[Federal Register Volume 87, Number 186 (Tuesday, September 27, 2022)]
[Rules and Regulations]
[Pages 58453-58456]
[FR Doc No: 2022-20621]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2022-0295; FRL-10162-02-R5]

Air Plan Approval; Michigan; Revisions to Part 1 and 2 Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
revisions to Michigan Air Pollution Control Rules Part 1 Definitions,
and Part 2 Air Use Approval for inclusion in the Michigan State
Implementation Plan (SIP). Additionally, EPA is removing rules from the
SIP that are part of Michigan's title V Renewable Operating Permit
program, and rules that have been moved to other sections of the
Michigan Administrative Code and approved into the Michigan SIP.

DATES: This direct final rule is effective November 28, 2022, unless
EPA receives adverse comments by October 27, 2022. If adverse comments
are received, EPA will publish a timely withdrawal of the direct final
rule in the Federal Register informing the public that the rule will
not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2022-0295 at https://www.regulations.gov or via email to
[email protected]. For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Constantine Blathras, Environmental
Engineer, Air Permits Section, Air Programs Branch (AR18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER>, [email protected].
The EPA Region 5 office is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding Federal holidays and facility closures due to
COVID-19.

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. Background

    Section 110(a)(2)(C) of the Clean Air Act (CAA) requires that the
SIP include a program to provide for the ``regulation of the
modification and construction of any stationary source within the areas
covered by the plan as necessary to assure that national ambient air
quality standards are achieved.'' This includes a program for
permitting construction and modification of both major and minor
sources that the state deems necessary to protect air quality. The
State of Michigan's minor source permit to install rules are contained
in Part 2, Air Use Approval, R. 336.1201 to R. 336.1299 of the Michigan
Administrative Code. Changes to the Part 2 rules were submitted on
November 12, 1993, May 16, 1996, April 3, 1998, September 2, 2003,
March 24, 2009, and February 28, 2017. EPA approved changes to the Part
2 rules most recently in a final approval dated August 31, 2018 (83 FR
44485). The Michigan Administrative Code at Part 1, General Provisions,
R. 336.1101 to R. 336.1128, contains the definitions of terms used in
the Michigan code.
    EPA is approving revisions to Michigan's Part 1. Definitions, and
Part 2. Air Use Approval for inclusion in the Michigan SIP. The
following Michigan Air Pollution Control Rules are being added or
revised: R 336.1101(q), R 336.1103(aa), R 336.1201a, R 336.1202-1203, R
336.1206-1207, R 336.1209, R 336.1214a, R 336.1219(1), R 336.1240-1241,
R 336.1278, R 336.1285, and R 336.1291.
    The Part 1 definition revisions include new or revised definitions
for the following, R 336.1101(q) ``Aqueous based parts washer'', and R
336.1103(aa) ``cold cleaner''.
    The Part 2 modifications consist of wording changes made to help
clarify the air use approval rules, and to update references and
terminology. Other changes include new and modified definitions of
phrases, new timeframes for processing air use permits, and two new
exemptions from the permitting program for small sources.
    EPA is removing the Michigan Air Pollution Control Rules R 336.1212
``Administratively complete applications; insignificant activities;
streamlining applicable requirements; emissions reporting and fee
calculations'', R 336.1216 ``Modifications to renewable operating
permits'', R 336.1219(2) ``Amendments for change of ownership or
operational

control'', R 336.1220 (rescinded), and R 336.1299 (rescinded) from the
Michigan SIP.
    The rescinded rules have been moved to other sections in the
Michigan Administrative Code where they have already been approved into
the Michigan SIP and rescinded from the original Part 2 location. This
action completes the transition process for these rescinded rules.
    The other Part 2 rules removed from the Michigan SIP by this action
do not address the requirements related to attainment and maintenance
of the National Ambient Air Quality Standards (NAAQS) under Section 110
of the CAA. EPA has determined that these rules were erroneously
incorporated into the SIP. These rules instead address the requirements
under title V of the CAA for operating permit programs. EPA fully
approved Michigan's title V Renewable Operating Permit Program on
November 10, 2003 (68 FR 63735) to implement its program. Since these
rules do not address the requirements related to attainment and
maintenance of the NAAQS under Section 110 of the CAA and have been
approved as part of the title V program approval, EPA will remove them
from this section of the Michigan SIP.
    EPA proposed to rescind rule R 336.1220 in a February 6, 2013 (78
FR 8485), action (in addition to approval of revisions to Michigan
rules in Parts 1 and 19). EPA did not receive any comments on that
proposal and published a final action on December 16, 2013 (78 FR
76064).
    As part of the SIP revision request, Michigan submitted a 110(l)
demonstration for each of the proposed revisions to the SIP. Section
110(l) of the CAA governs the submittal of SIP revisions as part of
Attachment E of its submittal. It states, ``Each revision to an
implementation plan submitted by a State under this chapter shall be
adopted by such State after reasonable notice and public hearing. The
Administrator shall not approve a revision of a plan if the revision
would interfere with any applicable requirement concerning the
attainment and reasonable further progress (as defined by 7501 of this
title), or any other applicable requirement of this chapter.'' The
110(l) demonstration in the SIP revision request adequately addresses
this requirement for each rule revision, and the revisions should cause
minimal to no impact on the emissions of any source, will have no
effect on Michigan's National Ambient Air Quality Standards attainment
status, or any backsliding on achieved improvements. The revision for
the removed and rescinded rules pertain to the Michigan Title V
renewable operating permit program which has already been approved.

II. What action is EPA taking?

    EPA is approving revisions to Michigan's Part 1 and Part 2
regulations. Specifically, EPA is approving revisions to Michigan Air
Pollution Control Rules R 336.1101, R 336.1103, R 336.1201a, R
336.1202, R 336.1203, R 336.1206, R 336.1207, R 336.1209, R 336.1214a,
R 336.1219, R 336.1240, R 336.1241, R 336.1278, and R 336.1291,
effective December 20, 2016, and R 336.1285, effective January 2, 2019.
EPA is also removing Michigan Air Pollution Control Rules R336.1212, R
336.1216, and R 336.1299 from the SIP.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the State plan if relevant adverse
written comments are filed. This rule will be effective November 28,
2022, without further notice unless we receive relevant adverse written
comments by October 27, 2022. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on the proposed action. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time. Please note that if EPA receives adverse comment on an
amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
If we do not receive any comments, this action will be effective
November 28, 2022.

III. 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 the incorporation by reference of the Michigan
Regulations described in Section I of this preamble and set forth in
the amendments to 40 CFR part 52 below. EPA has made, and will continue
to make, these documents generally available through
www.regulations.gov and at the EPA Region 5 Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information). Therefore, these materials have
been approved by EPA for inclusion in the SIP, have been incorporated
by reference by EPA into that plan, are fully federally enforceable
under sections 110 and 113 of the CAA as of the effective date of the
final rulemaking of EPA's approval, and will be incorporated by
reference in the next update to the SIP compilation.\1\
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    \1\ 62 FR 27968 (May 22, 1997).
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    Also in this document, as described in Section I of this preamble
and the amendments to 40 CFR part 52 set forth below, EPA is removing
provisions of the EPA-Approved Michigan Regulations from the Michigan
SIP, which is incorporated by reference in accordance with the
requirements of 1 CFR part 51.

