[Federal Register Volume 77, Number 17 (Thursday, January 26, 2012)]
[Rules and Regulations]
[Pages 3927-3928]
[FR Doc No: 2012-1622]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]

Oral Dosage Form New Animal Drugs; Deracoxib

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Novartis Animal Health U.S., Inc. The
supplemental NADA provides for veterinary prescription use of deracoxib
tablets in dogs for the control of postoperative pain and inflammation
associated with dental surgery and the addition of a 12-milligram (mg)
size tablet.

DATES: This rule is effective January 26, 2012.

FOR FURTHER INFORMATION CONTACT: Amy L. Omer, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Novartis Animal Health U.S., Inc., 3200
Northline Ave., Suite 300, Greensboro, NC 27408, filed a supplement to
NADA 141-203 that provides for veterinary prescription use of DERAMAXX
(deracoxib) Chewable Tablets in dogs for the control of postoperative
pain and inflammation associated with dental surgery and the addition
of a 12-mg size tablet. The supplemental NADA is

approved as of November 23, 2011, and 21 CFR 520.538 is amended to
reflect the approval.
    A summary of safety and effectiveness data and information
submitted to support approval of this application may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4
p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval.
    The Agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  520.538, revise paragraphs (a), (d)(1), and (d)(2) to read
as follows:

Sec.  520.538  Deracoxib.

    (a) Specifications. Each tablet contains 12, 25, 50, 75, or 100
milligrams (mg) deracoxib.
* * * * *
    (d) * * *
    (1) Amount. Administer orally as needed, as a single daily dose
based on body weight:
    (i) 1 to 2 mg/kilogram (kg) (0.45 to 0.91 mg/pound (lb)), for use
as in paragraph (d)(2)(i) of this section.
    (ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for 3 days, for use as in
paragraph (d)(2)(ii) of this section.
    (iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as
in paragraph (d)(2)(iii) of this section.
    (2) Indications for use. (i) For the control of pain and
inflammation associated with osteoarthritis.
    (ii) For the control of postoperative pain and inflammation
associated with dental surgery.
    (iii) For the control of postoperative pain and inflammation
associated with orthopedic surgery.
* * * * *

    Dated: January 23, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1622 Filed 1-25-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Page 11575]
[FR Doc No: 2016-04703]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0386]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Registration and Product Listing for
Owners and Operators of Domestic Tobacco Product Establishments and
Listing of Ingredients in Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Registration and Product Listing
for Owners and Operators of Domestic Tobacco Product Establishments and
Listing of Ingredients in Tobacco Products'' has been approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On July 29, 2015, the Agency submitted a
proposed collection of information entitled ``Registration and Product
Listing for Owners and Operators of Domestic Tobacco Product
Establishments and Listing of Ingredients in Tobacco Products'' to OMB
for review and clearance under 44 U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. OMB has now approved the information collection and has
assigned OMB control number 0910-0650. The approval expires on January
31, 2019. A copy of the supporting statement for this information
collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: February 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04703 Filed 3-3-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 186 (Tuesday, September 25, 2012)]
[Notices]
[Pages 59000-59001]
[FR Doc No: 2012-23542]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-D-0254 (Formerly Docket No. 2001D-0037)]

Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole
Blood and Blood Components Intended for Transfusion; 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 document entitled ``Guidance for Industry: Pre-
Storage Leukocyte Reduction of Whole Blood and Blood Components
Intended for Transfusion'' dated September 2012. The guidance document
provides blood establishments with recommendations for pre-storage
leukocyte reduction of Whole Blood and blood components intended for
transfusion, including recommendations for validation and quality
control monitoring of the leukocyte reduction process. The guidance
announced in this notice finalizes the draft guidance of the same title
dated January 2011 and supersedes the FDA memorandum issued on May 29,
1996, entitled ``Recommendations and Licensure Requirements for
Leukocyte-Reduced Blood Products.''

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the draft 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: Lori Jo Churchyard, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401

Rockville Pike, Suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood
and Blood Components Intended for Transfusion'' dated September 2012.
The guidance document provides blood establishments with
recommendations for pre-storage leukocyte reduction of Whole Blood and
blood components intended for transfusion, including recommendations
for validation and quality control monitoring of the leukocyte
reduction process. The guidance also provides information to assist
licensed blood establishments for submitting biologics license
application supplements to include leukocytes reduced components.
    In the Federal Register of January 31, 2011 (76 FR 5386), FDA
announced the availability of the draft guidance of the same title
dated January 2011. FDA received several comments on the draft guidance
and those comments were considered as the guidance was finalized. A
summary of changes includes the following: Removing the recommendation
for use of a mixing device during collection, modifying definitions,
and clarifying performance qualification criteria. In addition,
editorial changes were made to improve clarity. The guidance announced
in this notice finalizes the draft guidance dated January 2011 and
supersedes the FDA memorandum issued on May 29, 1996, entitled
``Recommendations and Licensure Requirements for Leukocyte-Reduced
Blood Products.''
    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. 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
requirement of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    The guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 607 and Form FDA 2830 have
been approved under OMB control number 0910-0052; the collections of
information in 21 CFR 606.100(b), 606.100(c), 606.121, and 606.122 have
been approved under OMB control number 0910-0116; the collections of
information in 21 CFR 211.192 and 211.198 have been approved under OMB
control number 0910-0139; and the collections of information in 21 CFR
601.12 and 610.60 and Form FDA 356h have been approved under OMB
control number 0910-0338.

III. 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.

IV. Electronic Access

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

    Dated: September 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23542 Filed 9-24-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 246 (Tuesday, December 23, 2014)]
[Notices]
[Pages 77011-77012]
[FR Doc No: 2014-30015]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0588]

Compliance Policy Guide Sec. 540.700 Labeling of Processed and
Blended Seafood Products Made Primarily With Fish Protein; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of Compliance Policy Guide Sec. 540.700 Labeling of
Processed and Blended Seafood Products Made Primarily with Fish Protein
(the CPG). The CPG provides guidance for our staff on our labeling
requirements for processed and blended seafood products made primarily
with fish protein.

DATES: Submit either electronic or written comments on FDA's CPGs at
any time.

