[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Notices]
[Pages 56590-56591]
[FR Doc No: 2014-22460]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

First Annual Neonatal Scientific Workshop--Roadmap for Applying
Regulatory Science to Neonates; Notice of Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
scientific workshop to discuss the roadmap for applying regulatory
science to neonates. This public scientific workshop is being co-
sponsored with the FDA, the Critical Path Institute (C-Path) and the
Burroughs Welcome Fund (BWF).
    The purpose of the public scientific workshop is to initiate
constructive discussion among regulators, researchers, health care
providers, representatives from the pharmaceutical industry and health
care organizations, and the general public to determine whether there
is sufficient interest on the part of stakeholders to develop a
neonatal consortium and to discuss potential working groups dedicated
to the regulatory science required to develop neonatal therapeutics.

DATES: The public scientific workshop will be held on October 28 and
29, 2014, from 8 a.m. to 5 p.m. Section II provides attendance and
registration information.

ADDRESSES: The public scientific workshop will be held at the FDA White
Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center,
the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for
the public scientific workshop participants (non-FDA employees) is
through Building 1 where routine security check procedures will be
performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Indira Hills, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 21, Rm. 4508, Silver Spring, MD 20993, 301-796-
9686, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    C-Path and BWF, in cooperation with FDA and various stakeholders,
including industry, academia, professional organizations, patient
advocacy groups, and other government Agencies, are proposing to
establish the Neonatal Consortium in order to leverage resources and
expertise toward mutually beneficial goals and in the interest of
public health. Some of the potential priorities of the Neonatal
Consortium to be discussed at the public scientific workshop would be
the following:
    1. Developing and qualifying biomarkers, clinical outcome
assessments, and other drug development tools. Valid and reliable
endpoints are presently lacking in neonatal clinical trials.
    2. Developing physiologically-based pharmacokinetic modeling and
simulation to predict on and off target responses to drugs.
    3. Optimizing clinical trial designs for the neonatal population.
One aspect of clinical trial design in neonates is the need for long-
term studies to properly evaluate the effects of an intervention. There
is also interest in examining bioethical questions related to neonatal
care and their solutions.
    4. Maximizing the use of registry data. Such registries may be
useful in long-term studies.
    5. Developing Clinical Data Interchange Standards Consortium data
standards for registry data, electronic health record information, and
clinical trial data.
    6. Building a neonatal database in which standardized data pooled
from industry and academic neonatal trials could reside. Such a
database would be an invaluable resource for the neonatal community.

II. Attendance and Registration

    The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Individuals who
wish to participate in the public scientific workshop (in person or via
web) must register on or before October 20, 2014, by visiting http://www.cvent.com/d/34qr03 and contacting Indira Hills (see FOR FURTHER
INFORMATION CONTACT) or Kerrie Bennymadho, Project Coordinator,
Critical Path Institute,<PHONE_NUMBER>, Cell:<PHONE_NUMBER>,
<EMAIL_ADDRESS>regarding registration. Early registration is
recommended. Registration is free and will be on a first-come, first-
served basis. However, FDA may limit the number of participants from
each organization based on space limitations. Onsite registration on
the day of the public scientific workshop will be based on space
availability. The registration deadline is October 20, 2014.
    FDA will provide additional background information at the time the
Federal Register notice is published and an agenda approximately 2
weeks before the public scientific workshop at FDA Meeting Information
page, which is available online at http://www.fda.gov/Drugs/NewsEvents/ucm410863.htm.
    If you need special accommodations because of disability, please
contact Indira Hills (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the public scientific workshop.
    A live Webcast of this public scientific workshop will be viewable
at Adobe Connect Link: https://collaboration.fda.gov/nsw2014/ on the
day of the public scientific workshop. A video record of the public
scientific workshop will be available at the same Web address for 1
year.

III. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305). A transcript will also be
available in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. Written requests are to be sent to the
Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn

Dr., Element Bldg., Rockville, MD 20857.

    Dated: September 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22460 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 67 (Tuesday, April 8, 2014)]
[Notices]
[Pages 19324-19325]
[FR Doc No: 2014-07807]

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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
rate filings:

    Docket Numbers: ER10-2354-002.
    Applicants: Midway-Sunset Cogeneration Company.
    Description: Notice of Change of Status of Midway Sunset
Cogeneration Company.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5489.
    Comments Due: 5 p.m. ET 4/21/14.

    Docket Numbers: ER10-2645-001; ER10-3050-001; ER10-2831-001; ER10-
3081-006; ER10-1530-002; ER10-3082-003; ER13-2106-002; ER10-1529-002;
ER10-3052-001; ER10-3083-003; ER10-3053-001.
    Applicants: Baconton Power LLC, Cabazon Wind Partners, LLC,
Colorado Green Holdings LLC, Equilon Enterprises LLC, Llano Estacado
Wind, LP, Motiva Enterprises LLC, NedPower Mount Storm LLC, Northern
Iowa Windpower LLC, Rock River I, LLC, Shell Chemical LP, Whitewater
Hill Wind Partners, LLC.
    Description: Notice of Non-Material Change in Status of Baconton
Power LLC, et al.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5522.
    Comments Due: 5 p.m. ET 4/21/14.

    Docket Numbers: ER12-1571-002; ER10-2543-001; ER11-2159-002.
    Applicants: Verso Bucksport LLC, Verso Androscoggin LLC, Verso
Maine Energy LLC.
    Description: Notice of Non-Material Change in Status of the Verso
MBR Companies.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5525.
    Comments Due: 5 p.m. ET 4/21/14.

    Docket Numbers: ER13-1430-001; ER13-1561-001; ER10-2755-002; ER10-
2739-005.
    Applicants: Arlington Valley Solar Energy II, LLC, Centinela Solar
Energy, LLC, Las Vegas Power Company, LLC, LS Power Marketing, LLC.
    Description: Supplement to June 28, 2013 Triennial Market Power
Analysis for the Southwest Region of the LS Power Development, LLC
subsidiaries.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5520.
    Comments Due: 5 p.m. ET 4/21/14.

    Docket Numbers: ER14-1205-001.
    Applicants: Commonwealth Edison Company, Commonwealth Edison
Company of Indiana, Inc., PJM Interconnection, L.L.C.
    Description: ComEd submits compliance filing per 3/19/2014 Order in
ER14-1205 to be effective 3/31/2014.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5446.
    Comments Due: 5 p.m. ET 4/21/14.

    Docket Numbers: ER14-1394-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Errata to Transmittal Letter in Docket No. ER14-1394-
000 to be effective N/A.
    Filed Date: 4/1/14.
    Accession Number: 20140401-5208.
    Comments Due: 5 p.m. ET 4/22/14.

    Docket Numbers: ER14-1610-000.
    Applicants: East Kentucky Power Cooperative, Inc.
    Description: Petition of East Kentucky Power Cooperative for
Limited Waiver of PJM Interconnection, L.L.C. Open Access Transmission
Tariff and Request for Expedited Action.
    Filed Date: 3/28/14.
    Accession Number: 20140328-5322.
    Comments Due: 5 p.m. ET 4/7/14.

    Docket Numbers: ER14-1618-000.
    Applicants: Mega Energy of New England, LLC.
    Description: Mega Energy of New England, LLC submits a notice of
cancellation of its market-based rate tariff.
    Filed Date: 3/31/14.
    Accession Number: 20140331-0001.
    Comments Due: 5 p.m. ET 4/21/14.

