[Federal Register Volume 88, Number 161 (Tuesday, August 22, 2023)]
[Notices]
[Pages 57146-57149]
[FR Doc No: 2023-17978]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98146; File No. SR-C2-2023-019]

Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Its Fees Schedule Relating to the Options Regulatory Fee

August 16, 2023.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the

``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 14, 2023, Cboe C2 Exchange, Inc. (the ``Exchange'' or ``C2'')
filed with the Securities and Exchange Commission (the ``Commission'')
the proposed rule change as described in Items I and II, below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe C2 Exchange, Inc. (the ``Exchange'' or ``C2 Options'')
proposes to amend its Fees Schedule relating to the Options Regulatory
Fee. The text of the proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/ctwo/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to reduce the Options Regulatory Fee
(``ORF'') from $0.0003 per contract to $0.0002 per contract in order to
help ensure that revenue collected from the ORF, in combination with
other regulatory fees and fines, does not exceed the Exchange's total
regulatory costs.\3\
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    \3\ The Exchange initially filed the proposed rule change on
August 1, 2023 (SR-C2-2023-018). On August 14, 2023, the Exchange
withdrew that filing and submitted this filing.
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    The ORF is assessed by C2 Options to each Trading Permit Holder
(``TPH'') for options transactions cleared by the TPH that are cleared
by the Options Clearing Corporation (``OCC'') in the customer range,
regardless of the exchange on which the transaction occurs.\4\ In other
words, the Exchange imposes the ORF on all customer-range transactions
cleared by a TPH, even if the transactions do not take place on the
Exchange. The ORF is collected by OCC on behalf of the Exchange from
the Clearing Trading Permit Holder (``CTPH'') or non-CTPH that
ultimately clears the transaction. With respect to linkage
transactions, C2 Options reimburses its routing broker providing
Routing Services pursuant to C2 Options Rule 5.36 for options
regulatory fees it incurs in connection with the Routing Services it
provides.
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    \4\ The Exchange notes ORF also applies to customer-range
transactions executed during Global Trading Hours.
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    Revenue generated from ORF, when combined with all of the
Exchange's other regulatory fees and fines, is designed to recover a
material portion of the regulatory costs to the Exchange of the
supervision and regulation of TPH customer options business including
performing routine surveillances, investigations, examinations,
financial monitoring, and policy, rulemaking, interpretive, and
enforcement activities. Regulatory costs include direct regulatory
expenses and certain indirect expenses for work allocated in support of
the regulatory function. The direct expenses include in-house and
third-party service provider costs to support the day-to-day regulatory
work such as surveillances, investigations and examinations. The
indirect expenses include support from such areas as human resources,
legal, information technology, facilities and accounting. These
indirect expenses are estimated to be approximately 25% of C2's total
regulatory costs for 2023. Thus, direct expenses are estimated to be
approximately 75% of total regulatory costs for 2023. In addition, it
is C2 Options' practice that revenue generated from ORF not exceed more
than 75% of total annual regulatory costs.
    These expectations are estimated, preliminary and may change. There
can be no assurance that the Exchange's final costs for 2023 will not
differ materially from these expectations and prior practice, nor can
the Exchange predict with certainty whether options volume will remain
at the current level going forward. The Exchange notes however, that
when combined with the Exchange's other non-ORF regulatory fees and
fines, the revenue being generated by ORF using the current rate
results in combined revenue that is running in excess of the Exchange's
estimated regulatory costs for the year.\5\ Particularly, as discussed
above, the options market has seen a substantial increase in volume
over the first half of the year, up even from last year's unprecedented
volume. This increase resulted in higher volume than was originally
projected by the Exchange (thereby resulting in higher ORF revenue than
projected). Moreover, in addition to projected reductions in regulatory
expenses, the Exchange's expenses have been reduced.\6\ Accordingly,
because revenue generated by the current ORF rates, when combined with
the Exchange's other non-ORF regulatory fees and fines, is expected to
exceed the Exchange's regulatory costs for the year, the Exchange
proposes to decrease its ORF rate. Particularly, the Exchange believes
that by decreasing the ORF, as amended, when combined with all of the
Exchange's other regulatory fees and fines, would allow the Exchange to
continue covering a material portion of its regulatory costs, while
lessening the potential for generating excess revenue that may
otherwise occur using the current rate.\7\
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    \5\ Consistent with Rule 2.2 (Regulatory Revenue), the Exchange
notes that notwithstanding the excess ORF revenue collected to date,
it has not used such revenue for nonregulatory purposes.
    \6\ The Exchange notes that in connection with proposed ORF rate
changes, it provides the Commission confidential details regarding
the Exchange's projected regulatory revenue, including projected
revenue from ORF, along with a breakout of its projected regulatory
expenses, including both direct and indirect allocations.
    \7\ The Exchange notes that its regulatory responsibilities with
respect to TPH compliance with options sales practice rules have
largely been allocated to FINRA under a 17d-2 agreement. The ORF is
not designed to cover the cost of that options sales practice
regulation.

