[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.108]

[Page 71-72]
 
                        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Prescription Drug User Fee Act of 1992, as originally enacted and as 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

[[Page 72]]

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if an application or supplement is withdrawn after filing (21 U.S.C. 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.