New Animal Drugs; Approvals; Changes of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address; Alfaxalone; Ivermectin and Clorsulon; Narasin; Triptorelin, 64715-64718 [2012-25989]
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Federal Register / Vol. 77, No. 205 / Tuesday, October 23, 2012 / Rules and Regulations
Paragraph 6005 Class E airspace areas
extending upward from 700 feet or more
above the surface of the earth.
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ANM MT E5 Wolf Point, MT [Modified]
Wolf Point, L M Clayton Airport, MT
(Lat. 48°05′40″ N., long. 105°34′30″ W.)
That airspace extending upward from 700
feet above the surface within an 8-mile radius
of L M Clayton Airport; that airspace
extending upward from 1,200 feet above the
surface bounded by a line beginning at lat.
48°02′00″ N., long. 104°13′00″ W.; to lat.
47°48′00″ N., long. 104°33′00″ W.; to lat.
47°48′00″ N., long. 106°00′02″ W.; to lat. 48°
20′00″ N., long. 106°00′02″ W.; to lat.
48°20′00″ N., long. 104°17′00″ W.; thence to
the point of beginning.
Issued in Seattle, Washington, on October
11, 2012.
John Warner,
Manager, Operations Support Group, Western
Service Center.
[FR Doc. 2012–26043 Filed 10–22–12; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, 524, 529, and
558
[Docket No. FDA–2012–N–0002]
New Animal Drugs; Approvals;
Changes of Sponsor; Change of
Sponsor’s Name; Change of Sponsor’s
Address; Alfaxalone; Ivermectin and
Clorsulon; Narasin; Triptorelin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
SUMMARY:
animal drug regulations to reflect
approval actions for new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during September 2012. FDA
is also informing the public of the
availability of summaries 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 four ophthalmic
ointments, a change of sponsor’s name,
and a change of sponsor’s address.
DATES: This rule is effective October 23,
2012.
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,
email: george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending the animal drug regulations to
reflect approval actions during
September 2012, as listed in table 1.
With respect to these actions, FDA is
also 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
through the Center for Veterinary
Medicine’s FOIA Electronic Reading
Room. FOI Summaries may be found
listed by application number at: https://
www.fda.gov/AnimalVeterinary/
Products/
ApprovedAnimalDrugProducts/
FOIADrugSummaries/default.htm.
Environmental Assessments (EAs) and
Finding Of No Serious Impacts
(FONSIs) may be found listed by the
established name of the active
pharmaceutical ingredient at: https://
www.fda.gov/AnimalVeterinary/
DevelopmentApprovalProcess/
EnvironmentalAssessments/
ucm300656.htm.
Also, Fougera Pharmaceuticals, Inc.,
P.O. Box 2006, 60 Baylis Rd., Melville,
NY 11747, has informed FDA that it has
transferred ownership of, and all rights
and interest in, NADA 065–015 for
VETROPOLYCIN HC (bacitracin zinc,
polymyxin B sulfate, neomycin sulfate,
and hydrocortisone) Ophthalmic
Ointment, NADA 065–016 for
VETROPOLYCIN (bacitracin zinc,
neomycin sulfate, and polymyxin B
sulfate) Ophthalmic Ointment, NADA
065–460 for VETROCLORICIN
(chloramphenicol) Ophthalmic
Ointment, and ANADA 200–273 for
VETRO–GEN (gentamicin sulfate)
Ophthalmic Ointment to Dechra Ltd.,
Dechra House, Jamage Industrial Estate,
Talke Pits, Stoke-on-Trent,
Staffordshire, ST7 1XW, United
Kingdom. Accordingly, the Agency is
amending the regulations in 21 CFR part
524 to reflect these changes.
In addition, UDL Laboratories, Inc.,
12720 Dairy Ashford Rd., Sugar Land,
TX 77478, has informed FDA that it has
changed its name to Mylan Institutional,
Inc., and ECO LLC, 8209 Hollister Ave.,
Las Vegas, NV 89131 has informed FDA
of a change of address to 344 Nassau St.,
Princeton, NJ 08540. Accordingly, the
Agency is amending the regulations in
21 CFR 510.600(c) to reflect these
changes.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY 2012
Sponsor
New animal drug
product name
Action
21 CFR
Section
FOIA
Summary
141–339 ...
