[Federal Register Volume 88, Number 132 (Wednesday, July 12, 2023)]
[Notices]
[Pages 44363-44365]
[FR Doc No: 2023-14691]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2647]

Inborn Errors of Metabolism That Use Dietary Management:
Considerations for Optimizing and Standardizing Diet in Clinical Trials
for Drug Product Development; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Inborn Errors of Metabolism That Use Dietary Management:
Considerations for Optimizing and Standardizing Diet in Clinical Trials
for Drug Product Development.'' This draft guidance describes FDA's
current recommendations for optimizing and standardizing dietary
management in clinical trials for the development of drug products
intended to treat inborn errors of metabolism (IEM) when dietary
management is a key component of patients' metabolic control.
Optimizing

and standardizing dietary management in these patients before they
enter clinical trials and during clinical trials is essential to
providing an accurate evaluation of the efficacy of new drug products.
This guidance revises the draft guidance of the same name issued on
July 24, 2018.

DATES: Submit either electronic or written comments on the draft
guidance by September 11, 2023, to ensure that the Agency considers
your comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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-2018-D-2647 for ``Inborn Errors of Metabolism That Use Dietary
Management: Considerations for Optimizing and Standardizing Diet in
Clinical Trials for Drug Product Development.'' Received comments 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Robert Temple, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6304, Silver Spring, MD 20993, 301-796-
1153; or Diane Maloney, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Inborn Errors of Metabolism That Use Dietary
Management: Considerations for Optimizing and Standardizing Diet in
Clinical Trials for Drug Product Development.'' This draft guidance
describes FDA's current recommendations for optimizing and
standardizing dietary management in clinical trials for the development
of drug products intended to treat IEM when dietary management is a key
component of patients' metabolic control. Optimizing and standardizing
dietary management in these patients before they enter into clinical
trials and during clinical trials is essential to providing an accurate
evaluation of the efficacy of new drug products.
    This draft guidance revises the draft guidance of the same name
issued on July 24, 2018 (83 FR 35006). FDA considered comments received
on the draft guidance and is reissuing the guidance in draft form.
Revisions from the previous draft include: (1) clarification that drug
products, including both small molecules and biological products,
should be studied in conjunction with dietary management for conditions
where dietary management is the current standard of clinical care; (2)
clarification that metabolic control may be evaluated by biochemical
analytes and clinical assessment as substantiated by current clinical
standards of care; (3) clarification that differences in baseline
dietary management standards among patients from different countries
should be considered and clearly stated in the protocol; and (4)
clarification that the

most informative design is a randomized, double-blind clinical trial
that includes a concurrent control group (approved drug or placebo).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Inborn
Errors of Metabolism That Use Dietary Management: Considerations for
Optimizing and Standardizing Diet in Clinical Trials for Drug Product
Development.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB Control
No. 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14691 Filed 7-11-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Rules and Regulations]
[Pages 54506-54510]
[FR Doc No: 2016-19388]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2016-0210; FRL-9950-71-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Case-by-Case Reasonably Available Control Technology for the
2008 8-Hour Ozone National Ambient Air Quality Standard (NAAQS)

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 revision to the Commonwealth of Virginia's
state implementation plan (SIP). The SIP revision includes revised
Virginia regulations which incorporate compliance dates necessary for
implementing planning requirements for the 2008 8-hour ozone national
ambient air quality standard (NAAQS). Specifically, the SIP revision
includes revised Virginia regulations which added notification and
compliance dates for sources seeking case-by-case reasonably available
control technology (RACT) determinations required under the 2008 8-hour
ozone NAAQS. EPA is approving this revision to the Virginia SIP in
accordance with the requirements of the Clean Air Act (CAA).

DATES: This rule is effective on October 17, 2016 without further
notice, unless EPA receives adverse written comment by September 15,
2016. 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 No. EPA-R03-
OAR-2016-0210 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the 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. The 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, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For 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: Leslie Jones Doherty,<PHONE_NUMBER>,
or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On February 5, 2016, the Commonwealth of Virginia, through the
Virginia Department of Environmental Quality (VADEQ), submitted a
formal revision to the Virginia SIP. The SIP revision submittal
includes revised provisions within 9VAC5 Chapter 40, Existing
Stationary Sources, to include revised notification and compliance
dates for sources subject to RACT for the 2008 8-hour ozone NAAQS to
submit a case-by-case RACT demonstration to VADEQ.
    On March 27, 2008, EPA revised the 8-hour ozone standard to a new
0.075

parts per million (ppm) level (73 FR 16436). On May 21, 2012, EPA
finalized designations for the 2008 8-hour ozone NAAQS (77 FR 30087) in
which the Washington, DC-MD-VA area was designated marginal
nonattainment. See 40 CFR 81.347. The northern portion of Virginia is
also part of the Metropolitan Statistical Area of the District Columbia
which is in the ozone transport region (OTR) established under section
184(a) of the CAA. Pursuant to section 184(b) of the CAA, all areas in
the OTR must comply with the CAA requirements for a moderate
nonattainment area which includes RACT requirements. On March 6, 2015,
EPA published a final implementation rule (80 FR 12264) which specifies
the compliance date (January 1, 2017) by which RACT measures must be
implemented for the 2008 8-hour ozone NAAQS. See 40 CFR 51.1112. Thus,
the northern portion of Virginia which is within the OTR must implement
RACT per CAA sections 172 and 182 for major stationary sources of
nitrogen oxides (NOX) and volatile organic compounds
(VOCs).\1\
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    \1\ Any stationary source which emits or has the potential to
emit at least 50 tons per year (tpy) of VOCs or 100 tpy of
NOX shall be considered a major stationary source subject
to attainment planning requirements, including RACT, as if the area
were a moderate nonattainment area. See CAA sections 182(b) and (f),
184(b), and 302.
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II. Summary of SIP Revision

