Procedures for the Handling of Retaliation Complaints Under Section 806 of the Sarbanes-Oxley Act of 2002, as Amended; Correction, 78150-78151 [2011-32095]
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78150
Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Rules and Regulations
Rockville, MD 20855, (240) 276–8322,
email: lisa.troutman@fda.hhs.gov.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
Authority: 21 U.S.C. 360b.
2. Add § 520.852 to read as follows:
§ 520.852
Estriol.
(a) Specifications. Each tablet
contains 1 milligram (mg) estriol.
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer at an initial dose of
2 mg per dog per day. The dosage may
be titrated to as low as 0.5 mg per dog
every second day, depending on
response.
(2) Indications for use. For the control
of estrogen-responsive urinary
incontinence in ovariohysterectomized
female dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: December 9, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–32214 Filed 12–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
[Docket No. FDA–2011–N–0003]
Ophthalmic and Topical Dosage Form
New Animal Drugs; Hydrocortisone
Aceponate, Miconazole Nitrate, and
Gentamicin Sulfate Otic Suspension
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original new animal drug
application (NADA) filed by Virbac AH,
Inc. The NADA provides for the
veterinary prescription use of a
hydrocortisone aceponate, miconazole
nitrate, and gentamicin sulfate
suspension for the treatment of otitis
externa in dogs.
DATES: This rule is effective December
16, 2011.
FOR FURTHER INFORMATION CONTACT: Lisa
M. Troutman, Center for Veterinary
Medicine (HFV–116), Food and Drug
Administration, 7500 Standish Pl.,
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(a) Specifications. Each milliliter (mL)
of suspension contains 1.11 milligrams
(mg) of hydrocortisone aceponate, 15.1
mg of miconazole nitrate, and 1,505
micrograms of gentamicin sulfate.
(b) Sponsor. See No.051311 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Instill 1.0 mL in the affected
ear once daily for 5 days.
(2) Indications for use. For the
treatment of otitis externa in dogs
associated with susceptible strains of
yeast (Malassezia pachydermatis) and
bacteria (Staphylococcus
pseudintermedius).
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
SUPPLEMENTARY INFORMATION:
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
■
Virbac
AH, Inc., 3200 Meacham Blvd., Fort
Worth, TX 76137, filed NADA 141–330
for the veterinary prescription use of
EASOTIC (hydrocortisone aceponate,
miconazole nitrate, gentamicin sulfate)
Suspension for the treatment of otitis
externa in dogs associated with
susceptible strains of yeast (Malassezia
pachydermatis) and bacteria
(Staphylococcus pseudintermedius).
The NADA is approved as of October
31, 2011, and 21 CFR part 524 is
amended 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.
Under section 512(c)(2)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
approval qualifies for 3 years of
marketing exclusivity beginning on the
date of approval.
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.
§ 524.1132 Hydrocortisone aceponate,
miconazole nitrate, gentamicin sulfate otic
suspension.
List of Subjects in 21 CFR Part 524
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 part 524 is amended as follows:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
2. Add § 524.1132 to read as follows:
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Dated: December 13, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–32226 Filed 12–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Part 1980
[Docket Number OSHA–2011–0126]
RIN 1218–AC53
Procedures for the Handling of
Retaliation Complaints Under Section
806 of the Sarbanes-Oxley Act of 2002,
as Amended; Correction
Occupational Safety and Health
Administration, Labor.
ACTION: Interim final rule; correction.
AGENCY:
The Occupational Safety and
Health Administration is correcting an
interim final rule on the procedures for
the handling of retaliation complaints
under Section 806 of the SarbanesOxley Act of 2002, As Amended,
published in the Federal Register of
November 3, 2011 (76 FR 68084).
DATES: Effective December 16, 2011.
FOR FURTHER INFORMATION CONTACT:
Sandra Dillon, Acting Director, Office of
the Whistleblower Protection Program,
Occupational Safety and Health
Administration, U.S. Department of
Labor, Room N–3610, 200 Constitution
Avenue NW., Washington, DC 20210;
telephone (202) 693–2199.
SUPPLEMENTARY INFORMATION: In FR Doc.
