[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Notices]
[Pages 28059-28062]
[FR Doc No: 2019-12677]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0350]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Tobacco Retailers on Tobacco Retailer
Training Programs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of

1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
aspects of the Guidance for Tobacco Retailers on Tobacco Retailer
Training Programs.

DATES: Submit either electronic or written comments on the collection
of information by August 16, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 16, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2010-D-0350 for ``Guidance for Tobacco Retailers on Tobacco
Retailer Training Programs.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Tobacco Retailers on Tobacco Retailer Training Programs

OMB Control Number 0910-0745--Extension

I. Background

    The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) does not require retailers to implement
retailer training programs. However, the statute does provide for
lesser civil money penalties for violations of access, advertising, and
promotion restrictions of regulations

issued under section 906(d) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 387f(d)), as amended by the Tobacco Control Act, for
retailers who have implemented a training program that complies with
standards developed by FDA for such programs. FDA intends to issue
regulations establishing standards for approved retailer training
programs. In the interim, the guidance is intended to assist tobacco
retailers in implementing effective training programs for employees.
    The guidance discusses recommended elements that should be covered
in a training program, such as: (1) Federal laws restricting the access
to, and the advertising and promotion of, cigarettes, smokeless, and
covered tobacco products; (2) the health and economic effects of
tobacco use, especially when the tobacco use begins at a young age; (3)
written company policies against sales to minors and other restrictions
on the access to, and the advertising and promotion of, tobacco
products; (4) identification of the tobacco products sold in the retail
establishment that are subject to the Federal laws prohibiting their
sale to persons under the age of 18; (5) age verification methods; (6)
practical guidelines for refusing sales; and (7) testing to ensure that
employees have the required knowledge. The guidance recommends that
retailers require current and new employees to take a written test
prior to selling tobacco products and that refresher training be
provided at least annually and more frequently as needed. The guidance
recommends that retailers maintain certain written records documenting
that all individual employees have been trained and that retailers
retain these records for 4 years in order to be able to provide
evidence of a training program during the 48-month time period covered
by the civil money penalty schedules in section 103(q)(2)(A) of the
Tobacco Control Act.
    The guidance also recommends that retailers implement certain
hiring and management practices as part of an effective retailer
training program. The guidance suggests that applicants and current
employees be notified both verbally and in writing of the importance of
complying with laws prohibiting the sales of tobacco products to
persons under the age of 18. In addition, FDA recommends that retailers
implement an internal compliance check program and document the
procedures and corrective actions for the program.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Develop training program........         273,900               1         273,900              16       4,382,400
Develop written policy against           273,900               1         273,900               1         273,900
 sales to minors and employee
 acknowledgement................
Develop internal compliance              273,900               1         273,900               8       2,191,200
 check program..................
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    Total.......................  ..............  ..............  ..............  ..............       6,847,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                            Number of      Number of records     Total annual
               Activity                   recordkeepers     per recordkeeper       records          Average burden per recordkeeper       Total hours
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Training program......................            273,900                  4          1,095,600  0.25 (15 minutes)...................            273,900
Written policy against sales to minors            273,900                  4          1,095,600  0.10 (6 minutes)....................            109,560
 and employee acknowledgement.
Internal compliance check program.....            273,900                  2            547,800  0.5 (30 minutes)....................            273,900
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    Total.............................  .................  .................  .................  ....................................            657,360
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's estimate of the number of respondents in tables 1 and 2 is
based on data reported to the U.S. Department of Health and Human
Services Substance Abuse and Mental Health Services Administration.
According to the fiscal year 2009 Annual Synar Report, there are
372,677 total retail tobacco outlets in the 50 States, District of
Columbia, and 8 U.S. territories that are accessible to youth (meaning
that there is no State law restricting access to these outlets to
individuals older than age 18). Inflating this number by about 10
percent to account for outlets in States that sell tobacco but are, by
law, inaccessible to minors, results in an estimated total number of
tobacco outlets of 410,000. We assume that 75 percent of tobacco
retailers already have some sort of training program for age and
identification verification. We expect that some of those retailer
training programs already meet the elements in the guidance, some
retailers would update their training program to meet the elements in
the guidance, and other retailers would develop a training program for
the first time. Thus, we estimate that two-thirds of tobacco retailers
would develop a training program that meets the elements in the
guidance (66 percent of 410,000 = 270,600).
    FDA estimates that the total burden for this collection will be
7,504,860 hours (6,847,500 reporting + 657,360 recordkeeping).
    We also estimate that there are approximately 5,000 to 10,000 vape
shops; we assume that 66 percent of them, or 3,300 (66% x 5,000) of the
low estimate, currently engage in retailing activities (Ref. 1).
    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

II. Reference

    The following reference is on display with the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is not
available electronically at https://www.regulations.gov as this
reference is copyright protected. It may be available at the website
address, if listed. FDA has verified the website addresses, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.

