[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
[Notices]
[Pages 58115-58116]
[FR Doc No: 2012-23030]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC12-15-000]

Commission Information Collection Activities (FERC-546); Comment
Request

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Comment request.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is submitting the information collection FERC-546 (Certificated
Filings: Gas Pipeline Rates) to the Office of Management and Budget
(OMB) for review of the information collection requirements. Any
interested person may file comments directly with OMB and should
address a copy of those comments to the Commission as explained below.
The Commission issued a Notice in the Federal Register (77 FR 40438, 7/
9/2012) requesting public comments. FERC received no comments on the
FERC-546 and is making this notation in its submittal to OMB.

DATES: Comments on the collection of information are due by October 19,
2012.

ADDRESSES: Comments filed with OMB, identified by the OMB Control No.
1902-0155, should be sent via email to the Office of Information and
Regulatory Affairs<EMAIL_ADDRESS>Attention: Federal Energy
Regulatory Commission Desk Officer. The Desk Officer may also be
reached via telephone at<PHONE_NUMBER>.
    A copy of the comments should also be sent to the Federal Energy
Regulatory Commission, identified by the Docket No. IC12-15-000, by
either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>by telephone at<PHONE_NUMBER>, and by fax at
(202) 273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-546, Certificated Filings: Gas Pipeline Rates.
    OMB Control No.: 1902-0155.
    Type of Request: Three-year extension of the FERC-546 information
collection requirements with no changes to the reporting requirements.
    Abstract: The Commission reviews the FERC-546 materials to decide
whether to determine an initial rate associated with an application for
a certificate under NGA Section 7(c). It reviews FERC-546 materials in
4(f) storage applications to evaluate market power and decide whether
to grant, deny, or condition market based rate authority for the
applicant. The Commission uses the FERC-546 information to monitor
jurisdictional transportation, natural gas storage, and unbundled sales
activities of interstate natural gas pipelines and Hinshaw \1\
pipelines. In addition to fulfilling the Commission's obligations under
the NGA, the FERC-546 enables the Commission to monitor the activities
and evaluate transactions of the natural gas industry, ensure
competitiveness, and improved efficiency of the industry's operations.
In summary, the Commission uses the FERC-546 information to:
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    \1\ Hinshaw pipelines are those that receive all out-of-state
gas from entities within or at the boundary of a state if all the
natural gas so received is ultimately consumed within the state in
which it is received, 15 U.S.C. 717(c). Congress concluded that
Hinshaw pipelines are ``matters primarily of local concern,'' and so
are more appropriately regulated by pertinent state agencies rather
than by FERC. The Natural Gas Act section 1(c) exempts Hinshaw
pipelines from FERC jurisdiction. A Hinshaw pipeline, however, may
apply for a FERC certificate to transport gas outside of state
lines.
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     Ensure adequate customer protections under section 4(f) of
the NGA;
     Review rate and tariff changes by natural gas companies
for the transportation of gas, natural gas storage services;
     Provide general industry oversight;
     And supplement documentation during its audits process.
    Failure to collect this information would prevent the Commission
from being able to monitor and evaluate transactions and operations of
interstate pipelines and perform its regulatory functions.
    Type of Respondents: Pipeline companies and storage operators.
    Estimate of Annual Burden: \2\ The Commission estimates the total
Public Reporting Burden for this information collection as:
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    \2\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, reference 5 Code of Federal Regulations 1320.3.

                     FERC-546 (IC12-15-000): Certificated Rate Filings (Gas Pipeline Rates)
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average        Estimated
                                     Number of     responses per   Total number    burden hours    total annual
                                    respondents     respondent     of responses    per response       burden
                                             (A)             (B)     (A) x (B) =             (D)       (C) x (D)
                                                                             (C)
----------------------------------------------------------------------------------------------------------------
Pipeline Companies..............              11               1              11              40             440

Storage Operators...............               2               1               2             350             700
                                 -------------------------------------------------------------------------------
    Total.......................              13             N/A              13             N/A           1,140
----------------------------------------------------------------------------------------------------------------

    The total estimated annual cost burden to respondents is $78,669.97
[1,140 hours / 2,080 \3\ hours/year = 0.54807 * $143,540/year \4\ =
$78,669.97].
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    \3\ 2080 hours/year = 40 hours/week * 52 weeks/year
    \4\ Average annual salary per employee in 2012.
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    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: September 12, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-23030 Filed 9-18-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64893-64894]
[FR Doc No: 2016-22639]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC16-179-000.
    Applicants: Solverde 1, LLC.
    Description: Application for Authorization under Section 203 of the
Federal Power Act, Request for Expedited Consideration and Confidential
Treatment of Solverde 1, LLC.
    Filed Date: 9/9/16.
    Accession Number: 20160909-5415.
    Comments Due: 5 p.m. ET 9/30/16.

    Docket Numbers: EC16-180-000.
    Applicants: Antelope DSR 1, LLC.
    Description: Application for Authorization under Section 203 of the
Federal Power Act, Request for Expedited Consideration and Confidential
Treatment of Antelope DSR 1, LLC.
    Filed Date: 9/9/16.
    Accession Number: 20160909-5417.
    Comments Due: 5 p.m. ET 9/30/16.

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

    Docket Numbers: ER10-1651-003.
    Applicants: Golden State Water Company.
    Description: Supplement to June 28 2016 Updated Market Power
Analysis of Golden State Water Company.
    Filed Date: 9/9/16.
    Accession Number: 20160909-5411.
    Comments Due: 5 p.m. ET 11/8/16.

    Docket Numbers: ER16-2044-000.
    Applicants: Elk Hills Power, LLC.
    Description: Supplement to June 28 2016 Updated Market Power
Analysis for the Southwest Region of Elk Hills Power, LLC.
    Filed Date: 9/9/16.
    Accession Number: 20160909-5421.
    Comments Due: 5 p.m. ET 11/8/16.

    Docket Numbers: ER16-2577-000.
    Applicants: Lindahl Wind Project, LLC.
    Description: Baseline eTariff Filing: MBR Tariff to be effective
11/10/2016.
    Filed Date: 9/12/16.
    Accession Number: 20160912-5708.
    Comments Due: 5 p.m. ET 10/3/16.

    Docket Numbers: ER16-2578-000.
    Applicants: North Lancaster Ranch LLC.
    Description: Baseline eTariff Filing: North Lancaster Ranch LLC MBR
Tariff to be effective 9/13/2016.
    Filed Date: 9/12/16.
    Accession Number: 20160912-5716.
    Comments Due: 5 p.m. ET 10/3/16.

    Docket Numbers: ER16-2579-000.
    Applicants: American Electric Power Service Corporation, PJM
Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: AEP Submits 48th Revised
Service Agreement No 1336 with Buckeye Power to be effective 8/11/2016.
    Filed Date: 9/12/16.
    Accession Number: 20160912-5848.
    Comments Due: 5 p.m. ET 10/3/16.

    Docket Numbers: ER16-2580-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Section 205(d) Rate Filing: 2016-09-12_Bi-Directional
EARS Exemption Filing to be effective 11/12/2016.
    Filed Date: 9/12/16.
    Accession Number: 20160912-5876.
    Comments Due: 5 p.m. ET 10/3/16.

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

    Dated: September 12, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-22639 Filed 9-20-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: September 23, 2010 (Volume 75, Number 184)]
[Notices]
[Page 57998-58002]
[DOCID:fr23se10-108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62935; File No. 4-613]

Program for Allocation of Regulatory Responsibilities Pursuant to
Rule 17d-2; Notice of Filing of Proposed Plan for the Allocation of
Regulatory Responsibilities Between the Financial Industry Regulatory
Authority, Inc. and BATS-Y Exchange, Inc.

