[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Rules and Regulations]
[Pages 19541-19544]
[FR Doc No: 2015-08417]

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 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2013-0593; FRL-9925-96-Region-3]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia--Prevention of Significant Deterioration; Amendment to the
Definition of ``Regulated NSR Pollutant'' Concerning Condensable
Particulate Matter

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve a July 25, 2013 State Implementation Plan (SIP)
revision submitted by the Virginia Department of Environmental Quality
(VADEQ) for the Commonwealth of Virginia. The revision includes a
correction to the definition of ``regulated NSR [New Source Review]
pollutant'' as it relates to condensable particulate matter under
Virginia's Prevention of Significant Deterioration (PSD) program. The
revision also includes the correction of a minor typographical error.
EPA is approving these revisions to the Virginia SIP in accordance with
the requirements of the Clean Air Act (CAA).

DATES: This rule is effective on June 12, 2015 without further notice,
unless EPA receives adverse written comment by May 13, 2015. If EPA
receives such comments, it will publish a timely withdrawal of the
direct final rule in the Federal Register and inform the public that
the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2013-0593 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2013-0593, David Campbell, Associate Director,
Office of Permits and Air Toxics, Mailcode 3AP10, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2013-0593. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Virginia Department of Environmental Quality, 629
East Main Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: David Talley,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 25, 2013, VADEQ submitted a formal revision to the Virginia
SIP. The SIP revision consists of an amendment to the definition of
``regulated NSR pollutant'' for VADEQ's PSD program under Article 8 of
Chapter 80 of the Virginia Administrative Code (VAC), as well as a
correction of a minor typographical error. The definition revision
pertains to the regulation of particulate matter, specifically, gases
that condense to form particles (condensables).
    ``Particulate matter'' (PM) is a term used to define an air
pollutant that consists of a mixture of solid particles and liquid
droplets found in the ambient air. PM occurs in many sizes and shapes
and can be made up of hundreds of different chemicals. As explained
further in the discussion that follows, EPA has regulated several size
ranges of particles under the CAA, referred to as indicators of
particles, namely PM, coarse PM (PM10), and fine PM
(PM2.5).
    Initially, EPA established a National Ambient Air Quality Standard
(NAAQS) for PM on April 30, 1971, under sections 108 and 109 of the
CAA. See 36 FR 8186. Compliance with the original PM NAAQS was based on
the measurement of particles in the ambient air using an indicator of
particles measuring up to a nominal size of 25 to 45 micrometers
([micro]m). EPA used the indicator name ``total suspended particulate''
or ``TSP'' to define the particle size range that was being measured.
Total suspended particulate remained the indicator for the PM NAAQS
until 1987 when EPA revised the NAAQS in part by replacing the TSP
indicator for both the primary and secondary standards with a new
indicator that includes only those particles with an aerodynamic
diameter less than or equal to a nominal 10 [micro]m (PM10).
    On July 18, 1997, the EPA made significant revisions to the PM
NAAQS in several respects. While the EPA determined that the PM NAAQS
should continue to focus on PM10, EPA also determined that
the fine and coarse fractions of PM10 should be considered
separately. Accordingly, on July 18, 1997, the EPA added a new
indicator for fine particles with a nominal mean aerodynamic diameter
less than or equal to 2.5 [micro]m (PM2.5), and continued to
use PM10 as the indicator for purposes of regulating the
coarse fraction of PM10. See 62 FR 38652.
    On May 16, 2008, EPA finalized the ``Implementation of the New
Source Review (NSR) Program for Particulate

