Document ID: FDA-2008-N-0039-0073
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds; Fenbendazole
Posted Date: 2008-10-08T04:00Z

[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Rules and Regulations]               
[Page 58873-58874]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc08-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2008-N-0039]

 
New Animal Drugs for Use in Animal Feeds; Fenbendazole

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 use of a fenbendazole free choice, liquid Type C medicated 
feed in dairy and beef cattle for the removal and control of various 
internal parasites.

DATES:  This rule is effective October 8, 2008.

FOR FURTHER INFORMATION CONTACT:  Donald A. Prater, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail: 
donald.prater@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet Inc., P.O. Box 318, 29160 Intervet 
Lane, Millsboro, DE 19966, filed a supplement to NADA 131-675 for SAFE-
GUARD (fenbendazole) 20% Type A medicated article. The supplemental 
NADA provides for manufacture of a fenbendazole free choice, liquid 
Type C medicated feed for use in dairy and beef cattle for the removal 
and control of various internal parasites. The supplemental NADA is 
approved as of September 5, 2008, and the regulations are amended in 21 
CFR 558.258 to reflect the approval.
    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 Division of Dockets Management 
(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 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning on the date of 
approval. The 3 years of exclusivity apply only to the use of 
fenbendazole liquid Type C medicated feed for the removal and control 
of lungworms (Dictyocaulus viviparus), one of the parasite species for 
which the supplement is approved.
    FDA has determined under 21 CFR 25.33(a) 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. In Sec.  558.258, in the table in paragraph (e)(1), in the 
``Indications for use'' column, remove ``round worms'' and in its place 
add ``roundworms''; and revise paragraph (e)(3) to read as follows:

Sec.  558.258  Fenbendazole.

* * * * *
    (e) * * *
    (3) Cattle.

------------------------------------------------------------------------
      Amount        Indications for
   fenbendazole           use            Limitations         Sponsor
------------------------------------------------------------------------
(i) 5 mg/kg body   Dairy and beef     Feed as the sole  057926
 weight (2.27 mg/   cattle: For the    ration or as a
 lb)                removal and        top dress for
                    control of:        one day.
                    Lungworms          Retreatment may
                    (Dictyocaulus      be needed after
                    viviparus);        4 to 6 weeks.
                    Stomach worms:     Cattle must not
                    barberpole worms   be slaughtered
                    (Haemonchus        within 13 days
                    contortus),        following last
                    brown stomach      treatment. For
                    worms              dairy cattle
                    (Ostertagia        the milk
                    ostertagi),        discard time is
                    small stomach      zero hours. A
                    worms              withdrawal
                    (Trichostrongylu   period has not
                    s axei);           been
                    Intestinal         established for
                    worms: hookworms   this product in
                    (Bunostomum        pre-ruminating
                    phlebotomum),      calves. Do not
                    thread-necked      use in calves
                    intestinal worms   to be processed
                    (Nematodirus       for veal.
                    helvetianus),
                    small intestinal
                    worms (Cooperia
                    oncophora and C.
                    punctata);
                    Bankrupt worms
                    (Trichostrongylu
                    s
                    colubriformis);
                    and Nodular
                    worms
                    (Oesophagostomum
                    radiatum).
(ii) [Reserved]    .................  ................  ................
------------------------------------------------------------------------

[[Page 58874]]

    (iii) Free-choice feeds--(A) Amount. 5 mg/kg body weight (2.27 mg/
lb), including the following formulations:

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              Ingredient\1\                             Percent                     International Feed No.
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(1) Free-choice, dry Type C feed:         ..................................  ..................................
 Salt (sodium chloride)                                                59.00                            6-04-152
 Monosodium phosphate                                                  31.16                            6-04-288
 Dried cane molasses                                                    3.12                            4-04-695
 Zinc sulfate                                                           0.76                            6-05-556
 Copper sulfate                                                         0.45                            6-01-720
 Fenbendazole 20% Type A article                                        5.51                                 n/a
(2) Free-choice, dry Type C feed:         ..................................  ..................................
 Salt (sodium chloride)                                                35.93                            6-04-152
 Dicalcium phosphate (18.5% P)                                         32.44                            6-00-080
 Calcium carbonate (38% Ca)                                            15.93                            6-01-069
 Magnesium oxide (56% Mg)                                              10.14                            6-02-756
 Zinc sulfate                                                           1.47                            6-05-556
 Mineral oil                                                            1.00                            8-03-123
 Dried cane molasses (46% sugars)                                       0.98                            4-04-695
 Potassium iodide                                                       0.01                            6-03-759
 Fenbendazole 20% Type A article                                        2.10                                 n/a
(3) Free-choice, liquid Type C feed:      ..................................  ..................................
 Cane molasses\2\                                                     80.902                            4-13-251
 Water                                                                  9.36                                 n/a
 Urea solution, 55%                                                     7.05                            5-05-707
 Phosphoric acid 75% (feed grade)                                       2.00                            6-03-707
 Xantham gum                                                            0.20                            8-15-818
 Trace minerals                                                         0.20                                 n/a
 Vitamin premix                                                         0.01                                 n/a
 Fenbendazole 20% Type A article                                       0.278                                 n/a
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\1\The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those
  used by the manufacturer for other free-choice cattle feeds. Formulation modifications require FDA approval
  prior to marketing. Selenium is not approved for the free-choice formulations described in paragraph
  (e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published
  regulations (see 21 CFR 573.920).
\2\The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the
  brix value of the molasses to the industry standard of 79.5 brix.

    (B) Indications for use. As in paragraph (e)(3)(i) of this section.
    (C) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27 
mg/lb) of body weight to cattle over a 3- to 6-day period. Retreatment 
may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 
13 days following last treatment. For dairy cattle the milk discard 
time is zero hours. A withdrawal period has not been established for 
this product in pre-ruminating calves. Do not use in calves to be 
processed for veal.
* * * * *

    Dated: September 29, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-23845 Filed 10-7-08; 8:45 am]

BILLING CODE 4160-01-S