[Federal Register Volume 84, Number 22 (Friday, February 1, 2019)]
[Proposed Rules]
[Pages 1037-1039]
[FR Doc No: 2019-00792]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2018-0064; FRL-9988-81-Region 4]

Air Plan Approval; Georgia: Permit Exemption for Fire Fighting
Equipment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
proposing to approve two revisions to the Georgia State Implementation
Plan (SIP), submitted by the State of Georgia, through the Georgia
Environmental Protection Division (Georgia EPD), with two letters dated
November 13, 2017, and July 31, 2018. Specifically, EPA is proposing to
approve changes that revise existing exemptions for firefighting
equipment. EPA is proposing to approve this SIP revision because the
Agency believes that it is consistent with the Clean Air Act (CAA or
Act).

DATES: Comments must be received on or before March 4, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2018-0064 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Andres Febres, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. The telephone number is<PHONE_NUMBER>. Mr. Febres can also
be reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What action is the Agency proposing?

    Through a letter dated November 13, 2017, Georgia EPD submitted a
SIP revision for EPA's approval that included several miscellaneous
rule amendments.\1\ Specifically, the November 13, 2017, SIP revision
included changes to Georgia's Air Quality Control Rule 391-3-1-.01--
``Definitions,'' Rule 391-3-1-.02(4)--``Ambient Air Standards,'' Rule
391-3-1-.02(7)--``Prevention of Significant Deterioration of Air
Quality,'' Rule 391-3-1-.03(6)--``Exemptions,'' Rule 391-3-

1-.03(8)--``Permit Requirements,'' and Rule 391-3-1-.03(10)--``Title V
Operating Permits.''
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    \1\ EPA notes that the Agency received this submittal on
November 29, 2017.
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    Through an additional letter dated July 31, 2018, Georgia EPD
submitted several SIP revisions that included some miscellaneous rule
amendments.\2\ Specifically, the July 31, 2018, SIP revisions included
changes to Georgia's Air Quality Control Rule 391-3-1-01--
``Definitions,'' Rule 391-3-1-.02(2)(c)--``Incinerators,'' Rule 391-3-
1-.02(4)--``Ambient Air Standards,'' Rule 391-3-1-.02(12)--``Cross
State Air Pollution Rule NOX Annual Trading Program,'' Rule
391-3-1-.02(13)--``Cross State Air Pollution Rule SO2 Annual
Trading Program,'' Rule 391-3-1-.02(14)--``Cross State Air Pollution
Rule NOX Ozone Season Trading Program,'' Rule 391-3-
1-.03(6)--``Exemptions,'' Rule 391-3-1-.03(11)--``Permit by Rule,''
Rule 391-3-1-.03(10)--``Title V Operating Permits,'' Rule 391-3-1-.11--
``Small Business Assistance Administration,'' and Rule 391-3-1-.12--
``Duties of the Small Business Ombudsman Office.''
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    \2\ EPA notes that the Agency received this submittal on August
2, 2018.
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    Through this proposed rulemaking, EPA is only proposing to approve
changes to Rule 391-3-1-.03(6), which addresses exemptions for
firefighting equipment from minor new source review (NSR) requirements.
EPA is considering and taking action on the other July 31, 2018, SIP
revisions involving the remaining changes to Georgia's Air Quality
Control Rules through other rulemaking. Additional detail on Georgia's
November 13, 2017, and July 31, 2018, SIP revisions and EPA's reasoning
for proposing to approve the aforementioned changes is presented below.

