[Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)]
[Proposed Rules]
[Pages 41449-41450]
[FR Doc No: 2015-16919]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2013-0816; FRL-9930-29-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Delaware; Nonattainment New Source Review; Emission Offset Provisions;
Reopening of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: Environmental Protection Agency (EPA) is reopening the comment
period for a notice of proposed rulemaking (NPR) published on May 26,
2015. In the NPR, EPA proposed disapproval of a revision to the
Delaware State Implementation Plan (SIP) related to nonattainment New
Source Review (NSR) preconstruction permit program requirements for
emission offsets. A commenter requested additional time to review the
proposal and prepare comments. In response to this request, EPA is
reopening the comment period for this proposal through August 14, 2015.
All comments received on or before August 14, 2015 will be entered into
the public record and considered by EPA before taking final action on
the proposed rule. Comments submitted between the close of the original
comment period and the reopening of this comment period will be
accepted and considered.

DATES: The comment period for the notice of proposed rulemaking (NPR)
published on May 26, 2015 (80 FR 30015), is reopened. Comments must be
received on or before August 14, 2015.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2013-0816 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2013-0816, Mr. David Campbell, Associate
Director, Office of Permits and Air Toxics, Mailcode 3AP10, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2013-0816. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your

comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Delaware Department of Natural Resources and
Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover, Delaware
19903.

FOR FURTHER INFORMATION CONTACT: Mrs. Amy Johansen,<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On May 26, 2015, EPA published a notice of
proposed rulemaking (80 FR 30015). In the NPR, EPA proposed disapproval
of a revision to the Delaware SIP related to nonattainment NSR
preconstruction permit program requirements for emission offsets. In
that action, EPA proposed disapproval, because the submittal did not
satisfy the requirements of Clean Air Act (CAA) or the Federal
implementing regulations, which establish the criteria under which the
owner or operator of a new or modified major stationary source must
obtain the required emission offsets ``from the same source or other
sources in the same nonattainment area'' with limited exceptions, for
Delaware's nonattainment NSR preconstruction permitting program. In
addition, EPA proposed disapproval of the SIP revision because Delaware
exercises authorities that are reserved for EPA under section 107 of
the CAA.

    Dated: June 25, 2015.
Shawn M. Garvin,
Regional Administrator, Region III.
[FR Doc. 2015-16919 Filed 7-14-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Rules and Regulations]
[Pages 39976-39977]
[FR Doc No: 2019-16934]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2018-0811; FRL-9997-58-Region 6]

Air Plan Approval; Texas; Control of Air Pollution From Motor
Vehicles

AGENCY: Environmental Protection Agency (EPA).

ACTION: Partial withdrawal of direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is withdrawing a
portion of a direct final rule published on June

6, 2019, because relevant adverse comments were received. The rule
pertained to EPA approval of revisions to the Texas State
Implementation Plan (SIP) submitted by the Texas Commission on
Environmental Quality. The revisions remove rules from the Texas SIP
that address motor vehicle anti-tampering requirements and the Low
Income Repair Assistance Program (LIRAP) for certain participating
counties. In a separate subsequent final rulemaking, EPA will address
the portion of the direct final rule on which relevant adverse comments
were received.

DATES: Effective August 13, 2019, the EPA withdraws amendatory
instruction 2 from the direct final rule published on June 6, 2019, at
84 FR 26349.

FOR FURTHER INFORMATION CONTACT: Carrie Paige, EPA Region 6 Office,
214-665-6521<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' means the EPA. On June 6, 2019, we published a direct final
rule to approve revisions to the Texas SIP to remove two rules from the
Texas SIP. The revisions remove 30 TAC 114, Subchapter B (the Motor
Vehicle Anti-tampering Requirements) in its entirety; and 30 TAC 114,
Section 114.86 (the LIRAP for Participating Early Action Compact (EAC)
Counties) from the SIP (see 84 FR 26349, June 6, 2019). The direct
final rule was published without prior proposal because we anticipated
no adverse comments. We stated in the direct final rule that if we
received relevant adverse comments by July 8, 2019, we would publish a
timely withdrawal in the Federal Register. We received relevant adverse
comments on the portion of the direct final rule regarding our approval
of revisions to the Texas SIP to remove rules from the Texas SIP that
address the LIRAP for Participating EAC Counties at 30 TAC 114, Section
114.86 and accordingly are withdrawing that portion of the direct final
rule on which adverse comments were received. In a separate subsequent
final rulemaking, we will address the comments received. The portion of
the direct final rule approving revisions to remove 30 TAC 114,
Subchapter B (the Motor Vehicle Anti-tampering Requirements) \1\ in its
entirety from the Texas SIP received only supportive comments and will
be effective on September 4, 2019, as provided in the direct final
action at 84 FR 26349.
---------------------------------------------------------------------------

    \1\ Due to an apparent oversight, 30 TAC 114 Subchapter B (Motor
Vehicle Anti-Tampering Requirements) was not included in Table (c)
``EPA Approved Regulations in the Texas SIP'' at 40 CFR 52.2270, so
there is no amendatory instruction in the direct final rule to
remove those provisions.
---------------------------------------------------------------------------

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Volatile organic compounds.

    Dated: August 1, 2019.
David Gray,
Acting Regional Administrator, Region 6.

0
Accordingly, amendatory instruction 2 from the direct final rule
published in the Federal Register on June 6, 2019 (84 FR 26349), which
was to become effective on September 4, 2019, is withdrawn.

[FR Doc. 2019-16934 Filed 8-12-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44883-44885]
[FR Doc No: 2016-16157]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1673]

Updating Abbreviated New Drug Application Labeling After the
Marketing Application for the Reference Listed Drug Has Been Withdrawn;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Updating
ANDA Labeling After the Marketing Application for the Reference Listed
Drug Has Been Withdrawn.'' This draft guidance describes a process for
updating labeling for abbreviated new drug applications (ANDAs) in
cases where FDA has withdrawn approval of the new drug application
(NDA) for the ANDA's reference listed drug (RLD) for reasons other than
safety or effectiveness. The process described in this guidance is
intended to complement existing Agency authorities and processes.