ADDRESSES: Submit written requests for single copies of the CPG to the
Office of Policy and Risk Management, Office of Regulatory Affairs,
Office of Global Regulatory Operations and Policy, Food and Drug
Administration, 12420 Parklawn Dr., Rockville, MD 20857. Send one self-
addressed adhesive label to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the CPG.
    Submit electronic comments on the CPG to http://www.regulations.gov. Submit written comments on the CPG to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Catalina Ferre-Hockensmith, Center for
Food Safety and Applied Nutrition (HFC-820), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-2371.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of revised Compliance Policy
Guide Sec. 540.700 Labeling of Processed and Blended Seafood Products
Made Primarily with Fish Protein. We are issuing the revisions to the
CPG as Level 2 guidance under our good guidance practices regulation
(21 CFR 10.115). Consistent with our good guidance practices
regulation, we will accept comments on the CPG at any time. The CPG
represents our current thinking on this topic. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternate approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
    The CPG updates previously issued CPG Sec. 540.700 Processed and/or

Blended Seafood Products, which provides guidance for our staff on
labeling requirements for processed and blended seafood products made
primarily with fish protein. The CPG has been revised for clarity and
format, including the addition of Regulatory Action Guidance and
Specimen Charges sections. The CPG contains information that may be
useful to the regulated industry and to the public.

II. Comments

    Interested persons may submit either written comments regarding the
guidance to the Division of Dockets Management (see ADDRESSES) or
electronic comments regarding the guidance 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. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.

    Dated: December 18, 2014.
Melinda K. Plaisir,
Associate Commissioner for Regulatory Affairs, Office of Regulatory
Affairs.
[FR Doc. 2014-30015 Filed 12-22-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78638-78640]
[FR Doc No: 2011-32377]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP12-11-000]

Elba Express Company, L.L.C; Notice of Intent To Prepare an
Environmental Assessment for the Proposed Coldwater Compressor Station
Project, Request for Comments on Environmental Issues, and Notice of
Public Scoping Meeting

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Coldwater Compressor Station
Project, involving construction and operation of facilities by Elba
Express Company, L.L.C (Elba Express) in Elbert County, Georgia. The
Commission will use this EA in its decision-making process to determine
whether the project is in the public convenience and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the project. Your input will help the Commission staff
determine what issues they need to evaluate in the EA. Please note that
the scoping period will close on January 20, 2012.
    You may submit comments in written form or verbally. Further
details on how to submit written comments are in the Public
Participation section of this notice. In lieu of or in addition to
sending written comments, the Commission invites you to attend the
public scoping meeting scheduled as follows:

    FERC Public Scoping Meeting Coldwater Compressor Station Project
------------------------------------------------------------------------
            Date and time                           Location
------------------------------------------------------------------------
January 10, 2012, 7 p.m..............  Elbert County Government Complex,
                                        45 Forest Avenue, Elberton, GA
                                        30635.
------------------------------------------------------------------------

    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    Elba Express provided landowners with a fact sheet prepared by the
FERC entitled ``An Interstate Natural Gas Facility On My Land? What Do
I Need To Know?''. This fact sheet addresses a number of typically-
asked questions, including the use of eminent domain and how to
participate in the Commission's proceedings. It is also available for
viewing on the FERC Web site (www.ferc.gov).

Summary of the Proposed Project

    Elba Express proposes to amend its authorization for Phase B of the
Elba Express Pipeline Project in Docket No. CP06-471-000 by changing a
previously approved compression site in Jenkins, Georgia, to a new site
in Elbert County, Georgia. Elba Express now proposes to construct the
previously approved 10,000-horsepower compressor station (Coldwater
Compressor Station) on a 30.8-acre site at milepost 184 on Elba
Express' pipeline. The proposed site is located along the east side of
Craft Road, about 0.8 mile southeast of the Craft Road/Montevideo Road
intersection in northern Elbert County. Minor auxiliary modifications
would also be made at Elba Express' Rincon Gate metering facility.
    Elba Express states that the new compressor station site
accommodates customer receipt and delivery point changes, which have
taken place since the pipeline was originally authorized. The project
would provide up to 220 million cubic feet per day of transportation
capacity, a decrease from the initially approved 230 million cubic feet
per day.
    The general location of the project facilities is shown in appendix
1.\1\
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    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called ``eLibrary'' or from the Commission's Public
Reference Room, 888 First Street NE., Washington, DC 20426, or call
(202) 502-8371. For instructions on connecting to eLibrary, refer to
the last page of this notice.
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Land Requirements for Construction

    Construction of the Coldwater Compressor Station facilities would
disturb about 22.7 acres of the 30.8-acre parcel. Following
construction, about 5.07 acres would be maintained for permanent
operation of the station's facilities; the remaining acreage would be
restored and allowed to revert to pre-construction conditions. An
existing graveled access road from Craft Road would be used during
construction and operation. Elba Express would also construct a
permanent graveled access road to access the proposed station.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\2\ to discover and address concerns the public may have about
proposals. This process is referred to as ``scoping.'' The main goal of
the scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
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    \2\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
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    In the EA, we will discuss impacts that could occur as a result of
the construction and operation of the proposed project under these
general headings:
     Geology and soils;
     Land use;
     Water resources, fisheries, and wetlands;
     Cultural resources;
     Vegetation and wildlife;
     Air quality and noise;
     Endangered and threatened species; and
     Public safety.
    We will also evaluate reasonable alternatives to the proposed
project or portions of the project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. Depending on
the comments received during the scoping process, we may also publish
and distribute the EA to the public for an allotted comment period. We
will consider all comments on the EA before making our recommendations
to the Commission. To ensure we have the opportunity to consider and
address your comments, please carefully follow the instructions in the
Public Participation section below.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the potential environmental
issues of this project to formally cooperate with us in the preparation
of the EA.\3\ Agencies that would like to request cooperating agency
status should follow the instructions for filing comments provided
under the Public Participation section of this notice.
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    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Sec.  1501.6.
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Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with the Georgia State Historic Preservation Office (SHPO), and to
solicit its views and those of other government agencies, interested
Indian tribes, and the public on the project's potential effects on
historic properties.\4\ We will define the project-specific Area of
Potential Effects (APE) in consultation with the SHPO as the project
develops. On natural gas facility projects, the APE at a minimum
encompasses all areas subject to ground disturbance (examples include
the construction right-of-way, contractor/pipe storage yards, and
access roads). Our EA for this project will document our findings on
the impacts of historic properties and summarize the status of
consultations under section 106.
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    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.

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Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the project. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. The more specific
your comments, the more useful they will be. To ensure that your
comments are timely and properly recorded, please send your comments so
that the Commission receives them in Washington, DC on or before
January 20, 2012.
    For your convenience, there are three methods, which you can use to
submit your comments to the Commission. In all instances please
reference the project docket number (CP12-11-000) with your submission.
The Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for interested persons to
submit brief, text-only comments on a project;
    (2) You can file your comments electronically using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing;'' or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed project.
    If we publish and distribute the EA, copies will be sent to the
environmental mailing list for public review and comment. If you would
prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor,'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the User's Guide under the ``e-filing'' link on the Commission's Web
site.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP12-
11). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription, which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/esubscribenow.htm.
    Finally, public meetings or site visits will be posted on the
Commission's calendar at www.ferc.gov/EventCalendar/EventsList.aspx
along with other related information.