Matter Less than 2.5 Micrometers (PM2.5)'' (2008 NSR
PM2.5 Rule) to implement the 1997 PM2.5 NAAQS,
including changes to the NSR program. See 73 FR 28321. The 2008 NSR
PM2.5 Rule revised the NSR program requirements to establish
the framework for implementing preconstruction permit review for the
PM2.5 NAAQS in both attainment and nonattainment areas.
Among other requirements, the 2008 NSR PM2.5 Rule required
states and sources to account for condensables in PM2.5
emission limits.
    The 2008 NSR PM2.5 Rule contained an error in the
regulations for PSD \1\ and in the EPA's Emission Offset Interpretative
Ruling.\2\ This error was introduced in the definition of ``regulated
NSR pollutant'' that was revised as part of the final rulemaking. The
wording of that revised definition had the effect of requiring that PM
emissions, PM10 emissions, and PM2.5 emissions--
representing three separate size ranges or indicators of particles--
must all include condensables. EPA did not intend in the 2008 NSR
PM2.5 Rule that the term ``particulate matter emissions'' be
listed with ``PM2.5 emissions'' and ``PM10
emissions'' in requirements to include the condensable fraction of
primary PM. Historically, for ``particulate matter emissions'' often
only the filterable fraction had been considered for NSR purposes,
consistent with the applicable New Source Performance Standards (NSPS)
for PM and the corresponding compliance test method. On October 25,
2012, EPA promulgated a final rule \3\ which revised the definition of
``regulated NSR pollutant'' to correct the error and remove the
unintended new requirement on state and local agencies and the
regulated community that ``particulate matter emissions'' must include
condensables in all cases. EPA's October 25, 2012 action ensured that
the originally-intended approach for regulating the three indicators
for emissions of particulate matter under the PSD program was codified.
Thus, ``PM10 emissions'' and ``PM2.5 emissions''
are regulated as criteria pollutants (that is, under the portion of the
definition of ``regulated NSR pollutant'' that refers to ``[a]ny
pollutant for which a national ambient air quality standard has been
promulgated. . .'' and are required to include the condensable PM
fraction emitted by a source. See 40 CFR 51.166(b)(49)(i) and
52.21(b)(50)(i). In contrast, ``particulate matter emissions'' is
regulated as a non-criteria pollutant under the portion of the
definition that refers to ``[a]ny pollutant that is subject to any
standard promulgated under section 111 of the Act,'' where the
condensable PM fraction generally is not required to be included in
measurements to determine compliance with standards of performance for
PM. See 40 CFR 51.166(b)(49)(ii) and 52.21(b)(50)(ii).
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    \1\ See 40 CFR 51.166 and 52.21.
    \2\ See 40 CFR part 51, appendix S.
    \3\ See 77 FR 65107 (October 25, 2012) (``Implementation of the
New Source Review (NSR) Program for Particulate Matter Less Than 2.5
Micrometers (PM2.5): Amendment to the Definition of
`Regulated NSR Pollutant' Concerning Condensable Particulate
Matter'').
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    Virginia submitted and EPA previously approved a SIP revision to
address the provisions of the 2008 PM2.5 NSR Rule which
included the errant language relating to ``particulate matter
emissions.'' See 79 FR 10377 (February 25, 2014). This direct final
rulemaking action makes Virginia's PSD SIP consistent with EPA's
original intent, as well as consistent with the corrected Federal
requirements that only PM10 and PM2.5 consider
condensables, unless a specific NSPS or SIP provision requires
otherwise. Additional discussion on EPA's requirements to consider
condensables for PM10 and PM2.5 for PSD is
available in the preamble to EPA's October 25, 2012 rulemaking action,
which is included in the docket for this action.
    EPA notes that on January 4, 2013, the U.S. Court of Appeals for
the District of Columbia Circuit (DC Circuit), in Natural Resources
Defense Council v. EPA \4\ (hereafter, NRDC v. EPA), issued a decision
that remanded the EPA's rules implementing the 1997 PM2.5
NAAQS, including the 2008 NSR PM2.5 Rule. The DC Circuit's
remand of the 2008 NSR PM2.5 Rule is relevant to this direct
final rulemaking. As previously discussed, this rule promulgated NSR
requirements for implementation of PM2.5 in both
nonattainment areas (nonattainment NSR) and attainment/unclassifiable
areas (PSD). The DC Circuit found that EPA erred in implementing the
PM2.5 NAAQS pursuant to the general implementation
provisions of subpart 1 of part D of title I of the CAA, rather than
pursuant to the additional implementation provisions specific to
particulate matter nonattainment areas in subpart 4. The court ordered
EPA to ``repromulgate these rules pursuant to Subpart 4 consistent with
this opinion.'' Id. at 437. However, as the requirements of subpart 4
only pertain to nonattainment areas, it is EPA's position that the
portions of the 2008 NSR PM2.5 Rule that address
requirements for PM2.5 in attainment and unclassifiable
areas are not affected by the DC Circuit's opinion in NRDC v. EPA.
Moreover, EPA does not anticipate the need to revise any PSD
requirements promulgated in the 2008 NSR PM2.5 Rule in order
to comply with the court's decision. Accordingly, EPA's approval of
Virginia's SIP as to the PSD requirements promulgated by the 2008 NSR
PM2.5 Rule does not conflict with the DC Circuit's opinion.
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    \4\ See 706 F.3d 428 (D.C. Cir. 2013).
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II. Summary of SIP Revision

    This action amends the previously approved definition of
``regulated NSR pollutant'' under 9VAC5-80-1615 to be consistent with
the Federal definition and requirements for condensable PM.
Additionally, 9VAC5-80-1615(B) is revised to correct a minor
typographical error (a regulatory citation to an incorrect section of
the VAC). The revisions being approved were effective in the
Commonwealth of Virginia on May 22, 2013.

III. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of revisions
to the definitions under 9VAC5-80-1615 as described in Section II of
this notice. EPA has made, and will continue to make, these documents
generally available electronically through www.regulations.gov and/or
in hard copy at the appropriate EPA office (see the ADDRESSES section
of this preamble for more information).

IV. Final Action

    EPA is approving VADEQ's July 25, 2013 submittal as a revision to
the Virginia SIP. EPA is publishing this rule without prior proposal
because EPA views this as a noncontroversial amendment and anticipates
no adverse comment. However, in the ``Proposed Rules'' section of this
Federal Register, EPA is publishing a separate document that will serve
as the proposal to approve the SIP revision if adverse comments are
filed. This rule will be effective on June 12, 2015 without further
notice unless EPA receives adverse comment by May 13, 2015. If EPA
receives adverse comment, EPA will publish a timely withdrawal in the
Federal Register informing the public that the rule will not take
effect. EPA will address all public comments in a subsequent final rule
based on the proposed rule. EPA will not institute a second comment
period on this action. Any parties interested in commenting must do so
at this time.

V. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information that: (1) Are generated or developed
before the commencement of a voluntary environmental assessment; (2)
are prepared independently of the assessment process; (3) demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege Law, Va. Code section 10.1-1198, precludes granting a
privilege to documents and information ``required by law,'' including
documents and information ``required by Federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
Federally authorized environmental programs in a manner that is no less
stringent than their Federal counterparts. . . .'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by Federal law to maintain program delegation, authorization or
approval.'' Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides
that ``[t]o the extent consistent with requirements imposed by Federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any Federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
Federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
PSD program consistent with the Federal requirements. In any event,
because EPA has also determined that a state audit privilege and
immunity law can affect only state enforcement and cannot have any
impact on Federal enforcement authorities, EPA may at any time invoke
its authority under the CAA, including, for example, sections 113, 167,
205, 211 or 213, to enforce the requirements or prohibitions of the
state plan, independently of any state enforcement effort. In addition,
citizen enforcement under section 304 of the CAA is likewise unaffected
by this, or any, state audit privilege or immunity law.

VI. Statutory and Executive Order Reviews

A. General Requirements

    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.

B. Submission to Congress and the Comptroller General

    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).

C. Petitions for Judicial Review

    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 June 12, 2015. 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 this 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 action.
    This action pertaining to Virginia's PSD program 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

     Dated: March 25, 2015.
William C. Early,
Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart VV--Virginia

0
2. In Sec.  52.2420, the table in paragraph (c) is amended by revising
the entry for Section 5-80-1615 to read as follows:

Sec.  52.2420  Identification of plan.

* * * * *
    (c) * * *

                                 EPA-Approved Virginia Regulations and Statutes
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                                                             State                           Explanation [former
          State citation              Title/Subject     effective date   EPA Approval date      SIP citation]
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                                                  * * * * * * *
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                         9 VAC 5, Chapter 80 Permits for Stationary Sources [Part VIII]
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                                                  * * * * * * *
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    Article 8 Permits--Major Stationary Sources and Major Modifications Located in Prevention of Significant
                                               Deterioration Areas
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                                                  * * * * * * *
5-80-1615........................  Definitions........         5/22/13  4/13/15 [Insert      Revised. Limited
                                                                         Federal Register     approval remains
                                                                         Citation].           in effect.

                                                  * * * * * * *
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* * * * *
[FR Doc. 2015-08417 Filed 4-10-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 35 (Friday, February 21, 2014)]
[Notices]
[Page 9908]
[FR Doc No: 2014-03669]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0853]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Current Good Manufacturing Practice;
Quality System Regulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Current Good Manufacturing
Practice (CGMP); Quality System (QS) Regulation'' has been approved by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On December 19, 2013, the Agency submitted a
proposed collection of information entitled ``Current Good
Manufacturing Practice (CGMP); Quality System (QS) Regulation'' to OMB
for review and clearance under 44 U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. OMB has now approved the information collection and has
assigned OMB control number 0910-0073. The approval expires on February
28, 2017. A copy of the supporting statement for this information
collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: February 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03669 Filed 2-20-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 114 (Thursday, June 13, 2019)]
[Notices]
[Page 27627]
[FR Doc No: 2019-12458]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-471-000]

Bluewater Gas Storage, LLC; Notice of Application

    Take notice that on March 23, 2019, Bluewater Gas Storage, LLC
(Bluewater) 333 South Wales Center Road, Columbus, MI 48063, filed in
Docket No. CP19-471-000, an application pursuant to section 7(c) of the
Natural Gas Act and Part 157 of the Commission's regulations to
construct and maintain a new compressor station in Macomb County,
Michigan adjacent to Bluewater's existing 20-inch-diameter pipeline.
The proposed compressor station will deliver natural gas to Vector
Pipeline L.P (Vector) using a single gas-driven turbine with a
centrifugal compressor unit, which will provide approximately 11,150
nominal horsepower of compression. Bluewater's proposed Project is an
operational upgrade that will restore the originally authorized 500,000
Mcf/d of firm delivery capacity of natural gas at its interconnect with
Vector, all as more fully set forth in the application, which is on
file with the Commission and open to public inspection.
    The filing may also be viewed on the web at http://www.ferc.gov
using the eLibrary link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Conor Ward, WEC Business Services LLC, 231 W Michigan Street,
Milwaukee, WI 53203 at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 3 copies of filings made with the Commission and must provide a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commentors will not be required to serve
copies of filed documents on all other parties. However, the non-party
commentors will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    As of the February 27, 2018 date of the Commission's order in
Docket No. CP16-4-001, the Commission will apply its revised practice
concerning out-of-time motions to intervene in any new Natural Gas Act
section 3 or section 7 proceeding.\1\ Persons desiring to become a
party to a certificate proceeding are to intervene in a timely manner.
If seeking to intervene out-of-time, the movant is required to show
good cause why the time limitation should be waived, and should provide
justification by reference to factors set forth in Rule 214(d)(1) of
the Commission's Rules and Regulations.\2\
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    \1\ Tennessee Gas Pipeline Company, L.L.C., 162 FERC 61,167 at
50 (2018).
    \2\ 18 CFR 385.214(d)(1).
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    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically should
submit an original and 3 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on June 28, 2019.

