[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48446-48447]
[FR Doc No: 2018-20776]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3197]

Further Testing of Donations That Are Reactive on a Licensed
Donor Screening Test for Antibodies to Hepatitis C Virus; Draft
Guidance for Industry; Availability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 or Agency) is announcing
the availability of a draft document entitled ``Further Testing of
Donations that are Reactive on a Licensed Donor Screening Test for
Antibodies to Hepatitis C Virus; Draft Guidance for Industry.'' The
draft guidance document provides blood establishments that collect
Whole Blood and blood components, including Source Plasma, with
recommendations for further testing of donations that are reactive on a
licensed donor screening test for antibodies to hepatitis C virus
(anti-HCV). The draft guidance also provides guidance to blood
establishments on how to report the implementation of these
recommendations. The draft guidance, when finalized, will update the
recommendations related to the use of an appropriate multiantigen
supplemental test contained in ``Guidance for Industry: `Lookback' for
Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification,
Further Testing, Product Disposition, and Notification of Transfusion
Recipients Based on Donor Test Results Indicating Infection with HCV''
dated December 2010.

DATES: Submit either electronic or written comments on the draft
guidance by December 24, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2018-D-3197 for ``Further Testing of Donations that are Reactive on
a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus;
Draft Guidance for Industry.'' 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), 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 the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: 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, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Further Testing of Donations that are Reactive on a Licensed Donor
Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for
Industry.'' The draft guidance provides blood establishments that
collect Whole Blood and blood components, including Source Plasma, with
recommendations for further testing of donations that are reactive on a
licensed donor screening test for anti-

HCV, as required under Sec.  610.40(e) (21 CFR 610.40(e)). The draft
guidance also provides guidance to blood establishments on how to
report the implementation of these recommendations.
    In accordance with Sec.  610.40(e), each donation, including
autologous donations, found to be reactive by a donor screening test
must be further tested using a licensed, approved, or cleared
supplemental test, when available. If no such supplemental test is
available, blood establishments must perform one or more licensed,
approved, or cleared tests as adequate and appropriate to provide
additional information concerning the reactive donor's infection status
(Sec.  610.40(e)). The draft guidance provides recommendations for
adequate and appropriate testing under Sec.  610.40(e), with the
licensed HCV NAT (nucleic acid test) and anti-HCV donor screening tests
that are currently available, to provide additional information
concerning the anti-HCV reactive donor's infection status. The draft
guidance, when finalized, will update the recommendations related to
the use of an appropriate multiantigen supplemental test contained in
``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV):
Product Quarantine, Consignee Notification, Further Testing, Product
Disposition, and Notification of Transfusion Recipients Based on Donor
Test Results Indicating Infection with HCV'' dated December 2010.
    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 further
testing of donations that are reactive on a licensed donor screening
test for antibodies to HCV. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338; and the collections of information in 21
CFR part 610 and 21 CFR 630.40 have been approved under OMB control
number 0910-0116.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: September 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20776 Filed 9-24-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58103-58106]
[FR Doc No: 2022-20636]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1874]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Perceptions of Prescription Drug Products With
Medication Tracking Capabilities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on a proposed study entitled ``Perceptions of
Prescription Drug Products With Medication Tracking Capabilities.''

DATES: Either electronic or written comments on the collection of
information must be submitted by November 22, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 22, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and

Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-1874 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Perceptions of Prescription Drug
Products With Medication Tracking Capabilities.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:
    Regarding the collection of information: JonnaLynn Capezzuto,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794, [email protected].
    For copies of the questionnaire: Amie O'Donoghue, Office of
Prescription Drug Promotion (OPDP) Research Team,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Perceptions of Prescription Drug Products With Medication Tracking
Capabilities

OMB Control Number 0910--NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the FD&C Act.
    The mission of the Office of Prescription Drug Promotion (OPDP) is
to protect the public health by helping to ensure that prescription
drug promotional material is truthful, balanced, and accurately
communicated so that patients and health care providers can make
informed decisions about treatment options. OPDP's research program
provides scientific evidence to help ensure that our policies related
to prescription drug promotion will have the greatest benefit to public
health. Toward that end, we have consistently conducted research to
evaluate the aspects of prescription drug promotion that are most
central to our mission, focusing in particular on three main topic
areas: advertising features, including content and format; target
populations; and research quality. Through the evaluation of
advertising features, we assess how elements such as graphics, format,
and the characteristics of the disease and product impact the
communication and understanding of prescription drug risks and
benefits. Focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience. Our focus on research quality aims at maximizing
the quality of research data through analytical methodology development
and investigation of sampling and response issues. This study will
inform the first topic area, advertising features.
    Because we recognize that the strength of data and the confidence
in the robust nature of the findings are improved through the results
of multiple converging studies, we continue to develop evidence to
inform our thinking. We evaluate the results from our studies within
the broader context of research and findings from other sources, and
this larger body of knowledge collectively informs our policies as well
as our research program. Our research is documented on our home page at
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research, which includes links
to the latest Federal Register notices and peer-reviewed publications
produced by our office.
    Patient non-adherence to medication regimens is a well-known
challenge in health care. The World Health Organization defines
adherence as the extent to which a person's behavior--taking
medication, following a diet,

