New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin; Ractopamine; Trimethoprim and Sulfadiazine Suspension; Tulathromycin, 63870-63872 [2013-25172]
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Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Rules and Regulations
boundaries; designated altitudes; times
of designation; or activities conducted
within the affected restricted areas.
DATES: Effective date: 0901 UTC,
December 12, 2013.
FOR FURTHER INFORMATION CONTACT:
Colby Abbott, Airspace Policy and ATC
Procedures Group, Office of Airspace
Services, Federal Aviation
Administration, 800 Independence
Avenue SW., Washington, DC 20591;
telephone: (202) 267–8783.
SUPPLEMENTARY INFORMATION:
Background
As a result of the realignment of
organizational responsibilities between
federal agencies, U.S. Customs and
Border Protection has been assigned the
function of using agency for restricted
areas R–2309 and R–2312 located in
Arizona. The transfer of using agency
operational control occurs October 1,
2013. This action is an administrative
name change only and does not affect
the current dimensions or use of the
restricted areas.
emcdonald on DSK67QTVN1PROD with RULES
The Rule
This action amends Title 14 Code of
Federal Regulations (14 CFR) part 73 by
amending the using agency name for
Restricted Areas R–2309 Yuma, AZ, and
R–2312 Fort Huachuca, AZ. The using
agency for these restricted areas is
changed from ‘‘U.S. Air Force, Western
Air Defense Sector/DOS, McChord AFB,
WA’’ to ‘‘U.S. Customs and Border
Protection, Air and Marine Operations
Center (AMOC), Riverside, CA.’’
This is an administrative change to
update the title of the using agencies. It
does not affect the boundaries,
designated altitudes, or activities
conducted within the restricted areas;
therefore, notice and public procedures
under 5 U.S.C. 553(b) are unnecessary.
The FAA has determined that this
action only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. Therefore, this regulation: (1) Is
not a ‘‘significant regulatory action’’
under Executive Order 12866; (2) is not
a ‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that only affects air traffic
procedures and air navigation, it is
certified that this rule, when
promulgated, does not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
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The FAA’s authority to issue rules
regarding aviation safety is found in
Title 49 of the United States Code.
Subtitle I, Section 106 describes the
authority of the FAA Administrator.
Subtitle VII, Aviation Programs,
describes in more detail the scope of the
agency’s authority.
This rulemaking is promulgated
under the authority described in
Subtitle VII, Part A, Subpart I, Section
40103. Under that section, the FAA is
charged with prescribing regulations to
assign the use of the airspace necessary
to ensure the safety of aircraft and the
efficient use of airspace. This regulation
is within the scope of that authority as
it amends the descriptions of restricted
areas R–2309 and R–2312 to reflect
current organizational responsibilities.
Operations Center (AMOC), Riverside,
CA.
*
*
*
*
*
R–2312 Fort Huachuca, AZ
[Amended]
By removing the current using agency
and substituting the following:
Using agency. U.S. Customs and
Border Protection, Air and Marine
Operations Center (AMOC), Riverside,
CA.
Issued in Washington, DC, on October 21,
2013.
Gary A. Norek,
Manager, Airspace Policy and ATC
Procedures Group.
[FR Doc. 2013–25210 Filed 10–24–13; 8:45 am]
BILLING CODE 4910–13–P
Environmental Review
The FAA has determined that this
action qualifies for categorical exclusion
under the National Environmental
Policy Act in accordance with FAA
Order 1050.1E, Environmental Impacts:
Policies and Procedures, paragraph
311d. This airspace action is an
administrative change to the
descriptions of the affected restricted
areas to update the using agency name.
It does not alter the dimensions,
altitudes, or times of designation of the
airspace; therefore, it is not expected to
cause any potentially significant
environmental impacts, and no
extraordinary circumstances exists that
warrant preparation of an
environmental assessment.
List of Subjects in 14 CFR Part 73
Airspace, Prohibited areas, Restricted
areas.
