Document ID: FDA-2008-N-0039-0032
Agency: fda
Document Type: Rule
Title: New Animal Drugs For Use in Animal Feed; Zilpaterol
Posted Date: 2008-04-10T04:00Z

[Federal Register: April 10, 2008 (Volume 73, Number 70)]
[Rules and Regulations]               
[Page 19432]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ap08-2]                         

[[Page 19432]]

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, monensin USP, and melengestrol acetate in three-way 
combination Type B and Type C medicated feeds for heifers fed in 
confinement for slaughter.

DATES:  This rule is effective April 10, 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 141-282 that provides for use of 
ZILMAX (zilpaterol hydrochloride), RUMENSIN (monensin USP), and MGA 
(melengestrol acetate) 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 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 22, 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 
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, redesignate paragraphs (e)(4) and (e)(5) as 
paragraphs (e)(5) and (e)(6), and add new paragraph (e)(4) to read as 
follows:

Sec.  558.665  Zilpaterol.

    (e) * * *

------------------------------------------------------------------------
  Zilpaterol     Combination    Indications
  grams/ton       grams/ton       for use      Limitations     Sponsor
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
(4) 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          Sec.  Sec.
                                paragraph      558.342(d)
                                (e)(1) of      and
                                this           558.355(d)
                                section; for   of this
                                prevention     chapter.
                                and control    Monensin as
                                of             provided by
                                coccidiosis    No. 000986;
                                due to         melengestrol
                                Eimeria        acetate as
                                bovis and E.   provided by
                                zuernii; and   No. 000009
                                for            in Sec.
                                suppression    510.600(c)
                                of estrus      of this
                                (heat).        chapter.
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------

    Dated: March 12, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-7583 Filed 4-9-08; 8:45 am]

BILLING CODE 4160-01-S