New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin, 65109-65110 [2011-27139]
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Federal Register / Vol. 76, No. 203 / Thursday, October 20, 2011 / Rules and Regulations
§ 422.310 Collection of overdue debts by
administrative offset.
sentence and adding in its place
‘‘persons’’ and by revising the last
sentence to read as follows:
§ 416.580 Referral of overpayments to the
Department of the Treasury for tax refund
offset—General.
*
*
*
*
*
(b) * * * We refer overpayments to
the Department of the Treasury for offset
against Federal tax refunds regardless of
the amount of time the debts have been
outstanding.
9. Amend § 416.581 by revising the
section heading, the introductory text,
and paragraphs (a) and (b), and in
paragraph (e), by removing the word
‘‘individual’’ in two places and adding
in its place ‘‘person’’.
■
§ 416.581
Notice to overpaid person.
We will make a request for collection
by reduction of Federal and State
income tax refunds only after we
determine that a person owes an
overpayment that is past due and
provide the overpaid person with
written notice. Our notice of intent to
collect an overpayment through tax
refund offset will state:
(a) The amount of the overpayment;
and
(b) That we will collect the
overpayment by requesting that the
Department of the Treasury reduce any
amounts payable to the overpaid person
as refunds of Federal and State income
taxes by an amount equal to the amount
of the overpayment unless, within 60
calendar days from the date of our
notice, the overpaid person:
(1) Repays the overpayment in full; or
(2) Provides evidence to us at the
address given in our notice that the
overpayment is not past due or legally
enforceable; or
(3) Asks us to waive collection of the
overpayment under section 204(b) of the
Act.
*
*
*
*
*
PART 422—ORGANIZATION AND
PROCEDURES
10. The authority citation for subpart
D of part 422 continues to read as
follows:
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■
Authority: Secs. 204(f), 205(a), 702(a)(5),
and 1631(b) of the Social Security Act (42
U.S.C. 404(f), 405(a), 902(a)(5), and 1383(b));
5 U.S.C. 5514; 31 U.S.C. 3711(e); 31 U.S.C.
3716.
11. In § 422.310 revise paragraphs
(a)(1) and (b) to read as follows:
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14:45 Oct 19, 2011
Jkt 226001
[FR Doc. 2011–27221 Filed 10–19–11; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2011–N–0003]
New Animal Drugs for Use in Animal
Feeds; Melengestrol; Monensin;
Tylosin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
John
K. Harshman, Center for Veterinary
Medicine (HFV–170), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Ivy
Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland
Park, KS 66214, filed a supplement to
ANADA 200–375 for use of
HEIFERMAX 500 (melengestrol acetate),
RUMENSIN (monensin, USP), and
TYLAN (tylosin phosphate) singleingredient Type A medicated articles to
make three-way, combination drug Type
C medicated feeds for heifers fed in
confinement for slaughter. The
supplemental ANADA provides for use
of increased dose levels of monensin.
The supplemental application is
approved as of September 1, 2011, and
the regulations in 21 CFR 558.342 are
amended 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.
The Agency has determined under 21
CFR 25.33 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.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 558
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
new animal drug application (ANADA)
filed by Ivy Laboratories, Division of Ivy
Animal Health, Inc. The supplemental
ANADA provides for use of increased
dose levels of monensin in three-way,
combination drug Type C medicated
feeds for heifers fed in confinement for
slaughter containing melengestrol
acetate, monensin, and tylosin.
DATES: This rule is effective October 20,
2011.
SUMMARY:
Subpart D—[Amended]
■
(a) Referral to the Department of the
Treasury for offset. (1) We recover
overdue debts by offsetting Federal and
State payments due the debtor through
the Treasury Offset Program (TOP). TOP
is a Government-wide delinquent debt
matching and payment offset process
operated by the Department of the
Treasury, whereby debts owed to the
Federal Government are collected by
offsetting them against Federal and State
payments owed the debtor. Federal
payments owed the debtor include
current ‘‘disposable pay,’’ defined in 5
CFR 550.1103, owed by the Federal
Government to a debtor who is an
employee of the Federal Government.
