Ophthalmic and Topical Dosage Form New Animal Drugs; Chlorhexidine, 264-265 [E6-22514]
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264
Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Atipamezole
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC65 with RULES
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by Orion
Corp. The supplemental NADA adds a
claim for reversal of the sedative and
analgesic effects of dexmedetomidine
hydrochloride to labeling for
atipamezole hydrochloride injectable
solution for dogs.
DATES: This rule is effective January 4,
2007.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Orion
Corp., Orionintie 1, 02200 Espoo,
Finland, filed a supplement to NADA
141–033 for ANTISEDAN (atipamezole
hydrochloride), an injectable solution
approved for reversal of the sedative
and analgesic effects of medetomidine
hydrochloride in dogs. The
supplemental NADA adds a claim for
reversal of sedative and analgesic effects
of dexmedetomidine hydrochloride to
labeling for atipamezole hydrochloride
injectable solution for dogs. The
application is approved as of December
1, 2006, and the regulations are
amended in 21 CFR 522.147 to reflect
the approval and a current format.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii),
summaries of the safety and
effectiveness data and information
submitted to support approval of these
applications 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(d)(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
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00:35 Jan 04, 2007
Jkt 211001
nor an environmental impact statement
is required.
Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
approval qualifies for 3 years of
marketing exclusivity beginning
December 1, 2006.
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 Parts 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
the Center for Veterinary Medicine, 21
CFR part 522 is amended as follows:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 522.147, revise the section
heading and paragraphs (a) and (c) to
read as follows:
I
§ 522.147
Atipamezole.
(a) Specifications. Each milliliter of
solution contains 5.0 milligrams
atipamezole hydrochloride.
*
*
*
*
*
(c) Conditions of use in dogs—(1)
Amount. Inject intramuscularly the
same volume as that of
dexmedetomidine or medetomidine
used.
(2) Indications for use. For reversal of
the sedative and analgesic effects of
dexmedetomidine hydrochloride or
medetomidine hydrochloride.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: December 19, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–22515 Filed 1–3–07; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
Ophthalmic and Topical Dosage Form
New Animal Drugs; Chlorhexidine
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 a supplemental new animal
drug application (NADA) filed by Fort
Dodge Animal Health, Division of
Wyeth. The supplemental NADA
provides for a revised food safety
warning on labeling for chlorhexidine
ointment.
DATES: This rule is effective January 4,
2007.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort
Dodge Animal Health, Division of
Wyeth, 800 Fifth St. NW., Fort Dodge,
IA 50501, filed a supplement to NADA
9–782 for NOLVASAN (chlorhexidine
acetate) Antiseptic Ointment, approved
as a topical antiseptic for superficial
wounds of dogs, cats, and horses. The
supplemental NADA provides for a
revised food safety warning on labeling.
The supplemental application is
approved as of November 28, 2006, and
the regulations are amended in 21 CFR
524.402 to reflect the approval and a
current format.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
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.
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04JAR1
Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations
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:
I
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.
I
2. Revise § 524.402 to read as follows:
§ 524.402
Chlorhexidine.
(a) Specifications. Each gram of
ointment contains 10 milligrams
chlorhexidine acetate.
(b) Sponsors. See Nos. 000856 and
058829 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs, cats,
and horses—(1) Indications for use. For
use as a topical antiseptic ointment for
surface wounds.
(2) Limitations. Do not use in horses
intended for human consumption.
Dated: December 19, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–22514 Filed 1–3–07; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R04–OAR–2006–0577–200620(a);
FRL–8265–4]
Approval and Promulgation of
Implementation Plans; Tennessee:
Approval of Revisions to the Knox
County Portion of the Tennessee State
Implementation Plan
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
pwalker on PROD1PC65 with RULES
AGENCY:
SUMMARY: EPA is taking direct final
action to approve revisions to the
Tennessee State Implementation Plan
(SIP) submitted by the State of
Tennessee, through the Tennessee
Department of Environment and
Conservation (TDEC), on January 20,
2006. The revisions pertain to the Knox
County portion of the Tennessee SIP,
and include changes to the Knox County
Air Quality Regulations (KCAQR)
Section 46.0—‘‘Regulation of Volatile
Organic Compounds.’’ The changes
were made following EPA action on the
corresponding federal law. The changes
VerDate Aug<31>2005
00:35 Jan 04, 2007
Jkt 211001
add four compounds to the list of
compounds excluded from the
definition of volatile organic
compounds (VOC) on the basis that they
make a negligible contribution to ozone
formation. This action is being taken
pursuant to section 110 of the Clean Air
Act (CAA).