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    The Exchange monitors its regulatory costs and revenues at a
minimum on a semi-annual basis. If the Exchange determines regulatory
revenues exceed or are insufficient to cover a material portion of its
regulatory costs in a given year, the Exchange will adjust the ORF by
submitting a fee change filing to the Commission. The Exchange also
notifies TPHs of adjustments to the ORF via Exchange Notice, including
for the change being proposed herein.\8\ Based on the Exchange's most
recent semi-annual review, the Exchange is proposing to reduce the
amount of ORF that will be collected by the Exchange from $0.0003 per
contract side to $0.0002 per contract side. The proposed decrease is
based on the Exchange's estimated projections for its regulatory costs,
which have decreased, balanced with recent options volumes, which has
increased. For example, total options contract volume in June 2023 was
approximately 19% higher than the total options contract volume in June
2022 and the total options contract volume in March 2023 was
approximately 12% higher than the total options contract volume in
March 2022.\9\ In fact, March 2023 was the high total volume in month
in the history of U.S. equities options industry and May 2023 was the
third highest options volume month in the history of U.S. equity
options industry.\10\ The below table displays monthly total volumes
for 2023.\11\
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    \8\ See Exchange Notice, C2023071301 ``Cboe Options Exchanges
Regulatory Fee Update Effective August 1, 2023.'' The Exchange will
endeavor to provide TPHs with notice of any future changes at least
30 calendar days prior to the effective date of the change.
    \9\ See https://www.theocc.com/newsroom/press-releases/2023/07-05-occ-clears-962-6m-contracts-in-june-2023,-up-19-4-year-over-year
and https://www.theocc.com/newsroom/press-releases/2023/04-04-occ-clears-over-1b-total-contracts-in-march-2023-highest-month-on-record-and-up-12-2-year.
    \10\ Id. See also https://www.theocc.com/newsroom/press-releases/2023/06-02-occ-clears-949-1m-contracts-in-may-2023-third-highest-month-on-record.
    \11\ Volume data in the table represents numbers of contracts;
each contract has two sides. June numbers reflect volumes through
June 29, 2023.

------------------------------------------------------------------------
                Month                   Total volume     Customer sides
------------------------------------------------------------------------
January 2023........................       919,299,330       802,712,235
February 2023.......................       883,234,837       780,284,838
March 2023..........................     1,052,984,722       915,674,991
April 2023..........................       760,808,909       673,183,772
May 2023............................       944,534,205       826,490,407
June 2023...........................       909,616,267       801,688,960
------------------------------------------------------------------------