DATES: Although you can comment on any guidance at any time (see 21 CFR

10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 9, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-1673 for ``Updating ANDA Labeling After the Marketing
Application for the Reference Listed Drug Has Been Withdrawn; Draft
Guidance for Industry; Availability.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Emily Helms Williams, Office of
Regulatory Policy, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Updating ANDA Labeling After the Marketing Application for
the Reference Listed Drug Has Been Withdrawn.'' This draft guidance
describes a process for updating labeling for ANDAs in cases where FDA
has withdrawn approval of the NDA for the ANDA's RLD for reasons other
than safety or effectiveness.
    A generic drug is required to have the same labeling as the RLD at
the time of approval, except for changes required because of
differences approved under a suitability petition (see section
505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
and 21 CFR 314.93) or because the generic drug and the RLD are
``produced or distributed by different manufacturers'' (see section
505(j)(2)(A)(v) of the FD&C Act and Sec.  314.94(a)(8)(iv) (21 CFR
314.94(a)(8)(iv))). As a general matter, all holders of marketing
applications for drug products have an ongoing obligation to ensure
their product labeling is accurate, and not false or misleading. ANDA
holders are expected to update their labeling after FDA has approved
relevant changes to the labeling for the corresponding NDA RLD.
    Where approval of an NDA RLD has been withdrawn, the NDA holder can
no longer update labeling for the withdrawn RLD. The labeling of ANDAs
that rely on the withdrawn RLD might eventually become inaccurate and
outdated, resulting in labeling that is false and/or misleading, for
example. Likewise, new original ANDAs that rely on the withdrawn RLD
might include proposed labeling based on the last approved RLD labeling
that includes outdated information that is false and/or misleading.
This draft guidance clarifies that consistent with the statute, where
the RLD is withdrawn, certain labeling changes may continue to be made
for pending ANDAs and marketed ANDAs. This draft guidance sets forth a
process for making such changes. The process described in this guidance
is intended to complement existing Agency authorities and processes.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA

on the process for updating ANDA labeling after approval of the NDA for
the RLD has been withdrawn. 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. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in 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. 3501-3520). The
collections of information in Sec.  314.94(a)(8) and 21 CFR 314.97 have
been approved under OMB Control No. 0910-0001.

III. Electronic Access

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

    Dated: June 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16157 Filed 7-8-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 30, 2006 (Volume 71, Number 61)]
[Notices]
[Page 16150-16151]
[DOCID:fr30mr06-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting Motions
To Intervene, Protests, and Comments

March 24, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12646-000.
    c. Date filed: February 1, 2006.
    d. Applicant: City of Broken Bow, Oklahoma.
    e. Name of Project: Pine Creek Lake Hydroelectric Project.
    f. Location: The project would be located at the existing Army
Corps of Engineers Pine Creek Lake Dam on the Little River in McCurtain
County, Oklahoma.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: City of Broken Bow, Oklahoma, 210 N.
Broadway, Broken Bow, Oklahoma 74728,<PHONE_NUMBER>.
    i. FERC Contact: Chris Yeakel,<PHONE_NUMBER>.
    j. Deadline for Filing Comments, Protests, and Motions to
Intervene: 60 days from the issuance date of this notice.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project would use the
existing Army Corps of Engineers' Pine Creek Lake Dam and consist of:
(1) A powerhouse containing two generating units with an installed
capacity of 6.4 megawatts, (2) a proposed 13-foot-diameter steel
penstock (3) a proposed switchyard, (4) a proposed diversion structure,
(5) a proposed tailrace, (6) a proposed 14.4 kilovolt transmission
line; and (7) appurtenant facilities. The project would have an annual
generation of 16.2 gigawatt-hours, which would be sold to a local
utility.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street NE, Room 2A,
Washington DC 20426, or by calling<PHONE_NUMBER>. This filing may also
be viewed on the Commission's Web site 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, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 C.F.R. 385.2001 (a)(1)(iii)
and the instructions on the Commission's web site under ``e-filing''
link. The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'',''COMPETING APPLICATION'' OR
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. Any of the above-
named documents must be filed by providing the original and the number
of copies provided by the Commission's regulations to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    t. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an

agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
[FR Doc. E6-4647 Filed 3-29-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Pages 45578-45579]
[FR Doc No: 2011-19067]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Request for Nominations for Members on a Public Advisory
Committee; Medical Imaging Drugs Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for 12 members to serve on the Medical Imaging Drugs
Advisory Committee in the Center for Drug Evaluation and Research.
    FDA has a special interest in ensuring that women, minority groups,
and individuals with physical disabilities are adequately represented
on advisory committees and, therefore, extends particular encouragement
to nominations for appropriately qualified female, minority, or
physically challenged candidates. Final selection from each vacancy
will be determined by the expertise required to meet specific Agency
needs and in a manner to ensure appropriate balance on membership.

DATES: Nominations should be received before September 27, 2011.

ADDRESSES: All nominations for membership, except for consumer-
nominated members and industry representatives members, should be sent
to Minh Doan (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT:
Minh Doan, Center for Drug Evaluation and Research, Food and Drug
Administration, Bldg. 31, rm. 2417, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, E-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members on the Medical Imaging Drugs Advisory Committee (the
Committee). (Elsewhere in this issue of the Federal Register is a final
rule adding the Medical Imaging Drugs Advisory Committee to the list of
FDA standing advisory committees in 21 CFR 14.100 as well as a request
for nominations of nonvoting industry representatives, and a request
for nominations of voting and nonvoting consumer representatives.)

