[Federal Register: January 22, 2007 (Volume 72, Number 13)]
[Notices]
[Page 2679]
[DOCID:fr22ja07-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Change in Meeting

January 17, 2007.
    Upon the affirmative vote of Chairman Kelliher and Commissioners
Kelly, Spitzer, Moeller and Wellinghoff the following Docket Nos. and
Companies are hereby added as Item M-3 on the Commission's open meeting
scheduled for January 18, 2007.

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             Item No.                      Docket No. and company
------------------------------------------------------------------------
M-3...............................  IN07-1-000, NorthWestern Corporation
                                    IN07-3-000, SCANA Corporation
                                    IN07-4-000, Entergy Services, Inc.
                                    IN07-5-000, PacifiCorp
                                    IN07-6-000, NRG Energy, Inc.
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Magalie R. Salas,
Secretary.
[FR Doc. E7-780 Filed 1-19-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 60 (Tuesday, March 29, 2016)]
[Notices]
[Pages 17522-17523]
[FR Doc No: 2016-06989]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77424; File No. SR-NYSEMKT-2016-39]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Extending the Pilot
Period for the Exchange's Retail Liquidity Program

March 23, 2016.
    Pursuant to section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on March 17, 2016, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the pilot period for the Exchange's
Retail Liquidity Program (the ``Retail Liquidity Program'' or the
``Program''), which is currently scheduled to expire on March 31, 2016,
until August 31, 2016. The proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The purpose of this filing is to extend the pilot period of the
Retail Liquidity Program, currently scheduled to expire on March 31,
2016, until August 31, 2016.\4\
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    \4\ See Securities Exchange Act Release No. 75995 (September 28,
2015), 80 FR 59836 (October 2, 2015) (SR-NYSEMKT-2015-69).
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Background
    In July 2012, the Commission approved the Retail Liquidity Program
on a pilot basis.\5\ The Program is designed to attract retail order
flow to the Exchange, and allows such order flow to receive potential
price improvement. The Program is currently limited to trades occurring
at prices equal to or greater than $1.00 per share. Under the Program,
Retail Liquidity Providers (``RLPs'') are able to provide potential
price improvement in the form of a non-displayed order that is priced
better than the Exchange's best protected bid or offer (``PBBO''),
called a Retail Price Improvement Order (``RPI''). When there is an RPI
in a particular security, the Exchange disseminates an indicator, known
as the Retail Liquidity Identifier, indicating that such interest
exists. Retail Member Organizations (``RMOs'') can submit a Retail
Order to the Exchange, which would interact, to the extent possible,
with available contra-side RPIs.
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    \5\ See Securities Exchange Act Release No. 67347 (July 3,
2012), 77 FR 40673 (July 10, 2012) (``RLP Approval Order'') (SR-
NYSEAmex-2011-84).
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    The Retail Liquidity Program was approved by the Commission on a
pilot basis. Pursuant to NYSE MKT Rule 107C(m)--Equities, the pilot
period for the Program is scheduled to end on March 31, 2016.
Proposal to Extend the Operation of the Program
    The Exchange established the Retail Liquidity Program in an attempt
to attract retail order flow to the Exchange by potentially providing
price improvement to such order flow. The Exchange believes that the
Program promotes competition for retail order flow by allowing Exchange
members to submit RPIs to interact with Retail Orders. Such competition
has the ability to promote efficiency by facilitating the price
discovery process and generating additional investor interest in
trading securities, thereby promoting capital formation. The Exchange
believes that extending the pilot is appropriate because it will allow
the Exchange and the Commission additional time to analyze data
regarding the Program that the Exchange has committed to provide.\6\ As
such, the Exchange believes that it is appropriate to extend the
current operation of the Program.\7\ Through this filing, the Exchange
seeks to amend NYSE MKT Rule 107C(m)--Equities and extend the current
pilot period of the Program until August 31, 2016.
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    \6\ See id. at 40681.
    \7\ Concurrently with this filing, the Exchange has submitted a
request for an extension of the exemption under Regulation NMS Rule
612 previously granted by the Commission that permits it to accept
and rank the undisplayed RPIs. See Letter from Martha Redding, Asst.
Corporate Secretary, NYSE Group, Inc. to Brent J. Fields, Secretary,
Securities and Exchange Commission, dated March 17, 2016.
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2. Statutory Basis
    The proposed rule change is consistent with section 6(b) of the
Act,\8\ in general, and furthers the objectives of section 6(b)(5),\9\
in particular, in that it is designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest. The Exchange
believes that extending the pilot period for the Retail Liquidity
Program is consistent with these principles because the Program is
reasonably designed to attract retail order flow to the exchange
environment, while helping to ensure that retail investors benefit from
the better price that liquidity providers are willing to give their
orders. Additionally, as previously stated, the competition promoted by
the Program may facilitate the price discovery process and potentially
generate additional investor interest in trading securities. The
extension of the pilot period will allow the Commission and the
Exchange to continue to monitor the Program for its potential effects
on public price discovery, and on the broader market structure.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change
simply extends an established pilot program for an additional six
months, thus allowing the Retail Liquidity Program to enhance
competition for retail order flow and

contribute to the public price discovery process.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to section
19(b)(3)(A) of the Act \10\ and Rule 19b-4(f)(6) thereunder.\11\
Because the proposed rule change does not: (i) significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to section 19(b)(3)(A) of the Act \12\ and Rule 19b-
4(f)(6) thereunder.\13\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \14\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\15\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposed
rule change may become operative before the current expiration of the
pilot period. The Commission believes that waiving the 30-day operative
delay is consistent with the protection of investors and the public
interest, because waiver would allow the pilot period to continue
uninterrupted after its current expiration date of March 31, 2016,
thereby avoiding any potential investor confusion that could result
from temporary interruption in the pilot program. For this reason, the
Commission hereby waives the 30-day operative delay and designates the
proposal operative upon filing.\16\
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    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2016-39 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-NYSEMKT-2016-39. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2016-39 and should
be submitted on or before April 19, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2016-06989 Filed 3-28-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 198 (Thursday, October 13, 2011)]
[Rules and Regulations]
[Pages 63549-63554]
[FR Doc No: 2011-26341]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2010-1001; FRL-9478-4]

