[Federal Register: May 15, 2003 (Volume 68, Number 94)]
[Rules and Regulations]
[Page 26204-26205]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15my03-4]
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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
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 supplemental new animal drug
application (NADA) filed by Intervet, Inc. The supplemental NADA
provides for a change to over-the-counter marketing status for the oral
use of fenbendazole suspension in goats for removal and control of
stomach worms.
DATES: This rule is effective May 15, 2003.
FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855; 301-827-7578; e-mail:
jmessenh@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., PO Box 318, 405 State St.,
Millsboro, DE 19966, filed a supplement to NADA 128-620 for the oral
use of SAFE-GUARD (fenbendazole) Suspension 10% in goats for removal
and control of stomach worms. The supplemental NADA is approved as of
February 13, 2003, and the regulations are amended in 21 CFR 520.905a
to reflect the approval. The basis of approval is discussed in the
freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
FDA 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,
[[Page 26205]]
neither an environmental assessment nor an environmental impact
statement is required.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 520
Animal drugs.
0
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
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1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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2. Section 520.905a is amended by revising paragraph (d)(4)(ii) and in
paragraph (d)(4)(iii) by removing the last sentence to read as follows:
Sec. 520.905a Febendazole suspension.
* * * * *
(d) * * *
(4) * * *
(ii) Indications for use. For the removal and control of stomach
worms (adults) Haemonchus contortus and Teladorsagia circumcincta.
* * * * *
Dated: April 30, 2003.
Steven F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-12121 Filed 5-14-03; 8:45 am]
BILLING CODE 4160-01-S