[Federal Register: March 22, 2010 (Volume 75, Number 54)]
[Notices]
[Page 13562-13563]
[DOCID:fr22mr10-84]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0133]

Revised Draft Guidance for Industry on Pharmacokinetics in
Patients With Impaired Renal Function--Study Design, Data Analysis, and
Impact on Dosing and Labeling; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised draft guidance for industry entitled
``Pharmacokinetics in Patients With Impaired Renal Function--Study
Design, Data Analysis, and Impact on Dosing and Labeling.'' The draft
guidance is intended to assist sponsors planning to conduct studies to
assess the influence of renal impairment on the pharmacokinetics of an
investigational drug. It provides recommendations on when studies
should be conducted to assess the influence of renal impairment on the
pharmacokinetics of an investigational drug, the design of such
studies, and how such studies should be carried out.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by May 21, 2010.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the guidance to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Shiew-Mei Huang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3188, Silver Spring, MD 20993-0002, 301-
796-1541, or;
    Lei Zhang, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3106, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance
entitled ``Pharmacokinetics in Patients With Impaired Renal Function--
Study Design, Data Analysis, and Impact on Dosing and Labeling.'' The
pharmacokinetics (PK) and pharmacodynamics of drugs primarily
eliminated through the kidneys may be altered by impaired renal
function to the extent that the dosage regimen needs to be changed from
that used in patients with normal renal function. Although the most
obvious type of change arising from renal impairment is a decrease in
renal excretion of a drug or its metabolites, changes in renal
metabolism can also occur. Renal impairment can also adversely affect
some pathways of hepatic and/or gut drug metabolism and has been
associated with other changes, such as changes in absorption, plasma
protein binding, transport, and tissue distribution. These changes may
be particularly prominent in patients with severely impaired renal
function and have been observed even when the renal route is not the
primary route of elimination of a drug. Thus, for most

drugs that are likely to be administered to patients with renal
impairment, including drugs that are not primarily excreted by the
kidney, PK should be assessed in patients with renal impairment to
provide appropriate dosing recommendations.
    This draft guidance provides recommendations on when studies should
be conducted to assess the influence of renal impairment on the
pharmacokinetics of an investigational drug, the design of such
studies, and how such studies should be carried out.
    In the Federal Register of May 15, 1998 (63 FR 27094), FDA
announced the availability of a guidance entitled ``Pharmacokinetics in
Patients With Impaired Renal Function--Study Design, Data Analysis, and
Impact on Dosing and Labeling.'' The guidance has been revised at this
time to indicate that a renal impairment study will be recommended for
all drugs (with a few exceptions). In the original guidance, the agency
stressed the need to evaluate only drugs that are renally eliminated. A
second change is that in the 1998 guidance, only the Cockcroft-Gault
equation was recommended to gauge renal function. The revised draft
guidance adds the Modification of Diet in Renal Disease equation as
another possible gauge for renal function and for dose adjustments.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance
represents the agency's current thinking on conducting PK studies in
patients with impaired renal function. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirement of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR 201.57 have been
approved under OMB control number 0910-0572.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances or http://
www.regulations.gov.

    Dated: March 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6171 Filed 3-19-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: March 27, 2007 (Volume 72, Number 58)]
[Notices]
[Page 14274-14275]
[DOCID:fr27mr07-40]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

March 21, 2007.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER99-2915-002.
    Applicants: Indeck-Olean Limited Partnership.
    Description: Indeck-Olean Limited Partnership submits its Triennial
Market Power update filed pursuant to FERC's 3/16/04 letter order.
    Filed Date: 03/16/2007.
    Accession Number: 20070321-0055.
    Comment Date: 5 p.m. Eastern Time on Friday, April 06, 2007.