    Dated: December 9, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-32377 Filed 12-16-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 61037-61039]
[FR Doc No: 2012-24576]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67955; File No. SR-ISE-2012-76]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Adopt Reduced Fees for Historical ISE Open/Close Trade
Profile Intraday Market Data Offering

October 1, 2012.
    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 September 20, 2012, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change as
described in Items I, II, and III below, which items have been prepared
by the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend its Schedule of Fees to adopt
reduced subscription fees for academics for the sale of historical ISE
Open/Close Trade Profile Intraday market data offering. The text of the
proposed rule change is available on the Exchange's Web site

www.ise.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 self-regulatory organization 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 currently sells the ISE Open/Close Trade Profile Intraday, a
market data offering comprised of the entire opening and closing trade
data of ISE listed options of both customers and firms updated at 10-
minute intervals throughout the trading day.\3\ The ISE Open/Close
Trade Profile Intraday offering is subdivided by origin code (i.e.,
customer or firm) and the customer data is then further subdivided by
order size. The volume data is summarized by day and series (i.e.,
symbol, expiration date, strike price, call or put). The ISE Open/Close
Trade Profile Intraday enables subscribers to create their own
proprietary put/call calculations. This market data offering is
currently available to both members and non-members on annual
subscription basis. The current subscription rate for both members and
non-members is $2,000 per month.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 61317 (January 8,
2010), 75 FR 2915 (January 19, 2010) (SR-ISE-2009-103).
---------------------------------------------------------------------------

    ISE also sells historical ISE Open/Close Trade Profile Intraday.
The historical ISE Open/Close Trade Profile Intraday offering is a
compilation of the ISE Open/Close Trade Profile Intraday files. ISE
sells historical ISE Open/Close Trade Profile Intraday on an ad-hoc
basis. An ad-hoc request can be for any number of months, quarters or
years for which the data is available. Members and non-members are
currently able to purchase this data by paying a one-time fee of $1,000
per month, $2,000 per quarter or $8,000 per year. For example, a
subscriber that wants to purchase data for August 2012 will pay $1,000;
a subscriber that wants to purchase data for July, August and September
of 2012 will pay $2,000; a subscriber that wants to purchase data for
all twelve months of 2011 will pay $8,000.
    The Exchange now proposes to adopt reduced fees for subscriptions
to historical ISE Open/Close Trade Profile Intraday by academic
institutions.\4\ Occasionally, academic institutions inquire with the
Exchange about subscribing to the historical ISE Open/Close Trade
Profile Intraday for research purposes but are not inclined to pay the
full price. In order to encourage and promote academic studies of its
market data, ISE proposes to charge a flat rate of $1,000 for an ad-hoc
request of up to 12 months of data or $2,000 for the complete data set.
Academic institutions may use this data for academic purposes only and
not for actual securities trading. The proposed discount applies only
to the market data fees and does not cover any access or
telecommunication charges that may be incurred by an academic
institution. Moreover, with the adoption of reduced fees for academic
institutions, ISE is not waiving any of its contractual rights and all
academic institutions that subscribe to this data will be required to
execute the appropriate subscriber agreement.
---------------------------------------------------------------------------

    \4\ The Exchange currently has reduced subscription fees for
academic institutions that want to purchase historical ISE Open/
Close Trade Profile End of Day market data offering. Academic
institutions are able to purchase a complete set of the data or on
an ad-hoc basis for up to 12 months of data. See Securities Exchange
Act Release No. 60859 (October 21, 2009), 74 FR 55610 (October 28,
2009) (SR-ISE-2009-64).
---------------------------------------------------------------------------

    Further, the Exchange will apply a credit towards the purchase of
historical ISE Open/Close Trade Profile Intraday data by an academic
institution or academic author if such academic institution or academic
author has previously purchased historical ISE Open/Close Trade Profile
End of Day data and if the academic institution and/or academic author
provides ISE with a link to published research papers on the use of the
ISE Open/Close data that can be posted on the Exchange's Web site. For
example, a university that previously purchased a complete set of the
ISE Open/Close Trade Profile End of Day data and paid the Exchange
$1,000 for that data will pay an incremental $1,000 for a complete set
of the ISE Open/Close Trade Profile Intraday data instead of paying
$2,000 for the complete set.
2. Basis
    The basis under the Securities Exchange Act of 1934 (the ``Act'')
for this proposed rule change is the requirement under Section 6(b)(4)
that an exchange have an equitable allocation of reasonable dues, fees
and other charges among its members and other persons using its
facilities. The Exchange believes that the proposed rule change is
consistent with the provisions of Section 6 of the Act,\5\ in general,
and with Section 6(b)(4) of the Act,\6\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and other persons using any facility or
system which ISE operates or controls. The Exchange notes that the
proposed fees are reasonable and equitable in that they are deeply
discounted and apply equally to all academic institutions as long as
the purpose for subscribing to the data is educational and not
vocational. Further, the Exchange believes the proposed rule filing
will promote academic research of market data which can be of benefit
to all market participants.
---------------------------------------------------------------------------

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

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

    ISE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes that the
proposed rule change will further promote and encourage academic
studies of the ISE Open/Close Trade data for the benefit of all market
participants.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \7\ and Rule 19b-4(f)(2) \8\ 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 shall institute proceedings to determine whether the
proposed rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \8\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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-2012-76 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2012-76. 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 on official business days
between the hours of 10 a.m. and 3 p.m. Copies of such filing also will
be available for inspection and copying at the principal offices 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-ISE-
2012-76, and should be submitted on or before October 26, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-24576 Filed 10-4-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Notices]
[Pages 31759-31760]
[FR Doc No: 2018-14535]

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

Food and Drug Administration

[Docket No. FDA-2018-D-1895]

Indications and Usage Section of Labeling for Human Prescription
Drug and Biological Products--Content and Format; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Indications and Usage Section of Labeling for Human Prescription Drug
and Biological Products--Content and Format.'' This guidance is
intended to assist applicants in writing the Indications and Usage
section of labeling. The recommendations in this draft guidance are
intended to help ensure that the labeling is clear, concise, useful,
and informative and, to the extent possible, consistent in content and
format within and across drug and therapeutic classes.

