Document ID: FDA-2011-N-0003-0035
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds: Melengestrol; Monensin
Posted Date: 2011-09-30T04:00Z

[Federal Register Volume 76, Number 190 (Friday, September 30, 2011)]
[Rules and Regulations]
[Page 60721]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25220]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2011-N-0003]

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

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 supplemental abbreviated new 
animal drug application (ANADA) filed by Ivy Laboratories, Division of 
Ivy Animal Health, Inc. The supplemental ANADA provides for use of 
increased dose levels of melengestrol acetate and monensin in two-way, 
combination drug Type C medicated feeds for heifers fed in confinement 
for slaughter.

DATES: This rule is effective September 30, 2011.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal 
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a 
supplement to ANADA 200-422 for use of HEIFERMAX 500 (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 
ANADA provides for use of increased dose levels of melengestrol acetate 
and monensin. The supplemental application is approved as of July 1, 
2011, and the regulations in 21 CFR 558.342 are amended to reflect the 
approval and minor revisions.
    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.
    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, in the table in paragraph (e)(1), remove and 
reserve paragraphs (e)(1)(v) and (e)(1)(vi); in paragraph (e)(1)(x), in 
the ``Sponsor'' column, add ``021641''; and revise paragraph (d)(2) to 
read as follows:

Sec.  558.342  Melengestrol.

* * * * *
    (d) * * *
    (2) A physically stable melengestrol acetate liquid Type B or C 
feed will not be subject to the requirements for mixing directions 
prescribed in paragraph (d)(1) of this section provided it has a pH of 
4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a 
viscosity of not less than 300 centipoises per second for 3 months.
* * * * *

    Dated: September 20, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2011-25220 Filed 9-29-11; 8:45 am]
BILLING CODE 4160-01-P