[Federal Register: April 28, 2008 (Volume 73, Number 82)]
[Proposed Rules]
[Page 22877-22879]
[DOCID:fr28ap08-24]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. FDA-2008-N-0163] (formerly Docket No. 2001N-0067)

Dental Devices: Classification of Encapsulated Amalgam Alloy and
Dental Mercury and Reclassification of Dental Mercury; Issuance of
Special Controls for Amalgam Alloy; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening for 90
days, the comment period for the proposed rule, published in the
Federal Register of February 20, 2002 (67 FR 7620), on the
classification of encapsulated amalgam alloy and dental mercury, the
reclassification of dental mercury, and the issuance of special
controls for amalgam alloy. In the Federal Register of July 17, 2002
(67 FR 46941), the initial comment period was reopened for 60 days. The
agency is taking this action to provide the public with an additional
opportunity to comment and to request data and information that may
have become available since publication of the proposed rule.

DATES:  Submit written or electronic comments by July 28, 2008.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0163 (formerly Docket No. 2001N-0067), by any of the following
methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``How to Submit Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
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.

FOR FURTHER INFORMATION CONTACT:  Michael E. Adjodha, Center for
Devices and Radiological Health (HFZ-480), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-
3688.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 20, 2002 (67 FR 7620), FDA
published a proposed rule entitled ``Dental Devices: Classification of
Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of
Dental Mercury; Issuance of Special Controls for Amalgam Alloy.'' In
that document, FDA proposed the following actions: (1) Issue a separate
classification regulation for encapsulated amalgam alloy and dental
mercury; (2) amend the classification for amalgam alloy by adding
special controls; and (3) reclassify dental mercury from class I
(general controls) to class II. FDA proposed that all three products
would have the same labeling guidance as a special control. In
addition, FDA proposed that dental mercury would have a voluntary
American National Standards Institute (ANSI) standard as a special
control; encapsulated amalgam alloy and dental mercury would have
voluntary ANSI and International Standards Organization (ISO) standards
as special controls; and the amalgam alloy products would have a
voluntary ISO standard as a special control. Since that time, a 2006
joint meeting of the Dental Products Panel and the Peripheral and
Central Nervous System Drugs Advisory Committee raised the need for FDA
to further consider scientific issues that are potentially relevant to
this classification and we seek additional comments on the proposed
classification.
    In an effort to provide an update on the latest scientific
information concerning dental amalgam, a working group of the U.S.
Department of Health and Human Services, known as the Trans-agency
Working Group on the Health Effects of Dental Amalgam, commissioned a
new review of the scientific literature in 2004 (the 2004 review). The
2004 review, funded by the National Institutes of Health in cooperation
with FDA, the Centers for Disease Control and Prevention, and the
Office of the Chief Dental Officer of the Public Health Service, was
completed in 2004 by Life Sciences Research Office, Inc. (LSRO). LSRO
engaged an independent panel of experts from academia with preeminent
qualifications and experience in the appropriate scientific disciplines
needed for the 2004 review. The 2004 review was a systematic and
comprehensive evaluation of approximately 300 peer-reviewed studies of
dental amalgam and mercury vapor published from 1996 through 2003,
intended to determine whether these studies provided new evidence
related to the health effects of dental amalgam in humans. The panel
concluded that the studies contained insufficient evidence to support a
correlation or causal relationship between exposure to dental amalgam
and kidney or cognitive dysfunction; neurodegenerative disease
(specifically Alzheimer's disease and Parkinson's disease); autoimmune
disease (including multiple sclerosis); or adverse pregnancy outcomes
(Refs. 1 and 2).
    Dental amalgam was the subject of an advisory committee meeting in
2006. As announced in the Federal Register of April 3, 2006 (71 FR
16582), on September 6 and 7, 2006, FDA held a joint meeting of the
Dental Products Panel and the Peripheral and Central Nervous System
Drugs Advisory Committee (the 2006 joint committee). The 2006 joint
meeting was held to discuss and make recommendations to FDA on a draft
FDA White Paper (2006 draft White Paper) (Ref. 3) regarding the
potential adverse health risks associated with exposure to mercury in
dental amalgam. The goal of the 2006 draft White Paper was to provide
an assessment and conclusions regarding significant new information and
health risks from mercury in dental amalgam and to build on previous
Public Health Service literature reviews and risk assessments (1993 and
1997) and reviews by other Federal agencies since 1997. The 2006 joint
committee, comprised of 24 panelists, heard presentations from the
following groups: (1) Scientists; (2) regulatory officials from Canada
and Sweden, on the scientific basis for the regulation of dental
amalgam in their respective countries; and (3) FDA, on how the United
States has regulated and evaluated dental amalgam. Numerous public
speakers also presented their views.
    The 2006 joint committee then deliberated on a series of questions
FDA had posed on its draft review of the dental amalgam literature and
provided recommendations to the agency related to those questions (Ref.
4). By majority vote, the committee concluded that FDA's draft White
Paper had significant limitations. Among its criticisms, the 2006 joint
committee identified insufficient explanation about the following: (1)
How the scientific references were chosen; (2) failure to identify the
significant gaps in the scientific knowledge, particularly with respect
to exposure limits; and (3) lack of attention to sensitive
subpopulations. The majority of the 2006 joint committee voted that it
could not find the conclusions of the draft White Paper to be
``reasonable.''
    Despite the limitation on the draft White Paper, the 2006 joint
committee generally agreed that there is no evidence that dental
amalgams cause health problems. The 2006 joint committee also agreed
that the most recent well-controlled clinical studies, including two
prospective clinical studies in children (Refs. 5 and 6), showed no
evidence of neurological harm from dental amalgams. In addition, a more
recent article corroborated this evidence (Ref. 7). Panelists provided
individual recommendations, including recommendations that FDA consider
requirements related to the use of dental amalgam in pregnant women and
small children, as well as patient information to ensure that consumers
understand that these devices contain mercury.