    This SIP revision includes revised 9VAC5-40-7400 and 9VAC5-40-7420
which incorporate EPA's compliance date for implementation of RACT
requirements for the 2008 8-hour ozone NAAQS (i.e., January 1, 2017)
into VADEQ's regulations. The SIP revision consists of amended versions
of 9VAC5-40-7400 and 9VAC5-40-7420, which were previously included in
the Virginia SIP, to add notification and compliance dates for RACT
case-by-case determinations to meet CAA deadlines for implementing RACT
for major stationary sources of NOX and VOC within Virginia
for the 2008 8-hour ozone NAAQS. These provisions now include the RACT
compliance date stated in EPA's implementation rule for the 2008 8-hour
ozone NAAQS. The notification date included in the Virginia regulations
is the date by which facilities subject to RACT for the 2008 ozone
NAAQS must notify the State Air Pollution Control Board of their
applicability status, commit to making a RACT determination, and
provide an acceptable schedule for implementing the proposed RACT
determination so the source achieves compliance with the RACT emission
standard as expeditiously as possible, but no later than the compliance
date of January 1, 2017 as required by CAA.
    Specifically, in section 9VAC5-40-7400, pertaining to stationary
sources of VOCs, Table 4-51B was amended to add the 2008 8-hour ozone
standard, emissions control area, source threshold limit in tpy which
subjects sources to VOC RACT, date for submission of notification to
VADEQ, and the compliance date to implement RACT. Table 1, in this
rulemaking action, describes Table 4-51B, Notification and Compliance
Dates for Facilities Located in VOC Emissions Control Areas.

        Table 1--Notification and Compliance Dates for Facilities Located in VOC Emissions Control Areas
----------------------------------------------------------------------------------------------------------------
                                   Emissions control
            Standard                     area          Source threshold    Notification date    Compliance date
----------------------------------------------------------------------------------------------------------------
1997 (0.08 ppm).................  Northern Virginia.  >=50 tpy..........  March 1, 2007.....  April 1, 2009.
2008 (0.075 ppm)................  Northern Virginia.  >=50 tpy..........  February 1, 2016..  January 1, 2017.
----------------------------------------------------------------------------------------------------------------

    In section 9VAC5-40-7420, pertaining to stationary sources of
NOX, Table 4-51E and Table 4-51F were amended to include the
2008 8-hour ozone standard, emissions control area, source threshold
limit in tpy which subjects sources to NOX RACT, date for
submission of notification to VADEQ, and compliance date to implement
RACT. Table 2, of this rulemaking action, describes Table 4-51E for
facilities in an emission control area where there is no applicable
presumptive RACT. Table 3, of this rulemaking action describes Table 4-
51F which pertains to facilities in an emission control area where
presumptive RACT is defined or applicable.

Table 2--Notification and Compliance Dates for Facilities Located in NOX Emissions Control Areas for Which There
                                             Is No Presumptive RACT
----------------------------------------------------------------------------------------------------------------
                                   Emissions control
            Standard                     area          Source threshold    Notification date    Compliance date
----------------------------------------------------------------------------------------------------------------
1997 (0.08 ppm).................  Northern Virginia.  >=100 tpy.........  March 1, 2007.....  April 1, 2009
2008 (0.075 ppm)................  Northern Virginia.  >=100 tpy.........  February 1, 2016..  January 1, 2017
----------------------------------------------------------------------------------------------------------------

   Table 3--Notification and Compliance Dates for Facilities Located in NOX Emissions Control Areas for Which
                                           Presumptive RACT Is Defined
----------------------------------------------------------------------------------------------------------------
                                   Emissions control
            Standard                     area          Source threshold    Notification date    Compliance date
----------------------------------------------------------------------------------------------------------------
1997 (0.08 ppm).................  Northern Virginia.  >=100 tpy.........  March 1, 2007.....  April 1, 2009
2008 (0.075 ppm)................  Northern Virginia.  >=100 tpy.........  February 1, 2016..  January 1, 2017
----------------------------------------------------------------------------------------------------------------

    The amendments to 9VAC5-40-7400 and 9VAC5-40-7420 are consistent
with the federal requirements for RACT implementation for the 2008 8-
hour ozone NAAQS contained within EPA's final implementation rule for
this NAAQS and with CAA requirements for RACT in CAA sections 172, 182,
and 184. See 80 FR 12264.

III. Final Action

    EPA is approving the February 5, 2016 SIP submission from Virginia
which includes amended Virginia regulations to include notification and

compliance dates for the submission and implementation of case-by-case
RACT to address requirements for the 2008 8-hour NAAQS. 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 today's 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 October 17, 2016 without further notice unless EPA
receives adverse comment by September 15, 2016. 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.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

IV. 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 Sec.  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
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.

V. Incorporation by Reference

    In this rulemaking action, the 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 VADEQ regulations described in the amendments to 40 CFR 52
set forth below which added notification and compliance dates for
sources seeking case-by-case RACT. The EPA has made, and will continue
to make, these documents generally available electronically through
www.regulations.gov and/or may be viewed at the appropriate EPA office
(see the ADDRESSES section of this preamble for more information).

