Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, Clotrimazole Ointment, 56867-56868 [E6-15888]
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Federal Register / Vol. 71, No. 188 / Thursday, September 28, 2006 / Rules and Regulations
jlentini on PROD1PC65 with RULES
§ 520.1484
Neomycin.
(a) Specifications—(1) Each ounce of
powder contains 20.3 grams (g)
neomycin sulfate (equivalent to 14.2 g
neomycin base).
(2) Each milliliter of solution contains
200 milligrams (mg) neomycin sulfate
(equivalent to 140 mg neomycin base).
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (e) of this section.
(1) Nos. 000069 and 054925 for use of
product described in paragraph (a)(1) as
in paragraph (e)(1) of this section.
(2) Nos. 000009, 046573, 058005, and
061623 for use of product described in
paragraph (a)(1) as in paragraphs (e)(1)
and (e)(2) of this section.
(3) Nos. 000009, 054925, and 059130
for use of product described in
paragraph (a)(2) as in paragraph (e)(1) of
this section.
(c) Related tolerances. See § 556.430
of this chapter.
(d) Special labeling considerations.
Labeling shall bear the following
warning statements: ‘‘A withdrawal
period has not been established for use
in preruminating calves. Do not use in
calves to be processed for veal. Use of
more than one product containing
neomycin or failure to follow
withdrawal times may result in illegal
drug residues.’’
(e) Conditions of use—(1) Cattle,
swine, sheep, and goats—(i) Amount. 10
mg per pound (/lb) of body weight per
day (22 mg per kilogram (/kg)) in
divided doses for a maximum of 14
days.
(ii) Indications for use. For the
treatment and control of colibacillosis
(bacterial enteritis) caused by
Escherichia coli susceptible to
neomycin sulfate.
(iii) Limitations. Add powder to
drinking water or milk; not for use in
liquid supplements. Administer
solution undiluted or in drinking water.
Prepare a fresh solution in drinking
water daily. If symptoms persist after
using this preparation for 2 or 3 days,
consult a veterinarian. Treatment
should continue 24 to 48 hours beyond
remission of disease symptoms, but not
to exceed a total of 14 consecutive days.
Discontinue treatment prior to slaughter
as follows: Cattle, 1 day; sheep, 2 days;
swine and goats, 3 days.
(2) Turkeys—(i) Amount. 10 mg/lb of
body weight per day (22 mg/kg) for 5
days.
(ii) Indications for use. For the control
of mortality associated with E. coli
susceptible to neomycin sulfate in
growing turkeys.
(iii) Limitations. Add to drinking
water; not for use in liquid
supplements. Prepare a fresh solution
VerDate Aug<31>2005
17:21 Sep 27, 2006
Jkt 208001
daily. If symptoms persist after using
this preparation for 2 or 3 days, consult
a veterinarian. Treatment should
continue 24 to 48 hours beyond
remission of disease symptoms, but not
to exceed a total of 5 consecutive days.
§ 520.1485
I
[Removed]
3. Remove § 520.1485.
Dated: September 12, 2006.
Stephen F. Sundlof
Director, Center for Veterinary Medicine.
[FR Doc. E6–15889 Filed 9–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
Ophthalmic and Topical Dosage Form
New Animal Drugs; Gentamicin
Sulfate, Betamethasone Valerate,
Clotrimazole Ointment
AGENCY:
Food and Drug Administration,
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
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
HHS.
Animal drugs.
Final rule; technical
amendment.
ACTION:
Frm 00015
Fmt 4700
Sfmt 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 part 524 is amended as follows:
I
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 provides for a
new container size, a 40-gram dropper
bottle, from which gentamicin sulfate,
betamethasone valerate, clotrimazole
ointment may be administered for the
treatment of acute and chronic canine
otitis externa.