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 73, as follows:
PART 73—SPECIAL USE AIRSPACE
1. The authority citation for part 73
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 73.23
[Amended]
2. Section 73.23 is amended as
follows:
*
*
*
*
*
■
R–2309
Yuma, AZ [Amended]
By removing the current using agency
and substituting the following:
Using agency. U.S. Customs and
Border Protection, Air and Marine
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and
558
[Docket No. FDA–2013–N–0002]
New Animal Drugs; Change of
Sponsor; Gonadorelin; Ivermectin;
Ractopamine; Trimethoprim and
Sulfadiazine Suspension;
Tulathromycin
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 July 2013. FDA is
also informing the public of the
availability of summaries of the basis of
approval and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to reflect a change of
sponsorship for an ANADA.
DATES: This rule is effective October 25,
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 July 2013, as listed in
table 1. In addition, FDA is informing
the public of the availability, where
SUMMARY:
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Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Rules and Regulations
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.
In addition, ECO LLC, 344 Nassau St.,
Princeton, NJ 08540 has informed FDA
that it has transferred ownership of, and
all rights and interest in, ANADA 200–
348 for ECOMECTIN (ivermectin)
Topical Solution to SmartVet USA, Inc.,
22201 West Innovation Dr., Suite 170A,
Olathe, KS 66061–1304. Accordingly,
the Agency is amending the regulations
to reflect this change of sponsorship.
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 JULY 2013
NADA/
ANADA
Sponsor
New Animal drug
product name
Action
21 CFR
Section
FOIA
Summary
139–237 ......
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
FACTREL
(gonadorelin injection) Injection.
522.1077
Yes .........
CE 1
141–349 ......
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
Aurora Pharmaceutical, LLC, 1196
Highway 3 South,
Northfield, MN
55057–3009.
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
DRAXXIN 25
(tulathromycin)
Injectable Solution.
EQUISUL–SDT (sulfadiazine/
trimethoprim) Oral
Suspension.
Supplemental approval for use with
LUTALYSE (dinoprost tromethamine)
Sterile Solution to synchronize estrous
cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.
Original approval for the treatment and
control of swine respiratory disease
(SRD).
Original approval for the treatment of lower
respiratory tract infections in horses
caused by susceptible strains of Streptococcus equi subsp. zooepidemicus.
522.2630
Yes .........
CE 1
520.2612
Yes .........
CE 1
Original approval as a generic copy of
NADA 140–863.
558.500
Yes .........
CE 1
Original approval as a generic copy of
NADA 141–221.
558.500
Yes .........
CE 1
141–360 ......
200–542 ......
200–548 ......
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
ENGAIN 9 and
ENGAIN 45
(ractopamine hydrochloride) Type
A medicated articles.
ACTOGAIN 45
(ractopamine hydrochloride) Type
A medicated articles.
NEPA
Review
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
PART 510—NEW ANIMAL DRUGS
(1) * * *
21 CFR Part 510
■
1. The authority citation for 21 CFR
part 510 continues to read as follows:
Firm name and address
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
21 CFR Parts 520, 522 and 524
Animal drugs.
emcdonald on DSK67QTVN1PROD with RULES
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, 522, 524, and 558
are amended as follows:
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2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add
entries for ‘‘Aurora Pharmaceutical,
LLC’’ and ‘‘SmartVet USA, Inc.’’; and in
the table in paragraph (c)(2),
numerically add entries for ‘‘051072’’
and ‘‘086001’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
PO 00000
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*
(c) * * *
Frm 00049
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Aurora Pharmaceutical, LLC,
1196 Highway 3 South,
Northfield, MN 55057–
3009 ..................................
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*
SmartVet USA, Inc., 22201
West Innovation Dr., Suite
170A, Olathe, KS 66061–
1304 ..................................
*
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(2) * * *
Fmt 4700
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Drug labeler
code
E:\FR\FM\25OCR1.SGM
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*
051072
*
086001
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Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Rules and Regulations
Drug labeler
code
Firm name and address
*
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*
051072 ........ Aurora Pharmaceutical, LLC,
1196 Highway 3 South,
Northfield, MN 55057–3009
*
*
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*
*
086001 ........ SmartVet USA, Inc., 22201
West Innovation Dr., Suite
170A, Olathe, KS 66061–
1304
*
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*
*
kilogram of body weight (2.7 mL/100 lb)
twice daily for 10 days.
(ii) Indications for use. For the
treatment of lower respiratory tract
infections in horses caused by
susceptible strains of Streptococcus equi
subsp. zooepidemicus.