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 CAA and applicable
Federal regulations. 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 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).
    In addition, 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 and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    This action is subject to the Congressional Review Act, and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. 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 28, 2022. 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. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of this Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. 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, Carbon monoxide,
Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Dated: September 19, 2022.
Debra Shore,
Regional Administrator, Region 5.

    For the reasons stated in the preamble, 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.

0
2. In Sec.  52.1170, the table in paragraph (c) is amended:
0
a. Under ``Part 1. General Provisions'' by revising the entries for R
336.1101 and R 336.1103; and
0
b. Under ``Part 2. Air Use Approval'' by:
0
i. Revising the entries for R 336.1201a, R 336.1202, R 336.1203, R
336.1206, R 336.1207, and R 336.1209;
0
ii. Removing the entry for R 336.1212;
0
iii. Adding the entry for R 336.1214a in numerical order;
0
iv. Removing the entry for R 336.1216;
0
v. Revising the entries for R 336.1219, R 336.1240, R 336.1241, R
336.1278, and R 336.1285;
0
vi. Adding the entry for R 336.1291 in numerical order; and
0
vii. Removing the entry for R 336.1299.
    The revisions and additions read as follows:

Sec.  52.1170  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Michigan Regulations
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                                                        State
    Michigan citation               Title          effective date     EPA approval date           Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                           Part 1. General Provisions
----------------------------------------------------------------------------------------------------------------
R 336.1101...............  Definitions; A........      12/20/2016  9/27/2022, [INSERT      All except for (a)
                                                                    FEDERAL REGISTER        Act and (h) Air
                                                                    CITATION].              pollution.

                                                  * * * * * * *
R 336.1103...............  Definitions; C........      12/20/2016  9/27/2022, [INSERT      .....................
                                                                    FEDERAL REGISTER
                                                                    CITATION].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                            Part 2. Air Use Approval
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
R 336.1201a..............  General permits to          12/20/2016  9/27/2022, [INSERT      .....................
                            install.                                FEDERAL REGISTER
                                                                    CITATION].
R 336.1202...............  Waivers of approval...      12/20/2016  9/27/2022, [INSERT      .....................
                                                                    FEDERAL REGISTER
                                                                    CITATION].
R 336.1203...............  Information required..      12/20/2016  9/27/2022, [INSERT      .....................
                                                                    FEDERAL REGISTER
                                                                    CITATION].

                                                  * * * * * * *
R 336.1206...............  Processing of               12/20/2016  9/27/2022, [INSERT      .....................
                            applications for                        FEDERAL REGISTER
                            permits to install.                     CITATION].
R 336.1207...............  Denial of permits to        12/20/2016  9/27/2022, [INSERT      .....................
                            install.                                FEDERAL REGISTER
                                                                    CITATION].
R 336.1209...............  Use of old permits to       12/20/2016  9/27/2022, [INSERT      .....................
                            limit potential to                      FEDERAL REGISTER
                            emit.                                   CITATION].
R 336.1214a..............  Consolidation of            12/20/2016  9/27/2022, [INSERT      .....................
                            permits to install                      FEDERAL REGISTER
                            within renewable                        CITATION].
                            operating.
                           permit................
R 336.1219...............  Amendments for change       12/20/2016  9/27/2022, [INSERT      .....................
                            of ownership or                         FEDERAL REGISTER
                            operational control.                    CITATION].
R 336.1240...............  Required air quality        12/20/2016  9/27/2022, [INSERT      .....................
                            models.                                 FEDERAL REGISTER
                                                                    CITATION].
R 336.1241...............  Air quality modeling        12/20/2016  9/27/2022, [INSERT      .....................
                            demonstration                           FEDERAL REGISTER
                            requirements.                           CITATION].
R 336.1278...............  Exclusion from              12/20/2016  9/27/2022, [INSERT      .....................
                            exemption.                              FEDERAL REGISTER
                                                                    CITATION].

                                                  * * * * * * *
R 336.1285...............  Permit to install             1/2/2019  9/27/2022, [INSERT      .....................
                            exemptions;                             FEDERAL REGISTER
                            miscellaneous.                          CITATION].

                                                  * * * * * * *
R 336.1291...............  Permit to install           12/20/2016  9/27/2022, [INSERT      All except for R
                            exemptions; emission                    FEDERAL REGISTER        336.1291(2)(a)
                            units with ``de                         CITATION].              through (d) and non-
                            minimis'' emissions.                                            criteria pollutants
                                                                                listed in Table 23.

                                                  * * * * * * *
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[FR Doc. 2022-20621 Filed 9-26-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 40 (Thursday, February 28, 2019)]
[Proposed Rules]
[Pages 6710-6711]
[FR Doc No: 2019-03289]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0035; Airspace Docket No. 19-ASW-2]
RIN. 2120-AA66

Proposed Amendment of Class E Airspace; Brady, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify Class E airspace extending
upward from 700 feet above the surface at Brady, Curtis Field, Brady,
TX. This action is necessary due to the decommissioning of the Brady
non-directional radio beacon (NDB), and cancellation of the NDB
approach. It would enhance the safety and management of standard
instrument approach procedures for instrument flight rules (IFR)
operations at this airport. Additionally, the geographic coordinates
are being updated to coincide with the FAA's aeronautical database.

DATES: Comments must be received on or before April 15, 2019.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or 1-800-647-5527. You must identify FAA Docket No.
FAA-2019-0035; Airspace Docket No. 19-ASW-2, at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11C, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11C at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Witucki, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend Class E airspace extending

upward from 700 feet above the surface at Brady Curtis Field, Brady,
TX, to support instrument flight rule operations at this airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2019-0035;
Airspace Docket No. 19-ASW-2.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov//air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace
Designations and Reporting Points, dated August 13, 2018, and effective
September 15, 2018. FAA Order 7400.11C is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11C lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by modifying the Class E airspace
extending upward from 700 feet above the surface within 6.4 mile radius
of the Brady Curtis Field. The geographic coordinates of the airport
would also be updated to coincide with the FAA's aeronautical database.
    Airspace reconfiguration is necessary due to the decommissioning of
the Brady NDB, and cancellation of the NDB approach, which would
enhance the safety and management of the standard instrument
approaches.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11C, dated August 13, 2018, and effective September 15,
2018, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
 1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11C,
Airspace Designations and Reporting Points, dated August 13, 2018, and
effective September 15, 2018, is amended as follows:

    Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.
* * * * *

ASW TX E5 Brady, TX [Amended]

Brady, Curtis Field, TX
    (Lat. 31[deg]10'45'' N, long. 99[deg]19'26'' W)

    That airspace extending upward from 700 feet above the surface
within 6.4 mile radius of Curtis Field.

    Issued in Fort Worth, TX, on February 19, 2019.
John Witucki,
 Manager (A), Operations Support Group, ATO Central Service Center.
[FR Doc. 2019-03289 Filed 2-27-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 64 (Tuesday, April 3, 2018)]
[Notices]
[Pages 14311-14312]
[FR Doc No: 2018-06685]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2018-0020 (Notice No. 2018-08)]

Hazardous Materials: Information Collection Activities

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, PHMSA
invites comments on an information collection pertaining to hazardous
materials transportation for which PHMSA intends to request from the
Office of Management and Budget.

DATES: Interested persons are invited to submit comments on or before
June 4, 2018.

