Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol, 42006-42008 [2013-16258]
Download as PDF
<![CDATA[
42006
Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Rules and Regulations
and alcohol testing program is
considered registered when the
following information is submitted to
the Flight Standards District Office
nearest your principal place of business:
(i) Company name.
(ii) Telephone number.
(iii) Address where your drug and
alcohol testing program records are
kept.
(iv) Type of safety-sensitive functions
you or your employees perform (such as
flight instruction duties, aircraft
dispatcher duties, maintenance or
preventive maintenance duties, ground
security coordinator duties, aviation
screening duties, air traffic control
duties).
(v) Whether you have 50 or more
covered employees, or 49 or fewer
covered employees.
(vi) A signed statement indicating that
your company will comply with this
part and 49 CFR part 40.
(2) This Letter of Authorization will
satisfy the requirements for both your
drug testing program under subpart E of
this part and your alcohol testing
program under this subpart.
(3) Update the Letter of Authorization
information as changes occur. Send the
updates to the Flight Standards District
Office nearest your principal place of
business.
(4) If you are a part 119 certificate
holder with authority to operate under
part 121 or part 135 and intend to begin
operations as defined in § 91.147 of this
chapter, you must also advise the
Federal Aviation Administration, Office
of Aerospace Medicine, Drug Abatement
Division (AAM–800), 800 Independence
Avenue SW., Washington, DC 20591.
(f) Obtaining a Drug and Alcohol
Testing Program Registration from the
FAA. (1) Except as provided in
paragraphs (d) and (e) of this section, to
obtain a Drug and Alcohol Testing
Program Registration from the FAA you
must submit the following information
to the Office of Aerospace Medicine,
Drug Abatement Division:
(i) Company name.
(ii) Telephone number.
(iii) Address where your drug and
alcohol testing program records are
kept.
(iv) Type of safety-sensitive functions
you or your employees perform (such as
flight instruction duties, aircraft
dispatcher duties, maintenance or
preventive maintenance duties, ground
security coordinator duties, aviation
screening duties, air traffic control
duties).
(v) Whether you have 50 or more
covered employees, or 49 or fewer
covered employees.
(vi) A signed statement indicating
that: your company will comply with
this part and 49 CFR part 40; and you
intend to provide safety-sensitive
functions by contract (including
subcontract at any tier) to a part 119
certificate holder with authority to
operate under part 121 or part 135 of
this chapter, an operator as defined in
§ 91.147 of this chapter, or an air traffic
control facility not operated by the FAA
or by or under contract to the U.S.
military.
(2) Send this information to the
Federal Aviation Administration, Office
of Aerospace Medicine, Drug Abatement
Division (AAM–800), 800 Independence
Avenue SW., Washington, DC 20591.
(3) This Drug and Alcohol Testing
Program Registration will satisfy the
registration requirements for both your
drug testing program under subpart E of
this part and your alcohol testing
program under this subpart.
(4) Update the registration
information as changes occur. Send the
updates to the address specified in
paragraph (f)(2) of this section.
Issued under authority provided by 49
U.S.C. 106(f) and 45102 in Washington, DC,
on July 1, 2013.
Michael P. Huerta,
Administrator.
[FR Doc. 2013–16852 Filed 7–12–13; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 558
[Docket No. FDA–2013–N–0002]
Oral Dosage Form New Animal Drugs;
Nicarbazin; Oclacitinib; Zilpaterol
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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 May 2013. FDA is
also informing the public of the
availability of summaries the basis of
approval and of environmental review
documents, where applicable.
SUMMARY:
DATES:
This rule is effective July 15,
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,
ghaibel@fda.hhs.gov.
FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during May 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 (FOI
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 CVM FOIA Electronic
Reading Room: https://www.fda.gov/
AboutFDA/CentersOffices/
OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm.
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.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with RULES
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY 2013
NADA/
ANADA
Sponsor
New animal drug
product name
Action
141–279 ....
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
NICARB 25% (nicarbazin)
and BMD (bacitracin methylene disalicylate) Type A
medicated articles.
