[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.108]

[Page 51]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
           Subpart C--Human Drugs; Redelegations of Authority
 
Sec. 5.108  Authority relating to waivers or reductions of prescription drug user fees.

    The Director, Center for Drug Evaluation and Research (CDER), and 
the Associate Director for Regulatory 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Prescription Drug User Fee Act of 1992, as originally enacted and as 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refunds of fees if an application or supplement is withdrawn after 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. 5.20(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.) These officials may not further redelegate this 
authority.