New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol; Tildipirosin; Zilpaterol, 52852-52854 [2013-20538]
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52852
Federal Register / Vol. 78, No. 166 / Tuesday, August 27, 2013 / Rules and Regulations
2013 (78 FR 45850). The regulations
amends its regulations to provide
optional notice procedures for
processing rate filings by those natural
gas pipelines that fall under the
Commission’s jurisdiction pursuant to
the Natural Gas Policy Act of 1978 or
the Natural Gas Act. The rule results in
regulatory certainty and a reduction of
regulatory burdens.
DATES: Effective September 30, 2013.
FOR FURTHER INFORMATION CONTACT:
David Tishman (Legal Information),
Office of the General Counsel, Federal
Energy Regulatory Commission, 888
First Street NE., Washington, DC
20426, (202) 502–8515,
David.Tishman@ferc.gov.
James Sarikas (Technical Information),
Office of Energy Market Regulation,
Federal Energy Regulatory
Commission, 888 First Street NE.,
Washington, DC 20426, (202) 502–
6831, James.Sarikas@ferc.gov.
SUPPLEMENTARY INFORMATION:
Need for Correction
On July 18, 2013, the Commission
issued a ‘‘Final Rule, Order No. 781’’ in
the above-captioned proceeding.
Revisions to Procedural Regulations
Governing Transportation by Intrastate
Pipelines, 144 FERC ¶ 61,034 (2013).
This document serves to correct the
table in Paragraph 82. Specifically, the
last figure in the ‘‘total Annual Burden
Hours’’ column is changed from ‘‘854’’
to ‘‘852’’.
Accordingly, in rule FR Doc. No.
2013–17822 published in the July 30,
2013 (78 FR 45850), on page 45861, in
the table in paragraph 82, the entry in
the ‘‘Total annual burden hours (a × b)’’
column for the entry ‘‘FERC–549 Total,’’
the figure ‘‘854’’ is corrected to read
‘‘852’’.
Rockville, MD 20855, 240–276–9019,
george.haibel@fda.hhs.gov.
Dated: August 21, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–20865 Filed 8–26–13; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 524, 556, and
558
[Docket No. FDA–2013–N–0002]
New Animal Drugs; Carprofen;
Enrofloxacin; Florfenicol; Tildipirosin;
Zilpaterol
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval actions for new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during June 2013. FDA is
also informing the public of the
availability of summaries of the basis of
approval and of environmental review
documents, where applicable.
DATES: This rule is effective August 27,
2013.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
SUMMARY:
FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during June 2013, as listed in
table 1. In addition, FDA is informing
the public of the availability, where
applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
review of safety or effectiveness data,
summaries of the basis of approval
(Freedom of Information Summaries)
under the Freedom of Information Act
(FOIA). These public documents 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. Persons with access to the
Internet may obtain these documents at
the Center for Veterinary Medicine
FOIA Electronic Reading Room: https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm.
In addition, the animal drug
regulations are being amended at 21
CFR 510.600 to correct a sponsor’s name
and at 21 CFR 556.733 to correct the
acceptable daily intake of total residues
of tildipirosin. This is being done to
improve the accuracy of the regulations.
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.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JUNE 2013
NADA/
ANADA
Sponsor
New animal drug product
name
Action
200–524 .......
Putney, Inc., 400 Congress
St., suite 200, Portland,
ME 04101.
Novartis Animal Health US,
Inc., 3200 Northline
Ave., suite 300, Greensboro, NC 27408.
Novartis Animal Health US,
Inc., 3200 Northline
Ave., suite 300, Greensboro, NC 27408.
Huvepharma AD, 5th
Floor, 3A Nikolay Haytov
Str., 1113 Sophia, Bulgaria.
Mupirocin Ointment 2% .....
Original approval as a generic copy of NADA
140–839.
Original approval as a generic copy of NADA
140–441.
524.1465
yes ...........
CE.1
520.812
yes ...........
CE.1
FLORVIO (florfenicol) 2.3%
Concentrate Solution.
Original approval as a generic copy of NADA
141–206.
520.995
yes ...........
CE.1
ZILMAX (zilpaterol hydrochloride) plus
RUMENSIN (monensin
USP) plus TYLOVET
100 (tylosin phosphate)
Type A medicated articles.
Original approval as a generic copy of NADA
141–276.
558.665
yes ...........
CE.1
200–517 .......
200–519 .......
pmangrum on DSK3VPTVN1PROD with RULES
200–547 .......
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ZOBUXA (enrofloxacin)
Flavored Antibacterial
Tablets.
