New Animal Drugs; Change of Sponsor's Address, 2352 [05-697]
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Federal Register / Vol. 70, No. 9 / Thursday, January 13, 2005 / Rules and Regulations
regulated organizations will not be
compromised.
After considering these factors, the
Commission has determined to amend
Part 171, as set forth below.
List of Subjects in 17 CFR Part 171
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
Food and Drug Administration
*
21 CFR Part 510
New Animal Drugs; Change of
Sponsor’s Address
Administrative practice and
procedure, Commodity exchanges,
Commodity futures.
AGENCY:
Food and Drug Administration,
HHS.
In consideration of the following, the
Commission hereby amends chapter I of
title 17 of the Code of Federal
Regulations as follows:
I
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
PART 171—RULES RELATING TO
change of sponsor’s address for Alstoe,
REVIEW OF NATIONAL FUTURES
Ltd.
ASSOCIATION DECISIONS IN
DATES: This rule is effective January 13,
DISCIPLINARY, MEMBERSHIP DENIAL, 2005.
REGISTRATION AND MEMBER
FOR FURTHER INFORMATION CONTACT:
RESPONSIBILITY ACTIONS
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
I 1. The authority citation for part 171
Administration, 7500 Standish Pl.,
continues to read as follows:
Rockville, MD 20855, 301–827–6967, eAuthority: 7 U.S.C. 4a, 12a, and 21.
mail: david.newkirk@fda.gov.
I 2. Section 171.1(b) is amended in
SUPPLEMENTARY INFORMATION: Alstoe,
paragraph (b)(4) by adding ‘‘, Hearing
Ltd., Animal Health, Granary Chambers,
Committee’’ between ‘‘Business Conduct 37–39 Burton St., Melton Mowbray,
Committees’’ and ‘‘or arbitration
Leicestershire LE13 1AF, England has
panels’’; and replacing ‘‘.’’ with ‘‘;’’ at the informed FDA of a change of address to
Pera Innovation Park, Nottingham Rd.,
end of (b)(4); and by adding new
Melton Mowbray, Leicestershire,
paragraph (b)(5):
England LE13 0PB. Accordingly, the
§ 171.1 Scope of rules.
agency is amending the regulations in
21 CFR 510.600(c) to reflect the change.
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This rule does not meet the definition
(b) * * *
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
(5) Suspension of a member or a
it is a rule of ‘‘particular applicability.’’
person associated with a member based
Therefore, it is not subject to the
solely on that person’s failure to pay an
congressional review requirements in 5
arbitration award or a settlement
U.S.C. 801–808.
agreement resulting from an arbitration
List of Subjects in 21 CFR Part 510
action brought pursuant to section
17(b)(10) of the Act or rules and
Administrative practice and
regulations of the National Futures
procedure, Animal drugs, Labeling,
Association, or a settlement agreement
Reporting and recordkeeping
resulting from a mediation proceeding
requirements.
sponsored by the National Futures
I Therefore, under the Federal Food,
Association, unless there are
Drug, and Cosmetic Act and under
extraordinary circumstances that
authority delegated to the Commissioner
involve something more than the
of Food and Drugs and redelegated to the
ministerial application of a
Center for Veterinary Medicine, 21 CFR
predetermined sanction, or raise a
part 510 is amended as follows:
colorable claim that the National
PART 510—NEW ANIMAL DRUGS
Futures Assocaition has acted
arbitrarily.
I 1. The authority citation for 21 CFR
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part 510 continues to read as follows:
Issued in Washington, DC on the 10th day
of January 2005, by the Commission.
Jean A. Webb,
Secretary of the Commission.
[FR Doc. 05–709 Filed 1–12–05; 8:45 am]
BILLING CODE 6351–01–M
VerDate jul<14>2003
14:42 Jan 12, 2005
Jkt 205001
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(c) * * *
(1) * * *
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. Section 510.600 is amended in the
table in paragraph (c)(1) by revising the
entry for ‘‘Alstoe, Ltd.’’; and in the table
in paragraph (c)(2) by revising the entry
for ‘‘062408’’ to read as follows.
I
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
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Firm name and address
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Drug labeler code
*
Alstoe, Ltd., Animal Health,
Pera Innovation Park,
Nottingham Rd., Melton
Mowbray, Leicestershire,
England LE13 0PB
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062408
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(2) * * *
Drug labeler
code
*
Firm name and address
*
062408
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Alstoe, Ltd., Animal Health,
Pera Innovation Park,
Nottingham Rd., Melton
Mowbray, Leicestershire,
England LE13 0PB
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Dated: January 3, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–697 Filed 1–12–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Levamisole Powder for Oral Solution
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
Phoenix Scientific, Inc. The ANADA
provides for use of levamisole
hydrochloride soluble powder to make
a drench solution for oral
administration to cattle and sheep
which is effective against various
internal parasites.
DATES: This rule is effective January 13,
2005.
E:\FR\FM\13JAR1.SGM
13JAR1
]]>Agencies
[Federal Register Volume 70, Number 9 (Thursday, January 13, 2005)]
[Rules and Regulations]
[Page 2352]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-697]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor's Address
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's address for Alstoe,
Ltd.
DATES: This rule is effective January 13, 2005.
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.gov.
SUPPLEMENTARY INFORMATION: Alstoe, Ltd., Animal Health, Granary
Chambers, 37-39 Burton St., Melton Mowbray, Leicestershire LE13 1AF,
England has informed FDA of a change of address to Pera Innovation
Park, Nottingham Rd., Melton Mowbray, Leicestershire, England LE13 0PB.
Accordingly, the agency is amending the regulations in 21 CFR
510.600(c) to reflect the change.
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 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 510 is
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. Section 510.600 is amended in the table in paragraph (c)(1) by
revising the entry for ``Alstoe, Ltd.''; and in the table in paragraph
(c)(2) by revising the entry for ``062408'' 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
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Alstoe, Ltd., Animal Health, Pera Innovation 062408
Park, Nottingham Rd., Melton Mowbray,
Leicestershire, England LE13 0PB
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* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
062408 Alstoe, Ltd., Animal Health, Pera Innovation
Park, Nottingham Rd., Melton Mowbray,
Leicestershire, England LE13 0PB
------------------------------------------------------------------------
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Dated: January 3, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 05-697 Filed 1-12-05; 8:45 am]
BILLING CODE 4160-01-S
