[Federal Register: May 24, 2006 (Volume 71, Number 100)]
[Proposed Rules]
[Page 29880-29882]
[DOCID:fr24my06-28]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1987-0002; FRL-8172-7]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of intent for partial deletion of the Rocky Mountain
Arsenal National Priorities List Site from the National Priorities
List; extension of public comment period.

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SUMMARY: The Environmental Protection Agency (EPA) Region 8 announced
its intent to delete the Internal Parcel, encompassing 7,399 acres of
the Rocky Mountain Arsenal National Priorities List Site (RMA/NPL Site)
On-Post Operable Unit (OU), from the National Priorities List (NPL) on
April 26, 2006. The 30-day public comment period is scheduled to end on
May 26, 2006. EPA has received a request to extend the public comment
period. In response, EPA is extending the public comment period for an
additional 30 days concluding on June 26, 2006.
    The NPL constitutes Appendix B of 40 CFR part 300 which is the
National Oil and Hazardous Substances Pollution Contingency Plan (NCP),
which EPA promulgated pursuant to section 105 of

the Comprehensive Environmental Response, Compensation, and Liability
Act (CERCLA).
    EPA bases its proposal to delete the Internal Parcel of the RMA/NPL
Site on the determination by EPA and the State of Colorado, through the
Colorado Department of Public Health and Environment (CDPHE), that all
appropriate actions under CERCLA have been implemented to protect human
health, welfare, and the environment and that no further response
action by responsible parties is appropriate.
    This partial deletion pertains to the surface media (soil, surface
water, sediment) and structures within the Internal Parcel of the On-
Post OU of the RMA/NPL Site as well as the groundwater below the
Internal Parcel that is east of E Street, with the exception of a small
area of contaminated groundwater located in the northwest corner of
Section 6. The rest of the On-Post OU, including groundwater below RMA
that is west of E Street, and the Off-Post OU will remain on the NPL
and response activities will continue at those OUs.

DATES: Comments must be received on or before June 26, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
SFUND-1987-0002, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instruction

for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Ms. Jennifer Chergo, Community Involvement
Coordinator (8OC), U.S. EPA, Region 8, 999 18th Street, Suite 300,
Denver, Colorado, 80202-2466.
     Hand Delivery: 999 18th Street, Suite 300, Denver,
Colorado, 80202-2466. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-SFUND-
1987-0002. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://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 e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://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 material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the EPA's Region 8

Superfund Records Center, 999 18th Street, Denver, Colorado 80202-2466
and the Joint Administrative Records Document Facility, Rocky Mountain
Arsenal, Building 129, Room 2024, Commerce City, Colorado 80022-1748.
The Region 8 Docket Facility is open from 8 a.m. to 4 p.m. by
appointment, Monday through Friday, excluding legal holidays. The EPA
Docket telephone number is<PHONE_NUMBER>. The RMA's Docket Facility is
open from 12 p.m. to 4 p.m., Monday through Friday, excluding legal
holidays, or by appointment. The RMA Docket telephone number is 303-
289-0362.

FOR FURTHER INFORMATION CONTACT: Ms. Jennifer Chergo, Community
Involvement Coordinator (8OC), U.S. Environmental Protection Agency,
Region 8, 999 18th Street, Suite 300, Denver Colorado, 80202-2466;
telephone number: 1-800-227-8917 or<PHONE_NUMBER>; fax number: 303-
312-6961; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Intended Partial Site Deletion

I. Introduction

    The Environmental Protection Agency (EPA) Region 8 announces a
thirty day extension of the public comment period for the proposed
deletion of the Internal Parcel of the Rocky Mountain Arsenal National
Priorities List (RMA/NPL) Site, Commerce City, Colorado, from the
National Priorities List (NPL) and requests comment on these proposed
actions. The NPL constitutes Appendix B of the National Oil and
Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR part 300,
which EPA promulgated pursuant to Section 105 of the Comprehensive
Environmental Response, Compensation and Liability Act (CERCLA), 42
U.S.C. 9605. EPA identifies sites that appear to present a significant
risk to public health or the environment and maintains the NPL as the
list of those sites. Sites on the NPL may be the subject of remedial
actions financed by the Hazardous Substance Superfund (Fund). The
partial deletion from the RMA/NPL Site is proposed in accordance with
40 CFR 300.425(e) and Notice of Policy Change: Partial Deletion of
Sites Listed on the National Priorities List (60 FR 55466 (Nov. 1,
1995)). As described in 40 CFR 300.425(e)(3), portions of a site
deleted from the NPL remain eligible for further remedial actions if
warranted by future conditions.
    EPA will accept comments concerning its intent for partial deletion
of the RMA/NPL Site until June 26, 2006.
    Section II of this notice explains the criteria for deleting sites
from the NPL. Section III discusses the procedures that EPA is using
for this proposed partial deletion. Section IV discusses the Internal
Parcel and explains how it meets the deletion criteria.

II. NPL Deletion Criteria

    The NCP establishes the criteria that EPA uses to delete sites from
the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted
from the NPL where no further response is appropriate to protect public
health or the environment. In making such a determination pursuant to
section 300.425(e), EPA will consider, in consultation with the State,
whether any of the following criteria have been met:
    Section 300.425(e)(1)(i). Responsible parties or other persons have
implemented all appropriate response actions required;

    Section 300.425(e)(1)(ii). All appropriate Fund-financed response
under CERCLA has been implemented, and no further response action by
responsible parties is appropriate; or
    Section 300.425(e)(1)(iii). The remedial investigation has shown
that the release poses no significant threat to public health or the
environment and, therefore, taking of remedial measures is not
appropriate.
    A partial deletion of a site from the NPL does not affect or impede
EPA's ability to conduct CERCLA response activities for portions not
deleted from the NPL. In addition, deletion of a portion of a site from
the NPL does not affect the liability of responsible parties or impede
agency efforts to recover costs associated with response efforts. The
U.S. Army and Shell Oil Company will be responsible for all future
remedial actions required at the areas deleted if future site
conditions warrant such actions.

