[Federal Register Volume 84, Number 135 (Monday, July 15, 2019)]
[Notices]
[Pages 33805-33807]
[FR Doc No: 2019-14968]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0031]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemption; request for comments.

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SUMMARY: FMCSA announces receipt of applications from ten individuals
for an exemption from the prohibition in the Federal Motor Carrier
Safety Regulations (FMCSRs) against persons with a clinical diagnosis
of epilepsy or any other condition that is likely to cause a loss of
consciousness or any loss of ability to control a commercial motor
vehicle (CMV) to drive in interstate commerce. If granted, the
exemptions would enable these individuals who have had one or more
seizures and are taking anti-seizure medication to operate CMVs in
interstate commerce.

DATES: Comments must be received on or before August 14, 2019.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2019-0031 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building, Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., ET,
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2019-0031), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that FMCSA can contact you if there are questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
put the docket number, FMCSA-2019-0031, in the keyword box, and click
``Search.'' When the new screen appears, click on the ``Comment Now!''
button and type your comment into the text box on the following screen.
Choose whether you are submitting your comment as an individual or on
behalf of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2019-0031, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. 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
www.dot.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the FMCSRs for a five-year period if it finds such exemption would
likely achieve a level of safety that is equivalent to, or greater
than, the level that would be achieved absent such exemption. The
statute also allows the Agency to renew exemptions at the end of the
five-year period. FMCSA grants exemptions from the FMCSRs for a two-
year period to align with the maximum duration of a driver's medical
certification.
    The ten individuals listed in this notice have requested an
exemption from the epilepsy and seizure disorders prohibition in 49 CFR
391.41(b)(8). Accordingly, the Agency will evaluate the qualifications
of each applicant to determine whether granting the exemption will
achieve the required level of safety mandated by statute.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]
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    \1\ See http://www.ecfr.gov/cgi-bin/text-idx?SID=e47b48a9ea42dd67d999246e23d97970&mc=true&node=pt49.5.391&rgn=div5#ap49.5.391_171.a and https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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    The advisory criteria states the following:
    If an individual has had a sudden episode of a non-epileptic
seizure or loss of consciousness of unknown cause that did not require
anti-seizure medication, the decision whether that person's condition
is likely to cause the loss of consciousness or loss of ability to
control a CMV should be made on an individual basis by the Medical
Examiner in consultation with the treating physician. Before
certification is considered, it is suggested that a six-month waiting
period elapse from the time of the episode. Following the waiting
period, it is suggested that the individual have a complete
neurological examination. If the results of the examination are
negative and anti-seizure medication is not required, then the driver
may be qualified.
    In those individual cases where a driver had a seizure or an
episode of loss of consciousness that resulted from a known medical
condition (e.g., drug reaction, high temperature, acute infectious
disease, dehydration, or acute metabolic disturbance), certification
should be deferred until the driver has recovered fully from that
condition, has no existing residual complications, and is not taking
anti-seizure medication.
    Drivers who have a history of epilepsy/seizures, off anti-seizure
medication and seizure-free for 10 years, may be qualified to operate a
CMV in interstate commerce. Interstate drivers with a history of a
single unprovoked seizure may be qualified to drive a CMV in interstate
commerce if seizure-free and off anti-seizure medication for a five-
year period or more.
    As a result of Medical Examiners misinterpreting advisory criteria
as regulation, numerous drivers have been prohibited from operating a
CMV in interstate commerce based on the fact that they have had one or
more seizures and are taking anti-seizure medication, rather than an
individual analysis of their circumstances by a qualified Medical
Examiner based on the physical qualification standards and medical best
practices.
    On January 15, 2013, FMCSA announced in a Notice of Final
Disposition titled, Qualification of Drivers; Exemption Applications;
Epilepsy and Seizure Disorders, (78 FR 3069), its decision to grant
requests from 22 individuals for exemptions from the regulatory
requirement that interstate CMV drivers have ``no established medical
history or clinical diagnosis of epilepsy or any other condition which

is likely to cause loss of consciousness or any loss of ability to
control a CMV.'' Since the January 15, 2013 notice, the Agency has
published additional notices granting requests from individuals for
exemptions from the regulatory requirement regarding epilepsy found in
49 CFR 391.41(b)(8).
    To be considered for an exemption from the epilepsy and seizure
disorders prohibition in 49 CFR 391.41(b)(8), applicants must meet the
criteria in the 2007 recommendations of the Agency's Medical Expert
Panel (MEP) (78 FR 3069).

III. Qualifications of Applicants

Aaron Ashford

    Mr. Ashford is a 22 year-old class C driver in Michigan. He has
history of childhood seizures and has been seizure free since 2002. His
anti-seizure medication was discontinued in 2002. His physician states
that he is supportive of Mr. Ashford receiving an exemption.

Elton Behnken

    Mr. Behnken is a 64 year-old class A CDL holder in Minnesota. He
has a history of a single disorder and has been seizure free since
2000. He takes anti-seizure medication with the dosage and frequency
remaining the same since 2000. His physician states that he is
supportive of Mr. Behnken receiving an exemption.

Tina Farmer

    Ms. Farmer is a 45 year-old class C driver in Pennsylvania. She has
a history of epilepsy and has been seizure free since 2009. She takes
anti-seizure medication with the dosage and frequency remaining the
same since December 2016. Her physician states that she is supportive
of Ms. Farmer receiving an exemption.

Elizabeth Galvin

    Ms. Galvin is a 56 year-old class C driver in Georgia. She has a
history of a seizure disorder and has been seizure free since 2009. She
takes anti-seizure medication with the dosage and frequency remaining
the same since 1998. Her physician states that he is supportive of Ms.
Galvin receiving an exemption.

Roderick Haslip

    Mr. Haslip is a 58 year-old class A CDL holder in New York. He has
a history of a seizure disorder and has been seizure free since 2010.
He takes anti-seizure medication with the dosage and frequency
remaining the same since 2010. His physician states that he is
supportive of Mr. Haslip receiving an exemption.

Brian E. Kinkade

    Mr. Kinkade is a 58 year-old class B CDL holder in Missouri. He has
a history of a seizure disorder and has been seizure free since 2002.
He takes anti-seizure medication with the dosage and frequency
remaining the same since 2012. His physician states that he is
supportive of Mr. Kinkade receiving an exemption.

Barbara Miller

    Ms. Miller is a 52 year-old class C driver in Texas. She has a
history of a single unprovoked seizure and has been seizure free since
2015. She takes anti-seizure medication with the dosage and frequency
remaining the same since 2016. Her physician states that he is
supportive of Ms. Miller receiving an exemption.

Ryan Moore

    Mr. Moore is a 38 year-old class A CDL holder in North Carolina. He
has a history of epilepsy and has been seizure free since 2009. He
takes anti-seizure medication with the dosage and frequency remaining
the same since 2014. His physician states that he is supportive of Mr.
Moore receiving an exemption.

Roger Prynn

    Mr. Prynn is a 58 year-old class DM CDL holder in New York. He has
a history of syncopal episodes and has been syncope episode free since
2009. He takes anti-seizure medication with the dosage and frequency
remaining the same since 2010. His physician states that he is
supportive of Mr. Prynn receiving an exemption.