    Docket Numbers: ER14-1626-000.
    Applicants: Constellation NewEnergy, Inc.
    Description: Revised Market-Based Rate Tariff to be effective 3/1/
2014.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5435.
    Comments Due: 5 p.m. ET 4/21/14.

    Docket Numbers: ER14-1627-000.
    Applicants: Constellation Energy Commodities Group Maine, LLC.
    Description: Revised Market-Based Rate Tariff to be effective 3/1/
2014.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5442.
    Comments Due: 5 p.m. ET 4/21/14.

    Docket Numbers: ER14-1628-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 2014 Southwestern Power Administration Amendatory
Agreement to be effective 3/1/2014.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5445.
    Comments Due: 5 p.m. ET 4/21/14.

    Docket Numbers: ER14-1629-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Amedment to BART NITSA to be effective 4/1/2014.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5449.
    Comments Due: 5 p.m. ET 4/21/14.

    Docket Numbers: ER14-1630-000.
    Applicants: Mantua Creek Solar, LLC.
    Description: Mantua Creek Solar, LLC Application for Market-Based
Rates to be effective 4/1/2014.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5459.
    Comments Due: 5 p.m. ET 4/21/14.

    Docket Numbers: ER14-1631-000.
    Applicants: Pacific Gas and Electric Company.
    Description: CCSF IA--2014 Annual Adjustment to Traffic Light Costs
to be effective 2/1/2014.
    Filed Date: 4/1/14.
    Accession Number: 20140401-5001.
    Comments Due: 5 p.m. ET 4/22/14.

    Docket Numbers: ER14-1632-000.
    Applicants: Public Service Company of New Mexico.
    Description: Modification of Real Power Loss Factor in OATT to be
effective 6/1/2014.
    Filed Date: 4/1/14.
    Accession Number: 20140401-5109.
    Comments Due: 5 p.m. ET 4/22/14.

    Docket Numbers: ER14-1633-000.
    Applicants: Public Service Company of New Mexico.
    Description: Modification of Real Power Loss Factor GFA to be
effective 6/1/2014.
    Filed Date: 4/1/14.
    Accession Number: 20140401-5110.
    Comments Due: 5 p.m. ET 4/22/14.

    Docket Numbers: ER14-1634-000.
    Applicants: California Independent System Operator Corporation.
    Description: 2014-04-01--TCAAmendment to be effective 6/1/2014.
    Filed Date: 4/1/14.
    Accession Number: 20140401-5192
    Comments Due: 5 p.m. ET 4/22/14.

    Docket Numbers: ER14-1635-000.
    Applicants: PacifiCorp.
    Description: OATT Revised Attachment H-1 (Rev Depreciation Rates
2014) to be effective 6/1/2014.

    Filed Date: 4/1/14.
    Accession Number: 20140401-5215.
    Comments Due: 5 p.m. ET 4/22/14.

    Docket Numbers: ER14-1636-000.
    Applicants: Otter Tail Power Company.
    Description: Revisions to Market-Based Rate Tariff to Clarify
Category Status to be effective 6/1/2014.
    Filed Date: 4/1/14.
    Accession Number: 20140401-5248.
    Comments Due: 5 p.m. ET 4/22/14.

    Docket Numbers: ER14-1637-000.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado 2013 Production
Formula Rate Charges and Transmission Formula Rate Charges for Post-
Retirement Benefits Other than Pensions.
    Filed Date: 4/1/14.
    Accession Number: 20140401-5254.
    Comments Due: 5 p.m. ET 4/22/14.

    Docket Numbers: ER14-1638-000.
    Applicants: New England Power Pool Participants Committee.
    Description: April 2014 Membership Filing to be effective 3/1/2014.
    Filed Date: 4/1/14.
    Accession Number: 20140401-5262.
    Comments Due: 5 p.m. ET 4/22/14.

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

    Docket Numbers: ES14-32-000.
    Applicants: American Transmission Company LLC, ATC Management Inc.
    Description: Application under Section 204 of the Federal Power Act
for Authorization to Issue Securities of American Transmission Company
LLC, et. al.
    Filed Date: 4/1/14.
    Accession Number: 20140401-5154.
    Comments Due: 5 p.m. ET 4/22/14.

    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: April 1, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-07807 Filed 4-7-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 25 (Tuesday, February 7, 2012)]
[Proposed Rules]
[Pages 6026-6027]
[FR Doc No: 2012-2761]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-1181; Airspace Docket No. 11-ANM-20]

Proposed Amendment of Class E Airspace; Boise, ID

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace at Boise Air
Terminal (Gowen Field), Boise, ID. Decommissioning of the Donnelly
Tactical Air Navigation System (TACAN) has made this action necessary
for the safety and management of Instrument Flight Rules (IFR)
operations at the airport. This action also would adjust the geographic
coordinates of the airport.

DATES: Comments must be received on or before March 23, 2012.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2011-
1181; Airspace Docket No. 11-ANM-20, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

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 (FAA Docket No.
FAA 2011-1181 and Airspace Docket No. 11-ANM-20) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2011-1181 and Airspace Docket No. 11-ANM-20''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. 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/airports_airtraffic/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 a.m. and 5 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by amending Class E airspace extending
upward from 700 feet above the surface at Boise Air Terminal (Gowen
Field), Boise, ID. Airspace reconfiguration is necessary due to the
decommissioning of the Donnelly TACAN. The geographic coordinates of
the airport would be adjusted in accordance with the FAA's aeronautical
database. Controlled airspace is necessary for the safety and
management of IFR operations at the airport.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9V, dated August 9, 2011, and effective September 15,
2011, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (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 this proposed 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.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes
the authority for 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 the 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 controlled airspace at Boise Air Terminal
(Gowen Field), Boise, ID.

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ANM ID E5 Boise, ID [Amended]

Boise Air Terminal (Gowen Field), ID
    (Lat. 43[deg]33'52'' N., long. 116[deg]13'22'' W.)

    That airspace extending upward from 700 feet above the surface
bounded by a line beginning at lat. 43[deg]56'00'' N., long.
116[deg]33'04'' W.; to lat. 43[deg]51'15'' N., long. 116[deg]25'03''
W., thence via the 18.8-mile radius of the Boise Air Terminal (Gowen
Field), clockwise to long. 116[deg]14'03'' W.; to lat.
43[deg]45'00'' N., long. 116[deg]14'03'' W.; to lat. 43[deg]31'00''
N., long. 115[deg]52'03'' W.; to lat. 43[deg]20'00'' N., long.
115[deg]58'03'' W.; to lat. 43[deg]25'00'' N., long. 116[deg]25'03''
W.; to lat. 43[deg]27'00'' N., long. 116[deg]29'03'' W.; to lat.
43[deg]25'12'' N., long. 116[deg]32'23'' W.; to lat. 43[deg]29'25''
N., long. 116[deg]37'53'' W.; to lat. 43[deg]32'45'' N., long.
116[deg]49'04'' W.; to lat. 43[deg]37'35'' N., long. 116[deg]47'04''
W.; to lat. 43[deg]42'00'' N., long. 116[deg]57'04'' W., thence to
the point of beginning; that airspace extending upward from 1,200
feet above the surface within the 30.5-mile radius of the airport
beginning at the 122[deg] bearing of the airport, thence via a line
to the intersection of the 34.8-mile radius of the airport and the
224[deg] bearing of the airport, thence clockwise along the 34.8-
mile radius of the airport to that airspace 7 miles each side of the
269[deg] bearing of the airport extending from the 34.8-mile radius
to 49.6 miles west of the airport, and within 7 miles northeast and
9.6 miles southwest of the 295[deg] bearing of the airport extending
from the 34.8-mile radius to 65.3 miles northwest of the airport, to
lat. 44[deg]00'27'' N., long. 117[deg]10'58'' W., thence along the
223[deg] bearing to V-253, thence south along V-253, thence along
the 30.5-mile radius of the airport to the point of beginning; that
airspace southeast of the airport extending upward from 9,000 feet
MSL bounded on the north by V-444, on the east by V-293, on the
south by V-330 and on the southwest by V-4; that airspace northeast
of the airport extending upward from 11,500 feet MSL, bounded on the
northeast by V-293, on the south by V-444, on the southwest by the
30.5-mile radius of the airport and on the west by V-253.