DATES: Submit either electronic or written comments on the draft
guidance by September 7, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1895 for ``Indications and Usage Section of Labeling for
Human Prescription Drug and Biological Products--Content and Format;
Draft Guidance for Industry; Availability.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Iris Masucci, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled

``Indications and Usage Section of Labeling for Human Prescription Drug
and Biological Products--Content and Format.'' This guidance provides
recommendations on the general principles to consider when drafting an
indication and how to write, organize, and format the information in
the Indications and Usage section of the labeling. The draft guidance
provides recommendations on what information to include in the
indication and when limitations of use should be considered for the
Indications and Usage section.
    The Indications and Usage section must state that the drug is
indicated for the treatment, prevention, mitigation, cure, or diagnosis
of a recognized disease or condition, or of a manifestation of a
recognized disease or condition, or for the relief of symptoms
associated with a recognized disease or condition.\1\ The draft
guidance describes how to clearly convey such information and addresses
circumstances where other information in addition to the identification
of the disease or condition may be warranted.
---------------------------------------------------------------------------

    \1\ See 21 CFR 201.57(c)(2).
---------------------------------------------------------------------------

    The draft guidance describes circumstances in which an indication
may be broader than the specific parameters of the clinical studies
supporting approval, as well as those where a narrower indication may
be appropriate, and explains that the Indications and Usage section
needs to make clear the scope of the indication. The draft guidance
also describes circumstances in which an indication in an age group
broader than the population that was studied may be considered for an
adult population. However, this approach is generally not appropriate
across pediatric populations or between adult and pediatric populations
because of the statutory requirements related to pediatric assessments
and the unique clinical considerations for pediatric patients. For
example, pediatric patients may metabolize drugs differently from
adults (in an age-related manner), are susceptible to different safety
risks, and often require different dosing regimens, even after
correction for weight. For these reasons, FDA recommends that age
groups should be included in indications. An indication should state
that a drug is approved, for example, ``in adults,'' ``in pediatric
patients X years of age and older,'' or ``in adults and pediatric
patients X years of age and older.'' FDA is interested in obtaining
information and public comment on this recommendation and the
implications of routinely including age groups in indications.
    This guidance is one in a series of guidances FDA is developing or
has developed to assist applicants with the content and format of
labeling for human prescription drug and biological products. In the
Federal Register of January 24, 2006 (71 FR 3922), FDA published a
final rule on labeling for human prescription drug and biological
products. The final rule and additional guidances on labeling can be
accessed at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084159.htm.
The labeling requirements and these guidances are intended to make
information in prescription drug labeling easier for health care
practitioners to access, read, and use.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the content
and format of the Indications and Usage section of labeling for human
prescription drug and biological products. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 201.56 and 201.57 have been
approved under OMB control number 0910-0572; the collections of
information in 21 CFR 312.41 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR 314.126(c)
and 314.70 have been approved under OMB control number 0910-0001; and
the collections of information in 21 CFR 601.12 have been approved
under OMB control number 0910-0338.

III. Electronic Access

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

    Dated: June 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14535 Filed 7-6-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 24, 2008 (Volume 73, Number 186)]
[Notices]
[Page 55062-55063]
[DOCID:fr24se08-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

September 15, 2008.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC08-124-000.
    Applicants: Suez Energy North America, Inc., SUEZ Bidco, LLC,
Energy Capital Partners GP I, LLC, FirstLight Power Enterprise, Inc.
    Description: SUEZ Energy North America, Inc's et al Joint
application for authorization under Section 203 of the Federal Power
Act, request for waiver of certain Commission requirements etc.
    Filed Date: 09/09/2008.
    Accession Number: 20080911-0101.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 30, 2008.

    Docket Numbers: EC08-125-000.
    Applicants: NaturEner Glacier Wind Energy 1, LLC, NaturEner Montana
Wind Energy LLC, NaturEner Glacier Financing, LLC.
    Description: Application for Authorization of Disposition of
Jurisdictional Facilities and Requests for Expedited Consideration and
Confidential Treatment of NaturEner Montana Wind Energy, LLC, et al.
    Filed Date: 09/12/2008.
    Accession Number: 20080912-5088.
    Comment Date: 5 p.m. Eastern Time on Friday, October 03, 2008.
    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG08-87-000.
    Applicants: Crystal Lake Wind, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status.
    Filed Date: 08/26/2008.
    Accession Number: 20080826-5086.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 16, 2008.

    Docket Numbers: EG08-88-000.
    Applicants: Crystal Lake Wind II, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status.
    Filed Date: 08/26/2008.
    Accession Number: 20080826-5087.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 16, 2008.

    Docket Numbers: EG08-89-000.
    Applicants: Osceola Windpower II, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status.
    Filed Date: 08/26/2008.
    Accession Number: 20080826-5088.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 16, 2008.

    Docket Numbers: EG08-90-000.
    Applicants: Story Wind, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status.
    Filed Date: 08/26/2008.
    Accession Number: 20080826-5089.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 16, 2008.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER98-4400-011.
    Applicants: Pittsfield Generating Company, L.P.
    Description: Pittsfield Generating Company, L.P. notification of
change in status.
    Filed Date: 09/12/2008.
    Accession Number: 20080912-5079.
    Comment Date: 5 p.m. Eastern Time on Friday, October 03, 2008.

    Docket Numbers: ER04-805-008.
    Applicants: Wabash Valley Power Association, Inc.
    Description: Wabash Valley Power Association, Inc submits the
corrected Second Revised Sheet 1 to FERC Electric Tariff, Original
Volume 2 as a replacement to the sheet submitted 8/14/08 etc.
    Filed Date: 09/08/2008.
    Accession Number: 20080912-0103.
    Comment Date: 5 p.m. Eastern Time on Monday, September 29, 2008.

    Docket Numbers: ER08-1398-001.
    Applicants: Smoky Hills Wind Project II, LLC.

    Description: Smoky Hills Wind Project II, LLC submits an Amendment
to Application for Order Accepting Market-Based Rate tariff, Granting
Waivers and Blanket Authority, and Request for Waiver of Prior Notice
Requirement etc.
    Filed Date: 09/10/2008.
    Accession Number: 20080912-0119.
    Comment Date: 5 p.m. Eastern Time on Monday, September 22, 2008.

    Docket Numbers: ER08-1513-000.
    Applicants: ISO New England Inc.
    Description: ISO New England, Inc submits an informational filing
for qualification in the Forward Capacity Market.
    Filed Date: 09/09/2008.
    Accession Number: 20080912-0121.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 24, 2008.

    Docket Numbers: ER08-1514-000.
    Applicants: American Transmission Systems, Incorporated.
    Description: American Transmission Systems, Inc submits a
Construction Agreement with Buckeye Power, Inc et al to be effective 9/
4/08.
    Filed Date: 09/10/2008.
    Accession Number: 20080912-0115.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 01, 2008.

