[Federal Register Volume 80, Number 107 (Thursday, June 4, 2015)]
[Notices]
[Pages 31933-31934]
[FR Doc No: 2015-13741]

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SECURITIES AND EXCHANGE COMMISSION

Order of Suspension of Trading; In the Matter of Anticus
International Corp., China Marketing Media Holdings, Inc., Cigma Metals
Corp., and LL&E Royalty Trust; File No. 500-1

June 2, 2015.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Anticus International Corp. (CIK No. 1192494), a revoked Nevada
corporation with its principal place of business listed as Montreal,
Quebec, Canada, with stock quoted on OTC Link (previously, ``Pink
Sheets'') operated by OTC Markets Group, Inc. (``OTC Link'') under the
ticker symbol ATCI, because it has not filed any periodic reports since
the period ended March 31, 2011. On July 5, 2013, Anticus International
received a delinquency letter sent by the Division of Corporation
Finance requesting compliance with their periodic filing obligations.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
China Marketing Media Holdings, Inc. (CIK No. 1353307), a forfeited
Texas corporation with its principal place of business listed as
Beijing, China, with stock quoted on OTC Link under the ticker symbol
CMKM, because it has not filed any periodic reports since the period
ended September 30, 2012. On April 15, 2014, the Division of
Corporation Finance sent China Marketing Media Holdings a delinquency
letter requesting compliance with its periodic filing obligations, but
the letter was returned because of China Marketing Media Holdings'
failure to maintain a valid address on file with the Commission.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Cigma Metals Corp. (CIK No. 1083410), a dissolved Florida corporation
with its principal place of business listed as Madrid, Spain, with
stock quoted on OTC Link under the ticker symbol CGMX, because it has
not filed any periodic reports since the period ended September 30,
2012. A delinquency letter sent to Cigma Metals by the Division of
Corporation Finance requesting compliance with their periodic filing
obligations was returned, but a letter sent to the company's registered
agent was delivered on August 17, 2012.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
LL&E Royalty Trust (CIK No. 721765), a Michigan trust with its
principal place of business listed as Troy, Michigan, with units of
interest quoted on OTC Link under the ticker symbol LRTR, because it
has not filed any periodic reports since the period ended September 30,
2011. On August 30, 2013, LL&E Royalty received a

delinquency letter sent by the Division of Corporation Finance
requesting compliance with their periodic filing obligations.
    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 2, 2015, through 11:59 p.m. EDT on June 15, 2015.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-13741 Filed 6-2-15; 11:15 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 87 (Monday, May 8, 2017)]
[Notices]
[Pages 21380-21381]
[FR Doc No: 2017-09252]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-219-000]

Southern Star Central Gas Pipeline; Notice of Application

    Take notice that on April 21, 2017, Southern Star Central Gas
Pipeline

(Southern Star), 4700 Highway 56, Owensboro, Kentucky 42301, filed an
application pursuant to section 7(c) of the Natural Gas Act (NGA)
requesting authorization to expand both vertically and laterally the
existing certificated boundary of its Webb Gas Storage Field located in
Grant County, Oklahoma. Southern Star states that the current
operational parameters and capabilities of the Webb Gas Storage Field
will remain the same and current certificated service levels to
customers will not be affected, all as more fully described in the
application which is on file with the Commission and open to public
inspection. The filing may also be viewed on the web at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this application should be directed to
Ronnie C. Hensley, Manager, Regulatory Affairs, Southern Star Central
Gas Pipeline, Inc., 4700 Highway 56, Owensboro, KY 42301, or call (270)
852-4658, or by email<EMAIL_ADDRESS>    Southern Star requests that the current certificated boundary be
expanded horizontally east of the current certificated boundary, in an
area noted as the North Nardin Field, totaling 1,120 surface acres.
Additionally, Southern Star requests that the vertical storage boundary
be expanded in the KLO area to include the Oswego Limestone formation.
The KLO area is a 160-acre section located in the northeast section
within the field's current certificate boundary.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made in the proceeding with the Commission
and must mail a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically should
submit an original and 5 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on May 23, 2017.

    Dated: May 2, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-09252 Filed 5-5-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 228 (Tuesday, November 27, 2012)]
[Notices]
[Pages 70776-70777]
[FR Doc No: 2012-28722]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9752-2; Docket ID No. EPA-HQ-ORD-2011-0051]

Draft Integrated Science Assessment for Lead

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: EPA is announcing the availability of a document titled,
``Third External Review Draft Integrated Science Assessment for Lead''
(EPA/600/R-10/075C). The document was prepared by the National Center
for Environmental Assessment (NCEA) within EPA's Office of Research and
Development as part of the review of the national ambient air quality
standards (NAAQS) for lead (Pb).
    EPA is releasing this draft document to seek review by the Clean
Air Scientific Advisory Committee (CASAC) and the public (meeting date
and location to be specified in a separate Federal Register Notice).
The draft document does not represent and should not be construed to
represent any final EPA policy, viewpoint, or determination. EPA will
consider any public comments submitted in response to this notice when
revising the document.

DATES: The public comment period begins, November 27, 2012, and ends
January 28, 2013. Comments must be received on or before January 28,
2013.

ADDRESSES: The ``Third External Review Draft Integrated Science
Assessment for Lead'' will be available primarily via the Internet on
the National Center for Environmental Assessment's home page under the
Recent Additions and Publications menus at http://www.epa.gov/ncea. A
limited number of CD-ROM or paper copies will be available. Contact Ms.
Marieka Boyd by phone<PHONE_NUMBER>), fax<PHONE_NUMBER>), or email
<EMAIL_ADDRESS>to request either of these, and please provide
your name, your mailing address, and the document title, ``Third
External Review Draft Integrated Science Assessment for Lead'' (EPA/
600/R-10/075C) to facilitate processing of your request.