1. Burke, D., ``Trends & Insights in the Nicotine Delivery
Category.'' Management Science Associates, Inc. Presentation at NATO
Show, April 23, 2015.

    Dated: June 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12677 Filed 6-14-19; 8:45 am]
BILLING CODE 4164-01-P


and funds which are in the custody or control of DTC or for which it is
responsible.\69\ The proposed rule changes to (1) require a Corporate
Contribution to a loss, (2) introduce an Event Period, and (3)
introduce the concept of ``rounds'' (and accompanying Loss Allocation
Notices) and apply this concept to the timing of loss allocation
payments and the Participant termination process in connection with the
loss allocation process, taken together, are intended to enhance the
overall resiliency of DTC's loss allocation process
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    \69\ 15 U.S.C. 78q-1(b)(3)(F).
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    By replacing the discretionary application of DTC retained earnings
to losses and liabilities with a mandatory and defined amount of the
Corporate Contribution, the proposed rule change is designed to provide
enhanced transparency and accessibility to Participants as to how much
DTC would contribute in the event of a loss or liability. The proposed
rule change also clarifies that the proposed Corporate Contribution
would apply to both Default Loss Events and Declared Non-Default Loss
Events. The proposed rule change would provide greater transparency as
to the proposed replenishment period for the Corporate Contribution,
which would allow Participants to better assess the adequacy of DTC's
loss allocation process. Taken together, the proposed rule changes with
respect to the Corporate Contribution would enhance the overall
resiliency of DTC's loss allocation process by specifying the
calculation and application of DTC's Corporate Contribution, including
the proposed replenishment period, and would allow Participants to
better assess the adequacy of DTC's loss allocation process.
    By introducing the concept of an Event Period, DTC would be able to
group Default Loss Events and Declared Non-Default Loss Events
occurring within a period of ten (10) Business

