Ophthalmic and Topical Dosage Form New Animal Drugs; Diclofenac, 47435-47436 [E9-22292]
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47435
Rules and Regulations
Federal Register
Vol. 74, No. 178
Wednesday, September 16, 2009
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
determined that an additional minor
amendment is needed in part 101.
In the first line of § 101.25(e), the
number ‘‘8’’ (kilometers) is changed to
‘‘9.26’’ to correct the metric conversion
when the word ‘‘statute’’ is replaced
with the word ‘‘nautical’’.
Technical Correction
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
This technical correction merely
ensures correct placement of
miscellaneous words. There are no other
changes to the existing regulatory text.
Justification for Immediate Adoption
14 CFR Part 101
[Docket No. FAA–2007–27390; Amendment
No. 101–8]
RIN 2120–AI88
Requirements for Amateur Rocket
Activities
Because this action is editorial, the
FAA finds that notice and public
comment under 5 U.S.C. section 553(b)
is unnecessary. For the same reason, the
FAA finds good cause exists under 5
U.S.C. section 553(d) for making this
rule effective upon publication.
AGENCY: Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule; correction.
List of Subjects for 14 CFR Part 101
SUMMARY: The FAA is making an
editorial change to the amateur rocket
regulations. This action corrects an
unintentional error in the difference
between statute and nautical miles. The
intent is to ensure the regulations are
clear and accurate.
DATES: This amendment is effective
September 16, 2009.
FOR FURTHER INFORMATION CONTACT: For
technical questions concerning this final
rule, contact Charles P. Brinkman,
Licensing and Safety Division (AST–
200), Commercial Space Transportation,
Federal Aviation Administration, 800
Independence Avenue, Washington, DC
20591, telephone (202) 267–7715, e-mail
Phil.Brinkman@faa.gov. For legal
questions concerning this final rule,
contact Gary Michel, Office of the Chief
Counsel, Federal Aviation
Administration, 800 Independence
Avenue, Washington, DC 20591,
telephone (202) 267–3148.
SUPPLEMENTARY INFORMATION:
The Amendment
Aircraft, Aviation safety.
sroberts on DSKD5P82C1PROD with RULES
Background
On Friday, July 31, 2009 (74 FR
38092), the FAA published a technical
amendment to the final rule
‘‘Requirements for Amateur Rocket
Activities.’’ The final rule was
published on December 4, 2008 (73 FR
73768). During the review process, we
VerDate Nov<24>2008
16:10 Sep 15, 2009
Jkt 217001
In consideration of the foregoing, the
FAA amends 14 CFR part 101, as
follows:
■
PART 101––MOORED BALLOONS,
KITES, UNMANNED ROCKETS AND
UNMANNED FREE BALLOONS
1. The authority citation for part 101
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40103, 40113–
40114, 45302, 44502, 44514, 44701–44702,
44721, 46308.
§ 101.25
[Amended]
2. Amend § 101.25(e) by removing the
number ‘‘8’’ and adding the number
‘‘9.26’’ in its place and removing the
word ‘‘statute’’ and adding the word
‘‘nautical’’ in its place.
■
Issued in Washington, DC, on September
10, 2009.
Brenda D. Courtney,
Acting Director, Office of Rulemaking.
[FR Doc. E9–22341 Filed 9–15–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
[Docket No. FDA–2009–N–0665]
Ophthalmic and Topical Dosage Form
New Animal Drugs; Diclofenac
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 a supplemental new animal
drug application (NADA) filed by
Boehringer Ingelheim Vetmedica, Inc.
The supplemental NADA provides for a
revised human food safety warning for
use of diclofenac sodium topical cream
in horses.
DATES: This rule is effective September
16, 2009.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Boehringer Ingelheim Vetmedica, Inc.,
2621 North Belt Highway, St. Joseph,
MO 64506–2002, filed a supplement to
NADA 141–186 that provides for use of
SURPASS (1% diclofenac sodium)
Topical Cream in horses for the control
of pain and inflammation associated
with osteoarthritis. The supplemental
NADA provides for a revised human
food safety warning on product labeling.
The supplemental NADA is approved as
of August 25, 2009, and the regulations
are amended in 21 CFR 524.590 to
reflect the approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33(d)(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.
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47436
Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Rules and Regulations
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 524
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 524 is amended as follows:
■
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 524.590
[Amended]
2. In § 524.590, remove the first
sentence of paragraph (c)(3) ‘‘Not for use
in horses intended for food.’’ and in its
place add ‘‘Do not use in horses
intended for human consumption.’’.
■
Dated: September 11, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–22292 Filed 9–15–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
26 CFR Parts 1 and 602
[TD 9463]
RIN 1545–BG77
Modifications of Commercial Mortgage
Loans Held by a Real Estate Mortgage
Investment Conduit (REMIC)
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AGENCY: Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulation.
SUMMARY: This document contains final
regulations that expand the list of
permitted loan modifications to include
certain modifications that are often
made to commercial mortgages. Changes
to the regulations are necessary to better
accommodate evolving practices in the
commercial-mortgage industry. These
changes will affect lenders, borrowers,
servicers, and sponsors of
securitizations of mortgages in REMICs.
DATES: Effective Date: These regulations
are effective on or after September 16,
2009.
