Food Additives Permitted in Feed and Drinking Water of Animals; Poly(2-vinylpyridine-co-styrene); Salts of Volatile Fatty Acids, 13099-13100 [05-5344]
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Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by
Phoenix Scientific, Inc. The ANADA
provides for use of tiamulin soluble
powder to prepare medicated drinking
water for the treatment of swine
dysentery and swine pneumonia.
DATES: This rule is effective March 18,
2005.
FOR FURTHER INFORMATION CONTACT:
Daniel A. Benz, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0223, email: daniel.benz@fda.gov.
SUPPLEMENTARY INFORMATION: Phoenix
Scientific, Inc., 3915 South 48th Street
Ter., St. Joseph, MO 64503, filed a
supplement to ANADA 200–344 that
provides for use of Tiamulin Soluble
Antibiotic to prepare medicated
drinking water for the treatment of
swine dysentery and swine pneumonia.
Phoenix Scientific, Inc.’s Tiamulin
Soluble Antibiotic is approved as a
generic copy of Boehringer Ingelheim
Vetmedica, Inc.’s DENAGARD
(tiamulin) Soluble Antibiotic approved
under NADA 134–644. The ANADA is
approved as of February 16, 2005, and
the regulations are amended in 21 CFR
520.2455 to reflect the approval. The
basis of approval is discussed in the
freedom of information summary.
FDA is also amending the regulations
in 21 CFR 520.2455 to reflect a more
recent genus name for the causative
pathogen for swine dysentery and in the
tables in 21 CFR 510.600(c) to reflect
accepted style for the sponsor’s street
address. These actions are being taken
to improve the accuracy of the
regulations.
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(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
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14:42 Mar 17, 2005
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13099
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
List of Subjects
21 CFR Part 573
21 CFR Part 510
Food Additives Permitted in Feed and
Drinking Water of Animals; Poly(2–
vinylpyridine-co-styrene); Salts of
Volatile Fatty Acids
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
21 CFR Part 520
Final rule; technical
amendment.
ACTION:
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
parts 510 and 520 are amended as
follows:
I
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal food additive regulations to
correct the specifications for two food
additives used in cattle feed. Incorrect
symbols describing permitted levels of
heavy metals such as lead and arsenic
are being corrected with text to reflect
PART 510—NEW ANIMAL DRUGS
the maximum permitted levels of these
two impurities in these food additives.
I 1. The authority citation for 21 CFR
This action is being taken to improve
part 510 continues to read as follows:
the accuracy of the agency’s regulations.
DATES: This rule is effective March 18,
Authority: 21 U.S.C. 321, 331, 351, 352,
2005.
353, 360b, 371, 379e.
FOR FURTHER INFORMATION CONTACT:
§ 510.600 [Amended]
Sharon Benz, Center for Veterinary
Medicine (HFV–220), Food and Drug
I 2. Section 510.600 is amended in the
Administration, 7519 Standish Pl.,
table in paragraph (c)(1) in the entry for
Rockville, MD 20855, 240–453–6864, e‘‘Phoenix Scientific, Inc.’’ and in the
mail: sbenz@cvm.fda.gov.
table in paragraph (c)(2) in the entry for
‘‘059130’’ by removing ‘‘St. Terrace’’ and SUPPLEMENTARY INFORMATION: FDA has
found that part 573 (21 CFR part 573)
by adding in its place ‘‘Street Ter.’’.
of the Code of Federal Regulations does
not accurately reflect the approved
PART 520—ORAL DOSAGE FORM
specifications for two food additives
NEW ANIMAL DRUGS
used in cattle feed, poly(2–
vinylpyridine-co-styrene) and salts of
I 3. The authority citation for 21 CFR
volatile fatty acids. The greater than
part 520 continues to read as follows:
symbols in the tables describing the
Authority: 21 U.S.C. 360b.
permitted levels of heavy metals such as
lead and arsenic were incorrect. FDA is
§ 520.2455 [Amended]
amending the regulations in §§ 573.870
and 573.914 to correctly reflect the
I 4. Section 520.2455 is amended in
paragraph (b) by removing ‘‘Sponsor. See maximum permitted levels of these two
impurities in these food additives. This
No. 000010’’ and by adding in its place
action is being taken to improve the
‘‘Sponsors. See Nos. 000010 and
accuracy of the agency’s regulations.
059130’’; and in paragraph (d)(1)(i) by
Publication of this document
removing ‘‘Treponema’’ and by adding
constitutes final action on these changes
in its place ‘‘Brachyspira’’.
under the Administrative Procedure Act
Dated: March 9, 2005.
