New Animal Drugs for Minor Use and Minor Species; Confirmation of Effective Date, 11331-11332 [2011-4593]
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Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations
11331
TABLE 2—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL OF FIVE NADAS BY TRUOW NUTRITION, INC.
Previous sponsor
NADA No. product
(established name of drug)
NutriBasics Co., P.O. Box 1014, Wilmar, MN 56201 ......
NADA 100–352; Seeco T–10 Premix (tylosin phosphate).
NADA 107–002; Seeco TYLAN-Sulfa 10 Premix (tylosin
phosphate and sulfamethazine).
NADA
123–000;
Super
Swine
Wormer
B–9
BANMINTH(pyrantel tartrate).
NADA 133–833; TYLAN 10 Premix (tylosin phosphate)
Seeco, Inc., P.O. Box 1014, Wilmar, MN 56201 .............
Seeco, Inc., P.O. Box 1014, Wilmar, MN 56201 .............
Southern Micro-Blenders, Inc., 3801 N. Hawthorne St.,
Chattanooga, TN 37406.
Southern Micro-Blenders, Inc., 3801 N. Hawthorne St.,
Chattanooga, TN 37406.
In a notice published elsewhere in
this issue of the Federal Register, FDA
gave notice that approval of NADA 48–
647, 96–161, 100–352, 107–002, 119–
062, 123–000, 133–833, and 135–243,
and all supplements and amendments
thereto, is withdrawn, effective March
14, 2011. As provided in the regulatory
text of this document, the animal drug
regulations are amended to reflect these
withdrawals of approval.
Following these changes of
sponsorship, Yoder Feed, Division of
Yoder, Inc., Triple ‘‘F’’, Inc., NutriBasics
Co., Seeco, Inc., and Southern MicroBlenders, Inc., are no longer the sponsor
of an approved application.
Accordingly, 21 CFR 510.600(c) is being
amended to remove the entries for these
firms.
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.
WReier-Aviles on DSKGBLS3C1PROD with RULES
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entries for
‘‘Triple ‘‘F’’, Inc.’’ and ‘‘Yoder Feed,
Division of Yoder, Inc.’’; and in the table
in paragraph (c)(2), remove the entries
for ‘‘011490’’, ‘‘011749’’, ‘‘035369’’,
‘‘049685’’, and ‘‘053740’’.
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
4. In § 520.1720a, revise paragraph
(b)(6) to read as follows:
■
§ 520.1720a
boluses.
Phenylbutazone tablets and
*
*
*
*
(b) * * *
(6) No. 058829 for use of 100-mg or
1-g tablets in dogs and horses.
*
*
*
*
*
5. The authority citation for 21 CFR
part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
6. In § 558.485, revise the section
heading and paragraph (b)(3) to read as
follows:
■
PART 510—NEW ANIMAL DRUGS
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.
Jkt 223001
Pyrantel.
*
*
*
*
*
(b) * * *
(3) Nos. 010439, 012286, 016968, and
017790: 9.6 and 19.2 grams per pound
for use as in paragraphs (e)(1)(i) through
(e)(1)(iii) of this section.
*
*
*
*
*
§ 558.625
[Amended]
7. In § 558.625, remove and reserve
paragraphs (b)(8), (b)(38), and (b)(80).
■
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Not codified.
§ 558.485 (011749).
§ 558.625 (049685).
§ 558.485 (049685).
Dated: February 18, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–4546 Filed 3–1–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 516
[Docket No. FDA–2010–N–0534]
New Animal Drugs for Minor Use and
Minor Species; Confirmation of
Effective Date
AGENCY:
*
§ 558.485
§ 558.625 (053740).
RIN 0910–AG58
Authority: 21 U.S.C. 360b.
■
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 parts 510, 520, and 558 are
amended as follows:
15:24 Mar 01, 2011
NADA 135–243; Swine Guard-BN BANMINTH Premix
(pyrantel tartrate).
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
21 CFR Part 520
Animal drugs.
VerDate Mar<15>2010
§ 510.600
21 CFR section affected
(sponsor drug labeler code)
Food and Drug Administration,
HHS.
Direct final rule; confirmation of
effective date.
ACTION:
The Food and Drug
Administration (FDA) is confirming the
effective date of March 30, 2011, for the
final rule that appeared in the Federal
Register of November 15, 2010 (75 FR
69586). The direct final rule amends the
regulations regarding new animal drugs
for minor use and minor species
(MUMS) to update language and clarify
the intent of the regulations consistent
with the preambles to the proposed and
final rules. This document confirms the
effective date of the direct final rule.
DATES: Effective date confirmed: March
30, 2011.
FOR FURTHER INFORMATION CONTACT: Meg
Oeller, Center for Veterinary Medicine
(HFV–50), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–9005,
e-mail: margaret.oeller@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 15, 2010
(75 FR 69586), FDA solicited comments
concerning the direct final rule for a
75-day period ending January 31, 2011.
FDA stated that the effective date of the
SUMMARY:
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Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations
direct final rule would be on March 30,
2011, 60 days after the end of the
comment period, unless any significant
adverse comment was submitted to FDA
during the comment period. FDA did
not receive any significant adverse
comments.
Authority: 21 U.S.C. 360ccc–1, 360ccc–2,
371. Accordingly, the amendments issued
thereby are effective.
Dated: February 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–4593 Filed 3–1–11; 8:45 am]
BILLING CODE 4160–01–P
Regulatory Information
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2010–1030]
RIN 1625–AA09
Drawbridge Operation Regulation;
Duluth Ship Canal, Duluth-Superior
Harbor, MN
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a drawbridge opening
schedule for the Duluth Aerial Lift
Bridge for vessels under 300 gross tons.