ADDRESSES: You may submit comments, identified by Docket No. PHMSA-
2018-0020 (Notice No. 2018-08), by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management System; U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, Routing
Symbol M-30, 1200 New Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: To the Docket Management System; Room W12-
140 on the ground floor of the West Building, 1200 New Jersey Avenue
SE, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    Instructions: All submissions must include the agency name and
Docket Number (PHMSA-2018-0020) for this notice at the beginning of the
comment. To avoid duplication, please use only one of these four
methods. All comments received will be posted without change to the
Federal Docket Management System (FDMS) and will include any personal
information provided.
    Requests for a copy of an information collection should be directed
to Steven Andrews or Shelby Geller, Standards and Rulemaking Division,
(202) 366-8553, Pipeline and Hazardous Materials Safety Administration,
U.S. Department of Transportation, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001.
    Docket: For access to the dockets to read background documents or
comments received, go to http://www.regulations.gov or DOT's Docket
Operations Office (see ADDRESSES).
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Steven Andrews or Shelby Geller,
Standards and Rulemaking Division,<PHONE_NUMBER>, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:
    Section 1320.8(d), title 5, Code of Federal Regulations (CFR)
requires PHMSA to provide interested members of the public and affected
agencies an opportunity to comment on information collection and
recordkeeping requests. This notice identifies a new information
collect request that PHMSA will be submitting to the Office of
Management and Budget (OMB). This information collection will be
contained in 49 CFR 171.6 of the Hazardous Materials Regulations (HMR;
49 CFR parts 171-180). PHMSA will revise burden estimates, where
appropriate, to reflect current reporting levels or adjustments based
on changes in proposed or final rules published once the information
collection is approved. The following information is provided for this
information collection: (1) Title of the information collection; (2)
summary of the information collection activity; (3) description of
affected public; (4) estimate of total annual reporting and
recordkeeping burden; and (5) frequency of collection. PHMSA will
request a 3-year approval for this information collection activity and
will publish a notice in the Federal Register upon OMB's approval.
    PHMSA requests comments on the following information collection:
    Title: Generic Clearance for the Collection of Qualitative Feedback
on Agency Service Delivery.
    Abstract: The information collection activity will garner
qualitative customer and stakeholder feedback in an efficient, timely
manner, in accordance with the Department's commitment to improving
service delivery. Qualitative feedback is information that provides
useful insights on perceptions and opinions, not statistical surveys
that yield quantitative results that can be generalized to the
population of study. This feedback will provide insight into customer
or stakeholder perceptions, opinions, experiences and expectations, as
well as an early warning of issues with service or focus attention on
areas where communication, training or changes in operations might
improve delivery of products or services. These collections will allow
for ongoing, collaborative, and actionable communications between PHMSA
and customers and stakeholders. It will also allow feedback to
contribute directly to the improvement of program management. Feedback
or information collected under this generic clearance will provide
useful information, but it will not yield data that can be generalized
to the overall population.
    The Department will submit a collection for approval under this
generic clearance if it meets the following conditions:
     The collections are voluntary.
     The collections are low-burden for respondents (based on
considerations of total burden hours, total number of respondents, or
burden-hours per respondent) and are low-cost for both the respondents
and the Federal Government.
     The collections are non-controversial and do not raise
issues of concern to other Federal agencies.
     Any collection is targeted to the solicitation of opinions
from respondents who have experience with the program or may have
experience with the program in the near future.
     Personally identifiable information (PII) is collected
only to the extent necessary and is not retained.
     Information gathered is intended to be used only
internally for general service improvement and program management
purposes and is not intended for release outside of the Department (if
released, the Department must indicate the qualitative nature of the
information).
    This type of generic clearance for qualitative information will not
be used for quantitative information collections that are designed to
yield reliably actionable results, such as monitoring trends over time
or documenting program performance. Such data uses require more
rigorous designs that address: The target population to which
generalizations will be made, the sampling frame, the sample design
(including stratification and clustering), the precision requirements
or power calculations that justify the proposed sample size, the
expected response rate, methods for assessing potential nonresponse
bias, the protocols for data collection, and any testing procedures
that were or will be undertaken prior to fielding the study. Depending
on the degree of influence the results are likely to have, such
collections may still be eligible for submission for other generic
mechanisms that are designed to yield quantitative results.
    Type of Review: New.
    Affected Public: Individuals and households, businesses and
organizations, State, Local or Tribal Governments.
    Annual Reporting and Recordkeeping Burden:
    Estimated Number of Respondents: 6,000.
    Estimated Annual Responses: 6,000.
    Estimated Annual Burden Hours: 3,000 hours.
    Frequency of Collection: One-time requirement.

    Issued in Washington, DC, on March 28, 2018.
William S. Schoonover,
Associate Administrator of Hazard Materials Safety, Pipeline and
Hazardous Materials Safety Administration.
[FR Doc. 2018-06685 Filed 4-2-18; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register Volume 85, Number 231 (Tuesday, December 1, 2020)]
[Notices]
[Page 77281]
[FR Doc No: 2020-26550]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT:  To Be Published.

PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING:  Wednesday, December
2, 2020 at 2:00 p.m.

CHANGES IN THE MEETING:  The Closed Meeting scheduled for Wednesday,
December 2, 2020 at 2:00 p.m. has been changed to Wednesday, December
2, 2020 at 10:00 a.m. The following additional matter will also be
considered during the Closed Meeting:

 Disclosure of non-public information

CONTACT PERSON FOR MORE INFORMATION:  For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact Vanessa A. Countryman from the Office of the Secretary
at<PHONE_NUMBER>.

    Dated: November 25, 2020.
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2020-26550 Filed 11-27-20; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49286-49287]
[FR Doc No: 2019-20257]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC19-138-000.
    Applicants: Valentine Solar, LLC, Glaciers Edge Wind Project, LLC,
PGGM Co[ouml]peratie U.A.
    Description: Application for Authorization Under Section 203 of the
Federal Power, et al. Act of Valentine Solar, LLC, et al.
    Filed Date: 9/11/19.
    Accession Number: 20190911-5140.
    Comments Due: 5 p.m. ET 10/2/19.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG19-182-000.
    Applicants: Blue Summit III Wind, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Blue Summit III Wind, LLC.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5099.
    Comments Due: 5 p.m. ET 10/3/19.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER19-2405-000.
    Applicants: Porterhouse Wind (4) LLC.
    Description: Supplement to July 15, 2019 Porterhouse Wind (4) LLC
tariff filing.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5022.
    Comments Due: 5 p.m. ET 9/23/19.

    Docket Numbers: ER19-2460-000.
    Applicants: DWW Solar II, LLC.
    Description: Supplement to July 25, 2019 DWW Solar II, LLC tariff
filing.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5065.
    Comments Due: 5 p.m. ET 9/26/19.

    Docket Numbers: ER19-2787-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2019-09-11 Amendment No. 3
to Amended and Restated PLA with CDWR to be effective 11/1/2019.
    Filed Date: 9/11/19.
    Accession Number: 20190911-5118.
    Comments Due: 5 p.m. ET 10/2/19.

    Docket Numbers: ER19-2788-000.
    Applicants: Emera Maine.
    Description: Sec.  205(d) Rate Filing: Interconnection Agreement
with Liberty Utilities (Tinker Transmission) LP to be effective 9/10/
2019.
    Filed Date: 9/11/19.
    Accession Number: 20190911-5130.
    Comments Due: 5 p.m. ET 10/2/19.

    Docket Numbers: ER19-2789-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: PSCo MBR Tariff_EFF 10.31.19
to be effective 10/31/2019.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5037.
    Comments Due: 5 p.m. ET 10/3/19.

