[Federal Register Volume 87, Number 144 (Thursday, July 28, 2022)]
[Rules and Regulations]
[Pages 45249-45251]
[FR Doc No: 2022-16215]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0333]
RIN 1625-AA87

Security Zone; Lower Mississippi River, Mile Marker 94 to 97
Above Head of Passes, New Orleans, LA

AGENCY: Coast Guard, Homeland Security (DHS).

ACTION: Final rule.

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SUMMARY: The Coast Guard is establishing a permanent security zone for
all navigable waters of the Lower Mississippi River (LMR) from mile
marker (MM) 94 to MM 97, Above Head of Passes (AHP), New Orleans, LA.
This security zone is necessary to expedite the establishment and
enforcement of the security zones to protect vessels, waterfront
facilities, the public, and other surrounding areas from destruction,
loss, or injury caused by sabotage, subversive acts, accidents, or
other actions of a similar nature. This rulemaking prohibits entry of
vessels or persons from entering the security zone unless specifically
authorized by the Captain of the Port Sector New Orleans (COTP) or a
designated representative. This security zone will be enforced only as
necessary by the COTP through a notice of enforcement published in the
Federal Register and announced through Vessel Traffic Service
Advisories, Broadcast Notices to Mariners (BNMs), Local Notice to
Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs) as
appropriate.

DATES: This rule is effective August 29, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0333 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander William A. Stewart, Sector New
Orleans, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

AHP Above Head of Passes
CFR Code of Federal Regulations
COTP Captain of the Port New Orleans
DHS Department of Homeland Security
FR Federal Register
LMR Lower Mississippi River
MM Mile Marker
NPRM Notice of Proposed Rulemaking
NOE Notice of Enforcement
Sec.  Section
TFR Temporary Final Rule
U.S.C. United States Code

II. Background Information and Regulatory History

    During the preceding several years, the COTP has published multiple
temporary final rules (TFRs) to implement heightened security measures
to protect waterfront facilities, visiting dignitaries, large volumes
of festival participants, and/or vessels from destruction, loss, or
injury from sabotage, subversive acts, or other malicious or potential
terrorist acts within the LMR from MM 94 to MM 97, AHP, New Orleans,
LA. The COTP expects that events requiring heightened protection will
increase as New Orleans continues to hold popular annual events, like
Mardi Gras and French Quarter Fest, as well as remains a top
destination for events of national significance, such as sporting
events and Navy Fleet Week.
    The Coast Guard is establishing a permanent security zone for all
navigable waters of the LMR from MM 94 to MM 97, AHP, New Orleans, LA
to expedite the establishment and enforcement of the security zones.
The enforcement of security zones within this area of the LMR is
usually limited in duration, lasting a few hours to a few days for each
waterway closure, creating minimal impact to vessel traffic. Moreover,
this rule allows vessels to seek permission to enter the security zone
from the COTP or a designated representative. The Coast Guard is
issuing this rulemaking under authority in 46 U.S.C. 70034 (previously
33 U.S.C. 1231). Therefore, on May 7, 2022, the Coast Guard published a
notice of proposed rulemaking (NPRM) titled ``Safety Zone; Lower
Mississippi River, Mile Marker 94 to 97 Above Head of Passes, New
Orleans, LA'' (87 FR 34607). There we stated why we issued the NPRM,
and invited comments on our proposed regulatory action related to
establishing this permanent security zone. During the comment period
that ended July 7, 2022, we received no comments.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The COTP has determined that a
permanent security zone, which can be enforced as necessary, will
better allow the COTP to protect vessels, waterfront facilities, the
public, and other surrounding areas from destruction, loss, or injury
caused by sabotage, subversive acts, accidents, or other actions of a
similar nature. This rule prohibits entry of vessels or persons from
entering the security zone unless specifically authorized by the
Captain of the Port Sector New Orleans (COTP) or a designated
representative.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published May
7, 2022. There are no changes in the regulatory text of this rule from
the proposed rule in the NPRM.
    This rule establishes a permanent security zone for all navigable
waters of the Lower Mississippi River (LMR) from mile marker (MM) 94 to
MM 97, Above Head of Passes (AHP), New Orleans, LA. This rule is
necessary to expedite the establishment and enforcement of the security
zones to protect vessels, waterfront facilities, the public, and other
surrounding areas from destruction, loss, or injury caused by sabotage,
subversive acts, accidents, or other actions of a similar nature. This
rule prohibits entry of vessels or persons from entering the security
zone unless specifically authorized by the Captain of the Port Sector
New Orleans (COTP) or a designated representative. This rule will be
enforced only as necessary by the COTP through a notice of enforcement
published in the Federal Register and announced through Vessel Traffic
Service Advisories, Broadcast Notices to Mariners (BNMs), Local Notice
to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs)
as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, and duration of the security zone. While this zone will be
permanent, it will only be enforced on an as needed basis where the
COTP will limit the enforcement to areas specified in the notice of
enforcement published in the Federal Register. Moreover, the Coast
Guard will inform the public of the enforcement area and period of this
security zone through Vessel Traffic Services, Broadcast Notices to
Mariners (BNMs), Local Notice to Mariners (LNMs), and/or Marine Safety
Information Bulletins (MSIBs) as appropriate, and the rule would allow
vessels to seek permission to enter the security zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
security zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves
establishing a security zone to protect the public in a designated area
of the Mississippi River near New Orleans, LA for a limited number of
days. It is categorically excluded from further review under paragraph
L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01,
Rev. 1. A Record of Environmental Consideration supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.846 to read as follows:

Sec.  165.846  Security Zone; Lower Mississippi River, Mile Marker 94
to 97 Above Head of Passes, New Orleans, LA.

