New Animal Drugs for Use in Animal Feeds; Monensin, 66231-66232 [E6-19203]
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Federal Register / Vol. 71, No. 219 / Tuesday, November 14, 2006 / Rules and Regulations
information. You may review copies at the
FAA, New England Region, Office of the
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Issued in Burlington, Massachusetts, on
November 3, 2006.
Peter A. White,
Acting Manager, Engine and Propeller
Directorate, Aircraft Certification Service.
[FR Doc. E6–18964 Filed 11–13–06; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal
Feeds; Monensin
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to simplify the
organization of special labeling
requirements for formulations (Type A
medicated articles, Type B and Type C
medicated feeds) containing monensin
sodium. This action is being taken to
improve the clarity of the regulations.
DATES: This rule is effective November
14, 2006.
FOR FURTHER INFORMATION CONTACT:
Dragan Momcilovic, Center for
Veterinary Medicine (HFV–226), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–453–
6856, e-mail:
dragan.momcilovic@fda.hhs.gov.
On
October 28, 2004, FDA approved a
supplemental new animal drug
application (sNADA 95–735) filed by
Elanco Animal Health for RUMENSIN
(monensin sodium) Type A medicated
article adding use in a new class of
cattle (dairy cows) for increased milk
production efficiency (69 FR 68783,
November 26, 2004). On December 15,
2005, FDA approved another
supplement to NADA 95–735 for use in
dairy cow component feeding systems
(71 FR 1689, January 11, 2006). The
approval of each of these new
conditions of use resulted in the
amendment of the animal drug
sroberts on PROD1PC70 with RULES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
18:19 Nov 13, 2006
Jkt 211001
regulations for monensin in § 558.355
(21 CFR 558.355).
Since these approvals for use of
monensin in dairy cow feeds as well as
beef cattle feeds, FDA has become aware
of confusion regarding which statements
on the approved Type A medicated
article labeling also appear on the
approved representative labeling (Blue
Bird labeling) for Type B and Type C
medicated feeds for each class of cattle.
At this time, the regulations are being
amended in § 558.355 to simplify the
organization of special labeling
requirements for formulations (Type A
medicated articles, Type B and Type C
medicated feeds) containing monensin
sodium. This action is being taken to
improve the clarity of the regulations.
Publication of this document
constitutes final action on this change
under the Administrative Procedures
Act (5 U.S.C. 553). Notice and public
procedure are unnecessary because FDA
is merely correcting nonsubstantive
errors.
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:
I
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. Amend § 558.355 as follows:
a. Revise paragraphs (d)(6) through
(d)(11);
I
b. Remove paragraph (d)(13); and
c. Revise the second sentence of
paragraph (f)(3)(xiii)(B), the third
sentence of paragraph (f)(3)(xiv)(B), and
the sixth sentence of paragraph
(f)(6)(i)(b)(1).
The revisions read as follows:
§ 558.355
Monensin.
*
*
*
*
*
(d) * * *
(6) All formulations containing
monensin shall bear the following
caution statement: Do not allow horses
or other equines access to feed
PO 00000
Frm 00003
Fmt 4700
Sfmt 4700
66231
containing monensin. Ingestion of
monensin by horses has been fatal.
(7) Type A medicated articles
containing monensin intended for use
in cattle and goats shall bear, in
addition to the caution statement in
paragraph (d)(6) of this section, the
following statements:
(i) Monensin medicated cattle and
goat feeds are safe for use in cattle and
goats only. Consumption by unapproved
species may result in toxic reactions.
(ii) Feeding undiluted or mixing
errors resulting in high concentrations
of monensin has been fatal to cattle and
could be fatal to goats.
(iii) Must be thoroughly mixed in
feeds before use.
(iv) Do not feed undiluted.
(v) Do not exceed the levels of
monensin recommended in the feeding
directions, as reduced average daily
gains may result.
(vi) Do not feed to lactating goats.
(vii) If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin in
the refusals and amount of refusals fed
should be taken into consideration to
prevent monensin overdosing.
(viii) A withdrawal period has not
been established for this product in preruminating calves. Do not use in calves
to be processed for veal.
(ix) You may notice the following:
Reduced voluntary feed intake in dairy
cows fed monensin. This reduction
increases with higher doses of monensin
fed. Rule out monensin as the cause of
reduced feed intake before attributing to
other causes such as illness, feed
management, or the environment.