JBS United Animal Health II LLC,
322 S. Main St., Sheridan, IN
46069.
OVUGEL (triptorelin acetate) .........
yes ..........
CE 1
Elanco Animal Health, A Division
of Eli Lilly & Co., Lilly Corporate
Center, Indianapolis, IN 46285.
SKYCIS 100 (narasin) Type A
medicated article.
558.363
yes ..........
EA/
FONSI 2
141–342 ...
Jurox Pty. Ltd., 85 Gardiner Rd., ALFAXAN (alfaxalone) Intravenous
Rutherford, NSW 2320, Australia.
Injectable Anesthetic for Cats
and Dogs.
Original approval for the synchronization of time of insemination in
weaned sows to facilitate a single fixed-time artificial insemination.
Original approval for use in medicated feed for increased rate of
weight gain and improved feed
efficiency in growing-finishing
swine.
Original approval for the induction
and maintenance of anesthesia
and for induction of anesthesia
followed by maintenance with an
inhalant anesthetic, in dogs and
cats.
529.2620
141–340 ...
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NADA/
ANADA
522.52
yes ..........
CE 1
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NEPA
Review
64716
Federal Register / Vol. 77, No. 205 / Tuesday, October 23, 2012 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY 2012—Continued
NADA/
ANADA
Sponsor
New animal drug
product name
Action
21 CFR
Section
FOIA
Summary
200–466 ...
Sparhawk
Laboratories,
Inc.,
12340 Santa Fe Trail Dr., Ft.
Lenexa, KS 66215.
SPARMECTIN
Plus
Clorsulon
(ivermectin and clorsulon) Injection for Cattle.
Original approval as a generic
copy of NADA 140–833.
522.1193
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 EA or an environmental impact
statement (EIS) because it is of a type that does not individually or cumulatively have a significant effect on the human environment.
2 Based on its review of an EA submitted by the sponsor, the Agency has concluded that this action will not have a significant impact on the human environment
and that an EIS is not required. A FONSI has been prepared.
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 522, 524, and 529
Animal drugs.
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, 522, 524, 529, and 558
are amended as follows:
■
Pty. Ltd.’’, ‘‘JBS United Animal Health
II LLC’’, and ‘‘Mylan Institutional, Inc.’’;
and remove the entry for ‘‘UDL
Laboratories, Inc.’’; and
■ b. In the table in paragraph (c)(2),
numerically add entries for ‘‘049480’’
and ‘‘051233’’ and revise the entries for
‘‘051079’’ and ‘‘066916’’.
The additions and revisions read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
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.
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
*
2. Amend § 510.600 as follows:
a. In the table in paragraph (c)(1),
revise the entry for ‘‘ECO LLC’’;
alphabetically add entries for ‘‘Jurox
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21 CFR Part 558
Animal drugs, Animal feeds.
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(c) * * *
(1) * * *
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Drug
labeler
code
Firm name and address
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ECO LLC, 344 Nassau St., Princeton, NJ 08540 .......................................................................................................................................
066916
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JBS United Animal Health II LLC, 322 S. Main St., Sheridan, IN 46069 ...................................................................................................
051233
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Jurox Pty. Ltd., 85 Gardiner Rd., Rutherford, NSW 2320, Australia ..........................................................................................................
049480
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Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478 ...............................................................................................
051079
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*
*
*
(2) * * *
Drug labeler code
Firm name and address
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*
Jurox Pty. Ltd., 85 Gardiner Rd., Rutherford, NSW 2320, Australia.
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051079 ............................................
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049480 ............................................
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Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478.
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051233 ............................................
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JBS United Animal Health II LLC, 322 S. Main St., Sheridan, IN 46069.
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066916 ............................................
