[Federal Register Volume 63, Number 244 (Monday, December 21, 1998)]
[Rules and Regulations]
[Pages 70334-70335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33637]
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DEPARTMENT OF HEALTH AND HUMAN RESOURCES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Oxytetracycline Tablet/Bolus
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 a new animal drug application
(NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides
for use of oxytetracycline boluses for control and treatment of
bacterial enteritis and bacterial pneumonia in beef and dairy calves.
EFFECTIVE DATE: December 21, 1998.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0212.
SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621
North Belt Highway, St. Joseph, MO 64506-2002, filed NADA 141-002 that
provides for use of Oxy 500 and 1,000 Calf Boluses (oxytetracycline
hydrochloride boluses) for control and treatment of bacterial diseases
of beef and dairy calves caused by organisms sensitive to
oxytetracycline, bacterial enteritis caused by Salmonella typhimurium
and Escherichia coli and bacterial pneumonia caused by Pasteurella
multocida. The NADA is approved as of October 26, 1998. The regulations
are amended in 21 CFR 520.1660c by revising the section heading,
paragraphs (a) and (b), by removing an outdated paragraph (c), by
redesignating paragraphs (d) and (e) as paragraphs (c) and (d), and by
amending paragraph (d)(3) 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 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.
List of Subjects in 21 CFR Part 520
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 520.1660c is amended by revising the section heading, by
revising paragraphs (a) and (b), by removing paragraph (c), by
redesignating paragraphs (d) and (e) as paragraphs (c) and (d), and by
revising the 4th sentence in newly redesignated paragraph (d)(3) to
read as follows:
Sec. 520.1660c Oxytetracycline hydrochloride tablets/boluses.
(a) Specifications. Each tablet or bolus contains 250, 500, or
1,000 milligrams of oxytetracycline hydrochloride.
(b) Sponsors. For sponsors in Sec. 510.600(c) of this chapter: See
000010 for use of 500 and 1,000 milligram boluses. See 000069 for use
of 250 and 500 milligram tablets.
* * * * *
(d) * * *
(3) * * * For sponsor 000069: Discontinue treatment 7 days prior to
slaughter. * * *
[[Page 70335]]
Dated: November 30, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-33637 Filed 12-18-98; 8:45 am]
BILLING CODE 4160-01-F