I. Function

    The Committee advises the Commissioner of Food and Drugs or
designee in discharging responsibilities as they relate to helping to
ensure safe and effective drugs for human use and, as required, any
other product for which FDA has regulatory responsibility. The
Committee also reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in diagnostic and therapeutic procedures using radioactive
pharmaceuticals and contrast media used in diagnostic radiology.

II. Criteria for Members

    Persons nominated for membership on the Committee must have
adequately diversified research and/or clinical experience appropriate
to the work of the committee in such fields as nuclear medicine,
radiology, epidemiology or statistics, and related specialties.
    The specialized training and experience necessary to qualify the
nominee as an expert suitable for appointment is subject to review, but
may include experience in medical practice, teaching, research, and/or
public service relevant to the field of activity of the committee. The
term of office is up to 4 years.

III. Nomination Procedure

    Any interested person may nominate one or more qualified persons
for membership on the Committee. Self-nominations are also accepted.
Nominations must include a current, complete resume or curriculum vitae
for each nominee, current business and/or home address, telephone
number, and e-mail address if available. Nominations must specify the
advisory committee for which the nominee is recommended. Nominations
must also acknowledge that the nominee is aware of the nomination,
unless self-nominated. Potential candidates will be required to provide
detailed information concerning such matters as financial holdings,
employment, and research grants and/or contracts to permit evaluation
of possible sources of conflicts of interest.
    This document is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: July 22, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19067 Filed 7-28-11; 8:45 am]
BILLING CODE 4160-01-P


Kathy Kaufman/RTP/USEPA/US

04/30/2008 04:06 PM

To

"King, Heidi R."<EMAIL_ADDRESS> cc

Ron Evans/RTP/USEPA/US@EPA, Neal Fann/RTP/USEPA/US@EPA, Darryl Weatherhead/RTP/USEPA/US@EPA, Tom Walton/RTP/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA

Subject

Fw: Updated lead benefits chapter

Heidi -- attached are new versions of chapters 1 through  7, plus the executive summary, of the Pb RIA.  Changes in response to your comments and the interagency comments you compiled are highlighted or colored in blue or red.

In terms of the assembled interagency comments from yesterday -- we've made changes in response to as many as we could. Some seem to be clarification questions that don't necessarily require changes to the document, and we can talk through those with you tomorrow.

WeI've also attached the Schwartz 1994 article used to estimate the $/IQ as well as a CDC report for which a commenter indicated that they couldn't find a particular page.

Note this is also being sent formally through OPEI; in the interest of time we are transmitting it informally directly to you.

Thanks!

-- Kathy

Kathy Kaufman

EPA/OAQPS Mail Code C539-03

Research Triangle Park, NC 27711

Phone<PHONE_NUMBER>

Fax<PHONE_NUMBER>


[Federal Register Volume 88, Number 74 (Tuesday, April 18, 2023)]
[Notices]
[Pages 23703-23707]
[FR Doc No: 2023-08143]

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

[Release No. 34-97289; File No. SR-CboeEDGX-2023-028]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend Its Fee Schedule

April 12, 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 April 5, 2023, Cboe EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    Cboe EDGX Exchange, Inc. (the ``Exchange'' or ``EDGX'') proposes to
amend its Fee Schedule. 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/edgx/), 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 amend its Fee Schedule.\3\ The Exchange
first notes that it operates in a highly competitive market in which
market participants can readily direct order flow to competing venues
if they deem fee levels at a particular venue to be excessive or
incentives to be insufficient. More specifically, the Exchange is only
one of 16 options venues to which market participants may direct their
order flow. Based on publicly available information, no single options
exchange has more than 17% of the market share and currently the
Exchange represents only approximately 6% of the market share.\4\ Thus,
in such a low-concentrated and highly competitive market, no single
options exchange, including the Exchange, possesses significant pricing
power in the execution of option order flow. The Exchange believes that
the ever-shifting market share among the exchanges from month to month
demonstrates that market participants can shift order flow or
discontinue to

reduce use of certain categories of products, in response to fee
changes. Accordingly, competitive forces constrain the Exchange's
transaction fees, and market participants can readily trade on
competing venues if they deem pricing levels at those other venues to
be more favorable.
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    \3\ The Exchange initially filed the proposed fee changes on
April 3, 2023 (SR-CboeEDGX-2023-025). On April 5, 2023, the Exchange
withdrew that filing and submitted SR-CboeEDGX-2023-027. On April 5,
2023, the Exchange withdrew that filing and submitted this proposal.
    \4\ See Cboe Global Markets U.S. Options Market Monthly Volume
Summary (March 28, 2023), available at https://markets.cboe.com/us/options/market_statistics/.
---------------------------------------------------------------------------

QCC Initiator/Solicitation Rebate Tiers
    The Exchange's Fee Schedule sets forth standard rebates and rates
applied per contract. For example, the Exchange assesses a fee of $0.20
per contract for SAM \5\ Contra Non-Customer orders (including SAM
Contra Professional orders), yielding fee code SF, and SAM Agency Non-
Customer orders (including SAM Agency Professional orders), yielding
fee code SA.
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    \5\ The term ``SAM'' refers to Solicitation Auction Mechanism.
---------------------------------------------------------------------------