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 Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     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 as
defined in 18 U.S.C. 1151 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 and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

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 October 17, 2016. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking action. This action pertaining to submission and compliance
dates for case-by-case RACT determinations in Virginia for the 2008 8-
hour ozone NAAQS may not be challenged later in proceedings to enforce
its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Volatile organic compounds.

    Dated: August 2, 2016.
Shawn M. Garvin,
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 entries for Sections 5-40-7400 and 5-40-7420 under 9VAC5, Chapter
40, Part 2, Article 51 to read as follows:

Sec.  52.2420   Identification of plan.

* * * * *
    (c) * * *

                                 EPA--Approved Virginia Regulations and Statutes
----------------------------------------------------------------------------------------------------------------
                                                             State                           Explanation [former
          State citation              Title/subject     effective date   EPA approval date      SIP citation]
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                            9 VAC 5, Chapter 40 Existing Stationary Sources (Part IV)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                           Part 2 Emissions Standards
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
       Article 51 Stationary Sources Subject to Case-by-Case Control Technology Determinations (Rule 4-51)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
5-40-7400........................  Standard for             12/02/2015  8/16/2016 [Insert    Notification and
                                    volatile organic                     Federal Register     compliance dates
                                    compounds (eight-                    Citation].           added
                                    hour ozone
                                    standard).

                                                  * * * * * * *
5-40-7420........................  Standard for             12/02/2015  8/16/2016 [Insert    Notification and
                                    nitrogen oxides                      Federal Register     compliance dates
                                    (eight-hour ozone                    Citation].           added
                                    standard).

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-19388 Filed 8-15-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Pages 3734-3735]
[FR Doc No: 2018-01470]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0073]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Irradiation in the Production, Processing, and
Handling of Food

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 provisions of
our requirements for food irradiation processors.

DATES: Submit either electronic or written comments on the collection
of information by March 27, 2018.

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 March 27, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of March 27, 2018. 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-2018-N-0073 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Irradiation in the Production,
Processing, and Handling of Food.'' 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, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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.

Irradiation in the Production, Processing, and Handling of Food

OMB Control Number 0910-0186--Extension

    This information collection supports FDA regulations. Specifically,
under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 321(s) and 348), food irradiation is subject
to regulation under the food additive premarket approval provisions of
the FD&C Act. The regulations providing for uses of irradiation in the
production, processing, and handling of food are found in part 179 (21
CFR part 179). To ensure safe use of a radiation source, Sec.
179.21(b)(1) requires that the label of sources bear appropriate and
accurate information identifying the source of radiation and the
maximum (or minimum and maximum) energy of the emitted radiation.
Section 179.21(b)(2) requires that the label or accompanying labeling
bear adequate directions for installation and use and a statement
supplied by us that indicates maximum dose of radiation allowed.
Section 179.26(c) requires that the label or accompanying labeling bear
a logo and a radiation disclosure statement. Section 179.25(e) requires
that food processors who treat food with radiation make and retain, for
1 year past the expected shelf life of the products up to a maximum of
3 years, specified records relating to the irradiation process (e.g.,
the food treated, lot identification, scheduled process, etc.). The
records required by Sec.  179.25(e) are used by our inspectors to
assess compliance with the regulation that establishes limits within
which radiation may be safely used to treat food. We cannot ensure safe
use without a method to assess compliance with the dose limits, and
there are no practicable methods for analyzing most foods to determine
whether they have been treated with ionizing radiation and are within
the limitations set forth in part 179. Records inspection is the only
way to determine whether firms are complying with the regulations for
treatment of foods with ionizing radiation.
    Description of respondents: Respondents to the information
collection are businesses engaged in the irradiation of food.
    FDA estimates the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
179.25(e), large processors.....               4             300           1,200               1           1,200
179.25(e), small processors.....               4              30             120               1             120
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,320
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Upon review of the information collection we have retained the
currently approved burden estimate. Our estimate of the recordkeeping
burden under Sec.  179.25(e) is based on our experience regulating the
safe use of radiation as a direct food additive. The number of firms
who process food using irradiation is extremely limited. We estimate
that there are four irradiation plants whose business is devoted
primarily (i.e., approximately 100 percent) to irradiation of food and
other agricultural products. Four other firms also irradiate small
quantities of food. We estimate that this irradiation accounts for no
more than 10 percent of the business for each of these firms.
Therefore, the average estimated burden is based on four facilities
devoting 100 percent of their business to food irradiation (4 x 300
hours = 1,200 hours for recordkeeping annually), and four facilities
devoting 10 percent of their business to food irradiation (4 x 30 hours
= 120 hours for recordkeeping annually).
    No burden has been estimated for the labeling requirements in
Sec. Sec.  179.21(b)(1), 179.21(b)(2), and 179.26(c) because the
disclosures are supplied by FDA. Under 5 CFR 1320.3(c)(2), the public
disclosure of information originally supplied by the Federal Government
to the recipient for the purpose of disclosure to the public is not
subject to review by the OMB under the PRA.

    Dated: January 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01470 Filed 1-25-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Rules and Regulations]
[Pages 33413-33418]
[FR Doc No: 2015-14338]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2014-0915; FRL-9928-88-Region 4]

Approval and Promulgation of Implementation Plans; South
Carolina; Charlotte-Rock Hill; Base Year Emissions Inventory and
Emissions Statements Requirements for the 2008 8-Hour Ozone Standard

AGENCY: Environmental Protection Agency.