17:18 Sep 15, 2009
FOR FURTHER INFORMATION CONTACT:
Diana Imholtz or Susan Thompson
Baker at (202) 622–3930 (not a toll-free
number).
SUPPLEMENTARY INFORMATION:
Paperwork Reduction Act
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–
2110. The collection of information in
this final regulation is in § 1.860G–
2(b)(7). This information is required in
order to show that certain modifications
to mortgages permitted by this final
regulation will not cause the modified
mortgage to cease to be a qualified
mortgage. The collection of information
is voluntary to obtain a benefit.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid OMB control
number.
Books or records relating to a
collection of information must be
retained as long as their contents may
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.
Background
Internal Revenue Service
VerDate Nov<24>2008
Applicability Date: For date of
applicability, see § 1.860A–1(b).
Jkt 217001
This document contains amendments
to 26 CFR part 1 under section 860G of
the Internal Revenue Code (Code). In
Notice 2007–17 (2007–1 CB 748 (March
19, 2007)), the IRS and the Treasury
Department requested input on whether
the present REMIC regulations should
be amended to permit additional types
of modifications incurred in connection
with commercial mortgage loans. See
§ 601.601(d)(2)(ii)(b). The IRS and the
Treasury Department received several
comments in response to this request
(the Notice 2007–17 Comments). After
consideration of the Notice 2007–17
Comments, the IRS and the Treasury
Department published in the Federal
Register (72 FR 63523) on November 9,
2007, proposed regulations (REG–
127770–07) that would expand the list
of permitted loan modifications to
include certain modifications that are
often made to commercial mortgages.
The IRS and the Treasury Department
received additional comments in
response to the proposed regulations
(the Proposed Regulation Comments). A
public hearing was requested and was
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held on April 4, 2008 (73 FR 12041).
After consideration of the Proposed
Regulation Comments, the proposed
regulations are adopted as revised by
this Treasury decision.
Summary of Comments and
Explanation of Provisions
Except as specifically provided in
§ 1.860G–2(b)(3), if there is a significant
modification of an obligation that is
held by a REMIC, then the modified
obligation is treated as one that was
newly issued in exchange for the
unmodified obligation that it replaced.
See § 1.860G–2(b)(1). For this purpose,
the rules in § 1.1001–3(e) determine
whether a modification is ‘‘significant.’’
See § 1.860G–2(b)(2). Because of when it
is treated as having been acquired in the
deemed exchange, a significantly
modified obligation generally fails to be
a qualified mortgage. Section 1.860G–
2(b)(3), however, contains a list of
modifications that are expressly
permitted without regard to the section
1001 modification rules.
The final regulations expand this list
of permitted exceptions to include
changes in collateral, guarantees, and
credit enhancement of an obligation and
changes to the recourse nature of an
obligation. These changes are permitted
so long as the obligation continues to be
principally secured by an interest in real
property. The final regulations also
clarify when a release of a lien on real
property securing a qualified mortgage
does not disqualify the mortgage.
The Proposed Regulation Comments
included requests for clarification and
recommendations relating to the
following: (i) The lien release rule; (ii)
the requirement to retest the collateral
value; (iii) the appraisal requirement;
(iv) changes in the nature of an
obligation from nonrecourse to recourse;
(v) investment trusts; and (vi) other
proposals set forth in the Notice 2007–
17 Comments that were not included in
the proposed regulations.
1. The Lien Release Rule
The proposed regulations would
provide that a lien release pursuant to
certain changes in collateral would not
cause a qualified mortgage to cease to be
a qualified mortgage on the date the lien
is released. Commentators indicated
that, as drafted, the proposed
regulations could be interpreted to
prohibit other types of lien releases,
including lien releases that are
occasioned by a default or reasonably
foreseeable default under § 1.860G–
2(b)(3)(i) and lien releases that are
permitted pursuant to the terms of the
mortgage loan and are not modifications
for purposes of § 1.1001–3. In response
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Agencies
[Federal Register Volume 74, Number 178 (Wednesday, September 16, 2009)]
[Rules and Regulations]
[Pages 47435-47436]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22292]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
[Docket No. FDA-2009-N-0665]
Ophthalmic and Topical Dosage Form New Animal Drugs; Diclofenac
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 a supplemental new animal drug
application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The
supplemental NADA provides for a revised human food safety warning for
use of diclofenac sodium topical cream in horses.
DATES: This rule is effective September 16, 2009.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621
North Belt Highway, St. Joseph, MO 64506-2002, filed a supplement to
NADA 141-186 that provides for use of SURPASS (1% diclofenac sodium)
Topical Cream in horses for the control of pain and inflammation
associated with osteoarthritis. The supplemental NADA provides for a
revised human food safety warning on product labeling. The supplemental
NADA is approved as of August 25, 2009, and the regulations are amended
in 21 CFR 524.590 to reflect the approval.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
The agency has determined under 21 CFR 25.33(d)(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.
[[Page 47436]]
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 524
Animal drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 524 is
amended as follows:
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.590 [Amended]
0
2. In Sec. 524.590, remove the first sentence of paragraph (c)(3)
``Not for use in horses intended for food.'' and in its place add ``Do
not use in horses intended for human consumption.''.
Dated: September 11, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-22292 Filed 9-15-09; 8:45 am]
BILLING CODE 4160-01-S