Approval and Promulgation of Air Quality Implementation Plans;
Indiana; Miscellaneous Metal and Plastic Parts Surface Coating Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is approving a revision to the Indiana State
Implementation Plan (SIP) submitted by the Indiana Department of
Environmental Management (IDEM) on November 24, 2010. The SIP revision
consists of amendments to 326 Indiana Administrative Code (IAC) 8-2-1
and 326 IAC 8-2-9, the applicability sections for Indiana's
miscellaneous metal and plastic parts surface coating rules. These
rules are approvable because they satisfy the requirements of the Clean
Air Act (CAA) for volatile organic compound (VOC) reasonably available
control technology (RACT) rules.

DATES: This direct final rule will be effective December 12, 2011,
unless EPA receives adverse comments by November 14, 2011. If adverse
comments are received, EPA 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-R05-
OAR-2010-1001, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Douglas Aburano, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Douglas Aburano, Chief, Control Strategies
Section, Air Programs Branch (AR-18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such
deliveries are only accepted during the Regional Office normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional Office official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal
holidays.

    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2010-1001. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://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 information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov website
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 e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail 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 http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., 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.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Environmental
Protection Agency, Region 5, Air and Radiation Division, 77 West
Jackson Boulevard, Chicago, Illinois 60604. This facility is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal
holidays. We recommend that you telephone Steven Rosenthal,
Environmental Engineer, at<PHONE_NUMBER> before visiting the Region 5
office.

FOR FURTHER INFORMATION CONTACT: Steven Rosenthal, Environmental
Engineer, Attainment Planning and Maintenance Section, Air Programs
Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. Background
II. What action is EPA taking?
III. Statutory and Executive Order Reviews

I. Background

    On February 24, 2010, at 75 FR 8246, EPA approved amendments to 326
IAC 8 into the Indiana SIP to address VOC RACT requirements for the
Lake and Porter County portion of the Chicago-Gary-Lake County, IL-IN,
8-hour ozone nonattainment area. These amendments added limits for
miscellaneous metal and plastic parts surface coating operations,
consistent with EPA's 2008 Control Technique Guideline document for
Miscellaneous Metal and Plastic Parts Coating operations. The State's
intention was to cover operations located only in Lake and Porter
Counties, with the limits specified in Subsection 326 IAC 8-2-9(d).
However, the applicability section, 326 IAC 8-2-9(a) did not clearly
state that only Lake and Porter County sources were subject to the
additional requirements.
    In its November 24, 2010, submittal to EPA, IDEM requested that EPA
approve amendments to 326 IAC 8-2-1 and 326 IAC 8-2-9 into the state
SIP. Specifically, IDEM requested that we approve amendments to the
applicability provisions in 326 IAC 8-2-9(a) to clarify that the new
VOC limits in subsection (d) apply only to miscellaneous metal and
plastic parts surface coating operations in Lake and Porter Counties.
IDEM also requested that we approve amendments to the general
applicability provisions at 326 IAC 8-2-1(a)(3) and 326 IAC 8-2-1(a)(4)
to clarify that the older (in Indiana's SIP prior to February 24, 2010)
surface coating requirements in 326 IAC 8-2 continue to apply to
miscellaneous metal coating operations outside of Lake and Porter
Counties. The revised rules were adopted by the Indiana Air Pollution
Control Board on September 1, 2010, and became effective on November
19, 2010. No public comments were received at the hearing held by the
state on September 1, 2010.

II. What action is EPA taking?

    EPA is approving the state's request to amend the general
applicability provisions at 326 IAC 8-2-1(a)(3) and (a)(4) and the
applicability provisions in 326 IAC 8-2-9(a).
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan if relevant adverse
written comments are filed. This rule will be effective December 12,
2011 without further notice unless we receive relevant adverse written
comments by November 14, 2011. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on the proposed action. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time. Please note that if EPA receives adverse comment on an
amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
If we do not receive any comments, this action will be effective
December 12, 2011.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 December 12, 2011. 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, Volatile organic compounds.

    Dated: September 30, 2011.
Susan Hedman,
Regional Administrator, Region 5.

    40 CFR part 52 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 P--Indiana

0
2. In Sec.  52.770 the table in paragraph (c) is amended by revising
the entry for ``Article 8. Volatile Organic Compound Rules'' to read as
follows:

Sec.  52.770  Identification of plan.

* * * * *
    (c) * * *

                                                            EPA-Approved Indiana Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Indiana
       Indiana  citation                  Subject           effective date            EPA approval date                            Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                     * * * * * * *
                                                       Article 8. Volatile Organic Compound Rules
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rule 1. General Provisions:
    8-1-0.5....................  Definitions..............      10/18/1995  11/3/1999, 64 FR 59642.
    8-1-1......................  Applicability............        6/5/1991  3/6/1992, 57 FR 8082.
    8-1-2......................  Compliance methods.......      12/15/2002  5/5/2003, 68 FR 23604.
    8-1-3......................  Compliance schedules.....       5/15/2010  4/14/2011, 76 FR 20850.
    8-1-4......................  Testing procedures.......       7/15/2001  9/11/2002, 67 FR 57515.
    8-1-5......................  Petition for site-             11/10/1988  9/6/1990, 55 FR 36635.
                                  specific reasonably
                                  available control
                                  technology (RACT) plan.
    8-1-6......................  New facilities; general         6/24/2006  6/13/2007, 72 FR 32531.
                                  reduction requirements.
    8-1-7......................  Military specifications    ..............  10/27/1982, 47 FR 20586.
    8-1-9......................  General recordkeeping and       5/22/1997  6/29/1998, 63 FR 35141.
                                  reporting requirements.
    8-1-10.....................  Compliance certification,       5/22/1997  6/29/1998, 63 FR 35141.
                                  recordkeeping, and
                                  reporting requirements
                                  for certain coating
                                  facilities using
                                  compliant coatings.
    8-1-11.....................  Compliance certification,       5/22/1997  6/29/1998, 63 FR 35141.
                                  recordkeeping, and
                                  reporting requirements
                                  for certain coating
                                  facilities using daily-
                                  weighted averaging.

