New Animal Drugs; Monensin, 5-6 [05-24671]
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Federal Register / Vol. 71, No. 1 / Tuesday, January 3, 2006 / Rules and Regulations
reimburse institutions for their costs in
connection with food service
operations, including administrative
expenses, under this part. Funds must
be made available in an amount no less
than the sum of the totals obtained
under paragraphs (b), (c), (d), (e), (f), and
(i) of this section. However, in any fiscal
year, the aggregate amount of assistance
provided to a State under this part must
not exceed the sum of the Federal funds
provided by the State to participating
institutions within the State for that
fiscal year and any funds used by the
State under paragraphs (i) and (k) of this
section.
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(c) Emergency shelter funds. For
meals and snacks served to children in
emergency shelters, funds will be made
available to each State agency in an
amount equal to the total calculated by
multiplying the number of meals and
snacks served in the Program within the
State to such children by the national
average payment rate for free meals and
free snacks under section 11 of the
National School Lunch Act.
*
*
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(h) * * *
(1) * * *
(2) The rates for meals, including
snacks, served in child care centers,
emergency shelters, adult day care
centers, and outside-school-hours care
centers will be adjusted annually, on
July 1, on the basis of changes in the
series for food away from home of the
Consumer Price Index for All Urban
Consumers published by the
Department of Labor. * * *
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■ 4. In § 226.6:
■ a. Revise the heading of paragraph (d)
and add a new second sentence to the
introductory text;
■ b. Redesignate paragraphs (d)(2) and
(d)(3) as paragraphs (d)(3) and (d)(4),
respectively, and add a new paragraph
(d)(2); and
■ c. Amend newly redesignated (d)(3)(i)
by removing the reference ‘‘(d)(3)’’ and
adding in its place the reference ‘‘(d)(4)’’.
The revision and additions read as
follows:
§ 226.6 State agency administrative
responsibilities.
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10:44 Nov 10, 2010
Jkt 223001
§ 226.7 State agency responsibilities for
financial management.
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(f) Rate assignment. Each State agency
must require institutions (other than
emergency shelters and sponsoring
organizations of emergency shelters or
day care homes) to submit, not less
frequently than annually, information
necessary to assign rates of
reimbursement as outlined in § 226.9.
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§ 226.8
[Amended]
6. In § 226.8, remove the reference
‘‘§ 226.4(h)’’ in the first sentence of
paragraph (b), the first sentence of
paragraph (c), and the first and second
sentences of paragraph (d), and add in
its place the reference ‘‘§ 226.4(i)’’.
■ 7. In § 226.9:
■ a. Add a new second sentence in
paragraph (a);
■ b. Revise paragraph (b) introductory
text; and
■ c. Revise paragraph (b)(2).
The addition and revisions read as
follows:
■
§ 226.9 Assignment of rates of
reimbursement for centers.
(a) * * * However, only free rates for
meals and snacks as described in
§ 226.4(i)(2) must be assigned for
emergency shelters. * * *
(b) Except for emergency shelters, the
State agency shall either:
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(2) Establish claiming percentages, not
less frequently than annually, for each
institution on the basis of the number of
enrolled participants eligible for free,
reduced price, and paid meals. Children
who only participate in emergency
shelters must not be considered to be
enrolled participants for the purpose of
establishing claiming percentages; or
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*
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*
§ 226.11
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(d) Licensing/approval for institutions
or facilities providing child care. * * *
Emergency shelters are exempt from
licensing/approval requirements
contained in this section but must meet
the requirements of paragraph (d)(2) to
be eligible to participate in the Program.
* * *
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VerDate Mar<15>2010
(2) Health and safety requirements for
emergency shelters. To be eligible to
participate in the Program, emergency
shelters must meet applicable State or
local health and safety standards.
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■ 5. In § 226.7, revise paragraph (f) to
read as follows:
8. In § 226.11, amend the first
sentence of paragraph (a) by adding the
words ‘‘, emergency shelters,’’ after the
words ‘‘adult day care centers’’.
■ 9. In § 226.15, revise the first two
sentences of paragraph (e)(2) to read as
follows:
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Institution provisions.