FOR FURTHER INFORMATION CONTACT: For technical information, contact Dr.
Ellen Kirrane, NCEA; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>;
or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About the Document

    Section 108 (a) of the Clean Air Act directs the Administrator to
identify certain pollutants which, among other things, ``cause or
contribute to air pollution, which may reasonably be anticipated to
endanger public health or welfare'' and to issue air quality criteria
for them. These air quality criteria are to ``accurately reflect the
latest scientific knowledge useful in indicating the kind and extent of
all identifiable effects on public health or welfare, which may be
expected from the presence of [a] pollutant in the ambient air * * *.''
Under section 109 of the Act, EPA is then to establish national ambient
air quality standards (NAAQS) for each pollutant for which EPA has
issued criteria. Section 109 (d) of the Act subsequently requires
periodic review and, if appropriate, revision of existing air quality
criteria to reflect advances in scientific knowledge on the effects of
the pollutant on public health or welfare. EPA is also to periodically
review and, if appropriate, revise the NAAQS, based on the revised air
quality criteria.
    Pb is one of six principal (or ``criteria'') pollutants for which
EPA has established NAAQS. Periodically, EPA reviews the scientific
basis for these standards by preparing an Integrated Science Assessment
(ISA) (formerly called an Air Quality Criteria Document). The ISA
provides a concise review, synthesis, and evaluation of the most
policy-relevant science to serve as a scientific foundation for the
review of the NAAQS. The CASAC, an independent science advisory
committee mandated by Section 109 (d) (2) of the Clean Air Act, is
charged with independent scientific review of EPA's air quality
criteria.
    On February 26, 2010 (75 FR 8934), EPA formally initiated its
current review of the air quality criteria for Pb, requesting the
submission of recent scientific information on specified topics. Soon
after, a science policy workshop was held to identify key policy issues
and questions to frame the review of the Pb NAAQS (75 FR 20843).
Drawing from the workshop discussions, a draft of EPA's ``Integrated
Review Plan for the Lead National Ambient Air Quality Standards
Review'' (EPA/452/D-11-001) was developed and made available in March
2011 for public comment and was discussed by the CASAC via a publicly
accessible teleconference consultation on May 5, 2011 (76 FR 21346).
The final IRP was released in December 2011 (76 FR 76972) and is
available at http://www.epa.gov/ttn/naaqs/standards/pb/s_pb_2010_pd.html.
    As part of the science assessment phase of the review, EPA held a
workshop in December 2010 to discuss, with invited scientific experts,
initial draft materials prepared in the development of the ISA (75 FR
69078). The first external review draft ISA for Pb was released on May
6, 2011 (http://cfpub.epa.gov/ncea/isa/recordisplay.cfm?deid=226323).
The CASAC Pb Review Panel met at a public meeting on July 20, 2011, to
review the draft ISA (76 FR 36120). Subsequently, on December 9, 2011,
the CASAC Pb Review Panel provided a consensus letter for their review
to the Administrator of the EPA (http://yosemite.epa.gov/sab/
sabproduct.nsf/D3E2E8488025344D852579610068A8A1/$File/EPA-CASAC-12-002-
unsigned.pdf). The second external review draft ISA for Pb was released
on February 2, 2012 (http://cfpub.epa.gov/ncea/isa/recordisplay.cfm?deid=235331#Download). The CASAC Pb Review Panel met
at a public meeting on April 10, 2012, to review the draft ISA (77 FR
14783). Subsequently, on July 20, 2012, the CASAC Pb Review Panel
provided a consensus letter for their review to the Administrator of
the EPA (http://yosemite.epa.gov/sab/SABPRODUCT.NSF/
13B1FD83815FA11885257A410064E0DC/$File/EPA-CASAC-12-005-unsigned.pdf).
The third external review draft ISA for Pb will be discussed at a
public meeting of the CASAC Pb Review Panel, and timely public comments
received will be provided to the CASAC panel. A future Federal Register
Notice will inform the public of the exact date and time of that CASAC
meeting.

II. How To Submit Technical Comments to the Docket at
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2011-
0051 by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.

     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 28221T), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Avenue NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information. If you provide comments by
mail or hand delivery, please submit three copies of the comments. For
attachments, provide an index, number pages consecutively with the
comments, and submit an unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2011-0051. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information through
www.regulations.gov or email that you consider to be CBI or otherwise
protected. The www.regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the OEI Docket in the EPA
Headquarters Docket Center.

    Dated: September 28, 2012.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2012-28722 Filed 11-26-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60242-60246]
[FR Doc No: 2017-27231]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82312; File No. SR-OCC-2017-009]

Self-Regulatory Organizations; The Options Clearing Corporation;
Order Approving Proposed Rule Change Relating to The Options Clearing
Corporation's Counterparty Credit Risk Management Policy

December 13, 2017.
    On October 12, 2017, The Options Clearing Corporation (``OCC'')
filed with the Securities and Exchange Commission (``Commission'')
proposed rule change SR-OCC-2017-009 pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4
thereunder.\2\ The proposed rule change was published for comment in
the Federal Register on November 1, 2017.\3\ The Commission did not
receive any comment letters on the proposed rule change. This order
approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 34-81949 (Oct. 26,
2017), 82 FR 50719 (Nov. 1, 2017) (File No. SR-OCC-2017-009).
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I. Description of the Proposed Rule Change