    8-1-12.....................  Compliance certification,       5/22/1997  6/29/1998, 63 FR 35141.
                                  recordkeeping, and
                                  reporting requirements
                                  for certain coating
                                  facilities using control
                                  devices.
Rule 2. Surface Coating
 Emission Limitations:
    8-2-1......................  Applicability............      11/19/2010  10/13/11, [Insert page number where
                                                                             the document begins].
    8-2-2......................  Automobile and light duty        1/2/2010  2/24/2010, 75 FR 8246.
                                  truck coating operations.
    8-2-3......................  Can coating operations...  ..............  2/10/1986, 51 FR 4912.
    8-2-4......................  Coil coating operations..  ..............  10/27/1982, 47 FR 20586.
    8-2-5......................  Paper coating operations.       12/3/2009  2/24/2010, 75 FR 8246.
    8-2-6......................  Metal furniture coating         12/3/2009  2/24/2010, 75 FR 8246.
                                  operations.
    8-2-7......................  Large appliance coating         12/3/2009  2/24/2010, 75 FR 8246.
                                  operations.
    8-2-8......................  Magnet wire coating        ..............  10/27/1982, 47 FR 20586.
                                  operations
    8-2-9......................  Miscellaneous metal and        11/19/2010  10/13/11, [Insert page number where
                                  plastic parts coating                      the document begins].
                                  operations.
    8-2-10.....................  Flat wood panels;               12/3/2009  2/24/2010, 75 FR 8246.
                                  manufacturing operations.
    8-2-11.....................  Fabric and vinyl coating.      10/23/1988  3/6/1992, 57 FR 8082.
    8-2-12.....................  Wood furniture and              4/10/1988  11/24/1990, 55 FR 39141.
                                  cabinet coating.
Rule 3. Organic Solvent
 Degreasing Operations:
    8-3-1......................  Applicability............       5/27/1999  9/14/2001, 66 FR 47887.
    8-3-2......................  Cold cleaner operation...  ..............  10/27/1982, 47 FR 47554.
    8-3-3......................  Open top vapor degreaser   ..............  10/27/1982, 47 FR 47554.
                                  operation.
    8-3-4......................  Conveyorized degreaser     ..............  10/27/1982, 47 FR 47554.
                                  operation.
    8-3-5......................  Cold cleaner degreaser     ..............  3/6/1992, 57 FR 8082.
                                  operation and control.
    8-3-6......................  Open top vapor degreaser   ..............  3/6/1992, 57 FR 8082.
                                  operation and control
                                  requirements.
    8-3-7......................  Conveyorized degreaser           6/5/1991  3/6/1992, 57 FR 8082.
                                  operation and control.
    8-3-8......................  Material requirements for       5/27/1999  9/14/2001, 66 FR 47887.
                                  cold cleaning degreasers.
Rule 4. Petroleum Sources:
    8-4-1......................  Applicability............       5/15/2010  4/14/2011, 76 FR 20850.
    8-4-2......................  Petroleum refineries.....  ..............  1/18/1983, 48 FR 2127.
    8-4-3......................  Petroleum liquid storage   ..............  2/10/1986, 51 FR 4912.
                                  facilities.
    8-4-4......................  Bulk gasoline terminals..  ..............  1/18/1983, 48 FR 2127.
    8-4-5......................  Bulk gasoline plants.....  ..............  1/18/1983, 48 FR 2127.
    8-4-6......................  Gasoline dispensing             5/15/2010  4/14/2011, 76 FR 20850.
                                  facilities.
    8-4-7......................  Gasoline transports......       11/5/1999  5/31/2002, 67 FR 38006.
    8-4-8......................  Leaks from petroleum             6/5/1991  3/6/1992, 57 FR 8082.
                                  refineries; monitoring;
                                  reports.
    8-4-9......................  Leaks from transports and       11/5/1999  5/31/2002, 67 FR 38006.
                                  vapor collection
                                  systems; records.
Rule 5. Miscellaneous
 Operations:
    8-5-1......................  Applicability of rule....       3/22/2007  2/20/2008, 73 FR 9201.
    8-5-2......................  Asphalt paving rules.....  ..............  2/10/1986, 51 FR 4912.
    8-5-3......................  Synthesized                     5/18/1990  3/6/1992, 57 FR 8082.
                                  pharmaceutical
                                  manufacturing operations.
    8-5-4......................  Pneumatic rubber tire      ..............  1/18/1983, 48 FR 2124.
                                  manufacturing.
    8-5-5......................  Graphic arts operations..       5/22/1997  6/29/1998, 63 FR 35141.
    8-5-6......................  Fuel grade ethanol              3/22/2007  2/20/2008, 73 FR 9201.
                                  production at dry mills.
Rule 6. Organic Solvent
 Emission Limitations:
    8-6-1......................  Applicability of rule....  ..............  1/18/1983, 48 FR 2124.
    8-6-2......................  Emission limits;           ..............  1/18/1983, 48 FR 2124.
                                  exemptions.
Rule 7. Specific VOC Reduction
 Requirements for Lake, Porter,
 Clark, and Floyd Counties:

    8-7-1......................  Definitions..............       1/21/1995  7/5/1995, 60 FR 34856.
    8-7-2......................  Applicability............       1/21/1995  7/5/1995, 60 FR 34856.
    8-7-3......................  Emission limits..........       1/21/1995  7/5/1995, 60 FR 34856.
    8-7-4......................  Compliance methods.......       1/21/1995  7/5/1995, 60 FR 34856.
    8-7-5......................  Compliance plan..........       1/21/1995  7/5/1995, 60 FR 34856.
    8-7-6......................  Certification,                  1/21/1995  7/5/1995, 60 FR 34856.
                                  recordkeeping, and
                                  reporting requirements
                                  for coating facilities.
    8-7-7......................  Test methods and                1/21/1995  7/5/1995, 60 FR 34856.
                                  procedures.
    8-7-8......................  General recordkeeping and       1/21/1995  7/5/1995, 60 FR 34856.
                                  reports.
    8-7-9......................  Control system operation,       1/21/1995  7/5/1995, 60 FR 34856.
                                  maintenance, and testing.
    8-7-10.....................  Control system                  1/21/1995  7/5/1995, 60 FR 34856.
                                  monitoring,
                                  recordkeeping, and
                                  reporting.
Rule 8. Municipal Solid Waste
 Landfills Located in Clark,
 Floyd, Lake, and Porter
 Counties:
    8-8-1......................  Applicability............       1/18/1996  1/17/1997, 62 FR 2591.
    8-8-2......................  Definitions..............       1/18/1996  1/17/1997, 62 FR 2591.
    8-8-3......................  Requirements;                   1/18/1996  1/17/1997, 62 FR 2591.
                                  incorporation by
                                  reference of federal
                                  standards.
    8-8-4......................  Compliance deadlines.....       1/18/1996  1/17/1997, 62 FR 2591.
    8-8-8.1....................  Municipal Solid Waste           1/18/1996  1/17/1997, 62 FR 2591.
                                  Landfills Not Located in
                                  Clark, Floyd, Lake, and
                                  Porter Counties.
    8-8.1-1....................  Applicability............       1/18/1996  1/17/1997, 62 FR 2591.
    8-8.1-2....................  Definitions..............       1/18/1996  1/17/1997, 62 FR 2591.
    8-8.1-3....................  Requirements;                   1/18/1996  1/17/1997, 62 FR 2591.
                                  incorporation by
                                  reference of federal
                                  standards.
    8-8.1-4....................  Compliance deadlines.....       1/18/1996  1/17/1997, 62 FR 2591.
    8-8.1-5....................  Alternative requirements.       1/18/1996  1/17/1997, 62 FR 2591.
Rule 9. Volatile Organic Liquid
 Storage Vessels:
    8-9-1......................  Applicability............       1/18/1996  1/17/1997, 62 FR 2593.
    8-9-2......................  Exemptions...............       1/18/1996  1/17/1997, 62 FR 2593.
    8-9-3......................  Definitions..............       1/18/1996  1/17/1997, 62 FR 2593.
    8-9-4......................  Standards................       1/18/1996  1/17/1997, 62 FR 2593.
    8-9-5......................  Testing and procedures...       1/18/1996  1/17/1997, 62 FR 2593.
    8-9-6......................  Recordkeeping and               1/18/1996  1/17/1997, 62 FR 2593.
                                  reporting requirements.
Rule 10. Automobile
 Refinishing:
    8-10-1.....................  Applicability............       8/13/1998  12/20/1999, 64 FR 71031.
    8-10-2.....................  Definitions..............       11/2/1995  6/13/1996, 61 FR 29965.
    8-10-3.....................  Requirements.............       5/23/1999  12/20/1999, 64 FR 71031.
    8-10-4.....................  Means to limit volatile         11/2/1995  6/13/1996, 61 FR 29965.
                                  organic compound
                                  emissions.
    8-10-5.....................  Work practice standards..       8/13/1998  12/20/1999, 64 FR 71031.
    8-10-6.....................  Compliance procedures....       8/13/1998  12/20/1999, 64 FR 71031.
    8-10-7.....................  Test procedures..........       11/2/1995  6/13/1996, 61 FR 29965.
    8-10-8.....................  Control system operation,       11/2/1995  6/13/1996, 61 FR 29965.
                                  maintenance, and
                                  monitoring (Repealed).
    8-10-9.....................  Recordkeeping and               8/13/1998  12/20/1999, 64 FR 71031.
                                  reporting.
Rule 11. Wood Furniture
 Coating:
    8-11-1.....................  Applicability............        1/4/1996  10/30/1996, 61 FR 55889.
    8-11-2.....................  Definitions..............        1/4/1996  10/30/1996, 61 FR 55889.
    8-11-3.....................  Emission limits..........        1/4/1996  10/30/1996, 61 FR 55889.
    8-11-4.....................  Work practice standards..        1/4/1996  10/30/1996, 61 FR 55889.
    8-11-5.....................  Continuous compliance            1/4/1996  10/30/1996, 61 FR 55889.
                                  plan.
    8-11-6.....................  Compliance procedures and        1/4/1996  10/30/1996, 61 FR 55889.
                                  monitoring requirements.
    8-11-7.....................  Test procedures..........        1/4/1996  10/30/1996, 61 FR 55889.
    8-11-8.....................  Recordkeeping                    1/4/1996  10/30/1996, 61 FR 55889.
                                  requirements.
    8-11-9.....................  Reporting requirements...        1/4/1996  10/30/1996, 61 FR 55889.
    8-11-10....................  Provisions for sources           1/4/1996  10/30/1996, 61 FR 55889.
                                  electing to use
                                  emissions averaging.