    Dated: June 7, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-12458 Filed 6-12-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: March 18, 2008 (Volume 73, Number 53)]
[Notices]
[Page 14543-14544]
[DOCID:fr18mr08-132]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57469; File No. SR-NYSEArca-2008-08)]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving
Proposed Rule Change Pertaining to the Imposition of Fines for Minor
Rule Violations

March 11, 2008.
    On January 18, 2008, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend NYSE Arca Rule 6.24, ``Exercise of
Options Contracts,'' and NYSE Arca Rule 10.12 ``Minor Rule Plan.'' The
proposed rule change was published for comment in the Federal Register
on February 5, 2008.\3\ The Commission received no comments regarding
the proposal. This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 57220 (January 29,
2008), 73 FR 6757.
---------------------------------------------------------------------------

    NYSE Arca Rule 6.24 contains special procedures that apply to the
exercise of options on the last business day before expiration. The
Exchange proposes to amend NYSE Arca Rule 6.24 to: (i) Add a reference
to new terminology; (ii) make minor revisions to the procedures related
to exercising option contracts; (iii) amend Commentary .08 of NYSE Arca
Rule 6.24 to authorize the Exchange to sanction an OTP Holder or OTP
Firm that fails to follow NYSE Arca Rule 6.24, pursuant to the Minor
Rule Plan (``MRP''); and (iv) add the recommended sanctions to the MRP
contained in NYSE Arca Rule 10.12.
    An option holder desiring to exercise or not exercise expiring
options must either: (i) take no action and allow exercise
determinations to be made in accordance with the Options Clearing
Corporation's (``OCC'') Ex-by-Ex procedures, where applicable; or (ii)
submit a Contrary Exercise Advice (``CEA'') to the Exchange.\4\ A CEA
is also referred to within the options industry as an Expiring Exercise
Declaration (``EED''). While the form itself may be called by a
different name, the purpose and procedure for submitting an EED is
identical to that of a CEA. Therefore, the Exchange proposes adding a
parenthetical reference to EEDs within NYSE Arca Rule 6.24.
---------------------------------------------------------------------------

    \4\ A CEA is a communication to either: (i) Not exercise an
option that would be automatically exercised under OCC's Ex-by-Ex
procedure, or (ii) exercise an option that would not be
automatically exercised under OCC's Ex-by-Ex procedure.
---------------------------------------------------------------------------

    An OTP Holder or OTP Firm that manually submits a CEA to the
Exchange does so by completing a form and putting it in the Exchange's
Contrary Exercise Advice Box. Going forward, the Exchange will
discontinue the use of the Contrary Exercise Advice Box; and instead,
an OTP Holder or OTP Firm will submit a CEA directly to a designated
representative of the Exchange's Options Surveillance Department.
    Commentary .08 to NYSE Arca Rule 6.24 provides that the failure of
any OTP Holder to follow the provisions contained in this rule may be
referred to the Ethics and Business Conduct Committee (``EBCC'') and
result in the assessment of a fine, which may include, but is not
limited to, the disgorgement of potential economic gain obtained or
loss avoided by the subject exercise. Referral to the EBCC involves a
formal disciplinary proceeding. NYSE Arca proposes to add a provision
to Commentary .08 that would authorize the Exchange to sanction an OTP
Holder or OTP Firm that fails to follow NYSE Arca Rule 6.24, pursuant
to the MRP. The Exchange would retain the authority to refer violators
to the EBCC for formal disciplinary proceedings.
    The Exchange also proposes adding the phrase ``or OTP Firm'' to
Commentary .08 to NYSE Arca Rule 6.24. The Exchange has always intended
to apply NYSE Arca Rule 6.24 equally to both OTP Holders and OTP Firms.
The addition of OTP Firms will codify the original intent of the NYSE
Arca Rule 6.24.
    Under this proposal, violators of the NYSE Arca Rule 6.24 may be
subject to MRP fines based on the number of violations occurring within
a rolling 24-month period. An individual OTP Holder would be subject to
a fine of $500 for the first offense, $1,000 for the second offense,
and $2,500 for the third offense. An OTP Firm would be subject to a
$1,000 fine for the first offense, $2,500 for the second offense, and
$5,000 for a third offense.\5\ A list of the proposed fines would be
added to the MRP fine schedule in NYSE Arca Rule 10.12. The addition of
a sanction under the MRP adds an additional method for disciplining
violators of NYSE Arca Rule 6.24.\6\ The Exchange submits that

it will continue to conduct surveillance with due diligence and make
its determination, on a case by case basis, whether a fine under the
MRP is appropriate, or whether a violation should be subject to formal
disciplinary proceedings.
---------------------------------------------------------------------------

