[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92925-92927]
[FR Doc No: 2016-30565]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79560; File No. SR-CBOE-2016-081]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Move the Web Site and Vendor Through Which It
Sells and Disseminates Open and Close Volume Data on the CBOE

December 14, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 9, 2016, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.

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

    The text of the proposed rule change is available on the Exchange's
Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx),
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
    The Exchange creates volume data for each Exchange-listed option
that consists of opening buys and opening sells and closing buys and
closing sells.\3\ This opening and closing position data is subdivided
by origin code (i.e. customer or firm), and the customer data is
further subdivided by order size. The volume data is summarized by day
and series (symbol, expiration date, strike price, call or put). This
volume data is referred to herein as the ``Open/Close Data.'' A fee
schedule for the sale of Open/Close data was codified pursuant to a
filing noticed [sic] on January 8, 2007.\4\
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    \3\ An opening buy is a transaction to create or increase a long
position, and an opening sell is a transaction to create or increase
a short position. A closing buy is a transaction to close out a
short position, and a closing sell is a transaction to reduce or
eliminate a long position.
    \4\ See Securities and Exchange Act Release No. 55062 (January
8, 2007), 72 FR 2048 (January 17, 2007) (SR-CBOE-2006-088) [sic].
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Current Status
    Currently, Open/Close Data is provided to the vendor Intelligent
Financial Systems, LTD (``IFS''). IFS hosts and supports a Web site for
Market Data Express, LLC (``MDX''), a wholly owned subsidiary of the
Exchange. The MDX Web site (MarketDataExpress.com) offers the Open/
Close Data for sale to CBOE Trading Permit Holders (``TPHs'') and non-
TPHs. The fees that MDX assesses for the Open/Close Data are set forth
in a price list on MDX's Web site. TPHs and non-TPHs (together,
``Customers'') are charged the same fees for the Open/Close Data.
    Customers may purchase Open/Close Data on a subscription basis or
by ad hoc request. Daily Open/Close Data covering all CBOE securities
may be purchased by subscribing to the Daily Update service at a cost
of $600 per month. Subscribers to the Daily Update service receive
access to a daily data file via download from MDX's Web site.
    Historical Open/Close Data covering all CBOE securities may be
purchased on an ad hoc request basis. The charge for historical Open/
Close Data covering all CBOE securities is $7,200 per year for requests
for one to four years of data. Requests for five or more years of
historical Open/Close Data receive a 50% discount beginning with the
fifth year of data (i.e., MDX charges $7,200 for each of the first four
years of data and $3,600 for year five and each subsequent year of
data).
    Alternatively, a Customer may purchase historical Open/Close Data
on an individual CBOE security at a cost of $4.50 per security per
month. This data is received via download from MDX's Web site. A 50%
discount is applied for requests for ten or more years of data,
beginning with the tenth year of data.
Proposed Change
    Development, Web site hosting, and customer support relating to the
Open/Close data will be transferred to CBOE Livevol, LLC (``Livevol''),
a wholly owned subsidiary of the Exchange's parent company, CBOE
Holdings, Inc. CBOE will make Open/Close data available on the Livevol
Data Shop Web site (datashop.cboe.com). Customer support will be
transitioned from<EMAIL_ADDRESS>to<EMAIL_ADDRESS>    Open/Close data (and customer support) will be available on both
the MDX and Livevol Web sites during a transition period, which began
on November 10, 2016 and is ending no later than January 31, 2017. At
least two weeks prior to the end of the transition period, the Exchange
will announce the end of the transition period via circular. At the end
of the transition period, availability of the Open/Close data through
the MDX Web site will be retired and the Open/Close data will only be
available through the Livevol Web site. The fees related to the Open/
Close Data, including all applicable discounts, will remain the same
during the transition period and once Open/Close data is available only
through the Livevol Web site. The Exchange is changing the vendor and
web address through which the Open/Close Data is purchased and
disseminated and adopting a substantively identical fee schedule for
Open/Close data on Livevol. At the end of the transition period, Open/
Close data will be removed from the MDX fee schedule.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\5\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \6\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \7\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers. Finally, as discussed below, the Exchange believes
the proposed rule change is consistent with Section 6(b)(4)8 of the
Act, which requires that Exchange rules provide for the equitable
allocation of reasonable dues, fees, and other charges among its
Trading Permit Holders and other persons using its facilities.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
    \7\ Id.
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    The proposed rule change addresses where and how Open/Close data is
sold and disseminated. The Exchange believes the proposed rule change
is equitable and does not permit unfair discrimination between
customers, issuers, brokers or dealers, as the Open/Close Data will be
available to all customers, including TPHs and other persons purchasing
the data, at the same price and in the same manner. During and after
the transition, the fees currently in place will continue to apply.

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

    The Exchange does not believe the proposed rule change will impose
any burden on competition not necessary or appropriate in furtherance
of the purposes of the Act. The proposed rule will have no impact on
competition because there is no change to the fee. The proposed rule
change is merely changing the Web site on which the data will be
available for purchase and adopting a substantively identical fee
schedule for the new Web site.

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 comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \9\ and paragraph (f) of Rule 19b-4 \10\
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.
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2016-081 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-CBOE-2016-081. 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-CBOE-2016-081 and should be
submitted on or before January 10, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-30565 Filed 12-19-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Notices]
[Pages 3433-3437]
[FR Doc No: 2013-00761]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0921]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Submission
of Food and Drug Administration Adverse Event Reports and Other Safety
Information Using the Electronic Submission Gateway and the Safety
Reporting Portal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by
February 15, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0645.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Electronic Submission of Food and Drug Administration Adverse Event
Reports and Other Safety Information Using the Electronic Submission
Gateway and the Safety Reporting Portal--21 CFR 310.305, 314.80,
314.98, 314.540, 514.80, 600.80, 1271.350 and Part 803 (OMB Control
Number 0910-0645)--Revision

    The FDA Safety Reporting Portal (the SRP) (formerly referred to as
the MedWatch\Plus\ Portal and Rational Questionnaire) and the
Electronic Submission Gateway (ESG) are the Agency's electronic systems
for collecting, submitting, and processing adverse event reports and
other safety information for FDA-regulated products. To ensure the
safety and identify any risks, harms, or other dangers to health for
all FDA-regulated human and animal products, the Agency needs to be
informed whenever an adverse event, product quality problem, or product
use error occurs. This risk identification process is the first
necessary step that allows the Agency to gather the information
necessary to be able to evaluate the risk associated with the product
and take whatever action is necessary to mitigate or eliminate the
public's exposure to the risk.
    Some adverse event reports are required to be submitted to FDA
(mandatory reporting) and some adverse event reports are submitted
voluntarily (voluntary reporting). Requirements regarding mandatory
reporting of adverse events or product problems have been codified in
21 CFR parts 310, 314, 514, 600, 803 and 1271, specifically Sec. Sec.
310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 803.30, 803.40,
803.50, 803.53, 803.56 and 1271.350(a) (21 CFR 310.305, 314.80, 314.98,
314.540, 514.80, 600.80, 803.30, 803.40, 803.50, 803.53, 803.56 and
1271.350(a)). Many of the adverse event reports submitted to FDA are
currently filed in paper format using FDA Forms FDA 3500, 3500A, 1932,
and 1932a, approved under OMB control numbers 0910-0284 and 0910-0291.
This notice solicits comments on adverse event reports filed
electronically via the SRP and the ESG, approved under OMB control
number 0910-0645.

