99-20257. Implantation and Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection; Technical Amendment

[Federal Register Volume 64, Number 151 (Friday, August 6, 1999)]
[Rules and Regulations]
[Pages 42830-42831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20257]


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DEPARTMENT OF HEALTH AND HUMAN RESOURCES

Food and Drug Administration

21 CFR Part 522


Implantation and Injectable Dosage Form New Animal Drugs; 
Oxytetracycline Injection; Technical Amendment

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 include a limitation in the approval of Pliva 
d.d.'s abbreviated new animal drug application (ANADA). The regulation 
did not state that use of Pliva d.d.'s oxytetracycline injection in 
cattle is limited to use in nonlactating dairy cattle. At this time, 
the regulation is amended to reflect the limitation.

EFFECTIVE DATE: August 6, 1999.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 30, 1999 
(64 FR 23186), FDA published a document reflecting approval of Pliva 
d.d.'s ANADA 200-232 for use of Geomycin 200 (oxytetracycline 
injection) in cattle and swine. The amendment to the regulation did not 
state that the product is not for use in lactating dairy cattle. At 
this time, the regulations in 21 CFR 522.1660(d)(1)(iii) are amended to 
reflect the limitation in the approval.
    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

    Animal drugs.
    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

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

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

[[Page 42831]]

Sec. 522.1660  [Amended]

    2. Section 522.1660 Oxytetracycline injection is amended in 
paragraph (d)(1)(iii) by adding in the eighth sentence the number 
``011722,'' after the number ``000010,''.

    Dated: June 29, 1999.
George A. Mitchell,
Acting Deputy Director, Center for Veterinary Medicine.
[FR Doc. 99-20257 Filed 8-5-99; 8:45 am]
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