(iii) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
5. The authority citation for 21 CFR
part 522 continues to read as follows:
■
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
8. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 524.1193
9. In paragraph (b)(2) of § 524.1193,
remove ‘‘066916’’ and in its place add
‘‘086001’’.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
10. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
6. Revise § 522.1077 to read as
follows:
§ 558.500
§ 522.1077
■
■
Authority: 21 U.S.C. 360b.
4. Revise § 520.2612 to read as
follows:
[Amended]
[Amended]
■
emcdonald on DSK67QTVN1PROD with RULES
§ 520.2612 Trimethoprim and sulfadiazine
suspension.
(a) Specifications. Each milliliter (mL)
of suspension contains:
(1) 10 milligrams (mg) trimethoprim
and 50 mg sulfadiazine; or
(2) 400 mg combined active
ingredients (67 mg trimethoprim and
333 mg sulfadiazine).
(b) Sponsors. See sponsor numbers in
§ 510.600 of this chapter:
(1) No. 000061 for use of product
described in paragraph (a)(1) for use as
in paragraph (c)(1) of this section.
(2) No. 051072 for use of product
described in paragraph (a)(2) for use as
in paragraph (c)(2) of this section.
(c) Conditions of use—(1) Dogs—(i)
Amount. Administer 1 mL (10 mg
trimethoprim and 50 mg sulfadiazine)
per 5 pounds (lb) of body weight once
daily, or one-half the recommended
daily dose every 12 hours, for up to 14
consecutive days.
(ii) Indications for use. The drug is
used in dogs where systemic
antibacterial action against sensitive
organisms is required, either alone or as
an adjunct to surgery or debridement
with associated infection. The drug is
indicated where control of bacterial
infection is required during the
treatment of acute urinary tract
infections, acute bacterial complications
of distemper, acute respiratory tract
infections, acute alimentary tract
infections, wound infections, and
abscesses.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Horses—(i) Amount. Administer
24 mg combined active ingredients per
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17:28 Oct 24, 2013
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Gonadorelin hydrochloride.
(a) Specifications. Each milliliter of
solution contains 50 micrograms (mcg)
of gonadorelin (as hydrochloride).
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in cattle—(1)
Indications for use and amounts—(i)
For the treatment of ovarian follicular
cysts in cattle, administer 100 mcg
gonadorelin by intramuscular injection.
(ii) For use with dinoprost
tromethamine to synchronize estrous
cycles to allow fixed-time artificial
insemination (FTAI) in lactating dairy
cows, administer to each cow 100 to 200
mcg gonadorelin by intramuscular
injection, followed 6 to 8 days later by
25 mg dinoprost tromethamine by
intramuscular injection, followed 30 to
72 hours later by 100 to 200 mcg
gonadorelin by intramuscular injection.
(2) Limitations. Dinoprost
tromethamine as provided by sponsor
No. 054771 in § 510.600(c) of this
chapter. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
■ 7. In § 522.2630, revise paragraphs (a)
and (b) to read as follows:
§ 522.2630
Tulathromycin.
(a) Specifications. Each milliliter of
solution contains:
(1) 100 milligrams (mg) tulathromycin
(2) 25 mg tulathromycin
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section:
(1) Product described as in paragraph
(a)(1) for use as in paragraph (d).
(2) Product described as in paragraph
(a)(2) for use as in paragraph (d)(2).
*
*
*
*
*
PO 00000
Frm 00050
Fmt 4700
Sfmt 4700
11. In § 558.500, in paragraph (a),
remove ‘‘45’’ and in its place add
‘‘45.4’’; in paragraph (b), remove ‘‘No.
000986’’ and in its place add ‘‘Nos.
000986 and 054771’’; in the table in
paragraph (e)(1), in the ‘‘Ractopamine in
grams/ton’’ column, remove ‘‘4.5 to 9’’
wherever it occurs and in its place add
‘‘4.5 to 9.0’’; and in the table in
paragraphs (e)(1)(i), (e)(2)(i), (e)(2)(vi),
and (e)(2)(xi), in the ‘‘Sponsor’’ column,
add ‘‘054771’’.