    This proposed rule change by OCC will formalize OCC's Counterparty
Credit Risk Management Policy (``CCRM Policy''). The proposed rule
change does not require any changes to the text of OCC's By-Laws or
Rules.\4\
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    \4\ All terms with initial capitalization that are not otherwise
defined herein have the same meaning as set forth in the OCC By-Laws
and Rules.
---------------------------------------------------------------------------

    OCC stated that, as a central counterparty (``CCP'') providing
clearance, settlement, and risk management services, it is exposed to
and must manage a range of risks, including credit risk. According to
OCC, the purpose of the CCRM Policy is to outline OCC's overall
approach to identify, measure, monitor, and manage its exposures to
direct and indirect participants, Liquidity Providers,\5\ asset
custodians, settlement banks, letter of credit issuers, investment
counterparties, other clearing agencies, and financial market utilities
(``FMUs'') \6\ (each a ``Counterparty'') arising from its payment,
clearing, and settlement processes. OCC noted that the CCRM Policy is
part of a broader framework used by OCC to manage credit risk,
including OCC's By-Laws, Rules, and other policies and procedures that
are designed collectively to ensure that OCC appropriately manages
counterparty credit risk.
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    \5\ Under the CCRM Policy, ``Liquidity Provider'' is defined as
a Commercial Bank or a non-banking institution--generally a pension
fund--that provides a committed liquidity facility to OCC.
    \6\ Under the CCRM Policy, ``Financial Market Utility'' is
defined as a derivatives clearing organization partnering with OCC
to provide a cross-margin program; a clearing agency providing
settlement services of securities arising from the exercise,
assignment or maturity of options or futures; or the Depository
providing book-entry securities transfers and asset custodian
services.
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    The CCRM Policy outlines the key components of OCC's framework for
identifying, measuring, monitoring, and managing OCC's exposures to its
Counterparties. This framework includes: (1) The identification of
credit risk, (2) Counterparty access and participation standards, (3)
the measurement of Counterparty exposures, (4) the monitoring and
managing of Counterparty exposures, and (5) voluntary termination of
Counterparty relationships. Each of these components is described in
more detail below.

A. Identification of Credit Risk

    The CCRM Policy identifies various ways in which credit risk
originates from the failure of a Counterparty to perform. With respect
to a Clearing Member, the CCRM Policy details a number of different
ways in which OCC may be exposed to credit risk. This includes the
potential failure of a Clearing Member to pay for purchased options, to
meet expiration-related settlement obligations, or to make certain
mark-to-market variation payments or initial margin deposits. It also
includes the potential insufficiency of a defaulting Clearing Member's
margin and Clearing Fund deposits in a liquidation scenario. Other
sources of credit risk identified in the CCRM Policy include the
inability of OCC to access collateral (e.g., cash or securities) from a
custodian or investment counterparty that is needed to facilitate a
liquidation, or a failure by an issuer of a letter of credit to honor
its corresponding obligations. The CCRM Policy also identifies that
certain relationships with other FMUs, such as cross-margining programs
and cash market settlement services, represent critical linkages that
may present certain degrees of credit exposure based on the terms and
design of the linkage. The CCRM Policy also notes that OCC may face
additional risks from Counterparties, such as the potential failure of
a Liquidity Provider to honor a borrowing request.

B. Counterparty Access and Participation Standards

    Under the CCRM Policy, OCC's management of Counterparty credit
risks begins with an initial evaluation process intended to ascertain
that Counterparties meet certain minimum financial and operational
standards and are considered as having a low probability of defaulting
on their obligations prior to engaging or effecting any new
transactions or expansion of business with OCC. To accomplish this
objective, OCC evaluates each Counterparty against established minimum
standards of creditworthiness, overall financial condition, and
operational capabilities. Pursuant to the Policy, the standards used to
evaluate Counterparties shall be objective, risk-based, and publicly-
disclosed to permit fair and open access. These standards shall be
developed independently for Clearing Members, Commercial and Central
Banks, investment counterparties, Liquidity Providers and FMUs,
accounting for differences in their regulatory reporting and overall
business operations.
Clearing Membership Standards
    OCC's minimum participation standards for Clearing Member are