    Docket Numbers: ER08-1519-000.
    Applicants: Ohio Valley Electric Corporation.
    Description: Ohio Valley Electric Corporation submits an ATC
Calculation Agreement between OVEC and Southwest Power Pool, Inc.
    Filed Date: 09/10/2008.
    Accession Number: 20080912-0168.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 1, 2008.
    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES08-60-001; ES08-61-001.
    Applicants: MidAmerican Energy Company.
    Description: MidAmerican Energy Co's revised Exhibit E worksheet
for computation of interest coverage.
    Filed Date: 09/12/2008.
    Accession Number: 20080912-5105.
    Comment Date: 5 p.m. Eastern Time on Friday, October 03, 2008.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E8-22318 Filed 9-23-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 97 (Monday, May 22, 2017)]
[Notices]
[Pages 23394-23398]
[FR Doc No: 2017-10303]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80699; File No. SR-MSRB-2017-02]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Order Granting Approval of a Proposed Rule Change Consisting of
Proposed Amendments to Rule G-3, on Professional Qualification
Requirements, and Rule G-8, on Books and Records, To Establish
Continuing Education Requirements for Municipal Advisors and
Accompanying Recordkeeping Requirements

May 16, 2017.

I. Introduction

    On March 22, 2017, 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 (i) proposed
amendments to MSRB Rule G-3, on professional qualification
requirements, to establish continuing education requirements for
municipal advisors; (ii) proposed amendments to MSRB Rule G-8, on books
and records to be made by brokers, dealers and municipal securities
dealers (``dealers'') and municipal advisors; and (iii) proposed
amendments to Rule G-3 to make minor technical changes to the rule to
reflect the renumbering of sections and updates to cross-referenced
provisions (collectively the ``proposed rule change''). The proposed
rule change was published for comment in the Federal Register on April
4, 2017.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 80327 (March 29, 2017)
(the ``Notice of Filing''), 82 FR 16449 (April 4, 2017).
---------------------------------------------------------------------------

    The Commission received one comment letter on the proposed rule
change.\4\ On May 10, 2017, the MSRB responded to the comments received
by the Commission.\5\
---------------------------------------------------------------------------

    \4\ See Letter to Secretary, Commission, from Susan Gaffney,
Executive Director, National Association of Municipal Advisors,
dated April 25, 2017 (the ``NAMA Letter'').
    \5\ See Letter to Secretary, Commission, from Gail Marshall,
Associate General Counsel, MSRB, dated May 10, 2017 (the ``MSRB
Response Letter''), available at https://www.sec.gov/comments/sr-msrb-2017-02/msrb201702-1745890-151491.pdf.>
---------------------------------------------------------------------------

II. Description of Proposed Rule Change

    According to the MSRB, the purpose of the proposed rule change is
to amend Rule G-3(i) to prescribe continuing education requirements for
municipal advisors pursuant to the MSRB's statutory mandate under
Section 15B(b) of the Act. As described in the Notice Filing, the goal
of continuing educations is to ensure that certain associated persons
of municipal advisors stay abreast of issues that may affect their job
responsibilities and of product and regulatory developments.\6\ The
proposed rule change also would amend Rule G-8 to establish
recordkeeping requirements related to the administration of a municipal
advisor's continuing education program and make technical changes to
Rule G-3 to reflect the renumbering of sections and updates to cross-
referenced provisions.
---------------------------------------------------------------------------

    \6\ See Notice of Filing.
---------------------------------------------------------------------------

    As further described in the Notice of Filing and the MSRB Response,
the development of the proposed rule change drew from the principles
and structure of the continuing education regulatory framework
currently in place for dealers.\7\
---------------------------------------------------------------------------

    \7\ Id.
---------------------------------------------------------------------------

    Pursuant to the proposed rule change, a municipal advisor would be
required to, at least annually, conduct a needs analysis that evaluates
and prioritizes their specific training needs, develop a written
training plan based on the needs identified in the analysis, and
deliver training concerning municipal advisory activities designed to
meet those training needs. However, the proposed requirements for
municipal advisors would differ from dealers with respect to
identifying those individuals that are subject to the training and the
content that must be covered as part of the minimum standards for the
annual training.
    Pursuant to proposed Rule G-3(i)(ii), a municipal advisor would be
required to implement a continuing education training program for each
individual qualified as either a municipal advisor representative or as
a municipal advisor principal (collectively, ``covered persons'').\8\
The MSRB states that the

establishment of continuing education requirements for municipal
advisors would assist in ensuring that all municipal advisor firms
provide a minimum-level standard of training that is appropriate in the
public interest and for the protection of investors and municipal
entities or obligated persons.\9\
---------------------------------------------------------------------------

    \8\ Under MSRB Rule G-3(d)(i)(A), ``municipal advisor
representative'' means ``a natural person associated with a
municipal advisor who engages in municipal advisory activities on
the municipal advisor's behalf.'' Under MSRB Rule G-3(e)(i),
``municipal advisor principal'' means ``a natural person associated
with a municipal advisor who is qualified as a municipal advisor
representative and is directly engaged in the management, direction
or supervision of the municipal advisory activities of the municipal
advisor and its associated persons.''
    \9\ See Notice of Filing.
---------------------------------------------------------------------------

    Pursuant to proposed Rule G-3(i)(ii)(B)(1), a municipal advisor
would be required to, at least annually, conduct a needs analysis that
evaluates and prioritizes its training needs, develop a written
training plan based on the needs analysis, and deliver training
applicable to its municipal advisory activities. Additionally, pursuant
to the proposed rule change, in developing a written training plan, a
municipal advisor must take into consideration the firm's size,
organizational structure, scope of municipal advisory activities, as
well as regulatory developments.
    Proposed Rule G-3(i)(ii)(B)(2) would prescribe the minimum
standards for continuing education training by requiring that each
municipal advisor's training include, at a minimum, training on the
applicable regulatory requirements and the fiduciary duty obligations
owed to municipal entity clients. Pursuant to the proposed rule change,
the minimum training on the applicable regulatory requirements would
require a municipal advisor's continuing education program to include
training on the regulatory requirements applicable to the municipal
advisory activities in which its covered persons engage. However,
training on the fiduciary duty obligation owed to municipal entity
clients would be a minimum component of the continuing education
training for all covered persons, even those that may not engage in
municipal advisory activities on behalf of a municipal entity client.
The MSRB states that the fiduciary duty obligation owed to a municipal
entity client is a keystone principle of the regulatory framework for
municipal advisors and that the MSRB believes every covered person
engaged in municipal advisory activities should be familiar with such
principle.\10\ A municipal advisor would, under the proposed rule
change, nonetheless, still have the flexibility to determine the
appropriate scope of training that its covered persons need on the
fiduciary duty obligation based on the municipal advisory activities in
which that its covered persons engages.
---------------------------------------------------------------------------

    \10\ Id.
---------------------------------------------------------------------------