    Issued in Seattle, Washington, on January 27, 2012.
Robert Henry,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2012-2761 Filed 2-6-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Notices]
[Pages 7130-7131]
[FR Doc No: 2023-02337]

=======================================================================
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UNIFIED CARRIER REGISTRATION PLAN

Sunshine Act Meetings

TIME AND DATE: February 9, 2023, 12:00 p.m. to 3:00 p.m., Eastern time.

PLACE: This meeting will be accessible via conference call and via Zoom
Meeting and Screenshare. Any interested person may call (i) 1-929-205-
6099 (US Toll) or 1-669-900-6833 (US Toll), Meeting ID: 922 4392 6406,
to listen and participate in this meeting. The website to participate
via Zoom Meeting and Screenshare is https://kellen.zoom.us/meeting/register/tJYvc-qhrD0uGtLL50ixEUs9e0MaorNIF3RM.

STATUS: This meeting will be open to the public.

MATTERS TO BE CONSIDERED: The Unified Carrier Registration Plan Audit
Subcommittee (the ``Subcommittee'') will continue its work in
developing and implementing the Unified Carrier Registration Plan and
Agreement. The subject matter of this meeting will include:

Proposed Agenda

I. Call to Order--UCR Audit Subcommittee Chair

    The UCR Audit Subcommittee Chair will welcome attendees, call the
meeting to order, call roll for the Audit Subcommittee, confirm whether
a quorum is present, and facilitate self-introductions.

II. Verification of Publication of Meeting Notice--UCR Executive
Director

    The UCR Executive Director will verify the publication of the
meeting notice on the UCR website and distribution to the UCR contact
list via email followed by the subsequent publication of the notice in
the Federal Register.

III. Review and Approval of Subcommittee Agenda and Setting of Ground
Rules--UCR Audit Subcommittee Chair

For Discussion and Possible Subcommittee Action

    The agenda will be reviewed, and the Subcommittee will consider
adoption.

Ground Rules

    Subcommittee action only to be taken in designated areas on the
agenda.

IV. Review and Approval of Subcommittee Minutes From the November 3,
2022 Meeting--UCR Audit Subcommittee Chair

For Discussion and Possible Subcommittee Action

    Draft minutes from the November 3, 2022 Subcommittee meeting via
teleconference will be reviewed. The Subcommittee will consider action
to approve.

V. Discuss Options To Replace the Retreat Audit Program With a Program
That Relies on Roadside Inspection Data--UCR Audit Subcommittee Chair,
UCR Audit Subcommittee Vice-Chair, and DSL Transportation

For Discussion and Possible Subcommittee Action

    The UCR Audit Subcommittee Chair, UCR Audit Subcommittee Vice-
Chair, and DSL Transportation will lead a discussion on options to
replace the Retreat Audit Program currently utilized by the States with
a roadside inspection data driven audit for non-IRP plated commercial
motor vehicles and the motor carriers operating this type of registered
equipment. The Subcommittee may consider and take action to recommend
to the UCR Board an alternative to the current Retreat Audit Program.

VI. Discuss Impacts of Reducing the Previous Year's Registration
Timeline for Registrants--UCR Audit Subcommittee Chair, UCR Audit
Subcommittee Vice-Chair, and DSL Transportation

    The UCR Audit Subcommittee Chair and UCR Audit Subcommittee Vice-
Chair and DSL Transportation will lead a discussion on the potential
impact to State Auditors, if the previous registration year's
registration period for registrants is reduced by three months.

VII. Update for Hosting a Monthly Question and Answer Session for State
Auditors--UCR Audit Subcommittee Chair, UCR Audit Subcommittee Vice-
Chair, and UCR Executive Director

    The UCR Audit Subcommittee Chair, UCR Audit Subcommittee Vice-Chair
and UCR Executive Director will lead a discussion regarding the value
of a series of 60-minute virtual question and answer sessions for state
auditors.

VIII. Review Snapshot of State Audit Compliance Percentages for Years
2021 and 2022--UCR Audit Subcommittee Chair

    The UCR Subcommittee Chair will review state audit compliance rates
for registration years 2021 and 2022 and related compliance percentages
for FARs, retreat audits and registration compliance percentages.

IX. General Review and Discussion of Audit Program--UCR Audit
Subcommittee Chair and UCR Subcommittee Vice-Chair

    The UCR Audit Subcommittee Chair and UCR Audit Subcommittee Vice-
Chair will lead discussion on auditing performance standards and
direction of the program.

X. Other Business--UCR Audit Subcommittee Chair

    The UCR Audit Subcommittee Chair will call for any other items
Subcommittee members would like to discuss.

XI. Adjournment--UCR Audit Subcommittee Chair

    The UCR Audit Subcommittee Chair will adjourn the meeting.
    The agenda will be available no later than 5:00 p.m. Eastern time,
January 30, 2023 at: https://plan.ucr.gov.

CONTACT PERSON FOR MORE INFORMATION: Elizabeth Leaman, Chair, Unified
Carrier Registration Plan Board of

Directors,<PHONE_NUMBER>, [email protected].

Alex B. Leath,
Chief Legal Officer, Unified Carrier Registration Plan.
[FR Doc. 2023-02337 Filed 1-31-23; 4:15 pm]
BILLING CODE 4910-YL-P


[Federal Register Volume 82, Number 97 (Monday, May 22, 2017)]
[Notices]
[Pages 23324-23325]
[FR Doc No: 2017-10308]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80686; File No. SR-BatsEDGA-2017-10]

Self-Regulatory Organizations; Bats EDGA Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change to Rule
11.21 of Bats EDGA Exchange, Inc. To Modify the Date of Appendix B Web
site Data Publication Pursuant to the Regulation NMS Plan To Implement
a Tick Size Pilot Program

May 16, 2017.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 4, 2017, Bats EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') 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 the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

