New Animal Drugs; Change of Sponsor; Ketamine, 66573 [E9-29888]
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Federal Register / Vol. 74, No. 240 / Wednesday, December 16, 2009 / Rules and Regulations
66573
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 510 and 522 are amended as
follows:
21 CFR Parts 510 and 522
PART 510—NEW ANIMAL DRUGS
21 CFR Part 522
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2009–N–0665]
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
New Animal Drugs; Change of
Sponsor; Ketamine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for an abbreviated
new animal drug application (ANADA)
for ketamine hydrochloride injectable
solution from Bioniche Animal Health
USA, Inc., to Bioniche Teoranta.
DATES: This rule is effective December
16, 2009.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Bioniche
Animal Health USA, Inc., 119 Rowe Rd.,
Athens, GA 30601, has informed FDA
that it has transferred ownership of, and
all rights and interest in, ANADA 200–
257 for Ketamine HCl (ketamine
hydrochloride injection, USP) to
Bioniche Teoranta, Inverin, County
Galway, Ireland. Accordingly, the
agency is amending the regulations in
21 CFR 522.1222a to reflect the transfer
of ownership.
In addition, Bioniche Teoranta is not
currently listed in the animal drug
regulations as a sponsor of an approved
application. Accordingly, 21 CFR
510.600(c) is being amended to add
entries for this sponsor.
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.
mstockstill on DSKH9S0YB1PROD with RULES
List of Subjects
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
Drug labeler
code
*
*
*
*
Bioniche Teoranta, Inverin,
County Galway, Ireland
*
*
*
*
063286
*
*
(2) * * *
Drug labeler
code
*
Firm name and address
*
063286
*
*
*
*
Bioniche Teoranta, Inverin,
County Galway, Ireland
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
[Amended]
4. In paragraph (b) of § 522.1222a,
remove ‘‘064847’’ and add in its place
‘‘063286’’.
■
21 CFR Part 522
Animal drugs.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
Jkt 220001
*
Firm name and address
§ 522.1222a
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
16:12 Dec 15, 2009
2. In § 510.600, in the table in
paragraph (c)(1) alphabetically add a
new entry for ‘‘Bioniche Teoranta’’; and
in the table in paragraph (c)(2)
numerically add a new entry for
‘‘063286’’ to read as follows:
■
Final rule.
VerDate Nov<24>2008
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Dated: December 10, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–29888 Filed 12–15–09; 8:45 am]
BILLING CODE 4160–01–S
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Food and Drug Administration
[Docket No. FDA–2009–N–0665]
Implantation or Injectable Dosage
Form New Animal Drugs; Florfenicol
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
Intervet, Inc. The supplemental NADA
adds Mycoplasma bovis to the bovine
respiratory disease pathogens for which
florfenicol injectable solution is
approved as a treatment.
DATES: This rule is effective December
16, 2009.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
Intervet,
Inc., 56 Livingston Ave., Roseland, NJ
07068, filed a supplement to NADA
141–265 that provides for use of
NUFLOR GOLD (florfenicol) Injectable
Solution for treatment of bovine
respiratory disease in beef and nonlactating dairy cattle. The supplement
adds Mycoplasma bovis to the list of
pathogens for which use of this product
is approved. The supplemental NADA is
approved as of September 4, 2009, and
the regulations are amended in 21 CFR
522.955 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 Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
supplemental approval qualifies for 3
years of marketing exclusivity beginning
on the date of approval.
The agency has determined under 21
CFR 25.33 that this action is of a type
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16DER1.SGM
16DER1
]]>Agencies
[Federal Register Volume 74, Number 240 (Wednesday, December 16, 2009)]
[Rules and Regulations]
[Page 66573]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-29888]
[[Page 66573]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA-2009-N-0665]
New Animal Drugs; Change of Sponsor; Ketamine
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for an abbreviated new
animal drug application (ANADA) for ketamine hydrochloride injectable
solution from Bioniche Animal Health USA, Inc., to Bioniche Teoranta.
DATES: This rule is effective December 16, 2009.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Bioniche Animal Health USA, Inc., 119 Rowe
Rd., Athens, GA 30601, has informed FDA that it has transferred
ownership of, and all rights and interest in, ANADA 200-257 for
Ketamine HCl (ketamine hydrochloride injection, USP) to Bioniche
Teoranta, Inverin, County Galway, Ireland. Accordingly, the agency is
amending the regulations in 21 CFR 522.1222a to reflect the transfer of
ownership.
In addition, Bioniche Teoranta is not currently listed in the
animal drug regulations as a sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this
sponsor.
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 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 parts 510 and
522 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1) alphabetically
add a new entry for ``Bioniche Teoranta''; and in the table in
paragraph (c)(2) numerically add a new entry for ``063286'' to read as
follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Bioniche Teoranta, Inverin, County Galway, 063286
Ireland
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
063286 Bioniche Teoranta, Inverin, County Galway,
Ireland
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1222a [Amended]
0
4. In paragraph (b) of Sec. 522.1222a, remove ``064847'' and add in
its place ``063286''.
Dated: December 10, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29888 Filed 12-15-09; 8:45 am]
BILLING CODE 4160-01-S