II. Analysis of the State's Submittal

    In this action, EPA is proposing to approve these revisions by
proposing to find that they are consistent with the flexibility
traditionally afforded to states in designing their minor NSR programs
and are not otherwise prohibited by EPA's federal minor NSR program
requirements. Under section 110(a)(2)(C) of the Act--and EPA's
implementing regulations at 40 CFR 51.160-164--each SIP must include a
program to regulate the construction and modification of stationary
sources, including so-called ``minor sources.'' \3\ The purpose of this
program is to ensure that each SIP sets forth legally enforceable
procedures that enable the state to determine whether the construction
or modification of a source would result in a violation of applicable
portions of the control strategy or would interfere with attainment or
maintenance of a National Ambient Air Quality Standard (NAAQS). See 40
CFR 51.160(a). However, the federal requirements for minor source
programs are considerably less prescriptive than those for major
sources, allowing the states flexibility to identify the types and
sizes of sources that will be subject to the program's review
requirements, and the discretion to exempt certain de minimis sources
whose emissions are too insignificant to impact attainment or
maintenance of a NAAQS. See 40 CFR 51.160(e).
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    \3\ A minor source is a source whose potential to emit is lower
than the major source applicability threshold for a particular
pollutant as defined in the applicable nonattainment major NSR
program or Prevention of Significant Deterioration program.
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    Georgia currently has a SIP-approved program for regulating the
construction or modification of minor sources at Rule 391-3-1-.03. The
rule also includes exemptions from the minor NSR requirements, found at
section (6) of the rule, which includes an exemption for combustion
equipment related to training of fire fighters. Specifically, Georgia's
current SIP provides an exemption from construction permit requirements
for ``Fire fighter or other emergency/safety equipment used to train
fire fighters.'' See Rule 391-3-1-.03(6)(b)(13).\4\ However, the
exemption does not allow the source category to avoid any other
applicable requirement, as that term is defined in 40 CFR 70.2. See
Rule 391-3-1-.03(6).
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    \4\ The provision would also exempt these sources from operating
permit requirements. Because minor source operating permits are not
a required element of a SIP under the Act, however, we do not
address that aspect of the proposed change.
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    Georgia EPD's November 13, 2017, and July 31, 2018, SIP revisions
request that EPA revise the existing exemption for firefighting
equipment. First, in its November 13, 2017, revision, Georgia EPD
amends the exemption language to explicitly include fire pumps, by
revising the language to state: ``Fire fighting equipment including
fire pumps or other emergency/safety equipment used to train fire
fighters.'' Additionally, in its July 31, 2018, revision, Georgia EPD
further revises the exemption to include equipment used for
firefighting or training by either firefighters or other emergency
personnel. Specifically, the revised exemption states: ``Firefighting
equipment, including fire pumps or other emergency/safety equipment,
used to fight fires or train firefighters or other emergency
personnel.'' Georgia states that these revisions clarify its existing
interpretation of the exemption.
    As noted above, the Act--as well as EPA's implementing regulations
at 40 CFR 51.160-164--provides states flexibility in establishing
approvable minor NSR programs, including the discretion to exempt
certain de minimis sources whose emissions are too insignificant to
impact attainment or maintenance of a NAAQS. In this case, EPA believes
the exemption of fire pumps and other emergency/safety equipment used
for fighting fires from the minor source construction permit
requirements would be de minimis (or insignificant) for the reasons
described below and as a result, EPA is proposing to find that the
revisions are approvable and consistent with the federal minor source
regulations at 40 CFR 51.160-164.
    In addition, EPA is proposing to find that, under CAA 110(l), the
exclusion of fire pumps and other emergency/safety firefighting
equipment from minor NSR permitting will not interfere with attainment
or maintenance of any NAAQS or with any other applicable requirement of
the Act. Such non-interference is based on EPA's belief that any
emissions increases that may result from the exclusion of fire pumps
and other emergency/safety firefighting equipment from minor NSR
permitting requirements would be de minimis or insignificant. This
belief is based upon the nature and use of such equipment. For example,
fire pumps are only operated in two time-limited circumstances: (1) For
testing and maintenance; and (2) during emergency situations, for the
purpose of putting out a fire. While testing and maintenance may be
periodic and routine, operation of the pumps during those times would
be limited. Similarly, operation of fire pumps during a fire emergency
would also be time-limited and would present an even more infrequent,
unusual operational circumstance. Furthermore, to the extent a fire
pump may be used for emergency firefighting purposes, such use would
likely aid in the overall reduction of air pollutant emissions
associated with fires, such as particulate matter emissions. Finally,
EPA notes that while fire pumps may be excluded from minor source
permitting requirements, they remain subject to any other applicable
federal requirements.\5\
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    \5\ EPA notes that fire pumps may be subject to federal New
Source Performance Standards at 40 CFR part 60, subpart IIII, and/or
National Emissions Standards for Hazardous Air Pollutants at 40 CFR
part 63, subpart ZZZZ. These standards restrict the emissions of
subject engines based on size and age, and limit non-emergency
operation to less than 100 hours per year.