found in Article V of OCC's By-Laws, Chapters II and III of OCC's
Rules, and other publicly-disclosed supplemental documentation
(together, ``Participation Standards Documentation''). Under the
Policy, OCC's Credit Risk Management and Member Services Departments
shall evaluate each Clearing Member applicant against the minimum
standards of creditworthiness and for its overall financial condition
and operational capabilities as provided in the Participation Standards
Documentation. Such evaluation shall also consider the Counterparty's
aggregation of exposure on an individual and related-entities level, as
applicable, as well as any material exposure that may arise from tiered
participation arrangements. The Credit Risk Management and Member
Services Departments shall document the results of this evaluation in a
memorandum, including the Clearing Member applicant's ability to meet
relevant participation standards, and report those results to OCC's
Executive Chairman, Chief Operating Officer, or Chief Administrative
Officer for review and approval, where appropriate, or for
recommendation to the Risk Committee or Board of Directors.\7\
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    \7\ Pursuant to Article V, Section 2 of OCC's By-Laws, the
Executive Chairman, Chief Operating Officer and Chief Administrative
Officer each have delegated authority to approve Clearing Member
applicants provided that (1) there is no recommendation to impose
additional membership criteria in accordance with Article V of the
By-Laws and (2) the Risk Committee is given not less than five days
to determine the application should be reviewed at a meeting of the
Risk Committee. Pursuant to Interpretation and Policy .06 to Article
V, Section 1 of OCC's By-Laws, the Risk Committee has the authority
to impose additional requirements on Clearing Member applicants,
such as increased capital or margin requirements as well as
restrictions on clearing activities. The Risk Committee also has the
authority to approve waivers of certain clearing membership
requirements under Article V, Section 1 of the By-Laws. Approvals of
a Clearing Member business expansion by the Executive Chairman,
Chief Operating Officer or Chief Administrative Officer are
subsequently presented to the Risk Committee for ratification,
except in limited circumstances detailed in Article V, Section
1.03(e) of OCC's By-Laws.
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Commercial and Central Banks
    OCC's minimum standards for asset custodians, settlement banks,
letter of credit issuers, and investment counterparties are found in
OCC Rule 604 and relevant OCC procedures. The Credit Risk Management
Department shall coordinate with various departments (such as
Collateral Services or Treasury) to evaluate each bank against the
minimum standards of creditworthiness and for its overall financial
condition and operational capabilities as provided in OCC Rule 604 and
related OCC procedures. Such evaluation shall also consider the
Counterparty's aggregation of exposure on an individual and related-
entities level, as applicable, as well as whether OCC would be able to
structure its custodial relationships in a manner that allows prompt
access to its own and its Clearing Members' assets. The latter shall
include holding assets at supervised and regulated institutions that
adhere to generally accepted accounting practices, maintain safekeeping
procedures, and have internal controls that fully protect these assets.
Under the Policy, Credit Risk Management and either the Collateral
Services or Treasury Department, as applicable, shall document the
results of its evaluation in a memorandum, including the bank's ability
to meet relevant participation standards, and report those results to
OCC's Executive Chairman, Chief Operating Officer or Chief
Administrative Officer, each of which shall have the authority to
approve new and expanded relationships with asset custodians,
settlement banks, letter of credit issuers, investment counterparties,
and Liquidity Providers.
Liquidity Providers
    Under the Policy, OCC maintains internal procedures outlining the
minimum standards for Commercial Banks \8\ and non-bank institutions
acting as Liquidity Providers. OCC's Credit Risk Management and
Treasury Departments would be responsible for evaluating each Liquidity
Provider against the minimum standards of creditworthiness and for its
overall financial condition and operational capabilities as provided in
the procedures. Because Liquidity Providers present both credit and
liquidity risk to OCC, the due diligence around such institutions shall
include a review of each lender's ability to perform their commitments
as well as understand and manage their liquidity risks. Pursuant to the
Policy, Credit Risk Management and Treasury shall document the results
of the evaluation in a memorandum, including the Liquidity Provider's
ability to meet relevant participation standards, and report those
results to the Executive Chairman, Chief Operating Officer or Chief
Administrative Officer, each of which shall have the authority to
approve new and expanded relationships with Liquidity Providers.
---------------------------------------------------------------------------

    \8\ Under the Policy, ``Commercial Bank'' is defined as a
banking or depository institution that is not an operating arm of a
Central Bank. Commercial Bank relationships shall be governed by
this Policy and all supporting bank-related procedures. Commercial
Banks act as Liquidity Providers, asset custodians, settlement
banks, letter of credit issuers, and investment counterparties on
behalf of OCC.
---------------------------------------------------------------------------

FMUs
    Under the Policy, OCC maintains internal procedures outlining
minimum standards for FMUs. OCC's Business Operations and Credit Risk
Management Departments shall evaluate each FMU for its overall
financial condition and operational capabilities as provided in the
procedure. Pursuant to the CCRM Policy, before entering into a link
with any FMU, the Legal Department shall assist the aforementioned
business units to identify legal risks relating to rights and
interests, collateral arrangements, settlement finality and netting
arrangements, and financial and custody risks. The Business Operations,
Credit Risk Management, and Legal Departments shall document the
results of its evaluation in a memorandum, including the FMU's ability
to meet relevant standards. All new and expanded FMU relationships
shall be reviewed and approved by the Risk Committee and subsequently
recommended for approval to the Board of Directors.

C. Measuring Counterparty Credit Risk

    The CCRM Policy describes various ways in which OCC measures the
credit risk posed by different Counterparties. With respect to Clearing
Members, the CCRM Policy provides that OCC measures its credit
exposures to Clearing Members under normal market conditions through
the calculation of margin requirements and under extreme but plausible
conditions through stress testing and the calculation of Clearing Fund
requirements, in accordance with applicable OCC policies. Margin,
Clearing Fund, and stress test results may be used by OCC's Financial
Risk Management Department (``FRM'') to evaluate OCC's counterparty
credit risk framework and inform Clearing Member surveillance
processes.
    With respect to Commercial Banks, Central Banks,\9\ Liquidity
Providers, and investment counterparties, OCC shall measure its credit
exposures to these

Counterparties by the balances generated from the various activities
provided by these institutions in accordance with relevant internal
procedures.
---------------------------------------------------------------------------

    \9\ Under the Policy, ``Central Bank'' is defined as a bank
serving as a bank for both depository institutions and a government,
a regulator for financial institutions, and/or a nation's money
manager. Central Banks act as asset custodians on behalf of OCC, and
OCC uses access to accounts and services at a Central Bank, when
available and where determined to be practical by the Board of
Directors, to enhance its management of liquidity risk. Due to the
inherently low credit risk presented by Central Banks, only limited
monitoring activities would be performed pursuant to relevant OCC
procedures.
---------------------------------------------------------------------------

    FMUs provide a range of services to OCC, including the Depository
Trust Company (``DTC'') as collateral custodian and provider of book-
entry recordkeeping of securities transfers, Chicago Mercantile
Exchange Inc. (``CME'') and ICE Clear U.S. as cross-margin clearing
organizations, and the National Securities Clearing Corporation
(``NSCC'') as a provider of securities settlement. Under the CCRM
Policy, DTC credit exposures shall be measured by the collateral
balances held and the value of securities lending/borrowing
transactions facilitated. CME and ICE Clear U.S. credit exposures shall
be measured by the projected margin impact in the event of suspension
of a cross-margin program and, therefore, the absence of risk reducing
positions cleared away from OCC. NSCC exposure shall be measured by the
value of securities and cash to be settled in connection with the
delivery obligations settled through NSCC.

