New Animal Drugs for Use in Animal Feed; Zilpaterol; Technical Amendment, 18958-18960 [E8-7307]
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18958
Federal Register / Vol. 73, No. 68 / Tuesday, April 8, 2008 / Rules and Regulations
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
I
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of the Federal Aviation
Administration Order 7400.9R, Airspace
Designations and Reporting Points,
signed August 15, 2007, and effective
September 15, 2007 is amended as
follows:
I
Paragraph 6005. Class E airspace areas
extending upward from 700 feet or more
above the surface of the earth.
*
*
*
*
*
ANM CO, E5 Pagosa Springs, CO [New]
Stevens Field, Pagosa Springs, CO
(Lat. 37°17′11″ N., long. 107°3′22″ W.)
That airspace extending upward from 700
feet above the surface within a 10.0-mile
radius of Stevens Field and within 8.0 miles
each side of the 169° bearing from the airport
extending from the 10.0 mile radius to 25.0
miles south of the airport.
*
*
*
*
*
Issued in Seattle, Washington, on March
28, 2008.
Clark Desing,
Manager, System Support Group, Western
Service Center.
[FR Doc. E8–7243 Filed 4–7–08; 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
Feed; Zilpaterol; Technical
Amendment
AGENCY:
Food and Drug Administration,
rwilkins on PROD1PC63 with RULES
HHS.
VerDate Aug<31>2005
16:20 Apr 07, 2008
Jkt 214001
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a new animal drug
application (NADA) filed by Intervet
Inc. The NADA provides for use of
approved, single-ingredient Type A
medicated articles containing zilpaterol
hydrochloride, monensin USP, tylosin
phosphate, and melengestrol acetate in
four-way combination Type B and Type
C medicated feeds for heifers fed in
confinement for slaughter.
DATES: This rule is effective April 8,
2008.
FOR FURTHER INFORMATION CONTACT:
Gerald L. Rushin, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8103, email: gerald.rushin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, filed NADA 141–
280 that provides for use of ZILMAX
(zilpaterol hydrochloride), and
RUMENSIN (monensin USP), TYLAN
(tylosin phosphate), and MGA
(melengestrol acetate) Type A
medicated articles to make dry and
liquid four-way combination Type B
and Type C medicated feeds used for
increased rate of weight gain, improved
feed efficiency, and increased carcass
leanness; for prevention and control of
coccidiosis due to Eimeria bovis and E.
zuernii; and for reduction of incidence
of liver abscesses caused by
Fusobacterium necrophorum and
Arcanobacterium (Actinomyces)
pyogenes; and suppression of estrus
(heat) in heifers fed in confinement for
slaughter during the last 20 to 40 days
on feed. The NADA is approved as of
February 29, 2008, and the regulations
in 21 CFR 558.342 and 558.665 are
amended to reflect the approval.
In addition, FDA has noticed that the
codified indications for use of tylosin in
combination with melengestrol and
lasalocid are not consistent with the
conditions of use approved for an
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
abbreviated new animal drug
application (71 FR 39204, July 12,
2006). At this time, the indications for
use are revised to include the associated
pathogens. This action is being taken to
improve the accuracy of the regulations.
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 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. In § 558.342, revise paragraphs
(e)(1)(iv) and (e)(2) to read as follows:
I
§ 558.342
*
Melengestrol.
*
*
(e) * * *
(1) * * *
E:\FR\FM\08APR1.SGM
08APR1
*
*
18959
Federal Register / Vol. 73, No. 68 / Tuesday, April 8, 2008 / Rules and Regulations
Melengestrol
acetate in mg/head/day
*
Combination in
mg/head/day
*
(iv) 0.25 to 0.5
*
*
Lasalocid 100
to 360 plus
tylosin 90.
*
*
rwilkins on PROD1PC63 with RULES
VerDate Aug<31>2005
16:20 Apr 07, 2008
Heifers fed in confinement for
slaughter: As in paragraph
(e)(1)(i) of this section; and for
reduced incidence of liver abscesses caused by
Fusobacterium necrophorum
and Actinomyces
(Corynebacterium) pyogenes.
Combination in
grams/ton
*
Monensin 10 to
40, plus tylosin
8 to 10, plus
melengestrol
acetate to provide 0.25 to
0.5 mg/ head/
day.
