[Federal Register Volume 63, Number 222 (Wednesday, November 18, 1998)]
[Rules and Regulations]
[Pages 63982-63983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30750]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Fenbendazole Suspension;
Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulation concerning veterinary prescription use of Hoechst
Roussel Vet's fenbendazole suspension for cattle. The amendment
clarifies the oral dose of fenbendazole suspension used as a dewormer
in cattle.
EFFECTIVE DATE: November 18, 1998.
FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7575.
SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, 30 Independence Blvd.,
P.O. Box 4915, Warren, NJ 07059, is sponsor of new animal drug
application (NADA) 128-620 that provides for oral, veterinary
prescription use of Panacur (fenbendazole) 10 percent
suspension. The drug is used as a dewormer in cattle, including dairy
cattle of breeding age at 5 milligrams per kilogram (mg/kg) of body
weight, and only in beef cattle at 10 mg/kg of body weight. The
regulations are amended in 21 CFR 520.905a to clarify the approval.
The amendments clarify the drug dose used to treat various classes
of animals and insert certain technical revisions. No additional safety
or effectiveness data were required. A revised freedom
[[Page 63983]]
of information summary is provided to reflect the clarification.
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
The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 520.905a is amended by removing paragraph (a); by
redesignating paragraphs (b) and (c) as paragraphs (a) and (b); by
adding paragraph (c); by revising the heading of paragraph (d)(2); by
redesignating paragraph (d)(3) as paragraph (d)(4); by redesignating
paragraphs (d)(2)(ii), (d)(2)(ii)(A), and (d)(2)(ii)(B) as paragraphs
(d)(3)(i), (d)(3)(ii), and (d)(3)(iii); by adding a heading for newly
redesignated paragraph (d)(3); by redesignating paragraphs (d)(2)(i)(A)
and (d)(2)(i)(B) as paragraphs (d)(2)(ii) and (d)(2)(iii) to read as
follows:
Sec. 520.905a Fenbendazole suspension.
* * * * *
(c) Related tolerances. See Sec. 556.275 of this chapter.
(d) * * *
(2) Cattle including dairy cows of breeding age--* * *
* * * * *
(3) Beef cattle--* * *
* * * * *
Dated: November 9, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-30750 Filed 11-17-98; 8:45 am]
BILLING CODE 4160-01-F
