Oral Dosage Form New Animal Drugs; Oxytetracycline Powder, 71038-71039 [E6-20928]
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71038
Federal Register / Vol. 71, No. 236 / Friday, December 8, 2006 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Lincomycin and Spectinomycin
Powder
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PRODPC60 with RULES
ACTION:
Final rule.
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 Agri
Laboratories, Ltd. The ANADA provides
for the oral use of lincomycin and
spectinomycin soluble powder to create
a solution administered in the drinking
water of chickens as an aid in the
control of airsacculitis.
DATES: This rule is effective December 8,
2006.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Agri
Laboratories, Ltd., P.O. Box 3103, St.
Joseph, MO 64503, filed ANADA 200–
407 that provides for use of LincomycinSpectinomycin (lincomycin
hydrochloride and spectinomycin
dihydrochloride pentahydrate) Water
Soluble Powder to create a solution
administered in the drinking water of
chickens as an aid in the control of
airsacculitis caused by either
Mycoplasma synoviae or M.
gallisepticum susceptible to lincomycinspectinomycin and complicated chronic
respiratory disease (air sac infection)
caused by Escherichia coli and M.
gallisepticum susceptible to lincomycinspectinomycin. Agri Laboratories, Ltd.’s
Lincomycin-Spectinomycin Water
Soluble Powder is approved as a generic
copy of L–S 50 Water Soluble Powder,
sponsored by Pharmacia & Upjohn Co.,
a Division of Pfizer, Inc., under NADA
046–109. The ANADA is approved as of
November 9, 2006, and the regulations
are amended in 21 CFR 520.1265 to
reflect the approval. The basis of
approval is discussed in the freedom of
information summary.
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
VerDate Aug<31>2005
16:20 Dec 07, 2006
Jkt 211001
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.
FDA 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
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 520
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 520 is amended as follows:
I
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 520.1265, revise the section
heading and paragraph (b)(2) to read as
follows:
I
§ 520.1265
powder.
Lincomycin and spectinomycin
*
*
*
*
*
(b) * * *
(2) Nos. 057561, 059130, and 061623
for use of product described in
paragraph (a)(2) of this section.
*
*
*
*
*
Dated: November 28, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–20929 Filed 12–7–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Oxytetracycline Powder
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Fmt 4700
List of Subjects in 21 CFR Part 520
Animal drugs.
I 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 520 is amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Final rule.
Frm 00002
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 IVX Animal Health, Inc. The
supplemental ANADA revises labeling
of generic oxytetracycline soluble
powder with the current scientific
names of the causative bacteria of
foulbrood of honeybees.
DATES: This rule is effective December 8,
2006.
FOR FURTHER INFORMATION CONTACT: Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IVX
Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed
a supplement to ANADA 200–247 that
provides for the use of Oxytetracycline
HCl Soluble Powder-343 in several
species. The supplement revises
labeling of generic oxytetracycline
soluble powder with the current
scientific names of the causative
bacteria of foulbrood of honeybees. The
supplemental ANADA is approved as of
November 9, 2006, and the regulations
are amended in 21 CFR 520.1660d to
reflect the approval and a current
format.
Approval of this supplemental
ANADA did not require review of
additional safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
FDA 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
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
Sfmt 4700
E:\FR\FM\08DER1.SGM
08DER1
Federal Register / Vol. 71, No. 236 / Friday, December 8, 2006 / Rules and Regulations
Authority: 21 U.S.C. 360b.
List of Subjects
2. In § 520.1660d, revise paragraph
(d)(2)(ii) to read as follows:
I
§ 520.1660d
26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Oxytetracycline powder.
*
*
*
*
*
(d) * * *
(2) * * *
(ii) Indications for use. For control of
American foulbrood caused by
Paenibacillus larvae and European
foulbrood caused by Streptococcus
pluton susceptible to oxytetracycline.
*
*
*
*
*
Dated: November 22, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–20928 Filed 12–7–06; 8:45 am]
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 1 and 602
[TD 9286]
RIN 1545–BE91
Railroad Track Maintenance Credit;
Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
AGENCY:
SUMMARY: This document corrects
temporary regulations (TD 9286) that
were published in the Federal Register
on Friday, September 8, 2006 (71 FR
53009) providing rules for claiming the
railroad track maintenance credit under
section 45G of the Internal Revenue
Code for qualified railroad track
maintenance expenditures paid or
incurred by a Class II railroad or Class
III railroad and other eligible taxpayers
during the taxable year.
DATES: This correction is effective
September 8, 2006.
FOR FURTHER INFORMATION CONTACT:
Winston H. Douglas, (202) 622–3110
(not a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
pwalker on PRODPC60 with RULES
The temporary regulations (TD 9286)
that is the subject of this document is
under section 45G of the Internal
Revenue Code.
Need for Correction
As published, the temporary
regulations (TD 9286) contain errors that
may prove to be misleading and are in
need of clarification.
16:20 Dec 07, 2006
Reporting and recordkeeping
requirements.
Correction of Publication
Accordingly, 26 CFR parts 1 and 602
are corrected by making the following
correcting amendments:
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 * * *
BILLING CODE 4160–01–S
VerDate Aug<31>2005
26 CFR Part 602
Jkt 211001
I Par. 2. Section 1.45G–0T is amended
by removing the entry for § 1.45G–1T(e)
and (e)(2) and redesignating the entries
for § 1.45G–1T(e)(1) and § 1.45G–
1T(e)(1)(i), (ii) and (iii) as the entries for
(e), (e)(1), (e)(2) and (e)(3) respectively.
