New Animal Drugs for Use in Animal Feeds; Tilmicosin, 76894-76895 [2011-31613]
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Federal Register / Vol. 76, No. 237 / Friday, December 9, 2011 / Rules and Regulations
(January 18, 2011); Notice of August 12,
2011, 76 FR 50661 (August 16, 2011); Notice
of November 9, 2011, 76 FR 70319
(November 10, 2011).
PART 745—[AMENDED]
6. The authority citation for 15 CFR
part 745 is revised to read as follows:
■
Authority: 50 U.S.C. 1701 et seq.; E.O.
12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
950; Notice of November 9, 2011, 76 FR
70319 (November 10, 2011).
Dated: December 5, 2011.
Kevin J. Wolf,
Assistant Secretary for Export
Administration.
[FR Doc. 2011–31687 Filed 12–8–11; 8:45 am]
BILLING CODE 3510–33–P
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; Tilmicosin
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 use of tilmicosin Type C
medicated feeds by veterinary feed
directive for the control of bovine
respiratory disease in groups of beef and
nonlactating dairy cattle.
DATES: This rule is effective December 9,
2011.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, (240) 276–
8341, email:
cindy.burnsteel@fda.hhs.gov.
SUMMARY:
Elanco
Animal Health, a division of Eli Lilly &
Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 141–064 for
PULMOTIL 90 (tilmicosin phosphate)
Type A medicated article. The
supplemental NADA provides for the
use of tilmicosin Type C medicated
feeds by veterinary feed directive for the
control of bovine respiratory disease
sroberts on DSK5SPTVN1PROD with RULES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
15:52 Dec 08, 2011
Jkt 226001
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni in groups of beef and
nonlactating dairy cattle where active
BRD has been diagnosed in at least 10
percent of the animals in the group. The
supplemental NADA is approved as of
August 19, 2011, and 21 CFR 558.4 and
558.618 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.
Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
supplemental approval qualifies for
3 years of marketing exclusivity
beginning on the date of approval.
The Agency 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.
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:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.4
[Amended]
2. In paragraph (d) of § 558.4, in the
‘‘Category II’’ table, in the ‘‘Type B
maximum (100x)’’ column, in the entry
for ‘‘Tilmicosin’’, remove ‘‘18.2 g/lb
■
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
(4.0%)’’ and in its place add ‘‘37.9 g/lb
(8.35%)’’.
■ 3. In § 558.618, revise paragraphs (a),
(c), and (e) to read as follows:
§ 558.618
Tilmicosin.
(a) Specifications. Type A medicated
article containing 90.7 grams (g) per
pound tilmicosin as tilmicosin
phosphate (200 g per kilogram).
*
*
*
*
*
(c) Special considerations—(1)
Tilmicosin medicated feeds are
restricted to use under a veterinary feed
directive (VFD). See § 558.6 of this
chapter for required label statements
and other limitations.
(2) VFDs for tilmicosin phosphate
shall not be refilled.
(3) Labeling of tilmicosin Type B or
Type C medicated feeds must bear the
following warnings:
(i) Do not allow horses or other
equines access to feeds containing
tilmicosin.
(ii) Use of antibacterial drugs in the
absence of a susceptible bacterial
infection is unlikely to provide benefit
to treated animals and may increase the
risk of the development of drug-resistant
pathogenic bacteria.
(4) Special considerations for use of
tilmicosin medicated swine feeds
include the following:
(i) The expiration date of VFDs for
tilmicosin must not exceed 90 days from
the time of issuance.
(ii) Labeling of tilmicosin Type B or
Type C medicated feeds for swine must
bear the following warning: ‘‘Do not use
in any feeds containing bentonite.
Bentonite in feeds may affect the
efficacy of tilmicosin.’’
(iii) Feed containing tilmicosin shall
not be fed to pigs for more than 21 days
during each phase of production
without ceasing administration for
reevaluation of antimicrobial use by a
licensed veterinarian before reinitiating
a further course of therapy with an
appropriate antimicrobial.
(5) Special consideration for use of
tilmicosin medicated cattle feeds
include the following:
(i) The expiration date of VFDs for
cattle must not exceed 45 days from the
time of issuance.
(ii) Labeling of tilmicosin Type B or
Type C medicated feeds for cattle must
bear the following warning: ‘‘Do not use
in any feeds containing bentonite,
cottonseed meal, or cottonseed hulls.
Bentonite, cottonseed meal, or
cottonseed hulls in feeds may affect the
efficacy of tilmicosin.’’
(iii) To assure both food safety and
responsible use in cattle, administration
of feed containing tilmicosin to cattle
E:\FR\FM\09DER1.SGM
09DER1
Federal Register / Vol. 76, No. 237 / Friday, December 9, 2011 / Rules and Regulations
experiencing an outbreak of BRD must
be initiated during the first 45 days of
the production period, shall not exceed
a single 14-consecutive-day treatment,
should not occur concurrent with or
following administration of an
injectable macrolide, and should not
occur within 3 days following
administration of a nonmacrolide
injectable BRD therapy. Tilmicosin
medicated feed treatment has not been
evaluated in cattle with severe clinical
disease. Cattle with severe clinical
illness should be evaluated for
individual treatment with an alternative
non-macrolide therapy.