    The Exchange will continue to monitor the amount of revenue
collected from the ORF to ensure that it, in combination with its other
regulatory fees and fines, does not exceed the Exchange's total
regulatory costs.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of section 6(b) of the Act.\12\ Specifically, the
Exchange believes the proposed rule change is consistent with section
6(b)(4) of the Act,\13\ which provides that Exchange rules may provide
for the equitable allocation of reasonable dues, fees, and other
charges among its TPHs and other persons using its facilities.
Additionally, the Exchange believes the proposed rule change is
consistent with the section 6(b)(5) \14\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(4).
    \14\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes the proposed fee change is reasonable because
customer transactions will be subject to a lower ORF fee than the
current rate. Moreover, the proposed reduction is necessary in order to
lessen the potential that the Exchange collects revenue in excess of
its anticipated regulatory costs, in combination with other regulatory
fees and fines, which is consistent with the Exchange's practices. The
Exchange had designed the ORF to generate revenues that would be less
than or equal to 75% of the Exchange's regulatory costs, which is
consistent with the view of the Commission that regulatory fees be used
for regulatory purposes and not to support the Exchange's business
operations. As discussed above, however, after its semi-annual review
of its regulatory costs and regulatory revenues, which includes
revenues from ORF and other regulatory fees and fines, the Exchange
determined that absent a reduction in ORF, it would be collecting
revenue in excess of 75% of its regulatory costs. Indeed, the Exchange
notes that when taking into account the recent options volume, coupled
with the projected reduction in regulatory costs, it estimates the ORF
will generate revenues that would cover more than the approximated 75%
of the Exchange's projected regulatory costs. Moreover, when coupled
with the Exchange's other regulatory fees and revenues, the Exchange
estimates ORF to generate over 100% of the Exchange's projected
regulatory costs. As such, the Exchange believes it's reasonable and
appropriate to decrease the ORF amount from $0.0003 to $0.0002 per
contract side.
    The Exchange also believes the proposed fee change is equitable and
not unfairly discriminatory in that it is charged to all TPHs on all
their transactions that clear in the customer range at the OCC. The
Exchange believes the ORF ensures fairness by assessing higher fees to
those TPHs that require more Exchange regulatory services based on the
amount of customer options business they conduct. Regulating customer
trading activity is much more labor intensive and requires greater
expenditure of human and technical resources than regulating non-
customer trading activity, which tends to be more automated and less
labor-intensive. For example, there are costs associated with main
office and branch office examinations (e.g., staff and travel
expenses), as well as investigations into customer complaints and the
terminations of Registered persons. As a result, the costs associated
with administering the customer component of the Exchange's overall
regulatory program are materially higher than the costs associated with
administering the non-customer component (e.g., TPH proprietary
transactions) of its regulatory program.\15\ Moreover, the Exchange
notes that it has broad regulatory responsibilities with respect to its
TPHs' activities, irrespective of where their transactions take place.

Many of the Exchange's surveillance programs for customer trading
activity may require the Exchange to look at activity across all
markets, such as reviews related to position limit violations and
manipulation. Indeed, the Exchange cannot effectively review for such
conduct without looking at and evaluating activity irregardless of
where it transpires. In addition to its own surveillance programs, the
Exchange also works with other SROs and exchanges on intermarket
surveillance related issues. Through its participation in the
Intermarket Surveillance Group (``ISG'') \16\ the Exchange shares
information and coordinates inquiries and investigations with other
exchanges designed to address potential intermarket manipulation and
trading abuses. Accordingly, there is a strong nexus between the ORF
and the Exchange's regulatory activities with respect to its TPHs'
customer trading activity.
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    \15\ If the Exchange changes its method of funding regulation or
if circumstances otherwise change in the future, the Exchange may
decide to modify the ORF or assess a separate regulatory fee on TPH
proprietary transactions if the Exchange deems it advisable.
    \16\ ISG is an industry organization formed in 1983 to
coordinate intermarket surveillance among the SROs by cooperatively
sharing regulatory information pursuant to a written agreement
between the parties. The goal of the ISG's information sharing is to
coordinate regulatory efforts to address potential intermarket
trading abuses and manipulations.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. This proposal does not create
an unnecessary or inappropriate intra-market burden on competition
because the ORF applies to all customer activity, thereby raising
regulatory revenue to offset regulatory expenses. It also supplements
the regulatory revenue derived from non-customer activity. The Exchange
notes, however, the proposed change is not designed to address any
competitive issues. Indeed, this proposal does not create an
unnecessary or inappropriate inter-market burden on competition because
it is a regulatory fee that supports regulation in furtherance of the
purposes of the Act. The Exchange is obligated to ensure that the
amount of regulatory revenue collected from the ORF, in combination
with its other regulatory fees and fines, does not exceed regulatory
costs.

