New Animal Drugs for Use in Animal Feeds; Ractopamine; Tylosin, 66914-66915 [E9-29998]
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Federal Register / Vol. 74, No. 241 / Thursday, December 17, 2009 / Rules and Regulations
natural resource priorities and criteria
for conservation activities and
programs; and
(3) Local Working Groups will follow
the standard operating procedures
described in § 610.23(b).
Signed this 10th day of December 2009 in
Washington, DC.
Dave White,
Chief, Natural Resources Conservation
Service.
[FR Doc. E9–30055 Filed 12–16–09; 8:45 am]
BILLING CODE 3410–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2009–N–0665]
New Animal Drugs for Use in Animal
Feeds; Ractopamine; Tylosin
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Final rule; technical
amendment.
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 provides for use of
two-way combination Type B and C
medicated swine feeds formulated with
ractopamine hydrochloride and tylosin
phosphate following use of tylosin
tartrate medicated drinking water
consistent with the sequential use
approved for single-ingredient tylosin
medicated swine feed.
SUMMARY:
Ractopamine in
grams/ton
*
DATES: This rule is effective December
17, 2009.
FOR FURTHER INFORMATION CONTACT:
Timothy Schell, Center for Veterinary
Medicine (HFV–128), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8116,
e-mail: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, a Div. of Eli Lilly & Co.,
Lilly Corporate Center, Indianapolis, IN
46285, filed a supplement to NADA
141–172 for use of two-way
combination Type B and C medicated
swine feeds formulated with PAYLEAN
(ractopamine hydrochloride) and
TYLAN (tylosin phosphate) singleingredient Type A medicated articles.
The supplement provides use of twoway combination Type B and C
medicated swine feeds formulated with
ractopamine hydrochloride and tylosin
phosphate following use of tylosin
tartrate medicated drinking water
consistent with the sequential use
approved for single-ingredient tylosin
medicated swine feed (73 FR 76946,
December 18, 2008). The supplemental
NADA is approved as of October 23,
2009, 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.
In addition, FDA has noticed that the
tylosin levels for single-ingredient Type
Combination in
grams/ton
*
C medicated swine feed are not clearly
described in 21 CFR 558.625. At this
time, those regulations are being revised
to clarify this use of levels. This action
is being taken to improve the accuracy
of the regulations.
FDA 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 the
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.
2. In § 558.500, revise the table in
paragraphs (e)(1)(ii) and (e)(1)(iii); and
add paragraph (e)(1)(iv) to read as
follows:
■
§ 558.500
*
Indications for use
*
Ractopamine.
*
*
(e) * * *
(1) * * *
*
*
Limitations
*
*
*
Sponsor
*
wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
(ii) 4.5 to 9
Tylosin
40 or 100
Finishing swine: As in paragraph
(e)(1)(i) of this section; and for control of swine dysentery associated
with Brachyspira hyodysenteriae
and porcine proliferative
enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.
Feed 100 grams per tons (g/ton) continuously as sole ration for at least
3 weeks followed by 40 g/ton until
market weight.
000986
(iii) 4.5 to 9
Tylosin
100
Finishing swine: As in paragraph
(e)(1)(i) of this section; and for control of porcine proliferative
enteropathies (PPE, ileitis) associated with L. intracellularis.
Feed continuously as sole ration for
21 days.
000986
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11:22 Dec 16, 2009
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Federal Register / Vol. 74, No. 241 / Thursday, December 17, 2009 / Rules and Regulations
Ractopamine in
grams/ton
Combination in
grams/ton
(iv) 4.5 to 9
*
*
Indications for use
Tylosin
40 to 100
*
*
Limitations
Finishing swine: As in paragraph
(e)(1)(i) of this section; for treatment and control of swine dysentery associated with B.
hyodysenteriae and for control of
porcine proliferative enteropathies
(PPE, ileitis) associated with L.
intracellularis.
*
Feed continuously as sole ration for 2
to 6 weeks, immediately after treatment with tylosin tartrate in drinking
water as in § 520.2640(d)(3) of this
chapter.
66915
Sponsor
000986
Background
DEPARTMENT OF THE TREASURY
The final regulations (TD 9443) that
are the subject of this document are
under section 7508A of the Internal
Revenue Code.
Internal Revenue Service
Need for Correction
RIN 1545–BG16
Dated: December 11, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–29998 Filed 12–16–09; 8:45 am]
As published, the final regulations
(TD 9443) contain errors that may prove
to be misleading and are in need of
clarification.
Postponement of Certain Tax-Related
Deadlines by Reason of a Federally
Declared Disaster or Terroristic or
Military Action; Correction
BILLING CODE 4160–01–S
List of Subjects in 26 CFR Part 301
DEPARTMENT OF THE TREASURY
Employment taxes, Estate taxes,
Excise taxes, Gift taxes, Income taxes,
Penalties, Reporting and recordkeeping
requirements.
§ 558.625
[Amended]
3. In § 558.625, in paragraph
(f)(1)(vi)(b), remove ‘‘Tylosin, 40–100
grams.’’ and in its place add ‘‘Tylosin,
40 or 100 grams.’’; and remove
paragraph (f)(1)(vi)(d)(vi).
■
Internal Revenue Service
Correction of Publication
26 CFR Part 301
Accordingly, 26 CFR part 301 is
corrected by making the following
correcting amendments:
■
[TD 9443]
RIN 1545–BG16
Postponement of Certain Tax-Related
Deadlines by Reason of a Federally
Declared Disaster or Terroristic or
Military Action; Correction
AGENCY: Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendments.