Reduced milk fat percentage in dairy
cows fed monensin. This reduction
increases with higher doses of monensin
fed. Increased incidence of cystic
ovaries and metritis in dairy cows fed
monensin. Reduced conception rates,
increased services per animal, and
extended days open and corresponding
calving intervals in dairy cows fed
monensin. Have a comprehensive and
ongoing nutritional, reproductive, and
herd health program in place when
feeding monensin to dairy cows.
(x) Inadequate mixing (recirculation
or agitation) of monensin liquid Type B
or Type C medicated feeds has resulted
in increased monensin concentration
which has been fatal to cattle and could
be fatal to goats.
(8) Type A medicated articles
containing monensin intended for use
in chickens shall bear the caution
statements specified in paragraphs
(d)(6), (d)(7)(iii), and (d)(7)(iv) of this
section.
E:\FR\FM\14NOR1.SGM
14NOR1
66232
Federal Register / Vol. 71, No. 219 / Tuesday, November 14, 2006 / Rules and Regulations
(9) Type B feeds containing monensin
shall bear the statements specified in
the following paragraphs of this section
when intended for use in:
(i) Cattle (as described in paragraphs
(f)(3)(i) through (f)(3)(xii) of this
section): See paragraphs (d)(6), (d)(7)(i)
through (d)(7)(v), (d)(7)(vii), and
(d)(7)(viii) of this section.
(ii) Dairy cows (as described in
paragraphs (f)(3)(xiii) and (f)(3)(xiv) of
this section): See paragraphs (d)(6),
(d)(7)(i) through (d)(7)(iv), (d)(7)(vii),
(d)(7)(viii), and (d)(7)(ix) of this section.
(iii) Goats: See paragraphs (d)(6) and
(d)(7)(i) through (d)(7)(vi) of this
section.
(10) Type C feeds containing
monensin shall bear the statements
specified in the following paragraphs of
this section when intended for use in:
(i) Cattle (as described in paragraphs
(f)(3)(i) through (f)(3)(xii) of this
section): See paragraphs (d)(6), (d)(7)(i),
(d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of
this section.
(ii) Dairy cows (as described in
paragraphs (f)(3)(xiii) and (f)(3)(xiv) of
this section): See paragraphs (d)(6),
(d)(7)(i), (d)(7)(vii), (d)(7)(viii), and
(d)(7)(ix) of this section.
(iii) Goats: See paragraphs (d)(6),
(d)(7)(i), (d)(7)(v), and (d)(7)(vi) of this
section.
(11) Type B and Type C liquid feeds
requiring recirculation or agitation that
contain monensin and are intended for
use in cattle (including dairy cows) and
goats shall bear the caution statement
specified in paragraph (d)(7)(x) of this
section.
*
*
*
*
*
(f) * * *
(3) * * *
(xiii) * * *
(B) * * * See special labeling
considerations in paragraph (d) of this
section.
sroberts on PROD1PC70 with RULES
(xiv) * * *
(B) * * * See special labeling
considerations in paragraph (d) of this
section.
*
*
*
*
*
(6) * * *
(i) * * *
(b) * * *
(1) * * * See special labeling
considerations in paragraph (d) of this
section.
*
*
*
*
*
Dated: October 31, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–19203 Filed 11–13–06; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
18:19 Nov 13, 2006
Jkt 211001
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD [9297]]
RIN 1545–BG02
Residence Rules Involving U.S.
Possessions
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
AGENCY:
SUMMARY: This document contains final
regulations that provide rules for
determining bona fide residency in the
following U.S. territories: American
Samoa, Guam, the Northern Mariana
Islands, Puerto Rico, and the United
States Virgin Islands under section
937(a) of the Internal Revenue Code.
DATES: Effective Date: These regulations
are effective November 14, 2006.
Applicability Dates: For dates of
applicability, see § 1.937–1(i).
FOR FURTHER INFORMATION CONTACT: J.
David Varley, (202) 435–5262 (not a tollfree number).
SUPPLEMENTARY INFORMATION:
Background
On April 11, 2005, the IRS and
Treasury Department published in the
Federal Register temporary regulations
(TD 9194, 70 FR 18920, as corrected at
70 FR 32589–01), which provided rules
to implement section 937 of the Internal
Revenue Code (Code) dealing with U.S.
possessions or territories specified in
that section (territories) and to conform
existing regulations to other legislative
changes with respect to the territories. A
notice of proposed rulemaking (REG–
159243–03, 70 FR 18949) crossreferencing the temporary regulations
was published in the Federal Register
on the same day. Written comments
were received in response to the notice
of proposed rulemaking and a public
hearing on the proposed regulations was
held on July 21, 2005. After
consideration of the comments, the IRS
and Treasury Department on January 31,
2006 published in the Federal Register
final regulations (TD 9248, 71 FR 4996,
as corrected at 71 FR 14099) under
section 937(a) dealing with determining
residency in a territory, adopting with
amendments the proposed regulations
(specifically, §§ 1.937–1 and 1.881–
5T(f)(4)).