I. The FDA Safety Reporting Portal Rational Questionnaires

    FDA currently has OMB approval to receive three types of adverse
event reports electronically via the SRP using rational questionnaires.
FDA sought comments on the extension of OMB approval for the existing
three rational questionnaires, as well as comments on a proposed fourth
rational questionnaire that will be used for a new safety reporting
program being launched by the Center for Tobacco Products (CTP).

A. Reportable Food Registry Reports

    The Food and Drug Administration Amendments Act of 2007 (Pub. L.
110-85) (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) by creating a new section 417 (21 U.S.C. 350f), Reportable
Food Registry (RFR or the Registry). Section 417 of the FD&C Act
defines ``reportable food'' as an ``article of food (other than infant
formula or dietary supplements) for which there is a reasonable

probability that the use of, or exposure to, such article of food will
cause serious adverse health consequences or death to humans or
animals.'' (See section 417(a)(2) of the FD&C Act). The Secretary of
Health and Human Services (the Secretary) has delegated to the
Commissioner of FDA the responsibility for administering the FD&C Act,
including section 417. To further the development of the RFR, section
417 of the FD&C Act required FDA to establish an electronic portal by
which instances of reportable food (``RFR reports'') must be submitted
to FDA by responsible parties and may be submitted by public health
officials. A ``responsible party'' is the person who submits the
registration under section 415(a) of the FD&C Act (21 U.S.C. 350d) for
a food facility that is required to register under section 415(a), at
which such article of food is manufactured, processed, packed, or held.
The RFR electronic portal was established in 2009 as part of the
MedWatch\Plus\ Portal, now the SRP, and approved under OMB control
number 0910-0645.
    The Congressionally identified purpose of the RFR is to provide ``a
reliable mechanism to track patterns of adulteration in food [which]
would support efforts by the Food and Drug Administration to target
limited inspection resources to protect the public health'' (121 Stat.
965). The RFR reports are designed to enable FDA to quickly identify,
track, and remove from commerce an article of food (other than infant
formula and dietary supplements) for which there is a reasonable
probability that the use of, or exposure to, such article of food will
cause serious adverse health consequences or death to humans or
animals. FDA uses the information collected to help ensure that such
products are quickly and efficiently removed from the market to prevent
foodborne illnesses.
    On January 4, 2011, the President signed into law the FDA Food
Safety Modernization Act (Pub. L. 111-353) (the legislation or FSMA).
Section 211 of the legislation amended section 417 of the FD&C Act to
require FDA to collect additional information in the Agency's RFR
reports: (1) A description of the article of food; (2) affected product
identification codes, such as universal product code (UPC), stock
keeping unit, or lot or batch numbers sufficient for the consumer to
identify the article of food; (3) contact information for the
responsible party; and (4) any other information the Secretary
determines is necessary to enable a consumer to accurately identify
whether such consumer is in possession of the reportable food.
    Section 211 of FSMA also amended section 417 of the FD&C Act to
require FDA to generate one-page notices from RFR reports to post on
www.fda.gov for grocery stores to display to consumers when a
reportable food has been sold. The amendment made by section 211 of
FSMA took effect June 4, 2012, 18 months after the date of enactment.
To comply with this statutory deadline, FDA initially obtained OMB
approval of the additional collection of information requirements under
the emergency processing provisions of the PRA under OMB control number
0910-0709. The new data improves the RFR's effectiveness in carrying
out its purpose of tracking patterns of adulteration in food and
supporting FDA's efforts to target limited inspection resources to
protect the public health.
    Table 1 of this document, entitled ``New Data Elements for RFR
Reports,'' presents the new data elements added by FDA to RFR Reports
on June 4, 2012.

               Table 1--New Data Elements for RFR Reports
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                                   Mandatory or         Authority if
          Field text              optional input         mandatory
------------------------------------------------------------------------
Reason this food is reportable  Mandatory........  Section 417(e)(4) of
 (agent).                                           the FD&C Act.
What did your investigation     Mandatory........  Section 417(e)(5) of
 identify as the root cause of                      the FD&C Act.
 the problem (if you were
 required to conduct an
 investigation under section
 417(d)(1)(B) of the FD&C
 Act)?
How did you determine which     Mandatory........  Section 417(e)(4) and
 products/lots/batches were                         (5) of the FD&C Act.
 affected?
To the best of your knowledge,  Mandatory........  Section 417(e)(6) of
 has all of the reportable                          the FD&C Act.
 food been removed from
 commerce?
What corrective actions have    Optional.........
 been taken to prevent future
 occurrences?
Product commodity type........  Mandatory........  Section 417(e)(3) of
                                                    the FD&C Act.
Manufacturing/production        Mandatory........  Section 417(e)(3) and
 date(s).                                           (4) of the FD&C Act.
Use-by dates, if any, or        Mandatory........  Section 417(e)(7) of
 approximate shelf life.                            the FD&C Act.
Was product treated to reduce   Mandatory (but     Section 417(e)(3) and
 microorganisms?                 conditional).      (4) of the FD&C Act.
Microbial reduction treatment   Mandatory (but     Section 417(e)(3) and
 details.                        conditional).      (4) of the FD&C Act
                                                    (Conditional for
                                                    microbial hazards
                                                    only and only after
                                                    ``yes'' answer to
                                                    ``Was product
                                                    treated to reduce
                                                    microorganisms?'').
Is a bacterial isolate          Mandatory (but     Section 417(e)(4) of
 available for collection?       conditional).      the FD&C Act
                                                    (Conditional for
                                                    microbial hazards
                                                    only.)
Animal species intended for...  Mandatory........  Section 417(e)(3) and
                                                    (4) of the FD&C Act.
Life stage of animal intended   Mandatory........  Section 417(e)(3) and
 for.                                               (4) of the FD&C Act.
Have you notified all           Optional.........
 immediate previous sources of
 this reportable food?
Have you notified all           Mandatory........  Section 417(e)(6) of
 immediate subsequent                               the FD&C Act.
 recipients of this reportable
 food?
------------------------------------------------------------------------

    In this request for extension of OMB approval, FDA is combining the
burden hours associated with OMB control number 0910-0709 with the
burden hours approved under this OMB control number (0910-0645).