Rule 12. Shipbuilding or Ship
 Repair Operations in Clark,
 Floyd, Lake, and Porter
 Counties:
    8-12-1.....................  Applicability............        5/1/1996  1/22/1997, 62 FR 3216.
    8-12-2.....................  Exemptions...............       7/15/2001  4/1/2003, 68 FR 15664.
    8-12-3.....................  Definitions..............        5/1/1996  1/22/1997, 62 FR 3216.
    8-12-4.....................  Volatile organic compound       7/15/2001  4/1/2003, 68 FR 15664.
                                  emissions limiting
                                  requirements.
    8-12-5.....................  Compliance requirements..       7/15/2001  4/1/2003, 68 FR 15664.
    8-12-6.....................  Test methods and                7/15/2001  4/1/2003, 68 FR 15664.
                                  procedures.
    8-12-7.....................  Recordkeeping,                  7/15/2001  4/1/2003, 68 FR 15664.
                                  notification, and
                                  reporting requirements.
Rule 13. Sinter Plants:
    8-13-1.....................  Applicability............       7/24/1998  7/5/2000, 65 FR 41350.
    8-13-2.....................  Definitions..............       7/24/1998  7/5/2000, 65 FR 41350.
    8-13-3.....................  Emission limit...........       7/24/1998  7/5/2000, 65 FR 41350.
    8-13-4.....................  Compliance requirements..       7/24/1998  7/5/2000, 65 FR 41350.
    8-13-5.....................  Test procedures..........       7/24/1998  7/5/2000, 65 FR 41350.
    8-13-6.....................  Control measure                 7/24/1998  7/5/2000, 65 FR 41350.
                                  operation, maintenance,
                                  and monitoring.
    8-13-7.....................  Recordkeeping and               7/24/1998  7/5/2000, 65 FR 41350.
                                  reporting.
    8-13-8.....................  Continuous emissions            7/24/1998  7/5/2000, 65 FR 41350.
                                  monitoring.
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* * * * *
[FR Doc. 2011-26341 Filed 10-12-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 147 (Tuesday, July 31, 2018)]
[Notices]
[Pages 36937-36940]
[FR Doc No: 2018-16312]

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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 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for biosimilar user fees for fiscal year (FY) 2019. The Federal Food,
Drug, and Cosmetic Act (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, 2018, through September 30, 2019.

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), authorize the collection
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 for
that product. 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
(section 744H(a)(2) and (3) of the FD&C Act). Under certain conditions,
FDA will 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 through FY 2022, the base revenue amounts for the total
revenues from all BsUFA fees are established by BsUFA II. For FY 2019,
the base revenue amount is the FY 2018 inflation adjusted fee revenue
amount of $40,214,000. The FY 2019 base revenue amount is to be
adjusted for inflation and may be reduced, as appropriate, for long-
term financial planning purposes.
    This document provides fee rates for FY 2019 for the initial and
annual BPD fee ($185,409), for the reactivation fee ($370,818), 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 are effective on October 1, 2018, and will
remain in effect through September 30, 2019. For applications that are
submitted on or after October 1, 2018, the new fee schedule must be
used.

II. Fee Revenue Amount for FY 2019

    The base revenue amount for FY 2019 is $40,214,000 prior to
adjustments for inflation and operating reserves (see section
744H(c)(1) and (3) of the FD&C Act).

A. FY 2019 Statutory Fee Revenue Adjustments for Inflation

    BsUFA II specifies that the $40,214,000 is to be adjusted for
inflation increases for FY 2019 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).
    The component of the inflation adjustment for payroll costs shall
be one plus the average annual percent change in the cost of all PC&B
paid per full-time equivalent (FTE) positions at FDA for the first 3 of
the preceding 4 FYs, multiplied by the proportion of PC&B costs to
total FDA costs of the process for the review of biosimilar biological
product applications for the first 3 of the preceding 4 FYs (see
section 744H(c)(1)(B) of the FD&C Act).
    Table 1 summarizes the actual cost and FTE data for the specified
FYs and provides the percent changes from the previous FYs and the
average percent changes over the first 3 of the 4 FYs preceding FY
2019. The 3-year average is 2.4152 percent.

                                 Table 1--FDA PC&B Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
                Fiscal year                       2015              2016              2017        3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................    $2,232,304,000    $2,414,728,159    $2,581,551,000  ..............
Total FTE.................................            15,484            16,381            17,022  ..............
PC&B per FTE..............................           144,168           147,408           151,660  ..............
Percent Change From Previous Year.........            2.1136            2.2474            2.8845          2.4152
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 2.4152 percent be multiplied by the
proportion of PC&B costs to the total FDA costs of the process for the
review of biosimilar biological product applications. Table 2 shows the
PC&B and the total obligations for the process for the review of
biosimilar biological product applications for the first 3 of the
preceding 4 FYs.

     Table 2--PC&B as a Percent of Total Cost of the Process for the Review of Biosimilar Biological Product
                                                  Applications
----------------------------------------------------------------------------------------------------------------
                Fiscal year                       2015              2016              2017        3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................       $23,265,434       $26,775,674       $30,707,050  ..............
Total Costs...............................        34,817,217        45,569,430        55,814,043  ..............

PC&B Percent..............................           66.8216           58.7580           55.0167         60.1988
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.4152 percent from table 1 multiplied by
60.1988 percent (or 1.4539 percent).
    The statute specifies that the portion of the inflation adjustment
for non-payroll costs is the average annual percent change that
occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items;
annual index) for the first 3 years of the preceding 4 years of
available data multiplied by the proportion of all costs other than
PC&B costs to total costs of the process for the review of biosimilar
biological product applications for the first 3 years of the preceding
4 FYs (see section 744H(c)(1)(B) of the FD&C Act). Table 3 provides the
summary data for the percent changes in the specified CPI for the
Washington-Baltimore area. The data are published by the Bureau of
Labor Statistics and can be found on its website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURA311SA0,CUUSA311SA0.