    Docket Numbers: ER19-2790-000.
    Applicants: LSP-Whitewater Limited Partnership.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 11/12/2019.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5075.
    Comments Due: 5 p.m. ET 10/3/19.

    Docket Numbers: ER19-2791-000.
    Applicants: Midcontinent Independent System Operator, Inc., Otter
Tail Power Company.
    Description: Sec.  205(d) Rate Filing: 2019-09-12_SA 3349 OTP-Deuel
Harvest Wind FSA (J526) to be effective 11/12/2019.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5074.
    Comments Due: 5 p.m. ET 10/3/19.

    Docket Numbers: ER19-2792-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA SA No. 5472;
Queue No AC1-204 and Cancellation of IISA No. 5373 to be effective 8/
13/2019.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5076.
    Comments Due: 5 p.m. ET 10/3/19.

    Docket Numbers: ER19-2793-000.
    Applicants: Northern States Power Company, a Minnesota corporation,

Northern States Power Company, a Wisconsin corporation.
    Description: Sec.  205(d) Rate Filing: 20190912_MBR_Tariff_Update
to be effective 10/31/2019.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5077.
    Comments Due: 5 p.m. ET 10/3/19.

    Docket Numbers: ER19-2794-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Certificate of Concurrence
PacifiCorp WIUFMP to be effective 10/9/2019.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5059.
    Comments Due: 5 p.m. ET 10/3/19.

    Docket Numbers: ER19-2795-000.
    Applicants: Midcontinent Independent System Operator, Inc., Otter
Tail Power Company.
    Description: Sec.  205(d) Rate Filing: 2019-09-12_SA 3350 OTP-Deuel
Harvest Wind FSA (J526) Ortonville-Morris to be effective 11/12/2019.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5063.
    Comments Due: 5 p.m. ET 10/3/19.

    Docket Numbers: ER19-2796-000.
    Applicants: American Transmission Systems, Incorporated, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: ATSI submits Amended and
Restated IA SA No. 4240 to be effective 11/11/2019.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5088.
    Comments Due: 5 p.m. ET 10/3/19.

    Docket Numbers: ER19-2797-000.
    Applicants: Midcontinent Independent System Operator, Inc., Otter
Tail Power Company.
    Description: Sec.  205(d) Rate Filing: 2019-09-12_SA 3351 OTP-
Flying Cow Wind FSA (J493) Ortonville-Morris to be effective 11/12/
2019.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5092.
    Comments Due: 5 p.m. ET 10/3/19.

    Docket Numbers: ER19-2798-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-09-12_SA 3347 NSP-
Nobles 2 Power Partners GIA (J512) to be effective 8/28/2019.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5095.
    Comments Due: 5 p.m. ET 10/3/19.

    Docket Numbers: ER19-2799-000.
    Applicants: Southwestern Public Service Company.
    Description: Sec.  205(d) Rate Filing: 2019-09-12_MBR_Tariff_Update
to be effective 10/31/2019.
    Filed Date: 9/12/19.
    Accession Number: 20190912-5113.
    Comments Due: 5 p.m. ET 10/3/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 12, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-20257 Filed 9-18-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: September 23, 2008 (Volume 73, Number 185)]
[Notices]
[Page 54877-54878]
[DOCID:fr23se08-120]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Ragen Corp. Rainwire Partners, Inc., Rako
Capital Corp., Ramtek Corp. (n/k/a Ramtek I Corp.), Ranger Industries,
Inc., RCS Holdings, Inc., and Recycling Industries, Inc., Respondents.;
Order of Suspension of Trading

September 19, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Ragen Corp. because it has not filed any periodic reports since the
period ended June 30, 1993.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Rainwire Partners, Inc. because it has not filed any periodic reports
since the period ended March 31, 2003.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Rako Capital Corp. because it has not filed any periodic reports since
the period ended March 31, 2003.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Ramtek Corp. (n/k/a Ramtek I Corp.) because it has not filed any
periodic reports since April 2, 1993.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Ranger Industries, Inc. because it has not filed

any periodic reports since September 30, 2003.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
RCS Holdings, Inc. because it has not filed any periodic reports since
January 31, 2002.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Recycling Industries, Inc. because it has not filed any periodic
reports since December 31, 1998.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed companies is suspended for the period from 9:30 a.m. EDT
on September 19, 2008, through 11:59 p.m. EDT on October 2, 2008.

    By the Commission.
J. Lynn Taylor,
Assistant Secretary.
[FR Doc. E8-22380 Filed 9-19-08; 4:15 pm]

BILLING CODE 8010-01-P


[Federal Register Volume 79, Number 158 (Friday, August 15, 2014)]
[Notices]
[Pages 48170-48172]
[FR Doc No: 2014-19360]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1279]

Pilot Program for Qualification of Medical Device Development
Tools

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is soliciting proposals
to participate in a pilot program for Medical Device Development Tools
(MDDT) qualification (MDDT Pilot Program). Under the MDDT Pilot
Program, FDA intends to work together with developers of tools that
meet the criteria for the proposed program, to determine whether
certain tools may be developed and qualified in order to facilitate
more predictable, efficient, and transparent regulatory evaluation when
MDDTs are used to generate valid scientific evidence for medical device
premarket applications.

DATES: FDA will begin accepting nominations for participation in the
voluntary MDDT Pilot Program September 15, 2014.

FOR FURTHER INFORMATION CONTACT: Joan Adams-White, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3650, Silver Spring, MD 20993-0002, 301-
796-5421<EMAIL_ADDRESS>or Kathryn O'Callaghan,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3614, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 14, 2013 (78 FR 68459), the
Food and Drug Administration (FDA) announced the availability of the
draft guidance entitled ``Medical Device Development Tools'' (http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm374427.htm) (MDDT draft guidance). When finalized,
the draft guidance will represent FDA's current thinking on
qualification of MDDTs for use in device development and evaluation.
The proposed MDDT qualification process is intended to support the
development of MDDTs--tools that manufacturers and FDA use to assess
and measure the performance,

safety, and effectiveness of medical devices. MDDT tools qualified by
FDA can then be relied upon by the medical device industry in support
of their device submissions to the Agency, potentially reducing time
and other resources needed to develop new products. This proposed
voluntary qualification process is intended to enable submitters of
MDDT proposals chosen for this pilot program to work closely with FDA
to determine the amount and type of evidence and other information
needed to support qualification for a specific tool and context of use.
    The anticipated benefits of the proposed MDDT qualification process
include facilitating timely development of tools that manufacturers and
FDA use to assess and measure the performance, safety, and
effectiveness of medical devices. FDA expects that manufacturers can
better rely on MDDTs that have been FDA reviewed and accepted
(qualified), and made available through this voluntary program, which
supports innovative medical device development and promotes regulatory
science. The proposed MDDT qualification process supports the FDA's
plan to advance regulatory science--the science of developing new
tools, methods and approaches to assess the safety, effectiveness,
performance, and quality of medical devices. Advancements in regulatory
science help to bridge the gap between research and discovery of
medical devices and the actual delivery of the device to patients. The
proposed qualification process also supports FDA's strategic priority
of strengthening the clinical trial enterprise by potentially
increasing the efficiency of the clinical studies. Finally, this
proposed qualification process supports FDA's strategic priority
actions to strike the right balance between premarket and postmarket
data collection, leading to earlier access to beneficial innovative
technologies for patients in the United States. For example, an MDDT
qualified for use as an intermediate or surrogate endpoint could
facilitate more efficient development and evaluation of devices,
especially for those intended to address unmet medical needs.
    FDA is proposing a new voluntary MDDT Pilot Program. Information
learned and experiences gained from the MDDT Pilot Program will help
inform the final guidance document and processes. FDA plans to
prioritize proposals based on public health need or potential to impact
multiple device development programs. Additionally, for the purposes of
the pilot, proposals are expected to be prioritized based on
feasibility, timeline, and FDA resources. See section II.B. Appropriate
Candidates, for details.