    \5\ The Exchange, in its discretion, processes subsequent
violations, after the third violation, according to NYSE Arca Rule
10.4. See NYSE Arca Rule 10.12(h), n.1.
    \6\ In addition, as a member of the Intermarket Surveillance
Group, the Exchange, as well as certain other self-regulatory
organizations (``SROs'') executed and filed on October 29, 2007 with
the Commission, a final version of an Agreement pursuant to Section
17(d) of the Act (the ``17d-2 Agreement''). As set forth in the 17d-
2 Agreement, the SROs have agreed that their respective rules
concerning the filing of Expiring Exercise Declarations, also
referred to as Contrary Exercise Advices, of options contracts, are
common rules. As a result, the proposal to amend NYSE Arca's MRVP
will result in further consistency in sanctions among the SROs that
are signatories to the 17d-2 Agreement concerning Contrary Exercise
Advice violations.
---------------------------------------------------------------------------

    Finally, the Exchange proposes to use NYSE Arca Rule 10.12(h)(33)
and Rule 10.12(k)(i)(33), which are presently designated as
``Reserved,'' for new NYSE Arca Rule 10.12(h)(33), which would
reference CEA/EED violations pursuant to Rule 6.24, and new NYSE Arca
Rule 10.12(k)(i)(33), which would include the recommended fines for
CEA/EED violations.
    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\7\ In
particular, the Commission believes that the proposal is consistent
with Section 6(b)(5) of the Act,\8\ which requires that the rules of an
exchange be designed to promote just and equitable principles of trade,
to facilitate transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \7\ In approving this proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission further believes that NYSE Arca's proposal to
sanction individuals and member organizations who fail to submit Advice
Cancel or exercise instructions in a timely manner is consistent with
Sections 6(b)(1) and 6(b)(6) of the Act,\9\ which require that the
rules of an exchange enforce compliance with, and provide appropriate
discipline for, violations of Commission and Exchange rules. In
addition, the Commission finds that the proposal is consistent with the
public interest, the protection of investors, or otherwise in
furtherance of the purposes of the Act, as required by Rule 19d-1(c)(2)
under the Act,\10\ which governs minor rule violation plans. The
Commission believes that the proposed rule change should strengthen the
Exchange's ability to carry out its oversight and enforcement
responsibilities as an SRO in cases where full disciplinary proceedings
are unsuitable in view of the minor nature of the particular violation.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b)(1) and 78f(b)(6).
    \10\ 17 CFR 240.19d-1(c)(2).
---------------------------------------------------------------------------

    In approving this proposed rule change, the Commission in no way
minimizes the importance of compliance with NYSE Arca rules and all
other rules subject to the imposition of fines under the MRVP. The
Commission believes that the violation of any SRO rules, as well as
Commission rules, is a serious matter. However, the MRVP provides a
reasonable means of addressing rule violations that do not rise to the
level of requiring formal disciplinary proceedings, while providing
greater flexibility in handling certain violations. The Commission
expects that NYSE Arca would continue to conduct surveillance with due
diligence and make a determination based on its findings, on a case-by-
case basis, whether a fine of more or less than the recommended amount
is appropriate for a violation under the NYSE Arca MRVP or whether a
violation requires formal disciplinary action.
    It is therefore ordered, pursuant to Section 19(b)(2) of the Act
\11\ and Rule 19d-1(c)(2) under the Act,\12\ that the proposed rule
change (SR-NYSEArca-2008-08) be, and hereby is, approved and declared
effective.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2).
    \12\ 17 CFR 240.19d-1(c)(2).
    \13\ 17 CFR 200.30-3(a)(12); 17 CFR 200.30-3(a)(44).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-5352 Filed 3-17-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: October 21, 2005 (Volume 70, Number 203)]
[Notices]
[Page 61276]
[DOCID:fr21oc05-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EC06-3-000]

Saracen Energy LP, et al.; Notice of Filing

October 17, 2005.
    Take notice that on October 5, 2005, Saracen Energy LP, Saracen
Merchant Energy LP and Saracen Energy Power Advisors LP submitted an
application pursuant to section 203 of the Federal Power Act for
authorization for a change in their upstream ownership structure. The
Applicants have requested privileged treatment of certain information
and documentation submitted with the application.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on October 26, 2005.