III. Deletion Procedures

    Upon determination that at least one of the criteria described in
Section 300.425(e) of the NCP has been met, EPA may formally begin
deletion procedures. The following procedures were used for the
proposed deletion of the Internal Parcel from the RMA/NPL Site:
    (1) The Army has requested the partial deletion and prepared the
relevant documents.
    (2) The State of Colorado, through the CDPHE, concurred with
publication of the notice of intent for partial deletion.
    (3) Concurrent with the national Notice of Intent for Partial
Deletion, a local notice was published in a newspaper of record and
distributed to appropriate Federal, State, and local officials, and
other interested parties. These notices announced a thirty day public
comment period, ending May 26, 2006, based upon publication of the
notice in the Federal Register and a local newspaper of record.
    (4) Concurrent with this national Notice of the Public Comment
Extension, a local notice has been published in a newspaper of record
and has been distributed to appropriate Federal, State, and local
officials, and other interested parties. These notices announce a
thirty day extension of the public comment period, ending June 26,
2006.
    (5) EPA has made all relevant documents available at the
information repositories listed previously for public inspection and
copying.
    Upon completion of the thirty calendar day extension of the public
comment period, EPA Region 8 will evaluate each significant comment and
any significant new data received before issuing a final decision
concerning the proposed partial deletion. EPA will prepare a
responsiveness summary for each significant comment and any significant
new data received during the public comment period and will address
concerns presented in such comments and data. The responsiveness
summary will be made available to the public at the EPA Region 8 office
and the information repositories listed above and will be included in
the final deletion package. Members of the public are encouraged to
contact EPA Region 8 to obtain a copy of the responsiveness summaries.
If, after review of all such comments and data, EPA determines that the
partial deletion from the NPL is appropriate, EPA will publish a final
notice of partial deletion in the Federal Register. Deletion of the
Internal Parcel of the RMA/NPL Site does not actually occur until a
final notice of partial deletion is published in the Federal Register.
A copy of the final partial deletion package will be placed at the EPA
Region 8 office and the information repositories listed above after the
final document has been published in the Federal Register.

IV. Basis for Intended Partial Site Deletion

    This notice announces a thirty day extension of the public comment
period for the proposed partial deletion from the RMA/NPL Site. EPA
Region 8 announced its intent to delete the Internal Parcel of the RMA/
NPL Site from the NPL on April 26, 2006. The original basis for
deleting the Internal Parcel from the RMA/NPL Site has not changed. The
Federal Register notice for the Internal Parcel (71 FR 24627, Apr. 26,
2006) provides a thorough discussion of the basis for the intended
partial deletion.

    Dated: May 15, 2006.
Robert E. Roberts,
Regional Administrator, Region 8.
 [FR Doc. E6-7664 Filed 5-23-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77877-77878]
[FR Doc No: 2010-31250]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-E-0022; FDA-2010-E-0023; FDA-2010-E-0024]

Determination of Regulatory Review Period for Purposes of Patent
Extension; VIBATIV

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for VIBATIV and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of patents
which claim that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.

Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product VIBATIV
(televancin hydrochloride). VIBATIV is indicated for treatment of adult
patients with complicated skin and skin structure infections caused by
susceptible Gram-positive bacteria. Subsequent to this approval, the
Patent and Trademark Office received patent term restoration
applications for VIBATIV (U.S. Patent Nos. 6,635,618; 6,872,701; and
7,208,471) from Theravance, Inc., and the Patent and Trademark Office
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated March 3, 2010, FDA advised
the Patent and Trademark Office that this human drug product had
undergone a regulatory review period and that the approval of VIBATIV
represented the first permitted commercial marketing or use of the
product. Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
VIBATIV is 2,635 days. Of this time, 1,637 days occurred during the
testing phase of the regulatory review period, while 998 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
June 27, 2002. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on June 27,
2002.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
19, 2006. The applicant claims December 7, 2006, as the date the new
drug application (NDA) for VIBATIV (NDA 22-110) was initially
submitted. However, FDA records indicate that NDA 22-110 was submitted
on December 19, 2006.
    3. The date the application was approved: September 11, 2009. FDA
has verified the applicant's claim that NDA 22-110 was approved on
September 11, 2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 719, 828, or
863 days of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by February 14, 2011. Furthermore, any interested
person may petition FDA for a determination regarding whether the
applicant for extension acted with due diligence during the regulatory
review period by June 13, 2011. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments.
    However, if you submit a written petition, you must submit three
copies of the petition. Identify comments with the docket number found
in brackets in the heading of this document. Comments and petitions
that have not been made publicly available on regulations.gov may be
viewed in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.

    Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-31250 Filed 12-13-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)]
[Notices]
[Pages 28931-28932]
[FR Doc No: 2017-13235]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2017-0051]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    Under part 235 of Title 49 of the Code of Federal Regulations (CFR)
and 49 U.S.C. 20502(a), this document provides the public notice that
on June 7, 2017, National Railroad Passenger Corporation (Amtrak)
petitioned the Federal Railroad Administration (FRA) seeking approval
for the discontinuance or modification of a signal system. FRA assigned
the petition Docket Number FRA-2017-0051.

Applicant: National Railroad Passenger Corporation, Mr. Nicholas J.
Croce III, PE, Deputy Chief Engineer C&S, Acting, 2995 Market Street,
Philadelphia, PA 19104

    Amtrak seeks to remove two derails, one in each direction
approaching the Spuyten Duyvil bridge on Main Track #1, at Inwood
interlocking, milepost (MP) 9.9 on the New York Division, Hudson Line,
Inwood, New York.
    Amtrak would like to remove the derails as they have been rendered
obsolete by advanced technologies which ensure that trains stop rather
than derail. They have been a source of considerable delay to time-
sensitive passenger trains. Amtrak desires to remove these derails from
the main tracks to eliminate maintenance and operation of obsolete
hardware that is no longer needed, and to reduce delays caused by
failures of the derails. Each of the interlocking home signals
protecting these derails and the associated movable bridge are equipped
with 100Hz coded cab signal system with speed control. The
interlockings have also been equipped with both Advanced Civil Speed
Enforcement System and Positive Train Stop.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.

    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by August 10, 2017 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

Robert C. Lauby,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2017-13235 Filed 6-23-17; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 9000-9001]
[FR Doc No: 2018-04283]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4098]

Reference Amounts Customarily Consumed: List of Products for Each
Product Category; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry entitled ``Reference Amounts
Customarily Consumed: List of Products for Each Product Category.'' The
guidance provides examples of products that belong to product
categories included in the tables of Reference Amounts Customarily
Consumed (RACCs) per Eating Occasion established in our regulations.

DATES: The announcement of the guidance is published in the Federal
Register on March 2, 2018.

