New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin, 59911-59912 [E9-27744]
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Federal Register / Vol. 74, No. 222 / Thursday, November 19, 2009 / Rules and Regulations
from the surface up to but not including
the overlying floor of the New York
Class B airspace area, between the east
and west banks of, and overlying, the
Hudson River within the area beginning
north of LaGuardia Airport on the west
bank of the Hudson River at lat.
40°57′45″N., long. 73°54′48″W. (near
Alpine Tower), thence south along the
west bank of the Hudson River to
intersect the Colts Neck VOR/DME 012°
radial, thence southwest along the Colts
Neck 012° radial to the Hudson River
shoreline, thence south along the
shoreline to the Verrazano-Narrows
Bridge, thence east along the Bridge to
the east bank of the Hudson River,
thence north along the east bank of the
Hudson River to lat. 40°38′39″N., long.
74°02′03″W., thence north along a line
drawn direct to the southwesternmost
point of Governors Island, thence north
along a line drawn direct to the
southwest tip of Manhattan Island,
thence north along the east bank of the
Hudson River to the LGA VOR/DME 11mile arc, north of LaGuardia Airport,
thence counterclockwise along the 11mile arc to lat. 40°57′54″N., long.
73°54′23″W., thence to the point of
beginning.
§ 93.351 General requirements for
operating in the East River and/or Hudson
River Exclusions.
Pilots must adhere to the following
requirements:
(a) Maintain an indicated airspeed not
to exceed 140 knots.
(b) Anti-collision lights and aircraft
position/navigation lights shall be on, if
equipped. Use of landing lights is
recommended.
(c) Self announce position on the
appropriate radio frequency for the East
River or Hudson River as depicted on
the New York VFR Terminal Area Chart
(TAC) and/or New York Helicopter
Route Chart.
(d) Have a current New York TAC
chart and/or New York Helicopter Route
Chart in the aircraft and be familiar with
the information contained therein.
erowe on DSK5CLS3C1PROD with RULES
§ 93.352 Hudson River Exclusion specific
operating procedures.
In addition to the requirements in
§ 93.351, the following procedures
apply:
(a) Pilots must self announce, at the
charted mandatory reporting points, the
following information: aircraft type,
current position, direction of flight, and
altitude.
(b) Pilots must fly along the west
shoreline of the Hudson River when
southbound, and along the east
shoreline of the Hudson River when
northbound; while remaining within the
VerDate Nov<24>2008
15:20 Nov 18, 2009
Jkt 220001
boundaries of the Hudson River
Exclusion as defined in § 93.350(d).
(c) Aircraft transiting the area within
the Hudson River Exclusion in
accordance with § 93.350(b) must transit
the Hudson River Exclusion at or above
an altitude of 1,000 feet MSL up to, but
not including, the floor of the overlying
Class B airspace.
§ 93.353 East River Exclusion specific
operating procedures.
No person may operate an airplane in
the East River Exclusion extending from
the southwestern tip of Governors
Island to the north tip of Roosevelt
Island except:
(a) Seaplanes landing on or taking off
from the river; or
(b) Airplanes authorized by ATC.
Pilots must contact LaGuardia Airport
Traffic Control Tower prior to
Governors Island for authorization.
Issued in Washington, DC, on November
10, 2009.
J. Randolph Babbitt,
Administrator.
[FR Doc. E9–27539 Filed 11–16–09; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2009–N–0665]
New Animal Drugs for Use in Animal
Feeds; Melengestrol; 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
drug application (NADA) filed by
Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA
provides for use of the same increased
dose levels approved for singleingredient Type C medicated feeds for
heifers fed in confinement for slaughter
containing melengestrol acetate or
monensin in two-way, combination
drug Type C medicated feeds containing
melengestrol acetate and monensin.
DATES: This rule is effective November
19, 2009.
FOR FURTHER INFORMATION CONTACT:
Suzanne J. Sechen, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8105, email: suzanne.sechen@fda.hhs.gov.
