[Federal Register: January 31, 2008 (Volume 73, Number 21)]
[Proposed Rules]
[Page 5777-5778]
[DOCID:fr31ja08-24]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-29361; Airspace Docket 07-AEA-5]

Proposed Amendment of Class E Airspace; Factoryville, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION:  Notice of proposed rulemaking.

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SUMMARY: This action proposes to amend the Class E airspace area at
Factoryville, PA, to accommodate a new Standard Instrument Approach
Procedure (SIAP) that has been developed for Seamans Field. This
proposal would enhance the safety and management of IFR operations at
Seamans Field, Factoryville, PA.

DATES: Comments must be received on or before March 17, 2008.

ADDRESSES: Send comments on this proposal to the Docket Management
Facility, U.S. Department of Transportation, Docket Operations, West
Building Ground Floor, Room W12-140, 1200 New Jersey Ave., SE.,
Washington, DC 20590; telephone: 1-800-647-5527. You must identify the
docket number FAA-2007-29361; Airspace Docket 07-AEA-5, at the
beginning of your comments. You may also submit comments on the
Internet at http://www.regulations.gov. You may review the public
docket containing the proposal, any comments received, and any final
disposition in person in the Dockets Office between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    An informal docket may also be examined during normal business
hours at the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, System Support,
Eastern Service Center, Federal Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views or arguments, as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Persons wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2007-29361/
Airspace Docket No. 07-AEA-5.'' The postcard will be date/time stamped
and returned to the commenter. All communications received before the
specified closing date for comments will be considered before taking
action on the proposed rule. The proposal contained in this notice may
be changed in light of the comments received. A report summarizing each
substantive public contact with FAA personnel concerned with this
rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://
www.faa.gov or the Federal Register's web page at http://
www.gpoaccess.gov/fr/index.html. Persons interested in being placed on
a mailing list for future NPRMs should contact the FAA's Office of
Rulemaking,<PHONE_NUMBER>, to request a copy of Advisory Circular No.
11-2A, Notice of Proposed Rulemaking Distribution System, which
describes the application procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to amend Class E airspace at Factoryville,
PA. A new Runway 4 Standard Instrument Approach Procedure (SIAP) has
been developed for Seamans Field. As a result, controlled airspace
extending upward from 700 feet Above Ground Level (AGL) is needed to
contain the SIAP and for Instrument Flight Rules (IFR) operations at
Seamans Field. This proposal would increase current Class E airspace
from a 6.2-mile radius to an 8.2-mile radius of Seamans Field and
including the airspace within 5.3 miles each side of the Lake Henry
VORTAC 299[deg] radial extending from the 8.2-mile radius of Seamans
Field to the VORTAC. Class E airspace designations for airspace areas
extending upward from 700 feet or more above the surface of the earth
are published in Paragraph 6005 of FAA Order 7400.9R, signed August 15,
2007, and effective September 15, 2007, which is incorporated by
reference in 14 CFR 71.1. The Class E airspace designation listed in
this document would be published subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in the Title 49 of the United States Code. Subtitle I, Section
106 describes the authority of the FAA administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part, A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E Airspace at Factoryville, PA.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9R, Airspace Designations and
Reporting Points, signed August 15, 2007, and effective September 15,
2007, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA PA E5 Factoryville, PA [Amended]

Seamans Field, PA
    (Lat. 41[deg]35'22'' N., long. 75[deg]45'22'' W.)
Lake Henry VORTAC
    (Lat. 41[deg]28'33'' N., long. 75[deg]28'57'' W.)

    That airspace extending upward from 700 feet above the surface
within an 8.2-mile radius of Seamans Field and including the
airspace within 5.3 miles each side of the Lake Henry VORTAC
299[deg] radial extending from the 8.2-mile radius of Seamans Field
to the VORTAC.
* * * * *

    Issued in College Park, Georgia, on December 17, 2007.
Mark D. Ward,
Manager, System Support Group, Eastern Service Center.
[FR Doc. 08-350 Filed 1-30-08; 8:45 am]

BILLING CODE 4910-13-M


 From: <EMAIL_ADDRESS> To: Byron Bunker/AA/USEPA/US@EPA  Cc: <EMAIL_ADDRESS><EMAIL_ADDRESS> Date: 06/12/2011 12:58 PM  Subject: HDV GHG rule:  weight reduction credit issues

Byron:

We understand that Navistar has requested that the EPA (and possibly NHTSA) add 13L engines to the list of items eligible for weight reduction credits in the GHG rule.  (By "credit" I mean being able to run GEM with a higher weight reduction input.)  While we do not object to Navistar's making such a request, we want the agencies to know that Navistar has not gotten industrywide agreement for this credit.  Daimler does not support the credit.  In particular, we see the idea as (1) lacking in scientific rigor and (2) possibly self-serving.

