New Animal Drugs for Use in Animal Feeds; Monensin, 4228 [2012-1755]
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Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations
Food and Drug Administration
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
21 CFR Part 558
List of Subjects in 21 CFR Part 558
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Animal drugs, Animal feeds.
[Docket No. FDA–2011–N–0003]
New Animal Drugs for Use in Animal
Feeds; Monensin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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, A Division of Eli
Lilly & Co. The supplemental NADA
provides for approval of free-choice
feeds for growing cattle on pasture or in
dry lot (stocker and feeder cattle and
dairy and beef replacement heifers).
DATES: This rule is effective January 27,
2012.
FOR FURTHER INFORMATION CONTACT:
Suzanne Sechen, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, (240) 276–8105,
email: suzanne.sechen@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 90
(monensin) Type A medicated article in
free-choice feeds for growing cattle on
pasture or in dry lot (stocker and feeder
cattle and dairy and beef replacement
heifers) for increased rate of weight gain
and for prevention and control of
coccidiosis. The supplemental NADA is
approved as of November 18, 2011, and
the regulations in 21 CFR 558.355 are
amended to reflect the approval.
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
pmangrum on DSK3VPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
15:16 Jan 26, 2012
Jkt 226001
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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1303, 1304, 1305,
1306, 1308, 1309, 1310, 1312, 1313,
1314, 1316
[Docket No. DEA–356]
Technical Amendments and
Corrections to DEA Regulations
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
AGENCY:
This final rule updates the
Code of Federal Regulations pertaining
to DEA by alphabetizing definitions and
eliminating the numeric listings in those
definitions in order to simplify future
rulemakings where additional
definitions are added or deleted. This
rule also corrects typographic errors,
reflects organizational changes, and
updates cross-reference listings in the
CFR. This action makes no substantive
changes to the affected rules.
DATES: The effective date of this rule is
January 27, 2012.
FOR FURTHER INFORMATION CONTACT:
Rhea D. Moore, Office of Diversion
Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone
(202) 307–7165.
SUPPLEMENTARY INFORMATION:
SUMMARY:
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
2. In § 558.355, add paragraph
(f)(3)(iv); and in paragraph (f)(3)(x)(c),
remove the last sentence.
The addition reads as follows:
■
§ 558.355
Monensin.
*
*
*
*
*
(f) * * *
(3) * * *
(iv) Amount. Monensin at
concentrations in free-choice Type C
medicated feeds to provide 50 to 200 mg
per head per day.
(a) Indications for use. Growing cattle
on pasture or in dry lot (stocker and
feeder cattle and dairy and beef
replacement heifers): For increased rate
of weight gain; for prevention and
control of coccidiosis due to Eimeria
bovis and E. zuernii.
(b) Limitations. During the first 5 days
of feeding, cattle should receive no more
than 100 milligrams per day. Do not
feed additional salt or minerals. Do not
mix with grain or other feeds. Monensin
is toxic to cattle when consumed at
higher than approved levels. Stressed
and/or feed- and/or water-deprived
cattle should be adapted to the pasture
and to unmedicated supplement before
using the monensin medicated
supplement. The product’s effectiveness
in cull cows and bulls has not been
established. See paragraph (d) of this
section for other required label
warnings.
*
*
*
*
*
Dated: January 23, 2012.
William T. Flynn,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. 2012–1755 Filed 1–26–12; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
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Background
DEA implements and enforces Titles
II and III of the Comprehensive Drug
Abuse Prevention and Control Act of
1970, often referred to as the Controlled
Substances Act (CSA) and the
Controlled Substances Import and
Export Act (CSIEA) (21 U.S.C. 801–971),
as amended. DEA publishes the
implementing regulations for these
statutes in Title 21 of the Code of
Federal Regulations (CFR), Parts 1300
through 1321.
The Administrative Procedure Act (5
U.S.C. 553) does not require notice and
the opportunity for public comment
where the agency for good cause finds
that notice and public comment are
unnecessary, impracticable, or contrary
to the public interest under 5 U.S.C.
553(b)(B) or on rules affecting agency
organization, procedure, or practice
under 5 U.S.C. 553(b)(A). This rule
contains technical corrections and
updates organizational changes in
agency regulations; it imposes no new
or substantive requirement on the
public or DEA registrants. As such, DEA
has determined that notice and
E:\FR\FM\27JAR1.SGM
27JAR1
]]>Agencies
[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Rules and Regulations]
[Page 4228]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1755]
[[Page 4228]]
-----------------------------------------------------------------------
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; 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, A Division of Eli
Lilly & Co. The supplemental NADA provides for approval of free-choice
feeds for growing cattle on pasture or in dry lot (stocker and feeder
cattle and dairy and beef replacement heifers).
DATES: This rule is effective January 27, 2012.
FOR FURTHER INFORMATION CONTACT: Suzanne Sechen, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, (240) 276-8105, email: suzanne.sechen@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 90
(monensin) Type A medicated article in free-choice feeds for growing
cattle on pasture or in dry lot (stocker and feeder cattle and dairy
and beef replacement heifers) for increased rate of weight gain and for
prevention and control of coccidiosis. The supplemental NADA is
approved as of November 18, 2011, and the regulations in 21 CFR 558.355
are amended to reflect the approval.
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. 558.355, add paragraph (f)(3)(iv); and in paragraph
(f)(3)(x)(c), remove the last sentence.
The addition reads as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(3) * * *
(iv) Amount. Monensin at concentrations in free-choice Type C
medicated feeds to provide 50 to 200 mg per head per day.
(a) Indications for use. Growing cattle on pasture or in dry lot
(stocker and feeder cattle and dairy and beef replacement heifers): For
increased rate of weight gain; for prevention and control of
coccidiosis due to Eimeria bovis and E. zuernii.
(b) Limitations. During the first 5 days of feeding, cattle should
receive no more than 100 milligrams per day. Do not feed additional
salt or minerals. Do not mix with grain or other feeds. Monensin is
toxic to cattle when consumed at higher than approved levels. Stressed
and/or feed- and/or water-deprived cattle should be adapted to the
pasture and to unmedicated supplement before using the monensin
medicated supplement. The product's effectiveness in cull cows and
bulls has not been established. See paragraph (d) of this section for
other required label warnings.
* * * * *
Dated: January 23, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1755 Filed 1-26-12; 8:45 am]
BILLING CODE 4160-01-P