(5 U.S.C. 553). Notice and public
Stephen F. Sundlof,
procedure are unnecessary because FDA
Director, Center for Veterinary Medicine.
is merely correcting nonsubstantive
errors.
[FR Doc. 05–5380 Filed 3–17–05; 8:45 am]
BILLING CODE 4160–01–S
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List of Subjects in 21 CFR 573
Animal feeds, Food additives.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to the
I
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Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations
Center for Veterinary Medicine, 21 CFR
part 573 is amended as follows:
DEPARTMENT OF THE TREASURY
PART 573—FOOD ADDITIVES
PERMITTED IN FEED AND DRINKING
WATER OF ANIMALS
26 CFR Part 1
1. The authority citation for 21 CFR
part 573 continues to read as follows:
I
Authority: 21 U.S.C. 321, 342, 348.
2. Section 573.870 is amended in
paragraph (a) in the table by revising the
entries for ‘‘Heavy metals such as lead’’
and ‘‘Arsenic’’ to read as follows:
I
§ 573.870
styrene).
*
Poly(2–vinylpyridine-co-
*
*
(a) * * *
*
Limitation
*
*
*
Heavy metals such
as lead
Arsenic
*
*
10 parts per million maximum.
3 parts per million
maximum.
*
*
*
*
3. Section 573.914 is amended in the
tables in paragraphs (b)(1) and (b)(2) by
revising the entries for ‘‘Arsenic’’ and
‘‘Heavy metals as lead’’ to read as
follows:
I
§ 573.914
*
Salts of volatile fatty acids.
*
*
(b) * * *
(1) * * *
*
*
Amount
*
*
Heavy metals such
as lead
*
*
3 parts per million
maximum.
10 parts per million
maximum.
(2) * * *
Components
*
Arsenic
Amount
*
*
Heavy metals such
as lead
*
*
*
*
*
*
3 parts per million
maximum.
10 parts per million
maximum.
*
Dated: March 8, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–5344 Filed 3–17–05; 8:45 am]
Time and Manner of Making Section
163(d)(4)(B) Election To Treat Qualified
Dividend Income as Investment
Income
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations and removal of
temporary regulations.
AGENCY:
This document contains final
regulations relating to an election that
may be made by noncorporate taxpayers
to treat qualified dividend income as
investment income for purposes of
calculating the deduction for investment
interest. The regulations reflect changes
to the law made by the Jobs and Growth
Tax Relief Reconciliation Act of 2003.
The regulations affect taxpayers making
the election under section 163(d)(4)(B)
to treat qualified dividend income as
investment income.
DATES: Effective Date: These regulations
are effective March 18, 2005.
Applicability Dates: For dates of
applicability, see § 1.163(d)–1(d).
FOR FURTHER INFORMATION CONTACT:
Amy Pfalzgraf, (202) 622–4950 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
14:42 Mar 17, 2005
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Drafting Information
The principal author of these
regulations is Amy Pfalzgraf of the
Office of Associate Chief Counsel
(Income Tax & Accounting). However,
other personnel from the IRS and
Treasury Department participated in
their development.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Adoption of Amendments to the
Regulations
Accordingly, 26 CFR part 1 is amended
as follows:
I
PART 1—INCOME TAXES
Paragraph 1. The authority citation for
part 1 continues to read, in part, as
follows:
I
Authority: 26 U.S.C. 7805 * * *
This document contains amendments
to 26 CFR part 1 under section 163(d)
of the Internal Revenue Code (Code). On
August 5, 2004, temporary regulations
(TD 9147) were published in the
Federal Register (69 FR 47364) relating
to an election that may be made by
noncorporate taxpayers to treat qualified
dividend income as investment income
for purposes of calculating the
deduction for investment interest. A
notice of proposed rulemaking (REG–
171386–03) cross-referencing the
temporary regulations also was
published in the Federal Register (69
FR 47395) on August 5, 2004. No
comments in response to the notice of
proposed rulemaking or requests to
speak at a public hearing were received,
and no hearing was held. This Treasury
decision adopts the proposed
regulations and removes the temporary
regulations.