Supplement revising
nicarbazin dosage to a
range consistent with dosage approved for use in
combination feeds.
VerDate Mar<15>2010
17:20 Jul 12, 2013
Jkt 229001
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
E:\FR\FM\15JYR1.SGM
21 CFR
section
15JYR1
558.366
FOIA
summary
No ..........
NEPA
review
CE 1
Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Rules and Regulations
42007
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY 2013—Continued
NADA/
ANADA
Sponsor
New animal drug
product name
Action
21 CFR
section
FOIA
summary
NEPA
review
141–345 ....
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
APOQUEL (oclacitinib tablet)
520.1604
Yes ........
CE 1
200–544 ....
Huvepharma AD, 5th Floor,
3A Nikolay Haytov Str.,
1113 Sophia, Bulgaria.
ZILMAX (zilpaterol hydrochloride) plus RUMENSIN
(monensin) plus TYLOVET
100 (tylosin phosphate)
plus MGA (melengestrol
acetate) Type A medicated
articles.
Original approval for control
of pruritus associated with
allergic dermatitis and control of atopic dermatitis in
dogs at least 12 months of
age.
Original aapproval as a generic copy of NADA 141–
280).
528.665
Yes .........
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
§ 520.1604
21 CFR Part 520
(a) Specifications. Each tablet
contains 3.6, 5.4, or 16 milligrams (mg)
of oclacitinib as oclacitinib maleate.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer orally 0.18 to 0.27 mg/per
pound of body weight (0.4 to 0.6 mg/kg
body weight) twice daily for up to 14
days; then administered once daily for
maintenance therapy.
(2) Indications for use. For control of
pruritus associated with allergic
dermatitis and control of atopic
dermatitis in dogs at least 12 months of
age.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Animal drugs.
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 520 and 558 are amended as
follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
2. Add § 520.1604 to read as follows:
Oclacitinib.
Nicarbazin in
grams per ton
Combination in grams per
ton
Indications for use
*
90.8 to 181.6
(0.01 to 0.02
pct).
*
............................................
*
*
Broiler chickens: As an aid
in preventing outbreaks
of cecal (Eimeria tenella)
and intestinal (E.
acervulina, E. maxima,
E. necatrix, and E.
brunetti) coccidiosis.
Broiler chickens: As an aid
in preventing outbreaks
of cecal (Eimeria tenella)
and intestinal (E.
acervulina, E. maxima,
E. necatrix, and E.
brunetti) coccidiosis; for
increased rate of weight
gain and improved feed
efficiency.
mstockstill on DSK4VPTVN1PROD with RULES
Bacitracin methylene disalicylate 4 to 50.
VerDate Mar<15>2010
17:20 Jul 12, 2013
Jkt 229001
PO 00000
Frm 00009
Fmt 4700
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
4. In § 558.366, in paragraph (d),
amend the table by:
■ a. Revising the entry for ‘‘90.8 to 181.6
(0.01 to 0.02 pct)’’, and
■ b. Removing the entry for ‘‘Bacitracin
methylene disalicylate 4 to 50’’ under
the heading ‘‘113.5 (0.0125 pct)’’; and
■ c. Removing the entry for ‘‘Bacitracin
methylene disalicylate 50’’ under the
heading ‘‘113.5 (0.0125 pct)’’.
The additions and revisions read as
follows:
■
§ 558.366
*
Nicarbazin.
*
*
(d) * * *
Limitations
*
*
Sponsor
*
*
*
Feed continuously as sole ration from time chicks are
066104
placed on litter until past the time when coccidiosis
is ordinarily a hazard. Do not use as a treatment for
coccidiosis. Do not feed to laying hens. Withdraw 4
days before slaughter for use levels at or below
113.5 g/ton. Withdraw 5 days before slaughter for
use levels above 113.5 g/ton.
Feed continuously as sole ration from time chicks are
054771
placed on litter until past the time when coccidiosis
is ordinarily a hazard. Do not use as a treatment for
coccidiosis. Do not feed to laying hens. Withdraw 4
days before slaughter for use levels at or below
113.5 g/ton. Withdraw 5 days before slaughter for
use levels above 113.5 g/ton. Bacitracin methylene
disalicylate as provided by No. 054771 in
§ 510.600(c) of this chapter.