II. MDDT Pilot Program

    FDA has developed a pilot program for interested tool developers.
This document outlines: (1) The guiding principles underlying the MDDT
Pilot Program, (2) appropriate candidates for the MDDT Pilot Program,
and (3) the procedures FDA intends to follow in the MDDT Pilot Program.

A. Guiding Principles

    The following basic principles underlie the MDDT Pilot Program
described in this document. FDA intends that these principles create a
common understanding between the submitter and FDA about the goals and
parameters of the MDDT Pilot Program:
    1. For qualified MDDTs, FDA intends to make public the context of
use, summary of evidence, and basis of the qualification determination
(analogous to summaries of approved devices). FDA will keep proprietary
information confidential. Submitters must consent to make MDDTs
accessible to the public for use (e.g. through sales, open source,
etc.), and not restrict to certain private entities, such as a single
manufacturer.
    2. FDA and the MDDT Pilot Program places no requirements on
licensing/cost/degree of access to intellectual property associated
with a tool, nor does it consider restrictions related to patent
claims. An MDDT submitter may include and protect proprietary methods
as long as access to the tool is not restricted to certain private
entities.
    3. Participating in this MDDT Pilot Program does not guarantee
qualification of an MDDT, nor is a submitter precluded from withdrawing
from the MDDT Pilot Program.
    4. Due to FDA resource constraints, FDA intends to limit the MDDT
Pilot Program to no more than 15 candidates.

B. Appropriate Candidates

    The process for MDDT qualification can be initiated in one of three
ways: (1) A tool developer chooses to pursue qualification for his or
her tool to allow for use across multiple device development programs;
(2) need and interest in an area is determined by individual or
consortia of stakeholders (may include academia, industry, medical
societies); or (3) FDA identifies an area of need and calls for
development of tools in a specific area.
    Appropriate candidates for the MDDT Pilot Program are:
    1. Tools which fit into one of the following categories:
     Clinical Outcome Assessments such as patient-reported
outcomes or clinical outcomes based on clearly defined subjective
clinical decision making as a measure of treatment benefit;
     Biomarker Tests such as in vitro laboratory tests or
medical imaging methods, or other objective measurement methods used to
detect or measure a biomarker; or
     Nonclinical Assessment Models such as in vitro (``bench'')
models, animal models, or computer models to measure a parameter of
interest or to substitute for another generally accepted test or
instrument.
    2. Tools which address the following factors:
     Public health need met by one or more of the following:
    [cir] Context of use includes life-threatening or serious chronic
diseases/conditions, or both;
    [cir] No/poor alternatives or unmet scientific need;
    [cir] Innovative technology with no established paradigm for
regulatory assessment; or
    [cir] Gain major efficiencies in device development and evaluation
time.
     Scope of impact:
    [cir] Potential to impact multiple device development programs; or
    [cir] Potential to impact multiple device sponsors.
    3. FDA intends to prioritize candidates for the pilot program based
on the following factors:
     Tool readiness: Does the tool exist in prototype or final
form?
     Acceptance of proposed context of use: Does available
information support acceptance of the tool principle/method of
measurement for the proposed context of use, or for any use?
     Timeline: What is the expected timeline to submission of a
qualification package?
     Potential for public health impact: Does the tool address
an unmet public health need or significantly reduce product development
timelines, or both?
    FDA encourages any interested developers who believe their tool is
an appropriate candidate for the MDDT Pilot Program to contact FDA
before initiating the procedures referenced under the following section
titled ``Procedures.''

C. Procedures

    FDA has developed the following procedures to ensure adequate
information to assess a candidate's suitability for the MDDT Pilot
Program is provided to FDA without creating a burdensome new
application process:
    1. Nomination. The submitter may nominate his or her tool for

participation in the MDDT Pilot Program by submitting a proposal to
<EMAIL_ADDRESS>FDA intends to acknowledge receipt of nominations via
email.
    A submitter's proposal for the MDDT Pilot Program should include
the following information to assist FDA in processing and responding to
nominations:
     A cover letter and a brief statement explaining why the
tool is an appropriate candidate for the MDDT Pilot Program as
described under section II., B. Appropriate Candidates; and
     A description of the tool, the proposed context of use, a
synopsis of the available evidence and plans for additional evidence
gathering, and an assessment of the advantages or disadvantages related
to the capabilities and limitations of the tool for the proposed
context of use.
    2. Submitter Notification. FDA intends to notify the submitter via
email whether or not the tool is an appropriate candidate for the MDDT
Pilot Program within approximately 30 days of receipt of the complete
information.
    3. Pre-qualification Plan. If the nominee is deemed an appropriate
candidate, the submitter will be notified by FDA and invited to submit
a pre-qualification plan within approximately 30 days of being notified
by the FDA that its nominee was accepted. One way to present the pre-
qualification plan is included in Appendix 1 of the MDDT draft
guidance. FDA recommends the pre-qualification and qualification plans
be submitted in accordance with FDA guidance entitled ``Medical
Devices: Pre-Submission Program and Meetings with FDA Staff''
(www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf) as the process for the MDDT pilot
program is expected to be modeled after the Pre-Submission Program.
    4. Pre-qualification Meeting. FDA intends to meet with the
submitter, either in person or by phone, in accordance with the process
outlined in the FDA guidance on ``Medical Devices: Pre-Submission
Programs and Meetings With FDA Staff.'' The qualification review team
(which may include FDA as well as external expertise, where
appropriate) will interact with the submitter to identify the amount
and type of data or information needed for qualification of the tool
for the proposed context of use.
    5. FDA Review. Under the MDDT Pilot Program, the Agency intends to
work interactively with submitters as follows:
     Where appropriate, FDA may seek input from external
individuals or groups for specific expertise, consistent with all
applicable statutory and regulatory requirements, including those
respecting confidentiality.
     During the process for MDDT qualification, FDA intends to
interact with submitters to efficiently determine the amount and type
of information needed to support qualification for a specific tool and
context of use, and as needed for clarification or to request
additional information.
     When the submitter has the data and information necessary
for a complete qualification package, they may submit it to justify
qualification of the tool for the proposed context of use. FDA intends
to hold a qualification meeting or teleconference to facilitate
discussion once the package has been reviewed.

D. Duration of the MDDT Pilot Program

    FDA intends to accept requests for participation in the MDDT Pilot
Program until such time that the MDDT draft guidance is finalized. FDA
may decide to terminate the MDDT Pilot Program at any time or extend
the MDDT Pilot Program. The decision to terminate or extend the MDDT
Pilot Program will be announced in the Federal Register. FDA may also
decide to modify the MDDT Pilot Program while it is in effect. Any
significant modifications will also be announced in the Federal
Register.

E. Evaluation

    FDA intends to use the experience gained from the MDDT Pilot
Program to inform the final version of the MDDT guidance and processes.