B. Reports Concerning Experience With Approved New Animal Drugs

    Section 512(l) of the FD&C Act (21 U.S.C. 360b(l)) and Sec.
514.80(b)) require applicants of approved new animal drug

applications (NADAs) and approved abbreviated new animal drug
applications (ANADAs) to report adverse drug experiences and product/
manufacturing defects.
    This continuous monitoring of approved NADAs and ANADAs affords the
primary means by which FDA obtains information regarding potential
problems with the safety and efficacy of marketed approved new animal
drugs as well as potential product/manufacturing problems. Postapproval
marketing surveillance is important because data previously submitted
to FDA may no longer be adequate, as animal drug effects can change
over time and less apparent effects may take years to manifest.
    If an applicant must report adverse drug experiences and product/
manufacturing defects and chooses to do so using the Agency's paper
forms, the applicant is required to use Form FDA 1932, ``Veterinary
Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.''
Periodic drug experience reports and special drug experience reports
must be accompanied by a completed Form FDA 2301, ``Transmittal of
Periodic Reports and Promotional Material for New Animal Drugs'' (see
Sec.  514.80(d)). Form FDA 1932a, ``Veterinary Adverse Drug Reaction,
Lack of Effectiveness or Product Defect Report'' allows for voluntary
reporting of adverse drug experiences or product/manufacturing defects.
Collection of information using existing paper forms FDA 2301, 1932,
and 1932a is approved under OMB control number 0910-0284.
Alternatively, an applicant may choose to report adverse drug
experiences and product/manufacturing defects electronically.
Collection of this information electronically was approved in 2010
under OMB control number 0910-0645. The electronic submission data
elements to report adverse drug experiences and product/manufacturing
defects electronically remain unchanged in this request for extension
of OMB approval.

C. Pet Food Early Warning System

    Section 1002(b) of FDAAA directed the Secretary to establish an
early warning and surveillance system to identify adulteration of the
pet food supply and outbreaks of illness associated with pet food. As
part of the effort to fulfill that directive, the Secretary tasked FDA
with developing the instrument that would allow consumers to report
voluntarily adverse events associated with pet food.
    FDA developed the Pet Food Early Warning System rational
questionnaire as a user-friendly data collection tool, to make it easy
for the public to report a safety problem with pet food. The Pet Food
Early Warning System is designed to identify adulteration of the pet
food supply and outbreaks of illness associated with pet food to enable
FDA to quickly identify, track and remove from commerce such articles
of food. FDA uses the information collected to help ensure that such
products are quickly and efficiently removed from the market to prevent
foodborne illnesses. In 2010, OMB approved the Pet Food Early Warning
System component of the SRP under OMB control number 0910-0645, and FDA
launched the rational questionnaire by which consumers may
electronically report adverse events associated with pet food. The
electronic submission data elements to report adverse events associated
with pet food remain unchanged in this request for extension of OMB
approval.

D. Voluntary Tobacco Product Adverse Event and Product Problem Reports

    As noted, this notice seeks comments on a proposed fourth rational
questionnaire that will be used for a new safety reporting program
being launched by the CTP to collect voluntary tobacco product adverse
event and product problem reports.
    FDA has broad legal authority under the FD&C Act to protect the
public health. CTP's mission is to protect Americans from tobacco-
related death and disease by regulating the manufacture, distribution,
and marketing of tobacco products and by educating the public,
especially young people, about tobacco products and the dangers their
use poses to themselves and others. The Family Smoking Prevention and
Tobacco Control Act of 2009 (Pub. L. 111-31) (Tobacco Control Act)
amended the FD&C Act by creating a new section 909 (21 U.S.C. 387i,
Records and Reports on Tobacco Products). Section 909(a) of the FD&C
Act (21 U.S.C. 387i(a)) authorizes FDA to establish regulations with
respect to mandatory adverse event reports associated with the use of a
tobacco product. At this time, FDA is proposing to collect voluntary
adverse event reports associated with the use of tobacco products from
interested parties such as health care providers, researchers,
consumers and other users of tobacco products. Information collected in
voluntary adverse event reports will contribute to CTP's ability to be
informed of, and assess the real consequences of, tobacco product use.
The need for this collection of information derives from our objective
to obtain current, timely, and policy-relevant information to carry out
our statutory functions. The FDA Commissioner is authorized to
undertake this collection as specified in section 1003(d)(2) of the
FD&C Act (21 U.S.C. 393(d)(2)).
    CTP currently receives adverse event and product problem reports
primarily via paper MedWatch forms, approved under OMB control number
0910-0291. MedWatch forms, although recently updated with field labels
and descriptions to better clarify for reporters the range of
reportable products, including tobacco products, do not specifically
include questions relevant for the analysis of adverse events or
product problems related to tobacco products. The proposed voluntary
tobacco product adverse event and product problem rational
questionnaire will include these specific questions. The questionnaire
evolved with input from a National Institutes of Health team of human-
factors experts, from other regulatory Agencies, and with extensive
input from consumer advocacy groups and the general public. FDA is also
working with the FDA Internet team to follow the Department of Health
and Human Services Internet guidelines for Web design. FDA has and will
continue to reach out to professional organizations and community
interest groups to collect feedback during the user acceptance testing.
The rational questionnaire will provide the user with detailed
navigation instructions to include drop-down menus, lists of values,
controlled vocabularies, and mouse over help where possible. In
addition, CTP will issue guidance for the rational questionnaire.
Finally, we note that users who are unable to submit reports using the
electronic system will still be able to provide their information by
paper form (by mail or FAX) or telephone.
    The proposed voluntary tobacco product adverse event and product
problem rational questionnaire requests the following information:
Introductory Information About the Submission
     Whether the submission is a new report, or a followup or
amendment to a previously transmitted report.
Information About the Sender and the Affected Person
     Unless the sender wishes to remain anonymous, the name of
and contact information for the person sending the report; and
     Unless the affected person wishes to remain anonymous, the
name, contact