September 17, 2010.
    Pursuant to Section 17(d) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 17d-2 thereunder,\2\ notice is hereby given that
on September 3, 2010, BATS-Y Exchange, Inc. (``BYX'') and the Financial
Industry Regulatory Authority, Inc. (``FINRA'') (together with BYX, the
``Parties'') filed with the Securities and Exchange Commission
(``Commission'' or ``SEC'') a plan for the allocation of regulatory
responsibilities, dated September 3, 2010 (``17d-2 Plan'' or the
``Plan''). The Commission is publishing this notice to solicit comments
on the 17d-2 Plan from interested persons.
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    \1\ 15 U.S.C. 78q(d).
    \2\ 17 CFR 240.17d-2.
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I. Introduction

    Section 19(g)(1) of the Act,\3\ among other things, requires every
self-regulatory organization (``SRO'') registered as either a national
securities exchange or national securities association to examine for,
and enforce compliance by, its members and persons associated with its
members with the Act, the rules and regulations thereunder, and the
SRO's own rules, unless the SRO is relieved of this responsibility
pursuant to Section 17(d) or Section 19(g)(2) of the Act.\4\ Without
this relief, the statutory obligation of each individual SRO could
result in a pattern of multiple examinations of broker-dealers that
maintain memberships in more than one SRO (``common members''). Such
regulatory duplication would add unnecessary expenses for common
members and their SROs.
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    \3\ 15 U.S.C. 78s(g)(1).
    \4\ 15 U.S.C. 78q(d) and 15 U.S.C. 78s(g)(2), respectively.
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    Section 17(d)(1) of the Act \5\ was intended, in part, to eliminate
unnecessary multiple examinations and regulatory duplication.\6\ With
respect to a common member, Section 17(d)(1) authorizes the Commission,
by rule or order, to relieve an SRO of the responsibility to receive
regulatory reports, to examine for and enforce compliance with
applicable statutes, rules, and regulations, or to perform other
specified regulatory functions.
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    \5\ 15 U.S.C. 78q(d)(1).
    \6\ See Securities Act Amendments of 1975, Report of the Senate
Committee on Banking, Housing, and Urban Affairs to Accompany S.
249, S. Rep. No. 94-75, 94th Cong., 1st Session 32 (1975).
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    To implement Section 17(d)(1), the Commission adopted two rules:
Rule 17d-1 and Rule 17d-2 under the Act.\7\ Rule 17d-1 authorizes the
Commission to name a single SRO as the designated examining authority
(``DEA'') to examine common members for compliance with the financial
responsibility requirements imposed by the Act, or by Commission or SRO
rules.\8\ When an SRO has been named as a common member's DEA, all
other SROs to which the common member belongs are relieved of the
responsibility to examine the firm for compliance with the applicable
financial responsibility rules. On its face, Rule 17d-1 deals only with
an SRO's obligations to enforce member compliance with financial
responsibility requirements. Rule 17d-1 does not relieve an SRO from
its obligation to examine a common member for compliance with its own
rules and provisions of the federal securities laws governing matters
other than financial responsibility, including sales practices and
trading activities and practices.
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    \7\ 17 CFR 240.17d-1 and 17 CFR 240.17d-2, respectively.
    \8\ See Securities Exchange Act Release No. 12352 (April 20,
1976), 41 FR 18808 (May 7, 1976).
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    To address regulatory duplication in these and other areas, the
Commission adopted Rule 17d-2 under the Act.\9\ Rule 17d-2 permits SROs
to propose joint plans for the allocation of regulatory
responsibilities with respect to their common members. Under paragraph
(c) of Rule 17d-2, the Commission may declare such a plan effective if,
after providing for appropriate notice and comment, it determines that
the plan is necessary or appropriate in the public interest and for the
protection of investors; to foster cooperation and coordination among
the SROs; to remove impediments to, and foster the development of, a
national market system and a national clearance and settlement system;
and is in conformity with the factors set forth in Section 17(d) of the
Act. Commission approval of a plan filed pursuant to Rule 17d-2
relieves an SRO of those regulatory responsibilities allocated by the
plan to another SRO.
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    \9\ See Securities Exchange Act Release No. 12935 (October 28,
1976), 41 FR 49091 (November 8, 1976).
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II. Proposed Plan

    The proposed 17d-2 Plan is intended to reduce regulatory
duplication for firms that are common members of both BYX and
FINRA.\10\ Pursuant to the proposed 17d-2 Plan, FINRA would assume
certain examination and enforcement responsibilities for common members
with respect to certain applicable laws, rules, and regulations.
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    \10\ The proposed 17d-2 Plan refers to these common members as
``Dual Members.'' See Paragraph 1(c) of the proposed 17d-2 Plan.
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    The text of the Plan delineates the proposed regulatory
responsibilities with respect to the Parties. Included in the proposed
Plan is an exhibit (the ``BATS-Y Exchange Rules Certification for 17d-2
Agreement with FINRA,'' referred to herein as the ``Certification'')
that lists every BYX rule, and select federal securities laws, rules,
and regulations, for which FINRA would bear responsibility under the
Plan for overseeing and enforcing with respect to BYX members that are
also members of FINRA and the associated persons therewith (``Dual
Members'').
    Specifically, under the 17d-2 Plan, FINRA would assume examination
and enforcement responsibility relating to compliance by Dual Members
with the rules of BYX that are substantially similar to the applicable
rules of FINRA,\11\ as well as any provisions of the federal securities
laws and the rules and regulations thereunder delineated in the
Certification (``Common Rules''). Common Rules would not include the
application of any BYX rule or FINRA rule, or any rule or regulation
under the Act, to the extent that it pertains to violations of insider
trading activities, because such matters are covered by a separate
multiparty agreement under Rule 17d-2.\12\ In the event that a Dual

Member is the subject of an investigation relating to a transaction on
BYX, the plan acknowledges that BYX may, in its discretion, exercise
concurrent jurisdiction and responsibility for such matter.\13\
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    \11\ See paragraph 1(b) of the proposed 17d-2 Plan (defining
Common Rules). See also paragraph 1(f) of the proposed 17d-2 Plan
(defining Regulatory Responsibilities). Paragraph 2 of the Plan
provides that annually, or more frequently as required by changes in
either BYX rules or FINRA rules, the parties shall review and
update, if necessary, the list of Common Rules. Further, paragraph 3
of the Plan provides that BYX shall furnish FINRA with a list of
Dual Members, and shall update the list no less frequently than once
each calendar quarter.
    \12\ See Securities Exchange Act Release No. 58350 (August 13,
2008), 73 FR 48247 (August 18, 2008) (File No. 4-566) (notice of
filing of proposed plan). See also Securities Exchange Act Release
No. 58536 (September 12, 2008) (File No. 4-566) (order approving and
declaring effective the plan). The Certification identifies several
Common Rules that may also be addressed in the context of regulating
insider trading activities pursuant to the proposed separate
multiparty agreement.
    \13\ See paragraph 6 of the proposed 17d-2 Plan.
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    Under the Plan, BYX would retain full responsibility for
surveillance and enforcement with respect to trading activities or
practices involving BYX's own marketplace, including, without
limitation, registration pursuant to its applicable rules of associated
persons (i.e., registration rules that are not Common Rules); its
duties as a DEA pursuant to Rule 17d-1 under the Act; and any BYX rules
that are not Common Rules, except for BYX rules for any broker-dealer
subsidiary of BYX's parent company, BATS Global Markets, Inc.\14\
Apparent violations of any BYX rules by any broker-dealer subsidiary of
BATS Global Markets will be processed by, and enforcement proceedings
in respect thereto will be conducted by, FINRA.\15\
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    \14\ See paragraph 2 of the proposed 17d-2 Plan.
    \15\ See paragraph 6 of the proposed 17d-2 Plan.
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    The text of the proposed 17d-2 Plan is as follows:\16\
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    \16\ The Commission notes that the Proposed 17d-2 Plan does not
contain a paragraph number 18 and skips from 17 to 19.
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AGREEMENT BETWEEN FINANCIAL INDUSTRY REGULATORY AUTHORITY, INC. AND
BATS Y-EXCHANGE, INC. PURSUANT TO RULE 17d-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934