D. Monitoring and Managing Counterparty Credit Risk

    The CCRM Policy also describes the manner in which OCC monitors and
manages credit risk from its Counterparties. Under the Policy, OCC's
monitoring and management of such risks is comprised of ``Watch Level
Reporting'' processes in conjunction with other tools including margin
adjustments, internal credit ratings, risk examinations, and monitoring
of tiered participation arrangements and dormant Counterparties.
Watch Level Reporting Overview
    Under the Policy, Counterparties are monitored by OCC's FRM,
Business Operations, and Treasury Departments for ongoing compliance
with the minimum participation standards described above to identify
any trends that might signal the deterioration of a Counterparty's
ability to timely meet its obligations. When these trends are
identified, Credit Risk Management shall report on a Counterparty
through OCC's Watch Level Reporting processes, which are described in
further detail below. As a Counterparty approaches, or no longer meets
minimum standards, FRM's monitoring heightens and, in the case of
Commercial Banks and Clearing Members, increasingly rigorous protective
measures may be imposed to limit or eliminate OCC's credit exposure.
    Pursuant to the Policy, the Watch Level Reporting process shall be
administered by OCC's Management Committee, which maintains approval
authority of Watch Level parameter changes. The Watch Level Reporting
process provides each of the Executive Chairman, Chief Operating
Officer, and Chief Administrative Officer with authority to take action
to protect OCC given the facts and circumstances of the exposure
presented by a Clearing Member or Commercial Bank. Under the Policy,
Credit Risk Management shall provide monthly internal reporting to FRM
summarizing the circumstances relating to (i) a violation; (ii)
additional risks observed and any corrective measure taken by any
Clearing Member, Commercial Bank, or FMU at or above Watch Level II
(described below); and (iii) monthly reporting to OCC's Credit and
Liquidity Risk Working Group, Management Committee, and the Risk
Committee of any Clearing Member or Commercial Bank at or above Watch
Level III (described below).
Clearing Member Watch Level Reporting and Bank Watch Level Reporting
    Pursuant to the CCRM Policy, the Clearing Member Watch Level
Reporting process and Bank Watch Level Reporting process shall support
initial and on-going participation standards by allowing OCC's Credit
Risk Management Department, with the support of other FRM business
units, Business Operations and Treasury, to detect business-related
concerns and/or financial or operational deterioration of a
Counterparty to protect OCC and its Clearing Members against the
potential default of a Clearing Member or Commercial Bank. Pursuant to
the CCRM Policy, the Clearing Member Watch Level Reporting process and
Bank Watch Level Reporting process shall be organized into a four-
tiered surveillance structure.
     Watch Level I. Watch Level I is the lowest tier of
severity and shall be used to categorize Clearing Members and
Commercial Banks presenting minimal to very low credit risk. This level
of violation shall be identified but not reported.
     Watch Level II. This tier shall be used to categorize
Clearing Members and Commercial Banks presenting low to lower moderate
credit risk. This level of violation shall be identified and reported
to internal personnel pursuant to FRM procedures.
     Watch Level III. This tier shall be used to categorize
Clearing Members and Commercial Banks potentially presenting upper
moderate to substantial credit risk. Violations in this tier may
indicate a Clearing Member or Commercial Bank that is below early
warning participation thresholds and may soon become non-compliant with
OCC's minimum participation standards, as specified in Article V of
OCC's By-Laws, Chapters II and III of OCC's Rules, and internal OCC
procedures. This level of violation shall be identified and reported to
the Executive Chairman, Chief Operating Officer, or Chief
Administrative Officer, who shall have the authority to approve the
imposition or waiver of protective measures. The Risk Committee shall
be informed of these violations on a monthly basis.
     Watch Level IV. Watch Level IV is the highest tier of
severity and shall be used to categorize Clearing Members and
Commercial Banks potentially presenting high to very high credit risk
with a heightened probability of default. Violations in this tier may
indicate a Clearing Member or Commercial Bank may imminently become or
has already become non-compliant with OCC's minimum participation
standards, as specified in Article V of OCC's By-Laws, Chapters II and
III of OCC's Rules, and internal OCC procedures. This level of
violation shall be identified and reported to OCC's Credit and
Liquidity Risk Working Group, with subsequent reporting to the
Executive Chairman, Chief Operating Officer, or Chief Administrative
Officer, who shall have the authority to approve the imposition or
waiver of protective measures, including the option to restrict
business of or suspend the Clearing Member or Commercial Bank. The Risk
Committee shall be promptly informed of these violations, and a meeting
of the Risk Committee may occur to discuss the event.
    In addition, under the Policy, if a Clearing Member is reporting
that its aggregate uncollateralized stress test exposure under normal
market conditions, minus the sum of base expected shortfall and stress
test charges as computed under OCC's margin methodology, exceeds 75% of
the Clearing Member's excess net capital, then the Clearing Member
shall be identified and reported on Watch Level II. When this exposure
exceeds 100% of net capital, a Clearing Member shall be identified and
reported on Watch Level III and shall be subject to a margin call for
the amount of exposure exceeding net capital. A margin call shall be
the standard form of protective measures for position risk monitoring
and shall not require officer approval or further prompt escalation.
However, Clearing Members may be reported to the Executive Chairman,
Chief Operating

