New Animal Drugs; Mupirocin, 79295-79296 [2010-31870]
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Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Rules and Regulations
Issued in College Park, Georgia on
December 10, 2010.
Barry A. Knight,
Acting Manager, Operations Support Group,
Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2010–31765 Filed 12–17–10; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA–2010–0692; Airspace
Docket No. 10–AEA–16]
Establishment of Class E Airspace;
Crewe, VA
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
AGENCY:
This action establishes Class
E Airspace at Crewe, VA, to
accommodate the additional airspace
needed for the Standard Instrument
Approach Procedures (SIAPs)
developed for Crewe Municipal Airport.
This action enhances the safety and
airspace management of Instrument
Flight Rules (IFR) operations at the
airport.
SUMMARY:
Effective 0901 UTC, March 10,
2011. The Director of the Federal
Register approves this incorporation by
reference action under title 1, Code of
Federal Regulations, part 51, subject to
the annual revision of FAA Order
7400.9 and publication of conforming
amendments.
DATES:
FOR FURTHER INFORMATION CONTACT:
Melinda Giddens, Operations Support
Group, Eastern Service Center, Federal
Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320;
telephone (404) 305–5610.
SUPPLEMENTARY INFORMATION:
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History
On September 20, 2010, the FAA
published in the Federal Register a
notice of proposed rulemaking to
establish Class E airspace at Crewe, VA
(75 FR 57215) Docket No. FAA–2010–
0692. Interested parties were invited to
participate in this rulemaking effort by
submitting written comments on the
proposal to the FAA. No comments
were received. Class E airspace
designations are published in paragraph
6005 of FAA Order 7400.9U dated
August 18, 2010, and effective
September 15, 2010, which is
incorporated by reference in 14 CFR
Part 71.1. The Class E airspace
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19:04 Dec 17, 2010
Jkt 223001
designations listed in this document
will be published subsequently in the
Order.
The Rule
This amendment to Title 14, Code of
Federal Regulations (14 CFR) part 71
establishes the Class E airspace
extending upward from 700 feet above
the surface at Crewe, VA, to provide
controlled airspace required to support
the SIAPs developed for Crewe
Municipal Airport. This action is
necessary for the safety and
management of IFR operations at the
airports.
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current, is non-controversial and
unlikely to result in adverse or negative
comments. It, therefore, (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 will only affect air traffic
procedures and air navigation, it is
certified that this rule, when
promulgated, will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
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 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 establishes Class E airspace at Crewe,
VA.
Lists 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:
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79295
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 Federal Aviation
Administration Order 7400.9U,
Airspace Designations and Reporting
Points, dated August 18, 2010, effective
September 15, 2010, is amended as
follows:
■
Paragraph 6005 Class E airspace areas
extending upward from 700 feet or more
above the surface of the earth.
*
*
*
*
*
AEA VA E5 Crewe, VA [NEW]
Crewe Municipal Airport, VA
(Lat. 37°10′52″ N., long. 78°05′54″ W.)
That airspace extending upward from 700
feet above the surface within a 6.3-mile
radius of Crewe Municipal Airport.
Issued in College Park, Georgia on
December 10, 2010.
Barry A. Knight,
Acting Manager, Operations Support Group,
Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2010–31762 Filed 12–17–10; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 524
[Docket No. FDA–2010–N–0002]
New Animal Drugs; Mupirocin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by Taro
Pharmaceuticals U.S.A., Inc. The
ANADA provides for veterinary
prescription use of mupirocin ointment
for the treatment of bacterial skin
infections in dogs.
DATES: This rule is effective December
20, 2010.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
SUMMARY:
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79296
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Rules and Regulations
Medicine (HFV–170), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197,
e-mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Taro
Pharmaceuticals U.S.A., Inc., 3 Skyline
Dr., Hawthorne, NY 10532, filed
ANADA 200–457 that provides for
veterinary prescription use of
Mupirocin Ointment USP, 2% for the
treatment of bacterial skin infections in
dogs. Taro Pharmaceuticals U.S.A.,
Inc.’s Mupirocin Ointment USP, 2% is
approved as a generic copy of Pfizer,
Inc.’s BACTODERM Ointment approved
under NADA 140–839. The ANADA is
approved as of November 29, 2010, and
the regulations are amended in 21 CFR
524.1465 to reflect the approval.
In addition, Taro Pharmaceuticals
U.S.A., Inc., has not been previously
listed in the animal drug regulations as
a sponsor of an approved application.
Accordingly, the tables in 21 CFR
510.600(c) are being amended to add
entries for this firm.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
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.
The Agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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
CFR parts 510 and 524 are amended as
follows:
Drug Enforcement Administration
PART 510—NEW ANIMAL DRUGS
21 CFR Part 1308
1. The authority citation for 21 CFR
part 510 continues to read as follows:
[Docket No. DEA–331F]
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Schedules of Controlled Substances:
Placement of 5-Methoxy-N,NDimethyltryptamine into Schedule I of
the Controlled Substances Act
■
2. In § 510.600, in the table in
paragraph (c)(1) alphabetically add an
entry for ‘‘Taro Pharmaceuticals U.S.A.,
Inc.’’; and in the table in paragraph (c)(2)
numerically add an entry for ‘‘051672’’
to read as follows:
■
3. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 524.1465
4. In paragraph (b) of § 524.1465,
remove ‘‘Nos. 000069 and 025463’’ and
in its place add ‘‘Nos. 000069, 025463,
and 051672’’.
