New Animal Drugs; Change of Sponsor; Methoxyflurane, 9766-9767 [E9-4758]
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9766
Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Rules and Regulations
or 505(j)(2)(A)(vii)(IV) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 355(b)(2)(A)(iv) or
355(j)(2)(A)(vii)(IV)). The Division of
Drug Information Resources no longer
exists. The agency contact for this
information is now the Orange Book
Staff, Office of Generic Drugs.
In § 314.53(f), FDA is updating the
agency unit to which notifications of
requests for correction of patent
information should be directed. The
Drug Information Services Branch no
longer exists. These notifications should
now be sent to the Office of Generic
Drugs Document Room, attention the
Orange Book Staff.
In § 314.107(e), FDA is updating the
listing of agency units to which a
505(b)(2) applicant must send
notification of entry of an order or
judgment in a court action. Instead of
the appropriate division in the Office of
Drug Evaluation I and Office of Drug
Evaluation II, these notifications should
now be sent to the appropriate division
in the Office of New Drugs.
In § 314.107(f)(2)(iv), FDA is updating
the agency recipient of a 505(b)(2)
applicant’s required notification that a
legal action has been filed within 45
days of receipt of a notice of paragraph
IV certification (submitted under section
505(b)(2)(A)(iv) of the act) from the
appropriate division in the Center for
Drug Evaluation and Research to the
appropriate division in the Office of
New Drugs.
In § 314.125(b)(16), FDA is correcting
a cross-reference to the agency’s
regulations on institutional review
boards (21 CFR part 56) by replacing
‘‘part 58’’ with ‘‘part 56.’’
Publication of this document
constitutes final action under the
Administrative Procedure Act (5 U.S.C.
553). FDA has determined that notice
and public comment are unnecessary
because the amendments to the
regulations provide only technical
changes to correct an inaccurate citation
and to update agency contacts, and are
nonsubstantive.
mstockstill on PROD1PC66 with RULES
List of Subjects in 21 CFR Part 314
Administrative practice and
procedure, Confidential business
information, Drugs, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 314 is
amended as follows:
■
VerDate Nov<24>2008
16:15 Mar 05, 2009
Jkt 217001
PART 314—APPLICATIONS FOR FDA
APPROVAL TO MARKET A NEW DRUG
1. The authority citation for 21 CFR
part 314 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 356, 356a, 356b, 356c, 371, 374,
379e.
§ 314.52
[Amended]
Dated: February 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy.
[FR Doc. E9–4813 Filed 3–5–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
2. Section 314.52 is amended in
paragraph (a)(2) by removing ‘‘Division
of Drug Information Resources (HFD–
80), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857’’ and by adding in
its place ‘‘Orange Book Staff, Office of
Generic Drugs, at the address identified
on FDA’s Web site (https://www.fda.gov/
cder/ogd)’’.
■
§ 314.53
[Amended]
3. Section 314.53 is amended in
paragraph (f) by removing ‘‘Drug
Information Services Branch (HFD–84),
Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857’’ and by adding in
its place ‘‘Office of Generic Drugs, OGD
Document Room, Attention: Orange
Book Staff, at the address identified on
FDA’s Web site (https://www.fda.gov/
cder/ogd)’’.
■
§ 314.95
[Amended]
4. Section 314.95 is amended in
paragraph (a)(2) by removing ‘‘Division
of Drug Information Resources (HFD–
80), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857’’ and by adding in
its place ‘‘Orange Book Staff, Office of
Generic Drugs, at the address identified
on FDA’s Web site (https://www.fda.gov/
cder/ogd)’’.
■
§ 314.107
[Amended]
5. Section 314.107 is amended in
paragraph (e) by removing ‘‘Office of
Drug Evaluation I (HFD–100) or Office
of Drug Evaluation II (HFD–500),
whichever is applicable,’’ and by adding
in its place ‘‘Office of New Drugs’’ and
in paragraph (f)(2)(iv) by removing
‘‘Center for Drug Evaluation and
Research’’ and by adding in its place
‘‘Office of New Drugs’’.
■
§ 314.125
[Amended]
6. Section 314.125 is amended in
paragraph (b)(16) by removing ‘‘part 58’’
and by adding in its place ‘‘part 56’’.
