permit. This preliminary eligibility demonstration must be submitted
with your application for approval of construction or
reconstruction. You must base your preliminary eligibility
demonstration on the maximum emissions allowed under your title V
permit. If the preliminary eligibility demonstration indicates that
your affected source facility is eligible for either compliance
alternative, then you may start up your new affected source and your
new affected source will be considered in compliance with the
alternative standard and subject to the compliance requirements in
this appendix.
    (2) You must conduct the emission tests or analyses specified in
section 4 of this appendix upon initial startup and use the results
of these emissions tests to complete and submit your eligibility
demonstration within 180 days following your initial startup date.

10. When Do I Become Eligible for the Health-Based Compliance
Alternatives?

    (a) For existing sources, new sources, or reconstructed sources
that start up before the effective date of subpart DDDDD, or an
affected source that is an area source that increases its emissions
or its potential to emit such that it becomes a major source of HAP
before the effective date of subpart DDDDD, you are eligible to
comply with a health-based compliance alternative upon submission of
a complete demonstration meeting all the requirements of paragraph 8
for the applicable alternative. However, your eligibility
demonstration may be reviewed by the permitting authority or by EPA
to verify that the demonstration meets the requirements of appendix
A to this subpart and is technically sound (i.e. use of the look-up
tables is appropriate or the site-specific assessment is technically
valid). If you are notified by the permitting authority or by EPA of
any deficiencies in your submission, then you are not eligible for
the health-based compliance alternative until the permitting
authority or EPA verifies that the deficiencies are corrected.
    (b) For new or reconstructed sources that start up after the
effective date of subpart DDDDD, you are eligible to comply with a
the health-based compliance alternatives upon submission of a
complete preliminary eligibility determination in accordance with
paragraph (c)(1) of section 9 that demonstrates your affected source
is eligible for the applicable alternative. You may then start up
your source and conduct the necessary testing in accordance with
paragraph (c)(2) of section 9. The eligibility demonstration
submitted in accordance with paragraph (c)(2) of section 9 may be
reviewed by the permitting authority or by EPA to verify that the
demonstration meets the requirements of appendix A to this subpart
and is technically sound (i.e. use of the look-up tables is
appropriate or the site-specific assessment is technically valid).
If you are notified in writing by the permitting authority of any
deficiencies in your submission, then you have 30 days to correct
the deficiencies unless the permitting authority agrees to extend
this time to a period not to exceed 90 days. If the deficiencies are
not corrected within the applicable time period, you will not be
eligible for the health-based compliance alternative until the
permitting authority verifies that the deficiencies are corrected.
    (c) If the title V permit conditions requested in accordance
with paragraph (d) of section 8 are disapproved by the permitting
authority, then your affected source must comply with the applicable
emission limits, operating limits, and work practice standards in
subpart DDDDD by the compliance dates specified in Sec.  63.7495.
Until the requested conditions (or alternative conditions meeting
the requirements of paragraph (d) of section 8) are incorporated
into the permit, compliance with the proposed conditions shall be
considered compliance with the health-based alternative.

11. How Do I Ensure That My Facility Remains Eligible for the Health-
Based Compliance Alternatives?

    (a) You must update your eligibility demonstration and resubmit
it each time that any of the parameters that defined your affected
source as eligible for the health-based compliance alternatives
changes in a way that could result in increased HAP emissions or
increased risk from exposure to emissions. These parameters include,
but are not limited to, fuel type, fuel mix (annual average), type
of control devices, HAP emission rate, stack height, process
parameters (e.g., heat input capacity), relevant reference values,
and locations where people live).
    (b) If you are updating your eligibility demonstration to
account for an action in paragraph (a) of this section that is under
your control (e.g. change in heat input capacity of your boiler),
you must submit your revised eligibility demonstration to the
permitting authority prior to making the change and revise your
permit to incorporate the change. If your affected source is no
longer eligible for the health-based compliance alternatives, then
you must comply with the applicable emission limits, operating
limits, and compliance requirements in subpart DDDDD prior to making
the process change and revising your permit. If you are updating
your eligibility demonstration to account for an action in paragraph
(a) of this section that is outside of your control (e.g. change in
a reference value), and that change causes your source to no longer
be able to meet the criteria for the health-based compliance
alternatives, your source must comply with the applicable emission
limits, operating limits, and compliance requirements in subpart
DDDDD within 3 years.
    (c) Your revised eligibility demonstration may be reviewed by
the permitting authority or EPA to verify that the demonstration
meets the requirements of appendix A to this subpart and is
technically sound (i.e. use of the look-up tables is appropriate or
the site-specific assessment is technically valid). If you are
notified by the permitting authority or EPA of any deficiencies in
your submission, you will not remain eligible for the health-based
compliance alternatives until the permitting authority or EPA
verifies that the deficiencies are corrected.
* * * * *
[FR Doc. 05-24299 Filed 12-27-05; 8:45 am]

BILLING CODE 6560-50-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Parts 52 and 81

	[EPA-R03-OAR-2006-0840; FRL-         ]

	Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Redesignation of the Lancaster 8-Hour Ozone Nonattainment
Area to Attainment and Approval of the Area’s Maintenance Plan and
2002 Base-Year Inventory

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

SUMMARY:  EPA is approving a redesignation request and State
Implementation Plan (SIP) revisions submitted by the Commonwealth of
Pennsylvania.  The Pennsylvania Department of Environmental Protection
(PADEP) is requesting that the Lancaster nonattainment area
(“Lancaster Area” or “Area”) be redesignated as attainment for
the 8-hour ozone national ambient air quality standard (NAAQS).  In
conjunction with its redesignation request, the PADEP submitted SIP
revisions consisting of a maintenance plan for the Lancaster Area that
provides for continued attainment of the 8-hour ozone NAAQS for at least
10 years after redesignation.  EPA is approving the 8-hour maintenance
plan.  PADEP also submitted a 2002 base-year inventory for the Lancaster
Area which EPA is approving.  In addition, EPA is approving the adequacy
determination for the motor vehicle emission budgets (MVEBs) that are
identified in the Lancaster Area maintenance plan for purposes of
transportation conformity, and is approving those MVEBs.  EPA is
approving the redesignation request, and the maintenance plan, and the
2002 base-year emissions inventory as revisions to the Pennsylvania SIP
in accordance with the requirements of the Clean Air Act (CAA).

EFFECTIVE DATE:  This final rule is effective on [insert date of
publication] pursuant to the authority of 5 USC 553(d)(1).

ADDRESSES:  EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2006-0840.  All documents in the docket are listed in
the www.regulations.gov website.  Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (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 through www.regulations.gov or in hard
copy for public inspection 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 Pennsylvania Department of Environmental
Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market
Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT:  Ellen Wentworth<PHONE_NUMBER>, or by
e-

mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:

I.  Background

On May 15, 2007 (72 FR 27265), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Pennsylvania.  The NPR proposed
approval of Pennsylvania’s redesignation request, a SIP revision that
establishes a maintenance plan for the Lancaster Area that provides for
continued attainment of the 8-hour ozone NAAQS for at least 10 years
after redesignation, and a 2002 base-year emissions inventory.  The
formal SIP revisions were submitted by PADEP on September 20, 2006, and
supplemented on November 8, 2006.  Other specific requirements of
Pennsylvania’s redesignation request and SIP revision for the
maintenance plan, and the rationale for EPA’s proposed actions are
explained in the NPR and will not be restated here.  No public comments
were received on the NPR.

