New Animal Drugs; Change of Sponsor; Monensin Blocks, 66304-66305 [2010-27287]
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Federal Register / Vol. 75, No. 208 / Thursday, October 28, 2010 / Rules and Regulations
removing Special Use Airspace R–3807
Glencoe, LA, and R–6320 Matagorda,
TX. The Department of Defense no
longer has a use for the two restricted
areas, which were originally established
as Tethered Air Radar Sites (TARS) to
contain aerostat balloons used in
detecting illegal entry across the
southern border of the United States.
The aerostat balloons have not been
operational for several years and the
USAF has no intent to replace them.
Additionally, the USAF no longer
controls the surface lands underlying
the restricted areas and has taken action
to terminate leases and return the
control of the lands to the owners.
Therefore, the FAA has determined that
a valid requirement for the airspace no
longer exists and the restricted areas are
being returned to the National Airspace
System.
Sections 73.38 and 73.63 of 14 CFR
part 73 were published in FAA Order
7400.8S, dated February 16, 2010.
Since this action reduces restricted
airspace, the solicitation of comments
would only delay the return of airspace
to public use without offering any
meaningful right or benefit to any
segment of the public; therefore, notice
and public procedure under 5 U.S.C.
553(b) are unnecessary.
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. Therefore, this action: (1) Is not
a ‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT Regulatory
Policies and Procedures (44 FR 11034;
February 26, 1979); and (3) does not
warrant preparation of a regulatory
evaluation as the anticipated impact is
so minimal. Since this is a routine
matter that will only affect air traffic
procedures and air navigation, it is
certified that this rule will not have a
significant economic impact on a
substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
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Environmental Review
The FAA has determined that this
action qualifies for categorical exclusion
under the National Environmental
Policy Act in accordance with FAA
Order 1050.1E, ‘‘Environmental Impacts:
Policies and Procedures.’’ paragraph
311c. This airspace action is not
expected to cause any potentially
significant environmental impacts, and
no extraordinary circumstances exist
that warrant preparation of an
environmental assessment.
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14:52 Oct 27, 2010
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List of Subjects in 14 CFR Part 73
Airspace, Prohibited areas, Restricted
areas.
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 73 as follows:
■
PART 73—SPECIAL USE AIRSPACE
1. The authority citation for part 73
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 73.38
Louisiana [Amended]
2. Section 73.38 is amended as
follows:
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■
R–3807
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Glencoe, LA [Removed]
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§ 73.63
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Texas [Amended]
3. Section 73.63 is amended as
follows:
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■
R–6320
Matagorda, TX [Removed]
Issued in Washington, DC, on October 21,
2010.
Edith V. Parish,
Manager, Airspace, Regulations and ATC
Procedures Group.
[FR Doc. 2010–27251 Filed 10–27–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
[Docket No. FDA–2010–N–0002]
New Animal Drugs; Change of
Sponsor; Monensin Blocks
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor from Farmland
Industries, Inc., to Land O’ Lakes Purina
Feed LLC for a free-choice supplement
block containing monensin for pasture
cattle.
DATES: This rule is effective October 28,
2010.
FOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary
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Fmt 4700
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 520
Animal drugs.
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 parts 510 and 520 are amended as
follows:
■
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
SUMMARY:
PO 00000
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855, 240–276–8300, email: steven.vaughn@fda.
hhs.gov.
SUPPLEMENTARY INFORMATION: Farmland
Industries, Inc., Kansas City, MO 64116,
has informed FDA that it has transferred
ownership of, and all rights and interest
in, NADA 118–509 for Pasture Gainer
Block-37 R350 (monensin) to Land O’
Lakes Purina Feed LLC, 100 Danforth
Dr., Gray Summit, MO 63039.
Accordingly, the regulations are
amended in 21 CFR 520.1448a to reflect
this change of sponsorship.
Following this change of sponsorship,
Farmland Industries, Inc., is no longer
the sponsor of an approved application.
Accordingly, § 510.600 (21 CFR
510.600) is being amended to remove
the entries for this firm.
