[Federal Register Volume 68, Number 111 (Tuesday, June 10, 2003)]
[Rules and Regulations]
[Pages 34534-34535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14545]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Fenbendazole.

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 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.

DATES: This rule is effective June 10, 2003.

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, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 405 State St., 
Millsboro, DE 19966, filed a supplement to NADA 131-675 that provides 
for the use of SAFE-GUARD (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. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

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 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.
0
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
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(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 1-day 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 1-day
                     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]     ..................  ..................  ............
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    Dated: May 27, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-14545 Filed 6-9-03; 8:45 am]
BILLING CODE 4160-01-S