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

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

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

    The foregoing rule change is effective upon filing pursuant to
section 19(b)(3)(A) \17\ of the Act and subparagraph (f)(2) of Rule
19b-4 \18\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
section 19(b)(2)(B) \19\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \19\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-C2-2023-019 on the subject line.

Paper Comments

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

All submissions should refer to file number SR-C2-2023-019. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-C2-2023-019 and should be
submitted on or before September 12, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-17978 Filed 8-21-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 171 (Thursday, September 4, 2014)]
[Notices]
[Pages 52732-52733]
[FR Doc No: 2014-21051]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1264]

Submission of a Proposed Draft Guidance for Industry on
Developing Drugs for Treatment of Duchenne Muscular Dystrophy;
Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to discuss issues related to developing drugs for
Duchenne muscular dystrophy (DMD). During a public-private policy forum
for DMD on December 12, 2013, FDA agreed that Parent Project Muscular
Dystrophy (PPMD) and other interested parties in the DMD community
could submit for FDA consideration a proposal for a draft guidance for
industry on developing drugs for DMD. That proposed draft guidance was
submitted to FDA on June 25, 2014. FDA values the guidance provided by
the DMD community and is posting the document to seek additional
guidance and public comment.

DATES: Submit electronic or written comments by October 6, 2014.

ADDRESSES: Submit written requests for single copies of the proposed
draft guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the proposed draft guidance document.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Colleen LoCicero, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4242, Silver Spring, MD 20993-0002, 301-
796-1114<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Comments

    FDA invites comment on all matters relating to topics for
consideration regarding DMD drug development. This request is not
limited to comments on the proposal described in the submission by
PPMD.
    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

II. Electronic Access

    Persons with access to the Internet may obtain the proposed draft
guidance document at http://www.regulations.gov.

    Dated: August 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21051 Filed 9-3-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 7, 2009 (Volume 74, Number 128)]
[Notices]
[Page 32138-32139]
[DOCID:fr07jy09-38]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP09-433-000; PF09-4-000]

Fayetteville Express Pipeline LLC; Notice of Application

June 26, 2009.
    Take notice that on June 15, 2009, Fayetteville Express Pipeline
LLC (Fayetteville Express), 500 Dallas Street, Suite 1000, Houston,
Texas 77002, filed an application in Docket No. CP09-433-000 pursuant
to section 7(c) of the Natural Gas Act (NGA), and parts 157 and 284 of
the Commission's regulations requesting: (1) Authorization to construct
and operate a new approximately 185-mile, 42-inch natural gas pipeline
located in Arkansas and Mississippi capable of transporting up to
2,000,000 Dth/day; (2) a blanket certificate authorizing Fayetteville
Express to engage in certain self-implementing routine activities under
part 157, subpart F, of the Commission's regulations; and (3) a blanket
certificate authorizing Fayetteville Express to transport natural gas,
on an open access and self-implementing basis, under part 284, subpart
G of the Commission's regulations. Additionally, Fayetteville Express
seeks approval of its proposed recourse rates, and pro forma tariff,
all as more fully set forth in the application which is on file with
the Commission and open for public inspection.
    Any questions regarding the applications should be directed to
Ronald Brown, Vice President, Fayetteville Express Pipeline LLC, 500
Dallas Street, Suite 1000, Houston, Texas 77002; telephone: (713) 369-
9290 or e-mail<EMAIL_ADDRESS>    The filing is available for review at the Commission in the Public
Reference Room or may be viewed on the Commission's Web site Web at
http://www.ferc.gov using the eLibrary link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.

