New Animal Drugs; Change of Sponsor's Address, 48272 [05-16280]
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48272
Federal Register / Vol. 70, No. 158 / Wednesday, August 17, 2005 / Rules and Regulations
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[FR Doc. 05–16305 Filed 8–16–05; 8:45 am]
BILLING CODE 3510–06–P
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 Peptech
Animal Health Pty, Ltd.
DATES: This rule is effective August 17,
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, email: david.newkirk@fda.gov.
SUPPLEMENTARY INFORMATION: Peptech
Animal Health Pty, Ltd., 35–41
Waterloo Rd., North Ryde, New South
Wales 2113, Australia has informed
FDA of a change of address to 19–25
Khartoum Rd., Macquarie Park, New
South Wales 2113, Australia.
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.
VerDate jul<14>2003
11:00 Aug 16, 2005
Jkt 205001
List of Subjects in 21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
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:
I
PART 510—NEW ANIMAL DRUGS
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs;
Phenylbutazone Injection
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
Authority: 21 U.S.C. 321, 331, 351, 352,
drug application (ANADA) filed by
353, 360b, 371, 379e.
Sparhawk Laboratories, Inc. The
ANADA provides for the veterinary
I 2. Section 510.600 is amended in the
prescription use of phenylbutazone
table in paragraph (c)(1) by revising the
injectable solution in horses for relief of
entry for ‘‘Peptech Animal Health Pty,
Ltd.’’; and in the table in paragraph (c)(2) inflammatory conditions associated
with the musculoskeletal system.
by revising the entry for ‘‘064288’’ to
read as follows:
DATES: This rule is effective August 17,
2005.
§ 510.600 Names, addresses, and drug
FOR FURTHER INFORMATION CONTACT: John
labeler codes of sponsors of approved
K. Harshman, Center for Veterinary
applications.
Medicine (HFV 104), Food and Drug
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Administration, 7500 Standish Pl.,
(c) * * *
Rockville, MD 20855, 240–276–9808, email: john.harshman@fda.gov.
(1) * * *
SUPPLEMENTARY INFORMATION: Sparhawk
Laboratories, Inc., 12340 Santa Fe Trail
Drug labeler
Firm name and address
code
Dr., Lenexa , KS 66215–3591, filed
ANADA 200–371 for the use of
Phenylbutazone 20% Injection by
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veterinary prescription for relief of
Peptech Animal Health Pty, 064288
inflammatory conditions associated
Ltd., 19–25 Khartoum
with the musculoskeletal system in
Rd., Macquarie Park,
horses. Sparhawk Laboratories, Inc.’s,
New South Wales 2113,
Phenylbutazone 20% Injection is
Australia.
approved as a generic copy of Schering*
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Plough Animal Health Corp.’s,
BUTAZOLIDIN Injectable 20%,
(2) * * *
approved under NADA 11–575. The
ANADA is approved as of July 8, 2005,
Drug labeler
Firm name and adand the regulations in 21 CFR 522.1720
code
dress
are amended to reflect the approval. The
basis of approval is discussed in the
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freedom of information(FOI) summary.
064288 .................... Peptech Animal
In accordance with the FOI provisions
Health Pty, Ltd.,
of 21 CFR part 20 and 21 CFR
19–25 Khartoum
514.11(e)(2)(ii), a summary of safety and
Rd., Macquarie
effectiveness data and information
Park, New South
submitted to support approval of this
Wales 2113, Ausapplication may be seen in the Division
tralia
of Dockets Management (HFA–305),
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Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
July 28, 2005.
20852, between 9 a.m. and 4 p.m.,
Bernadette A. Dunham,
Monday through Friday.
Deputy Director, Office of New Animal Drug
The agency has determined under 21
Evaluation, Center for Veterinary Medicine.
CFR 25.33(a)(1) that this action is of a
[FR Doc. 05–16280 Filed 8–16–05; 8:45 am]
type that does not individually or
cumulatively have a significant effect on
BILLING CODE 4160–01–S
the human environment. Therefore,
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
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[Federal Register Volume 70, Number 158 (Wednesday, August 17, 2005)]
[Rules and Regulations]
[Page 48272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16280]
=======================================================================
-----------------------------------------------------------------------
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 Peptech
Animal Health Pty, Ltd.
DATES: This rule is effective August 17, 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: Peptech Animal Health Pty, Ltd., 35-41
Waterloo Rd., North Ryde, New South Wales 2113, Australia has informed
FDA of a change of address to 19-25 Khartoum Rd., Macquarie Park, New
South Wales 2113, Australia. 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 ``Peptech Animal Health Pty, Ltd.''; and in the
table in paragraph (c)(2) by revising the entry for ``064288'' 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
------------------------------------------------------------------------
* * * * *
Peptech Animal Health Pty, Ltd., 19-25 064288
Khartoum Rd., Macquarie Park, New South
Wales 2113, Australia.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
064288............................. Peptech Animal Health Pty, Ltd., 19-
25 Khartoum Rd., Macquarie Park,
New South Wales 2113, Australia
* * * * *
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July 28, 2005.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 05-16280 Filed 8-16-05; 8:45 am]
BILLING CODE 4160-01-S
