Document ID: FDA-2008-N-0039-0086
Agency: fda
Document Type: Notice
Title: New Animal Drugs for Use in Animal Feeds; Ractopamine
Posted Date: 2008-12-11T05:00Z

[Federal Register: December 11, 2008 (Volume 73, Number 239)]
[Rules and Regulations]               
[Page 75323-75324]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de08-8]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2008-N-0039]

 
New Animal Drugs for Use in Animal Feeds; Ractopamine

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 (ANADA) filed by Ivy Laboratories, Division of Ivy Animal 
Health, Inc. The supplemental ANADA provides for an increased level of 
monensin in four-way combination Type C medicated feeds containing 
ractopamine, melengestrol, monensin, and tylosin for heifers fed in 
confinement for slaughter; and a revision to bacterial pathogen 
nomenclature.

DATES: This rule is effective December 11, 2008.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), 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 200-424 that provides for use of OPTAFLEXX 
(ractopamine hydrochloride), HEIFERMAX 500 (melengestrol acetate), and 
RUMENSIN (monensin), and TYLAN (tylosin phosphate) Type A medicated 
articles to make dry and liquid four-way combination 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; for suppression of 
estrus (heat); and for reduction of incidence of liver abscesses caused 
by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes 
in heifers fed in confinement for slaughter during the last 28 to 42 
days on feed. The supplemental NADA provides for an increased level of 
monensin in four-way combination Type C medicated feeds containing 
ractopamine, melengestrol, monensin, and tylosin for heifers fed in 
confinement for slaughter; and a revision to bacterial pathogen 
nomenclature. The supplemental NADA is approved as of November 13, 
2008, and the regulations in 21 CFR 558.500 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 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.

Sec.  558.500  [Amended]

0
2. In Sec.  558.500, in the table in paragraph (e)(2)(x), in the 
``Limitations'' column, remove ``No. 000009'' and in its

[[Page 75324]]

place add ``Nos. 000009 and 021641'' and in the ``Sponsor'' column add 
``021641''; and remove and reserve paragraph (e)(2)(xi).

    Dated: December 3, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-29177 Filed 12-11-08; 8:45 am]

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