Specifically, regarding the first point, we believe that a lot more contributes to total vehicle mass than just the bare engine weight.  The full engine system weight would capture cooling system weight, aftertreatment and associated hardware, mounting provisions, accessories, etc.  In particular, a lightweight 13L engine, operated frequently at high torque, may require a relatively heavy cooling system, the weight of which is not appropriately captured by Navistar's proposal.  Yes a 13L engine and its cooling system will likely be lighter than a 15L, but not by the amount that Navistar proposes.  We would be happy to work with the agency and our industry colleagues to develop a more scientifically robust procedure for credits based on full system weight.  While we are at it, we should also consider other equally valid weight savings, such as that for a reduced weight cab and cab-mount assembly, a reduced weight drive train, etc.

Regarding the second point, we think that a manufacturer who has primarily 13L engines to offer (besides two low rated 15L offerings) is trying to get a competitive advantage from the agency seal of approval that would come with this credit.  For example, where a manufacturer offers no equivalent 15L engine rating, why should the manufacturer get credit for putting a 13L engine into the vehicle?  In short, because we believe the agencies should not give competitive advantages to one manufacturer or another, we do not support the credit.

One final point, in case we have not yet made this clear to the agencies:  we think the weight reduction table, with credits for aluminum parts, needs much work before it is ready for the regulation.  Many of the parts on the list (e.g., the hood, fairings, fan shroud) are made of plastic or fiberglass, such that going to aluminum would increase the weight.  Again, we would be happy to work with the EPA and NHTSA in developing a more robust list or, alternatively, a procedure for taking weight into account.

Thanks, Dave ------------------------- David Kayes Compliance and Regulatory Affairs --- Environmental Compliance Daimler Trucks (503) 745-9162 Office (503) 265-9838 Mobile <EMAIL_ADDRESS> If you are not the intended addressee, please inform us immediately that you have received this e-mail in error, and delete it. We thank you for your cooperation.


[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Page 60893]
[FR Doc No: 2015-25631]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL12-101-000; EL14-29-000; EL13-16-000]

New York Association of Public Power v. Niagara Mohawk Power
Corporation and New York Independent System Operator, Inc., New York
Association of Public Power v. Niagara Mohawk Power Corporation and New
York Independent System Operator, Inc., Municipal Electric Utilities
Association of New York v. Niagara Mohawk Power Corporation and New
York Independent System Operator, Inc.; Notice of Filing

    Take notice that on September 30, 2015, Niagara Mohawk Power
Corporation submitted tariff filing: Refund Report to be effective N/A.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on October 21, 2015.

    Dated: October 1, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-25631 Filed 10-7-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 9039-9042]
[FR Doc No: 2018-04209]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82772; File No. SR-FINRA-2018-010]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Revise the Securities Trader (Series 57)
Examination

February 26, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 12, 2018, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as ``constituting a stated policy,
practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule'' under Section
19(b)(3)(A)(i) of the Act \3\ and Rule 19b-4(f)(1) thereunder,\4\ which
renders the proposal effective upon receipt of this filing by the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing revisions to the content outline and selection
specifications for the Securities Trader (Series 57) examination as
part of the restructuring of the representative-level examination
program.\5\ In addition, FINRA is proposing to make changes to the
format of the content outline. FINRA is not proposing any textual
changes to the By-Laws, Schedules to the By-Laws or Rules of FINRA.
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    \5\ FINRA also is proposing corresponding revisions to the
Series 57 question bank. Based on instruction from SEC staff, FINRA
is submitting this filing for immediate effectiveness pursuant to
Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(1) thereunder, and
is not filing the question bank. See Letter to Alden S. Adkins,
Senior Vice President and General Counsel, NASD Regulation, from
Belinda Blaine, Associate Director, Division of Market Regulation,
SEC, dated July 24, 2000. The question bank is available for SEC
review.
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    The revised Series 57 content outline is attached.\6\ The revised
Series 57 selection specifications have been submitted to the
Commission under separate cover with a request for confidential
treatment pursuant to SEA Rule 24b-2.\7\
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    \6\ The Commission notes that the content outline is attached to
the filing, not to this Notice.
    \7\ 17 CFR 240.24b-2.
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    The text of the proposed rule change is available on FINRA's
website at http://www.finra.org, at the principal office of FINRA and
at the Commission's Public Reference Room.[sic]