Deducting from such disposable pay to
collect an overdue debt owed by the
employee is called ‘‘Federal salary
offset’’ in this subpart.
*
*
*
*
*
(b) Debts we refer. We refer for
administrative offset all qualifying debts
that meet or exceed the threshold
amounts used by the Department of the
Treasury for collection from State and
Federal payments, including Federal
salaries.
*
*
*
*
*
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65109
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Animal drugs, Animal feeds.
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 558 is amended as follows:
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
E:\FR\FM\20OCR1.SGM
20OCR1
65110
§ 558.342
Federal Register / Vol. 76, No. 203 / Thursday, October 20, 2011 / Rules and Regulations
[Amended]
2. In § 558.342, in the table in
paragraph (e)(1), remove and reserve
paragraph (e)(1)(vii); and in paragraph
(e)(1)(xi), in the ‘‘Sponsor’’ column, add
‘‘021641’’.
■
Dated: October 14, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2011–27139 Filed 10–19–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9548]
RIN 1545–BH49
Guidance Regarding the Treatment of
Stock of a Controlled Corporation
Under Section 355(a)(3)(B)
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations and removal of
temporary regulations.
AGENCY:
This document contains final
regulations regarding the distribution of
stock of a controlled corporation
acquired in a transaction described in
section 355(a)(3)(B) of the Internal
Revenue Code (Code). This action is
necessary in light of amendments to
section 355(b). These final regulations
will affect corporations and their
shareholders.
SUMMARY:
Effective Date: These final
regulations are effective on October 20,
2011.
Applicability Date: For dates of
applicability, see § 1.355–2(i).
FOR FURTHER INFORMATION CONTACT:
Russell P. Subin, (202) 622–7790 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
DATES:
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Background
This document contains amendments
to 26 CFR part 1 regarding section
355(a)(3)(B).
Section 355(a) provides that, under
certain circumstances, a corporation
may distribute stock and securities in a
corporation it controls to its
shareholders and security holders
without causing either the distributing
corporation (distributing) or its
shareholders and security holders to
recognize income, gain, or loss.
Sections 355(a)(1)(C) and 355(b)(1)
generally require that distributing and
the controlled corporation (controlled)
VerDate Mar<15>2010
14:45 Oct 19, 2011
Jkt 226001
each be engaged, immediately after the
distribution, in the active conduct of a
trade or business. Section 355(b)(2)(A)
provides that a corporation shall be
treated as engaged in the active conduct
of a trade or business if and only if it
is engaged in the active conduct of a
trade or business.
Section 355(b)(2)(B) requires that the
trade or business have been actively
conducted throughout the five-year
period ending on the date of the
distribution (pre-distribution period).
Section 355(b)(2)(C) provides that the
trade or business must not have been
acquired in a transaction in which gain
or loss was recognized in whole or in
part (taxable transaction) within the predistribution period. Section 355(b)(2)(D)
provides that control of a corporation
that (at the time of acquisition of
control) was conducting the trade or
business must not have been directly or
indirectly acquired by any distributee
corporation or by distributing during the
pre-distribution period in a taxable
transaction.
Section 355(b)(3)(A) provides that for
purposes of determining whether a
corporation meets the requirements of
section 355(b)(2)(A), all members of
such corporation’s separate affiliated
group (SAG) shall be treated as one
corporation. Section 355(b)(3)(B)
provides that for purposes of section
355(b)(3), the term SAG means, with
respect to any corporation, the affiliated
group that would be determined under
section 1504(a) if such corporation were
the common parent and section 1504(b)
did not apply. Section 355(b)(3)(C)
provides that if a corporation became a
SAG member as a result of one or more
taxable transactions, any trade or
business conducted by such corporation
(at the time that such corporation
became such a member) shall be treated
for purposes of section 355(b)(2) as
acquired in a taxable transaction.
Section 355(a)(3)(B) provides that for
purposes of section 355 (other than
section 355(a)(1)(D)) and so much of
section 356 as relates to section 355,
stock of controlled acquired by
distributing by reason of any transaction
(i) which occurs within five years of the
distribution of such stock, and (ii)
which is a taxable transaction, shall not
be treated as stock of controlled, but as
other property.
