New Animal Drugs For Use in Animal Feeds; Amprolium, 52429-52430 [E6-14673]
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Federal Register / Vol. 71, No. 172 / Wednesday, September 6, 2006 / Rules and Regulations
3. This rule does not contain policies
with Federalism implications as that
term is defined under E.O. 13132.
4. The provisions of the
Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed
rulemaking, the opportunity for public
participation, and a delay in effective
date, are inapplicable because this
regulation involves a military and
foreign affairs function of the United
States (5 U.S.C. 553(a)(1)). Further, no
other law requires that a notice of
proposed rulemaking and an
opportunity for public comment be
given for this final rule. Because a
notice of proposed rulemaking and an
opportunity for public comment are not
required to be given for this rule under
the Administrative Procedure Act or by
any other law, the analytical
requirements of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.) are
not applicable. Therefore, this
regulation is issued in final form.
Although there is no formal comment
period, public comments on this
regulation are welcome on a continuing
basis. Comments should be submitted to
Timothy Mooney, Office of Exporter
Services, Bureau of Industry and
Security, Department of Commerce, P.O.
Box 273, Washington, DC 20044.
List of Subjects in 15 CFR Part 774
Exports, Reporting and recordkeeping
requirements.
I Accordingly, part 774 of the Export
Administration Regulations (15 CFR
parts 730–799) is corrected by making
the following correcting amendment:
PART 774—[CORRECTED]
1. The authority citation for 15 CFR
part 774 is revised to read as follows:
I
2. In Supplement No. 1 to part 774
(the Commerce Control List), Category
jlentini on PROD1PC65 with RULES
VerDate Aug<31>2005
16:42 Sep 05, 2006
Jkt 205001
Supplement No. 1 to Part 774—The
Commerce Control List
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*
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9A120 Complete unmanned aerial
vehicles, not specified in 9A012, having all
of the following:
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Eileen Albanese,
Director, Office of Exporter Services.
[FR Doc. E6–14739 Filed 9–5–06; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feeds; Amprolium
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 new animal
drug application (NADA) filed by Merial
Ltd. The supplemental NADA provides
for formulation of Type C medicated
calf feeds containing amprolium used
for the prevention and treatment of
coccidiosis at a broader range of
concentrations.
This rule is effective September
6, 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: Merial
Ltd., 3239 Satellite Blvd., Bldg. 500,
Duluth, GA 30096–4640, filed a
supplement to NADA 12–350 for CORID
(amprolium) Type A Medicated Article
25%. The supplemental NADA provides
DATES:
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C.
7430(e); 18 U.S.C. 2510 et seq.; 22 U.S.C.
287c, 22 U.S.C. 3201 et seq., 22 U.S.C. 6004;
30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. app.
466c; 50 U.S.C. app. 5; Sec. 901–911, Pub. L.
106–387; Sec. 221, Pub. L. 107–56; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001
Comp., p. 783; Notice of August 3, 2006, 71
FR 44551 (August 7, 2006).
I
9—Propulsion Systems, Space Vehicles
and Related Equipment, Export Control
Classification Number (ECCN) 9A120 is
amended by revising the heading to read
as follows:
PO 00000
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52429
for formulation of Type C medicated
calf feeds used for the prevention and
treatment of coccidiosis at a broader
range of concentrations. The
supplemental NADA is approved as of
July 19, 2006, and 21 CFR 558.55 is
amended 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
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 558
Animal drugs, Animal feeds.
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 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:
I
Authority: 21 U.S.C. 360b, 371.
2. Revise paragraph (d)(1) of § 558.55
to read as follows:
I
§ 558.55
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Amprolium.
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(d) * * *
(1) Cattle. It is used as follows:
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06SER1
52430
Federal Register / Vol. 71, No. 172 / Wednesday, September 6, 2006 / Rules and Regulations
Amprolium in
Grams per Ton
(i) 113.5 to 11,
350; to provide 5 milligrams (mg)
per kilogram
of body
weight per
day.
*
Limitations
Top-dress on or mix in the daily ration. Feed for 21 days during periods of
exposure or when experience indicates that coccidiosis is likely to be a
hazard; as sole source of amprolium. Withdraw 24 hours before slaughter.
A withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
050604
Calves: As an aid in the
treatment of coccidiosis
caused by Eimeria bovis and
E. zurnii.
*
Top-dress on or mix in the daily ration. Feed for 5 days; as sole source of
amprolium. Withdraw 24 hours before slaughter. A withdrawal period has
not been established for this product in preruminating calves. Do not use
in calves to be processed for veal. For a satisfactory diagnosis, a
microscopic examination of the feces should be done by a veterinarian or
diagnostic laboratory before treatment; when treating outbreaks, the drug
should be administered promptly after diagnosis is determined.
050604
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*
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 1 and 602
[TD 9285]
RIN 1545–BB43
Nonaccrual-Experience Method of
Accounting Under Section 448(d)(5)
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
jlentini on PROD1PC65 with RULES
AGENCY:
SUMMARY: This document contains final
regulations relating to the use of a
nonaccrual-experience method of
accounting by taxpayers using an
accrual method of accounting and
performing services. The final
regulations reflect amendments under
the Job Creation and Worker Assistance
Act of 2002. The final regulations affect
qualifying taxpayers that want to adopt,
change to, or change a nonaccrualexperience method of accounting under
section 448(d)(5) of the Internal
Revenue Code (Code).