This document contains
corrections to final regulations (TD
9443) that were published in the
Federal Register on Thursday, January
15, 2009 (74 FR 2370) relating to
postponement of certain tax-related
deadlines either due to service in a
combat zone or due to a Federally
declared disaster. The regulations reflect
changes in the law made by the Victims
of Terrorism Tax Relief Act of 2001, the
Tax Extenders and Alternative
Minimum Tax Relief Act of 2008
(TEAMTRA), and current IRS practice.
DATES: This correction is effective on
December 17, 2009, and is applicable on
January 15, 2010.
FOR FURTHER INFORMATION CONTACT:
Mary Ellen Keys, (202) 622–4570 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
SUMMARY:
VerDate Nov<24>2008
11:22 Dec 16, 2009
Jkt 220001
PART 301—PROCEDURE AND
ADMINISTRATION
Paragraph 1. The authority citation
for part 301 continues to read in part as
follows:
■
Authority: 26 U.S.C. 7805 * * *
Par. 2. Section 301.7508A–1(f) is
amended by removing the existing
Example 8, and redesignating Example
9 as Example 8.
■
LaNita Van Dyke,
Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
Counsel, (Procedure and Administration).
[FR Doc. E9–29978 Filed 12–16–09; 8:45 am]
BILLING CODE 4830–01–P
PO 00000
26 CFR Part 301
[TD 9443]
AGENCY: Internal Revenue Service (IRS),
Treasury.
ACTION: Correction to final regulations.
SUMMARY: This document contains a
correction to final regulations (TD 9443)
that were published in the Federal
Register on Thursday, January 15, 2009
(74 FR 2370) relating to postponement
of certain tax-related deadlines either
due to service in a combat zone or due
to a Federally declared disaster. The
regulations reflect changes in the law
made by the Victims of Terrorism Tax
Relief Act of 2001, the Tax Extenders
and Alternative Minimum Tax Relief
Act of 2008 (TEAMTRA), and current
IRS practice.
DATES: This correction is effective on
December 17, 2009, and is applicable on
January 15, 2009.
FOR FURTHER INFORMATION CONTACT:
Mary Ellen Keys, (202) 622–4570 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
Background
The final regulations (TD 9443) that
are the subject of this document are
under section 7508A of the Internal
Revenue Code.
Need for Correction
As published, the final regulations
(TD 9443) contain an error that may
prove to be misleading and is in need
of clarification.
Correction of Publication
Accordingly, the publication of the
final regulations (TD 9443), which were
the subject of FR Doc. E9–767, is
corrected as follows:
Frm 00009
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]]>Agencies
[Federal Register Volume 74, Number 241 (Thursday, December 17, 2009)]
[Rules and Regulations]
[Pages 66914-66915]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-29998]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2009-N-0665]
New Animal Drugs for Use in Animal Feeds; Ractopamine; Tylosin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
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
provides for use of two-way combination Type B and C medicated swine
feeds formulated with ractopamine hydrochloride and tylosin phosphate
following use of tylosin tartrate medicated drinking water consistent
with the sequential use approved for single-ingredient tylosin
medicated swine feed.
DATES: This rule is effective December 17, 2009.
FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, a Div. of Eli Lilly &
Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement
to NADA 141-172 for use of two-way combination Type B and C medicated
swine feeds formulated with PAYLEAN (ractopamine hydrochloride) and
TYLAN (tylosin phosphate) single-ingredient Type A medicated articles.
The supplement provides use of two-way combination Type B and C
medicated swine feeds formulated with ractopamine hydrochloride and
tylosin phosphate following use of tylosin tartrate medicated drinking
water consistent with the sequential use approved for single-ingredient
tylosin medicated swine feed (73 FR 76946, December 18, 2008). The
supplemental NADA is approved as of October 23, 2009, 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.
In addition, FDA has noticed that the tylosin levels for single-
ingredient Type C medicated swine feed are not clearly described in 21
CFR 558.625. At this time, those regulations are being revised to
clarify this use of levels. This action is being taken to improve the
accuracy of the regulations.
FDA 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.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
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. 558.500, revise the table in paragraphs (e)(1)(ii) and
(e)(1)(iii); and add paragraph (e)(1)(iv) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Ractopamine in Combination in
grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(ii) 4.5 to 9 Tylosin Finishing swine: As in Feed 100 grams per tons (g/ 000986
40 or 100 paragraph (e)(1)(i) of this ton) continuously as sole
section; and for control of ration for at least 3
swine dysentery associated weeks followed by 40 g/ton
with Brachyspira until market weight.
hyodysenteriae and porcine
proliferative enteropathies
(PPE, ileitis) associated
with Lawsonia
intracellularis.
----------------------------------------------------------------------------------------------------------------
(iii) 4.5 to 9 Tylosin Finishing swine: As in Feed continuously as sole 000986
100 paragraph (e)(1)(i) of this ration for 21 days.
section; and for control of
porcine proliferative
enteropathies (PPE,
ileitis) associated with L.
intracellularis.
----------------------------------------------------------------------------------------------------------------
[[Page 66915]]
(iv) 4.5 to 9 Tylosin Finishing swine: As in Feed continuously as sole 000986
40 to 100 paragraph (e)(1)(i) of this ration for 2 to 6 weeks,
section; for treatment and immediately after
control of swine dysentery treatment with tylosin
associated with B. tartrate in drinking water
hyodysenteriae and for as in Sec.
control of porcine 520.2640(d)(3) of this
proliferative enteropathies chapter.
(PPE, ileitis) associated
with L. intracellularis.
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.625 [Amended]
0
3. In Sec. 558.625, in paragraph (f)(1)(vi)(b), remove ``Tylosin, 40-
100 grams.'' and in its place add ``Tylosin, 40 or 100 grams.''; and
remove paragraph (f)(1)(vi)(d)(vi).
Dated: December 11, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29998 Filed 12-16-09; 8:45 am]
BILLING CODE 4160-01-S