    On November 25, 2008, the Commission staff granted Fayetteville
Express' request to utilize the Pre-Filing Process and assigned Docket
No. PF09-4 to staff activities involved with the Fayetteville Express
project. Now as of the filing of the June 15, 2009 application, the
Pre-Filing Process for this project has ended. From this time forward,
this proceeding will be conducted in Docket No. CP09-433-000, as noted
in the caption of this Notice.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made in the proceeding with the Commission
and must mail a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for review in the Commission's Public
Reference Room in Washington, DC. There is an eSubscription link on the
Web site that enables subscribers to receive e-mail notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please e-mail<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: July 17, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-15894 Filed 7-6-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: April 21, 2009 (Volume 74, Number 75)]
[Notices]
[Page 18223-18224]
[DOCID:fr21ap09-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of FERC Staff Attendance at Southwest Power Pool Board of
Directors/Members Committee Meeting, Southwest Power Pool Regional
State Committee Meeting and Cost Allocation Working Group Meeting

April 14, 2009.
    The Federal Energy Regulatory Commission hereby gives notice that
members of its staff may attend the meetings of the Southwest Power
Pool (SPP) Regional State Committee, SPP Members Committee, SPP Board
of Directors and Cost Allocation Working Group, as noted below. Their
attendance is part of the Commission's ongoing outreach efforts.

SPP Regional State Committee Meeting

April 27, 2009 (1 p.m.-5 p.m.), Skirvin Hotel, One Park Avenue,
Oklahoma City, OK 73102,<PHONE_NUMBER>.

SPP Board of Directors--Members Committee Meeting

April 28, 2009 (8:30 a.m.-3 p.m.), Skirvin Hotel, One Park Avenue,
Oklahoma City, OK 73102,<PHONE_NUMBER>.

SPP Cost Allocation Working Group Meeting

April 29, 2009 (8 a.m.-12 p.m.), Skirvin Hotel, One Park Avenue,
Oklahoma City, OK 73102,<PHONE_NUMBER>.
    The discussions may address matters at issue in the following
proceedings:
Docket No. ER06-451, Southwest Power Pool, Inc.
Docket Nos. ER07-319 and EL07-73, Southwest Power Pool, Inc.
Docket No. ER07-371, Southwest Power Pool, Inc.
Docket No. ER07-1255, Southwest Power Pool, Inc.
Docket No. ER08-923, Southwest Power Pool, Inc.
Docket No. ER08-1307, Southwest Power Pool, Inc.
Docket No. ER08-1308, Southwest Power Pool, Inc.
Docket No. ER08-1357, Southwest Power Pool, Inc.
Docket No. ER08-1358, Southwest Power Pool, Inc.
Docket No. ER08-1419, Southwest Power Pool, Inc.
Docket No. ER08-1516, Southwest Power Pool, Inc.
Docket No. EL08-80-, Oklahoma Corporation Commission
Docket No. ER09-35, Tallgrass Transmission LLC
Docket No. ER09-36, Prairie Wind Transmission LLC
Docket No. ER09-149, Southwest Power Pool, Inc.
Docket No. ER09-262, Southwest Power Pool, Inc.
Docket No. ER09-336, Southwest Power Pool, Inc.
Docket No. ER09-342, Southwest Power Pool, Inc.
Docket No. ER09-443, Southwest Power Pool, Inc.
Docket No. ER09-659, Southwest Power Pool, Inc.
Docket No. ER09-748, Southwest Power Pool, Inc.
Docket No. OA08-5 and EL09-40, Southwest Power Pool, Inc.
Docket No. OA08-60, Southwest Power Pool, Inc.
Docket No. OA08-61, Southwest Power Pool, Inc.
Docket No. OA08-104, Southwest Power Pool, Inc.
    These meetings are open to the public.
    For more information, contact Patrick Clarey, Office of Energy
Market Regulation, Federal Energy Regulatory Commission at (317) 249-
5937 or<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. E9-9078 Filed 4-20-09; 8:45 am]

