[Federal Register Volume 63, Number 151 (Thursday, August 6, 1998)]
[Rules and Regulations]
[Pages 41959-41960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20954]


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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

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 regulation that covers general redelegations 
of authority from the Commissioner of Food and Drugs to other officers 
of FDA. The amendment delegates an authority related to the waiver and 
reduction of prescription drug user fees to the Deputy Commissioner for 
Management and Systems and the Director, Office of Financial 
Management. Redelegation of this authority would allow for more 
efficient operations. Additionally, this amendment revokes part of the 
above authority from the FDA User Fee Waiver Officer, Deputy Chief 
Mediator and Ombudsman, and the Deputy User Fee Waiver Officer.

EFFECTIVE DATE: August 6, 1998.

FOR FURTHER INFORMATION CONTACT:
    Suzanne O'Shea, Office of the Chief Mediator and Ombudsman (HF-7), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-3390, or
    Donna G. Page, Division of Management Systems and Policy (HFA-340), 
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

[[Page 41960]]

revising Sec. 5.20(h) to authorize the Deputy Commissioner for 
Management and Systems and the Director, Office of Financial Management 
to perform the functions of the Commissioner of Food and Drugs under 
section 736(d)(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379h(d)(C)), as amended hereafter, to waive or reduce 
prescription drug user fees in situations where it is determined that 
``the fees will exceed the anticipated present and future costs.'' 
Further, this authority is revoked from the delegations to the Chief 
Mediator and Ombudsman/Deputy User Fee Waiver Officer, the Deputy Chief 
Mediator and Ombudsman, and the Deputy User Fee Waiver Officer, who 
previously had the authority.
    Further redelegation of this authority is not authorized at this 
time. Authority delegated to a position by title may be exercised by a 
person officially designated to serve in such position in an acting 
capacity or on a temporary basis.

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, designated as the User Fee 
Waiver Officer; the Deputy Chief Mediator and Ombudsman; and the Deputy 
User Fee Waiver Officer are authorized to perform the functions of the 
Commissioner under the Prescription Drug User Fee Act of 1992, as 
amended by the FDA Modernization Act of 1997 (21 U.S.C. 379h(d)), as 
amended hereafter, relating to waiving or reducing prescription drug 
user fees except for the functions under 21 U.S.C. 379h(d)(C), which 
pertains to situations where ``the fees will exceed the anticipated 
present and future costs.'' These authorities may not be further 
redelegated.
    (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)(C), as amended 
hereafter, to waive or reduce prescription drug user fees in situations 
where it is determined that ``the fees will exceed the anticipated 
present and future costs.'' This authority may not be further 
redelegated.
    (3) The Deputy Commissioner for Operations, designated as 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.
 * * * * *

    Dated: July 29, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20954 Filed 8-5-98; 8:45 am]
BILLING CODE 4160-01-F