    Docket Numbers: ER00-2885-015; ER06-864-007; ER06-1543-005; ER01-
2765-014; ER02-1582-013; ER02-1785-010; ER02-2102-014; ER97-2414-010;
ER03-1283-008.
    Applicants: Cedar Brakes I, L.L.C.; Bear Energy LP; Brush
Cogeneration Partners; Cedar Brakes II, L.L.C.; Mohawk River Funding
IV, L.L.C.; Thermo Cogeneration Partnership L.P.; Utility contract
Funding, L.L.C.; Lowell Cogeneration Company Limited Partnership;
Vineland Energy LLC.
    Description: Bear Energy, LP and its Affiliates notify the FERC
that it has entered into an energy management agreement with Milford
Power Co, LLC in accordance with Order 652.
    Filed Date: 03/19/2007.
    Accession Number: 20070321-0056.
    Comment Date: 5 p.m. Eastern Time on Monday, April 09, 2007.

    Docket Numbers: ER98-2259-005.
    Applicants: LSP Energy Limited Partnership.
    Description: LSP Energy Limited Partnership submits its updated
triennial market power analysis pursuant to the requirements of FERC's
5/14/98 Order.
    Filed Date: 03/19/2007.
    Accession Number: 20070321-0054.
    Comment Date: 5 p.m. Eastern Time on Monday, April 09, 2007.

    Docket Numbers: ER01-1385-028; ER01-3155-019; ER04-230-029; EL01-
45-027.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits its
Tenth Quarterly Report regarding effort to efficiently utilize combined
cycle units in the NYISO markets.
    Filed Date: 03/15/2007.
    Accession Number: 20070315-5035.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 05, 2007.

    Docket Numbers: ER07-570-001.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc submits a
minor amendment/addition to the proposed revisions to Attachment F to
its Open Access Transmission Tariff.
    Filed Date: 03/16/2007.
    Accession Number: 20070321-0057.
    Comment Date: 5 p.m. Eastern Time on Friday, April 06, 2007.

    Docket Numbers: ER07-637-000.
    Applicants: Entergy Gulf States, Inc.; Calcasieu Power, LLC.
    Description: American Electric Power Service Corporation submits a
Unit Power Agreement under which AEP Generating Co proposes to sell all
of the capacity and associated energy, & ancillary services from MW
Lawrenceburg generating plant.
    Filed Date: 03/16/2007.
    Accession Number: 20070321-0062.
    Comment Date: 5 p.m. Eastern Time on Friday, April 06, 2007.

    Docket Numbers: ER07-r638-000.
    Applicants: Maine Public Service Company.
    Description: Maine Public Service Company submits an informational
filing setting forth the changed loss factor effective 3/1/07 together
with back-up materials.
    Filed Date: 03/15/2007.
    Accession Number: 20070321-0063.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 05, 2007.
    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES07-17-001.
    Applicants: AEP Generating Company.
    Description: AEP Generating Company submits an amended application
under section 204 of the FPA for authorization to issue securities.
    Filed Date: 03/20/2007.
    Accession Number: 20070320-5017.
    Comment Date: 5 p.m. Eastern Time on Friday, March 30, 2007.

    Docket Numbers: ES07-27-000.
    Applicants: Detroit Edison Company.
    Description: The Detroit Edison Company's application for an order
authorizing short-term securities bearing final maturity dates not to
exceed one year after issue, in an aggregate principal amount not to
exceed $1.0 billion.
    Filed Date: 03/19/2007.
    Accession Number: 20070321-0058.
    Comment Date: 5 p.m. Eastern Time on Monday, April 09, 2007.
    Take notice that the Commission received the following electric
reliability filings:

    Docket Numbers: RR06-1-007.
    Applicants: North American Electric Reliability Corporation.
    Description: North American Electric Reliability Corporation
submits a compliance filing in response to the Commission's 1/18/07 and
3/9/07 Order.
    Filed Date: 03/19/2007.
    Accession Number: 20070319-5027.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 18, 2007.