On December 22, 2006, the U.S. Court of Appeals for the District of
Columbia Circuit vacated EPA’s Phase 1 Implementation Rule for the
8-hour Ozone Standard. (69 FR 23951, April 30, 2004).  South Coast Air
Quality Management Dist. v. EPA, 472 F.3d 882 (D.C.Cir. 2006).  On June
8, 2007, in South Coast Air Quality Management Dist. v. EPA, Docket No.
04-1201, in response to several petitions for rehearing, the D.C.
Circuit clarified that the Phase 1 Rule was vacated only with regard to
those parts of the rule that had been successfully challenged.
Therefore, the Phase 1 Rule provisions related to classifications for
areas currently classified under subpart 2 of Title I, part D of the Act
as 8-hour nonattainment areas, the 8-hour attainment dates, and the
timing for emissions reductions needed for attainment of the 8-hour
ozone NAAQS remain effective.  The June 8 decision left intact the
Court’s rejection of EPA’s reasons for implementing the 8-hour
standard in certain nonattainment areas under subpart 1 in lieu of
subpart 2.  By limiting the vacatur, the Court let stand EPA’s
revocation of the 1-hour standard and those anti-backsliding provisions
of the Phase 1 Rule that had not been successfully challenged.  The June
8 decision reaffirmed the December 22, 2006 decision that EPA had
improperly failed to retain four measures required for 1-hour
nonattainment areas under the anti-backsliding provisions of the
regulations:  (1) nonattainment area nonattainment New Source Review
(NSR) requirements based on an area’s 1-hour nonattainment
classification; (2) Section 185 penalty fees for 1-hour severe or
extreme nonattainment areas; (3) measures to be implemented pursuant to
section 172(c)(9) or 182(c)(9) of the Act, on the contingency of an area
not making reasonable further progress toward attainment of the 1-hour
NAAQS, or for failure to attain that NAAQS; and (4) certain
transportation conformity requirements for certain types of Federal
actions.  The June 8 decision clarified that the Court’s reference to
conformity requirements was limited to requiring the continued use of
1-hour motor vehicle emissions budgets until 8-hour budgets were
available for 8-hour conformity determinations.

For the reasons set forth in the proposal, EPA does not believe that the
Court’s rulings alter any requirements relevant to this redesignation
action so as to preclude redesignation, and do not prevent EPA from
finalizing this redesignation.  EPA believes that the Court’s December
22, 2006 and June 8, 2007 decisions impose no impediment to moving
forward with the redesignation of this Area to attainment, because even
in light of the Court’s decisions, redesignation is appropriate under
the relevant redesignation provisions of the Act and longstanding
policies regarding redesignation requests.

With respect to the 8-hour standard, the Lancaster Area is classified
under subpart 2.  The June 8, 2007 opinion clarifies that the Court did
not vacate the Phase 1 Rule’s provisions with respect to
classifications for areas under subpart 2.  The Court’s decision
therefore upholds EPA’s classifications for those areas classified
under subpart 2 for the 8-hour ozone standard.

In its proposal, EPA proposed to find that the Area had satisfied the
requirements under the 1-hour standard whether the 1-hour standard was
deemed to be reinstated or whether the Court’s decision on the
petition for rehearing was modified to require something less than
compliance with all applicable 1-hour requirements.  Because EPA
proposed to find that the Area satisfied the requirements under either
scenario, EPA is proceeding to finalize the redesignation and to
conclude that the Area met the requirements under the 1-hour standard
applicable for purposes of redesignation under the 8-hour standard.
These include the provisions of EPA’s anti-backsliding rules, as well
as the additional anti-backsliding provisions identified by the court in
its rulings.  In its June 8, 2007 decision the Court limited its vacatur
so as to uphold those provisions of the anti-backsliding requirements
that were not successfully challenged.  Therefore, EPA finds that the
Area has met the anti-backsliding requirements, see 40 CFR 51.900 et
seq; 70 FR 30592, 30604 (May 26, 2005), which apply by virtue of the
Area’s classification for the 1-hour ozone NAAQS, as well as the four
additional anti-backsliding provisions identified by the Court, or
alternatively, that such requirements are not applicable for purposes of
redesignation.  In addition, with respect to the requirement for
transportation conformity under the 1-hour standard, the Court in its
June 8 decision clarified that for those areas with 1-hour MVEBs,
anti-backsliding requires only that those 1-hour budgets must be used
for 8-hour conformity determinations until replaced by 8-hour budgets.
To meet this requirement, conformity determinations in such areas must
comply with the applicable requirements of EPA’s conformity
regulations at 40 CFR part 93.

II.  Final Action

EPA is approving the Commonwealth of Pennsylvania’s redesignation
request, maintenance plan, and the 2002 base-year emissions inventory
because the requirements for approval have been satisfied.  EPA has
evaluated Pennsylvania’s redesignation request that was submitted on
September 20, 2006, and determined that it meets the redesignation
criteria set forth in section 107(d)(3)(E) of the CAA.  EPA believes
that the redesignation request and monitoring data demonstrate that the
Lancaster Area has attained the 8-hour ozone standard.  The final
approval of this redesignation request will change the designation of
the Lancaster Area from nonattainment to attainment for the 8-hour ozone
standard.  EPA is approving the maintenance plan for the Lancaster Area
submitted on September 20, 2006 as a revision to the Pennsylvania SIP.
EPA is also approving the MVEBs submitted by PADEP in conjunction with
its redesignation request.  In addition, EPA is approving the 2002
base-year emissions inventory submitted by PADEP on September 20, 2006,
and supplemented on November 8, 2006 as a revision to the Pennsylvania
SIP.  In this final rulemaking, EPA is notifying the public that we have
found that the MVEBs for NOx and VOCs in the Lancaster Area for the
8-hour ozone maintenance plan are adequate and approved for conformity
purposes.  As a result of our finding, the Lancaster Area must use the
MVEBs from the submitted 8-hour ozone maintenance plan for future
conformity determinations.  The adequate and approved MVEBs are provided
in the following table:

Adequate and Approved Motor Vehicle Emissions Budgets in Tons Per Day
(TPD)

Budget Year	NOx	VOC

2009	22.3	14.3

2018	9.0	7.8

The Lancaster Area is subject to the CAA’s requirements for marginal
nonattainment areas until and unless it is redesignated to attainment.

III.  Statutory and Executive Order Reviews

General Requirements

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action
is not a "significant regulatory action" and therefore is not subject to
review by the Office of Management and Budget.  For this reason, this
action is also not subject to Executive Order 13211, "Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use" (66 FR 28355, May 22, 2001).  This action merely approves state law
as meeting Federal requirements and imposes no additional requirements
beyond those imposed by state law.  Accordingly, the Administrator
certifies that this rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.).  Because this rule approves pre-existing
requirements under state law and does not impose any additional
enforceable duty beyond that required by state law, it does not contain
any unfunded mandate or significantly or uniquely affect small
governments, as described in the Unfunded Mandates Reform Act of 1995
(Public Law 104-4).  This rule also does not have tribal implications
because it will not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).  This action also
does not have Federalism implications because it does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999).  This
action merely approves a state rule implementing a Federal requirement,
and does not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act.  This rule also is
not subject to Executive Order 13045 (Protection of Children from
Environmental Health Risks and Safety Risks( (62 FR 19885, April 23,
1997), because it approves a state rule implementing a Federal standard.

In reviewing SIP submissions, EPA(s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  In this
context, in the absence of a prior existing requirement for the State to
use voluntary consensus standards (VCS), EPA has no authority to
disapprove a SIP submission for failure to use VCS.  It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act.  Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply.  This rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B.   Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.  EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.  This rule is not a
(major rule( as defined by 5 U.S.C. 804(2).

C.  Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial
review of this action must be filed in the United States Court of
Appeals for the appropriate circuit by [insert date 60 days from date of
publication of this document in the Federal Register].  Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action.

This action, approving the redesignation of the Lancaster Area to
attainment for the 8-hour ozone NAAQS, the associated maintenance plan,
the 2002 base-year emissions inventory, and the MVEBs identified in the
maintenance plan, may not be challenged later in proceedings to enforce
its requirements.  (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements,Volatile organic
compounds.

40 CFR Part 81

Air Pollution Control, National Parks, Wilderness Areas.

                                  /s/

____June 25, 2007
_______________________________

Dated:                            				Donald S. Welsh,
              								Regional Administrator,

                                  					Region III.

40 CFR part 52 is amended as follows:

Part 52 – [AMENDED]

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

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

Subpart NN-Pennsylvania

2.  In §52.2020, the table in paragraph (e)(1) is amended by adding an
entry for the 8-hour Ozone  Maintenance Plan and the 2002 Base Year
Emissions Inventory for the Lancaster, Pennsylvania Area at the end of
the table to read as follows:

§ 52.2020	Identification of plan.