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

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

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

1. Purpose
    Section 15A(g)(3) of the Act \8\ authorizes FINRA to prescribe
standards of training, experience, and competence for persons
associated with FINRA members. In accordance with that provision, FINRA
has developed

examinations that are designed to establish that persons associated
with FINRA members have attained specified levels of competence and
knowledge, consistent with applicable registration requirements under
FINRA rules. FINRA periodically reviews the content of the examinations
to determine whether revisions are necessary or appropriate in view of
changes pertaining to the subject matter covered by the examinations.
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    \8\ 15 U.S.C. 78o-3(g)(3).
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    The SEC recently approved a proposed rule change to restructure the
FINRA representative-level qualification examination program.\9\ The
rule change, which will become effective on October 1, 2018,\10\
restructures the examination program into a new format whereby all new
representative-level applicants will be required to take a general
knowledge examination (the Securities Industry Essentials or
SIETM) and a tailored, specialized knowledge examination (a
revised representative-level qualification examination) for their
particular registered role.
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    \9\ See Securities Exchange Act Release No. 81098 (July 7,
2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-
FINRA-2017-007).
    \10\ See Regulatory Notice 17-30 (SEC Approves Consolidated
FINRA Registration Rules, Restructured Representative-Level
Qualification Examinations and Changes to Continuing Education
Requirements) (October 2017).
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    The restructured program eliminates duplicative testing of general
securities knowledge on the current representative-level qualification
examinations by moving such content into the SIE examination.\11\ The
SIE examination will test fundamental securities-related knowledge,
including knowledge of basic products, the structure and function of
the securities industry, the regulatory agencies and their functions
and regulated and prohibited practices, whereas the revised
representative-level qualification examinations will test knowledge
relevant to day-to-day activities, responsibilities and job functions
of representatives.\12\
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    \11\ Each of the current representative-level examinations
covers general securities knowledge, with the exception of the
Research Analyst (Series 86 and 87) examinations.
    \12\ FINRA filed the SIE content outline with the SEC for
immediate effectiveness. See Securities Exchange Act Release No.
82578 (January 24, 2018), 83 FR 4375 (January 30, 2018) (Notice of
Filing and Immediate Effectiveness of File No. SR-FINRA-2018-002).
In addition to the proposed rule change relating to the revised
Series 57 examination, FINRA is filing with the Commission for
immediate effectiveness the content outlines for the other revised
representative-level qualification examinations.
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    As part of the restructuring process and in consultation with a
committee of industry representatives, FINRA undertook a review of the
Securities Trader (Series 57) examination to remove the general
securities knowledge currently covered on the examination and to create
a tailored examination to test knowledge relevant to the day-to-day
activities, responsibilities and job functions of a Securities Trader.
In addition, FINRA is proposing to make changes to the format of the
Series 57 content outline.
    Beginning on October 1, 2018, new applicants seeking to register as
Securities Traders must pass the SIE examination and the revised
Securities Trader (Series 57) examination.
Current Content Outline
    The current Series 57 content outline is divided into four major
job functions that are performed by a Securities Trader. The following
are the four major job functions, denoted Function 1 through 4, with
the associated number of questions:
    Function 1: Market Overview and Products, 22 questions;
    Function 2: Engaging in Professional Conduct and Adhering to
Regulatory Requirements, 12 questions;
    Function 3: Trading Activities, 79 questions; and
    Function 4: Maintaining Books and Records and Trade Reporting, 12
questions.
    Each function also includes specific tasks describing activities
associated with performing that function. There are three tasks (1.1-
1.3) associated with Function 1; two tasks (2.1-2.2) associated with
Function 2; three tasks (3.1-3.3) associated with Function 3; and two
tasks (4.1-4.2) associated with Function 4. For example, one such task
(Task 4.2) relates to creating, retaining, and reporting required
records of orders and transactions. Further, the content outline lists
the knowledge required to perform each function and associated tasks
(e.g., in connection with Task 4.2, large trader ID and related
reporting and monitoring requirements and order execution and routing
information). In addition, where applicable, the content outline lists
the laws, rules and regulations a candidate is expected to know to
perform each function and associated tasks. These include applicable
federal securities laws, as well as FINRA and other self-regulatory
organization rules and regulations. The content outline also includes a
preface (e.g., table of contents, details regarding the purpose of the
examination and eligibility requirements), sample questions and
reference materials.
Revised Content Outline
    As noted above, FINRA is proposing to move the general securities
knowledge currently covered on the Series 57 examination to the SIE
examination. For example, FINRA Rule 3220 (Influencing or Rewarding
Employees of Others) (the Gifts Rule) will now be tested on the SIE
examination, rather than on the Series 57 examination. As a result, the
revised Series 57 examination will test knowledge specific to the day-
to-day activities, responsibilities and job functions of a Securities
Trader.
    Further, FINRA is proposing to make changes to the major job
functions that are performed by a Securities Trader. The following are
the revised job functions, denoted Function 1 and Function 2, with the
associated number of questions:
    Function 1: Trading Activities, 41 questions; and
    Function 2: Maintaining Books and Records, Trade Reporting and
Clearance and Settlement, 9 questions.
    FINRA also is proposing to adjust the number of questions assigned
to each major job function to ensure that the overall examination
better reflects the key tasks performed by a Securities Trader. The
questions on the revised Series 57 examination will place emphasis on
tasks such as trading activities, trade reporting and related books and
records.
    Further, FINRA is proposing to make changes to the specific tasks
associated with performing each function. There are three tasks (1.1-
1.3) associated with Function 1 \13\ and three tasks (2.1-2.3)
associated with Function 2.\14\ For example, one such task (Task 2.1)
is reporting trades to the designated reporting facility.\15\ The
content outline also lists the knowledge required to perform each
revised function and associated tasks (e.g., distinctions among
reporting facilities). In addition, where applicable, the content
outline lists the laws, rules and regulations a candidate is expected
to know to perform each revised function and associated tasks (e.g.,
SEA Rule 13h-1).
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    \13\ See Exhibit 3a, Outline Pages 3-9. The outline is attached
as Exhibit 3a to the 19b-4 form.
    \14\ See Exhibit 3a, Outline Pages 10-12.
    \15\ See Exhibit 3a, Outline Page 10.
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    FINRA is proposing similar changes to the Series 57 selection
specifications and question bank.
    Finally, FINRA is proposing to make changes to the format of the
content outline, including to the preface, sample questions and
reference materials.\16\ Among other changes, FINRA is proposing to:
(1) Reduce the preface to one page of introductory information;