Magalie R. Salas,
Secretary.
[FR Doc. E5-5840 Filed 10-20-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Pages 28076-28078]
[FR Doc No: 2017-12838]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1429]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Guidance for Industry on Registration of Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection in the guidance
on registration of human drug compounding outsourcing facilities under
the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

DATES: Submit either electronic or written comments on the collection
of information by August 21, 2017.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 21, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N 1429 for ``Guidance for Industry on Registration of Human
Drug Compounding Outsourcing Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Registration of Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act: OMB Control Number 0910-0777--Extension

    A facility that compounds drugs may elect to register with FDA as
an outsourcing facility under section 503B of the FD&C Act (21 U.S.C.
353b), as added by the Drug Quality and Security Act (DQSA). Drug
products compounded in a registered outsourcing facility can qualify
for exemptions from the FDA approval requirements in section 505 of the
FD&C Act (21 U.S.C. 355), the requirement to label products with
adequate directions for use under section 502(f)(1) of the FD&C Act (21
U.S.C. 352(f)(1)), and drug supply chain security requirements in
section 582 of the FD&C Act (21 U.S.C. 360eee) if the requirements in
section 503B are met.
    After the initial registration, under section 503B(b) of the FD&C
Act, a facility that elects to register with FDA as an outsourcing
facility must also do so annually between October 1 and December 31.
Upon registration, the outsourcing facility must provide its name,
place of business, a unique facility identifier, and a point of contact
email address. The outsourcing facility must also indicate whether it
intends to compound, within the next calendar year, a drug that appears
on FDA's drug shortage list in effect under section 506E of the FD&C
Act (21 U.S.C. 356e), and whether it compounds from bulk drug
substances, and, if so, whether it compounds sterile or non-sterile
drugs from bulk drug substances.
    Outsourcing facilities that elect to register should submit the
following registration information to FDA for each facility:
     Name of the facility;
     Place of business;
     Unique facility identifier;
     Point of contact email address and phone number;
     Whether the facility intends to compound drugs that appear
on FDA's drug shortage list in effect under section 506E of the FD&C
Act; and

     An indication of whether the facility compounds from bulk
drug substances, and if so, whether it compounds sterile or nonsterile
drugs from bulk drug substances.
    Registration information should be submitted to FDA electronically
using the Structured Product Labeling (SPL) format and in accordance
with section IV of the FDA guidance entitled ``Providing Regulatory
Submissions in Electronic Format--Drug Establishment Registration and
Drug Listing.'' Under the final guidance, outsourcing facilities may
request a waiver from the SPL electronic submission process by
submitting a written request to FDA explaining why the use of
electronic means is not reasonable.
    This information collection supports the Agency guidance discussed
above. We estimate that approximately 62 outsourcing facilities
(``number of respondents'' and ``total annual responses'' in table 1,
row 1) will annually submit to FDA registration information using the
SPL format as specified in the guidance, and that preparing and
submitting this information will take approximately 4.5 hours per
registrant (``average burden per response'' in table 1, row 1). We
expect to receive no more than one waiver request from the electronic
submission process annually (``number of respondents'' and ``total
annual responses'' in table 1, row 2), and that each request should
take approximately 1 hour to prepare and submit to us (``average burden
per response'' in table 1, row 2).
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    Compounding  outsourcing         Number of    responses  per   Total annual     burden per      Total hours
            facility                respondents      respondent      responses       response
----------------------------------------------------------------------------------------------------------------
Electronic Submission of                      62               1              62             4.5             279
 Registration Information Using
 SPL Format.....................
Waiver Request From Electronic                 1               1               1               1               1
 Submission of Registration
 Information....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             280
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning Legislation, and Analysis.
[FR Doc. 2017-12838 Filed 6-19-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Pages 47719-47721]
[FR Doc No: 2021-18420]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket Number NHTSA-2021-0058]

Agency Information Collection Activities; Notice and Request for
Comments; Event Data Recorders

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice and request for comments on a request for approval.

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

SUMMARY: NHTSA invites public comments about our intention to request
approval from the Office of Management and Budget (OMB) for an
information collection currently in use. Before a Federal agency can
collect certain information from the public, it must receive approval
from OMB. Under procedures established by the Paperwork Reduction Act
of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatements of previously approved collections. This
document describes a collection of information on event data recorders
(EDRs) for which NHTSA intends to seek OMB approval. The information
collection currently does not have an OMB control number.

DATES: Written comments should be submitted by October 25, 2021.

ADDRESSES: You may submit comments [identified by Docket No. NHTSA-
2021-0058] through one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail or Hand Delivery: Docket Management Facility, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, West Building,
Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except on Federal holidays. To be sue someone is there
to help you, please call<PHONE_NUMBER> before coming.
    Instructions: All submissions must include the agency name and
docket number for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit https://www.transportation.gov/privacy.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. Follow the online instructions for accessing the
dockets via internet.

