Implantation or Injectable Dosage Form New Animal Drugs; Flunixin, 2808-2809 [E8-699]
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Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Firocoxib Tablets
AGENCY:
Food and Drug Administration,
HHS.
ebenthall on PRODPC61 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 Merial
Ltd. The supplemental NADA provides
for veterinary prescription use of
firocoxib chewable tablets in dogs for
the control of postoperative pain and
inflammation associated with soft-tissue
surgery.
DATES: This rule is effective January 16,
2008.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Merial
Ltd., 3239 Satellite Blvd., Bldg. 500,
Duluth, GA 30096–4640, filed a
supplement to NADA 141–230 for
PREVICOX (firocoxib) Chewable
Tablets. The supplemental application
provides for the veterinary prescription
use of firocoxib chewable tablets in dogs
for the control of postoperative pain and
inflammation associated with soft-tissue
surgery. The NADA is approved as of
December 18, 2007, and the regulations
in 21 CFR 520.928 are amended to
reflect the approval.
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 Cosmetics Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
approval qualifies for 3 years of
marketing exclusivity beginning on the
date of approval.
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
VerDate Aug<31>2005
15:01 Jan 15, 2008
Jkt 214001
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 520
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 520 is amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 520.928, revise paragraphs
(c)(1) and (c)(2) to read as follows:
I
§ 520.928
Firocoxib tablets.
*
*
*
*
*
(c) * * *
(1) Amount. 5 mg/kg (2.27 mg/lb)
body weight. Administer once daily for
osteoarthritis. Administer
approximately 2 hours before soft-tissue
surgery.
(2) Indications for use. For the control
of pain and inflammation associated
with osteoarthritis and for the control of
postoperative pain and inflammation
associated with soft-tissue surgery.
*
*
*
*
*
Dated: January 4, 2008.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E8–730 Filed 1–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Flunixin
AGENCY:
Final rule.
Frm 00016
Fmt 4700
This rule is effective January 16,
2008.
John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Norbrook
Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed
supplemental ANADA 200–308 that
provides for veterinary prescription use
of Flunixin Injection intravenously in
lactating dairy cattle for control of
pyrexia associated with acute bovine
mastitis. The supplemental ANADA is
approved as of December 19, 2007, and
the regulations are amended in 21 CFR
522.970 to reflect the approval.
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.
SUPPLEMENTARY INFORMATION:
List of Subject in 21 CFR Part 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
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
PO 00000
DATES:
Food and Drug Administration,
HHS.
ACTION:
new animal drug application (ANADA)
filed by Norbrook Laboratories, Ltd. The
supplemental ANADA provides for the
veterinary prescription use of flunixin
meglumine solution by intravenous
injection in lactating dairy cattle for
control of pyrexia associated with acute
bovine mastitis.
Sfmt 4700
E:\FR\FM\16JAR1.SGM
16JAR1
Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations
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 § 522.970, revise paragraph (b)(2)
and add paragraph (b)(4) to read as
follows:
I
§ 522.970
Flunixin.
*
*
*
*
*
(b) * * *
(2) See Nos. 057561, 059130, and
061623 for use as in paragraphs (e)(1),
(e)(2)(i)(A), (e)(2)(ii)(A), and (e)(2)(iii), of
this section.
*
*
*
*
*
(4) See No. 055529 for use as in
paragraphs (e)(1) and (e)(2) of this
section.
*
*
*
*
*
Dated: January 4, 2008.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E8–699 Filed 1–15–08; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0733; FRL–8348–1]
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (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 in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; e-mail address:
stanton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
Acetamiprid; Pesticide Tolerance
I. General Information
Environmental Protection
Agency (EPA).
ACTION: Final rule.
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
ebenthall on PRODPC61 with RULES
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of acetamiprid in
or on bushberry subgroup 13–07B;
caneberry subgroup 13–07A; low
growing berry subgroup 13–07G; onion,
bulb, subgroup 3–07A; and onion,
green, subgroup 3–07B. Nippon Soda
Co., Ltd. requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 16, 2008. Objections and
requests for hearings must be received
on or before March 17, 2008, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION.
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0733. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
VerDate Aug<31>2005
15:01 Jan 15, 2008
Jkt 214001
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
2809
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s pilot
e-CFR site at https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, any
person may file an objection to any
aspect of this regulation and may also
request a hearing on those objections.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2006–0733 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before March 17, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2006–0733, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
E:\FR\FM\16JAR1.SGM
16JAR1
]]>Agencies
[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Rules and Regulations]
[Pages 2808-2809]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-699]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form 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 abbreviated new
animal drug application (ANADA) filed by Norbrook Laboratories, Ltd.
The supplemental ANADA provides for the veterinary prescription use of
flunixin meglumine solution by intravenous injection in lactating dairy
cattle for control of pyrexia associated with acute bovine mastitis.
DATES: This rule is effective January 16, 2008.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed supplemental ANADA 200-308 that
provides for veterinary prescription use of Flunixin Injection
intravenously in lactating dairy cattle for control of pyrexia
associated with acute bovine mastitis. The supplemental ANADA is
approved as of December 19, 2007, and the regulations are amended in 21
CFR 522.970 to reflect the approval.
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 Subject in 21 CFR Part 522
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 522 is
amended as follows:
[[Page 2809]]
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. In Sec. 522.970, revise paragraph (b)(2) and add paragraph (b)(4)
to read as follows:
Sec. 522.970 Flunixin.
* * * * *
(b) * * *
(2) See Nos. 057561, 059130, and 061623 for use as in paragraphs
(e)(1), (e)(2)(i)(A), (e)(2)(ii)(A), and (e)(2)(iii), of this section.
* * * * *
(4) See No. 055529 for use as in paragraphs (e)(1) and (e)(2) of
this section.
* * * * *
Dated: January 4, 2008.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E8-699 Filed 1-15-08; 8:45 am]
BILLING CODE 4160-01-S