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    As for the revised exemption language concerning other emergency/
safety equipment used to fight fires or train fire fighters or other
emergency personnel, EPA believes such use would also be time-limited
and any emissions increases associated with its exclusion from minor
source permitting requirements would also be insignificant. For these
reasons, EPA is proposing to approve these revisions and is proposing
to find that they are consistent with the CAA, including 110(l), and
with federal regulations.

III. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule,
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference a portion of Georgia EPD's Rule 391-3-1-.03--``Permits,''
specifically section (6)--``Exemptions,'' which became state effective
July 23, 2018. EPA has made, and will continue to make, these materials
generally available through www.regulations.gov and at the EPA Region 4
office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).

IV. Proposed Action

    EPA is proposing to approve Georgia EPD's November 13, 2017, and
July 31, 2018, SIP revisions. Specifically, EPA is proposing to approve
these SIP revisions that modify Georgia's Rule 391-3-1-.03(6). The
proposed changes exempt fire pumps and other equipment used by
firefighters and other emergency personnel to fight fires from the
Act's preconstruction review requirement. EPA believes that any air
quality impacts from these activities are de minimis, and will often
lead to net emissions reductions by mitigating or eliminating the air
quality impacts of uncontrolled fires. EPA is proposing to approve
these SIP revisions because the Agency has determined that they are
consistent with the CAA, and would not interfere with attainment or
maintenance of any NAAQS, reasonable further progress, or any other
applicable requirement.

V. 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. See 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. This action merely
proposes to approve state law as meeting Federal requirements and does
not impose additional requirements beyond those imposed by state law.
For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     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).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

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

    Dated: December 17, 2018.
Mary S. Walker,
Acting Regional Administrator, Region 4.
[FR Doc. 2019-00792 Filed 1-31-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: January 26, 2010 (Volume 75, Number 16)]
[Notices]
[Page 4127-4128]
[DOCID:fr26ja10-109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61378; File No. SR-NYSEArca-2010-01]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change by NYSE Arca, Inc. Amending Its
Fee Schedule

January 19, 2010.
    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 January 7, 2010, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') 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 Substance
of the Proposed Rule Change

    The Exchange proposes to amend its Fee Schedule to remove obsolete
language pertaining to its expired Linkage Pilot Program and introduce
a new Royalty Fee for Nasdaq 100 Index Options (``NDX'') and Mini-NDX
Options (``MNX''). A copy of this filing is available on the Exchange's
Web site at http://www.nyse.com, at the Exchange's principal office and
at the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend its Fee Schedule to delete obsolete
references pertaining to the Linkage Pilot Program. The Linkage Pilot
Program expired on December 31, 2009. Accordingly, the Exchange
proposes to remove the ``Linkage Fees'' portion of its fee schedule as
well as endnote 7, 11 and obsolete portions of endnote 12. Furthermore,
the Exchange proposes to renumber subsequent endnotes accordingly.
    Additionally, the Exchange plans to commence trading of options on
the Nasdaq 100 Index (``NDX'') and Mini-NDX (``MNX''). In order to
trade options on NDX and MNX, the Exchange has entered into a licensing
agreement with the Nasdaq Stock Market (``Nasdaq''), the exchange that
created and maintains both indexes. As a part of this agreement, NYSE
Arca will pay a fee to Nasdaq on every contract traded on the Exchange.
Effective with this filing, the Exchange will assess a $0.22 Royalty
Fee for transactions in NDX and MNX options. Accordingly, the $0.22
rate will be applied to the ``Take'' side of electronic Penny Pilot
executions. All non-electronic Penny Pilot executions and all non-Penny
Pilot executions will pay the $0.22 rate when there is a firm, broker
dealer or market maker executing the transaction.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with Section
6(b) of the Act,\3\ in general, and Section 6(b)(4),\4\ in particular,
in that it provides for the equitable allocation of dues, fees and
other charges among its members. Under this proposal, all similarly
situated Exchange participants will be charged the same reasonable
dues, fees and other charges.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4).
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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.

