[Federal Register Volume 75, Number 77 (Thursday, April 22, 2010)]
[Rules and Regulations]
[Page 20917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9304]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2010-N-0002]
New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin,
and 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 abbreviated new
animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy
Animal Health, Inc. The supplemental NADA provides for an increased
level of monensin in three-way combination Type C medicated feeds
containing ractopamine, melengestrol, and monensin for heifers fed in
confinement for slaughter.
DATES: This rule is effective April 22, 2010.
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:
[email protected].
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Div. of Ivy Animal Health,
Inc., 8857 Bond St., Overland Park, KS 66214, filed a supplement to
ANADA 200-448 that provides for use of HEIFERMAX 500 (melengestrol
acetate) Liquid Premix, OPTAFLEXX (ractopamine hydrochloride), and
RUMENSIN (monensin, USP) single-ingredient Type A medicated articles to
make dry and liquid, three-way combination drug Type C medicated feeds
for heifers fed in confinement for slaughter. The supplemental ANADA
provides for an increased level of monensin. The supplemental ANADA is
approved as of February 16, 2010, and the regulations are amended in 21
CFR 558.500 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.
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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
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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]
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2. In Sec. 558.500, in paragraph (e)(2)(viii), in the ``Limitations''
column, remove ``000009''and add in its place ``000009 or 021641'', and
in the ``Sponsor'' column, remove ``No. 000986''and add in its place
``000986, 021641''; and remove paragraph (e)(2)(xii).
Dated: April 19, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-9304 Filed 4-21-10; 8:45 am]
BILLING CODE 4160-01-S