Jerel Sayers

    Mr. Sayers is a 51 year-old class A CDL holder in Idaho. He has a
history of epilepsy and has been seizure free since 2006. He takes
anti-seizure medication with the dosage and frequency remaining the
same since 2014. His physician states that he is supportive of Mr.
Sayers receiving an exemption.

IV. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the dates
section of the notice.

    Issued on: July 5, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-14968 Filed 7-12-19; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 246 (Monday, December 23, 2019)]
[Notices]
[Pages 70557-70559]
[FR Doc No: 2019-27475]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5743]

Importation of Certain Food and Drug Administration-Approved
Human Prescription Drugs, Including Biological Products, Under Section
801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Importation of Certain FDA-Approved Human Prescription Drugs,
Including Biological Products, under Section 801(d)(1)(B) of the
Federal Food, Drug, and Cosmetic Act.'' This draft guidance describes
procedures to obtain a National Drug Code (NDC) for an FDA-approved
prescription drug that is imported into the United States in compliance
with the Federal Food, Drug, and Cosmetic Act (FD&C Act), which would
provide an additional avenue through which drugs could be sold at a
lower cost in the U.S. market. This draft guidance is intended to
address certain challenges in the private market faced by manufacturers
seeking to sell their drugs at lower costs.

DATES: Submit either electronic or written comments on the draft
guidance by February 21, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2019-D-5743 for ``Importation of Certain FDA-Approved Human
Prescription Drugs, Including Biological Products, under Section
801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act.'' 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.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/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 draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lyndsay Hennessey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Importation of Certain FDA-Approved Human Prescription
Drugs, Including Biological Products, under Section 801(d)(1)(B) of the
Federal Food, Drug, and Cosmetic Act,'' which, when finalized, will
represent the Agency's current thinking on the importation of multi-
market approved (MMA) products. This draft guidance describes
procedures to obtain an NDC for an FDA-approved prescription drug that
is imported into the United States in compliance with section 801 of
the FD&C Act (21 U.S.C. 381), which would provide an additional avenue
through which drugs could be sold at a lower cost in the U.S. market.
In recent years, FDA has become aware that some drug manufacturers may
be interested in offering certain of their drugs at lower costs and
that obtaining additional NDCs for these drugs may help them to address
certain challenges in the private market. This guidance is not intended
to address the applicability of the Medicaid drug rebate program for
manufacturers. This guidance is intended to outline a potential pathway
by which manufacturers could obtain an additional NDC for an FDA-
approved drug that was originally intended to be marketed in a foreign
country. This guidance specifically addresses the importation of FDA-
approved drugs that were also authorized for sale in a foreign country
in which the drugs were originally intended to be marketed (``MMA
product''). This guidance describes: (1) The process for submitting a
supplement to an approved FDA application for an MMA product; (2) the
recommended labeling for an MMA product; (3) the process for
registration and listing and for obtaining an NDC for the MMA product;
(4) the requirements of section 582 of the FD&C Act (21 U.S.C. 360eee-
1) as added by the Drug Supply Chain Security Act (DSCSA) (Title II of
Pub. L. 113-54); (5) recommendations related to procedures for
importation of the MMA product; and (6) other FDA requirements
applicable to MMA products.
    This guidance, when finalized, will help ensure manufacturers are
aware of procedures to provide access to lower-cost drugs in the United
States.\1\ The guidance details procedures that will enable
manufacturers to obtain an additional NDC for the MMA product, which
could allow greater pricing flexibility for a drug or biological
product. The additional NDC also will support pharmacovigilance,
accurate billing and reimbursement, and facilitate clearance of the MMA
products through customs. This draft guidance is not final nor is it in
effect at this time.
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    \1\ Elsewhere in this issue of the Federal Register, FDA is
issuing a Notice of Proposed Rulemaking under 21 U.S.C. 384 to offer
a pathway for importation of drugs from Canada without the
authorization of the manufacturer.
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    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the
importation of MMA products. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Issues for Consideration

    As previously noted, FDA is interested in receiving comments on the
draft guidance. Regarding the approach set forth in the draft guidance,
in addition to any other issues addressed, FDA requests that commenters
consider the following issues when submitting comments:
    1. Are there additional considerations for certain types of drug
products with special handling, such as sterile injectables, drugs with
boxed warnings, drugs with REMS (Risk Evaluation and Mitigation
Strategy), controlled substances, or drugs that do not meet the
definition of ``product'' under the DSCSA (21 U.S.C. 360eee(13))? Are
there additional considerations for combination products related to the
content of the guidance (e.g., supplement, labeling, NDC) that would
warrant additional guidance for use of this approach for those
products? To the extent that interested parties believe that different
or additional considerations from those described in the draft guidance
should apply to such an approach for combination products, we are
interested in input on that, as well.
    2. The draft guidance uses ``MMA product'' to describe FDA-approved
drugs that were originally intended to be marketed in a foreign country
and also authorized for sale in that foreign country. Is this new term
adequate and understandable? Is there another term that would provide
more clarity regarding the products discussed in the guidance?
    3. The draft guidance describes how an NDC could be obtained for
MMA products. What is the effect of a manufacturer using a new labeler
code as opposed to a new product code to distinguish these products,
such as for reimbursement?
    4. The draft guidance recommends a labeling statement in the FDA-
approved labeling for the MMA product, including the carton and
container label, to assist pharmacists and others in accurately
identifying, dispensing, and billing for these products. FDA seeks
comment on the specific wording that could be included in the statement
to differentiate MMA products from other drugs that are not the subject
of the guidance, if finalized, and to help ensure MMA products are
easily identifiable to pharmacists and not confusing to patients. FDA
also seeks comment on other types of distinguishing characteristics on
the carton and container label that would further enable pharmacists to
identify an MMA product and distinguish it from other packages of the
FDA-approved drug, without confusing patients and consistent with other
applicable requirements relating to carton and container labeling.
Additionally, would other possible mechanisms, such as a Dear
Healthcare Provider letter, provide further clarity and reduce
confusion for pharmacists and other healthcare providers as well as
patients?
    5. We request comment about how much, on average, the labeling and
packaging changes described in the draft guidance would cost drug
manufacturers and repackagers or relabelers. Are there other ways to

distinguish the appearance of an MMA product? We also request comment
about alternative labeling approaches that would display the required
information with equal prominence but may result in lower costs.
    6. The draft guidance describes procedures for manufacturers of
drug products approved under new drug applications or biologics license
applications to obtain an additional NDC for an MMA product. FDA is
interested as to whether manufacturers of generic drugs approved under
an abbreviated new drug application confront similar pricing issues
such that it would be appropriate to provide guidance on a similar
approach for generic drugs. To the extent that interested parties
believe that different considerations should apply to such an approach
for generic drugs from those described in the draft guidance, input is
requested on that as well.
    7. There are complex considerations that impact biosimilar
development, market entry, and uptake. We are interested in the
possible impacts of MMA products that are biological products on
biosimilar development, market entry, and uptake.
    8. Similarly, there are complex considerations impacting generic
drug market entry. We are interested in the possible impacts of MMA
products on generic drug development and market entry.
    9. Are there voluntary steps a manufacturer may take in addition to
the requirements in the DSCSA to ensure the security of the supply
chain for products imported pursuant to the guidance?
    10. Are there any potential risks associated with the importation
of products as described in the draft guidance that could be addressed
by a rulemaking? For example, to what extent, if any, are there
additional procedures that might better protect against entities
seeking to introduce counterfeit drugs in the United States? If so,
please be specific about the potential risk and how it could be
addressed through rulemaking.

