Document ID: FDA-2008-N-0039-0024
Agency: fda
Document Type: Rule
Title: New Animal Drugs For Use in Animal Feed; Zilpaterol
Posted Date: 2008-03-31T04:00Z

[Federal Register: March 31, 2008 (Volume 73, Number 62)]
[Rules and Regulations]
[Page 16754-16755]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr08-4]

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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 Type A medicated articles containing zilpaterol
hydrochloride and melengestrol acetate in two-way combination Type B
and Type C medicated feeds for heifers fed in confinement for
slaughter.

DATES: This rule is effective March 31, 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 141-284 that provides for use of
ZILMAX (zilpaterol hydrochloride) and MGA (melengestrol acetate) 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
suppression of estrus (heat) in heifers fed in confinement for
slaughter during the last 20 to 40 days on feed. The NADA is approved
as of February 29, 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,

[[Page 16755]]

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)(2) to read as follows:

Sec.  558.665  Zilpaterol.

* * * * *
    (e) * * *

------------------------------------------------------------------------
Zilpaterol in  Combination in   Indications
  grams/ton       grams/ton       for use      Limitations     Sponsor
------------------------------------------------------------------------
                              * * * * * * *
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(2) 6.8 to     Melengestrol    Heifers fed    As in               057926
 provide 60     acetate to      in             paragraph
 to 90 mg/      provide 0.25    confinement    (e)(1) of
 head/day       to 0.5 mg/      for            this
                head/day        slaughter:     section; see
                                As in          paragraph
                                paragraph      Sec.  Sec.
                                (e)(1) of      558.342(d)
                                this           of this
                                section; and   chapter.
                                for            Melengestrol
                                suppression    acetate as
                                of estrus      provided by
                                (heat).        No. 000009
                                               in Sec.
                                               510.600(c)
                                               of this
                                               chapter.
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                              * * * * * * *
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    Dated: March 21, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-6601 Filed 3-28-08; 8:45 am]

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