ADDRESSES: You may submit either electronic or written comments on FDA
guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-4098 for ``Reference Amounts Customarily Consumed: List of
Products for Each Product Category.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Nutrition and Food Labeling, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Reference Amounts Customarily Consumed: List of Products for
Each Product Category.'' We are issuing this guidance consistent with
our good guidance practices regulation (21 CFR 10.115). 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. This guidance
is not subject to Executive Order 12866.
    This guidance is intended to help industry comply with the
statutory requirement, under section 403(q)(1)(A)(i) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(q)(1)(A)(i)),
that food that is intended for human consumption and offered for sale
bear nutrition information that provides a serving size

that reflects the amount of food customarily consumed and is expressed
in a common household measure that is appropriate to the food. To
comply with this requirement, manufacturers must determine and label
their food products with the appropriate label serving size based on
the amount of the product customarily consumed.
    In the Federal Register of May 27, 2016, we issued a final rule
entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed at One Eating Occasion; Dual-Column Labeling; Updating,
Modifying, and Establishing Certain Reference Amounts Customarily
Consumed; Serving Size for Breath Mints; and Technical Amendments'' (81
FR 34000). The final rule amends our regulations in Sec.  101.12(b) (21
CFR 101.12(b)) to update or modify certain pre-existing RACCs, and to
establish RACCs for new product categories.
    In the Federal Register of January 5, 2017 (82 FR 1344), we
announced the availability of a draft guidance for industry entitled
``Reference Amounts Customarily Consumed: List of Products for Each
Product Category; Draft Guidance for Industry'' and gave interested
parties an opportunity to submit comments by March 6, 2017, for us to
consider before beginning work on the final version of the guidance. We
received several comments on the draft guidance and have modified the
content, where appropriate, for this final guidance. Changes to the
guidance include the addition of flavored nut butter spreads (e.g.,
cocoa, cookie, and coffee flavored) as an example in the ``Nut and seed
butters, pastes, or creams'' product category. In the Federal Register
of November 2, 2016, we published a Request for Information and
Comments requesting information and comments on the appropriate product
category and RACC for flavored nut butter spreads (e.g., cocoa, cookie,
and coffee flavored) (81 FR 76323). Based upon the information and
comments received, and our own assessment, we have determined that
flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored)
are comparable to nut butters and belong in the ``Nut and seed butters,
pastes, or creams'' product category with a RACC of two tablespoons. In
addition to this and other clarifying substantive changes that we made
to the guidance, we made editorial changes to improve clarity and to
help ensure consistency with Sec.  101.12(b). The guidance announced in
this notice finalizes the draft guidance dated January 2017.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: February 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04283 Filed 3-1-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)]
[Notices]
[Pages 39078-39081]
[FR Doc No: 2016-14085]

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

[Release No. 34-78027; File No. SR-Phlx-2016-64]

Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Exchange's Pricing Schedule Under Section VIII

June 9, 2016.
    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 May 31, 2016, NASDAQ PHLX LLC (``Exchange'') filed with the
Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I, II, and III, below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's Pricing Schedule
under Section VIII, entitled ``NASDAQ OMX PSX FEES,'' with respect to
execution and routing of orders in securities priced at $1 or more per
share.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

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

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to amend certain charges
and credits for the use of the order execution and routing services of
the NASDAQ OMX PSX System (``PSX'') by member organizations for all
securities traded at $1 or more per share. The Exchange is proposing
to: (1) Add an additional Consolidated Volume \3\ requirement to the
existing fee tiers assessed a member organization that enters an order
that executes in PSX; (2) add an new default fee assessed a member
organization that enters an order that executes in PSX in the security
of any Tape \4\ of $0.0030 per share executed; and (3) delete text from
the preamble of paragraph (a)(1) of Section VIII, Order Execution and

Routing concerning Consolidated Volume.
---------------------------------------------------------------------------

    \3\ Consolidated Volume is defined as the total consolidated
volume reported to all consolidated transaction reporting plans by
all exchanges and trade reporting facilities during a month in
equity securities, excluding executed orders with a size of less
than one round lot. For purposes of calculating Consolidated Volume
and the extent of a member's trading activity, expressed as a
percentage of, or ratio to, Consolidated Volume, the date of the
annual reconstitution of the Russell Investments Indexes shall be
excluded from both total Consolidated Volume and the member's
trading activity. See of Section VIII, Order Execution and Routing,
paragraph (a)(1).
    \4\ There are three Tapes, which are based on the listing venue
of the security: Tape C securities are Nasdaq-listed; Tape A
securities are New York Stock Exchange-listed securities; and Tape B
securities are listed on exchanges other than Nasdaq and NYSE.
---------------------------------------------------------------------------

First Change
    The purpose of the first change is to add a new requirement to
qualify for each of the existing fee tiers assessed a member
organization that enters an order that executes in PSX. The Exchange
currently assesses a member organization a fee of $0.0029 per share
executed in Nasdaq-listed securities (``Tape C''), and fee of $0.0028
per share executed in NYSE-Listed Securities (``Tape A'') and in
securities listed on exchanges other than Nasdaq and NYSE (``Tape B'').
These fees currently do not require a member organization to have met a
performance measure in return for the fees, but rather are the
``default'' fees assessed for removal of liquidity from PSX. In light
of the proposed new $0.0030 default removal fee discussed below, the
Exchange is proposing to add a Consolidated Volume-based requirement to
the existing fee tiers in order to qualify for the now-lower charges
assessed member organizations for removing liquidity. Specifically, the
Exchange is proposing to require a member organization to access 0.065%
or more of Consolidated Volume during the month to be eligible to
receive the lower charges assessed under the fee tiers.
Second Change
    The purpose of the second change is to add a new default fee
assessed a member organization that enters an order that executes in
PSX in the security of any Tape. Currently, a member organization is
assessed a fee of $0.0029 per share executed in Tape C securities, and
fee of $0.0028 per share executed in Tape A and Tape B securities. The
Exchange is proposing to assess a member organization that enters an
order that executes in PSX a fee of $0.0030 per share executed in a
security of any Tape.
Third Change
    The purpose of the third change is to delete rule text from the
preamble of paragraph (a)(1) of Section VIII, Order Execution and
Routing, concerning Consolidated Volume. The rule currently defines
Consolidated Volume as the total consolidated volume reported to all
consolidated transaction reporting plans by all exchanges and trade
reporting facilities during a month in equity securities, excluding
executed orders with a size of less than one round lot. The Exchange
excludes from the calculations of fees and credits that have a
Consolidated Volume component all trading that occurs on the date of
the annual reconstitution of the Russell Investments. The annual
reconstitution represents a day of abnormal trading volume, as the
Russell Investment indexes adjust holdings to accurately reflect the
current state of equity markets and their market segments.\5\
Consequently, the Exchange excludes the date of the Russell Investment
reconstitution in all calculations of fees and credits because it is
not reflective of a member organization's normal trading. The Exchange
expresses this under the rule by stating that, ``[f]or purposes of
calculating Consolidated Volume and the extent of a member's trading
activity, expressed as a percentage of, or ratio to, Consolidated
Volume, the date of the annual reconstitution of the Russell
Investments Indexes shall be excluded from both total Consolidated
Volume and the member's trading activity.'' The Exchange believes that
the text stating ``expressed as a percentage of, or ratio to,
Consolidated Volume'' may be confusing to market participants in
understanding how the Exchange excludes trading activity on the day of
the Russell Investment reconstitution should the Exchange ever adopt a
fee or credit tier based on a different measure of Consolidated Volume.
Specifically, the Exchange seeks to clarify that all trading activity
on the date of the Russell Investment reconstitution (including trading
activity not based on a percentage or ratio of Consolidated Volume) is
excluded from a member's trading activity for determining credit and
fee tiers. This proposed change has no impact on PSX at this time, as
all tiers under the rule are currently expressed as a percentage of
Consolidated Volume; however, if the Exchange adopted a new metric,
such as a certain nominal level of share volume (e.g., a requirement to
add 5 million shares), the Exchange wants to ensure that member
organizations understand that all trading activity on the day of the
Russell Investment reconstitution would be excluded for purposes of
determining what fees and credits a member qualifies for.
---------------------------------------------------------------------------