II. Reopening of the Comment Period

    FDA believes it is important for members of the public to have the
opportunity to further comment on FDA's proposal. Accordingly, FDA is
asking for comments concerning whether these devices should be
classified into class II (special controls). We specifically request
comments supported by empirical data and scientific evidence concerning
this classification and these special controls. In addition, if class
II (special controls) is the appropriate classification for these
devices, FDA requests comment on whether the two types of special
controls proposed by FDA in 2002 (materials and labeling) provide
reasonable assurance of the safety and effectiveness of these devices
and on whether the proposed special control guidance document should be
revised in light of the recommendations and with respect to the
discussions by the 2006 joint committee.
     Controls on the Materials. For example, should the
material controls proposed by FDA address conformance to recognized
consensus standards that make recommendations for testing, compressive
strength, and identifying the mercury vapor released by the device?
     Labeling Controls. For example, how should labeling
controls, if any,

address the disclosure of composition, including mercury content, and
precautions regarding use of the device in sensitive subpopulations
composed of individuals who respond biologically at lower levels of
exposure to mercury than the general population? If so, which
subpopulations should be included (e.g., children under age 6, pregnant
and lactating women, hypersensitive or immunocompromised individuals)?
Should the labeling controls require more specific patient labeling
(e.g., informing patients of identified sensitive subpopulations of the
mercury content, the alternatives to the device and their relative
costs, and health risks associated with the failure to obtain dental
care)?
    For the agency's future analysis of benefits and costs of the
regulatory options for dental amalgams, FDA also requests comments,
including available data, on the following questions:
    (1) How many annual procedures use mercury amalgams? What are the
trends?
    (2) What are the differences in cost between amalgams and
alternative materials (e.g., composite, other metals, ceramics, etc.)?
Are there differences in replacement lives?
    (3) What are reimbursement rates for dental amalgam and the
alternative materials?
    (4) How would labeling describing the risks of amalgam for certain
subpopulations (e.g., children under age 6, pregnant and lactating
women, hypersensitive or immunocompromised individuals) affect the
demand for, and use of, mercury amalgam? How would the risks included
in the labeling be communicated to those subpopulations?
    (5) What is the current exposure to mercury for patients? For
professionals? What would be the reduction in exposure associated with
the alternatives described previously in this section of this document?

III. How to Submit Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments to http://
www.regulations.gov or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Governmental-wide, electronic docket
management system. Electronic comments or submissions will be accepted
by FDA only through FDMS at http://www.regulations.gov.