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
59911
Pharmacia
& Upjohn Co., a Division of Pfizer, Inc.,
235 East 42d St., New York, NY 10017,
filed a supplement to NADA 125–476
for use of MGA (melengestrol acetate)
and RUMENSIN (monensin, USP)
single-ingredient Type A medicated
articles to make two-way, combination
drug Type C medicated feeds for heifers
fed in confinement for slaughter. The
supplemental NADA provides for use of
the same increased dose levels approved
for single ingredient Type C medicated
feeds containing melengestrol acetate or
monensin in the two-way, combination
drug Type C medicated feeds. The
supplemental application is approved as
of October 1, 2009, and the regulations
are amended in 21 CFR 558.342 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 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.
SUPPLEMENTARY INFORMATION:
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:
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
2. In § 558.342, add paragraph (e)(1)(x)
to read as follows:
■
§ 558.342
*
Melengestrol.
*
*
(e) * * *
E:\FR\FM\19NOR1.SGM
19NOR1
*
*
59912
Federal Register / Vol. 74, No. 222 / Thursday, November 19, 2009 / Rules and Regulations
(1) * * *
Melengestrol acetate in mg/
head/day
*
Combination in mg/
head/day
*
(x) 0.25 to 0.5
Indications for use
*
Monensin 50 to
480.
Limitations
*
*
Heifers fed in confinement for
slaughter: As in paragraph
(e)(1)(i) of this section; and for
the prevention and control of
coccidiosis due to Eimeria
bovis and E. zuernii.
*
Sponsor
*
Add at the rate of 0.5 to 2.0 lb/head/
day a medicated feed (liquid or dry)
containing 0.125 to 1.0 mg
melengestrol acetate/lb to a feed
containing 10 to 40 g of monensin
per ton to provide 0.25 to 0.5 mg
melengestrol acetate/head/day and
0.14 to 0.42 mg monensin/lb body
weight, depending on severity of
coccidiosis challenge, up to 480 mg
monensin/head/day.
000009
Monensin provided by No. 000986 in
§ 510.600(c) of this chapter.
*
*
*
*
*
Dated: November 9, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E9–27744 Filed 11–18–09; 8:45 am]
BILLING CODE 4160–01–S
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[DA 09–2267; MB Docket No. 09–98; RM–
11536]
Radio Broadcasting Services, Leupp,
Arizona
AGENCY: Federal Communications
Commission.
ACTION: Final rule.
The Audio Division, at the
request of Chochise Broadcasting LLC,
substitutes Channel 293C2 for vacant
FM Channel 255C2 at Leupp, Arizona.
Channel 293C2 can be allotted at Leupp,
Arizona. Channel 293C2 can be allotted
at Leupp, Arizona, in compliance with
the Commission’s minimum distance
separation requirements without site
restriction at the following reference
coordinates: 35–17–02 North Latitude
and 110–57–52 West Longitude.
DATES: December 21, 2009.
ADDRESSES: Secretary, Federal
Communications Commission, 445 12th
Street, SW, Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT:
Deborah Dupont, Media Bureau, (202)
418–2180.
SUPPLEMENTARY INFORMATION: This is a
synopsis of the Commission’s Report
and Order, MB Docket No. 09–98,
adopted October 21, 2009, and released
erowe on DSK5CLS3C1PROD with RULES
SUMMARY:
VerDate Nov<24>2008
15:20 Nov 18, 2009
Jkt 220001
October 23, 2009. The full text of this
Commission document is available for
inspection and copying during normal
business hours in the FCC Reference
Information Center (Room CY–A257),
445 12th Street, SW., Washington, DC.
20554.
The complete text of this decision
may also be purchased from the
Commission’s copy contractor, Best
Copy and Printing, Inc., 445 12th Street,
SW, Room CY–B402, Washington, DC
20554, 800–378–3160 or via the
company’s website, https://
www.bcpiweb.com.
This document does not contain any
information collection requirements
subject to the Paperwork Reduction Act
of 1995, Public Law 104–13. In addition,
therefore, it does not contain any
information collection burden ’’for
small business concerns with fewer than
25 employees,’’ pursuant to the Small
Business Paperwork Relief Act of 2002,
Public Law 107–198, see 44 U.S.C.
3506(c)(4). The Commission will send a
copy of this Report and Order in a
report to be sent to Congress and the
Government Accountability Office
pursuant to the Congressional Review
Act, see 5 U.S.C. 801(a)(1)(A).
Provisions of the Regulatory
Flexibility Act of 1980 does not apply
to this proceeding.