    \5\ See https://www.ftserussell.com/research-insights/russell-reconstitution.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \6\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act \7\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility or
system which the Exchange operates or controls, and is not designed to
permit unfair discrimination between customers, issuers, brokers, or
dealers.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The proposed increases to the credits and charges in the fee
schedule under the Exchange's Pricing Schedule under Section VIII are
reflective of the Exchange's ongoing efforts to use pricing incentives
to attract order flow to the Exchange and improve market quality, while
also providing a profit to the Exchange through the operation of its
market.
First Change
    The Exchange believes that the proposed new requirement to qualify
for each of the existing fee tiers assessed a member organization that
enters an order that executes in PSX is reasonable because the Exchange
is providing member organizations the ability to continue to have the
ability to qualify for current lower removal fees. The Exchange uses
credits and reduced fees to provide incentive to market participants to
improve the markets. In the present case, the Exchange is adding to
each of the existing fee tiers under the rule a new requirement that a
member organization access 0.065% or more of Consolidated Volume during
the month. Removal of liquidity adds to the price discovery process and
therefore benefits all market participants. Consequently, the Exchange
believes that requiring member organizations to improve the market
through the removal of liquidity by a certain level of Consolidated
Volume in return for lower liquidity removal fees is reasonable.
    The Exchange believes that the proposed new requirement to qualify
for each of the lower fee tiers assessed a member organization that
enters an order that executes in PSX is an equitable allocation and is
not unfairly discriminatory because the Exchange will apply the same
fee to all similarly situated members. The Exchange is not proposing to
adjust the fee assessed for removal of the securities of each Tape, but
rather is adding a new Consolidated Volume-based requirement in light
of the proposed new $0.0030 per share executed fee, which will be the
new ``default'' rate assessed member organizations for removal of
liquidity. Thus, to qualify for a reduced fee in any of the amended fee
tiers, a member organization must accesses 0.065% or more of
Consolidated Volume during the month.

Second Change
    The Exchange believes that the new base removal fee is reasonable
because although it will increase the fee assessed to access liquidity
on the Exchange, it is identical to the fee assessed by The NASDAQ
Stock Market LLC (``Nasdaq'') for removing liquidity in the securities
of any Tape from the Nasdaq Market Center.\8\ As a general principle,
the Exchange must, from time to time, adjust the level of fees and
credits provided to most efficiently allocate such fees and credits in
terms of market-improving behavior. In this regard, the Exchange is
limited in how far it may reduce fees and in the amount of credits that
it can provide to market participants. In the present case, the
Exchange has observed high levels of liquidity removal on PSX
sufficient to allow the Exchange to increase removal fees, which will
allow the Exchange to offer credits for market-improving behavior, and
to realize a greater profit.
---------------------------------------------------------------------------

    \8\ See Nasdaq Rules 7018(a)(1)-(3).
---------------------------------------------------------------------------

    The Exchange believes that the increased removal fee is an
equitable allocation and is not unfairly discriminatory because the
Exchange will apply the same fee to all similarly situated members. In
this regard, the Exchange notes that the fee is uniform across the
securities of all three Tapes. In addition, the Exchange will offer
reduced fees for removal of liquidity, but in return for market
improving behavior. Last, the Exchange believes that increasing the fee
assessed does not discriminate unfairly because it is a modest increase
that is consistent with the fee assessed for removing liquidity at
other exchanges.
Third Change
    The Exchange believes that deleting rule text from the preamble of
paragraph (a)(1) of Section VIII, Order Execution and Routing,
concerning Consolidated Volume is reasonable because it will help
clarify how credit and fee tiers that rely on a calculation of
Consolidated Volume will be handled by the Exchange during the annual
Russell Indexes reconstitution. Currently, the rule text could be
interpreted to apply to only a member organization's trading activity
under a fee or credit tier that is expressed as a ratio or percentage
of Consolidated Volume. The Exchange believes that, should it ever
adopt a credit or fee tier based on another measure of Consolidated
Volume, such an interpretation would undermine the Exchange's intent to
exclude the abnormal trading activity that occurs on that day.
Accordingly, the Exchange believes that it is reasonable to remove the
potentially confusing rule text.
    The Exchange believes that deleting rule text from the preamble of
paragraph (a)(1) of Section VIII, Order Execution and Routing,
concerning Consolidated Volume is an equitable allocation and is not
unfairly discriminatory because the proposed change only serves to
clarify the application of the rule and does not alter how Consolidated
Volume is calculated. Thus, the Exchange will apply the same process to
all similarly situated member organizations that seek to qualify under
a fee or credit tier under the rule that relies on a calculation of
Consolidated Volume.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of inter-market
competition, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive, or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees to remain competitive with other exchanges and with
alternative trading systems that have been exempted from compliance
with the statutory standards applicable to exchanges. Because
competitors are free to modify their own fees in response, and because
market participants may readily adjust their order routing practices,
the Exchange believes that the degree to which fee changes in this
market may impose any burden on competition is extremely limited.
    In this instance, the changes to the fees assessed for removing
liquidity do not impose a burden on competition because the Exchange
membership is optional and is the subject of competition from other
exchanges. The increased charges are reflective of the intent to
balance the fees that it assesses with the order flow it receives. For
these reasons, the Exchange does not believe that any of the proposed
changes will impair the ability of members or competing order execution
venues to maintain their competitive standing in the financial markets.
Moreover, because there are numerous competitive alternatives to the
use of the Exchange, it is likely that the Exchange will lose market
share as a result of the changes if they are unattractive to market
participants. As noted above, the proposed changes are consistent with
similar fees assessed members of other markets.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\9\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