DATES: This direct final rule is effective
March 5, 2007 without further notice,
unless EPA receives adverse comment
by February 5, 2007. If adverse comment
is received, EPA will publish a timely
withdrawal of the direct final rule in the
Federal Register and inform the public
that the rule will not take effect.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R04–
OAR–2006–0577 by one of the following
methods:
1. https://www.regulations.gov: Follow
the on-line instructions for submitting
comments.
2. E-mail: louis.egide@epa.gov.
3. Fax: (404) 562–9019.
4. Mail: ‘‘EPA–R04–OAR–2006–
0577,’’ Regulatory Development Section,
Air Planning Branch, Air, Pesticides and
Toxics Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303–8960.
5. Hand Delivery or Courier: Dr. Egide
Louis, Regulatory Development Section,
Air Planning Branch, Air, Pesticides and
Toxics Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303–8960. Such
deliveries are only accepted during the
Regional Office’s normal hours of
operation. The Regional Office’s official
hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding
federal holidays.
Instructions: Direct your comments to
Docket ID No. EPA–R04–OAR–2006–
0577. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit through https://
www.regulations.gov or e-mail,
information that you consider to be CBI
or otherwise protected. The https://
www.regulations.gov Web site is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through https://
PO 00000
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265
www.regulations.gov, your e-mail
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses. For additional information
about EPA’s public docket visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the
electronic docket are listed in the https://
www.regulations.gov index. Although
listed in the index, some information is
not publicly available, i.e., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically in https://
www.regulations.gov or in hard copy at
the Regulatory Development Section,
Air Planning Branch, Air, Pesticides and
Toxics Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303–8960. EPA
requests that if at all possible, you
contact the person listed in the FOR
FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional
Office’s official hours of business are
Monday through Friday, 8:30 a.m. to
4:30 p.m. excluding federal holidays.
FOR FURTHER INFORMATION CONTACT: Dr.
Egide Louis, Regulatory Development
Section, Air Planning Branch, Air,
Pesticides and Toxics Management
Division, U.S. Environmental Protection
Agency, Region 4, 61 Forsyth Street,
SW., Atlanta, Georgia 30303–8960. The
telephone number is (404) 562–9240.
Dr. Louis can also be reached via
electronic mail at louis.egide@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Today’s Action
On January 20, 2006, the State of
Tennessee, through TDEC, submitted
revisions to the Knox County portion of
the Tennessee SIP to include changes to
KCAQR Section 46.0—‘‘Regulation of
Volatile Organic Compounds.’’ The
change adds four compounds to the list
E:\FR\FM\04JAR1.SGM
04JAR1
]]>Agencies
[Federal Register Volume 72, Number 2 (Thursday, January 4, 2007)]
[Rules and Regulations]
[Pages 264-265]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22514]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
Ophthalmic and Topical Dosage Form New Animal Drugs;
Chlorhexidine
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 a supplemental new animal drug
application (NADA) filed by Fort Dodge Animal Health, Division of
Wyeth. The supplemental NADA provides for a revised food safety warning
on labeling for chlorhexidine ointment.
DATES: This rule is effective January 4, 2007.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth,
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 9-
782 for NOLVASAN (chlorhexidine acetate) Antiseptic Ointment, approved
as a topical antiseptic for superficial wounds of dogs, cats, and
horses. The supplemental NADA provides for a revised food safety
warning on labeling. The supplemental application is approved as of
November 28, 2006, and the regulations are amended in 21 CFR 524.402 to
reflect the approval and a current format.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
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.
[[Page 265]]
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. Revise Sec. 524.402 to read as follows:
Sec. 524.402 Chlorhexidine.
(a) Specifications. Each gram of ointment contains 10 milligrams
chlorhexidine acetate.
(b) Sponsors. See Nos. 000856 and 058829 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use in dogs, cats, and horses--(1) Indications
for use. For use as a topical antiseptic ointment for surface wounds.
(2) Limitations. Do not use in horses intended for human
consumption.
Dated: December 19, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E6-22514 Filed 1-3-07; 8:45 am]
BILLING CODE 4160-01-S