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ECO LLC, 344 Nassau St., Princeton, NJ 08540.
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Federal Register / Vol. 77, No. 205 / Tuesday, October 23, 2012 / Rules and Regulations
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
6. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
Authority: 21 U.S.C. 360b.
■
4. Add § 522.52 to read as follows:
§ 522.52
§ 524.154
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(a) Specifications. Each milliliter
contains 10 milligrams (mg) alfaxalone.
(b) Sponsor. See No. 049480 in
§ 510.600(c) of this chapter.
(c) Conditions of use in cats and
dogs—(1) Amount—(i) Cats—(A)
Induction of general anesthesia.
Administer by intravenous injection
over approximately 60 seconds or until
clinical signs show the onset of
anesthesia, 2.2 to 9.7 mg/kilogram (kg)
for cats that did not receive a
preanesthetic or 1.0 to 10.8 mg/kg for
cats that received a preanesthetic.
(B) Maintenance of general anesthesia
following induction. Administer an
intravenous bolus containing 1.1 to 1.3
mg/kg to provide an additional 7 to 8
minutes of anesthesia in
preanesthetized cats; a dose containing
1.4 to 1.5 mg/kg provides an additional
3 to 5 minutes anesthesia in
unpreanesthetized cats.
(ii) Dogs—(A) Induction of general
anesthesia. Administer by intravenous
injection over approximately 60 seconds
or until clinical signs show the onset of
anesthesia, 1.5 to 4.5 mg/kg for dogs that
did not receive a preanesthetic or 0.2 to
3.5 mg/kg for dogs that received a
preanesthetic.
(B) Maintenance of general anesthesia
following induction. Administer an
intravenous bolus containing 1.2 to 1.4
mg/kg to provide an additional 6 to 8
minutes of anesthesia in
preanesthetized dogs; a dose of 1.5 to
2.2 mg/kg provides an additional 6 to 8
minutes of anesthesia in
unpreanesthetized dogs.
(2) Indications for use. For the
induction and maintenance of
anesthesia and for induction of
anesthesia followed by maintenance
with an inhalant anesthetic, in dogs and
cats.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 5. In § 522.1193, revise paragraph (b)
to read as follows:
§ 522.1193
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(b) Sponsors. See Nos. 050604,
055529, and 058005 in § 510.600(c) of
this chapter.
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16:04 Oct 22, 2012
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§ 524.155
[Amended]
8. In § 524.155, in paragraph (a)(2),
remove ‘‘025463’’ and in its place add
‘‘043264’’; and in paragraph (b)(3),
remove the first and second sentences.
■
§ 524.390
[Amended]
9. In § 524.390, in paragraph (b),
remove ‘‘025463’’ and in its place add
‘‘043264’’.
■
§ 524.1044c
[Amended]
10. In § 524.1044c, in paragraph (b),
remove ‘‘025463’’ and in its place add
‘‘043264’’.
■
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
11. The authority citation for 21 CFR
part 529 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
12. Add § 529.2620 to read as follows:
■
§ 529.2620
Triptorelin.
(a) Specifications. Each milliliter of
gel contains 100 micrograms (mcg)
triptorelin as triptorelin acetate.
(b) Sponsor. See No. 051233 in
§ 510.600(c) of this chapter.
(c) Conditions of use in swine—(1)
Amount. Administer 200 mcg
intravaginally approximately 96 hours
after weaning.
(2) Indications for use. For the
synchronization of time of insemination
in weaned sows to facilitate a single
fixed-time artificial insemination.
(3) Limitations. Not approved for use
in gilts. Safety and effectiveness have
not been evaluated in these animals.
Should not be used in sows with
obvious reproductive tract
abnormalities.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
13. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Ivermectin and clorsulon.
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[Amended]
7. In § 524.154, in paragraph (a)(2),
remove ‘‘025463’’ and in its place add
‘‘043264’’; and in paragraph (b)(3),
remove the first sentence.
■
Alfaxalone.
Authority: 21 U.S.C. 360b, 371.