    (a) Location. The following area is a security zone: All navigable
waters of Lower Mississippi River from mile marker (MM) 94
(29[deg]57'32'' N, 90[deg]03'05'' W) to MM 97 (29[deg]55'19'' N,
90[deg]04'00'' W), NAD83 datum, Above Head of Passes in New Orleans,
LA.
    (b) Enforcement period. The security zone established by this
section will be enforced only upon notice of the Captain of the Port
New Orleans (COTP). In accordance with subpart A of this part, for each
enforcement of the security zone established under this section, the
COTP will publish a notice of enforcement in the Federal Register as
early as is practicable. In addition, the COTP will also inform the
public of the enforcement area and times of this section as indicated
in paragraph (d) of this section.
    (c) Regulations. (1) Under the general security zone regulations in
subpart D of this part, no person or vessel may enter the security zone
described in paragraph (a) of this section unless authorized by the
COTP or a designated representative. A designated representative means
any Coast Guard commissioned, warrant, or petty officer of the U.S.
Coast Guard assigned to units under the operational control of Sector
New Orleans; to include a Federal, State, and/or local officer
designated by or assisting the Captain of the Port New Orleans (COTP)
in the enforcement of the security zone.
    (2) To seek permission to enter, contact the COTP or a designated
representative by telephone at<PHONE_NUMBER> or VHF-FM Channel 16 or
67. Those in the security zone must transit at their slowest speed and
comply with all lawful orders or directions given to them by the COTP
or a designated representative.
    (d) Information broadcasts. The COTP or a designated representative
will inform the public of the enforcement period of this security zone
through Vessel Traffic Service Advisories, Broadcast Notices to
Mariners (BNMs), Local Notice to Mariners (LNMs), and/or Marine Safety
Information Bulletins (MSIBs) as appropriate.

    Dated: July 21, 2022.
K.K. Denning,
Captain, U.S. Coast Guard, Captain of the Port New Orleans.
[FR Doc. 2022-16215 Filed 7-27-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Rules and Regulations]
[Pages 57727-57729]
[FR Doc No: 2015-24325]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2015-0133; FRL-9934-72-Region 4]

Approval and Promulgation of Implementation Plans; Florida; Combs
Oil Company Variance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a
revision to the State Implementation Plan (SIP) submitted by the State
of Florida through the Department of Environmental Protection (DEP) on
July 31, 2009. The revision grants a variance to the Combs Oil Company,
located in Naples, Florida. This source specific revision relieves the
Combs Oil Company of the requirement to comply with the Florida rule
governing installation and operation of vapor collection and control
systems on loading racks at bulk gasoline plants. EPA is approving
Florida's July 31, 2009, source specific SIP revision.

DATES: This rule will be effective October 26, 2015.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2015-0133. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Mr. Lakeman can be reached by phone at<PHONE_NUMBER> or
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Florida Rule 62-296.418 requires bulk gasoline plants which
began operation on or after August 1, 2007, to install and operate
vapor collection and control systems on their loading racks. The rule
became effective on May 9, 2007, and was submitted to EPA as a proposed
SIP revision on May 31, 2007. EPA approved the SIP revision on June 1,
2009 (74 FR 26103).
    On May 30, 2007, Combs Oil Company submitted a petition for
variance from the requirements of Rule 62-296.418(2)(b)2, Florida
Administrative Code (F.A.C.), for its new bulk gasoline plant. The
company operates an existing bulk gasoline plant in Naples, Florida.
The new plant would replace the existing plant and be constructed at a
different site in the area.
    Under Section 120.542 of the Florida Statutes, the DEP may grant a
variance when the person subject to a rule demonstrates that the
purpose of the underlying statute will be or has been achieved by other
means, or when application of a rule would create a substantial
hardship or violate principles of fairness. The DEP determined that
Combs Oil Company had demonstrated that principles of fairness would be
violated because the facility would have begun operations prior to
August 1, 2007, but for delays in building and relocating to the new
facility related to hurricanes, which were beyond the control of the
company. Therefore, the DEP issued an Order Granting Variance to Combs
Oil Company on August 20, 2008, relieving the company from the
requirements of Rule 62-296.418(2)(b)2., F.A.C., for its proposed new
facility.
    In a notice of proposed rulemaking (NPR) published on July 20,
2015, EPA proposed to approve Florida's July 31, 2009, SIP revision
granting a variance to the Combs Oil Company, located in Naples,
Florida. See 80 FR 42763. The details of Florida's submittal and the
rationale for EPA's actions are explained in the NPR. Comments on the
proposed rulemaking were due on or before August 19, 2015. No adverse
comments were received.

II. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing incorporate by reference of ``Combs Oil Company
Source Specific Variance'' order granting variance on August 20, 2008.
EPA has made, and will continue to make, these documents generally
available electronically through www.regulations.gov and/or in hard
copy at the EPA Region 4 office (see the ADDRESSES section of this
preamble for more information).

III. Final Action

    EPA is approving a source specific SIP revision submitted by the
Florida DEP on July 31, 2009. The revision grants a variance to the
Combs Oil Company, located in Naples, Florida. This source specific
revision relieves the Combs Oil Company of the requirement to comply
with the Florida rule governing installation and operation of vapor
collection and control systems on loading racks at bulk gasoline
plants. It should be noted that approval of the variance for Combs Oil
Company only relieves them from the requirements of Rule 62-
296.418(2)(b)2 F.A.C., for its new bulk gasoline plant, it does not
relieve them from any requirements established in 40 CFR parts 60 and
63.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves a state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 24, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Nitrogen dioxide,
Particulate Matter, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: September 16, 2015.
Heather McTeer Toney,
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42.U.S.C. 7401 et seq.

Subpart K--Florida

0
2. Section 52.520(d), is amended by adding a new entry for ``Combs Oil
Company'' at the end of the table to read as follows:

Sec.  52.520  Identification of plan.

* * * * *
    (d) * * *

                                EPA-Approved Florida Source-Specific Requirements
----------------------------------------------------------------------------------------------------------------
                                                     State
           Name of source               Permit     effective     EPA approval date            Explanation
                                        number        date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Combs Oil Company..................  ...........    7/31/2009  9/25/2015 [Insert      Order Granting Variance
                                                                citation of            from Rule 62-
                                                                publication].          296.418(2)(b)2.
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* * * * *
[FR Doc. 2015-24325 Filed 9-24-15; 8:45 am]
BILLING CODE 6560-50-P


123456789 10 11 12 13 14 15 16 A B C D E F G H Date: 3 Feb 03 Author: US EPA Comments: This file presents the costing module compliance decisions for the proposed main option for detailed questionnaire facilities withdrawing from Freshwater Rivers/ Streams.

Confidentiality: Non CBI 123456789 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 A B C D E F G H I J K L Survey ID CWIS ID Unique Intake ID Under Capacity Utilization Cutoff?

( 1= yes) Impingement Compliance Requirement?

( 1= yes) Entrainment Compliance Requirement?

( 1= yes) Technology Costing Module Application Technology Costing Module Application ( additional) Debris Loading ( 1= high, 0 = typical) Relocation Distance Estimate. ( meters)