    Recognizing that the nature of municipal advisory activities
engaged in by municipal advisors can be diverse; the proposed rule
change would provide municipal advisors with the flexibility to
determine their firm-specific training needs and the content and scope
of the training appropriate for their covered persons. For example, a
municipal advisor that only provides advice to municipal entities on
swap transactions would, under the proposed rule change, be permitted
to design its annual training plan based upon the rules and practices
applicable to its limited business model, so long as such training plan
included the applicable regulatory requirements applicable to that
limited business and a component regarding the fiduciary duty
obligation owed to municipal entity clients. Moreover, under the
proposed rule change, municipal advisors would be able to determine the
method for delivering such training. For example, a municipal advisor
could determine that the most effective manner for delivering the
training would be to require its covered persons to attend an
applicable seminar by subject matter experts and/or to utilize an on-
line training resource.
    The MSRB notes that the minimum requirements for continuing
education training, outlined under the proposed rule change, should not
be viewed by municipal advisors as the full scope of the subject matter
appropriate for municipal advisors' training programs.\11\ The minimum
standard for training does not negate the need for each municipal
advisor to consider whether, based on its needs analysis, additional
training applicable to the municipal advisory activities it conducts is
appropriate.
---------------------------------------------------------------------------

    \11\ Id.
---------------------------------------------------------------------------

    Proposed Rule G-3(i)(ii)(B)(3) would require a municipal advisor to
administer its continuing education program in accordance with the
annual evaluation and prioritization of its training needs and the
written training plan developed as consistent with its needs analysis.
Also, pursuant to this provision, a municipal advisor would be required
to maintain records documenting the content of its training programs
and a record that each of its covered persons identified completed the
applicable training.
    Pursuant to proposed Rule G-3(i)(ii)(C), a municipal advisor's
covered persons (each individual qualified as a municipal advisor
representative or municipal advisor principal) would be required to
participate in the firm's continuing education training programs. If
consistent with its training plan, a municipal advisor could deliver
training appropriate for all covered persons. In addition, a municipal
advisor could determine that its training needs indicate that it should
also deliver particular training for certain covered persons, for
example, those covered persons that have been designated with
supervisory responsibilities under MSRB Rule G-44, or those covered
persons that have been engaged in municipal advisory activities for a
short period of time.
    Pursuant to proposed Rule G-3(i)(ii)(D), on specific training
requirements, the appropriate examining authority could require a
municipal advisor, individually or as part of a larger group, to
provide specific training to its covered persons in such areas the
appropriate examining authority deems appropriate.\12\ Such a
requirement could stipulate the class of covered persons for which it
is applicable, the time period in which the requirement must be
satisfied and, where appropriate, the actual training content.
---------------------------------------------------------------------------

    \12\ For purposes of proposed Rule G-3(i)(ii)(D), ``appropriate
examining authority'' would mean ``a registered securities
association with respect to a municipal advisor that is a member of
such association, or the Commission, or the Commission's designee,
with respect to any other municipal advisor.''
---------------------------------------------------------------------------

    The MSRB states that, in an effort to reduce regulatory overlap for
dealer-municipal advisors,\13\ the proposed rule change would allow a
dealer-municipal advisor to deliver continuing education training that
would satisfy its training needs for the firm's dealer and municipal
advisor activities.\14\ More specifically, pursuant to proposed Rule G-
3(i)(ii)(E), each dealer-municipal advisor will be permitted to develop
a single written training plan, if that training plan is consistent
with each needs analysis that was conducted of the firm's municipal
advisory activities and municipal securities activities. In addition,
the proposed rule provision would allow a municipal advisor to conduct
training for its covered persons and covered registered persons, which
would satisfy the continuing education requirements under Rules G-
3(i)(i)(B) and G-3(i)(ii), if such training is consistent with the
firm's written training plan(s) and that training meets the minimum
standards for the training programs, as required under the rule.
---------------------------------------------------------------------------

    \13\ A member of the Financial Industry Regulatory Authority
that is a municipal securities dealer and municipal advisor is
commonly referred to as a ``dealer-municipal advisor.''
    \14\ See Notice of Filing.

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

Proposed Amendments to MSRB Rule G-8

    The proposed amendments to MSRB Rule G-8 address the books and
records that must be made and maintained by a municipal advisor to show
compliance with recordkeeping requirements related to the
administration of a municipal advisor's continuing education program.
The Board adopted the approach of specifying, in some detail, the
information to be reflected in various records.\15\ Specifically, the
proposed amendments to Rule G-8(h) would require each municipal advisor
to make and maintain records regarding the firm's completion of its
needs analysis and the development of its corresponding written
training plan. Moreover, with respect to each municipal advisor's
written training plan, municipal advisors would be required to make and
keep records documenting the content of the firm's training programs
and a record evidencing completion of the training programs by each
covered person.\16\ The MSRB believes that recordkeeping requirements
are an important element of compliance and the proposed amendments to
Rule G-8 are appropriately tailored to facilitate the examination of a
municipal advisor's compliance with the continuing education
requirements.\17\
---------------------------------------------------------------------------

    \15\ Id.
    \16\ MSRB Rule G-9(h) generally requires municipal advisors to
preserve the books and records described in MSRB Rule G-8(h) for a
period of not less than five years for purposes of consistency with
SEC Rule 15Ba1-8 of the Act on books and records to be made and
maintained by municipal advisors. See Exchange Act Release No. 73415
(October 23, 2014), 79 FR 64423 (October 29, 2014) (SR-MSRB-2014-
06).
    \17\ Id.
---------------------------------------------------------------------------

Technical Amendments

    The proposed rule change would make minor technical amendments to
add paragraph headers, and renumber and update rule cross-references to
Rule G-3(i)(i) and Rule G-3(i)(ii). Rule G-3(i)(i) would be revised by
adding the paragraph header ``Continuing Education Requirements for
Brokers, Dealers, and Municipal Securities Dealers.'' Rule G-3(i)(i)(D)
would be revised by adding the paragraph header ``Reassociation'' and
renumbered Rule G-3(i)(i)(A)(4). Rule G-3(i)(i)(E) would be relocated
to proposed subparagraph Rule G-3(i)(i)(A)(4). Rule G-3(i)(ii) would be
re-lettered Rule G-3(i)(i)(B). Due to these changes, other paragraphs
under Rule G-3(i) would be renumbered and re-lettered.
    The MSRB requested in the Notice of Filing that the proposed rule
change be approved with an implementation date of January 1, 2018.\18\
To comply with the annual training requirement for calendar year 2018,
in accordance with the proposed implementation date, a municipal
advisor would need to complete a needs analysis, develop a written
training plan and deliver the appropriate training by December 31,
2018.
---------------------------------------------------------------------------

    \18\ See Notice of Filing.
---------------------------------------------------------------------------