    This Agreement, by and between the Financial Industry Regulatory
Authority, Inc. (``FINRA'') and BATS Y-Exchange, Inc. (``BYX''), is
made this 3rd day of September, 2010 (the ``Agreement''), pursuant
to Section 17(d) of the Securities Exchange Act of 1934 (the
``Exchange Act'') and Rule 17d-2 thereunder, which permits
agreements between self-regulatory organizations to allocate
regulatory responsibility to eliminate regulatory duplication. FINRA
and BYX may be referred to individually as a ``party'' and together
as the ``parties.''
    Whereas, FINRA and BYX desire to reduce duplication in the
examination of their Dual Members (as defined herein) and in the
filing and processing of certain registration and membership
records; and
    Whereas, FINRA and BYX desire to execute an agreement covering
such subjects pursuant to the provisions of Rule 17d-2 under the
Exchange Act and to file such agreement with the Securities and
Exchange Commission (the ``SEC'' or ``Commission'') for its
approval.
    Now, therefore, in consideration of the mutual covenants
contained hereinafter, FINRA and BYX hereby agree as follows:
    1. Definitions. Unless otherwise defined in this Agreement or
the context otherwise requires, the terms used in this Agreement
shall have the same meaning as they have under the Exchange Act and
the rules and regulations thereunder. As used in this Agreement, the
following terms shall have the following meanings:
    (a) ``BYX Rules'' or ``FINRA Rules'' shall mean: (i) the rules
of BYX, or (ii) the rules of FINRA, respectively, as the rules of an
exchange or association are defined in Exchange Act Section
3(a)(27).
    (b) ``Common Rules'' shall mean BYX Rules that are substantially
similar to the applicable FINRA Rules and certain provisions of the
Exchange Act and SEC rules set forth on Exhibit 1 in that
examination for compliance with such provisions and rules would not
require FINRA to develop one or more new examination standards,
modules, procedures, or criteria in order to analyze the application
of the provision or rule, or a Dual Member's activity, conduct, or
output in relation to such provision or rule; provided, however,
Common Rules shall not include the application of the SEC, BYX or
FINRA rules as they pertain to violations of insider trading
activities, which is covered by a separate 17d-2 Agreement by and
among the American Stock Exchange, LLC, BATS Exchange, Inc., Chicago
Board Options Exchange, Inc., Chicago Stock Exchange, Inc., EDGA
Exchange, Inc., EDGX Exchange, Inc., Financial Industry Regulatory
Authority, Inc., International Securities Exchange, LLC, The NASDAQ
Stock Market LLC, National Stock Exchange, Inc., New York Stock
Exchange, LLC, NYSE Arca Inc., NYSE Regulation, Inc., NASDAQ OMX BX,
Inc. and NASDAQ OMX PHLX, Inc. approved by the SEC on April 15, 2010
as the same may be amended from time to time.
    (c) ``Dual Members'' shall mean those BYX members that are also
members of FINRA and the associated persons therewith.
    (d) ``Effective Date'' shall be the date this Agreement is
approved by the Commission.
    (e) ``Enforcement Responsibilities'' shall mean the conduct of
appropriate proceedings, in accordance with FINRA's Code of
Procedure (the Rule 9000 Series) and other applicable FINRA
procedural rules, to determine whether violations of Common Rules
have occurred, and if such violations are deemed to have occurred,
the imposition of appropriate sanctions as specified under FINRA's
Code of Procedure and sanctions guidelines.
    (f) ``Regulatory Responsibilities'' shall mean the examination
responsibilities and Enforcement Responsibilities relating to
compliance by the Dual Members with the Common Rules and the
provisions of the Exchange Act and the rules and regulations
thereunder, and other applicable laws, rules and regulations, each
as set forth on Exhibit 1 attached hereto.
    2. Regulatory and Enforcement Responsibilities. FINRA shall
assume Regulatory Responsibilities and Enforcement Responsibilities
for Dual Members. Attached as Exhibit 1 to this Agreement and made
part hereof, BYX furnished FINRA with a current list of Common Rules
and certified to FINRA that such rules that are BYX Rules are
substantially similar to the corresponding FINRA Rules (the
``Certification''). FINRA hereby agrees that the rules listed in the
Certification are Common Rules as defined in this Agreement. Each
year following the Effective Date of this Agreement, or more
frequently if required by changes in either the rules of BYX or
FINRA, BYX shall submit an updated list of Common Rules to FINRA for
review which shall add BYX Rules not included in the current list of
Common Rules that qualify as Common Rules as defined in this
Agreement; delete BYX Rules included in the current list of Common
Rules that no longer qualify as Common Rules as defined in this
Agreement; and confirm that the remaining rules on the current list
of Common Rules continue to be BYX Rules that qualify as Common
Rules as defined in this Agreement. Within 30 days of receipt of
such updated list, FINRA shall confirm in writing whether the rules
listed in any updated list are Common Rules as defined in this
Agreement. Notwithstanding anything herein to the contrary, it is
explicitly understood that the term ``Regulatory Responsibilities''
does not include, and BYX shall retain full responsibility for
(unless otherwise addressed by separate agreement or rule)
(collectively, the ``Retained Responsibilities'') the following:
    (a) Surveillance, examination, investigation and enforcement
with respect to trading activities or practices involving BYX's own
marketplace;
    (b) registration pursuant to its applicable rules of associated
persons (i.e., registration rules that are not Common Rules);
    (c) discharge of its duties and obligations as a Designated
Examining Authority pursuant to Rule 17d-1 under the Exchange Act;
and
    (d) any BYX Rules that are not Common Rules, except for BYX
Rules for any broker-dealer subsidiary of BATS Global Markets, Inc.,
as provided in paragraph 6.
    3. Dual Members. Prior to the Effective Date, BYX shall furnish
FINRA with a current list of Dual Members, which shall be updated no
less frequently than once each quarter.
    4. No Charge. There shall be no charge to BYX by FINRA for
performing the Regulatory Responsibilities and Enforcement
Responsibilities under this Agreement except as hereinafter
provided. FINRA shall provide BYX with ninety (90) days advance
written notice in the event FINRA decides to impose any charges to
BYX for performing the Regulatory Responsibilities under this
Agreement. If FINRA determines to impose a charge, BYX shall have
the right at the time of the imposition of such charge to terminate
this Agreement; provided, however, that FINRA's Regulatory
Responsibilities under this Agreement shall continue until the
Commission approves the termination of this Agreement.
    5. Applicability of Certain Laws, Rules, Regulations or Orders.
Notwithstanding any provision hereof, this Agreement shall be
subject to any statute, or any rule or order of the Commission. To
the extent such statute, rule or order is inconsistent with this
Agreement, the statute, rule or order shall supersede the
provision(s) hereof to the extent necessary for them to be properly
effectuated and the provision(s) hereof in that respect shall be
null and void.

    6. Notification of Violations.
    (a) In the event that FINRA becomes aware of apparent violations
of any BYX Rules, which are not listed as Common Rules, discovered
pursuant to the performance of the Regulatory Responsibilities
assumed hereunder, FINRA shall notify BYX of those apparent
violations for such response as BYX deems appropriate.
    (b) In the event that BYX becomes aware of apparent violations
of any Common Rules, discovered pursuant to the performance of the
Retained Responsibilities, BYX shall notify FINRA of those apparent
violations and such matters shall be handled by FINRA as provided in
this Agreement. With respect to apparent violations of any BYX Rules
by any broker-dealer subsidiary of BYX's parent company, BATS Global
Markets, Inc., FINRA shall not make referrals to BYX pursuant to
this paragraph 6. Such apparent violations shall be processed by,
and enforcement proceedings in respect thereto will be conducted by,
FINRA as provided in this Agreement.
    (c) Apparent violations of Common Rules shall be processed by,
and enforcement proceedings in respect thereto shall be conducted by
FINRA as provided hereinbefore; provided, however, that in the event
a Dual Member is the subject of an investigation relating to a
transaction on BYX, BYX may in its discretion assume concurrent
jurisdiction and responsibility.
    (d) Each party agrees to make available promptly all files,
records and witnesses necessary to assist the other in its
investigation or proceedings.
    7. Continued Assistance.
    (a) FINRA shall make available to BYX all information obtained
by FINRA in the performance by it of the Regulatory Responsibilities
hereunder with respect to the Dual Members subject to this
Agreement. In particular, and not in limitation of the foregoing,
FINRA shall furnish BYX any information it obtains about Dual
Members which reflects adversely on their financial condition. BYX
shall make available to FINRA any information coming to its
attention that reflects adversely on the financial condition of Dual
Members or indicates possible violations of applicable laws, rules
or regulations by such firms.
    (b) The parties agree that documents or information shared shall
be held in confidence, and used only for the purposes of carrying
out their respective regulatory obligations. Neither party shall
assert regulatory or other privileges as against the other with
respect to documents or information that is required to be shared
pursuant to this Agreement.
    (c) The sharing of documents or information between the parties
pursuant to this Agreement shall not be deemed a waiver as against
third parties of regulatory or other privileges relating to the
discovery of documents or information.
    8. Statutory Disqualifications. When FINRA becomes aware of a
statutory disqualification as defined in the Exchange Act with
respect to a Dual Member, FINRA shall determine pursuant to Sections
15A(g) and/or Section 6(c) of the Exchange Act the acceptability or
continued applicability of the person to whom such disqualification
applies and keep BYX advised of its actions in this regard for such
subsequent proceedings as BYX may initiate.
    9. Customer Complaints. BYX shall forward to FINRA copies of all
customer complaints involving Dual Members received by BYX relating
to FINRA's Regulatory Responsibilities under this Agreement. It
shall be FINRA's responsibility to review and take appropriate
action in respect to such complaints.
    10. Advertising. FINRA shall assume responsibility to review the
advertising of Dual Members subject to the Agreement, provided that
such material is filed with FINRA in accordance with FINRA's filing
procedures and is accompanied with any applicable filing fees set
forth in FINRA Rules.
    11. No Restrictions on Regulatory Action. Nothing contained in
this Agreement shall restrict or in any way encumber the right of
either party to conduct its own independent or concurrent
investigation, examination or enforcement proceeding of or against
Dual Members, as either party, in its sole discretion, shall deem
appropriate or necessary.
    12. Termination. This Agreement may be terminated by BYX or
FINRA at any time upon the approval of the Commission after one (1)
year's written notice to the other party, except as provided in
paragraph 4.
    13. Arbitration. In the event of a dispute between the parties
as to the operation of this Agreement, BYX and FINRA hereby agree
that any such dispute shall be settled by arbitration in Washington,
DC in accordance with the rules of the American Arbitration
Association then in effect, or such other procedures as the parties
may mutually agree upon. Judgment on the award rendered by the
arbitrator(s) may be entered in any court having jurisdiction. Each
party acknowledges that the timely and complete performance of its
obligations pursuant to this Agreement is critical to the business
and operations of the other party. In the event of a dispute between
the parties, the parties shall continue to perform their respective
obligations under this Agreement in good faith during the resolution
of such dispute unless and until this Agreement is terminated in
accordance with its provisions. Nothing in this Section 13 shall
interfere with a party's right to terminate this Agreement as set
forth herein.
    14. Notification of Members. BYX and FINRA shall notify Dual
Members of this Agreement after the Effective Date by means of a
uniform joint notice.
    15. Amendment. This Agreement may be amended in writing duly
approved by each party. All such amendments must be filed with and
approved by the Commission before they become effective.
    16. Limitation of Liability. Neither FINRA nor BYX nor any of
their respective directors, governors, officers or employees shall
be liable to the other party to this Agreement for any liability,
loss or damage resulting from or claimed to have resulted from any
delays, inaccuracies, errors or omissions with respect to the
provision of Regulatory Responsibilities as provided hereby or for
the failure to provide any such responsibility, except with respect
to such liability, loss or damages as shall have been suffered by
one or the other of FINRA or BYX and caused by the willful
misconduct of the other party or their respective directors,
governors, officers or employees. No warranties, express or implied,
are made by FINRA or BYX with respect to any of the responsibilities
to be performed by each of them hereunder.
    17. Relief from Responsibility. Pursuant to Sections 17(d)(1)(A)
and 19(g) of the Exchange Act and Rule 17d-2 thereunder, FINRA and
BYX join in requesting the Commission, upon its approval of this
Agreement or any part thereof, to relieve BYX of any and all
responsibilities with respect to matters allocated to FINRA pursuant
to this Agreement; provided, however, that this Agreement shall not
be effective until the Effective Date.
    19. Severability. Any term or provision of this Agreement that
is invalid or unenforceable in any jurisdiction shall, as to such
jurisdiction, be ineffective to the extent of such invalidity or
unenforceability without rendering invalid or unenforceable the
remaining terms and provisions of this Agreement or affecting the
validity or enforceability of any of the terms or provisions of this
Agreement in any other jurisdiction.
    20. Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, and such
counterparts together shall constitute one and the same instrument.
    In witness whereof, each party has executed or caused this
Agreement to be executed on its behalf by a duly authorized officer
as of the date first written above.