BILLING CODE 6717-01-P


Jackson County Wind Rose Analysis  2000 Wind Speed and Wind Direction on 4 Highest 8 hour Ozone Days Maximum 8 hour ozone concentration of 91 ppb Maximum 8 hour ozone concentration of 90 ppb Maximum 8 hour ozone concentration of 91 ppb Maximum 8 hour Ozone concentration of 82 ppb


[Federal Register Volume 79, Number 76 (Monday, April 21, 2014)]
[Notices]
[Page 22183]
[FR Doc No: 2014-09030]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms and Record Keeping Requirements; Agency
Information Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collections and their expected
burden. The Federal Register Notice with a 60-day comment period was
published January 16, 2014 at Vol. 79, No. 11 p. 2936-2938.

DATES: Comments must be submitted on or before May 28, 2014.

FOR FURTHER INFORMATION CONTACT: Andrea Noel at the National Highway
Traffic Safety Administration, Office of Defects Investigation, NVS-
210, 1200 New Jersey Avenue SE., Washington, DC 20590, phone 202-493-
0210.

SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: Record Retention.
    OMB Number: 2127-0042.
    Type of Request: Renewal of a currently approved information
collection.
    Abstract: Under 49 U.S.C. 30166(e), NHTSA ``reasonably may require
a manufacturer of a motor vehicle or motor vehicle equipment to keep
records, and a manufacturer, distributor or dealer to make reports, to
enable [NHTSA] to decide whether the manufacturer, distributor, or
dealer has complied or is complying with this chapter or a regulation
prescribed or order issued under this chapter.''
    To ensure that NHTSA will have access to this type of information,
the agency exercised the authority granted in 49 U.S.C. 30166(e) and
promulgated 49 CFR Part 576 Record Retention, initially published on
August 20, 1974 and most recently amended on July 10, 2002 (67 FR
45873), requiring manufacturers to retain one copy of all records that
contain information concerning malfunctions that may be related to
motor vehicle safety for a period of five calendar years after the
record is generated or acquired by the manufacturer. Manufacturers are
also required to retain for ten years (five years for manufacturers of
child seats and tires) the underlying records related to early warning
reporting (EWR) information submitted under 49 CFR Part 579.
    Affected Public: Businesses or other for profit.
    Estimated Total Annual Burden: 40,020 annual hours burden (20
respondents times 1 hour, plus 1,000 respondents times 40 hours).
ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725-17th
Street NW., Washington, DC 20503, Attention NHTSA Desk Officer.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.
    A Comment to OMB is most effective if OMB receives it within 30
days of publication.

    Issued in Washington, DC, on April 14, 2014.
Frank S. Borris, II,
Director, Office of Defects Investigation.
[FR Doc. 2014-09030 Filed 4-18-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 87, Number 108 (Monday, June 6, 2022)]
[Notices]
[Pages 34275-34277]
[FR Doc No: 2022-12099]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3787]

Electromagnetic Compatibility of Medical Devices; Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is

announcing the availability of a final guidance entitled
``Electromagnetic Compatibility (EMC) of Medical Devices.'' FDA has
developed this guidance document to recommend information that should
be provided in a premarket submission (i.e., premarket approval
application (PMA), humanitarian device exemption (HDE), premarket
notification (510(k)) submission, investigational device exemption
(IDE), De Novo request, and certain biologics license applications
(BLAs) and investigational new drug (IND) applications to demonstrate
electromagnetic compatibility (EMC) for electrically powered medical
devices and medical devices with electrical or electronic functions.
This guidance provides specific technical information to address the
recommendations originally described in the guidance entitled
``Information to Support a Claim of Electromagnetic Compatibility (EMC)
of Electrically-Powered Medical Devices,'' which was published July 11,
2016 (2016 EMC guidance).

