[Federal Register Volume 62, Number 4 (Tuesday, January 7, 1997)]
[Rules and Regulations]
[Page 923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-290]


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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 regulations that cover general redelegations 
of authority from the Commissioner of Food and Drugs to other officers 
of FDA. The amendment delegates the FDA Deputy User Fee Waiver Officer 
authority to consider and decide requests under certain circumstances 
for waivers or reductions of user fees. Redelegation of this authority 
would allow for more efficient operations.

EFFECTIVE DATE: Janaury 7, 1997.

FOR FURTHER INFORMATION CONTACT:
    Suzanne M. 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 revising Sec. 5.20(h) to add the title of Deputy User Fee 
Waiver Officer to those authorized to perform all of the functions of 
the Commissioner under the Prescription Drug User Fee Act of 1992 (21 
U.S.C. 379h(d)), as amended hereafter, relating to the authority to 
waive or reduce user fees. The Chief Mediator and Ombudsman and the 
Deputy Chief Mediator and Ombudsman currently have this authority. This 
action is being taken in order to redelegate authority to the Deputy 
User Fee Waiver Officer, which will provide a more efficient process 
for considering and making decisions on requests for waivers or 
reduction of user fees.
    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 is revised 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; secs. 2-12 of the Fair Packaging 
and Labeling Act (15 U.S.C. 1451-1461); 21 U.S.C. 41-50, 61-63, 141-
149, 467f, 679(b), 801-886, 1031-1309; secs. 201-903 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321-394); 35 U.S.C. 156; 
secs. 301, 302, 303, 307, 310, 311, 351, 352, 361, 362, 1701-1706, 
2101 of the Public Health Service Act (42 U.S.C. 241, 242, 242a, 
242l, 242n, 243, 262, 263, 264, 265, 300u-300u-5, 300aa-1); 42 
U.S.C. 1395y, 3246b, 4332, 4831(a), 10007-10008; E.O. 11490, 11921, 
and 12591.
    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) The Chief Mediator and Ombudsman is designated as User Fee 
Waiver Officer and is authorized to perform all of the functions of the 
Commissioner under the Prescription Drug User Fee Act of 1992 (21 
U.S.C. 379h(d)), as amended hereafter, relating to the authority to 
waive or reduce user fees. The User Fee Waiver Officer's authority may 
be redelegated to the Deputy Chief Mediator and Ombudsman and to the 
Deputy User Fee Waiver Officer, without further redelegation. The 
Deputy Commissioner for Operations is designated User Fee Appeals 
Officer and 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: December 31, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-290 Filed 1-6-97; 8:45 am]
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