Document ID: FDA-2009-N-0665-0057
Agency: fda
Document Type: Notice
Title: New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin
Posted Date: 2009-11-19T05:00Z

[Federal Register: November 19, 2009 (Volume 74, Number 222)]
[Rules and Regulations]               
[Page 59911-59912]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no09-3]                         

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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

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 
increased dose levels approved for single-ingredient Type C medicated 
feeds for heifers fed in confinement for slaughter containing 
melengestrol acetate or monensin in two-way, combination drug Type C 
medicated feeds containing melengestrol acetate and monensin.

DATES:  This rule is effective November 19, 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 125-476 for use of MGA (melengestrol acetate) and RUMENSIN 
(monensin, USP) single-ingredient Type A medicated articles to make 
two-way, combination drug Type C medicated feeds for heifers fed in 
confinement for slaughter. The supplemental NADA provides for use of 
the same increased dose levels approved for single ingredient Type C 
medicated feeds containing melengestrol acetate or monensin in the two-
way, combination drug Type C medicated feeds. The supplemental 
application is approved as of October 1, 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)(x) to read as follows:

Sec.  558.342  Melengestrol.

* * * * *
    (e) * * *

[[Page 59912]]

    (1) * * *

------------------------------------------------------------------------
 Melengestrol    Combination
acetate in mg/   in mg/head/    Indications    Limitations     Sponsor
   head/day          day          for use
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
(x) 0.25 to     Monensin 50    Heifers fed   Add at the           000009
 0.5             to 480.        in            rate of 0.5
                                confinement   to 2.0 lb/
                                for           head/day a
                                slaughter:    medicated
                                As in         feed (liquid
                                paragraph     or dry)
                                (e)(1)(i)     containing
                                of this       0.125 to 1.0
                                section;      mg
                                and for the   melengestrol
                                prevention    acetate/lb to
                                and control   a feed
                                of            containing 10
                                coccidiosis   to 40 g of
                                due to        monensin per
                                Eimeria       ton to
                                bovis and     provide 0.25
                                E. zuernii.   to 0.5 mg
                                              melengestrol
                                              acetate/head/
                                              day and 0.14
                                              to 0.42 mg
                                              monensin/lb
                                              body weight,
                                              depending on
                                              severity of
                                              coccidiosis
                                              challenge, up
                                              to 480 mg
                                              monensin/head/
                                              day.
                                             ..............
                                             Monensin
                                              provided by
                                              No. 000986 in
                                              Sec.
                                              510.600(c) of
                                              this chapter.
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    Dated: November 9, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-27744 Filed 11-18-09; 8:45 am]

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