    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 5:00 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>.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-5533 Filed 3-26-07; 8:45 am]

BILLING CODE 6717-01-P


Proposal to Revise the National Ambient Air Quality Standards for Particle Pollution Presentation to the CEED Jason K. Burnett May 2006 ° On December 20, 2005 the EPA proposed revisions to the National Ambient Air Quality Standards ( NAAQS) for particle pollution.

° The proposed revisions would strengthen a fine particle standard important for both health and visibility, and would improve and refocus the coarse particle standards on those particles that are associated with public health concerns.

° The proposed revisions address two categories of particle pollution:

  fine particles ( PM 2.5 ), which are 2.5 micrometers in diameter and smaller;

and   inhalable coarse particles ( PM 10 2.5 ), which are smaller than 10 micrometers in diameter but larger than PM2.5. ( Not covered in this presentation.)

° For more information go to www. epa. gov/ air/ particlepollution Overview PM2.5   Primary 24 hour Standard ° Under the proposal, EPA would revise the level of the 24 hour standard from the current level of 65 µ g/ m3 to 35 µ g/ m3.

  EPA is proposing this change based on its assessment of a significantly expanded body of scientific information.

° Studies show health effects at and below the level of the current standard ° EPA also is considering alternative levels for the 24 hour standard, between the range of 35 and 30 µ g/ m3 and is soliciting public comment on these levels.

° In addition, the Agency took comment on alternative approaches for selecting the level of the standard, and on levels as high as the current level of 65 µ g/ m3 and as low as 25 µ g/ m3. PM2.5   Primary Annual Standard ° EPA is proposing to retain the current annual standard at 15 µ g/ m3   EPA is proposing to retain this standard based on its assessment of several expanded, re analyzed and new studies that have increased the Agency's confidence in associations between long term PM 2.5 exposure and serious health effects,

including heart and lung related death.

° EPA is considering and is seeking public comment on lower alternatives for the annual standard including 14 and 13 µ g/ m3.

° In addition, the Agency took comment on alternative views including a standard as low as 12 µ g/ m3. PM2.5   Secondary Standards ° The proposal would set the secondary standards for both the annual and 24 hour standards at levels identical to the primary standards ° EPA also took comment on whether to set a separate PM2.5 standard, designed to address visibility ( principally in urban areas)

  At levels within a range of 20 to 30 µ g/ m3, and   On averaging times within a range of four to eight daylight hours ° Rulemaking on PM NAAQS:

  Proposal signed on December 20, 2005 ( consent agreement)

  Public comment period: 90 days   Public Hearings held in Philadelphia, Chicago and San Francisco   Final Rule to be signed by September 27, 2006 ( consent agreement)

  Proposal includes simultaneous rulemakings ° PM NAAQS, Federal Reference Method, & Data Handling ( Part 50)

° Air Monitoring Regulations: Requirements for Reference and Equivalent Methods, Network Design Requirements ( Parts 53 & 58)

  Related rulemakings:

° Exceptional & Natural Events, Implementation Advanced Notice of Proposed Rulemaking Current PM NAAQS Review   Schedule April 2020 April 2015 ( based on 2012

2104 monitoring data)

April 2013 April 2010 Nov. 2009 Nov. 2007 ( based on 2004 2006 monitoring data)

Nov. 2006 2006 PM2.5 Primary NAAQS Up to April 2015 Attainment Date with Extension April 2010 ( based on 2007 2009 monitoring data)

Attainment Date April 2008 SIPs Due April 2005 Effective Date of Designations Dec. 2004 Final Designations Signature Feb. 2004 ( based on 2001

2003 monitoring data)

State Recommendations to EPA July 1997 Promulgation of Standard 1997 PM2.5 Primary NAAQS Milestone Timeline if PM2.5 NAAQS are Revised Questions Posed in the Regulatory Impact Analysis ° What are the costs and benefits ( nationally and by region)

with 15/ 35 ( or alternatives)?