information, and demographic information for the person who experienced
the adverse event.
Details of Any Attachments
     The type of attachment and a description of it.
Tobacco Product Details
     Information about the product that is the subject of the
report, such as the brand name, product name, UPC, and a description of
the tobacco product or component;
     Information about the product or component purchase date
and location; and
     Information about the manufacturer of the product or
component.
Problem Summary
     Information about the product problem or adverse event,
such as the date and duration of the problem or adverse event, a
description of the use of the product, a description of the product
problem or adverse event, and a description of the main symptoms or
health problems.
     Information about the medical treatment received by the
affected person, such as whether the person was taken to an emergency
facility, a description of any medical testing or treatment performed,
and the results of any tests;
     Information about any similar product problems or adverse
events previously had by the affected person; and
     In the event of death, the date of death and the reported
cause of death.
Other Products Used
     Information about the affected person's use of other
tobacco products, alcohol, prescription medications, over-the-counter
medications, vitamins, or dietary supplements.
    The rational questionnaire will capture tobacco-specific adverse
event and product problem information from voluntary reporting entities
such as health care providers, researchers, consumers, and other users
of tobacco products. To carry out its responsibilities, FDA needs to be
informed when an adverse event, product problem, or error with use is
suspected or identified. When FDA receives tobacco-specific adverse
event and product problem information, it will use the information to
assess and evaluate the risk associated with the product, and then FDA
will take whatever action is necessary to reduce, mitigate, or
eliminate the public's exposure to the risk through regulatory and
public health interventions.
    In the Federal Register of September 14, 2012 (77 FR 56847), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.

II. Information Collection Burden Estimate

    Description of respondents: The respondents to this collection of
information include all persons submitting mandatory or voluntary
adverse event reports electronically to FDA via the ESG or the SRP.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                        Average
                        Activity                           FDA Form No.      Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary Adverse Event Report via the SRP (Other than              3800           1,513               1           1,513             0.6             908
 RFR Reports)...........................................                                                                    (36 minutes)
Mandatory Adverse Event Report via the SRP (Other than              3800             636               1             636               1             636
 RFR Reports)...........................................
Mandatory Adverse Event Report via the ESG (Gateway-to-             3800       1,491,228               1       1,491,228             0.6         894,737
 Gateway transmission)..................................                                                                    (36 minutes)
Mandatory and Voluntary RFR Reports via the SRP.........            3800           1,413               1           1,413             0.6             848
                                                                                (36 minutes)
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............         897,129
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The Agency's estimate of the number of respondents and the total
annual responses in table 2, Estimated Annual Reporting Burden, is
based primarily on mandatory and voluntary adverse event reports
electronically submitted to the Agency. The estimated total annual
responses are based on initial reports. Followup reports, if any, are
not counted as new reports. Based on its experience with adverse event
reporting, FDA estimates that it will take a respondent 0.6 hour to
submit a voluntary adverse event report via the SRP, 1 hour to submit a
mandatory adverse event report via the SRP, and 0.6 hour to submit a
mandatory adverse event report via the ESG (gateway-to-gateway
transmission). Both mandatory and voluntary RFR reports must be
submitted via the SRP. FDA estimates that it will take a respondent 0.6
hour to submit a RFR report, whether the submission is mandatory or
voluntary.
    Voluntary adverse event reports submitted via the SRP (other than
RFR Reports) include reports associated with pet food (the Pet Food
Early Warning System) and the new tobacco product adverse event and
product problem reports. The Center for Veterinary Medicine (CVM)
received 845 pet food adverse event reports in 2010; 1,293 reports in
2011; and 471 reports in the first 4 months of 2012, and estimates that
for the full 12 months of 2012 it will receive 1,413 reports. Based on
this experience, CVM estimates that it will receive, on average, 1,413
pet food reports annually over the next 3 years. CTP estimates that it
will receive approximately 100 voluntary tobacco product adverse event
and product problem reports annually, after implementation of
electronic reporting. CTP received 27 reports in 2010, 30 reports in
2011, and 22 reports in the first half of 2012, and estimates that for
the full 12 months of 2012 it will receive over 40 reports. Based on
this experience and an expectation that reporting will increase once
electronic

reporting is launched, CTP estimates that it will receive, on average,
100 voluntary adverse event and product problem reports annually over
the next 3 years. Thus, FDA estimates that over the next 3 years it
will receive annually 1,513 voluntary adverse event reports submitted
via the SRP, with a burden of 907.8 hours, rounded to 908 hours, as
reported in table 2, row 1 (1,413 + 100 = 1,513).
    Mandatory adverse event reports submitted via the SRP (other than
RFR Reports) include reports of adverse animal drug experiences and
product/manufacturing defects associated with approved NADAs and
ANADAs. CVM received 144 such adverse event reports in 2010, 537
reports in 2011, and 212 reports in the first four months of 2012, and
estimates that for the full 12 months of 2012 it will receive 636
reports. Based on this experience, CVM estimates that it will receive,
on average, 636 reports of adverse drug experiences and product/
manufacturing defects associated with approved NADAs and ANADAs
annually over the next 3 years. Thus, FDA estimates that over the next
3 years it will receive annually 636 mandatory adverse event reports
submitted via the SRP, with a burden of 636 hours, as reported in table
2, row 2.
    Adverse event reports submitted via the ESG include reports of
adverse experiences related to drugs, biological products, and medical
devices, as well as, adverse animal drug experiences and product/
manufacturing defects associated with approved NADAs and ANADAs. FDA
received 586,229 such adverse event reports in 2010; 850,161 reports in
2011; and 497,076 reports in the first 4 months of 2012; and estimates
that for the full 12 months of 2012 it will receive 1,491,228 reports.
Based on this experience, FDA estimates that it will receive, on
average, 1,491,228 adverse event reports submitted via the ESG, with a
burden of 894,736.8 hours, rounded to 894,737 hours, as reported in
table 2, row 3.
    FDA estimates that over the next 3 years it will receive annually
1,413 mandatory and voluntary RFR Reports submitted via the SRP, as
reported in table 2, row 4. The Center for Food Safety and Applied
Nutrition (CFSAN) received 845 such adverse event reports in 2010;
1,293 reports in 2011; and 471 reports in the first four months of
2012; and estimates that for the full 12 months of 2012 it will receive
1,413 reports. Based on this experience, CFSAN estimates that it will
receive, on average, 1,413 mandatory and voluntary RFR Reports
submitted via the SRP annually over the next 3 years, with a burden of
847.8 hours, rounded to 848 hours, as reported in table 2, row 4.
    The burden hours required to complete paper FDA reporting forms
(Forms FDA 3500, 3500A, 1932, and 1932a) are reported under OMB control
numbers 0910-0284 and 0910-0291.
    While FDA does not charge for the use of the ESG, FDA requires
respondents to obtain a public key infrastructure certificate in order
to set up the account. This can be obtained in-house or outsourced by
purchasing a public key certificate that is valid for 1 year to 3
years. The certificate typically costs from $20 to $30.