IV. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Review and Analysis of the Literature on the Potential
Adverse Health Effects of Dental Amalgam, LSRO, July 2004.
    2. Brownawell, A.M., et al., ``The Potential Adverse Health
Effects of Dental Amalgam,'' Toxicological Reviews, 24(1):1-10,
2006.
    3. Draft FDA Update/Review of Potential Adverse Health Risks
Associated With Exposure to Mercury in Dental Amalgam, National
Center for Toxicological Research, FDA, August 2006.
    4. Transcripts from the Joint Meeting of Dental Products Panel
and Central Nervous System Drugs Advisory Committee, September 6 and
7, 2006.
    5. Bellinger, D.C., et al., ``Neuropsychological and Renal
Effects of Dental Amalgam in Children: A Randomized Trial,'' Journal
of the American Medical Association, 295:1775-1783, 2006.
    6. DeRouen, T.A., et al., ``Neurobehavioral Effects of Dental
Amalgam in Children: A Randomized Clinical Trial,'' Journal of the
American Medical Association, 295:1784-1792, 2006.
    7. Dunn, Julie E., ``Scalp hair and urine mercury content of
children in the Northeast United States: The New England Children's
Amalgam Trial,'' Environmental Research, Vol. 107, Issue 1, pages 79
to 88, May 2008.

    Dated: April 22, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 08-1187 Filed 4-23-08; 10:15 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 161 (Tuesday, August 24, 2021)]
[Notices]
[Pages 47335-47336]
[FR Doc No: 2021-18145]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0042]

TUV Rheinland of North America, Inc.: Grant of Expansion of
Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces the final decision to expand
the scope of recognition for TUV Rheinland of North America, Inc., as a
Nationally Recognized Testing Laboratory (NRTL).

DATES: The expansion of the scope of recognition becomes effective on
August 24, 2021.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor; telephone:
(202) 693-2110; email<EMAIL_ADDRESS>OSHA's web page includes
information about the NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of TUV Rheinland of North America, Inc. (TUVRNA), as a
NRTL. TUVRNA's expansion covers the addition of four test standards to
the NRTL scope of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition. Each NRTL's scope of recognition includes (1) the
type of products the NRTL may test, with each type specified by the
applicable test standard and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The agency processes applications by NRTLs or applicant
organizations for initial recognition, as well as for expansion or
renewal of recognition, following requirements in Appendix A to 29 CFR
1910.7. This appendix requires that the agency publish two notices in
the Federal Register in processing an application. In the first notice,
OSHA announces the application and provides the preliminary finding. In
the second notice, the agency provides the final decision on the
application. These notices set forth the NRTL's scope of recognition or
modifications of that scope. OSHA maintains an informational web page
for each NRTL, including TUVRNA, which details that NRTL's scope of
recognition. These pages are available from the OSHA website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    TUVRNA submitted an application, dated January 30, 2019 (OSHA-2007-
0042-0051), to expand recognition to include the addition of four test
standards. OSHA staff performed a detailed analysis of the application
packet and reviewed other pertinent information. OSHA did not perform
any on-site reviews in relation to this application.
    OSHA published the preliminary notice announcing TUVRNA's

expansion applications in the Federal Register on June 25, 2021 (86 FR
33779). The agency requested comments by July 12, 2021, but it received
no comments in response to this notice. OSHA now is proceeding with
this final notice to grant expansion of TUVRNA's scope of recognition.
    To review copies of all public documents pertaining to TUVRNA's
application, go to www.regulations.gov or contact the Docket Office,
Occupational Safety and Health Administration, U.S. Department of Labor
at<PHONE_NUMBER>. Docket No. OSHA-2007-0042 contains all materials in
the record concerning TUVRNA's recognition.

II. Final Decision and Order

    OSHA staff examined TUVRNA's expansion application, their
capability to meet the requirements of the test standards, and other
pertinent information. Based on its review of this evidence, OSHA finds
that TUVRNA meets the requirements of 29 CFR 1910.7 for expansion of
its recognition, subject to the limitations and conditions listed
below. OSHA, therefore, is proceeding with this final notice to grant
TUVRNA's scope of recognition. OSHA limits the expansion of TUVRNA's
recognition to testing and certification of products for demonstration
of conformance to the test standards listed below in Table 1.