III. Summary of Comments Received and MSRB's Responses to Comments

    As noted previously, the Commission received one comment letter on
the proposed rule change, as well as the MSRB Response Letter. The
commenter, the National Association of Municipal Advisors (``NAMA''),
expressed general support for the establishment of continuing education
requirements for municipal advisors, noting that it believes it is
imperative for municipal advisors to continue to expand their knowledge
and improve their professional skills beyond the Municipal Advisor
Representative Qualification Examination (Series 50 exam).\19\ NAMA
also suggested that certain aspects of the proposed rule change be
amended to include additional clarifications and guidance prior to its
implementation.\20\ The MSRB believes the proposed rule change is
consistent with its statutory mandate and has responded to the
comments, as discussed below.\21\
---------------------------------------------------------------------------

    \19\ See NAMA Letter.
    \20\ Id.
    \21\ See MSRB Response Letter.
---------------------------------------------------------------------------

1. Additional Guidance on Needs Analysis Requirement and Effective Date

    NAMA requested that the MSRB develop interpretive guidance to help
municipal advisor firms, especially small municipal advisor firms,
better understand how to conduct needs analysis and provide examples of
the types of trainings that could be employed by municipal advisors to
meet the requirements of the proposed rule change.\22\ NAMA also
requested that the implementation date of the proposed rule change be
delayed until the MSRB has issued the interpretive guidance regarding
the need analysis requirement, which NAMA believes is necessary for
municipal advisors to adequately understand and comply with the
proposed rule change.\23\
---------------------------------------------------------------------------

    \22\ See NAMA Letter.
    \23\ Id.
---------------------------------------------------------------------------

    The MSRB responded that, as it previously noted in the Notice of
Filing, it recognizes that additional guidance on conducting a needs
analysis and how to implement a continuing education program may
benefit municipal advisor firms.\24\ The MSRB articulated that it
intends to provide guidance to municipal advisor firms in understanding
their obligations to develop a continuing education program before the
proposed rule change is implemented.\25\ According to the MSRB, such
guidance will include a sample needs analysis, a sample training plan
and a non-exclusive list of delivery mechanisms that a municipal
advisor firm could use in delivering and documenting training.\26\
Also, the MSRB stated that such guidance will be designed to assist a
municipal advisor firm in tailoring the development and implementation
of a continuing education program based on regulatory developments, the
size and organizational structure of the firm and the municipal
advisory activities the firm engages in.\27\ Such guidance, the MSRB
stated, will not promote a one-size-fits-all continuing education
program and will not create a safe harbor.\28\ The MSRB responded that
it intends to provide implementation guidance in a webinar shortly
following approval of the proposed rule change.\29\ In addition, the
MSRB stated that it intends to issue additional guidance, including
sample documentation, at least 90 days prior to the implementation
date.\30\ The MSRB also noted that although it is proposed a January 1,
2018 effective date, municipal advisors would have until December 31,
2018 to complete a needs analysis, develop a written training plan and
deliver the appropriate training to comply with the annual training
requirements for calendar year 2018.\31\ Accordingly, the MSRB believes
that municipal advisor firms will have sufficient time to implement
procedures reasonably designed to achieve compliance with the
continuing education requirements.\32\
---------------------------------------------------------------------------

    \24\ See Notice of Filing.
    \25\ Id.
    \26\ Id.
    \27\ Id.
    \28\ Id.
    \29\ Id.
    \30\ Id.
    \31\ Id.
    \32\ Id.
---------------------------------------------------------------------------

2. Additional Guidance on ``Appropriate Enforcement Authority''

    NAMA requested that the MSRB provide additional interpretive
guidance regarding the scope of the power of the ``appropriate
enforcement authority'' to require, pursuant to amended Rule G-
3(i)(ii)(D), training for individuals or a

group within a municipal advisor following an examination.\33\
---------------------------------------------------------------------------

    \33\ See NAMA Letter.
---------------------------------------------------------------------------

    The MSRB stated that this provision is designed to provide the
appropriate examining authority the discretion to determine, in the
course of examining and enforcing compliance with MSRB rules, whether
an associated person(s) of a municipal advisor requires additional
training.\34\ The MSRB believes the provision is consistent with
similar authority provided under MSRB Rule G-3(h)(ii)(D) with respect
to the continuing education requirements for dealers.\35\
---------------------------------------------------------------------------

    \34\ See MSRB Response Letter.
    \35\ Id.
---------------------------------------------------------------------------

3. Economic Impact of MSRB Rulemaking

    NAMA stated that the MSRB should empirically evaluate the economic
impact that the proposed rule change would have on sole practitioners
and small municipal advisor firms, as well as the potential economic
impact the entire municipal advisor regulatory regime has municipal
advisors.\36\ In expressing its concerns, NAMA cited to a response it
provided to a MSRB request for comment regarding an earlier stage of
this rulemaking initiative where it stated the MSRB should recognize
the multiple roles a principal in a small municipal advisor firm or a
sole-practitioner municipal advisor has to their clients under the
rulemaking regime already imposed by the MSRB and that the additional
requirements of the proposed rule change for all municipal advisor and
especially sole practitioners and smaller firms should be considered
along with the already existing regulatory burden imposed by MSRB rules
and not create an overwhelming economic or administrative burden on
these professionals.\37\
---------------------------------------------------------------------------

    \36\ See NAMA Letter.
    \37\ Id. See also Letter to Ronald W. Smith, MSRB, from Susan
Gaffney, Executive Director, National Association of Municipal
Advisors, dated November 14, 2016.
---------------------------------------------------------------------------

    The MSRB stated that it has evaluated and articulated the economic
impact associated with the proposed rule change in Notice of Filing in
accordance with its Policy on the Use of Economic Analysis in MSRB
Rulemaking \38\ and that it believes that the proposed rule change is
consistent with the requirements of Section 15B(b)(2)(L)(iv) of the Act
\39\ which provides that MSRB rules with respect to municipal advisors
may not impose a regulatory burden on small municipal advisors that is
not necessary or appropriate in the public interest and for the
protection of investors, municipal entities, and obligated persons,
provided that there is robust protection of investors against
fraud.\40\ The MSRB also stated that it plans to assess retrospectively
the impact and effectiveness of the municipal advisory framework once
it is more fully in place and that the Board has discussed the
importance of this future analysis to understanding the benefits and
costs of the municipal advisory regulatory regime.\41\
---------------------------------------------------------------------------

    \38\ See Policy on the Use of Economic Analysis in MSRB
Rulemaking, MSRB, available at: http://msrb.org/rules-and-interpretations/economic-analysis-policy.
    \39\ 15 U.S.C. 78o-4(b)(2)(L)(iv).
    \40\ See MSRB Response Letter. See also Notice of Filing.
    \41\ See MSRB Response Letter.
---------------------------------------------------------------------------