PO 00000
*
§ 558.665
*
Zilpaterol.
*
*
(e) * * *
*
Sfmt 4700
*
*
*
As in paragraph (e)(1) of this section;
see §§ 558.342(d), 558.355(d), and
558.625(c) of this chapter. Monensin
and tylosin as provided by No.
000986; melengestrol acetate as
provided by No. 000009 in
§ 510.600(c) of this chapter.
E:\FR\FM\08APR1.SGM
000009,
021641
*
Limitations
Heifers fed in confinement for
slaughter: As in paragraph
(e)(1) of this section; for prevention and control of coccidiosis due to Eimeria bovis and
E. zuernii; for reduction of incidence of liver abscesses
caused by Fusobacterium
necrophorum and
Arcanobacterium (Actinomyces)
pyogenes; and for suppression
of estrus (heat).
Fmt 4700
*
To administer 0.25 to 0.5 mg
melengestrol acetate plus 100 to
360 mg lasalocid plus 90 mg
tylosin/head/day:
1. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg
melengestrol acetate/lb to a medicated feed containing 10 to 30 g
lasalocid and 8 to 10 g tylosin per
ton; or
2. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg
melengestrol acetate plus 50 to 720
mg lasalocid/lb to 4.5 to 18 lb of a
dry medicated feed containing 10 to
40 g tylosin per ton; or
3. Add 0.5 to 2.0 lb/head/day of a dry
pelleted medicated feed containing
0.125 to 1.0 mg melengestrol acetate (from a dry Type A article), 50
to 720 mg lasalocid, and 45 to 180
mg tylosin/lb to a ration of nonmedicated feed.
Lasalocid provided by No. 046573
and tylosin as tylosin phosphate by
No. 000986 in § 510.600(c) of this
chapter.
*
*
Frm 00017
Sponsor
*
Indications for use
*
Jkt 214001
*
(ii) Zilpaterol as in § 558.665 of this
chapter.
I 3. In § 558.665, add paragraph (e)(5) to
read as follows:
*
(5) 6.8 to provide 60 to 90
mg/head/day.
Limitations
*
*
(2) Melengestrol may also be used
with:
(i) Ractopamine as in § 558.500 of this
chapter.
Zilpaterol in
grams/ton
Indications for use
08APR1
Sponsor
*
057926
18960
Federal Register / Vol. 73, No. 68 / Tuesday, April 8, 2008 / Rules and Regulations
Dated: March 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–7307 Filed 4–7–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[USCG–2008–0037]
Drawbridge Operation Regulation;
Upper Mississippi River, Rock Island,
IL, Quad City Marathon
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
AGENCY:
rwilkins on PROD1PC63 with RULES
ACTION:
SUMMARY: The Commander, Eighth
Coast Guard District has issued a
temporary deviation from the regulation
governing the operations of the Rock
Island Railroad and Highway
Drawbridge across the Upper
Mississippi River, Mile 482.9, Rock
Island, Illinois. The deviation is
necessary as the drawbridge is part of
the annual route for the Quad City
Marathon. This deviation allows the
bridge to remain in the closed-tonavigation position during the event.
DATES: This deviation is effective from
7:30 a.m. until 11:30 a.m., September
28, 2008.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2008–
0037 and are available online at
www.regulations.gov. They are also
available for inspection or copying at
two locations: The Docket Management
Facility (M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays,
and the Robert A. Young Federal
Building, Room 2.107F, 1222 Spruce
Street, St. Louis, MO 63103–2832,
between 8 a.m. and 4 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT:
Roger K. Wiebusch, Bridge
Administrator, (314) 269–2378.
SUPPLEMENTARY INFORMATION: The U.S.
Army Rock Island Arsenal requested a
temporary deviation for the Rock Island
Railroad and Highway Drawbridge, Mile
482.9, at Rock Island, Illinois, across the
Upper Mississippi to remain in the
closed-to-navigation position as the
drawbridge is part of the Annual Quad
VerDate Aug<31>2005
16:20 Apr 07, 2008
Jkt 214001
City Marathon route. The Rock Island
Railroad and Highway Drawbridge
currently operates in accordance with
33 CFR 117.5, which states the general
requirement that drawbridges shall open
promptly and fully for the passage of
vessels when a request to open is given
in accordance with the subpart. In order
to facilitate the annual event, the
drawbridge must be kept in the closedto-navigation position. This deviation
allows the bridge to remain in the
closed-to-navigation position for four
hours from 7:30 a.m. until 11:30 a.m.,
September 28, 2008.