    Dated: January 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00761 Filed 1-15-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 71 (Wednesday, April 13, 2016)]
[Notices]
[Pages 21858-21859]
[FR Doc No: 2016-08409]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-1763-002; ER10-1765-002; ER10-1766-002; ER10-
1769-002; ER10-1767-002; ER10-1532-002; ER10-1541-003; ER10-1642-004;
ER10-1529-003; ER13-2349-001; ER13-2350-001.
    Applicants: Entergy Arkansas, Inc., Entergy Louisiana, LLC, Entergy
Mississippi, Inc., Entergy New Orleans, Inc., Entergy Texas, Inc.,
Entergy Nuclear Palisades, LLC, Entergy Power, LLC, EWO Marketing, LLC,
Northern Iowa Windpower, LLC, EAM Nelson Holding, LLC, RS Cogen, LLC.
    Description: Notice of Change in Status of the Entergy Central MBR
Utilities.
    Filed Date: 4/1/16.
    Accession Number: 20160401-5475.
    Comments Due: 5 p.m. ET 4/22/16.

    Docket Numbers: ER15-746-004.
    Applicants: RC Cape May Holdings, LLC.
    Description: Compliance filing: RC Cape May 90-day Informational
Filing to be effective 3/1/2016.
    Filed Date: 3/3/16.
    Accession Number: 20160303-5110.
    Comments Due: 5 p.m. ET 4/19/16.

    Docket Numbers: ER16-1342-000.
    Applicants: Arizona Public Service Company.
    Description: Notice of Cancellation, Request for Approval of
Accounting and Rate Treatment, and Request for Expedited Action and
Shortened Comment Period of Arizona Public Service Company.
    Filed Date: 4/1/16.
    Accession Number: 20160401-5485.
    Comments Due: 5 p.m. ET 4/11/16.

    Docket Numbers: ER16-1344-000.
    Applicants: Seward Generation, LLC.
    Description: Baseline eTariff Filing: Notice of Sucession to be
effective 4/4/2016.
    Filed Date: 4/4/16.
    Accession Number: 20160404-5260.
    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: ER16-1345-000.
    Applicants: Virginia Electric and Power Company, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: VEPCO submits 3 Wholesale
Distribution Service Agreements Nos. 4433, 4434, 4435 to be effective
12/26/2015.
    Filed Date: 4/5/16.
    Accession Number: 20160405-5047.
    Comments Due: 5 p.m. ET 4/26/16.

    Docket Numbers: ER16-1346-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2016-04-05_SA 2911 LEPA-MISO
e-NRIS (J373) to be effective 4/6/2016.
    Filed Date: 4/5/16.
    Accession Number: 20160405-5063.
    Comments Due: 5 p.m. ET 4/26/16.

    Docket Numbers: ER16-1347-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to WMPA SA No.
3636, Queue No. X1-085 per Assignment to be effective 8/12/2013.
    Filed Date: 4/5/16.
    Accession Number: 20160405-5098.
    Comments Due: 5 p.m. ET 4/26/16.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern

time on the specified comment date. Protests may be considered, but
intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 5, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-08409 Filed 4-12-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 90 (Thursday, May 11, 2017)]
[Notices]
[Page 22048]
[FR Doc No: 2017-09588]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2017-32]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of title 14, Code of Federal Regulations
(14 CFR). The purpose of this notice is to improve the public's
awareness of, and participation in, this aspect of the FAA's regulatory
activities. Neither publication of this notice nor the inclusion or
omission of information in the summary is intended to affect the legal
status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before May 31, 2017.

ADDRESSES: You may send comments identified by docket number FAA-2017-
0076 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments digitally.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review the
DOT's complete Privacy Act Statement in the Federal Register published
on April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Lynette Mitterer, ANM-113, Federal
Aviation Administration, 1601 Lind Avenue Southwest, Renton, WA 98057-
3356, email<EMAIL_ADDRESS>phone<PHONE_NUMBER>.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Renton, Washington, on May 3, 2017.
Victor Wicklund,
Manager, Transport Standards Staff.

Petition for Exemption

    Docket No.: FAA-2017-0076.
    Petitioner: Gulfstream.
    Section 14 CFR Affected: Sec. Sec.  25.841(a)(2)(i) and (a)(2)(ii).
    Description of Relief Sought: Allow for inflight access to the
baggage compartment above FL400 on the Gulfstream GVI model airplane.

[FR Doc. 2017-09588 Filed 5-10-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)]
[Notices]
[Pages 26851-26853]
[FR Doc No: 2016-10437]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No 34-77744; File No. SR-MSRB-2016-04]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Order Granting Approval of a Proposed Rule Change Consisting of
Proposed Amendments to Rules G-12 and G-15 To Define Regular-Way
Settlement for Municipal Securities Transactions as Occurring on a Two-
Day Settlement Cycle and Technical Conforming Amendments

April 29, 2016.

I. Introduction

    On March 1, 2016, the Municipal Securities Rulemaking Board (the
``MSRB'' or ``Board'') filed with the Securities and Exchange
Commission (the ``SEC'' or ``Commission''), pursuant to Section
19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule
19b-4 thereunder,\2\ a proposed rule change consisting of proposed
amendments to the MSRB Rules G-12 and G-15 to define regular-way
settlement for municipal securities transactions as occurring on a two-
day settlement cycle and technical conforming amendments (the
``proposed rule change'').
---------------------------------------------------------------------------

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

    The proposed rule change was published for comment in the Federal
Register on March 18, 2016.\3\ The Commission received four comment
letters on the proposed rule change.\4\ This order approves the
proposed rule change.
---------------------------------------------------------------------------

    \3\ Securities Exchange Act Release No. 77364 (Mar. 14, 2016),
81 FR 14906 (Mar. 18, 2016) (the ``Notice of Filing'').
    \4\ See Letters from Martin A. Burns, Chief Industry Operations
Officer, Investment Company Institute (``ICI''), dated April 4, 2016
(``ICI Letter''); Michael Nicholas, Chief Executive Office, Bond
Dealers of America (``BDA''), dated April 8, 2016 (``BDA Letter'');
Leslie M. Norwood, Managing Director and Associate General Counsel,
Securities Industry Financial Markets Association (``SIFMA''), dated
April 8, 2016 (``SIFMA Letter''); David T. Bellaire, Executive Vice
President & General Counsel, Financial Services Institute (``FSI''),
dated April 8, 2016 (``FSI Letter'' and, together with the BDA
Letter, the ICI Letter, and the SIFMA Letter, the ``Comment
Letters'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    The MSRB's proposed rule change consists of proposed amendments to
Rule G-12, on uniform practice, and Rule G-15, on confirmation,
clearance, settlement and other uniform practice requirements with
respect to transactions with customers, to define

regular-way settlement for municipal securities transactions as
occurring on a two-day settlement cycle (``T+2'') and technical
conforming amendments.\5\ According to the MSRB, following the
financial crisis in 2008, regulators implemented additional rules and
regulations designed to reduce risk in the markets, achieve greater
transparency and improve efficiency in the financial industry.\6\
Consistent with those goals, the MSRB stated that the securities
industry launched a voluntary initiative to shorten the settlement
cycle for securities transactions to reduce counterparty risk, decrease
clearing capital requirements, reduce liquidity demands, and harmonize
the settlement cycle globally.\7\
---------------------------------------------------------------------------