4. Standards of Conduct Applicable to Municipal Advisor Clients

    NAMA requested that the MSRB adopt a clarifying amendment to
proposed Rule G-3(i)(ii)(B)(2)(a) to include ``obligated persons'' to
the language of the proposed rule change to accommodate municipal
advisors that have obligated person clients and not municipal entity
clients.
    The MSRB believes that NAMA's suggested change would materially
change the spirit and intent of the proposed rule change.\42\ The MSRB
stated that the fiduciary duty standard is a keystone principal of the
regulatory framework for municipal advisors and every municipal advisor
needs to address the fiduciary duty obligation in their continuing
education program.\43\ According to the MSRB, it recognizes that
municipal advisory activities can vary from firm to firm and the
proposed rule change therefore affords a municipal advisor sufficient
flexibility to determine the extent and scope of the fiduciary duty
training that needs to be included in its continuing education program
based on the municipal advisory activities in which the firm
engages.\44\
---------------------------------------------------------------------------

    \42\ Id.
    \43\ Id. See also Notice of Filing.
    \44\ See MSRB Response Letter.
---------------------------------------------------------------------------

IV. Discussion and Commission Findings

    The Commission has carefully considered the proposed rule change,
the comment letter received, and the MSRB Response Letter. 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 proposed rule change is consistent with Sections
15B(b)(2)(A), 15B(b)(2)(L) and 15B(b)(2)(G) and of the Act.\45\ Section
15B(b)(2)(A) of the Act states that the MSRB's rules shall provide that
no municipal securities broker or municipal securities dealer shall
effect any transaction in, or induce or attempt to induce the purchase
or sale of, any municipal security, and no broker, dealer, municipal
securities dealer, or municipal advisor shall provide advice to or on
behalf of a municipal entity or obligated person with respect to
municipal financial products or the issuance of municipal securities,
unless such municipal securities broker or municipal securities dealer
meets such standards of operational capability and such municipal
securities broker or municipal securities dealer and every natural
person associated with such municipal securities broker or municipal
securities dealer meets such standards of training, experience,
competence, and such other qualifications as the Board finds necessary
or appropriate in the public interest or for the protection of
investors and municipal entities or obligated persons.\46\ The
Commission believes the proposed rule change is consistent with Section
15B(b)(2)(A) in that the proposed rule will provide for minimum levels
of training for persons engaged in municipal advisor activities, which
is in the public interest and for the protection of investors,
municipal entities and obligated persons.
---------------------------------------------------------------------------

    \45\ 15 U.S.C. 78o-4(b)(2)(A), 78o-4(b)(2)(L) and 78o-
4(b)(2)(G).
    \46\ 15 U.S.C. 78o-4(b)(2)(A).
---------------------------------------------------------------------------

    Section 15B(b)(2)(L) of the Act \47\ provides that the MSRB's rules
shall, with respect to municipal advisors: Prescribe means reasonably
designed to prevent acts, practices, and courses of business as are not
consistent with a municipal advisor's fiduciary duty to its clients;
provide continuing education requirements for municipal advisors;
provide professional standards; and not impose a regulatory burden on
small municipal advisors that is not necessary or appropriate in the
public interest and for the protection of investors, municipal
entities, and obligated persons, provided that there is robust
protection of investors against fraud. The Commission believes the
proposed rule change is consistent with Section 15B(b)(2)(L) in that
the proposed rule will establish continuing education program
requirements for municipal advisors. Requiring municipal advisors to
establish a formal continuing education program for covered persons
will ensure that individuals qualified as either a municipal advisor

representative or as a municipal advisor principal are kept informed of
issues that affect their job responsibilities and of regulatory
developments, which is in furtherance of the protection of investors
against fraud and misconduct. The Commission also finds that the
proposed rule change is consistent with Section 15B(b)(2)(L)(iv) of the
Act in that it will not impose a regulatory burden on small municipal
advisors that is not necessary or appropriate in the public interest
and for the protection of investors, municipal entities, and obligated
persons, provided that there is robust protection of investors against
fraud. Although the proposed rule change will affect all municipal
advisors, including small municipal advisors, the proposed rule change
is a necessary and appropriate regulatory burden in order to protect
investors, municipal entities and obligated persons.
---------------------------------------------------------------------------

    \47\ 15 U.S.C. 78o-4(b)(2)(L).
---------------------------------------------------------------------------

    The Commission also finds that the proposed rule change is
consistent with Section 15B(b)(2)(G) of the Act \48\ which provides
that the MSRB's rules shall prescribe records to be made and kept by
municipal securities brokers, municipal securities dealers, and
municipal advisors and the periods for which such records shall be
preserved. The proposed rule change will, among other things, assist in
ensuring that municipal advisors are complying with the amendments to
proposed MSRB Rule G-3 by extending the existing recordkeeping
requirements applicable to municipal advisors to include making and
maintaining records relating to their continuing education program.
Establishing a requirement for municipal advisors to maintain records
reflecting their continuing education programs will assist the
appropriate examining authority that examines municipal advisors in
monitoring and promoting compliance with the proposed rule change.
---------------------------------------------------------------------------

    \48\ 15 U.S.C. 78o-4(b)(2)(G).
---------------------------------------------------------------------------

    In approving the proposed rule change, the Commission also has
considered the impact of the proposed rule change on efficiency,
competition, and capital formation.\49\ The Commission 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. The
proposed rule change grants municipal advisors flexibility to develop
regulatory training based on firm size, organizational structure, and
scope of business activities. In addition, the proposed rule change
allows for the development of a single training plan that is consistent
with each needs analysis conducted by a dealer-municipal advisor.
Moreover, dealer-municipal advisors can incorporate identified, firm-
specific training needs, with respect to their municipal advisory
activities, into their existing training programs, as long as any
offered training is consistent with the written training plan(s). Also,
the Commission believes requiring municipal advisor's to meet
continuing education requirements will promote compliance by municipal
advisors with the regulations and laws that protect investors,
municipal entities and obligated person by requiring them to keep
informed of current issues and regulatory developments that affect
their job responsibilities and will reduce the risk that users of
municipal advisory services would receive advice that results in harm
or negative impact. This improved compliance, in turn, will likely
improve the market for municipal advisory services and its efficient
operation. Furthermore, the Commission believes that the potential
burdens created by the proposed rule change are to be likely outweighed
by the benefits.
---------------------------------------------------------------------------

    \49\ 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,\50\ that the proposed rule change (SR-2017-02) be, and hereby is,
approved.
---------------------------------------------------------------------------

    \50\ 15 U.S.C. 78s(b)(2).

    For the Commission, pursuant to delegated authority.\51\
---------------------------------------------------------------------------

    \51\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-10303 Filed 5-19-17; 8:45 am]
BILLING CODE 8011-01-P