Document ID: FDA-2008-N-0039-0003
Agency: fda
Document Type: Rule
Title: New Animal Drugs For Use in Animal Feed; Zilpaterol
Posted Date: 2008-02-01T05:00Z

[Federal Register: February 1, 2008 (Volume 73, Number 22)]
[Rules and Regulations]               
[Page 6018-6019]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01fe08-6]                         

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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 Feed; Zilpaterol

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 new animal drug application 
(NADA) filed by Intervet, Inc. The NADA provides for use of zilpaterol, 
monensin, and tylosin in three-way combination Type B and Type C 
medicated feeds for cattle fed in confinement for slaughter.

DATES:  This rule is effective February 1, 2008.

FOR FURTHER INFORMATION CONTACT:  Gerald L. Rushin, Center for 
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8103, e-mail: 
gerald.rushin@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:  Intervet, Inc., P.O. Box 318, 29160 
Intervet Lane, Millsboro, DE 19966, filed NADA 141-276 that provides 
for use of ZILMAX (zilpaterol hydrochloride), and RUMENSIN (monensin), 
and TYLAN (tylosin phosphate) Type A medicated articles to make dry and 
liquid three-way combination Type B and Type C medicated feeds used for 
increased rate of weight gain, improved feed efficiency, and increased 
carcass leanness; for prevention and control of coccidiosis due to 
Eimeria bovis and E. zuernii; and for reduction of incidence of liver 
abscesses caused by Fusobacterium necrophorum and Arcanobacterium 
(Actinomyces) pyogenes in cattle fed in confinement for slaughter 
during the last 20 to 40 days on feed. The NADA is approved as of 
January 10, 2008, and the regulations in 21 CFR 558.355, 558.625, and 
558.665 are amended 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.
    The agency has determined under 21 CFR 25.33(a)(2) 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 the 
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.  558.355, add paragraph (f)(7)(iv) to read as follows:

Sec.  558.355   Monensin.

* * * * *
    (f) * * *
    (7) * * *

[[Page 6019]]

    (iv) Zilpaterol alone or in combination as in Sec.  558.665.

0
3. In Sec.  558.625, add paragraph (f)(2)(ix) to read as follows:

Sec.  558.625   Tylosin.

* * * * *
    (f) * * *
    (2) * * *
    (ix) Zilpaterol alone or in combination as in Sec.  558.665.

0
4. In Sec.  558.665, revise paragraph (e) to read as follows:

Sec.  558.665   Zilpaterol.

* * * * *
    (e) Conditions of use in cattle. It is administered in feed as 
follows:

----------------------------------------------------------------------------------------------------------------
  Zilpaterol in     Combination in
    grams/ton         grams/ton            Indications for use                 Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 6.8 to        .................  Cattle fed in confinement for   Feed continuously as the sole        057926
 provide 60 to                        slaughter: For increased rate   ration during the last 20 to
 90 mg/head/day                       of weight gain, improved feed   40 days on feed. Withdrawal
                                      efficiency, and increased       period: 3 days.
                                      carcass leanness in cattle
                                      fed in confinement for
                                      slaughter during the last 20
                                      to 40 days on feed.
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(2) [Reserved]    .................  ..............................  ..............................  ...........
----------------------------------------------------------------------------------------------------------------
(3) [Reserved]    .................  ..............................  ..............................  ...........
----------------------------------------------------------------------------------------------------------------
(4) 6.8 to        Monensin 10 to     Cattle fed in confinement for   As in paragraph (e)(1) of this       057926
 provide 60 to     40, plus tylosin   slaughter: As in paragraph      section; see Sec.  Sec.
 90 mg/head/day    8 to 10            (e)(1) of this section; for     558.355(d) and 558.625(c) of
                                      prevention and control of       this chapter. Monensin and
                                      coccidiosis due to Eimeria      tylosin as provided by No.
                                      bovis and E. zuernii; and for   000986 in Sec.   510.600(c)
                                      reduction of incidence of       of this chapter.
                                      liver abscesses caused by
                                      Fusobacterium necrophorum and
                                      Arcanobacterium (Actinomyces)
                                      pyogenes.
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    Dated: January 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-1903 Filed 1-31-08; 8:45 am]

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