[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Notices]
[Pages 31968-31970]
[FR Doc No: 2013-12580]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: [FEMA-2013-0020] OMB No. 1660-0114]

Agency Information Collection Activities: Proposed Collection;
Comment Request

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this notice seeks

comments concerning the information collection activities required to
administer the Port Security Grant Program (PSGP).

DATES: Comments must be submitted on or before July 29, 2013.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2013-0020. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., Washington, DC 20472-3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jeffrey Hall, Program Manager, FEMA,
Grant Programs Directorate,<PHONE_NUMBER>. You may contact the Records
Management Division for copies of the proposed collection of
information at facsimile number<PHONE_NUMBER> or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Port Security Grant Program (PSGP) is a
DHS grant program that focuses on infrastructure protection activities.
The PSGP is one tool in the comprehensive set of measures authorized by
Congress and implemented by the Administration to strengthen the
Nation's critical infrastructure against risks associated with
potential terrorist attacks. The vast bulk of U.S. critical
infrastructure is owned and/or operated by State, local and private
sector partners. PSGP funds support increased port-wide risk
management; enhanced domain awareness; training and exercises; and
further capabilities to prevent, detect, respond to, and recover from
attacks involving improvised explosive devices (IEDs) and other non-
conventional weapons. Section 102 of the Maritime Transportation
Security Act of 2002, as amended (46 U.S.C. 70107), established the
PSGP to provide for the establishment of a grant program for a risk-
based allocation of funds to implement Area Maritime Transportation
Security Plans and facility security plans among port authorities,
facility operators, and State and local government agencies required to
provide port security services.

Collection of Information

    Title: FEMA Preparedness Grants: Port Security Grant Program
(PSGP).
    OMB Number: 1660-0114.
    Type of Information Collection: Revision of a currently approved
information collection.
    FEMA Forms: FEMA Form 089-5, PSGP Investment Justification.
    Abstract: The PSGP is an important tool among a comprehensive set
of measures to help strengthen the Nation against risks associated with
potential terrorist attacks. DHS/FEMA uses the information to evaluate
applicants' familiarity with the national preparedness architecture and
identify how elements of this architecture have been incorporated into
regional/state/local planning, operations, and investments.
    Affected Public: State, Local or Tribal Government; business or
other for-profit.
    Number of Respondents: 370.
    Number of Responses: 1,112.
    Estimated Total Annual Burden Hours: 17,414 hours.

State Table

                                                 Table A.12--Estimated Annualized Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Avg.        Total                     Total
                                                             Number of      Number of       Total      burden per     annual    Avg. hourly     annual
         Type of respondent            Form name/Form No.   respondents   responses per   number of     response   burden  (in  wage rate *   respondent
                                                                           respondent     responses    (in hours)     hours)                     cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
State, Local or Tribal Government..  PSGP Investment                 56               4          224           16        3,584       $52.91  $189,629.44
                                      Justification/FEMA
                                      Form 089-5.
State, Local or Tribal Government..  PSGP--Memorandum of              4               1            4            2            8        52.91       423.28
                                      Understanding (MOU)
                                      or Memorandum of
                                      Agreement (MOA).
                                                           ---------------------------------------------------------------------------------------------
    Total..........................  .....................           60  ..............          228  ...........        3,592  ...........   190,052.72
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Note: The ``Avg. Hourly Wage Rate'' for each respondent includes a 1.4 multiplier to reflect a fully-loaded wage rate.

Local Table

                                                 Table A.12--Estimated Annualized Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                    Avg.        Total                     Total
                                                                Number of    responses      Total      burden per     annual    Avg. hourly     annual
         Type of respondent              Form name/Form No.    respondents      per       number of     response   burden  (in  wage rate *   respondent
                                                                             respondent   responses    (in hours)     hours)                     cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
State, Local or Tribal Government...  PSGP Investment                  128            3          384           16        6,144       $52.91  $325,079.04
                                       Justification/FEMA
                                       Form 089-5.
State, Local or Tribal Government...  PSGP--Memorandum of               17            1           17            2           34        52.91     1,798.94
                                       Understanding (MOU) or
                                       Memorandum of
                                       Agreement (MOA).
                                                              ------------------------------------------------------------------------------------------
    Total...........................  .......................          145  ...........          401  ...........        6,178  ...........   326,877.98
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Note: The ``Avg. Hourly Wage Rate'' for each respondent includes a 1.4 multiplier to reflect a fully-loaded wage rate.