*
*
*
*
*
(e) Conditions of use. It is used in feed
as follows:
Tilmicosin phosphate
in grams/ton
Indications for use
Limitations
(1) 181 to 363 ..........
Swine: For the control of swine respiratory disease
associated with Actinobacillus pleuropneumoniae
and Pasteurella multocida.
(2) 568 to 757 ..........
Cattle: For the control of bovine respiratory disease
(BRD) associated with Mannheimia haemolytica,
Pasteurella multocida, and Histophilus somni in
groups of beef and nonlactating dairy cattle,
where active BRD has been diagnosed in at least
10 percent of the animals in the group.
Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an
anticipated disease outbreak. The safety of
tilmicosin has not been established in male swine
intended for breeding purposes. Swine intended
for human consumption must not be slaughtered
within 7 days of the last treatment with this drug
product.
Feed continuously for 14 days to provide 12.5 milligrams/kilogram/head/day. The safety of tilmicosin
has not been established in cattle intended for
breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of
age or older. Use in these cattle may cause drug
residues in milk. This drug product is not approved for use in calves intended to be processed for veal.
A withdrawal period has not been established in
preruminating calves. Cattle intended for human
consumption must not be slaughtered within 28
days of the last treatment with this drug product.
Dated: December 5, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2011–31613 Filed 12–8–11; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–P
Background
Quyen P. Huynh at (202) 622–3880 (not
a toll-free number).
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9562]
RIN 1545–BH77
Conduit Financing Arrangements
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulation.
AGENCY:
This document contains final
regulations relating to conduit financing
arrangements. The final regulations
apply to multiple-party financing
arrangements that are effected through
disregarded entities, and are necessary
in order to determine which of those
arrangements should be recharacterized
as a conduit financing arrangement.
DATES: Effective Date: These regulations
are effective on December 9, 2011.
Applicability Date: These regulations
apply to payments made on or after
December 9, 2011.
sroberts on DSK5SPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
15:52 Dec 08, 2011
Jkt 226001
On August 10, 1995, the Department
of the Treasury (Treasury Department)
and the Internal Revenue Service (IRS)
published final regulations under Treas.
Reg. § 1.881–3 relating to conduit
financing arrangements pursuant to the
authority granted by section 7701(l) of
the Internal Revenue Code (the conduit
financing regulations). See TD 8611
(1995–37 IRB 20; 60 FR 40997). On
December 22, 2008, the Treasury
Department and the IRS published in
the Federal Register (73 FR 246) a
notice of proposed rulemaking (REG–
113462–08) that proposed amending
§ 1.881–3(a)(2)(i)(C) of the conduit
financing regulations to treat an entity
disregarded as an entity separate from
its owner for U.S. tax purposes as a
person for purposes of determining
whether a conduit financing
arrangement exists. The proposed
regulations were proposed to be
effective as of the date final regulations
are published in the Federal Register. In
addition, the preamble to the proposed
regulations requested comments on
whether ‘‘hybrid instruments’’
(instruments treated as debt for foreign
law purposes and equity for U.S.
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
76895
Sponsor
000986
000986
purposes) should constitute per se
‘‘financing transactions’’ under § 1.881–
3(a)(2)(ii)(A) and part of a ‘‘financing
arrangement’’ within the meaning of
§ 1.881–3(a)(2)(i)(A), or whether, at a
minimum, certain hybrid instruments
should be so treated, depending on
specific factors or criteria.
Only one comment letter responding
to the notice of proposed rulemaking
was received. No public hearing was
requested or held. After consideration of
the comment, this Treasury decision
adopts the proposed regulations with
minor edits to Example 3 and to clarify
that the effective date of the final
regulations also applies to new Example
3.
Explanation and Summary of Comment
The comment supported the proposed
regulations and their interpretation of
the term ‘‘person’’ to include a business
entity that is disregarded as an entity
separate from its single member owner
under § 301.7701–1 through § 301.7701–
3. The comment stated that to disregard
an entity that is ‘‘regarded’’ for purposes
of claiming treaty benefits would be
inconsistent with the policy and
purpose of the anti-conduit financing
regulations.
As relates to hybrid instruments, the
comment did not support either
approach raised in the preamble to the
proposed regulations, expressing both
policy and administrative concerns with
E:\FR\FM\09DER1.SGM
09DER1
]]>Agencies
[Federal Register Volume 76, Number 237 (Friday, December 9, 2011)]
[Rules and Regulations]
[Pages 76894-76895]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31613]
=======================================================================
-----------------------------------------------------------------------
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; Tilmicosin
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 use of tilmicosin Type C
medicated feeds by veterinary feed directive for the control of bovine
respiratory disease in groups of beef and nonlactating dairy cattle.
