New Animal Drugs; Change of Sponsor; Isoflurane, 43967 [E6-12570]
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Federal Register / Vol. 71, No. 149 / Thursday, August 3, 2006 / Rules and Regulations
Related Information
(l) Information related to the subject of this
AD can be found in Rolls-Royce Corporation
Alert Commercial Engine Bulletins (CEBs),
all at Revision 1, and all dated August 30,
2004, listed in the following Table 5:
TABLE 5.—RELATED ALERT
COMMERCIAL ENGINE BULLETINS
CEB–A–313 ...................
CEB–A–73–2075 ...........
CEB–A–1394 .................
CEB–A–73–3118 ...........
CEB–A–73–4056 ...........
CEB–A–73–5029
CEB–A–73–6041
TP CEB–A–183
TP CEB–A–1336
TP CEB–A–73–
2032
Issued in Burlington, Massachusetts, on
July 27, 2006.
Francis A. Favara,
Manager, Engine and Propeller Directorate,
Aircraft Certification Service.
[FR Doc. E6–12420 Filed 8–2–06; 8:45 am]
Following these changes of
sponsorship, Rhodia UK Ltd. is no
longer the sponsor of an approved
application. In addition, Nicholas
Piramal India Ltd. UK 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 remove the entries for
Rhodia UK Ltd. to add entries for
Nicholas Piramal India Ltd. UK.
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.
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:
21 CFR Parts 510 and 529
New Animal Drugs; Change of
Sponsor; Isoflurane
PART 529—OTHER DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 529 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
I
Isoflurane.
(a) Specifications. The drug is a clear,
colorless, stable liquid.
*
*
*
*
*
(c) Conditions of use. Administer by
inhalation:
*
*
*
*
*
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
I
Food and Drug Administration,
HHS.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Dated: July 24, 2006.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–12570 Filed 8–2–06; 8:45 am]
BILLING CODE 4160–01–S
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
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 isoflurane, U.S.P., from Rhodia UK
Ltd. to Nicholas Piramal India Ltd. UK.
DATES: This rule is effective August 3,
2006.
FOR FURTHER INFORMATION CONTACT:
rwilkins on PROD1PC63 with RULES
*
§ 529.1186
I
Food and Drug Administration
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Rhodia
UK Ltd., P.O. Box 46, St. Andrews Rd.,
Avonmouth, Bristol BS11 9YF, England,
UK, has informed FDA that it has
transferred ownership of, and all rights
and interest in, ANADA 200–237 for
isoflurane, U.S.P., to Nicholas Piramal
India Ltd. UK, 1st Floor, Alpine House,
Unit II, Honeypot Lane, London,
NW99RX, England, UK. Accordingly,
the regulations are amended in 21 CFR
529.1186 to reflect this change of
sponsorship and a current format.
16:16 Aug 02, 2006
*
*
*
*
Nicholas Piramal India Ltd.
UK, 1st Floor, Alpine
House, Unit II, Honeypot
Lane, London, NW99RX,
England, UK
*
*
*
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 529
VerDate Aug<31>2005
*
21 CFR Part 510
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
*
066112
Firm name and address
4. In § 529.1186, in paragraph (b),
remove ‘‘059258’’ and numerically add
‘‘066112’’; and revise paragraph (a), the
introductory text of paragraph (c), and
paragraph (c)(3) to read as follows:
List of Subjects
BILLING CODE 4910–13–P
AGENCY:
Drug labeler
code
43967
Jkt 208001
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add an
entry for ‘‘Nicholas Piramal India Ltd.
UK’’ and remove the entry for ‘‘Rhodia
UK Limited’’; and in the table in
paragraph (c)(2) remove the entry for
‘‘059258’’ and numerically add an entry
for ‘‘066112’’ to read as follows:
I
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
Oral Dosage Form New Animal Drugs;
Kanamycin, Bismuth Subcarbonate,
Activated Attapulgite
*
AGENCY:
*
*
(c) * * *
(1) * * *
*
*
*
*
*
Nicholas Piramal India Ltd.
UK, 1st Floor, Alpine
House, Unit II, Honeypot
Lane, London, NW99RX,
England, UK.
*
*
*
Drug labeler
code
*
066112
*
*
*
(2) * * *
Frm 00013
Final rule; technical
amendment.
ACTION:
Firm name and address
PO 00000
Food and Drug Administration,
HHS.
Fmt 4700
Sfmt 4700
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to remove
inactive ingredients from the
specifications for an oral suspension
and for tablets containing kanamycin,
bismuth subcarbonate, and activated
attapulgite; and to consolidate and
reformat these sections. These actions
are being taken to improve the accuracy
E:\FR\FM\03AUR1.SGM
03AUR1
]]>Agencies
[Federal Register Volume 71, Number 149 (Thursday, August 3, 2006)]
[Rules and Regulations]
[Page 43967]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12570]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 529
New Animal Drugs; Change of Sponsor; Isoflurane
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 isoflurane, U.S.P., from Rhodia UK
Ltd. to Nicholas Piramal India Ltd. UK.
DATES: This rule is effective August 3, 2006.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Rhodia UK Ltd., P.O. Box 46, St. Andrews
Rd., Avonmouth, Bristol BS11 9YF, England, UK, has informed FDA that it
has transferred ownership of, and all rights and interest in, ANADA
200-237 for isoflurane, U.S.P., to Nicholas Piramal India Ltd. UK, 1st
Floor, Alpine House, Unit II, Honeypot Lane, London, NW99RX, England,
UK. Accordingly, the regulations are amended in 21 CFR 529.1186 to
reflect this change of sponsorship and a current format.
Following these changes of sponsorship, Rhodia UK Ltd. is no longer
the sponsor of an approved application. In addition, Nicholas Piramal
India Ltd. UK 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 remove the entries for Rhodia UK Ltd. to add entries
for Nicholas Piramal India Ltd. UK.
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 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 ``Nicholas Piramal India Ltd. UK'' and remove the
entry for ``Rhodia UK Limited''; and in the table in paragraph (c)(2)
remove the entry for ``059258'' and numerically add an entry for
``066112'' 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
------------------------------------------------------------------------
* * * * *
Nicholas Piramal India Ltd. UK, 1st Floor, 066112
Alpine House, Unit II, Honeypot Lane,
London, NW99RX, England, UK.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
066112 Nicholas Piramal India Ltd. UK, 1st Floor,
Alpine House, Unit II, Honeypot Lane,
London, NW99RX, England, UK
* * * * *
------------------------------------------------------------------------
PART 529--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. In Sec. 529.1186, in paragraph (b), remove ``059258'' and
numerically add ``066112''; and revise paragraph (a), the introductory
text of paragraph (c), and paragraph (c)(3) to read as follows:
Sec. 529.1186 Isoflurane.
(a) Specifications. The drug is a clear, colorless, stable liquid.
* * * * *
(c) Conditions of use. Administer by inhalation:
* * * * *
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Dated: July 24, 2006.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. E6-12570 Filed 8-2-06; 8:45 am]
BILLING CODE 4160-01-S