III. Paperwork Reduction Act of 1995

    FDA has tentatively concluded that there are no new collections of
information in this draft guidance. This draft guidance refers to
previously approved collections of information found in the FD&C Act
and 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). In accordance with the
Paperwork Reduction Act, if FDA's tentative conclusion changes, prior
to publication of any final guidance document FDA intends to solicit
public comment and obtain OMB approval for any information collections
recommended in this guidance that are new or that would represent
material modifications to those previously approved collections of
information found in FDA regulations or guidances.
    The collections of information in 21 CFR part 314 (new drug
applications) have been approved under OMB control number 0910-0001;
the collections of information in 21 CFR part 601 (biologics license
applications) have been approved under OMB control number 0910-0338;
the collections of information in 21 CFR part 207 (domestic and foreign
facility registration, including assignment of an NDC) have been
approved under OMB control number 0910-0045; the collections of
information in 21 CFR part 1 (general enforcement regulations) have
been approved under OMB control number 0910-0046; the collections of
information in 21 CFR part 201 (labeling) have been approved under OMB
control number 0910-0572; the collections of information pertaining to
current good manufacturing practice requirements for finished
pharmaceuticals and combination products under 21 CFR parts 4, 210,
211, 610, and 680 have been approved under OMB control numbers 0910-
0139 and 0910-0834; and the collections of information pertaining to
suspect product identification and notification under section 582 of
the FD&C Act have been approved under OMB control number 0910-0806.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: December 11, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019-27475 Filed 12-18-19; 8:45 am]
 BILLING CODE 4164-01-P


Placeholder: confidential business information item

CA Walnut Commission  (pre-plant) CUE Application for 2008

For more information please contact Aaron Levy by phone at<PHONE_NUMBER>
or by email at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>


[Federal Register Volume 76, Number 235 (Wednesday, December 7, 2011)]
[Notices]
[Pages 76457-76463]
[FR Doc No: 2011-31337]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65862; File No. SR-NYSEArca-2011-86]

 Self-Regulatory Organizations; NYSE Arca Inc.; Notice of Filing
of Proposed Rule Change To List and Trade the Accuvest Global
Opportunities ETF Under NYSE Arca Equities Rule 8.600

December 1, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that, on November 16, 2011, NYSE Arca, Inc.
(``Exchange'' or ``NYSE Arca'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to list and trade the following under NYSE
Arca Equities Rule 8.600 (``Managed Fund Shares''): The Accuvest Global
Opportunities ETF. The text of the proposed rule change is available at
the Exchange, the Commission's Public Reference Room, and www.nyse.com.

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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to list and trade the following Managed Fund