DATES: The announcement of the guidance is published in the Federal
Register on June 6, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-3787 for ``Electromagnetic Compatibility (EMC) of Medical
Devices.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Electromagnetic Compatibility (EMC) of Medical Devices'' to the
Office of Policy, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002; or to the Office of Communication,
Outreach and Development, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Seth J. Seidman, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 62, Rm. 1108, Silver Spring, MD 20993-0002, 301-
796-2477; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this guidance document to recommend information
that should be provided in a premarket submission (i.e., PMA, HDE,
510(k), IDE, De Novo request, and certain BLAs and IND applications) to
demonstrate EMC for electrically powered medical devices and medical
devices with electrical or electronic functions. Typically, the review
of EMC information in a submission is based on the risk associated with
malfunction or degradation of the medical device under consideration,
where malfunction or degradation could be caused by inadequate EMC. The
review is also based on the use of appropriate consensus standards.
This guidance, when final, will replace the FDA guidance entitled
``Information to Support a Claim of Electromagnetic

Compatibility (EMC) of Electrically-Powered Medical Devices'' (2016 EMC
guidance), which was published July 11, 2016. This guidance provides
additional technical information to address the recommendations in the
2016 EMC guidance.
    FDA recognizes and anticipates that the Agency and industry may
need up to 1 year to perform activities to operationalize the policies
within the guidance, only for in vitro diagnostic products. Because
this guidance generally reflects current practice for the assessment of
EMC for other device types, but some activities to fully operationalize
the policies are needed (e.g., updates to eSTAR \1\), FDA intends to
implement this guidance 60 days after issuance for device types within
the scope of this guidance, excluding in vitro diagnostic products. If
new information regarding electromagnetic compatibility as outlined in
this guidance is not included in a premarket submission for an in vitro
diagnostic received by FDA before or up to 1 year after the publication
of this guidance or for other device types within the scope of this
guidance before or up to 60 days after the publication of this
guidance, FDA does not generally intend to request such information
during the review of the submission. FDA does, however, intend to
review any such information if submitted.
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/medical-devices/premarket-notification-510k/voluntary-estar-program.
---------------------------------------------------------------------------

    A notice of availability of the draft guidance appeared in the
Federal Register of November 17, 2020 (85 FR 73276). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including clarification of scope; addressing the use
of IEC 60601-1-2:2020, which was published after the draft guidance was
issued; and adding a transition period to facilitate the implementation
of the guidance.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on EMC of medical devices. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products or from the Center for Biologics
Evaluation and Research at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. This guidance document is also available at
https://www.regulations.gov and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download
an electronic copy of ``Electromagnetic Compatibility (EMC) of Medical
Devices'' may send an email request to [email protected] to
receive an electronic copy of the document. Please use the document
number 1400057 and complete title to identify the guidance you are
requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations have been approved by
OMB as listed in the following table:

----------------------------------------------------------------------------------------------------------------
               21 CFR part                                       Topic                          OMB Control No.
----------------------------------------------------------------------------------------------------------------
807, subpart E..........................  Premarket notification.............................          0910-0120
814, subparts A through E...............  Premarket approval.................................          0910-0231
814, subpart H..........................  Humanitarian Device Exemption......................          0910-0332
812.....................................  Investigational Device Exemption...................          0910-0078
860, subpart D..........................  De Novo classification process.....................          0910-0844
800, 801, and 809.......................  Medical Device Labeling Regulations................          0910-0485
803.....................................  Medical Devices; Medical Device Reporting;                   0910-0437
                                           Manufacturer reporting, importer reporting, user
                                           facility reporting, distributor reporting.
820.....................................  Current Good Manufacturing Practice (CGMP); Quality          0910-0073
                                           System (QS) Regulation.
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    Dated: May 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12099 Filed 6-3-22; 8:45 am]
BILLING CODE 4164-01-P