[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) * * *
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Firm name and address Drug labeler code
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* * * *
* * *
Pliva d.d., Ulica grada Vukovara 011722
49, 10000 Zagreb, Croatia
* * * *
* * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * *
* * *
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