Shares \3\ (``Shares'') under NYSE Arca Equities Rule 8.600: The
Accuvest Global Opportunities ETF (``Fund'').\4\ The Shares will be
offered by AdvisorShares Trust (``Trust''), a statutory trust organized
under the laws of the State of Delaware and registered with the
Commission as an open-end management investment company.\5\ The
investment adviser to the Fund is AdvisorShares Investments, LLC
(``Adviser''). Accuvest Global Advisers is the Fund's sub-adviser
(``Sub-Adviser'') and provides day-to-day portfolio management of the
Fund. Foreside Fund Services, LLC (``Distributor'') is the principal
underwriter and distributor of the Fund's Shares.
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    \3\ A Managed Fund Share is a security that represents an
interest in an investment company registered under the Investment
Company Act of 1940 (15 U.S.C. 80a) (``1940 Act'') organized as an
open-end investment company or similar entity that invests in a
portfolio of securities selected by its investment adviser
consistent with its investment objectives and policies. In contrast,
an open-end investment company that issues Investment Company Units,
listed and traded on the Exchange under NYSE Arca Equities Rule
5.2(j)(3), seeks to provide investment results that correspond
generally to the price and yield performance of a specific foreign
or domestic stock index, fixed income securities index or
combination thereof.
    \4\ The Commission approved NYSE Arca Equities Rule 8.600 and
the listing and trading of certain funds of the PowerShares Actively
Managed Exchange-Traded Funds Trust on the Exchange pursuant to Rule
8.600 in Securities Exchange Act Release No. 57619 (April 4, 2008)
73 FR 19544 (April 10, 2008) (SR-NYSEArca-2008-25). The Commission
also has approved listing and trading on the Exchange of a number of
actively managed funds under Rule 8.600. See, e.g., Securities
Exchange Act Release Nos. 57801 (May 8, 2008), 73 FR 27878 (May 14,
2008) (SR-NYSEArca-2008-31) (order approving Exchange listing and
trading of twelve actively-managed funds of the WisdomTree Trust);
60460 (August 7, 2009), 74 FR 41468 (August 17, 2009) (SR-NYSEArca-
2009-55) (order approving listing of Dent Tactical ETF); 63076
(October 12, 2010), 75 FR 63874 (October 18, 2010) (SR-NYSEArca-
2010-79) (order approving Exchange listing and trading of Cambria
Global Tactical ETF); 63802 (January 31, 2011), 76 FR 6503 (February
4, 2011) (SR-NYSEArca-2010-118) (order approving Exchange listing
and trading of the SiM Dynamic Allocation Diversified Income ETF and
SiM Dynamic Allocation Growth Income ETF).
    \5\ The Trust is registered under the 1940 Act. On May 9, 2011,
the Trust filed with the Commission Post-Effective Amendment No. 25
to Form N-1A under the Securities Act of 1933 (15 U.S.C. 77a), and
under the 1940 Act relating to the Fund (File Nos. 333-157876 and
811-22110) (``Registration Statement''). The description of the
operation of the Trust and the Fund herein is based, in part, on the
Registration Statement. In addition, the Commission has issued an
order granting certain exemptive relief to the Trust under the1940
Act. See Investment Company Act Release No. 29291 (May 28, 2010)
(File No. 812-13677) (``Exemptive Order'').
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    Commentary .06 to Rule 8.600 provides that, if the investment
adviser to the investment company issuing Managed Fund Shares is
affiliated with a broker-dealer, such investment adviser shall erect a
``fire wall'' between the investment adviser and the broker-dealer with
respect to access to information concerning the composition and/or
changes to such investment company portfolio.\6\ In addition,
Commentary .06 further requires that personnel who make decisions on
the open-end fund's portfolio composition must be subject to procedures
designed to prevent the use and dissemination of material nonpublic
information regarding the open-end fund's portfolio. Commentary .06 to
Rule 8.600 is similar to Commentary .03(a)(i) and (iii) to NYSE Arca
Equities Rule 5.2(j)(3); however, Commentary .06 in connection with the
establishment of a ``fire wall'' between the investment adviser and the
broker-dealer reflects the applicable open-end fund's portfolio, not an
underlying benchmark index, as is the case with index-based funds.
Neither the Adviser nor the Sub-Adviser is affiliated with a broker-
dealer. In the event (a) The Adviser or the Sub-Adviser becomes newly
affiliated with a broker-dealer, or (b) any new adviser or sub-adviser
becomes affiliated with a broker-dealer, it will implement a fire wall
with respect to such broker-dealer regarding access to information
concerning the composition and/or changes to the portfolio, and will be
subject to procedures designed to prevent the use and dissemination of
material non-public information regarding such portfolio.
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    \6\ An investment adviser to an open-end fund is required to be
registered under the Investment Advisers Act of 1940 (``Advisers
Act''). As a result, the Adviser and Sub-Adviser and their related
personnel are subject to the provisions of Rule 204A-1 under the
Advisers Act relating to codes of ethics. This Rule requires
investment advisers to adopt a code of ethics that reflects the
fiduciary nature of the relationship to clients as well as
compliance with other applicable securities laws. Accordingly,
procedures designed to prevent the communication and misuse of non-
public information by an investment adviser must be consistent with
Rule 204A-1 under the Advisers Act. In addition, Rule 206(4)-7 under
the Advisers Act makes it unlawful for an investment adviser to
provide investment advice to clients unless such investment adviser
has (i) Adopted and implemented written policies and procedures
reasonably designed to prevent violation, by the investment adviser
and its supervised persons, of the Advisers Act and the Commission
rules adopted thereunder; (ii) implemented, at a minimum, an annual
review regarding the adequacy of the policies and procedures
established pursuant to subparagraph (i) Above and the effectiveness
of their implementation; and (iii) designated an individual (who is
a supervised person) responsible for administering the policies and
procedures adopted under subparagraph (i) above.
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Description of the Fund
    According to the Registration Statement, the Fund will seek long-
term capital appreciation in excess of global equity benchmarks such as
the MSCI All Country World Index. The Fund will be a ``fund-of-funds''
that seeks to achieve its investment objective by investing primarily
in other U.S.-listed exchange-traded products (``Underlying ETPs'').\7\
The Sub-Adviser will seek to achieve the Fund's investment objective by
investing in Underlying ETPs that provide diversified exposure to
select economies around the world. The Sub-Adviser will rank countries
on a monthly basis using its proprietary country ranking model in order
to determine their relative attractiveness. The Sub-Adviser then will
endeavor to invest in Underlying ETPs that individually or in
combination correspond generally to the price and yield performance of
the specific countries (or regions) identified as most attractive by
the model. The Fund's portfolio will be invested only in countries with
the highest ranking as identified by the Sub-Adviser's proprietary
country ranking process.
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    \7\ Underlying ETPs include Investment Company Units (as
described in NYSE Arca Equities Rule 5.2(j)(3)); Portfolio
Depositary Receipts (as described in NYSE Arca Equities Rule 8.100);
Trust Issued Receipts (as described in NYSE Arca Equities Rule
8.200); Commodity-Based Trust Shares (as described in NYSE Arca
Equities Rule 8.201); Currency Trust Shares (as described in NYSE
Arca Equities Rule 8.202); Commodity Index Trust Shares (as
described in NYSE Arca Equities Rule 8.203); Trust Units (as
described in NYSE Arca Equities Rule 8.500); Managed Fund Shares (as
described in NYSE Arca Equities Rule 8.600), and closed-end funds.
The Underlying ETPs all will be listed and traded in the U.S. on
registered exchanges. The Underlying ETPs in which the Fund may
invest will primarily be index-based exchange-traded funds that hold
substantially all of their assets in securities representing a
specific index.
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    The Fund intends to invest primarily in the securities of
Underlying ETPs consistent with the requirements of Section 12(d)(1) of
the 1940 Act, or any rule, regulation or order of the Commission or
interpretation thereof. The Fund will only make such investments in
conformity with the requirements of Section 817 of the Internal Revenue
Code of 1986, as amended (``Code'').\8\
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    \8\ 26 CFR 1.817-5.
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    The Fund, through its investment in Underlying ETPs, may invest in
equity securities, which represent ownership interests in a company or
partnership and consist of common stocks, preferred stocks, warrants to
acquire common stock, securities convertible into common stock,
investments in master limited partnerships and American Depositary
Receipts (``ADRs''), as well as Global Depositary Receipts (``GDRs'',
together with ADRs, ``Depositary Receipts'').\9\ The Fund, through its