Once through, Combination, or Other Cooling Systems In Place Freshwater River / Stream Intakes DMU3310 1 DMU33101 0 1 0 1 0 1 0 DNU2010 1 DNU20101 0 1 0 4 0 0 0 DNU2021 1 DNU20211 0 1 0 1 0 1 0 DNU2030 1 DNU20301 0 1 0 1 0 1 0 DNU2031 1 DNU20311 0 1 1 0 0 0 0 DUT0062 1 DUT00621 0 1 1 4 0 1 0 DUT0062 2 DUT00622 0 1 1 4 0 1 0 DUT1003 1 DUT10031 0 1 0 4 0 0 0 DUT1005 1 DUT10051 0 1 1 4 0 0 0 DUT1006 1 DUT10061 0 1 0 1 0 1 0 DUT1006 2 DUT10062 0 1 0 1 0 1 0 DUT1010 1 DUT10101 1 1 0 0 0 0 0 DUT1010 2 DUT10102 1 1 0 0 0 0 0 DUT1012 1 DUT10121 0 1 0 1 0 1 0 DUT1014 1 DUT10141 0 1 1 2 0 0 0 DUT1017 1 DUT10171 0 1 0 5 0 1 0 DUT1017 2 DUT10172 0 1 0 5 0 1 0 DUT1017 3 DUT10173 0 1 0 5 0 1 0 DUT1017 4 DUT10174 0 1 0 5 0 1 0 DUT1017 5 DUT10175 0 1 0 5 0 1 0 DUT1017 6 DUT10176 0 1 0 5 0 1 0 DUT1021 1 DUT10211 0 1 0 0 0 0 0 DUT1024 1 DUT10241 0 1 1 2 0 0 0 DUT1026 1 DUT10261 1 1 0 0 0 0 0 DUT1028 1 DUT10281 0 1 0 4 0 1 0 DUT1030 1 DUT10301 0 1 1 11 0 0 0 DUT1031 1 DUT10311 0 1 1 4 0 0 0 DUT1031 2 DUT10312 0 1 1 4 0 0 0 DUT1041 1 DUT10411 0 1 0 1 0 1 0 DUT1046 1 DUT10461 0 1 0 0 0 0 0 DUT1047 1 DUT10471 0 1 1 7 0 0 125 DUT1049 1 DUT10491 0 1 0 0 0 0 0 DUT1051 1 DUT10511 0 1 0 1 0 0 0 DUT1052 1 DUT10521 0 1 1 4 0 0 0 DUT1053 1 DUT10531 0 1 1 2 5 0 0 DUT1053 2 DUT10532 0 0 0 0 0 0 0 DUT1057 1 DUT10571 0 1 1 4 0 0 0 DUT1060 1 DUT10601 0 1 1 2 0 0 0 DUT1069 1 DUT10691 0 1 1 4 0 0 0 DUT1069 2 DUT10692 0 1 1 4 0 0 0 DUT1071 1 DUT10711 0 1 0 0 0 0 0 DUT1074 2 DUT10742 0 1 1 4 0 0 0 DUT1075 2 DUT10752 0 1 1 0 0 0 0 DUT1085 1 DUT10851 0 1 1 2 0 0 0 DUT1088 1 DUT10881 0 1 1 7 0 0 20 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 A B C D E F G H I J K L DUT1088 2 DUT10882 0 1 1 7 0 0 20 DUT1089 1 DUT10891 0 1 1 4 0 0 0 DUT1095 1 DUT10951 0 1 1 4 0 0 0 DUT1097 1 DUT10971 0 1 1 11 0 0 0 DUT1098 1 DUT10981 1 1 0 1 0 0 0 DUT1099 1 DUT10991 0 1 1 2 0 0 0 DUT1103 5 DUT11035 0 1 0 1 0 0 0 DUT1107 1 DUT11071 0 1 1 4 0 0 0 DUT1107 2 DUT11072 0 1 1 4 0 0 0 DUT1108 1 DUT11081 0 1 1 2 0 0 0 DUT1111 1 DUT11111 0 1 1 11 0 1 0 DUT1111 2 DUT11112 0 1 1 11 0 1 0 DUT1117 1 DUT11171 0 1 0 0 0 0 0 DUT1118 1 DUT11181 0 1 0 5 0 0 0 DUT1132 1 DUT11321 0 1 1 11 0 1 0 DUT1135 1 DUT11351 0 1 1 2 0 0 0 DUT1141 1 DUT11411 0 1 1 11 0 0 0 DUT1141 2 DUT11412 0 1 1 11 0 0 0 DUT1141 3 DUT11413 0 1 1 9 0 0 0 DUT1142 1 DUT11421 1 1 0 0 0 0 0 DUT1143 1 DUT11431 0 1 1 0 0 0 0 DUT1144 1 DUT11441 0 1 0 1 0 0 0 DUT1148 1 DUT11481 0 1 0 0 0 0 0 DUT1148 2 DUT11482 0 1 0 0 0 0 0 DUT1153 1 DUT11531 0 1 0 0 0 0 0 DUT1154 1 DUT11541 1 1 0 0 0 0 0 DUT1156 1 DUT11561 0 1 1 7 0 0 250 DUT1157 1 DUT11571 0 1 1 4 0 0 0 DUT1157 2 DUT11572 0 1 1 4 0 0 0 DUT1161 1 DUT11611 1 1 0 0 0 0 0 DUT1161 2 DUT11612 1 1 0 0 0 0 0 DUT1163 1 DUT11631 0 1 1 2 0 1 0 DUT1163 2 DUT11632 0 1 1 2 0 1 0 DUT1166 1 DUT11661 0 1 1 4 0 1 0 DUT1167 1 DUT11671 0 1 0 0 0 0 0 DUT1167 2 DUT11672 0 1 0 0 0 0 0 DUT1167 3 DUT11673 0 1 0 0 0 0 0 DUT1167 4 DUT11674 0 1 0 0 0 0 0 DUT1167 5 DUT11675 0 1 0 0 0 0 0 DUT1170 1 DUT11701 1 1 0 0 0 0 0 DUT1173 1 DUT11731 0 1 1 2 0 0 0 DUT1185 1 DUT11851 0 1 1 7 0 0 20 DUT1188 1 DUT11881 0 1 0 0 0 0 0 DUT1191 1 DUT11911 1 1 0 0 0 0 0 DUT1191 2 DUT11912 1 1 0 0 0 0 0 DUT1192 1 DUT11921 0 1 0 0 0 0 0 DUT1193 1 DUT11931 1 1 0 11 0 1 0 DUT1193 2 DUT11932 1 1 0 11 0 1 0 DUT1194 1 DUT11941 0 1 0 0 0 0 0 DUT1198 1 DUT11981 0 1 1 11 0 0 0 DUT1207 1 DUT12071 0 1 0 5 0 1 0 DUT1207 2 DUT12072 0 1 0 5 0 1 0 DUT1207 3 DUT12073 0 1 0 5 0 1 0 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 A B C D E F G H I J K L DUT1209 1 DUT12091 0 1 1 11 0 0 0 DUT1209 2 DUT12092 0 1 1 11 0 0 0 DUT1212 1 DUT12121 0 1 0 1 0 1 0 DUT1213 1 DUT12131 0 1 0 0 0 0 0 DUT1214 1 DUT12141 0 1 0 4 0 0 0 DUT1216 1 DUT12161 0 1 0 1 0 0 0 DUT1225 1 DUT12251 1 1 0 0 0 0 0 DUT1225 2 DUT12252 1 1 0 0 0 0 0 DUT1227 1 DUT12271 0 1 0 1 0 1 0 DUT1227 2 DUT12272 0 1 0 1 0 1 0 DUT1228 1 DUT12281 1 1 0 0 0 0 0 DUT1228 2 DUT12282 1 1 0 0 0 0 0 DUT1228 3 DUT12283 1 1 0 0 0 0 0 DUT1228 4 DUT12284 1 1 0 0 0 0 0 DUT1228 5 DUT12285 1 1 0 0 0 0 0 DUT1229 1 DUT12291 0 1 1 2 0 0 0 DUT1230 1 DUT12301 0 1 1 4 0 1 0 DUT1230 2 DUT12302 0 1 1 4 0 1 0 DUT1235 1 DUT12351 0 1 0 0 0 0 0 DUT1235 2 DUT12352 0 1 0 0 0 0 0 DUT1236 1 DUT12361 0 1 1 4 0 0 0 DUT1237 1 DUT12371 0 1 0 1 0 0 0 DUT1238 1 DUT12381 1 1 0 2 5 0 0 DUT1238 2 DUT12382 1 1 0 2 5 0 0 DUT1244 1 DUT12441 0 1 1 2 0 0 0 DUT1247 1 DUT12471 1 1 0 4 0 1 0 DUT1250 1 DUT12501 0 1 1 7 0 1 125 DUT1252 1 DUT12521 0 1 0 1 0 1 0 DUT1254 1 DUT12541 1 1 0 0 0 0 0 DUT1260 1 DUT12601 0 1 1 4 0 0 0 DUT1260 2 DUT12602 0 1 1 4 0 0 0 DUT1261 1 DUT12611 0 1 1 2 0 0 0 DUT1261 2 DUT12612 0 1 1 4 0 0 0 DUT1263 1 DUT12631 0 1 1 4 0 0 0 DUT1263 2 DUT12632 0 1 1 4 0 0 0 DUT1263 3 DUT12633 0 1 1 4 0 0 0 DUT1265 1 DUT12651 0 1 1 2 0 0 0 DUT1270 1 DUT12701 1 1 0 5 0 1 0 DUT1276 1 DUT12761 0 1 1 11 0 0 0 Notes: Module # Description 1 Add Fish Handling and Return System 2 Add Fine Mesh Travelling Screens with Fish Handling and Return 3 Add New Larger Intake Structure with Fine Mesh, Handling and Return 4 Add Passive Fine Mesh Screens at Shoreline 5 Add Fish Barrier Net 6 Gunderboom ( not used here)