DATES: This rule is effective December 9, 2011.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, (240) 276-8341, email:
cindy.burnsteel@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 141-064 for PULMOTIL 90 (tilmicosin phosphate) Type
A medicated article. The supplemental NADA provides for the use of
tilmicosin Type C medicated feeds by veterinary feed directive for the
control of bovine respiratory disease (BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and Histophilus somni in groups of
beef and nonlactating dairy cattle where active BRD has been diagnosed
in at least 10 percent of the animals in the group. The supplemental
NADA is approved as of August 19, 2011, and 21 CFR 558.4 and 558.618
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.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval.
The Agency 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.
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. 558.4 [Amended]
0
2. In paragraph (d) of Sec. 558.4, in the ``Category II'' table, in
the ``Type B maximum (100x)'' column, in the entry for ``Tilmicosin'',
remove ``18.2 g/lb (4.0%)'' and in its place add ``37.9 g/lb (8.35%)''.
0
3. In Sec. 558.618, revise paragraphs (a), (c), and (e) to read as
follows:
Sec. 558.618 Tilmicosin.
(a) Specifications. Type A medicated article containing 90.7 grams
(g) per pound tilmicosin as tilmicosin phosphate (200 g per kilogram).
* * * * *
(c) Special considerations--(1) Tilmicosin medicated feeds are
restricted to use under a veterinary feed directive (VFD). See Sec.
558.6 of this chapter for required label statements and other
limitations.
(2) VFDs for tilmicosin phosphate shall not be refilled.
(3) Labeling of tilmicosin Type B or Type C medicated feeds must
bear the following warnings:
(i) Do not allow horses or other equines access to feeds containing
tilmicosin.
(ii) Use of antibacterial drugs in the absence of a susceptible
bacterial infection is unlikely to provide benefit to treated animals
and may increase the risk of the development of drug-resistant
pathogenic bacteria.
(4) Special considerations for use of tilmicosin medicated swine
feeds include the following:
(i) The expiration date of VFDs for tilmicosin must not exceed 90
days from the time of issuance.
(ii) Labeling of tilmicosin Type B or Type C medicated feeds for
swine must bear the following warning: ``Do not use in any feeds
containing bentonite. Bentonite in feeds may affect the efficacy of
tilmicosin.''
(iii) Feed containing tilmicosin shall not be fed to pigs for more
than 21 days during each phase of production without ceasing
administration for reevaluation of antimicrobial use by a licensed
veterinarian before reinitiating a further course of therapy with an
appropriate antimicrobial.
(5) Special consideration for use of tilmicosin medicated cattle
feeds include the following:
(i) The expiration date of VFDs for cattle must not exceed 45 days
from the time of issuance.
(ii) Labeling of tilmicosin Type B or Type C medicated feeds for
cattle must bear the following warning: ``Do not use in any feeds
containing bentonite, cottonseed meal, or cottonseed hulls. Bentonite,
cottonseed meal, or cottonseed hulls in feeds may affect the efficacy
of tilmicosin.''
(iii) To assure both food safety and responsible use in cattle,
administration of feed containing tilmicosin to cattle
[[Page 76895]]
experiencing an outbreak of BRD must be initiated during the first 45
days of the production period, shall not exceed a single 14-
consecutive-day treatment, should not occur concurrent with or
following administration of an injectable macrolide, and should not
occur within 3 days following administration of a nonmacrolide
injectable BRD therapy. Tilmicosin medicated feed treatment has not
been evaluated in cattle with severe clinical disease. Cattle with
severe clinical illness should be evaluated for individual treatment
with an alternative non-macrolide therapy.
* * * * *
(e) Conditions of use. It is used in feed as follows:
------------------------------------------------------------------------
Tilmicosin phosphate in Indications for
grams/ton use Limitations Sponsor
------------------------------------------------------------------------
(1) 181 to 363........... Swine: For the Feed 000986
control of continuously
swine as the sole
respiratory ration for 21-
disease day period,
associated beginning
with approximately
Actinobacillus 7 days before
pleuropneumoni an anticipated
ae and disease
Pasteurella outbreak. The
multocida. safety of
tilmicosin has
not been
established in
male swine
intended for
breeding
purposes.
Swine intended
for human
consumption
must not be
slaughtered
within 7 days
of the last
treatment with
this drug
product.
(2) 568 to 757........... Cattle: For the Feed 000986
control of continuously
bovine for 14 days to
respiratory provide 12.5
disease (BRD) milligrams/
associated kilogram/head/
with day. The
Mannheimia safety of
haemolytica, tilmicosin has
Pasteurella not been
multocida, and established in
Histophilus cattle
somni in intended for
groups of beef breeding
and purposes. This
nonlactating drug product
dairy cattle, is not
where active approved for
BRD has been use in female
diagnosed in dairy cattle
at least 10 20 months of
percent of the age or older.
animals in the Use in these
group. cattle may
cause drug
residues in
milk. This
drug product
is not
approved for
use in calves
intended to be
processed for
veal.
A withdrawal
period has not
been
established in
preruminating
calves. Cattle
intended for
human
consumption
must not be
slaughtered
within 28 days
of the last
treatment with
this drug
product.
------------------------------------------------------------------------
Dated: December 5, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-31613 Filed 12-8-11; 8:45 am]
BILLING CODE 4160-01-P
