Document ID: FDA-2008-N-0039-0030
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feed; Zilpaterol; Technical Amendment
Posted Date: 2008-04-08T04:00Z

[Federal Register: April 8, 2008 (Volume 73, Number 68)]
[Rules and Regulations]               
[Page 18958-18960]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap08-6]                         

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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; Technical 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

DATES: This rule is effective April 8, 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 141-280 that provides for use of 
ZILMAX (zilpaterol hydrochloride), and RUMENSIN (monensin USP), TYLAN 
(tylosin phosphate), and MGA (melengestrol acetate) Type A medicated 
articles to make dry and liquid four-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; and 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 558.342 and 558.665 are amended to reflect 
the approval.
    In addition, FDA has noticed that the codified indications for use 
of tylosin in combination with melengestrol and lasalocid are not 
consistent with the conditions of use approved for an abbreviated new 
animal drug application (71 FR 39204, July 12, 2006). At this time, the 
indications for use are revised to include the associated pathogens. 
This action is being taken to improve the accuracy of the regulations.
    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 
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.  558.342, revise paragraphs (e)(1)(iv) and (e)(2) to read as 
follows:

Sec.  558.342  Melengestrol.

* * * * *
    (e) * * *
    (1) * * *

[[Page 18959]]

------------------------------------------------------------------------
 Melengestrol    Combination
acetate in mg/   in  mg/head/   Indications    Limitations     Sponsor
   head/day          day          for use
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------

(iv) 0.25 to    Lasalocid 100  Heifers fed   To administer       000009,
 0.5             to 360 plus    in            0.25 to 0.5         021641
                 tylosin 90.    confinement   mg
                                for           melengestrol
                                slaughter:    acetate plus
                                As in         100 to 360 mg
                                paragraph     lasalocid
                                (e)(1)(i)     plus 90 mg
                                of this       tylosin/head/
                                section;      day:
                                and for      1. Add 0.5 to
                                reduced       2.0 lb/head/
                                incidence     day of a
                                of liver      liquid or dry
                                abscesses     medicated
                                caused by     feed
                                Fusobacteri   containing
                                um            0.125 to 1.0
                                necrophorum   mg
                                and           melengestrol
                                Actinomyces   acetate/lb to
                                (Corynebact   a medicated
                                erium)        feed
                                pyogenes.     containing 10
                                              to 30 g
                                              lasalocid and
                                              8 to 10 g
                                              tylosin per
                                              ton; or
                                             2. Add 0.5 to
                                              2.0 lb/head/
                                              day of a
                                              liquid or dry
                                              medicated
                                              feed
                                              containing
                                              0.125 to 1.0
                                              mg
                                              melengestrol
                                              acetate plus
                                              50 to 720 mg
                                              lasalocid/lb
                                              to 4.5 to 18
                                              lb of a dry
                                              medicated
                                              feed
                                              containing 10
                                              to 40 g
                                              tylosin per
                                              ton; or
                                             3. Add 0.5 to
                                              2.0 lb/head/
                                              day of a dry
                                              pelleted
                                              medicated
                                              feed
                                              containing
                                              0.125 to 1.0
                                              mg
                                              melengestrol
                                              acetate (from
                                              a dry Type A
                                              article), 50
                                              to 720 mg
                                              lasalocid,
                                              and 45 to 180
                                              mg tylosin/lb
                                              to a ration
                                              of
                                              nonmedicated
                                              feed.
                                             Lasalocid
                                              provided by
                                              No. 046573
                                              and tylosin
                                              as tylosin
                                              phosphate by
                                              No. 000986 in
                                              Sec.
                                              510.600(c) of
                                              this chapter.
------------------------------------------------------------------------

                              * * * * * * *

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

    (2) Melengestrol may also be used with:
    (i) Ractopamine as in Sec.  558.500 of this chapter.
    (ii) Zilpaterol as in Sec.  558.665 of this chapter.

0
3. In Sec.  558.665, add paragraph (e)(5) to read as follows:

Sec.  558.665  Zilpaterol.

* * * * *
    (e) * * *

------------------------------------------------------------------------
 Zilpaterol
 in  grams/    Combination    Indications     Limitations      Sponsor
     ton      in  grams/ton     for use
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------

(5) 6.8 to    Monensin 10    Heifers fed    As in paragraph       057926
 provide 60    to 40, plus    in             (e)(1) of this
 to 90 mg/     tylosin 8 to   confinement    section; see
 head/day.     10, plus       for            Sec.  Sec.
               melengestrol   slaughter:     558.342(d),
               acetate to     As in          558.355(d),
               provide 0.25   paragraph      and 558.625(c)
               to 0.5 mg/     (e)(1) of      of this
               head/day.      this           chapter.
                              section; for   Monensin and
                              prevention     tylosin as
                              and control    provided by
                              of             No. 000986;
                              coccidiosis    melengestrol
                              due to         acetate as
                              Eimeria        provided by
                              bovis and E.   No. 000009 in
                              zuernii; for   Sec.
                              reduction of   510.600(c) of
                              incidence of   this chapter.
                              liver
                              abscesses
                              caused by
                              Fusobacteriu
                              m
                              necrophorum
                              and
                              Arcanobacter
                              ium
                              (Actinomyces
                              ) pyogenes;
                              and for
                              suppression
                              of estrus
                              (heat).
------------------------------------------------------------------------

[[Page 18960]]

    Dated: March 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-7307 Filed 4-7-08; 8:45 am]

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