Implantation or Injectable Dosage Form New Animal Drugs; Doxapram, 260-261 [E6-22510]
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Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations
F2511012920095 with titanium-reinforced
brackets having P/N F2511305220096; and
perform any related investigative and
corrective actions (which may include
detailed inspections for cracking of the
bracket or damage to surrounding structure
caused by a broken bracket, and applicable
corrective actions for any damage that is
found); in accordance with the
Accomplishment Instructions of Airbus
Service Bulletins A330–25–3249 and A340–
25–4245, excluding Appendix 01, both dated
May 3, 2005, as applicable. If any crack is
found, before further flight, repair in
accordance with the applicable service
bulletin. Replacement of the affected bracket
with a titanium-reinforced bracket having
P/N F2511305220096 ends the repetitive
inspections required by paragraph (h) or (i)
of this AD. Although the service bulletins
specify to submit certain information to the
manufacturer, this AD does not include that
requirement.
Alternative Methods of Compliance
(AMOCs)
(l)(1) The Manager, International Branch,
ANM–116, has the authority to approve
AMOCs for this AD, if requested in
accordance with the procedures found in 14
CFR 39.19.
(2) Before using any AMOC approved in
accordance with 14 CFR 39.19 on any
airplane to which the AMOC applies, notify
the appropriate principal inspector in the
FAA Flight Standards Certificate Holding
District Office.
Related Information
(m) EASA airworthiness directives 2006–
0045 and 2006–0047, both dated February 16,
2006, also address the subject of this AD.
Material Incorporated by Reference
(n) You must use the applicable service
bulletin specified in Table 1 of this AD to
perform the actions that are required by this
AD, unless the AD specifies otherwise.
(1) The Director of the Federal Register
approved the incorporation by reference of
the service bulletins specified in Table 2 of
this AD in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51.
(2) On April 25, 2005 (70 FR 13345, March
21, 2005), the Director of the Federal Register
approved the incorporation by reference of
Airbus Service Bulletin A330–25–3227,
including Appendix 01, dated June 17, 2004;
and Airbus Service Bulletin A340–25–4230,
including Appendix 01, dated June 17, 2004.
(3) Contact Airbus, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France, for a
copy of this service information. You may
review copies at the Docket Management
Facility, U.S. Department of Transportation,
400 Seventh Street SW., Room PL–401,
Nassif Building, Washington, DC; on the
Internet at https://dms.dot.gov; or at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at the NARA,
call (202) 741–6030, or go to https://
www.archives.gov/federal_register/
code_of_federal_regulations/
ibr_locations.html.
TABLE 1.—ALL MATERIAL INCORPORATED BY REFERENCE
Airbus service bulletin
A330–25–3227,
A330–25–3227,
A330–25–3249
A340–25–4230,
A340–25–4230,
A340–25–4245
Revision level
including Appendix 01 .............
excluding Appendix 01 ............
..................................................
including Appendix 01 .............
excluding Appendix 01 ............
..................................................
Date
Original .............................................................
01 ......................................................................
Original .............................................................
Original .............................................................
01 ......................................................................
Original .............................................................
June 17, 2004.
May 3, 2005.
May 3, 2005.
June 17, 2004.
May 3, 2005.
May 3, 2005.
TABLE 2.—NEW MATERIAL INCORPORATED BY REFERENCE
Airbus service bulletin
A330–25–3227,
A330–25–3249
A340–25–4230,
A340–25–4245
Revision level
excluding Appendix 01 ............
..................................................
excluding Appendix 01 ............
..................................................
Issued in Renton, Washington, on
December 21, 2006.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. E6–22473 Filed 1–3–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
pwalker on PROD1PC65 with RULES
Implantation or Injectable Dosage
Form New Animal Drugs; Doxapram
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
VerDate Aug<31>2005
00:35 Jan 04, 2007
Jkt 211001
Date
01 ......................................................................
Original .............................................................
01 ......................................................................
Original .............................................................
May
May
May
May
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by
Modern Veterinary Therapeutics, LLC.
