[Federal Register Volume 60, Number 51 (Thursday, March 16, 1995)]
[Rules and Regulations]
[Pages 14217-14218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6527]
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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 Phoenix Scientific, 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: March 16, 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: Phoenix Scientific, Inc., 3915 South 48th
Street Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, has filed
ANADA 200-123 which provides for use of oxytetracycline injection as
follows: (1) 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;
(2) 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; and (3) intramuscular
use in sows for control of infectious enteritis (baby pig scours,
colibacillosis) in suckling pigs caused by E. coli.
Phoenix Scientific's ANADA 200-123 for oxytetracycline injection
(Maxim 200) is approved as a generic copy of Pfizer's NADA 113-232 for
oxytetracycline injection (Liquamycin [[Page 14218]] LA-200).
The ANADA is approved as of February 10, 1995, and the regulations are
amended in 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 removing the
phrase ``000010 and 000069'' and adding in its place ``000010, 000069,
and 059130'', 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 and 28 days prior to slaughter when
provided by 000069 or 059130.
Dated: March 8, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-6527 Filed 3-15-95; 8:45 am]
BILLING CODE 4160-01-F