Section 937(a) provides that an
individual is a bona fide resident of a
territory if the individual meets a
presence test, a tax home test and a
closer connection test. In order to satisfy
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
the presence test, a person must be
present in the territory for at least 183
days during the taxable year (the 183day rule), unless otherwise provided in
regulations. The final section 937(a)
regulations provide several alternatives
to the 183-day rule in the statute.
Treasury Reg. § 1.937–1 provides that
an individual who does not satisfy the
183-day rule nevertheless meets the
presence test if the individual satisfies
one of three alternative tests: (1) The
individual spends no more than 90 days
in the United States during the taxable
year; (2) the individual has no more
than $3,000 of earned income from U.S.
sources and is present for more days in
the territory than in the United States
during the taxable year; or (3) the
individual has no significant connection
to the United States during the tax year.
The term ‘‘significant connection’’ is
generally defined as a permanent home,
voter registration, spouse, or minor
child in the United States. The final
regulations also provide that certain
days count as days of presence in the
relevant territory for the purposes of the
presence test, even if the person was not
physically present in the territory.
Similarly, certain days that an
individual spends in the United States
do not count as days of presence in the
United States for purposes of the
presence test.
Before finalizing the regulations, the
IRS and Treasury Department received
comments suggesting that days spent
outside of a territory for nonmedical
family emergencies, charitable pursuits
or business travel should count as days
spent in the territory and outside the
United States. The IRS and Treasury
Department were sympathetic to the
concern that the realities of life in the
territories might require periodic
temporary absences from the territories,
but found that the particular suggestions
would have been very difficult to
implement and monitor
administratively. Further, the IRS and
Treasury Department declined to adopt
the commentators’ suggestion to import
a simple mirroring of the substantial
presence test of section 7701(b) on the
ground that Congress had considered
but rejected this approach for
determining residency in a territory. See
H.R. Conf. Rep. No. 108–755, at 791–795
(2004). Nonetheless, the IRS and
Treasury Department believed that final
regulations provided meaningful
advantages to taxpayers over the
proposed and temporary regulations.
Explanation of Provisions
Following publication of the final
regulations, additional comments were
made requesting that the IRS and
E:\FR\FM\14NOR1.SGM
14NOR1
]]>Agencies
[Federal Register Volume 71, Number 219 (Tuesday, November 14, 2006)]
[Rules and Regulations]
[Pages 66231-66232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19203]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Monensin
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 simplify the organization of special labeling
requirements for formulations (Type A medicated articles, Type B and
Type C medicated feeds) containing monensin sodium. This action is
being taken to improve the clarity of the regulations.
DATES: This rule is effective November 14, 2006.
FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-453-6856, e-mail:
dragan.momcilovic@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On October 28, 2004, FDA approved a
supplemental new animal drug application (sNADA 95-735) filed by Elanco
Animal Health for RUMENSIN (monensin sodium) Type A medicated article
adding use in a new class of cattle (dairy cows) for increased milk
production efficiency (69 FR 68783, November 26, 2004). On December 15,
2005, FDA approved another supplement to NADA 95-735 for use in dairy
cow component feeding systems (71 FR 1689, January 11, 2006). The
approval of each of these new conditions of use resulted in the
amendment of the animal drug regulations for monensin in Sec. 558.355
(21 CFR 558.355).
Since these approvals for use of monensin in dairy cow feeds as
well as beef cattle feeds, FDA has become aware of confusion regarding
which statements on the approved Type A medicated article labeling also
appear on the approved representative labeling (Blue Bird labeling) for
Type B and Type C medicated feeds for each class of cattle. At this
time, the regulations are being amended in Sec. 558.355 to simplify
the organization of special labeling requirements for formulations
(Type A medicated articles, Type B and Type C medicated feeds)
containing monensin sodium. This action is being taken to improve the
clarity of the regulations.
Publication of this document constitutes final action on this
change under the Administrative Procedures Act (5 U.S.C. 553). Notice
and public procedure are unnecessary because FDA is merely correcting
nonsubstantive errors.