In addition, Land O’ Lakes Purina
Feed LLC is not currently listed in the
animal drug regulations as a sponsor of
an approved application. Accordingly,
§ 510.600 is being amended to add
entries for this sponsor.
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.
Sfmt 4700
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Farmland Industries, Inc.’’, and
alphabetically add a new entry for
‘‘Land O’ Lakes Purina Feed LLC’’; and
in the table in paragraph (c)(2), remove
the entry for ‘‘021676’’ and numerically
add an entry for ‘‘066071’’ to read as
follows:
■
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Federal Register / Vol. 75, No. 208 / Thursday, October 28, 2010 / Rules and Regulations
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
Final rule.
The Department of the Navy
(DoN) is amending its certifications and
exemptions under the International
Regulations for Preventing Collisions at
Sea, 1972 (72 COLREGS), to reflect that
Drug
the Deputy Assistant Judge Advocate
Firm name and address
labeler
General (DAJAG) (Admiralty and
code
Maritime Law) has determined that USS
WILLIAM P. LAWRENCE (DDG 110) is
a vessel of the Navy which, due to its
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Land O’ Lakes Purina Feed LLC,
special construction and purpose,
100 Danforth Dr., Gray Summit,
cannot fully comply with certain
MO 63039 .................................
066071
provisions of the 72 COLREGS without
interfering with its special function as a
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naval ship. The intended effect of this
rule is to warn mariners in waters where
(2) * * *
72 COLREGS apply.
DATES: This rule is effective October 28,
Drug
labeler
Firm name and address
2010 and is applicable beginning
code
October 7, 2010.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Commander Ted Cook,
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066071
Land O’ Lakes Purina Feed LLC, JAGC, U.S. Navy, Admiralty Attorney,
100 Danforth Dr., Gray Summit, (Admiralty and Maritime Law), Office of
MO 63039.
the Judge Advocate General, Department
of the Navy, 1322 Patterson Ave., SE.,
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Suite 3000, Washington Navy Yard, DC
20374–5066, telephone number: 202–
PART 520—ORAL DOSAGE FORM
685–5040.
NEW ANIMAL DRUGS
SUPPLEMENTARY INFORMATION: Pursuant
to the authority granted in 33 U.S.C.
■ 3. The authority citation for 21 CFR
1605, the DoN amends 32 CFR Part 706.
part 520 continues to read as follows:
This amendment provides notice that
Authority: 21 U.S.C. 360b.
the DAJAG (Admiralty and Maritime
Law), under authority delegated by the
§ 520.1448a [Amended]
Secretary of the Navy, has certified that
■ 4. Section 520.1448a is amended in
USS WILLIAM P. LAWRENCE (DDG
paragraph (c)(2) by removing ‘‘021676’’
and by adding in its place ‘‘No. 066071’’. 110) is a vessel of the Navy which, due
to its special construction and purpose,
Dated: October 21, 2010.
cannot fully comply with the following
Elizabeth Rettie,
specific provisions of 72 COLREGS
Deputy Director, Office of New Animal Drug
without interfering with its special
Evaluation, Center for Veterinary Medicine.
function as a naval ship: Annex I,
[FR Doc. 2010–27287 Filed 10–27–10; 8:45 am]
paragraph 2(f)(i), pertaining to the
BILLING CODE 4160–01–P
placement of the masthead light or
lights above and clear of all other lights
and obstructions; Annex I, paragraph
DEPARTMENT OF DEFENSE
2(f)(ii), pertaining to the vertical
placement of task lights; Annex I,
Department of the Navy
paragraph 3(a), pertaining to the
location of the forward masthead light
32 CFR Part 706
in the forward quarter of the ship, and
the horizontal distance between the
Certifications and Exemptions Under
forward and after masthead lights; and
the International Regulations for
Annex I, paragraph 3(c), pertaining to
Preventing Collisions at Sea, 1972
placement of task lights not less than
AGENCY: Department of the Navy, DoD.
two meters from the fore and aft
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ACTION:
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(1) * * *
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SUMMARY:
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14:52 Oct 27, 2010
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PO 00000
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66305
centerline of the ship in the athwartship
direction. The DAJAG (Admiralty and
Maritime Law) has also certified that the
lights involved are located in closest
possible compliance with the applicable
72 COLREGS requirements.
Moreover, it has been determined, in
accordance with 32 CFR Parts 296 and
701, that publication of this amendment
for public comment prior to adoption is
impracticable, unnecessary, and
contrary to public interest since it is
based on technical findings that the
placement of lights on this vessel in a
manner differently from that prescribed
herein will adversely affect the vessel’s
ability to perform its military functions.