  Table 1--List of Appropriate Test Standards for Inclusion in TUVRNA's
                        NRTL Scope of Recognition
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               Test standard                     Test standard title
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UL 399....................................  Standard for Drinking-Water
                                             Coolers.
UL 1973...................................  Standard for Batteries for
                                             Use in Stationary, Vehicle
                                             Auxillary Power and Light
                                             Electric Rail (LER)
                                             Applications.
UL 2054...................................  Standard for Household and
                                             Commercial Batteries.
UL 2271...................................  Standard for Batteries for
                                             Use in Light Electric
                                             Vehicle Applications.
------------------------------------------------------------------------

    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials for which OSHA standards require
third-party testing and certification before using them in the
workplace. Consequently, if a test standard also covers any products
for which OSHA does not require such testing and certification, a
NRTL's scope of recognition does not include these products.

A. Conditions

    Recognition is contingent on continued compliance with 29 CFR
1910.7, including but not limited to, abiding by the following
conditions of recognition:
    1. TUVRNA must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. TUVRNA must meet all the terms of its recognition and comply
with all OSHA policies pertaining to this recognition; and
    3. TUVRNA must continue to meet the requirements for recognition,
including all previously published conditions on TUVRNA's scope of
recognition, in all areas for which it has recognition.
    OSHA hereby expands the scope of recognition of TUVRNA, subject to
the limitations and conditions specified above.

III. Authority and Signature

    James S. Frederick, Acting Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW, Washington,
DC 20210, authorized the preparation of this notice. Accordingly, the
agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2),
Secretary of Labor's Order No. 8-2020 (85 FR 58393, September 18, 2020)
and 29 CFR 1910.7.

    Signed at Washington, DC, on August 17, 2021.
James S. Frederick,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2021-18145 Filed 8-23-21; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Pages 3782-3784]
[FR Doc No: 2018-01358]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82543; File No. SR-OCC-2018-003]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify OCC's Rules Regarding the Exercise Procedures for Certain
Options on Futures

January 19, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 11, 2018, The Options Clearing Corporation (``OCC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by OCC. OCC filed the proposed rule change
pursuant to Section 19(b)(3)(A) \3\ of the Act and Rule 19b-4(f)(4)(ii)
\4\ thereunder so that the proposal was effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4)(ii).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    This proposed rule change by OCC concerns modifications to OCC's
Rules regarding the exercise procedures for certain options on futures
in order to conform to changes proposed by Nasdaq Futures, Inc.
(``NFX''), a futures market for which OCC clears such contracts. The
proposed changes to OCC's Rules can be found in Exhibit 5 to the
filing. All terms with initial capitalization that are not otherwise
defined herein have the same meaning as set forth in the By-Laws and
Rules.\5\
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    \5\ OCC's By-Laws and Rules can be found on OCC's public
website: http://optionsclearing.com/about/publications/bylaws.jsp.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

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

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(1) Purpose
    The purpose of this proposed rule change is to amend OCC's Rules to
permit a futures market that lists certain options on futures to
instruct OCC to: (1) Eliminate a Clearing Member's ability to provide
contrary instructions with respect to such futures options, and (2)
permit automatic exercise of futures options that are call options and
that settle at exactly the strike price for the option (i.e., an ``at-
the-money'' futures option). These amendments to OCC's Rules would
accommodate certain corresponding amendments to the rules of NFX, for
which OCC clears relevant futures option contracts, and would not apply
to any options on security futures to the extent OCC clears such
products in the future.\6\
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    \6\ Options on security futures currently do not trade on the
exchange for which OCC clears security futures. The proposed rule
change would not apply to any securities, but rather futures
products (i.e., options on futures that are not security futures)
that are subject to the exclusive jurisdiction of the Commodity
Futures Trading Commission (``CFTC''). See infra note 16.
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Contrary Instructions
    NFX has proposed to eliminate the ability of the holders of certain
futures options contracts to provide ``contrary instructions'' or
``contrary exercises'' to the futures markets with respect to such
contracts.\7\ NFX has advised OCC that the New York Mercantile
Exchange, Inc. (``NYMEX'') has already made comparable changes to its
rules for certain comparable options traded on NYMEX based on market
feedback.\8\ NFX would like to replicate these changes for the
comparable options contracts traded on NFX, none of which are options
on security futures.
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    \7\ See SR-NFX-2017-56, filed December 15, 2017 with the CFTC.
    \8\ See NYMEX Submission No. 17-272 filed July 21, 2017 with the
CFTC. The filing also amended the rules of the Commodity Exchange,
Inc. (``COMEX'') to make comparable changes for certain options
traded on COMEX.
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    A contrary instruction allows an option holder to exercise an
``out-of-the-money'' option to receive the underlying futures contract
or to abandon an ``in-the-money'' option. Existing OCC Rule 1305
governs the exercise procedures for American and European-styled
options on futures cleared by OCC that settle into the underlying
futures contract. Subparagraph (c) of Rule 1305 provides