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 foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \5\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \6\ thereunder, because it establishes a due, fee, or other charge
imposed by NYSE Arca on its members.
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    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2010-01 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2010-01. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of 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 publicly available. All
submissions should refer to File Number SR-NYSEArca-2010-01 and should
be submitted on or before February 16, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-1433 Filed 1-25-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 149 (Friday, August 2, 2019)]
[Notices]
[Pages 37888-37891]
[FR Doc No: 2019-16495]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3560]

Biosimilar User Fee Rates for Fiscal Year 2020

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for biosimilar user fees for fiscal year (FY) 2020. 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, 2019, through
September 30, 2020.

FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61075, Beltsville, MD 20705-4304,<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 the sponsor
discontinues participation in FDA's BPD program for the product.
    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 2020,
the base revenue amount is the FY 2019 inflation adjusted fee revenue
amount of $40,947,463. The FY 2020 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 2020 for the initial and
annual BPD fee ($117,987), for the reactivation fee ($235,975), 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, 2019, and will
remain in effect through September 30, 2020. For applications that are
submitted on or after October 1, 2019, the new fee schedule must be
used.

II. Fee Revenue Amount for FY 2020

    The base revenue amount for FY 2020 is $40,947,463 prior to
adjustments for inflation and operating reserves (see section
744H(c)(1) and (3) of the FD&C Act).

A. FY 2020 Statutory Fee Revenue Adjustments for Inflation

    BsUFA II specifies that the $40,947,463 is to be adjusted for
inflation increases for FY 2020 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
2020. The 3-year average is 3.1175 percent.

                                 Table 1--FDA PC&B Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
           Fiscal year                   2016                2017                2018           3-Year  average
----------------------------------------------------------------------------------------------------------------
Total PC&B......................      $2,414,728,159      $2,581,551,000      $2,690,678,000  ..................
Total FTE.......................              16,381              17,022              17,023  ..................
PC&B per FTE....................            $147,408            $151,660            $158,061  ..................
Percent Change From Previous                 2.2474%             2.8845%             4.2206%             3.1175%
 Year...........................
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    The statute specifies that this 3.1175 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
----------------------------------------------------------------------------------------------------------------
                                                                                3-Year
                   Fiscal year                         2016            2017            2018           average
----------------------------------------------------------------------------------------------------------------
Total PC&B......................................     $26,775,674     $30,707,050     $35,477,032  ..............
Total Costs.....................................     $45,569,430     $55,814,043     $62,604,122  ..............
PC&B Percent....................................        58.7580%        55.0167%        56.6688%        56.8145%
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    The payroll adjustment is 3.1175 percent from table 1 multiplied by
56.8145 percent (or 1.7712 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). As a result of a
geographical revision made by the Bureau of Labor and Statistics in
January 2018,\1\ the ``Washington-Baltimore, DC-MD-VA-WV'' index was
discontinued and replaced with two separate indices (i.e.,
``Washington-Arlington-Alexandria, DC-VA-MD-WV'' and ``Baltimore-
Columbia-Towson, MD''). In order to continue applying a CPI which best
reflects the geographic region in which FDA is headquartered and which
provides the most current data available, the Washington-Arlington-
Alexandria index will be used in calculating the relevant adjustment
factors for FY 2020 and subsequent years. Table 3 provides the summary
data for the percent changes in the specified CPI for the Washington-
Arlington-Alexandria 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=CUURS35ASA0,CUUSS35ASA0.

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

    \1\ The Bureau of Labor Statistics' announcement of the
geographical revision can be viewed at https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

        Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
----------------------------------------------------------------------------------------------------------------
                                                                                3-Year
                      Year                             2016            2017            2018           average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................................         253.422         256.221         261.445  ..............
Annual Percent Change...........................         1.1003%         1.1045%         2.0389%         1.4146%
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 1.4146 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 56.8145 percent was obligated for PC&B (as shown in table 2),
43.1855 percent is the portion of costs other than PC&B (100 percent
minus 56.8145 percent equals 43.1855 percent). The non-payroll
adjustment is 1.4146 percent times 43.1855 percent, 0.6109 percent.
    Next, we add the payroll adjustment (1.7712 percent) to the non-
payroll adjustment (0.6109 percent), for a total inflation adjustment
of 2.3821 percent (rounded) for FY 2020.
    We then multiply the base revenue amount for FY 2020 ($40,947,463)
by one plus the inflation adjustment percentage (1.023821), yielding an
inflation-adjusted amount of $41,923,000 (rounded to the nearest
thousand).