2011–28274 on page 68084 in the
Federal Register of Thursday,
SUMMARY:
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Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Rules and Regulations
November 3, 2011, an incorrect
amendatory instruction published
inadvertently creating duplicate
paragraphs (b)(1)(ii) in § 1980.102. This
document corrects that error.
Therefore, OSHA amends 29 CFR part
1980 by making the following correcting
amendment:
PART 1980—PROCEDURES FOR THE
HANDLING OF RETALIATION
COMPLAINTS UNDER SECTION 806
OF THE SARBANES-OXLEY ACT OF
2002, AS AMENDED
1. The authority citation for part 1980
continues to read as follows:
■
Authority: 18 U.S.C. 1514A, as amended
by the Dodd-Frank Wall Street Reform and
Consumer Protection Act of 2010, Pub. L.
111–203 (July 21, 2010); Secretary of Labor’s
Order No. 4–2010 (Sept. 2, 2010), 75 FR
55355 (Sept. 10, 2010); Secretary of Labor’s
Order No. 1–2010 (Jan. 15, 2010), 75 FR 3924
(Jan. 25, 2010).
§ 1980.102
[Corrected]
2. In § 1980.102, redesignate the
second paragraph (b)(1)(ii) as paragraph
(b)(1)(iii).
■
Signed at Washington, DC on December 9,
2011.
David Michaels,
Assistant Secretary of Labor for Occupational
Safety and Health.
[FR Doc. 2011–32095 Filed 12–15–11; 8:45 am]
BILLING CODE 4510–26–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2011–1078]
RIN 1625–AA08
Special Local Regulations; Boca Raton
Holiday Boat Parade, Intracoastal
Waterway, Boca Raton, FL
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing special local regulations on
the waters of the Intracoastal Waterway
in Boca Raton, Florida during the Boca
Raton Holiday Boat Parade on Saturday,
December 17, 2011. The marine parade
will consist of approximately 60 vessels.
The marine parade will begin at C–15
Canal then head south on the
Intracoastal Waterway to the
Hillsborough Bridge, where the marine
parade will conclude. These special
local regulations are necessary to
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SUMMARY:
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provide for the safety of life on
navigable waters of the United States
during the marine parade. The special
local regulations consist of a series of
moving buffer zones around participant
vessels as they transit from C–15 Canal
to the Hillsborough Bridge. Persons and
vessels that are not participating in the
marine parade are prohibited from
entering, transiting through, anchoring
in, or remaining within any of the buffer
zones unless authorized by the Captain
of the Port Miami or a designated
representative.
DATES: This rule is effective from 6 p.m.
until 9 p.m. on December 17, 2011.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2011–
1078 and are available online by going
to https://www.regulations.gov, inserting
USCG–2011–1078 in the ‘‘Keyword’’
box, and then clicking ‘‘Search.’’ They
are also available for inspection or
copying at 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.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
final rule, call or email Lieutenant
Jennifer S. Makowski, Sector Miami
Prevention Department, Coast Guard;
telephone (305) 535–8724, email
Jennifer.S.Makowski@uscg.mil. If you
have questions on viewing the docket,
call Renee V. Wright, Program Manager,
Docket Operations, telephone (202)
366–9826.
SUPPLEMENTARY INFORMATION:
Regulatory Information
The Coast Guard is issuing this
temporary final rule without prior
notice and opportunity to comment
pursuant to authority under section 4(a)
of the Administrative Procedure Act
(APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because the
Coast Guard did not receive necessary
information about this year’s Boca Raton
Holiday Boat Parade until November 7,
2011. As a result, the Coast Guard did
not have sufficient time to publish an
NPRM and to receive public comments
prior to the event. Any delay in the
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78151
effective date of this rule would be
contrary to the public interest because
immediate action is needed to minimize
potential danger to marine parade
participants, participant vessels,
spectators, and the general public.
For the same reason discussed above,
under 5 U.S.C. 553(d)(3) the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register.
Basis and Purpose
The legal basis for the rule is the
Coast Guard’s authority to establish
special local regulations: 33 U.S.C.
1233.
The purpose of the rule is to insure
safety of life on navigable waters of the
United States during the Boca Raton
Holiday Boat Parade.
