Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Spray, 3598 [2012-1501]
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Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Rules and Regulations
§ 230.146
Act.
Rules under section 18 of the
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(b) * * *
(1) For purposes of Section 18(b) of
the Act (15 U.S.C. 77r), the Commission
finds that the following national
securities exchanges, or segments or
tiers thereof, have listing standards that
are substantially similar to those of the
New York Stock Exchange (‘‘NYSE’’),
the NYSE Amex LLC (‘‘NYSE Amex’’),
or the National Market System of the
Nasdaq Stock Market (‘‘Nasdaq/NGM’’),
and that securities listed, or authorized
for listing, on such exchanges shall be
deemed covered securities:
(i) Tier I of the NYSE Arca, Inc.;
(ii) Tier I of the NASDAQ OMX PHLX
LLC;
(iii) The Chicago Board Options
Exchange, Incorporated;
(iv) Options listed on the
International Securities Exchange, LLC;
(v) The Nasdaq Capital Market; and
(vi) Tier I and Tier II of BATS
Exchange, Inc.
(2) The designation of securities in
paragraphs (b)(1)(i) through (vi) of this
section as covered securities is
conditioned on such exchanges’ listing
standards (or segments or tiers thereof)
continuing to be substantially similar to
those of the NYSE, NYSE Amex, or
Nasdaq/NGM.
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By the Commission.
Dated: January 20, 2012.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012–1521 Filed 1–24–12; 8:45 am]
BILLING CODE 8011–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
[Docket No. FDA–2011–N–0003]
Ophthalmic and Topical Dosage Form
New Animal Drugs; Gentamicin and
Betamethasone Spray
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
original approval of an abbreviated new
animal drug application (ANADA) filed
by Sparhawk Laboratories, Inc. The
ANADA provides for the veterinary
prescription use of gentamicin sulfate
sroberts on DSK4TPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
21:03 Jan 24, 2012
Jkt 226001
and betamethasone valerate topical
spray in dogs.
DATES: This rule is effective January 25,
2012.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–170), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, (240) 276–8197,
email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Sparhawk
Laboratories, Inc., 12340 Santa Fe Trail
Dr., Lenexa, KS 66215, filed ANADA
200–416 that provides for veterinary
prescription use of Gentamicin Topical
Spray (gentamicin sulfate and
betamethasone valerate) in dogs.
Sparhawk Laboratories, Inc.’s
Gentamicin Topical Spray is approved
as a generic copy of Intervet, Inc.’s
GENTOCIN Topical Spray, approved
under NADA 132–338. The ANADA is
approved as of November 10, 2011, and
the regulations are amended in 21 CFR
524.1044f to reflect the approval and
revised terminology in the indication.
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 in 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 part 524 is amended as follows:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 524 continues to read as follows:
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PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
Authority: 21 U.S.C. 360b.
§ 524.1044f
[Amended]
2. In § 524.1044f, revise paragraphs (b)
and (c)(2) to read as follows:
■
§ 524.1044f Gentamicin and
betamethasone spray.
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(b) Sponsors. See Nos. 000061,
054925, 058005, 058829, and 065531 in
§ 510.600(c) of this chapter.
(c) * * *
(2) Indications for use. For the
treatment of infected superficial lesions
caused by bacteria susceptible to
gentamicin.
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Dated: January 19, 2012.
William T. Flynn,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. 2012–1501 Filed 1–24–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 203
[Docket No. FR–5156–F–02]
RIN 2502–AI58
Federal Housing Administration (FHA)
Single Family Lender Insurance
Process: Eligibility, Indemnification,
and Termination
Office of the Assistant
Secretary for Housing—Federal Housing
Commissioner, HUD.
ACTION: Final rule.
AGENCY:
This final rule updates and
enhances the Lender Insurance process,
through which the majority of Federal
Housing Administration (FHA)-insured
mortgages are endorsed for insurance.
These changes also further HUD efforts
to improve and expand the risk
management activities of the FHA. This
final rule follows the publication of an
October 8, 2010, proposed rule, and
takes into consideration public
comments received in response to it.
DATES: Effective Date: February 24,
2012.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Karin Hill, Director, Office of Single
Family Program Development, Office of
Housing, Department of Housing and
Urban Development, 451 Seventh Street
SW., Room 9278, Washington, DC
20410–8000; telephone number (202)
708–4308 (this is not a toll-free
number). Persons with hearing or
speech impairments may access these
E:\FR\FM\25JAR1.SGM
25JAR1
]]>Agencies
[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Rules and Regulations]
[Page 3598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1501]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
[Docket No. FDA-2011-N-0003]
Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin
and Betamethasone Spray
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the original approval of an abbreviated new
animal drug application (ANADA) filed by Sparhawk Laboratories, Inc.
The ANADA provides for the veterinary prescription use of gentamicin
sulfate and betamethasone valerate topical spray in dogs.
DATES: This rule is effective January 25, 2012.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, (240) 276-8197, email:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Sparhawk Laboratories, Inc., 12340 Santa Fe
Trail Dr., Lenexa, KS 66215, filed ANADA 200-416 that provides for
veterinary prescription use of Gentamicin Topical Spray (gentamicin
sulfate and betamethasone valerate) in dogs. Sparhawk Laboratories,
Inc.'s Gentamicin Topical Spray is approved as a generic copy of
Intervet, Inc.'s GENTOCIN Topical Spray, approved under NADA 132-338.
The ANADA is approved as of November 10, 2011, and the regulations are
amended in 21 CFR 524.1044f to reflect the approval and revised
terminology in the indication.
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 in 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 part 524 is
amended as follows:
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1044f [Amended]
0
2. In Sec. 524.1044f, revise paragraphs (b) and (c)(2) to read as
follows:
Sec. 524.1044f Gentamicin and betamethasone spray.
* * * * *
(b) Sponsors. See Nos. 000061, 054925, 058005, 058829, and 065531
in Sec. 510.600(c) of this chapter.
(c) * * *
(2) Indications for use. For the treatment of infected superficial
lesions caused by bacteria susceptible to gentamicin.
* * * * *
Dated: January 19, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1501 Filed 1-24-12; 8:45 am]
BILLING CODE 4160-01-P