III. Paperwork Reduction Act of 1995

    This notice contains information collection that is subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in 21 CFR part 812 have been approved under OMB control
number 0910-0078 (Investigative Device Exemption); the collections of
information in 21 CFR part 814 have been approved under OMB control
number 0910-0231 (Premarket Approval); the collections of information
in 21 CFR part 807, subpart E have been approved under OMB control
number 0910-0120 (Premarket Notification); and the collections of
information in 21 CFR part 809 have been approved under OMB control
number 0910-0485.

    Dated: August 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19360 Filed 8-14-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34429-34431]
[FR Doc No: 2012-14074]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67134; File No. SR-C2-2012-018]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated:
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Regarding the Approval of Trading Permit Holders

June 5, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of
1934, 15 U.S.C. 78s(b)(1), notice is hereby given that on June 5, 2012,
C2 Options Exchange, Incorporated (``C2'' or the ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by C2. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.

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

    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (the ``Act''),\1\ the Exchange proposes to
temporarily suspend the requirements of C2 Rule 3.1 and related C2
rules concerning the approval of new Permit Holders in order to approve
Apex Clearing, Inc., f/k/a Ridge Clearing and Outsourcing Solutions,
Inc. (``Apex Clearing'') as a C2 Permit Holder, subject to Apex
Clearing complying with Exchange rules for a new Permit Holder within
30 calendar days of the date that Apex Clearing is provisionally
approved as a C2 Permit Holder. The Exchange is also proposing to
accept Apex Clearing's assumption of all of the existing clearing
agreements and arrangements currently in effect between Penson
Financial Services Inc. (``PFSI'') and various other C2 Permit Holders
by execution of a global agreement thereto. The text of the proposed
rule change is available on the Exchange's Web site (http://www.C2exchange.com), at the Exchange's Office of the Secretary and at
the Commission.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

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

    In its filing with the Commission, C2 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. C2 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 this rule filing to temporarily suspend the
requirements of C2 Rule 3.1 and related rules regarding the approval of
Permit Holders in order to immediately approve Apex Clearing as a C2
Permit Holder. The Exchange proposes this temporary suspension on an
emergency basis to ensure that Apex Clearing can continue the clearing
operations of PFSI without unnecessary disruption, which could have a
significant collateral impact to a number of other Permit Holders. The
proposed temporary suspension is contingent upon Apex having complied
with all new Permit Holder Exchange rules within 30 calendar days of
the date Apex is provisionally approved as a C2 Permit Holder pursuant
to this filing.
    On May 31, 2012, Apex Clearing Holdings, LLC (``Apex Holdings''),
Apex Clearing Solutions, LLC, Broadridge Financial Solutions, Inc.
(``Broadridge''), PFSI and Penson Worldwide, Inc. (``PWI'') (together,
the ``Parties'') consummated a transaction resulting in a change in
ownership of Apex Clearing.\2\ Broadridge, Apex Holdings, PWI and PFSI
each made capital investments in Apex Holdings, the holding company
parent of Apex Clearing. PFSI also assigned all of its U.S. clearing
contracts and all customer and introducing broker proprietary

accounts along with key personnel to Apex Clearing (the ``Transferring
Accounts'').\3\
---------------------------------------------------------------------------

    \2\ Prior to the Transaction, Apex Clearing's name was Ridge
Clearing & Outsourcing Solutions, Inc. Prior to the transaction,
Ridge Clearing & Outsourcing Solutions, Inc. contributed its
outsourcing operations and all associated personnel and systems to
its affiliated entity, Broadridge Securities Processing Solutions,
LLC (``BSPS'') where it will continue to provide operations support
and outsourcing services to a number of broker-dealers, including
Apex Clearing.
    \3\ See Penson Worldwide, Inc. Form 8-K dated May 31, 2012.
---------------------------------------------------------------------------

    As a result of the transaction, Apex Clearing, which is not a C2
Permit Holder, will provide the clearing and execution services
currently provided to the Transferring Accounts by PFSI. On May 31,
2012, Apex Clearing submitted an application for approval as a C2
Permit Holder. However, because of the expedited nature of the
transaction, Apex Clearing was unable to fully comply with C2 Rule 3.1
and related new Permit Holder rules. Because of the need for seamless
continuity with respect to the Transferring Accounts, Apex Clearing has
requested that the Exchange temporarily suspend its rules applicable to
new Permit Holders in order to enable Apex Clearing's approval as a
Permit Holder on an expedited basis. Pursuant to its request, Apex
Clearing will fully comply with the Exchange's new Permit Holder
requirements within 30 calendar days after the provisional approval.
    C2 Rule 3.1 sets forth the application process for becoming a C2
Permit Holder, including the requirements for Trading Permit Holders at
the Chicago Board Options Exchange, Incorporated (``CBOE''). A CBOE
Trading Permit Holder in good standing is eligible to receive one
Trading Permit. CBOE Trading Permit Holder applicants are not required
to complete and submit an Exchange application but are instead required
to complete and submit only Exchange forms concerning electing to trade
on the Exchange, submitting to Exchange jurisdiction and operational
matters need to be completed and tendered.
    C2 Rule 3.1 requires non-CBOE Trading Permit Holders to submit,
among other things, (i) an application in accordance with such
procedures as shall be established by the Exchange and (ii) any
additional information requested by the Exchange in connection with the
Exchange's review of the application. The Exchange may approve an
application submitted pursuant to C2 Rule 3.1 only if any investigation
has been completed, and any applicable orientation and/or exam
requirements established by the Exchange have been satisfied.
    In addition, the Exchange reviews whether the applicant meets
federal and C2 capital requirements and whether it has adopted controls
and procedures to comply with Exchange rules.
    Due to the amount of information an applicant is required to
provide and have completed prior to being approved as a Permit Holder,
the Permit Holder approval process generally takes several weeks to
complete. The length of time varies based on the timing of the
applicant's response to requests for information and documentation.
    As proposed, Apex Clearing will continue the clearing and certain
other operations of PFSI as of June 6, 2012. In order to avoid
interruption of the services PFSI currently provides to other Exchange
Permit Holders, C2 believes that Apex Clearing should be approved
immediately as a C2 Permit Holder. The Exchange notes that Apex
Clearing is already a registered broker dealer and FINRA member.
    The Exchange therefore proposes providing Apex Clearing with a
temporary suspension of C2 Rule 3.1 and any additional rules as they
relate to approval to operate a C2 Permit Holder and approval of a
proposed Permit Holder's associated persons (as applicable), and
immediately approve Apex as a Permit Holder. As proposed this temporary
suspension is contingent upon:
     Apex providing the Exchange with sufficient information to
confirm that Apex will meet its capital requirements as a C2 Permit
Holder; and
     Within 30 calendar days of Apex Clearing's provisional
approval as a C2 Permit Holder under this proposed filing, Apex
Clearing and its approved persons will have complied with the
Exchange's requirements for new Permit Holders as set forth in C2 Rule
3.1 and any additional rules related to the approval to operate a C2
Permit Holder and approval of a proposed Permit Holder's associated
persons (as applicable).
    As proposed, if Apex Clearing does not comply with all applicable
C2 Permit Holder application requirements within 30 calendar days of
the date of the provisional approval, its status as an approved C2
Permit Holder will no longer be effective.
    In addition, the Exchange proposes to permit Apex Clearing to
assume all existing clearing agreements and arrangements currently in
effect with other C2 Permit Holders by execution of global agreements
thereto. Notice of such assumption will be provided to impacted Trading
Permit Holders through issuance of an Information Circular prior to the
effective date thereof.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) \4\ of the Securities Exchange Act of 1934 (the ``Act''),
in general, and furthers the objectives of Section 6(b)(5) \5\ in
particular in that it is designed to promote just and equitable
principles of trade, to prevent fraudulent and manipulative acts, to
remove impediments to and to perfect the mechanism for a free and open
market and a national market system and, in general, to protect
investors and the public interest. The Exchange believes that
permitting the expeditious approval of Apex Clearing as a C2 Permit
Holder will avoid interruption of the services PFSI currently provides
to other Exchange Permit Holders. Based on information and
representations provided by Apex Clearing, a temporary suspension of
certain C2 rules related to the approval of a Permit Holder is needed
based on the expedited nature of the transaction to enable seamless
continuity with respect to the transferring accounts. Consequently, C2
believes that temporary suspension of these requirements so that Apex
can be approved immediately as a C2 Permit Holder will help to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities and is consistent with the Act.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    C2 does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \6\ and Rule 19b-4(f)(6) thereunder.\7\
Because the 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 prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if