I Par. 3. Section 1.45G–1T is amended
by:
I 1. Removing paragraph (e)(2);
I 2. Redesignating paragraphs (e)(1)(i),
(e)(1)(ii), and (e)(1)(iii) as paragraphs
(e)(1), (e)(2), and (e)(3), respectively;
I 3. Revising paragraph (a), sixth
sentence, paragraph (b)(9), paragraph
(d)(6) Example 2.(ii), last sentence,
paragraph headings (e), (e)(1), (e)(2) and
(e)(3), paragraph (e)(2), second and fifth
sentences, paragraph (e)(3), first
sentence, Example 1.(i), third sentence,
Example 1.(iii), second sentence,
Example 2.(iii), fourth sentence, and
paragraph (g)(3). The revisions read as
follows:
§ 1.45G–1T Railroad track maintenance
credit (temporary).
(a) * * * Paragraph (e) of this section
contains rules for adjusting basis for the
amount of the RTMC claimed by an
eligible taxpayer. * * *
(b) * * *
(9) Except as provided in paragraph
(e)(2) of this section, railroad track is
property described in STB property
accounts 8 (ties), 9 (rails and other track
material), and 11 (ballast) in 49 CFR part
1201, subpart A.
*
*
*
*
*
(d) * * *
(6) * * *
Example 2. * * *
(ii) * * * Because O’s tentative
amount of RTMC does not exceed O’s
credit limitation amount for the taxable
year ending March 31, 2007, O may
claim a RMTC for the taxable year
PO 00000
Frm 00003
Fmt 4700
Sfmt 4700
71039
ending March 31, 2007, in the amount
of $75,000.
*
*
*
*
*
(e) Adjustments to basis—* * *
(1) In general. * * *
(2) Basis adjustment made to railroad
track. * * * For purposes of section
45G(e)(3) and this paragraph (e)(2), the
adjusted basis of any railroad track with
respect to which the eligible taxpayer
claims the RTMC is limited to the
amount of QRTME, if any, that is
required to be capitalized into the
qualifying railroad structure or an
intangible asset. * * * If all or some of
the QRTME paid or incurred by an
eligible taxpayer during the taxable year
is capitalized under section 263(a) to
more than one asset, whether tangible or
intangible (for example, railroad track
and bridges), the reduction to the basis
of these assets under this paragraph
(e)(2) is allocated among each of the
assets subject to the reduction in
proportion to the unadjusted basis of
each asset at the time the QRTME is
paid or incurred during that taxable
year.
(3) Examples. The application of this
paragraph (e) is illustrated by the
following examples. * * *
Example 1. * * *
(i) * * * X uses the track
maintenance allowance method for
track structure expenditures (for further
guidance, see Rev. Proc. 2002–65 (2002–
2 CB 700) and § 601.601(d)(2)(ii)(b) of
this chapter). * * *
(iii) * * * In accordance with
paragraph (e)(2) of this section, X
reduces the capitalized amount of
$250,000 by the RTMC of $500,000
claimed by X for 2006, but not below
zero. * * *
Example 2. * * *
(iii) * * * In accordance with
paragraph (e)(2) of this section, Z
reduces the capitalized amount of $1
million by the RTMC of $500,000
claimed by Z for 2006. * * *
*
*
*
*
*
(g) * * *
(3) Special rules for 2005 returns. If a
taxpayer’s Federal income tax return for
a taxable year beginning after December
31, 2004, and ending before September
7, 2006, is filed before October 10, 2006,
and the taxpayer is not filing an
amended Federal income tax return for
that taxable year pursuant to paragraph
(g)(2) of this section before the
taxpayer’s next filed original Federal
income tax return, see paragraphs
(d)(4)(iv) and (f)(7) of this section for the
statements that must be attached to the
taxpayer’s next filed original Federal
income tax return.
E:\FR\FM\08DER1.SGM
08DER1
]]>Agencies
[Federal Register Volume 71, Number 236 (Friday, December 8, 2006)]
[Rules and Regulations]
[Pages 71038-71039]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20928]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Oxytetracycline Powder
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 IVX Animal Health, Inc. The
supplemental ANADA revises labeling of generic oxytetracycline soluble
powder with the current scientific names of the causative bacteria of
foulbrood of honeybees.
DATES: This rule is effective December 8, 2006.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-247
that provides for the use of Oxytetracycline HCl Soluble Powder-343 in
several species. The supplement revises labeling of generic
oxytetracycline soluble powder with the current scientific names of the
causative bacteria of foulbrood of honeybees. The supplemental ANADA is
approved as of November 9, 2006, and the regulations are amended in 21
CFR 520.1660d to reflect the approval and a current format.
Approval of this supplemental ANADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
FDA 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 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 520
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
[[Page 71039]]
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.1660d, revise paragraph (d)(2)(ii) to read as follows:
Sec. 520.1660d Oxytetracycline powder.
* * * * *
(d) * * *
(2) * * *
(ii) Indications for use. For control of American foulbrood caused
by Paenibacillus larvae and European foulbrood caused by Streptococcus
pluton susceptible to oxytetracycline.
* * * * *
Dated: November 22, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E6-20928 Filed 12-7-06; 8:45 am]
BILLING CODE 4160-01-S