Dated: October 22, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013–25172 Filed 10–24–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1240
[Docket No. FDA–2013–N–0639]
Turtles Intrastate and Interstate
Requirements
Correction
In rule document 2013–17751
appearing on pages 44878–44881 in the
issue of July 25, 2013, make the
following correction:
On page 44879, in the first column,
under the DATES heading, in the first and
second lines, ‘‘January 16, 2014’’ should
read ‘‘December 9, 2013’’.
[FR Doc. C1–2013–17751 Filed 10–24–13; 8:45 am]
BILLING CODE 1505–01–D
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]]>Agencies
[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Rules and Regulations]
[Pages 63870-63872]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25172]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2013-N-0002]
New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin;
Ractopamine; Trimethoprim and Sulfadiazine Suspension; Tulathromycin
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 July 2013. FDA is also informing the public of the
availability of summaries of the basis of approval and of environmental
review documents, where applicable. The animal drug regulations are
also being amended to reflect a change of sponsorship for an ANADA.
DATES: This rule is effective October 25, 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 July 2013, as
listed in table 1. In addition, FDA is informing the public of the
availability, where
[[Page 63871]]
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.
In addition, ECO LLC, 344 Nassau St., Princeton, NJ 08540 has
informed FDA that it has transferred ownership of, and all rights and
interest in, ANADA 200-348 for ECOMECTIN (ivermectin) Topical Solution
to SmartVet USA, Inc., 22201 West Innovation Dr., Suite 170A, Olathe,
KS 66061-1304. Accordingly, the Agency is amending the regulations to
reflect this change of sponsorship.
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 July 2013
----------------------------------------------------------------------------------------------------------------
New Animal drug 21 CFR
NADA/ANADA Sponsor product name Action Section FOIA Summary NEPA Review
----------------------------------------------------------------------------------------------------------------
139-237.......... Zoetis Inc., FACTREL Supplemental 522.1077 Yes......... CE \1\
333 Portage (gonadorelin approval for use
St., injection) with LUTALYSE
Kalamazoo, MI Injection. (dinoprost
49007. tromethamine)
Sterile Solution to
synchronize estrous
cycles to allow
fixed-time
artificial
insemination (FTAI)
in lactating dairy
cows.
141-349.......... Zoetis Inc., DRAXXIN 25 Original approval 522.2630 Yes......... CE \1\
333 Portage (tulathromycin for the treatment
St., ) Injectable and control of
Kalamazoo, MI Solution. swine respiratory
49007. disease (SRD).
141-360.......... Aurora EQUISUL-SDT Original approval 520.2612 Yes......... CE \1\
Pharmaceutical (sulfadiazine/ for the treatment
, LLC, 1196 trimethoprim) of lower
Highway 3 Oral respiratory tract
South, Suspension. infections in
Northfield, MN horses caused by
55057-3009. susceptible strains
of Streptococcus
equi subsp.
zooepidemicus.
200-542.......... Zoetis Inc., ENGAIN 9 and Original approval as 558.500 Yes......... CE \1\
333 Portage ENGAIN 45 a generic copy of
St., (ractopamine NADA 140-863.
Kalamazoo, MI hydrochloride)
49007. Type A
medicated
articles.
200-548.......... Zoetis Inc., ACTOGAIN 45 Original approval as 558.500 Yes......... CE \1\
333 Portage (ractopamine a generic copy of
St., hydrochloride) NADA 141-221.
Kalamazoo, MI Type A
49007. 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 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522 and 524
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 510,
520, 522, 524, 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), alphabetically
add entries for ``Aurora Pharmaceutical, LLC'' and ``SmartVet USA,
Inc.''; and in the table in paragraph (c)(2), numerically add entries
for ``051072'' and ``086001'' 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
------------------------------------------------------------------------
* * * * *
Aurora Pharmaceutical, LLC, 1196 Highway 3 South, 051072
Northfield, MN 55057-3009..............................
* * * * *
SmartVet USA, Inc., 22201 West Innovation Dr., Suite 086001
170A, Olathe, KS 66061-1304............................