consistent with the protection of investors and the public interest,
the proposed rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6)(iii) thereunder.\9\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \7\ 17 CFR 240.19b-4(f)(6).
    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6)(iii). 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 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 Commission is waiving this five-day pre-filing
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \10\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\11\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the five-day pre-
filing requirement and the 30-day operative delay so that the proposed
rule change may become operative immediately upon filing. The
Commission notes that the Exchange is proposing that certain of its
rules relating to membership requirements be temporarily suspended so
that Apex Clearing can be provisionally approved as a C2 Trading Permit
Holder. The proposed relief does not exempt Apex Clearing from Exchange
rule requirements governing C2 Trading Permit Holders. Apex Clearing
would have a 30 calendar day grace period within which to apply for and
be approved under relevant Exchange rules. Moreover, the Commission
believes that waiver of the 30-day operative delay is appropriate to
ensure a smooth transition of PFSI operations to Apex Clearing. In
particular, given the rapidity with which events have developed, waiver
of the 30-day operative delay is necessary to avoid significant
disruption to PFSI's existing customers and the market generally.
Therefore, the Commission believes that waiving the 30-day operative
delay is consistent with the protection of investors and the public
interest and designates the proposed rule change as operative upon
filing.\12\
---------------------------------------------------------------------------

    \12\ For purposes only of waiving the 30-day operative delay,
the Commission 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 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-C2-2012-018 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-C2-2012-018. 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 Web site (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 Web site 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-C2-2012-018 and should be
submitted on or before July 2, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-14074 Filed 6-8-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: September 16, 2009 (Volume 74, Number 178)]
[Notices]
[Page 47630-47631]
[DOCID:fr16se09-98]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60645; File No. SR-FINRA-2009-039]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Order Approving Proposed Rule Change To Adopt FINRA
Rule 3310 (Anti-Money Laundering Compliance Program) in the
Consolidated FINRA Rulebook

September 10, 2009.

I. Introduction

    On June 1, 2009, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') (f/k/a National Association of Securities Dealers, Inc.
(``NASD'')) filed with the Securities and Exchange Commission (``SEC''
or ``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to adopt FINRA Rule 3310 (Anti-
Money Laundering (``AML'') Compliance Program). The Commission
published the proposed rule change for comment in the Federal Register
on June 22, 2009.\3\ The comment period expired on July 13, 2009. The
Commission received seven comments in response to the proposed rule
change.\4\ On July 29, 2009, FINRA responded to the comments.\5\ This
order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 60112 (June 15,
2009), 74 FR 29527 (June 22, 2009).
    \4\ See Letters from Deborah M. Castiglioni, CEO, Cutter &
Company, Inc., dated July 9, 2009 (``Cutter''); Larry Dorn, Owner/
President/AML Officer/Financial Principal, Dorn & Co., Inc., dated
July 16, 2009 (``Dorn''); Joe Giordano, President, Joseph James
Financial Services, Inc., dated July 14, 2009 (``Joseph James''); S.
Lauren Heyne, Chief Compliance Officer, RW Smith & Associates, Inc.,
dated July 13, 2009 (``RW Smith''); Judy L. Loy, CEO, Nestlerode &
Loy Inc., dated July 8, 2009 (``Nestlerode''); William R. Pictor,
CEO, Trubee Collins Co., Inc., dated July 10, 2009 (``Trubee
Collins''); Terri F. Rumans, Chief Compliance Officer, Sage Rutty
Co., Inc., dated July 13, 2009 (``Sage Rutty''). Unless otherwise
indicated, all letters cited in this order were addressed to either
Florence Harmon, Deputy Secretary of the Commission or Elizabeth M.
Murphy, Secretary of the Commission.
    \5\ See Letter from Patricia Albrecht, Assistant General
Counsel, FINRA, dated July 29, 2009 (``FINRA's Response'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    FINRA proposed to adopt: (1) NASD Rule 3011 (AML Compliance
Program) as FINRA Rule 3310 (AML Compliance Program), without
substantive change; (2) NASD IM-3011-1 (Independent Testing
Requirements) as supplementary material to proposed FINRA Rule 3310,
subject to certain amendments; and (3) NASD IM-3011-2 (Review of AML
Compliance Person Information) as supplementary material to proposed
FINRA Rule 3310, without substantive change. The proposed rule change
would delete Incorporated NYSE Rule 445 (AML Compliance Program) in its
entirety as duplicative.

A. Background

    NASD Rule 3011 (AML Compliance Program) and Incorporated NYSE Rule
445 (AML Compliance Program) are substantially similar rules requiring
members to develop and implement a written AML program reasonably
designed to achieve and monitor compliance with the requirements of the
Bank Secrecy Act (``BSA'') \6\ and the implementing regulations
promulgated by the Department of the Treasury. Each member's AML
compliance program must be approved, in writing, by a member of senior
management.
---------------------------------------------------------------------------

    \6\ See Currency and Foreign Transactions Reporting Act of 1970
(commonly referred to as the Bank Secrecy Act), 12 U.S.C. 1829b, 12
U.S.C. 1951-1959, and 31 U.S.C. 5311-5330).
---------------------------------------------------------------------------

    Both NASD 3011 and NYSE 445 require that each AML compliance
program must, at a minimum: (1) Establish and implement policies and
procedures that can be reasonably expected to detect and cause the
reporting of suspicious transactions; (2) establish and implement
policies, procedures, and internal controls reasonably designed to
achieve compliance with the BSA and its implementing regulations; (3)
provide for annual (on a calendar-year basis) independent testing for
compliance to be conducted by member personnel or a qualified outside
party; \7\ (4) designate and identify to FINRA an individual or
individuals (i.e., AML compliance person(s)) who will be responsible
for implementing and monitoring the day-to-day operations and internal
controls of the AML compliance program and provide prompt notification
to FINRA of any changes to the designation; and (5) provide on-going
training for appropriate persons.
---------------------------------------------------------------------------

