[Federal Register Volume 68, Number 94 (Thursday, May 15, 2003)]
[Rules and Regulations]
[Pages 26204-26205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12121]


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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: 
[email protected].

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.

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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