[Federal Register Volume 67, Number 247 (Tuesday, December 24, 2002)]
[Rules and Regulations]
[Page 78357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32276]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 Boehringer Ingelheim 
Vetmedica, Inc. The supplemental ANADA provides for the administration 
of an oxytetracycline injectable solution to lactating dairy cattle.

DATES: This rule is effective December 24, 2002.

FOR FURTHER INFORMATION CONTACT: Julia W. Punderson, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7570, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Hwy., St. Joseph, MO 64506-2002, filed a supplement to 
approved ANADA 200-008 that provides for the use of BIO-MYCIN 200 
(oxytetracycline injection) and OXY-TET 200 (oxytetracycline injection) 
as treatments for various bacterial diseases in cattle and swine. The 
supplemental ANADA provides for the administration of these 
oxytetracycline injectable solutions to lactating dairy cattle. The 
supplemental application is approved as of September 3, 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 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 (d)(1)(iii) by removing in the eighth sentence ``000010, 
059130, and 061623'' and adding in its place``059130 and 061623'', and 
by removing in the ninth sentence ``For sponsors'' and adding in its 
place ``For sponsors 000010,''.

    Dated: December 4, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 02-32276 Filed 12-23-02; 8:45 am]
BILLING CODE 4160-01-S