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve the portions of the state implementation plan
(SIP) revisions submitted by the State of South Carolina, through South
Carolina Department of Health and Environmental Control (SC DHEC) on
August 8, 2014, and August 22, 2014, that address the base year
emissions inventory and emissions statements requirements for the
State's portion of the bi-state Charlotte-Gastonia-Rock Hill North
Carolina-South Carolina 2008 8-hour ozone national ambient air quality
standards (NAAQS) nonattainment area (hereinafter referred to as the
``bi-state Charlotte Area'' or ``Area''). Annual emissions reporting
(i.e., emissions statements) and a base year emissions inventory are
required for all ozone nonattainment areas. The Area is comprised of
the entire county of Mecklenburg and portions of Cabarrus, Gaston,
Lincoln, Rowan, and Union Counties in North Carolina and a portion of
York County in South Carolina. EPA has published proposed and direct
final actions on the emissions inventory and emissions statements
requirements for the North Carolina portion of the bi-state Charlotte
Area in separate rulemaking documents.

DATES: This direct final rule is effective August 11, 2015 without
further notice, unless EPA receives adverse comment by July 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 No. EPA-R04-
OAR-2014-0915, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2014-0915,'' 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.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, 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. Such deliveries are only accepted during the Regional
Office's normal hours of

operation. The Regional Office's official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2014-0915. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov or
email, information that you consider to be CBI or otherwise protected.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    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 at the 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. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Tiereny Bell, 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. Ms. Bell can be reached at<PHONE_NUMBER> and via
electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of
0.075 parts per million (ppm). See 73 FR 16436 (March 27, 2008). Under
EPA's regulations at 40 CFR part 50, the 2008 8-hour ozone NAAQS is
attained when the 3-year average of the annual fourth-highest daily
maximum 8-hour average ambient air quality ozone concentrations is less
than or equal to 0.075 ppm. 40 CFR 50.15. Ambient air quality
monitoring data for the 3-year period must meet a data completeness
requirement. The ambient air quality monitoring data completeness
requirement is met when the average percent of days with valid ambient
monitoring data is greater than 90 percent, and no single year has less
than 75 percent data completeness as determined in Appendix I of part
50.
    Upon promulgation of a new or revised NAAQS, the Clean Air Act (CAA
or Act) requires EPA to designate as nonattainment any area that is
violating the NAAQS based on the three most recent years of ambient air
quality data at the conclusion of the designation process. The bi-state
Charlotte Area was designated nonattainment for the 2008 8-hour ozone
NAAQS on April 30, 2012 (effective July 20, 2012) using 2009-2011
ambient air quality data. See 77 FR 30088 (May 21, 2012). At the time
of designation, the bi-state Charlotte Area was classified as a
marginal nonattainment area for the 2008 8-hour ozone NAAQS. On March
6, 2015, EPA finalized a rule entitled ``Implementation of the 2008
National Ambient Air Quality Standards for Ozone: State Implementation
Plan Requirements'' (SIP Requirements Rule) that establishes the
requirements that state, tribal, and local air quality management
agencies must meet as they develop implementation plans for areas where
air quality exceeds the 2008 8-hour ozone NAAQS.\1\ See 80 FR 12264.
This rule establishes nonattainment area attainment dates based on
Table 1 of section 181(a) of the CAA, including an attainment date
three years after the July 20, 2012, effective date, for areas
classified as marginal for the 2008 8-hour ozone NAAQS. Therefore, the
attainment date for the bi-state Charlotte Area is July 20, 2015.
---------------------------------------------------------------------------

    \1\ The SIP Requirements Rule addresses a range of nonattainment
area SIP requirements for the 2008 ozone NAAQS, including
requirements pertaining to attainment demonstrations, reasonable
further progress (RFP), reasonably available control technology,
reasonably available control measures, major new source review,
emission inventories, and the timing of SIP submissions and of
compliance with emission control measures in the SIP. The rule also
revokes the 1997 ozone NAAQS and establishes anti-backsliding
requirements.
---------------------------------------------------------------------------

    Based on the nonattainment designation, South Carolina was required
to develop a SIP revision addressing certain CAA requirements for the
Area. Specifically, pursuant to CAA section 182(a)(3)(B) and section
182(a)(1), South Carolina was required to submit a SIP revision
addressing the emissions statements and emissions inventory
requirements, respectively.
    Ground level ozone is not emitted directly into the air, but is
created by chemical reactions between oxides of nitrogen
(NOX) and volatile organic compounds (VOC) in the presence
of sunlight. Emissions from industrial facilities and electric
utilities, motor vehicle exhaust, gasoline vapors, and chemical
solvents are some of the major sources of NOX and VOC.
Section 182(a)(3)(B) of the CAA requires each state with ozone
nonattainment areas to submit a SIP revision requiring annual emissions
statements to be submitted to the state by the owner or operator of
each NOX or VOC stationary source \2\ located within a
nonattainment area showing the actual emissions of NOX and
VOC from that source. The first statement is due three years from the
area's nonattainment designation, and subsequent statements are due at
least annually thereafter. Section 182(a)(1) of the CAA requires states
with areas designated nonattainment for the ozone NAAQS to submit a SIP
revision providing a comprehensive, accurate, and current inventory of
actual emissions from all sources of the relevant pollutant or
pollutants in such area. NOX and VOCs are the relevant
pollutants because they are the precursors of ozone.
---------------------------------------------------------------------------

