[Federal Register Volume 82, Number 58 (Tuesday, March 28, 2017)]
[Notices]
[Pages 15417-15418]
[FR Doc No: 2017-06046]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2017-0002-N-3]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), U.S. Department of
Transportation (DOT).

ACTION: Notice and request for comments.

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SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA) and its
implementing regulations, FRA is seeking to conduct the information
collection activities listed below. Before submitting this information
collection request (ICR) to the Office of Management and Budget (OMB)
for approval, FRA is soliciting public comment on specific aspects of
the activity identified below.

DATES: Comments must be received no later than May 30, 2017.

ADDRESSES: Submit written comments on the following information
collection activity by mail to either: Mr. Robert Brogan, Information
Collection Clearance Officer, Office of Railroad Safety, Regulatory
Safety Analysis Division, RRS-21, Federal Railroad Administration, 1200
New Jersey Ave. SE., Mail Stop 17, Washington, DC 20590, or Ms. Kim
Toone, Information Collection Clearance Officer, Office of Information
Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey
Ave. SE., Mail Stop 35, Washington, DC 20590. Commenters requesting FRA
to acknowledge receipt of their respective comments must include a
self-addressed stamped postcard stating, ``Comments on OMB control
number 2130--NEW'', and should also include the title of the
information collection. Alternatively, comments may be faxed to (202)
493-6216 or<PHONE_NUMBER>, or emailed to Mr. Brogan at
<EMAIL_ADDRESS>or to Ms. Toone at<EMAIL_ADDRESS>Please
refer to the assigned OMB control number in any correspondence
submitted. FRA will summarize comments received in response to this
notice in a subsequent notice and include them in its information
collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Information
Collection Clearance Officer, Office of Railroad Safety, Regulatory
Safety Analysis Division, RRS-21, Federal Railroad Administration, 1200
New Jersey Ave. SE., Mail Stop 17, Washington, DC 20590 (telephone:
(202) 493-6292) or Ms. Kimberly Toone, Information Collection Clearance
Officer, Office of Information Technology, RAD-20, Federal Railroad
Administration, 1200 New Jersey Ave. SE., Mail Stop 35, Washington, DC
20590 (telephone:<PHONE_NUMBER>). These telephone numbers are not
toll-free.

