Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid, 70496 [2013-28256]
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70496
Federal Register / Vol. 78, No. 228 / Tuesday, November 26, 2013 / Rules and Regulations
Columbia/Mount Pleasant, TN, Maury
County, Takeoff Minimums and Obstacle
DP, Amdt 3
Millington, TN, Millington Rgnl Jetport,
RNAV (GPS) RWY 4, Amdt 1
Oak Harbor, WA, AJ Eisenberg, RNAV (GPS)
RWY 7, Amdt 2D
Milwaukee, WI, General Mitchell Intl, RNAV
(RNP) Y RWY 7R, Orig
Milwaukee, WI, General Mitchell Intl, RNAV
(RNP) Y RWY 25L, Orig
Spencer, WV, Boggs Field, RNAV (GPS) RWY
10, Amdt 2
[FR Doc. 2013–27947 Filed 11–25–13; 8:45 am]
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
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:
BILLING CODE 4910–13–P
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Food and Drug Administration
Authority: 21 U.S.C. 360b, 371.
21 CFR Part 558
§ 558.62
[Docket No. FDA–2013–N–0002]
■
Withdrawal of Approval of New Animal
Drug Applications; Arsanilic Acid
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
withdrawal of approval of a new animal
drug application (NADA) for an
arsanilic acid Type A medicated article
at the sponsor’s request because the
product is no longer manufactured or
marketed.
SUMMARY:
Withdrawal of approval is
effective December 6, 2013.
[Amended]
2. In § 558.62, remove and reserve
paragraphs (a)(1), (a)(2), (c)(1)(i), and
(c)(1)(ii); and in paragraphs (c)(1)(iii),
(c)(1)(iv), (c)(1)(v), (c)(1)(vi), and
(c)(1)(vii), in the ‘‘Arsanilic acid in
grams per ton’’ column, add ‘‘90’’.
Dated: November 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013–28256 Filed 11–25–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
DATES:
rmajette on DSK2TPTVN1PROD with RULES
FOR FURTHER INFORMATION CONTACT:
33 CFR Part 117
John
Bartkowiak, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9079,
email: john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fleming
Laboratories, Inc., P.O. Box 34384,
Charlotte, NC 28234 has requested that
FDA withdraw approval of NADA 008–
019 for PRO–GEN (arsanilic acid) Type
A medicated article because the
product, used to manufacture Type B
and Type C medicated feeds, is no
longer manufactured or marketed.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADA 008–019, and all supplements
and amendments thereto, is withdrawn,
effective December 6, 2013. As provided
in the regulatory text of this document,
the animal drug regulations are
amended to reflect these voluntary
withdrawals of approval.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
VerDate Mar<15>2010
14:32 Nov 25, 2013
Jkt 232001
[Docket No. USCG–2013–0947]
Drawbridge Operation Regulation; Old
River, Between Victoria Island and
Byron Tract, CA
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the State Highway
4 Drawbridge across Old River, mile
14.8 between Victoria Island and Byron
Tract, CA. The deviation is necessary to
allow the bridge owner to make critical
repairs to the bridge gears. This
deviation allows the bridge to remain in
the closed-to-navigation position during
the deviation period.
DATES: This deviation is effective
without actual notice from November
26, 2013 until December 6, 2013. For the
purposes of enforcement, actual notice
will be used from the date the deviation
SUMMARY:
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
was signed, November 15, 2013, until
December 6, 2013.
ADDRESSES: The docket for this
deviation, [USCG–2013–0947], is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH.’’
Click on Open Docket Folder on the line
associated with this deviation. You may
also visit the Docket Management
Facility in Room W12–140 on the
ground floor of the Department of
Transportation West Building, 1200
New Jersey Avenue SE., Washington,
DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email David H.
Sulouff, Chief, Bridge Section, Eleventh
Coast Guard District; telephone 510–
437–3516, email David.H.Sulouff@
uscg.mil. If you have questions on
viewing the docket, call Barbara
Hairston, Program Manager, Docket
Operations, telephone 202–366–9826.
SUPPLEMENTARY INFORMATION: California
Department of Transportation has
requested a temporary change to the
operation of the State Highway 4
Drawbridge, mile 14.8, over Old River,
between Victoria Island and Byron
Tract, CA. The drawbridge navigation
span provides 12 feet vertical clearance
above Mean High Water in the closedto-navigation position. Pursuant to 33
CFR 117.183, the draw opens on signal
from May 1 through October 31 from 6
a.m. to 10 p.m. and from November 1
through April 30 from 9 a.m. to 5 p.m.
and at other times, opening the draw on
signal if at least four hours advance
notice is given to the drawtender at the
Rio Vista drawbridge across the
Sacramento River, mile 12.8. Navigation
on the waterway is recreational and
commercial.
The drawspan will be secured in the
closed-to-navigation position from 6
p.m. on November 8, 2013 to 6 p.m. on
December 6, 2013, to allow the bridge
owner to repair the gears inside the
main bridge gearbox, critical
components of the drawbridge. This
temporary deviation has been
coordinated with the waterway users.
No objections to the proposed
temporary deviation were raised.
Vessels able to pass through the
bridge in the closed positions may do so
at anytime. The bridge will not be able
to open for emergencies. An alternative
route around Victoria Island may be
used for vessels unable to pass through
the bridge in the closed position. The
Coast Guard will also inform the users
of the waterways through our Local and
E:\FR\FM\26NOR1.SGM
26NOR1
]]>Agencies
[Federal Register Volume 78, Number 228 (Tuesday, November 26, 2013)]
[Rules and Regulations]
[Page 70496]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28256]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2013-N-0002]
Withdrawal of Approval of New Animal Drug Applications; Arsanilic
Acid
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the withdrawal of approval of a new animal
drug application (NADA) for an arsanilic acid Type A medicated article
at the sponsor's request because the product is no longer manufactured
or marketed.
DATES: Withdrawal of approval is effective December 6, 2013.
FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9079, email: john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fleming Laboratories, Inc., P.O. Box 34384,
Charlotte, NC 28234 has requested that FDA withdraw approval of NADA
008-019 for PRO-GEN (arsanilic acid) Type A medicated article because
the product, used to manufacture Type B and Type C medicated feeds, is
no longer manufactured or marketed.
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADA 008-019, and all supplements and amendments
thereto, is withdrawn, effective December 6, 2013. As provided in the
regulatory text of this document, the animal drug regulations are
amended to reflect these voluntary withdrawals of approval.
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
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.
Sec. 558.62 [Amended]
0
2. In Sec. 558.62, remove and reserve paragraphs (a)(1), (a)(2),
(c)(1)(i), and (c)(1)(ii); and in paragraphs (c)(1)(iii), (c)(1)(iv),
(c)(1)(v), (c)(1)(vi), and (c)(1)(vii), in the ``Arsanilic acid in
grams per ton'' column, add ``90''.
Dated: November 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-28256 Filed 11-25-13; 8:45 am]
BILLING CODE 4160-01-P