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

    The Exchange filed a proposal to amend Rule 11.21 to modify the
date of Appendix B Web site data publication pursuant to the Regulation
NMS Plan to Implement a Tick Size Pilot Program (``Plan'').
    The text of the proposed rule change is available at the Exchange's
Web site at www.bats.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    Rule 11.21(b) (Compliance with Data Collection Requirements) \5\
implements the data collection and Web site publication requirements of
the Plan.\6\ Rule 11.21(b).08 provides, among other things, that the
requirement that the Exchange or Designated Examining Authority
(``DEA'') make certain data for the Pre-Pilot Period and Pilot Period
\7\ publicly available on their Web site pursuant to Appendix B and C
to the Plan shall commence on April 28, 2017.\8\ The Exchange is
proposing to amend Rule 11.21.08 to delay the Appendix B data Web site
publication date until August 31, 2017. The Exchange is proposing to
further delay the Web site publication of Appendix B data until August
31, 2017 to permit additional time to consider a methodology to
mitigate concerns raised in connection with the publication of Appendix
B data.
---------------------------------------------------------------------------

    \5\ See Exchange Rule 11.21(b). See also Securities Exchange Act
Release Nos. 77417 (March 22, 2016), 81 FR 17219 (March 28, 2016);
and 78799 (September 9, 2016), 81 FR 63549 (September 15, 2016).
    \6\ The Participants filed the Plan to comply with an order
issued by the Commission on June 24, 2014. See Letter from Brendon
J. Weiss, Vice President, Intercontinental Exchange, Inc., to
Secretary, Commission, dated August 25, 2014 (``SRO Tick Size Plan
Proposal''). See Securities Exchange Act Release No 72460 (June 24,
2014), 79 FR 36840 (June 30, 2014); see also Securities Exchange Act
Release No. 74892 (May 6, 2015), 80 FR 27513 (May 13, 2015).
    \7\ Unless otherwise defined herein, capitalized terms have the
meaning ascribed to them in Exchange Rule 11.21.
    \8\ See Exchange Rule 11.21.08. See also Securities Exchange Act
Release No. 80215 (March 10, 2017), 82 FR 14061 (March 16, 2017).
See also Letter from David S. Shillman, Associate Director, Division
of Trading and Markets, Commission, to Robert L.D. Colby, Executive
Vice President and Chief Legal Officer, FINRA, dated February 28,
2017.
---------------------------------------------------------------------------

    Pursuant to this proposed amendment, the Exchange or DEA would
publish the required Appendix B data for the Pre-Pilot Period through
April 30, 2017, by August 31, 2017.\9\ Thereafter, Appendix B data for
a given month would be published within 120 calendar days following
month end.\10\ Thus, for example, Appendix B data for May 2017 would be
made available on the Exchange or DEA's Web site by September 28, 2017,
and data for the month of June 2017 would be made available on the
Exchange or DEA's Web site by October 28, 2017.
---------------------------------------------------------------------------

    \9\ The Exchange initially submitted this proposed rule change
on April 28, 2017. (SR-BatsEDGA-2017-08). On May 4, 2017, the
Exchange withdrew SR-BatsEDGA-2017-08 and submitted this filing.
    \10\ FINRA, on behalf of the Exchange, also is submitting an
exemptive request to the SEC in connection with the instant filing.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with section
6(b) of the Act \11\ in general, and furthers the objectives of section
6(b)(5) of the Act \12\ in particular, in that it is designed to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Plan is designed to allow the Commission, market participants,
and the public to study and assess the impact of increment conventions
on the liquidity and trading of the common stock of small-
capitalization companies. The Exchange believes that this proposal is
consistent with the Act because it is in furtherance of the objectives
of section VII(A) of the Plan in that it is designed to provide the
Exchange with additional time to consider a methodology to mitigate
concerns raised in connection with the publication of Appendix B data.

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
notes that the proposed rule change implements the provisions of the
Plan.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become

operative for 30 days from the date on which it was filed, or such
shorter time as the Commission may designate, it has become effective
pursuant to section 19(b)(3)(A) of the Act \13\ and Rule 19b-4(f)(6)
thereunder.\14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19(b)-4(f)(6) normally does
not become operative prior to 30 days after the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii), the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has filed
the proposed rule change for immediate effectiveness and has requested
that the Commission waive the requirement that the proposed rule change
not become operative for 30 days after the date of the filing so that
it may become operative on the date of filing.
    The Exchange notes that the proposed rule change is intended to
mitigate confidentiality concerns raised in connection with section
VII(A) of the Plan, which provides that the data made publicly
available will not identify the Trading Center that generated the data.
The Exchange states that the additional time would allow consideration
of a methodology to mitigate concerns related to the publication of
Appendix B data.\15\
---------------------------------------------------------------------------

    \15\ The Commission recently approved a FINRA proposal to
implement an aggregated, anonymous grouped masking methodology for
the publication of Appendix B data related to OTC trading activity.
See Securities Exchange Release No. 80551, (April 28, 2017), 82 FR
20948 (May 4, 2017). See also Letter from David S. Shillman,
Associate Director, Division of Trading and Markets, Commission, to
Marcia E. Asquith, Executive Vice President FINRA, dated April 28,
2017.
---------------------------------------------------------------------------

    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because it will synchronize the timing for publication of Appendix B
data for all Participants, which should enhance the consistency and
usefulness of the data.\16\ Therefore, the Commission hereby waives the
30-day operative delay and designates the proposed rule change to be
operative on the date of filing.\17\
---------------------------------------------------------------------------

    \16\ The Commission recently granted exemptive relief to the
Participants delay the publication of their Appendix B data until
August 31, 2017. See Letter from David S. Shillman, Associate
Director, Division of Trading and Markets, Commission, to Jennifer
Piorko Mitchell, Vice President and Deputy Corporate Secretary,
FINRA, dated April 28, 2017. The Commission notes that other
Participants have submitted proposed rule changes to delay the
publication of Appendix B data until August 31, 2017. See e.g., SR-
BatsBZX-2017-31; BatsBYX-2017-10; BatsEDGX-2017-19; SR-BX-2017-022;
SR-CHX-2017-07; SR-FINRA-2017-010; SR-IEX-2017-12; SR-NASDAQ-2017-
044; SR-Phlx-2017-33; SR-NYSE-2017-19; SR-NYSEArca-2017-49; SR-
NYSEMKT-2017-24.
    \17\ For purposes only of waiving the operative delay for this
proposal, 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-BatsEDGA-2017-10 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BatsEDGA-2017-10. 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-BatsEDGA-2017-10 and should
be submitted on or before June 12, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-10308 Filed 5-19-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 248 (Wednesday, December 28, 2022)]
[Rules and Regulations]
[Pages 79801-79803]
[FR Doc No: 2022-28173]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2022-N-3185]

Medical Devices; Cardiovascular Devices; Classification of the
Interventional Cardiovascular Implant Simulation Software Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA, Agency or we) is
classifying the interventional cardiovascular implant simulation
software device into class II (special controls). The special controls
that apply to the device type are identified in this order and will be
part of the codified language for the interventional cardiovascular
implant simulation software device's classification. We are taking this
action because we have determined that classifying the device into
class II (special controls) will provide a reasonable assurance of
safety and effectiveness of the device. We believe this action will
also enhance patients' access to beneficial innovative devices.

DATES: This order is effective December 28, 2022. The classification
was applicable on September 8, 2021.

FOR FURTHER INFORMATION CONTACT: Judy Ji, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2543, Silver Spring, MD, 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the interventional cardiovascular
implant simulation software device as class II (special controls),
which we have determined will provide a reasonable assurance of safety
and effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for

future devices of that type, including for 510(k)s (see section
513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do
not have to submit a De Novo request or premarket approval application
to market a substantially equivalent device (see section 513(i) of the
FD&C Act, defining ``substantial equivalence''). Instead, sponsors can
use the less-burdensome 510(k) process, when necessary, to market their
device.