*
Frm 00005
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Fmt 4700
(e) * * *
(2) Documentation of the enrollment
of each participant at centers (except for
outside-school-hours care centers and
emergency shelters). All types of
centers, except for emergency shelters,
must maintain information used to
determine eligibility for free or reduced
price meals in accordance with
§ 226.23(e)(1). * * *
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§ 226.16
[Amended]
10. In § 226.16:
a. Amend paragraph (f) by adding the
words ‘‘emergency shelters,’’ after the
words ‘‘adult day care centers,’’; and
■ b. Amend the first sentence of
paragraph (h) by adding the words ‘‘,
emergency shelters,’’ after the words
‘‘adult day care centers’’.
■ 11. In § 226.23:
■ a. Revise the second sentence of
paragraph (d); and
■ b. Amend the first sentence of
paragraph (e)(1)(i) by adding the words
‘‘(other than emergency shelters)’’‘‘ after
the word ‘‘institutions’’.
The revision reads as follows:
■
■
§ 226.23
Free and reduced-price meals.
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(d) * * * All media releases issued by
institutions, except for sponsoring
organizations of day care homes,
emergency shelters, and other
institutions that elect not to charge
separately for meals, shall include the
Secretary’s Income Eligibility
Guidelines for Free and Reduced-Price
Meals. * * *
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Dated: December 23, 2005.
Roberto Salazar,
Administrator, Food and Nutrition Service.
[FR Doc. 05–24683 Filed 12–30–05; 8:45 am]
BILLING CODE 3410–30–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Amended]
■
§ 226.15
5
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Sfmt 4700
New Animal Drugs; Monensin
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
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03JAR1
6
Federal Register / Vol. 71, No. 1 / Tuesday, January 3, 2006 / Rules and Regulations
rmajette on DSK29S0YB1PROD with RULES6
drug application (NADA) filed by
Elanco Animal Health. The
supplemental NADA revises the
description of growing cattle fed
monensin Type C medicated feeds for
increased rate of weight gain and for
prevention and control of coccidiosis.
DATES: This rule is effective January 3,
2006.
FOR FURTHER INFORMATION CONTACT: Eric
S. Dubbin, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0232, email: edubbin@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 95–735 that
provides for the use of RUMENSIN 80
(monensin sodium) Type A medicated
article. The supplemental NADA revises
the description of growing cattle fed
monensin Type C medicated feeds for
increased rate of weight gain and for
prevention and control of coccidiosis.
The supplemental NADA is approved as
of November 18, 2005, and the
regulations in 21 CFR 558.355 are
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.
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 558
Animal drugs, Animal feeds.
■ 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:
VerDate Mar<15>2010
10:44 Nov 10, 2010
Jkt 223001
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
2. In § 558.355, in paragraph
(f)(3)(iii)(b), remove ‘‘Feed to pasture
cattle (slaughter, stocker, feeder, and
dairy and beef replacement heifers).’’;
and revise paragraphs (f)(3)(iii)(a),
(f)(3)(x)(a), and (f)(3)(x)(c) to read as
follows:
■
Monensin.
*
*
*
*
*
(f) * * *
(3) * * *
(iii) * * *
(a) Indications for use. Growing cattle
on pasture or in dry lot (stocker and
feeder cattle and dairy and beef
replacement heifers): For increased rate
of weight gain; for prevention and
control of coccidiosis due to Eimeria
bovis and E. zuernii.
*
*
*
*
*
(x) * * *
(a) Indications for use. Growing cattle
on pasture or in dry lot (stocker and
feeder cattle and dairy and beef
replacement heifers): For increased rate
of weight gain; for prevention and
control of coccidiosis due to Eimeria
bovis and E. zuernii.
*
*
*
*
*
(c) Limitations. Feed at a rate of 50 to
200 milligrams per head per day. During
the first 5 days of feeding, cattle should
receive no more than 100 milligrams per
day. Do not feed additional salt or
minerals. Do not mix with grain or other
feeds. Monensin is toxic to cattle when
consumed at higher than approved
levels. Stressed and/or feed- and/or
water-deprived cattle should be adapted
to the pasture and to unmedicated
mineral supplement before using the
monensin mineral supplement. The
product’s effectiveness in cull cows and
bulls has not been established.