Business or Other For-Profit Table

                                                 Table A.12--Estimated Annualized Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Avg.        Total                     Total
                                                             Number of      Number of       Total      burden per     annual    Avg. hourly     annual
         Type of respondent            Form name/Form No.   respondents   responses per   number of     response   burden  (in  wage rate *   respondent
                                                                           respondent     responses    (in hours)     hours)                     cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Business or other for-profit.......  PSGP Investment                159               3          477           16        7,632       $52.91  $403,809.12
                                      Justification/FEMA
                                      Form 089-5.
Business or other for-profit.......  PSGP--Memorandum of              6               1            6            2           12        52.91       634.92
                                      Understanding (MOU)
                                      or Memorandum of
                                      Agreement (MOA).
                                                           ---------------------------------------------------------------------------------------------
    Total..........................  .....................          165  ..............          483  ...........        7,644  ...........   404,444.04
        Grand Total................  .....................          370  ..............        1,112  ...........       17,414  ...........   921,374.74
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Note: The ``Avg. Hourly Wage Rate'' for each respondent includes a 1.4 multiplier to reflect a fully-loaded wage rate.

    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $921,374.74. There are no annual costs to respondents
operations and maintenance costs for technical services. There is no
annual start-up or capital costs. The cost to the Federal Government is
$897,447.60.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: May 20, 2013.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2013-12580 Filed 5-24-13; 8:45 am]
BILLING CODE 9111-19-P


[Federal Register Volume 84, Number 225 (Thursday, November 21, 2019)]
[Notices]
[Pages 64368-64370]
[FR Doc No: 2019-25215]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87546; File No. SR-CBOE-2019-105]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Its Fee Schedule

November 15, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 1, 2019, Cboe Exchange, Inc. (the ``Exchange'' or
``Cboe Options'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II and III below, which Items have been prepared by the Exchange. The
Commission is publishing this

notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to amend its Fees Schedule. The text of the proposed rule change is
provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    In 2016, the Exchange's parent company, Cboe Global Markets, Inc.
(formerly named CBOE Holdings, Inc.) (``Cboe Global''), which is also
the parent company of Cboe C2 Exchange, Inc. (``C2''), acquired Cboe
EDGA Exchange, Inc. (``EDGA''), Cboe EDGX Exchange, Inc. (``EDGX'' or
``EDGX Options''), Cboe BZX Exchange, Inc. (``BZX'' or ``BZX
Options''), and Cboe BYX Exchange, Inc. (``BYX'' and, together with
Cboe Options, C2, EDGX, EDGA, and BZX, the ``Cboe Affiliated
Exchanges''). Cboe Options migrated its trading platform to the same
system used by the Cboe Affiliated Exchanges, on October 7, 2019 (the
``migration''). As a result of the migration, the Exchange adopted a
new connectivity infrastructure, including new physical ports and
corresponding fees.\3\ The Exchange proposes to waive physical port
fees for connections to PULSe, effective November 1, 2019.
---------------------------------------------------------------------------

    \3\ The Exchange notes that effective October 7, 2019, market
participants will no longer have connectivity to the old Exchange
architecture.
---------------------------------------------------------------------------

    By way of background, a physical port is utilized by a Trading
Permit Holder (``TPH'') or non-TPH to connect to the Exchange at the
data centers where the Exchange's servers are located. Prior to
migration, the Exchange utilized Network Access Ports for these
physical connections to the Exchange and assessed fees based on the
gigabit size of the port. Specifically, TPHs and non-TPHs could elect
to connect to Cboe Options' trading system via either a 1 gigabit per
second (``Gb'') Network Access Port or a 10 Gb Network Access Port. The
Exchange assessed a monthly fee of $1,500 per port for 1 Gb Network
Access Ports and a monthly fee of $5,000 per port for 10 Gb Network
Access Ports for access to Cboe Options primary system. Network Access
Ports could also be used to send orders to PULSe. Upon migration, the
TPHs and non-TPHs had the option to alternatively elect to connect to
Cboe Options via new latency equalized Physical Ports. Through January
31, 2020 however, Cboe Options market participants will still have the
ability to connect to Cboe Options' trading system via the current
Network Access Ports. For the month of October 2019, TPHs and non-TPHs
would be assessed (1) $1,500 per 1 Gb port, regardless if it was a
legacy Network Access Port or new Physical Port and (2) $5,000 per 10
Gb port, regardless if it was a legacy Network Access Port or Physical
Port.\4\ As of November 1, 2019, the monthly fee per 1 Gb Network
Access Port and Physical Port is $1,500 and the monthly fee per 10 Gb
Network Access Port and Physical Port is $7,000.
---------------------------------------------------------------------------