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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
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19:04 Dec 17, 2010
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[Amended]
■
21 CFR Part 524
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
AGENCY:
With the issuance of this final
rule, the Deputy Administrator of the
Drug Enforcement Administration
(DEA) places the substance 5-methoxy*
*
*
*
*
N,N-dimethyltryptamine (5-MeO-DMT),
(c) * * *
including its salts, isomers and salts of
isomers whenever the existence of such
(1) * * *
salts, isomers, and salts of isomers is
possible, into schedule I of the
Drug labeler
Firm name and address
code
Controlled Substances Act (CSA). This
action by the DEA Deputy
Administrator is based on a scheduling
*
*
*
*
*
recommendation from the Assistant
Taro Pharmaceuticals
Secretary for Health of the Department
U.S.A., Inc., 3 Skyline Dr.,
of Health and Human Services (DHHS)
Hawthorne, NY 10532 ......
051672
and a DEA review indicating that 5MeO-DMT meets the criteria for
*
*
*
*
*
placement in schedule I of the CSA.
This final rule will impose the criminal
(2) * * *
sanctions and regulatory controls of
schedule I substances under the CSA on
Drug labeler
the manufacture, distribution,
Firm name and address
code
dispensing, importation, exportation,
and possession of 5-MeO-DMT.
DATES: Effective Date: January 19, 2011.
*
*
*
*
*
051672 ........ Taro Pharmaceuticals U.S.A.,
FOR FURTHER INFORMATION CONTACT:
Inc., 3 Skyline Dr., HawChristine A. Sannerud, PhD, Chief, Drug
thorne, NY 10532.
and Chemical Evaluation Section, Office
of Diversion Control, Drug Enforcement
*
*
*
*
*
Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152, Telephone:
(202) 307–7183.
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
SUPPLEMENTARY INFORMATION:
ANIMAL DRUGS
Background
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
DEPARTMENT OF JUSTICE
Dated: December 10, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–31870 Filed 12–17–10; 8:45 am]
BILLING CODE 4160–01–P
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Fmt 4700
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SUMMARY:
In accordance with 21 U.S.C. 811(b) of
the CSA, DEA gathered and reviewed
the available information regarding the
pharmacology, chemistry, trafficking,
actual abuse, pattern of abuse, and the
relative potential for abuse of 5methoxy-N,N-dimethyltryptamine (5MeO-DMT). On February 21, 2007, the
Deputy Administrator of the DEA
submitted these data to the Assistant
Secretary for Health, Department of
Health and Human Services. In
accordance with 21 U.S.C. 811(b), the
Deputy Administrator also requested a
scientific and medical evaluation and a
scheduling recommendation for 5-MeO-
E:\FR\FM\20DER1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Rules and Regulations]
[Pages 79295-79296]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31870]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 524
[Docket No. FDA-2010-N-0002]
New Animal Drugs; Mupirocin
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 of an abbreviated new animal drug
application (ANADA) filed by Taro Pharmaceuticals U.S.A., Inc. The
ANADA provides for veterinary prescription use of mupirocin ointment
for the treatment of bacterial skin infections in dogs.
DATES: This rule is effective December 20, 2010.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary
[[Page 79296]]
Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8197, e-mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Taro Pharmaceuticals U.S.A., Inc., 3 Skyline
Dr., Hawthorne, NY 10532, filed ANADA 200-457 that provides for
veterinary prescription use of Mupirocin Ointment USP, 2% for the
treatment of bacterial skin infections in dogs. Taro Pharmaceuticals
U.S.A., Inc.'s Mupirocin Ointment USP, 2% is approved as a generic copy
of Pfizer, Inc.'s BACTODERM Ointment approved under NADA 140-839. The
ANADA is approved as of November 29, 2010, and the regulations are
amended in 21 CFR 524.1465 to reflect the approval.
In addition, Taro Pharmaceuticals U.S.A., Inc., has not been
previously listed in the animal drug regulations as a sponsor of an
approved application. Accordingly, the tables in 21 CFR 510.600(c) are
being amended to add entries for this firm.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application 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.
The Agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
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 524
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 and
524 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 ``Taro Pharmaceuticals U.S.A., Inc.''; and in the
table in paragraph (c)(2) numerically add an entry for ``051672'' 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
------------------------------------------------------------------------
* * * * *
Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., 051672
Hawthorne, NY 10532....................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
051672........................... Taro Pharmaceuticals U.S.A., Inc., 3
Skyline Dr., Hawthorne, NY 10532.
* * * * *
------------------------------------------------------------------------
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1465 [Amended]
0
4. In paragraph (b) of Sec. 524.1465, remove ``Nos. 000069 and
025463'' and in its place add ``Nos. 000069, 025463, and 051672''.
Dated: December 10, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-31870 Filed 12-17-10; 8:45 am]
BILLING CODE 4160-01-P