Scheduled drawbridge openings will
improve traffic congestion in the area
and enhance safety for all modes of
transportation.
SUMMARY:
DATES:
This rule is effective April 1,
2011.
Comments and related
materials received from the public, as
well as documents mentioned in this
preamble as being available in the
docket, are part of docket USCG–2010–
1030 and are available online by going
to https://www.regulations.gov, inserting
USCG–2010–1030 in the ‘‘Keyword’’
box, and then clicking ‘‘Search.’’ This
material is also available for inspection
or copying at the Docket Management
ADDRESSES:
May
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.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
e-mail Mr. Lee Soule, Bridge
Management Specialist, Ninth Coast
Guard District; telephone (216) 902–
6085, e-mail lee.d.soule@uscg.mil. If you
have questions on viewing material in
the docket, call Renee V. Wright,
Program Manager, Docket Operations,
telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
Commander, Ninth Coast Guard
District, published a temporary
deviation from these regulations, with
request for comments, on April 22,
2010, in the Federal Register (75 FR
20918). The temporary deviation was
used to test a new bridge schedule
during the 2010 navigation and tourist
season. On December 8, 2010, we
published a notice of proposed
rulemaking (NPRM) entitled Drawbridge
Operation Regulation; Duluth Ship
Canal, Duluth-Superior Harbor, MN. in
the Federal Register (75 FR 76324). We
received two comments in response to
the proposed rule. No public meeting
was requested, and none was held.
Basis and Purpose
The Duluth Aerial Bridge is located
0.25 miles from Duluth Harbor North
Pier Light at the lakeward end of the
Duluth Ship Canal. It is a vertical lift
type bridge that provides 15 feet of
vertical clearance in the down position
and up to 141 feet in the open position.
The bridge currently opens on signal for
all vessel traffic that requires a bridge
opening. Marine traffic on the waterway
consists of both large and smaller
commercial vessels, as well as both
power and sail recreational vessels.
Pursuant to 33 CFR 117.8 various
entities in Duluth requested scheduled
openings instead of opening on signal.
The requesting entities included the
City of Duluth, the Duluth Fire
June
July
Department-Emergency Management,
the Duluth Police Department, the Park
Point Community Association, and the
Canal Park Business Association. The
scheduled drawbridge openings were
requested during the peak navigation
and tourist season to improve the flow
of vehicular traffic over the bridge,
relieve vehicular traffic congestion near
the bridge and on city streets on both
sides of the bridge (Park Point and Canal
Park), improve access and response
times for emergency response entities,
and enhance pedestrian safety in the
vicinity of the bridge. The test schedule
allowed for scheduled bridge openings
on the hour and half-hour for all vessels
under 300 gross tons between the hours
of 6 a.m. and 9 p.m., seven days per
week, and on signal between 9 p.m. and
6 a.m., from May 3 to October 29, 2010.
The bridge continued to open on signal
at all times for all vessels over 300 gross
tons and Federal, state, and local
government vessels, vessels in distress,
commercial vessels engaged in rescue or
emergency salvage operations, vessels
engaged in pilot duties, and vessels
seeking shelter from severe weather.
The City of Duluth collected data
throughout the test period related to
vehicular and vessel traffic counts, and
the number of bridge openings. In
addition to the data collected, each
stakeholder had the opportunity to
amplify their written comments and
provide additional direct input to the
Coast Guard during the October 20,
2010 meeting. During the stakeholder
meeting it was generally agreed by all
parties that the scheduled bridge
openings appeared to improve the
general flow of vehicular traffic on both
sides of the bridge and reduced
vehicular traffic congestion. Regarding
the time of year and hours each day that
the scheduled openings would apply, it
was generally agreed during the
stakeholders meeting that the scheduled
openings would be beneficial and
effective between Memorial Day and
Labor Day each year between the hours
of 7 a.m. and 9 p.m. The data below
collected by the City of Duluth
illustrates support for the times and
dates:
Aug
Sep
Oct
1974
1430
1331
1016
212
380
1184
630
800
752
350
429
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TOTAL VESSELS UNDER 300 GROSS TONS
2009
2010
383
528
1287
1066
2015
2088
TOTAL BRIDGE OPENINGS
2009
2010
VerDate Mar<15>2010
320
300
15:24 Mar 01, 2011
841
576
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860
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]]>Agencies
[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Rules and Regulations]
[Pages 11331-11332]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 516
[Docket No. FDA-2010-N-0534]
RIN 0910-AG58
New Animal Drugs for Minor Use and Minor Species; Confirmation of
Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of March 30, 2011, for the final rule that appeared in
the Federal Register of November 15, 2010 (75 FR 69586). The direct
final rule amends the regulations regarding new animal drugs for minor
use and minor species (MUMS) to update language and clarify the intent
of the regulations consistent with the preambles to the proposed and
final rules. This document confirms the effective date of the direct
final rule.
DATES: Effective date confirmed: March 30, 2011.
FOR FURTHER INFORMATION CONTACT: Meg Oeller, Center for Veterinary
Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-9005, e-mail: margaret.oeller@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 15, 2010
(75 FR 69586), FDA solicited comments concerning the direct final rule
for a 75-day period ending January 31, 2011. FDA stated that the
effective date of the
[[Page 11332]]
direct final rule would be on March 30, 2011, 60 days after the end of
the comment period, unless any significant adverse comment was
submitted to FDA during the comment period. FDA did not receive any
significant adverse comments.
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371. Accordingly, the
amendments issued thereby are effective.
Dated: February 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4593 Filed 3-1-11; 8:45 am]
BILLING CODE 4160-01-P