II. De Novo Classification

    On May 7, 2020, FDA received FEops NV's request for De Novo
classification of the FEops HEARTguide. FDA reviewed the request in
order to classify the device under the criteria for classification set
forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on September 8, 2021, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
870.1405.\1\ We have named the generic type of device interventional
cardiovascular implant simulation software device, and it is identified
as a prescription device that provides a computer simulation of an
interventional cardiovascular implant device inside a patient's
cardiovascular anatomy. It performs computational modeling to predict
the interaction of the interventional cardiovascular implant device
with the patient-specific anatomical environment.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

   Table 1--Interventional Cardiovascular Implant Simulation Software
                  Device Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Inaccurate simulation results leading    Software verification,
 to selection of suboptimal treatment     validation, and hazard
 plan, leading to prolonged procedure     analysis; Computational
 time and/or patient injury.              modeling verification and
                                          validation; Performance
                                          validation with clinical data;
                                          Labeling; and Human factors
                                          testing.
Delayed delivery of results due to       Software verification,
 software failure or use error, leading   validation, and hazard
 to delay of treatment.                   analysis; Human factors
                                          testing; and Labeling.
Failure to properly interpret device     Human factors testing, and
 results leading to selection of          Labeling.
 suboptimal treatment plan, leading to
 prolonged procedure time and/or
 patient injury.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, interventional cardiovascular
implant simulation software device is for prescription use only.
Prescription devices are exempt from the requirement for adequate
directions for use for the layperson under section 502(f)(1) of the
FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the
conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in 21 CFR part 860, subpart D, regarding De Novo
classification have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR parts 801, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  870.1405 to subpart B to read as follows:

Sec.  870.1405  Interventional cardiovascular implant simulation
software device.

    (a) Identification. An interventional cardiovascular implant
simulation software device is a prescription device that provides a
computer simulation of an interventional cardiovascular implant device
inside a patient's cardiovascular anatomy. It performs computational
modeling to predict the interaction of the interventional
cardiovascular implant device with the patient-specific anatomical
environment.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Software verification, validation, and hazard analysis, with
identification of appropriate mitigations, must be performed, including
a full verification and validation of the software according to the
predefined software specifications.
    (2) Computational modeling verification and validation activities
must be performed to establish the predictive capability of the device
for its indications for use.
    (3) Performance validation testing must be provided to demonstrate
the accuracy and clinical relevance of the modeling methods for the
intended implantation simulations, including the following:
    (i) Computational modeling results must be compared to clinical
data supporting the indications for use to demonstrate accuracy and
clinical meaningfulness of the simulations;
    (ii) Agreement between computational modeling results and clinical
data must be assessed and demonstrated across the full intended
operating range (e.g., full range of patient population, implant device
sizes and patient anatomic morphologies). Any selection criteria or
limitations of the samples must be described and justified;
    (iii) Endpoints (e.g., performance goals) and sample sizes
established must be justified as to how they were determined and why
they are clinically meaningful; and
    (iv) Validation must be performed and controls implemented to
characterize and ensure consistency (i.e., repeatability and
reproducibility) of modeling outputs:
    (A) Testing must be performed using multiple qualified operators
and using the procedure that will be implemented under anticipated
conditions of use; and
    (B) The factors (e.g., medical imaging dataset, operator) must be
identified regarding which were held constant and which were varied
during the evaluation, and a description must be provided for the
computations and statistical analyses used to evaluate the data.
    (4) Human factors evaluation must be performed to evaluate the
ability of the user interface and labeling to allow for intended users
to correctly use the device and interpret the provided information.
    (5) Device labeling must be provided that describes the following:
    (i) Warnings that identify anatomy and image acquisition factors
that may impact simulation results and provide cautionary guidance for
interpretation of the provided simulation results;
    (ii) Device simulation inputs and outputs, and key assumptions made
in the simulation and determination of simulated outputs; and
    (iii) The computational modeling performance of the device for
presented simulation outputs, and the supporting evidence for this
performance.

    Dated: December 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28173 Filed 12-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 91 (Tuesday, May 12, 2015)]
[Rules and Regulations]
[Pages 27086-27087]
[FR Doc No: 2015-11441]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2011-0595]

Special Local Regulation; Annual Kennewick, Washington, Columbia
Unlimited Hydroplane Races

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the special local regulation for
the ``Annual Kennewick, Washington, Columbia Unlimited Hydroplane
Races'' from 8:30 a.m. to 7:30 p.m. each day, from July 24, 2015
through July 26, 2015. This action is necessary to assist in minimizing
the inherent dangers associated with hydroplane races. During the
enforcement period, no person or vessel may enter the regulated area
without permission from the Sector Columbia River Captain of the Port.

DATES: The regulation in 33 CFR 100.1303 will be enforced from 8:30
a.m. until 7:30 p.m. on July 24, 2015 through July 26, 2015.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Mr. Ken Lawrenson, Waterways Management Division, MSU
Portland, Oregon, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulation for the Annual Kennewick, Washington, Columbia
Unlimited Hydroplane Races detailed in 33 CFR 100.1303 from 8:30 a.m.
to 7:30 p.m. each day from July 24, 2015 through July 26, 2015.
    Under the provisions of 33 CFR 100.1303, a vessel may not enter the
regulated area, unless it receives permission from the Coast Guard
Patrol Commander. Vessels granted permission to enter the zone by the
Patrol Commander shall not exceed minimum wake speed. A succession of
sharp, short signals by whistle, siren, or horn from vessels patrolling
the area under the direction of the U.S. Coast Guard Patrol Commander
shall serve as a signal to stop. Vessels signaled to stop shall stop
and comply with orders of the patrol vessel personnel; failure to do so
may result in expulsion from the area, citation, or both. The Coast
Guard may be assisted by other federal, state, or local law enforcement
agencies in enforcing this regulation.
    This notice is issued under authority of 33 CFR 100.1303 and 5
U.S.C. 552(a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with notification of
this enforcement period via the Local Notice to Mariners.

    Dated: April 21, 2015.
D.J. Travers,
Captain, U.S. Coast Guard, Captain of the Port, Sector Columbia River.
[FR Doc. 2015-11441 Filed 5-11-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Rules and Regulations]
[Pages 9770-9772]
[FR Doc No: 2016-04082]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2015-0582; FRL-9942-79-Region 7]

Approval of Iowa's Air Quality Implementation Plans; Iowa Plan
for the 2008 Lead Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve Iowa's attainment demonstration State Implementation
Plan (SIP) for the lead National Ambient Air Quality Standard (NAAQS)
nonattainment area of Council Bluffs, Pottawattamie County, Iowa,
received by EPA on February 9, 2015. The applicable standard addressed
in this action is the lead NAAQS promulgated by EPA in 2008. EPA
believes that the SIP submitted by the state satisfies the applicable
requirements of the Clean Air Act (CAA), and will bring the designated
portions of Council Bluffs, Iowa into attainment of the 0.15 microgram
per cubic meter ([mu]g/m\3\) lead NAAQS.