BATS Y-EXCHANGE, INC.

By:--------------------------------------------------------------------

Name:------------------------------------------------------------------

Title:-----------------------------------------------------------------

FINANCIAL INDUSTRY REGULATORY AUTHORITY, INC.

By:--------------------------------------------------------------------

Name:------------------------------------------------------------------

Title:-----------------------------------------------------------------

BATS Y-Exchange, Inc. (``BYX'') Rules Certification for 17d-2
Agreement With FINRA

    BYX hereby certifies that the requirements contained in the
rules listed below are identical to, or substantially similar to,
the comparable FINRA Rule, NASD Rule, Exchange Act provision or SEC
rule identified (``Common Rules'').

------------------------------------------------------------------------
                                         FINRA Rule, NASD Rule, Exchange
               BYX Rule:                    Act Provision or SEC Rule:

------------------------------------------------------------------------
Rule 2.5, Interpretation and Policy .02  NASD Rule 1120(a)(1)-(4)
 Continuing Education Requirement for     Continuing Education
 Authorized Traders of Members.           Requirements
Rule 2.5, Interpretation and Policy .04  FINRA By-Laws of the
 Termination of Employment.               Corporation, Article V,
                                          Section 3 Notification by
                                          Member to the Corporation and
                                          Associated Person of
                                          Termination; Amendments to
                                          Notification
Rule 2.6 (g) Application Procedures for  FINRA By-Laws of the
 Membership or to become an Associated    Corporation, Article IV,
 Person of a Member.                      Section 1(c) Application for
                                          Membership
Rule 3.1 Business Conduct of Members...  FINRA Rule 2010 Standards of
                                          Commercial Honor and
                                          Principles of Trade
Rule 3.2 Violations Prohibited \1\.....  FINRA Rule 2010 Standards of
                                          Commercial Honor and
                                          Principles of Trade and NASD
                                          Rule 3010 Supervision\*\
Rule 3.3 Use of Fraudulent Devices.....  FINRA Rule 2020 Use of
                                          Manipulative, Deceptive or
                                          Other Fraudulent Device
Rule 3.5(a) Advertising Practices......  NASD Rule 2210(d)(1)(B)
                                          Communications with the Public
Rule 3.5(b) Advertising Practices......  NASD Rule 2210(d)(2)(C)
                                          Communications with the Public
                                          \2\
Rule 3.5(c) Advertising Practices......  NASD Rule 2210(d)(1)
                                          Communications with the Public
Rule 3.5(d) Advertising Practices......  NASD Rule 2210(b)(1)
                                          Communications with the Public
                                          \3\
Rule 3.5(e) Advertising Practices......  NASD Rule 2210(b)(2)(A) and
                                          2210(c) Communications with
                                          the Public
Rule 3.5(f) Advertising Practices......  NASD Rule 2210(d)(2)(A) and
                                          2210(d)(1)(E) Communications
                                          with the Public
Rule 3.5(g) Advertising Practices......  NASD Rule 2210(d)(1)
                                          Communications with the Public
Rule 3.5(h) Advertising Practices......  NASD Rule 2210(d)(1)
                                          Communications with the Public
Rule 3.6 Fair Dealing with Customers...  NASD Rule IM-2310-2(b)(1), (2),
                                          (4)(A)(i), (4)(A)(iii),
                                          (4)(A)(iv), and (5) Fair
                                          Dealing with Customers
Rule 3.7(a) Recommendations to           NASD Rule 2310(a) and (b)
 Customers.                               Recommendations to Customers
                                          (Suitability)
Rule 3.8(a) The Prompt Receipt and       NASD Rule 3370 Purchases
 Delivery of Securities.
Rule 3.8(b) The Prompt Receipt and       SEC Regulation SHO
 Delivery of Securities.
Rule 3.9 Charges for Services Performed  NASD Rule 2430 Charges for
                                          Services Performed
Rule 3.10 Use of Information...........  FINRA Rule 2060 Use of
                                          Information Obtained in
                                          Fiduciary Capacity
Rule 3.13 Payment Designed to Influence  FINRA Rule 5230 Payment
 Market Prices, Other than Paid           Designed to Influence Market
 Advertising.                             Prices, Other than Paid
                                          Advertising \4\
Rule 3.14 Disclosure on Confirmations..  NASD Rule 2230 Confirmations
                                          and SEC Rule 10b-10
                                          Confirmation of Transactions
Rule 3.15 Disclosure of Control........  FINRA Rule 2262 Disclosure of
                                          Control Relationship With
                                          Issuer
Rule 3.16 Discretionary Accounts.......  NASD Rule 2510 Discretionary
                                          Accounts
Rule 3.17 Customer's Securities or       FINRA Rule 2150(a) Customers'
 Funds.                                   Securities or Funds--Improper
                                          Use
Rule 3.18 Prohibition Against            FINRA Rule 2150(b) Customers'
 Guarantees.                              Securities or Funds--
                                          Prohibition Against Guarantees
Rule 3.19 Sharing in Accounts; Extent    FINRA Rule 2150(c) Customers'
 Permissible.                             Securities or Funds--Sharing
                                          in Accounts; Extent
                                          Permissible
Rule 3.21 Customer Disclosures.........  FINRA Rule 2265 Extended Hours
                                          Trading Risk Disclosure
Rule 4.1 Requirements..................  Section 17 of the Exchange Act
                                          and the rules thereunder
Rule 5.1 Written Procedures............  NASD Rule 3010(b)(1)
                                          Supervision--Written
                                          Procedures\*\
Rule 5.2 Responsibility of Members.....  NASD Rule 3010(a)(4) and (b)(4)
                                          Supervision*
Rule 5.3 Records.......................  NASD Rule 3010(a)(1), (b) and
                                          (c) Supervision\*\
Rule 5.4 Review of Activities..........  NASD Rule 3010(c) & (d)
                                          Supervision--Internal
                                          Inspections/Review of
                                          Transactions and
                                          Correspondence\*\
Rule 5.6 Anti-Money Laundering           FINRA Rule 3310 Anti-Money
 Compliance Program.                      Laundering Compliance Program
Rule 9.3 Predispute Arbitration          NASD Rule 3110(f) Books and
 Agreements.                              Records; Requirements When
                                          Using Predispute Arbitration
                                          Agreements for Customer
                                          Accounts\*\
Rule 12.11 Best Execution..............  NASD Rule 2320 Best Execution
                                          and Interpositioning
Rule 12.13 Trading Ahead of Research     FINRA Rule 5280 Trading Ahead
 Reports.                                 of Research Reports
------------------------------------------------------------------------
\1\ FINRA shall only have Regulatory Responsibility regarding the first
  phrase of the BYX rule regarding prohibitions from violating the
  Securities Exchange Act of 1934 and the rules and regulations
  thereunder; responsibility for the remainder of the Rule shall remain
  with BYX.
\2\ FINRA shall only have Regulatory Responsibility with regard to
  market letters and sales literature to the extent the rule requires
  the disclosure of the name of the Member.
\3\ FINRA shall not have Regulatory Responsibility with regard to the
  requirement that all market letters be approved prior to use.
\4\ FINRA shall not have Regulatory Responsibility with regard to the
  prohibitions set forth under subsection (a) of FINRA Rule 5230 to the
  extent subsections (b)(2) or (b)(3) of the rule apply.
\*\ FINRA shall not have any Regulatory Responsibilities for these rules
  as they pertain to violations of insider trading activities, which is
  covered by a separate 17d-2 Agreement by and among the American Stock
  Exchange, LLC, BATS Exchange, Inc., Chicago Board Options Exchange,
  Inc., Chicago Stock Exchange, Inc., EDGA Exchange, Inc., EDGX
  Exchange, Inc., Financial Industry Regulatory Authority, Inc.,
  International Securities Exchange, LLC, The NASDAQ Stock Market LLC,
  National Stock Exchange, Inc., New York Stock Exchange, LLC, NYSE Arca
  Inc., NYSE Regulation, Inc., NASDAQ OMX BX, Inc. and NASDAQ OMX PHLX,
  Inc. approved by the SEC on April 15, 2010, as the same may be amended
  from time to time.

