Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Luprostiol, 25146-25147 [E9-12269]
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Federal Register / Vol. 74, No. 100 / Wednesday, May 27, 2009 / Rules and Regulations
of FAA Order 7400.9S, dated October 3,
2008, and effective October 31, 2008,
which is incorporated by reference in 14
CFR 71.1. The Class D and E airspace
designations listed in this document
will be published subsequently in the
Order.
PWALKER on PROD1PC71 with RULES
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 various levels of
government. Therefore, it is determined
that this final rule does not have
federalism implications under Executive
Order 13132.
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. It, therefore, (1) is not a
‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
Regulatory Evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
traffic procedures and air navigation, it
is certified that this rule, when
promulgated, will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
The FAA’s authority to issue rules
regarding aviation safety is found in
Title 49 of the United States code.
Subtitle I, Section 106 describes the
authority of the FAA Administrator.
Subtitle VII, Aviation Programs,
describes in more detail the scope of the
agency’s authority.
This rulemaking is promulgated
under the authority described in
Subtitle VII, Part A, Subpart I, Section
40103. Under that section, the FAA is
charged with prescribing regulations to
assign the use of airspace necessary to
ensure the safety of aircraft and the
efficient use of airspace. This regulation
is within the scope of that authority as
it establishes Class D and modifies Class
E airspace at Flagler County Airport in
Bunnell, FL.
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
1. The authority citation for Part 71
continues to read as follows:
21 CFR Part 522
■
Authority: 49 U.S.C. 106(g); 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of Federal Aviation
Administration Order 7400.9S, Airspace
Designations and Reporting Points,
dated October 3, 2008, and effective
October 31, 2008, is amended as
follows:
Paragraph 5000
Class D Airspace
*
*
ASO FL D
*
*
Bunnell, FL [New]
Flagler County Airport, Bunnell, FL
(Lat. 29°28′03″ N, long. 81°12′23″ W)
That airspace extending upward from the
surface of the Earth, to and including 1,500
feet MSL, within a 4.0-mile radius of the
Flagler County Airport. This Class D airspace
area is effective during the specific days and
times established in advance by a Notice to
Airmen. The effective days and times will
thereafter be continuously published in the
Airport/Facility Directory.
*
*
*
*
*
Paragraph 6005 Class E Airspace Extending
Upward from 700 feet or more above the
Surface of the Earth.
*
*
ASO FL E5
*
*
*
Bunnell, FL [Revised]
Flagler County Airport, Bunnell, FL
(Lat. 29°28′03″ N, long. 81°12′23″ W)
That airspace extending upward from 700
feet above the surface within a 6.5-mile
radius of the Flagler County Airport.
*
*
*
*
[Docket No. FDA–2009–N–0665]
Implantation or Injectable Dosage
Form New Animal Drugs; Change of
Sponsor; Luprostiol
AGENCY:
■
*
Food and Drug Administration
*
Issued in College Park, Georgia, on May 11,
2009.
Barry A. Knight,
Manager, Operations Support Group, Eastern
Service Center, Air Traffic Organization.
[FR Doc. E9–12028 Filed 5–26–09; 8:45 am]
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for luprostiol
injectable solution from Intervet, Inc., to
Virbac AH, Inc.
DATES: This rule is effective May 27,
2009.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, has informed FDA
that it has transferred ownership of, and
all rights and interest in, NADA 140–
857 for EQUESTROLIN (luprostiol)
injectable solution to Virbac AH, Inc.,
3200 Meacham Blvd., Ft. Worth, TX
76137. Accordingly, the regulations are
amended in 21 CFR 522.1290 to reflect
the change of sponsorship and a current
format.
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 522
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 part 522 is amended as follows:
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Adoption of the Amendment
Authority: 21 U.S.C. 360b.
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR Part 71 as follows:
2. In § 522.1290, revise the section
heading and paragraphs (a), (b), and (d)
to read as follows:
■
16:09 May 26, 2009
Final rule.
BILLING CODE 4910–13–P
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
VerDate Nov<24>2008
Food and Drug Administration,
HHS.
Jkt 217001
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Federal Register / Vol. 74, No. 100 / Wednesday, May 27, 2009 / Rules and Regulations
§ 522.1290
Luprostiol.
Paperwork Reduction Act
(a) Specifications. Each milliliter of
solution contains 7.5 milligrams (mg)
luprostiol.
(b) Sponsor. See No. 051311 in
§ 510.600(c) of this chapter.
*
*
*
*
*
(d) Conditions of use in horses—(1)
Amount. 7.5 mg by intramuscular
injection.
(2) Indications for use. For estrus
control and termination of pregnancy in
mares.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. Do not use in
horses intended for human
consumption.
Dated: May 12, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E9–12269 Filed 5–26–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
Background and Explanation of
Provisions
[TD 9451]
RIN 1545–BF25
Guidance Necessary To Facilitate
Business Election Filing; Finalization
of Controlled Group Qualification
Rules
AGENCY: Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulation and removal of
temporary regulation.
This document contains a
final regulation that provides guidance
to taxpayers for determining which
corporations are included in a
controlled group of corporations. This
regulation is being published to replace
an expiring temporary regulation.
DATES: Effective Date: This regulation is
effective on May 27, 2009.
Applicability Date: Section 1.1563–
1T(c)(2)(i)–(iii) expired on May 26,
2009, pursuant to section 7805(e)(2) and
§ 1.1563–1T(e)(2). In accordance with
section 7805(b)(1)(B), this regulation
applies to taxable years beginning on or
after May 26, 2009. However, taxpayers
may apply this regulation to taxable
years beginning before May 26, 2009.
