Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, Clotrimazole Ointment, 16481 [06-3149]
Download as PDF
<![CDATA[
Federal Register / Vol. 71, No. 63 / Monday, April 3, 2006 / Rules and Regulations
Issued in Renton, Washington, on March
17, 2006.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 06–3065 Filed 3–31–06; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
Ophthalmic and Topical Dosage Form
New Animal Drugs; Gentamicin
Sulfate, Betamethasone Valerate,
Clotrimazole Ointment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
cchase on PROD1PC60 with RULES
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
new animal drug application (ANADA)
filed by Med-Pharmex, Inc. The
supplemental ANADA provides for a
new container size, a 15-gram bottle,
from which gentamicin sulfate,
betamethasone valerate, clotrimazole
ointment may be dispensed for the
treatment of acute and chronic canine
otitis externa.
DATES: This rule is effective April 3,
2006.
FOR FURTHER INFORMATION CONTACT:
Christopher Melluso, Center for
Veterinary Medicine (HFV–104), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 301–827–
0169, e-mail:
christopher.melluso@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: MedPharmex, Inc., 2727 Thompson Creek
Rd., Pomona, CA 91767–1861, filed a
supplement to ANADA 200–229 that
provides for use of TRI-OTIC
(gentamicin sulfate, USP;
betamethasone valerate, USP; and
clotrimazole, USP) Ointment for the
treatment of canine otitis externa
associated with yeast (Malassezia
pachydermatis, formerly Pityrosporum
canis) and/or bacteria susceptible to
gentamicin. The supplement provides
for a new container size, a 15-gram
bottle. The supplemental ANADA is
approved as of February 27, 2006, and
the regulations are amended in
§ 524.1044g (21 CFR 524.1044g) to
reflect the approval. The basis of
approval is discussed in the freedom of
information summary.
VerDate Aug<31>2005
16:38 Mar 31, 2006
Jkt 208001
In addition, FDA has noticed that a
215-gram bottle size was approved for
this product under ANADA 200–229 but
not codified. At this time, that bottle
size is being added to § 524.1044g. This
action is being taken to improve the
accuracy of the regulations.
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(a)(1) 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.
I 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:
I
Authority: 21 U.S.C. 360b.
2. In § 524.1044g, revise paragraphs
(b)(2) and (c)(1)(i) to read as follows:
I
§ 524.1044g Gentamicin sulfate,
betamethasone valerate, clotrimazole
ointment.
*
*
*
*
*
(b) * * *
(2) No. 054925 for use of 7.5- or 15g tubes; 10-, 15-, 25-, or 215-g bottles.
*
*
*
*
*
(c) * * *
(1) * * *
(i) From 7.5- or 15-g tubes; 10-,
12.5-, 15-, 25-, or 30-g bottles: 4 drops
for dogs weighing less than 30 pounds
(lb) or 8 drops for dogs weighing 30 lb
or more.
*
*
*
*
*
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
16481
Dated: March 24, 2006.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 06–3149 Filed 3–31–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF STATE
22 CFR Part 34
[Public Notice: 5310]
Debt Collection
Department of State.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Department of State is
revising its debt collection regulations
to conform to changes in Federal
Government-wide debt collection laws
and regulations, including the Debt
Collection Improvement Act of 1996
and the revised Federal Claims
Collections Standards jointly issued by
the Department of the Treasury and
Department of Justice in 2000.
DATES: This rule is effective May 3,
2006.
ADDRESSES: You may submit comments
by any of the following methods:
• E-mail: AmoryER@state.gov
• Mail paper submissions to the
Deputy Assistant Secretary for Global
Financial Services, Charleston Financial
Service Center, P.O. Box 150008,
Charleston, S.C. 29415–5008.
Persons with access to the internet
may also view this notice by going to
the regulations.gov Web site at: https://
www.regulations.gov/index.cfm.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Amory, Office of the Legal
Adviser, Charleston Financial Service
Center, telephone 843–308–5605.
SUPPLEMENTARY INFORMATION: This rule
revises the Department of State’s (State)
debt collection regulations found at 22
CFR part 34 to conform to the Debt
Collection Improvement Act of 1996
(DCIA), Public Law 104–134, 110 Stat.
1321, 1358 (Apr. 26, 1996), the revised
Federal Claims Collection Standards, 31
CFR Chapter IX (parts 900 through 904),
and other laws applicable to the
collection of non-tax debt owed to the
Government.
This regulation provides procedures
for the collection of debts owed to State
entities. State adopts the Governmentwide debt collection standards
promulgated by the Departments of the
Treasury and Justice, known as the
Federal Claims Collection Standards
(FCCS), as revised on November 22,
2000 (65 FR 70390), and supplements
the FCCS by prescribing procedures
E:\FR\FM\03APR1.SGM
03APR1
]]>Agencies
[Federal Register Volume 71, Number 63 (Monday, April 3, 2006)]
[Rules and Regulations]
[Page 16481]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3149]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin
Sulfate, Betamethasone Valerate, Clotrimazole Ointment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental abbreviated new
animal drug application (ANADA) filed by Med-Pharmex, Inc. The
supplemental ANADA provides for a new container size, a 15-gram bottle,
from which gentamicin sulfate, betamethasone valerate, clotrimazole
ointment may be dispensed for the treatment of acute and chronic canine
otitis externa.
DATES: This rule is effective April 3, 2006.
FOR FURTHER INFORMATION CONTACT: Christopher Melluso, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
christopher.melluso@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd.,
Pomona, CA 91767-1861, filed a supplement to ANADA 200-229 that
provides for use of TRI-OTIC (gentamicin sulfate, USP; betamethasone
valerate, USP; and clotrimazole, USP) Ointment for the treatment of
canine otitis externa associated with yeast (Malassezia pachydermatis,
formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
The supplement provides for a new container size, a 15-gram bottle. The
supplemental ANADA is approved as of February 27, 2006, and the
regulations are amended in Sec. 524.1044g (21 CFR 524.1044g) to
reflect the approval. The basis of approval is discussed in the freedom
of information summary.
In addition, FDA has noticed that a 215-gram bottle size was
approved for this product under ANADA 200-229 but not codified. At this
time, that bottle size is being added to Sec. 524.1044g. This action
is being taken to improve the accuracy of the regulations.
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(a)(1) 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.
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 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.
0
2. In Sec. 524.1044g, revise paragraphs (b)(2) and (c)(1)(i) to read
as follows:
Sec. 524.1044g Gentamicin sulfate, betamethasone valerate,
clotrimazole ointment.
* * * * *
(b) * * *
(2) No. 054925 for use of 7.5- or 15-g tubes; 10-, 15-, 25-, or
215-g bottles.
* * * * *
(c) * * *
(1) * * *
(i) From 7.5- or 15-g tubes; 10-, 12.5-, 15-, 25-, or 30-g bottles:
4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs
weighing 30 lb or more.
* * * * *
Dated: March 24, 2006.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 06-3149 Filed 3-31-06; 8:45 am]
BILLING CODE 4160-01-S