Officer, or Chief Administrative Officer for consideration of
additional protective measures.
FMU Watch Level Reporting
    The FMU Watch Level Reporting process allows Credit Risk
Management, with the support of other FRM business units and Business
Operations, to detect business-related concerns and/or financial or
operational deterioration of a FMU. Pursuant to the CCRM Policy, the
FMU Watch Level Reporting process is organized into a two-tiered
surveillance structure.
     Watch Level I. Watch Level I is the lowest tier of
severity and shall be used to categorize FMUs presenting minimal to
very low credit risk. This level of violation shall be identified but
not reported.
     Watch Level II. Watch Level II is the highest tier of
severity and shall be used to categorize FMUs presenting low to lower
moderate credit risk. This level of violation shall be identified and
reported.
Other Tools for Monitoring and Managing Credit Risk
    In addition to the Watch Level Reporting processes discussed above,
the CCRM Policy discusses other tools and processes used by OCC to
monitor and manage credit risks arising from its Counterparties. For
example, in cases where ongoing monitoring of Clearing Members
identifies circumstances impacting margin levels due to changing
portfolio characteristics, market conditions, elevated Clearing Fund
stress test results, upcoming holidays where trading is allowed but OCC
is unable to call for additional margin deposits, and certain other
situations, OCC shall have the authority to call for additional margin
deposits or otherwise adjust margin requirements as further detailed in
OCC's margin and Clearing Fund-related policies.
    Under the Policy, OCC's Credit Risk Management department also
maintains Internal Credit Ratings (``ICRs'') which shall be
incorporated into the Watch Level Reporting process and shall be
designed to identify quarterly creditworthiness scores of Clearing
Members and Commercial Banks. ICR reporting shall summarize the
underlying cause of the ICR score, recent scoring trend, and exposure
introduced by a Clearing Member or Commercial Bank.
    In addition, the CCRM Policy provides that Credit Risk Management
shall perform examinations of the risk management frameworks, policies,
procedures, and practices of each Clearing Member no less than once in
a three calendar year period, focusing on the risks posed to OCC. For
certain exams, Credit Risk Management may coordinate with external
parties to realize operational efficiencies for both the Clearing
Member and OCC.
    The CCRM Policy also provides that OCC's Counterparty monitoring
includes managing the material risks that arise from indirect
participants through tiered participation arrangements. In particular,
Credit Risk Management, supported by other FRM business units and
Business Operations, shall monitor the material risks that arise from
indirect participants through tiered participation arrangements. Credit
Risk Management (or other FRM business units, as appropriate) shall
identify these tiered participation arrangements through standard
monitoring processes when they present elevated risk to the Clearing
Member or OCC. Furthermore, Clearing Member risk examinations shall
seek to understand how direct participants identify, measure, and
manage the risks posed to OCC from indirect participants.
    Additionally, under the CCRM Policy, OCC shall monitor Clearing
Members, Commercial Banks, and investment counterparties during
prolonged periods of inactivity, and Clearing Members shall be allowed
to voluntarily enter a dormant state to reduce credit risk originating
from unexpected trading activity. A dormant Clearing Member shall
continuously adhere to all operational and financial standards and may
reactivate its membership after submitting to an operational and
financial review. OCC shall maintain sole discretion to terminate
inactive Commercial Banks and investment counterparties to reduce
credit risk.

E. Counterparty Credit Risk Termination

    Finally, the CCRM Policy addresses the voluntary off-boarding of
Counterparties. Under the Policy, voluntary off-boarding shall be
performed in a manner designed to wind down all credit exposures in an
orderly fashion before a relationship is terminated.

II. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \10\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that such proposed rule change is consistent with the
requirements of the Act and rules and regulations thereunder applicable
to such organization. The Commission finds that the proposal is
consistent with Section 17A(b)(3)(F) of the Act \11\ and Rules 17Ad-
22(e)(3), (e)(4), (e)(16), (e)(18), (e)(19), and (e)(20) \12\
thereunder, as described in detail below.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2)(C).
    \11\ 15 U.S.C. 78q-1(b)(3)(F).
    \12\ 17 CFR 240.17Ad-22(e)(1), (e)(4), (e)(16), (e)(18),
(e)(19), (e)(20).
---------------------------------------------------------------------------

A. Consistency With Section 17A(b)(3)(F) of the Act

    The Commission finds OCC's proposed changes to be consistent with
Section 17A(b)(3)(F) of the Act,\13\ which requires, among other
things, that the rules of a clearing agency be designed to assure the
safeguarding of securities and funds which are in its custody or
control of for which it is responsible, in general, to protect
investors and the public interest. As noted above, one of the risks OCC
faces as a CCP is credit risk. OCC states that the CCRM Policy provides
a framework that is designed to enable it to identify, evaluate,
measure, monitor, and manage potential credit risks posed by its
Counterparties. That framework includes: (1) The identification of
credit risk, (2) Counterparty access and participation standards, (3)
the measurement of Counterparty exposures, (4) the monitoring and
managing of Counterparty exposures, and (5) voluntary termination of
Counterparty relationships. Furthermore, OCC also noted that the CCRM
Policy is part of a broader framework used by OCC to manage credit
risk, including OCC's By-Laws, Rules, and other policies and procedures
that are designed collectively to ensure that OCC appropriately manages
counterparty credit risk. By formalizing the components of the CCRM
Policy, OCC has taken measures to provide that its the rules are
designed to assure the safeguarding of securities and funds which are
in its custody or control of for which it is responsible, and, in
general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78q-1(b)(3)(A).
---------------------------------------------------------------------------

