[Federal Register Volume 60, Number 2 (Wednesday, January 4, 1995)]
[Rules and Regulations]
[Pages 362-363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-163]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 abbreviated new animal drug 
application (ANADA) filed by Boehringer Ingelheim Animal Health, Inc. 
The ANADA provides for the use of oxytetracycline injection in cattle 
and swine for the treatment of diseases caused by oxytetracycline 
susceptible organisms.

EFFECTIVE DATE: January 4, 1995.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Animal Health, 
[[Page 363]] Inc., 2621 North Belt Hwy., St. Joseph, MO 64506, has 
filed ANADA 200-008 which provides for use of oxytetracycline injection 
as follows: intramuscular or intravenous use in beef and nonlactating 
dairy cattle for the treatment of pneumonia and shipping fever 
associated with Pasteurella spp. and Hemophilus spp.; infectious bovine 
keratoconjunctivitis (pinkeye) caused by Moraxella bovis; foot rot and 
diphtheria caused by Fusobacterium necrophorum; bacterial enteritis 
(scours) caused by Escherichia coli; wooden tongue caused by 
Actinobacillus lignieresi; leptospirosis caused by Leptospira pomona; 
and wound infections and acute metritis caused by strains of 
staphylococci and streptococci organisms sensitive to oxytetracycline-
intramuscular use in swine for treatment of bacterial enteritis 
(scours, colibacillosis) caused by E. coli; pneumonia caused by P. 
multocida; and leptospirosis caused by L. pomona-intramuscular use in 
sows for control of infectious enteritis (baby pig scours, 
colibacillosis) in suckling pigs caused by E. coli.
    Boehringer Ingelheim's ANADA 200-008 for oxytetracycline injection 
(OXY-TET 200/BIO-MYCIN 200) is approved as a generic copy of Pfizer's 
NADA 113-232 for oxytetracycline injection (Liquamycin LA-200). The 
ANADA is approved as of November 16, 1994, and the regulations are 
amended by revising Sec. 522.1660(b) and (c)(2)(iii) (21 CFR 
522.1660(b) and (c)(2)(iii)) to reflect the approval. The basis for 
approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 522.1660 is amended in paragraph (b) by adding the 
phrase ``000010 and'' before the number ``000069'', and in paragraph 
(c)(2)(iii) by revising the last sentence to read as follows:


Sec. 522.1660  Oxytetracycline injection.

* * * * *
    (c) * * *
    (2) * * *
    (iii) * * * Discontinue treatment at least 42 days prior to 
slaughter when provided by 000010 or 28 days prior to slaughter when 
provided by 000069.

    Dated: December 21, 1994.
Michael J. Blackwell,
Deputy Director, Post-market Surveillance and Compliance, Center for 
Veterinary Medicine.
[FR Doc. 95-163 Filed 1-3-95; 8:45 am]
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