There are no alternate routes for
vessels transiting this section of the
Upper Mississippi River.
The Rock Island Railroad and
Highway Drawbridge, in the closed-tonavigation position, provides a vertical
clearance of 23.8 feet above normal
pool. Navigation on the waterway
consists primarily of commercial tows
and recreational watercraft. This
temporary deviation has been
coordinated with waterway users. No
objections were received.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the designated time period. This
deviation from the operating regulations
is authorized under 33 CFR 117.35.
Dated: March 20, 2008.
Roger K. Wiebusch,
Bridge Administrator.
[FR Doc. E8–7382 Filed 4–7–08; 8:45 am]
BILLING CODE 4910–15–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[USCG–2008–0036]
Drawbridge Operation Regulation;
Upper Mississippi River, Rock Island,
IL, Quad Cities Heart Walk
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
AGENCY:
ACTION:
SUMMARY: The Commander, Eighth
Coast Guard District has issued a
temporary deviation from the regulation
governing the operations of the Rock
Island Railroad and Highway
Drawbridge, across the Upper
Mississippi River, Mile 482.9, Rock
Island, Illinois. The deviation is
necessary as the drawbridge is part of
the annual route for the Quad Cities
Heart Walk. This deviation allows the
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
bridge to remain in the closed-to
navigation position during that event.
DATES: This temporary deviation is
effective from 8:30 a.m. until 11 a.m.,
May 17, 2008.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2008–
0036 and are available online at
www.regulations.gov. They are also
available for inspection or copying at
two locations: The Docket Management
Facility (M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays,
and the Robert A. Young Federal
Building, Room 2.107F, 1222 Spruce
Street, St. Louis, MO 63103–2832,
between 8 a.m. and 4 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT:
Roger K. Wiebusch, Bridge
Administrator, (314) 269–2378.
SUPPLEMENTARY INFORMATION: The U.S.
Army Rock Island Arsenal requested a
temporary deviation for the Rock Island
Railroad and Highway Drawbridge, mile
482.9, at Rock Island, Illinois across the
Upper Mississippi to remain in the
closed-to-navigation position as the
drawbridge is part of the Annual Quad
Cities Heart Walk. The Rock Island
Railroad and Highway Drawbridge
currently operates in accordance with
33 CFR 117.5, which states the general
requirement that drawbridges shall open
promptly and fully for the passage of
vessels when a request to open is given
in accordance with the subpart. In order
to facilitate the annual event, the
drawbridge must be kept in the closedto-navigation position. This deviation
allows the bridge to remain in the
closed-to-navigation position for two
and one half hours from 8:30 a.m. until
11 a.m., May 17, 2008.
There are no alternate routes for
vessels transiting this section of the
Upper Mississippi River.
The Rock Island Railroad and
Highway Drawbridge, in the closed-tonavigation position, provides a vertical
clearance of 23.8 feet above normal
pool. Navigation on the waterway
consists primarily of commercial tows
and recreational watercraft. This
temporary deviation has been
coordinated with waterway users. No
objections were received.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the designated time period. This
deviation from the operating regulations
is authorized under 33 CFR 117.35.
E:\FR\FM\08APR1.SGM
08APR1
]]>Agencies
[Federal Register Volume 73, Number 68 (Tuesday, April 8, 2008)]
[Rules and Regulations]
[Pages 18958-18960]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7307]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feed; Zilpaterol; Technical
Amendment
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 reflect approval of a new animal drug application
(NADA) filed by Intervet Inc. The NADA provides for use of approved,
single-ingredient Type A medicated articles containing zilpaterol
hydrochloride, monensin USP, tylosin phosphate, and melengestrol
acetate in four-way combination Type B and Type C medicated feeds for
heifers fed in confinement for slaughter.
DATES: This rule is effective April 8, 2008.