for the automatic exercise of such options that are in-the-money at
expiration by ``such threshold amount as [OCC] may from time to time
establish with respect to particular classes of options,'' unless the
Clearing Member instructs OCC not to exercise such in-the-money
options. The provision also incorporates by reference certain
operational aspects of the exercise-at-expiration procedures for listed
options found in OCC Rule 805. Neither Rule 1305 nor Rule 805 provide a
futures market with the ability to limit contrary instructions.
Consequently, OCC proposes to add a new paragraph (d) to Rule 1305 that
would provide futures markets with this ability in order to accommodate
NFX's proposal to prohibit the use of contrary instructions. The
proposed ability would not apply, however, to options on security
futures cleared by OCC to the extent OCC clears such products in the
future.
At-the-Money Options
    Existing Rules 1305 and 805 are silent on what happens to options
that expire at-the-money. By specifying what happens to options that
expire in-the-money (i.e., automatic exercise), OCC's Rules indicate
that options expiring at-the-money would be treated as if they were
out-of-the-money and not automatically exercised, and therefore the
holders would not automatically buy (or sell) futures contracts or
equity securities at the strike price. NFX has proposed to amend its
own rules regarding the treatment of certain at-the-money options. In
order to accommodate these proposed changes at NFX, OCC proposes to add
a new paragraph (e) to Rule 1305, which would permit a futures market
to instruct OCC that futures options that are call options and settle
at-the-money should be treated as if they settled in-the-money and
futures options that are put options and settle at-the-money should be
treated as if they settled out-of-the-money. However, the proposed
ability would not apply to options on security futures that are cleared
by OCC to the extent OCC clears such products in the future. Therefore,
in the case of a call option the holder of the option would
automatically buy the underlying futures contract at the option strike
price, and in the case of a put option the holder would not
automatically sell the underlying futures contract at the option strike
price.
Timing of Implementation
    OCC proposes that the proposed amendments to Rule 1305 would apply
to any futures option for which a futures market has instructed OCC to
apply the exercise procedures specified in Rules 1305(d) and/or (e).
(2) Statutory Basis
    Section 17A(b)(3)(F) of the Act,\9\ requires, among other things,
that the rules of a clearing agency be designed to promote the prompt
and accurate clearance and settlement of securities and derivatives
transactions, to foster cooperation and coordination with persons
engaged in clearance and settlement, and, in general, to protect
investors and the public interest. OCC believes that the proposed rule
change is consistent with Section 17A(b)(3)(F) of the Act \10\ and the
rules and regulations thereunder, because it would grant the futures
markets for which OCC clears futures options contracts the ability to
coordinate OCC's exercise procedures with the futures market's
treatment of at-the-money options and to prohibit the use of contrary
instructions, thereby promoting the prompt and accurate clearance and
settlement of securities and derivatives transactions, fostering
cooperation and coordination with persons engaged in clearance and
settlement, and, in general, protecting investors and the public
interest.
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    \9\ 15 U.S.C. 78q-1(b)(3)(F).
    \10\ Id.
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    Rule 17Ad-22(e)(21) \11\ requires that a covered clearing agency
establish, implement, maintain and enforce written policies and
procedures reasonably designed to, in part, be efficient and effective
in meeting the requirements of its participants and the markets it
serves. OCC believes that granting futures markets, like NFX, this
flexibility would encourage efficiency and coordination across the
market as a whole and reduce potential sources of operational risk for
market participants. A lack of conformity in futures option contract
terms across different futures markets could reduce efficiency and pose
operational risks to market participants and would require them to
undertake additional monitoring. OCC therefore believes that the
proposed rule change is reasonably designed to comply with the
requirements of Rule 17Ad-22(e)(21).\12\
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    \11\ 17 CFR 240.17Ad-22(e)(21).
    \12\ Id.
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    The proposed rule change is not inconsistent with the existing
rules of OCC, including any other rules proposed to be amended.

