04-28578. New Animal Drugs for Use in Animal Feeds; Chlortetracycline

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule, technical amendment.

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: [e-mail].

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

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

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:

§ 558.128

Chlortetracycline.

* * * * *

(e) * * *

(1) * * *

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

* * * * *

Dated: December 16, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.