*	*	*	*	*

(e) ***

     (1) * * *

Name of non-regulatory SIP revision	Applicable

Geographic area	State submittal

Date	EPA approval

date	Additional

explanation

*           *               *            *               *           *
          *

8-Hour Ozone Maintenance Plan and 2002 Base Year Emissions Inventory
Lancaster Area (Lancaster County)	9/20/06

11/08/06	[Insert Federal Register publication date] [Insert page number
where the document begins]

PART 81- [AMENDED]

The authority citation for Part 81 continues to read as follows:

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

In §81.339, the table entitled “Pennsylvania- Ozone (8-Hour
Standard)” is amended by revising the entry for the Lancaster, PA Area
to read as follows:

§81.339                    Pennsylvania

*          *          *          *          *

Pennsylvania – Ozone (8-Hour Standard)

Designated Area	Designationa	Category/Classification

	Date1	Type	Date1	Type

*           *           *           *           *           *
*

Lancaster, PA:

Lancaster County	[Insert date of publication]	Attainment

*           *           *           *           *           *
*

aIncludes Indian County located in each county or area, except otherwise
noted.

1This date is June 15, 2004, unless otherwise noted.

*           *           *           *           *

 PAGE  10


[Federal Register: August 27, 2010 (Volume 75, Number 166)]
[Notices]
[Page 52765-52768]
[DOCID:fr27au10-74]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0437]

Development and Distribution of Patient Medication Information
for Prescription Drugs; Public Hearing

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public hearing; request for comment.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing a 2-day
public hearing to obtain input on a new framework for development and
distribution of patient medication information (PMI) to be provided to
patients who are prescribed drug products. Under the current system,
patients may receive several different types of information, developed
by different sources that may be duplicative, incomplete, or difficult
to read and understand. FDA has determined that the current system is
not adequate to ensure that patients receive the essential medication
information that is needed to use the drug safely. Based on
recommendations from FDA's Risk Communication Advisory Committee (RCAC)
and other stakeholder input, FDA sees merit in adopting use of a single
document that is standardized with respect to content and format. The
purpose of this hearing is to solicit public input on processes and
procedures for standardizing PMI using a quality system approach for
monitoring development and distribution of PMI.

DATES: The public hearing will be held on September 27 and 28, 2010,
from 8:30 a.m. to 4:30 p.m. Registration requests and requests to
present at the public hearing should be received by September 13, 2010
(see section III of this document for details). Electronic or written
comments will be accepted after the public hearing until October 29,
2010 (see section V of this document for details).

ADDRESSES:  The public hearing will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, MD 20993.
To register for the public hearing, email your registration information
to<EMAIL_ADDRESS>See section III of this document for
registration details. 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. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denise Hinton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6348, Silver Spring, MD 20993, 301-796-
1090, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Ensuring that patients who are prescribed medical products have
access to quality information about those products is an important
component of medical product safety. Currently, patients receive
multiple types of written prescription drug information in varying
formats, which

complicates information accessibility and comprehension. The types of
written prescription drug information include:
     Consumer Medication Information (CMI) is written
information about prescription drugs developed by organizations or
individuals other than a drug manufacturer that is intended for
distribution to consumers at the time of drug dispensing. The
information is not FDA reviewed or approved and is voluntarily
distributed by pharmacies to consumers (Ref. 1).
     A Patient Package Insert (PPI) is patient labeling that is
part of the FDA-approved prescription drug labeling. PPIs are developed
by the manufacturer, approved by FDA, and are required to be dispensed
with specific products or classes of products (i.e., oral
contraceptives and estrogen-containing products). Other PPIs are
submitted to FDA voluntarily by the manufacturer and approved by FDA,
but their distribution is not mandated.
     A Medication Guide is also patient labeling that is part
of the FDA-approved prescription drug labeling. Medication Guides are
required for certain drugs ``that pose a serious and significant public
health concern'' (see 21 CFR part 208). Medication Guides are developed
by the manufacturer, approved by FDA, and are required to be given to
patients each time the medication is dispensed.
    By objective measures, current systems for providing high quality,
easily accessible prescription medication information to patients have
failed. For example, an evaluation of CMI in 2008 showed that while 94
percent of consumers receive CMI with new prescriptions, only 75
percent of CMI received met even minimum criteria for usefulness (Ref
2.). FDA presented these concerns to the RCAC at a February 26 and 27,
2009 meeting. That committee recommended that FDA adopt a standard,
single document for communicating essential information about
prescription drugs to replace CMI, PPIs, and Medication Guides. FDA is
engaged in a collaborative effort to explore this recommendation.
    The major challenges in providing patients with quality
prescription drug information are as follows: (1) Development of
uniform, evidence-based content and format standards for PMI, including
that the PMI contains the essential information about the drug, and is
accurate, balanced, comprehensible, and accessible; (2) identification
and assessment of mechanisms to ensure that PMI meets these standards;
and (3) identification and assessment of mechanisms to ensure that the
PMI reaches its target audience. This public hearing is intended to
focus primarily on issues 2 and 3, and related issues, while the first
issue is being addressed separately, as discussed in the following
paragraphs.
    There are two key limitations that underpin FDA's expectations for
how improvements in providing patient information might be structured.
First, although one approach could include FDA review and approval of
all PMI prior to distribution, FDA recognizes that this may not be
feasible given FDA's resource constraints and the potential volume of
products that will require PMI (perhaps as many 22,000 if counting all
innovator and generic products). Second, based on FDA's compliance and
enforcement experience in a variety of program areas, including
professional labeling, manufacturing, and clinical trials, FDA
recognizes that relying primarily or exclusively on retrospective
Agency evaluations and inspections may not be an optimal approach to
providing assurance that PMI meets format and content standards prior
to distribution to patients. For these reasons, FDA is interested in
exploring an approach centered on effective processes for PMI
development and distribution and process controls for a PMI
implementation program. With a system in place that assures high
quality PMI, FDA believes that development of PMI by the manufacturer
would be more efficient and fulfill the information needs of patients.
    Such an approach for PMI would provide manufacturers with a quality
framework for developing, distributing, and amending PMI and would
facilitate continual improvement of PMI. FDA envisions that this
approach would provide assurance that manufacturers have implemented
the following: (1) Effective procedures for developing PMI that reflect
quality standards for PMI content and format, for ensuring appropriate
distribution, and for ensuring PMI revision if necessary; (2)
mechanisms to monitor whether these procedures are being followed; and
(3) mechanisms to implement process changes as needed.
    Because it will take a substantial amount of time to transition
from the existing system to the use of a standard, single document for
PMI, FDA is also seeking public input on a potential structure and
challenges and solutions for a step-wise transition to a new PMI
paradigm.
    As described in the explanation of major challenges earlier in this
document, FDA is also continuing its efforts and seeking additional
information to identify and assess the development of format and
content standards for PMI as a standard, single document. With input
from the following sources FDA has developed three draft PMI prototypes
to be used in consumer testing:
    (1) FDA's RCAC meeting (Ref. 3);
    (2) a public workshop held on September 24 and 25, 2009 (available
at http://www.fda.gov/Drugs/NewsEvents/ucm168106.htm); and
    (3) an expert panel meeting convened by the Brookings Institute on
July 21, 2010 (available at http://www.brookings.edu/events/2010/0721_
CMI.aspx),\1\
---------------------------------------------------------------------------

    \1\ FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.
---------------------------------------------------------------------------

Based on public comment (75 FR 23775, May 4, 2010) and expert panel
input, FDA is also finalizing the design of the consumer testing study
for the prototypes (available on the Internet at http://
edocket.access.gpo.gov/2010/pdf/2010-10359.pdf). Consumer testing will
begin when the final study design is approved by the Office of
Management and Budget. The results of this study will inform FDA of the
usefulness and parameters of various format options for patient
information documents. FDA is interested in any formal research
conducted on this topic and encourages submission to this docket. See
section III of this document for details on how to register and or
participate in the meeting. See section V of this document for details
on how to post comments to the docket.