The ANADA provides for the use of
doxapram hydrochloride injectable
solution in dogs, cats, and horses to
stimulate respiration during and after
general anesthesia.
DATES: This rule is effective January 4,
2007.
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, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Modern
Veterinary Therapeutics, LLC, 18301
SW. 86th Ave., Miami, FL 33157, filed
ANADA 200–435 that provides for use
of RESPIRAM (doxapram
hydrochloride), an injectable solution,
in dogs, cats, and horses to stimulate
respiration during and after general
anesthesia. Modern Veterinary
Therapeutics, LLC’s RESPIRAM is
approved as a generic copy of
DOPRAM-V Injectable, sponsored by
Fort Dodge Animal Health, Division of
Wyeth, under NADA 034 879. The
ANADA is approved as of November 21,
2006, and the regulations are amended
in 21 CFR 522.775 to reflect the
approval and a current format. The basis
of approval is discussed in the freedom
of information summary.
In addition, Modern Veterinary
Therapeutics, LLC, has not been
previously 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 firm.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
PO 00000
Frm 00014
Fmt 4700
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E:\FR\FM\04JAR1.SGM
3,
3,
3,
3,
2005.
2005.
2005.
2005.
04JAR1
Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations
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.
*
*
*
*
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:
I
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add a
new entry for ‘‘Modern Veterinary
Therapeutics, LLC’’; and in the table in
paragraph (c)(2) numerically add a new
entry for ‘‘015914’’ to read as follows:
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
Firm name and address
Drug labeler
code
*
*
*
00:35 Jan 04, 2007
Jkt 211001
Food and Drug Administration
21 CFR Part 520
*
*
*
Modern Veterinary Therapeutics, LLC, 18301 SW.
86th Ave., Miami, FL
33157
*
*
*
4. Revise § 522.775 to read as follows:
Doxapram.
(a) Specifications. Each milliliter of
solution contains 20 milligrams (mg)
doxapram hydrochloride.
(b) Sponsor. See Nos. 000856 and
015914 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
For intravenous use in dogs and cats at
a dose of 21⁄2 to 5 mg per pound (/lb)
body weight in barbiturate anesthesia,
0.5 mg/lb in inhalation anesthesia; for
intravenous use in horses at 0.25 mg/lb
body weight in barbiturate anesthesia,
0.2 mg/lb in inhalation anesthesia, 0.25
mg/lb with chloral hydrate with or
without magnesium sulfate; for
subcutaneous, sublingual, or umbilical
vein administration in neonate puppies
at a dose rate of 1 to 5 mg; for
subcutaneous or sublingual use in
neonate kittens at 1 to 2 mg. Dosage may
be repeated in 15 to 20 minutes if
necessary.
(2) Indications for use. Administer to
dogs, cats, and horses to stimulate
respiration during and after general
anesthesia; or to speed awakening and
return of reflexes after anesthesia.
Administer to neonate dogs and cats to
initiate respiration following dystocia or
caesarean section; or to stimulate
respiration following dystocia or
caesarean section.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
*
PO 00000
Frm 00015
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Firm name and address
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
§ 522.775
Animal drugs.
pwalker on PROD1PC65 with RULES
*
015914
I
21 CFR Part 522
VerDate Aug<31>2005
*
(2) * * *
Drug labeler
code
Dated: December 19, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–22510 Filed 12–29–06; 8:45 am]
BILLING CODE 4160–01–S
Authority: 21 U.S.C. 360b.
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
*
015914
3. The authority citation for 21 CFR
part 522 continues to read as follows:
21 CFR Part 510
*
*
(c) * * *
(1) * * *
Modern Veterinary Therapeutics, LLC, 18301 SW.
86th Ave., Miami, FL
33157.
*
*
*
Drug labeler
code
I
List of Subjects
*
Firm name and address
261
Fmt 4700
Sfmt 4700
Oral Dosage Form New Animal Drugs;
Clomipramine Tablets
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
Novartis Animal Health US, Inc. The
supplemental NADA adds a 5-milligram
tablet size of clomipramine
hydrochloride, used in dogs for
treatment of separation anxiety.