investment in Underlying ETPs, may invest in closed-end funds, pooled
investment vehicles that are registered under the 1940 Act and whose
shares are listed and traded on U.S. national securities exchanges. The
Fund, through its investment in Underlying ETPs, may invest in shares
of real estate investment trusts (``REITs''), which are pooled
investment vehicles that invest primarily in real estate or real estate
related loans.
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    \9\ ADRs and GDRs are certificates evidencing ownership of
shares of a foreign issuer. Depositary Receipts may be sponsored or
unsponsored. These certificates are issued by depositary banks and
generally trade on an established market in the United States or
elsewhere. The underlying shares are held in trust by a custodian
bank or similar financial institution in the issuer's home country.
The depositary bank may not have physical custody of the underlying
securities at all times and may charge fees for various services,
including forwarding dividends and interest and corporate actions.
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    The Sub-Adviser has developed its country ranking model around the
premise that in the long run, country-specific effects are the most
important drivers of global equity returns.
Investment Process and Portfolio Construction
    According to the Registration Statement, through its proprietary
country ranking model, the Sub-Adviser ranks countries on a monthly
basis in order to determine their relative merit.
    The Sub-Adviser will use a four step process to create its
portfolio allocations:
    1. Qualify Countries: In order to determine which countries are to
be included in the country ranking model, the Sub-Adviser will apply
two consistent criteria. All qualified countries (a) must be part of
the MSCI All Country World Index and (b) have a liquid Underlying ETP
that tracks the performance of its equity market.
    2. Analyze Factor Data: The Sub-Adviser will collect and analyze
monthly factor data on every qualified country in the model. Currently,
the Sub-Adviser uses nearly 40 factors that are classified within
fundamental (e.g., short-term earnings growth), momentum (e.g., 3 month
local price momentum), risk (e.g., change in 30-day standard
deviation), and valuation (e.g., earnings growth) factor groups.
    3. Rank Countries: Each month the Sub-Adviser will use the weighted
individual factor scores for each country in the model to assign each
country a relative attractiveness score. This monthly score will be
used to rank countries from most attractive to least attractive.
    4. Create Portfolio: The Sub-Adviser will create the portfolio
based on the underlying attractiveness score of each country in the
model. The most attractive 5-6 countries will receive allocations in
the portfolio, and the Sub-Adviser will purchase single country
Underlying ETPs that represent investments in those countries' equity
markets. No single country Underlying ETP may receive more than a 25%
allocation at purchase price.
    The Underlying ETPs in which the Fund will invest will primarily
hold substantially all of their assets in securities representing a
country (or region) specific index.
    The Underlying ETPs may invest in complex securities such as equity
options, index options, repurchase agreements, foreign currency
contracts, swaps, and futures contracts.
Other Investments
    To respond to adverse market, economic, political or other
conditions,\10\ the Fund may invest 100% of its total assets, without
limitation, in high-quality short-term debt securities and money market
instruments. The Fund may be invested in these instruments for extended
periods, depending on the Sub-Adviser's assessment of market
conditions. These short-term debt securities and money market
instruments include shares of other mutual funds, commercial paper,
certificates of deposit, bankers' acceptances, U.S. Government
securities,\11\ repurchase agreements \12\ and bonds that are BBB or
higher. The Fund may also invest a substantial portion of its assets in
such instruments at any time to maintain liquidity or pending selection
of investments in accordance with its policies.
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    \10\ Adverse market conditions would include large downturns in
the broad market value of two or more times current average
volatility, where the Sub-Adviser views such downturns as likely to
continue for an extended period of time. Adverse economic conditions
would include significant negative results in factors deemed
critical at the time by the Sub-Adviser, including significant
negative results regarding unemployment, Gross Domestic Product,
consumer spending or housing numbers. Adverse political conditions
would include events such as government overthrows or instability,
where the Sub-Adviser expects that such events may potentially
create a negative market or economic condition for an extended
period of time.
    \11\ Securities issued or guaranteed by the U.S. government or
its agencies or instrumentalities include U.S. Treasury securities,
which are backed by the full faith and credit of the U.S. Treasury
and which differ only in their interest rates, maturities, and times
of issuance.
    \12\ The Fund may enter into repurchase agreements with
financial institutions, which may be deemed to be loans. The Fund
follows certain procedures designed to minimize the risks inherent
in such agreements. These procedures include effecting repurchase
transactions only with large, well-capitalized and well-established
financial institutions whose condition will be continually monitored
by the Sub-Adviser. In addition, the value of the collateral
underlying the repurchase agreement will always be at least equal to
the repurchase price, including any accrued interest earned on the
repurchase agreement. In the event of a default or bankruptcy by a
selling financial institution, the Fund will seek to liquidate such
collateral. In addition, the Fund may enter into reverse repurchase
agreements without limit as part of the Fund's investment strategy.
Reverse repurchase agreements involve sales by the Fund of portfolio
assets concurrently with an agreement by the Fund to repurchase the
same assets at a later date at a fixed price.
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    Under normal market conditions, while the Fund will primarily
invest in Underlying ETPs, the Fund may, to a limited extent, invest
directly in other investments, as described below.
    The Fund, or the Underlying ETPs in which it invests, may invest in
U.S. government securities.
    The Fund may invest in exchange-traded notes (``ETNs''). ETNs are
debt obligations of investment banks which are traded on exchanges and
the returns of which are linked to the performance of market indexes.
    The Fund, or the Underlying ETPs in which it invests, may invest in
U.S. Treasury zero-coupon bonds. These securities are U.S. Treasury
bonds which have been stripped of their unmatured interest coupons, the
coupons themselves, and receipts or certificates representing interests
in such stripped debt obligations and coupons. Interest is not paid in
cash during the term of these securities, but is accrued and paid at
maturity.
    Diversification. The Fund may not (i) With respect to 75% of its
total assets, purchase securities of any issuer (except securities
issued or guaranteed by the U.S. Government, its agencies or
instrumentalities or shares of investment companies) if, as a result,
more than 5% of its total assets would be invested in the securities of
such issuer; or (ii) acquire more than 10% of the outstanding voting
securities of any one issuer. For purposes of this policy, the issuer
of the underlying security will be deemed to be the issuer of any
respective Depositary Receipt.\13\
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    \13\ The diversification standard is set forth in Section
5(b)(1) of the 1940 Act.
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    Concentration. The Fund may not invest 25% or more of its total
assets in the securities of one or more issuers conducting their
principal business activities in the same industry or group of
industries. This limitation does not apply to investments in securities
issued or guaranteed by the U.S. Government, its agencies or
instrumentalities, or shares of investment companies. The Fund will not
invest 25% or more of its total assets in any investment company that
so concentrates. For purposes of this policy, the issuer of the
underlying

security will be deemed to be the issuer of any respective Depositary
Receipt.\14\
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    \14\ See Form N-1A, Item 9. The Commission has taken the
position that a fund is concentrated if it invests more than 25% of
the value of its total assets in any one industry. See, e.g.,
Investment Company Act Release No. 9011 (October 30, 1975), 40 FR
54241 (November 21, 1975).
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    The Fund will seek to qualify for treatment as a regulated
investment company (``RIC'') under Subchapter M of the Code.\15\
---------------------------------------------------------------------------