and/or executing lifestyle changes--corresponds with agreed
recommendations from a health care provider (Ref. 1). It is estimated
that only half of all patients with chronic health conditions take
their medications as prescribed (Ref. 2), leading to as many as 100,000
preventable deaths and $100 billion in additional medical costs every
year (Ref. 3). Numerous solutions have been tried to improve adherence,
including resource-intensive approaches such as directly observed
therapy, which entails a trained observer watching as the patient takes
their medications (Ref. 4), and technology-supported tools for patients
(e.g., smartphone apps) (Ref. 5). As attention to the public health
issue of medication adherence has grown, OPDP has noted a corresponding
increase in the number of claims and presentations in prescription drug
promotion that focus, either directly or through implication, on a
product's potential to improve adherence to treatment regimens. Many of
these presentations include information about options and capabilities
available to help patients track their medication usage.
    One avenue that prescription drug sponsors have begun exploring to
track medication use includes the development of software that is
disseminated by or on behalf of the drug sponsor and accompanies one or
more of the sponsor's prescription drugs. This software is called
prescription drug use-related software.\1\ Studies exploring drug
products with prescription drug use-related software have been
conducted with medications to treat an array of chronic disorders,
including psychiatric disorders (Ref. 6), uncontrolled type 2 diabetes
(Ref. 7), end-stage renal disease requiring transplants (Ref. 8), and
opioid use among patients with acute fractures (Ref. 9).
---------------------------------------------------------------------------

    \1\ In 2018, FDA established a public docket to solicit public
comment on a proposed framework for regulating software applications
disseminated by or on behalf of drug sponsors for use with one or
more of their prescription drug products. See https://www.federalregister.gov/documents/2018/11/20/2018-25206/prescription-drug-use-related-software-establishment-of-a-public-docket-request-for-comments.
---------------------------------------------------------------------------

    In recent years, new technologies that capture data on medication-
taking behavior and drug administration have been employed. The
SureClick 2.0 autoinjector for the prescription medication ENBREL, for
example, has Bluetooth built into the white cap that covers the needle.
The autoinjector records initial removal of the cap and can send this
data via Bluetooth to a paired smartphone using a mobile app (Ref. 10).
Technology can also now support the use of ingestible sensors embedded
in pills that will emit a weak signal to a receiver (patch or lanyard)
worn by the patient after the pill has been swallowed (Ref. 11). This
data can then be transmitted to a paired mobile device and viewed by
the patient through a smartphone app (Ref. 12). Whether these new
technologies will have an impact on adherence is currently unknown.
    Very little is known about patient and health care provider
perceptions of products that track medication use or that work in
tandem with software to track medication use, with most commentaries
having been largely theoretical (Refs. 13, 14). The focus of the
present study is to explore patient and health care provider
perceptions of a fictitious prescription drug product that is
accompanied by software that is intended to track medication use.
    We have the following specific questions:
    Research questions:
    1. When prescription drug promotional communications include claims
about a product's ability to track medication use, do these claims
influence perceptions about the product's risks and/or benefits
(including its effect on medication adherence)?
    2. If the promotional claims about the product's ability to track
medication use are accompanied by a disclosure that describes what is
known about the effect of medication tracking on medication adherence,
does this have an influence on perceptions of the product's risks and/
or benefits (including its effect on medication adherence)?
    To complete this research, we propose the design in table 1, which
varies based on:
     Whether the fictitious prescription drug product includes
technology that tracks medication use;
     Whether the prescription drug promotional communication
includes a disclosure describing what is known about the tracking
technology's effect on medication adherence; and
     What the disclosure communicates about the tracking
technology's effect on medication adherence (positive effect shown, no
effect shown, or unknown effect).

                              Table 1--Proposed One-Way, Five-Level Design (1 x 5)
----------------------------------------------------------------------------------------------------------------
                                                 Claims about     Disclosure
                                                 existence of        about
            Experimental condition                medication     technology's         Content of disclosure
                                                   tracking        effect on
                                                  technology       adherence
----------------------------------------------------------------------------------------------------------------
1. Drug.......................................              No             No.  ................................
2. Drug + medication tracking technology......             Yes             No.  ................................
3. Drug + medication tracking technology + no              Yes             Yes  No data is available on the
 adherence data collected.                                                       technology's effect on
                                                                                adherence.
4. Drug + medication tracking technology +                 Yes             Yes  Data show the technology has no
 data show no effect on adherence.                                               effect on adherence.
5. Drug + medication tracking technology +                 Yes             Yes  Data show the technology has a
 data show a positive effect on adherence.                                       positive effect on adherence.
----------------------------------------------------------------------------------------------------------------
Note: Condition 5 is the only condition in which an adherence benefit has been demonstrated for the fictitious
  product. The evidence required to support a medication adherence claim is not the focus of this study, and the
  evidence will not be described in the disclosure.
Condition 2 is a control because the drug product does include medication tracking technology, but the
  promotional communication does not include a disclosure about the technology's effect on medication adherence.
  Condition 1 is a true control because the drug product does not include medication tracking technology.
  Comparisons between conditions 1 and 2 will show us the baseline of this issue, i.e., will indicate whether
  the fact that the drug product contains a tracking technology will alter perceptions of risks and benefits
  (including adherence).

