[Federal Register Volume 64, Number 83 (Friday, April 30, 1999)]
[Rules and Regulations]
[Pages 23186-23187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10793]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 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 Pliva d.d. The ANADA provides for 
intramuscular use of oxytetracycline injection in swine and 
intramuscular and intravenous use in cattle for treatment of bacterial 
infections susceptible to oxytetracycline.

EFFECTIVE DATE:  April 30, 1999.

FOR FURTHER INFORMATION CONTACT:  Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Pliva d.d., Ulica grada Vukovara 49, 10000 
Zagreb, Croatia, filed ANADA 200-232 that provides for the use of 
Geomycin 200 (oxytetracycline injection) for treatment of diseases 
caused by oxytetracycline susceptible organisms as follows: 
Intramuscular use in swine for treatment of bacterial enteritis 
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused 
by Pasteurella multocida, and leptospirosis caused by Leptospira 
pomona, and in sows as an aid in the control of infectious enteritis 
(baby pig scours, colibacillosis) in suckling pigs caused by E. coli; 
intramuscular and intravenous use in cattle for the treatment of 
bacterial pneumonia and shipping fever complex associated with 
Pasteurella spp. and Haemophilus spp., infectious bovine 
keratoconjunctivitis (pinkeye) caused by Moraxella bovis, foot rot and 
diptheria caused by Fusobacterium necrophorum, bacterial enteritis 
(scours) caused by E. coli, wooden tongue caused by Actinobacillus 
lignieresi, leptospirosis caused by L. pomona, and wound infections and 
acute metritis caused by strains of streptococcal and staphylococcal 
organisms.
    Approval of Pliva d.d.'s ANADA 200-232 for oxytetracycline 
injection is as a generic copy of Pfizer, Inc.'s NADA 113-232 for 
Liquamycin LA-200 (oxytetracycline injection). 
ANADA 200-232 is approved as of February 12, 1999, and the regulations 
are amended in 21 CFR 522.1660(b) and (d) to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    Because Pliva d.d. has not been previously listed in the animal 
drug regulations as the sponsor of an approved application, 21 CFR 
510.600 is amended in paragraphs (c)(1) and (c)(2) to add entries for 
the firm.
    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

[[Page 23187]]

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.

List of Subjects

21 CFR Part 510

    Administrative practices and procedures, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

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 parts 510 and 
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding an entry for ``Pliva d.d.'' and in the table in 
paragraph (c)(2) by numerically adding an entry for ``011722'' to read 
as follows:


Sec. 510.600   Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

 
------------------------------------------------------------------------
       Firm name and address                  Drug labeler code
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  *                    *                    *                    *
                   *                    *                    *
Pliva d.d., Ulica grada Vukovara     011722
 49, 10000 Zagreb, Croatia
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

    (2) * * *

 
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
011722                               Pliva d.d., Ulica grada Vukovara
                                      49, 10000 Zagreb, Croatia
  *                    *                    *                    *
                   *                    *                    *
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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 
paragraphs (b) and (d)(2)(iii) by adding the number ``011722,'' after 
``000069''.

    Dated: April 21, 1999.
George A. Mitchell,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 99-10793 Filed 4-29-99; 8:45 am]
BILLING CODE 4160-01-F