    The Fee Codes and Associated Fees section of the Fee Schedule also
provides for certain fee codes associated with certain order types and
market participants that provide for various other fees or rebates.
Additionally, the Fee Schedule offers tiered pricing which provides
Members \6\ opportunities to qualify for higher rebates or reduced fees
where certain volume criteria and thresholds are met. Tiered pricing
provides an incremental incentive for Members to strive for higher tier
levels, which provides increasingly higher benefits or discounts for
satisfying increasingly more stringent criteria.
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    \6\ See Exchange Rule 1.5(n).
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    For example, pursuant to Footnote 7 of the Fee Schedule, the
Exchange currently offers four QCC \7\ Initiator/Solicitation Rebate
Tiers which provide rebates between $0.14 and $0.26 per contract for
qualifying QCC Agency Orders or Solicitation Agency Orders where a
Member meets incrementally increasing volume thresholds. Particularly,
the Exchange will apply the QCC Initiator/Solicitation Rebate to a
Member that submits QCC Agency Orders or Solicitation Agency Orders,
including a Member who routed orders to the Exchange with a Designated
Give Up, when at least one side of the transaction is of Non-Customer,
Non-Professional capacity. Fee codes QA,\8\ QM,\9\ QO,\10\ SA \11\ and
SC \12\ qualify for these rebates.\13\ There are two separate rebates
that are available under each tier, depending on whether one or both
sides of the transaction are of Non-Customer, Non-Professional
capacity. A qualifying order will receive the rebate under ``Rebate 1''
if one side of the transaction is of Non-Customer, Non-Professional
capacity. A qualifying order will receive the rebate under ``Rebate
2'', if both sides of the transaction are of Non-Customer, Non-
Professional capacity.
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    \7\ The term ``QCC'' refers to Qualified Contingent Cross
Orders.
    \8\ Fee Code ``QA'' is appended to QCC Agency (Customer) Orders.
    \9\ Fee Code ``QM'' is appended to QCC Agency (Non-Customer,
Non-Professional) Orders.
    \10\ Fee Code ``QO'' is appended to QCC Agency (Professional)
orders.
    \11\ Fee Code ``SA'' is appended to SAM Agency Non-Customer
orders.
    \12\ Fee Code ``SC'' is appended to SAM Agency (Customer)
orders.
    \13\ See Cboe EDGX U.S. Options Exchange Fees Schedule, Footnote
7, QCC Initiator/Solicitation Rebate Tiers.
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    The Exchange proposes to amend the QCC Initiator/Solicitation
Rebate Tier program by (1) amending the volume threshold for Tier 3,
(2) eliminating Tier 4, and (3) amending current rebates for Tiers 2
and 3.
    The Exchange proposes to amend the volume thresholds for Tier 3.
Currently, the volume threshold (per month) for Tier 1 is 0 to 999,999
contracts, for Tier 2 is 1,000,000 to 1,999,999 contracts, for Tier 3
is 2,000,000 to 2,999,999 contracts, and for Tier 4 is 3,000,000+
contracts. As proposed, the volume threshold (per month) for Tier 1
remains at 0 to 999,999 contracts, for Tier 2 remains at 1,000,000 to
1,999,999, and for Tier 3 is 2,000,000+ contracts. The Exchange
proposes to eliminate Tier 4, as the volume thresholds and rebates for
these tiers are now contained within the volume threshold for Tier 3,
as amended.
    Further, the Exchange proposes to change the rebates for Tiers 2
and 3. Specifically, the Exchange proposes to increase Tier 2 Rebate 1
from $0.15 to $0.16, Tier 2 Rebate 2 from $0.23 to $0.25, Tier 3 Rebate
1 from $0.16 to $0.18, and Tier 3 Rebate 2 from $0.24 to $0.28. The
rebates for Tier 1 remain unchanged. The proposed rebate changes
account for the elimination of Tier 4, and maintain an established
rebate structure based on volume.
    The Exchange believes the proposed rebate structure is competitive
with rebates offered at another exchange for similar transactions.\14\
Additionally, the proposed changes to the QCC Initiator/Solicitation
Rebate Tiers are designed to incentivize Members to grow their QCC
Initiator and/or Solicitation order flow to receive the enhanced
rebates. The Exchange believes that incentivizing greater QCC Initiator
and/or Solicitation order flow would provide more opportunities for
participation in QCC trades or in the SAM Auction which increases
opportunities for price improvement.
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    \14\ See Box Options Fee Schedule, Section IV(D)(1), which
provides rebates ranging from $0.14 to $0.17 per contract to the
Agency Order where at least one party to the QCC transaction is a
Broker-Dealer or Market-Maker (i.e., a non-customer, non-
professional) and from $0.22 to $0.27 per contract where both
parties to the QCC transaction are a Broker-Dealer or Market-Maker.
---------------------------------------------------------------------------

SAM Standard Fee Changes
    In connection with the proposed changes to Footnote 7 of the Fee
Schedule, the Exchange proposes to amend the Fee Codes and Associated
Fees table of the Fee Schedule to adopt new fee codes for SAM Contra
\15\ Professional \16\ and SAM Agency \17\ Professional orders.
Specifically, the Exchange proposes to adopt new fee codes, SH and SG,
to apply to SAM Contra Professional orders and SAM Agency Professional
orders, respectively. The Exchange proposes to assess a fee of $0.04
per contract for SAM Contra Professional orders yielding fee code SH
and a fee of $0.04 per contract for SAM Agency Professional orders
yield fee code SG.\18\
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    \15\ The term ``SAM Contra Order'' refers to an order submitted
by a Member entering a SAM Agency Order for execution within SAM
that will potentially execute against the SAM Agency Order pursuant
to Rule 21.21 and 21.23.
    \16\ The term ``Professional'' means any person or entity that:
(A) is not a broker or dealer in securities; and (B) places more
than 390 orders in listed options per day on average during a
calendar month for its own beneficial account(s). All Professional
orders shall be appropriately marked by Options Members.
    \17\ The term ``SAM Agency Order'' refers to an order
represented as agent by a Member on behalf of another party and
submitted to SAM for potential price improvement pursuant to Rule
21.21 and 21.23.
    \18\ The proposed rule change also adds fee code SG to the ``QCC
Initiator/Solicitation Rebate Tiers'' table under footnote 7 of the
Fee Schedule.
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    The Exchange also proposes to amend the description of current fee
code SF to provide it applies to SAM Contra Non-Customer, Non-
Professional orders, and to amend the current description of current
fee code SA to provide it applies to SAM Agency Non-Customer, Non-
Professional orders. The Exchange proposes to decrease the standard fee
for SAM Contra Non-Customer, Non-Professional orders and SAM Agency
Non-Customer, Non-Professional orders (i.e., yield fee codes SF and SA,
respectively) from $0.20 per contract to $0.18 per contract.
    The proposed rule change also amends Footnote 6 of the Fee Schedule
to include new fee codes SG and SH, and to reflect the proposed change
in fees for orders yielding fee codes SF and SA.
Customer Volume Tiers
    The Exchange also proposes to amend Footnote 1 (Customer Volume
Tiers), applicable to orders yielding fee codes