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21 CFR
section
27AUR1
FOIA
summary
NEPA
review
52853
Federal Register / Vol. 78, No. 166 / Tuesday, August 27, 2013 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JUNE 2013—Continued
NADA/
ANADA
New animal drug product
name
Sponsor
200–555 .......
Piedmont Animal Health,
204 Muirs Chapel Rd.,
suite 200, Greensboro,
NC 27410.
Action
21 CFR
section
LIBREVIA (carprofen) Soft
Chewable Tablets.
Original approval as a generic copy of NADA
141–111.
FOIA
summary
520.309
yes ...........
NEPA
review
CE.1
1 The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the human environment.
List of Subjects
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
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 parts 510, 520, 524, 556, and 558
are amended as follows:
21 CFR Parts 520 and 524
PART 510—NEW ANIMAL DRUGS
21 CFR Part 510
Animal drugs.
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
21 CFR Part 556
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Animal drugs, Foods.
21 CFR Part 558
*
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
■
Animal drugs, Animal feeds.
‘‘Purina Nutrition LLC’’, and
alphabetically add entries for
‘‘Piedmont Animal Health’’ and ‘‘Purina
Animal Nutrition LLC’’; and in the table
in paragraph (c)(2), in the entry for
‘‘017800’’, remove ‘‘Purina Nutrition’’
and in its place add ‘‘Purina Animal
Nutrition’’, and numerically add an
entry for ‘‘058147’’ to read as follows:
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
*
Piedmont Animal Health, 204 Muirs Chapel Rd., suite 200, Greensboro, NC 27410 ....................................................................
*
*
*
*
*
*
058147
*
Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN 55126–2910 ...............................................................
*
*
*
*
*
017800
*
*
*
*
(2) * * *
Drug labeler code
*
Firm name and address
*
*
058147 .........................................
*
*
*
pmangrum on DSK3VPTVN1PROD with RULES
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
[Amended]
4. In paragraph (b)(2) of § 520.309,
remove ‘‘Nos. 000115, 055529, and
■
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*
Piedmont Animal Health, 204 Muirs Chapel Rd., suite 200, Greensboro, NC 27410
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
§ 520.309
*
Jkt 229001
*
*
062250’’ and in its place add ‘‘Nos.
000115, 055529, 058147, and 062250’’.
■ 5. In § 520.812, revise paragraphs (a)
and (b) to read as follows:
§ 520.812
Enrofloxacin.
(a) Specifications. Each tablet
contains:
(1) 22.7, 68.0, or 136.0 milligrams
(mg) enrofloxacin; or
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
*
*
(2) 22.7, 68.0, 136.0, or 272 mg
enrofloxacin.
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter for use as in
paragraph (c) of this section.
(1) Nos. 000859 and 026637 for use of
product described in paragraph (a)(1) of
this section.
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Federal Register / Vol. 78, No. 166 / Tuesday, August 27, 2013 / Rules and Regulations
§ 524.1465
[Amended]
(2) No. 058198 for use of product
described in paragraph (a)(2) of this
section.
*
*
*
*
*
■
§ 520.955
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
8. In paragraph (b) of § 524.1465, add
‘‘026637,’’ after ‘‘025463,’’.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
11. The authority citation for 21 CFR
part 558 continues to read as follows:
■
[Amended]
6. In paragraph (b) of § 520.955,
remove ‘‘No. 000061’’ and in its place
add ‘‘Nos. 000061 and 058198’’.
■
Authority: 21 U.S.C. 360b, 371.
12. In § 558.665, in the table, revise
paragraph (e)(5) to read as follows:
■
9. The authority citation for 21 CFR
part 556 continues to read as follows:
■
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
§ 558.665
Authority: 21 U.S.C. 342, 360b, 371.
§ 556.733
7. The authority citation for 21 CFR
part 524 continues to read as follows:
■
*
[Amended]
Zilpaterol.
*
*
(e) * * *
*
*
10. In paragraph (a) of § 556.733,
remove ‘‘10 micrograms’’ and in its
place add ‘‘50 micrograms’’.
■
Authority: 21 U.S.C. 360b.
Zilpaterol in grams/
ton
Combination in
grams/ton
Indications for use
Limitations
*
(5) 6.8 to provide 60
to 90 mg/head/
day.
*
Monensin 10 to 40,
plus tylosin 8 to
10.