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
provide 60-days' notice to the public to allow comment on information
collection activities before seeking OMB approval of the activities. 44
U.S.C. 3506(c)(2)(A); 5 CFR 1320.8(d)(1), 1320.10(e)(1), 1320.12(a).
Specifically, FRA invites interested parties to comment on the
following summary of an information collection activity regarding: (1)
Whether the information collection activity is necessary for FRA to
properly execute its functions, including whether the activities will
have practical utility; (2) the accuracy of FRA's estimate of the
burden of the information collection activity, including the validity
of the methodology and assumptions used to determine the estimate; (3)
how FRA can enhance the quality, utility, and clarity of the
information being collected; and (4) how FRA can minimize the burden of
the information collection activity on the public by automated,
electronic, mechanical, or other technological collection techniques
and other forms of information technology (e.g., permitting electronic
submission of responses). See 44 U.S.C. 3506(c)(2)(A); 5 CFR
1320.8(d)(1).
    FRA believes soliciting public comment will promote its efforts to
reduce the administrative and paperwork burdens associated with the
collection of information. In summary, FRA reasons that comments
received will advance three objectives: (1) Reduce reporting burdens;
(2) ensure it organizes information collection requirements in a
``user-friendly'' format to improve the use of such information; and
(3) accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    Below is a brief summary of the proposed ICR that FRA will submit
for OMB clearance as required under the PRA:
    Title: Workforce Development (WFD) Survey.
    OMB Control Number: 2130--NEW.
    Abstract: FRA has statutory responsibility to ensure the safety of
railroad operations under 49 U.S.C. 20103. To conduct safe railroad
operations, the workforce must have the requisite skills to operate
equipment and technologies. Therefore, it is FRA's responsibility to
promote workforce development policy and standards to ensure the
workforce has the necessary skills and talent to conduct safe railroad
operations. Due to an increasingly dynamic and maturing workforce
combined with changing skills' requirements new technologies impose,
there is an increasing risk of not having the necessary talent pools to
fill critical railroad operational positions.
    In 2011, FRA published the Railroad Industry Modal Profile: An
Outline of the Railroad Industry Workforce Trends, Challenges, and
Opportunities (Railroad Industry Modal Profile), which provided a
comprehensive overview of the railroad industry workforce as of
December 31, 2008. This document is available to the public through
FRA's Web site at https://www.fra.dot.gov/eLib/Details/L01294. FRA
published the Railroad Industry Modal Profile in response to the DOT
National Transportation Workforce Development Initiative that required
each DOT Operating Administration (OA) to produce an analysis of its
industry workforce. See https://www.rita.dot.gov/ntwd for information
on the initiative.
    The prevailing workforce concerns during the early stages of the
DOT National Transportation Workforce Development Initiative were the
large number of retirement-eligible employees in transportation-related
fields and the national shortage of science, technology, engineering,
and math graduates. Since the railroad industry did very little hiring
in the late 1980s and through most of the 1990s, the retirement-
eligible population became quite large--even more than most other
industries and transportation modes (which were grappling with similar
retirement population concerns).
    These industry hiring practices create risk in maintaining a viable
workforce, and, to take effective and efficient action to minimize
these risks, FRA requires railroads to submit trustworthy information
on current Work Force Development strategies and challenges. Initial
data FRA collected for the Railroad Industry Modal Profile established
a baseline understanding of the risks and status. FRA proposes this
survey to validate and further develop its understanding of the risks.
With this submission, FRA is requesting permission to acquire the
necessary information on the railroad industry workforce.
    Form Number(s): FRA 240.

    Affected Public: Class I freight and passenger railroads, short
line and regional railroads, labor unions, major associations,
academia, and specialty experts.
    Respondent Universe: 91.
    Frequency of Submission: One-time.
    Reporting Burden:

------------------------------------------------------------------------
                                                                Burden
                                                    Number    hours @ \1/
               Stakeholder segment                invited to    3\ hour
                                                    survey    per survey
------------------------------------------------------------------------
Class I Passenger...............................           5        1.65
Class I Freight.................................          10         3.3
Short Line and Regional.........................          50        16.5
Labor Unions....................................           7         2.3
Associations....................................          10         3.3
Academia........................................           9           3
                                                 -----------------------
    Total.......................................          91       30.05
------------------------------------------------------------------------

    Total Estimated Annual Responses: 91.
    Total Estimated Annual Burden: 30.05 hours.
    Type of Request: Approval of a new Information Collection.
    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b), 1320.8(b)(3)(vi), FRA
informs all interested parties that it may not conduct or sponsor, and
a respondent is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

    Authority: 44 U.S.C. 3501-3520.

Sarah L. Inderbitzin,
Acting Chief Counsel.
[FR Doc. 2017-06046 Filed 3-27-17; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register: May 5, 2006 (Volume 71, Number 87)]
[Notices]
[Page 26577-26579]
[DOCID:fr05my06-141]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53746; File No. SR-MSRB-2006-01]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing of Proposed Rule Change and Amendment No. 1
Relating to Withdrawal of Obsolete Question-and-Answer Interpretive
Guidance Under Former Rule G-38, on Consultants, and Certain Question-
and-Answer Interpretive Guidance Relating to the Definition of
``Solicitation'' Under Rule G-37, on Political Contributions and
Prohibitions on Municipal Securities Business