    We will conduct pretests with 50 consumers who self-identify as
having been diagnosed with diabetes and 50 primary care physicians who
treat diabetes (both obtained from a web-based research vendor) to
ensure that

the questionnaire programming works as expected. For the main study, we
will then recruit 350 consumers who self-identify as having been
diagnosed with diabetes and 350 primary care physicians who treat
diabetes. Each participant will see one of five versions of a consumer
web page for a fictitious prescription diabetes treatment, as reflected
in table 1. They will answer a questionnaire designed to take no more
than 20 minutes regarding their perception of the product's benefits,
risks, and effect on adherence.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 2--Estimated Annual Reporting Burden 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
                   Activity                        Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent      respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener Consumers............................             680               1             680  .08 (5 minutes).........................            54.4
Screener Primary Care Physicians..............             680               1             680  .08 (5 minutes).........................            54.4
Pretest Consumers.............................              50               1              50  .33 (20 minutes)........................            16.5
Pretest Primary Care Physicians...............              50               1              50  .33 (20 minutes)........................            16.5
Main Study Consumers..........................             350               1             350  .33 (20 minutes)........................           115.5
                                               ---------------------------------------------------------------------------------------------------------
Main Study Primary Care Physicians............             350               1             350  .33 (20 minutes)........................           115.5
    Total.....................................  ..............  ..............  ..............  ........................................           372.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.

References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852) and
are available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also are available electronically at
https://www.regulations.gov. References without asterisks are not on
public display at https://www.regulations.gov because they have
copyright restriction. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff. FDA has verified the website addresses,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.

*1. World Health Organization, ``Adherence to Long-Term Therapies:
Evidence for Action,'' p. 3, 2003, available at https://apps.who.int/iris/handle/10665/42682, accessed May 16, 2022.
2. Frias, J., N. Virdi, P. Raja, et al., ``Effectiveness of Digital
Medicines to Improve Clinical Outcomes in Patients with Uncontrolled
Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-
Randomized Pilot Clinical Trial,'' Journal of Medical Internet
Research, vol. 19, Issue 7, Article e246, 2017, doi:10.2196/
jmir.7833.
3. Kleinsinger, F., ``The Unmet Challenge of Medication
Nonadherence,'' The Permanente Journal, vol. 22, Issue 3, Article
18-033, 2018, doi:10.7812/TPP/18-033.
4. Karumbi, J. and P. Garner, ``Directly Observed Therapy for
Treating Tuberculosis,'' Cochrane Database of Systematic Reviews,
Issue 5, Article CD003343, 2015, doi:10.1002/14651858.CD003343.pub4.
5. Dayer, L., S. Heldenbrand, P.O. Gubbins, et al., ``Smartphone
Medication Adherence Apps: Potential Benefits to Patients and
Providers,'' Journal of the American Pharmacy Association (2003),
vol. 53, Issue 2, pp. 172-181, 2013, doi:10.1331/JAPhA.2013.12202.
*6. FDA, ``FDA Approves Pill with Sensor That Digitally Tracks If
Patients Have Ingested Their Medication,'' FDA News Release,
November 13, 2017, available at https://www.fda.gov/news-events/press-announcements/fda-approves-pill-sensor-digitally-tracks-if-patients-have-ingested-their-medication, accessed May 16, 2022.
7. Browne, S.H., Y. Behzadi, and G. Littlewort, ``Let Visuals Tell
the Story: Medication Adherence in Patients with Type II Diabetes
Captured by a Novel Ingestion Sensor Platform,'' JMIR mHealth
uHealth, vol. 3, Issue 4, Article e108, 2015, doi:10.2196/
mhealth.4292.
8. Eisenberger, U., R.P. W[uuml]thrich, A. Bock, et al.,
``Medication Adherence Assessment: High Accuracy of the New
Ingestible Sensor System in Kidney Transplants,'' Transplantation,
vol. 96, Issue 3, pp. 245-250, 2013, doi:10.1097/
TP.0b013e31829b7571.
9. Chai, P.R., S. Carreiro, B.J. Innes, et al., ``Oxycodone
Ingestion Patterns in Acute Fracture Pain with Digital Pills,''
Anesthesia and Analgesia, vol. 125, Issue 6, pp. 2105-2112, 2017,
doi:10.1213/ANE.0000000000002574.
*10. Amgen Inc., ``Enbrel (etanercept): Highlights of Prescribing
Information,'' revised April 2021, available at https://
www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/enbrel/
enbrel_pi.pdf, accessed May 16, 2022.
*11. Reuter, E., '' `Smart Pill' Startup EtectRx Strikes Partnership
with Pear Therapeutics,'' Med City News, January 14, 2021, available
at https://medcitynews.com/2021/01/smart-pill-startup-etectrx-strikes-partnership-with-pear-therapeutics, accessed May 16, 2022.
12. The Medical Futurist, ``The Present and Future of Digital
Pills,'' July 21, 2020, available at https://medicalfuturist.com/the-present-and-future-of-digital-pills, accessed May 16, 2022.
13. George, C.E., ``Should a Psychiatrist Prescribe a Nanodrug to
Help Parents Monitor a Teen's Adherence?,'' AMA Journal of Ethics,
vol. 21, issue 4, article e317-323, 2019, doi:10.1001/
amajethics.2019.317.
*14. Yang, M., ``A Psychiatrist's Perspective on the Digital Pill,''
KevinMD.com, December 2, 2017, available at https://www.kevinmd.com/blog/2017/12/psychiatrists-perspective-digital-pill.html, accessed
May 16, 2022.

    Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20636 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 184 (Thursday, September 22, 2011)]
[Notices]
[Pages 58805-58806]
[FR Doc No: 2011-24307]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF11-10-000]

Western Area Power Administration; Notice of Filing

    Take notice that on September 7, 2011, the Western Area Power
Administration submitted its Rate Order No. WAPA-155 and certain Rate
Schedules concerning formula rates adjustment for Loveland Area
Projects transmission and Western Area Colorado Missouri Balancing
Authority ancillary services, for confirmation and approval on a final
basis effective

October 1, 2011, and ending September 30, 2016.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on October 7, 2011.

    Dated: September 15, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-24307 Filed 9-21-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 30 (Thursday, February 13, 2014)]
[Notices]
[Pages 8722-8723]
[FR Doc No: 2014-03139]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Gastroenterology and Urology Devices Panel of the Medical Devices
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: Gastroenterology and Urology Devices Panel of
the Medical Devices 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 March 20, 2014, from 8
a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel's telephone number is<PHONE_NUMBER>.
    Contact Person: Avena Russell, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1535, Silver Spring, MD 20993-0002<EMAIL_ADDRESS>
301-796-3805, 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: On March 20, 2014, the committee will discuss, make
recommendations, and vote on information regarding the humanitarian
device exemption (HDE) application for the XVIVO Perfusion System
(XPS\TM\) sponsored by XVIVO Perfusion, Inc. The proposed Indication
for Use for the XVIVO Perfusion System, as stated in the HDE, is as
follows:
    The XPS\TM\ is intended to be used with STEEN Solution for flushing
and temporary continuous normothermic machine perfusion of initially
unacceptable excised donor lungs during which time the function of the
lungs can be reassessed for transplantation.
    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
March 13, 2014. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before March 5, 2014. 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 March 6, 2014.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams at
<EMAIL_ADDRESS>or<PHONE_NUMBER> 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: February 7, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-03139 Filed 2-12-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Proposed Rules]
[Pages 71729-71731]
[FR Doc No: 2012-29171]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1222; Directorate Identifier 2012-NM-134-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede an existing airworthiness directive
(AD) that applies to certain Bombardier, Inc. Model DHC-8-400 series
airplanes. The existing AD currently requires a free-play check for
excessive free-play of the shaft swaged bearing installed in the
tailstock end of each elevator power control unit (PCU), and replacing
any PCU on which the bearing exceeds allowable limits with a
serviceable PCU. Since we issued that AD, we have determined that
additional airplanes are affected by the identified unsafe condition.
This proposed AD would add airplanes to the applicability in the
existing AD. We are proposing this AD to detect and correct excessive
freeplay of the swaged bearings, which could lead to excessive airframe
vibrations and difficulties in pitch control, and consequent loss of
controllability of the airplane.

DATES: We must receive comments on this proposed AD by January 18,
2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard,
Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>; fax 416-375-
4539; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Cesar Gomez, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
New York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-1222;
Directorate Identifier 2012-NM-134-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On June 14, 2011, we issued AD 2011-13-08, Amendment 39-16731 (76
FR 37253, June 27, 2011). That AD required actions intended to address
an unsafe condition on Bombardier, Inc. Model DHC-8-400 series
airplanes.
    Since we issued the existing AD (76 FR 37253, June 27, 2011), we
have determined that additional airplanes are affected by the
identified unsafe condition. Transport Canada Civil Aviation (TCCA),
which is the aviation authority for Canada, has issued Canadian
Airworthiness Directive CF-2010-28R1, dated June 12, 2012 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    Several reports have been received on the elevator power control
units (PCUs) where the shaft (tailstock) swaged bearing liners had
shown a higher than normal rate of wear. Investigation revealed that
the excessive wear was due to the paint contamination between the
bearing roller and bearing liner. The bearing paint contamination is
known to be abrasive and could seize the bearing.
    This condition, if not corrected, could lead to excessive
airframe vibrations and difficulties in aircraft pitch control.
    This [TCCA] directive mandates a free-play check of the shaft
swaged bearing installed in the elevator PCU tailstock end and
replacement of the shaft swaged bearings if excessive free-play is
found.