List of Subjects in 32 CFR Part 706
Marine safety, Navigation (water), and
Vessels.
For the reasons set forth in the
preamble, amend part 706 of title 32 of
the CFR as follows:
■
PART 706—CERTIFICATIONS AND
EXEMPTIONS UNDER THE
INTERNATIONAL REGULATIONS FOR
PREVENTING COLLISIONS AT SEA,
1972
1. The authority citation for part 706
continues to read as follows:
■
Authority: 33 U.S.C. 1605.
2. Section 706.2 is amended as
follows:
■ A. In Table Four, Paragraph 15 by
adding, in alpha numerical order, by
vessel number, an entry for USS
WILLIAM P. LAWRENCE (DDG 110);
■ B. In Table Four, Paragraph 16 by
adding, in alpha numerical order, by
vessel number, an entry for USS
WILLIAM P. LAWRENCE (DDG 110);
and
■ C. In Table Five, by adding, in alpha
numerical order, by vessel number, an
entry for USS WILLIAM P. LAWRENCE
(DDG 110).
■
§ 706.2 Certifications of the Secretary of
the Navy under Executive Order 11964 and
33 U.S.C. 1605.
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15. * * *
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]]>Agencies
[Federal Register Volume 75, Number 208 (Thursday, October 28, 2010)]
[Rules and Regulations]
[Pages 66304-66305]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27287]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
[Docket No. FDA-2010-N-0002]
New Animal Drugs; Change of Sponsor; Monensin Blocks
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor from Farmland
Industries, Inc., to Land O' Lakes Purina Feed LLC for a free-choice
supplement block containing monensin for pasture cattle.
DATES: This rule is effective October 28, 2010.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 240-276-8300, e-mail:
steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Farmland Industries, Inc., Kansas City, MO
64116, has informed FDA that it has transferred ownership of, and all
rights and interest in, NADA 118-509 for Pasture Gainer Block-37 R350
(monensin) to Land O' Lakes Purina Feed LLC, 100 Danforth Dr., Gray
Summit, MO 63039. Accordingly, the regulations are amended in 21 CFR
520.1448a to reflect this change of sponsorship.
Following this change of sponsorship, Farmland Industries, Inc., is
no longer the sponsor of an approved application. Accordingly, Sec.
510.600 (21 CFR 510.600) is being amended to remove the entries for
this firm.
In addition, Land O' Lakes Purina Feed LLC is not currently listed
in the animal drug regulations as a sponsor of an approved application.
Accordingly, Sec. 510.600 is being amended to add entries for this
sponsor.
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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 520
Animal drugs.
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 parts 510 and
520 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entry
for ``Farmland Industries, Inc.'', and alphabetically add a new entry
for ``Land O' Lakes Purina Feed LLC''; and in the table in paragraph
(c)(2), remove the entry for ``021676'' and numerically add an entry
for ``066071'' to read as follows:
[[Page 66305]]
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug
Firm name and address labeler
code
------------------------------------------------------------------------
* * * * *
Land O' Lakes Purina Feed LLC, 100 Danforth Dr., Gray 066071
Summit, MO 63039...........................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
066071........................... Land O' Lakes Purina Feed LLC, 100
Danforth Dr., Gray Summit, MO 63039.
* * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1448a [Amended]
0
4. Section 520.1448a is amended in paragraph (c)(2) by removing
``021676'' and by adding in its place ``No. 066071''.
Dated: October 21, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-27287 Filed 10-27-10; 8:45 am]
BILLING CODE 4160-01-P