    \5\ See supra note 3.
    \6\ Id.
    \7\ Id.
---------------------------------------------------------------------------

    The MSRB has identified two MSRB rules--G-12(b)(ii)(B)-(D) and Rule
G-15(b)(ii)(B)-(C)--essential to facilitate the move to T+2.\8\ As
stated by the MSRB, these rules currently define regular-way settlement
as occurring on a three day settlement cycle (``T+3'').\9\ The MSRB,
therefore, proposes to amend Rules G-12(b)(ii)(B)-(D) and G-
15(b)(ii)(B)-(C) to define regular-way settlement as occurring on T+2,
and to make certain technical conforming amendments to MSRB Rules G-
12(b)(i)(B), G-15(b)(i)(B), and G-15(g)(ii)(B).\10\
---------------------------------------------------------------------------

    \8\ Id.
    \9\ Id.
    \10\ Id.
---------------------------------------------------------------------------

    According to the MSRB, the migration to T+2 will provide
significant benefits to the financial industry broadly.\11\ The MSRB
stated that the benefits to the industry include the mitigation of
counterparty risk, a decrease in margin requirements for National
Securities Clearing Corporation's (``NSCC'') clearing members, a
reduction in pro-cyclical margin and liquidity demands especially
during periods of market volatility, and an increase in global
settlement harmonization by aligning the U.S. markets with other major
markets, such as the European Union.\12\ The MSRB also asserted that by
shortening the time between trade and execution and settlement by one
business day (from T+3 to T+2), the risk of counterparty default and
the capital required to mitigate this risk would be reduced.\13\ In the
MSRB's view, the likely costs of the proposed rule change, including
the changes in processes and technology as well as behavioral
modifications by the industry and investors, are justified by the
likely benefits associated with transitioning to T+2.\14\
---------------------------------------------------------------------------

    \11\ Id.
    \12\ Id.
    \13\ Id.
    \14\ Id.
---------------------------------------------------------------------------

Proposed Amendments to MSRB Rules G-12(b)(ii)(B)-(D) and G-
15(b)(ii)(B)-(C)

    According to the MSRB, Rule G-12 establishes uniform industry
practices for processing, clearance and settlement of transactions in
municipal securities between a broker, dealer or municipal securities
dealer and any other broker, dealer or municipal securities dealer.\15\
Specifically, the MSRB noted that Rule G-12(b)(ii) defines ``regular
way'' settlement as occurring on a T+3 basis.\16\ As proposed by the
MSRB, the proposed rule change would amend Rule G-12(b)(ii)(B)-(D) to
define ``regular way'' settlement as occurring on a T+2 basis.\17\
---------------------------------------------------------------------------

    \15\ Id.
    \16\ Id.
    \17\ Id.
---------------------------------------------------------------------------

    According to the MSRB, Rule G-15 requires municipal securities
brokers and municipal securities dealers to provide customers with
written confirmations of transactions, containing specified
information; and prescribes certain uniform practice procedures for
dealers that transact municipal securities business with customers.\18\
Specifically, the MSRB noted that Rule G-15(b)(ii) defines ``regular
way'' settlement as occurring on a T+3 basis.\19\ As proposed by the
MSRB, the proposed rule change would amend Rule G-15(b)(ii)(B)-(C) to
define ``regular way'' settlement as occurring on a T+2 basis.\20\
---------------------------------------------------------------------------

    \18\ Id.
    \19\ Id.
    \20\ Id.
---------------------------------------------------------------------------

Technical Conforming Amendments

    The MSRB has proposed technical conforming amendments to Rules G-
12(b)(i)(B), G-15(b)(i)(B) and G-15(g)(ii)(B).\21\ As proposed by the
MSRB, Rules G-12(b)(i)(B) and G-15(b)(i)(B) would both be revised by
replacing the reference to ``National Association of Securities
Dealers, Inc.'' with the ``Financial Industry Regulatory Authority.''
\22\ Similarly, the MSRB proposes to amend Rule G-15(g)(ii)(B) to
replace the reference to ``NASD Conduct Rule 2260(g),'' which is
retired, and replace it with the current relevant rule cite ``FINRA
Rule 2251(g).'' \23\
---------------------------------------------------------------------------

    \21\ Id.
    \22\ Id.
    \23\ Id.
---------------------------------------------------------------------------

Compliance Date

    The MSRB has stated that the compliance date of the proposed rule
change will be announced by the MSRB in a notice published on the MSRB
Web site, which date would correspond with the industry's transition to
a T+2 regular-way settlement, which would include amendments by the SEC
to Exchange Act Rule 15c6-1(a).\24\
---------------------------------------------------------------------------

    \24\ Id.
---------------------------------------------------------------------------

 III. Summary of Comments Received

    As noted previously, the Commission received four comment letters
on the proposed rule change.\25\ The commenters generally support the
proposed rule change. The SIFMA Letter, ICI Letter, FSI Letter, and BDA
Letter, each, expressed general support for the proposed rule
change.\26\ In its comment letter, however, BDA expressed concern with
respect to the impact the proposed rule change will have on certain
retail investors who purchase securities by written check.\27\ BDA made
a substantially similar comment in its response to the MSRB's Request
for Comment on Changes to MSRB Rules to Facilitate Shortening the
Securities Settlement Cycle, published on November 10, 2015 (the
``Request for Comment''), which the MSRB addressed in the Notice of
Filing.\28\ The MSRB stated in the Notice of Filing that it believes
that the vast majority of firms have access to technology that would
enable their clients to deliver funds in order to settle their
municipal securities trades on a T+2 basis, and firms should encourage
their customers to leverage electronic funds payment to streamline
processing.
---------------------------------------------------------------------------

    \25\ See supra note 4.
    \26\ See SIFMA Letter; BDA Letter; ICI Letter; and FSI Letter.
    \27\ See BDA Letter.
    \28\ See supra note 3.
---------------------------------------------------------------------------