FOR FURTHER INFORMATION CONTACT: For additional information or access
to background documents, contact Carla Rush, NHTSA, 1200 New Jersey
Avenue SE, West Building, Room W43-417, NRM-100, Washington, DC 20590.
Telephone number:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), before an agency submits a proposed
collection of

information to OMB for approval, it must first publish a document in
the Federal Register providing a 60-day comment period and otherwise
consult with members of the public and affected agencies concerning
each proposed collection of information. The OMB has promulgated
regulations describing what must be included in such a document. Under
OMB's regulation (at 5 CFR 1320.8(d)), an agency must ask for public
comment on the following: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) how to enhance the quality,
utility, and clarity of the information to be collected; (d) how to
minimize the burden of the collection of information on those who are
to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology, e.g. permitting electronic submission of
responses. In compliance with these requirements, NHTSA asks for public
comments on the following proposed collection of information for which
the agency is seeking approval from OMB.
    Title: Event Data Recorders.
    OMB Control Number: New.
    Type of Request: Approval of an existing collection in use without
an OMB Control Number.
    Type of Review Requested: Regular.
    Requested Expiration Date of Approval: Three years from the date of
approval.
    Summary of the Collection of Information: 49 CFR part 563, Event
Data Recorders, specifies uniform, national requirements for vehicles
voluntarily equipped with EDRs concerning the collection, storage, and
retrievability of onboard motor vehicle crash event data. More
specifically it requires voluntarily installed EDRs in vehicles with a
gross vehicle weight rating (GVWR) of 3,855 kilograms (8,500 pounds) or
less to:
     Record 15 essential data elements;
     Record up to 30 additional data elements if the vehicle is
equipped to record these elements;
     Record these data elements in a standardized format, with
specifications for range, accuracy, resolution, sampling rate,
recording duration, and filter class;
     Function after full-scale vehicle crash tests specified in
FMVSS Nos. 208 and 214; and
     Have the capacity to record two events in a multi-event
crash.
    In addition, Part 563 requires vehicle manufacturers to make a
retrieval tool for the EDR information commercially available, and
include a standardized statement in the owner's manual indicating that
the vehicle is equipped with an EDR and describing its purpose. Part
563 helps ensure that EDRs record, in a readily usable manner, data
valuable for effective crash investigations and for analysis of safety
equipment performance (e.g., advanced restraint systems).
    Description of the Need for the Information and Use of the
Information: Under 49 U.S.C. 322(a), the Secretary of Transportation
(the ``Secretary'') is authorized to prescribe regulations to carry out
the duties and powers of the Secretary. One of the duties of the
Secretary is to administer the National Traffic and Motor Vehicle
Safety Act, as amended. The Secretary has delegated the responsibility
for carrying out the National Traffic and Motor Vehicle Safety Act to
NHTSA.\1\ Two statutory provisions, 49 U.S.C. 30182 and 23 U.S.C. 403,
authorize NHTSA to collect motor vehicle crash data to support its
safety mission. NHTSA collects motor vehicle crash information under
these authorities to support its statutory mandate to establish motor
vehicle safety standards and reduce the occurrence and cost of traffic
crashes.\2\ NHTSA also utilizes crash data in the enforcement of motor
vehicle safety recalls and other motor vehicle highway safety programs
that reduce fatalities, injuries, and property damage caused by motor
vehicle crashes. In 2006, NHTSA exercised its general authority to
issue such rules and regulations as deemed necessary to carry out
Chapter 301 of Title 49, United States Code to promulgate 49 CFR part
563.\3\
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    \1\ 49 U.S.C. 105 and 322; delegation of authority at 49 CFR
1.95.
    \2\ See 49 U.S.C. 30101 and 30111.
    \3\ 71 FR 50997, August 28, 2006.
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    NHTSA issued part 563 to improve crash data collection by
standardizing data recorded on EDRs to help provide a better
understanding of the circumstances in which crashes and injuries occur,
which will in turn lead to the development of safer vehicle designs.
EDR data are used to improve the quality of crash data collection to
assist safety researchers, vehicle manufacturers, and the agency in
crash investigations to understand vehicle crashes better and more
precisely. Similarly, vehicle manufacturers are able to utilize EDRs in
improving vehicle designs and developing more effective vehicle safety
countermeasures, and EDR data may be used by Advanced Automatic Crash
Notification (AACN) systems to aid emergency response teams in
assessing the severity of a crash and estimating the probability of
serious injury.
    Additionally, the agency's experience in handling unintended
acceleration and pedal entrapment allegations has demonstrated that, if
a vehicle is equipped with an EDR, the data from that EDR can improve
the ability of both the agency and the vehicle's manufacturer to
identify and address safety concerns associated with possible defects
in the design or performance of the vehicle.
    Description of the Likely Respondents: The respondents are
manufacturers that voluntarily equip passenger cars, multipurpose
passenger vehicles, trucks, and buses having a GVWR of 3,855 kg (8,500
pounds) or less and an unloaded vehicle weight of 2,495 kg (5,500
pounds) with EDRs. The agency estimates that there are approximately 18
such manufacturers.
    Estimate Total Annual Burden Hours: NHTSA estimates that there are
no annual reporting or recordkeeping burdens associated with Part 563,
except for the owner's manual statement requirement which will be
incorporated into the consolidated owner's manual requirements
information collection (OMB Control Number 2127-0541). Vehicle
manufacturers are not required to retain or report information gathered
by EDRs because the devices themselves continuously monitor vehicle
systems and determine when to record, retain, and/or overwrite
information. The information is collected automatically by electronic
means. Data are only required to be locked and cannot be overwritten
when a recordable event occurs (e.g., an air bag deploys in a crash
event). When recordable events do occur, EDRs only capture data for a
few seconds. NHTSA estimates that there is no annual hourly burden
associated with the information standardization requirements of part
563.
    Estimated Total Annual Burden Cost: In the August 2006 final rule,
the agency estimated that the costs associated with the final rule were
negligible. Several factors contributed to this determination. First,
NHTSA estimated that about 64 percent of new light vehicles in 2005
already added the EDR capability to the vehicles' existing air bag
control systems. Thus, the EDRs were simply capturing information that
was already being processed by the vehicle. Additionally, in the final
rule the agency sought to limit the number of EDR data elements and
associated

