[Federal Register Volume 69, Number 250 (Thursday, December 30, 2004)]
[Rules and Regulations]
[Pages 78305-78306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28578]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Chlortetracycline

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 animal 
drug regulations to add the approved withdrawal time to the limitations 
to conditions of use for chlortetracycline Type C medicated feeds for 
chickens when fed at the 500 gram per ton level. This change is being 
made to improve the accuracy of the regulations.

DATES: This rule is effective December 30, 2004.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV- 6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA has found that the April 1, 2004, 
edition of Title 21, Parts 500 to 599 of the Code of Federal 
Regulations (CFR) does not reflect the approved withdrawal time for 
chlortetracycline in Type C medicated feeds for chickens when fed at 
the 500 gram per ton level. The approved 24-hour withdrawal time at 
this dose level was inadvertently removed for all sponsors at the time 
of a supplemental approval of a zero-day withdrawal time for AUREOMYCIN 
Type C medicated chicken feeds under NADA 48-761 (63 FR 57245 at 57247, 
October 27, 1998). At this time, FDA is amending the regulations to 
correct this error in 21 CFR 558.128. This action is being taken to 
improve the accuracy of the regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. Section 558.128 is amended by revising paragraph (e)(1)(iv) to read 
as follows:


Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount      Indications for use                   Limitations                     Sponsor
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
(iv) 500 g/ton            Chickens: For the           1. Feed for 5 d; 0-day withdrawal time   .................
                           reduction of mortality      when formulated from                               046573
                           due to E. coli infections  AUREOMYCIN Type A medicated articles or
                           susceptible to              Type B medicated feeds under NADA 48-
                           chlortetracycline.          761.
                                                      2. Feed for 5 d; withdraw 24 h prior to
                                                       slaughter; do not feed to chickens
                                                       producing eggs for human consumption.
                          ..........................  .......................................  .................
                                                                                                         017519,
                                                                                                         046573,
                                                                                                         048164,
                                                                                                          066104
                                                  * * * * * * *
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[[Page 78306]]

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    Dated: December 16, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-28578 Filed 12-29-04; 8:45 am]
BILLING CODE 4160-01-S