B. Consistency With Rules 17Ad-22(e)(3) and (e)(4)

    Rules 17Ad-22(e)(3) and (e)(4) \14\ require each covered clearing
agency to establish, implement, maintain and enforce written policies
and procedures reasonably designed to, among other things, (i) maintain
a sound risk management framework for addressing credit risk and (ii)
effectively identify, measure, monitor, and manage its credit exposures
to participants and those arising from its payment, clearing, and

settlement processes. As noted above, by formalizing the CCRM Policy,
OCC is organizing and describing in a central location the policies and
procedures that compose its framework for the comprehensive management
of credit risk. The CCRM Policy specifically describes the various
processes by which OCC identifies, measures, monitors, and manages its
credit exposures arising from its payment, clearing, and settlement
processes. Accordingly, the Commission finds that the proposed changes
are consistent with Rules 17Ad-22(e)(3) and (e)(4).\15\
---------------------------------------------------------------------------

    \14\ 17 CFR 240.17Ad-22(e)(3), (e)(4).
    \15\ Id.
---------------------------------------------------------------------------

C. Consistency With Rule 17Ad-22(e)(16)

    Rule 17Ad-22(e)(16) \16\ requires each covered clearing agency to
establish, implement, maintain and enforce written policies and
procedures reasonably designed to among other things, safeguard the
covered clearing agency's own and its participants' assets and minimize
the risk of loss and delay in access to these assets. According to OCC,
the access and participation requirements for Commercial and Central
Banks outlined in the CCRM Policy enable it to appropriately evaluate
each bank against relevant minimum standards of creditworthiness and
for its overall financial condition and operational capabilities, and
are therefore designed to minimize the risk of loss and delay in access
to OCC's assets and its participants' assets. Accordingly, the
Commission finds that these policies and procedures are consistent with
the requirements in Rule 17Ad-22(e)(16).\17\
---------------------------------------------------------------------------

    \16\ 17 CFR 240.17Ad-22(e)(16).
    \17\ Id.
---------------------------------------------------------------------------

D. Consistency With Rule 17Ad-22(e)(18)

    Rule 17Ad-22(e)(18) \18\ requires each covered clearing agency to
establish, implement, maintain and enforce written policies and
procedures reasonably designed to among other things, establish
objective, risk-based, and publicly disclosed criteria for
participation, which permit fair and open access and require
participants to have sufficient financial resources and robust
operational capacity to meet obligations arising from participation in
the clearing agency, and monitor compliance with such participation
requirements on an ongoing basis. OCC stated that the CCRM Policy
ensures that OCC has objective, risk-based, and publicly disclosed
criteria for participation and requiring Clearing Members to have
sufficient financial resources to meet their obligations to OCC.
Moreover, the CCRM Policy outlines the Watch Level Reporting process
used by OCC to monitor compliance with such participation requirements
on an ongoing basis. Accordingly, the Commission finds that these
policies and procedures are consistent with the requirements in Rule
17Ad-22(e)(18).\19\
---------------------------------------------------------------------------

    \18\ 17 CFR 240.17Ad-22(e)(18).
    \19\ Id.
---------------------------------------------------------------------------

E. Consistency With Rule 17Ad-22(e)(19)

    Rule 17Ad-22(e)(19) \20\ requires each covered clearing agency to
establish, implement, maintain and enforce written policies and
procedures reasonably designed to identify, monitor, and manage the
material risks to the covered clearing agency arising from arrangements
in which firms that are indirect participants in the covered clearing
agency rely on the services provided by direct participants to access
the covered clearing agency's payment, clearing, or settlement
facilities. OCC represented that the CCRM Policy outlines the process
by which OCC identifies and monitors the material risks arising from
indirect participants through tiered participation arrangements,
including through the use of risk examinations of its Clearing Members.
Accordingly, the Commission finds that these policies and procedures
are consistent with the requirements in Rule 17Ad-22(e)(19).\21\
---------------------------------------------------------------------------

    \20\ 17 CFR 240.17Ad-22(e)(19).
    \21\ Id.
---------------------------------------------------------------------------

F. Consistency With Rule 17Ad-22(e)(20)

    Rule 17Ad-22(e)(20) \22\ requires each covered clearing agency to
establish, implement, maintain and enforce written policies and
procedures reasonably designed to among other things, identify,
monitor, and manage risks related to any link the covered clearing
agency establishes with one or more other clearing agencies or FMUs.
OCC represented that the CCRM Policy outlines the standards OCC uses to
evaluate FMU Counterparties prior to entering into any link arrangement
(including the evaluations OCC would perform relating to rights and
interests, collateral arrangements, settlement finality and netting
arrangements, and financial and custody risks that may arise due to
such link arrangement) and the processes by which OCC measures and
monitors the risks arising from such FMU Counterparties (including its
FMU Watch Level Reporting process). Accordingly, the Commission finds
that these policies and procedures are consistent with the requirements
in Rule 17Ad-22(e)(20).\23\
---------------------------------------------------------------------------

    \22\ 17 CFR 240.17Ad-22(e)(20).
    \23\ Id.
---------------------------------------------------------------------------

III. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed change is consistent with the requirements of the Act, and in
particular, with the requirements of Section 17A of the Act \24\ and
the rules and regulations thereunder.
---------------------------------------------------------------------------

    \24\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Exchange Act,\25\ that the proposed rule change (SR-OCC-2017-009) be,
and it hereby is, approved.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(2).
    \26\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-27231 Filed 12-18-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 89950-89951]
[FR Doc No: 2016-29776]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0508]