    \2\ A state may waive the emission statement requirement for any
class or category of stationary sources which emit less than 25 tons
per year of VOCs or NOX if the state meets the
requirements of section 182(a)(3)(B)(ii).
---------------------------------------------------------------------------

    On August 8, 2014, South Carolina submitted a SIP revision that,
among

other things, addressed emissions statements requirements related to
the 2008 8-hour ozone NAAQS for its portion of the bi-state Charlotte
Area. Additionally, on August 22, 2014, South Carolina submitted a SIP
revision that included a base year emissions inventory for the Area.
EPA is now taking action to approve the portion of the August 8, 2014
SIP revision related to emissions statements as meeting the
requirements of sections 110 and 182(a)(3)(B) of the CAA and to approve
the portion of the August 22, 2014 SIP revision related to the base
year inventory as meeting the requirements of sections 110 and
182(a)(1) of the CAA.\3\ More information on EPA's analysis of South
Carolina's SIP revisions provided below.
---------------------------------------------------------------------------

    \3\ Regarding the emissions statements requirements, today's
direct final rulemaking is only approving certain revisions to
Section III, Emissions Inventory and Emission Statements, of state
Regulation No. 61-62.1 into the SIP. See sections II.b. and III,
below, for further detail. EPA will act on the remaining portions of
South Carolina's August 8, 2014, SIP revision in a separate action.
---------------------------------------------------------------------------

II. Analysis of State's Submittal

a. Base Year Emission Inventory

    As discussed above, section 182(a)(1) of the CAA requires states to
submit a comprehensive, accurate, and current inventory of actual
emissions from all sources of the relevant pollutant or pollutants in
each ozone non-attainment area. The section 182(a)(1) base year
inventory is defined in the SIP Requirements Rule as ``a comprehensive,
accurate, current inventory of actual emissions from sources of VOC and
NOX emitted within the boundaries of the nonattainment area
as required by CAA section 182(a)(1).'' See 40 CFR 51.1100(bb). The
inventory year must be selected consistent with the baseline year for
the RFP plan as required by 40 CFR 51.1110(b),\4\ and the inventory
must include actual ozone season day emissions as defined in 40 CFR
51.1100(cc) \5\ and contain data elements consistent with the detail
required by 40 CFR part 51, subpart A. See 40 CFR 51.1115(a), (c), (e).
In addition, the point source emissions included in the inventory must
be reported according to the point source emissions thresholds of the
Air Emissions Reporting Requirements (AERR) in 40 CFR part 51, subpart
A. 40 CFR 51.1115(d).
---------------------------------------------------------------------------

    \4\ 40 CFR 51.1110(b) states that ``at the time of designation
for the 2008 ozone NAAQS the baseline emissions inventory shall be
the emissions inventory for the most recent calendar year for which
a complete triennial inventory is required to be submitted to EPA
under the provisions of subpart A of this part. States may use an
alternative baseline emissions inventory provided the state
demonstrates why it is appropriate to use the alternative baseline
year, and provided that the year selected is between the years 2008
to 2012.''
    \5\ ``Ozone season day emissions'' is defined as ``an average
day's emissions for a typical ozone season work weekday. The state
shall select, subject to EPA approval, the particular month(s) in
the ozone season and the day(s) in the work week to be represented,
considering the conditions assumed in the development of RFP plans
and/or emissions budgets for transportation conformity.'' 40 CFR
51.1100(cc).
---------------------------------------------------------------------------

    South Carolina selected 2011 as the base year for the emissions
inventory which is the year corresponding with the first triennial
inventory under 40 CFR part 51, subpart A. This base year is one of the
three years of ambient data used to designate the Area as a
nonattainment area and therefore represents emissions associated with
nonattainment conditions. The emissions inventory is based on data
developed and submitted by SC DHEC to EPA's 2011 National Emissions
Inventory (NEI), and it contains data elements consistent with the
detail required by 40 CFR part 51, subpart A.\6\
---------------------------------------------------------------------------

    \6\ Data downloaded from the EPA EIS from the 2011 NEI was
subjected to quality assurance procedures described under quality
assurance details under 2011 NEI Version 1 Documentation located at
http://www.epa.gov/ttn/chief/net/2011inventory.html#inventorydoc.
The quality assurance and quality control procedures and measures
associated with this data are outlined in the State's EPA-approved
Emission Inventory Quality Assurance Project Plan.
---------------------------------------------------------------------------

    South Carolina's emissions inventory for its portion of the Area
provides 2011 typical average summer day emissions data for
NOX and VOCs for the following general source categories:
stationary point, area, non-road mobile, on-road mobile, and events.\7\
A detailed discussion of the inventory development is located in
Appendix A of the South Carolina submittal which is provided in the
docket for this action. The table below provides a summary of the
emissions inventory.
---------------------------------------------------------------------------

    \7\ South Carolina included events (i.e. wildfires and
prescribed fires) to account for actual event source emissions.