    This [TCCA] AD is revised to amend the applicability for DHC-8
Series 400 aeroplanes.

    The unsafe condition is loss of controllability of the airplane.
You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Bombardier Inc. has issued Service Bulletin 84-27-52, Revision A,
dated March 5, 2012. The actions described in this service information
are intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 81 products of U.S. registry.
    The actions that are required by AD 2011-13-08, Amendment 39-16731
(76 FR 37253, June 27, 2011), and retained in this proposed AD take
about 3 work-hours per product, at an average labor rate of $85 per
work hour. Based on these figures, the estimated cost of the currently
required actions is $255 per product.
    We estimate that it would take about 3 work-hours per product to
comply with the new basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of the proposed AD on U.S. operators for the added airplanes
to be $255 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 5 work-hours and require parts costing $33, for a cost of
$458 per product. We have no way of determining the number of products
that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing airworthiness directive
AD 2011-13-08, Amendment 39-16731 (76 FR 37253, June 27, 2011), and
adding the following new AD:

Bombardier, Inc.: Docket No. FAA-2012-1222; Directorate Identifier
2012-NM-134-AD.

(a) Comments Due Date

    We must receive comments by January 18, 2013.

(b) Affected ADs

    This AD supersedes AD 2011-13-08, Amendment 39-16731 (76 FR
37253, June 27, 2011).

(c) Applicability

    This AD applies to Bombardier, Inc. Model DHC-8-400, -401, and -
402 airplanes; certificated in any category; having serial numbers
(S/Ns) 4001 through 4334 inclusive, and 4336.

(d) Subject

    Air Transport Association (ATA) of America Code 27: Flight
controls.

(e) Reason

    This AD was prompted by reports of replacement of several
elevator power control units (PCUs) due to worn swaged bearings
located in the elevator PCU tailstock. We are issuing this AD to
detect and correct excessive freeplay of the swaged bearings, which
could lead to excessive airframe vibrations and difficulties in
pitch control, and consequent loss of controllability of the
airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Retained Free-Play Check With Revised Service Information

    This paragraph restates the requirements of paragraph (g) of AD
2011-13-08, Amendment 39-16731 (76 FR 37253, June 27, 2011), with
revised service information. For airplanes identified in paragraph
(c) of this AD, except airplanes having S/N 4305 through 4334
inclusive, and 4336: At the applicable time specified in paragraphs
(g)(1) and (g)(2) of this AD, perform a free-play check for any
shaft swaged bearing having part number (P/N) MS14103-7 that is
installed in the tailstock end of each elevator PCU (three PCUs per
elevator surface) having P/Ns<PHONE_NUMBER> and<PHONE_NUMBER>, in
accordance with paragraph 3.B., Part A, of Bombardier Service
Bulletin 84-27-52, dated May 25, 2010; or Revision A, dated March 5,
2012. As of the effective date of this AD, only Bombardier Service
Bulletin 84-27-52, Revision A, dated March 5, 2012, may be used to
accomplish the actions required by this paragraph.
    (1) For airplanes that have accumulated 8,000 or more total
flight hours as of August 1, 2011 (the effective date of AD 2011-13-
08, Amendment 39-16731 (76 FR 37253, June 27, 2011)): Within 2,000
flight hours after August 1, 2011 (the effective date of AD 2011-13-
08).

    (2) For airplanes that have accumulated less than 8,000 total
flight hours as of August 1, 2011 (the effective date of AD 2011-13-
08, Amendment 39-16731 (76 FR 37253, June 27, 2011)): Within 6,000
flight hours after August 1, 2011 (the effective date of AD 2011-13-
08), or before the accumulation of 10,000 total flight hours,
whichever occurs first.

(h) Retained Follow-on Action

    This paragraph restates the requirements of paragraph (h) of AD
2011-13-08, Amendment 39-16731 (76 FR 37253, June 27, 2011), with
revised service information. If, during the check required by
paragraph (g) of this AD, the bearing free-play is within the limits
specified in Bombardier Service Bulletin 84-27-52, dated May 25,
2010, or Revision A, dated March 5, 2012; no further action is
required by this AD. As of the effective date of this AD, only
Bombardier Service Bulletin 84-27-52, Revision A, dated March 5,
2012, may be used to accomplish the actions required by this
paragraph.

(i) Retained Corrective Actions

    This paragraph restates the requirements of paragraph (i) of AD
2011-13-08, Amendment 39-16731 (76 FR 37253, June 27, 2011), with
revised service information. If, during the check required by
paragraph (g) of this AD, the bearing free-play exceeds the limits
specified in Bombardier Service Bulletin 84-27-52, dated May 25,
2010; or Revision A, dated March 5, 2012: Before further flight,
replace the elevator PCU with a serviceable one, in accordance with
paragraph 3.B., Part B, of Bombardier Service Bulletin 84-27-52,
dated May 25, 2010; or Revision A, dated March 5, 2012. As of the
effective date of this AD, only Bombardier Service Bulletin 84-27-
52, Revision A, dated March 5, 2012, may be used to accomplish the
actions required by this paragraph.

