New Animal Drugs; Flunixin, 70998-70999 [05-23294]
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70998
Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations
revised labeling for the veterinary
prescription use of injectable boldenone
solution in horses.
This rule is effective November
25, 2005.
DATES:
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.gov.
Fort
Dodge Animal Health, A Division of
Wyeth Holdings Corp., P.O. Box 1339,
Fort Dodge, IA 50501, filed a
supplement to NADA 34–705 that
provides for veterinary prescription use
of EQUIPOISE (boldenone
undecylenate) by injection in horses.
The supplemental NADA provides for a
revised indication and food safety
warning on labeling. The supplemental
NADA is approved as of October 7,
2005, and the regulations are amended
in 21 CFR 522.204 to reflect the
approval and a current format.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data. Therefore, a
freedom of information summary is not
required.
FDA 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.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 522
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
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. Section 522.204 is revised to read
as follows:
I
VerDate Aug<31>2005
12:24 Nov 23, 2005
Jkt 208001
§ 522.204
Boldenone.
(a) Specifications. Each milliliter of
solution contains 25 or 50 milligrams
(mg) boldenone undecylenate.
(b) Sponsor. See No. 053501 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. 0.5 mg per pound body weight
by intramuscular injection. Treatment
may be repeated at 3-week intervals.
(2) Indications for use. As an aid for
treating debilitated horses when an
improvement in weight, hair coat, or
general physical condition is desired.
(3) Limitations. Do not administer to
horses intended for human
consumption. Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
Dated: November 15, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–23295 Filed 11–23–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
New Animal Drugs; Flunixin
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
Schering-Plough Animal Health Corp.
The supplemental NADA provides for
the veterinary prescription use of
flunixin meglumine solution by
intramuscular injection for the control
of pyrexia associated with swine
respiratory disease.
DATES: This rule is effective November
25, 2005.
FOR FURTHER INFORMATION CONTACT: Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095
Morris Ave., Union, NJ 07083, filed a
supplement to NADA 101–479 that
provides for the veterinary prescription
use of BANAMINE-S (flunixin
meglumine) Injectable Solution by
intramuscular injection for the control
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Fmt 4700
Sfmt 4700
of pyrexia associated with swine
respiratory disease. The supplemental
NADA is approved as of November 1,
2005, and the regulations are amended
in 21 CFR 522.970 and 556.286 to reflect
the approval. The basis of approval is
discussed in the freedom of information
summary.
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.
Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360b(c)(2)(F)(iii)),
this supplemental approval qualifies for
3 years of marketing exclusivity
beginning November 1, 2005.
FDA has determined under
§ 25.33(d)(5) 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 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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 522 and 556 are 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. Section 522.970 is amended by
adding paragraph (e)(3) to read as
follows:
I
§ 522.970
Flunixin.
*
*
E:\FR\FM\25NOR1.SGM
*
25NOR1
*
*
Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations
(e) * * *
(3) Swine—(i) Amount. Administer
2.2 mg/kg (1.0 mg/lb) of body weight as
a single intramuscular injection.
(ii) Indications for use. For the control
of pyrexia associated with swine
respiratory disease.
(iii) Limitations. Swine must not be
slaughtered for human consumption
within 12 days of last treatment.
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
3. The authority citation for 21 CFR
part 556 continues to read as follows:
I
Authority: 21 U.S.C. 342, 360b, 371.
4. Section 556.286 is amended by
adding paragraph (b)(2) to read as
follows:
I
§ 556.286
Flunixin.
*
*
*
*
*
(b) * * *
(2) Swine. The tolerance for flunixin
free acid (the marker residue) is:
(i) Liver (the target tissue). 30 ppb.
(ii) Muscle. 25 ppb.
*
*
*
*
*
Dated: November 15, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–23294 Filed 11–23–05; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[R05–OAR–2005–IN–0007; FRL–7999–3]
Approval and Promulgation of
Implementation Plan; Indiana
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
SUMMARY: The EPA is approving
Indiana’s April 8, 2005, submittal which
revises existing sulfur dioxide (SO2)
emission limits for sources in Dearborn
County, makes minor corrections
removing obsolete rule language, and
updates information for sources listed in
the rule. These revisions will not result
in an increase in SO2 emissions in
Dearborn County because no emission
limits were increased.
DATES: This rule is effective on January
24, 2006, unless EPA receives adverse
written comments by December 27,
2005. If EPA receives adverse
comments, EPA will publish a timely
withdrawal of the rule in the Federal
VerDate Aug<31>2005
12:24 Nov 23, 2005
Jkt 208001
Register and inform the public that the
rule will not take effect.
ADDRESSES: Submit comments,
identified by Regional Material in
EDocket (RME) ID No. R05–OAR–2005–
IN–0007, by one of the following
methods:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
Agency Web site: https://
docket.epa.gov/rmepub/. Regional RME,
EPA’s electronic public docket and
comments system, is EPA’s preferred
method for receiving comments. Once
in the system, select ‘‘quick search,’’
then key in the appropriate RME Docket
identification number. Follow the online instructions for submitting
comments.