Sfmt 4700
E:\FR\FM\15JYR1.SGM
15JYR1
42008
Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Rules and Regulations
Nicarbazin in
grams per ton
Combination in grams per
ton
Indications for use
Limitations
Bacitracin methylene disalicylate 4 to 50 and
roxarsone 22.7 to 45.4.
Broiler chickens: As an aid
in preventing outbreaks
of cecal (Eimeria tenella)
and intestinal (E.
acervulina, E. maxima,
E. necatrix, and E.
brunetti) coccidiosis; for
increased rate of weight
gain and improved feed
efficiency.
Broiler chickens: As an aid
in preventing outbreaks
of cecal (Eimeria tenella)
and intestinal (E.
acervulina, E. maxima,
E. necatrix, and E.
brunetti) coccidiosis; for
increased rate of weight
gain and improved feed
efficiency.
Broiler chickens: As an aid
in preventing outbreaks
of cecal (Eimeria tenella)
and intestinal (E.
acervulina, E. maxima,
E. necatrix, and E.
brunetti) coccidiosis; as
an aid in the prevention
of necrotic enteritis
caused or complicated
by Clostridium spp. or
other organisms susceptible to bacitracin.
Feed continuously as sole ration from time chicks are
placed on litter until past the time when coccidiosis
is ordinarily a hazard. Do not use as a treatment for
coccidiosis. Discontinue medication 5 days before
marketing birds for human consumption. Do not feed
to laying hens. Nicarbazin as provided by No.
066104; bacitracin methylene disalicylate and
roxarsone as provided by No. 054771 in
§ 510.600(c) of this chapter.
066104
Feed continuously as sole ration from time chicks are
placed on litter until past the time when coccidiosis
is ordinarily a hazard. Do not use as a treatment for
coccidiosis. Do not feed to laying hens. Withdraw 4
days before slaughter for use levels at or below
113.5 g/ton. Withdraw 5 days before slaughter for
use levels above 113.5 g/ton. Bacitracin methylene
disalicylate as provided by No. 054771 in
§ 510.600(c) of this chapter.
066104
Feed continuously as sole ration from time chicks are
placed on litter until past the time when coccidiosis
is ordinarily a hazard. Do not use as a treatment for
coccidiosis. Do not feed to laying hens. Withdraw 4
days before slaughter for use levels at or below
113.5 g/ton. Withdraw 5 days before slaughter for
use levels above 113.5 g/ton. Bacitracin methylene
disalicylate as provided by No. 054771 in
§ 510.600(c) of this chapter.
054771
Bacitracin methylene disalicylate 30.
Bacitracin methylene disalicylate 50.
*
*
*
*
*
*
*
*
5. In § 558.665, in the table, in
paragraphs (e)(2), (e)(4), and (e)(6),
*
*
revise the last sentence in the
‘‘Limitations’’ column and revise the
‘‘Sponsor’’ column to read as follows:
■
Sponsor
*
§ 558.665
*
*
Zilpaterol.
*
*
(e) * * *
*
*
Combination in grams/ton
Indications for use
*
(2) ...................
*
............................................
*
*
............................................
*
*
*
* * * Melengestrol acetate as provided by Nos.
000061
000986 or 054771 in § 510.600(c) of this chapter.
000986
*
(4) ...................
*
............................................
*
*
............................................
*
*
*
* * * Monensin as provided by No. 000986; and
000061
melengestrol acetate as provided by Nos. 000986 or
000986
054771 in § 510.600(c) of this chapter.
*
(6) ...................
mstockstill on DSK4VPTVN1PROD with RULES
Zilpaterol
in grams/ton
*
............................................
*
*
............................................
*
*
*
* * * Monensin as provided by No. 000986; tylosin as
000061
provided by Nos. 000986 or 016592; and
000986
melengestrol acetate as provided by Nos. 000986 or
016592
054771 in § 510.600(c) of this chapter.