Section 355(b)(3)(D) provides that the
Secretary shall prescribe such
regulations as are necessary or
appropriate to carry out the purposes of
section 355(b)(3), including regulations
that provide for the proper application
of section 355(b)(2)(B), (C), and (D), and
modify the application of section
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Fmt 4700
Sfmt 4700
355(a)(3)(B), in connection with the
application of section 355(b)(3).
Pursuant to section 355(b)(3)(D) and
section 7805, temporary regulations (TD
9435) under section 355(a)(3)(B) were
published in the Federal Register (73
FR 75946) on December 15, 2008. A
notice of proposed rulemaking (REG–
150670–07) cross-referencing the
temporary regulation was published in
the Federal Register on the same day
(73 FR 75979). The temporary
regulations were intended to harmonize
the application of section 355(a)(3)(B)
with section 355(b). Generally, the
temporary regulations: (1) Disregarded
transfers of controlled stock between
members of the distributing
corporation’s SAG (DSAG), (2) did not
treat controlled stock as other property
if controlled became a DSAG member,
and (3) retained the exception of prior
regulation § 1.355–2(g) as contained in
26 CFR part 1, revised as of April 1,
2008, for acquisitions from affiliates
described in § 1.355–3(b)(4)(iii).
The preamble to the temporary
regulations requested comments
regarding a variety of issues under
section 355(a)(3)(B). One written
comment responding to the request was
received. No public hearing was
requested or held.
Summary of Comment and Guidance
The comment generally agreed with
the text of the temporary regulations. In
addition, the comment addressed,
among other things, the treatment of
cash paid to acquire controlled stock in
lieu of fractional shares, indirect
acquisitions and acquisitions of
controlled stock by a predecessor to a
member of the DSAG, issuances of
controlled stock, and redemptions of
controlled stock. After considering the
comment, the IRS and Treasury
Department have decided not to expand
the scope of the final regulation to cover
additional situations at this time. These
final regulations adopt the substantive
rules of the temporary regulations
without change.
The IRS and Treasury Department
continue to study the interrelationship
between section 355(a)(3)(B) and section
355(b). No inference regarding the
content of future section 355(b)
guidance should be drawn from these
final regulations. In addition, further
guidance may be issued under section
355(a)(3)(B) in connection with future
section 355(b) guidance if it is necessary
to harmonize the two provisions.
Special Analyses
It has been determined that this
Treasury Decision is not a significant
regulatory action as defined in
E:\FR\FM\20OCR1.SGM
20OCR1
]]>Agencies
[Federal Register Volume 76, Number 203 (Thursday, October 20, 2011)]
[Rules and Regulations]
[Pages 65109-65110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27139]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2011-N-0003]
New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin;
Tylosin
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 abbreviated new
animal drug application (ANADA) filed by Ivy Laboratories, Division of
Ivy Animal Health, Inc. The supplemental ANADA provides for use of
increased dose levels of monensin in three-way, combination drug Type C
medicated feeds for heifers fed in confinement for slaughter containing
melengestrol acetate, monensin, and tylosin.
DATES: This rule is effective October 20, 2011.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a
supplement to ANADA 200-375 for use of HEIFERMAX 500 (melengestrol
acetate), RUMENSIN (monensin, USP), and TYLAN (tylosin phosphate)
single-ingredient Type A medicated articles to make three-way,
combination drug Type C medicated feeds for heifers fed in confinement
for slaughter. The supplemental ANADA provides for use of increased
dose levels of monensin. The supplemental application is approved as of
September 1, 2011, and the regulations in 21 CFR 558.342 are amended 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.
The Agency has determined under 21 CFR 25.33 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 558
Animal drugs, Animal feeds.
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 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
[[Page 65110]]
Sec. 558.342 [Amended]
0
2. In Sec. 558.342, in the table in paragraph (e)(1), remove and
reserve paragraph (e)(1)(vii); and in paragraph (e)(1)(xi), in the
``Sponsor'' column, add ``021641''.
Dated: October 14, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2011-27139 Filed 10-19-11; 8:45 am]
BILLING CODE 4160-01-P
