[Federal Register Volume 68, Number 34 (Thursday, February 20, 2003)]
[Rules and Regulations]
[Page 8153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3434]



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  Federal Register / Vol. 68, No. 34 / Thursday, February 20, 2003 / 
Rules and Regulations  

[[Page 8153]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Oxytetracycline Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental abbreviated new 
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The 
supplemental ANADA provides for the administration of an 
oxytetracycline injectable solution to lactating dairy cattle.

DATES: This rule is effective February 20, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Terr., St. Joseph, MO 64506-0457, filed a supplement to approved 
ANADA 200-123 that provides for the use of MAXIM-200 (oxytetracycline) 
Injection as a treatment for various bacterial diseases in cattle and 
swine. The supplemental ANADA provides for the administration of this 
oxytetracycline injectable solution to lactating dairy cattle. The 
supplemental ANADA is approved as of November 19, 2002, and the 
regulations are amended in 21 CFR 522.1660 to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this supplemental application may be seen in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through 
Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    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.


Sec.  522.1660  [Amended]

    2. Section 522.1660 Oxytetracycline injection is amended in 
paragraph (d)(1)(iii) in the eighth sentence by removing ``sponsors 
059130 and 061623''; and adding in its place ``sponsor 061623''; and in 
the ninth sentence by removing ``and 055529'' and adding in its place 
``055529, and 059130''.

    Dated: January 21, 2003.
Steven F. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-3434 Filed 2-19-03; 8:45 am]
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