requirements to the minimum necessary to achieve our stated purposes.
At that time, NHTSA determined that the industry's current state-of-
the-art EDRs largely met the purposes of part 563. Thus, it was
unnecessary to specify requirements for additional sensors or other
hardware that would increase EDR costs appreciably. NHTSA stated in the
final rule that the most significant technology cost could result from
the need to upgrade data storage.
    The cost of data storage, long-term or short-term, has drastically
reduced over the years.\4\ Regardless of the storage type, costs are
now a fraction of what they were even 10 years ago.\5\ A recent study
from NHTSA looking at EDR technologies reported that information
provided by industry indicated that a typical recorded event requires
about 2 kilobytes (Kb) of memory depending on the manufacturer.\6\
Information from manufacturers also indicated that the typical
microprocessor used in vehicle applications, in approximately the 2013
timeframe, had 32 Kb or 64 Kb of flash data as part of the air bag
control module (ACM) and that only a fraction of the memory is
dedicated to the EDR data. This study also estimated the total memory
usage for all Table I and Table II data elements, listed at 49 CFR
563.7, recorded for the minimum required duration and frequency
requirements in part 563. It reported that to record Table I and II
data elements would require 0.072 Kb and 0.858 Kb of memory storage,
respectively.
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    \4\ https://www.computerworld.com/article/3182207/cw50-data-storage-goes-from-1m-to-2-cents-per-gigabyte.html
    \5\ https://hblok.net/blog/posts/2017/12/17/historical-cost-of-computer-memory-and-storage-4/
    \6\ DOT HS 812 929, https://www.nhtsa.gov/document/light-vehicle-event-data-recorder-technologies
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    In addition, NHTSA now estimates that 99.5 percent of model year
2021 light vehicles have a compliant EDR, meaning manufacturers have
largely already incurred the cost of meeting the part 563 requirements.
Given that EDRs are installed on nearly all new light vehicles, the
large amount of storage that is part of the air bag control module (32
kb or 64 kb), the small fraction required for EDR data (<1 kb), and the
negligible costs for data storage, NHTSA continues to believe that
there would be no additional costs or negligible costs associated with
the Part 563 requirements. Therefore, the cost burden for this
collection of information is discussed qualitatively.
    Part 563 only applies to vehicles voluntarily-equipped with EDRs.
Therefore, any burden is based on the differences in cost between a
compliant and non-compliant EDR. In considering additional burden for
compliant EDRs, NHTSA considered: (1) The additional burden of meeting
the 10-day data crash survivability requirement; and (2) the additional
burden of meeting the data format requirements. Part 563 requires that
an EDR must function during and after the compliance tests specified in
FMVSS Nos. 208 and 214. The EDR's stored data is required to be
downloadable 10 days after the crash tests. This requirement provides a
basic functioning and survivability level for EDRs, but does not ensure
that EDRs survive extremely severe crashes, fire, or fluid immersion.
The burden for data survivability can include costs for an additional
power supply and enhancements for computer area network (CAN) such as
wiring, data bus, and harness. However, before part 563 was established
the agency had not documented an EDR survivability problem except in
rare and extremely severe events such as fire and submergence. Thus,
the agency does not believe vehicle manufacturers incur additional
costs to comply with the ability to retrieve the essential data
elements 10 days after the crash test.
    With regard to the memory capacity required to meet the part 563
data requirements, due to proprietary concerns, the adequacy of
existing memory capacity of part 563 non-compliant vehicles is not
known. However, we believe that the part 563 requirements are
comparable to the current industry EDR practices. In terms of the
burden associated with software algorithm changes to meet the data
format requirements, the agency believes that, in the event a vehicle
manufacturer needs to redesign their software algorithm, the redesign
would be minor (e.g., changing the specifications in their codes). The
agency estimates that the cost of algorithm redesign would be
negligible on a per vehicle basis and it would be an upfront cost
(i.e., not a recurring burden).
    Public Comments Invited: You are asked to comment on any aspects of
this information collection, including (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Department, including whether the information will
have practical utility; (b) the accuracy of the Department's estimate
of the burden of the proposed information collection; (c) ways to
enhance the quality, utility and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including the use of automated collection
techniques or other forms of information technology.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended; 49 CFR 1.49; and DOT Order 1351.29.

R. Ryan Posten,
Associate Administrator for Rulemaking, National Highway Traffic Safety
Administration.
[FR Doc. 2021-18420 Filed 8-25-21; 8:45 am]
BILLING CODE 4910-59-P