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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Fenbendazole.

DATES: This rule is effective June 10, 2003.

DOCUMENT 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 use of an approved fenbendazole Type A medicated article to make Type B and Type C medicated feeds used for the control of gastrointestinal worms in horses.

SUMMARY: Fenbendazole,

SUPPLEMENTAL INFORMATION

Intervet, Inc., P.O. Box 318, 405 State St., Millsboro, DE 19966, filed a supplement to NADA 131675 that provides for the use of SAFEGUARD (fenbendazole) 20% Type A medicated article to make Type B and Type C medicated horse feeds. The medicated feeds are used for the control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus spp.), small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp.), pinworms (Oxyuris equi), and ascarids (Parascaris equorum) in horses. The NADA is approved as of March 14, 2003 , and the regulations are amended in 21 CFR 558.258 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.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning March 14, 2003.

The agency has determined under Sec. 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. 801808.
List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.
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 558 is amended as follows:
PART 558NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.
2. Section 558.258 is amended by redesignating paragraph (e)(4) as paragraph (e)(5) and by adding new paragraph (e)(4) to read as follows: Sec. 558.258 Fenbendazole.
* * * * *
(e) * * *
(4) Horses.
[[Page 34535]]
Amount
fenbendazole in Indications for Limitations Sponsor grams per ton use
(i) 4,540 5 mg/kg body Feed at the rate 057926 weight (2.27 mg/ of 0. 1lb of feed
lb) for the per 100 lb of
control of large body weight to
strongyles provide 2.27 mg
(Strongylus fenbendazole/lb
edentatus, S. of body weight in
equinus, S. a 1day treatment
vulgaris, or 0.2 lb of feed
Triodontophorus per 100 lb of
spp.), small body weight to
strongyles provide 4.54 mg
(Cyathostomum fenbendazole/lb
spp., of body weight in
Cylicocyclus a 1day
spp., treatment. All
Cylicostephanus horses must be
spp.), and eating normally
pinworms (Oxyuris to ensure that
equi); 10 mg/kg each animal
body weight (4.54 consumes an
mg/lb) for the adequate amount
control of of the medicated
ascarids feed. Regular
(Parascaris deworming at
equorum). intervals of 6 to
8 weeks may be
required due to
the possibility
of reinfection.
Do not use in
horses intended
for food.
(ii) [Reserved] .................. .................. ............ * * * * *

Dated: May 27, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 0314545 Filed 6903; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Melanie R. Berson, Center for Veterinary Medicine (HFV110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018277540, email:
mberson@cvm.fda.gov.