 May 1, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 28, 2006, the Municipal Securities Rulemaking Board (``MSRB''
or ``Board'') 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 MSRB.
On April 20, 2006, the MSRB filed Amendment No. 1 to the proposed rule
change.\3\ The Commission is publishing this notice to solicit comments
on the proposed rule change, as amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 deletes one additional Q&A providing
interpretive guidance under Rule G-37 and former Rule G-38.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The MSRB is filing with the Commission a proposed rule change to
delete obsolete Question-and-Answer (``Q&A'') interpretive guidance
under former Rule G-38, on consultants, and certain Q&A interpretive
guidance relating to the definition of ``solicitation'' under Rule G-
37, on

political contributions and prohibitions on municipal securities
business. The text of the proposed rule change, as amended, is
available on the MSRB's Web site (http://www.msrb.org), at the MSRB's

principal office, 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 MSRB 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 MSRB 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
    On August 29, 2005, new Rule G-38, on solicitation of municipal
securities business, became effective, superseding former Rule G-38 on
consultants.\4\ The MSRB had previously published a number of Q&A
interpretations on the former rule, none of which continue to apply to
new Rule G-38 since the consultant provisions to which they relate are
no longer in effect. Accordingly, the MSRB is deleting all obsolete
Rule G-38 Qs&As. In addition, the MSRB is deleting three Qs&As and
partially deleting a fourth Q&A under Rule G-37 relating to the
definition of solicitation of municipal securities business (the ``Rule
G-37 solicitation Qs&As'').\5\
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    \4\ SEC Release No. 34-52278 (August 17, 2005); 70 FR 49342
(August 23, 2005).
    \5\ The three deleted Rule G-37 solicitation Qs&As are published
as Qs&As IV.10, IV.11 and IV.13 in MSRB Rule Book (January 1, 2006).
In addition, the last sentence of Q&A IV.18, published in MSRB Rule
Book (January 1, 2006), is deleted.
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    In December 2005, the Commission published for comment the MSRB's
proposed interpretive notice on the definition of ``solicitation''
under Rules G-37 and G-38 (the ``Solicitation Notice'').\6\ Among other
things, the Solicitation Notice incorporated, by means of footnote 2
thereof and the text accompanying such footnote, guidance on the
meaning of solicitation under Rule G-37 previously provided in the Rule
G-37 solicitation Qs&As. The Commission received one comment letter in
response to the Solicitation Notice.\7\ The commentator supported the
Solicitation Notice but suggested that the MSRB withdraw all of its
prior published Q&A guidance regarding the definition of solicitation
of municipal securities business in order to avoid potential conflicts
between such prior Q&A guidance and the Solicitation Notice.\8\
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    \6\ SEC Release No. 34-52948 (December 13, 2005); 70 FR 75514
(December 20, 2005).
    \7\ See Letter from Leslie M. Norwood, Vice President and
Assistant General Counsel, The Bond Market Association, to Jonathan
G. Katz, Commission Secretary, dated January 10, 2006.
    \8\ The commentator stated that, in certain respects, the
guidance on solicitation and related matters provided in the
Solicitation Notice may not be wholly consistent with guidance
previously provided by the MSRB and that such prior guidance should
be withdrawn. The MSRB addresses this and other statements and
concerns in the companion filing to this filing. See Amendment No. 2
(March 17, 2006) to File No. SR-MSRB-2005-11 (June 8, 2005).
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    The MSRB believes that it would be appropriate to consolidate its
guidance on the definition of solicitation for purposes of Rules G-37
and G-38 by amending its Solicitation Notice and simultaneously
deleting (1) the Rule G-37 solicitation Qs&As, and (2) all obsolete
Rule G-38 Q&A guidance relating to consultants. Thus, in addition to
the Q&A deletions which are the subject of this filing, the MSRB has
submitted to the Commission a companion filing consisting of an
amendment to the Solicitation Notice that would delete footnote 2 in
the Solicitation Notice, which contains references to the Rule G-37
solicitation Qs&As, and would instead insert the substantive language
of those Qs&As into the text of the Solicitation Notice.\9\ Thus, the
language of the Rule G-37 solicitation Qs&As which had previously been
incorporated by reference would now be explicitly included within the
Solicitation Notice. The amendment to the Solicitation Notice and the
withdrawal of the Rule G-37 solicitation Qs&As and obsolete Rule G-38
Qs&As do not effect a substantive change in the MSRB's guidance on the
definition of solicitation as set forth in the Solicitation Notice.
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    \9\ See Amendment No. 2 (March 17, 2006) to File No. SR-MSRB-
2005-11 (June 8, 2005).
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2. Statutory Basis
    The MSRB believes that the proposed rule change, as amended, is
consistent with Section 15B(b)(2)(C) of the Act,\10\ which provides
that the MSRB's rules shall: 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, to remove impediments to and perfect the mechanism of a
free and open market in municipal securities, and, in general, to
protect investors and the public interest.
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    \10\ 15 U.S.C. 78o-4(b)(2)(C).
---------------------------------------------------------------------------