List of Subjects in 47 CFR Part 73
Radio, Radio broadcasting.
As stated in the preamble, the Federal
Communications Commission amends
47 CFR part 73 as follows:
■
PART 73 – RADIO BROADCAST
SERVICES
1. The authority citation for Part 73
continues to read as follows:
■
Authority: 47 U.S.C. 154, 303, 334, 336.
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
§ 73.202
[Amended]
2. Section 73.202(b), the Table of
Allotments under Arizona, is amended
by removing Channel 255C2 and by
adding Channel 293C2 at Leupp.
■
Federal Communications Commission.
John A. Karousos,
Assistant Chief, Audio Division, Media
Bureau.
[FR Doc. E9–27691 Filed 11–18–09; 8:45 am]
BILLING CODE 6712–01–S
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[DA 09–2280; MB Docket No. 08–3; RM–
11407]
Radio Broadcasting Services,
Wheatland, WY
AGENCY: Federal Communications
Commission.
ACTION: Final rule.
SUMMARY: The staff grants a rulemaking
petition filed by Appaoloosa
Broadcasting, Company, Inc., the
licensee of Station KIMX(FM), Channel
244C2, Laramie, Wyoming, by
substituting FM Channel 286A for
vacant Channel 247A at Wheatland,
Wyoming. The reference coordinates for
Channel 286A at Wheatland are 42–04–
28 NL and 104–56–51 WL.
DATES: Effective December 7, 2009.
ADDRESSES: Federal Communications
Commission, 445 12th Street, SW,
Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT:
Andrew J. Rhodes, Media Bureau, (202)
418–2180.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Report
and Order, MB Docket No. 08–3,
E:\FR\FM\19NOR1.SGM
19NOR1
]]>Agencies
[Federal Register Volume 74, Number 222 (Thursday, November 19, 2009)]
[Rules and Regulations]
[Pages 59911-59912]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27744]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2009-N-0665]
New Animal Drugs for Use in Animal Feeds; Melengestrol; 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 drug
application (NADA) filed by Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA provides for use of the same
increased dose levels approved for single-ingredient Type C medicated
feeds for heifers fed in confinement for slaughter containing
melengestrol acetate or monensin in two-way, combination drug Type C
medicated feeds containing melengestrol acetate and monensin.
DATES: This rule is effective November 19, 2009.
FOR FURTHER INFORMATION CONTACT: Suzanne J. Sechen, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8105, e-mail:
suzanne.sechen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement
to NADA 125-476 for use of MGA (melengestrol acetate) and RUMENSIN
(monensin, USP) single-ingredient Type A medicated articles to make
two-way, combination drug Type C medicated feeds for heifers fed in
confinement for slaughter. The supplemental NADA provides for use of
the same increased dose levels approved for single ingredient Type C
medicated feeds containing melengestrol acetate or monensin in the two-
way, combination drug Type C medicated feeds. The supplemental
application is approved as of October 1, 2009, and the regulations are
amended in 21 CFR 558.342 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 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, add paragraph (e)(1)(x) to read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
[[Page 59912]]
(1) * * *
------------------------------------------------------------------------
Melengestrol Combination
acetate in mg/ in mg/head/ Indications Limitations Sponsor
head/day day for use
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(x) 0.25 to Monensin 50 Heifers fed Add at the 000009
0.5 to 480. in rate of 0.5
confinement to 2.0 lb/
for head/day a
slaughter: medicated
As in feed (liquid
paragraph or dry)
(e)(1)(i) containing
of this 0.125 to 1.0
section; mg
and for the melengestrol
prevention acetate/lb to
and control a feed
of containing 10
coccidiosis to 40 g of
due to monensin per
Eimeria ton to
bovis and provide 0.25
E. zuernii. to 0.5 mg
melengestrol
acetate/head/
day and 0.14
to 0.42 mg
monensin/lb
body weight,
depending on
severity of
coccidiosis
challenge, up
to 480 mg
monensin/head/
day.
..............
Monensin
provided by
No. 000986 in
Sec.
510.600(c) of
this chapter.
------------------------------------------------------------------------
* * * * *
Dated: November 9, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-27744 Filed 11-18-09; 8:45 am]
BILLING CODE 4160-01-S
