Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chloramphenicol; Lincomycin; Pyrantel Tartrate; and Tylosin Phosphate and Sulfamethazine, 55676-55677 [2010-22808]
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55676
Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Rules and Regulations
c. A subaward may be provided through
any legal agreement, including an agreement
that you consider a contract.
5. Subrecipient means an entity that:
a. Receives a subaward from you under this
award; and
b. Is accountable to you for the use of the
Federal funds provided by the subaward.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
congressional review requirements in 5
U.S.C. 801–808.
Food and Drug Administration
List of Subjects
PART 26–39—[RESERVED]
Animal Drugs, Feeds, and Related
Products; Withdrawal of Approval of
New Animal Drug Applications;
Chloramphenicol; Lincomycin;
Pyrantel Tartrate; and Tylosin
Phosphate and Sulfamethazine
4. Subchapter C to chapter I,
consisting of parts 40 through 59, is
established and reserved to read as
follows:
■
Subchapter C—Award Content and Format
[Reserved]
PARTS 40–59—[RESERVED]
5. Subchapter D to chapter I,
consisting of parts 60 through 79, is
established and added to read as
follows:
Subchapter D—Post-Award Responsibilities
PARTS 60–79—[RESERVED]
6. Subchapter E to chapter I,
consisting of parts 80 through 99, is
established and reserved to read as
follows:
■
Subchapter E—Cost Principles [Reserved]
7. Subchapter F to chapter I,
consisting of parts 100 through 119, is
established and reserved to read as
follows:
■
Subchapter F—Audit Requirements
[Reserved]
PARTS 100–119—[RESERVED]
8. Subchapter G to chapter I,
consisting of parts 120 through 199, is
established, and a new subchapter
heading is added to read as follows:
■
Subchapter G—National Policy
Requirements
[FR Doc. 2010–22706 Filed 9–13–10; 8:45 am]
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[Docket No. FDA–2010–N–0002]
AGENCY:
ACTION:
21 CFR Part 520
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Final rule.
Frm 00014
Fmt 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 parts 510, 520, and 558 are
amended as follows:
■
The Food and Drug
Administration (FDA) is amending the
animal drug regulations by removing
those portions that reflect approval of
four new animal drug applications
(NADAs). In a notice published
elsewhere in this issue of the Federal
Register, FDA is withdrawing approval
of these NADAs.
DATES: This rule is effective September
24, 2010.
FOR FURTHER INFORMATION CONTACT: John
Bartkowiak, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9079;
email: john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: John J.
Ferrante, 11 Fairway Lane, Trumbull,
CT 06611; International Nutrition, Inc.,
7706 ‘‘I’’ Plaza, Omaha, NE 68127; and
Feed Service Co., Inc., 303 Lundin
Blvd., P.O. Box 698, Mankato, MN
56001 have requested that FDA
withdraw approval of the four NADAs
listed in the following paragraph
because they are no longer
manufactured or marketed:
In a notice published elsewhere in
this issue of the Federal Register, FDA
gave notice that approval of NADA 65–
137, 121–337, 132–923, and 138–342,
and all supplements and amendments
thereto, is withdrawn, effective
September 24, 2010. As provided in the
regulatory text of this document, the
animal drug regulations are amended to
reflect these withdrawals of approval.
Following these changes of
sponsorship, Feed Service Co., Inc., and
John J. Ferrante are no longer the
sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being
amended to remove the entries for these
firms.
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
PO 00000
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Food and Drug Administration,
HHS.
SUMMARY:
■
PARTS 80–99—[RESERVED]
21 CFR Part 510
21 CFR Parts 510, 520, and 558
Sfmt 4700
PART 510—NEW ANIMAL DRUGS
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.
510.600
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entries for
‘‘Feed Service Co., Inc.’’ and ‘‘John J.
Ferrante’’; and in the table in paragraph
(c)(2), remove the entries for ‘‘030841’’
and ‘‘058034’’.
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
4. In § 520.390b, revise paragraph (b)
to read as follows:
■
§ 520.390b
Chloramphenicol capsules.
*
*
*
*
*
(b) Sponsors. See Nos. 000069 and
050057 in § 510.600(c) of this chapter
for use as in paragraph (d) of this
section.