14. In § 558.363, add paragraphs (a)(8)
and (c); revise paragraph (d)(1)(xi)(B);
redesignate paragraph (d)(2) as
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64717
paragraph (d)(3); and add new
paragraph (d)(2) to read as follows:
§ 558.363
Narasin.
(a) * * *
(8) To 000986: 45.4 grams per pound
for use as in paragraph (d)(2) of this
section.
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(c) Special considerations. An
expiration date of 2 months (8 weeks) is
required for narasin Type C medicated
swine feeds.
(d) * * *
(1) * * *
(xi) * * *
(B) Limitations. For broiler chickens
only. Feed continuously as sole ration.
Do not allow adult turkeys, horses, or
other equines access to formulations
containing narasin. Ingestion of narasin
by these species has been fatal. Narasin
and tylosin as provided by 000986 in
§ 510.600(c) of this chapter.
(2) Growing-finishing swine—(i)
Amount per ton. Narasin, 13.6 to 27.2
grams.
(A) Indications for use. For increased
rate of weight gain when fed for at least
4 weeks.
(B) Limitations. Feed continuously for
at least 4 weeks to swine during the
growing-finishing period as the sole
ration. No increased benefit in rate of
weight gain has been shown when
narasin concentrations in the diet are
greater than 13.6 g/ton. Effectiveness
has not been demonstrated when fed for
durations less than 4 weeks. Do not
allow adult turkeys, horses, or other
equines access to narasin formulations.
Ingestion of narasin by these species has
been fatal. Not approved for use in
breeding animals because safety and
effectiveness have not been evaluated in
these animals. Swine being fed with
narasin should not have access to feeds
containing pleuromutilins (e.g.,
tiamulin) as adverse reactions may
occur. If signs of toxicity occur,
discontinue use.
(ii) Amount per ton. Narasin, 18.1 to
27.2 grams.
(A) Indications for use. For increased
rate of weight gain and improved feed
efficiency when fed for at least 4 weeks.
(B) Limitations. Feed continuously for
at least 4 weeks to swine during the
growing-finishing period as the sole
ration. No increased benefit in rate of
weight gain has been shown when
narasin concentrations in the diet are
greater than 13.6 g/ton. Effectiveness
has not been demonstrated when fed for
durations less than 4 weeks. Do not
allow adult turkeys, horses, or other
equines access to narasin formulations.
Ingestion of narasin by these species has
been fatal. Not approved for use in
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Federal Register / Vol. 77, No. 205 / Tuesday, October 23, 2012 / Rules and Regulations
breeding animals because safety and
effectiveness have not been evaluated in
these animals. Swine being fed with
narasin should not have access to feeds
containing pleuromutilins (e.g.,
tiamulin) as adverse reactions may
occur. If signs of toxicity occur,
discontinue use.
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Dated: October 17, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
Table of Acronyms
[FR Doc. 2012–25989 Filed 10–22–12; 8:45 am]
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2012–0939]
RIN 1625–AA00
Safety Zone; Steam Ship Col. James M.
Schoonmaker Relocation Project,
Maumee River, Toledo, OH
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary Safety Zone on
the waters of Maumee River, Toledo,
Ohio, in support of the relocation of
S/S Col. James M. Schoonmaker
(hereinafter referred to as ‘the
Schoonmaker’). This temporary safety
zone will encompass all waters of the
Maumee River within a 100 yard radius
of the Schoonmaker as it makes its
transit from International Park to
Skyway Marina. This temporary Safety
Zone is necessary to protect persons
operating around the area.
DATES: This regulation is effective from
10:00 a.m. on October 27, 2012 until
4:00 p.m. on November 3, 2012.