    The MSRB believes that the proposed rule change is consistent with
these provisions in that it will further investor protection and the
public interest by ensuring that dealers understand their obligations
under MSRB rules designed to maintain standards of fair practice and
professionalism, thereby helping to maintain public trust and
confidence in the integrity of the municipal securities market.

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

    The MSRB does not believe that the proposed rule change, as
amended, will result in any burden on competition that is not necessary
or appropriate in furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    A. By order approve such proposed rule change, or
    B. Institute proceedings to determine whether the proposed rule
change should be disapproved.
    The MSRB has requested accelerated approval of the proposed rule
change. The Commission is not granting accelerated approval at this
time in order to allow interested persons to comment on this proposal
and on Amendment 2 to a companion proposed rule change relating to the
definition of solicitation under MSRB Rules G-37 and G-38.\11\ The MSRB
also requested that the Commission approve the proposal simultaneously
with the companion proposed rule change. The

Commission expects to consider these proposals simultaneously after the
close of their respective comment periods.
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    \11\ See File No. SR-MSRB-2005-11 (the ``companion proposed rule
change'').
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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, as amended, 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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-MSRB-2006-01 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street., NE, Washington, DC 20549-1090.
    All submissions should refer to File Number SR-MSRB-2006-01. This
file number should be included on the subject line if e-mail 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 inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the MSRB's
offices. 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-
MSRB-2006-01 and should be submitted on or before May 26, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E6-6807 Filed 5-4-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69632-69633]
[FR Doc No: 2012-28198]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0643]

Draft Guidance for Industry on Electronic Source Data in Clinical
Investigations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Electronic
Source Data in Clinical Investigations.'' This document revises and
updates the draft guidance entitled ``Electronic Source Documentation
in Clinical Investigations.'' This revised draft document provides
guidance to sponsors, contract research organizations (CROs), data
management centers, clinical investigators, and others involved in
capturing, reviewing, and archiving electronic source data in FDA-
regulated clinical investigations. The revised draft guidance promotes
capturing source data in electronic form, and it is intended to assist
in ensuring the reliability, quality, integrity, and traceability of
electronic source data.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that FDA considers your comment on the revised
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance within January 22, 2013.

ADDRESSES: Submit written requests for single copies of the revised
draft guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002;
Office of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448; Division of Small
Manufacturers, International and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002;
and Office of Critical Path Programs, Office of the Commissioner, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4173,
Silver Spring,