16:42 Sep 05, 2006
Effective Date: These regulations
are effective September 6, 2006.
Applicability Date: These regulations
are applicable for taxable years ending
on or after August 31, 2006.
Comment Date: Written comments
must be received by January 4, 2007.
These regulations require that a
taxpayer’s nonaccrual-experience
method must be self-tested against the
taxpayer’s actual experience to
determine whether the nonaccrualexperience method clearly reflects the
taxpayer’s experience. The
determination of actual experience is
reserved in these regulations. Comments
are requested concerning how to
determine actual experience for
purposes of timely performing selftesting. Send submissions to:
CC:PA:LPD:PR (REG–141402–02),
Internal Revenue Service, POB 7604,
Ben Franklin Station, Washington, DC
20044. Taxpayers also may submit
comments electronically to the IRS
internet site at https://www.irs.gov/regs.
FOR FURTHER INFORMATION CONTACT:
Concerning the regulations, W. Thomas
McElroy, Jr., (202) 622–4970;
concerning submission of comments,
Kelly Banks, (202) 622–0392 (not tollfree numbers).
SUPPLEMENTARY INFORMATION:
DATES:
Dated: August 22, 2006.
Steven D. Vaughn,
Office of New Animal Drug Evaluation, Center
for Veterinary Medicine.
[FR Doc. E6–14673 Filed 9–5–06; 8:45 am]
VerDate Aug<31>2005
Sponsor
Calves: As an aid in the
prevention of coccidiosis
caused by Eimeria bovis and
E. zurnii.
(ii) 113.5 to 11,
350; to provide 10 mg
per kilogram
of body
weight per
day.
*
Indications for Use
Jkt 205001
Paperwork Reduction Act
The collection of information
contained in these final regulations has
been reviewed and approved by the
Office of Management and Budget in
accordance with the Paperwork
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
Reduction Act of 1995 (44 U.S.C.
3507(d)) under control number 1545–
1855.
The collection of information in these
final regulations is in § 1.448–2(d)(8)
and (e)(5). This information is required
to enable the IRS to verify that a
taxpayer is reporting the correct amount
of income or gain or claiming the correct
amount of losses, deductions, or credits
from the taxpayer’s use of the
nonaccrual-experience method of
accounting. The collection of
information is required to obtain a
benefit.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless the collection of information
displays a valid control number.
The estimated annual burden per
respondent is 3 hours.
Comments concerning the accuracy of
this burden estimate and suggestions for
reducing this burden should be sent to
the Internal Revenue Service, Attn: IRS
Reports Clearance Officer,
SE:W:CAR:MP:T:T:SP, Washington, DC
20224, and to the Office of Management
and Budget, Attn: Desk Officer for the
Department of the Treasury, Office of
Information and Regulatory Affairs,
Washington, DC 20503.
Books and records relating to a
collection of information must be
retained as long as their contents may
become material in the administration
of any internal revenue law. Generally,
tax returns and tax return information
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]]>Agencies
[Federal Register Volume 71, Number 172 (Wednesday, September 6, 2006)]
[Rules and Regulations]
[Pages 52429-52430]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14673]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feeds; Amprolium
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 new animal drug
application (NADA) filed by Merial Ltd. The supplemental NADA provides
for formulation of Type C medicated calf feeds containing amprolium
used for the prevention and treatment of coccidiosis at a broader range
of concentrations.
DATES: This rule is effective September 6, 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: Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA 30096-4640, filed a supplement to NADA 12-350 for CORID
(amprolium) Type A Medicated Article 25%. The supplemental NADA
provides for formulation of Type C medicated calf feeds used for the
prevention and treatment of coccidiosis at a broader range of
concentrations. The supplemental NADA is approved as of July 19, 2006,
and 21 CFR 558.55 is amended 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 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 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 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.
0
2. Revise paragraph (d)(1) of Sec. 558.55 to read as follows:
Sec. 558.55 Amprolium.
* * * * *
(d) * * *
(1) Cattle. It is used as follows:
[[Page 52430]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amprolium in Grams per Ton Indications for Use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 113.5 to 11, 350; to provide 5 Calves: As an aid in the Top-dress on or mix in the daily ration. Feed for 21 days during 050604
milligrams (mg) per kilogram of prevention of coccidiosis periods of exposure or when experience indicates that coccidiosis is
body weight per day. caused by Eimeria bovis and likely to be a hazard; as sole source of amprolium. Withdraw 24 hours
E. zurnii before slaughter. A withdrawal period has not been established for
this product in preruminating calves. Do not use in calves to be
processed for veal
--------------------------------------------------------------------------------------------------------------------------------------------------------
(ii) 113.5 to 11, 350; to provide Calves: As an aid in the Top-dress on or mix in the daily ration. Feed for 5 days; as sole 050604
10 mg per kilogram of body weight treatment of coccidiosis source of amprolium. Withdraw 24 hours before slaughter. A withdrawal
per day. caused by Eimeria bovis and period has not been established for this product in preruminating
E. zurnii calves. Do not use in calves to be processed for veal. For a
satisfactory diagnosis, a microscopic examination of the feces should
be done by a veterinarian or diagnostic laboratory before treatment;
when treating outbreaks, the drug should be administered promptly
after diagnosis is determined
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
Dated: August 22, 2006.
Steven D. Vaughn,
Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. E6-14673 Filed 9-5-06; 8:45 am]
BILLING CODE 4160-01-S