(2) streamline details regarding the purpose of the examination; (3)
move the application procedures to FINRA's website; and (4) explain
that the passing score is established using a standard setting
procedure, and that a statistical adjustment process known as equating
is used in scoring the examination.\17\
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    \16\ FINRA is proposing similar changes to the content outlines
for other representative-level examinations.
    \17\ See Exhibit 3a, Outline Page 2.
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    As a result of the proposed changes, the number of scored questions
on the Series 57 examination will be reduced from 125 questions to 50
questions.\18\ Further, the test time, which is the amount of time
candidates will have to complete the examination, will be reduced from
three hours and 45 minutes to one hour and 45 minutes. Currently, a
score of 70 percent is required to pass the examination. FINRA will
publish the passing score of the revised Series 57 examination on its
website, at www.finra.org, prior to its first administration.
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    \18\ Consistent with FINRA's practice of including ``pretest''
questions on examinations, the Series 57 examination includes five
additional, unidentified pretest questions that do not contribute
towards the candidate's score. The pretest questions are designed to
ensure that new examination questions meet acceptable testing
standards prior to use for scoring purposes. Therefore, the Series
57 examination actually consists of 55 questions, 50 of which are
scored. The five pretest questions are randomly distributed
throughout the examination.
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Availability of Content Outline
    The current Series 57 content outline is available on FINRA's
website. The revised Series 57 content outline will replace the current
content outline on FINRA's website, and it will be made available on
the website on the date of this filing.
    FINRA is filing the proposed rule change for immediate
effectiveness. The implementation date will be October 1, 2018, to
coincide with the implementation of the restructured representative-
level examination program. FINRA will also announce the implementation
date of the proposed rule change in a Regulatory Notice.
2. Statutory Basis
    FINRA believes that the proposed revisions to the Series 57
examination program are consistent with the provisions of Section
15A(b)(6) of the Act,\19\ which requires, among other things, that
FINRA rules must be designed to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
and, in general, to protect investors and the public interest, and
Section 15A(g)(3) of the Act,\20\ which authorizes FINRA to prescribe
standards of training, experience, and competence for persons
associated with FINRA members. The proposed rule change will improve
the examination program, without compromising the qualification
standards, by removing the general knowledge content currently covered
on the Series 57 examination, since that content will be covered in the
co-requisite SIE examination.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78o-3(b)(6).
    \20\ 15 U.S.C. 78o-3(g)(3).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The updated examination aligns
with the functions and associated tasks currently performed by a
Securities Trader and tests knowledge of the most current laws, rules,
regulations and skills relevant to those functions and associated
tasks. As such, the proposed revisions would make the examination more
effective. FINRA also provided a detailed economic impact assessment
regarding the introduction of the SIE examination and the restructuring
of the representative-level examinations as part of the proposed rule
change to restructure the FINRA representative-level qualification
examination program.\21\
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    \21\ See Securities Exchange Act Release No. 80371 (April 4,
2017), 82 FR 17336 (April 10, 2017) (Notice of Filing of File No.
SR-FINRA-2017-007).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \22\ and paragraph (f)(1) of Rule 19-4
thereunder.\23\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act. If
the Commission takes such action, the Commission shall institute
proceedings to determine whether the proposed rule should be approved
or disapproved.
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    \22\ 15 U.S.C. 78s(b)(3)(A).
    \23\ 17 CFR 240.19b-4(f)(1).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-FINRA-2018-010 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2018-010. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of FINRA. All comments received will be
posted without change. Persons submitting comments are cautioned that
we do not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
FINRA-2018-010 and should be submitted on or before March 23, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-04209 Filed 3-1-18; 8:45 am]
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[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Notices]
[Page 79362]
[FR Doc No: 2015-31929]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76658; File No. SR-BX-2015-071]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Withdrawal of Proposed Rule Change To Amend the Fees Schedule