*
*
Cattle fed in confinement for slaughter:
As in paragraph (e)(1) of this section;
for prevention and control of coccidiosis due to Eimeria bovis and E.
zuernii; and for reduction of incidence
of liver abscesses caused by
Fusobacterium necrophorum and
Arcanobacterum
(Actinomyces)
pyogenes.
*
*
As in paragraph (e)(1) of this section;
see §§ 558.355(d) and 558.625(c) of
this chapter. Monensin as provided
by No. 000986; tylosin as provided by
Nos.
000986
or
016592
in
§ 510.600(c) of this chapter.
*
*
*
Dated: August 19, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
*
*
Sponsor
*
*
000061
016592
*
DATES:
DEPARTMENT OF THE TREASURY
Effective Date: These regulations
are effective on August 27, 2013.
Applicability Dates: For dates of
applicability, see § 1.482–7(l).
FOR FURTHER INFORMATION CONTACT:
Mumal R. Hemrajani, (202) 622–3800
(not a toll-free call).
SUPPLEMENTARY INFORMATION:
on December 23, 2011 (‘‘temporary and
proposed regulations’’). Comments were
submitted, which we address in this
Preamble. No request for a public
hearing was received. The Treasury
Department and the IRS are finalizing
the proposed regulations without
change.
Internal Revenue Service
Background
Explanation of Provisions
Final cost sharing regulations were
published in the Federal Register (76
FR 80082) (REG–144615–02) (TD 9568)
on December 22, 2011 (‘‘final cost
sharing regulations’’). Corrections to the
final cost sharing regulations were
published in the Federal Register (77
FR 3606, 77 FR 8143, and 77 FR 8144)
on January 25, 2012, and February 14,
2012. Certain guidance regarding
application of the differential income
stream approach was reserved in the
final cost sharing regulations because
the Treasury Department and the IRS
believed it was appropriate to solicit
public comments on that subject matter.
Temporary cost sharing regulations
and a notice of proposed rule making on
application of the differential income
stream approach were published in the
Federal Register (76 FR 80249 and 76
FR 80309) (REG–145474–11) (TD 9569)
The Treasury Department and the IRS
were aware that some taxpayers were
taking unreasonable positions in
applying the income method by using
relatively low licensing discount rates,
and relatively high cost sharing
discount rates, without sufficiently
considering the appropriate
interrelationship of the discount rates
and financial projections. This practice
gave rise to material distortions and the
potential for PCT Payments not in
accordance with the arm’s length
standard. To address these problems,
the temporary and proposed regulations
provided additional guidance on
evaluating the results of an application
of the income method (§ 1.482–
7T(g)(2)(v)(B)(2) (Implied discount rates)
and (g)(4)(vi)(F)(2) (Use of differential
income stream as a consideration in
assessing the best method)), and
[FR Doc. 2013–20538 Filed 8–26–13; 8:45 am]
BILLING CODE 4160–01–P
26 CFR Part 1
[TD 9630 ]
RIN 1545–BK71
Use of Differential Income Stream as
an Application of the Income Method
and as a Consideration in Assessing
the Best Method
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations and removal of
temporary regulations.
pmangrum on DSK3VPTVN1PROD with RULES
AGENCY:
This document contains final
regulations that implement the use of
the differential income stream as a
consideration in assessing the best
method in connection with a cost
sharing arrangement and as a specified
application of the income method.
SUMMARY:
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13:33 Aug 26, 2013
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27AUR1
]]>Agencies
[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Rules and Regulations]
[Pages 52852-52854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20538]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 524, 556, and 558
[Docket No. FDA-2013-N-0002]
New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol;
Tildipirosin; Zilpaterol
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 actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during June 2013. FDA is also informing the public of the
availability of summaries of the basis of approval and of environmental
review documents, where applicable.
DATES: This rule is effective August 27, 2013.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during June 2013, as
listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (Freedom of Information Summaries) under the
Freedom of Information Act (FOIA). These public documents 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. Persons with access
to the Internet may obtain these documents at the Center for Veterinary
Medicine FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
In addition, the animal drug regulations are being amended at 21
CFR 510.600 to correct a sponsor's name and at 21 CFR 556.733 to
correct the acceptable daily intake of total residues of tildipirosin.
This is being done to improve the accuracy of the regulations.
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.
Table 1--Original and Supplemental NADAs and ANADAs Approved During June 2013
----------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR
NADA/ANADA Sponsor product name Action section FOIA summary NEPA review
----------------------------------------------------------------------------------------------------------------
200-524.......... Putney, Inc., Mupirocin Original 524.1465 yes.......... CE.\1\
400 Congress Ointment 2%. approval as a
St., suite 200, generic copy
Portland, ME of NADA 140-
04101. 839.