    \4\ If a TPH replaced a legacy Network Access Port with a new C1
latency equalized Physical Port in October 2019, the TPH was not
billed an additional fee for the new C1 platform physical connection
for October.
---------------------------------------------------------------------------

    The Exchange notes that although the new latency equalized Physical
Ports became available on October 7, 2019, the new Physical Ports
cannot currently be utilized to send orders to PULSe. Accordingly,
users who wish to route orders to PULSe via the Exchange's physical
ports must maintain and use a legacy Network Access Fee Port and cannot
use any of the new Physical Ports for such purpose. As such, the
Exchange proposes to provide that fees for one Network Access Port that
is used only to access PULSe will be waived per TPH or non-TPH. As
such, the Exchange proposes to provide that fees for one Network Access
Port that is used only to access PULSe will be waived per TPH or non-
TPH. The Exchange notes that whether a user requires a 1 Gb Network
Access Port or 10 Gb Network Access Port for this particular purpose
may depend on their own connectivity architecture (i.e., some
participants may not be able to route orders to PULSe over a 1 Gb,
whereas others may not be able to route over a 10 Gb). Accordingly, the
Exchange will waive fees for either a 1 Gb or 10 Gb Network Access
Port. Such ports will be configured to only allow routing of orders to
PULSe, regardless of size, and notes further that for this particular
purpose, a 10 Gb port does not have an advantage over a 1 Gb port.
    The Exchange lastly proposes to eliminate now obsolete language in
the Physical Connectivity Fees table. Particularly, the Exchange
proposes to eliminate the Monthly Fees column for fees through October
31, 2019 and eliminate the reference to ``Effective November 1, 2019''
in the title of the column with for fees effective November 1, 2019.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\5\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \6\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with
Section 6(b)(4) of the Act,\7\ which requires that Exchange rules
provide for the equitable allocation of reasonable dues, fees, and
other charges among its Trading Permit Holders and other persons using
its facilities.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes the proposed waiver is reasonable as users
subject to the proposed waiver would not have to pay a fee for one
Network Access Port used only to access PULSe. As noted above, the
recently adopted latency equalized Physical Ports that TPHs and

non-TPHs may purchase to connect to the Exchange's trading system, do
not support the routing of orders to PULSe. As such, TPHs that wish to
route orders to PULSe via physical ports must maintain a legacy Network
Access Port. Due to this limitation, the Exchange believe it's
reasonable to waive fees for one Network Access Port that is used only
to access PULSe. As noted above, the Exchange believes it's appropriate
to waive either one 1 Gb Network Access Port or one 10 Gb Network
Access Port, as for this particular purpose, there is no latency
advantages to maintain a 10 Gb versus 1 Gb port and because users' own
architecture may require one size over the other. The Exchange believes
the proposed waiver is equitable and not unfairly discriminatory as it
applies to any TPH or non-TPH that must maintain a Network Access Port
for the sole purpose of accessing PULSe.
    Lastly, the Exchange believes eliminating obsolete language in the
Fees Schedule pertaining to fees assessed in a prior month maintains
clarity in the Fees Schedule and alleviates potential confusion,
thereby removing impediments to and perfecting the mechanism of a free
and open market and a national market system, and, in general,
protecting investors and the public interest.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act because the proposed changes
applies uniformly to all similarly situated market participants. The
Exchange believes that the proposed rule change will not cause an
unnecessary burden on intermarket competition because it only applies
to trading on Cboe Options. To the extent that the proposed changes
make Cboe Options a more attractive marketplace for market participants
at other exchanges, such market participants are welcome to become Cboe
Options market participants.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and paragraph (f) of Rule 19b-4 \9\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2019-105 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2019-105. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CBOE-2019-105, and should be submitted
on or before December 12, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-25215 Filed 11-20-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 205 (Tuesday, October 23, 2012)]
[Notices]
[Page 64836]
[FR Doc No: 2012-26149]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, October
25, 2012 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
October 25, 2012 will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings; and
Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