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_ADDRESS>Please include
File Number SR-Phlx-2016-64 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2016-64. 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 Web site (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 Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.
    All submissions should refer to File Number SR-Phlx-2016-64 and
should be submitted on or before July 6, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-14085 Filed 6-14-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Notices]
[Pages 65689-65690]
[FR Doc No: 2013-26019]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2013-0039]

Technical Mapping Advisory Council

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Committee Management; Request for Applicants for Appointment to
the Federal Emergency Management Agency's Technical Mapping Advisory
Council.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) is requesting
qualified individuals interested in serving on the Technical Mapping
Advisory Council (TMAC) to apply for appointment. As provided for in
the Biggert-Waters Flood Insurance Reform Act of 2012, the TMAC makes
recommendations to the FEMA Administrator on how to improve, in a cost-
effective manner, the accuracy, general quality, ease of use, and
distribution and dissemination of flood insurance rate maps (FIRMs) and
risk data; and performance metrics and milestones required to
effectively and efficiently map flood risk areas in the United States.

DATES: Applications will be accepted until December 2, 2013.

ADDRESSES: Applications for membership should be submitted by one of
the following methods:
     Email<EMAIL_ADDRESS>     Mail: FEMA, Federal Insurance and Mitigation
Administration, Risk Analysis Division, Attn: Michael Godesky or Mark
Crowell, 1800 South Bell Street, Arlington, VA 20598-3035.

FOR FURTHER INFORMATION CONTACT: Michael Godesky, 1800 South Bell
Street, Arlington, Virginia 20598-3035, email<EMAIL_ADDRESS>
phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The TMAC is an advisory committee that was
established by the Biggert-Waters Flood Insurance Reform Act of 2012,
42 U.S.C. 4101a, and in accordance with the provisions of the Federal
Advisory Committee Act (FACA), 5 U.S.C. App. (Pub. L. 92-463). The TMAC
is required to recommend to the Administrator: (1) Mapping standards
and guidelines for FIRMs and data accuracy, data quality, data
currency, and data eligibility; (2) how to maintain, on an ongoing
basis, FIRMs and flood insurance identification; and (3) procedures for
delegating mapping activities to State and local mapping partners. The
TMAC is also required to recommend to the Administrator, and other
Federal agencies participating on the Council, methods for improving
interagency and intergovernmental coordination on flood mapping and
flood risk determination, and a funding strategy to leverage and
coordinate budgets and expenditures across Federal agencies. In
consultation with scientists and technical experts, other Federal
agencies, and local communities, the TMAC will develop recommendations
on how to ensure that FIRMs incorporate the best available climate
science to assess flood risks and ensure that FEMA uses the best
available methodology to consider the impact of the rise in sea level
and future development on flood risk. Members of the TMAC will be
appointed based on their demonstrated knowledge and competence
regarding surveying, cartography, remote sensing, geographic
information systems, or the technical aspects of preparing and using
FIRMs. To the maximum extent practicable, FEMA will ensure that
membership of the TMAC has a balance of Federal, State, local, Tribal,
and private members, and includes geographic diversity, including
representation from areas with coastline on the Gulf of Mexico and
other States containing areas identified by the Administrator as at
high risk for flooding or as areas having special flood hazards.
    FEMA is requesting qualified individuals who are interested in
serving on the TMAC to apply for appointment. Certain members of the
TMAC, as described below, will be appointed and serve as Special
Government Employees (SGE) as defined in section 202(a) of title 18
United States Code. Candidates selected for appointment as SGEs are
required to complete a Confidential Financial Disclosure Form (Office
of Government Ethics (OGE) Form 450). This form can be obtained by
visiting the Web site of

the Office of Government Ethics (http://www.oge.gov). Please do not
submit this form with your application. Qualified applicants will be
considered for one or more of the following membership categories:
    a. One member of a recognized professional surveying association or
organization (SGE appointment);
    b. One member of a recognized professional mapping association or
organization (SGE appointment);
    c. One member of a recognized professional engineering association
or organization (SGE appointment);
    d. One member of a recognized professional association or
organization representing flood hazard determination firms (SGE
appointment);
    e. One representative of the United States Geological Survey;
    f. One representative of a recognized professional association or
organization representing State geographic information;
    g. One representative of State national flood insurance
coordination offices;
    h. One representative of the Corps of Engineers;
    i. One member of a recognized regional flood and storm water
management organization (SGE appointment);
    j. Two representatives of different State government agencies that
have entered into cooperating technical partnerships with the
Administrator and have demonstrated the capability to produce FIRMs;
    k. Two representatives of different local government agencies that
have entered into cooperating technical partnerships with the
Administrator and have demonstrated the capability to produce FIRMs;
    l. One member of a recognized floodplain management association or
organization (SGE appointment);
    m. One member of a recognized risk management association or
organization (SGE appointment); and
    n. One State mitigation officer (SGE appointment).
    Members of the TMAC will serve terms of office of two years.
However, up to half (eight) of those initially appointed to the TMAC
may serve one-year terms to allow for staggered turnover. There is no
application form. However, applications must include the following
information: The applicant's full name, home and business phone
numbers, preferred email address, home and business mailing addresses,
current position title & organization, resume or curriculum vitae, and
the membership category of interest (e.g., State mitigation officer).
Contact information is provided in the FOR FURTHER INFORMATION CONTACT
section of this notice.
    The TMAC will meet not less than twice a year. Members may be
reimbursed for travel and per diem, and all travel for TMAC business
must be approved in advance by the Designated Federal Officer. The
Department of Homeland Security (DHS) does not discriminate in
employment on the basis of race, color, religion, sex, national origin,
political affiliation, sexual orientation, gender identity, marital
status, disability and genetic information, age, membership in an
employee organization, or other non-merit factor. DHS strives to
achieve a widely diverse candidate pool for all of its recruitment
actions. Registered lobbyists and current FEMA employees, Disaster
Assistance Employees, reservists, contractors, and potential
contractors will not be considered for membership.

    Dated: October 23, 2013.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-26019 Filed 10-31-13; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Rules and Regulations]
[Pages 30353-30355]
[FR Doc No: 2015-12852]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2015-N-1297]

Medical Devices; Gastroenterology-Urology Devices; Classification
of the Vibrator for Climax Control of Premature Ejaculation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the
vibrator for climax control of premature ejaculation into class II
(special controls). The special controls that will apply to the device
are identified in this order and will be part of the codified language
for the classification of the vibrator for climax control of premature
ejaculation. The Agency is classifying the device into class II
(special controls) in order to provide a reasonable assurance of safety
and effectiveness of the device.