ADDRESSES: Comments and material
received from the public, as well as
documents mentioned in this preamble
as being available in the docket, are part
of docket USCG–2012–0939 and are
available online by going to https://
www.regulations.gov, inserting USCG–
2011–0195 in the ‘‘Keyword’’ box, and
then clicking ‘‘Search.’’ This material is
also available for inspection or copying
at the Docket Management Facility (M–
30), U.S. Department of Transportation,
West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
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SUMMARY:
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If
you have questions on this rule, call or
email LT Mallorie Schell, Prevention
Department, MSU Toledo, Coast Guard;
telephone (419) 418–6030, email
Mallorie.G.Schell@uscg.mil. If you have
questions on viewing or submitting
material to the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
A. Regulatory History and Information
The Coast Guard is issuing this
temporary final rule without prior
notice and opportunity to comment
pursuant to authority under section 4(a)
of the Administrative Procedure Act
(APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because doing
so would be impracticable and contrary
to the public interest. Although the
Coast Guard has known about the
relocation of the Schoonmaker for
several weeks, only recently did the
Coast Guard become aware of an
expected high volume of spectator
vessel traffic. Consequently, the need for
this safety zone was not identified until
there was insufficient time to allow a
full comment period to run. Thus,
waiting for a comment period to run
prior to enforcing this safety zone would
inhibit the Coast Guard’s ability to
protect the public and vessels from the
hazards associated with the heightened
spectator activity associated with the
relocation of the Schoonmaker.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. For the same reasons
discussed above about not publishing an
NPRM, the Coast Guard finds that
waiting for a 30 day notice period to run
would be impracticable and contrary to
the public interest.
B. Basis and Purpose
The legal basis for the rule is the
Coast Guard’s authority to establish
regulated navigation areas and limited
access areas: 33 U.S.C. 1231; 46 U.S.C.
Chapter 701, 3306, 3703; 50 U.S.C. 191,
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195; 33 CFR 1.05–1, 6.04–1, 6.04–6,
160.5; Pub. L. 107–295, 116 Stat. 2064;
Department of Homeland Security
Delegation No. 0170.1.
The Great Lakes Historical Society
(GLHS) is relocating the Schoonmaker
from International Park to Skyway
Marina. This relocation is scheduled for
October 27, 2012. If the relocation of the
vessel on October 27 is cancelled for
any reason, this safety zone will be
effective and enforced from 10:00 a.m.
until 4:00 p.m. on October 28, 2012.
Likewise, if relocation on October 28th
is cancelled, this safety zone will be
effective and enforced from 10:00 a.m.
until 4:00 p.m. on November 3, 2012. In
light of the expected volume of
spectator activity, the Captain of the
Port Detroit has determined that this
operation could pose certain public
hazards, such as the increased risk of
collisions.
C. Discussion of Rule
With aforementioned hazards in
mind, the Captain of the Port Detroit has
determined that a safety zone is
necessary to ensure the safety of
participants and vessels during the
operation. The temporary safety zone
established herein will be effective and
enforced from 10:00 a.m. until 4:00 p.m.
on October 27, 2012. If the relocation of
the vessel on October 27 is cancelled for
any reason, this safety zone will be
effective and enforced from 10:00 a.m.
until 4:00 p.m. on October 28, 2012.
Likewise, if relocation on October 28 is
cancelled, this safety zone will be
effective and enforced from 10:00 a.m.
until 4:00 p.m. on November 3, 2012.
Entry into, transiting, or anchoring
within the safety zone is prohibited
unless authorized by the Captain of the
Port, Sector Detroit or his designated on
scene representative. The Captain of the
Port, Sector Detroit or his designated on
scene representative may be contacted
via VHF Channel 16. All persons and
vessels allowed to enter the safety zone
shall comply with the instructions of
the Coast Guard Captain of the Port,
designated on scene patrol personnel, or
operation personnel.
D. Regulatory Analyses
We developed this rule after
considering numerous statutes and
executive orders related to rulemaking.
Below we summarize our analyses
based on these statutes or executive
orders.