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

    Section 17A(b)(3)(I) of the Act \13\ requires that the rules of a
clearing agency not impose any burden on competition not necessary or
appropriate in furtherance of the Act. OCC does not believe that the
proposed rule change would impact or impose any burden on competition.
This proposed rule change would not inhibit access to OCC's services or
disadvantage or favor any particular user in relationship to another,
and it will be applied uniformly to all Clearing Members. The proposed
rule change is intended to accommodate NFX's proposed rule change,
which is designed to bring the terms of the futures options contracts
listed by NFX into conformity with those listed by other futures
markets. Accommodating such a change would help promote a level playing
field among market participants trading futures options by ensuring
that such contracts could have identical terms. For the foregoing
reasons, OCC believes the proposed rule change is in the public
interest, would be consistent with the requirements of the Act
applicable to clearing agencies, and would not impact or impose a
burden on competition.
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    \13\ 15 U.S.C. 78q-1(b)(3)(I).
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(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments on the proposed rule change were not and are not
intended to be solicited with respect to the proposed rule change and
none have been received.

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

    Pursuant to Section 19(b)(3)(A) of the Act,\14\ and Rule 19b-
4(f)(4)(ii) thereunder,\15\ the proposed rule change is filed for
immediate effectiveness because it effects a change in an existing
service of OCC that (i) primarily affects the clearing operations of
OCC with respect to products that are not securities, i.e., options on
futures that are not security futures,\16\ and (ii) does

not significantly affect any securities clearing operations of OCC or
any rights or obligations of OCC with respect to securities clearing or
persons using such securities clearing services.
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    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(4)(ii).
    \16\ Section 3(a)(10) of the Act defines a ``security'' as ``any
note, stock, treasury stock, security future, security-based swap,
bond, debenture, certificate of interest or participation in any
profit-sharing agreement or in any oil, gas, or other mineral
royalty or lease, any collateral-trust certificate, preorganization
certificate or subscription, transferable share, investment
contract, voting-trust certificate, certificate of deposit for a
security, any put, call, straddle, option, or privilege on any
security, certificate of deposit, or group or index of securities
(including any interest therein or based on the value thereof), or
any put, call, straddle, option, or privilege entered into on a
national securities exchange relating to foreign currency, or in
general, any instrument commonly known as a `security'; or any
certificate of interest or participation in, temporary or interim
certificate for, receipt for, or warrant or right to subscribe to or
purchase, any of the foregoing; but shall not include currency or
any note, draft, bill of exchange, or banker's acceptance which has
a maturity at the time of issuance of not exceeding nine months,
exclusive of days of grace, or any renewal thereof the maturity of
which is likewise limited.'' 15 U.S.C. 77b(a)(1). Section 3(a)(55)
of the Exchange Act defines ``security future'' as ``a contract of
sale for future delivery of a single security or of a narrow-based
security index, including any interest therein or based on the value
thereof, except an exempted security.'' 15 U.S.C. 78c(a)(55). An
option on a futures contract that is not a security future does not
meet the definition of ``security'' and therefore is a product that
is subject to the exclusive jurisdiction of the CFTC.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.\17\
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    \17\ Notwithstanding its immediate effectiveness, implementation
of this rule change will be delayed until this change is deemed
certified under CFTC Rule 40.6.
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-OCC-2018-003 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-OCC-2018-003. 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 such filing also will be available for inspection
and copying at the principal office of OCC and on OCC's website at
https://www.theocc.com/about/publications/bylaws.jsp.
    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-OCC-2018-003 and
should be submitted on or before February 16, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
Eduardo A. Aleman,
Assistant Secretary.
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    \18\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2018-01358 Filed 1-25-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Page 59852]
[FR Doc No: 2015-24552]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Application of Aviation Partners of Boynton Beach, LLC; D/B/A
Hummingbird Air for Commuter Authority

AGENCY: Department of Transportation.