  Benefits likely exceed costs by wide margin for most of the country.

  Significant questions about attainment feasibility in some areas.

° To what extent is attainment of 15/ 65 by 2015 on the path towards attaining 15/ 35 ( or alternatives) by 2020?

° What is known about differential toxicity and what does this imply for attainment strategies?

  Diverse strategies covering many types of particles and particle precursors. What would change this attainment strategy?

° How might a controlling daily standard affect attainment strategy decisions? Local controls, seasonal controls? Table & Maps Summary of Counties Violating the PM2.5 Primary Standards Current and Projected 2015 * See Technical Support Document for details on projection method used here ( i. e., Speciated Modeled Attainment Test SMAT). 62 116 178 62 264 326 15/ 30 46 50 96 50 185 235 14/ 35 46 30 76 50 141 191 15/ 35 14 18 32 14 102 116 15/ 65  current standard West East National West East National Projected with CAIR/ CAVR/ CAMR*

Current Standard Options PM2.5 Nonattainment Areas Currently Designated  Annual and 24 hour PM 2.5 Nonattainment ( 53 counties)

 24 hour Only PM 2.5 Nonattainment ( 69)

 Annual PM 2.5 Only Nonattainment ( 15)

( 2002 2004; includes all sites w/ 11+ observations per quarter or those deemed complete via ` data substitution') ( 137 counties)

Counties Exceeding 15 µ g/ m3 Annual and/ or 35 µ g/ m3 24 hour PM2.5 Standard Based on 2002 2004 Data*

* These projections are based on the most recent data ( 2002 2004). EPA will not designate areas as nonattainment on these data, but likely on 2006 2008 data which we expect to show improved air quality. Exceptional events ( e. g., fires)

that may contribute to violations of the proposed standards may be included in this dataset. Modeled Estimates for the Year 2015 Number of Counties 7 0 25 Legend Annual and 24 hour PM2.5 Nonattainment 24 hour Only PM2.5 Nonattainment Annual PM2.5 Only Nonattainment Counties Projected to attain 84 Total Nonattainment 32 CAIR/ CAMR/ CAVR 2015 SMAT 15/ 65 Counties Projected to Exceed the PM2.5 NAAQS in 2015 Based on EPA Modeling*

Annual 15 ug/ m3 and 24 Hour 65 ug/ m3 * EPA models assume implementation of CAIR/ CAMR/ CAVR, mobile source and other federal rules and existing state programs. Air quality is expected to be better than shown. This approach does not forecast actions states will take to meet current PM standards. Also note that modeled air quality forecasts are subject to a number of uncertainties. Counties Projected to Exceed the PM2.5 NAAQS in 2015 Based on EPA Modeling*

Annual 15 ug/ m3 and 24 Hour 35 ug/ m3 Number of Counties 25 44 7 Legend Annual and 24 hour PM2.5 Nonattainment 24 hour Only PM2.5 Nonattainment Annual PM2.5 Only Nonattainment Counties Projected to attain 115 Total Nonattainment 76 CAIR/ CAMR/ CAVR 2015 SMAT 15/ 35 * EPA models assume implementation of CAIR/ CAMR/ CAVR, mobile source and other federal rules and existing state programs. Air quality is expected to be better than shown. This approach does not forecast actions states will take to meet current PM standards. Also note that modeled air quality forecasts are subject to a number of uncertainties. Counties Projected to Exceed the PM2.5 NAAQS in 2015 Based on EPA Modeling*

Annual 14 ug/ m3 and 24 Hour 35 ug/ m3 Number of Counties 32 37 27 Legend Annual and 24 hour PM2.5 Nonattainment 24 hour Only PM2.5 Nonattainment Annual PM2.5 Only Nonattainment Counties Projected to attain 139 Total Nonattainment 96 CAIR/ CAMR/ CAVR 2015 SMAT 14/ 35 * EPA models assume implementation of CAIR/ CAMR/ CAVR, mobile source and other federal rules and existing state programs. Air quality is expected to be better than shown. This approach does not forecast actions states will take to meet current PM standards. Also note that modeled air quality forecasts are subject to a number of uncertainties.