Days for purposes of allocating losses to Participants. DTC believes
that the Event Period would provide a defined structure for the loss
allocation process to encompass potential sequential Default Loss
Events or Declared Non-Default Loss Events that may or may not be
closely linked to an initial event and/or a market dislocation episode.
Having this structure would enhance the overall resiliency of DTC's
loss allocation process because the proposed rule would expressly
address losses that may arise from multiple Default Loss Events and/or
Declared Non-Default Loss Events that arise in quick succession.
Moreover, the proposed Event Period structure would provide certainty
for Participants concerning their maximum exposure to mutualized loss
allocation with respect to such events.
    By introducing the concept of ``rounds'' (and accompanying Loss
Allocation Notices) and applying this concept to the timing of loss
allocation payments and the Participant termination process in
connection with the loss allocation process, DTC would (i) set forth a
defined amount that it would allocate to Participants during each round
(i.e., the round cap), (ii) advise Participants of loss allocation
obligation information as well as round information through the
issuance of Loss Allocation Notices, and (iii) provide Participants
with the option to limit their loss allocation exposure after the
issuance of the first Loss Allocation Notice in each round. These
proposed rule changes would enhance the overall resiliency of DTC's
loss allocation process because they would expressly permit DTC to
continue the loss allocation process in successive rounds until all of
DTC's losses are allocated and enable DTC to identify continuing
Participants for purposes of calculating subsequent loss allocation
obligations in successive rounds. Moreover, the proposed rule changes
would define for Participants a clear manner and process in which they
could cap their loss allocation exposure to DTC.
    Taken together, the foregoing proposed rule changes would establish
a stronger (for all the reasons discussed above) and clearer loss
allocation process for DTC, which DTC believes would allow it to take
timely action to address losses. The ability to timely address losses
would allow DTC to continue to meet its clearance and settlement
obligations, especially in circumstances that may involve a series of
substantially contemporaneous loss events. Therefore, DTC believes that
these proposed rule changes would promote the prompt and accurate
clearance and settlement of securities transactions, consistent with
Section 17A(b)(3)(F) of the Act.
    By reducing the time within which DTC is required to return the
Actual Participants Fund Deposit of a former Participant, DTC would
enable firms that have exited DTC to have access to their funds sooner
than under current Rule 4 while maintaining the protection of DTC and
its provision of clearance and settlement services. DTC would continue
to be protected under the proposed rule change, which will maintain the
provision that DTC may offset the return of funds against the amount of
any loss or liability of DTC arising out of or relating to the
obligations of the former Participant to DTC, and would provide that
DTC could retain the funds for up to two (2) years. As such, DTC would
maintain a necessary level of coverage for possible claims arising in
connection with the DTC activities of a former Participant. Therefore,
DTC believes that this proposed rule change would promote the prompt
and accurate clearance and settlement of securities transactions,
consistent with Section 17A(b)(3)(F) of the Act.
    The proposed rule changes to clarify the Voluntary Retirement of a
Participant would improve the clarity of the Rule and help to ensure
that DTC's Voluntary Retirement process is transparent and clear to
Participants. Having clear Voluntary Retirement provisions would enable
Participants to better understand the Voluntary Retirement process and
provide Participants with increased predictability and certainty
regarding their rights and obligations with respect to such process.
Enabling Participants to readily understand DTC's Voluntary Retirement
process and their rights and obligations in connection thereto would
help a Participant that is voluntarily terminating its business with
DTC, and the membership at large, to understand the point at which a
Participant may no longer a Participant of DTC, and would thereby
promote the prompt and accurate clearance and settlement of securities
transactions, consistent with Section 17A(b)(3)(F) of the Act.
    Rule 17Ad-22(e)(7)(i) under the Act requires, in part, that DTC
establish, implement, maintain and enforce written policies and
procedures reasonably designed to effectively measure, monitor, and
manage the liquidity risk that arises in or is borne by DTC, including
measuring, monitoring, and managing its settlement and funding flows on
an ongoing and timely basis, and its use of intraday liquidity, by
maintaining sufficient liquid resources to effect same-day settlement
of payment obligations with a high degree of confidence under a wide
range of foreseeable stress scenarios.\70\ By clarifying the remedies
available to DTC with respect to a Participant Default, including the
application of the Participants Fund as a liquidity resource, and by
clarifying and providing the related processes, the proposed rule
change is designed so that DTC may manage its settlement and funding
flows on a timely basis and apply the Participants Fund as a liquid
resource in order to effect same day settlement of payment obligations
with a high degree of confidence. Therefore, DTC believes that the
proposed rule changes with respect to the application of the Actual
Participants Fund Deposits of non-defaulting Participants to complete
settlement are consistent with Rule 17Ad-22(e)(7)(i) under the Act.
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    \70\ 17 CFR 240.17Ad-22(e)(7)(i).
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    Rule 17Ad-22(e)(13) under the Act requires, in part, that DTC
establish, implement, maintain and enforce written policies and
procedures reasonably designed to ensure DTC has the authority and
operational capacity to take timely action to contain losses and
liquidity demands and continue to meet its obligations.\71\ The
proposed rule changes to (1) require a defined Corporate Contribution
to a loss, (2) introduce an Event Period, (3) introduce the concept of
``rounds'' (and accompanying Loss Allocation Notices) and apply this
concept to the timing of loss allocation payments and the Participant
termination process in connection with the loss allocation process,
taken together, are designed to enhance the resiliency of DTC's loss
allocation process. Having a resilient loss allocation process would
help ensure that DTC can effectively and timely address losses relating
to or arising out of Default Loss Events and/or Declared Non-Default
Loss Events, which in turn would help DTC contain losses and continue
to conduct its clearance and settlement business. In addition, by
providing clarity as to the application of the Participants Fund to
fund settlement in the event of a Participant Default, the proposed
rule change is designed to clarify that DTC is authorized to use the
Participants Fund to fund settlement. Therefore, DTC believes that the
proposed rule changes to enhance the resiliency of DTC's loss
allocation process, and to provide clarity as to the application of the
Participants Fund to fund settlement, are consistent with Rule 17Ad-
22(e)(13) under the Act.
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    \71\ Id. at 240.17Ad-22(e)(13).

