[Federal Register Volume 71, Number 108 (Tuesday, June 6, 2006)]
[Rules and Regulations]
[Pages 32436-32437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8694]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


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

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 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.

DATES: This rule is effective June 6, 2006.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: 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.''

[[Page 32437]]

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

    Animal drugs.

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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


Sec.  522.1660a  [Amended]

0
2. In Sec.  522.1660a, remove paragraphs (e)(1)(i)(D) and (e)(1)(i)(E).

    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