(j) New Requirements

    For airplanes having S/N 4305 through 4334 inclusive, and 4336:
At the applicable time specified in paragraphs (j)(1) and (j)(2) of
this AD, perform a free-play check for any shaft swaged bearing
having P/N MS14103-7 that is installed in the tailstock end of each
elevator PCU (three PCUs per elevator surface), having P/Ns 390600-
1007 and<PHONE_NUMBER>, in accordance with paragraph 3.B., Part A, of
Bombardier Service Bulletin 84-27-52, Revision A, dated March 5,
2012.
    (1) For airplanes that have accumulated 8,000 or more total
flight hours as of the effective date of this AD: Within 2,000
flight hours after the effective date of this AD.
    (2) For airplanes that have accumulated less than 8,000 total
flight hours as of the effective date of this AD: Within 6,000
flight hours after the effective date of this AD, or before the
accumulation of 10,000 total flight hours, whichever occurs first.

(k) Corrective Actions

    During the check required by paragraph (j) of this AD, if the
bearing free-play is found to exceed the limits specified in
Bombardier Service Bulletin 84-27-52, Revision A, dated March 5,
2012: Before further flight, replace the elevator PCU with a
serviceable one, in accordance with paragraph 3.B., Part B, of
Bombardier Service Bulletin 84-27-52, Revision A, dated March 5,
2012.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the ACO, send it to Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax (516) 794-
5531. Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office. The AMOC approval letter must specifically
reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2010-28R1, dated June 12,
2012, and the service information specified in paragraphs (l)(1)(i)
and (l)(1)(ii) of this AD, for related information.
    (i) Bombardier Service Bulletin 84-27-52, dated May 25, 2010.
    (ii) Bombardier Service Bulletin 87-27-52, Revision A, dated
March 5, 2012.
    (2) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com. You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on November 21, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-29171 Filed 12-3-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28740-28742]
[FR Doc No: 2015-12030]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34- 74953; File No. SR-FINRA-2015-011]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Relating to the Reporting Requirements of FINRA
Rule 4530(a)(1)(H)

May 13, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 5, 2015, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by FINRA. FINRA has designated
the proposed rule change as constituting a ``non-controversial'' rule
change under paragraph (f)(6) of Rule 19b-4 under the Act,\3\ which
renders the proposal effective upon receipt of this filing by the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    FINRA is proposing to amend FINRA Rule 4530 (Reporting
Requirements) to provide an exception from the requirements of
paragraph (a)(1)(H) of the rule for dealings with a member or
associated person subject to statutory disqualification, if that member
or associated person has been approved (or is otherwise permitted
pursuant to FINRA rules and the federal securities laws) to be a member
or to be associated with a member.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    FINRA Rule 4530 requires members to report to FINRA specified
events, such as statutory disqualifications, and quarterly statistical
and summary information regarding written customer complaints.\4\ FINRA
uses the information for regulatory purposes to identify and initiate
investigations of firms, offices and associated persons that may pose a
risk.
---------------------------------------------------------------------------

    \4\ The specified events and customer complaint information must
be electronically reported to FINRA via an application on FINRA's
Firm Gateway.
---------------------------------------------------------------------------

    FINRA Rule 4530(a)(1)(H) requires a member to report whenever the
member itself or an associated person of the member is subject to a
``statutory disqualification'' as defined in the Act. The rule also
requires a member to report whenever the member or an associated person
of the member is involved in the sale of any financial instrument, the
provision of any investment advice or the financing of any such
activities with any person that is subject to a ``statutory
disqualification'' as defined in the Act. The report must include the
name of the person subject to the statutory disqualification and
details concerning the disqualification. In addition, the report must
be submitted to FINRA within 30 calendar days after the member knows or
should have known of the event.
    The definition of ``statutory disqualification'' under the Act
includes, among other events, findings by the SEC, Commodity Futures
Trading Commission or a self-regulatory organization that a person: (1)
Willfully violated the federal securities or commodities laws, or the
Municipal Securities Rulemaking Board rules; (2) willfully aided,
abetted, counseled, commanded, induced or procured such violations; or
(3) failed to supervise another person who commits violations of such
laws or rules.\5\ Thus, for instance, a member is currently required to
report under FINRA Rule 4530(a)(1)(H) each time the member is involved
in the sale of any financial instrument, such as participating in a
selling syndicate or selling group, with a member that has been found
to have willfully violated the federal securities laws. This would be
true even if the member that is subject to the willful violation has
been approved, or is otherwise permitted pursuant to FINRA rules and
the federal securities laws, to continue in membership notwithstanding
the disqualification.\6\
---------------------------------------------------------------------------