Registration and Product Listing for Owners and Operators of
Domestic Tobacco Product Establishment; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised guidance for industry entitled ``Registration
and Product Listing for Owners and Operators of Domestic Tobacco
Product Establishments.'' This guidance is intended to assist persons
making tobacco product establishment registration and product listing
submissions to FDA.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2009-D-0508 for ``Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product

Establishments.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised guidance for
industry entitled ``Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments.'' This guidance
is intended to assist persons making tobacco product establishment
registration and product listing submissions to FDA. We are issuing
this guidance consistent with our good guidance practices (GGP)
regulation (Sec.  10.115 (21 CFR 10.115)).
    We are implementing this guidance without prior public comment
because we have determined that prior public participation is not
feasible or appropriate (Sec.  10.115(g)(2)). Persons who owned or
operated domestic manufacturing establishments engaged in the
manufacture of newly deemed products prior to August 8, 2016, and
continued to own or operate such establishment(s) on or after August 8,
2016, are required to register and submit product listing under section
905 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21
U.S.C. 387e) by December 31, 2016. However, FDA is announcing that it
does not intend to enforce these requirements with respect to newly
deemed products provided the registration and product listing
submissions are received by FDA on or before June 30, 2017. Although
this guidance document is immediately effective, it remains subject to
comment in accordance with FDA's GGP regulation.
    The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) added section 905 to the FD&C Act,
establishing requirements for tobacco product establishment
registration and product listing. Cigarettes, cigarette tobacco, roll-
your-own tobacco, and smokeless tobacco were immediately covered by
FDA's tobacco product authorities in chapter IX of the FD&C Act,
including section 905, when the Tobacco Control Act went into effect.
As for other types of tobacco products, section 901(b) of the FD&C Act
(21 U.S.C. 387a(b)) grants FDA authority to deem those products subject
to chapter IX of the FD&C Act. Pursuant to that authority, on April 25,
2014, FDA issued a proposed rule seeking to deem all other products
that meet the statutory definition of tobacco product, set forth in
section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) (except for
accessories of those products) (79 FR 23142). After review and
consideration of comments on the proposed rule, FDA published the final
rule on May 10, 2016 (81 FR 28974) (``the deeming rule'') and it became
effective on August 8, 2016. As a result, owners and operators of
domestic establishments engaged in the manufacture, preparation,
compounding, or processing of tobacco products subject to the deeming
rule are now required to comply with chapter IX of the FD&C Act,
including the establishment registration and product listing
requirements in section 905. The guidance addresses tobacco products
that were immediately covered by FDA's tobacco product authorities
under chapter IX of the FD&C Act and newly deemed tobacco products.
    The guidance represents the current thinking of FDA on this topic.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in section 905 of the FD&C Act have been
approved under OMB control number 0910-0650.

III. Electronic Access

    Persons with access to the Internet may obtain an electronic
version of the guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: December 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29776 Filed 12-12-16; 8:45 am]
 BILLING CODE 4164-01-P


ENCLOSURE 2

PUBLIC PARTICIPATION CERTIFICATION

AND COMPLIANCE WITH

STATE ADMINISTRATIVE PROCEDURES

As required by 40 CFR 51.102 and Section 2.1 of Appendix V of 40 CFR
Part 51, the following information regarding public participation
activities and compliance with state administrative procedures is
provided.

PUBLIC PARTICIPATION ACTIVITIES

As required by 40 CFR 51.102(a), a hearing to accept public testimony
concerning a proposed revision to the Commonwealth of Virginia State
Implementation Plan was held in the Obenshain Room, DEQ West Central
Regional Office, 3019 Peters Creek Road, Roanoke, Virginia, at 5:30 p.m.
on June 3, 2008.

As required by 40 CFR Part 51.102(d)(1) and (2), the public was given
notice of the hearing in the Roanoke Times and Lynchburg News and
Advance, along with the location of the proposal for public inspection,
on May 2, 2008.  The attached copy of the notice provides the evidence
required by Section 2.1(f) of Appendix V of 40 CFR Part 51.  As required
by 40 CFR 51.102(f) and Section 2.1(g) of Appendix V of 40 CFR Part 51,
the hearing was held in accordance with the information found in the
public notice, and according to the state's laws.

The Regional Administrator for the U.S. Environmental Protection Agency
was notified of the hearing.  This notification follows the requirements
of 40 CFR Part 51.102(d)(3), (4) and (5).  As provided in 40 CFR
51.302(b)(2), the federal land managers (FLMs) were given the
opportunity to comment on this permit on December 7, 2007. No comments
were received, and no meeting was requested.  This information regarding
FLM consultation was provided in the public hearing notice.

COMPLIANCE WITH STATE ADMINISTRATIVE PROCEDURES

As required by Section 2.1(b) of Appendix V of 40 CFR Part 51, the
permit was issued by the Department of Environmental Quality on June 12,
2008, to be effective that same day.  The statement of authority and
procedures followed for approval and issuance of the permit and the
signature of the Regional Director on the permit are included in
Attachment A to Enclosure 1, providing the evidence required by Section
2.1(b) and (e) of Appendix V of 40 CFR Part 51.  As required by Section
2.1(d) of Appendix V of 40 CFR Part 51, a copy of the actual permit
submitted for approval and incorporation by reference into the
Commonwealth of Virginia State Implementation Plan is included in
Attachment A to Enclosure 1.

TEMPLATES\SOURCE-SPECIFIC\PLN02

SRCESPEC\GPBI-SIP-2.DOC