December 15, 2015.
    On November 12, 2015, the NASDAQ OMX BX, Inc. (``Exchange'') filed
with the Securities and Exchange Commission (``Commission''), pursuant
to section 19(b)(1) of the Securities Exchange Act of 1934\1\ and Rule
19b-4 thereunder,\2\ a proposed rule change to amend the Exchange's
fees schedule. The proposed rule change was published for comment in
the Federal Register on December 1, 2015.\3\ The Commission received no
comment letters on the proposal. On December 11, 2015, the Exchange
withdrew the proposed rule change (SR-BX-2015-071).
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 76520 (November 24,
2015), 80 FR 75157.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\4\
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    \4\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-31929 Filed 12-18-15; 8:45 am]
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[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)]
[Notices]
[Pages 43241-43243]
[FR Doc No: 2017-19493]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]

Biosimilar User Fee Rates for Fiscal Year 2018

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for biosimilar user fees for fiscal year (FY) 2018. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar
User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and
collect user fees for certain activities in connection with biosimilar
biological product development; review of certain applications for
approval of biosimilar biological products; and each biosimilar
biological product approved in a biosimilar biological product
application.
    BsUFA II directs FDA to establish, before the beginning of each
fiscal year, the amount of initial and annual biosimilar biological
product development (BPD) fees, the reactivation fee, and the
biosimilar biological product application and program fees for such
year. These fees apply to the period from October 1, 2017, through
September 30, 2018.