1. Regulatory Planning and Review
This rule is not a significant
regulatory action under section 3(f) of
Executive Order 12866, Regulatory
Planning and Review, as supplemented
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]]>Agencies
[Federal Register Volume 77, Number 205 (Tuesday, October 23, 2012)]
[Rules and Regulations]
[Pages 64715-64718]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25989]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, 524, 529, and 558
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Approvals; Changes of Sponsor; Change of
Sponsor's Name; Change of Sponsor's Address; Alfaxalone; Ivermectin and
Clorsulon; Narasin; Triptorelin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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 September 2012. FDA is also informing the public of the
availability of summaries 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 four
ophthalmic ointments, a change of sponsor's name, and a change of
sponsor's address.
DATES: This rule is effective October 23, 2012.
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, email:
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions during September 2012, as listed in table
1. With respect to these actions, FDA is also 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 through the Center for Veterinary Medicine's
FOIA Electronic Reading Room. FOI Summaries may be found listed by
application number at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/default.htm. Environmental
Assessments (EAs) and Finding Of No Serious Impacts (FONSIs) may be
found listed by the established name of the active pharmaceutical
ingredient at: https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/EnvironmentalAssessments/ucm300656.htm.
Also, Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd.,
Melville, NY 11747, has informed FDA that it has transferred ownership
of, and all rights and interest in, NADA 065-015 for VETROPOLYCIN HC
(bacitracin zinc, polymyxin B sulfate, neomycin sulfate, and
hydrocortisone) Ophthalmic Ointment, NADA 065-016 for VETROPOLYCIN
(bacitracin zinc, neomycin sulfate, and polymyxin B sulfate) Ophthalmic
Ointment, NADA 065-460 for VETROCLORICIN (chloramphenicol) Ophthalmic
Ointment, and ANADA 200-273 for VETRO-GEN (gentamicin sulfate)
Ophthalmic Ointment to Dechra Ltd., Dechra House, Jamage Industrial
Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United
Kingdom. Accordingly, the Agency is amending the regulations in 21 CFR
part 524 to reflect these changes.
In addition, UDL Laboratories, Inc., 12720 Dairy Ashford Rd., Sugar
Land, TX 77478, has informed FDA that it has changed its name to Mylan
Institutional, Inc., and ECO LLC, 8209 Hollister Ave., Las Vegas, NV
89131 has informed FDA of a change of address to 344 Nassau St.,
Princeton, NJ 08540. Accordingly, the Agency is amending the
regulations in 21 CFR 510.600(c) to reflect these changes.
Table 1--Original and Supplemental NADAs and ANADAs Approved During July 2012
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New animal drug 21 CFR
NADA/ ANADA Sponsor product name Action Section FOIA Summary NEPA Review
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141-339........................ JBS United Animal OVUGEL (triptorelin Original approval for 529.2620 yes.............. CE \1\
Health II LLC, 322 S. acetate). the synchronization
Main St., Sheridan, of time of
IN 46069. insemination in
weaned sows to
facilitate a single
fixed-time artificial
insemination.
141-340........................ Elanco Animal Health, SKYCIS 100 (narasin) Original approval for 558.363 yes.............. EA/
A Division of Eli Type A medicated use in medicated feed FONSI \2\
Lilly & Co., Lilly article. for increased rate of
Corporate Center, weight gain and
Indianapolis, IN improved feed
46285. efficiency in growing-
finishing swine.
141-342........................ Jurox Pty. Ltd., 85 ALFAXAN (alfaxalone) Original approval for 522.52 yes.............. CE \1\
Gardiner Rd., Intravenous the induction and
Rutherford, NSW 2320, Injectable Anesthetic maintenance of
Australia. for Cats and Dogs. anesthesia and for
induction of
anesthesia followed
by maintenance with
an inhalant
anesthetic, in dogs
and cats.
[[Page 64716]]
200-466........................ Sparhawk Laboratories, SPARMECTIN Plus Original approval as a 522.1193 yes.............. CE \1\
Inc., 12340 Santa Fe Clorsulon (ivermectin generic copy of NADA
Trail Dr., Ft. and clorsulon) 140-833.
Lenexa, KS 66215. Injection for Cattle.
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\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an EA or an
environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant effect on the human
environment.