Discussion of Rule
On December 17, 2011, the City of
Boca Raton is hosting the Boca Raton
Holiday Boat Parade on the Intracoastal
Waterway in Boca Raton, Florida. The
marine parade will consist of
approximately 60 vessels. The marine
parade will begin at C–15 Canal and
transit south on the Intracoastal
Waterway to the Hillsborough Bridge.
Although this event occurs annually,
and special local regulations have been
promulgated in the Code of Federal
Regulations at 33 CFR 100.701, the date
of the marine parade does not
correspond with the date published in
the Code of Federal Regulations, and the
special local regulations have been
modified. Therefore, the special local
regulations set forth in 33 CFR 100.701
are inapplicable for this year’s Boca
Raton Holiday Boat Parade.
The special local regulations consist
of a series of buffer zones around vessels
participating in the Boca Raton Holiday
Boat Parade. These buffer zones are as
follows: (1) All waters within 75 yards
of the lead marine parade vessel; (2) all
waters within 75 yards of the last
marine parade vessel; and (3) all waters
within 50 yards of all other marine
parade vessels. Notice of the special
local regulations, including the
identities of the lead marine parade
vessel and the last marine parade vessel,
will be provided prior to the marine
parade by Local Notice to Mariners and
Broadcast Notice to Mariners. These
special local regulations will be
enforced from 6 p.m. until 9 p.m. on
December 17, 2011. Persons and vessels
are prohibited from entering, transiting
through, anchoring, or remaining within
the buffer zones unless authorized by
the Captain of the Port Miami or a
designated representative. Persons and
E:\FR\FM\16DER1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 242 (Friday, December 16, 2011)]
[Rules and Regulations]
[Pages 78150-78151]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32095]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1980
[Docket Number OSHA-2011-0126]
RIN 1218-AC53
Procedures for the Handling of Retaliation Complaints Under
Section 806 of the Sarbanes-Oxley Act of 2002, as Amended; Correction
AGENCY: Occupational Safety and Health Administration, Labor.
ACTION: Interim final rule; correction.
-----------------------------------------------------------------------
SUMMARY: The Occupational Safety and Health Administration is
correcting an interim final rule on the procedures for the handling of
retaliation complaints under Section 806 of the Sarbanes-Oxley Act of
2002, As Amended, published in the Federal Register of November 3, 2011
(76 FR 68084).
DATES: Effective December 16, 2011.
FOR FURTHER INFORMATION CONTACT: Sandra Dillon, Acting Director, Office
of the Whistleblower Protection Program, Occupational Safety and Health
Administration, U.S. Department of Labor, Room N-3610, 200 Constitution
Avenue NW., Washington, DC 20210; telephone (202) 693-2199.
SUPPLEMENTARY INFORMATION: In FR Doc. 2011-28274 on page 68084 in the
Federal Register of Thursday,
[[Page 78151]]
November 3, 2011, an incorrect amendatory instruction published
inadvertently creating duplicate paragraphs (b)(1)(ii) in Sec.
1980.102. This document corrects that error.
Therefore, OSHA amends 29 CFR part 1980 by making the following
correcting amendment:
PART 1980--PROCEDURES FOR THE HANDLING OF RETALIATION COMPLAINTS
UNDER SECTION 806 OF THE SARBANES-OXLEY ACT OF 2002, AS AMENDED
0
1. The authority citation for part 1980 continues to read as follows:
Authority: 18 U.S.C. 1514A, as amended by the Dodd-Frank Wall
Street Reform and Consumer Protection Act of 2010, Pub. L. 111-203
(July 21, 2010); Secretary of Labor's Order No. 4-2010 (Sept. 2,
2010), 75 FR 55355 (Sept. 10, 2010); Secretary of Labor's Order No.
1-2010 (Jan. 15, 2010), 75 FR 3924 (Jan. 25, 2010).
Sec. 1980.102 [Corrected]
0
2. In Sec. 1980.102, redesignate the second paragraph (b)(1)(ii) as
paragraph (b)(1)(iii).
Signed at Washington, DC on December 9, 2011.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2011-32095 Filed 12-15-11; 8:45 am]
BILLING CODE 4510-26-P