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. Amend Sec. 558.355 as follows:
a. Revise paragraphs (d)(6) through (d)(11);
b. Remove paragraph (d)(13); and
c. Revise the second sentence of paragraph (f)(3)(xiii)(B), the
third sentence of paragraph (f)(3)(xiv)(B), and the sixth sentence of
paragraph (f)(6)(i)(b)(1).
The revisions read as follows:
Sec. 558.355 Monensin.
* * * * *
(d) * * *
(6) All formulations containing monensin shall bear the following
caution statement: Do not allow horses or other equines access to feed
containing monensin. Ingestion of monensin by horses has been fatal.
(7) Type A medicated articles containing monensin intended for use
in cattle and goats shall bear, in addition to the caution statement in
paragraph (d)(6) of this section, the following statements:
(i) Monensin medicated cattle and goat feeds are safe for use in
cattle and goats only. Consumption by unapproved species may result in
toxic reactions.
(ii) Feeding undiluted or mixing errors resulting in high
concentrations of monensin has been fatal to cattle and could be fatal
to goats.
(iii) Must be thoroughly mixed in feeds before use.
(iv) Do not feed undiluted.
(v) Do not exceed the levels of monensin recommended in the feeding
directions, as reduced average daily gains may result.
(vi) Do not feed to lactating goats.
(vii) If feed refusals containing monensin are fed to other groups
of cattle, the concentration of monensin in the refusals and amount of
refusals fed should be taken into consideration to prevent monensin
overdosing.
(viii) A withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in calves to be processed
for veal.
(ix) You may notice the following: Reduced voluntary feed intake in
dairy cows fed monensin. This reduction increases with higher doses of
monensin fed. Rule out monensin as the cause of reduced feed intake
before attributing to other causes such as illness, feed management, or
the environment. Reduced milk fat percentage in dairy cows fed
monensin. This reduction increases with higher doses of monensin fed.
Increased incidence of cystic ovaries and metritis in dairy cows fed
monensin. Reduced conception rates, increased services per animal, and
extended days open and corresponding calving intervals in dairy cows
fed monensin. Have a comprehensive and ongoing nutritional,
reproductive, and herd health program in place when feeding monensin to
dairy cows.
(x) Inadequate mixing (recirculation or agitation) of monensin
liquid Type B or Type C medicated feeds has resulted in increased
monensin concentration which has been fatal to cattle and could be
fatal to goats.
(8) Type A medicated articles containing monensin intended for use
in chickens shall bear the caution statements specified in paragraphs
(d)(6), (d)(7)(iii), and (d)(7)(iv) of this section.
[[Page 66232]]
(9) Type B feeds containing monensin shall bear the statements
specified in the following paragraphs of this section when intended for
use in:
(i) Cattle (as described in paragraphs (f)(3)(i) through
(f)(3)(xii) of this section): See paragraphs (d)(6), (d)(7)(i) through
(d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of this section.
(ii) Dairy cows (as described in paragraphs (f)(3)(xiii) and
(f)(3)(xiv) of this section): See paragraphs (d)(6), (d)(7)(i) through
(d)(7)(iv), (d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of this section.
(iii) Goats: See paragraphs (d)(6) and (d)(7)(i) through (d)(7)(vi)
of this section.
(10) Type C feeds containing monensin shall bear the statements
specified in the following paragraphs of this section when intended for
use in:
(i) Cattle (as described in paragraphs (f)(3)(i) through
(f)(3)(xii) of this section): See paragraphs (d)(6), (d)(7)(i),
(d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of this section.
(ii) Dairy cows (as described in paragraphs (f)(3)(xiii) and
(f)(3)(xiv) of this section): See paragraphs (d)(6), (d)(7)(i),
(d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of this section.
(iii) Goats: See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), and
(d)(7)(vi) of this section.
(11) Type B and Type C liquid feeds requiring recirculation or
agitation that contain monensin and are intended for use in cattle
(including dairy cows) and goats shall bear the caution statement
specified in paragraph (d)(7)(x) of this section.
* * * * *
(f) * * *
(3) * * *
(xiii) * * *
(B) * * * See special labeling considerations in paragraph (d) of
this section.
(xiv) * * *
(B) * * * See special labeling considerations in paragraph (d) of
this section.
* * * * *
(6) * * *
(i) * * *
(b) * * *
(1) * * * See special labeling considerations in paragraph (d) of
this section.
* * * * *
Dated: October 31, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-19203 Filed 11-13-06; 8:45 am]
BILLING CODE 4160-01-S