PC \19\ and NC.\20\ Pursuant to Footnote 1 of the Fee Schedule, the
Exchange currently offers four Customer Volume Rebate Tiers which
provide rebates between $0.10 and $0.21 per contract for qualifying
customer orders yielding fee codes PC and NC where a Member meets
required criteria. The Exchange proposes to amend the Customer Volume
Rebate Tier program by (1) amending the current rebate for Tier 3, and
(2) amending required criteria for Tier 4.
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    \19\ Fee Code ``PC'' is appended to Customer (contra Non-
Customer), (contra Customer, removes liquidity), Penny orders.
    \20\ Fee Code ``NC'' is appended to Customer (contra Non-
Customer), (contra Customer, removes liquidity), Non-Penny orders.
---------------------------------------------------------------------------

    The Exchange proposes to change the rebates for Tier 3.
Specifically, the Exchange proposes to amend the Tier 3 rebate from
$0.21 to $0.17.\21\ The rebates for Tiers 1, 2, and 4 remain unchanged.
---------------------------------------------------------------------------

    \21\ The Exchange proposes to amend this tier rebate as
described in the table in Footnote 1 and amend the amounts of the
rebates in the Standard Rates table.
---------------------------------------------------------------------------

    The Exchange also proposes to amend the required criteria for Tier
4. Currently, to qualify for Tier 4, a Member must have (1) an ADV in
Customer orders greater than or equal to 0.75% of average OCV; and (2)
an ADV in Customer or Market Maker orders greater than or equal to
1.00% of average OCV; and (3) an ADV in Customer Non-Crossing orders
greater than or equal to 0.40% of average OCV. The Exchange proposes to
amend Tier 4 required criteria to state that a Member must have (1) an
ADV in Customer orders greater than or equal to 0.75% of average OCV;
and (2) an ADV in Customer or Market Maker orders greater than or equal
to 1.50% of average OCV; and (3) an ADV in Customer Non-Crossing orders
greater than or equal to 0.50% of average OCV; and (4) an ADAV in
Customer Non-Crossing orders greater than or equal to 0.40% of average
OCV.
    The Exchange believes that the proposed changes to the Customer
Volume Rebate Tier program are designed overall to incentivize more
Customer order flow and to direct an increase of order flow to the EDGX
Options Order Book. The Exchange believes that an increase in Customer
order flow and overall order flow to the Exchange's Book creates more
trading opportunities, which, in turn attracts Market-Makers. A
resulting increase in Market-Maker activity may facilitate tighter
spreads, which may lead to an additional increase of order flow from
other market participants, further contributing to a deeper, more
liquid market to the benefit of all market participants by creating a
more robust and well-balanced market ecosystem.
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.\22\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \23\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \24\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers. The Exchange also believes the proposed rule
change is consistent with Section 6(b)(4) of the Act,\25\ which
requires that Exchange rules provide for the equitable allocation of
reasonable dues, fees, and other charges among its Trading Permit
Holders and other persons using its facilities.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78f(b).
    \23\ 15 U.S.C. 78f(b)(5).
    \24\ Id.
    \25\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    As described above, the Exchange operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. The proposed rule change
reflects a competitive pricing structure designed to incentivize market
participants to direct their order flow to the Exchange, which the
Exchange believes would enhance market quality to the benefit of all
market participants. The Exchange is only one of several options venues
to which market participants may direct their order flow, and it
represents a small percentage of the overall market. The proposed fee
changes reflect a competitive pricing structure designed to incentivize
market participants to direct their order flow, which the Exchange
believes would enhance market quality to the benefit of all Members.
    The Exchange believes the proposed changes to the QCC Initiator/
Solicitation Rebate Tiers are reasonable, equitable, and not unfairly
discriminatory. The Exchange believes the changes to the QCC Initiator/
Solicitation Rebate Tiers are reasonable overall because, as stated
above, in order to operate in the highly competitive markets, the
Exchange and its competing exchanges seek to offer similar pricing
structures, including assessing comparable rates and offering multiple
enhanced pricing opportunities for various types of orders. Thus, the
Exchange believes the proposed changes are reasonable as they are
generally aligned with and competitive with the amounts assessed for
similar orders on other options exchanges.\26\ Further, the Exchange
believes the rebate tiers, as modified, continue to serve as a
reasonable means to encourage Members to increase their liquidity on
the Exchange, particularly in connection with additional QCC and/or
Solicitation Agency Order flow to the Exchange in order to benefit from
the proposed enhanced rebates. The Exchange believes that incentivizing
greater QCC Initiator and/or Solicitation order flow would provide more
opportunities for participation in QCC trades or in the SAM Auction
which increases opportunities for price improvement. The Exchange also
believes that amending the rebate tier structure represents an
equitable allocation of fees and is not unfairly discriminatory because
they will continue to automatically and uniformly apply to all Members'
respective qualifying orders.
---------------------------------------------------------------------------

    \26\ See supra note 13 [sic].
---------------------------------------------------------------------------