\2\ Based on its review of an EA submitted by the sponsor, the Agency has concluded that this action will not have a significant impact on the human
environment and that an EIS is not required. A FONSI has been prepared.
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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 522, 524, and 529
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,
522, 524, 529, 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. Amend Sec. 510.600 as follows:
0
a. In the table in paragraph (c)(1), revise the entry for ``ECO LLC'';
alphabetically add entries for ``Jurox Pty. Ltd.'', ``JBS United Animal
Health II LLC'', and ``Mylan Institutional, Inc.''; and remove the
entry for ``UDL Laboratories, Inc.''; and
0
b. In the table in paragraph (c)(2), numerically add entries for
``049480'' and ``051233'' and revise the entries for ``051079'' and
``066916''.
The additions and revisions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug
Firm name and address labeler
code
------------------------------------------------------------------------
* * * * * * *
ECO LLC, 344 Nassau St., Princeton, NJ 08540................. 066916
* * * * * * *
JBS United Animal Health II LLC, 322 S. Main St., Sheridan, 051233
IN 46069....................................................
* * * * * * *
Jurox Pty. Ltd., 85 Gardiner Rd., Rutherford, NSW 2320, 049480
Australia...................................................
* * * * * * *
Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar 051079
Land, TX 77478..............................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
049480............................ Jurox Pty. Ltd., 85 Gardiner Rd.,
Rutherford, NSW 2320, Australia.
* * * * * * *
051079............................ Mylan Institutional, Inc., 12720
Dairy Ashford Rd., Sugar Land, TX
77478.
* * * * * * *
051233............................ JBS United Animal Health II LLC, 322
S. Main St., Sheridan, IN 46069.
* * * * * * *
066916............................ ECO LLC, 344 Nassau St., Princeton,
NJ 08540.
* * * * * * *
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[[Page 64717]]
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. Add Sec. 522.52 to read as follows:
Sec. 522.52 Alfaxalone.
(a) Specifications. Each milliliter contains 10 milligrams (mg)
alfaxalone.
(b) Sponsor. See No. 049480 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats and dogs--(1) Amount--(i) Cats--(A)
Induction of general anesthesia. Administer by intravenous injection
over approximately 60 seconds or until clinical signs show the onset of
anesthesia, 2.2 to 9.7 mg/kilogram (kg) for cats that did not receive a
preanesthetic or 1.0 to 10.8 mg/kg for cats that received a
preanesthetic.
(B) Maintenance of general anesthesia following induction.
Administer an intravenous bolus containing 1.1 to 1.3 mg/kg to provide
an additional 7 to 8 minutes of anesthesia in preanesthetized cats; a
dose containing 1.4 to 1.5 mg/kg provides an additional 3 to 5 minutes
anesthesia in unpreanesthetized cats.
(ii) Dogs--(A) Induction of general anesthesia. Administer by
intravenous injection over approximately 60 seconds or until clinical
signs show the onset of anesthesia, 1.5 to 4.5 mg/kg for dogs that did
not receive a preanesthetic or 0.2 to 3.5 mg/kg for dogs that received
a preanesthetic.
(B) Maintenance of general anesthesia following induction.
Administer an intravenous bolus containing 1.2 to 1.4 mg/kg to provide
an additional 6 to 8 minutes of anesthesia in preanesthetized dogs; a
dose of 1.5 to 2.2 mg/kg provides an additional 6 to 8 minutes of
anesthesia in unpreanesthetized dogs.
(2) Indications for use. For the induction and maintenance of
anesthesia and for induction of anesthesia followed by maintenance with
an inhalant anesthetic, in dogs and cats.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
5. In Sec. 522.1193, revise paragraph (b) to read as follows:
Sec. 522.1193 Ivermectin and clorsulon.
* * * * *
(b) Sponsors. See Nos. 050604, 055529, and 058005 in Sec.
510.600(c) of this chapter.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.154 [Amended]
0
7. In Sec. 524.154, in paragraph (a)(2), remove ``025463'' and in its
place add ``043264''; and in paragraph (b)(3), remove the first
sentence.