DATES: This order is effective May 28, 2015. The classification was
applicable on March 20, 2015.

FOR FURTHER INFORMATION CONTACT: Tuan Nguyen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G118, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order

finding the device to be substantially equivalent, in accordance with
section 513(i) of the FD&C Act, to a predicate device that does not
require premarket approval. The Agency determines whether new devices
are substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1), the
person requests a classification under section 513(f)(2). Under the
second procedure, rather than first submitting a premarket notification
under section 510(k) and then a request for classification under the
first procedure, the person determines that there is no legally
marketed device upon which to base a determination of substantial
equivalence and requests a classification under section 513(f)(2) of
the FD&C Act. If the person submits a request to classify the device
under this second procedure, FDA may decline to undertake the
classification request if FDA identifies a legally marketed device that
could provide a reasonable basis for review of substantial equivalence
with the device or if FDA determines that the device submitted is not
of ``low-moderate risk'' or that general controls would be inadequate
to control the risks and special controls to mitigate the risks cannot
be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device. On
November 21, 2013, Ergon Medical, Ltd., submitted a request for
classification of the ProlongTM under section 513(f)(2) of
the FD&C Act. The manufacturer recommended that the device be
classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on March 20, 2015, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 876.5025.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a vibrator
for climax control of premature ejaculation will need to comply with
the special controls named in this final order. The device is assigned
the generic name vibrator for climax control of premature ejaculation,
and it is identified as a device used for males who suffer from
premature ejaculation. It is designed to increase the time between
arousal and ejaculation using the stimulating vibratory effects of the
device on the penis.
    FDA has identified the following risks to health associated
specifically with this type of device, as well as the measures required
to mitigate these risks in table 1.

 Table 1--Vibrator for Climax Control of Premature Ejaculation Risks and
                           Mitigation Measures
------------------------------------------------------------------------
              Identified risk                    Mitigation measures
------------------------------------------------------------------------
Pain or Discomfort due to Misuse of Device  Labeling.
Burns.....................................  Electrical and Thermal
                                             Safety Testing.
                                            Labeling.
Electrical Shock..........................  Electrical Safety Testing.
                                            Labeling.
Adverse Skin Reactions....................  Biocompatibility Testing.
Patient Injury due to Device Breakage or    Mechanical Safety Testing.
 Failure.                                   Labeling.
Interference With Other Devices/Electrical  Electromagnetic
 Equipment.                                  Compatibility Testing.
                                            Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination
with the general controls, address these risks to health and provide
reasonable assurance of the safety and effectiveness:
     The labeling must include specific instructions regarding
the proper placement and use of the device.
     The portions of the device that contact the patient must
be demonstrated to be biocompatible.
     Appropriate analysis/testing must demonstrate
electromagnetic compatibility safety, electrical safety, and thermal
safety of the device.
     Mechanical safety testing must demonstrate that the device
will withstand forces encountered during use.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the vibrator for climax control of
premature ejaculation they intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other 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
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR part 801, regarding labeling have been
approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.

1. DEN130047: De Novo Request per 513(f)(2) from Ergon Medical Ltd.,
dated November 21, 2013.

List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
876 is amended as follows:

PART 876--GASTROENTEROLOGY--UROLOGY DEVICES

0
1. The authority citation for 21 CFR part 876 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  876.5025 to subpart F to read as follows:

Sec.  876.5025  Vibrator for climax control of premature ejaculation.

    (a) Identification. A vibrator for climax control of premature
ejaculation is used for males who suffer from premature ejaculation. It
is designed to increase the time between arousal and ejaculation using
the stimulating vibratory effects of the device on the penis.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The labeling must include specific instructions regarding the
proper placement and use of the device.
    (2) The portions of the device that contact the patient must be
demonstrated to be biocompatible.
    (3) Appropriate analysis/testing must demonstrate electromagnetic
compatibility safety, electrical safety, and thermal safety of the
device.
    (4) Mechanical safety testing must demonstrate that the device will
withstand forces encountered during use.

    Dated: May 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12852 Filed 5-27-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Notices]
[Pages 57513-57516]
[FR Doc No: 2018-24870]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84556; File No. SR-ICEEU-2018-011]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing and Immediate Effectiveness of Proposed Rule Change Relating
to Amendments to the F&O Guaranty Fund Policy (the ``Policy''),
Clearing Rules (the ``Rules'') and Finance Procedures (``Finance
Procedures'')

November 8, 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 October 29, 2018, ICE Clear Europe Limited (``ICE Clear Europe'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule changes described in Items I, II and III below, which
Items have been prepared primarily by ICE Clear Europe. ICE Clear
Europe filed the proposed rule changes pursuant to Section 19(b)(3)(A)
of the Act,\3\ and Rule 19b-4(f)(4)(ii) thereunder,\4\ so that the
proposal was immediately effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

    ICE Clear Europe proposes to make certain amendments to the Policy,
Rules and Finance Procedures relating to the calculation methodology
for F&O Clearing Member contributions, the minimum size of the F&O
Guaranty Fund and the review cycle and to make various drafting
clarifications and improvements.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe 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. ICE Clear Europe has prepared summaries,
set forth in sections (A), (B), and (C) below, of the most significant
aspects of such statements.

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

(a) Purpose
    ICE Clear Europe is generally amending the Policy to address the
following aspects of the F&O Guaranty Fund: Changing the calculation
methodology for F&O Clearing Member contributions to incorporate an
uncollateralized stress loss factor (in addition to a factor based on
the intraday original margin requirement), in line with the Clearing
House principle of `polluter pays'; specifying the minimum size of the
F&O Guaranty Fund at 2% of the amount of F&O original margin; and
changing the review cycle for the F&O Guaranty Fund level from
quarterly to every two months, in line with the F&O Risk Committee
meeting schedule. Various drafting clarifications and improvements have
also been made, and certain descriptions in the Policy that duplicate
or describe provisions in other Rules, ICE Clear Europe Procedures and
policies have been removed as unnecessary. ICE Clear Europe is also
making corresponding amendments to the Rules and Finance Procedures to
accommodate the changes being made to the Policy. Set out below are
further details regarding the specific proposed amendments.
    ICE Clear Europe is proposing to amend its description of the
purposes and objectives of the Policy to include a broader statement
that the Policy defines how and how often the F&O Guaranty Fund is
sized, how Clearing Member contributions are apportioned and the sizing
frequency, as well as that the Policy also defines stress margin and
its uses, eligible assets covering F&O Guaranty Fund requirement
liabilities, the default sequence and powers of assessment. Certain
descriptions of the

