New Animal Drugs For Use in Animal Feeds; Ractopamine and Tylosin, 41618-41619 [E7-14699]
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Federal Register / Vol. 72, No. 146 / Tuesday, July 31, 2007 / Rules and Regulations
(b) The visual check required by paragraph
(a) of this AD may be performed by an
owner/operator (pilot) holding at least a
private pilot certificate, and must be entered
into the aircraft records showing compliance
with paragraph (a) of this AD in accordance
with 14 CFR sections 43.11 and
91.417(a)(2)(v).
(c) Determine the number of hours TIS for
any affected retention pin and replace the
retention pin with an airworthy retention pin
as follows:
(1) For a retention pin with 545 or more
hours TIS, remove the retention pin and
replace it with an airworthy retention pin
with a S/N that is not listed in the
Applicability section of this AD within the
next 5 hours TIS or within 30 days,
whichever occurs first.
(2) For a retention pin with less than 545
hours TIS, remove the retention pin and
replace it with an airworthy retention pin
with a S/N that is not listed in the
Applicability section of this AD on or before
reaching 550 hours TIS or within 30 days,
whichever occurs first.
Note: Enstrom Service Directive Bulletin
No. T–029 and Enstrom Service Directive
Bulletin 0102, both dated March 20, 2007,
pertain to the subject of this AD.
(d) Removing any affected retention pin
and replacing it with an airworthy retention
pin that is not included in the Applicability
section of this AD is considered a terminating
action for the requirements of this AD for that
retention pin.
VerDate Aug<31>2005
13:44 Jul 30, 2007
Jkt 211001
(e) To request a different method of
compliance or a different compliance time
for this AD, follow the procedures in 14 CFR
39.19. Contact the Manager, Chicago Aircraft
Certification Office, FAA, ATTN: Gregory J.
Michalik, Senior Aerospace Engineer, 2300 E.
Devon Ave., Room 107, Des Plaines, Illinois,
60018, telephone (847) 298–7135, fax (847)
294–7834, for information about previously
approved alternative methods of compliance.
(f) This amendment becomes effective on
August 15, 2007.
Issued in Fort Worth, Texas, on July 24,
2007.
David A. Downey,
Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 07–3711 Filed 7–30–07; 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; Ractopamine and Tylosin
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
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 revises the
indications for use of two-way
combination Type B and Type C
medicated swine feeds formulated with
ractopamine hydrochloride and tylosin
phosphate.
DATES:
This rule is effective July 31,
2007.
FOR FURTHER INFORMATION CONTACT:
Harlan J. Howard, Center for Veterinary
Medicine (HFV–120), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0231, email: harlan.howard@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 141–172 that
provides for use of two-way
combination Type B and Type C
medicated swine feeds formulated with
PAYLEAN (ractopamine hydrochloride)
and TYLAN (tylosin phosphate) single-
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31JYR1
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rmajette on PROD1PC64 with RULES
41618
41619
Federal Register / Vol. 72, No. 146 / Tuesday, July 31, 2007 / Rules and Regulations
ingredient Type A medicated articles.
The supplement provides for revised
indications for use of Type C medicated
feeds used for increased rate of weight
gain, improved feed efficiency, and
increased carcass leanness; and for
control of swine dysentery associated
with Brachyspira hyodysenteriae and
porcine proliferative enteropathies
(ileitis) associated with Lawsonia
intracellularis in finishing swine,
weighing not less than 150 pounds (lbs),
fed a complete ration containing at least
16 percent crude protein for the last 45
to 90 lbs of gain prior to slaughter. The
supplemental NADA is approved as of
June 20, 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
Ractopamine grams/
ton
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)(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 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.
Combination
grams/ton
*
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.
2. In § 558.500, revise the table in
paragraphs (e)(1)(ii) and (e)(1)(iii) to
read as follows:
I
§ 558.500
*
Indications for use
*
*
Ractopamine.
*
*
(e) * * *
(1) * * *
*
*
Limitations
*
*
*
Sponsor
*
(ii) 4.5 to 9
Tylosin 40
Finishing swine: As in paragraph (e)(1)(i) of this
section; and for control of swine dysentery associated with Brachyspira hyodysenteriae and porcine
proliferative enteropathies (ileitis) associated with
Lawsonia intracellularis.
Feed continuously as sole ration until market weight following the use of tylosin at
100 grams per ton (g/ton) for
at least 3 weeks.
000986
(iii) 4.5 to 9
Tylosin 100
1. Finishing swine: As in paragraph (e)(1)(i) of this
section; and for control of porcine proliferative
enteropathies (ileitis) associated with Lawsonia
intracellularis.
2. Finishing swine: As in paragraph (e)(1)(i) of this
section; and for control of swine dysentery associated with Brachyspira hyodysenteriae.
Feed continuously as sole ration for 21 days.