    In addition, the following provisions shall be part of this 17d-2
Agreement:
    Securities Exchange Act of 1934: Section 15(f)
    SEC Rules:
    Rule 200 of Regulation SHO--Definition of ``Short Sale'' and
Marking Requirements
    Rule 203 of Regulation SHO--Borrowing and Delivery Requirements
    Rule 606 of Regulation NMS--Disclosure of Order Routing Information
    Rule 607 of Regulation NMS--Customer Account Statements

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

    Pursuant to Section 17(d)(1) of the Act \17\ and Rule 17d-2
thereunder,\18\ after October 8, 2010, the Commission may, by written
notice, declare the plan submitted by BYX and FINRA, File No. 4-613, to
be effective if the Commission finds that the plan is necessary or
appropriate in the public interest and for the protection of investors,
to foster cooperation and coordination among self-regulatory
organizations, or to remove impediments to and foster the development
of the national market system and a national system for the clearance
and settlement of securities transactions and in conformity with the
factors set forth in Section 17(d) of the Act.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78q(d)(1).
    \18\ 17 CFR 240.17d-2.
---------------------------------------------------------------------------

IV. Solicitation of Comments

    In order to assist the Commission in determining whether to approve
the proposed 17d-2 Plan and to relieve BYX of the responsibilities
which would be assigned to FINRA, interested persons are invited to
submit written data, views, and arguments concerning the foregoing.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/other.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number 4-613 on the subject line.

Paper Comments

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

All submissions should refer to File Number 4-613. This file number
should be included on the subject line if e-mail 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/other.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed plan that are filed with the
Commission, and all written communications relating to the proposed
plan 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, on official business days between
the hours of 10 am and 3 pm. Copies of the plan also will be available
for inspection and copying at the principal offices of BYX and FINRA.
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 4-613 and should
be submitted on or before October 8, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(34).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-23772 Filed 9-22-10; 8:45 am]
BILLING CODE 8010-01-P


                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY                              2000 TRAVERWOOD DRIVE                            ANN ARBOR, MI  48105-2498

									     OFFICE OF 									AIR AND RADIATION April 9, 2012

MEMORANDUM

SUBJECT:  Meeting with VNG Co.

FROM:  Steven Silverman

TO:  EPA Docket # EPA-HQ-OAR-2010-0799

On April 6, 2012 various EPA officials met with representatives of VNG Co.  VNG produces infrastructure -- chiefly refueling apparatus, for compressed natural gas vehicles.  They view CNG refueling infrastructure as a bridge to fuel cell electric vehicles, since the same infrastructure used for CNG refueling is compatible with fuel cells (a steam reformer would need to be added).  The company's representatives echoed their public comments that some type of incentive like a multiplier would be appropriate for CNG vehicles, at least in the program's initial years.  A version of the company's presentation is attached.

Attachment


[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Notices]
[Pages 79059-79061]
[FR Doc No: 2013-31073]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Public Notice for Waiver of Aeronautical Land-Use Assurance

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of intent of waiver with respect to land; DuPage
Airport, West Chicago, Illinois.

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

SUMMARY: The FAA is considering a proposal to change a 1.771-acre
portion

of airport land from aeronautical use to non-aeronautical use and to
authorize the sale of airport property located at DuPage Airport, West
Chicago, Illinois.
    The subject portion of airport property considered for release from
obligation to be maintained for aeronautical use and sale includes a
0.677-acre portion of Parcel 601 (83.62 total acres), a 0.298-acre
portion of Parcel 8 (1.21 total acres), and a 0.795-acre portion of
Tract A (136.95 total acres) that are located in the northeast quadrant
of the airport along Illinois Route 64 (North Avenue) and currently not
being used directly for aeronautical purposes. Currently, ownership of
the property provides for protection of FAR Part 77 surfaces and
compatible land use which would continue to be protected with deed
restrictions required in the transfer of land ownership. The change
from aeronautical to non-aeronautical use would allow for the widening
of Route 64 which is directly adjacent to the airport. The
aforementioned land is not needed for aeronautical use.

DATES: Comments must be received on or before January 27, 2014.

ADDRESSES: Documents are available for review by prior appointment at
the FAA Airports District Office, Mr. Richard Pur, Airports Engineer,
Federal Aviation Administration, Chicago Airports District Office, 2300
East Devon Avenue, Des Plaines, Illinois 60018. Telephone: (847) 294-
7527/Fax:<PHONE_NUMBER>, and DuPage Airport Authority, 2700
International Drive, Suite 200, West Chicago, Illinois 60185, and (630)
584-2211.
    Written comments on the Sponsor's request must be delivered or
mailed to: Mr. Richard Pur, Airports Engineer, Federal Aviation
Administration, Chicago Airports District Office, 2300 East Devon
Avenue, Des Plaines, Illinois 60018. Telephone:<PHONE_NUMBER>/Fax:
(847) 294-7046.

FOR FURTHER INFORMATION CONTACT: Mr. Richard Pur, Airports Engineer,
Federal Aviation Administration, Chicago Airports District Office, 2300
East Devon Avenue, Des Plaines, Illinois 60018. Telephone: (847) 294-
7527/Fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In accordance with section 47107(h) of Title
49, United States Code, this notice is required to be published in the
Federal Register 30 days before modifying the land-use assurance that
requires the property to be used for an aeronautical purpose.
    The acquisition of Parcel 601 was originally funded under Federal
ADAP Grant 8-17-0017-01 in June, 1972, with Parcel 8 acquisition funded
with local funds. Tract A was acquired via a Quitclaim Deed from the US
Government and Reconstruction Finance Corporation (War Assets
Administration) in December, 1947. The subject portions of those
parcels are currently used for FAR Part 77 protection and to ensure
compatible land use. The DuPage Airport Authority plans to sell the
subject property to the Illinois Department of Transportation--Division
of Highways for the purpose of improvements to be made on Illinois
Route 64 (North Avenue) adjacent to the airport. Fair Market Value will
be obtained from the sale of the subject property.
    This notice announces that the FAA is considering the release of
the subject airport property at DuPage Airport, West Chicago, Illinois,
from Federal land covenants, subject to a reservation for continuing
right of flight as well as restrictions on the released property as
required in FAA Order 5190.6B Section 22.16. Approval does not
constitute a commitment by the FAA to financially assist in the
disposal of the subject airport property nor a determination of
eligibility for grant-in-aid funding from the FAA. The use of the
revenue generated from the sale of the airport property will be in
accordance with FAA's Policy and Procedures concerning the Use of
Airport Revenue, published in the Federal Register on February 16, 1999
(64 FR 7696).

