New Animal Drugs For Use in Animal Feeds; Ractopamine, 65666-65667 [E7-22882]
Download as PDF
<![CDATA[
65666
Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Rules and Regulations
COMMENTS ON DOCUMENT MANUAL—Continued
No.
Commenter
Manual ¶
Comment
13 ........
Enbridge, p. 10 .........
12 .....................
14 ........
Enbridge, p. 10;
INGAA, App. A, pp.
7–8.
13 .....................
With regard to the location of data in the
headers and footers, clarify that if there is
no specific instruction for the data’s location, it may be placed in any location in
the header.
Clarify the meaning of ‘‘hard-keyed’’ headers or footers in tab-delimited or native
format data files, and whether this requirement is applicable to headers and
footers created by text programs such as
Word.
15 ........
EEI, p. 14 PJM, p. 3
17 .....................
16 ........
EEI, p. 14 INGAA,
App. A, p. 5–6.
28.d ..................
17 ........
INGAA, App. A, p. 3
passim ..............
[FR Doc. E7–22799 Filed 11–21–07; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feeds; Ractopamine
AGENCY:
Food and Drug Administration,
HHS.
ebenthall on PROD1PC69 with RULES
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
Elanco Animal Health. The
supplemental NADA provides for an
increased level of monensin in two-way
combination Type B and Type C
medicated feeds containing ractopamine
hydrochloride and monensin for cattle
fed in confinement for slaughter.
DATES: This rule is effective November
23, 2007.
FOR FURTHER INFORMATION CONTACT:
Daniel A. Benz, Center for Veterinary
VerDate Aug<31>2005
14:51 Nov 21, 2007
Jkt 214001
Response
EEI notes that the last sentence is in error
and should be deleted; whereas PJM is
concerned about the implications this instruction may have with regard to access
to its internal data.
Clarify the use and appearance of
hyperlinks in an electronic document, and
whether their use will result in a rejection
of the filing.
INGAA notes that the Commission’s Part
154 electronic document instructions date
from 1977[sic]. INGAA requests that
those instructions be updated to reflect
some of the flexibility offered by the new
general instructions for electronic documents.
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0223, email: daniel.benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 141 225 that
provides for use of OPTAFLEXX
(ractopamine hydrochloride) and
RUMENSIN (monensin USP) Type A
medicated articles to make dry and
liquid two-way combination medicated
feeds for cattle fed in confinement for
slaughter. The supplemental NADA
provides for an increased level of
monensin in combination Type B and
Type C medicated feeds. The
supplemental NADA is approved as of
October 30, 2007, and the regulations in
21 CFR 558.500 are amended 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
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
See item 11 above.
Most native format data files and some
spreadsheet files should not have hardkeyed headers or footers, as they disrupt
the analysis and manipulation of the contents. The instruction is not relevant for
text files, where the word processor normally manages headers and footers separate from the text content.
EEI is correct, the last sentence should be
struck. This moots PJM’s concern.
The Commission clarifies that parties may
not use hyperlinks as a means to include
items as part of the record they intend to
rely upon. Hyperlinks may be used as
part of citations, and word processor conversions into hyperlinks were not the
focus of this instruction.
While beyond the scope of this proceeding,
INGAA should contact the Secretary with
a list of suggested changes and procedures.
a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33(a)(2) 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 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 the
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.
E:\FR\FM\23NOR1.SGM
23NOR1
65667
Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Rules and Regulations
§ 558.500
2. In § 558.500, in the table in
paragraph (e)(2), revise paragraphs
(e)(2)(ii) and (e)(2)(vii) to read as
follows:
I
Ractopamine grams/ton
*
*
*
*
*
*
*
BILLING CODE 4160–01–S
*
*
*
ebenthall on PROD1PC69 with RULES
VerDate Aug<31>2005
14:51 Nov 21, 2007
Jkt 214001
*
000986
*
Department of the Army, Corps of
Engineers
The temporary regulations that are the
subject of this correction are under
section 6033 of the Internal Revenue
Code.
Correction of Publication
SUMMARY: This document contains a
correction to temporary regulations (TD
9366) that was published in the Federal
Register on Thursday, November 15,
2007 (72 FR 64147) describing the time
and manner in which certain taxexempt organizations not currently
required to file an annual information
return under section 6033(a)(1) are
required to submit an annual electronic
notice including certain information
required by section 6033(i)(1)(A)
through (F).
DATES: The correction is effective
November 23, 2007.
FOR FURTHER INFORMATION CONTACT:
Monice Rosenbaum at (202) 622–6070
(not a toll-free number).
000986
Background
RIN 1545–BG38
Internal Revenue Service (IRS),
Treasury.
ACTION: Correction to temporary
regulations.
*
*
DEPARTMENT OF DEFENSE
As published, the temporary
regulations (TD 9366) contain an error
that may prove to be misleading and is
in need of clarification.
AGENCY:
As in paragraph
(e)(2)(vi) of this section; see paragraph
§§ 558.355(d) of this
chapter.
Sponsor
SUPPLEMENTARY INFORMATION:
Internal Revenue Service
Notification Requirement for TaxExempt Entities Not Currently
Required to File; Correction
*
*
DEPARTMENT OF THE TREASURY
[TD 9366]
As in paragraph (e)(2)(i)
of this section; see
paragraph
§§ 558.355(d) of this
chapter.