DATES: This final rule is effective on March 28, 2016.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R07-OAR-2015-0582. All documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index,
some information is not publicly available, i.e., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available electronically at
www.regulations.gov and at EPA Region 7, 11201 Renner Boulevard,
Lenexa, Kansas 66219. Please schedule an appointment during normal
business hours with the contact listed in the FOR FURTHER INFORMATION
CONTACT section. For additional information and general guidance,
please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Stephanie Doolan, Environmental
Protection Agency, Air Planning and Development Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to EPA.

Table of Contents

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. EPA's Response to Comments
IV. What action is EPA taking?

I. What is being addressed in this document?

    In this document, EPA is granting final approval of Iowa's
attainment demonstration SIP for the lead NAAQS nonattainment area in
portions of Council Bluffs, Pottawattamie County, Iowa. The applicable
standard addressed in this action is the lead NAAQS promulgated by EPA
in 2008. EPA believes that the SIP submitted by the state satisfies the
applicable requirements of the CAA identified in EPA's Final Rule (73
FR 66964, October 15, 2008), and will bring the area into attainment of
the 0.15 microgram per cubic meter ([mu]g/m\3\) lead NAAQS. EPA's
proposal containing the background information for this action can be
found at 80 FR 59695 (October 2, 2015).

II. Have the requirements for the approval of a SIP revision been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. In
addition, as explained above and in more detail in the technical
support document which is part of the docket, the revision meets the
substantive SIP requirements of the CAA, including section 110 and
implementing regulations.

III. EPA's Response to Comments

    The public comment period on EPA's proposed rule opened October 2,
2015, the date of its publication in the Federal Register, and closed
on November 2, 2015. During this period, EPA received no comments.

IV. What action is EPA taking?

    EPA is taking final action to amend the Iowa SIP to approve Iowa's
SIP for the Council Bluffs lead NAAQS nonattainment area in
Pottawattamie County, Iowa. The applicable standard addressed in this
action is the lead NAAQS promulgated by EPA in 2008 (73 FR 66964).

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 proposing to incorporate by reference the proposed
amendments to 40 CFR part 52 set forth below. EPA has made, and will
continue to make, these documents generally available electronically
through www.regulations.gov and/or in hard copy at the appropriate EPA
office (see the ADDRESSES section of this preamble for more
information).

Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 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 Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications 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).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. Section 804, however, exempts from section 801 the
following types of rules: Rules of particular applicability; rules
relating to agency management or personnel; and rules of agency
organization, procedure, or practice that do not substantially affect
the rights or obligations of non-agency parties. 5 U.S.C. 804(3).
Because this is a rule of particular applicability, EPA is not required
to submit a rule report regarding this action under section 801.
    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 April 26, 2016. Filing a petition for
reconsideration by the Administrator of this rule does not affect the
finality of this rulemaking 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 future rule
or action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: February 17, 2016.
Mark Hague,
Regional Administrator, Region 7.
    For the reasons stated in the preamble, EPA amends 40 CFR part 52
as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart Q--Iowa

0
2. Section 52.820 is amended by:

0
a. Adding entries (110) and (111) in numerical order to table (d); and
0
b. Adding new entry (42) in numerical order to table (e) to read as
follows:

Sec.  52.820  Identification of plan.

* * * * *
    (d) * * *

                                EPA-Approved Iowa Source-Specific Orders/Permits
----------------------------------------------------------------------------------------------------------------
                                                                  State
          Name of source               Order/Permit No.      effective date   EPA Approval date     Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(110) Griffin Pipe Products Co.,   Administrative Consent           1/29/15  2/26/16 [Insert
 LLC.                               Order No. 2015-AQ-02.                     Federal Register
                                                                              citation].
(111) Alter Metal Recycling......  Permit No. 14-A-521.....          9/2/14  2/26/16 [Insert
                                                                              Federal Register
                                                                              citation].
----------------------------------------------------------------------------------------------------------------

    (e) * * *

                                   EPA-Approved Iowa Nonregulatory Provisions
----------------------------------------------------------------------------------------------------------------
    Name of nonregulatory SIP      Applicable geographic or       State
            provision                 nonattainment area     submittal date   EPA Approval date     Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(42) Lead attainment SIP.........  Portions of                      1/30/15  2/26/16 [Insert      [EPA-R07-OAR-2
                                    Pottawattamie County.                     Federal Register    015-0582; FRL-
                                                                              citation].          9942-79-Region
                                                                                7].
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2016-04082 Filed 2-25-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Notices]
[Pages 74177-74178]
[FR Doc No: 2015-30092]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 31906; File No. 812-14475]

ETF Series Solutions and AlphaClone, Inc.; Notice of Application

November 19, 2015.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act, as well as from certain
disclosure requirements in rule 20a-1 under the Act, Item 19(a)(3) of
Form N-1A, Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of
Schedule 14A under the Securities Exchange Act of 1934, and Sections 6-
07(2)(a), (b), and (c) of Regulation S-X (``Disclosure Requirements'').
The requested exemption would permit an investment adviser to hire and
replace certain sub-advisers without shareholder approval and grant
relief from the Disclosure Requirements as they relate to fees paid to
the sub-advisers.

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    Applicants: ETF Series Solutions (the ``Trust''), a Delaware
statutory trust registered under the Act as an open-end management
investment company with multiple series, and AlphaClone, Inc. (the
``Initial Adviser''), a Delaware corporation registered as an
investment adviser under the Investment Advisers Act of 1940.
    Filing Dates: The application was filed on May 28, 2015 and amended
on September 25, 2015.
    Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on December 14, 2015, and

should be accompanied by proof of service on applicants, in the form of
an affidavit or, for lawyers, a certificate of service. Pursuant to
rule 0-5 under the Act, hearing requests should state the nature of the
writer's interest, any facts bearing upon the desirability of a hearing
on the matter, the reason for the request, and the issues contested.
Persons who wish to be notified of a hearing may request notification
by writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Applicants: ETF Series
Solutions, 615 E. Michigan Street, Milwaukee, WI 53202, and AlphaClone,
Inc., One Market Street, Steuart Tower, Suite 1208, San Francisco, CA
94105.

FOR FURTHER INFORMATION CONTACT: Courtney S. Thornton, Senior Counsel,
at<PHONE_NUMBER>, or David P. Bartels, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Summary of the Application

    1. The Initial Adviser is the investment adviser to the Trust's
AlphaClone Small Cap ETF, AlphaClone International ETF, AlphaClone
Activist ETF, and AlphaClone Value ETF (collectively, ``Initial
Funds'') pursuant to an investment management agreement with the Trust
(``Investment Management Agreement'').\1\ Under the terms of the
Investment Management Agreement, the Adviser, subject to the
supervision of the board of trustees of the Trust (``Board''), provides
continuous investment management of the assets of each Subadvised Fund.
Consistent with the terms of the Investment Management Agreement, the
Adviser may, subject to the approval of the Board, delegate portfolio
management responsibilities of all or a portion of the assets of a
Subadvised Fund to one or more Sub-Advisers.\2\ The Adviser will
continue to have overall responsibility for the management and
investment of the assets of each Subadvised Fund. The Adviser will
evaluate, select, and recommend Sub-Advisers to manage the assets of a
Subadvised Fund and will oversee, monitor and review the Sub-Advisers
and their performance and recommend the removal or replacement of Sub-
Advisers.
---------------------------------------------------------------------------