II. Scope of the Hearing

    FDA is particularly interested in seeking input on the following
issues:
    (1) How can we best ensure PMI quality and compliance with content
and format criteria?
     What are the elements that should be addressed with a
quality system approach, or other type of system, to ensure PMI
quality?
     What functions and procedures should be the responsibility
of manufacturers (e.g., PMI development, consumer testing, marketplace
surveillance)?
     What functions and procedures should be FDA's
responsibility (e.g., surveillance, audit, enforcement)?
     Are there a subset of products that should receive more
regulatory scrutiny than would be provided by an approach that relies
heavily on manufacturers implementing and monitoring the adequacy of
procedures for generating PMI content (i.e., types of products for

which PMI should be prospectively reviewed and approved by FDA before
use)? If so, what categories of drugs might be included in this subset?
What other approaches to ensuring quality should be considered for
drugs in this subset?
     At what time-point should evaluation of the PMI be
initiated and how often should it be repeated?
    (2) What are the components of an effective framework for ensuring
patient access to PMI?
     Who should be responsible for processes to ensure
distribution of PMI?
     What types of processes are needed to ensure distribution
of PMI? For example, should there be a process or system to monitor
patient receipt of PMI?
     How can we ensure adequate distribution of PMI while
minimizing disruption to health care delivery processes (e.g., medical
practice, pharmacy practice)?
     Are there situations where the distribution of PMI would
not be appropriate (e.g., for medications administered by a health care
professional in an inpatient or outpatient setting, dialysis unit,
oncology setting, or operating room)?
     Should there be a centralized repository for all PMI? If
so, how might a repository be implemented and maintained to ensure the
integrity and sustainability of the repository? Are there relevant,
existing systems that could serve as a business model for a central PMI
repository?
    (3) What approaches should be considered to ensure that FDA can
rapidly move from the current system to a new PMI paradigm?
     How might the existing framework be phased if a new
framework is phased in?
     How should a new PMI system be applied to generic drugs?
    (4) What accommodations might be needed to ensure that PMI is
accessible to special populations (e.g., elderly, children, those with
low literacy, the visually impaired)?

III. How to Register and/or Participate in the Public Hearing

    FDA is seeking input from a broad group of stakeholders, including
interested prescribers, pharmacists, other health care professionals,
consumers, pharmacies, CMI developers, publishers, industry, and any
other interested parties. FDA's Conference Center at the White Oak
Campus is a Federal facility with security procedures and limited
seating. Attendance is free and will be on a first-come, first-served
basis. To register for the public hearing, email your registration to
<EMAIL_ADDRESS>Registration information should include
registrant name, company or organization, address, phone number, and
email address. Because seating is limited, FDA may limit the numbers of
participants from each organization. Registrants will receive
confirmation once they have been accepted for participation in the
workshop. Onsite registration on the day of the hearing will be based
on space availability on the day of the event starting at 7:30 a.m. If
registration reaches maximum capacity, FDA will post a notice closing
meeting registration for the hearing at http://www.fda.gov/Drugs/
NewsEvents/ucm219716.htm.
    Individuals who wish to present at the public hearing must register
on or before September 13, 2010, through the email
<EMAIL_ADDRESS>and state this intention on their notice
of participation. An abstract of the presentation along with slides are
due on September 17, 2010. You must provide complete contact
information, including name, title, affiliation, address, email, and
phone number. In section II of this document, FDA has included
questions for comment. You should identify by number each question you
wish to address in your presentation, so that FDA can consider that in
organizing the presentations. FDA will do its best to accommodate
requests to speak, and will determine the amount of time allotted to
each presenter and the approximate time that each oral presentation is
scheduled to begin. An agenda will be available approximately 1 week
before the hearing at http://www.fda.gov/Drugs/NewsEvents/
ucm219716.htm.
    If you need special accommodations because of disability, please
contact Denise Hinton (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the hearing.
    A live webcast of this hearing will be viewable at https://
collaboration.fda.gov/p15d109272010/ on September 27 and https://
collaboration.fda.gov/p15d209272010/ on September 28. If you have never
attended an Adobe[reg] Acrobat[reg] Connect\TM\ Pro meeting before,
test your connection at https://collaboration.fda.gov/common/help/en/
support/meeting_test.htm. For a quick overview, go to http://
www.adobe.com/go/connectpro_overview.

IV. Notice of Hearing Under Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by senior management from the Office of the Commissioner,
the Center for Drug Evaluation and Research, and the Center for
Biologics and Research.
    Under Sec.  15.30(f), the hearing is informal and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10, subpart C (21 CFR part 10, subpart C)). Under
Sec.  10.205, representatives of the electronic media may be permitted,
subject to certain limitations, to videotape, film, or otherwise record
FDA's public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see section VI of this document). To the extent that the
conditions for the hearing, as described in this notice, conflict with
any provisions set out in part 15, this notice acts as a waiver of
those provisions as specified in Sec.  15.30(h).

V. Comments

    Regardless of attendance at the public hearing, interested persons
may submit to the Division of Dockets Management (see ADDRESSES) either
electronic or written comments. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. To ensure consideration, submit comments
by October 29, 2010. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

VI. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and

Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.

VII. References

    1. ``Useful Written Consumer Medication Information (CMI)''
published in July 2006, available on the Internet at http://
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm080602.pdf.
    2. Kimberlin CL, Winterstein AG. ``Expert and Consumer Evaluation
of Consumer Medication Information--2008.'' Final Report to FDA.
November 2008 available on the Internet at http://www.fda.gov/
downloads/AboutFDA/CentersOffices/CDER/ReportsBudgets/UCM163783.pdf.
    3. FDA's Risk Communication Advisory Committee meeting, held on
February 26 and 27, 2009 (73 FR 74505, December 8, 2008), available on
the Internet at http://www.fda.gov/downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/
UCM152593.pdf.
    4. ``Providing Effective Information to Consumers about
Prescription Drug Risks and Benefits--The Issues Paper'' from the 2009
public workshop available on the Internet at http://www.fda.gov/
downloads/Drugs/NewsEvents/UCM182799.pdf.
    5. ``Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Patient Information
Prototypes,'' available on the Internet at\2\ http://
edocket.access.gpo.gov/2010/pdf/2010-10359.pdf
---------------------------------------------------------------------------

    \2\ FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.

    Dated: August 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21326 Filed 8-26-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: May 6, 2008 (Volume 73, Number 88)]
[Proposed Rules]
[Page 24906-24910]
[DOCID:fr06my08-29]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 544

[Docket No.: NHTSA-2008-0055]
RIN 2127-AK30

Insurer Reporting Requirements; List of Insurers Required To File
Reports

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of proposed rulemaking.

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

SUMMARY: This document proposes to amend Appendices A and C of 49 CFR
Part 544, Insurer Reporting Requirements. The appendices list those
passenger motor vehicle insurers that are required to file reports on
their motor vehicle theft loss experiences. An insurer included in any
of these appendices would be required to file three copies of its
report for the 2005 calendar year before October 25, 2008. If the
passenger motor vehicle insurers remain listed, they must submit
reports by each subsequent October 25. We are proposing to add and
remove several insurers from relevant appendices.

DATES: Comments must be submitted not later than July 7, 2008. Insurers
listed in the appendices are required to submit reports on or before
October 25, 2008.

ADDRESSES: You may submit comments, identified by DOT Docket No. NHTSA-
2007-0055 by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building, Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m. ET, Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Public
Participation heading of the Supplementary Information section of this
document. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://
DocketInfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to the street

address listed above. The internet access to the docket will be at
http://www.regulations.gov. Follow the online instructions for
accessing the dockets.

FOR FURTHER INFORMATION CONTACT: Rosalind Proctor, Office of
International Policy, Fuel Economy and Consumer Programs, NHTSA, 1200
New Jersey Avenue, SE., Washington, DC 20590, by electronic mail to
<EMAIL_ADDRESS>Ms. Proctor's telephone number is (202) 366-
0846. Her fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Pursuant to 49 U.S.C. 33112, Insurer reports and information, NHTSA
requires certain passenger motor vehicle insurers to file an annual
report with the agency. Each insurer's report includes information
about thefts and recoveries of motor vehicles, the rating rules used by
the insurer to establish premiums for comprehensive coverage, the
actions taken by the insurer to reduce such premiums, and the actions
taken by the insurer to reduce or deter theft. Under the agency's
regulation, 49 CFR Part 544, the following insurers are subject to the
reporting requirements:
    (1) issuers of motor vehicle insurance policies whose total
premiums account for 1 percent or more of the total premiums of motor
vehicle insurance issued within the United States;
    (2) issuers of motor vehicle insurance policies whose premiums
account for 10 percent or more of total premiums written within any one
state; and
    (3) rental and leasing companies with a fleet of 20 or more
vehicles not covered by theft insurance policies issued by insurers of
motor vehicles, other than any governmental entity.
    Pursuant to its statutory exemption authority, the agency exempted
certain passenger motor vehicle insurers from the reporting
requirements.

