[Federal Register Volume 64, Number 212 (Wednesday, November 3, 1999)]
[Rules and Regulations]
[Pages 59617-59618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization; Office of the 
Commissioner and the Center for Drug Evaluation and Research

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
delegations of authority statement that covers general redelegations of 
authority from the Commissioner of Food and Drugs to other officers of 
FDA. The amendment delegates authority to perform all functions 
relating to waivers or reductions of prescription drug user fees under 
the Prescription Drug User Fee Act of 1992 (PDUFA), as originally 
enacted and as reauthorized by the FDA Modernization Act of 1997 (the 
Modernization Act), to the Director, Center for Drug Evaluation and 
Research (CDER) and to the Associate Director for Policy, CDER, except 
for the functions that pertain to situations where ``the fees will 
exceed the anticipated present and future costs.'' The authority to 
waive or reduce user fees, previously redelegated to the Chief Mediator 
and Ombudsman/User Fee Waiver Officer, the Deputy Chief Mediator and 
Ombudsman, and the Deputy User Fee Waiver Officer is hereby revoked, 
except the authority to act upon requests for reconsideration of any 
user fee decision made by such officers prior to July 1, 1999. Also, as 
a result of the June 20, 1999, FDA reorganization, the Office of 
Operations component and the Deputy Commissioner for Operations 
position were abolished; therefore, the Deputy Commissioner will assume 
the role of the User Fee Appeals Officer and perform the associated 
functions.

EFFECTIVE DATE: July 1, 1999.
ADDRESSES:  As of July 1, 1999, submit all requests for waivers, 
refunds, and reductions in user fees under PDUFA, originally enacted 
and reauthorized by the Modernization Act, to the Associate Director 
for Policy, Center for Drug Evaluation and Research (HFD-5), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, Attn: User 
Fee Waiver Office. Submit requests sent via a courier that requires a 
street address to the Associate Director for Policy, Center for Drug 
Evaluation and Research (HFD-5), Food and Drug Administration, 1451 
Rockville Pike, Rockville, MD 20852, Attn: User Fee Waiver Office. 
Submit requests for reconsideration of user fee waiver determinations 
made prior to the effective date of this document to the Office of the 
Chief Mediator and Ombudsman, (HF-7), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: 
    Beverly J. Friedman, User Fee Staff (HFD-5), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041, 
or
    Donna G. Page, Division of Management Programs (HFA-340),

[[Page 59618]]

Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-4816.

SUPPLEMENTARY INFORMATION: FDA is amending the delegations of authority 
under Sec. 5.20 General redelegations of authority from the 
Commissioner to other officers of the Food and Drug Administration (21 
CFR 5.20) by revising Sec. 5.20(h) to revoke the authority of the Chief 
Mediator and Ombudsman/User Fee Waiver Officer, the Deputy Chief 
Mediator and Ombudsman, and the Deputy User Fee Waiver Officer to waive 
or reduce user fees under the waiver provisions of PDUFA as originally 
enacted and as amended by the Modernization Act (section 736(d) and 
(a)(1)(G) of the Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
379h(d) and (a)(1)(G)), except the authority to act upon requests for 
reconsideration of any user fee decision made by such officers prior to 
July 1, 1999. FDA is also revising the section to reflect that the 
Deputy Commissioner is designated as the User Fee Appeals Officer and 
in the case of a vacancy in the position, to reflect the designation of 
the Senior Associate Commissioner, Office of the Commissioner as the 
User Fee Appeals Officer.
    FDA is adding Sec. 5.101 Authority relating to waivers or 
reductions of prescription drug user fees to reflect redelegation of 
certain user fee-related authorities under section 736(d) and (a)(1)(G) 
of the act, as amended, to the Director, CDER and to the Associate 
Director for Policy, CDER. CDER will exercise the authority now being 
delegated to resolve requests for waivers, reductions, or refunds of 
assessable fees relating to human drug products reviewed and regulated 
by CDER, the Center for Biologics Evaluation and Research, and any 
other FDA center.
    Authority delegated to a position by title may be exercised by a 
person officially designated to serve in such a position in an acting 
capacity or on a temporary basis, unless prohibited by a restriction in 
the document designating him/her as ``acting'' or unless not legally 
permissible. These authorities may not be further redelegated.

List of Subjects in 21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
5 is amended as follows:

 PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION

    1. The authority citation for 21 CFR part 5 continues to read as 
follows:
    Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15 
U.S.C. 638, 1261-1282, 3701-3711a; 15 U.S.C. 1451-1461; 21 U.S.C. 
41-50, 61-63, 141-149, 321-394, 467f, 679(b), 801-886, 1031-1309; 35 
U.S.C. 156; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 
264, 265, 300u-300u-5, 300aa-1; 1395y, 3246b, 4332, 4831(a), 10007-
10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131; E.O. 
12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223.
    2. Section 5.20 is amended by revising paragraph (h) to read as 
follows:

Sec. 5.20  General redelegations of authority from the Commissioner to 
other officers of the Food and Drug Administration.

* * * * *
    (h)(1) The Chief Mediator and Ombudsman and the Deputy Chief 
Mediator and Ombudsman are authorized to act upon requests for 
reconsideration of any user fee decisions (under 21 U.S.C. 379h(d)) 
made by such officers and the former Deputy User Fee Waiver Officer 
prior to July 1, 1999. This authority may not be further redelegated. 
(See Sec. 5.101 for the user fee-related redelegation to officials 
within the Center for Drug Evaluation and Research.)
    (2) The Deputy Commissioner for Management and Systems and the 
Director, Office of Financial Management are authorized to perform the 
functions of the Commissioner under 21 U.S.C. 379h(d)(1)(C), as 
amended, to waive or reduce prescription drug user fees in situations 
where he/she finds that ``the fees will exceed the anticipated present 
and future costs.'' This authority may not be further redelegated.
    (3) The Deputy Commissioner or, in the event of a vacancy in that 
position, the Senior Associate Commissioner, Office of the 
Commissioner, is designated as the User Fee Appeals Officer. The User 
Fee Appeals Officer is authorized to hear and decide user fee waiver 
appeals. The decision of the User Fee Appeals Officer will constitute 
final agency action on such matters. This authority may not be further 
redelegated.
    3. Section 5.101 is added to subpart C to read as follows:


Sec. 5.101  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 Policy, CDER, are authorized to perform all 
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 l992, as originally enacted and as reauthorized by the 
FDA Modernization Act of l997, except for the functions under 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 FDA 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. 
These authorities may not be further redelegated. (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.)
* * * * *

    Dated: October 25, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-28562 Filed 11-2-99; 8:45 am]
BILLING CODE 4160-01-F