*
Need for Correction
26 CFR Part 1
*
Cattle fed in confinement for slaughter: As in paragraph (e)(2)(vi) of
this section; for prevention and
control of coccidiosis due to
Eimeria bovis and E zuernii.
*
Dated: November 8, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–22882 Filed 11–21–07; 8:45 am]
Limitations
Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of
this section; for prevention and
control of coccidiosis due to
Eimeria bovis and E zuernii.
*
Monensin 10 to 40 to provide 0.14
to 0.42 mg monensin/lb of body
weight, depending on severity of
coccidiosis challenge, up to 480
mg/head/day
*
Indications for use
*
Monensin 10 to 40 to provide 0.14
to 0.42 mg monensin/lb of body
weight, depending on severity of
coccidiosis challenge, up to 480
mg/head/day
(vii) 9.8 to 24.6
*
Combination grams/ton
*
(ii) 8.2 to 24.6
Ractopamine.
*
*
(e) * * *
(2) * * *
Accordingly, the publication of the
temporary regulations (TD 9366), which
was the subject of FR Doc. E7–22299, is
corrected as follows:
On page 64149, column 1, second
paragraph of the column, in the
preamble, under the paragraph heading
‘‘Organizations Required To File
Returns or Submit Electronic Notice’’,
line 5, the language ‘‘an organization
exemption from’’ is corrected to read
‘‘an organization exempt from’’.
LaNita Van Dyke,
Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
Counsel (Procedure and Administration).
[FR Doc. E7–22892 Filed 11–21–07; 8:45 am]
BILLING CODE 4830–01–P
PO 00000
33 CFR Part 334
Department of the Navy, Chesapeake
Bay, in Vicinity of Bloodsworth Island,
MD
United States Army Corps of
Engineers, Department of Defense.
ACTION: Final rule.
AGENCY:
SUMMARY: The Corps of Engineers is
amending its regulations to modify an
existing danger zone, in waters of the
United States in the vicinity of
Bloodsworth Island, Maryland. The
amendment reflects the current
operational and safety procedures at the
Bloodsworth Island Range and
highlights a change in the enforcement
authority from the Commander, Naval
Base Norfolk, Virginia to the
Commander, Naval Air Station Patuxent
River, Maryland. The regulations are
necessary to safeguard United States
Navy vessels and United States
Government facilities/installations from
sabotage and other subversive acts,
accidents, or incidents of a similar
nature. These regulations are also
necessary to protect the public from
potentially hazardous conditions which
may exist as a result from use of the
areas by the United States Navy.
DATES: Effective Date: December 24,
2007.
U.S. Army Corps of
Engineers, Attn: CECW–CO (David B.
Olson), 441 G Street, NW., Washington,
DC 20314–1000.
ADDRESSES:
Frm 00013
Fmt 4700
Sfmt 4700
E:\FR\FM\23NOR1.SGM
23NOR1
]]>Agencies
[Federal Register Volume 72, Number 225 (Friday, November 23, 2007)]
[Rules and Regulations]
[Pages 65666-65667]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22882]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feeds; Ractopamine
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 Elanco Animal Health. The supplemental NADA
provides for an increased level of monensin in two-way combination Type
B and Type C medicated feeds containing ractopamine hydrochloride and
monensin for cattle fed in confinement for slaughter.
DATES: This rule is effective November 23, 2007.
FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 141 225 that provides for use of OPTAFLEXX
(ractopamine hydrochloride) and RUMENSIN (monensin USP) Type A
medicated articles to make dry and liquid two-way combination medicated
feeds for cattle fed in confinement for slaughter. The supplemental
NADA provides for an increased level of monensin in combination Type B
and Type C medicated feeds. The supplemental NADA is approved as of
October 30, 2007, and the regulations in 21 CFR 558.500 are amended 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)(2) 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 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 the
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.
[[Page 65667]]
0
2. In Sec. 558.500, in the table in paragraph (e)(2), revise
paragraphs (e)(2)(ii) and (e)(2)(vii) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(2) * * *
------------------------------------------------------------------------
Ractopamine Combination Indications for
grams/ton grams/ton use Limitations Sponsor
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(ii) 8.2 to Monensin 10 to Cattle fed in As in 000986
24.6 40 to provide confinement for paragraph
0.14 to 0.42 mg slaughter: As (e)(2)(i)
monensin/lb of in paragraph of this
body weight, (e)(2)(i) of section;
depending on this section; see
severity of for prevention paragraph
coccidiosis and control of Sec. Sec.
challenge, up coccidiosis due
to 480 mg/head/ to Eimeria 558.355(d)
day bovis and E of this
zuernii. chapter.
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(vii) 9.8 to Monensin 10 to Cattle fed in As in 000986
24.6 40 to provide confinement for paragraph
0.14 to 0.42 mg slaughter: As (e)(2)(vi)
monensin/lb of in paragraph of this
body weight, (e)(2)(vi) of section;
depending on this section; see
severity of for prevention paragraph
coccidiosis and control of Sec. Sec.
challenge, up coccidiosis due
to 480 mg/head/ to Eimeria 558.355(d)
day bovis and E of this
zuernii. chapter.
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Dated: November 8, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-22882 Filed 11-21-07; 8:45 am]
BILLING CODE 4160-01-S