use of F&O Guaranty Fund that summarize provisions of the Rules have
been removed as unnecessary, and a cross reference to the Rules has
been added.
    The provisions of the Policy relating to the sizing of the F&O
Guaranty Fund would be amended to remove details found in other
Clearing House policies and documentation, including the methodology
used to calculate and allocate the additional guaranty fund
apportionment (``AGA'') between the energy and financials & softs
segments of the F&O Guaranty Fund. Detail regarding the review of the
validity of the stress testing scenario(s) is being removed, as it is
covered by other existing stress-testing policies. These changes do not
represent a modification to ICE Clear Europe's current practices.
    The amendments to the Policy also reflect that the frequency of
certain reviews will be changed from a quarterly basis to each time the
F&O Risk Committee meets (which is typically every two months).
Corresponding amendments to the Rules specify that the Guaranty Fund
Period will be set pursuant to the Finance Procedures, instead of being
a fixed three month period. The amendments to the Finance Procedures
state that the start and end dates of Guaranty Fund Periods will be
communicated to F&O Clearing Members.
    The amendments change the deadline for Clearing Members to deposit
additional funds to comply with an increased F&O Guaranty Fund
requirement. Specifically, as amended in section 6.1(i)(iii) of the
Finance Procedures and as set out in the amended Policy, the deadline
has been reduced from ten business days to five business days.
    The proposed amendments define the minimum overall F&O Guaranty
Fund size as 2% of the total F&O original margin requirement (averaged
over the review period), as compared to the current minimum which is
based on the fixed ICE Clear Europe initial contribution to the F&O
Guaranty Fund.
    The discussion of extraordinary reviews of the F&O Guaranty Fund is
being amended to remove certain details relating to actions that will
be taken by the clearing risk department when the stress testing
results are observed to exceed the level of the relevant F&O Guaranty
Fund segment, as this is documented in other Clearing House policies
and documentation. The description instead notes that the amber and red
limits defined as part of the Board Risk Appetite will potentially
trigger an extraordinary review of the F&O Guaranty Fund which would be
communicated via the standard process for review.
    The requirements of the Policy regarding information presented to
the F&O Risk Committee are being simplified such that the following
information will be presented to the F&O Risk Committee at each review
of the level of the Fund: Historical daily stress-testing results from
the Members showing at least the first and second largest
uncollateralized losses; details of the stress scenario driving the
largest exposures; and any other information supporting a resizing
decision. Certain more prescriptive information requirements have been
removed, as ICE Clear Europe believes they are unnecessary.
    The provisions of the Policy relating to recommendations as to
changes in the overall level of the F&O Guaranty Fund have been
condensed and simplified. The revised Policy identifies several factors
on which the Clearing House will base its recommendations on the level
of the Fund (including the level of uncollateralized losses as compared
to the F&O Guaranty Fund or relevant segments and the level of stress
margin called for relevant F&O product categories), rather than
describing specific circumstances under which a `no change'
recommendation or a recommendation to increase a Fund segment will be
made. The Clearing House believes the more flexible approach better
takes into account the range of factors that may warrant a change in
the F&O Guaranty Fund level. In any case, as under the current Policy,
a full explanation of the conclusions and related data is to be
presented to the F&O Risk Committee and Board Risk Committee.
    As noted above, the amendments alter the calculation of F&O
Clearing Member contributions to take into account potential
uncollateralized, or stress, loss as well as the maximum intraday
original margin requirement. The governing principle with respect to
this determination is that each Clearing Member's contribution to each
of the Fund segments should reflect their relative share of clearing
activity as well as their relative share of uncollateralized loss.
Under the revised approach, subject to minimum contribution
requirements set out in the Policy, an F&O Clearing Member's relative
share of the F&O Guaranty Fund requirement will be based 40% on its
maximum intraday original margin requirement and 60% on its
uncollateralized loss. This will be recalculated at each review
(instead of on a quarterly cycle). This two factor contribution model
is intended to offer a balanced contribution taking into account
clearing activity and stress results. Various conforming and clarifying
changes have been made throughout the Policy. As discussed above, F&O
Clearing Members will have five (instead of ten) UK business days from
notification to cover any increase in their F&O Guaranty Fund
requirement. The description of the data validation process is being
deleted (as the process is documented in other Clearing House
procedures). The proposed amendments to the Policy also specify the
minimum fund contribution for an F&O Clearing Member to be the larger
of USD 1 million or the calculated member's contribution under the
revised methodology. The corresponding proposed amendments to section
14.1(b) of the Finance Procedures accommodate this change, by
specifying that the Clearing House will establish from time to time a
minimum fund contribution for an F&O Clearing Member based on a
methodology adopted by the Clearing House, of not less than USD 1
million.
    The proposed amendments also remove a description of the manner in
which a drawdown of the F&O Guaranty Fund is made across the different
fund segments, as that is covered in greater detail in the existing
Rules.
    Finally, references to quarterly reviews of stress test results are
being replaced with references to general review cycles throughout the
Policy and an appendix with an example of a stress margin request is
being deleted as unnecessary.
(b) Statutory Basis
    ICE Clear Europe believes that the proposed amendments are
consistent with the requirements of Section 17A of the Act \5\ and the
regulations thereunder applicable to it, including the standards under
Rule 17Ad-22.\6\ Section 17A(b)(3)(F) of the Act \7\ requires, among
other things, that the rules of a clearing agency be designed to
promote the prompt and accurate clearance and settlement of securities
transactions and, to the extent applicable, derivative agreements,
contracts, and transactions, to assure the safeguarding of securities
and funds in the custody or control of the clearing agency or for which
it is responsible, and the protection of investors and the public
interest. The proposed amendments are generally intended to enhance the
F&O Guaranty Fund allocation methodology to take into account both
original margin