■
PO 00000
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21 CFR Parts 510 and 529
[Docket No. FDA–2009–N–0665]
New Animal Drugs; Change of
Sponsor; Methoxyflurane
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 a new animal drug
application (NADA) from ScheringPlough Animal Health, Inc., to Medical
Developments International, Ltd.
DATES:
This rule is effective March 6,
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.
ScheringPlough Animal Health Corp., 556 Morris
Ave., Summit, NJ 07901, has informed
FDA that it has transferred ownership
of, and all rights and interest in, NADA
14–485 for ANAFANE (methoxyflurane)
Volatile Liquid for Inhalation
Anesthesia to Medical Developments
International, Ltd., P.O. Box 21,
Sandown Village, 3171 VIC Australia.
Medical Developments International,
Ltd., is not currently listed in the animal
drug regulations as a sponsor of an
approved application. In addition, FDA
has noticed that this new animal drug
has not been previously codified in 21
CFR part 529. Accordingly, the
regulations are amended in 21 CFR
510.600(c) to add entries for Medical
Developments International, Ltd., and in
21 CFR part 529 to add this new animal
drug.
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:
E:\FR\FM\06MRR1.SGM
06MRR1
Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Rules and Regulations
List of Subjects
§ 529.1455
21 CFR Part 510
(a) Specifications. Methoxyflurane
liquid.
(b) Sponsor. See No. 025245 in
§ 510.600 of this chapter.
(c) Conditions of use—(1) Amount.
The amount of methoxyflurane used
depends on the weight of the patient,
the depth of anesthesia, and the type of
equipment used. Anesthesia may be
induced with methoxyflurane alone, or
by the intravenous administration of a
short-acting general anesthetic or by
inhalation of another anesthetic agent.
(2) Indications for use. For the
induction and maintenance of general
anesthesia.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 529
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 parts 510 and 529 are amended as
follows:
■
PART 510—NEW ANIMAL DRUGS
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.
2. In § 510.600, in the table in
paragraph (c)(1) alphabetically add an
entry for ‘‘Medical Developments
International, Ltd.’’; and in the table in
paragraph (c)(2) numerically add an
entry for ‘‘025245’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
Drug labeler
code
*
025245
*
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
*
ACTION:
Firm name and address
*
*
025245 .........
*
*
*
Medical Developments
International, Ltd.,P.O.
Box 21, Sandown Village, 3171 VIC Australia
*
*
*
*
*
*
mstockstill on PROD1PC66 with RULES
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 529 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
4. Add § 529.1455 to read as follows:
VerDate Nov<24>2008
16:15 Mar 05, 2009
Jkt 217001
Drawbridge Operation Regulation;
Park Street Drawbridge, Oakland Inner
Harbor, Alameda, CA
AGENCY:
*
Drug labeler
code
*
DEPARTMENT OF HOMELAND
SECURITY
33 CFR Part 117
(2) * * *
*
BILLING CODE 4160–01–S
[Docket No. USCG–2009–0026]
*
*
*
Medical Developments
International, Ltd.,P.O.
Box 21, Sandown Village, 3171 VIC Australia
*
*
*
*
Dated: March 3, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E9–4758 Filed 3–5–09; 8:45 am]
Coast Guard
*
Firm name and address
*
Methoxyflurane.
SUMMARY: The Commander, Eleventh
Coast Guard District, has issued a
temporary deviation from the regulation
governing the operation of the Park
Street drawbridge across the Oakland
Inner Harbor, mile 5.2, at Alameda, CA.
The deviation is necessary to allow
seismic retrofitting of the bridge. This
deviation allows single leaf operation of
the double leaf, bascule style
drawbridge, during the deviation
period.
DATES: This deviation is effective from
12:01 a.m. on February 1, 2009 until
11:59 p.m. on May 31, 2009.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of the docket USCG–
2009–0026 and are available online at
https://www.regulations.gov. They are
also available for inspection or copying
at two locations: the Docket
Management Facility (M–30), U.S.
PO 00000
Frm 00009
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Sfmt 4700
9767
Department of Transportation, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays, and the
Commander (dpw), Eleventh Coast
Guard District, Building 50–2, Coast
Guard Island, Alameda, CA 94501–
5100, between 8 a.m. and 4 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT:
David H. Sulouff, Chief, Bridge Section,
Eleventh Coast Guard District,
telephone (510) 437–3516. If you have
questions on viewing the docket, call
Renee Wright, Program Manager, Docket
Operations, telephone (202) 366–9826.