    Overall, the Exchange believes that its proposed adoption of new
fee codes for SAM Contra Professional and SAM Agency Professional
orders (and related fee changes for SAM Contra Non-Customer, Non-
Professional and SAM Agency Non-Customer, Non-Professional orders) is
consistent with Section 6(b)(4) of the Act in that the proposed fees
are reasonable, equitable and not unfairly discriminatory. The Exchange
believes that the proposed fees are reasonable, equitable, and not
unfairly discriminatory in that competing options exchanges offer a
similar distinction between market participant types in connection with
similar price improvement auctions,\27\

as the Exchange now proposes. Further, competing exchanges charge
different rates for transactions in their price improvement mechanisms,
based on market participant type, in a manner similar to the proposal.
The Exchange believes the fee and rebate schedule as proposed continues
to reflect differentiation among different market participants
typically found in options fee and rebate schedules.
---------------------------------------------------------------------------

    \27\ See MIAX Options Fee Schedule, Section 1(a)(v), ``MIAX
Price Improvement Mechanism (``PRIME'') Fees, which provides for
comparable rates for similar market participant type orders
submitted into its PRIME auctions. For example, PRIME Customer
Agency orders are free of charge; PRIME Agency orders for a Public
Customer that is Not a Priority Customer, MIAX Market Maker, Non-
MIAX Market Maker, Non-Member Broker-Dealer, and Firm are assessed a
fee of $0.30; PRIME Customer Contra-side orders are free of charge;
PRIME Contra-side orders for a Public Customer that is Not a
Priority Customer, MIAX Market Maker, Non-MIAX Market Maker, Non-
Member Broker-Dealer, and Firm are assessed a fee of $0.30. See also
Box Options Fee Schedule, Section IV(C), which provides varying
rates for similar market participant type orders submitted as a
solicitation transaction.
---------------------------------------------------------------------------

    The proposed fees in relation to SAM orders are designed to promote
order flow through SAM and, in particular, to attract liquidity, which
benefits all market participants by providing additional trading
opportunities at improved prices. This, in turn, attracts increased
large-order flow from liquidity providers which facilitates tighter
spreads and potentially triggers a corresponding increase in order flow
originating from other market participants.
    Also, the Exchange believes that the proposed fee for SAM Non-
Customer, Non-Professional Agency and Contra orders ($0.18 per
contract) is reasonable because it encourages participation in SAM by
offering a rate that is equivalent to or better than most other price
improvement auctions offered by other options exchanges as well as the
Exchange itself.\28\
---------------------------------------------------------------------------

    \28\ Id.
---------------------------------------------------------------------------

    The Exchange believes the proposed changes to the Customer Volume
Rebate Tier program are reasonable because they continue to provide
opportunities for Members to receive higher rebates by providing for
incrementally increasing volume-based criteria they can reach for. The
Exchange believes the tiers, as modified, continue to serve as a
reasonable means to encourage Members to increase their liquidity on
the Exchange, particularly in connection with additional Customer Order
flow to the Exchange in order to benefit from the proposed enhanced
rebates. The Exchange also notes that any overall increased liquidity
that may result from the proposed tier incentives benefits all
investors by offering additional flexibility for all investors to enjoy
cost savings, supporting the quality of price discovery, promoting
market transparency and improving investor protection.
    The Exchange believes that the proposed changes to the Customer
Volume Rebate Tier program represent an equitable allocation of fees
and is not unfairly discriminatory because Members will be eligible for
these tiers and the corresponding enhanced rebates will apply uniformly
to all Members that reach the proposed tier criteria. The Exchange
believes that a number of market participants have a reasonable
opportunity to satisfy the tiers' criteria as modified. While the
Exchange has no way of knowing whether this proposed rule change would
definitively result in any particular Member qualifying for Tier 4 as
amended, the Exchange anticipates at least two Members meeting, or
being reasonably able to meet, the revised Tier 4 criteria; however,
the proposed tier is open to any Member that satisfies the tier's
criteria. The Exchange also notes that the proposed changes will not
adversely impact any Member's pricing or their ability to qualify for
other rebate tiers. Rather, should a Member not meet the proposed
criteria, the Member will merely not receive the corresponding enhanced
rebates.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Rather, as discussed above,
the Exchange believes that the proposed change would encourage the
submission of additional order flow to a public exchange, thereby
promoting market depth, execution incentives and enhanced execution
opportunities for all Members. As a result, the Exchange believes that
the proposed change furthers the Commission's goal in adopting
Regulation NMS of fostering competition among orders, which promotes
``more efficient pricing of individual stocks for all types of orders,
large and small.''
    The Exchange believes that the proposed rule change does not impose
any burden on intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. First, the
Exchange notes that the proposed changes apply uniformly to similarly
situated Members. The Exchange believes that the proposed changes
related to QCC and SAM transactions would not impose any burden on
intramarket competition, but rather, serves to increase intramarket
competition by incentivizing members, including Professionals, to
direct their QCC and SAM orders to the Exchange, in turn providing for
more opportunities to compete at improved prices. Similarly, the
changes to the Customer Volume Rebate Tier program provides an
incentive to bring additional liquidity to the Exchange, thereby
promoting price discovery and enhancing order execution opportunities
for Members.
    Additionally, the proposed rule change benefits all market
participants as any overall increased liquidity that may result from
the proposed fee and tier incentives benefits all investors by offering
additional flexibility for all investors to enjoy cost savings,
supporting the quality of price discovery, promoting market
transparency and improving investor protection.
    The Exchange also believes the proposed rule change does not impose
any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. As previously
discussed, the Exchange operates in a highly competitive market.
Members have numerous alternative venues they may participate on and
direct their order flow, including 15 other options exchanges.
Additionally, the Exchange represents a small percentage of the overall
market. Based on publicly available information, no single options
exchange has more than 17% of the market share. Therefore, no exchange
possesses significant pricing power in the execution of order flow.
Indeed, participants can readily choose to send their orders to other
exchanges if they deem fee levels at those other venues to be more
favorable. Moreover, the Commission has repeatedly expressed its
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. Specifically,
in Regulation NMS, the Commission highlighted the importance of market
forces in determining prices and SRO revenues and, also, recognized
that current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' The fact that
this market is competitive has also long been recognized by the courts.
In NetCoalition v. Securities and Exchange Commission, the D.C. Circuit
stated as follows: ``[n]o one disputes that competition for order flow
is `fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-