     Dated: October 18, 2012.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-26149 Filed 10-19-12; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Notices]
[Pages 31603-31604]
[FR Doc No: 2015-13471]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0194]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Biosimilars User Fee
Cover Sheet; Form FDA 3792

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by July 6,
2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0718.
Also include the FDA docket number found in brackets in the heading of
this document.

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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Biosimilars User Fee Cover Sheet; Form FDA 3792

OMB Control Number 0910-0718--Extension

    The Patient Protection and Affordable Care Act (Pub. L. 111-148)
contains a subtitle called the Biologics Price Competition and
Innovation Act of 2009 (Title VII Subtitle A) (BPCI Act) that amends
the Public Health Service Act (42 U.S.C. 262) (PHS Act) and other
statutes to create an abbreviated approval pathway for biological
products shown to be biosimilar to or interchangeable with an FDA-
licensed reference biological product. Section 351(k) of the PHS Act,
added by the BPCI Act, allows a company to submit an application for
licensure of a biosimilar or interchangeable biological product. The
BPCI Act also amends section 735 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications in the
definition of ``human drug application'' for the purposes of the
prescription drug user fee provisions. The BPCI Act directs FDA to
develop recommendations for a biosimilar biological product user fee
program for fiscal years 2013 through 2017. FDA's recommendations for a
biosimilar biological product user fee program were submitted to
Congress on January 13, 2012.
    FDA's biosimilar biological product user fee program requires FDA
to assess and collect user fees for certain meetings concerning
biosimilar biological product development (BPD meetings),
investigational new drug applications (INDs) intended to support a
biosimilar biological product application, and biosimilar biological
product applications and supplements. Form FDA 3792, the Biosimilars
User Fee Cover Sheet, requests the minimum necessary information to
determine the amount of the fee required, and to account for and track
user fees. The form provides a cross-reference of the fees submitted
for a submission with the actual submission by using a unique number
tracking system. The information collected is used by FDA's Center for
Drug Evaluation and Research and Center for Biologics Evaluation and
Research to initiate the administrative screening of biosimilar
biological product INDs, applications, and supplements, and to account
for and track user fees associated with BPD meetings.
    In the Federal Register of January 27, 2015 (80 FR 4272), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    Respondents to this collection of information are manufacturers of
biosimilar biological product candidates. Based on the number of Form
FDA 3792s we have received, we estimate the burden of this collection
of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                No. of
                          FDA form No.                               No. of       responses per   Total annual     Average burden  per      Total hours
                                                                   respondents     respondent       responses            response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Biosimilars User Fee Cover Sheet; Form FDA 3792................              20               1              20        0.50 (30 minutes)              10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13471 Filed 6-2-15; 8:45 am]
BILLING CODE 4164-01-P


P-21-0095 Sanitized Support Documents Index:
 P-21-0095 Sanitized Premanufacture Notice (linked)
 P-21-0095 Sanitized Determination Document (linked)
 P-21-0095 Sanitized CHEM Report (attached)
 P-21-0095 Sanitized ECO Report (attached)
 P-21-0095 Sanitized ENG Report (attached)
 P-21-0095 Sanitized EXP Report (attached)
 P-21-0095 Sanitized Fate Report (attached)
 P-21-0095 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Rules and Regulations]
[Pages 57267-57270]
[FR Doc No: 2013-22619]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2013-0511; FRL-9901-01-Region 7]

Approval and Promulgation of Implementation Plans; State of
Missouri; Conformity of General Federal Actions to State Implementation
Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve the State
Implementation Plan (SIP) submitted by the state of Missouri on August
12, 2011. This revision will update the state general conformity rule
in its entirety to bring in into compliance with the Federal general
conformity rule which was updated in the Federal Register on April 5,
2010. General conformity regulations prohibit Federal agencies from
taking actions that may cause or contribute to violations of the
National Ambient Air Quality Standards (NAAQS). This rule applies to
non-

attainment and maintenance areas of the state. The revision to
Missouri's rule does not have an adverse affect on air quality. EPA's
approval of this SIP revision is being done in accordance with the
requirements of the Clean Air Act (CAA).