    \5\ See 15 U.S.C. 78c(a)(39).
    \6\ In general, persons subject to a statutory disqualification
would be required to obtain approval from FINRA to enter or remain
in the securities industry. A firm seeking to continue in
membership, notwithstanding the existence of such a
disqualification, generally would be required to file an MC-400A
application with FINRA. Similarly, a firm seeking to sponsor (i.e.,
employ or associate with) a disqualified person generally would be
required to file an MC-400 application with FINRA. However, as
described in Regulatory Notice 09-19 (April 2009), a firm would not
be required to file an application for approval for specific
disqualifying events. For instance, a firm that is subject to a
statutory disqualification based on a willful violation of the
federal securities laws would not be required to file an MC-400A
application with FINRA if the sanction is no longer in effect. Such
a firm would be permitted to continue in membership notwithstanding
the disqualification and without having to file an application with
FINRA for approval.
---------------------------------------------------------------------------

    For the following reasons, FINRA believes that there is no
regulatory value

in requiring a firm to report dealings with a disqualified member or
associated person that has been approved or is otherwise permitted to
be a member or associated with a member. First, FINRA is aware of the
statutory disqualification status of such members and associated
persons. Second, disqualified members and associated persons that have
been approved to be members or associated with members typically are
subject to special supervisory conditions, and FINRA periodically
examines them to ensure compliance with the supervisory conditions and
to monitor for other problems.
    Therefore, FINRA is proposing to amend Rule 4530(a)(1)(H) to
exclude activities with a disqualified member or associated person that
has been approved (or is otherwise permitted pursuant to FINRA rules
and the federal securities laws) to be a member or associated with a
member.
    FINRA has filed the proposed rule change for immediate
effectiveness. The implementation date of the proposed rule change will
be the date of filing.
 2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\7\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change will
further these purposes by eliminating unnecessary reporting of
information to FINRA and allowing FINRA to use its resources more
efficiently. FINRA also believes that the proposed rule change will
serve to reduce potential compliance burdens on firms without
compromising the regulatory information available to FINRA.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.
    The proposed rule change would reduce potential compliance burdens
on firms by eliminating the requirement under FINRA Rule 4530(a)(1)(H)
to report to FINRA each instance where a firm or an associated person
is involved in a financial activity with a disqualified member or
associated person that has been approved or is otherwise permitted to
be a member or associated with a member.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received from Members, Participants, or Others Written
comments were neither solicited nor received.

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

    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 for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6)
thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. FINRA has fulfilled this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \10\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii)\11\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. FINRA
requested the Commission to waive the 30-day operative delay so it can
implement the proposed rule change immediately. FINRA stated that
waiver of the operative delay would eliminate unnecessary reporting
requirements relating to dealings with members or associated persons
that are subject to a statutory disqualification where FINRA already
has access to information regarding the status of such persons and they
have either been approved or are otherwise permitted to be a member or
associated with a member. The Commission believes the waiver of the
operative delay is consistent with the protection of investors and the
public interest. Therefore, the Commission hereby waives the operative
delay and designates the proposal operative upon filing.\12\
---------------------------------------------------------------------------

    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2015-011 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2015-011. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet 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 FINRA. 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-FINRA-2015-011 and should be submitted
on or before June 9, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-12030 Filed 5-18-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Notices]
[Pages 21288-21290]
[FR Doc No: 2015-08796]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74719; File No. SR-C2-2015-008]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Change the Close of Trading Hours on the Last Day of Trading in
Expiring Quarterly Index Expirations

April 13, 2015.
    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 April 9, 2015 C2 Options Exchange, Incorporated (the
``Exchange'' or ``C2'') 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 Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend C2 Rule 6.1 (Days and Hours of
Business) to change the close of trading hours from 3:15 p.m. (Chicago
time) to 3:00 p.m. (Chicago time) on the last day of trading in
expiring Quarterly Index Expirations (``QIXs''). The text of the
proposed rule change is available on the Exchange's Web site (http://www.c2exchange.com/Legal/), at the Exchange's Office of the Secretary,
and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    This filing is based on existing Chicago Board Options Exchange,
Incorporated (``CBOE'') Rule 24.6.01.\5\
---------------------------------------------------------------------------

    \5\ CBOE Rule 24.6.01 provides, ``On the last trading day,
transactions in expiring Quarterly Index Expirations (QIXs) may be
effected on the Exchange during Extended Trading Hours and during
the Regular Trading Hours of 8:30 a.m. (Chicago time) to 3:00 p.m.
(Chicago time). This Interpretation and Policy .01 applies to all
outstanding expiring QIXs that expire at the end of the second
calendar quarter in 2009 and thereafter.'' See also Securities
Exchange Act Release Nos.[sic] 59676 (April 1, 2009), 74 FR 16018
(April 8, 2009) (Notice of Filing and Immediate Effectiveness of
Proposed Rule Change to Change the Close of Trading Hours on the
Last Day of Trading in Expiring Quarterly Index Expirations) (SR-
CBOE-2009-020).
---------------------------------------------------------------------------