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    Rule 17Ad-22(e)(23)(i) under the Act requires DTC to establish,
implement, maintain and enforce written policies and procedures
reasonably designed to publicly disclose all relevant rules and
material procedures, including key aspects of DTC's default rules and
procedures.\72\ The proposed rule changes to (i) separate the
provisions for the use of the Participants Fund for settlement and for
loss allocation, (ii) make clarifying changes to the provisions
regarding the application of the Participants Fund to complete
settlement and for the allocation of losses, (iii) further align the
loss allocation rules of the DTCC Clearing Agencies, (iv) improve the
overall transparency and accessibility of the provisions in the Rules
governing loss allocation, and (v) make technical and conforming
changes, would not only ensure that DTC's loss allocation rules are, to
the extent practicable and appropriate, consistent with the loss
allocation rules of the other DTCC Clearing Agencies, but also would
help to ensure that DTC's loss allocation rules are transparent and
clear to Participants. Aligning the loss allocation rules of the DTCC
Clearing Agencies would provide consistent treatment, to the extent
practicable and appropriate, especially for firms that are participants
of two or more DTCC Clearing Agencies. Having transparent and clear
loss allocation rules would enable Participants to better understand
the key aspects of DTC's Rules and Procedures relating to Participant
Default, as well as non-default events, and provide Participants with
increased predictability and certainty regarding their exposures and
obligations. As such, DTC believes that the proposed rule changes with
respect to pro rata settlement charges, and to align the loss
allocation rules across the DTCC Clearing Agencies and to improve the
overall transparency and accessibility of DTC's loss allocation rules
are consistent with Rule 17Ad-22(e)(23)(i) under the Act.
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    \72\ Id. at 240.17Ad-22(e)(23)(i).
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    The proposed rule changes to clarify the Voluntary Retirement of a
Participant would improve the clarity of the Rules and help to ensure
that DTC's Voluntary Retirement process is transparent and clear to
Participants. Having clear Voluntary Retirement provisions would enable
Participants to better understand the Voluntary Retirement process and
provide Participants with increased predictability and certainty
regarding their rights and obligations with respect to such process. As
such, DTC believes that the proposed rule changes with respect to
Voluntary Retirement are also consistent with Rule 17Ad-22(e)(23)(i)
under the Act.

(B) Clearing Agency's Statement on Burden on Competition

    DTC does not believe that the proposed rule changes to clarify the
remedies available to DTC with respect to a Participant Default,
including the application of the Participants Fund as a liquidity
resource, and to clarify and provide the related processes, would
impact competition.\73\ The proposed rule changes retain the existing
core concepts of the pro rata use of the Participants Fund deposits of
non-defaulting Participants to complete settlement when a Participant
fails to settle, and does not materially change their rights to elect
to terminate their business with DTC and limit their exposure to
settlement charges. Based on the foregoing, DTC believes that the
proposed rule changes relating to pro rata settlement charges would not
have any impact on competition.
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    \73\ 15 U.S.C. 78q-1(b)(3)(I).
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    DTC believes that the proposed rule change to replace the
discretionary application of DTC retained earnings to losses and
liabilities with a mandatory and defined Corporate Contribution would
impact competition, but would not impose a burden on competition.\74\
By requiring a defined corporate contribution to losses and liabilities
that are incurred by DTC before the allocation of losses to
Participants, the proposed rule change would relieve Participants of a
defined amount of potential obligations, which would allow them to
apply those resources elsewhere. Based on the foregoing, DTC believes
that the proposed rule changes relating to the Corporate Contribution
would not impose a burden on competition, but may promote competition.
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    \74\ Id.
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    DTC does not believe that the proposed rule changes to enhance the
resiliency of DTC's loss allocation process would impact
competition.\75\ As described above, the proposed rule changes to (1)
introduce an Event Period, and (2) introduce the concept of ``rounds''
(and accompanying Loss Allocation Notices) and apply this concept to
the timing of loss allocation payments and the Participant termination
process in connection with the loss allocation process, taken together,
are intended to enhance the overall resiliency of DTC's loss allocation
process, and would apply equally to all Participants. Moreover, the
proposed changes with respect to loss allocation retain the core
concept of the allocation of losses and liabilities among Participants
proportionally to the amount of risk that their activities present to
DTC as measured by their Required Participants Fund Deposits.\76\ Since
there would not be a change to the mutualized obligations with respect
to a loss arising from a Default Loss Event or Declared Non-Default
Loss Event, the proposed rule changes with respect to loss allocation
would not substantively affect the rights and obligations of
Participants.
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    \75\ Id.
    \76\ Supra note 14.
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    DTC believes that the proposed rule change to reduce the time after
a Participant ceases to be a Participant within which DTC would be
required to return the amount of the Actual Participants Fund Deposit
of the former Participant may have an impact on competition, but would
not impose a burden on competition.\77\ This proposed rule change is
intended to enable firms who have exited DTC to have use of their funds
sooner, while at the same time retaining the existing requirements
around the return. The reduction of the applicable timeframe from four
(4) years to two (2) years would improve systemic efficiency by
releasing the resources of the former Participant sooner, allowing them
to allocate those resources where needed. Based on the foregoing, DTC
believes the proposed rule change to reduce the time within which DTC
is required to return the Actual Participants Fund Deposit of a former
Participant would not impose a burden on competition, but may promote
competition.
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    \77\ 15 U.S.C. 78q-1(b)(3)(I).
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    DTC also does not believe that the proposed rule changes to (i)
further align the loss allocation rules of the DTCC Clearing Agencies,
(ii) increase the transparency and accessibility of provisions in the
Rules governing loss allocation, and (iii) make technical and
conforming changes, would impact competition.\78\ These changes would
apply equally to all Participants. Further alignment of the loss
allocation rules of the DTCC Clearing Agencies are intended to increase
the consistency of the Rules with the rules of other DTCC Clearing
Agencies in order to provide consistent treatment, to the extent
practicable and appropriate, especially for firms that are participants
of two or more DTCC Clearing Agencies. Having transparent and
accessible provisions in the Rules governing loss allocation are
intended to improve the readability and