[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Rules and Regulations]
[Pages 11583-11585]
[FR Doc No: 2013-03606]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0888; FRL-9780-8]

Approval and Promulgation of Implementation Plans Tennessee:
Revisions to Volatile Organic Compound Definition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve changes to the
Tennessee State Implementation Plan (SIP), submitted by the State of
Tennessee, through the Tennessee Department of Environment and
Conservation (TDEC) on September 3, 1999. Tennessee's September 3,
1999, SIP adds 17 compounds to the list of compounds excluded from the
definition of ``Volatile Organic Compound'' (VOC). EPA is approving
this SIP revision because the State has demonstrated that it is
consistent with the Clean Air Act (CAA or Act).

DATES: This direct final rule is effective April 22, 2013 without
further notice, unless EPA receives adverse comment by March 21, 2013.
If adverse comment is received, EPA 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-2012-0888, 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-2012-0888,'' Regulatory Development Section,
Air Planning 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, Regulatory
Development Section, Air Planning 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 to 4:30, excluding federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2012-0888. 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 Regulatory Development Section, Air Planning
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 to 4:30, excluding
federal holidays.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-9043. Mr. Lakeman can be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Analysis of the State's Submittal
II. Final Action
III. Statutory and Executive Order Reviews

I. Analysis of the State's Submittal

    Tennessee's September 3, 1999, SIP submission changes rule 1200-3-
9-.01 to add a total of 17 compounds to the list of compounds excluded
from the definition of VOC to be consistent with EPA's definition of
VOC at 40 CFR 51.100(s). The SIP submittal is in response to EPA's
revision to the definition of VOC, (at 40 CFR 51.100(s)) published in
the Federal Register on August 25, 1997 (62 FR 44900) and April 9, 1998
(63 FR 17331) adding the 16 compounds listed below in Table 1 and the
compound methyl acetate respectively. These compounds were added to the
exclusion list for VOC on the basis that they have a negligible effect
on tropospheric ozone formation.
    Tropospheric ozone, commonly known as smog, occurs when VOC and
nitrogen oxide (NOX) react in the atmosphere. Because of the
harmful health effects of ozone, EPA limits the amount of VOC and
NOX that can be released into the atmosphere. VOCs are those
compounds of carbon (excluding carbon monoxide, carbon dioxide,
carbonic acid, metallic carbides, or carbonates, and ammonium
carbonate) which form ozone through atmospheric photochemical
reactions. Compounds of carbon (or organic compounds) have different
levels of reactivity; they do not react at the same speed, or do not
form ozone to the same extent. It has been EPA's policy that compounds
of carbon with a negligible level of reactivity need not be regulated
to reduce ozone (42 FR 35314, July 8, 1977). EPA determines whether a
given carbon compound has ``negligible'' reactivity by comparing the
compound's reactivity to the reactivity of ethane. EPA lists these
compounds in

its regulations at 40 CFR 51.100(s), and excludes them from the
definition of VOC. The chemicals on this list are often called
``negligibly reactive.'' EPA may periodically revise the list of
negligibly reactive compounds to add compounds to or delete them from
the list.
    TDEC's September 3, 1999, SIP revision changes rule 1200-3-9-.01 to
add a total of 17 compounds to the list of compounds excluded from the
definition of VOC in accordance with the federal list of compounds
designated as having negligible photochemical reactivity at 40 CFR
51.100(s).