                           Table 1--2011 Emissions for the South Carolina, York County Portion of the bi-state Charlotte Area
                                                                  [Tons per summer day]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Point             Area         Non-road mobile   On-road mobile        Events
                            County                             -----------------------------------------------------------------------------------------
                                                                  NOX      VOC      NOX      VOC      NOX      VOC      NOX      VOC      NOX      VOC
--------------------------------------------------------------------------------------------------------------------------------------------------------
York County *.................................................     4.71     4.02     0.93     6.93     2.63     1.78    11.43     5.30     0.04     0.42
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Only a portion of York County is located in the nonattainment area.

    The emissions reported for York County reflect the emissions for
only the nonattainment portion of the county. The inventory contains
point source emissions data for facilities located within the South
Carolina portion of the Area based on Geographic Information Systems
(GIS) mapping. For the remaining emissions categories, emissions from
the South Carolina portion of the bi-state Charlotte Area were
determined based on the population of the portion of York County that
is included in the Area. More detail on the emissions inventory for
individual sources categories is provided below and in Appendix A of
the State's August 22, 2014 submittal.
    Point sources are large, stationary, identifiable sources of
emissions that release pollutants into the atmosphere. The point source
emissions inventory for South Carolina's portion of the bi-state
Charlotte Area was developed from facility-specific emissions data. A
detailed account of the point sources can be found in Appendix A of the
August 22, 2014, submittal, which is located in the docket for today's
action. The point source emissions data meets the point source
emissions thresholds of 40 CFR part 51, subpart A.
    Area sources are small emission stationary sources which, due to
their large number, collectively have significant emissions (e.g., dry
cleaners, service stations). Emissions for these sources were estimated
by multiplying an emission factor by such indicators of collective
emissions activity as production, number of employees, or population.
These emissions were estimated at the county level. South Carolina
developed its inventory according to the current EPA emissions

inventory guidance for area sources.\8\ A detailed account of the area
sources can be found in Appendix A of the August 22, 2014, submittal.
---------------------------------------------------------------------------

    \8\ This guidance includes: Procedures for the Preparation of
Emission Inventories of Carbon Monoxide and Precursors of Ozone,
Vol. 1, EPA-450/4-91-016 (May 1991) and Emissions Inventory
Improvement Program (EIIP) Technical Report, Vol. 3, Area Sources
(Revised January 2001, updated April 2001).
---------------------------------------------------------------------------

    On-road mobile sources include vehicles used on roads for
transportation of passengers or freight. South Carolina developed its
on-road emissions inventory using EPA's Motor Vehicle Emissions
Simulator (MOVES) model for each ozone nonattainment county.\9\ County
level on-road modeling was conducted using county-specific vehicle
population and other local data. South Carolina developed its inventory
according to the current EPA emissions inventory guidance for on-road
mobile sources.\10\ A detailed account of the on-road sources can be
found in Appendix A of the August 22, 2014, submittal.
---------------------------------------------------------------------------

    \9\ South Carolina used MOVES version 2010b because this was the
latest version available at the time that the State submitted its
SIP revision.
    \10\ This guidance includes: Emissions Inventory Guidance for
Implementation of Ozone and Particulate Matter National Ambient Air
Quality Standards (NAAQS) and Regional Haze Regulations, EPA-454/R-
05-001 (August 2005, updated November 2005); Policy Guidance on the
Use of MOVES2010 for State Implementation Plan Development,
Transportation Conformity, and Other Purposes, EPA-420-B-09-046
(December 2009); and Technical Guidance on the Use of MOVES2010 for
Emission Inventory Preparation in State Implementation Plans and
Transportation Conformity, EPA-420-B-10-023 (April 2010).
---------------------------------------------------------------------------

    Non-road mobile sources include vehicles, engines, and equipment
used for construction, agriculture, recreation, and other purposes that
do not use roadways (e.g., lawn mowers, construction equipment,
railroad locomotives, and aircraft). South Carolina calculated
emissions for most of the non-road mobile sources using EPA's
NONROAD2008a model \11\ and developed its non-road mobile source
inventory according to the current EPA emissions inventory guidance for
non-road mobile sources.\12\ The railroad locomotive emissions are
calculated with fuel use data, track miles and emission factors. A
detailed account of the non-road mobile sources can be found in
Appendix A of the August 22, 2014, submittal.
---------------------------------------------------------------------------

    \11\ For consistency with the NEI, South Carolina included
emissions data aircraft (where they are reported to occur at the
locations of the airports where they are generated) with the point
source data in the base year inventory. See Appendix A and Appendix
A of the State's SIP revision for a detailed discussion of the
methodology used to calculate aircraft and locomotive emissions. No
rail yards are located in York County, South Carolina.
    \12\ This guidance includes: Procedures for Emission Inventory
Preparation, Volume IV: Mobile Sources, EPA-450/4-81-026d (July
1991).
---------------------------------------------------------------------------

    SC DEHC included 2011 actual emissions from event sources in its
emissions inventory. Events sources in 2011 included wildfires and
prescribed fires. Wildfires are unplanned, unwanted wild land fires
including unauthorized human-caused fires, escaped prescribed fire
projects, or other inadvertent fire situations where the objective is
to put the fire out. Prescribed fires are any fires ignited by
management actions to meet specific objectives related to the reduction
of the biomass potentially available for wildfires. South Carolina
calculated actual event source emissions using the 2011 NEI version 1
dataset developed by EPA. A detailed account of the event sources can
be found in Appendix A of the August 22, 2014 submittal.
    For the reasons discussed above, EPA has determined that South
Carolina's emissions inventory meets the requirements under CAA section
182(a)(1) and the SIP Requirements Rule for the 2008 8-hour ozone
NAAQS.