DATES: This rule is effective September
28, 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: IVX
Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed
a supplement to ANADA 200–287 for
use of TRIPLEMAX (gentamicin sulfate,
USP; betamethasone valerate, USP; and
clotrimazole, USP ointment) for the
treatment of acute and chronic canine
otitis externa. The supplemental
ANADA provides for a new container
size, a 40-gram dropper bottle. The
supplemental ANADA is approved as of
August 23, 2006, and the regulations are
amended in 21 CFR 524.1044g to reflect
the approval.
PO 00000
56867
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 524 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 524.1044g, revise paragraph
(b)(3), paragraph (c)(1) introductory text,
and paragraph (c)(1)(ii) to read as
follows:
I
§ 524.1044g Gentamicin sulfate,
betamethasone valerate, clotrimazole
ointment.
*
*
*
*
*
(b) * * *
(3) No. 059130 for use of 10-, 20-, 40, or 215-g bottles.
(c) * * *
(1) Amount. Instill ointment twice
daily into the ear canal for 7 consecutive
days.
*
*
*
*
*
(ii) From 20-, 40-, or 215-g bottles: 2
drops for dogs weighing less than 30 lb
or 4 drops for dogs weighing 30 lb or
more.
*
*
*
*
*
E:\FR\FM\28SER1.SGM
28SER1
56868
Federal Register / Vol. 71, No. 188 / Thursday, September 28, 2006 / Rules and Regulations
Dated: September 15, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–15888 Filed 9–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
regulations are effective August 17,
2006.’’.
Cynthia E. Grigsby,
Senior Federal Register Liaison Officer,
Publications and Regulations Branch, Legal
Processing Division, Associate Chief Counsel,
(Procedure and Administration).
[FR Doc. E6–15891 Filed 9–27–06; 8:45 am]
Internal Revenue Service
DEPARTMENT OF THE TREASURY
[TD 9281]
Internal Revenue Service
RIN 1545–BF70
26 CFR Part 1
Determination of Interest Expense
Deduction of Foreign Corporations;
Correction
[TD 9281]
Internal Revenue Service (IRS),
Treasury.
ACTION: Correction to final and
temporary regulations.
AGENCY:
SUMMARY: This document contains a
correction to final and temporary
regulations (TD 9281), that were
published in the Federal Register on
Thursday, August 17, 2006 (71 FR
47443). This regulation revised the
Income Tax Regulations relating to the
determination of the interest expense
deduction of foreign corporations and
applies to foreign corporations engaged
in a trade or business within the United
States.
DATES: This correction is effective
August 17, 2006.
FOR FURTHER INFORMATION CONTACT:
Gregory Spring or Paul Epstein, (202)
622–3870 (not a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
The final and temporary regulations
(TD 9281) that is the subject of this
correction are under sections 882 and
884 of the Internal Revenue Code.
Need for Correction
jlentini on PROD1PC65 with RULES
*
*
*
*
*
(a)(7) through (a)(7)(iii) [Reserved].
For further guidance, see entry in
§ 1.882–5T(a)(7) through (a)(7)(iii).
*
*
*
*
*
I Par. 3. Section 1.882–5T is amended
by revising the last sentence of
paragraph (c)(2)(iv) to read as follows:
Determination of Interest Expense
Deduction of Foreign Corporations;
Correction
*
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
AGENCY:
SUMMARY: This document contains a
correction to final and temporary
regulations (TD 9281), that were
published in the Federal Register on
Thursday, August 17, 2006 (71 FR
47443). This regulation revised the
Income Tax Regulations relating to the
determination of the interest expense
deduction of foreign corporations and
applies to foreign corporations engaged
in a trade or business within the United
States.
DATES: This correction is effective
August 17, 2006.
FOR FURTHER INFORMATION CONTACT:
Gregory Spring or Paul Epstein, (202)
622–3870 (not a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
Correction of Publication
Need for Correction
Accordingly, the publication of the
final and temporary regulations (TD
9281), that were the subject of FR Doc.
E6–13402, is corrected as follows:
On page 47443, column 1, in the
preamble under the caption ‘‘DATES:
Effective Date:’’, lines 1 through 5, the
language, ‘‘These regulations are
effective starting the tax year end for
which the original tax return due date
(including extensions) is after August
17, 2006.’’ is corrected to read ‘‘These
As published, TD 9281 contains errors
that may prove to be misleading and are
in need of clarification.