*
*
*
*
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
5. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
6. In § 558.325, revise paragraphs (a)
and (c)(3)(ii); and in the table in
paragraphs (d)(2)(ii) and (d)(2)(iii), in
the ‘‘Sponsor’’ column, remove ‘‘043733’’
to read as follows:
■
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Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Rules and Regulations
§ 558.325
Lincomycin.
§ 558.485
[Amended]
7. In paragraph (b)(3) of § 558.485,
remove ‘‘043733’’.
■
§ 558.630
This correction is effective on
September 14, 2010, and is applicable
on August 13, 2010.
FOR FURTHER INFORMATION CONTACT:
Concerning the acceleration rules for
deferred COD income and deferred OID
deductions, and the rules for earnings
and profits, Robert M. Rhyne at (202)
622–7790; and concerning the rules for
deferred OID deductions, Rubin B.
Ranat at (202) 622–7530 (not toll-free
numbers).
DATES:
(a) Approvals. Type A articles and
Type B feeds approved for sponsors in
§ 510.600(c) of this chapter for specific
uses as in paragraph (d) of this section
as follows:
(1) No. 000009 for 20 and 50 grams
per pound.
(2) No. 051311 for 2.5 and 8 grams per
pound.
*
*
*
*
*
(c) * * *
(3) * * *
(ii) No. 051311:‘‘CAUTION: Not to be
fed to swine that weigh more than 250
lb.’’
*
*
*
*
*
SUPPLEMENTARY INFORMATION:
8. In paragraph (b)(5) of § 558.630,
remove ‘‘030841’’.
Dated: September 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
The temporary regulations (TD 9497)
that are the subject of this document are
under section 108 of the Internal
Revenue Code.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
[FR Doc. 2010–22808 Filed 9–13–10; 8:45 am]
Correction of Publication
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendments:
Internal Revenue Service
PART 1—INCOME TAXES
26 CFR Part 1
■
■
Paragraph 1. The authority citation
for part 1 continues to read in part as
follows:
[TD 9497]
RIN 1545–BI97
Authority: 26 U.S.C. 7805 * * *.
Guidance Regarding Deferred
Discharge of Indebtedness Income of
Corporations and Deferred Original
Issue Discount Deductions; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
AGENCY:
This document contains
correcting amends to temporary
regulations under section 108(i) of the
Internal Revenue Code. These
regulations primarily affect C
corporations regarding the acceleration
of deferred discharge of indebtedness
(COD) income (deferred COD income)
and deferred original issue discount
(OID) deductions (deferred OID
deductions) under section 108(i)(5)(D),
and the calculation of earnings and
profits as a result of an election under
section 108(i). These errors were made
when the agency published temporary
regulations (TD 9497) in the Federal
Register on Friday, August 13, 2010 (75
FR 49394).
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SUMMARY:
VerDate Mar<15>2010
14:52 Sep 13, 2010
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LaNita Van Dyke,
Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
Counsel, (Procedure and Administration).
[FR Doc. 2010–22792 Filed 9–13–10; 8:45 am]
Background
As published, the temporary
regulations (TD 9497) contain errors that
may prove to be misleading and are in
need of clarification.
■
(D) * * * If an electing corporation
has been in existence for less than three
years, the period during which the
electing corporation has been in
existence is substituted for the
preceding three taxable years. * * *
*
*
*
*
*
BILLING CODE 4830–01–P
Need for Correction
[Amended]
55677
Par. 2. Section 1.108(i)–1T is
amended by revising the fifth sentence
of paragraph (b)(2)(iii)(A) and the fifth
sentence of paragraph (b)(2)(iii)(D) to
read as follows:
■
§ 1.108(i)–1T Deferred discharge of
indebtedness income and deferred original
issue discount deductions of C
corporations (temporary).
*
*
*
*
*
(b) * * *
(2) * * *
(iii) * * *
(A) * * * For purposes of
determining an electing corporation’s
gross asset value, the amount of any
distribution that is not treated as an
impairment transaction under paragraph
(b)(2)(iii)(D) of this section
(distributions and charitable
contributions consistent with historical
practice) or under paragraph
(b)(2)(iii)(E) of this section (special rules
for RICs and REITs) is treated as an asset
of the electing corporation. * * *
*
*
*
*
*
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2010–0672]
Notice of Enforcement for Special
Local Regulation; Thunderboat
Regatta; Mission Bay, CA
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
the Thunderboat Regatta Special Local
Regulation from 7 a.m. PST on
September 17, 2010 through 5:30 p.m.
on September 19, 2010. This action is
necessary to provide for the safety of the
participants, crew, spectators,
participating vessels, and other vessels
and users of the waterway. During the
enforcement period, no person or vessel
may enter the zone established by the
special local regulation without
permission of the Captain of the Port.