7 Relocate Intake to Submerged Offshore with passive screen 8 Add Velocity Cap at Inlet 9 Add Passive Fine Mesh Screen at Inlet of Offshore Submerged 10 Add/ Modify Shoreline Tech for Submerged Offshore 155 156 157 158 159 160 A B C D E F G H I J K L 11 Add Double Entry, Single Exit with Fine Mesh, Handling and Return If a single facility with multiple intakes implements a barrier net, it is inherently assumed that one ( 1) net would be sized for the full intake flow instead of a set of nets.

If a single facility with multiple intakes has separate technology modules implemented, it is inherently assumed that this is Not an error, but a function of separate, distinct intake types.


[Federal Register Volume 85, Number 237 (Wednesday, December 9, 2020)]
[Notices]
[Pages 79250-79251]
[FR Doc No: 2020-26994]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90562; File No. SR-PEARL-2020-29]

Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend the
Exchange's Certificate of Formation

December 3, 2020.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on November 24, 2020, MIAX PEARL, LLC (``MIAX
PEARL'' or the ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') a proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend the Exchange's Amended
and Restated Certificate of Formation (the ``Certificate of
Formation'').
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/pearl at MIAX
PEARL's principal office, and at the Commission's Public Reference
Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the Certificate of Formation to make
several corrective edits and clarifying changes. On February 11, 2016,
the Exchange executed the original Certificate of Formation. On October
28, 2020, the Exchange filed its proposal to amend the Certificate of
Formation, among other corporate documents, to make several non-
substantive, administrative and clarifying changes.\3\ The Initial
Proposal included changes to the title of the Certificate of Formation
to be amended to be titled the ``Amended and Restated Certificate of
Formation of MIAX PEARL, LLC.'' On November 10, 2020, the Commission
published for comment the Initial Proposal, which granted the
Exchange's request for waiver of the 30-day operative delay.\4\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 90394 (November 10,
2020) (SR-PEARL-2020-23) (Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change to Amend the Exchange's
Certificate of Formation, Amended and Restated Limited Liability
Company Agreement, and the By-Laws) (the ``Initial Proposal'').
    \4\ See id.
---------------------------------------------------------------------------

    The Exchange now proposes to amend the title of the Certificate of
Formation to delete the words ``Amended and'' in order to accurately
reflect the amended document that was filed with the Secretary of State
for the State of Delaware, titled the ``Restated Certificate of
Formation of MIAX PEARL, LLC.'' \5\ The Exchange also proposes to amend
the second sentence in the first paragraph of the Certificate of
Formation to delete the words ``amending and'' in order to clarify that
the amended document is the ``Restated Certificate of Formation of MIAX
PEARL, LLC.'' With the proposed changes, the first paragraph of the
Certificate of Formation is as follows:
---------------------------------------------------------------------------

    \5\ The Certificate of Formation is available the Exchange's
website, at https://www.miaxoptions.com/sites/default/files/page-files/MIAX_PEARL_Restated_Certificate_of_Formation_11122020.pdf.