           Table 3--Annual and Three-Year Average Percent Change in CPI for Washington-Baltimore Area
----------------------------------------------------------------------------------------------------------------
                   Year                           2015              2016              2017        3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI................................           155.353           157.180           159.202  ..............
Annual Percent Change.....................            0.3268            1.1760            1.2864          0.9297
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 0.9297 percent be multiplied by the
proportion of all costs other than PC&B to total costs of the process
for the review of biosimilar biological product applications obligated.
Since 60.1988 percent was obligated for PC&B (as shown in table 2),
39.8012 percent is the portion of costs other than PC&B (100 percent
minus 60.1988 percent equals 39.8012 percent). The non-payroll
adjustment is 0.9297 percent times 39.8012 percent, 0.3700 percent.
    Next, we add the payroll adjustment (1.4539 percent) to the non-
payroll adjustment (0.3700 percent), for a total inflation adjustment
of 1.8239 percent (rounded) for FY 2019.
    We then multiply the base revenue amount for FY 2019 ($40,214,000)
by one plus the inflation adjustment percentage (1.018239), yielding an
inflation-adjusted amount of $40,947,463.

B. FY 2019 Statutory Fee Revenue Adjustments for Operating Reserve

    BsUFA II provides for an operating reserve adjustment to allow FDA
to adjust the fee revenue and fees for any given fiscal year during
BsUFA II, after FY 2018, to maintain an appropriate operating reserve
of carryover user fees. Beginning in FY 2019, FDA may reduce the fee
revenue and fees for long-term financial planning purposes. Once the
capacity planning adjustment is effective (see section 744H(c)(2) of
the FD&C Act), which FDA expects to occur in FY 2021, FDA also may, if
necessary, increase the fee revenue and fees to maintain not more than
21 weeks of operating reserve of carryover user fees.
    As described in the BsUFA II commitment letter, Biosimilar
Biological Product Reauthorization Goals and Procedures Fiscal Years
2018 Through 2022, FDA is committed to reducing the BsUFA carryover
reserve to an amount no greater than 21 weeks of operating reserve of
carryover user fees by the end of FY 2022. In support of this
commitment, FDA has determined that it shall apply an operating reserve
adjustment to lower the FY 2019 target revenue amount by $2,100,000.
This would establish an adjusted FY 2019 BsUFA fee revenue amount of
$38,847,000 (rounded to the nearest thousand dollars).

III. Fee Amounts for FY 2019

    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 second year of BsUFA II, FDA considered how best to balance the fee
allocation to provide stable funding and reasonable fee amounts. 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 2019, FDA considered historical program information as
well as input from an annual industry survey. Based on the available
information, FDA estimates it will receive nine biosimilar biological
product applications requiring clinical data for approval in FY 2019.
    FDA will maintain the biosimilar biological product application fee
for FY 2019 at the same level as FY 2018, which is $1,746,745. This is
estimated to provide a total of $15,720,705 representing 40 percent
(rounded to the nearest whole number) of the FY 2019 target revenue
amount.

B. Biosimilar Biological Product Program Fee

    Under BsUFA II, FDA assesses biosimilar biological product program
fees (``program fees''). An applicant in a biosimilar biological
product application shall not be assessed more than five program fees
for a fiscal year for biosimilar biological products identified in a
single biosimilar biological product application (see FD&C Act section
744H(a)(3)(D)). Applicants are assessed a program fee for a fiscal year
only for biosimilar biological products identified in a biosimilar
biological product application approved as of October 1 of such fiscal
year.
    Based on available information, FDA estimates that 23 program fees
will be

invoiced for FY 2019, including currently approved products and
products with the potential to be approved in pending applications with
goal dates in FY 2018. For products invoiced in the FY 2019 regular
billing cycle, FDA anticipates that zero program fees will be refunded.
This is based on observations dating to 2015, when the first biosimilar
product was approved.
    FDA will maintain the biosimilar biological product program fee for
FY 2019 at the same level as FY 2018, which is $304,162. This is
estimated to provide a total of $6,995,726, representing 18 percent
(rounded to the nearest whole number) of the FY 2019 target revenue
amount.

C. Initial and Annual BPD Fees, Reactivation Fees

    To estimate the number of participants in the BPD program in FY
2019, 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 and a survey of BPD sponsors to estimate the
total number of participants in the BPD program. In FY 2019, FDA
estimates 24 participants entering the BPD program, zero reactivations,
and 63 participants to be invoiced for the annual BPD fee for a total
of 87 participants in the BPD program in FY 2019.
    The remainder of the target revenue of $16,130,569, or 42 percent
(rounded to the nearest whole number), is to be collected from the BPD
fees. Dividing this amount by the estimated 87 BPD fees to be paid
equals a BPD fee amount of $185,409. The reactivation fee is set at
twice the initial/annual BPD amount at $370,818. This represents a
reduction of the BPD fee from the FY 2018 levels.

IV. Fee Schedule for FY 2019

    The fee rates for FY 2019 are displayed in table 4.

