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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule, technical amendment.

SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Chlortetracycline

DATES: This rule is effective December 30, 2004.

DOCUMENT 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.

SUMMARY: Chlortetracycline,

SUPPLEMENTAL 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 24hour withdrawal time at this dose level was inadvertently removed for all sponsors at the time of a supplemental approval of a zeroday withdrawal time for AUREOMYCIN Type C medicated chicken feeds under NADA 48761 (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. 801808.
List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.
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 558NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.
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; 0day 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 * * * * * * * [[Page 78306]]
* * * * *

Dated: December 16, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 0428578 Filed 122904; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT George K. Haibel, Center for Veterinary Medicine (HFV 6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 3018274567, email:
george.haibel@fda.gov.