B. FY 2020 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. FDA has determined that it
shall not apply an operating reserve adjustment to lower the FY 2020
target revenue amount as FDA appears on track to reduce the carryover
reserve to the committed level.

III. Fee Amounts for FY 2020

    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 third 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 2020, FDA considered historical program information as
well as input from an annual industry survey. Based on the available
information, FDA estimates it will receive 10 biosimilar biological
product applications requiring clinical data for approval in FY 2020.
    FDA will maintain the biosimilar biological product application fee
for FY 2020 at the same level as FY 2019, which is $1,746,745. This is
estimated to provide a total of $17,467,450 representing 42 percent
(rounded to the nearest whole number) of the FY 2020 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 42 program fees
will be invoiced for FY 2020, including currently approved products and
products with the potential to be approved in pending applications with
goal dates in FY 2019. For products invoiced in the FY 2020 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 2020 at the same level as FY 2019, which is $304,162. This is
estimated to provide a total of $12,774,804, representing 30 percent
(rounded to the nearest whole number) of the FY 2020 target revenue
amount.

C. Initial and Annual BPD Fees, Reactivation Fees

    To estimate the number of BPD fees to be paid in FY 2020, FDA must
consider the number of new BPD programs, the number of current BPD
programs, and the number of BPD programs that will be reactivated.
These estimates provide information that, when aggregated, allows FDA
to set BPD fees (initial BPD fees, annual BPD fees, reactivation fees).
    FDA uses internal data and a survey of BPD sponsors to estimate the
total number of BPD programs for FY 2020. In FY 2020, FDA estimates 25
new BPD programs, one reactivation (a single reactivation is weighted
as two BPD fees), and 72 BPD programs to be invoiced for the annual BPD
fee, for a total equivalent of 99 BPD fees assessed in FY 2020.
    The remainder of the target revenue of $11,680,746, or 28 percent
(rounded to the nearest whole number), is to be collected from the BPD
fees. Dividing this amount by the estimated 99 BPD fees to be paid
equals an initial BPD and annual BPD fee amount of $117,987. The
reactivation fee is set at twice the initial/annual BPD amount at
$235,975. This represents a reduction of the BPD fees from the FY 2019
levels.

IV. Fee Schedule for FY 2020

    The fee rates for FY 2020 are displayed in table 4.

                    Table 4--Fee Schedule for FY 2020
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee category                            FY 2020
------------------------------------------------------------------------
Initial BPD.............................................        $117,987
Annual BPD..............................................         117,987
Reactivation............................................         235,975
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 2020,
i.e., the period from October 1, 2019, through September 30, 2020. 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). 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. 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.
    If a check, bank draft, or postal money order is submitted, make it
payable to the order of the Food and Drug Administration and include
the user fee ID number to ensure that the payment is applied to the
correct fee(s). Payments can be mailed 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<PHONE_NUMBER>. 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.
    For payments made by wire transfer, include the unique user fee ID
number to ensure that the payment is applied to the correct fee(s).
Without the unique user fee ID number, the payment may not be applied.
The originating financial institution may charge a wire transfer fee.
Include applicable wire transfer fees with payment to ensure fees are
fully paid. Questions about wire transfer fees should be addressed to
the financial institution. The following account information should be
used to send payments by wire transfer: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.:
75060099, Routing No.: 021030004, SWIFT: FRNYUS33. FDA's tax
identification number is 53-0196965.

B. Annual BPD and Program Fees

    FDA will issue invoices with payment instructions for FY 2020
annual BPD and program fees under the new fee schedule in August 2019.
Payment will be due on October 1, 2019. If sponsors join the BPD
program after the annual BPD invoices have been issued in August 2019,
FDA will issue invoices in December 2019 to firms subject to fees for
FY 2020 that qualify for the annual BPD fee after the August 2019
billing. FDA will issue invoices in December 2019 for any annual
program fees for FY 2020 that qualify for fee assessments and were not
issued in August 2019.