clarity of the Rules regarding the loss allocation process. Clarifying
DTC's Voluntary Retirement provisions would improve the clarity of the
Rules and help ensure that DTC's Voluntary Retirement process is
transparent and clear to all Participants. Making technical and
conforming changes to ensure the Rules remain clear and accurate would
facilitate Participants' understanding of the Rules and their
obligations thereunder. As such, DTC believes that these proposed rule
changes would not have any impact on competition.
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    \78\ Id.
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(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    Written comments relating to this proposed rule change have not
been solicited or received. DTC will notify the Commission of any
written comments received by DTC.

III. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-DTC-2017-022 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-DTC-2017-022. 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 DTC and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). 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-DTC-2017-022 and should be submitted on
or before August 3, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\79\
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    \79\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-15364 Filed 7-18-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53584-53585]
[FR Doc No: 2023-16949]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2023-0047]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on June 25, 2023, Whitewater
Valley Railroad (WVRR) petitioned the Federal Railroad Administration
(FRA) for a waiver of compliance from certain provisions of the Federal
railroad safety regulations contained at 49 CFR parts 215 (Railroad
Freight Car Safety Standards) and 224 (Reflectorization of Rail Freight
Rolling Stock). FRA assigned the petition Docket Number FRA-2023-0047.
    Specifically, WVRR requested a special approval pursuant to 49 CFR
215.203, Restricted cars, for a total of 6 cars, comprised of 1 side
dump car (CN 56752) and 5 cabooses (B&O C-2125, Erie 04946, NKP 759,
EJ&E 521, and C&O 90299) that are more than 50 years from the date of
original construction. WVRR also requests relief from Sec.  215.303,
Stenciling of restricted cars, and Sec.  224.101, General requirements,
to operate the cars in tourist/excursion service. In support of its
request, WVRR states that the cars will not be interchanged and will be
operated at a maximum speed of 15 miles per hour.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by October 10, 2023 will be considered by
FRA

before final action is taken. Comments received after that date will be
considered if practicable. Anyone can search the electronic form of any
written communications and comments received into any of our dockets by
the name of the individual submitting the comment (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). Under 5 U.S.C. 553(c), the U.S. Department of
Transportation (DOT) solicits comments from the public to better inform
its processes. DOT posts these comments, without edit, including any
personal information the commenter provides, to www.regulations.gov, as
described in the system of records notice (DOT/ALL-14 FDMS), which can
be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the privacy notice of
regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2023-16949 Filed 8-7-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: June 6, 2008 (Volume 73, Number 110)]
[Notices]
[Page 32317-32318]
[DOCID:fr06jn08-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP08-410-000; Docket No. CP02-74-000]