    \7\ NASD Rule 3011 permits a member to conduct the independent
testing every two years (on a calendar-year basis) if it does not
execute transactions for customers or otherwise hold customer
accounts or act as an introducing broker with respect to customer
accounts (e.g., engages solely in proprietary trading, or conducts
business only with other broker-dealers). Incorporated NYSE Rule 445
uses slightly different terminology to achieve the same result,
specifically providing that a member may conduct independent testing
every two years (on a calendar-year basis) if it ``does not engage
in a public business (e.g., engages solely in proprietary trading,
or conducts business only with other broker-dealers).''
---------------------------------------------------------------------------

    NASD IM-3011-1 (Independent Testing Requirements) and the
supplementary material to Incorporated NYSE Rule 445 also contain
substantially similar provisions clarifying that: (1) Members should
undertake more frequent testing than required if circumstances warrant;
(2) the person conducting the independent test must have a working
knowledge of applicable requirements under the BSA and its implementing
regulations; and (3) the testing cannot be conducted by the AML
compliance person(s), by any person who performs the functions being
tested, or by any person who reports to any of these persons.
    NASD IM-3011-1, however, permits the AML compliance program testing
to be conducted by persons who report to either the AML compliance
person or persons performing the functions being tested if: (1) The
member has no other qualified internal personnel to conduct the test;
(2) the member establishes written policies and procedures to address
conflicts that may arise from allowing the test to be conducted by a
person who reports to the person(s) whose activities he or she is
testing (e.g., anti-retaliation procedures); (3) to the extent
possible, the person conducting the test reports the results of the
test to someone who is senior to the AML compliance person or persons
performing the functions being tested; and (4) the member documents its
rationale, which must be reasonable, for determining there is no other
alternative than to comply in this manner. In addition, if the person
does not report the results consistent with (3) above, the member must
document a reasonable explanation for not doing so. This provision is
referred to as the ``independent testing exception.'' Incorporated NYSE
Rule 445 does not have a comparable provision.
    Finally, NASD IM-3011-2 (Review of AML Compliance Person
Information) requires each member to identify, review, and if
necessary, update the information regarding its AML compliance person
in the manner prescribed in NASD Rule 1160.\8\ This provision is
comparable to SM .03 of NYSE Rule 445.
---------------------------------------------------------------------------

    \8\ FINRA is proposing to replace NASD Rule 1160 with FINRA Rule
4540 (Member Information and Data Reporting and Filing
Requirements). See Regulatory Notice 09-02 (January 2009).
---------------------------------------------------------------------------

B. Proposed FINRA Rule 3310 and Related Supplementary Material

    The proposed rule change would adopt NASD Rule 3011 without

substantive change into the Consolidated FINRA Rulebook as FINRA Rule
3310 (AML Compliance Program). In addition, the proposed rule change
would adopt NASD IM-3011-2, without substantive change, as
supplementary material to proposed FINRA Rule 3310.
    With respect to NASD IM-3011-1, the proposed rule change would
adopt its provisions as supplementary material to proposed FINRA Rule
3310, but would eliminate the independent testing exception. The
Financial Crimes Enforcement Network (``FinCEN''), a bureau within the
Department of the Treasury that is responsible for administering the
BSA and its implementing regulations, has stated that the independent
testing provision of the BSA \9\ precludes AML program testing by
personnel with an interest in the outcome of the testing and that an
independent testing exception, such as the one in NASD IM-3011-1, is
inconsistent with the BSA's independent testing provision and FinCEN's
interpretation of this provision.\10\ Accordingly, consistent with
FinCEN's guidance, FINRA is proposing to eliminate the independent
testing exception in connection with its adoption of proposed FINRA
Rule 3310.
---------------------------------------------------------------------------

    \9\ See 31 U.S.C. 5318(h)(1)(D). See also 31 CFR 103.120 (AML
programs requirements for financial institutions regulated by, among
others, self-regulatory organizations).
    \10\ See Letter from Jamal El-Hindi, Associate Director,
Regulatory Policy & Programs Division, FinCEN, to Nancy M. Morris,
Secretary, SEC (August 22, 2007) (``FinCEN Comment Letter''). FinCEN
submitted the letter to the SEC in response to the NYSE's ``omnibus
filing,'' which sought to achieve greater harmonization between the
NYSE and NASD rules, including the AML compliance program rules (SR-
NYSE-2007-22). See Securities Exchange Act Release No. 56142 (July
16, 2007), 72 FR 42195 (August 1, 2007).
---------------------------------------------------------------------------

    Finally, as stated previously, the proposed rule change would
delete Incorporated NYSE Rule 445 and its related supplementary
material in their entirety as duplicative. FINRA will announce the
implementation date of the proposed rule change in a Regulatory Notice
to be published no later than 90 days following Commission approval.

III. Comment Letters

    Seven commenters raised objections to the elimination of the
independent testing exception.\11\ Three commenters expressed their
view that the exception was being eliminated to address a problem that
has not been shown to exist.\12\ These commenters also took exception
with FinCEN's view that the independent testing exception was
inconsistent with the requirements of the BSA.\13\ Commenters also
expressed concern that elimination of the independent testing exception
would require small firms to incur additional expenses.\14\ Some
commenters also suggested that FINRA should seek additional member
comment on the proposed elimination of the independent testing
exception.\15\ In responding to the comments, FINRA stated that it was
proposing to eliminate the independent testing exception to be
consistent with FinCEN's views regarding the BSA's independent testing
requirements.\16\
---------------------------------------------------------------------------

    \11\ See supra note 4.
    \12\ Cutter, Dorn, and Nestlerode.
    \13\ Id. The commenters asserted that employees of a small
broker-dealer have an interest in bringing problems to light, not
ignoring them.
    \14\ Cutter, Dorn, Joseph James, RW Smith, Sage Rutty, and
Trubee Collins.
    \15\ Nestlerode, Cutter, RW Smith, and Dorn.
    \16\ See FINRA's Response, supra note 5. See also FinCEN Comment
Letter, supra note 10 and accompanying text.
---------------------------------------------------------------------------

IV. Discussion and Findings

    After a careful review of the proposal, the comments received, and
FINRA's Response, the Commission finds that the proposed rule change is
consistent with the requirements of the Exchange Act and the rules and
regulations thereunder applicable to FINRA.\17\ In particular, the
Commission finds that the proposed rule change is consistent with
Section 15A(b)(6) of the Exchange Act,\18\ which requires, among other
things, that FINRA's rules be designed to prevent fraudulent and
manipulative practices and to promote just and equitable principles of
trade.
---------------------------------------------------------------------------

    \17\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \18\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

    The Commission finds that the proposed rule change is reasonably
designed to accomplish these ends by aligning the independent testing
requirements of proposed FINRA Rule 3310 with FinCEN's interpretation
of the BSA's independent testing requirement. The Commission notes in
particular that FinCEN is responsible for administering the BSA and its
implementing regulations. In light of FinCEN's view that the
independent testing provisions of the BSA preclude AML program testing
by persons with an interest in the outcome of the test, the independent
testing exception in NASD IM-3011-1, is not consistent with the
BSA.\19\
---------------------------------------------------------------------------

    \19\ See FinCEN Comment Letter, supra note 10 and accompanying
text.
---------------------------------------------------------------------------

V. Conclusion

    It is therefore concluded, pursuant to Section 19(b)(2) of the
Exchange Act,\20\ that the proposed rule change (SR-FINRA-2009-039) be,
and hereby is, approved.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
Florence E. Harmon,
Deputy Secretary.
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    \21\ 17 CFR 200.30-3(a)(12).
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[FR Doc. E9-22240 Filed 9-15-09; 8:45 am]

BILLING CODE 8010-01-P