    \15\ 26 U.S.C. 851. One of several requirements for RIC
qualification is that the Fund must receive at least 90% of the
Fund's gross income each year from dividends, interest, payments
with respect to securities loans, gains from the sale or other
disposition of stock, securities or foreign currencies, or other
income derived with respect to the Fund's investments in stock,
securities, foreign currencies and net income from an interest in a
qualified publicly traded partnership (``90% Test''). A second
requirement for qualification as a RIC is that the Fund must
diversify its holdings so that, at the end of each fiscal quarter of
the Fund's taxable year: (a) At least 50% of the market value of the
Fund's total assets is represented by cash and cash items, U.S.
Government securities, securities of other RICs, and other
securities, with these other securities limited, in respect to any
one issuer, to an amount not greater than 5% of the value of the
Fund's total assets or 10% of the outstanding voting securities of
such issuer; and (b) not more than 25% of the value of its total
assets are invested in the securities (other than U.S. Government
securities or securities of other RICs) of any one issuer or two or
more issuers which the Fund controls and which are engaged in the
same, similar, or related trades or businesses, or the securities of
one or more qualified publicly traded partnership (``Asset Test'').
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    The Fund will not purchase illiquid securities, including Rule 144A
securities, and loan participation interests.\16\ Further, in
accordance with the Exemptive Order, the Fund will not invest in
options, futures or swaps. The Fund's investments will be consistent
with the Fund's investment objective and will not be used to enhance
leverage.
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    \16\ A fund's portfolio security is illiquid if it cannot be
disposed of in the ordinary course of business within seven days at
approximately the value ascribed to it by the fund. See Investment
Company Act Release No. 14983 (March 12, 1986), 51 FR 9773 (March
21, 1986) (adopting amendments to Rule 2a-7 under the 1940 Act);
Investment Company Act Release No. 17452 (April 23, 1990), 55 FR
17933 (April 30, 1990) (adopting Rule 144A under the Securities Act
of 1933).
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    Except for Underlying ETPs that may hold non-U.S. issues, the Fund
will not otherwise invest in non-U.S. issues.
Net Asset Value (``NAV'')
    The Fund will calculate NAV by: (i) Taking the current market value
of its total assets; (ii) subtracting any liabilities; and (iii)
dividing that amount by the total number of Shares owned by
shareholders. The Fund will calculate NAV once each business day as of
the regularly scheduled close of trading on the New York Stock Exchange
(``NYSE'') (normally, 4 p.m., Eastern Time).
    In calculating NAV, the Fund generally will value investment
portfolios at market price. If market prices are unavailable or the
Adviser believes that they are unreliable, or when the value of a
security has been materially affected by events occurring after the
relevant market closes, the Fund will price those securities at fair
value as determined in good faith using methods approved by the Fund's
Board of Trustees.
Creations and Redemptions
    Creations and redemptions of Shares will occur in large specified
blocks of Shares, referred to as ``Creation Units.'' According to the
Registration Statement, the Shares of the Fund will be ``created'' at
their NAV by authorized participants only in block-size Creation Units
of 25,000 Shares or more. An authorized participant enters into an
agreement (``Participant Agreement'') with the Fund's Distributor or a
Depository Trust Company participant that has executed a Participant
Agreement with the Distributor, and deposits into the Fund a portfolio
of securities closely approximating the holdings of the Fund and a
specified amount of cash, together totaling the NAV of the Creation
Unit(s), in exchange for 25,000 Shares of the Fund (or multiples
thereof). Similarly, Shares can only be redeemed in Creation Units,
generally 25,000 Shares or more, principally in-kind for a portfolio of
securities held by the Fund and a specified amount of cash together
totaling the NAV of the Creation Unit(s). Shares will not be redeemable
from the Fund except when aggregated in Creation Units. The prices at
which creations and redemptions occur will be based on the next
calculation of NAV after an order is received in a form prescribed in
the Participant Agreement.
    The Shares will conform to the initial and continued listing
criteria under NYSE Arca Equities Rule 8.600. The Exchange represents
that, for initial and/or continued listing, the Fund will be in
compliance with Rule 10A-3 under the Exchange Act,\17\ as provided by
NYSE Arca Equities Rule 5.3. A minimum of 100,000 Shares will be
outstanding at the commencement of trading on the Exchange. The
Exchange will obtain a representation from the issuer of the Shares
that the NAV per Share will be calculated daily and that the NAV and
the Disclosed Portfolio will be made available to all market
participants at the same time.
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    \17\ 17 CFR 240.10A-3.
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Availability of Information
    The Fund's Web site (www.advisorshares.com), which will be publicly
available prior to the public offering of Shares, will include a form
of the prospectus for the Fund that may be downloaded. The Fund's Web
site will include additional quantitative information updated on a
daily basis, including, for the Fund, (1) Daily trading volume, the
prior business day's reported closing price, NAV and mid-point of the
bid/ask spread at the time of calculation of such NAV (``Bid/Ask
Price''),\18\ and a calculation of the premium and discount of the Bid/
Ask Price against the NAV, and (2) data in chart format displaying the
frequency distribution of discounts and premiums of the daily Bid/Ask
Price against the NAV, within appropriate ranges, for each of the four
previous calendar quarters. On each business day, before commencement
of trading in Shares in the Core Trading Session on the Exchange, the
Fund will disclose on its Web site the Disclosed Portfolio as defined
in NYSE Arca Equities Rule 8.600(c)(2) that will form the basis for the
Fund's calculation of NAV at the end of the business day.\19\
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    \18\ The Bid/Ask Price of the Fund will be determined using the
midpoint of the highest bid and the lowest offer on the Exchange as
of the time of calculation of the Fund's NAV. The records relating
to Bid/Ask Prices will be retained by the Fund and its service
providers.
    \19\ Under accounting procedures followed by the Fund, trades
made on the prior business day (``T'') will be booked and reflected
in NAV on the current business day (``T+1''). Accordingly, the Fund
will be able to disclose at the beginning of the business day the
portfolio that will form the basis for the NAV calculation at the
end of the business day.
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    On a daily basis, the Adviser will disclose on the Fund's Web site
for each portfolio security or other financial instrument of the Fund
the following information: Ticker symbol (if applicable), name of
security or financial instrument, number of shares or dollar value of
financial instruments held in the portfolio, and percentage weighting
of the security or financial instrument in the portfolio. The Web site
information will be publicly available at no charge.
    In addition, a basket composition file, which includes the security
names and share quantities required to be delivered in exchange for
Fund Shares, together with estimates and actual cash components, will
be publicly disseminated daily prior to the opening of the NYSE via the
National Securities Clearing Corporation. The basket represents one
Creation Unit of the Fund.
    Investors can also obtain the Trust's Statement of Additional
Information

(``SAI''), the Fund's Shareholder Reports, and its Form N-CSR and Form
N-SAR, filed twice a year. The Trust's SAI and Shareholder Reports are
available free upon request from the Trust, and those documents and the
Form N-CSR and Form N-SAR may be viewed on-screen or downloaded from
the Commission's Web site at www.sec.gov. Information regarding market
price and trading volume of the Shares is and will be continually
available on a real-time basis throughout the day on brokers' computer
screens and other electronic services. Information regarding the
previous day's closing price and trading volume information for the
Shares will be published daily in the financial section of newspapers.
Quotation and last sale information for the Shares will be available
via the Consolidated Tape Association (``CTA'') high-speed line, and,
for the Underlying ETPs, will be available from the national securities
exchanges on which they are listed. In addition, the Portfolio
Indicative Value, as defined in NYSE Arca Equities Rule 8.600 (c)(3),
will be widely disseminated by one or more major market data vendors at
least every 15 seconds during the Core Trading Session.\20\ The
dissemination of the Portfolio Indicative Value, together with the
Disclosed Portfolio, will allow investors to determine the value of the
underlying portfolio of the Fund on a daily basis and will provide a
close estimate of that value throughout the trading day.
---------------------------------------------------------------------------

    \20\ Currently, it is the Exchange's understanding that several
major market data vendors display and/or make widely available
Portfolio Indicative Values published on CTA or other data feeds.
---------------------------------------------------------------------------

