New Animal Drugs; Change of Sponsor; Azaperone, 65689-65690 [E9-29494]
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Federal Register / Vol. 74, No. 237 / Friday, December 11, 2009 / Rules and Regulations
within the scope of that authority as it
revises Colored Federal Airways in
Alaska.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Environmental Review
PART 510—NEW ANIMAL DRUGS
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:
Polices and Procedures, paragraph 311a.
This airspace action is not expected to
cause any potentially significant
environmental impacts, and no
extraordinary circumstances exist that
warrant preparation of an
environmental assessment.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
■
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for part 71
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.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.9T,
Airspace Designations and Reporting
Points, signed August 27, 2009, and
effective September 15, 2009, is to be
amended as follows:
■
Paragraph 6009(a)
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Green Federal Airways.
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G–16 [Revised]
From Point Lay, AK, NDB; Wainwright
Village, AK, NDB; Browerville, AK, NDB;
Nuiqsut Village, AK, NDB; to Put River, AK,
NDB.
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Paragraph 6009(d)
WReier-Aviles on DSKGBLS3C1PROD with RULES
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Issued in Washington, DC, December 3,
2009.
Kenneth L. McElroy,
Acting Manager, Airspace and Rules Group.
[FR Doc. E9–29396 Filed 12–10–09; 8:45 am]
BILLING CODE 4910–13–P
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1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
[Docket No. FDA–2009–N–0665]
New Animal Drugs; Change of
Sponsor; Azaperone
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for a new animal drug
application (NADA) from ScheringPlough Animal Health Corp. to Janssen
Pharmaceutica NV.
DATES: This rule is effective December
11, 2009.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 556 Morris
Ave., Summit, NJ 07901, has informed
FDA that it has transferred ownership
of, and all rights and interest in,
approved NADA 115–732 for STRESNIL
(azaperone) Injection to Janssen
Pharmaceutica NV, Turnhoutseweg 30,
B–2340 Beerse, Belgium. Accordingly,
the agency is amending the regulations
in 21 CFR 522.150 to reflect the transfer
of ownership and a current format.
In addition, Janssen Pharmaceutica
NV is not currently listed in the animal
drug regulations as a sponsor of an
approved application. Accordingly, 21
CFR 510.600(c) is being amended to add
entries for this sponsor.
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.
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
*
B–26 [Revised]
From Chena, AK, NDB, to Yukon River,
AK, NDB.
*
21 CFR Parts 510 and 522
List of Subjects
Blue Federal Airways.
*
the Center for Veterinary Medicine, 21
CFR parts 510 and 522 are amended as
follows:
21 CFR Part 522
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
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Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add an
entry for ‘‘Janssen Pharmaceutica NV’’;
and in the table in paragraph (c)(2),
numerically add an entry for ‘‘012578’’
to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
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*
(c) * * *
(1) * * *
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*
Firm name and address
Drug labeler
code
*
*
*
*
Janssen Pharmaceutica
NV, Turnhoutseweg 30,
B–2340 Beerse, Belgium
*
*
*
*
012578
*
*
(2) * * *
Drug labeler
code
*
Firm name and address
*
012578
*
*
*
*
Janssen Pharmaceutica
NV, Turnhoutseweg 30,
B–2340 Beerse, Belgium
*
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PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
4. Revise § 522.150 to read as follows:
§ 522.150
Azaperone.
(a) Specifications. Each milliliter of
solution contains 40 milligrams (mg)
azaperone.
(b) Sponsor. See No. 012578 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Indications
for use. For control of aggressiveness
when mixing or regrouping weanling or
feeder pigs weighing up to 80 pounds.
(2) Dosage. 2.2 mg per kilogram (1 mg
per pound) by deep intramuscular
injection.
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65690
Federal Register / Vol. 74, No. 237 / Friday, December 11, 2009 / Rules and Regulations
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: December 7, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–29494 Filed 12–10–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2009–0484]
RIN 1625–AA00
Safety Zone; San Diego Parade of
Lights Fireworks; San Diego Bay, CA
Coast Guard, DHS.
Temporary final rule.
AGENCY:
WReier-Aviles on DSKGBLS3C1PROD with RULES
ACTION:
SUMMARY: The Coast Guard proposes a
safety zone upon the navigable waters of
San Diego Bay in San Diego, CA in
support of the San Diego Parade of
Lights Fireworks. This safety zone is
necessary to provide for the safety of the
participants, crew, spectators,
participating vessels, and other users of
the waterway. Persons and vessels are
prohibited from entering into, transiting
through, or anchoring within this safety
zone unless authorized by the Captain
of the Port or his designated
representative.
DATES: This rule is effective from 5:30
p.m. to 10 p.m., each day, on December
13, 2009, and December 20, 2009.
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–2009–0484 and are
available online by going to https://
www.regulations.gov, inserting USCG–
2009–0484 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.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
rule, call or e-mail Petty Officer Shane
Jackson, Waterways Management, U.S.
Coast Guard Sector San Diego at
telephone 619–278–7262, E-mail
Shane.E.Jackson@uscg.mil. If you have
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15:09 Dec 10, 2009
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questions on viewing the docket, call
Renee V. Wright, Program Manager,
Docket Operations, telephone 202–366–
9826.