    This filing has been executed and filed in accordance with
Section 18-208 of the Limited Liability Company Act. This document
is being executed for the purpose of restating the original
Certificate of Formation, filed on February 11, 2016, under file
---------------------------------------------------------------------------
number: 5880323.

    The purpose of the proposed changes to the Certificate of Formation
are to ensure that the Exchange's Certificate of Formation accurately
reflects the correct filed document in order to reduce potential
investor or market participant confusion.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\6\ Specifically, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \7\ requirements that the rules of
an exchange be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \8\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
    \8\ Id.
---------------------------------------------------------------------------

    The Exchange believes that the proposed changes to the Certificate
of Formation are designed to prevent fraudulent and manipulative acts
and practices, promote just and equitable principles of trade, foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, protect investors and the public interest. The
Exchange believes that the proposed changes are non-substantive,
corrective edits and clarifying changes and will reduce potential
investor or market participant confusion regarding the Exchange's
Certificate of Formation. Further, the Exchange believes the proposed
changes are not material and will have no impact on the governance,
ownership, or operations of the Exchange.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose

any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange does not believe
the proposed rule change will impose any burden on intra-market and
inter-market competition that is not necessary or appropriate in
furtherance of the purposes of the Act because the proposed changes are
not intended to address competitive issues but rather are corrective,
non-substantive changes that are concerned solely with correcting the
title of the Certificate of Formation to reflect current, accurate
information.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \11\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \12\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has requested that the Commission waive the 30-day operative delay. As
the proposed rule change raises no novel issues and merely corrects the
title of the Exchange's Certificate of Formation, the Commission
believes that waiver of the 30-day operative delay is consistent with
the protection of investors and the public interest. Accordingly, the
Commission hereby waives the operative delay and designates the
proposed rule change operative upon filing.\13\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-PEARL-2020-29 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-PEARL-2020-29. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-PEARL-2020-29, and should be submitted
on or before December 30, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-26994 Filed 12-8-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3777-3779]
[FR Doc No: 2012-1433]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369; (Formerly Docket No. 2007D-0168)]

Draft and Revised Draft Guidances for Industry Describing
Product-Specific Bioequivalence Recommendations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of additional draft and revised draft product-specific
bioequivalence (BE) recommendations. The recommendations provide
product-specific guidance on the design of BE studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
May 31, 2007 (72 FR 30386), FDA announced the availability of a draft
guidance for industry entitled ``Bioequivalence Recommendations for
Specific Products,'' explaining the process that would be used to make
product-specific BE recommendations available to the public on FDA's
Web site. The BE recommendations identified in this notice were
developed using the process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
these draft and revised draft guidances before it begins work on the
final versions of the guidances, submit either electronic or written
comments on the draft and revised draft product-specific BE
recommendations listed in this notice by March 26, 2012.

ADDRESSES: Submit written requests for single copies of the individual
BE guidances to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance recommendations.
    Submit electronic comments on the draft product-specific BE
recommendations to http://www.regulations.gov. Submit written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Doan T. Nguyen, Center for Drug Evaluation and Research (HFD-600),
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855,
(240) 276-8608.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 31, 2007, FDA announced the
availability of a draft guidance for industry entitled ``Bioequivalence
Recommendations for Specific Products,'' which explained the process
that would be used to make product-specific BE recommendations
available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As
described in that draft guidance, FDA adopted this process as a means
to develop and disseminate product-specific BE recommendations and
provide a meaningful opportunity for the public to consider and comment
on those recommendations. Under that process, draft recommendations are
posted on the FDA's Web site and announced periodically in the Federal
Register. The public is encouraged to submit comments on those
recommendations within 60 days of their announcement in the Federal
Register. FDA considers any comments received and either publishes
final recommendations or publishes revised draft recommendations for
comment. Recommendations were last announced in the Federal Register of
December 1, 2009 (74 FR 62793). This notice announces draft product-
specific recommendations, either new or revised, that have been posted
on the FDA's Web site in the period from December 1, 2009, through June
30, 2011.

II. Drug Products for Which New Draft Product-Specific BE
Recommendations Are Available

    FDA is announcing draft BE product-specific recommendations for
drug products containing the following active ingredients:

A

Acetaminophen
Acetaminophen; Butalbital (multiple reference listed drugs (RLDs))
Acetaminophen; Butalbital; Caffeine (multiple RLDs)
Acetaminophen; Hydrocodone Bitartrate (multiple RLDs)
Acetaminophen Oxycodone (multiple RLDs)
Acetazolamide
Adapalene
Aliskiren Hemifumarate; Valsartan
Altretamine
Amantadine HCl (multiple RLDs)
Amiodarone HCl
Amitriptyline HCl (multiple RLDs)
Amlodipine Besylate; Telmisartan
Amlodipine; Hydrochlorothiazide; Valsartan
Amoxicillin; Clavulanate Potassium (multiple RLDs)
Aripiprazole
Aspirin; Butalbital; Caffeine (multiple RLDs)
Aspirin; Dipyridamole
Aspirin; Oxycodone
Aspirin; Butalbital; Caffeine; Codeine Phosphate
Atovaquone
Auranofin
Azelaic Acid (multiple RLDs)

