[Federal Register Volume 67, Number 234 (Thursday, December 5, 2002)]
[Rules and Regulations]
[Pages 72366-72367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30782]


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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 an original abbreviated new 
animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. 
The ANADA provides for the administration

[[Page 72367]]

of an oxytetracycline injectable solution to cattle and swine for the 
treatment of various bacterial diseases.

DATES: This rule is effective December 5, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-101), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, 
Newry BT35 6JP, Northern Ireland, filed original ANADA 200-306 that 
provides for the use of Oxytetracycline Injection (200 milligrams per 
milliliter (mg/mL)) as a treatment for various bacterial diseases in 
cattle and swine. Norbrook's Oxytetracycline Injection (200 mg/mL) is 
approved as a generic copy of Pfizer's LIQUAMYCIN LA-200, approved 
under NADA 113-232. The application is approved as of June 18, 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 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 (b) by removing ``Sponsor'' and by adding in its place 
``Sponsors'', and by numerically adding ``055529''; in paragraph 
(d)(1)(iii) in the second and ninth sentences by numerically adding 
``055529''; and in paragraph (d)(2)(iii) in the third sentence by 
removing ``when provided by 000010, 000069, 011722, 053389, 059130, and 
061623''.

    Dated: November 15, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-30782 Filed 12-4-02; 8:45 am]
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