West Texas Gas, Inc.; Reef International, L.L.C.; Notice of
Application To Transfer Natural Gas Act Section 3 Authorization and
Presidential Permit

May 30, 2008.
    On May 22, 2008, West Texas Gas, Inc. (West Texas) and Reef
International, L.L.C. (Reef) filed a joint application in Docket No.
CP08-410-000 pursuant to section 3 of the Natural Gas Act (NGA) and
section 153 of the Commission's Regulations and Executive Order No.
10485, as amended by Executive Order No. 12038, and the Secretary of
Energy's Delegation Order No. 00-004.00A, effective May 16, 2006,
seeking authorization to transfer Reef's existing NGA section 3
authorization and Presidential Permit \1\ to West Texas, all as more
fully set forth in the application which is on file with the Commission
and open to the public for inspection. This filing is available for
review at the Commission or may be viewed on the Commission's Web site
at http://www.ferc.gov, using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>.
---------------------------------------------------------------------------

    \1\ 99 FERC ] 61,221 (2002)
---------------------------------------------------------------------------

    Any questions regarding the application may be directed to: Richard
D. Hatchett, 211 North Colorado, Midland, Texas 79701, or call (432)
682-4349 or e-mail<EMAIL_ADDRESS>    Specifically, West Texas and Reef request the Commission to issue
an

order: (1) Transferring Reef's NGA section 3 authorization to West
Texas for the operation and maintenance of facilities used to export
natural gas at the International Border near Eagle Pass, Maverick
County, Texas, to Coahuila, Mexico; and (2) authorizing the assignment
of Reef's May 30, 2002, Presidential Permit for the operation and
maintenance of facilities at the Coahuila, Mexico/Texas export point.
    The export facilities consist of approximately 400 feet of 12-inch
diameter pipeline extending from certain intrastate pipeline facilities
in Texas to an interconnection with pipeline facilities owned by
Compania National de Gas, S.A. (Conagas) in Coahuila, Mexico. West
Texas would continue to operate and maintain these border crossing
facilities in its own name rather than as Reef. West Texas and Reef
state that no new facilities would be constructed.
    West Texas and Reef state that the border facilities will remain in
place and operation following the requested transfer and assignment.
West Texas and Reef also state that the border crossing facilities
would be used for transportation services subject to the jurisdiction
of the Texas Railroad Commission.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date, file with the Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426, a motion to
intervene in accordance with the requirements of the Commission's Rules
of Practice and Procedure (18 CFR 385.214 or 385.211) and the
Regulations under the NGA (18 CFR 157.10). A person obtaining party
status will be placed on the service list maintained by the Secretary
of the Commission and will receive copies of all documents filed by the
applicant and by all other parties. A party must submit 14 copies of
filings made with the Commission and must mail a copy to the applicant
and to every other party in the proceeding. Only parties to the
proceeding can ask for court review of Commission orders in the
proceeding.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.
    Comment Date: June 20, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-12657 Filed 6-5-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 14 (Friday, January 21, 2011)]
[Notices]
[Pages 3912-3913]
[FR Doc No: 2011-1223]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.

    Name of Committee: Advisory Committee for Pharmaceutical Science
and Clinical Pharmacology.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 2, 2011, from
7:15 a.m. to 3 p.m.
    Location: Hyatt Regency Dallas at Reunion, Landmark Ballroom,
300 Reunion Blvd., Dallas, TX 75207. The hotel phone number is 214-
651-1234.
    Contact Person: Yvette Waples, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:
301-847-8540, e-mail<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area), and follow prompts to the desired center or
product area. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough
to provide timely notice. Therefore, you