B

Baclofen (multiple RLDs)
Benazepril HCl
Benzoyl Peroxide Clindamycin Phosphate (multiple RLDs)
Benzoyl Peroxide; Erythromycin (multiple RLDs)
Betamethasone Acetate; Sodium Phosphate
Betamethasone Dipropionate; Calcipotriene Hydrate (multiple RLDs)
Betamethasone Dipropionate; Clotrimazole
Betamethasone; Clotrimazole
Bexarotene
Bosentan
Buprenorphine HCl
Buprenorphine HCl; Naloxone HCl
Bupropion HBr
Bupropion HCl
Buspirone
Butoconazole Nitrate (multiple RLDs)

C

Calcipotriene (multiple RLDs)
Carbidopa; Levodopa
Carisoprodol
Carvedilol Phosphate
Cefaclor
Cefadroxil; Cefadroxil Hemihydrate
Cefditoren Pivoxil
Cefixime
Cefuroxime Axetil (multiple RLDs)
Cetirizine HCl
Chlorambucil
Chlorpheniramine Polistirex; Hydrocodone Polistirex

Chlorthalidone (multiple RLDs)
Choline Fenofibrate (multiple RLDs)
Ciclopirox (multiple RLDs)
Ciprofloxacin HCl (multiple RLDs)
Clarithromycin
Clindamycin Phosphate (multiple RLDs)
Clobetasol Propionate (multiple RLDs)
Clonazepam
Clonidine
Clotrimazole (multiple RLDs)
Clozapine
Colchicine
Colesevelam HCl
Cyclobenzaprine

D

Dapsone (multiple RLDs)
Darunavir Ethanolate
Dexamethasone
Dexamethasone; Tobramycin
Dexlansoprazole
Diazepam
Diclofenac Potassium
Diclofenac Sodium (multiple RLDs)
Dienogest; Estradiol Valerate
Diethylpropion
Diphenhydramine; Ibuprofen
Disulfiram (multiple RLDs)
Divalproex Sodium
Dolasetron Mesylate
Donepezil HCl
Doxazosin Mesylate
Doxepin HCl (multiple RLDs)
Doxorubicin HCl
Dronabinol
Dronedarone HCl

E

Econazole Nitrate
Ergocalciferol
Erythromycin (multiple RLDs)
Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl
Esomeprazole Magnesium
Esomeprazole Magnesium; Naproxen
Estradiol (multiple RLDs)
Estrogens Conjugated Synthetic A
Ethacrynic Acid
Ethinyl Estradiol; Norethindrone
Ethinyl Estradiol; Norethindrone Acetate
Ethinyl Estradiol; Norgestimate (multiple RLDs)
Etodolac
Etoposide
Everolimus

F

Febuxostat
Felodipine
Fenofibrate
Fenofibric Acid
Fentanyl Citrate
Fesoterodine Fumarate
Finasteride
Flucytosine
Fluorouracil (multiple RLDs)
Fluoxetine HCl (multiple RLDs)
Fluticasone Propionate
Fluvoxamine Maleate
Furosemide

G

Galantamine HBr
Gemfibrozil
Glipizide
Griseofulvin
Griseofulvin Microcrystalline
Guanfacine HCl

H

Hydrochlorothiazide; Moexipril
Hydrochlorothiazide; Spironolactone
Homatropine Methylbromide; Hydrocodone Bitartrate
Hydralazine; Isosorbide
Hydrochlorothiazide
Hydrochlorothiazide; Quinapril HCl
Hydrocodone; Ibuprofen (multiple RLDs)
Hydromorphone HCl
Hydroxychloroquine
Hydroxyzine HCl (multiple RLDs)

I

Ibuprofen (multiple RLDs)
Iloperidone
Imipramine Pamoate
Imiquimod (multiple RLDs)
Indomethacin (multiple RLDs)

K

Ketoconazole

L

Labetalol HCl
Lamotrigine
Lansoprazole
Lapatinib Ditosylate
Lenalidomide
Leuprolide Acetate (multiple RLDs)
Levetiracetam
Levonorgestrel
Lithium Carbonate (multiple RLDs)
Loratadine; Pseudoephedrine Sulfate
Lorazepam
Loteprednol
Lubiprostone

M

Maraviroc
Meclizine
Meclizine HCl
Mefenamic Acid
Megestrol Acetate (multiple RLDs)
Mestranol; Norethindrone
Metformin HCl; Pioglitazone HCl
Methimazole
Methoxsalen (multiple RLDs)
Methylphenidate
Methylphenidate HCl
Methylprednisolone
Metoclopramide HCl
Metolazone
Metoprolol Tartrate; Hydrochlorothiazide
Metronidazole (multiple RLDs)
Mifepristone
Milnacipran HCl
Minocycline HCl
Minoxidil (multiple RLDs)
Mirtazapine
Misoprostol
Molindone HCl
Morphine Sulfate (multiple RLDs)
Mupirocin
Mupirocin Calcium (multiple RLDs)
Mycophenolate Mofetil