Limitations
Dated: July 1, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013–16258 Filed 7–12–13; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
17:20 Jul 12, 2013
Jkt 229001
PO 00000
Frm 00010
Fmt 4700
Sfmt 9990
E:\FR\FM\15JYR1.SGM
15JYR1
Sponsor
]]>Agencies
[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Rules and Regulations]
[Pages 42006-42008]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16258]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 558
[Docket No. FDA-2013-N-0002]
Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib;
Zilpaterol
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 actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during May 2013. FDA is also informing the public of the
availability of summaries the basis of approval and of environmental
review documents, where applicable.
DATES: This rule is effective July 15, 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, ghaibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during May 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 (FOI 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 CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
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 May 2013
----------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR
NADA/ANADA Sponsor product name Action section FOIA summary NEPA review
----------------------------------------------------------------------------------------------------------------
141-279........ Zoetis Inc., 333 NICARB 25% Supplement 558.366 No........... CE \1\
Portage St., (nicarbazin) and revising
Kalamazoo, MI BMD (bacitracin nicarbazin
49007. methylene dosage to a
disalicylate) range
Type A medicated consistent with
articles. dosage approved
for use in
combination
feeds.
[[Page 42007]]
141-345........ Zoetis Inc., 333 APOQUEL Original 520.1604 Yes.......... CE \1\
Portage St., (oclacitinib approval for
Kalamazoo, MI tablet). control of
49007. pruritus
associated with
allergic
dermatitis and
control of
atopic
dermatitis in
dogs at least
12 months of
age.
200-544........ Huvepharma AD, ZILMAX Original 528.665 Yes.......... CE \1\
5th Floor, 3A (zilpaterol aapproval as a
Nikolay Haytov hydrochloride) generic copy of
Str., 1113 plus RUMENSIN NADA 141-280).
Sophia, Bulgaria. (monensin) plus
TYLOVET 100
(tylosin
phosphate) plus
MGA
(melengestrol
acetate) Type A
medicated
articles.
----------------------------------------------------------------------------------------------------------------
\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 520
Animal drugs.
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 520 and
558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Add Sec. 520.1604 to read as follows:
Sec. 520.1604 Oclacitinib.
(a) Specifications. Each tablet contains 3.6, 5.4, or 16 milligrams
(mg) of oclacitinib as oclacitinib maleate.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer orally 0.18 to 0.27
mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily
for up to 14 days; then administered once daily for maintenance
therapy.
(2) Indications for use. For control of pruritus associated with
allergic dermatitis and control of atopic dermatitis in dogs at least
12 months of age.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
4. In Sec. 558.366, in paragraph (d), amend the table by:
0
a. Revising the entry for ``90.8 to 181.6 (0.01 to 0.02 pct)'', and
0
b. Removing the entry for ``Bacitracin methylene disalicylate 4 to 50''
under the heading ``113.5 (0.0125 pct)''; and
0
c. Removing the entry for ``Bacitracin methylene disalicylate 50''
under the heading ``113.5 (0.0125 pct)''.
The additions and revisions read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(d) * * *
----------------------------------------------------------------------------------------------------------------
Nicarbazin in grams Combination in grams
per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
90.8 to 181.6 (0.01 .................... Broiler chickens: As Feed continuously as sole ration 066104
to 0.02 pct). an aid in from time chicks are placed on
preventing litter until past the time when
outbreaks of cecal coccidiosis is ordinarily a
(Eimeria tenella) hazard. Do not use as a treatment
and intestinal (E. for coccidiosis. Do not feed to
acervulina, E. laying hens. Withdraw 4 days
maxima, E. before slaughter for use levels
necatrix, and E. at or below 113.5 g/ton. Withdraw
brunetti) 5 days before slaughter for use
coccidiosis. levels above 113.5 g/ton.