requirements and potential stress losses that may exceed normal margin
levels. The amendments also clarify the minimum size of the F&O
Guaranty Fund, in a manner tied to the original margin requirements and
thus the overall level of F&O clearing activity. The amendments further
shorten the deadline under which F&O Clearing Members must provide
additional F&O Guaranty Fund contributions when required. The Clearing
House believes that these changes will more appropriately allocate F&O
Guaranty Fund Contributions among F&O Clearing Members, further the
risk management of the Clearing House and more generally promote the
prompt and accurate clearance and settlement of transactions. The
amendments also streamline the Policy to reduce redundancies with other
Clearing House policies and the Rules and increase the review cycle
from quarterly to every two months, consistent with the cycle of F&O
Risk Committee meetings. In ICE Clear Europe's view, enhancing the
clarity of the Policy and increasing the oversight of the Policy
through more frequent reviews is also expected to better risk
management and promote the prompt and accurate clearance and settlement
of transactions. As a result, in ICE Clear Europe's view, the
amendments are consistent with the requirements of Section 17A(b)(3)(F)
of the Act.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
    \6\ 17 CFR 240.17Ad-22.
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The amendments are also consistent with relevant requirements of
Rule 17Ad-22.\8\ Rules 17Ad-22(e)(4) \9\ and 17Ad-22(b)(3) \10\ require
clearing agencies to maintain certain financial resources at specified
levels sufficient to support their clearing operations, including
through the use of guaranty funds. The amendments will facilitate
compliance with these requirements, through an enhanced approach to
allocating F&O Guaranty Fund requirements that takes into account both
clearing activity (as indicated through original margin levels) and
potential stress losses in extreme but plausible market conditions. The
revised Policy also contemplates review of by the F&O Risk Committee of
daily stress testing results showing at least the first and second
largest uncollateralized losses and details of the stress scenario
driving the largest exposures. Taken together, the changes will help
the Clearing House ensure that, consistent with regulatory
requirements, the F&O Guaranty Fund, together with other financial
resources, is sufficient to enable the Clearing House to cover a wide
range of foreseeable stress scenarios.
---------------------------------------------------------------------------

    \8\ 17 CFR 240.17Ad-22.
    \9\ 17 CFR 240.17Ad-22(e)(4)(i)--(v). The rule states that
``[e]ach covered clearing agency shall establish, implement,
maintain and enforce written policies and procedures reasonably
designed to, as applicable:
    (4) Effectively identify, measure, monitor, and manage its
credit exposures to participants and those arising from its payment,
clearing, and settlement processes, including by:
    (i) Maintaining sufficient financial resources to cover its
credit exposure to each participant fully with a high degree of
confidence;
    (ii) To the extent not already maintained pursuant to paragraph
(e)(4)(i) of this section, for a covered clearing agency providing
central counterparty services that is either systemically important
in multiple jurisdictions or a clearing agency involved in
activities with a more complex risk profile, maintaining additional
financial resources at the minimum to enable it to cover a wide
range of foreseeable stress scenarios that include, but are not
limited to, the default of the two participant families that would
potentially cause the largest aggregate credit exposure for the
covered clearing agency in extreme but plausible market conditions;
    (iii) To the extent not already maintained pursuant to paragraph
(e)(4)(i) of this section, for a covered clearing agency not subject
to paragraph (e)(4)(ii) of this section, maintaining additional
financial resources at the minimum to enable it to cover a wide
range of foreseeable stress scenarios that include, but are not
limited to, the default of the participant family that would
potentially cause the largest aggregate credit exposure for the
covered clearing agency in extreme but plausible market conditions;
    (iv) Including prefunded financial resources, exclusive of
assessments for additional guaranty fund contributions or other
resources that are not prefunded, when calculating the financial
resources available to meet the standards under paragraphs (e)(4)(i)
through (iii) of this section, as applicable;
    (v) Maintaining the financial resources required under
paragraphs (e)(4)(ii) and (iii) of this section, as applicable, in
combined or separately maintained clearing or guaranty funds;''
    \10\ 17 CFR 240.17Ad-22(b)(3). The rule states that ``[a]
registered clearing agency that performs central counterparty
services shall establish, implement, maintain and enforce written
policies and procedures reasonably designed to: Maintain sufficient
financial resources to withstand, at a minimum, a default by the
participant family to which it has the largest exposure in extreme
but plausible market conditions.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(2) \11\ requires clearing agencies to establish
reasonably designed policies and procedures to provide for governance
arrangements that are clear and transparent and specify clear and
direct lines of responsibility. To facilitate compliance with this
requirement, the proposed amendments to the Policy more clearly set out
the information that will be provided to the F&O Risk Committee at each
review of the level of the F&O Guaranty Fund and the factors that will
be considered in making recommendations on the appropriate level of the
F&O Guaranty Fund.
---------------------------------------------------------------------------

    \11\ 17 CFR 240.17 Ad-22(e)(2). The rule states that ``[e]ach
covered clearing agency shall establish, implement, maintain and
enforce written policies and procedures reasonably designed to, as
applicable:
    (2) Provide for governance arrangements that:
    (i) Are clear and transparent
    (ii) Clearly prioritize the safety and efficiency of the covered
clearing agency;
    (iii) Support the public interest requirements in Section 17A of
the Act (15 U.S.C. 78q-1) applicable to clearing agencies, and the
objectives of owners and participants;
    (iv) Establish that the board of directors and senior management
have appropriate experience and skills to discharge their duties and
responsibilities;
    (v) Specify clear and direct lines of responsibility; and
    (vi) Consider the interests of participants' customers,
securities issuers and holders, and other relevant stakeholders of
the covered clearing agency.''
---------------------------------------------------------------------------

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

    ICE Clear Europe does not believe the proposed rule changes would
have any impact, or impose any burden, on competition not necessary or
appropriate in furtherance of the purposes of the Act. The changes are
being proposed in order to clarify and enhance the Policy and reduce
overlap with other Clearing House Rules and policies. The amendments
will apply to all F&O Clearing Members. ICE Clear Europe does not
believe the amendments will generally affect the overall cost of
clearing for F&O Clearing Members or other market participants or
otherwise affect access to clearing generally. The amendments may alter
the allocation of F&O Guaranty Fund requirements across F&O Clearing
Members, which could increase requirements for some members, but such
changes are designed to more appropriately take into account potential
stress losses as well as clearing activity of such members. In ICE
Clear Europe's view, such amendments will enhance the risk management
of the Clearing House and tailor the F&O Guaranty Fund requirements to
the risks presented by F&O Clearing Members. As a result, any
additional burdens placed on F&O Clearing Members will be appropriate
in furtherance of that goal. The amendments will provide a transparent
and objective methodology for the calculation of F&O Guaranty Fund
requirements, and are not intended to disadvantage any particular
Clearing Member. As a result, ICE Clear Europe believes that any impact
on competition is appropriate in furtherance of the purposes of the
Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments relating to the proposed amendments have not been
solicited or received by ICE Clear Europe. ICE Clear Europe will notify
the Commission of any comments received

with respect to the proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act and paragraph (f) of Rule 19b-4 thereunder. At
any time within 60 days of the filing of the proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

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-ICEEU-2018-011 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-ICEEU-2018-011. 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 filings will also be available for inspection
and copying at the principal office of ICE Clear Europe and on ICE
Clear Europe's website at https://www.theice.com/clear-europe/regulation.
    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-ICEEU-2018-011 and should be
submitted on or before December 6, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-24870 Filed 11-14-18; 8:45 am]
 BILLING CODE 8011-01-P