A. Small Insurers of Passenger Motor Vehicles

    Section 33112(f)(2) provides that the agency shall exempt small
insurers of passenger motor vehicles if NHTSA finds that such
exemptions will not significantly affect the validity or usefulness of
the information in the reports, either nationally or on a state-by-
state basis. The term ``small insurer'' is defined, in Section
33112(f)(1)(A) and (B), as an insurer whose premiums for motor vehicle
insurance issued directly or through an affiliate, including pooling
arrangements established under state law or regulation for the issuance
of motor vehicle insurance, account for less than 1 percent of the
total premiums for all forms of motor vehicle insurance issued by
insurers within the United States. However, that section also
stipulates that if an insurance company satisfies this definition of a
``small insurer,'' but accounts for 10 percent or more of the total
premiums for all motor vehicle insurance issued in a particular state,
the insurer must report about its operations in that state.
    In the final rule establishing the insurer reports requirement (52
FR 59; January 2, 1987), 49 CFR Part 544, NHTSA exercised its exemption
authority by listing in Appendix A each insurer that must report
because it had at least 1 percent of the motor vehicle insurance
premiums nationally. Listing the insurers subject to reporting, instead
of each insurer exempted from reporting because it had less than 1
percent of the premiums nationally, is administratively simpler since
the former group is much smaller than the latter. In Appendix B, NHTSA
lists those insurers required to report for particular states because
each insurer had a 10 percent or greater market share of motor vehicle
premiums in those states. In the January 1987 final rule, the agency
stated that it would update Appendices A and B annually. NHTSA updates
the appendices based on data voluntarily provided by insurance
companies to A.M. Best\1\ A.M. Best publishes in its State/Line Report
each spring. The agency uses the data to determine the insurers' market
shares nationally and in each state.
---------------------------------------------------------------------------

    \1\ A.M. Best Company is a well-recognized source of insurance
company ratings and information. 49 U.S.C. 33112(i) authorizes NHTSA
to consult with public and private organizations as necessary.
---------------------------------------------------------------------------

B. Self-insured Rental and Leasing Companies

    In addition, upon making certain determinations, NHTSA grants
exemptions to self-insurers, i.e., any person who has a fleet of 20 or
more motor vehicles (other than any governmental entity) used for
rental or lease whose vehicles are not covered by theft insurance
policies issued by insurers of passenger motor vehicles, 49 U.S.C.
33112(b)(1) and (f). Under 49 U.S.C. 33112(e)(1) and (2), NHTSA may
exempt a self-insurer from reporting, if the agency determines:
    (1) the cost of preparing and furnishing such reports is excessive
in relation to the size of the business of the insurer; and 33112(e)(1)
and (2),
    (2) the insurer's report will not significantly contribute to
carrying out the purposes of Chapter 331.
    In a final rule published June 22, 1990 (55 FR 25606), the agency
granted a class exemption to all companies that rent or lease fewer
than 50,000 vehicles, because it believed that the largest companies'
reports sufficiently represent the theft experience of rental and
leasing companies. NHTSA concluded that smaller rental and leasing
companies' reports do not significantly contribute to carrying out
NHTSA's statutory obligations and that exempting such companies will
relieve an unnecessary burden on them. As a result of the June 1990
final rule, the agency added Appendix C, consisting of an annually
updated list of the self-insurers subject to Part 544. Following the
same approach as in Appendix A, NHTSA included, in Appendix C, each of
the self-insurers subject to reporting instead of the self-insurers
which are exempted.
    NHTSA updates Appendix C based primarily on information from
Automotive Fleet Magazine and Auto Rental News.\2\
---------------------------------------------------------------------------

    \2\ Automotive Fleet Magazine and Auto Rental News are
publications that provide information on the size of fleets and
market share of rental and leasing companies.
---------------------------------------------------------------------------

C. When a Listed Insurer Must File a Report

    Under Part 544, as long as an insurer is listed, it must file
reports on or before October 25 of each year. Thus, any insurer listed
in the appendices must file a report before October 25, and by each
succeeding October 25, absent an amendment removing the insurer's name
from the appendices.

II. Proposal

1. Insurers of Passenger Motor Vehicles

    Appendix A lists insurers that must report because each had 1
percent of the motor vehicle insurance premiums on a national basis.
The list was last amended in a final rule published on August 30, 2007
(72 FR 50077). Based on the 2005 calendar year data market shares from
A.M. Best, NHTSA proposes to remove CNA Insurance Companies and add
Auto Club Southern California Group and California State Auto Group to
Appendix A.
    Each of the 19 insurers listed in Appendix A are required to file a
report before October 25, 2008, setting forth the information required
by Part 544 for each State in which it did business in the 2005
calendar year. As long as these 19 insurers remain listed, they will be
required to submit reports by each subsequent October 25 for the
calendar year ending slightly less than 3 years before.
    Appendix B lists insurers required to report for particular States
for calendar

year 2005, because each insurer had a 10 percent or greater market
share of motor vehicle premiums in those States. Based on the 2005
calendar year data for market shares from A.M. Best, we propose to make
no changes.
    The nine insurers listed in Appendix B are required to report on
their calendar year 2005 activities in every State where they had a 10
percent or greater market share. These reports must be filed by October
25, 2008, and set forth the information required by Part 544. As long
as these nine insurers remain listed, they would be required to submit
reports on or before each subsequent October 25 for the calendar year
ending slightly less than 3 years before.

2. Rental and Leasing Companies

    Appendix C lists rental and leasing companies required to file
reports. However, subsequent to publishing the final rule (See 71 FR
52292), the agency was informed by Enterprise Rent-A-Car Company
(Enterprise) on behalf of its subsidiary, Enterprise Fleet Services
(EFS), that when EFS offers vehicles for lease, it also includes as a
condition of its lease agreement that lessees purchase and maintain its
own motor vehicle insurance. Enterprise also submitted a copy of EFS'
lease agreement showing that insurance was required as a condition of
the lease. Enterprise further stated that EFS' lessees are also given
the option of contractually waiving (``self-insuring'') the physical
damage, including theft, of the leased vehicle by the Enterprise entity
but states that the total number of self-insured vehicles in EFS' fleet
is well under the 50,000 exemption threshold. Therefore, Enterprise
Rent-A-Car has requested that Enterprise Fleet Services be removed from
the list of insurers required to meet the insurer reporting
requirements. Since Enterprise Fleet Services requires its lessees to
provide the insurance for its vehicles or does not self-insure 50,000
or more of its vehicles in its leasing fleet, it does not meet the
criteria the agency uses to determine that an insurer should be
included in Appendix C. Therefore, NHTSA proposes to remove Enterprise
Fleet Services from the list of insurers required to meet the reporting
requirements.
    Each of the seven companies (including franchisees and licensees)
listed in Appendix C would be required to file reports for calendar
year 2005 no later than October 25, 2008, and set forth the information
required by Part 544. As long as those seven companies remain listed,
they would be required to submit reports before each subsequent October
25 for the calendar year ending slightly less than 3 years before.

III. Regulatory Impacts

1. Costs and Other Impacts

    This notice has not been reviewed under Executive Order 12866.
NHTSA has considered the impact of this proposed rule and determined
that the action is not ``significant'' within the meaning of the
Department of Transportation's regulatory policies and procedures. This
proposed rule implements the agency's policy of ensuring that all
insurance companies that are statutorily eligible for exemption from
the insurer reporting requirements are in fact exempted from those
requirements. Only those companies that are not statutorily eligible
for an exemption are required to file reports.
    NHTSA does not believe that this proposed rule, reflecting current
data, affects the impacts described in the final regulatory evaluation
prepared for the final rule establishing Part 544 (52 FR 59; January 2,
1987). Accordingly, a separate regulatory evaluation has not been
prepared for this rulemaking action. Using the Bureau of Labor
Statistics Consumer Price Index for 2007 (see http://www.bls.gov/cpi),
the cost estimates in the 1987 final regulatory evaluation were
adjusted for inflation. The agency estimates that the cost of
compliance is $103,671 for any insurer added to Appendix A, $41,468 for
any insurer added to Appendix B, and $11,964 for any insurer added to
Appendix C. If this proposed rule is made final, for Appendix A, the
agency would propose to remove one company and add two companies; for
Appendix B, the agency would propose that no changes be made; and for
Appendix C, the agency would propose to remove one company. The agency
estimates that the net effect of this proposal, if made final, would be
a cost of approximately $91,707 to insurers as a group.
    Interested persons may wish to examine the 1987 final regulatory
evaluation. Copies of that evaluation were placed in Docket No. T86-01;
Notice 2. Any interested person may obtain a copy of this evaluation by
writing to NHTSA, Technical Reference Division, 1201 New Jersey Avenue,
SE., East Building, Ground Floor, Room E12-100, Washington, DC 20590,
or by calling<PHONE_NUMBER>.