E-mail: mooney.john@epa.gov.
Fax: (312) 886–5824.
Mail: You may send written
comments to: John M. Mooney, Chief,
Criteria Pollutant Section, Air Programs
Branch (AR–18J), U.S. Environmental
Protection Agency, 77 West Jackson
Boulevard, Chicago, Illinois 60604.
Hand delivery: Deliver your
comments to: John M. Mooney, Chief,
Criteria Pollutant Section, Air Programs
Branch, (AR–18J), U.S. Environmental
Protection Agency, Region 5, 77 West
Jackson Boulevard, 18th floor, Chicago,
Illinois 60604.
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
RME ID No. R05–OAR–2005–IN–0007.
EPA’s policy is that all comments
received will be included in the public
docket without change, 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 information that you
consider to be CBI or otherwise
protected through RME, regulations.gov,
or e-mail. The EPA RME Web site and
the Federal regulations.gov Web site are
‘‘anonymous access’’ systems, 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 RME or
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
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70999
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 instructions on
submitting comments, go to Section I of
the SUPPLEMENTARY INFORMATION section
of the related proposed rule which is
published in the Proposed Rules section
of this Federal Register.
Docket: All documents in the
electronic docket are listed in the RME
index at https://docket.epa.gov/rmepub/.
Although listed in the index, some
information is not publicly available,
i.e., CBI or other information whose
disclosure is restricted by statute.
Publicly available docket materials are
available either electronically in RME or
in hard copy at Environmental
Protection Agency, Region 5, Air and
Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. We
recommend that you telephone Charles
Hatten, Environmental Engineer, at
(312) 886–6031 before visiting the
Region 5 office. This Facility is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays.
FOR FURTHER INFORMATION CONTACT:
Charles Hatten, Environmental
Engineer, Criteria Pollutant Section, Air
Programs Branch (AR–18J), U.S.
Environmental Protection Agency,
Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604, (312) 886–6031,
hatten.charles@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document whenever
‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean
EPA. This supplementary information
section is arranged as follows:
I. General Information.
A. Does This Action Apply to Me?
B. How Can I Get Copies of This Document
and Other Related Information?
C. How and to Whom Do I Submit
Comments?
II. What Is EPA Approving?
III. What Are the Changes From the Current
Rule?
IV. What Action Is EPA Taking Today?
V. Statutory and Executive Order Reviews.
I. General Information
A. Does This Action Apply to Me?
This action only applies to specific
SO2 sources located in Dearborn
County, Indiana.
E:\FR\FM\25NOR1.SGM
25NOR1
]]>Agencies
[Federal Register Volume 70, Number 226 (Friday, November 25, 2005)]
[Rules and Regulations]
[Pages 70998-70999]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23294]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
New Animal Drugs; Flunixin
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 Schering-Plough Animal Health Corp. The
supplemental NADA provides for the veterinary prescription use of
flunixin meglumine solution by intramuscular injection for the control
of pyrexia associated with swine respiratory disease.
DATES: This rule is effective November 25, 2005.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095
Morris Ave., Union, NJ 07083, filed a supplement to NADA 101-479 that
provides for the veterinary prescription use of BANAMINE-S (flunixin
meglumine) Injectable Solution by intramuscular injection for the
control of pyrexia associated with swine respiratory disease. The
supplemental NADA is approved as of November 1, 2005, and the
regulations are amended in 21 CFR 522.970 and 556.286 to reflect the
approval. The basis of approval is discussed in the freedom of
information summary.
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.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this
supplemental approval qualifies for 3 years of marketing exclusivity
beginning November 1, 2005.
FDA has determined under Sec. 25.33(d)(5) 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 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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 522 and
556 are amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Section 522.970 is amended by adding paragraph (e)(3) to read as
follows:
Sec. 522.970 Flunixin.
* * * * *
[[Page 70999]]
(e) * * *
(3) Swine--(i) Amount. Administer 2.2 mg/kg (1.0 mg/lb) of body
weight as a single intramuscular injection.
(ii) Indications for use. For the control of pyrexia associated
with swine respiratory disease.
(iii) Limitations. Swine must not be slaughtered for human
consumption within 12 days of last treatment.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
3. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
4. Section 556.286 is amended by adding paragraph (b)(2) to read as
follows:
Sec. 556.286 Flunixin.
* * * * *
(b) * * *
(2) Swine. The tolerance for flunixin free acid (the marker
residue) is:
(i) Liver (the target tissue). 30 ppb.
(ii) Muscle. 25 ppb.
* * * * *
Dated: November 15, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 05-23294 Filed 11-23-05; 8:45 am]
BILLING CODE 4160-01-S