Feed continuously as sole ration for at least 3 weeks followed by tylosin at 40 g/ton
until market weight.
000986
*
*
*
*
*
*
*
*
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
rmajette on PROD1PC64 with RULES
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations for food
substances affirmed as generally
recognized as safe (GRAS) in feed and
drinking water of animals to correct a
cross-reference. This action is being
taken to improve the accuracy of the
regulations.
This rule is effective July 31,
2007.
FOR FURTHER INFORMATION CONTACT:
21 CFR Part 584
Food Substances Affirmed as
Generally Recognized as Safe in Feed
and Drinking Water of Animals; Ethyl
Alcohol Containing Ethyl Acetate
Food and Drug Administration,
HHS.
13:44 Jul 30, 2007
Final rule; technical
amendment.
DATES:
Food and Drug Administration
VerDate Aug<31>2005
*
ACTION:
Dated: July 12, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–14699 Filed 7–30–07; 8:45 am]
AGENCY:
*
Jkt 211001
Michaela G. Alewynse, Center for
Veterinary Medicine (HFV–228), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–453–
6866, e-mail:
mika.alewynse@fda.hhs.gov.
FDA has
found that the regulation affirming as
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
*
*
GRAS the use of ethyl alcohol
containing ethyl acetate as a source of
added energy in ruminant feed does not
reflect the correct cross-reference to the
regulations of the Bureau of Alcohol,
Tobacco, Firearms and Explosives
(ATF). This error was introduced when
sections containing formulas for
denatured alcohol and rum were
removed and added by ATF in 1983 (48
FR 24672, June 2, 1983). At this time,
the regulation is being amended in 21
CFR 584.200 to add the correct crossreference. This action is being taken to
improve the accuracy of the regulations.
Publication of this document
constitutes final action on this change
under the Administrative Procedure Act
(5 U.S.C. 553). Notice and public
procedure are unnecessary because FDA
is merely correcting a nonsubstantive
error.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
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31JYR1
]]>Agencies
[Federal Register Volume 72, Number 146 (Tuesday, July 31, 2007)]
[Rules and Regulations]
[Pages 41618-41619]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14699]
=======================================================================
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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; Ractopamine and Tylosin
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
revises the indications for use of two-way combination Type B and Type
C medicated swine feeds formulated with ractopamine hydrochloride and
tylosin phosphate.
DATES: This rule is effective July 31, 2007.
FOR FURTHER INFORMATION CONTACT: Harlan J. Howard, Center for
Veterinary Medicine (HFV-120), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0231, e-mail:
harlan.howard@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 141-172 that provides for use of two-way combination
Type B and Type C medicated swine feeds formulated with PAYLEAN
(ractopamine hydrochloride) and TYLAN (tylosin phosphate) single-
[[Page 41619]]
ingredient Type A medicated articles. The supplement provides for
revised indications for use of Type C medicated feeds used for
increased rate of weight gain, improved feed efficiency, and increased
carcass leanness; and for control of swine dysentery associated with
Brachyspira hyodysenteriae and porcine proliferative enteropathies
(ileitis) associated with Lawsonia intracellularis in finishing swine,
weighing not less than 150 pounds (lbs), fed a complete ration
containing at least 16 percent crude protein for the last 45 to 90 lbs
of gain prior to slaughter. The supplemental NADA is approved as of
June 20, 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.
FDA 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 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 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.
0
2. In Sec. 558.500, revise the table in paragraphs (e)(1)(ii) and
(e)(1)(iii) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(1) * * *
------------------------------------------------------------------------
Ractopamine Combination
grams/ton grams/ton Indications for use Limitations Sponsor
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(ii) 4.5 to Tylosin 40 Finishing swine: As Feed 000986
9 in paragraph continuous
(e)(1)(i) of this ly as sole
section; and for ration
control of swine until
dysentery market
associated with weight
Brachyspira following
hyodysenteriae and the use of
porcine tylosin at
proliferative 100 grams
enteropathies per ton (g/
(ileitis) ton) for
associated with at least 3
Lawsonia weeks.
intracellularis.
------------------------------------------------------------------------
(iii) 4.5 Tylosin 100 1. Finishing swine: Feed 000986
to 9 As in paragraph continuous
(e)(1)(i) of this ly as sole
section; and for ration for
control of porcine 21 days.
proliferative Feed
enteropathies continuous
(ileitis) ly as sole
associated with ration for
Lawsonia at least 3
intracellularis. weeks
2. Finishing swine: followed
As in paragraph by tylosin
(e)(1)(i) of this at 40 g/
section; and for ton until
control of swine market
dysentery weight.
associated with
Brachyspira
hyodysenteriae.
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
* * * * *
Dated: July 12, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-14699 Filed 7-30-07; 8:45 am]
BILLING CODE 4160-01-S