Consumption by unapproved species
may result in toxic reactions.
*
*
*
*
*
Dated: December 14, 2005.
Stephen D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–24671 Filed 12–30–05; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
Internal Revenue Service
26 CFR Parts 1 and 602
[TD 9237]
Authority: 21 U.S.C. 360b, 371.
§ 558.355
DEPARTMENT OF THE TREASURY
RIN 1545–BE05
Designated Roth Contributions to
Cash or Deferred Arrangements Under
Section 401(k)
AGENCY: Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
SUMMARY: This document contains
amendments to the regulations under
section 401(k) and (m) of the Internal
Revenue Code. These regulations
provide guidance concerning the
requirements for designated Roth
contributions under qualified cash or
deferred arrangements described in
section 401(k). These regulations affect
section 401(k) plans that provide for
designated Roth contributions and
participants eligible to make elective
contributions under these plans.
DATES: Effective Date: These regulations
are effective January 1, 2006.
Applicability Date: These regulations
apply to plan years beginning on or after
January 1, 2006.
FOR FURTHER INFORMATION CONTACT:
Cathy A. Vohs, 202–622–6090 or R. Lisa
Mojiri-Azad, 202–622–6060 (not tollfree numbers).
SUPPLEMENTARY INFORMATION:
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
Reduction Act of 1995 (44 U.S.C.
3507(d)) under control number 1545–
1930.
The collection of information in these
regulations is in 26 CFR 1.401(k)–
1(f)(1)&(2). This information is required
to comply with the separate accounting
and recordkeeping requirements of
section 402A.
The estimated annual burden per
respondent under control number 1545–
1930 is 1 hour.
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: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
E:\FR\FM\03JAR1.SGM
03JAR1
]]>Agencies
[Federal Register Volume 71, Number 1 (Tuesday, January 3, 2006)]
[Rules and Regulations]
[Pages 5-6]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24671]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs; Monensin
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
[[Page 6]]
drug application (NADA) filed by Elanco Animal Health. The supplemental
NADA revises the description of growing cattle fed monensin Type C
medicated feeds for increased rate of weight gain and for prevention
and control of coccidiosis.
DATES: This rule is effective January 3, 2006.
FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0232, e-mail: edubbin@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 95-735 that provides for the use of RUMENSIN 80
(monensin sodium) Type A medicated article. The supplemental NADA
revises the description of growing cattle fed monensin Type C medicated
feeds for increased rate of weight gain and for prevention and control
of coccidiosis. The supplemental NADA is approved as of November 18,
2005, and the regulations in 21 CFR 558.355 are 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.
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 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. In Sec. 558.355, in paragraph (f)(3)(iii)(b), remove ``Feed to
pasture cattle (slaughter, stocker, feeder, and dairy and beef
replacement heifers).''; and revise paragraphs (f)(3)(iii)(a),
(f)(3)(x)(a), and (f)(3)(x)(c) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(3) * * *
(iii) * * *
(a) Indications for use. Growing cattle on pasture or in dry lot
(stocker and feeder cattle and dairy and beef replacement heifers): For
increased rate of weight gain; for prevention and control of
coccidiosis due to Eimeria bovis and E. zuernii.
* * * * *
(x) * * *
(a) Indications for use. Growing cattle on pasture or in dry lot
(stocker and feeder cattle and dairy and beef replacement heifers): For
increased rate of weight gain; for prevention and control of
coccidiosis due to Eimeria bovis and E. zuernii.
* * * * *
(c) Limitations. Feed at a rate of 50 to 200 milligrams per head
per day. During the first 5 days of feeding, cattle should receive no
more than 100 milligrams per day. Do not feed additional salt or
minerals. Do not mix with grain or other feeds. Monensin is toxic to
cattle when consumed at higher than approved levels. Stressed and/or
feed- and/or water-deprived cattle should be adapted to the pasture and
to unmedicated mineral supplement before using the monensin mineral
supplement. The product's effectiveness in cull cows and bulls has not
been established. Consumption by unapproved species may result in toxic
reactions.
* * * * *
Dated: December 14, 2005.
Stephen D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 05-24671 Filed 12-30-05; 8:45 am]
BILLING CODE 4160-01-S