Jkt 208001
Par. 2. Section 1.882–5 paragraph
(a)(7) is revised to read as follows:
§ 1.882–5T Determination of interest
deduction (temporary).
As published, TD 9281 contains an
error that may prove to be misleading
and is in need of clarification.
17:21 Sep 27, 2006
Authority: 26 U.S.C. 7805 * * *
I
RIN 1545–BF70
The final and temporary regulations
(TD 9281) that is the subject of this
correction are under sections 882 and
884 of the Internal Revenue Code.
VerDate Aug<31>2005
Paragraph 1. The authority citation
for part 1 continues to read in part as
follows:
§ 1.882–5 Determination of interest
deduction.
BILLING CODE 4830–01–P
26 CFR Parts 1 and 602
PART 1—INCOME TAXES
I
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Correction of Publication
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendment:
I
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
*
*
*
*
(c) * * *
(2) * * *
(iv) * * * The rules of § 1.882–5(b)(3)
apply in determining the total value of
applicable worldwide assets for the
taxable year, except that the minimum
number of determination dates are those
stated in § 1.882–5(c)(2)(i).
*
*
*
*
*
Cynthia E. Grigsby,
Senior Federal Register Liaison Officer,
Publications and Regulations Branch, Legal
Processing Division, Associate Chief Counsel,
(Procedure and Administration).
[FR Doc. E6–15893 Filed 9–27–06; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 19
RIN 2900–AL97
Board of Veterans’ Appeals:
Clarification of a Notice of
Disagreement
Department of Veterans Affairs.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Department of Veterans
Affairs (VA) is amending its regulations
governing appeals to the Board of
Veterans’ Appeals (BVA or Board) to
clarify the actions an agency of original
jurisdiction (AOJ) must take to
determine whether a written
communication from a claimant that is
ambiguous in its purpose is intended to
be a Notice of Disagreement (NOD) with
an adverse claims decision.
DATES: Effective Date: This rule is
effective October 30, 2006.
Applicability Date: VA will apply this
rule to appeals pending before VA in
E:\FR\FM\28SER1.SGM
28SER1
]]>Agencies
[Federal Register Volume 71, Number 188 (Thursday, September 28, 2006)]
[Rules and Regulations]
[Pages 56867-56868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15888]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin
Sulfate, Betamethasone Valerate, Clotrimazole Ointment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
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 provides for a new container size, a 40-gram dropper
bottle, from which gentamicin sulfate, betamethasone valerate,
clotrimazole ointment may be administered for the treatment of acute
and chronic canine otitis externa.
DATES: This rule is effective September 28, 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, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-287
for use of TRIPLEMAX (gentamicin sulfate, USP; betamethasone valerate,
USP; and clotrimazole, USP ointment) for the treatment of acute and
chronic canine otitis externa. The supplemental ANADA provides for a
new container size, a 40-gram dropper bottle. The supplemental ANADA is
approved as of August 23, 2006, and the regulations are amended in 21
CFR 524.1044g 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(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 524
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 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.
0
2. In Sec. 524.1044g, revise paragraph (b)(3), paragraph (c)(1)
introductory text, and paragraph (c)(1)(ii) to read as follows:
Sec. 524.1044g Gentamicin sulfate, betamethasone valerate,
clotrimazole ointment.
* * * * *
(b) * * *
(3) No. 059130 for use of 10-, 20-, 40-, or 215-g bottles.
(c) * * *
(1) Amount. Instill ointment twice daily into the ear canal for 7
consecutive days.
* * * * *
(ii) From 20-, 40-, or 215-g bottles: 2 drops for dogs weighing
less than 30 lb or 4 drops for dogs weighing 30 lb or more.
* * * * *
[[Page 56868]]
Dated: September 15, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E6-15888 Filed 9-27-06; 8:45 am]
BILLING CODE 4160-01-S
