New Animal Drugs; Change of Sponsor's Name and Address, 26288-26289 [E7-8870]
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26288
Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations
A new
Standard Instrument Approach
Procedure (SIAP) to Front Royal-Warren
County Airport, Front Royal, VA
(KFFR), RNAV (GPS)–A, requires the
establishment of Class E airspace
extending upward from 700 feet above
the surface in the vicinity of the airport.
This action provides adequate
controlled airspace to contain those
aircraft executing the RNAV (GPS)–A
approach. Class E airspace designations
for airspace areas extending upward
from 700 feet above the surface of the
earth are published in paragraph 6005 of
FAA Order 7400.9P, effective September
16, 2006, which is incorporated by
reference in 14 CFR 71.1. The Class E
airspace designation listed in this
document will be published
subsequently in this Order.
SUPPLEMENTARY INFORMATION:
rmajette on PROD1PC67 with RULES
The Direct Final Rule Procedure
The FAA anticipates that this
regulation will not result in adverse or
negative comment, and, therefore, issues
it as a direct final rule. The FAA has
determined that this regulation only
involves an established body of
technical regulations for which frequent
and routine amendments are necessary
to keep them operationally current.
Unless a written adverse or negative
comment or a written notice of intent to
submit an adverse or negative comment
is received within the comment period,
the regulation will become effective on
the date specified above. After the close
of the comment period, the FAA will
publish a document in the Federal
Register indicating that no adverse or
negative comments were received and
confirming the date on which the final
rule will become effective. If the FAA
does receive, within the comment
period, an adverse or negative comment,
or written notice of intent to submit
such a comment, a document
withdrawing the direct final rule will be
published in the Federal Register, and
a notice of proposed rulemaking may be
published with a new comment period.
Comments Invited
Although this action is in the form of
a direct final rule, and was not preceded
by a notice of proposed rulemaking,
interested persons are invited to
comment on this rule by submitting
such written data, views, or arguments
as they may desire. Communications
should identify the Rules Docket
number and be submitted in triplicate to
the address specified under the caption
ADDRESSES. All communications
received on or before the closing date
for comments will be considered, and
this rule may be amended or withdrawn
in light of the comments received.
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13:44 May 08, 2007
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Factual information that supports the
commenter’s ideas and suggestions is
extremely helpful in evaluating the
effectiveness of this action and
determining whether additional
rulemaking action would be needed.
Comments are specifically invited on
the overall regulatory, economic,
environmental, and energy aspects of
the rule that might suggest a need to
modify the rule. All comments
submitted will be available, both before
and after the closing date for comments,
in the Rules Docket for examination by
interested persons. A report that
summarizes each FAA-public contact
concerned with the substance of this
action will be filed in the Rules Docket.
Commenters wishing the FAA to
acknowledge receipt of their comments
submitted in response to this rule must
submit a self-addressed, stamped
postcard on which the following
statement is made: ‘‘Comments to
Docket No. FAA 2007–27512; Airspace
Docket No. 07–AEA–01.’’ The postcard
will be date stamped and returned to the
commenter.
Agency Findings
The regulations adopted herein will
not have substantial direct effects on the
States, on the relationship between the
national government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Therefore, in
accordance with Executive Order 12612,
it is determined that this final rule does
not have sufficient federalism
implications to warrant the preparation
of a Federalism Assessment.
The FAA has determined that this
regulation is non-controversial and
unlikely to result in adverse or negative
comments. For the reasons discussed in
the preamble, I certify that this
regulation (1) is not a ‘‘significant
regulatory action’’ under Executive
Order 12866; (2) is not a ‘‘significant
rule’’ under Department of
Transportation (DOT) Regulatory
Policies and Procedures (44 FR 11034,
February 26, 1979); and (3) does not
warrant preparation of a Regulatory
Evaluation as these routine matters will
only affect air traffic procedures and air
navigation. It is certified that these
proposed rules will not have significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
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Adoption of the Amendment
Accordingly, pursuant to the authority
delegated to me, the Federal Aviation
Administration amends part 71 of the
Federal Aviation Regulations (14 CFR
part 71) as follows:
I
PART 71—[Amended]
1. The authority citation for part 71
continues to read as follows:
I
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
2. The incorporation by reference in
14 CFR 71.1 of Federal Aviation
Administration Order 7400.9P, Airspace
Designations and Reporting Points,
dated September 1, 2006 and effective
September 15, 2006, is amended as
follows:
I
Paragraph 6005 Class E Airspace Areas
Extending Upward from 700 Feet or More
Above the Surface of the Earth.
*
*
*
*
*
AEA VA E5 FRONT ROYAL, VA [New]
Front Royal-Warren County Airport, VA
(Lat. 38°55′03.11″ N., long. 78°15′12.65″
W.)
That airspace extending upward from 700
feet above the surface within a 11.3-mile
radius of Front Royal-Warren County Airport,
VA.
*
*
*
*
*
Issued in College Park, GA, on April 18,
2007.
Lynda Otting,
Acting Group Manager, System Support,
AJ02–E2, Eastern Service Center.
[FR Doc. 07–2210 Filed 5–8–07; 8:45am]
BILLING CODE 4910–13–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of
Sponsor’s Name and 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 name from
American Pharmaceutical Partners, Inc.,
to Abraxis Pharmaceuticals Products
and to change the sponsor’s mailing
address.
DATES: This rule is effective May 9,
2007.
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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
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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
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26289
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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
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09MYR1
]]>Agencies
[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Rules and Regulations]
[Pages 26288-26289]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8870]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor's Name and 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 name from American
Pharmaceutical Partners, Inc., to Abraxis Pharmaceuticals Products and
to change the sponsor's mailing address.
DATES: This rule is effective May 9, 2007.
[[Page 26289]]
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: 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.
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
removing the entry for ``American Pharmaceuticals Partners, Inc.'' and
alphabetically adding a new entry for ``Abraxis Pharmaceutical
Products''; and in the table in paragraph (c)(2) by revising the entry
for ``063323'' 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
------------------------------------------------------------------------
* * * * *
Abraxis Pharmaceutical Products, a Div. of 063323
Abraxis Bioscience, 6133 River Rd., suite 500,
Rosemont, IL 60018.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
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