    The majority of C2's Rules are the same as CBOE's Rules and were
adopted as part of the Securities and Exchange Commission's (``SEC'' or
``Commission'') order approving C2's application for registration as a
national securities exchange.\6\ CBOE Rule 24.9(c) permits CBOE to list
QIXs, which are cash-settled options on certain specified broad-based
indices that expire on the first business day of the month following
the end of a calendar quarter. QIXs trade simultaneously with, not
independent of, standard options on the same underlying index. QIXs are
subject to the same rules that currently govern the trading of standard
index options, including sales practice rules, margin requirements, and
floor trading proceedings. Contract terms for QIXs are similar to
traditional index options, with one general exception: the exercise
settlement value is based on the index value derived from the closing
prices of component stocks. In addition, the contract multiplier for
QIXs may be set at 500 rather than the customary 100. Positions in QIXs
are aggregated with option contracts on the same broad-based index and
are subject to the applicable overall position limit.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 61152 (December 10,
2009), 74 FR 66699, 66709-10 (December 16, 2009) (In the Matter of
the Application of C2 Options Exchange, Incorporated for
Registration as a National Securities Exchange Findings, Opinion,
and Order of the Commission (File No. 10-191). In the Order, the
Commission granted C2's request for exemption, pursuant to Section
36 of the Securities Exchange Act of 1934 (the ``Act''), from the
rule filing requirements of Section 19(b) of the Act with respect to
the rules that C2 proposed to incorporate by reference. The
exemption was conditioned upon C2 providing written notice to its
members whenever CBOE proposes to change a rule that C2 has
incorporated by reference. In the Order, the Commission stated its
belief that ``this exemption is appropriate in the public interest
and consistent with the protection of investors because it will
promote more efficient use of Commission and SRO resources by
avoiding duplicative rule flings based on simultaneous changes to
identical rules sought by more than one SRO.''
---------------------------------------------------------------------------

    C2 Chapter 24 provides, in relevant part, ``[t]he rules contained
in CBOE Chapter XXIV, as such rules may be in effect from time to time,
shall apply to C2 and are hereby incorporated into this Chapter.''
Accordingly, C2 may list QIXs. However, C2 Chapter 24, in relevant
part, expressly provides that certain Rules from CBOE Chapter XXIV
shall not apply to C2, including CBOE Rule 24.6 (Days and Hours of
Business). CBOE Rule 24.6 has a provision that permits the Exchange to
close trading in expiring QIXs at 3:00 p.m. (Chicago time), which C2
now proposes to add as new Interpretation and Policy .03 to C2 Rule
6.1.
    In support of this rule change, C2 states that generally, QIXs are
priced in the market based on corresponding futures values. On the last
day of trading, the closing prices of the component stocks (which are
used to derive the exercise settlement value) are known at 3 p.m.
(Chicago time) (or soon after) when the equity markets close. Despite
the fact that the exercise settlement value is fixed after 3 p.m.
(Chicago time), trading in expiring QIXs continues, however, for an
additional fifteen minutes until 3:15 p.m. (Chicago time) and are not
priced on corresponding futures values, but rather the known cash
value. At the same time, the prices of non-expiring QIX series continue
to move and be priced in response to changes in corresponding futures
prices.
    Because of the potential pricing divergence that could occur
between 3:00 and 3:15 p.m. on the final trading day in expiring QIXs
(e.g., switch from pricing off of futures to cash), the Exchange
believes that, in order to mitigate potential investor confusion, it is
appropriate to stop trading expiring QIX contracts at 3 p.m. (Chicago
time) on the last day of trading. C2 notes that, as of the date of this
filing, there are no outstanding QIXs currently listed for trading on
C2.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act \7\ and the rules and regulations thereunder and, in
particular, the requirements of Section 6(b) of the Act.\8\
Specifically, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \9\ requirements that the rules of
an exchange be designed to promote just and equitable principles of
trade, to prevent fraudulent and manipulative acts, to remove
impediments to and to perfect the mechanism for a free and open market
and a national market system, and, in general, to protect investors and
the public interest. Preventing continued trading in a product after
the exercise settlement value has been fixed eliminates potential
confusion and thereby protects investors and the public interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(1).
    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    This proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act. In this regard and as indicated above, the Exchange notes that
the rule change is based on existing CBOE Rules. Closing expiring QIXs
listed on C2 at 3:00 p.m. (Chicago time) on their last trading day will
align this practice with the existing practice on CBOE.

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

    The Exchange neither solicited nor received written comments on the
proposed rule change.

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

    Because the foregoing proposed rule change does not:
    A. Significantly affect the protection of investors or the public
interest;
    B. impose any significant burden on competition; and
    C. become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) of the

Act \10\ and Rule 19b-4(f)(6) \11\ thereunder. At any time within 60
days of the filing of the proposed rule change, the Commission
summarily may temporarily suspend such rule change if it appears to the
Commission that such action is necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act. If the Commission takes such action, the
Commission will institute proceedings to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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-C2-2015-008 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-C2-2015-008. 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-C2-2015-008 and should be
submitted on or before May 8, 2015.

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

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

Brent J. Fields,
Secretary.
[FR Doc. 2015-08796 Filed 4-16-15; 8:45 am]
 BILLING CODE 8011-01-P