FOR FURTHER INFORMATION CONTACT: David Haas, Office of Financial
Management, Food and Drug Administration, 8455 Colesville Rd., COLE-
14202I, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 744G, 744H, and 744I of the FD&C Act (21 U.S.C. 379j-51,
379j-52, and 379j-53), as amended by BsUFA II (title IV of the FDA
Reauthorization Act of 2017, Pub. L. 115-52), authorizes the program of
fees for biosimilar biological products. Under section 744H(a)(1)(A) of
the FD&C Act, the initial BPD fee for a product is due when the sponsor
submits an investigational new drug (IND) application that FDA
determines is intended to support a biosimilar biological product
application or within 5 calendar days after FDA grants the first BPD
meeting, whichever occurs first. A sponsor who has paid the initial BPD
fee is considered to be participating in FDA's BPD program for that
product.
    Under section 744H(a)(1)(B) of the FD&C Act, once a sponsor has
paid the initial BPD fee for a product, the annual BPD fee is assessed
beginning with the next fiscal year. The annual BPD fee is assessed for
the product each fiscal year until the sponsor submits a marketing
application for the product that is accepted for filing, or
discontinues participation in FDA's BPD program.
    Under section 744H(a)(1)(D) of the FD&C Act, if a sponsor has
discontinued participation in FDA's BPD program and wants to re-engage
with FDA on development of the product, the sponsor must pay a
reactivation fee to resume participation in the program. The sponsor
must pay the reactivation fee by the earlier of the following dates: No
later than 5 calendar days after FDA grants the sponsor's request for a
BPD meeting for that product, or upon the date of submission by the
sponsor of an IND describing an investigation that FDA determines is
intended to support a biosimilar biological product application. The
sponsor will be assessed an annual BPD fee beginning with the first
fiscal year after payment of the reactivation fee.
    BsUFA II also authorizes fees for certain biosimilar biological
product applications and for each biosimilar biological product
identified in an approved biosimilar biological product application
(sections 744H(a)(2) and 744H(a)(3) of the FD&C Act). Under certain
conditions, FDA may grant a small business a waiver from its first
biosimilar biological product application fee (section 744H(d)(1) of
the FD&C Act).
    For FY 2018, the fee revenue amount is $45,000,000, adjusted as
needed to reflect an updated assessment of the workload for the process
for the review of biosimilar biological product applications. FDA is
adjusting the FY 2018 revenue amount to $40,214,000 (rounded to the
nearest thousand dollars) reflecting its updated assessment of the
likely workload for the BsUFA program in FY 2018.
    This document provides fee rates for FY 2018 for the initial and
annual BPD fee ($227,213), for the reactivation fee ($454,426), for an
application requiring clinical data ($1,746,745), for an application
not requiring clinical data ($873,373), and for the program fee
($304,162). These fees apply to the period from October 1, 2017,
through September 30, 2018. For applications that are submitted for
this period, this FY 2018 fee schedule must be used.

II. Fee Revenue Amount for FY 2018

    The fee revenue amount for FY 2018 is $45,000,000 adjusted for
updated workload estimates (see sections 744H(b)(1) and 744H(c)(4) of
the FD&C Act).

A. Statutory Fee Revenue Adjustments for Inflation

    BsUFA II specifies that the annual fee revenue amount is to be
further adjusted for inflation increases for FY 2019 through FY 2022
using two separate adjustments--one for personnel

compensation and benefits (PC&B) and one for non-PC&B costs (see
section 744H(c)(1) of the FD&C Act). Because the adjustment for
inflation does not take effect until FY 2019, FDA will not adjust the
FY 2018 fee revenue amount for inflation.

B. FY 2018 Statutory Fee Revenue Adjustment for Workload

    BsUFA II specifies that for FY 2018, the fee revenue amount
includes an adjustment to reflect an updated assessment of the workload
for the process for the review of biosimilar biological product
applications (see section 744H(c)(4) of the FD&C Act).
    In considering the appropriate FY 2018 fee revenue adjustment, FDA
considered a range of factors including its best estimated level of
submissions and activities (including forecasts of new BPDs, new
351(k)s, resubmitted 351(k)s, advisory committee meetings,
interchangeability supplements, industry meetings, inspection activity,
science and research activities, policy work, and other activities).
Considering the totality of work forecasted for FY 2018 (and
recognizing the inherent uncertainty of any forecast), FDA has
determined that the appropriate adjusted level of the FY 2018 BsUFA fee
revenue amount to be $40,214,000 (rounded to the nearest thousand
dollars). FDA will use this amount as the target revenue amount for FY
2018.