* * * * *
------------------------------------------------------------------------
(2) * * *
[[Page 63872]]
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
051072.............................. Aurora Pharmaceutical, LLC, 1196
Highway 3 South, Northfield, MN
55057-3009
* * * * *
086001.............................. SmartVet USA, Inc., 22201 West
Innovation Dr., Suite 170A,
Olathe, KS 66061-1304
* * * * *
------------------------------------------------------------------------
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.
0
4. Revise Sec. 520.2612 to read as follows:
Sec. 520.2612 Trimethoprim and sulfadiazine suspension.
(a) Specifications. Each milliliter (mL) of suspension contains:
(1) 10 milligrams (mg) trimethoprim and 50 mg sulfadiazine; or
(2) 400 mg combined active ingredients (67 mg trimethoprim and 333
mg sulfadiazine).
(b) Sponsors. See sponsor numbers in Sec. 510.600 of this chapter:
(1) No. 000061 for use of product described in paragraph (a)(1) for
use as in paragraph (c)(1) of this section.
(2) No. 051072 for use of product described in paragraph (a)(2) for
use as in paragraph (c)(2) of this section.
(c) Conditions of use--(1) Dogs--(i) Amount. Administer 1 mL (10 mg
trimethoprim and 50 mg sulfadiazine) per 5 pounds (lb) of body weight
once daily, or one-half the recommended daily dose every 12 hours, for
up to 14 consecutive days.
(ii) Indications for use. The drug is used in dogs where systemic
antibacterial action against sensitive organisms is required, either
alone or as an adjunct to surgery or debridement with associated
infection. The drug is indicated where control of bacterial infection
is required during the treatment of acute urinary tract infections,
acute bacterial complications of distemper, acute respiratory tract
infections, acute alimentary tract infections, wound infections, and
abscesses.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Horses--(i) Amount. Administer 24 mg combined active
ingredients per kilogram of body weight (2.7 mL/100 lb) twice daily for
10 days.
(ii) Indications for use. For the treatment of lower respiratory
tract infections in horses caused by susceptible strains of
Streptococcus equi subsp. zooepidemicus.
(iii) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
6. Revise Sec. 522.1077 to read as follows:
Sec. 522.1077 Gonadorelin hydrochloride.
(a) Specifications. Each milliliter of solution contains 50
micrograms (mcg) of gonadorelin (as hydrochloride).
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cattle--(1) Indications for use and
amounts--(i) For the treatment of ovarian follicular cysts in cattle,
administer 100 mcg gonadorelin by intramuscular injection.
(ii) For use with dinoprost tromethamine to synchronize estrous
cycles to allow fixed-time artificial insemination (FTAI) in lactating
dairy cows, administer to each cow 100 to 200 mcg gonadorelin by
intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost
tromethamine by intramuscular injection, followed 30 to 72 hours later
by 100 to 200 mcg gonadorelin by intramuscular injection.
(2) Limitations. Dinoprost tromethamine as provided by sponsor No.
054771 in Sec. 510.600(c) of this chapter. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
0
7. In Sec. 522.2630, revise paragraphs (a) and (b) to read as follows:
Sec. 522.2630 Tulathromycin.
(a) Specifications. Each milliliter of solution contains:
(1) 100 milligrams (mg) tulathromycin
(2) 25 mg tulathromycin
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section:
(1) Product described as in paragraph (a)(1) for use as in
paragraph (d).
(2) Product described as in paragraph (a)(2) for use as in
paragraph (d)(2).
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1193 [Amended]
0
9. In paragraph (b)(2) of Sec. 524.1193, remove ``066916'' and in its
place add ``086001''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
10. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.500 [Amended]
0
11. In Sec. 558.500, in paragraph (a), remove ``45'' and in its place
add ``45.4''; in paragraph (b), remove ``No. 000986'' and in its place
add ``Nos. 000986 and 054771''; in the table in paragraph (e)(1), in
the ``Ractopamine in grams/ton'' column, remove ``4.5 to 9'' wherever
it occurs and in its place add ``4.5 to 9.0''; and in the table in
paragraphs (e)(1)(i), (e)(2)(i), (e)(2)(vi), and (e)(2)(xi), in the
``Sponsor'' column, add ``054771''.
Dated: October 22, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-25172 Filed 10-24-13; 8:45 am]
BILLING CODE 4160-01-P