                    Table 4--Fee Schedule for FY 2019
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee category                            FY 2019
------------------------------------------------------------------------
Initial BPD.............................................        $185,409
Annual BPD..............................................         185,409
Reactivation............................................         370,818
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 2019,
i.e., the period from October 1, 2018, through September 30, 2019. 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 for a
product and seek to resume participation in such 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 for that product.
    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
website (https://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
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after the
user fee ID number is generated.
    Please include the user fee ID number on your check, bank draft, or
postal money order. Mail your payment to: Food and Drug Administration,
P.O. Box 979108, St. Louis, MO 63197-9000. If a check, bank draft, or
money order is to be sent by a courier that requests a street address,
the courier should deliver your payment to: U.S. Bank, Attention:
Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This U.S. Bank address is for courier delivery only. If you have
any questions concerning courier delivery, contact U.S. Bank at 314-
418-4013. This telephone number is only for questions about 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 the Treasury, TREAS NYC, 33 Liberty
St., New York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004,
SWIFT: FRNYUS33. If needed, FDA's tax identification number is 53-
0196965.

B. Annual BPD and Program Fees

    FDA will issue invoices with payment instructions for FY 2019
annual BPD and program fees under the new fee schedule in August 2018.
Payment will be due on October 1, 2018. If sponsors join the BPD
program after the annual BPD invoices have been issued in August 2018,
FDA will issue invoices in December 2018 to firms subject to fees for
FY 2019 that qualify for the annual BPD fee after the August 2018
billing. FDA will issue invoices in December 2018 for any annual
program fees for FY 2019 that qualify for fee assessments and were not
issued in August 2018.

    Dated: July 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16312 Filed 7-30-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)]
[Notices]
[Pages 54975-54977]
[FR Doc No: 2018-23881]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0175]

Hours of Service of Drivers: American Concrete Pumping
Association (ACPA); Application for Exemption

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to grant the American Concrete
Pumping Association (ACPA) request for exemption from the requirement
that short-haul drivers utilizing the records of duty status (RODS)
exception return to their normal work-reporting location within 12
hours of coming on duty. The exemption enables all concrete pump
operators, concrete pumping companies, and drivers who operate concrete
pumps to use the short-haul exception but return to their work-
reporting location within 14 hours instead of the usual 12 hours. FMCSA
has analyzed the exemption application and the public comments and has
determined that the exemption, subject to the terms and conditions
imposed, will achieve a level of safety that is equivalent to, or
greater than, the level that would be achieved absent such exemption.

DATES: This exemption is effective November 1, 2018 and expires October
31, 2023.

FOR FURTHER INFORMATION CONTACT: For information concerning this
notice, please contact Ms. Pearlie Robinson, FMCSA Driver and Carrier
Operations Division; Telephone:<PHONE_NUMBER>; Email: [email protected].
If you have questions on viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to www.regulations.gov and insert
the docket number, FMCSA-2018-0175 in the ``Keyword'' box and click
``Search.'' Next, click the ``Open Docket Folder'' button and choose
the document to review. If you do not have access to the internet, you
may view the docket online by visiting the Docket Management Facility
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
e.t., Monday through Friday, except Federal holidays.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain Federal Motor Carrier Safety Regulations
(FMCSRs). FMCSA must publish a notice of each exemption request in the
Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must also provide an opportunity for public comment on the
request.
    The Agency reviews safety analyses and public comments submitted,
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)) with the reasons for denying or granting the application
and, if granted, the name of the person or class of persons receiving
the exemption, and the regulatory provision from which the exemption is
granted. The notice must also specify the effective period (up to 5
years) and explain the terms and conditions of the exemption. The
exemption may be renewed (49 CFR 381.300(b)) exemption may be renewed
(49 CFR 381.300(b)).

III. Request for Exemption

    ACPA seeks an exemption from the restriction of the RODS exception
for short-haul drivers who return to their normal work reporting
location and are released from work within 12 hours [49 CFR
395.1(e)(1)(ii)(A)]. Specifically, ACPA requests that concrete pump
operators be treated the same as drivers operating ready-mixed concrete
delivery vehicles as provided in 49 CFR 395.1(e)(1)(ii)(B). Section
395.1(e)(1)(ii)(B) allows drivers of ready-mixed concrete delivery
vehicles to rely on the short-haul exception provided they return to
their work-reporting locations and are released from work within 14
consecutive hours. The requested exemption would apply industry-wide to
all concrete pump operators, concrete pumping companies, and drivers
who deliver, set-up, and operate concrete pumps across the United
States.
    ACPA currently represents more than 600 member companies employing
over 7,000 workers nationwide. The exemption would be applied to all
interstate concrete pumper trucks and their operators. Although many of
the trucks operate intrastate and would therefore not be covered by an
FMCSA exemption, an unknown number of the pumping trucks are operated
in metropolitan areas and do routinely cross State lines.\1\
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    \1\ FMCSA does not generally have jurisdiction over intrastate
transportation; however, most States have commercial motor vehicle
statutes and regulations that are compatible with Federal
regulations. With few exceptions, an FMCSA exemption only applies to
interstate transportation, although some States honor them for
intrastate traffic.
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    ACPA explained that, like ready-mixed concrete delivery trucks and
asphalt pavement delivery trucks, concrete pumps work with a perishable
product delivered on a just-in-time basis. Timing and scheduling are
critical to ensure a high-quality result. Allowing concrete pump
drivers to use the short-haul exception, but return to their reporting
location within 14 hours instead of 12 hours, would harmonize the
hours-of-service rules for drivers of concrete pumps with the rules for
drivers of the vehicles that supply the concrete.
    ACPA explained that only a small percentage of the concrete pump
operator's time is spent driving. On average, concrete pump operators
spend between 25-32% of their time driving during a shift, and average
daily driving distances are 20-25 miles. A pump operator has plenty of
rest time with breaks ranging from 33%-55% of their total time pumping.
The majority of an operator's time is spent waiting on ready-mixed
concrete for them to pump.
    ACPA further explained that a concrete pump cannot operate without
concrete supplied by a ready-mixed truck. Having conflicting
requirements creates confusion on job sites. Clear and consistent
requirements between the concrete pumps and the ready-mixed trucks will
help ensure an equivalent level of safety on the job site. ACPA adds
that concrete pumping and placement companies work in collaboration
with ready-mixed companies. Scheduling local business contracts in
compliance with State and Federal regulations is complicated, given
that some concrete companies operate under different FMCSA rules.
    ACPA asserts that the concrete pumping industry has a solid safety
record. Break periods, spent waiting for the ready-mixed truck
deliveries, provide opportunity for concrete pump operators to rest and
relax. The ACPA Operator Certification Program ensures, encourages, and
educates the concrete pump operators on safe concrete pumping and
placement procedures. These safety practices allow concrete operators
to maintain their safety record through careful training and well-
developed safety guidelines. Because of the concrete pump operators'
training and preparation and numerous rest breaks, providing the
additional 2 duty hours to concrete pump operators will have no impact
on the level of safety provided under the short-haul exception. The
requested exemption is for 5 years. A copy of the ACPA's