Parcel 601-A--Subject Portion of Parcel 601 (Legal Description)

    That part of the West Half of the West Half of Section 29, Township
40 North, Range 9 East of the Third Principal Meridian, Beginning at
the intersection of the north right of way line of Illinois Route 64
(North Avenue and the west right of way of Powis Road per Document
95-67851; thence North 78 degrees 10 minutes 29 seconds West
along said north right of way line a distance of 89.34 feet; thence
North 51 degrees 30 minutes 35 seconds East a distance of 80.63 feet;
thence North 00 degrees 33 minutes 42 seconds East a distance of 359.96
feet to the north line of the Southwest Quarter of said Section 29;
thence South 89 degrees 25 minutes 44 seconds East a distance of 30.00
feet; thence South 02 degrees 17 minutes 34 seconds West a distance of
165.52 feet; thence South 00 degrees 33 minutes 42 seconds West a
distance of 262.76 feet to the Point of Beginning.
    Said parcel contains  13,037.99 square feet,  0.299 acres.

Parcel 601-B--Subject Portion of Parcel 601 (Legal Description)

    That part of the West Half of the West Half of Section 29, Township
40 North, Range 9 East of the Third Principal Meridian, Commencing at
the intersection of the north right of way line of Illinois Route 64
(North Avenue) and the west right of way line of Powis Road per
Document 95-67851; thence North 78 degrees 10 minutes 29
seconds West along said north right of way line a distance of 89.34
feet; thence North 51 degrees 30 minutes 35 seconds East a distance of
80.63 feet; thence North 00 degrees 33 minutes 42 seconds East a
distance of 359.96 feet to the Point of Beginning; thence North 00
degrees 30 minutes 50 seconds East a distance of 137.76 feet; thence
South 89 degrees 29 minutes 10 seconds East a distance of 18.00 feet;
thence North 00 degrees 30 minutes 50 seconds East a distance of 397.30
feet; thence South 89 degrees 29 minutes 10 seconds East a distance of
15.00 feet; thence North 00 degrees 30 minutes 50 seconds East a
distance of 356.05 feet; thence South 89 degrees 29 minutes 10 seconds
East a distance of 9.00 feet; thence South 00 degrees 30 minutes 50
seconds West a distance of 726.13 feet; thence North 89 degrees 29
minutes 10 seconds West a distance of 12.00 feet to a point on the west
right of way line of Powis Road per Document 95-67851; thence
South 00 degrees 30 minutes 50 seconds West along said right of way
line a distance of 160.01 feet; thence North 89 degrees 25 minutes 44
seconds West a distance of 30.00 feet to the Point of Beginning.
    Said parcel contains  16,485.33 square feet, 0.378 acres.

Parcel 8-B--Subject Portion of Parcel 8 (Legal Description)

    That Part of Tract 8 Lying within IDOT Parcel 1EA0006, described as
follows.

    That part of the Southwest Quarter of Section 29, Township 40
North, Range 9 East of the Third Principal Meridian, in DuPage
County, State of Illinois, more particularly described as follows:
    Beginning at the intersection of the South Right of Way line of
North Avenue (Illinois Route 64) with the West Right of Way line of
Powis Road per Document 95-67851; thence South 00 degrees 33 minutes
19 seconds West along the east line of IDOT Parcel 1EA 0006 a
distance of 223.29 feet; thence continuing along said east line
South 01 degrees 13 minutes 52 seconds East a distance of 111.18
feet to the south line of Tract 8; thence North 80 degrees 06
minutes 09 seconds West along said south line a distance of 30.91
feet to the west line of said IDOT Parcel 1EA0006; thence north
along the west line of said IDOT Parcel, North 00 degrees 33 minutes
42 seconds East a

distance of 90.69 feet, thence North 89 degrees 26 minutes 18
seconds West a distance of 11.00 feet; thence North 00 degrees 33
minutes 42 seconds East a distance of 198.39 feet; thence North 37
degrees 33 minutes 19 seconds West a distance of 72.17 feet to the
southerly right of way line of North Avenue (Illinois Route 64);
thence South 78 degrees 10 minutes 29 seconds East along said
southerly right of way line a distance of 84.17 feet to the Point of
Beginning.
    Said part of Tract 8 as described lying within IDOT Parcel
1EA0006 contains +/- 12,974.3 square feet, +/- 0.298 Acres.

Parcel A-E--Subject Portion of Tract A (Legal Description)

    That Part of Tract A lying within IDOT Parcel 1EA0006, described as
follows.

    That part of the Southwest Quarter of Section 29, Township 40
North, Range 9 East of the Third Principal Meridian, in DuPage
County, State of Illinois, more particularly described as follows:
    Commencing at the intersection of the South Right of Way line of
North Avenue (Illinois Route 64) with the West Right of Way line of
Powis Road per Document 95-67851; thence South 78 degrees 10 minutes
29 seconds East along the southerly extension of North Avenue
(Illinois Route 64) a distance of 51.06 feet to the east line of the
west half of the Southwest Quarter (SW \1/4\) of Section 29,
Township 40 North, Range 9 East of the Third Principal Meridian;
thence South 00 degrees 33 minutes 42 seconds West along said east
line of the west half of the Southwest Quarter of Section 29 a
distance of 758.35 feet to the south line of Right of Way Document
95-67851; thence North 89 degrees 28 minutes 49 seconds West a
distance of 33.00 feet to the Point of Beginning: thence South 00
degree 33 minutes 42 seconds West a distance of 539.03 feet; thence
west and north along and following IDOT Parcel 1EA0006, North 89
degrees 18 minutes 55 seconds West a distance of 35.00 feet: thence
North 00 degree 33 minutes 42 seconds East a distance of 583.11
feet; thence North 89 degrees 18 minutes 55 seconds West a distance
of 9.00 feet; thence North 00 degrees 33 minutes 42 seconds East a
distance of 394.67 feet to the south line of Tract 8; thence South
80 degrees 06 minutes 09 East seconds along said south line a
distance of 30.91 feet to the west line of Right of Way Document 95-
67851; thence south and east along said right of way, South 01
degrees 13 minutes 52 seconds East a distance of 434.12 feet to the
Point of Beginning.
    Said Part of Tract A as described lying within IDOT Parcel 1EA0006
contains +/- 34,635.8 square feet, +/- 0.795 Acres.

    Issued in Des Plaines, Illinois, on December 18, 2013.
James G. Keefer,
Manager, Chicago Airports District Office, Federal Aviaition
Administration, Great Lakes Region.
[FR Doc. 2013-31073 Filed 12-26-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48837-48841]
[FR Doc No: 2023-16030]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD23-4-000]

Billing Procedures for Annual Charges for the Costs of Other
Federal Agencies for Administering Part I of the Federal Power Act;
Notice Reporting Costs for Other Federal Agencies' Administrative
Annual Charges for Fiscal Year 2022

    1. The Federal Energy Regulatory Commission (Commission) is
required to determine the reasonableness of costs incurred by other
Federal agencies (OFAs) \1\ in connection with their participation in
the Commission's proceedings under the Federal Power Act (FPA) Part I
\2\ when those agencies seek to include such costs in the
administrative charges licensees must pay to reimburse the United
States for the cost of administering Part I.\3\ The Commission's Order
on Remand and Acting on Appeals of Annual Charge Bills \4\ determined
which costs are eligible to be included in the administrative annual
charges. This order also established a process whereby the Commission
would annually request each OFA to submit cost data, using a form \5\
specifically designed for this purpose. In addition, the order
established requirements for detailed cost accounting reports and other
documented analyses to explain the cost assumptions contained in the
OFAs' submissions.
---------------------------------------------------------------------------

    \1\ The OFAs include: the U.S. Department of the Interior
(Bureau of Land Management, Bureau of Reclamation, National Park
Service, U.S. Fish and Wildlife Service, Office of the Solicitor,
Office of Environmental Policy & Compliance); the U.S. Department of
Agriculture (U.S. Forest Service); the U.S. Department of Commerce
(National Marine Fisheries Service); and the U.S. Army Corps of
Engineers.
    \2\ 16 U.S.C. 791a-823d (2018).
    \3\ See id. 803(e)(1) and 42 U.S.C. 7178 (2018).
    \4\ 107 FERC ] 61,277, order on reh'g, 109 FERC ] 61,040 (2004).
    \5\ Other Federal Agency Cost Submission Form, available at
https://www.ferc.gov/docs-filing/forms.asp#ofa.
---------------------------------------------------------------------------

    2. The Commission has completed its review of the forms and
supporting documentation submitted by the U.S. Department of the
Interior (Interior), the U.S. Department of Agriculture (Agriculture),
and the U.S. Department of Commerce (Commerce) for fiscal year (FY)
2022. This notice reports the costs the Commission included in its
administrative annual charges for FY 2023.