2. Paperwork Reduction Act

    The information collection requirements in this proposed rule were
submitted and approved by the Office of Management and Budget (OMB)
pursuant to the requirements of the Paperwork Reduction Act (44 U.S.C.
3501 et seq.). This collection of information is assigned OMB Control
Number 2127-0547 (``Insurer Reporting Requirements''), is approved for
use through August 31, 2009, and the agency will seek to extend the
approval afterwards.

3. Regulatory Flexibility Act

    The agency also considered the effects of this rulemaking under the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.). I certify that
this proposed rule will not have a significant economic impact on a
substantial number of small entities. The rationale for the
certification is that none of the companies proposed for Appendices A,
B, or C are construed to be a small entity within the definition of the
RFA. ``Small insurer'' is defined, in part under 49 U.S.C. 33112, as
any insurer whose premiums for all forms of motor vehicle insurance
account for less than 1 percent of the total premiums for all forms of
motor vehicle insurance issued by insurers within the United States, or
any insurer whose premiums within any State, account for less than 10
percent of the total premiums for all forms of motor vehicle insurance
issued by insurers within the State. This notice would exempt all
insurers meeting those criteria. Any insurer too large to meet those
criteria is not a small entity. In addition, in this rulemaking, the
agency proposes to exempt all ``self insured rental and leasing
companies'' that have fleets of fewer than 50,000 vehicles. Any self-
insured rental and leasing company too large to meet that criterion is
not a small entity.

4. Federalism

    This action has been analyzed according to the principles and
criteria contained in Executive Order 12612, and it has been determined
that the proposed rule does not have sufficient federalism implications
to warrant the preparation of a Federalism Assessment.

5. Environmental Impacts

    In accordance with the National Environmental Policy Act, NHTSA has
considered the environmental impacts of this proposed rule and
determined that it would not have a significant impact on the quality
of the human environment.

6. Regulation Identifier Number (RIN)

    The Department of Transportation assigns a regulation identifier
number (RIN) to each regulatory action listed in the Unified Agenda of
Federal Regulations. The Regulatory Information

Service Center publishes the Unified Agenda in April and October of
each year. You may use the RIN contained in the heading, at the
beginning, of this document to find this action in the Unified Agenda.

7. Plain Language

    Executive Order 12866 and the President's memorandum of June 1,
1998, require each agency to write all rules in plain language.
Application of the principles of plain language includes consideration
of the following questions:
     Have we organized the material to suit the public's needs?
     Are the requirements in the proposal clearly stated?
     Does the proposal contain technical language or jargon
that is not clear?
     Would a different format (grouping and order of sections,
use of headings, paragraphing) make the rule easier to understand?
     Would more (but shorter) sections be better?
     Could we improve clarity by adding tables, lists, or
diagrams?
     What else could we do to make the proposal easier to
understand?
If you have any responses to these questions, you can forward them to
me several ways:
    a. Mail: Rosalind Proctor, Office of International Policy, Fuel
Economy and Consumer Programs, NHTSA, 1200 New Jersey Avenue, SE.,
(West Building) Washington, DC 20590;
    b. E-mail<EMAIL_ADDRESS>or
    c. Fax:<PHONE_NUMBER>.

IV. Comments

Submission of Comments

1. How Can I Influence NHTSA's Thinking on This Proposed Rule?
    In developing our rules, NHTSA tries to address the concerns of all
our stakeholders. Your comments will help us improve this rule. We
invite you to provide views on our proposal, new data, a discussion of
the effects of this proposal on you, or other relevant information. We
welcome your views on all aspects of this proposed rule. Your comments
will be most effective if you follow the suggestions below:
     Explain your views and reasoning clearly.
     Provide solid technical and cost data to support your
views.
     If you estimate potential costs, explain how you derived
the estimate.
     Provide specific examples to illustrate your concerns.
     Offer specific alternatives.
     Include the name, date, and docket number with your
comments.
2. How Do I Prepare and Submit Comments?
    Your comments must be written in English. To ensure that your
comments are correctly filed in the Docket, please include the docket
number of this document in your comments.
    Your comments must not exceed 15 pages long (49 CFR 553.21). We
established this limit to encourage you to write your primary comments
concisely. You may attach necessary documents to your comments. We have
no limit on the attachments' length.
    Please submit two copies of your comments, including the
attachments, to Docket Management at the address given above under
ADDRESSES.
    Comments may also be submitted to the docket electronically by
logging onto the Federal eRulemaking Portal Web site at http://
www.regulations.gov. Follow the online instructions for submitting
comments.
3. How Can I Be Sure That My Comments Were Received?
    If you wish Docket Management to notify you, upon its receipt of
your comments, enclose a self-addressed, stamped postcard in the
envelope containing your comments. Upon receiving your comments, Docket
Management will mail the postcard.
4. How Do I Submit Confidential Business Information?
    If you wish to submit any information under a confidentiality
claim, you should submit three copies of your complete submission,
including the information you claim as confidential business
information, to the Chief Counsel, Office of Chief Counsel, NHTSA, 1200
New Jersey Avenue, SE., West Building, Washington, DC 20590. In
addition, you should submit two copies, from which you have deleted the
claimed confidential business information, to Docket Management at the
address given above under ADDRESSES. When you send a comment containing
information claimed to be confidential business information, you should
include a cover letter addressing the information specified in our
confidential business information regulation (49 CFR Part 512).
5. Will the Agency Consider Late Comments?
    NHTSA will consider all comments that Docket Management receives
before the close of business on the comment closing date indicated
above under DATES. To the extent possible, we will also consider
comments that Docket Management receives after that date. If Docket
Management receives a comment too late for us to consider, in
developing a final rule (assuming that one is issued), we will consider
that comment as an informal suggestion for future rulemaking action.
6. How Can I Read the Comments Submitted by Other People?
    You may read the comments received by Docket Management at the
address given above under ADDRESSES. The hours of the Docket are
indicated above, in the same location. You may also see the comments on
the Internet. To read the comments on the Internet, log onto the
Federal eRulemaking Portal at http://www.regulations.gov.

V. Conclusion

    Based on the foregoing, we are proposing to amend Appendices A and
C of 49 CFR 544, Insurer Reporting Requirements. We are also amending
Sec.  544.5 to revise the example given the recent update to the
reporting requirements.

List of Subjects in 49 CFR Part 544

    Crime insurance, Insurance, Insurance companies, Motor vehicles,
Reporting and recordkeeping requirements.

    In consideration of the foregoing, 49 CFR Part 544 is proposed to
be amended as follows:

PART 544--[AMENDED]

    1. The authority citation for Part 544 continues to read as
follows:

    Authority: 49 U.S.C. 33112; delegation of authority at 49 CFR
1.50.

    2. Paragraph (a) of Sec.  544.5 is revised to read as follows:

Sec.  544.5  General requirements for reports.

    (a) Each insurer to which this part applies shall submit a report
annually before October 25, beginning on October 25, 1986. This report
shall contain the information required by Sec.  544.6 of this part for
the calendar year 3 years previous to the year in which the report is
filed (e.g., the report due by October 25, 2008, will contain the
required information for the 2005 calendar year).
* * * * *
    3. Appendix A to Part 544 is revised to read as follows:

Appendix A--Insurers of Motor Vehicle Insurance Policies Subject to the
Reporting Requirements in Each State in Which They Do Business

Allstate Insurance Group
American Family Insurance Group
American International Group

Auto Club Southern California Group \1\
Auto-Owners Insurance Group
Erie Insurance Group
Berkshire Hathaway/GEICO Corporation Group
California State Auto Group \1\
Hartford Insurance Group
Liberty Mutual Insurance Companies
Metropolitan Life Auto & Home Group
Mercury General Group
Nationwide Group
Progressive Group
Safeco Insurance Companies
State Farm Group
St. Paul Travelers Companies
USAA Group
Farmers Insurance Group

    \1\ Indicates a newly listed company, which must file a report
beginning with the report due October 25, 2008.
---------------------------------------------------------------------------

    4. Appendix B to Part 544 is revised to read as follows:

Appendix B--Issuers of Motor Vehicle Insurance Policies Subject to the
Reporting Requirements Only in Designated States