DATES: This direct final rule will be effective November 18, 2013,
without further notice, unless EPA receives adverse comment by October
18, 2013. If EPA receives adverse comment, we will publish a timely
withdrawal of the direct final rule in the Federal Register informing
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2013-0511, by one of the following methods:
    1. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Mail or Hand Delivery: Amy Bhesania, Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219.
    Instructions: Direct your comments to Docket ID No. EPA-R07-OAR-
2013-0511. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov or
email information that you consider to be CBI or otherwise protected.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically in www.regulations.gov or in hard copy at the
Environmental Protection Agency, Air Planning and Development Branch,
11201 Renner Boulevard, Lenexa, Kansas 66219. The Regional Office's
official hours of business are Monday through Friday, 8:00 to 4:30
excluding legal holidays. The interested persons wanting to examine
these documents should make an appointment with the office at least 24
hours in advance.

FOR FURTHER INFORMATION CONTACT: Amy Bhesania at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to EPA. This section provides additional information by
addressing the following:

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. What action is EPA taking?

I. What is being addressed in this document?

    EPA is approving the revision to the Missouri SIP submitted to EPA
on August 12, 2011. Missouri's revision amends rule 10 CSR 10-6.300
Conformity of General Federal Actions to State Implementation Plans,
which updates the state general conformity This revision will update
the state general conformity rule in its entirety to bring it into
compliance with the amended Federal general conformity rule. EPA has
conducted an analysis of the State's amendments and has concluded that
these revisions do not adversely affect the stringency of the SIP or
adversely impact air quality.

II. Have the requirements for approval of a SIP revision been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. In
addition, the revision meets the substantive SIP requirements of the
CAA, including section 110 and implementing regulations.

III. What action is EPA taking?

    EPA is approving the revision to the Missouri SIP by approving the
State's request to amend 10 CSR 10-6.300 Conformity of General Federal
Actions to State Implementation Plans. Conformity of General Federal
Actions prohibits Federal agencies from taking actions that may cause
or contribute to violations of the National Ambient Air Quality
Standards (NAAQS). This amendment improves the process entities use to
demonstrate their actions will not contribute to a NAAQS violation,
provides tools to encourage better communication and air quality
planning between the state and Federal agencies, and encourages both
Federal agencies and states to take early action to ensure projects
will conform to SIPs. This rule applies to non-attainment and
maintenance areas of the state. There are two revisions in the state
rule that differ from the Federal rule. In 10 CSR 10-6.300 (3)(F)1.A.
``Procedures for Conformity Determinations of General Federal
Actions,'' the state has added that planning assumptions must be
derived from estimates of current, as well as, future population. The
second revision that differs from the Federal rule is in 10 CSR 10-
6.300 (3)(G)1, ``Mitigation of Air Quality Impacts.'' Language has been
added that includes the identification and quantification of all
emission reductions claimed for measures intended to mitigate air
quality. In the same paragraph, language has been added that the
process for implementation of these measures should include any
necessary funding and tracking of emissions reductions. EPA has
determined that these changes will not relax the SIP or adversely
impact air quality.
    We are processing this action as a direct final action because the
revisions do not adversely impact air quality, and we do not anticipate
any adverse comments. Please note that if EPA receives adverse comment
on part of this rule and if that part can be severed from the remainder
of the rule, EPA may adopt as final those parts of the rule that are
not the subject of an adverse comment.

Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting

Federal requirements and does not impose additional requirements beyond
those imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 18, 2013. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: August 16, 2013.
Karl Brooks,
Regional Administrator, Region 7.

