Document ID: FDA-2009-N-0665-0061
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin
Posted Date: 2009-11-23T05:00Z

[Federal Register: November 23, 2009 (Volume 74, Number 224)]
[Rules and Regulations]               
[Page 61029-61030]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no09-8]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2009-N-0665]

 
New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; 
Tylosin

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 supplemental new animal drug 
application (NADA) filed by Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc. The supplemental NADA provides for use of the same dose 
levels approved for single-ingredient Type C medicated feeds containing 
melengestrol acetate, monensin, or tylosin phosphate for heifers fed in 
confinement for slaughter in three-way, combination drug Type C 
medicated feeds containing melengestrol acetate, monensin, and tylosin 
phosphate.

DATES:  This rule is effective November 23, 2009.

FOR FURTHER INFORMATION CONTACT:  Suzanne J. Sechen, Center for 
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8105, e-mail: 
suzanne.sechen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:  Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement 
to NADA 138-870 for use of MGA (melengestrol acetate), RUMENSIN 
(monensin, USP), and TYLAN (tylosin phosphate) single-ingredient Type A 
medicated articles to make three-way, combination drug Type C medicated 
feeds for heifers fed in confinement for slaughter. The supplemental 
NADA provides for use of the same dose levels approved for single 
ingredient Type C medicated feeds containing melengestrol acetate, 
monensin, or tylosin phosphate in the three-way, combination drug Type 
C medicated feeds. The supplemental application is approved as of 
October 19, 2009, and the regulations are amended in 21 CFR 558.342 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 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, add paragraph (e)(1)(xi) to read as follows:

Sec.  558.342  Melengestrol.

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

----------------------------------------------------------------------------------------------------------------
Melengestrol acetate in mg/head/ Combination in mg/head/
              day                          day            Indications for use        Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(xi) 0.25 to 0.5...............  Monensin 50 to 480,      Heifers fed in       Feed continuously as       000009
                                  plus tylosin 60 to 90.   confinement for      sole ration (liquid or
                                                           slaughter: As in     dry) at a rate of 0.5
                                                           paragraph            to 2.0 lb/head/day to
                                                           (e)(1)(i) of this    provide 0.25 to 0.5 mg/
                                                           section; for the     head/day melengestrol
                                                           prevention and       acetate; 0.14 to 0.42
                                                           control of           mg monensin/lb body
                                                           coccidiosis due to   weight/day, depending
                                                           Eimeria bovis and    on the severity of the
                                                           E. zuernii; and      coccidiosis challenge,
                                                           for reduction of     up to 480 mg/head/day;
                                                           incidence of liver   and 60 to 90 mg/head/
                                                           abscesses caused     day tylosin. The
                                                           by Fusobacterium     melengestrol acetate
                                                           necrophorum and      portion of this Type C
                                                           Arcanobacterium      medicated feed must be
                                                           pyogenes.            mixed into a complete
                                                                                feed containing 10 to
                                                                                40 g/ton monensin and
                                                                                8 to 10 g/ton tylosin
                                                                                in the amount of
                                                                                complete feed consumed
                                                                                by an animal per day.
                                                                               .......................
                                                                               Monensin and tylosin
                                                                                phosphate provided by
                                                                                No. 000986 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.
----------------------------------------------------------------------------------------------------------------

[[Page 61030]]

* * * * *

    Dated: November 17, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-28019 Filed 11-20-09; 8:45 am]

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