    \1\ Applicants request relief with respect to the Initial Funds,
as well as to any future series of the Trust and any other existing
or future registered open-end management investment company or
series thereof that, in each case, is advised by the Initial Adviser
or any entity controlling, controlled by, or under common control
with, the Initial Adviser or its successors (each, also an
``Adviser''), uses the multi-manager structure described in the
application, and complies with the terms and conditions set forth in
the application (each, a ``Subadvised Fund''). For purposes of the
requested order, ``successor'' is limited to an entity that results
from a reorganization into another jurisdiction or a change in the
type of business organization. Future Subadvised Funds may be
operated as a master-feeder structure pursuant to section
12(d)(1)(E) of the Act. In such a structure, certain series of the
Trust (each, a ``Feeder Fund'') may invest substantially all of
their assets in a Subadvised Fund (a ``Master Fund'') pursuant to
section 12(d)(1)(E) of the Act. No Feeder Fund will engage any sub-
advisers other than through approving the engagement of one or more
of the Master Fund's sub-advisers.
    \2\ As used herein, a ``Sub-Adviser'' for a Subadvised Fund is
(1) an indirect or direct ``wholly owned subsidiary'' (as such term
is defined in the Act) of the Adviser for that Subadvised Fund, or
(2) a sister company of the Adviser for that Subadvised Fund that is
an indirect or direct ``wholly-owned subsidiary'' of the same
company that, indirectly or directly, wholly owns the Adviser (each
of (1) and (2) a ``Wholly-Owned Sub-Adviser'' and collectively, the
``Wholly-Owned Sub-Advisers''), or (3) not an ``affiliated person''
(as such term is defined in section 2(a)(3) of the Act) of the
Subadvised Fund, any Feeder Fund invested in a Master Fund, the
Trust, or the Adviser, except to the extent that an affiliation
arises solely because the Sub-Adviser serves as a sub-adviser to a
Subadvised Fund (``Non-Affiliated Sub-Advisers'').
---------------------------------------------------------------------------

    2. Applicants request an order to permit the Adviser, subject to
the approval of the Board, to enter into investment sub-advisory
agreements with the Sub-Advisers (each, a ``Sub-Advisory Agreement'')
and materially amend such Sub-Advisory Agreements without obtaining the
shareholder approval required under section 15(a) of the Act and rule
18f-2 under the Act.\3\ Applicants also seek an exemption from the
Disclosure Requirements to permit a Subadvised Fund to disclose (as
both a dollar amount and a percentage of the Subadvised Fund's net
assets): (a) The aggregate fees paid to the Adviser and any Wholly-
Owned Sub-Adviser; (b) the aggregate fees paid to Non-Affiliated Sub-
Advisers; and (c) the fee paid to each Affiliated Sub-Adviser
(collectively, Aggregate Fee Disclosure'').\4\
---------------------------------------------------------------------------

    \3\ The requested relief will not extend to any sub-adviser,
other than a Wholly-Owned Sub-Adviser, who is an affiliated person,
as defined in section 2(a)(3) of the Act, of the Subadvised Fund, of
any Feeder Fund, or of the Adviser, other than by reason of serving
as a sub-adviser to one or more of the Subadvised Funds
(``Affiliated Sub-Adviser'').
    \4\ For any Subadvised Fund that is a Master Fund, the relief
would also permit any Feeder Fund invested in that Master Fund to
disclose Aggregate Fee Disclosure.
---------------------------------------------------------------------------

    3. Applicants agree that any order granting the requested relief
will be subject to the terms and conditions stated in the application.
Such terms and conditions provide for, among other safeguards,
appropriate disclosure to Subadvised Funds' shareholders and
notification about sub-advisory changes and enhanced Board oversight to
protect the interests of the Subadvised Funds' shareholders.
    4. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
any rule thereunder, if such relief is necessary or appropriate in the
public interest and consistent with the protection of investors and
purposes fairly intended by the policy and provisions of the Act.
Applicants believe that the requested relief meets this standard
because, as further explained in the application, the Investment
Management Agreements will remain subject to shareholder approval,
while the role of the Sub-Advisers is substantially equivalent to that
of individual portfolio managers, so that requiring shareholder
approval of Sub-Advisory Agreements would impose unnecessary delays and
expenses on the Subadvised Funds. Applicants believe that the requested
relief from the Disclosure Requirements meets this standard because it
will improve the Adviser's ability to negotiate fees paid to the Sub-
Advisers that are more advantageous for the Subadvised Funds.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-30092 Filed 11-25-15; 8:45 am]
 BILLING CODE 8011-01-P


Alan Stout EPA OAR, OTAQ, ASD Transmission Date: 11/ 12/ 2004 03: 10: 28 PM To: mark_ riechers@ mercmarine. com cc: Subject: part 91 comments Mark, Attached is an updated draft of part 91 that reflects your comments on the equations. I confirmed most of the corrections, but wanted to make sure you agreed with my syntax. I am starting with the unformatted version of presenting the equations. I may get to the fancier version with the equation editor before we are all done.

Three things are noteworthy:  For the " finished calculation you suggest for 91.325, I would most like to go with the approach adopted in 89.318. If you could confirm that or identify the reasons for any adjustments, I can process that. If you have broader concerns, I'll need to get some input from someone who understands these things better than I do.  While the test cycle clear departs from the ISO cycle, the slight correction you recommend would change the fundamental test procedure, which arguably affects the stringency of the standard. We may want to propose this change in our upcoming NPRM, but I don't think our attorneys will approve of this post NPRM change in this rule. Let me know what you recommend.  You should take special care in checking the S( t) equation, since it looks like I read the CFR differently than you did. This is another case of me not knowing the background on this one, so let me know if this is wrong and I'll work it with the experts.

We will be talking over the rest of your comments shortly, so there may be further changes to part 91 before we're all done. This isn't intended to prejudge Let me know if you have any questions.

Alan PART 91   CONTROL OF EMISSIONS FROM MARINE SPARK IGNITION ENGINES 1. The authority citation for part 91 is revised to read as follows: Authority: 42 U. S. C. 7401  7671q.

2. Section 91.3 is amended by revising the definitions for " Marine spark ignition engine", " Marine vessel", and " United States", adding definitions for " Amphibious vehicle", " Marine engine", and " Spark ignition" in alphabetical order to read as follows: § 91.3 Definitions. * * * * * Amphibious vehicle means a vehicle with wheels or tracks that is designed primarily for operation on land and secondarily for operation in water. * * * * * Marine engine means a nonroad engine that is installed or intended to be installed on a marine vessel. This includes a portable auxiliary marine engine only if its fueling, cooling, or exhaust system is an integral part of the vessel. There are two kinds of marine engines: ( 1) Propulsion marine engine means a marine engine that moves a vessel through the water or directs the vessel's movement. ( 2) Auxiliary marine engine means a marine engine not used for propulsion. Marine spark ignition engine means a spark ignition marine engine that propels a marine vessel. * * * * * Marine vessel has the meaning given in 1 U. S. C. 3, except that it does not include amphibious vehicles. The definition in 1 U. S. C. 3 very broadly includes every craft capable of being used as a means of transportation on water. * * * * * Spark ignition means relating to a gasoline fueled engine or any other type of engine with a spark plug ( or other sparking device) and with operating characteristics significantly similar to the theoretical Otto combustion cycle. Spark ignition engines usually use a throttle to regulate intake air flow to control power during normal operation. * * * * * United States means the States, the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, Guam, American Samoa, and the U. S. Virgin Islands. * * * * *

3. Section 91.207 is amended by revising the second equation for S( t) in paragraph ( a) to read as follows: § 91.207 Credit calculation and manufacturer compliance with emission standards.