    Chapter I, title 40 of the Code of Federal Regulations is amended
as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart AA--Missouri

0
2. In Sec.  52.1320 the table in paragraph (c) is amended by revising
the entry for 10-6.300 to read as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Missouri Regulations
----------------------------------------------------------------------------------------------------------------
                                                             State
        Missouri citation                 Title         effective date   EPA approval date       Explanation
----------------------------------------------------------------------------------------------------------------
                                    Missouri Department of Natural Resources
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
    Chapter 6--Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control
                                      Regulations for the State of Missouri
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
10-6.300.........................  Conformity of              07/31/11  09/18/13 [Insert     10-6.300(3)(F)1.A
                                    General Federal                      Federal Register     and 10-
                                    Actions to State                     page number where    6.300(3)(G)1
                                    Implementation                       the document         includes language
                                    Plans.                               begins].             that differs from
                                                                                the Federal rule.
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-22619 Filed 9-17-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Pages 15590-15591]
[FR Doc No: 2015-06586]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: PR15-26-000.
    Applicants: Enterprise Texas Pipeline LLC.
    Description: Submits tariff filing per 284.123(b)(2) + (g): 2015
Petition for Rate Approval to be effective 3/13/2015; Filing Type:
1310.
    Filed Date: 3/13/15.
    Accession Number: 20150313-5032.
    Comments Due: 5 p.m. ET 4/3/15.
    284.123(g) Protests Due: 5 p.m. ET 5/12/15.

    Docket Numbers: PR15-29-000.
    Applicants: ONEOK Gas Transportation, L.L.C.
    Description: Submits tariff filing per 284.123(b)(1) + (g):
Petition for Authorization of Firm 311 Service to be effective 6/1/
2015; Filing Type: 1300.
    Filed Date: 3/13/15.
    Accession Number: 20150313-5173.
    Comments Due: 5 p.m. ET 4/3/15.
    284.123(g) Protests Due: 5 p.m. ET 5/12/15.

    Docket Numbers: RP13-459-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Compliance filing per 154.501: 2014 Penalty Revenue
Crediting Reporting.
    Filed Date: 3/16/15.
    Accession Number: 20150316-5202.
    Comments Due: 5 p.m. ET 3/30/15.

    Docket Numbers: RP15-649-000.
    Applicants: Southeast Supply Header, LLC.
    Description: Sec.  4(d) rate filing per 154.204: SESH Backhaul
Contracts to be effective 5/1/2015.
    Filed Date: 3/16/15.
    Accession Number: 20150316-5091.
    Comments Due: 5 p.m. ET 3/30/15.

    Docket Numbers: RP15-650-000.
    Applicants: Northern Natural Gas Company.
    Description: Compliance filing per 154.203: 20150401 System Maps to
be effective 4/1/2015.
    Filed Date: 3/16/15.
    Accession Number: 20150316-5104.
    Comments Due: 5 p.m. ET 3/30/15.

    Docket Numbers: RP15-651-000.
    Applicants: OkTex Pipeline Company, L.L.C.
    Description: Sec.  4(d) rate filing per 154.204: Update Contact
Information on Tariff's Title Sheet to be effective 4/16/2015.
    Filed Date: 3/16/15.
    Accession Number: 20150316-5106.
    Comments Due: 5 p.m. ET 3/30/15.

    Docket Numbers: RP15-652-000.
    Applicants: Portland General Electric Company.
    Description: Compliance filing per 154.203: Part II System Map
Compliance Filing to be effective 4/1/2015.
    Filed Date: 3/16/15.
    Accession Number: 20150316-5107.
    Comments Due: 5 p.m. ET 3/30/15.

    Docket Numbers: RP15-653-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Compliance filing per 154.203: 2015 Maps Compliance to
be effective 4/1/2015.
    Filed Date: 3/16/15.
    Accession Number: 20150316-5114.
    Comments Due: 5 p.m. ET 3/30/15.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP15-523-001.
    Applicants: Sabine Pipe Line LLC.
    Description: Tariff Amendment per 154.205(b): Sabine Annual LUAF
and Fuel Filing Amendment to be effective 4/1/2015.

    Filed Date: 3/17/15.
    Accession Number: 20150317-5029.
    Comments Due: 5 p.m. ET 3/24/15.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 17, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-06586 Filed 3-23-15; 8:45 am]
BILLING CODE 6717-01-P