Alfa Insurance Group (Alabama)
Auto Club (Michigan)
Commerce Group, Inc. (Massachusetts)
Farm Bureau of Idaho Group (Idaho)
Kentucky Farm Bureau Group (Kentucky)
New Jersey Manufacturers Group (New Jersey)
Safety Group (Massachusetts)
Southern Farm Bureau Group (Arkansas, Mississippi)
Tennessee Farmers Companies (Tennessee)
    5. Appendix C to Part 544 is revised to read as follows:

Appendix C--Motor Vehicle Rental and Leasing Companies (Including
Licensees and Franchisees) Subject to the Reporting Requirements of
Part 544

Cendant Car Rental
Dollar Thrifty Automotive Group
EmKay, Inc.
Enterprise Rent-A-Car
Hertz Rent-A-Car Division (subsidiary of The Hertz Corporation)
U-Haul International, Inc. (Subsidiary of AMERCO)
Vanguard Car Rental USA

    Issued on May 1, 2008.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
[FR Doc. E8-9999 Filed 5-5-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 87, Number 197 (Thursday, October 13, 2022)]
[Notices]
[Pages 62125-62129]
[FR Doc No: 2022-22178]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95995; File No. SR-CboeEDGX-2022-044]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend Rule 21.17 Concerning Drill-Through Protection and Fat Finger
Check

October 6, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 4, 2022, Cboe EDGX Exchange, Inc.

(``Exchange'' or ````EDGX'''') filed with the Securities and Exchange
Commission (``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 Options'')
proposes to amend Rule 21.17. 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 Rule 21.17. Specifically, the
Exchange proposes to amend its drill-through protection mechanism and
limit order fat finger check for both simple and complex orders.
    The Exchange proposes to amend Rule 21.17(a)(4) and (b)(6) to
update the drill-through protection mechanism for simple and complex
orders, respectively, to provide orders with additional execution
opportunities. Pursuant to the current simple drill-through protection,
if a buy (sell) order enters the Book at the conclusion of the opening
auction process or would execute or post to the Book at the time of
order entry, the System executes the order up to a buffer amount (the
Exchange determines the buffer amount on a class and premium basis)
above (below) the offer (bid) limit of the opening collar \3\ or the
national best bid (``NBO'') (national best offer (``NBB'')) that
existed at the time of order entry, respectively (the ``drill-through
price'').\4\ The System enters an order (or unexecuted portion) not
executed pursuant to the provision in the immediately preceding
sentence in the Book with a displayed equal to the drill-through
price.\5\ The order (or unexecuted portion) rests in the Book at the
drill-through price \6\ until the earlier to occur of its full
execution and the end of the duration of a number of consecutive time
periods (the Exchange determines on a class-by-class basis the number
of periods, which may not exceed five, and the length of the time
period in milliseconds, which may not exceed three seconds).\7\
---------------------------------------------------------------------------

    \3\ See Rule 21.7(a) for the definition of Opening Collars.
    \4\ See Rule 21.17(a)(4)(A).
    \5\ See Rule 21.17(a)(4)(B).
    \6\ The proposed rule change adds ``at the drill-through price''
in the first sentence of subparagraph (a)(1)(B)(i), [sic] which is a
nonsubstantive change, as it reflects current functionality and is
stated in the introductory paragraph to Rule 21.17(a)(1)(B). [sic]
The proposed rule change merely includes this detail in the next
portion of the rule for additional clarity.
    \7\ See Rule 21.17(a)(4)(B)(i).
---------------------------------------------------------------------------

    The proposed rule change amends Rule 21.17(a)(4)(B)(i) to eliminate
the concept that there will be a maximum number of time periods and
proposes that the order (or unexecuted portion) will rest in the Book
at the drill-through price for the duration of consecutive time
periods.\8\ The proposed rule change makes conforming changes to
subparagraph (ii) by deleting references to ``the final period'' and
subparagraph (iv) by deleting the reference to ``any remaining time
period(s),'' as there will no longer be an Exchange-determined limited
number of time periods. Currently, as set forth in current subparagraph
(i), the drill-through mechanism will continue until the earlier to
occur of the order's full execution and the end of the duration of the
Exchange-determined number of time periods. The Exchange proposes to
amend subparagraph (iv) to describe when the drill-through process will
conclude. Specifically, proposed Rule 21.17(a)(4)(B)(iv) provides that
the order continues through the process described in subparagraph (ii)
(as proposed to be amended) until the earliest of the following to
occur: (a) the order fully executes; (b) the User cancels the order;
and (c) the order's limit price equals or is less than (if a buy order)
or greater than (if a sell order) the drill-through price at any time
during application of the drill-through mechanism, in which case the
order rests in the Book at its limit price, subject to a User's
instructions. In other words, the order will continue through
consecutive time periods until it fully executes (unless it is
cancelled by the User or reaches its limit price prior to full
execution), compared to today when the order will continue through
consecutive time periods until it fully executes or reaches the
Exchange-determined final time period, at which time the order would be
cancelled (unless it reaches its limit price prior to full execution).
The Exchange believes eliminating the limit on the number of time
periods may increase execution opportunities for limit orders, which
will still continue to be bound by their limit prices and protected by
the limit order fat finger check.\9\
---------------------------------------------------------------------------

    \8\ The Exchange will continue to determine on a class-by-class
basis the length of the time periods in milliseconds, which may
continue to not exceed three seconds.
    \9\ If a limit price is ``too far away'' from the market, the
order will continue to be subject to the limit order fat finger
protection set forth in Rule 21.17(c)(1) and thus will still be
subject to protection against a potentially erroneous execution due
to an order pricing error upon submission.
---------------------------------------------------------------------------

    The proposed rule change makes a similar change to the drill-
through protection mechanism for complex orders. Specifically, the
proposed rule change eliminates the concept that, for complex orders
for which the user does not establish a buffer amount (and instead the
Exchange-determined default buffer amount applies),\10\ there will be a
maximum number of time periods and proposes that the complex order (or
unexecuted portion) will rest in the Book at the drill-through price
for the duration of consecutive time periods.\11\ Currently, similar to
the drill-through protection mechanism for simple orders (as described
above), if a user enters a buy (sell) complex order into the System
(and does not enter its own buffer amount), the System executes the
order \12\ up to a buffer amount above (below) the Synthetic National
Best Offer (``SNBO'') (Synthetic National Best Bid (``SNBB'')) that
existed at the time of entry (the ``drill-through price'') or initiates
a complex order auction (``COA'') at the drill-through price if the
order would initiate

a COA.\13\ For complex orders for which the user did not establish a
buffer amount, the complex order (or unexecuted portion) rests in the
COB with a displayed price equal to the drill-through price until the
earlier to occur of the complex order's full execution and the end of
the duration of a number of time periods (the Exchange determines on a
class-by-class basis the number of periods, which may not exceed five,
and the length of the time period in milliseconds, which may not exceed
three seconds). Following the end of each period prior to the final
period, the System adds (if a buy order) or subtracts (if a sell order)
one buffer amount to the drill-through price displayed during the
immediately preceding period (each new price becomes the ``drill-
through price''). The complex order (or unexecuted portion) rests in
the COB at that new drill-through price during the subsequent period.
Following the end of the final period, the System cancels, the complex
order (or unexecuted portion) not executed during any time period.\14\
---------------------------------------------------------------------------

    \10\ See Rule 21.17(b)(6)(A).
    \11\ See proposed Rule 21.17(b)(6)(B). The proposed rule change
has no impact on how the drill-through protection mechanism applies
to a complex order for which the inputting user establishes a buffer
amount, as in that situation, there is only a single time period
pursuant to the current rule (which will continue to be the case).
    \12\ Executions occur pursuant to Rule 21.20(e).
    \13\ Unlike the simple order drill-through protection mechanism,
the complex order drill-through protection mechanism permits users
to establish a buffer amount different than the Exchange-determined
default buffer amount. See Rule 21.17(b)(6)(A). A description of
COAs is located in Rule 21.20(d).
    \14\ See current Rule 21.17(b)(6)(B)(i) and (ii). As set forth
in current subparagraph (iv), if the complex order's limit price is
reached during the application of the drill-through mechanism, the
order will rest in the COB at its limit price.
---------------------------------------------------------------------------