b. Emissions Statements

    Pursuant to section 182(a)(3)(B), states with ozone nonattainment
areas must require annual emissions statements from NOX and
VOC stationary sources within those nonattainment areas. This
requirement applies to all ozone nonattainment areas regardless of
classification (e.g., Marginal, Moderate).
    On August 8, 2014, South Carolina submitted a SIP revision to amend
portions of Regulation No. 61-62.1, Definitions and General
Requirements, as currently incorporated into the SIP, to reflect recent
changes to the rule.\13\ The changes to Regulation No. 61-62.1 that
address emission statement requirements are the revision to the Section
III title,\14\ the addition of a second paragraph to Section
III.A.,\15\ and the addition of Section III.C.\16\ EPA has determined
that these three specific changes to Section III of Regulation No. 61-
62.1, identified in the August 8, 2014 SIP submission, meet the
requirements of section 182(a)(3)(B) for the 2008 8-hour ozone NAAQS
and is approving those changes into the SIP.
---------------------------------------------------------------------------

    \13\ EPA initially approved this state regulation into South
Carolina's SIP in 2006. See 71 FR 70880 (December 7, 2006).
    \14\ The revised title of Section III is ``Emissions Inventory
and Emissions Statements.''
    \15\ Paragraph two reads: ``An emissions statement is a less
detailed statement which focuses on emissions estimates for
pollutants associated with a nonattainment designation.''
    \16\ Section III.C. of the revised regulation states: ``1.
Sources in areas designated nonattainment for an ozone National
Ambient Air Quality Standard (NAAQS) must submit to the Department
by March 31 for the previous calendar year an emissions statement
which includes emissions estimates for both VOCs and nitrogen oxides
(NOX) beginning with the effective date of this
regulation. 2. The statement must contain a certification that the
information contained in the statement is accurate to the best
knowledge of the individual certifying the statement. 3. All
applicable information must be recorded in the current format for
reporting emissions data provided by the Department. 4. Copies of
all records and reports relating to emissions statements as required
in this section must be retained by the owner or operator at the
source for a minimum of five (5) years.'' On May 18, 2015, South
Carolina submitted an email to EPA clarifying that the State used
the term ``estimate'' in Section III.C.1 to ``make a distinction
between a more detailed emissions inventory, which is also required,
and the more general emission statement document'' and clarifying
that the emission statement is a ``certified document submitted to
the State, by the owner or operator of each stationary source in a
nonattainment area, that reports actual prior year VOC and
NOX emissions from the respective nonattainment area
stationary sources.'' This email is available in the docket for
today's action. SC DHEC's Web site contains additional information
regarding the State's emissions statements requirements. See http://www.scdhec.gov/Environment/AirQuality/ComplianceandReporting/EmissionsInventory/OzoneNonattainmentAreaReportingRequirements/.
---------------------------------------------------------------------------

III. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with the requirements of 1
CFR 51.5, EPA is incorporating the following changes to Regulation No.
61-62.1, titled ``Definitions and General Requirements'': modification
of the title of Section III, addition of a second paragraph to Section
III.A defining an ``emissions statement,'' and addition of Section
III.C titled ``Emissions Statement Requirements'' which were state
effective on June 27, 2014. EPA has made, and will continue to make,
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 the portions of the SIP revisions submitted by
South Carolina on August 22, 2014 and August 8, 2014, that relate to
the base year emissions inventory and emissions statement
requirements,\17\ respectively, for the State's portion of the bi-state
Charlotte Area. EPA has concluded that the portions of the State's
submissions that EPA is approving meet the relevant requirements of
sections 110 and 182 of the CAA. EPA is publishing this rule without
prior proposal because the Agency views this as a noncontroversial
submittal and anticipates no adverse

comments. However, in the proposed rules section of this Federal
Register publication, EPA is publishing a separate document that will
serve as the proposal to approve the SIP revision should adverse
comments be filed. This rule will be effective August 11, 2015 without
further notice unless the Agency receives adverse comments by July 13,
2015.
---------------------------------------------------------------------------

    \17\ EPA is only incorporating the changes to Regulation No. 61-
62.1 identified in sections II.b and III, above, into the SIP.
---------------------------------------------------------------------------

    If EPA receives such comments, then EPA will publish a document
withdrawing the final rule and informing the public that the rule will
not take effect. All adverse comments received will then be addressed
in a subsequent final rule based on the proposed rule. EPA will not
institute a second comment period. Parties interested in commenting
should do so at this time. If no such comments are received, the public
is advised that this rule will be effective on August 11, 2015 and no
further action will be taken on the proposed rule. Please note that if
EPA receives adverse comment on an amendment, paragraph, or section of
this rule and if that provision may be severed from the remainder of
the rule, the Agency may adopt as final those provisions of the rule
that are not the subject of an adverse comment.

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. 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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 direct final rule for the South Carolina portion
of the bi-state Charlotte area does not have Tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because it does not have substantial direct effects on an Indian Tribe.
The Catawba Indian Nation Reservation is located within the South
Carolina portion of the bi-state Charlotte Area. Pursuant to the
Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120, ``all
state and local environmental laws and regulations apply to the
[Catawba Indian Nation] and Reservation and are fully enforceable by
all relevant state and local agencies and authorities.'' EPA notes that
today's action will not impose substantial direct costs on Tribal
governments or preempt Tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 11, 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 today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

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

    Dated: May 28, 2015.
Heather McTeer Toney,
Regional Administrator, Region 4.