    Dated: July 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16495 Filed 8-1-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Notices]
[Page 50913]
[FR Doc No: 2018-21940]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-8-000]

Supplemental Notice That Initial Market-Based Rate Filing
Includes Request for Blanket Section 204 Authorization: Sweetwater
Solar, LLC

    This is a supplemental notice in the above-referenced proceeding
Sweetwater Solar, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 22, 2018.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
[email protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: October 2, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-21940 Filed 10-9-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 43901-43902]
[FR Doc No: 2012-17980]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2012-0108]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 23 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions will enable these individuals to operate CMVs in
interstate commerce.

DATES: The exemptions are effective July 26, 2012. The exemptions
expire on July 28, 2014.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room
W64-224, Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

Background

    On June 6, 2012, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 23 individuals and requested
comments from the public (77 FR 33551). The public comment period
closed on July 6, 2012, and no comments were received.
    FMCSA has evaluated the eligibility of the 23 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 23 applicants have had ITDM over a range of 1 to 40 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the June 6, 2012, Federal Register
notice and they will not be repeated in this notice.

Discussion of Comments

    FMCSA did not receive any comments in this proceeding.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document

and they include the following: (1) That each individual submit a
quarterly monitoring checklist completed by the treating
endocrinologist as well as an annual checklist with a comprehensive
medical evaluation; (2) that each individual reports within 2 business
days of occurrence, all episodes of severe hypoglycemia, significant
complications, or inability to manage diabetes; also, any involvement
in an accident or any other adverse event in a CMV or personal vehicle,
whether or not it is related to an episode of hypoglycemia; (3) that
each individual provide a copy of the ophthalmologist's or
optometrist's report to the medical examiner at the time of the annual
medical examination; and (4) that each individual provide a copy of the
annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy in his/her driver's
qualification file if he/she is self-employed. The driver must also
have a copy of the certification when driving, for presentation to a
duly authorized Federal, State, or local enforcement official.

Conclusion

    Based upon its evaluation of the 23 exemption applications, FMCSA
exempts, Larry J. Anderson (MN), Kevin J. Blue (IL), Wade D. Calvin
(WA), Carl A. Candelaria (NM), Owen R. Dossett (MS), David K. Dylak
(IL), Jennifer A. Ferguson (SC), Michael E. Fritz (MN), Jason W.
Griffith (KS), Lee A. Haerterich (WI), Eric W. Holland (CO), Richard P.
Holmen (MN), Edward Jones (NJ), Paul A. Lacina (ND), Robert L. Lawson
(SC), Richard N. Listro (FL), Bradley J. Moore (MO), Jeremy T. Newton
(MO), Ross W. Petermann (MN), James W. Pickard, Jr. (CO), Robert G.
Shane (NY), Randall J. Tatum (MA), and Curtis J. Young (FL) from the
ITDM requirement in 49 CFR 391.41(b)(3), subject to the conditions
listed under ``Conditions and Requirements'' above.
    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption will
be valid for two years unless revoked earlier by FMCSA. The exemption
will be revoked if the following occurs: (1) The person fails to comply
with the terms and conditions of the 1/exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: July 18, 2012.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2012-17980 Filed 7-25-12; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Page 26514]
[FR Doc No: 2021-10212]

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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:

    Docket Numbers: RP21-815-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Amendment to a Negotiated Rate
Agreement Filing--ConnocoPhillips Company to be effective 5/6/2021.
    Filed Date: 5/6/21.
    Accession Number: 20210506-5047.
    Comments Due: 5 p.m. ET 5/18/21.

    Docket Numbers: RP21-816-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Permanant Capacity Release--
Negotiated Rate Agreements--5/7/2021 to be effective 5/7/2021.
    Filed Date: 5/6/21.
    Accession Number: 20210506-5070.
    Comments Due: 5 p.m. ET 5/18/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    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 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    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: May 10, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-10212 Filed 5-13-21; 8:45 am]
BILLING CODE 6717-01-P