ACTION: Notice of Order to Show Cause (Order 2015-9-14), Docket DOT-
OST-2014-0116.

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SUMMARY: The Department of Transportation is directing all interested
persons to show cause why it should not issue an order finding Aviation
Partners of Boynton Beach, LLC d/b/a Hummingbird Air fit, willing, and
able, and awarding it a Commuter Air Carrier Authorization.

DATES: Persons wishing to file objections should do so no later than
October 5, 2015.

ADDRESSES: Objections and answers to objections should be filed in
Docket DOT-OST-2014-0116 and addressed to U.S. Department of
Transportation, Docket Operations, (M-30, Room W12-140), 1200 New
Jersey Avenue SE., West Building Ground Floor, Washington, DC 20590,
and should be served upon the parties listed in Attachment A to the
order.

FOR FURTHER INFORMATION CONTACT: Lauralyn Remo, Air Carrier Fitness
Division (X-56), U.S. Department of Transportation, 1200 New Jersey
Avenue SE., Washington, DC 20590,<PHONE_NUMBER>.

    Dated: September 21, 2015.
Susan L. Kurland,
Assistant Secretary for Aviation and International Affairs.
[FR Doc. 2015-24552 Filed 10-1-15; 8:45 am]
 BILLING CODE 4910-9X-P


OMB # 2060 0170 Expiration Date: 8/ 31/ 05 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS I CONTROLLED SUBSTANCE REPORT:

CERTIFICATION OF ORDER/ PURCHASE OF QPS METHYL BROMIDE ( Sec 82.13( y)( 1)( 2)) AND Sec 82.13( z)( 2))

SECTION 1 PURCHASER IDENTIFICATION AND METHYL BROMIDE USE 1.1 Date of Submission 1.2 Quantity of Methyl Bromide Ordered/ Purchased ( kg)

1.3 Company Information Purchaser Name Street Address City State Zip Code 1.4 Company Contact Identification Reporting Company Contact Person Phone Number Fax Number Quarantine Applications, with respect to class I, Group VI controlled substances ( methyl bromide), are treatments to prevent the introduction, establishment and/ or spread of quarantine pests ( including diseases), or to ensure their official control, where: ( 1) Official control is that performed by, or authorized by, a national ( including state, tribal or local) plant, animal or environmental protection or health authority; ( 2) quarantine pests are pests of potential importance to the areas endangered thereby and not yet present there, or present but not widely distributed and being officially controlled. This definition excludes treatments of commodities not entering or leaving the United States or any State ( or political subdivision thereof). Preshipment Applications, with respect to class I, Group VI controlled substances ( methyl bromide), are those non quarantine applications applied within 21 days prior to export to meet the official requirements of the importing country or existing official requirements of the exporting country. Official requirements are those which are performed by, or authorized by, a national plant, animal, environmental, health or stored product authority.

1.5 Signature of Reporting Company Representative Check one box only. I certify that the quantities of methyl bromide specified in Section 1.2 of this form are ordered/ purchased and will be used exclusively for quarantine & preshipment applications as defined above, and not sold/ transferred to another person. will not be used for quarantine & preshipment applications as defined above. I certify under penalty of law that I have personally examined and am familiar with the information submitted in this and all attached documents, and that based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment.

Name Title Signature Date SEND COMPLETED FORMS TO: The Company from Whom the Methyl Bromide is being Ordered/ Purchased Information in reports submitted in compliance with the final rule may be claimed as confidential. A company may assert a claim of confidentiality for information submitted by clearly marking that information as confidential. Such information shall be treated in accordance with EPA's procedures for information claimed as confidential at 40 CFR Part 2, Subpart B, and will only be disclosed by the means set forth in the subpart. If no claim of confidentiality accompanies the report when it is received by EPA, it may be made public without further notice to the company ( 40 CFR 2.203)

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Public reporting burden for this collection of information is estimated to average 16 hours per response. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, OPPE Regulatory Information Division, U. S. Environmental Protection Agency ( 2137), 1200 Pennsylvania Avenue, NW, Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number and OMB control number in any correspondence. DO NOT SEND THIS FORM TO THESE ADDRESSES; ONLY SEND COMMENTS.

ICR NUMBER 1432.22 C 1MB, Revised 5/ 05