Certain Other Dosage Form New Animal Drugs; Oxytetracycline, 26289 [E7-8869]
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Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
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.
Food and Drug Administration
List of Subjects in 21 CFR Part 529
(2) * * *
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.hhs.gov.
American
Pharmaceuticals Partners, Inc., 2045
North Cornell Ave., Melrose Park, IL
60160, has informed FDA of a change of
name and mailing address to Abraxis
Pharmaceutical Products, a Div. of
Abraxis Bioscience, 6133 River Rd.,
suite 500, Rosemont, Il 60018.
Accordingly, the agency is amending
the regulations in 21 CFR 510.600(c) to
reflect these changes.
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:
Drug labeler
code
Firm name and address
*
*
*
*
*
063323 ....... Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd.,
suite 500, Rosemont, IL
60018
*
*
*
*
*
Dated: May 1, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–8870 Filed 5–8–07; 8:45 am]
BILLING CODE 4160–01–S
List of Subjects in 21 CFR Part 510
rmajette on PROD1PC67 with RULES
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
I 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:
Animal drugs.
21 CFR Part 529
Certain Other Dosage Form New
Animal Drugs; Oxytetracycline
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
PART 510—NEW ANIMAL DRUGS
drug application (ANADA) filed by
Cross Vetpharm Group Ltd. The
I 1. The authority citation for 21 CFR
ANADA provides for use of
part 510 continues to read as follows:
oxytetracycline hydrochloride soluble
Authority: 21 U.S.C. 321, 331, 351, 352,
powder for skeletal marking of finfish
353, 360b, 371, 379e.
fry and fingerlings by immersion.
I 2. Section 510.600 is amended in the
DATES: This rule is effective May 9,
table in paragraph (c)(1) by removing
2007.
the entry for ‘‘American
FOR FURTHER INFORMATION CONTACT: John
Pharmaceuticals Partners, Inc.’’ and
K. Harshman, Center for Veterinary
alphabetically adding a new entry for
‘‘Abraxis Pharmaceutical Products’’; and Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
in the table in paragraph (c)(2) by
Rockville, MD 20855, 301–827–0169, erevising the entry for ‘‘063323’’ to read
mail: john.harshman@fda.hhs.gov.
as follows:
SUPPLEMENTARY INFORMATION: Cross
§ 510.600 Names, addresses, and drug
Vetpharm Group Ltd., Broomhill Rd.,
labeler codes of sponsors of approved
Tallaght, Dublin 24, Ireland, filed
applications.
ANADA 200–460 that provides for use
*
*
*
*
*
of TETROXY Aquatic (oxytetracycline
(c) * * *
hydrochloride) Soluble Powder for
(1) * * *
skeletal marking of finfish fry and
fingerlings by immersion. The
Drug labeler
Firm name and address
application is approved as of April 20,
code
2007, and the regulations are amended
*
*
*
*
*
in 21 CFR 529.1660 to reflect the
Abraxis Pharmaceutical Prod063323 approval.
ucts, a Div. of Abraxis BioIn accordance with the freedom of
science, 6133 River Rd.,
information provisions of 21 CFR part
suite 500, Rosemont, IL
20 and 21 CFR 514.11(e)(2)(ii), a
60018.
summary of safety and effectiveness
*
*
*
*
*
data and information submitted to
VerDate Aug<31>2005
13:44 May 08, 2007
Jkt 211001
26289
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
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 529 is amended as follows:
I
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 529 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 529.1660, revise paragraph
(b)(1) to read as follows:
I
§ 529.1660
Oxytetracycline.
*
*
*
*
*
(b) * * *
(1) Nos. 046573 and 061623 for use of
product in paragraph (a)(1) of this
section.
*
*
*
*
*
Dated: May 1, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–8869 Filed 5–8–07; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\09MYR1.SGM
09MYR1
]]>Agencies
[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Rules and Regulations]
[Page 26289]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8869]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 529
Certain Other Dosage Form New Animal Drugs; Oxytetracycline
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 Cross Vetpharm Group Ltd. The ANADA
provides for use of oxytetracycline hydrochloride soluble powder for
skeletal marking of finfish fry and fingerlings by immersion.
DATES: This rule is effective May 9, 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: Cross Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed ANADA 200-460 that provides for use
of TETROXY Aquatic (oxytetracycline hydrochloride) Soluble Powder for
skeletal marking of finfish fry and fingerlings by immersion. The
application is approved as of April 20, 2007, and the regulations are
amended in 21 CFR 529.1660 to reflect the approval.
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 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 in 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 part 529 is
amended as follows:
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 529.1660, revise paragraph (b)(1) to read as follows:
Sec. 529.1660 Oxytetracycline.
* * * * *
(b) * * *
(1) Nos. 046573 and 061623 for use of product in paragraph (a)(1)
of this section.
* * * * *
Dated: May 1, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-8869 Filed 5-8-07; 8:45 am]
BILLING CODE 4160-01-S
