Document ID: FDA-2008-N-0039-0019
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feed; Zilpaterol
Posted Date: 2008-03-18T04:00Z

[Federal Register: March 18, 2008 (Volume 73, Number 53)]
[Rules and Regulations]               
[Page 14385-14386]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr08-8]                         

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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 approved, 
single-ingredient zilpaterol hydrochloride and monensin U.S.P. Type A 
medicated articles to make two-way combination Type B and Type C 
medicated feeds for cattle fed in confinement for slaughter.

DATES: This rule is effective March 18, 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@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet 
Lane, Millsboro, DE 19966, filed NADA 141-278 that provides for use of 
ZILMAX (zilpaterol hydrochloride) and RUMENSIN (monensin U.S.P.) Type A 
medicated articles to make dry and liquid, two-way combination Type B 
and Type C medicated feeds used for increased rate of weight gain, 
improved feed efficiency, and increased carcass leanness; and for 
prevention and control of coccidiosis due to Eimeria bovis and E. 
zuernii in cattle fed in confinement for slaughter during the last 20 
to 40 days on feed. The NADA is approved as of February 15, 2008, and 
the regulations in 21 CFR 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 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.  558.665, add paragraph (e)(3) to read as follows:

Sec.  558.665  Zilpaterol.

* * * * *
    (e) * * *

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  Zilpaterol in     Combination in
    grams/ton         grams/ton            Indications for use                 Limitations             Sponsor
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                                                  * * * * * * *
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(3) 6.8 to        Monensin 10 to 40  Cattle fed in confinement for   As in paragraph (e)(1) of this       057926
 provide 60 to                        slaughter: As in paragraph      section; see paragraph Sec.
 90 mg/head/day                       (e)(1) of this section; and     558.355(d) of this chapter.
                                      for prevention and control of   Monensin as provided by No.
                                      coccidiosis due to Eimeria      000986 in Sec.   510.600(c)
                                      bovis and E. zuernii.           of this chapter.
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[[Page 14386]]

    Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-5450 Filed 3-17-08; 8:45 am]

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