Bacitracin methylene Broiler chickens: As Feed continuously as sole ration 054771
disalicylate 4 to an aid in from time chicks are placed on
50. preventing litter until past the time when
outbreaks of cecal coccidiosis is ordinarily a
(Eimeria tenella) hazard. Do not use as a treatment
and intestinal (E. for coccidiosis. Do not feed to
acervulina, E. laying hens. Withdraw 4 days
maxima, E. before slaughter for use levels
necatrix, and E. at or below 113.5 g/ton. Withdraw
brunetti) 5 days before slaughter for use
coccidiosis; for levels above 113.5 g/ton.
increased rate of Bacitracin methylene disalicylate
weight gain and as provided by No. 054771 in Sec.
improved feed 510.600(c) of this chapter.
efficiency.
[[Page 42008]]
Bacitracin methylene Broiler chickens: As Feed continuously as sole ration 066104
disalicylate 4 to an aid in from time chicks are placed on
50 and roxarsone preventing litter until past the time when
22.7 to 45.4. outbreaks of cecal coccidiosis is ordinarily a
(Eimeria tenella) hazard. Do not use as a treatment
and intestinal (E. for coccidiosis. Discontinue
acervulina, E. medication 5 days before
maxima, E. marketing birds for human
necatrix, and E. consumption. Do not feed to
brunetti) laying hens. Nicarbazin as
coccidiosis; for provided by No. 066104;
increased rate of bacitracin methylene disalicylate
weight gain and and roxarsone as provided by No.
improved feed 054771 in Sec. 510.600(c) of
efficiency. this chapter.
Bacitracin methylene Broiler chickens: As Feed continuously as sole ration 066104
disalicylate 30. an aid in from time chicks are placed on
preventing litter until past the time when
outbreaks of cecal coccidiosis is ordinarily a
(Eimeria tenella) hazard. Do not use as a treatment
and intestinal (E. for coccidiosis. Do not feed to
acervulina, E. laying hens. Withdraw 4 days
maxima, E. before slaughter for use levels
necatrix, and E. at or below 113.5 g/ton. Withdraw
brunetti) 5 days before slaughter for use
coccidiosis; for levels above 113.5 g/ton.
increased rate of Bacitracin methylene disalicylate
weight gain and as provided by No. 054771 in Sec.
improved feed 510.600(c) of this chapter.
efficiency.
Bacitracin methylene Broiler chickens: As Feed continuously as sole ration 054771
disalicylate 50. an aid in from time chicks are placed on
preventing litter until past the time when
outbreaks of cecal coccidiosis is ordinarily a
(Eimeria tenella) hazard. Do not use as a treatment
and intestinal (E. for coccidiosis. Do not feed to
acervulina, E. laying hens. Withdraw 4 days
maxima, E. before slaughter for use levels
necatrix, and E. at or below 113.5 g/ton. Withdraw
brunetti) 5 days before slaughter for use
coccidiosis; as an levels above 113.5 g/ton.
aid in the Bacitracin methylene disalicylate
prevention of as provided by No. 054771 in Sec.
necrotic enteritis 510.600(c) of this chapter.
caused or
complicated by
Clostridium spp. or
other organisms
susceptible to
bacitracin.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
5. In Sec. 558.665, in the table, in paragraphs (e)(2), (e)(4), and
(e)(6), revise the last sentence in the ``Limitations'' column and
revise the ``Sponsor'' column to read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(e) * * *
----------------------------------------------------------------------------------------------------------------
Zilpaterol in grams/ Combination in grams/
ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(2).................. .................... .................... * * * Melengestrol acetate as 000061
provided by Nos. 000986 or 054771 000986
in Sec. 510.600(c) of this
chapter.
* * * * * * *
(4).................. .................... .................... * * * Monensin as provided by No. 000061
000986; and melengestrol acetate 000986
as provided by Nos. 000986 or
054771 in Sec. 510.600(c) of
this chapter.
* * * * * * *
(6).................. .................... .................... * * * Monensin as provided by No. 000061
000986; tylosin as provided by 000986
Nos. 000986 or 016592; and 016592
melengestrol acetate as provided
by Nos. 000986 or 054771 in Sec.
510.600(c) of this chapter.
----------------------------------------------------------------------------------------------------------------
Dated: July 1, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-16258 Filed 7-12-13; 8:45 am]
BILLING CODE 4160-01-P