    Additional information regarding the Trust and the Shares,
including investment strategies, risks, creation and redemption
procedures, fees, portfolio holdings disclosure policies, distributions
and taxes is included in the Registration Statement. All terms relating
to the Fund that are referred to, but not defined in, this proposed
rule change are defined in the Registration Statement.
Trading Halts
    With respect to trading halts, the Exchange may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the Shares of the Fund.\21\ Trading in Shares of the Fund
will be halted if the circuit breaker parameters in NYSE Arca Equities
Rule 7.12 have been reached. Trading also may be halted because of
market conditions or for reasons that, in the view of the Exchange,
make trading in the Shares inadvisable. These may include: (1) The
extent to which trading is not occurring in the securities and/or the
financial instruments comprising the Disclosed Portfolio of the Fund;
or (2) whether other unusual conditions or circumstances detrimental to
the maintenance of a fair and orderly market are present. Trading in
the Shares will be subject to NYSE Arca Equities Rule 8.600(d)(2)(D),
which sets forth circumstances under which Shares of the Fund may be
halted.
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    \21\ See NYSE Arca Equities Rule 7.12, Commentary .04.
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Trading Rules
    The Exchange deems the Shares to be equity securities, thus
rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities. Shares will trade on
the NYSE Arca Marketplace from 4 a.m. to 8 p.m. Eastern Time in
accordance with NYSE Arca Equities Rule 7.34 (Opening, Core, and Late
Trading Sessions). The Exchange has appropriate rules to facilitate
transactions in the Shares during all trading sessions. As provided in
NYSE Arca Equities Rule 7.6, Commentary .03, the minimum price
variation (``MPV'') for quoting and entry of orders in equity
securities traded on the NYSE Arca Marketplace is $0.01, with the
exception of securities that are priced less than $1.00 for which the
MPV for order entry is $0.0001.
Surveillance
    The Exchange intends to utilize its existing surveillance
procedures applicable to derivative products (which include Managed
Fund Shares) to monitor trading in the Shares. The Exchange represents
that these procedures are adequate to properly monitor Exchange trading
of the Shares in all trading sessions and to deter and detect
violations of Exchange rules and applicable federal securities laws.
    The Exchange's current trading surveillance focuses on detecting
securities trading outside their normal patterns. When such situations
are detected, surveillance analysis follows and investigations are
opened, where appropriate, to review the behavior of all relevant
parties for all relevant trading violations.
    The Exchange may obtain information via the Intermarket
Surveillance Group (``ISG'') from other exchanges that are members of
ISG or with which the Exchange has entered into a comprehensive
surveillance sharing agreement.\22\ All Underlying ETPs are listed on
national securities exchanges, all of which are members of ISG.
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    \22\ For a list of the current members of ISG, see
www.isgportal.org. The Exchange notes that not all components of the
Disclosed Portfolio for the Fund may trade on markets that are
members of ISG or with which the Exchange has in place a
comprehensive surveillance sharing agreement.
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    In addition, the Exchange also has a general policy prohibiting the
distribution of material, non-public information by its employees.
Information Bulletin
    Prior to the commencement of trading, the Exchange will inform its
Equity Trading Permit (``ETP'') Holders in an Information Bulletin
(``Bulletin'') of the special characteristics and risks associated with
trading the Shares. Specifically, the Bulletin will discuss the
following: (1) The procedures for purchases and redemptions of Shares
in Creation Unit aggregations (and that Shares are not individually
redeemable); (2) NYSE Arca Equities Rule 9.2(a), which imposes a duty
of due diligence on its ETP Holders to learn the essential facts
relating to every customer prior to trading the Shares; (3) the risks
involved in trading the Shares during the Opening and Late Trading
Sessions when an updated Portfolio Indicative Value will not be
calculated or publicly disseminated; (4) how information regarding the
Portfolio Indicative Value is disseminated; (5) the requirement that
ETP Holders deliver a prospectus to investors purchasing newly issued
Shares prior to or concurrently with the confirmation of a transaction;
and (6) trading information.
    In addition, the Bulletin will reference that the Fund is subject
to various fees and expenses described in the Registration Statement.
The Bulletin will discuss any exemptive, no-action, and interpretive
relief granted by the Commission from any rules under the Exchange Act.
The Bulletin will also disclose that the NAV for the Shares will be
calculated after 4 p.m. Eastern Time each trading day.
2. Statutory Basis
    The basis under the Exchange Act for this proposed rule change is
the requirement under Section 6(b)(5) \23\ that an exchange have rules
that are designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to remove
impediments to, and perfect the mechanism of a free and open market
and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

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

    The Exchange believes that the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices in that the
Shares will

be listed and traded on the Exchange pursuant to the initial and
continued listing criteria in NYSE Arca Equities Rule 8.600. The
Exchange has in place surveillance procedures that are adequate to
properly monitor trading in the Shares in all trading sessions and to
deter and detect violations of Exchange rules and applicable federal
securities laws. The Exchange may obtain information via ISG from other
exchanges that are members of ISG or with which the Exchange has
entered into a comprehensive surveillance sharing agreement. All
Underlying ETPs will be listed on national securities exchanges, all of
which are members of ISG, and the listing and trading of such
securities is subject to rules of the exchanges on which they are
listed and traded, as approved by the Commission. The Fund will not
purchase illiquid securities, including Rule 144A securities, and loan
participation interests. Further, the Fund will not invest in options,
futures or swaps. The Fund's investments will be consistent with the
Fund's investment objective and will not be used to enhance leverage.
Except for Underlying ETPs that may hold non-U.S. issues, the Fund will
not otherwise invest in non-U.S. issues.
    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the public interest in
that the Exchange will obtain a representation from the issuer of the
Shares that the NAV per Share will be calculated daily and that the NAV
and the Disclosed Portfolio will be made available to all market
participants at the same time. In addition, a large amount of
information is publicly available regarding the Fund and the Shares,
thereby promoting market transparency. Quotation and last sale
information for the Shares will be available via the CTA high-speed
line and, for the Underlying ETPs, will be available from the national
securities exchange on which they are listed. In addition, the
Portfolio Indicative Value will be widely disseminated at least every
15 seconds during the Core Trading Session by one or more major market
data vendors. On each business day, before commencement of trading in
Shares in the Core Trading Session on the Exchange, the Fund will
disclose on its Web site the Disclosed Portfolio that will form the
basis for the Fund's calculation of NAV at the end of the business day.
On a daily basis, the Adviser will disclose for each portfolio security
or other financial instrument of the Fund the following information:
Ticker symbol (if applicable), name of security or financial
instrument, number of Shares or dollar value of financial instruments
held in the portfolio, and percentage weighting of the security or
financial instrument in the portfolio. The Web site for the Fund will
include a form of the prospectus for the Fund and additional data
relating to NAV and other applicable quantitative information.
Moreover, prior to the commencement of trading, the Exchange will
inform its ETP Holders in an Information Bulletin of the special
characteristics and risks associated with trading the Shares. Trading
in Shares of the Fund will be halted if the circuit breaker parameters
in NYSE Arca Equities Rule 7.12 have been reached or because of market
conditions or for reasons that, in the view of the Exchange, make
trading in the Shares inadvisable. Trading in the Shares will be
subject to NYSE Arca Equities Rule 8.600(d)(2)(D), which sets forth
circumstances under which Shares of the Fund may be halted. In
addition, as noted above, investors will have ready access to
information regarding the Fund's holdings, the Portfolio Indicative
Value, the Disclosed Portfolio, and quotation and last sale information
for the Shares.
    The proposed rule change is designed to perfect the mechanism of a
free and open market and, in general, to protect investors and the
public interest in that it will facilitate the listing and trading of
additional types of actively-managed exchange-traded products that will
enhance competition among market participants, to the benefit of
investors and the marketplace. As noted above, the Exchange has in
place surveillance procedures relating to trading in the Shares and may
obtain information via ISG from other exchanges that are members of ISG
or with which the Exchange has entered into a comprehensive
surveillance sharing agreement. In addition, as noted above, investors
will have ready access to information regarding the Fund's holdings,
the Portfolio Indicative Value, the Disclosed Portfolio, and quotation
and last sale information for the Shares.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) As the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be 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-NYSEArca-2011-86 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2011-86. 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 Section, 100 F Street NE., Washington, DC 20549-1090, on
official business days between 10 a.m. and 3 p.m. Copies of the filing
will also be available for inspection and copying at the NYSE's
principal office and on its Internet Web site at www.nyse.com. 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-NYSEArca-2011-86 and should
be submitted on or before December 28, 2011.
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-31337 Filed 12-6-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13376-13377]
[FR Doc No: 2016-05683]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Peripheral and Central Nervous System Drugs Advisory Committee;
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Peripheral and Central Nervous System Drugs
Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 25, 2016, from 8
a.m. to 5:30 p.m. This meeting is a reschedule of a postponed meeting
announced in the Federal Register of December 18, 2015 (80 FR 79047),
originally scheduled for January 22, 2016.
    Location: College Park Marriott Hotel and Conference Center,
Chesapeake Ballroom, 3501 University Blvd. East, Hyattsville, MD 20783.
The conference center's telephone number is<PHONE_NUMBER>.
    Contact Person: Moon Hee V. Choi, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss new drug application (NDA)
206488,

