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[Federal Register: July 19, 2002 (Volume 67, Number 139)]
[Rules and Regulations]               
[Page 47450-47451]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jy02-5]                         

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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 Pliva d.d. The supplemental 
ANADA provides for the subcutaneous administration of an 
oxytetracycline injectable solution to cattle, and for its use in 
lactating dairy cattle.

DATES: This rule is effective July 19, 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: 
<A HREF="mailto:lluther@cvm.fda.gov">lluther@cvm.fda.gov</A>.

SUPPLEMENTARY INFORMATION: Pliva d.d., Ulica grada Vukovara 49, 10000 
Zagreb, Croatia, filed a supplement to approved ANADA 200-232 that 
provides for the use of GEOMYCIN 200 (oxytetracycline)

[[Page 47451]]

Injection as a treatment for various bacterial diseases in cattle and 
swine. The supplemental ANADA provides for the subcutaneous 
administration of this oxytetracycline injectable solution to cattle, 
and for its use in lactating dairy cattle. The supplemental application 
is approved as of April 8, 2002, and the regulations are amended in 21 
CFR 522.1660d 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 
paragraph (d)(1)(iii) in the second sentence by numerically adding 
``011722,''; in the eighth sentence by removing ``011722,''; and in the 
ninth sentence by removing ``sponsor 000069'' and by adding in its 
place ``sponsors 000069 and 011722''.

    Dated: July 11, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-18178 Filed 7-18-02; 8:45 am]
BILLING CODE 4160-01-S

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