS

AUTHORITY UNDER THE ANIMAL DRUG USER FEE ACT (ADUFA)

Effective Date: 02/24/2011

[PDF Version]

1. AUTHORITIES DELEGATED AND TO WHOM DELEGATED.

The Director, Center for Veterinary Medicine (CVM), is authorized to take actions necessary to implement and administer Section 740 of the Federal Food, Drug, and Cosmetic Act (FFDCA), as added by the ADUFA, which includes, but is not limited to, the authority to:

1. assess animal drug user fees;

2. under Section 740(d) of the FFDCA, waive or reduce animal drug user fees, except for waivers and reductions under Section 740(d)(1)(B) of the FFDCA, pertaining to situations where the fees assessed exceed the costs to FDA for reviewing applications; and,

3. decide appeals of CVM’s initial animal drug user fee waiver and reduction decisions and reconsideration of those decisions.*

(*NOTE: Agency-level appeals are to be made to the Chief Scientist and Deputy Commissioner for Science and Public Health delegated authority under SMG 1410.21, whose decision will constitute final agency action.)

2. REDELEGATION.

This official may further redelegate this authority in whole or in part. Any redelegation must be in writing and specify the nature and extent of the authority redelegated. Delegatees must be certified as knowledgeable about relevant legal, regulatory, and policy requirements. Each time a redelegation is made, a copy must be furnished to the FDA Delegations Officer (HFA-340).

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