    The BDA Letter and the SIFMA Letter each addressed the impact of
the proposed rule change on MSRB Rule G-32.\29\ BDA expressed its
desire that the MSRB leave Rule G-32 unchanged,\30\ while SIFMA
expressed its belief that the proposed rule change provided ``an
opportune time to revise customer disclosure requirements of brokers,
dealers, and municipal securities dealers'' under Rule G-32 but stated
that such considerations should not impede progress of the proposed
rule change.\31\ Both BDA and SIFMA made substantially similar comments
in their responses to the Request for Comment, which the MSRB noted in
the Notice of Filing and stated that it may consider suggested
clarifications in the future.\32\
---------------------------------------------------------------------------

    \29\ See BDA Letter; See SIFMA Letter.
    \30\ See BDA Letter.
    \31\ See SIFMA Letter.
    \32\ See supra note 3.
---------------------------------------------------------------------------

    The FSI Letter also expressed general support and agreement with
the

proposed rule change, and noted interest in seeing the MSRB coordinate
with other regulators and market participants to educate investors and
other market participants about the effects of shortening the
settlement cycle to T+2.\33\ The MSRB stated that it expects to
coordinate implementation of a T+2 regular-way settlement cycle for
municipal securities transactions with other regulators.\34\
---------------------------------------------------------------------------

    \33\ See FSI Letter.
    \34\ See supra note 3.
---------------------------------------------------------------------------

IV. Discussion and Commission Findings

    The Commission has carefully considered the proposed rule change as
well as the comments received. The Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to the MSRB.
    In particular, the Commission finds that the proposed rule change
is consistent with Section 15B(b)(2)(C) of the Act,\35\ which requires,
among other things, that the rules of the MSRB be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in municipal
securities and municipal financial products, to remove impediments to
and perfect the mechanism of a free and open market in municipal
securities and municipal financial products, and, in general, to
protect investors, municipal entities, obligated persons, and the
public interest. The Commission believes that the proposed rule change
is consistent with Section 15B(b)(2)(C) of the Act because the proposed
rule change is reasonably designed to remove impediments to, and
perfect the mechanism of, a free and open market in municipal
securities by shortening the time between trade execution and
settlement by one business day. According to the MSRB, the benefits of
the proposed rule change will enhance the overall efficiency of the
securities markets, promote financial stability, and better align U.S.
securities markets with global markets.
---------------------------------------------------------------------------

    \35\ 15 U.S.C. 78o-4(b)(2)(C).
---------------------------------------------------------------------------

    In approving the proposed rule change, the Commission has also
considered the proposed rule change's impact on efficiency,
competition, and capital formation.\36\ The Commission does not believe
that the proposed rule change would impose any burden on competition
not necessary or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \36\ 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    For the reasons noted above, the Commission believes that the
proposed rule change is consistent with the Act.

V. Conclusion

    IT IS THEREFORE ORDERED, pursuant to Section 19(b)(2) of the
Act,\37\ that the proposed rule change (SR-MSRB-2016-04) be, and hereby
is, approved.
---------------------------------------------------------------------------

    \37\ 15 U.S.C. 78s(b)(2).

    For the Commission, pursuant to delegated authority.\38\
---------------------------------------------------------------------------

    \38\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-10437 Filed 5-3-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 48 (Tuesday, March 12, 2013)]
[Proposed Rules]
[Pages 15655-15658]
[FR Doc No: 2013-05597]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0594; Directorate Identifier 2012-NM-019-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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

SUMMARY: We are revising an earlier proposed airworthiness directive
(AD) for certain Bombardier, Inc. Model DHC-8-400, -401, and -402
airplanes. That NPRM proposed to require an inspection to determine if
certain rudder feel trim units (RFTUs) are installed, an operational
check for signs of seizure of affected parts, repetitive lubrication
for certain RFTUs, and replacement of the RFTU if necessary. Installing
replaced RFTUs with conformal bushings would terminate the repetitive
lubrication requirements. That NPRM was prompted by reports of movement
of the rudder pedals being impeded due to corrosion of the trunnion
shaft of the RFTU. This action revises that NPRM by reducing compliance
times, increasing compliance costs, expanding affected parts to include
additional serial numbers and include those parts with a suffix `A,'
and adding the condition of rough movement to the operational check. We
are proposing this AD to detect and correct any sign of rough movement
or seizure of the trunnion shaft and its bushing, which could cause a
rudder control jam or a large and rapid alternating rudder input
leading to a structural failure of the vertical fin. Since these
actions impose an additional burden over that proposed in the NPRM, we
are reopening the comment period to allow the public the chance to
comment on these proposed changes.

DATES: We must receive comments on this proposed AD by April 26, 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, 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-2012-0594;
Directorate Identifier 2012-NM-019-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

    We proposed to amend 14 CFR part 39 with an earlier NPRM for the
specified products, which was published in the Federal Register on June
12, 2012 (77 FR 34874). That earlier NPRM proposed to require actions
intended to address the unsafe condition for certain Bombardier, Inc.
Model DHC-8-400, -401, and -402 airplanes.
    Since that NPRM (77 FR 34874, June 12, 2012) was issued, we have
determined that a reduction to the compliance times is needed in order
to address the identified specified unsafe condition. We are reducing
the compliance times for the inspection in paragraph (g) of this
supplemental NPRM from within 600 flight hours or six months, whichever
occurs first, to within 200 flight hours or two months, whichever
occurs first after the effective date of this AD. We are reducing the
compliance time for the replacement specified in paragraph (h) of this
supplemental NPRM from within 6,000 flight hours to within 5,000 flight
hours or 3 years, whichever occurs first. We have also determined that
it is necessary to increase the costs of compliance, expand the
affected parts, and revise the operational check specified in the NPRM.
The affected parts for the action specified in paragraphs (g)(1) and
(g)(2) have been expanded in this supplemental NPRM to include
additional serial numbers (S/N) 0008 through 0509 inclusive, and to
include those parts with suffix `A.' Also, the operational check
specified in paragraph (g)(2) of this supplemental NPRM now includes an
additional condition of ``any sign of rough movement.''
    Since the NPRM (77 FR 34874, June 12, 2012) was issued, Transport
Canada Civil Aviation (TCCA), which is the aviation authority for
Canada, has issued Canadian Airworthiness Directive CF-2012-02R1, dated
October 12, 2012 (referred to after this as Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for the specified products. The MCAI reduced compliance
times, expanded the affected parts to include the new part serial
numbers and parts with suffix `A,' and added the condition of ``rough
movement'' to the operational check. You may obtain further information
by examining the MCAI in the AD docket.

