[Federal Register Volume 64, Number 83 (Friday, April 30, 1999)]
[Rules and Regulations]
[Pages 23184-23185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10847]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegation of Authority and Organization; Center for Veterinary 
Medicine; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulation to reflect a redelegation of authority with respect to 
approval of supplemental new animal drug applications to the Director, 
Division of Manufacturing Technology, Office of New Animal Drug 
Evaluation, Center for Veterinary Medicine (CVM). This action is 
necessary to ensure the continued accuracy of the regulation.

EFFECTIVE DATE: December 22, 1998.

FOR FURTHER INFORMATION CONTACT:
     Carol Haley, Center for Veterinary Medicine (HFV-6), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1682;
     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: In the Federal Register of December 22, 1998 
(63 FR 70650), FDA amended the regulation for redelegations of 
authority to incorporate provisions for feed mill licensing and to 
update positions and component titles associated with the authorities 
under Sec. 5.83 (21 CFR 5.83). The regulation in Sec. 5.83(c)(1) 
reflected a redelegation with respect to approval of certain 
supplemental new animal drug applications to the position title 
``Director, Division of Human Food Safety, Office of New Animal Drug 
Evaluation, CVM.'' The correct position title to which these functions 
should have been redelegated is the ``Director, Division of 
Manufacturing Technologies, Office of New Animal Drug Evaluation, 
CVM,'' because that office is responsible for supplemental applications 
for manufacturing. Therefore, the redelegation to the ``Director, 
Division of Human Safety Office of New Animal Drug Evaluation, CVM'' 
has been amended and a new redelegation made to the ``Director, 
Division of Manufacturing Technologies, Office of New Animal Drug 
Evaluation, CVM.'' The regulation in Sec. 5.83(c)(1) has been revised 
to reflect this redelegation. Further redelegation of authorities is 
not authorized at this time. Authority delegated to a position 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 to read 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 5.83 is amended by revising paragraph (c)(1) to read as 
follows:


Sec. 5.83   Approval of new animal drug applications, medicated feed 
mill license applications, and their supplements.

* * * * *
     (c) * * *
     (1) The Director, Division of Manufacturing Technologies, Office 
of New Animal Drug Evaluation, CVM.
* * * * *


[[Page 23185]]


    Dated: April 23, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-10847 Filed 4-29-99; 8:45 am]
BILLING CODE 4160-01-F