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: Novartis
Animal Health US, Inc., 3200 Northline
Ave., suite 300, Greensboro, NC 27408,
filed a supplement to NADA 141–120
that provides for the veterinary
prescription use of CLOMICALM
(clomipramine hydrochloride) Tablets
for treatment of separation anxiety in
dogs. The supplement provides for a 5milligram tablet size of clomipramine
hydrochloride. The supplemental
NADA is approved as of November 22,
2006, and 21 CFR 520.455 is amended
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.
FDA has determined under 21 CFR
25.33(a)(1) that this action is of a type
E:\FR\FM\04JAR1.SGM
04JAR1
]]>Agencies
[Federal Register Volume 72, Number 2 (Thursday, January 4, 2007)]
[Rules and Regulations]
[Pages 260-261]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22510]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
Implantation or Injectable Dosage Form New Animal Drugs; Doxapram
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 abbreviated new animal drug
application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The
ANADA provides for the use of doxapram hydrochloride injectable
solution in dogs, cats, and horses to stimulate respiration during and
after general anesthesia.
DATES: This rule is effective January 4, 2007.
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: Modern Veterinary Therapeutics, LLC, 18301
SW. 86th Ave., Miami, FL 33157, filed ANADA 200-435 that provides for
use of RESPIRAM (doxapram hydrochloride), an injectable solution, in
dogs, cats, and horses to stimulate respiration during and after
general anesthesia. Modern Veterinary Therapeutics, LLC's RESPIRAM is
approved as a generic copy of DOPRAM-V Injectable, sponsored by Fort
Dodge Animal Health, Division of Wyeth, under NADA 034 879. The ANADA
is approved as of November 21, 2006, and the regulations are amended in
21 CFR 522.775 to reflect the approval and a current format. The basis
of approval is discussed in the freedom of information summary.
In addition, Modern Veterinary Therapeutics, LLC, has not been
previously 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 firm.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a
[[Page 261]]
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 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 ``Modern Veterinary Therapeutics, LLC''; and in the
table in paragraph (c)(2) numerically add a new entry for ``015914'' 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
------------------------------------------------------------------------
* * * * *
Modern Veterinary Therapeutics, LLC, 18301 015914
SW. 86th Ave., Miami, FL 33157.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
015914 Modern Veterinary Therapeutics, LLC, 18301
SW. 86th Ave., Miami, FL 33157
* * * * *
------------------------------------------------------------------------
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.
0
4. Revise Sec. 522.775 to read as follows:
Sec. 522.775 Doxapram.
(a) Specifications. Each milliliter of solution contains 20
milligrams (mg) doxapram hydrochloride.
(b) Sponsor. See Nos. 000856 and 015914 in Sec. 510.600(c) of this
chapter.
(c) Conditions of use--(1) Amount. For intravenous use in dogs and
cats at a dose of 2\1/2\ to 5 mg per pound (/lb) body weight in
barbiturate anesthesia, 0.5 mg/lb in inhalation anesthesia; for
intravenous use in horses at 0.25 mg/lb body weight in barbiturate
anesthesia, 0.2 mg/lb in inhalation anesthesia, 0.25 mg/lb with chloral
hydrate with or without magnesium sulfate; for subcutaneous,
sublingual, or umbilical vein administration in neonate puppies at a
dose rate of 1 to 5 mg; for subcutaneous or sublingual use in neonate
kittens at 1 to 2 mg. Dosage may be repeated in 15 to 20 minutes if
necessary.
(2) Indications for use. Administer to dogs, cats, and horses to
stimulate respiration during and after general anesthesia; or to speed
awakening and return of reflexes after anesthesia. Administer to
neonate dogs and cats to initiate respiration following dystocia or
caesarean section; or to stimulate respiration following dystocia or
caesarean section.
(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. E6-22510 Filed 12-29-06; 8:45 am]
BILLING CODE 4160-01-S