It has been determined that this
Treasury decision is not a significant
BILLING CODE 4160–01–S
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RIN 1545–BD16
Background
Components
*
Arsenic
[TD 9191]
SUMMARY:
*
Component/property
*
Internal Revenue Service
regulatory action as defined in
Executive Order 12866. Therefore, a
regulatory assessment is not required. It
also has been determined that section
553(b) of the Administrative Procedure
Act (5 U.S.C. chapter 5) does not apply
to these regulations, and because the
regulations do not impose a collection
of information on small entities, the
Regulatory Flexibility Act (5 U.S.C.
chapter 6) does not apply. Pursuant to
section 7805(f) of the Code, the
proposed regulations preceding these
regulations were submitted to the Chief
Counsel for Advocacy of the Small
Business Administration for comment
on their impact on small business.
Sfmt 4700
I Par. 2. Section 1.163(d)–1 is revised to
read as follows:
§ 1.163(d)–1 Time and manner for making
elections under the Omnibus Budget
Reconciliation Act of 1993 and the Jobs and
Growth Tax Relief Reconciliation Act of
2003.
(a) Description. Section
163(d)(4)(B)(iii), as added by section
13206(d) of the Omnibus Budget
Reconciliation Act of 1993 (Pub. L. 103–
66, 107 Stat. 467), allows an electing
taxpayer to take all or a portion of
certain net capital gain attributable to
dispositions of property held for
investment into account as investment
income. Section 163(d)(4)(B), as
amended by section 302(b) of the Jobs
and Growth Tax Relief Reconciliation
Act of 2003 (Pub. L. 108–27, 117 Stat.
762), allows an electing taxpayer to take
all or a portion of qualified dividend
income, as defined in section
1(h)(11)(B), into account as investment
income. As a consequence, the net
capital gain and qualified dividend
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]]>Agencies
[Federal Register Volume 70, Number 52 (Friday, March 18, 2005)]
[Rules and Regulations]
[Pages 13099-13100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5344]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
Food Additives Permitted in Feed and Drinking Water of Animals;
Poly(2-vinylpyridine-co-styrene); Salts of Volatile Fatty Acids
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
food additive regulations to correct the specifications for two food
additives used in cattle feed. Incorrect symbols describing permitted
levels of heavy metals such as lead and arsenic are being corrected
with text to reflect the maximum permitted levels of these two
impurities in these food additives. This action is being taken to
improve the accuracy of the agency's regulations.
DATES: This rule is effective March 18, 2005.
FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6864, e-mail: sbenz@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: FDA has found that part 573 (21 CFR part
573) of the Code of Federal Regulations does not accurately reflect the
approved specifications for two food additives used in cattle feed,
poly(2-vinylpyridine-co-styrene) and salts of volatile fatty acids. The
greater than symbols in the tables describing the permitted levels of
heavy metals such as lead and arsenic were incorrect. FDA is amending
the regulations in Sec. Sec. 573.870 and 573.914 to correctly reflect
the maximum permitted levels of these two impurities in these food
additives. This action is being taken to improve the accuracy of the
agency's regulations.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice
and public procedure are unnecessary because FDA is merely correcting
nonsubstantive errors.
List of Subjects in 21 CFR 573
Animal feeds, Food additives.
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
[[Page 13100]]
Center for Veterinary Medicine, 21 CFR part 573 is amended as follows:
PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS
0
1. The authority citation for 21 CFR part 573 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348.
0
2. Section 573.870 is amended in paragraph (a) in the table by revising
the entries for ``Heavy metals such as lead'' and ``Arsenic'' to read
as follows:
Sec. 573.870 Poly(2-vinylpyridine-co-styrene).
* * * * *
(a) * * *
------------------------------------------------------------------------
Component/property Limitation
------------------------------------------------------------------------
* * * * *
Heavy metals such as lead 10 parts per million maximum.
Arsenic 3 parts per million maximum.
------------------------------------------------------------------------
* * * * *
0
3. Section 573.914 is amended in the tables in paragraphs (b)(1) and
(b)(2) by revising the entries for ``Arsenic'' and ``Heavy metals as
lead'' to read as follows:
Sec. 573.914 Salts of volatile fatty acids.
* * * * *
(b) * * *
(1) * * *
------------------------------------------------------------------------
Components Amount
------------------------------------------------------------------------
* * * * *
Arsenic 3 parts per million maximum.
Heavy metals such as lead 10 parts per million maximum.
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Components Amount
------------------------------------------------------------------------
* * * * *
Arsenic 3 parts per million maximum.
Heavy metals such as lead 10 parts per million maximum.
------------------------------------------------------------------------
* * * * *
Dated: March 8, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-5344 Filed 3-17-05; 8:45 am]
BILLING CODE 4160-01-S