III. Fee Amounts for FY 2018

    Under section 744H(b)(3)(A) of the FD&C Act, FDA must determine the
percentage of the total revenue amount for a fiscal year to be derived
from: (1) Initial and annual BPD fees and reactivation fees, (2)
biosimilar biological product application fees, and (3) biosimilar
biological product program fees. In establishing the fee amounts for
the first year of BsUFA II, FDA considered how best to balance the fee
allocation to provide stable funding and reasonable fee amounts, and
utilized benchmarks as described below. In future years, FDA will
consider the most appropriate means of allocating the fee amounts to
collect the adjusted target revenue amount, subject to the relevant
statutory provisions.

A. Application Fees

    In establishing the biosimilar biological product application fee
amount for FY 2018, FDA estimated the total number of fee-paying full
applications equivalents (FAEs) it expects to receive in FY 2018. A
full original 351(k) submission requiring clinical data counts as one
FAE. An original 351(k) application not requiring clinical data counts
as one-half of an FAE. An application that is withdrawn before filing,
or refused for filing, counts as one-fourth of an FAE if the applicant
initially paid a full application fee. An application that is
withdrawn, or refused for filing, counts as one-eighth of an FAE if the
applicant initially paid one-half of the full application fee.
    FDA considered the likelihood of submissions based on various
indicators including a survey of sponsors on their intention to submit
a 351(k) application. Based on the available information, FDA estimates
it may receive 13 351(k) applications in FY 2018.
    FDA has determined that the amount of the biosimilar biological
product application fee for FY 2018 is $1,746,745, which is estimated
to provide a total of $22,707,685, representing 56 percent (rounded to
the nearest one) of the FY 2018 target revenue amount.

B. Biosimilar Biological Product Program Fee

    BsUFA II renamed the product fee as the biosimilar biological
product program fee (``program fee''); in addition, BsUFA II introduced
a limitation that a person who is named as an applicant in a 351(k)
application shall not be assessed more than five program fees for a
fiscal year for biosimilar biological products identified in each
351(k) application (see FD&C Act section 744H(a)(3)(D)). The program
fee was also modified so that applicants are assessed a program fee
only for biosimilar biological products identified in a biosimilar
biological product application approved as of October 1 of such fiscal
year.
    FDA estimates up to nine program fees will be invoiced in FY 2018,
including currently approved products and products with the potential
to be approved in pending applications with goal dates in FY 2017. For
products invoiced in the FY 2018 regular billing cycle, FDA anticipates
that zero program fees will be refunded. This prediction is based on
observations dating to 2015, when the first biosimilar product was
approved.
    FDA has determined that the amount of the biosimilar biological
product program fee for FY 2018 is $304,162, which is estimated to
provide a total of $2,737,458, representing 7 percent (rounded to the
nearest one) of the FY 2018 target revenue amount.

C. Initial and Annual BPD Fees, Reactivation Fees

    To estimate the number of participants in the BPD program in FY
2018, FDA must consider the number of new participants in the BPD
program (initial BPD), the number of current participants (annual BPD),
and the number of participants who will re-enter the BPD program
(reactivation). FDA uses internal data, a survey of BPD sponsors,
market sales data on reference products, and expected reference product
expiration dates to estimate the total number of participants in the
BPD program. FDA estimates 10 participants entering the BPD program,
zero reactivations, and 55 participants to be invoiced for the annual
BPD fee for a total of 65 participants in the BPD program in FY 2018.
    The remainder of the target revenue of $14,768,857, or 37 percent
(rounded to the nearest one), is to be collected from the BPD fees.
Dividing this amount by the estimated 65 BPD fees to be paid equals a
BPD fee amount of $227,213. The reactivation fee is set at twice the
initial/annual BPD amount at $454,426. FDA estimates zero reactivation
fees will be paid, as none have yet been paid in the history of the
BsUFA program.