should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: The committee will discuss innovative approaches to the
development of drugs for orphan and rare diseases to support
decisions such as dose and trial design selection. FDA will seek
input and comment on how to optimally utilize mechanistic biomarkers
and apply clinical pharmacology tools, such as pharmacogenetics and
modeling and simulation, to facilitate efficient and informative
drug development and regulatory review. FDA will present and seek
input from the committee on how lessons learned from other
applications of clinical pharmacology tools in pediatrics and
oncology can be applied to orphan and rare disease drugs. The
committee will be asked to comment on the current status and future
direction for clinical pharmacology studies (e.g., dose-response,
drug-drug interactions, pharmacokinetics in patients with renal or
hepatic impairment) as they pertain to drug development for orphan
and rare diseases.
    FDA intends to make background material available to the public
no later than 2 business days before the meeting. If FDA is unable
to post the background material on its Web site prior to the
meeting, the background material will be made publicly available at
the location of the advisory committee meeting, and the background
material will be posted on FDA's Web site after the meeting.
Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 15, 2011. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
February 7, 2011. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person
will notify interested persons regarding their request to speak by
February 8, 2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to
electrical outlets.
    FDA welcomes the attendance of the public at its advisory
committee meetings and will make every effort to accommodate persons
with physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Yvette Waples, at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory
committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for
procedures on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-1223 Filed 1-20-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 123 (Thursday, June 26, 2014)]
[Notices]
[Page 36366]
[FR Doc No: 2014-15053]

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SECURITIES AND EXCHANGE COMMISSION

 In the Matter of BioMedical Technology Solutions Holdings, Inc.,
Chaolei Marketing and Finance Company, Clear-Lite Holdings, Inc.,
Encompass Group Affiliates, Inc. (n/k/a Re-Act Enterprises, Inc.),
Hydron Technologies, Inc., Sun American Bancorp, and XenaCare Holdings,
Inc.; File No. 500-1; Order of Suspension of Trading

June 24, 2014.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
BioMedical Technology Solutions Holdings, Inc. because it has not filed
any periodic reports since the period ended September 30, 2011.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Chaolei Marketing and Finance Company because it has not filed any
periodic reports since the period ended September 30, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Clear-Lite Holdings, Inc. because it has not filed any periodic reports
since the period ended January 31, 2011.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Encompass Group Affiliates, Inc. (n/k/a Re-Act Enterprises, Inc.)
because it has not filed any periodic reports since the period ended
March 31, 2011.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Hydron Technologies, Inc. because it has not filed any periodic reports
since the period ended June 30, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Sun American Bancorp because it has not filed any periodic reports
since the period ended September 30, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
XenaCare Holdings, Inc. because it has not filed any periodic reports
since the period ended March 31, 2011.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EDT on June 24, 2014, through 11:59 p.m.
EDT on July 8, 2014.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2014-15053 Filed 6-24-14; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 240 (Friday, December 15, 2017)]
[Notices]
[Pages 59679-59680]
[FR Doc No: 2017-26984]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82281; File No. SR-NYSEArca-2013-107]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting an
Extension to Limited Exemption From Rule 612(c) of Regulation NMS in
Connection With the Exchange's Retail Liquidity Program Until June 30,
2018