Scope of Eligible Costs

    3. The basis for eligible costs that should be included in the
OFAs' administrative annual charges is prescribed by the Office of
Management and Budget's (OMB) Circular A-25--User Charges and the
Federal Accounting Standards Advisory Board's Statement of Federal
Financial Accounting Standards (SFFAS) Number 4--Managerial Cost
Accounting Concepts and Standards for the Federal Government. Circular
A-25 establishes Federal policy regarding fees assessed for government
services and provides specific information on the scope and type of
activities subject to user charges. SFFAS Number 4 provides a
conceptual framework for federal agencies to determine the full costs
of government goods and services.
    4. Circular A-25 provides for user charges to be assessed against
recipients of special benefits derived from federal activities beyond
those received by the general public.\6\ With regard to licensees, the
special benefit derived from federal activities is the license to
operate a hydropower project. The guidance provides for the assessment
of sufficient user charges to recover the full costs of services
associated with these special benefits.\7\ SFFAS Number 4 defines full
costs as the costs of resources consumed by a specific governmental
unit that contribute directly or indirectly to a provided service.\8\
Thus, pursuant to OMB requirements and authoritative accounting
guidance, the Commission must base its OFA administrative annual charge
on all direct and indirect costs incurred by agencies in administering
Part I of the FPA. The special form the Commission designed for this
purpose, the ``Other Federal Agency Cost Submission Form,'' captures
the full range of costs recoverable under the FPA and the referenced
accounting guidance.\9\
---------------------------------------------------------------------------

    \6\ OMB Circular A-25 6.
    \7\ OMB Circular A-25 6.a.2.
    \8\ SFFAS Number 4 ] 7.
    \9\ For the past few years, the form has excluded ``Other Direct
Costs'' to avoid the possibility of confusion that occurred in
earlier years as to whether costs were being entered twice as
``Other Direct Costs'' and ``Overhead.''
---------------------------------------------------------------------------

    5. Our guidance directs the OFAs to ensure that the costs are for
FPA Part I activities and that the documented costs are segregated
between activities covering municipal projects from those for non-
municipal projects. This year, we also asked the OFAs to provide
additional narrative descriptions of the type of work performed in
administering FPA Part I (including a list of the projects for which
work was performed during the covered period) and a detailed
description of what managerial/administrative or other activities are
included in the non-specific category.

Commission Review of OFA Cost Submittals

    5. The Commission received cost forms and other supporting
documentation from the Departments of the Interior, Agriculture, and
Commerce. The Commission completed a review of each OFA's cost
submission forms and supporting reports. In its examination of the
OFAs' cost data, the Commission considered each agency's ability to
demonstrate a system or process which effectively captured, isolated,
and reported FPA Part I costs as required by the ``Other Federal Agency
Cost Submission Form.''
    6. The Commission held a Technical Conference on March 23, 2023 to
report its initial findings to licensees and OFAs. Representatives for
several licensees and most of the OFAs attended the conference.
Following the technical conference, a transcript was posted, and
licensees had the opportunity to submit comments to the Commission
regarding its initial review.
    7. Idaho Falls Group (Idaho Falls) filed written comments \10\
raising concerns that several of the agencies failed to provide a list
of projects for which activities were taken during the fiscal year. The
issues are addressed in the Appendix to this notice.
---------------------------------------------------------------------------

    \10\ See Letter from Michael A. Swiger, Van Ness Feldman, to the
Honorable Kimberly D. Bose, FERC, Docket No. AD23-4-000 (filed April
17, 2023).
---------------------------------------------------------------------------

    8. After additional review, full consideration of the comments
presented, and in accordance with the previously cited guidance, the
Commission accepted as reasonable any costs reported via the cost
submission forms that were clearly documented in the OFAs' accompanying
reports and/or analyses. These documented costs will be included in the
administrative annual charges for FY 2023.

[GRAPHIC] [TIFF OMITTED] TN28JY23.048

    9. Figure 1 summarizes the total reported costs incurred by
Interior, Agriculture, and Commerce with respect to their participation
in administering Part I of the FPA. Additionally, Figure 1 summarizes
the reported costs that the Commission determined were clearly
documented and accepted for inclusion in its FY 2023 administrative
annual charges.

Summary Findings of Commission's Costs Review

    10. As presented in Figure 1, the Commission has determined that
$5,152,487 of the $5,935,317 in total reported costs were reasonable
and clearly documented in the OFAs' accompanying reports and/or
analyses. Based on this finding, 13% of the total reported cost was
determined to be unreasonable. The Commission notes the most
significant issue with the documentation provided by the OFAs was the
lack of detailed description of type of work performed and a list of
projects for work performed during the fiscal year.
    11. The cost reports that the Commission determined were clearly
documented and supported could be traced to detailed cost-accounting
reports, which reconciled to data provided from agency financial
systems or other pertinent source documentation. A further breakdown of
these costs is included in the Appendix to this notice, along with an
explanation of how the Commission determined their reasonableness.

Points of Contact

    12. If you have any questions regarding this notice, please contact
Raven Rodriguez at<PHONE_NUMBER>.

    Dated: July 24, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.

Appendix

    The supporting documentation provided by Interior's Bureau of
Land Management (BLM), Bureau of Reclamation (Reclamation), National
Park Service (NPS), U.S. Fish and Wildlife Service (FWS), Office of
Environmental Policy & Compliance (OEPC), and Office of the
Solicitor (SOL) can be found in the Commission's eLibrary electronic
filing system using the following information:

Docket No. AD23-4-000

    As part of their supporting documentation for FY 2022, the
participating Interior organizations provided detailed cost-
accounting reports from their financial accounting systems that
clearly tracked FPA Part I-related costs through specific job and
activity-based codes. The reporting entities also further clarified
how FPA Part I-related costs were being recorded and classified,
including job cost-code tables to support their municipal and non-
municipal distinctions, narrative descriptions of the type of work
performed and listing of the projects for which work was performed.
In addition, the various Interior organizations' indirect cost rates
were substantiated and deemed reasonable based on the detailed
explanation provided in their submission. Figures 2 through 8 below
detail the specific reported and accepted cost categories for these
organizations.
    Idaho Falls group raises concerns regarding BLM's cost
submission not containing information of work performed or a list of
projects. BLM subsequently provided a list of five projects for
which BLM performed work. The projects listed are licensed projects
that are partially located on BLM land. However, BLM provided no
statement even generally describing what work was done on these
projects. Therefore, we are disallowing the costs.
[GRAPHIC] [TIFF OMITTED] TN28JY23.049

    Idaho Falls Group proposes exclusion of all of Reclamation costs
because the projects listed by Reclamation were all federal projects
rather than projects licensed under Part I of the FPA. We reviewed
the submittal and confirmed that no projects subject to the
Commission's jurisdiction were listed; therefore, we are disallowing
the costs submitted by Reclamation costs.
[GRAPHIC] [TIFF OMITTED] TN28JY23.050

    Idaho Falls Group raises concerns regarding the Commission's
acceptance of NPS' costs arguing that NPS' cost of non-project
specific work, $342,626.76, comprises 55% of its total direct costs
and lacks sufficient explanation. NPS, in response to Idaho Falls'
comment, notes that it does not have a system in place to track
allowable costs incurred by NPS staff in other programs and parks
across the Service. It states that if these costs were included in
the submittal, the percentage of non-specific costs would not be as
high. Subsequent response contain an adequate explanation of non-
specific costs as well as a list of projects. We are accepting the
submitted costs.
[GRAPHIC] [TIFF OMITTED] TN28JY23.051

    Idaho Falls Group raises no concerns regarding the Commission's
acceptance of FWS' costs. FWS provided a list of projects for all
but one of its branches, with a brief description of activities
undertaken for each. We accept most of the submitted costs.
[GRAPHIC] [TIFF OMITTED] TN28JY23.052

    Idaho Falls Group raises concerns regarding the Commission's
acceptance of costs submitted by SOL, arguing that while SOL did
submit a general description of the types of activities in each cost
code, it did not provide a list of projects that the its staff
worked on during the fiscal year. At the technical conference, the
SOL representative acknowledged that SOL did not provide a project
list, noting that SOL's system was not set up for project by project
reporting. Because the new requirement to provide a list of projects
was not provided to the OFAs until after the fiscal year had passed,
we will not use the missing project list as a disqualifying factor
for this billing cycle. The submittal otherwise provided sufficient
information for a determination. Therefore, we are accepting the
submitted costs.
[GRAPHIC] [TIFF OMITTED] TN28JY23.053

    Based on OEPC's initial submission, we originally disallowed
costs in the non-specific cost category due to the absence of an
explanation. Idaho Falls, in its comments, noted its agreement with
the proposed disallowance, noting the high percentage of non-
specific costs. After the technical conference, OEPC provided
clarification containing the reclassification of some erroneously
coded costs as well as an explanation of non-specific costs. We find
the explanations reasonable and accept the costs.
[GRAPHIC] [TIFF OMITTED] TN28JY23.054

    The supporting documentation provided by Agriculture's U.S.
Forest Service can be found in the Commission's eLibrary electronic
filing system using the following information: Docket No. AD23-4-000
    As part of its supporting documentation for FY 2022, Forest
Service provided detailed cost-accounting reports from its financial
accounting system that clearly tracked FPA Part I-related costs
through specific job and activity-based codes. Forest Service also
further clarified how FPA Part I-related costs were being recorded
and classified, including job cost-code tables to support its
municipal and non-municipal distinctions, narrative descriptions of
the type of work performed and listing of the projects for which
work was performed. In addition, its indirect cost rates were
substantiated and deemed reasonable based on the detailed
explanation provided in its submission.
    Idaho Falls states in its comments that it concurs with our
findings with regard to the costs submitted by Forest Service.