DATES: The regulations in 33 CFR
100.1101 will be enforced from 7 a.m.
to 5:30 p.m. on September 17, 18, and
19, 2010.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice, call
or e-mail Petty Officer Shane Jackson,
Waterways Management, U.S. Coast
Guard Sector San Diego, Coast Guard;
telephone 619–278–7262, e-mail
Shane.E.Jackson@USCG.mil.
SUMMARY:
SUPPLEMENTARY INFORMATION:
The Coast Guard will enforce the
special local regulation for the
Thunderboat Regatta in 33 CFR
100.1101 on September 17, 2010, from
7 a.m. PST to 5:30 p.m., September 18,
2010, from 7 a.m. PST to 5:30 p.m., and
September 19, 2010, from 7 a.m. PST to
5:30 p.m.
Under the provisions of 33 CFR
100.1101, a vessel may not enter the
regulated area, unless it receives
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]]>Agencies
[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Rules and Regulations]
[Pages 55676-55677]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22808]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 558
[Docket No. FDA-2010-N-0002]
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval
of New Animal Drug Applications; Chloramphenicol; Lincomycin; Pyrantel
Tartrate; and Tylosin Phosphate and Sulfamethazine
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations by removing those portions that reflect approval of
four new animal drug applications (NADAs). In a notice published
elsewhere in this issue of the Federal Register, FDA is withdrawing
approval of these NADAs.
DATES: This rule is effective September 24, 2010.
FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9079; email:
john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: John J. Ferrante, 11 Fairway Lane, Trumbull,
CT 06611; International Nutrition, Inc., 7706 ``I'' Plaza, Omaha, NE
68127; and Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698,
Mankato, MN 56001 have requested that FDA withdraw approval of the four
NADAs listed in the following paragraph because they are no longer
manufactured or marketed:
In a notice published elsewhere in this issue of the Federal
Register, FDA gave notice that approval of NADA 65-137, 121-337, 132-
923, and 138-342, and all supplements and amendments thereto, is
withdrawn, effective September 24, 2010. As provided in the regulatory
text of this document, the animal drug regulations are amended to
reflect these withdrawals of approval.
Following these changes of sponsorship, Feed Service Co., Inc., and
John J. Ferrante are no longer the sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to remove the entries
for these firms.
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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 520
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
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 parts 510,
520, and 558 are 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.
510.600 [Amended]
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the
entries for ``Feed Service Co., Inc.'' and ``John J. Ferrante''; and in
the table in paragraph (c)(2), remove the entries for ``030841'' and
``058034''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.390b, revise paragraph (b) to read as follows:
Sec. 520.390b Chloramphenicol capsules.
* * * * *
(b) Sponsors. See Nos. 000069 and 050057 in Sec. 510.600(c) of
this chapter for use as in paragraph (d) of this section.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
5. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
6. In Sec. 558.325, revise paragraphs (a) and (c)(3)(ii); and in the
table in paragraphs (d)(2)(ii) and (d)(2)(iii), in the ``Sponsor''
column, remove ``043733'' to read as follows:
[[Page 55677]]
Sec. 558.325 Lincomycin.
(a) Approvals. Type A articles and Type B feeds approved for
sponsors in Sec. 510.600(c) of this chapter for specific uses as in
paragraph (d) of this section as follows:
(1) No. 000009 for 20 and 50 grams per pound.
(2) No. 051311 for 2.5 and 8 grams per pound.
* * * * *
(c) * * *
(3) * * *
(ii) No. 051311:``CAUTION: Not to be fed to swine that weigh more
than 250 lb.''
* * * * *
Sec. 558.485 [Amended]
0
7. In paragraph (b)(3) of Sec. 558.485, remove ``043733''.
Sec. 558.630 [Amended]
0
8. In paragraph (b)(5) of Sec. 558.630, remove ``030841''.
Dated: September 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-22808 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S