IV. Fee Schedule for FY 2018

    The fee rates for FY 2018 are provided in table 1.

                    Table 1--Fee Schedule for FY 2018
------------------------------------------------------------------------
                                                          Fee rates  for
                      Fee category                         FY 2018  ($)
------------------------------------------------------------------------
Initial BPD.............................................         227,213
Annual BPD..............................................         227,213
Reactivation............................................         454,426
Applications:
  Requiring clinical data...............................       1,746,745
  Not requiring clinical data...........................         873,373
Program.................................................         304,162
------------------------------------------------------------------------

V. Fee Payment Options and Procedures

A. Initial BPD, Reactivation, and Application Fees

    The fees established in the new fee schedule apply to FY 2018,
i.e., the period from October 1, 2017, through September 30, 2018. The
initial BPD fee for a product is due when the sponsor submits an IND
that FDA determines is intended to support a biosimilar biological
product application for the product or within 5 calendar days after FDA
grants the first BPD meeting for the product, whichever occurs first.
Sponsors who have discontinued participation in the BPD program must
pay the reactivation fee by the earlier of the following dates: No
later than 5 calendar days after FDA grants the sponsor's request for a
BPD meeting for that product, or upon the date of

submission by the sponsor of an IND describing an investigation that
FDA determines is intended to support a biosimilar biological product
application.
    The application fee for a biosimilar biological product is due upon
submission of the application (see section 744H(a)(2)(C) of the FD&C
Act).
    To make a payment of the initial BPD, reactivation, or application
fee, complete the Biosimilar User Fee Cover Sheet, available on FDA's
Web site (http://www.fda.gov/bsufa) and generate a user fee
identification (ID) number. Payment must be made in U.S. currency by
electronic check, check, bank draft, U.S. postal money order, or wire
transfer. The preferred payment method is online using electronic check
(Automated Clearing House (ACH) also known as eCheck) or credit card
(Discover, VISA, MasterCard, American Express). Secure electronic
payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay (Note: Only full payments are accepted. No
partial payments can be made online). Once you search for your invoice,
click ``Pay Now'' to be redirected to Pay.gov. Electronic payment
options are based on the balance due. Payment by credit card is
available for balances that are less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
made using U.S. bank accounts as well as U.S. credit cards.
    FDA has partnered with the U.S. Department of the Treasury to use
http://www.pay.gov, a web-based payment application, for online
electronic payment. The Pay.gov feature is available on FDA's Web site
after completing the Biosimilar User Fee Cover Sheet and generating the
user fee ID number.
    Please include the user fee ID number on your check, bank draft, or
postal money order, and make it payable to the Food and Drug
Administration. Your payment can be mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. To send a
check by a courier such as Federal Express or United Parcel Service,
the courier must deliver the check and printed copy of the cover sheet
to: U.S. Bank, ATTN: Government Lockbox 979108, 1005 Convention Plaza,
St. Louis, MO 63101. (Note: This U.S. Bank address is for courier
delivery only. Contact U.S. Bank at<PHONE_NUMBER> if you have any
questions concerning courier delivery.) Please make sure that the FDA
post office box number (P.O. Box 979108) is written on the check, bank
draft, or postal money order.
    If paying by wire transfer, please reference your unique user fee
ID number when completing the transfer. The originating financial
institution may charge a wire transfer fee. Please ask your financial
institution about the fee and include it with your payment to ensure
that your fee is fully paid. The account information for wire transfers
is as follows: U.S. Department of Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT:
FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd., 14th Floor, Silver
Spring, MD 20993-0002. If needed, FDA's tax identification number is
53-0196965.

B. Annual BPD and Program Fees

    FDA will issue invoices for annual BPD and program fees for FY 2018
under the new fee schedule in September 2017. Payment instructions will
be included in the invoices, including payment due dates. If sponsors
join the BPD program after the annual BPD invoices have been issued in
September 2017, FDA will issue invoices in December 2017 to firms
subject to fees for FY 2018 that qualify for the annual BPD fee after
the September 2017 billing. FDA will issue invoices in December 2017
for any annual program fees for FY 2018 that qualify for fee
assessments and were not issued in September 2017.

    Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19493 Filed 9-13-17; 8:45 am]
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