200-517.......... Novartis Animal ZOBUXA Original 520.812 yes.......... CE.\1\
Health US, (enrofloxacin) approval as a
Inc., 3200 Flavored generic copy
Northline Ave., Antibacterial of NADA 140-
suite 300, Tablets. 441.
Greensboro, NC
27408.
200-519.......... Novartis Animal FLORVIO Original 520.995 yes.......... CE.\1\
Health US, (florfenicol) approval as a
Inc., 3200 2.3% generic copy
Northline Ave., Concentrate of NADA 141-
suite 300, Solution. 206.
Greensboro, NC
27408.
200-547.......... Huvepharma AD, ZILMAX Original 558.665 yes.......... CE.\1\
5th Floor, 3A (zilpaterol approval as a
Nikolay Haytov hydrochloride) generic copy
Str., 1113 plus RUMENSIN of NADA 141-
Sophia, (monensin USP) 276.
Bulgaria. plus TYLOVET
100 (tylosin
phosphate)
Type A
medicated
articles.
[[Page 52853]]
200-555.......... Piedmont Animal LIBREVIA Original 520.309 yes.......... CE.\1\
Health, 204 (carprofen) approval as a
Muirs Chapel Soft Chewable generic copy
Rd., suite 200, Tablets. of NADA 141-
Greensboro, NC 111.
27410.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the
requirement to submit an environmental assessment or an environmental impact statement because it is of a type
that does not individually or cumulatively have a significant effect on the human environment.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520 and 524
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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 parts 510,
520, 524, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entry
for ``Purina Nutrition LLC'', and alphabetically add entries for
``Piedmont Animal Health'' and ``Purina Animal Nutrition LLC''; and in
the table in paragraph (c)(2), in the entry for ``017800'', remove
``Purina Nutrition'' and in its place add ``Purina Animal Nutrition'',
and numerically add an entry for ``058147'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Piedmont Animal Health, 204 Muirs Chapel Rd., suite 058147
200, Greensboro, NC 27410............................
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Purina Animal Nutrition LLC, 1080 County Road F West, 017800
Shoreview, MN 55126-2910.............................
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
058147....................... Piedmont Animal Health, 204 Muirs Chapel
Rd., suite 200, Greensboro, NC 27410
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.309 [Amended]
0
4. In paragraph (b)(2) of Sec. 520.309, remove ``Nos. 000115, 055529,
and 062250'' and in its place add ``Nos. 000115, 055529, 058147, and
062250''.
0
5. In Sec. 520.812, revise paragraphs (a) and (b) to read as follows:
Sec. 520.812 Enrofloxacin.
(a) Specifications. Each tablet contains:
(1) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or
(2) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter for use as in paragraph (c) of this section.
(1) Nos. 000859 and 026637 for use of product described in
paragraph (a)(1) of this section.
[[Page 52854]]
(2) No. 058198 for use of product described in paragraph (a)(2) of
this section.
* * * * *
Sec. 520.955 [Amended]
0
6. In paragraph (b) of Sec. 520.955, remove ``No. 000061'' and in its
place add ``Nos. 000061 and 058198''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1465 [Amended]
0
8. In paragraph (b) of Sec. 524.1465, add ``026637,'' after
``025463,''.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
9. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.733 [Amended]
0
10. In paragraph (a) of Sec. 556.733, remove ``10 micrograms'' and in
its place add ``50 micrograms''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
11. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
12. In Sec. 558.665, in the table, revise paragraph (e)(5) to read as
follows:
Sec. 558.665 Zilpaterol.
* * * * *
(e) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Zilpaterol in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(5) 6.8 to provide 60 to 90 mg/ Monensin 10 to Cattle fed in As in paragraph 000061 016592
head/day. 40, plus tylosin confinement for (e)(1) of this
8 to 10. slaughter: As in section; see Sec.
paragraph (e)(1) of Sec. 558.355(d)
this section; for and 558.625(c) of
prevention and this chapter.
control of Monensin as provided
coccidiosis due to by No. 000986;
Eimeria bovis and E. tylosin as provided
zuernii; and for by Nos. 000986 or
reduction of 016592 in Sec.
incidence of liver 510.600(c) of this
abscesses caused by chapter.
Fusobacterium
necrophorum and
Arcanobacterum
(Actinomyces)
pyogenes.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Dated: August 19, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-20538 Filed 8-26-13; 8:45 am]
BILLING CODE 4160-01-P