December 11, 2017.
    On December 23, 2013, the Securities and Exchange Commission
(``Commission'') issued an order pursuant to its authority under Rule
612(c) of Regulation NMS (``Sub-Penny Rule'') \1\ that granted NYSE
Arca, Inc. (``Exchange'') a limited exemption from the Sub-Penny Rule
in connection with the operation of the Exchange's Retail Liquidity
Program (``Program'').\2\ The limited exemption was granted
concurrently with the Commission's approval of the Exchange's proposal
to adopt the Program for a one-year pilot term.\3\ The exemption was
granted coterminous with the effectiveness of the pilot Program; both
the pilot Program and exemption, as previously extended, are scheduled
to expire on December 31, 2017.\4\
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    \1\ 17 CFR 242.612(c).
    \2\ See Securities Exchange Act Release No. 71176 (December 23,
2013), 78 FR 79524 (December 30, 2013) (SR-NYSEArca-2013-107) (``RLP
Approval Order'').
    \3\ See id.
    \4\ The Sub-Penny Exemption was originally granted by the
Commission concurrently with the approval of the Program. See id. On
March 19, 2015, the Exchange requested an extension of the exemption
for the Program. See letter from Martha Redding, Senior Counsel and
Assistant Secretary, to Brent J. Fields, Secretary, Commission,
dated March 19, 2015. The pilot period for the Program was extended
until September 30, 2015. See Securities Exchange Act Release No.
74572 (Mar. 24, 2015), 80 FR 16705 (Mar. 30, 2015) (SR-NYSEArca-
2015-22). On September 17, 2015, the Exchange requested an extension
of the exemption for the Program. See letter from Martha Redding,
Senior Counsel and Assistant Secretary, to Brent J. Fields,
Secretary, Commission, dated September 17, 2015. The pilot period
for the Program was extended until March 31, 2016. See Securities
Exchange Act Release Nos. 75994 (Sept. 28, 2015), 80 FR 59834 (Oct.
2, 2015) (SR-NYSEArca-2015-84) and 77236 (Feb. 25, 2016), 81 FR
10943 (Mar. 2, 2016) (SR-NYSEArca-2016-30). On March 17, 2016, the
Exchange requested another extension of the exemption for the
Program. See letter from Martha Redding, Senior Counsel and
Assistant Secretary, to Brent J. Fields, Secretary, Commission,
dated March 17, 2016. The pilot period for the Program was extended
until August 31, 2016. See Securities Exchange Act Release No. 77425
(Mar. 23, 2016), 81 FR 17523 (Mar. 29, 2016) (SR-NYSEArca-2016-47).
On August 8, 2016, the Exchange requested another extension of the
exemption for the Program. See Letter from Martha Redding, Associate
General Counsel and Assistant Secretary, to Brent J. Fields,
Secretary, Commission, dated August 8, 2016. The pilot period for
the Program was extended until December 31, 2016. See Securities
Exchange Act Release No. 78601 (Aug. 17, 2016), 81 FR 57632 (Aug.
23, 2016) (SR-NYSEArca-2016-113). On November 28, 2016, the Exchange
requested another extension of the exemption for the program. See
Letter from Martha Redding, Associate General Counsel and Assistant
Secretary, to Brent J. Fields, Secretary, Commission, dated November
28, 2016. The pilot period for the Program was extended until June
30, 2017. See Securities Exchange Act Release No. 79495 (Dec. 7,
2016), 81 FR 90033 (Dec. 13, 2016) (SR NYSEArca-2016-157). On May
23, 2017, the Exchange requested another extension of the exemption
for the program. See Letter from Martha Redding, Associate General
Counsel and Assistant Secretary, to Brent J. Fields, Secretary,
Commission, dated May 23, 2017. The pilot period for the Program was
extended until December 31, 2017. See Securities Exchange Act
Release No.80851 (June 2, 2017), 82 FR 26722 (June 8, 2017) (SR-
NYSEArca-2017-63).
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    The Exchange now seeks to further extend the exemption until June
30, 2018.\5\ The Exchange's request was made in conjunction with an
immediately effective filing that extends the operation of the Program
through the same date.\6\ In its request to extend the exemption, the
Exchange notes that participation in the program has increased
recently.\7\ Accordingly, the Exchange has asked for additional time to
allow the Exchange and the Commission to analyze more data concerning
the Program, which the Exchange committed to provide to the
Commission.\8\ For this reason and the reasons stated in the RLP
Approval Order originally granting the limited exemption, the
Commission finds, pursuant to its authority under Rule 612(c) of
Regulation NMS, that extending the exemption is appropriate in the
public interest and consistent with the protection of investors.
---------------------------------------------------------------------------

    \5\ See Letter from Martha Redding, Assistant Secretary, NYSE,
to Brent J. Fields, Secretary, Commission, dated November 30, 2017
(``NYSE Arca Letter'').
    \6\ See SR-NYSEArca-2017-137.
    \7\ See NYSE Arca Letter, supra note 5, at 3.
    \8\ See RLP Approval Order, supra note 2, 78 FR at 79529.
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    Therefore, it is hereby ordered that, pursuant to Rule 612(c) of
Regulation NMS, the Exchange is granted a limited exemption from Rule
612 of Regulation NMS that allows it to accept and rank orders priced
equal to or greater than $1.00 per share in increments of $0.001, in
connection with the operation of its Retail Liquidity Program, until
June 30, 2018.

    The limited and temporary exemption extended by this Order is
subject to modification or revocation if at any time the Commission
determines that such action is necessary or appropriate in furtherance
of the purposes of the Securities Exchange Act of 1934.
    Responsibility for compliance with any applicable provisions of the
Federal securities laws must rest with the persons relying on the
exemptions that are the subject of this Order.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(83).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2017-26984 Filed 12-14-17; 8:45 am]
 BILLING CODE 8011-01-P