MD 20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ronald Fitzmartin, Office of Planning
and Informatics, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1160, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Electronic Source Data in Clinical Investigations.'' This
document revises and updates the draft guidance entitled ``Electronic
Source Documentation in Clinical Investigations.'' This revised draft
document provides guidance to sponsors, CROs, data management centers,
clinical investigators, and others involved in capturing, reviewing,
and archiving electronic source data in FDA-regulated clinical
investigations. The revised draft guidance promotes capturing source
data in electronic form, and it is intended to assist in ensuring the
reliability, quality, integrity, and traceability of electronic source
data.
    With the use of computerized systems for capturing clinical study
data, it is common to find at least some source data recorded
electronically. Common examples include clinical data initially
recorded in electronic health records maintained by hospitals and
institutions, electronic laboratory reports, electronic medical images
from devices, and electronic diaries provided by study subjects.
    Capturing source data electronically should help to: (1) Eliminate
unnecessary duplication of data; (2) reduce the possibility for
transcription errors; (3) encourage entering source data at the time of
a subject's visit; (4) eliminate transcribing source data before
entering the data into an electronic data capture system; (5) promote
real-time data access for review; and (6) ensure the accuracy and
completeness of the data.
    In the Federal Register of January 7, 2011 (76 FR 1173), FDA
announced the availability of the draft guidance entitled ``Electronic
Source Documentation in Clinical Investigations.'' Based on public
comment, we have revised the January 2011 draft guidance to clarify a
number of points made by industry. The Agency is publishing the draft
guidance as a revised draft guidance to collect additional public
comments. This revised draft guidance addresses source data (from
clinical investigations) used to fill the predefined fields in an
electronic case report form (eCRF), according to protocol. The draft
guidance discusses the following topics related to electronic source
data:
     Identifying and specifying authorized source data
originators;
     Creating data element identifiers to facilitate sponsors,
FDA, and other authorized parties in examining the audit trail of data;
     Capturing source data into the eCRF using either manual or
electronic capture methods; and
     Investigator responsibilities with respect to reviewing
and retaining electronic data.
    The revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CDR 10.115). The draft guidance,
when finalized, will represent the Agency's current thinking on
capturing, using, and archiving electronic data in FDA-regulated
clinical investigations. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    The draft guidance refers to collections of information that 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 draft
guidance pertains to sponsors, clinical investigators, contract
research organizations, and others involved in capturing, reviewing,
and archiving electronic source data in FDA-regulated clinical
investigations and who send certain information to FDA or others, or
keep certain records and make them available to FDA inspectors. The
information collection discussed in the draft guidance is contained in
our investigational new drug regulations (21 CFR 312) and approved
under OMB control number 0910-0014, including Sec. Sec.  312.62(b) and
312.58(a). In addition, the collection of information in 21 CFR part
11, as discussed in the draft guidance, is approved under OMB control
number 0910-0303. OMB approval of the information collection in the
guidance entitled ``Computerized Systems Used in Clinical
Investigations,'' as mentioned in the draft guidance, is discussed in
the May 10, 2007 (72 FR 26638), Federal Register Notice of Availability
of that guidance. The capture, review, and archiving of electronic
source data, as described in the draft guidance, would not result in
any new costs, including capital costs or operating and maintenance
costs, because sponsors and others already have and are experienced
with using the computer-based equipment and software necessary to be
consistent with the guidance.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, http://www.fda.gov/RegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov.

    Dated: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28198 Filed 11-19-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Pages 57786-57787]
[FR Doc No: 2019-23428]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87380; File No. SR-ISE-2019-28]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Extend the
Pilot Period for the Exchange's Nonstandard Expirations Pilot Program

