[Federal Register Volume 66, Number 43 (Monday, March 5, 2001)]
[Rules and Regulations]
[Page 13235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5223]


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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 a supplemental abbreviated new 
animal drug application (ANADA) filed by Pennfield Oil Co. The ANADA 
provides for the subcutaneous administration of oxytetracycline 
injectable solution in cattle.

DATES: This rule is effective March 5, 2001.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0212.

SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68137, filed a supplement to ANADA 200-154 that provides for 
the use of PENNOX<SUP>TM</SUP> (oxytetracycline) 200 Injection as 
treatment for various bacterial diseases in cattle and swine. The 
supplemental ANADA provides for the subcutaneous administration of 
oxytetracycline injectable solution in beef cattle, nonlactating dairy 
cattle, and calves, including preruminating (veal) calves. The 
supplemental ANADA is approved as of January 12, 2001, 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 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 Subject 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 the 
second sentence in paragraph (d)(1)(iii) by removing ``Sponsor 
000010,'' and by adding in its place ``Sponsors 000010 and 053389''.

    Dated: February 8, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-5223 Filed 3-2-01; 8:45 am]
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