dealers that act as their order-routing agents, have a wide range of
choices of where to route orders for execution'; [and] `no exchange can
afford to take its market share percentages for granted' because `no
exchange possesses a monopoly, regulatory or otherwise, in the
execution of order flow from broker dealers' . . . . ''. Accordingly,
the Exchange does not believe its proposed fee change imposes any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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 has become effective pursuant to Section
19(b)(3)(A) of the Act \29\ and paragraph (f) of Rule 19b-4 \30\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 78s(b)(3)(A).
    \30\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-CboeEDGX-2023-028 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-CboeEDGX-2023-028. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-CboeEDGX-2023-028, and
should be submitted on or before May 9, 2023.
---------------------------------------------------------------------------

    \31\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-08143 Filed 4-17-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Notices]
[Page 69488]
[FR Doc No: 2012-28042]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1045]

Medical Devices; Custom Devices; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration Safety and Innovation Act
(FDASIA), which was signed into law on July 9, 2012, amended the
Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Food and Drug
Administration (FDA) is in the process of developing an implementation
strategy and policy for the custom device exemption criteria in the
FD&C Act amended by FDASIA. FDA is seeking information on appropriate
uses of the custom device exemption.

DATES: Submit either electronic or written comments by January 18,
2013.

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT: Bryan Benesch, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3424, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 520(b) of the FD&C Act (21 U.S.C. 360j(b), as amended by
section 617 of FDASIA (Pub. L. 112-144), sets forth the requirements
that must be met in order for a device to qualify for a custom device
exemption (Ref. 1). Section 520(b) of the FD&C Act exempts ``custom
devices'' from performance standard or premarket approval requirements
under sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e),
if these devices meet the enumerated statutory requirements, including,
among others, the following for each device: (1) Is ``created or
modified in order to comply with the order of an individual physician
or dentist (or any other specially qualified person designated under
regulations promulgated by the Secretary after an opportunity for an
oral hearing)''; (2) must not be ``generally available in the United
States in finished form through labeling or advertising by the
manufacturer, importer, or distributor for commercial distribution'';
(3) must be for the purpose of treating a ``unique pathology or
physiological condition that no other device is domestically available
to treat''; and (4) must be manufactured for the ``special needs of
such physician or dentist (or other specially qualified person so
designated) in the course of the professional practice of the physician
or dentist (or other specially qualified person so designated)'' or by
an individual patient named in such order.
    In addition to these new requirements for establishing a custom
device, manufacturers will have limitations for use of a custom device
only for the purpose of treating a ``sufficiently rare condition, such
that conducting clinical investigations on such device would be
impracticable'' and production of the device must be limited to no more
than five units per year of a particular device type. Lastly,
manufacturers will be required to submit an annual report explaining
their use of the custom device exemption under section 617 of FDASIA.
    FDA is seeking information on and examples of appropriate uses of
the custom device exemption identified in section 520(b) of the FD&C
Act. FDA encourages all stakeholders, including patients, physicians,
dentists, and manufacturers, to submit comments on the appropriate use
of this statutory provision.
    FDA is particularly interested in receiving information relating
to:
    1. Input from patients, manufacturers, dentists, or physicians on
where use of the custom device exemption is appropriate.
    2. Specific instances where manufacturers, dentists, or physicians
have used, would have liked to use, or plan to use the custom device
exemption for treatment of a sufficiently rare condition.
    3. Product areas other than orthopedic and dental devices where the
custom device exemption may be useful.
    4. The type of information manufacturers intend to require a
physician, dentist, or other qualified person to submit to them when
ordering a custom device.
    5. How often a custom device is ordered due to unusual anatomical
features of the individual physician/dentist, or due to a unique need
in the physician's/dentist's practice not shared by health
professionals of the same specialty (i.e., a special need of a
physician or dentist).
    This notice provides the first opportunity for the public to
comment on these issues. The public will have a second opportunity to
provide input when the Agency announces the availability of a draft
guidance document and a draft regulation for implementing section
520(b) of the FD&C Act.

II. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. 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.

III. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and are
available electronically at http://www.regulations.gov.
    1. The Food and Drug Administration Safety and Innovation Act,
available at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm.

    Dated: November 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28042 Filed 11-16-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 1, 2010 (Volume 75, Number 39)]
[Rules and Regulations]
[Page 9111-9113]
[DOCID:fr01mr10-13]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2010-0003; Internal Agency Docket No. FEMA-8121]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: This rule identifies communities, where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP), that are scheduled for suspension on the effective
dates listed within this rule because of noncompliance with the
floodplain management requirements of the program. If the Federal
Emergency Management Agency (FEMA) receives documentation that the
community has adopted the required floodplain management measures prior
to the effective suspension date given in this rule, the suspension
will not occur and a notice of this will be provided by publication in
the Federal Register on a subsequent date.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact David Stearrett, Mitigation Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
flood insurance which is generally not otherwise available. In return,
communities agree to adopt and administer local floodplain management
aimed at protecting lives and new construction from future flooding.
Section 1315 of the National Flood Insurance Act of 1968, as amended,
42 U.S.C. 4022, prohibits flood insurance coverage as authorized under
the NFIP, 42 U.S.C. 4001 et seq.; unless an appropriate public body
adopts adequate floodplain management measures with effective
enforcement measures. The communities listed in this document no longer
meet that statutory requirement for compliance with program
regulations, 44 CFR part 59. Accordingly, the communities will be
suspended on the effective date in the third column. As of that date,
flood insurance will no longer be available in the community. However,
some of these communities may adopt and submit the required
documentation of legally enforceable floodplain management measures
after this rule is published but prior to the actual suspension date.
These communities will not be suspended and will continue their
eligibility for the sale of insurance. A notice withdrawing the
suspension of