    Therefore, 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 PP--South Carolina

0
2. In Sec.  52.2120:
0
a. Paragraph (c) is amended by revising the entry for ``Section III''
under ``Regulation No. 62.1''; and
0
b. Paragraph (e) is amended by adding an entry for ``2011 Base Year
Emissions Inventory for the South Carolina portion of the bi-state
Charlotte 2008 8-Hour Ozone Nonattainment Area'' at the end of the
table.
    The revisions read as follows:

Sec.  52.2120  Identification of plan.

* * * * *
    (c) * * *

                              Air Pollution Control Regulations for South Carolina
----------------------------------------------------------------------------------------------------------------
                                                     State       EPA Approval
        State citation          Title/Subject   effective date       date            Federal Register notice
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section III..................  Emission              6/27/2014       6/12/2015  [Insert Federal Register
                                Inventory and                                    citation]
                                Emissions
                                Statement.
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    (e) * * *

                              EPA-Approved South Carolina Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                   State
          Provision           effective date          EPA Approval date                    Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
2011 Base Year Emissions           8/22/2014  6/12/2015
 Inventory for the South                      , [Insert Federal Register
 Carolina portion of the bi-                   citation]
 state Charlotte 2008 8-Hour
 Ozone Nonattainment Area.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-14338 Filed 6-11-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: September 5, 2008 (Volume 73, Number 173)]
[Notices]
[Page 51802-51803]
[DOCID:fr05se08-34]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

August 29, 2008.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC08-119-000.
    Applicants: Tiverton Power Inc., Rumford Power Inc.
    Description: Application of Rumford Power Inc. and Tiverton Power
Inc. under section 203 of FPA to Transfer Control.
    Filed Date: 08/20/2008.
    Accession Number: 20080820-5114.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 10, 2008.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER08-1356-001.
    Applicants: Maine Yankee Atomic Power Company.
    Description: Maine Yankee Atomic Power Co. submits an amendment to
the 8/1/08 filing of Third Revised Rate Schedule FERC No. 1.
    Filed Date: 08/27/2008.
    Accession Number: 20080828-0104.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 17, 2008.

    Docket Numbers: ER08-1445-000.
    Applicants: American Electric Power Service Corporate.
    Description: AEP Operating Companies submits an eighth revision to
the Interconnection and Local Delivery Agreement between AEP and the
Blue Ridge Power Authority.
    Filed Date: 08/26/2008.
    Accession Number: 20080828-0106.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 16, 2008.

    Docket Numbers: ER08-1446-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits revisions to its FERC Electric
Tariff, Seventh Revised Volume 11.
    Filed Date: 08/26/2008.
    Accession Number: 20080828-0107.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 16, 2008.

    Docket Numbers: ER08-1447-000.
    Applicants: NaturEner Glacier Wind Energy 1, LLC.
    Description: NaturEner Glacier Wind Energy 1, LLC submits an
executed Coordinated Operating Agreement.
    Filed Date: 08/26/2008.
    Accession Number: 20080828-0105.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 16, 2008.

    Docket Numbers: ER08-1448-000.

    Applicants: Southern Company Services, Inc.
    Description: Southern Companies submits a table showing each of the
applicable Southern Companies 2007 actual accruals for PBOP costs and
projected accruals for 2008, and independent actuarial assumptions and
serve as a basis for the 2008 projections under ER08-1448.
    Filed Date: 08/27/2008.
    Accession Number: 20080828-0102.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 17, 2008.

    Docket Numbers: ER08-1449-000.
    Applicants: Tieton Hydropower, LLC.
    Description: Tieton Hydropower, LLC submits its non-confirming
Initial Transmission Rate Schedule FERC No. 1.
    Filed Date: 08/27/2008.
    Accession Number: 20080828-0103.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 17, 2008.

    Docket Numbers: ER08-1450-000.
    Applicants: NorthWestern Corporation.
    Description: NorthWestern Corporation submits an executed Large
Generator Interconnection Agreement between North Western and NaturEner
Glacier Wind Energy 1, LLC.
    Filed Date: 08/26/2008.
    Accession Number: 20080828-0108.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 16, 2008.
    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES08-59-000.
    Applicants: AEP Generating Company.
    Description: Application of AEP Generating Company under section
204 of the Federal Power Act for Authorization to Issue Securities.
    Filed Date: 08/21/2008.
    Accession Number: 20080821-5032.
    Comment Date: 5 p.m. Eastern Time on Thursday, September 11, 2008.
    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA08-32-002.
    Applicants: PJM Interconnection, LLC.
    Description: Supplemental Information of PJM Interconnection L.L.C.
re the second compliance filing to PJM's transmission planning process
to reflect further revisions to Schedule 6.
    Filed Date: 08/13/2008.
    Accession Number: 20080813-5111.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 9, 2008.

    Docket Numbers: OA08-58-002.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. et al. submits proposed revisions
to Appendix 1 to Attachment K of its Open Access Transmission Tariff
etc., to comply with FERC's order issued on 5/15/08 under OA08-58.
    Filed Date: 08/13/2008.
    Accession Number: 20080828-0211.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 9, 2008.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    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
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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 dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

 Kimberly D. Bose,
Secretary.
[FR Doc. E8-20549 Filed 9-4-08; 8:45 am]

BILLING CODE 6717-01-P