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SMG 1410.109

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - HUMAN DRUGS

AUTHORITY RELATING TO WAIVERS OR REDUCTIONS OF PRESCRIPTION DRUG USER FEES

Effective Date: 04/27/2007

[PDF Version]

1. AUTHORITIES DELEGATED AND TO WHOM DELEGATED.

The Director, Center for Drug Evaluation and Research (CDER), and the Associate Director for Policy, CDER, are authorized to perform all the functions of the Commissioner of Food and Drugs relating to waivers or reductions of prescription drug user fees under the Prescription Drug User Fee Act of 1992, as originally enacted and as reauthorized by the Food and Drug Administration Modernization Act of 1997, except for the functions under section 736(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379h(d)(1)(C)) that pertain to situations where "the fees will exceed the anticipated present and future costs,'' on behalf of CDER, the Center for Biologics Evaluation and Research, and any other Food and Drug Administration Center. This authority pertains to waivers requested under the public health waiver provision (21 U.S.C. 379h(d)(1)(A)); the barrier to innovation waiver provision (21 U.S.C. 379h(d)(1)(B)); the applications submitted under section 505(b)(1) and (b)(2) of the Federal Food, Drug, and Cosmetic Act waiver provision (21 U.S.C. 379h(d)(1)(D)); the small business waiver provision (21 U.S.C. 379h(d)(1)(E)); and to requests for refunds of fees if an application or supplement is withdrawn after filing (21 U.S.C. 379h(a)(1)(G)); as well as waivers, reductions, or refunds requested on any other basis except fees exceeding the cost. (See Sec. SMG 1410.21 H.1.) for the authority to reconsider any user fee decisions made by the Chief Mediator and Ombudsman, the Deputy Chief Mediator and Ombudsman, and/or the former Deputy User Fee Waiver Officer prior to July 1, 1999.)

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 April 27, 2007.