Sec. 524.155 [Amended]
0
8. In Sec. 524.155, in paragraph (a)(2), remove ``025463'' and in its
place add ``043264''; and in paragraph (b)(3), remove the first and
second sentences.
Sec. 524.390 [Amended]
0
9. In Sec. 524.390, in paragraph (b), remove ``025463'' and in its
place add ``043264''.
Sec. 524.1044c [Amended]
0
10. In Sec. 524.1044c, in paragraph (b), remove ``025463'' and in its
place add ``043264''.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
11. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
12. Add Sec. 529.2620 to read as follows:
Sec. 529.2620 Triptorelin.
(a) Specifications. Each milliliter of gel contains 100 micrograms
(mcg) triptorelin as triptorelin acetate.
(b) Sponsor. See No. 051233 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in swine--(1) Amount. Administer 200 mcg
intravaginally approximately 96 hours after weaning.
(2) Indications for use. For the synchronization of time of
insemination in weaned sows to facilitate a single fixed-time
artificial insemination.
(3) Limitations. Not approved for use in gilts. Safety and
effectiveness have not been evaluated in these animals. Should not be
used in sows with obvious reproductive tract abnormalities.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
13. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
14. In Sec. 558.363, add paragraphs (a)(8) and (c); revise paragraph
(d)(1)(xi)(B); redesignate paragraph (d)(2) as paragraph (d)(3); and
add new paragraph (d)(2) to read as follows:
Sec. 558.363 Narasin.
(a) * * *
(8) To 000986: 45.4 grams per pound for use as in paragraph (d)(2)
of this section.
* * * * *
(c) Special considerations. An expiration date of 2 months (8
weeks) is required for narasin Type C medicated swine feeds.
(d) * * *
(1) * * *
(xi) * * *
(B) Limitations. For broiler chickens only. Feed continuously as
sole ration. Do not allow adult turkeys, horses, or other equines
access to formulations containing narasin. Ingestion of narasin by
these species has been fatal. Narasin and tylosin as provided by 000986
in Sec. 510.600(c) of this chapter.
(2) Growing-finishing swine--(i) Amount per ton. Narasin, 13.6 to
27.2 grams.
(A) Indications for use. For increased rate of weight gain when fed
for at least 4 weeks.
(B) Limitations. Feed continuously for at least 4 weeks to swine
during the growing-finishing period as the sole ration. No increased
benefit in rate of weight gain has been shown when narasin
concentrations in the diet are greater than 13.6 g/ton. Effectiveness
has not been demonstrated when fed for durations less than 4 weeks. Do
not allow adult turkeys, horses, or other equines access to narasin
formulations. Ingestion of narasin by these species has been fatal. Not
approved for use in breeding animals because safety and effectiveness
have not been evaluated in these animals. Swine being fed with narasin
should not have access to feeds containing pleuromutilins (e.g.,
tiamulin) as adverse reactions may occur. If signs of toxicity occur,
discontinue use.
(ii) Amount per ton. Narasin, 18.1 to 27.2 grams.
(A) Indications for use. For increased rate of weight gain and
improved feed efficiency when fed for at least 4 weeks.
(B) Limitations. Feed continuously for at least 4 weeks to swine
during the growing-finishing period as the sole ration. No increased
benefit in rate of weight gain has been shown when narasin
concentrations in the diet are greater than 13.6 g/ton. Effectiveness
has not been demonstrated when fed for durations less than 4 weeks. Do
not allow adult turkeys, horses, or other equines access to narasin
formulations. Ingestion of narasin by these species has been fatal. Not
approved for use in
[[Page 64718]]
breeding animals because safety and effectiveness have not been
evaluated in these animals. Swine being fed with narasin should not
have access to feeds containing pleuromutilins (e.g., tiamulin) as
adverse reactions may occur. If signs of toxicity occur, discontinue
use.
* * * * *
Dated: October 17, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-25989 Filed 10-22-12; 8:45 am]
BILLING CODE 4160-01-P
