Implantation or Injectable Dosage Form New Animal Drugs; Flunixin, 34236 [E9-16735]
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Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Rules and Regulations
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
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(c) * * *
(1) * * *
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Firm name and address
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Cephazone Pharma, LLC,
250 East Bonita Ave.,
Pomona, CA 91767
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Drug labeler
code
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068330
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(2) * * *
Drug labeler
code
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068330
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Firm name and address
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Cephazone Pharma, LLC,
250 East Bonita Ave.,
Pomona, CA 91767
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PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
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Authority: 21 U.S.C. 360b.
4. In § 522.313c, revise paragraph (b)
to read as follows:
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§ 522.313c
Ceftiofur sodium
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(b) Sponsors. See Nos. 000009 and
068330 in § 510.600(c) of this chapter.
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Dated: July 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–16734 Filed 7–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2009–N–0665]
Implantation or Injectable Dosage
Form New Animal Drugs; Flunixin
AGENCY:
Food and Drug Administration,
srobinson on DSKHWCL6B1PROD with RULES
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original abbreviated new
animal drug application (ANADA) filed
by Norbrook Laboratories, Ltd. The
SUMMARY:
VerDate Nov<24>2008
15:15 Jul 14, 2009
Jkt 217001
ANADA provides for the use of flunixin
meglumine injectable solution in swine.
DATES: This rule is effective July 15,
2009.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197,
e-mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook
Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed
ANADA 200–476 that provides for use
of Flunixin Injection -S in swine for
various bacterial infections. Norbrook
Laboratories, Ltd.’s Flunixin Injection -S
is approved as a generic copy of
BANAMINE–S (flunixin meglumine)
injectable solution, sponsored by
Schering-Plough Animal Health Corp.
under NADA 101–479. The ANADA is
approved as of June 22, 2009, 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 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 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:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
PO 00000
Authority: 21 U.S.C. 360b.
Frm 00028
Fmt 4700
Sfmt 4700
2. In § 522.970, revise paragraphs
(b)(1) and (b)(4) to read as follows:
■
§ 522.970
Flunixin.
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(b) * * *
(1) See Nos. 000061 and 055529 for
use as in paragraph (e) of this section.
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(4) See Nos. 059130 and 061623 for
use as in paragraphs (e)(1) and (e)(2) of
this section.
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Dated: July 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–16735 Filed 7–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2009–N–0665]
New Animal Drugs for Use in Animal
Feeds; Lasalocid; Roxarsone
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 an original new animal drug
application (NADA) filed by Alpharma
Inc. The NADA provides for use of
single-ingredient Type A medicated
articles containing lasalocid and
roxarsone to formulate two-way
combination drug Type C medicated
feeds for use in growing turkeys.
DATES: This rule is effective July 15,
2009.
FOR FURTHER INFORMATION CONTACT:
Timothy Schell, Center for Veterinary
Medicine (HFV–128), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8116,
e-mail: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma
Inc., 440 Rte. 22, Bridgewater, NJ 08807,
filed NADA 141–293 that provides for
use of AVATEC (lasalocid sodium) and
3-NITRO (roxarsone) single-ingredient
Type A medicated articles to formulate
two-way combination drug Type C
medicated feeds for use in growing
turkeys. The NADA is approved as of
May 22, 2009, and the regulations are
amended in 21 CFR 558.311 and
§ 558.530 (21 CFR 558.530) to reflect the
approval.
E:\FR\FM\15JYR1.SGM
15JYR1
]]>Agencies
[Federal Register Volume 74, Number 134 (Wednesday, July 15, 2009)]
[Rules and Regulations]
[Page 34236]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16735]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2009-N-0665]
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 an original abbreviated new
animal drug application (ANADA) filed by Norbrook Laboratories, Ltd.
The ANADA provides for the use of flunixin meglumine injectable
solution in swine.
DATES: This rule is effective July 15, 2009.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed ANADA 200-476 that provides for
use of Flunixin Injection -S in swine for various bacterial infections.
Norbrook Laboratories, Ltd.'s Flunixin Injection -S is approved as a
generic copy of BANAMINE-S (flunixin meglumine) injectable solution,
sponsored by Schering-Plough Animal Health Corp. under NADA 101-479.
The ANADA is approved as of June 22, 2009, 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 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 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:
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 paragraphs (b)(1) and (b)(4) to read as
follows:
Sec. 522.970 Flunixin.
* * * * *
(b) * * *
(1) See Nos. 000061 and 055529 for use as in paragraph (e) of this
section.
* * * * *
(4) See Nos. 059130 and 061623 for use as in paragraphs (e)(1) and
(e)(2) of this section.
* * * * *
Dated: July 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-16735 Filed 7-14-09; 8:45 am]
BILLING CODE 4160-01-S