SUPPLEMENTARY INFORMATION: The
County of Alameda requested a
temporary change to the operation of the
Park Street drawbridge across the
Oakland Inner Harbor, mile 5.2, at
Alameda, CA. The Park Street
drawbridge navigation span provides a
horizontal clearance of 241 feet between
pier fenders. During single leaf
operation, horizontal clearance is
reduced to approximately 100 feet. The
drawbridge provides a vertical clearance
of 15 feet above Mean High Water in the
closed-to-navigation position and
unlimited vertical clearance in the
open-to-navigation position. As required
by 33 CFR 117.181, the draw shall open
on signal; except that, from 8 a.m. to 9
a.m. and 4:30 p.m. to 6:30 p.m. Monday
through Friday except Federal holidays,
the draw need not be opened for the
passage of vessels. However, the draw
shall open during the above closed
periods for vessels which must, for
reasons of safety, move on a tide or
slack water, if at least two hours notice
is given. The waterway is navigated by
commercial, recreational, emergency
and law enforcement vessels.
Between the hours of 7 a.m. and 9
p.m. Monday through Thursday, and
between the hours of 7 a.m. and 3:30
p.m. on Friday, the drawspan will be
operated, one leaf at a time, while the
opposite leaf, counterweight and hinges
are seismically retrofitted. The
drawbridge will be operated in the
normal double leaf operation mode at
night and on weekends, when work is
not actually being performed on the
bridge. The starting and ending dates for
the project are from 12:01 a.m. on
February 1, 2009 until 11:59 p.m. on
May 31, 2009. This temporary deviation
has been coordinated with the waterway
users. The largest tug and barge
combination on the waterway will be
able to continue navigating safely
through the bridge. Recreational and
E:\FR\FM\06MRR1.SGM
06MRR1
]]>Agencies
[Federal Register Volume 74, Number 43 (Friday, March 6, 2009)]
[Rules and Regulations]
[Pages 9766-9767]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4758]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 529
[Docket No. FDA-2009-N-0665]
New Animal Drugs; Change of Sponsor; Methoxyflurane
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 a new animal drug
application (NADA) from Schering-Plough Animal Health, Inc., to Medical
Developments International, Ltd.
DATES: This rule is effective March 6, 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: Schering-Plough Animal Health Corp., 556
Morris Ave., Summit, NJ 07901, has informed FDA that it has transferred
ownership of, and all rights and interest in, NADA 14-485 for ANAFANE
(methoxyflurane) Volatile Liquid for Inhalation Anesthesia to Medical
Developments International, Ltd., P.O. Box 21, Sandown Village, 3171
VIC Australia.
Medical Developments International, Ltd., is not currently listed
in the animal drug regulations as a sponsor of an approved application.
In addition, FDA has noticed that this new animal drug has not been
previously codified in 21 CFR part 529. Accordingly, the regulations
are amended in 21 CFR 510.600(c) to add entries for Medical
Developments International, Ltd., and in 21 CFR part 529 to add this
new animal drug.
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.
[[Page 9767]]
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 529
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
529 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 an entry for ``Medical Developments International, Ltd.''; and in
the table in paragraph (c)(2) numerically add an entry for ``025245''
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
------------------------------------------------------------------------
* * * * *
Medical Developments International, 025245
Ltd.,P.O. Box 21, Sandown Village, 3171 VIC
Australia
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
025245..................... Medical Developments International,
Ltd.,P.O. Box 21, Sandown Village, 3171
VIC Australia
* * * * *
------------------------------------------------------------------------
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. Add Sec. 529.1455 to read as follows:
Sec. 529.1455 Methoxyflurane.
(a) Specifications. Methoxyflurane liquid.
(b) Sponsor. See No. 025245 in Sec. 510.600 of this chapter.
(c) Conditions of use--(1) Amount. The amount of methoxyflurane
used depends on the weight of the patient, the depth of anesthesia, and
the type of equipment used. Anesthesia may be induced with
methoxyflurane alone, or by the intravenous administration of a short-
acting general anesthetic or by inhalation of another anesthetic agent.
(2) Indications for use. For the induction and maintenance of
general anesthesia.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: March 3, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-4758 Filed 3-5-09; 8:45 am]
BILLING CODE 4160-01-S