See § 1.1563–1(e).
FOR FURTHER INFORMATION CONTACT: Grid
Glyer, (202) 622–7930 (not a toll-free
number).
PWALKER on PROD1PC71 with RULES
SUMMARY:
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
16:09 May 26, 2009
The collection of information
contained in this final regulation has
been reviewed and approved by the
Office of Management and Budget in
accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
3507(d)) under control number 1545–
2019.
This collection of information is in
§ 1.1563–1(c)(2). This information is
required if a taxpayer or taxpayers could
be a member of more than one brothersister controlled group and does not
elect which group to be a member of. In
that case, the IRS would designate a
group.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless the collection of information
displays a valid control number by the
Office of Management and Budget.
Books or records relating to a
collection of information must be
retained as long as their contents might
become material in the administration
of any internal revenue law. Generally,
tax returns and tax return information
are confidential, as required by 26
U.S.C. 6103.
Jkt 217001
On December 22, 2006, the IRS and
the Treasury Department published
several temporary regulations, including
§ 1.1563–1T. See TD 9304 (71 FR
76904), 2007–1 CB 423. Also on
December 22, 2006, the IRS and the
Treasury Department issued a notice of
proposed rulemaking cross-referencing
those temporary regulations. See REG–
161919–05 (71 FR 76955), 2007–1 CB
463. Section 1.1563–1T was also
amended by the publication of a
temporary regulation on December 26,
2007. See TD 9369 (72 FR 72929), 2008–
6 IRB 394. Also on December 26, 2007,
the IRS and Treasury Department issued
a notice of proposed rulemaking crossreferencing that temporary regulation.
See REG–104713–07 (72 FR 72970),
2008–6 IRB 409.
Section 1.1563–1T republished
§ 1.1563–1 to conform it to current
formatting conventions. It was not
intended that any such reformatting
constitute a substantive change. See
§ 3.A of the preamble to TD 9304.
Treasury decision 9304 also removed
§ 1.1563–1. Section 1.1563–1T provides
guidance to taxpayers for determining
which corporations are included in a
controlled group of corporations.
This Treasury decision adopts the
proposed regulation § 1.1563–1 with no
substantive changes. In addition, this
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25147
Treasury decision removes the
corresponding temporary regulation,
§ 1.1563–1T.
This Treasury decision does not adopt
the other proposed regulations that were
published as part of TD 9304. Those
proposed regulations are now found in
REG–113688–09, and their status will be
addressed at a later date.
The IRS and the Treasury Department
received no written or electronic
comments from the public in response
to the notice of proposed rulemaking
and no public hearing was requested or
held.
Special Analysis
It has been determined that this
Treasury Decision is not a significant
regulatory action as defined in
Executive Order 12866. Therefore, a
regulatory assessment is not required. It
has also been determined that section
553(b) of the Administrative Procedure
Act (5 U.S.C. chapter 5) does not apply
to this regulation. Pursuant to the
Regulatory Flexibility Act (5 U.S.C.
chapter 6), it is hereby certified that this
rule will not have a significant
economic impact on a substantial
number of small entities. This
certification is based on the fact that this
regulation primarily affects large
corporations (which are members of
either controlled or consolidated
groups). Accordingly, a regulatory
flexibility analysis is not required.
Pursuant to section 7805(f) of the
Internal Revenue Code, the notice of
proposed rulemaking preceding this
regulation was submitted to the Chief
Counsel for Advocacy of the Small
Business Administration for comment
on their impact on small business.
Drafting Information
The principal author of this regulation
is Grid Glyer, Office of Associate Chief
Counsel (Corporate). However, other
personnel from the IRS and the Treasury
Department participated in its
development.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Adoption of Amendments to the
Regulation
Accordingly, 26 CFR part 1 is
amended as follows:
■
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 is amended by removing the
entry for § 1.1563–1T to read in part as
follows:
■
Authority: 26 U.S.C. 7805 * * *
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27MYR1
]]>Agencies
[Federal Register Volume 74, Number 100 (Wednesday, May 27, 2009)]
[Rules and Regulations]
[Pages 25146-25147]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12269]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2009-N-0665]
Implantation or Injectable Dosage Form New Animal Drugs; Change
of Sponsor; Luprostiol
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 luprostiol
injectable solution from Intervet, Inc., to Virbac AH, Inc.
DATES: This rule is effective May 27, 2009.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, has informed FDA that it has transferred
ownership of, and all rights and interest in, NADA 140-857 for
EQUESTROLIN (luprostiol) injectable solution to Virbac AH, Inc., 3200
Meacham Blvd., Ft. Worth, TX 76137. Accordingly, the regulations are
amended in 21 CFR 522.1290 to reflect the change of sponsorship and a
current format.
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 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.1290, revise the section heading and paragraphs (a),
(b), and (d) to read as follows:
[[Page 25147]]
Sec. 522.1290 Luprostiol.
(a) Specifications. Each milliliter of solution contains 7.5
milligrams (mg) luprostiol.
(b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter.
* * * * *
(d) Conditions of use in horses--(1) Amount. 7.5 mg by
intramuscular injection.
(2) Indications for use. For estrus control and termination of
pregnancy in mares.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Do not use in horses intended for
human consumption.
Dated: May 12, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-12269 Filed 5-26-09; 8:45 am]
BILLING CODE 4160-01-S