the communities will be published in the Federal Register.
    In addition, FEMA has identified the Special Flood Hazard Areas
(SFHAs) in these communities by publishing a Flood Insurance Rate Map
(FIRM). The date of the FIRM, if one has been published, is indicated
in the fourth column of the table. No direct Federal financial
assistance (except assistance pursuant to the Robert T. Stafford
Disaster Relief and Emergency Assistance Act not in connection with a
flood) may legally be provided for construction or acquisition of
buildings in identified SFHAs for communities not participating in the
NFIP and identified for more than a year, on FEMA's initial flood
insurance map of the community as having flood-prone areas (section
202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a),
as amended). This prohibition against certain types of Federal
assistance becomes effective for the communities listed on the date
shown in the last column. The Administrator finds that notice and
public comment under 5 U.S.C. 553(b) are impracticable and unnecessary
because communities listed in this final rule have been adequately
notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended, 42
U.S.C. 4022, prohibits flood insurance coverage unless an appropriate
public body adopts adequate floodplain management measures with
effective enforcement measures. The communities listed no longer comply
with the statutory requirements, and after the effective date, flood
insurance will no longer be available in the communities unless
remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

0
Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Effective date
                                                 authorization/
                                   Community    cancellation of    Current effective map   Date certain Federal
       State and location             No.        sale of flood             date            assistance no longer
                                                  insurance in                              available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
           Region IV
Alabama:
    Bayou La Batre, City of,           015001  July 30, 1971,     March 17, 2010........  March 17, 2010.
     Mobile County.                             Emerg; March 17,
                                                1972, Reg; March
                                                17, 2010, Susp.
    Citronelle, City of, Mobile        010277  July 23, 1975,     ......do..............  -do.-
     County.                                    Emerg; June 17,
                                                1977, Reg; March
                                                17, 2010, Susp.
    Creola, City of, Mobile            010409  December 31,       ......do..............  -do.-
     County.                                    1981, Emerg;
                                                December 31,
                                                1981, Reg; March
                                                17, 2010, Susp.
    Dauphin Island, Town of,           010418  December 11,       ......do..............  -do.-
     Mobile County.                             1970, Emerg;
                                                December 11,
                                                1970, Reg; March
                                                17, 2010, Susp.
    Mobile County,                     015008  December 11,       ......do..............  -do.-
     Unincorporated Areas.                      1970, Emerg;
                                                December 11,
                                                1970, Reg; March
                                                17, 2010, Susp.
    Mount Vernon, Town of,             010169  July 25, 1975,     ......do..............  -do.-
     Mobile County.                             Emerg; December
                                                16, 1977, Reg;
                                                March 17, 2010,
                                                Susp.
    Prichard, City of, Mobile          010170  April 22, 1975,    ......do..............  -do.-
     County.                                    Emerg; February
                                                4, 1981, Reg;
                                                March 17, 2010,
                                                Susp.
    Saraland, City of, Mobile          010171  May 9, 1974,       ......do..............  -do.-
     County.                                    Emerg; December
                                                18, 1979, Reg;
                                                March 17, 2010,
                                                Susp.
Mississippi:
    Canton, City of, Madison           280109  August 9, 1974,    ......do..............  -do.-
     County.                                    Emerg; November
                                                15, 1979, Reg;
                                                March 17, 2010,
                                                Susp.
    Flora, Town of, Madison            280399  N/A, Emerg;        ......do..............  -do.-
     County.                                    January 31,
                                                1995, Reg; March
                                                17, 2010, Susp.
    Madison, City of, Madison          280229  October 17, 1974,  ......do..............  -do.-
     County.                                    Emerg; December
                                                16, 1980, Reg;
                                                March 17, 2010,
                                                Susp.
    Madison County,                    280228  July 17, 1975,     ......do..............  -do.-
     Unincorporated Areas.                      Emerg; January
                                                2, 1980, Reg;
                                                March 17, 2010,
                                                Susp.
    Pearl River Valley Water           280338  N/A, Emerg; March  ......do..............  -do.-
     Supply District, Madison,                  5, 1993, Reg;
     Hinds, Leake, Rankin, and                  March 17, 2010,
     Scott Counties.                            Susp.
    Ridgeland, City of, Madison        280110  December 27,       ......do..............  -do.-
     County.                                    1973, Emerg;
                                                September
                                                28,1979, Reg;
                                                March 17, 2010,
                                                Susp.

           Region VI

Arkansas:
    Batesville, City of,               050091  April 9, 1975,     ......do..............  -do.-
     Independence County.                       Emerg; August
                                                16, 1982, Reg;
                                                March 17, 2010,
                                                Susp.
    Cave City, City of,                050313  December 10,       ......do..............  -do.-
     Independence and Sharp                     1982, Emerg; May
     Counties.                                  1, 1985, Reg;
                                                March 17, 2010,
                                                Susp.
    Independence County,               050090  July 3, 1978,      ......do..............  -do.-
     Unincorporated Areas.                      Emerg; January
                                                6, 1988, Reg;
                                                March 17, 2010,
                                                Susp.
    Newark, City of,                   050092  August 8, 1975,    ......do..............  -do.-
     Independence County.                       Emerg; September
                                                1, 1987, Reg;
                                                March 17, 2010,
                                                Susp.
    Oil Trough, Town of,               050093  July 3, 1975,      ......do..............  -do.-
     Independence County.                       Emerg; June 1,
                                                1987, Reg; March
                                                17, 2010, Susp.
----------------------------------------------------------------------------------------------------------------
*-do- = Ditto.
Code for reading third column: Emerg--Emergency; Reg--Regular; Susp--Suspension.

    Dated: February 23, 2010.
Sandra K. Knight,
Deputy Assistant Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2010-4137 Filed 2-26-10; 8:45 am]
BILLING CODE 9110-12-P