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Rule

Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection, 200 Milligram/Milliliter

Action

Final Rule; Technical Amendment.

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to correct the indications for use for the 200 milligram (mg)/milliliter (mL) strength of oxytetracycline injectable solution used in beef cattle for the treatment and control of various bacterial diseases. This action is being taken to improve the accuracy of the regulations.

 

Table of Contents Back to Top

DATES: Back to Top

This rule is effective June 6, 2006.

FOR FURTHER INFORMATION CONTACT: Back to Top

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail: george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Back to Top

FDA has found that the April 1, 2005, edition of Title 21 parts 500 to 599 of the Code of Federal Regulations (CFR) does not accurately reflect the approved indications for use for the 200 mg/mL strength of oxytetracycline injectable solution. Certain indications of use for the 300 mg/mL strength of oxytetracycline injectable solution appear to have been included as an error in the section for the 200 mg/mL strength solution during reformatting (69 FR 31878, June 8, 2004). At this time, FDA is amending the regulations in 21 CFR 522.1660a to reflect the correct approved indications for use. 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 522 Back to Top

begin regulatory text

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 522 is amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS Back to Top

1.The authority citation for 21 CFR part 522 continues to read as follows:

Authority:

21 U.S.C. 360b.

§ 522.1660a [Amended]

2.In § 522.1660a, remove paragraphs (e)(1)(i)(D) and (e)(1)(i)(E).

end regulatory text

Dated: May 25, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. E6-8694 Filed 6-5-06; 8:45 am]

BILLING CODE 4160-01-S

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