FOR FURTHER INFORMATION CONTACT: Gerald L. Rushin, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8103, e-mail:
gerald.rushin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed NADA 141-280 that provides for use of
ZILMAX (zilpaterol hydrochloride), and RUMENSIN (monensin USP), TYLAN
(tylosin phosphate), and MGA (melengestrol acetate) Type A medicated
articles to make dry and liquid four-way combination Type B and Type C
medicated feeds used for increased rate of weight gain, improved feed
efficiency, and increased carcass leanness; for prevention and control
of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction
of incidence of liver abscesses caused by Fusobacterium necrophorum and
Arcanobacterium (Actinomyces) pyogenes; and suppression of estrus
(heat) in heifers fed in confinement for slaughter during the last 20
to 40 days on feed. The NADA is approved as of February 29, 2008, and
the regulations in 21 CFR 558.342 and 558.665 are amended to reflect
the approval.
In addition, FDA has noticed that the codified indications for use
of tylosin in combination with melengestrol and lasalocid are not
consistent with the conditions of use approved for an abbreviated new
animal drug application (71 FR 39204, July 12, 2006). At this time, the
indications for use are revised to include the associated pathogens.
This action is being taken to improve the accuracy of the regulations.
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 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. 558.342, revise paragraphs (e)(1)(iv) and (e)(2) to read as
follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(1) * * *
[[Page 18959]]
------------------------------------------------------------------------
Melengestrol Combination
acetate in mg/ in mg/head/ Indications Limitations Sponsor
head/day day for use
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(iv) 0.25 to Lasalocid 100 Heifers fed To administer 000009,
0.5 to 360 plus in 0.25 to 0.5 021641
tylosin 90. confinement mg
for melengestrol
slaughter: acetate plus
As in 100 to 360 mg
paragraph lasalocid
(e)(1)(i) plus 90 mg
of this tylosin/head/
section; day:
and for 1. Add 0.5 to
reduced 2.0 lb/head/
incidence day of a
of liver liquid or dry
abscesses medicated
caused by feed
Fusobacteri containing
um 0.125 to 1.0
necrophorum mg
and melengestrol
Actinomyces acetate/lb to
(Corynebact a medicated
erium) feed
pyogenes. containing 10
to 30 g
lasalocid and
8 to 10 g
tylosin per
ton; or
2. Add 0.5 to
2.0 lb/head/
day of a
liquid or dry
medicated
feed
containing
0.125 to 1.0
mg
melengestrol
acetate plus
50 to 720 mg
lasalocid/lb
to 4.5 to 18
lb of a dry
medicated
feed
containing 10
to 40 g
tylosin per
ton; or
3. Add 0.5 to
2.0 lb/head/
day of a dry
pelleted
medicated
feed
containing
0.125 to 1.0
mg
melengestrol
acetate (from
a dry Type A
article), 50
to 720 mg
lasalocid,
and 45 to 180
mg tylosin/lb
to a ration
of
nonmedicated
feed.
Lasalocid
provided by
No. 046573
and tylosin
as tylosin
phosphate by
No. 000986 in
Sec.
510.600(c) of
this chapter.
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(2) Melengestrol may also be used with:
(i) Ractopamine as in Sec. 558.500 of this chapter.
(ii) Zilpaterol as in Sec. 558.665 of this chapter.
0
3. In Sec. 558.665, add paragraph (e)(5) to read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(e) * * *
------------------------------------------------------------------------
Zilpaterol
in grams/ Combination Indications Limitations Sponsor
ton in grams/ton for use
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(5) 6.8 to Monensin 10 Heifers fed As in paragraph 057926
provide 60 to 40, plus in (e)(1) of this
to 90 mg/ tylosin 8 to confinement section; see
head/day. 10, plus for Sec. Sec.
melengestrol slaughter: 558.342(d),
acetate to As in 558.355(d),
provide 0.25 paragraph and 558.625(c)
to 0.5 mg/ (e)(1) of of this
head/day. this chapter.
section; for Monensin and
prevention tylosin as
and control provided by
of No. 000986;
coccidiosis melengestrol
due to acetate as
Eimeria provided by
bovis and E. No. 000009 in
zuernii; for Sec.
reduction of 510.600(c) of
incidence of this chapter.
liver
abscesses
caused by
Fusobacteriu
m
necrophorum
and
Arcanobacter
ium
(Actinomyces
) pyogenes;
and for
suppression
of estrus
(heat).
------------------------------------------------------------------------
[[Page 18960]]
Dated: March 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-7307 Filed 4-7-08; 8:45 am]
BILLING CODE 4160-01-S