Table 1--16 Compounds Added to the List of Negligibly Reactive Compounds
------------------------------------------------------------------------
                 Compound                          Chemical name
------------------------------------------------------------------------
HFC-32...................................  Difluoromethane
HFC-161..................................  Ethylfluoride
HFC-236fa................................  1,1,1,3,3,3-hexafluoropropane
HFC-245ca................................  1,1,2,2,3-pentafluoropropane
HFC-245ea................................  1,1,2,3,3-pentafluoropropane
HFC-245eb................................  1,1,1,2,3-pentafluoropropane
HFC-245fa................................  1,1,1,3,3-pentafluoropropane
HFC-236ea................................  1,1,1,2,3,3-hexafluoropropane
HFC-365mfc...............................  1,1,1,3,3-pentafluorobutane
HCFC-31..................................  Chlorofluoromethane
HCFC-123a................................  1,2-dichloro-1,1,2-
                                            trifluoroethane
HCFC-151a................................  1-chloro-1-fluoroethane
C4F9OCH3.................................  1,1,1,2,2,3,3,4,4-nonafluoro-
                                            4-methoxybutane
(CF3)2CFCF2OCH3..........................  2-(difluoromethoxymethyl)-
                                            1,1,1,2,3,3,3-
                                            heptafluoropropane
C4F9OC2H5................................  1-ethoxy-1,1,2,2,3,3,4,4,4-
                                            nonafluorobutane
(CF3)CFCF2OC2H5..........................  2-(ethoxydifluoromethyl)-
                                            1,1,1,2,3,3,3-
                                            heptafluoropropane
------------------------------------------------------------------------

II. Final Action

    EPA is approving the aforementioned changes to the State of
Tennessee SIP, because it is consistent with EPA's definition of VOC
and 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 April 22, 2013
without further notice unless the Agency receives adverse comments by
March 21, 2013.
    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 public 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 April 22, 2013 and no
further action will be taken on the proposed rule.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country, and EPA
notes that it will not impose substantial direct costs on tribal
governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by April 22, 2013. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file any 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, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: February 5, 2013.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart RR--Tennessee

0
2. Section 52.2220(c) is amended by revising the entry in Table 1 for
``Section 1200-3-9.01'' to read as follows:

Sec.  52.2220(c).  Identification of plan.

* * * * *
    (c) * * *

                                   Table 1--EPA Approved Tennessee Regulations
----------------------------------------------------------------------------------------------------------------
                                                     State
        State citation            Title/subject    effective     EPA  approval             Explanation
                                                      date           date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
                               CHAPTER 1200-3-9 CONSTRUCTION AND OPERATING PERMITS
1200-3-9-.01..................  Definitions.....    6/27/2011  2/19/2013         On 2/19/2013 EPA revised this
                                                                [Insert first     section to add 17 compounds to
                                                                page of           the list of compounds excluded
                                                                publication].     from the definition of VOC
                                                                                that was state effective on 9/
                                                                                3/1999.
                                                                                EPA is approving Tennessee's
                                                                                July 29, 2011, SIP revisions
                                                                                to Chapter 1200-3-9-.01 with
                                                                                the exception of the term
                                                                                ``particulate matter
                                                                                emissions'' at 1200-03-09-
                                                                                .01(4)(b)47(vi) as part of the
                                                                                definition for ``regulated NSR
                                                                                pollutant'' regarding the
                                                                                inclusion of condensable
                                                                                emissions in applicability
                                                                                determinations and in
                                                                                establishing emissions
                                                                                limitations.
                                                                                EPA approved Tennessee's May
                                                                                28, 2009 SIP revisions to
                                                                                Chapter 1200-3-9-.01 with the
                                                                                exception of the ``baseline
                                                                                actual emissions'' calculation
                                                                                revision found at 1200-3-9-.01
                                                                                (4)(b)45(i)(III),
                                                                                (4)(b)45(ii)(IV),
                                                                                (5)(b)1(xlvii)(I)(III) and
                                                                                (5)(b)1(xlvii)(II)(IV) of the
                                                                                submittal.

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

* * * * *
[FR Doc. 2013-03606 Filed 2-15-13; 8:45 am]
BILLING CODE 6560-50-P