    The proposed rule change amends Rule 21.17(b)(6)(B)(i) and (ii) to
eliminate the concept that there will be a maximum number of time
periods and proposes that the order (or unexecuted portion) will rest
in the COB at the drill-through price for the duration of consecutive
time periods when a User does not establish its own buffer amount.\15\
The proposed rule change makes conforming changes to current
subparagraphs (i), (ii), and (iv) (proposed subparagraphs (ii) and
(iii)) by deleting references to ``the final period'' and deleting the
reference to ``any remaining time period(s),'' as there will no longer
be an Exchange-determined limited number of time periods. Currently, as
set forth in current subparagraphs (i), (ii), and (iv), if the
inputting User does not establish a buffer amount for the complex
order, the drill-through mechanism will continue until the earlier to
occur of the order's full execution and the end of the duration of the
Exchange-determined number of time periods (unless it reaches its limit
price prior to full execution), at which time the order would be
cancelled. The Exchange proposes to add to the end of proposed
subparagraph (ii) when the drill-through process will conclude and what
happens at that time for complex orders for which the user did not
establish a buffer amount. Specifically, proposed Rule
21.17(b)(6)(B)(ii) provides that the complex order continues through
the process described in proposed subparagraph (ii) until the earliest
of the following to occur: (a) the complex order fully executes; (b)
the User cancels the order; and (c) the complex order's limit price
equals or is less than (if a buy order) or greater than (if a sell
order) the drill-through price at any time during application of the
drill-through mechanism, in which case the complex order rests in the
COB at its limit price, subject to a User's instructions.\16\ In other
words, a complex order for which the User did not establish a buffer
amount will continue through consecutive time periods until it fully
executes (or is cancelled or reaches its limit price), compared to
today when the complex order will continue through consecutive time
periods until it fully executes or reaches the Exchange-determined
final time period, at which time the order would be cancelled (unless
it reaches its limit price, as described in current subparagraph (iv)).
The Exchange believes eliminating the limit on the number of time
periods may increase execution opportunities for limit orders, which
will still continue to be bound by their limit prices and protected by
the limit order fat finger check.\17\
---------------------------------------------------------------------------

    \15\ The Exchange will continue to determine on a class-by-class
basis the length of the time periods in milliseconds, which may
continue to not exceed three seconds.
    \16\ Proposed clause (c) is applicable today and located in
current subparagraph (iv). As described below, the proposed rule
change merely moves this provision from current subparagraph (iv) to
proposed subparagraph (ii).
    \17\ If a limit price is ``too far away'' from the market, the
order will continue to be subject to the limit order fat finger
protection set forth in Rule 21.17(a)(2) and (b)(7) and thus will
still be subject to protection against a potentially erroneous
execution due to an order pricing error upon submission.
---------------------------------------------------------------------------

    The proposed rule change also makes certain nonsubstantive changes
to Rule 21.17(b)(6). Specifically, the proposed rule change moves all
provisions specific to the application of the drill-through mechanism
if the user establishes a buffer amount into Rule 21.17(b)(6)(B)(i) and
moves all provisions specific to the application of the drill-through
mechanism if the user does not establish a buffer amount into Rule
21.17(b)(6)(B)(ii). This includes incorporating into each of proposed
subparagraphs (i) and (ii) how the System handles a complex order if
its limit price equals or less than (if a buy order) or greater than
(if a sell order) the drill-through price, as described in current
subparagraph (iv). As a result, the proposed rule change deletes
current subparagraph (iv). Additionally, the proposed rule change moves
certain language regarding what happens if the SBBO changes during any
period, which applies to all complex orders subject to the drill-
through protection mechanism, regardless of whether the user input its
own buffer amount, to proposed subparagraph (iii) from current
subparagraph (ii) and correspondingly changes current subparagraph
(iii) to proposed subparagraph (iv). The proposed rule change makes a
nonsubstantive change to the beginning of proposed subparagraph (iii)
by changing ``However'' to ``Notwithstanding the above,'' as the
Exchange believes that phrase is more appropriate.
    In addition, the Exchange proposes to amend Rule 21.17(a)(2) and
(b)(7) to add Limit-on-Close orders \18\ to the list of orders to which
the limit order fat finger check (for simple and complex orders,
respectively) does not apply. Pursuant to the limit order fat finger
check, if a User submits a buy (sell) limit order to the System with a
price that is more than a buffer amount \19\ above (below) the NBO
(NBB) for simple orders or the SNBO (SNBB) for complex orders, the
System cancels or rejects the order.\20\ Currently, the simple limit
order fat finger check does not apply to bulk messages.\21\ The
Exchange proposes to also not apply the limit order fat finger check to
Limit-on-Close orders (simple and complex). The limit order fat finger
check applies to orders upon entry to the System. However, the limit
price of a Limit-on-Close order is intended to relate to the price at
the market close, and thus may intentionally be further away from the
NBBO or SNBBO, as applicable, at the time the order is entered. This
may cause the order to be inadvertently rejected pursuant to this
check. The Exchange believes it is not

appropriate for this limit order to be subject to the fat finger check,
as the check may inadvertently cause rejections for orders with limit
prices that are intentionally ``far away'' from the market at the time
of order entry.
---------------------------------------------------------------------------

    \18\ A ``Limit-on-Close'' or ``LOC'' order is, for an order so
designated, a limit order that may not execute on the Exchange until
three minutes prior to market close. At that time, the System enters
LOC orders into the Book in time sequence (based on the times at
which the System initially received them), where they may be
processed in accordance with Rule 21.8. The System cancels an LOC
order (or unexecuted portion) that does not execute by the market
close. Users may not designate bulk messages as LOC. See Rule
21.1(f)(7) (definition of ``Limit-on-Close'' and ``LOC'' order).
    \19\ The Exchange determines a default buffer amount on a class-
by-class basis; however, for complex orders, a User may establish a
higher or lower amount than the Exchange default for a class.
    \20\ Rule 21.17(a)(2).
    \21\ Id.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

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

    In particular, the Exchange believes the proposed rule change to
eliminate the maximum number of time periods for which a simple or
complex order will rest in the Book or COB, respectively, during
application of the drill-through protection mechanism will remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, protect investors, because
it will provide simple and complex orders with additional execution
opportunities. These orders may continue to be available on the Book or
COB, as applicable, for execution, at a wider range of prices, as
opposed to today when such orders are cancelled after a specified
number of time periods (depending on the User's instructions and if the
order does not reach its limit price prior to the end of those time
periods). The Exchange believes these additional execution
opportunities will benefit investors that submit such orders and
believes such orders will continue to receive protection against
potentially erroneous executions, as the limit order fat finger check
will continue to apply to them.
    The Exchange believes the proposed nonsubstantive rule changes to
the complex order drill-through protection mechanism will protect
investors and the public interest, because these changes improve the
organization of this rule's provisions by grouping all provisions that
apply when a User establishes its own buffer and all provisions that
apply when a User does not establish its own buffer, eliminating
potential confusion.
    Finally, the Exchange believes excluding Limit-on-Close orders from
the limit order fat finger check will remove impediments to and perfect
the mechanism of a free and open market and a national market system,
and, in general, protect investors, because it may reduce inadvertent
rejections of Limit-on-Close orders, which may be purposely priced
further away from the NBBO or SNBBO, as applicable, at the time of
entry, as their limit prices are intended to relate to price at the
market close. Therefore, this proposed rule change may increase
execution opportunities for Users that submit Limit-on-Close orders.

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. The Exchange does not
believe that the proposed rule change will impose any burden on
intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act, because the amended drill-
through protection mechanism (for both simple and complex orders) and
limit order fat finger check will continue to apply in the same manner
to orders of all Users and may lead to increased execution
opportunities. The Exchange does not believe that the proposed rule
change will impose any burden on intermarket competition that is not
necessary or appropriate in furtherance of purposes of the Act, because
the proposed rule change relates solely to Exchange risk controls and
how the Exchange handles orders subject to those risk controls.

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

    Because the foregoing proposed rule change does not:
    A. significantly affect the protection of investors or the public
interest;
    B. impose any significant burden on competition; and
    C. become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) of the Act \25\ and
Rule 19b-4(f)(6) \26\ 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.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(3)(A).
    \26\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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-2022-044 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-2022-044. 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. All comments received will be posted
without change. 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-2022-044 and should be submitted on or before November 3,
2022.
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
J. Lynn Taylor,
Assistant Secretary.
[FR Doc. 2022-22178 Filed 10-12-22; 8:45 am]
BILLING CODE 8011-01-P