( a) * * * S( t) = exp ( 0.906 × t/

life) 4 * * * * *

4. Section 91.301 is amended by revising paragraph ( c) to read as follows: § 91.301 Scope; applicability. * * * * * ( c) Additional information about system design, calibration methodologies, and so forth, for raw gas sampling can be found in 40 CFR part 1065. Examples for system design, calibration methodologies, and so forth, for dilute sampling can be found in 40 CFR part 1065. 5. Section 91.316 is amended by revising paragraphs ( b)( 2)( ii) and ( c) introductory text, and the first equation in paragraph ( d)( 6) to read as follows: § 91.316 Hydrocarbon analyzer calibration. * * * * * ( b) * * * ( 2) * * * ( ii) The HFID optimization procedures outlined in 40 CFR part 1065, subpart D. * * * * * ( c) Initial and periodic calibration. Prior to introduction into service and monthly thereafter, or within one month prior to the certification test, calibrate the FID or HFID hydrocarbon analyzer on all normally used instrument ranges, using the steps in this paragraph. Use the same flow rate and pressures as when analyzing samples. Introduce calibration gases directly at the analyzer. An optional method for dilute sampling described in 40 CFR part 1065, subpart F, may be used. * * * * * ( d) * * * ( 6) * * *

percent O2 I = ( B Analyzer response ( ppm C))/ B × 100 * * * * *

6. Section 91.318 is amended by revising paragraph ( d) and the equation in paragraph ( b)( 11) to read as follows: § 91.318 Oxides of nitrogen analyzer calibration. * * * * * ( b) * * * ( 11) * * * percent efficiency = ( 1 + ( a b)/( c d)) × 100 * * * * * ( d) The initial and periodic interference, system check, and calibration test procedures specified in 40 CFR part 1065, subparts C and D, may be used in lieu of the procedures specified in this section.

7. Section 91.320 is amended by revising paragraph ( b) to read as follows: § 91.320 Carbon dioxide analyzer calibration. * * * * * ( b) The initial and periodic interference, system check, and calibration test procedures specified in 40 CFR part 1065, subparts C and D, may be used in lieu of the procedures in this section.

8. Section 91.325 is amended by revising the equations in paragraphs ( c)( i)( iv) and ( c)( 2)( iii) to read as follows: § 91.325 Analyzer interference checks. * * * * * ( c) * * * ( 1) * * * ( iv)* * * percent CO2 quench = 100  100 × [ c × a/( d × a  d × b)] × a/ b * * * * * ( 2) * * * ( iii) * * * D1 = D × ( 1 Z1/ 100) 9. Section 91.419 is amended by revising the entry defining " MHCexh" in paragraph ( b) to read as follows: § 91.419 Raw emission sampling calculations. * * * * * ( b) * * * MHCexh = Molecular weight of hydrocarbons in the exhaust; see the following equation: MHCexh = 12.01 + 1.008 ×   * * * * *

10. Section 91.421 is amended by revising paragraph ( b)( 4)( ii) and ( b)( 4)( iii) to read as follows: § 91.421 Dilute gaseous exhaust sampling and analytical system description. * * * * * ( b) * * * ( 4) * * * ( ii) Conform to the continuous NOX, CO, or CO2 sampling and analysis system to the specifications of 40 CFR 1065.145, with the following exceptions and revisions: ( A) Heat the system components requiring heating only to prevent water condensation, the minimum component temperature is 55  C. ( B) Coordinate analysis system response time with CVS flow fluctuations and sampling time/ test cycle offsets to meet the time alignment and dispersion specifications in 40 CFR pat 1065, subpart C. ( C) Use only analytical gases conforming to the specifications of 40 CFR 1065.750 for calibration, zero, and span checks. ( D) Use a calibration curve conforming to 40 CFR part 1065, subparts C and D, for CO, CO2, and NOX for any range on a linear analyzer below 155 ppm. ( iii) Convert the chart deflections or voltage output of analyzers with non linear calibration curves to concentration values by the calibration curve( s) specified in 40 CFR part 1065, subpart D, before flow correction ( if used) and subsequent integration takes place. * * * * *

11. Section 91.705 is amended by revising paragraph ( d) to read as follows: § 91.705 Prohibited acts; penalties. * * * * * ( d) An importer who violates § 91.1103( a)( 1), section 213( d) and section 203 of the Act is subject to a civil penalty under § 91.1106 and section 205 of the Act of not more than $ 32,500 for each marine engine subject to the violation. In addition to the penalty provided in the Act, where applicable, a person or entity who imports an engine under the exemption provisions of § 91.704( b) and, who fails to deliver the marine engine to the U. S. Customs Service by the end of the period of conditional admission is liable for liquidated damages in the amount of the bond required by applicable Customs laws and regulations. The maximum penalty value listed in this paragraph ( d) is shown for calendar year 2004. Maximum penalty limits for later years may be adjusted based on the Consumer Price Index. The specific regulatory provisions for changing the maximum penalties, published in 40 CFR part 19, reference the applicable U. S. Code citation on which the prohibited action is based.

12. Section 91.1106 is amended by revising paragraphs ( a)( 1), ( a)( 2), ( a)( 5), and ( c)( 1) and adding paragraph ( a)( 6) to read as follows: § 91.1106 Penalties. ( a) * * * ( 1) A person who violates § 91.1103 ( a)( 1), ( a)( 4), or ( a)( 5), or a manufacturer or dealer who violates § 91.1103( a)( 3)( i), is subject to a civil penalty of not more than $ 32,500 for each violation. ( 2) A person other than a manufacturer or dealer who violates § 91.1103( a)( 3)( i) or any person who violates § 91.1103( a)( 3)( ii) is subject to a civil penalty of not more than $ 2,750 for each violation. * * * * * ( 5) A person who violates § 91.1103 ( a)( 2) or ( a)( 6) is subject to a civil penalty of not more than $ 32,500 per day of violation. ( 6) The maximum penalty values listed in this section are shown for calendar year 2004. Maximum penalty limits for later years may be adjusted based on the Consumer Price Index. The specific regulatory provisions for changing the maximum penalties, published in 40 CFR part 19, reference the applicable U. S. Code citation on which the prohibited action is based. * * * * * ( c) * * * ( 1) Administrative penalty authority. In lieu of commencing a civil action under paragraph ( b) of this section, the Administrator shall assess any civil penalty prescribed in paragraph ( a) of this section, except that the maximum amount of penalty sought against each violator in a penalty assessment proceeding can not exceed $ 270,000, unless the Administrator and the Attorney General jointly determine that a matter involving a larger penalty amount is appropriate for administrative penalty assessment. Any such determination by the Administrator and the Attorney General is not subject to judicial review. Assessment of a civil penalty is made by an order made on the record after opportunity for a hearing held in accordance with the procedures found at part 22 of this chapter. The Administrator may compromise, or remit, with or without conditions, any administrative penalty which may be imposed under this section. * * * * *