[Federal Register Volume 67, Number 139 (Friday, July 19, 2002)]
[Rules and Regulations]
[Page 47450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18177]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Fenbendazole Granules

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 change from prescription to over-the-counter marketing 
status for the oral use in dogs of fenbendazole granules for removal of 
certain internal parasites.

DATES: This rule is effective July 19, 2002.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, [email protected].

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 405 State St., 
Millsboro, DE 19966, filed a supplement to NADA 121-473 that provides 
for oral use in dogs of PANACUR-C (fenbendazole) Granules 22.2% for 
removal of certain internal parasites. The supplemental NADA provides 
for change from prescription to over-the-counter marketing status. The 
supplemental NADA is approved as of March 19, 2002, and the regulations 
are amended in 21 CFR 520.905b to reflect the approval. The basis of 
approval is discussed in the freedom of information summary. Section 
520.905b is also being revised to reflect a current format.
    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(d)(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.
    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.

    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 520.905b is amended by redesignating paragraph (c) as 
paragraph (d); by adding new paragraph (c); by removing the last 
sentence in newly designated paragraphs (d)(1)(iii) and (d)(2)(iii); by 
revising paragraphs (a), and newly designated (d)(1)(i), (d)(2)(i), and 
(d)(3)(i) to read as follows:


Sec. 520.905b  Fenbendazole granules.

    (a) Specifications. Each gram of granules contains 222 milligrams 
(mg) fenbendazole.
* * * * *
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. 5 mg/kilogram (kg) 
for large strongyles, small strongyles, and pinworms; 10 mg/kg for 
ascarids.
* * * * *
    (2) Dogs--(i) Amount. 50 mg/kg daily for 3 consecutive days.
* * * * *
    (3) Zoo and wildlife animals--(i) Amount. 10 mg/kg per day for 3 
days.
* * * * *

    Dated: July 8, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-18177 Filed 7-18-02; 8:45 am]
BILLING CODE 4160-01-S