N

Naltrexone HCl
Naproxen
Naproxen Sodium
Naproxen Sodium; Sumatriptan Succinate
Nebivolol
Niacin; Simvastatin
Nicotine Polacrilex
Nifedipine
Nilotinib HCl Monohydrate
Nitroglycerin (multiple RLDs)
Nystatin (multiple RLDs)

O

Octreotide
Ofloxacin
Orlistat (multiple RLDs)
Orphenadrine Citrate
Oseltamivir Phosphate (multiple RLDs)
Oxybutynin
Oxycodone
Oxycodone HCl (multiple RLDs)
Oxymetholone

P

Palonosetron HCl
Pantoprazole Sodium
Paroxetine
Penbutolol
Penicillin V Potassium
Perphenazine (multiple RLDs)
Phenelzine Sulfate
Phytonadione
Pioglitazone HCl
Pitavastatin
Potassium Citrate
Pramipexole Dihydrochloride
Prasugrel HCl
Prednisolone Acetate
Progesterone
Promethazine HCl (multiple RLDs)
Propafenone HCl
Propranolol HCl
Protriptyline HCl
Pseudoephedrine HCl

R

Rabeprazole Sodium
Ranitidine HCl
Ranolazine
Rifabutin
Risedronate
Risperidone (multiple RLDs)
Ritonavir
Rivastigmine
Ropinirole HCl

S

Sevelamer Carbonate
Sitagliptin Phosphate
Sotalol (multiple RLDs)
Spironolactone
Sulfacetamide Sodium
Sulfasalazine (multiple RLDs)
Sunitinib Malate

T

Tapentadol HCl
Tazarotene (multiple RLDs)
Terbinafine HCl
Terconazole (multiple RLDs)
Tetracycline
Theophylline (multiple RLDs)
Tioconazole
Tizanidine HCl
Topotecan
Tranexamic Acid
Trazodone HCl (multiple RLDs)
Tretinoin
Triamcinolone Acetonide (multiple RLDs)
Triazolam
Trimethoprim

U

Ursodiol

V

Valproic Acid
Venlafaxine HCl
Verapamil HCl

W

Warfarin Sodium

Z

Zolmitriptan
Zolpidem

III. Drug Products for Which Revised Draft Product-Specific BE
Recommendations Are Available

    FDA is announcing revised draft BE product-specific recommendations
for drug products containing the following active ingredients. These
recommendations were previously posted on the FDA's Web site:

A

Amantadine HCl
Atorvastatin

B

Bupropion HBr

C

Calcipotriene
Calcium Acetate
Calcitriol
Capecitabine (multiple RLDs)
Cefditoren Pivoxil
Ciclopirox
Clotrimazole
Colesevelam HCl (multiple RLDs)

D

Darunavir Ethanolate
Desogestrel; Ethinyl Estradiol
Desvenlafaxine Succinate
Diclofenac Sodium
Diclofenac Sodium; Misoprostol
Disulfiram
Donepezil HCl (multiple RLDs)

E

Emtricitabine
Esomeprazole Magnesium
Estradiol
Ethinyl Estradiol; Ethynodiol Diacetate (multiple RLDs)
Ethinyl Estradiol; Norethindrone

F

Felbamate (multiple RLDs)
Fentanyl
Fentanyl Citrate
Fluorouracil (multiple RLDs)

G

Glyburide Metformin
Granisetron HCl

L

Labetalol HCl
Lamotrigine (multiple RLDs)
Lapatinib Ditosylate
Levofloxacin
Levonorgestrel (multiple RLDs)
Linezolid

M

Memantine HCl
Mercaptopurine (multiple RLDs)
Metformin HCl (multiple RLDs)
Minoxidil
Morphine

N

Nebivolol
Niacin
Nilutamide
Nitroglycerin

O

Omeprazole
Orlistat (multiple RLDs)
Oxymorphone HCl

P

Prednisolone
Progesterone

R

Rivastigmine
Rivastigmine Tartrate
Ropinirole

S

Scopolamine
Sevelamer Carbonate (multiple RLDs)
Sevelamer HCl (multiple RLDs)
Sirolimus

T

Telmisartan
Tiagabine HCl
Topiramate
Tranexamic Acid
Triamcinolone Acetonide (multiple RLDs)

V

Varenicline Tartrate
Venlafaxine HCl

    For a complete history of previously published Federal Register
notices, please go to http://www.regulations.gov and enter docket
number FDA-2007-D-0369.
    These draft and revised draft guidances are being issued consistent
with FDA's good guidance practices regulation (21 CFR 10.115). The
guidances represent the Agency's current thinking on product-specific
design of BE studies to support ANDAs. They do not create or confer any
rights for or on any person and do not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments on any of the
specific BE recommendations posted on FDA's Web site. It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document. The
guidance, notices, and received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 19, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-1433 Filed 1-24-12; 8:45 am]
BILLING CODE 4160-01-P