application for exemption is available for review in the docket for
this notice.

IV. Public Comments

    On June 21, 2018, FMCSA published notice of this application and
requested public comment (83 FR 28898). The Agency received four
comments. One individual and the National Ready Mixed Concrete
Association (NRMCA) filed comments in support of the proposed
exemption. The Advocates for Highway and Auto Safety (Advocates) and
the Alliance for Driver Safety & Security (Trucking Alliance) filed
joint comments in opposition to the proposed exemption.
    NRMCA wrote, ``As outlined in ACPA's request, due to the nature of
concrete pump operators' schedules and inherent work practices that are
closely aligned with the ready mixed concrete industry, NRMCA agrees
that increasing the return to work-reporting location threshold from 12
to 14 hours would not diminish safety on our nation's roadways and
ready mixed concrete construction sites.''
    Mr. Jake Ford stated, ``I feel the FMCSA should look into expanding
the 12-hour short-haul exemption to 14 hours to more than just Concrete
Pumps. I work in the oilfield industry as a DOT/Fleet/Compliance
Manager. Just like the concrete pump operators my drivers drive very
little and spend 85% of their time on an oilfield service location
operating equipment.''
    ``The Advocates and the Trucking Alliance oppose the ACPA
Application for exemption on the grounds that the Application fails to
meet the statutory and regulatory requirements of applications for
exemption. The Application is defective in several respects since it
does not justify the need for the exemption, does not access the safety
impacts of the exemption, and does not explain or document how an
equivalent level of safety would be achieved. All of which are
statutory requirements of a valid exemption application.''

V. FMCSA Decision

    FMCSA has evaluated ACPA's application and the public comments and
decided to grant the exemption. The Agency believes that the exempted
concrete pump drivers will likely achieve a level of safety that is
equivalent to or greater than, the level of safety achieved without the
exemption [49 CFR 381.305(a)]. The Agency granted similar exemptions to
the National Asphalt Paving Association [January 26, 2018, (83 FR
3864)], and the Motion Picture Association of America [January 19,
2018, (83 FR 2869)]. In each of these situations, the driver spends
relatively little time driving and is off duty for substantial periods
of time during the day, making cumulative fatigue unlikely. In any
case, a 14-hour driving window has been allowed for most drivers since
early 2004, with no evidence of adverse effects. There is no reason to
believe that the experience of drivers of concrete pump vehicles will
be different.

VI. Terms and Conditions for the Exemption

    (1) Drivers must return to the work reporting location and be
released from work within 14 consecutive hours of coming on duty.
    (2) Drivers must have a copy of this exemption document in their
possession while operating under the terms of the exemption. The
exemption document must be presented to law enforcement officials upon
request.
    (3) All motor carriers operating under this exemption must have a
``Satisfactory'' safety rating with FMCSA, or be ``unrated.'' Motor
carriers with ``Conditional'' or ``Unsatisfactory'' FMCSA safety
ratings are prohibited from using this exemption.

Extent of the Exemption

    This exemption is limited to the provisions of 49 CFR
395.1(e)(1)(ii)(A). These drivers must comply will all other applicable
provisions of the FMCSRs.

Preemption

    In accordance with 49 U.S.C. 31313(d), as implemented by 49 CFR
381.600, during the period this exemption is in effect, no State shall
enforce any law or regulation applicable to interstate commerce that
conflicts with or is inconsistent with this exemption with respect to a
firm or person operating under the exemption. States may, but are not
required to, adopt the same exemption with respect to operations in
intrastate commerce.

Notification to FMCSA

    Any motor carrier utilizing this exemption must notify FMCSA within
5 business days of any accident (as defined in 49 CFR 390.5), involving
any of the motor carrier's CMVs operating under the terms of this
exemption. The notification must include the following information:
    (a) Identity of the exemption: ``ACPA''
    (b) Name of operating motor carrier and USDOT number,
    (c) Date of the accident,
    (d) City or town, and State, in which the accident occurred, or
closest to the accident scene,
    (e) Driver's name and license number and State of issuance
    (f) Vehicle number and State license plate number,
    (g) Number of individuals suffering physical injury,
    (h) Number of fatalities,
    (i) The police-reported cause of the accident,
    (j) Whether the driver was cited for violation of any traffic laws
or motor carrier safety regulations, and
    (k) The driver's total driving time and total on-duty time period
prior to the accident.
    Reports filed under this provision shall be emailed to
MCPSD[email protected]

Termination

    FMCSA does not believe the drivers covered by this exemption will
experience any deterioration of their safety record. However, should
this occur, FMCSA will take all steps necessary to protect the public
interest, including revocation of the exemption. The FMCSA will
immediately revoke or restrict the exemption for failure to comply with
its terms and conditions.

    Issued on: October 25, 2018.
Raymond P. Martinez,
Administrator.
[FR Doc. 2018-23881 Filed 10-31-18; 8:45 am]
 BILLING CODE 4910-EX-P