October 22, 2019.
    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 October 11, 2019, Nasdaq ISE, LLC (``ISE'' or the ``Exchange'')
filed with the Securities and Exchange Commission (the ``Commission'')
the proposed rule change as described in Items I and II 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).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the pilot period for the Exchange's
nonstandard expirations pilot program, currently set to expire on
November 4, 2019.
    The text of the proposed rule change is available on the Exchange's
website at http://ise.cchwallstreet.com/, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    ISE filed a proposed rule change for the listing and trading on the
Exchange, on a twelve month pilot basis, of p.m.-settled options on
broad-based indexes with nonstandard expirations dates.\5\ The pilot
program permits both Weekly Expirations and End of Month (``EOM'')
expirations similar to those of the a.m.-settled broad-based index
options, except that the exercise settlement value of the options
subject to the pilot are based on the index value derived from the
closing prices of component stocks. This pilot was extended through May
6, 2019 \6\ and then subsequently extended through November 4, 2019.\7\
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    \5\ See Securities Exchange Act Release No. 82612 (February 1,
2018), 83 FR 5470 (February 7, 2018) (approving SR-ISE-2017-111)
(Order Approving a Proposed Rule Change To Establish a Nonstandard
Expirations Pilot Program).
    \6\ See Securities Exchange Act Release No. 85030 (February 1,
2019), 84 FR 2633 (February 7, 2019) (SR-ISE-2019-01) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Extend
the Nonstandard Expirations Pilot Program).
    \7\ See Securities Exchange Act Release No. 85672 (April 17,
2019), 84 FR 16899 (April 23, 2019) (SR-ISE-2019-11) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Extend
the Pilot Period for the Exchange's Nonstandard Expirations Pilot
Program).
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    Supplementary Material .07(a) to Options 4A, Section 12 provides
that the Exchange may open for trading Weekly Expirations on any broad-
based index eligible for standard options trading to expire on any
Monday, Wednesday, or Friday (other than the third Friday-of-the-month
or days that coincide with an EOM expiration). Weekly Expirations are
subject to all provisions of Options 4A, Section 12 and are treated the
same as options on the same underlying index that expire on the third
Friday of the expiration month. Unlike the standard monthly options,
however, Weekly Expirations are p.m.-settled.
    Pursuant to Supplementary Material .07(b) to Options 4A, Section 12
the Exchange may open for trading EOM expirations on any broad-based
index eligible for standard options trading to expire on the last
trading day of the month. EOM expirations are subject to all provisions
of Options 4A, Section 12 and treated the same as options on the same
underlying index that expire on the third Friday of the expiration
month. However, the EOM expirations are p.m.-settled.
    The Exchange now proposes to amend Supplementary Material .07(c) to
Options4A, Section 12 so that the duration of the pilot program for
these nonstandard expirations will be through May 4, 2020. The Exchange
continues to have sufficient systems capacity to handle p.m.-settled
options on broad-based indexes with nonstandard expirations dates and
has not encountered any issues or adverse market effects as a result of
listing them. Additionally, there is continued investor interest in
these products. The Exchange will continue to make public on its
website any data and analysis it submits to the Commission under the
pilot program.

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\8\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\9\ in particular, in that it is designed to promote
just and equitable principles of trade, 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.
The Exchange believes the proposed rule change will protect investors
and the public interest by providing the Exchange, the Commission and
investors the benefit of additional time to analyze nonstandard
expiration options. By extending the pilot program, investors may
continue to benefit from a wider array of investment opportunities.
Additionally, both the Exchange and the Commission may continue to
monitor the potential for adverse market effects of p.m.-settlement on
the market, including the underlying cash equities market, at the
expiration of these options.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. Options with nonstandard
expirations would be available for trading to all market participants.

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

    No written comments were either solicited or received.

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

    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, it has become effective pursuant to Section
19(b)(3)(A) of the Act \10\ and subparagraph (f)(6) of Rule 19b-4
thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
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.
The Exchange has satisfied this requirement.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \12\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \13\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
investors may continue to trade nonstandard expiration options listed
by the Exchange as part of the pilot program on an uninterrupted basis.
The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest as
it will allow the pilot program to continue uninterrupted, thereby
avoiding investor confusion that could result from a temporary
interruption in the pilot program. Accordingly, the Commission hereby
waives the operative delay and designates the proposed rule change
operative upon filing.\14\
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    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change 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-ISE-2019-28 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-ISE-2019-28. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-ISE-2019-28 and should be submitted on
or before November 18, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-23428 Filed 10-25-19; 8:45 am]
BILLING CODE 8011-01-P