Relevant Service Information

    Bombardier has issued Service Bulletin 84-27-60, dated July 12,
2012. The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

Comments

    We gave the public the opportunity to comment on the NPRM (77 FR
34874, June 12, 2012). The following presents the comments received on
the NPRM and the FAA's response to each comment.

Request To Allow Additional Replacement Units

    Horizon Air (Horizon) requested that we add units with suffix `B,'
in addition to units with suffix `A,' to the RFTUs allowed as
replacement parts in paragraphs (g), (h), and (i) of the NPRM (77 FR
34874, June 12, 2012). Horizon stated that Parker Aerospace, which
manufacturers RFTU part number (P/N)<PHONE_NUMBER>, has since issued
Parker Aerospace Service Bulletin 399500-27-003, dated April 19, 2012,
which introduced an additional modification for RFTU (S/Ns) 0009
through 0388 inclusive. Horizon noted RFTUs modified by that service
bulletin are identified by a suffix `B' to the unit serial number.
Horizon stated the addition of units with suffix `B'' would allow
operators that have taken actions to incorporate Parker Aerospace
Service Bulletin 399500-27-003, dated April 19, 2012, suffix `B' units
into their fleet, to be in compliance with the NPRM and to keep
operators from having to request an alternative means of compliance
(AMOC) to keep suffix `B' units in service once the final rule is
issued.
    We partially agree with the commenter. This supplemental NPRM does
allow installation of units with suffix `B.' However, as stated
previously, units with suffix `A,' are now affected parts and this
supplemental NPRM would not allow installations of units with suffix
`A.' We have changed paragraphs (g), (h), and (i) of this supplemental
NPRM to include the addition of units with suffix `B.'

Request To Revise Paragraph (g)(2)(i) of the NPRM (77 FR 34874, June
12, 2012)

    Horizon requested that we revise paragraph (g)(2)(i) of the NPRM
(77 FR 34874, June 12, 2012) to allow installing serviceable RFTUs and
RFTUs having suffix `B.' Horizon added that paragraph (g)(2)(i) of the
NPRM requires ``replacing the RFTU with a new RFTU.'' Horizon stated
that the word `new' implies a zero-time unit that is new from the
manufacturer, and that operators should not be required to purchase a
new unit to meet the requirements of paragraph (g)(2)(i) of the NPRM
when a serviceable RFTU outside the serial number range, or that has a
serial number with a suffix `A,' would address the unsafe condition.
Horizon pointed out that requiring use of a new unit since it adds an
additional financial cost that is unnecessary to address the unsafe
condition.
    We agree. We have revised paragraph (g)(2)(i) of this supplemental
NPRM to specify replacing RFTUs with new or serviceable RFTUs, which
includes those with suffix `B.'

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.
    Certain changes described above expand the scope of the earlier
NPRM (77 FR 34874, June 12, 2012). As a result, we have determined that
it is necessary to reopen the comment period to provide additional
opportunity for the public to comment on this proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 83 products of U.S. registry. We also estimate that
it would take about 5 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $0 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these parts.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $35,275, or $425 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 17 work-hours and require parts costing $0, for a cost of
$1,445 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

0
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]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

Bombardier, Inc.: Docket No. FAA-2012-0594; Directorate Identifier
2012-NM-019-AD.

(a) Comments Due Date

    We must receive comments by April 26, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model DHC-8-400, -401, and -
402 airplanes; certificated in any category; serial numbers (S/N)
4001, 4003 and subsequent, equipped with rudder feel trim unit
(RFTU) part number (P/N)<PHONE_NUMBER>.

(d) Subject

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

(e) Reason

    This AD was prompted by reports of movement of the rudder pedals
being impeded due to corrosion of the trunnion shaft of the RFTU. We
are issuing this AD to detect and correct any sign of rough movement
or seizure of the trunnion shaft and its bushing, which could cause
a rudder control jam or a large and rapid alternating rudder input
leading to a structural failure of the vertical fin.

(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) Inspection, Replacement, and Lubrication

    Within 200 flight hours or two months after the effective date
of this AD whichever occurs first: Inspect the RTFU to determine
whether the serial number is in the range from S/N 0008 through 0509
inclusive without a suffix `B,' in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 84-27-60,
dated July 12, 2012. A review of airplane maintenance records is
acceptable in lieu of this inspection if the serial number of the
RFTU can be conclusively determined from that review.
    (1) If the RFTU's serial number is not in the range from S/N
0008 through 0509 inclusive, or if the serial number has a suffix
`B,' no further action is required for this paragraph.
    (2) If the RFTU's serial number is in the range from (S/N) 0008
through 0509 inclusive, including those with a suffix `A,' but not
including those with suffix `B': Before further flight, perform an
operational check of the RFTU for any sign of rough movement or
seizure of the trunnion or center shaft, in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 84-27-60,
dated July 12, 2012.
    (i) If rough movement or seizure of the RFTU trunnion or center
shaft is found: Before further flight, replace the RFTU with a new
or serviceable RFTU, in accordance with the Accomplishment
Instructions of Bombardier Service Bulletin 84-27-60, dated July 12,
2012.
    (ii) If no rough movement or seizure of the RFTU trunnion or
center shaft is found: Before further flight, lubricate the RFTU, in
accordance with the Accomplishment Instructions of Bombardier
Service Bulletin 84-27-60, dated July 12, 2012. Repeat the
lubrication of the RFTU at intervals not to exceed 600 flight hours
or 3 months, whichever occurs first, until the RFTU is replaced with
a unit that has a serial number outside the affected range or a
serial number with a suffix `B.'

(h) Replacement

    For airplanes having an RFTU identified in paragraph (g)(2) of
this AD: Except as required by paragraph (g)(2)(i) of this AD,
within 5,000 flight hours or 3 years after the effective date of
this AD, whichever occurs first, replace all affected RFTUs with
units that have a serial number outside the range from S/Ns 0008
through 0509 inclusive, or

that have a serial number with a suffix `B,' in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 84-27-60,
dated July 12, 2012.

(i) Parts Installation Prohibition

    As of the effective date of this AD, no person may install an
RFTU P/N<PHONE_NUMBER> with a serial number from (S/N) 0008 through
0509 inclusive, including serial numbers with suffix `A,' on any
airplane, except RFTUs that have a serial number with suffix `B,'
may be installed.

(j) 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 ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, New York 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.

(k) Related Information

    (1) Refer to MCAI Canadian Airworthiness Directive CF-2012-02R1,
dated October 12, 2012; and Bombardier Service Bulletin 84-27-60,
dated July 12, 2012; for related information.
    (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, Washington. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on February 28, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-05597 Filed 3-11-13; 8:45 am]
BILLING CODE 4910-13-P