New Animal Drugs For Use in Animal Feeds; Monensin, 653 [E7-4]
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Federal Register / Vol. 72, No. 4 / Monday, January 8, 2007 / Rules and Regulations
Issued in College Park, Georgia, on
December 14, 2006.
Kathy Kutch,
Manager, System Support Group, Eastern
Service Center.
[FR Doc. 06–9996 Filed 1–5–07; 8:45 am]
BILLING CODE 4910–13–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feeds; Monensin
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with RULES
ACTION:
Final rule.
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
Elanco Animal Health. The
supplemental NADA revises the
concentration of monensin in Type C
medicated feeds used for improved feed
efficiency, and for the prevention and
control of coccidiosis in cattle fed in
confinement for slaughter.
DATES: This rule is effective January 8,
2007.
FOR FURTHER INFORMATION CONTACT: Eric
S. Dubbin, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0232, email: eric.dubbin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 95–735 that
provides for use of RUMENSIN 80
(monensin) Type A medicated articles.
The supplement revises the
concentration of monensin in Type C
medicated feeds used for improved feed
efficiency, and for the prevention and
control of coccidiosis in cattle fed in
confinement for slaughter. The
supplemental NADA is approved as of
December 1, 2006, and the regulations
in 21 CFR 558.355 are amended to
reflect the approval. The basis of
approval is discussed in the freedom of
information summary.
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
VerDate Aug<31>2005
16:04 Jan 05, 2007
Jkt 211001
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.
FDA has carefully considered the
potential environmental impact of this
action and has concluded that the action
will not have a significant impact on the
human environment and that an
environmental impact statement is not
required. FDA’s finding of no significant
impact and the evidence supporting that
finding, contained in an environmental
assessment, may be seen in the Division
of Dockets Management (address above)
between 9 a.m. and 4 p.m., Monday
through Friday.
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.
I 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
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
2. Section 558.355 is amended as
follows:
a. Revise paragraph (d)(2);
b. Revise the introductory text of
paragraphs (f)(3)(i) and (f)(3)(vii);
c. Revise paragraph (f)(3)(vii)(b);
d. Amend paragraph (f)(3)(i)(b)(1) by
revising the second sentence and adding
a new third sentence.
The revisions read as follows:
I
§ 558.355
Monensin.
*
*
*
*
*
(d) * * *
(2) Type C cattle feeds containing 40
grams or less monensin per ton shall
bear an expiration date of 30 days after
its date of manufacture.
(f) * * *
(3) * * *
(i) [Amount per ton]. Monensin, 5 to
40 grams.
(b) * * *
(1) Limitations. * * * Feed
continuously in complete feed at a rate
of 50 to 480 milligrams of monensin per
head per day. No additional
improvement in feed efficiency has been
shown from feeding monensin at levels
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
653
greater than 30 grams per ton (360
milligrams per head per day). * * *
*
*
*
*
*
(vii) Amount per ton. Monensin, 10 to
40 grams.
*
*
*
*
*
(b) Limitations. For cattle fed in
confinement for slaughter, feed at a rate
of 0.14 to 0.42 milligram per pound of
body weight per day, depending upon
the severity of challenge, up to
maximum of 480 milligrams per head
per day.
*
*
*
*
*
Dated: December 19, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E7–4 Filed 1–5–07; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R03–OAR–2006–0648; FRL–8266–1]
Approval and Promulgation of Air
Quality Implementation Plans; Virginia;
Identification of the Northern Virginia
PM2.5 Nonattainment Area
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
SUMMARY: EPA is taking direct final
action to approve revisions to the
Virginia State Implementation Plan
(SIP). The revision consists of the
addition of counties in Northern
Virginia which were designated as
nonattainment for the fine particulate
(PM2.5) national ambient air quality
standard (NAAQS). EPA is approving
this revision in accordance with the
requirements of the Clean Air Act.
DATES: This rule is effective on March 9,
2007 without further notice, unless EPA
receives adverse written comment by
February 7, 2007. If EPA receives such
comments, it will publish a timely
withdrawal of the direct final rule in the
Federal Register and inform the public
that the rule will not take effect.
ADDRESSES: Submit your comments,
identified by Docket ID Number EPAR03-OAR–2006–0648 by one of the
following methods:
A. www.regulations.gov. Follow the
on-line instructions for submitting
comments.
B. E-mail: miller.linda@epa.gov.
C. Mail: EPA–R03–OAR–2006–0648,
Linda Miller, Acting Chief, Air Quality
Planning and Analysis Branch,
E:\FR\FM\08JAR1.SGM
08JAR1
]]>Agencies
[Federal Register Volume 72, Number 4 (Monday, January 8, 2007)]
[Rules and Regulations]
[Page 653]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-4]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feeds; 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 new animal drug
application (NADA) filed by Elanco Animal Health. The supplemental NADA
revises the concentration of monensin in Type C medicated feeds used
for improved feed efficiency, and for the prevention and control of
coccidiosis in cattle fed in confinement for slaughter.
DATES: This rule is effective January 8, 2007.
FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0232, e-mail: eric.dubbin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 95-735 that provides for use of RUMENSIN 80
(monensin) Type A medicated articles. The supplement revises the
concentration of monensin in Type C medicated feeds used for improved
feed efficiency, and for the prevention and control of coccidiosis in
cattle fed in confinement for slaughter. The supplemental NADA is
approved as of December 1, 2006, and the regulations in 21 CFR 558.355
are amended to reflect the approval. The basis of approval is discussed
in the freedom of information summary.
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.
FDA has carefully considered the potential environmental impact of
this action and has concluded that the action will not have a
significant impact on the human environment and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Division of Dockets
Management (address above) between 9 a.m. and 4 p.m., Monday through
Friday.
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. Section 558.355 is amended as follows:
a. Revise paragraph (d)(2);
b. Revise the introductory text of paragraphs (f)(3)(i) and
(f)(3)(vii);
c. Revise paragraph (f)(3)(vii)(b);
d. Amend paragraph (f)(3)(i)(b)(1) by revising the second sentence
and adding a new third sentence.
The revisions read as follows:
Sec. 558.355 Monensin.
* * * * *
(d) * * *
(2) Type C cattle feeds containing 40 grams or less monensin per
ton shall bear an expiration date of 30 days after its date of
manufacture.
(f) * * *
(3) * * *
(i) [Amount per ton]. Monensin, 5 to 40 grams.
(b) * * *
(1) Limitations. * * * Feed continuously in complete feed at a rate
of 50 to 480 milligrams of monensin per head per day. No additional
improvement in feed efficiency has been shown from feeding monensin at
levels greater than 30 grams per ton (360 milligrams per head per day).
* * *
* * * * *
(vii) Amount per ton. Monensin, 10 to 40 grams.
* * * * *
(b) Limitations. For cattle fed in confinement for slaughter, feed
at a rate of 0.14 to 0.42 milligram per pound of body weight per day,
depending upon the severity of challenge, up to maximum of 480
milligrams per head per day.
* * * * *
Dated: December 19, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E7-4 Filed 1-5-07; 8:45 am]
BILLING CODE 4160-01-S