eteplirsen injection for intravenous infusion, sponsored by Sarepta
Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy
(DMD) in patients who have a confirmed mutation of the DMD gene that is
amenable to exon 51 skipping.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 11, 2016. Oral presentations from the public will be scheduled
between approximately 12:40 p.m. and 2:40 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before April 1, 2016. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by April 4, 2016.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Moon Hee V. Choi at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 9, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-05683 Filed 3-10-16; 8:45 am]
 BILLING CODE 4164-01-P


Permitting Information Data Standard ( 04/ 08/ 2003)

Original Permitting Data Standard Permit Identification PermitName i entifier Context ProgramName Permit Administration Permit/ Permitted Feature Permit Application Completion Date Permit Issue Date Permit Effective Date Permit Expiration Date Permit Revocation Date Permit Termination Date Administrative or Legal Status Permitting Information Data Standard Facility/ Feature Characteristic I Reporting Condition 0 Facility/ Feature Characteristic Name I Report Recipient Name Facility/ Feature Characteristic Text 0 Facility/ Feature Characteristic Measure Name FacilityIFeature Characteristic Measure Value Facility/ Feature Characteristic Measure Unit Facility/ Feature Characteristic Statistical Basis of Measure Reporting Frequency Report Due Date Report Received Date Report Identifier Name Control Methodology Monitoring Condition Methodology Type I Monitoring Site Description D D D D B D Basis of Condition Condition Status Name Condition Start Date Condition End Date Text Condition Condition Trigger Text Numeric Condition Quantity Numeric Condition Unit of Measure Name Numeric Condition Statistical Basis Name Numeric Condition Qualifier ~~

References to Other Data Standards Contact Information Data Standard a Standard, the following data elements were removed and can be formation Data Standard fur such entities as:

0 Latitude/ Longitude Data Standard Permitted Entity Contact Information, e. g., mailing address, phone number, etc.

irements may require the identification of a monitoring location, which can be ,


[Federal Register Volume 81, Number 60 (Tuesday, March 29, 2016)]
[Notices]
[Pages 17520-17521]
[FR Doc No: 2016-06996]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77433; File No. SR-NYSEMKT-2016-38]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending Rule 13--
Equities To Expand the Availability of Self-Trade Prevention Modifiers
to Non-Algorithmically Entered Floor Broker Interest

March 23, 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 March 15, 2016, NYSE MKT LLC (the ``Exchange'' or ``NYSE MKT'')
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.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 13--Equities to expand the
availability of self-trade prevention (``STP'') modifiers to non-
algorithmically entered Floor broker interest. The proposed rule change
is available on the Exchange's Web site at www.nyse.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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to amend Rule 13--Equities (``Rule 13'') to
expand the availability of STP modifiers to non-algorithmically entered
e-Quotes, pegging e-Quotes, and g-Quotes.
    STP modifiers arEe [sic] designed to prevent two orders from the
same market participant identifier (``MPID'') assigned to a member
organization from executing against each other. The STP modifier on the
incoming order determines the interaction between two orders marked
with STP modifiers and whether the incoming or the resting order would
cancel. Both the buy and the sell order must include an STP modifier in
order to prevent a trade from occurring and to effect a cancel
instruction.\3\ Currently, under Rule 13(f)(3)(B), STP modifiers are
available for Limit Orders and Market Orders entered by off-Floor
participants, and for e-Quotes, pegging e-Quotes, and g-Quotes sent to
the matching engine by an algorithm on behalf of a Floor broker.
---------------------------------------------------------------------------

    \3\ See Rule 13(f)(3)(A); Securities Exchange Act Release No.
69098 (Mar. 11, 2013), 78 FR 16544 (Mar. 15, 2013) (SR-NYSEMKT-2013-
21).
---------------------------------------------------------------------------

    The Exchange amended Rule 13 to add STP modifiers in 2013.\4\ At
the time, the supporting technology was not compatible with Floor
broker systems and the Exchange chose to deploy STP modifiers for other
market participants while it performed the technical modifications
required for the use of STP modifiers for Floor brokers.\5\ The
Exchange later made STP modifiers available for algorithms used by
Floor brokers to route interest to the Exchange's matching engine, but
the technology supporting STP modifiers was still incompatible with all
Floor broker systems.\6\ Now that the technology to extend STP
modifiers to all Floor broker systems is available, the Exchange
proposes to delete the clause ``sent to the matching engine by an
algorithm on behalf of a Floor broker'' in Rule 13 to make STP
modifiers available for eQuotes, pegging e-Quotes, and g-Quotes without
limitation. No other changes are proposed to Rule 13.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 69098, 78 FR at
16544.
    \5\ See id.
    \6\ See Securities Exchange Act Release No. 69501 (May 2, 2013),
78 FR 26821 (May 8, 2013) (SR-NYSEMKT-2013-36).
---------------------------------------------------------------------------

    Because of the technology changes associated with this rule
proposal, the Exchange will announce the

implementation date in a Trader Update.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\7\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\8\ in particular, because it
is designed to prevent fraudulent and manipulative acts and practices,
promote just and equitable principles of trade, remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and protect investors and the public interest. In
particular, the Exchange believes that extending STP modifiers to non-
algorithmically entered Floor broker interest would provide Floor
brokers with an additional opportunity to prevent unintended executions
by Floor broker customers with themselves or the potential for ``wash
sales'' that may occur as a result of the velocity of trading in
today's high-speed marketplace, thereby removing impediments to and
perfecting the mechanism of a free and open market. The Exchange notes
that STP modifiers would not alleviate, or otherwise exempt, broker-
dealers from their best execution obligations.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposal would provide Floor brokers with an additional opportunity
to prevent unintended self-trades from occurring. The Exchange notes
that it operates in a highly competitive market in which market
participants can readily direct order flow to competing venues offering
similar functionality. Many competing venues offer similar
functionality to market participants. To this end, the Exchange is
proposing a market enhancement to provide greater protections from
inadvertent executions, and encourage market participants to trade on
the Exchange.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \9\ and Rule 19b-4(f)(6) thereunder.\10\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\12\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \13\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSEMKT-2016-38 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-NYSEMKT-2016-38. 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-NYSEMKT-2016-38, and should
be submitted on or before April 19, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Brent J. Fields,
Secretary.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2016-06996 Filed 3-28-16; 8:45 am]
 BILLING CODE 8011-01-P