SUPPLEMENTARY INFORMATION:
Regulatory Information
On September 29, 2009 we published
a notice of proposed rulemaking
(NPRM) entitled Safety Zone; San Diego
Parade of Lights Fireworks; San Diego,
CA in the Federal Register (74 FR
49831). We received no comments on
the proposed rule. Additionally, no
public meeting was requested, and none
was held.
Background and Purpose
Fireworks & Stage FX Inc is
sponsoring the San Diego Parade of
Lights Fireworks, which will include a
fireworks presentation from a barge in
San Diego Bay. This temporary safety
zone is necessary to provide for the
safety of the crew, spectators,
participants, and other vessels and users
of the waterway.
Discussion of Comments and Changes
No comments were submitted in
response to the NPRM. After publication
of the NPRM, the sponsor informed the
Coast Guard that changes to the
fireworks show plans required
enlargement of the safety zone. The
NPRM described a safety zone
extending in a 400 foot radius around
a barge in approximate position
32°43′23″ N, 117°11′57″ W. Instead, in
order to protect members of the public
from the hazards associated with
fireworks displays, the zone will extend
in a 600 foot radius from the same
approximate position. Vessel traffic will
continue to be able to pass safely
around the zone, and no other negative
impacts are expected to result from this
change.
Regulatory Analyses
We developed this rule after
considering numerous statutes and
executive orders related to rulemaking.
Below we summarize our analyses
based on 13 of these statutes or
executive orders.
Regulatory Planning and Review
This rule is not a significant
regulatory action under section 3(f) of
Executive Order 12866, Regulatory
Planning and Review, and does not
require an assessment of potential costs
and benefits under section 6(a)(3) of that
Order. The Office of Management and
Budget has not reviewed it under that
Order.
We expect the economic impact of
this proposed rule to be so minimal that
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a full Regulatory Evaluation is
unnecessary. This determination is
based on the size and location of the
safety zone. Commercial vessels will not
be hindered by the safety zone.
Recreational vessels will not be allowed
to transit through the designated safety
zone during the specified times unless
authorized to do so by the Captain of the
Port or his designated representative.
Small Entities
Under the Regulatory Flexibility Act
(5 U.S.C. 601–612), we have considered
whether this rule would have a
significant economic impact on a
substantial number of small entities.
The term ‘‘small entities’’ comprises
small businesses, not-for-profit
organizations that are independently
owned and operated and are not
dominant in their fields, and
governmental jurisdictions with
populations of less than 50,000.
The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have
a significant economic impact on a
substantial number of small entities.
This rule will affect the following
entities, some of which may be small
entities: The owners or operators of
vessels intending to transit or anchor in
a portion of the San Diego Bay from 5:30
p.m. to 10 p.m. on December 13 and 20,
2009.
This safety zone will not have a
significant economic impact on a
substantial number of small entities for
the following reasons. Vessel traffic can
pass safely around the zone.
Additionally, before the effective
period, the Coast Guard will publish a
local notice to mariners (LNM).
Assistance for Small Entities
Under section 213(a) of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121),
in the NPRM we offered to assist small
entities in understanding the rule so
that they could better evaluate its effects
on them and participate in the
rulemaking process.
Small businesses may send comments
on the actions of Federal employees
who enforce, or otherwise determine
compliance with, Federal regulations to
the Small Business and Agriculture
Regulatory Enforcement Ombudsman
and the Regional Small Business
Regulatory Fairness Boards. The
Ombudsman evaluates these actions
annually and rates each agency’s
responsiveness to small business. If you
wish to comment on actions by
employees of the Coast Guard, call
1–888–REG–FAIR (1–888–734–3247).
The Coast Guard will not retaliate
against small entities that question or
E:\FR\FM\11DER1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 237 (Friday, December 11, 2009)]
[Rules and Regulations]
[Pages 65689-65690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-29494]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA-2009-N-0665]
New Animal Drugs; Change of Sponsor; Azaperone
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for a new animal drug
application (NADA) from Schering-Plough Animal Health Corp. to Janssen
Pharmaceutica NV.
DATES: This rule is effective December 11, 2009.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556
Morris Ave., Summit, NJ 07901, has informed FDA that it has transferred
ownership of, and all rights and interest in, approved NADA 115-732 for
STRESNIL (azaperone) Injection to Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium. Accordingly, the agency is
amending the regulations in 21 CFR 522.150 to reflect the transfer of
ownership and a current format.
In addition, Janssen Pharmaceutica NV is not currently listed in
the animal drug regulations as a sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this
sponsor.
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 Part 522
Animal drugs.
0
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 and
522 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 an entry for ``Janssen Pharmaceutica NV''; and in the table in
paragraph (c)(2), numerically add an entry for ``012578'' to read as
follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Janssen Pharmaceutica NV, Turnhoutseweg 30, 012578
B-2340 Beerse, Belgium
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
012578 Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
* * * * *
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. Revise Sec. 522.150 to read as follows:
Sec. 522.150 Azaperone.
(a) Specifications. Each milliliter of solution contains 40
milligrams (mg) azaperone.
(b) Sponsor. See No. 012578 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Indications for use. For control of
aggressiveness when mixing or regrouping weanling or feeder pigs
weighing up to 80 pounds.
(2) Dosage. 2.2 mg per kilogram (1 mg per pound) by deep
intramuscular injection.
[[Page 65690]]
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: December 7, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29494 Filed 12-10-09; 8:45 am]
BILLING CODE 4160-01-S