[GRAPHIC] [TIFF OMITTED] TN28JY23.055

    The supporting documentation provided by the U.S. Department of
Commerce's National Marine Fisheries Service (NMFS) can be found in
the Commission's eLibrary electronic filing system using the
following information: Docket No. AD23-4-000
    As part of its supporting documentation for FY 2022, NMFS
provided detailed cost-accounting reports from its financial
accounting system that clearly tracked FPA Part I-related costs
through specific job and activity-based codes. NMFS also further
clarified how FPA Part I-related costs were being recorded and
classified, including job cost-code tables to support its municipal
and non-municipal distinctions, narrative descriptions of the type
of work performed and listing of the projects for which work was
performed. In addition, its indirect cost rates were substantiated
and deemed reasonable based on the detailed explanation provided in
its submission.
    Idaho Falls argues in its comments that all costs associated
with NMFS' PHY General/Non-Specific category should be disallowed
because NMFS fails to explain why the majority of time is spent on
non-project specific activities that are only generally related to
FPA Part I. Following the technical conference, NMFS provided a
fuller description of the non-project specific work performed. We
find the explanations reasonable and accept the costs.
[GRAPHIC] [TIFF OMITTED] TN28JY23.056

[FR Doc. 2023-16030 Filed 7-27-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Rules and Regulations]
[Pages 6419-6422]
[FR Doc No: 2022-02357]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2021-N-0948]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Carbon Dioxide Gas Controlled Tissue Expander

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the carbon dioxide gas

controlled tissue expander 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 carbon dioxide
gas controlled tissue expander'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 February 4, 2022. The classification was
applicable on December 21, 2016.

FOR FURTHER INFORMATION CONTACT: Tajanay Ki, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4553, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the carbon dioxide gas controlled
tissue expander 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, 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 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). 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.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation. 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 c(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 December 8, 2015, FDA received AirXpanders' request for De Novo
classification of the AeroForm[supreg] Tissue Expander System. 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 section 513(a)(1)(B) of the FD&C Act). 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 December 21, 2016, 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
878.3510.\1\ We have named the generic type of device carbon dioxide
gas-controlled tissue expander, and it is identified as a prescription
device intended for temporary subcutaneous or submuscular implantation
to stretch the skin for surgical applications, specifically to develop
surgical flaps and additional tissue coverage. The device is made of an
inflatable elastomer shell and is filled with carbon dioxide gas. The
device utilizes a remote controller to administer doses of carbon
dioxide gas from an implanted canister inside the device.
---------------------------------------------------------------------------

    \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--Carbon Dioxide Gas Controlled Tissue Expander Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Pain...................................  Labeling; and
     From overexpansion with      Software verification,
     carbon dioxide.                      validation and hazard
                                          analysis.
Tissue damage..........................  In-vivo performance testing;
                                          Labeling; and
     From overexpansion with     Software verification,
     carbon dioxide.                      validation and hazard
                                          analysis.
Prolonged treatment time...............  In-vivo performance testing;
     Due to under expansion       Non-clinical performance
     because of carbon dioxide            testing; Labeling; and
     permeation.
     Due to overexpansion with   Software verification,
     carbon dioxide.                      validation and hazard
                                          analysis.
Re-operation...........................  In-vivo performance testing and
                                          Non-clinical performance
                                          testing.
     Due to no expansion
     because of device failure
     Due to overexpansion with
     carbon dioxide
Under expansion, overexpansion, or no    Electromagnetic compatibility,
 expansion.                               electrical safety, and
                                          wireless compatibility
                                          testing; Labeling;
     Due to interference with    Software verification,
     other devices.                       validation and hazard
                                          analysis;
     Due to user error.........  Human factors testing; and
                                          Patient training.
Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation and
                                          Shelf life testing.
------------------------------------------------------------------------

    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. In order 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, carbon dioxide gas controlled tissue
expanders are 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. 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
the guidance document ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' 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 part 801, regarding labeling, have
been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 878

    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
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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

0
2. Add Sec.  878.3510 to subpart D to read as follows:

Sec.  878.3510   Carbon dioxide gas controlled tissue expander.

    (a) Identification. A carbon dioxide gas controlled tissue expander
is a prescription device intended for temporary subcutaneous or
submuscular implantation to stretch the skin for surgical applications,
specifically to develop surgical flaps and additional tissue coverage.
The device is made of an inflatable elastomer shell and is filled with
carbon dioxide gas. The device utilizes a remote controller to
administer doses of carbon dioxide gas from an implanted canister
inside the device.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) In-vivo performance testing must be conducted to obtain the
adverse event profile associated with use, and demonstrate that the
device performs as intended under anticipated conditions of use.
    (2) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (3) Performance data must demonstrate the sterility of patient-
contacting components of the device.
    (4) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
    (i) Cycle testing of expander showing that there are no leaks or
tears after repeated cycling;
    (ii) Mechanical assessment of implanted carbon dioxide
(CO2) canister including high impact testing;
    (iii) Leak testing of expander showing that device does not leak
CO2;
    (iv) Assessment of gas permeability during expansion and after full
expansion; and
    (v) Mechanical assessment of expander (tensile set, breaking force,
shell joint test, and fused or adhered joint testing).
    (5) Performance data must be provided to demonstrate the
electromagnetic compatibility, electrical safety, and wireless
compatibility of the device.

    (6) Software verification, validation, and hazard analysis must be
performed.
    (7) Performance data must support shelf life by demonstrating
continued sterility of the device or the sterile components, package
integrity, and device functionality over the identified shelf life.
    (8) Human factors testing and analysis must validate that the
device design and labeling are sufficient for the end user.
    (9) Physician labeling must include:
    (i) The operating parameters, name, and model number of the
indicated external dosage controller;
    (ii) Information on how the device operates and the typical course
of treatment;
    (iii) Information on the population for which the device has been
demonstrated to be effective;
    (iv) A detailed summary of the device technical parameters; and
    (v) Provisions for choosing an appropriate size implant that would
be exchanged for the tissue expander.
    (10) Patient labeling must include:
    (i) Warnings, precautions, and contraindications, and adverse
events/complications;
    (ii) Information on how the device operates and the typical course
of treatment;
    (iii) The probable risks and benefits associated with the use of
the device;
    (iv) Post-operative care instructions; and
    (v) Alternative treatments.
    (11) Patient training must include instructions for device use,
when it may be necessary to contact a physician, and cautionary
measures to take when the device is implanted.

    Dated: January 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02357 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 132 (Tuesday, July 12, 2022)]
[Notices]
[Page 41374]
[FR Doc No: 2022-14749]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95202; File No. SR-MEMX-2022-13]

Self-Regulatory Organizations; MEMX LLC; Notice of Withdrawal of
a Proposed Rule Change To Amend Its Fee Schedule To Adopt Connectivity
Fees

July 6, 2022.
    On May 6, 2022, MEMX LLC (``MEMX'') filed with the Securities and
Exchange Commission (``Commission''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend its Fee Schedule to adopt Connectivity
Fees. The proposed rule change was immediately effective upon filing
with the Commission pursuant to Section 19(b)(3)(A) of the Act.\3\ The
proposed rule change was published for comment in the Federal Register
on May 20, 2022.\4\ On July 1, 2022, MEMX withdrew the proposed rule
change (SR-MEMX-2022-13).
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ See Securities Exchange Act Release No. 94924 (May 16,
2022), 87 FR 31026
    \5\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-14749 Filed 7-11-22; 8:45 am]
BILLING CODE 8011-01-P