[Federal Register: March 22, 2007 (Volume 72, Number 55)]
[Proposed Rules]
[Page 13452-13458]
[DOCID:fr22mr07-24]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-HQ-OAR-2007-0170; FRL-8290-9]

Supplemental Proposed Rulemaking on 8-Hour Ozone Redesignations
for Various Areas in Michigan, Ohio and West Virginia

AGENCY: Environmental Protection Agency (EPA).

ACTION: Supplemental proposed rule.

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SUMMARY: On December 22, 2006, the U.S. Court of Appeals for the
District of Columbia Circuit vacated EPA's Phase 1 Implementation Rule
for the 8-hour ozone standard. This supplemental proposed rulemaking
sets forth EPA's views on the potential effect of the Court's ruling on
a number of proposed redesignation actions. This rulemaking applies to
eighteen 8-hour ozone nonattainment areas in Michigan, Ohio and West
Virginia, for which EPA has proposed approval of the States'
redesignation requests. For the reasons set forth in the notice, EPA
proposes to find that the Court's ruling does not alter any
requirements relevant to these proposed redesignations that would
prevent EPA from finalizing these redesignations. The EPA believes that
the Court's decision, as it currently stands or as it may be modified
based upon any petition for rehearing that may be filed, imposes no
impediment to moving forward with redesignation of these areas to
attainment, because in either circumstance, redesignation is
appropriate under the relevant redesignation provisions of the Clean
Air Act (CAA) and EPA's longstanding policies regarding redesignation
requests.

DATES: Comments must be received on or before April 6, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-0170 by one of the following methods:
     http://www.regulations.gov: Follow the online instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Air and Radiation Docket and Information Center,
Environmental Protection Agency, Mailcode: 6102T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
     Hand Delivery: Environmental Protection Agency, EPA West
Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC. Such
deliveries are only accepted during the Docket's

normal hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2007-0170. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal

information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov 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 e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, avoid 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.
 For additional instructions on

submitting comments, go to section I.B of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, 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 http://www.regulations.gov
 or in hard copy at the Air and Radiation Docket and

Information Center, EPA/DC, EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air and Radiation Docket and Information
Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Butch Stackhouse, Air Quality Policy
Division, Office of Air Quality Planning and Standards, State and
Locals Program Group, U.S. Environmental Protection Agency, Research
Triangle Park, NC 27711; telephone number<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    This action applies to you if you are a State that has proposed
areas for redesignation from nonattainment to attainment of the 8-hour
ozone standard, but EPA has not yet finalized such actions. This action
is applicable therefore to the following States: Michigan; Ohio, and
West Virginia. This supplemental proposed rulemaking applies to
eighteen 8-hour ozone nonattainment areas, sixteen of which were
designated nonattainment for the 8-hour ozone standard and classified
under Subpart 1 of Part D of the CAA, and which were previously
designated Unclassifiable/Attainment, or Attainment subject to a CAA
section 175A maintenance plan under the 1-hour standard. EPA has
published proposed rulemakings to redesignate these areas to attainment
for the 8-hour ozone standard. The areas and dates of proposed
rulemakings for these areas are: Parkersburg-Marietta, OH-WV
(Washington County, OH), request submitted on November 17, 2006 and
proposed on January 17, 2007, 72 FR 1956, previously Unclassifiable/
Attainment for the 1-hour standard; Parkersburg-Marietta, OH-WV (Wood
County, WV), request submitted on September 8, 2006 and proposed on
January 12, 2007, 72 FR 1474, previously Attainment subject to a
maintenance plan for the 1-hour standard; Steubenville-Weirton, OH-WV
(Brooke and Hancock Counties, WV) request submitted on August 3, 2006
and proposed on October 2, 2006, 71 FR 57905, previously designated
Unclassifiable/Attainment for the 1-hour standard; Wheeling, OH-WV
(Marshall and Ohio counties, WV) request submitted on July 24, 2006 and
proposed on October 2, 2006, 71 FR 57894, previously designated
Unclassifiable/Attainment for the 1-hour standard; Flint (Genesee and
Lapeer Counties), MI request submitted on June 13, 2006 and proposed on
January 8, 2007, 72 FR 699, previously designated Attainment subject to
a maintenance plan for the 1-hour standard (Genesee County) and
Unclassifiable/Attainment (Lapeer County) for the 1-hour standard;
Benton Harbor (Berrien County), MI request submitted on June 13, 2006
and proposed on January 8, 2007, 72 FR 699, previously designated
Unclassifiable/Attainment for the 1-hour standard; Benzie County, MI
request submitted on May 9, 2006 and proposed on December 7, 2006, 70
FR 70915, previously designated Unclassifiable/ Attainment for the 1-
hour standard; Grand Rapids, (Kent and Ottawa Counties), MI request
submitted on May 9, 2006 and proposed on December 7, 2006, 70 FR 70915,
previously designated Attainment subject to a maintenance plan for the
1-hour standard; Huron County, MI request submitted on May 9, 2006 and
proposed on December 7, 2006, 70 FR 70915, previously designated
Unclassifiable/Attainment for the 1-hour standard; Kalamazoo-Battle
Creek (Calhoun, Kalamazoo, and Van Buren Counties), MI request
submitted on May 9, 2006 and proposed on December 7, 2006, 70 FR 70915,
previously designated Unclassifiable/Attainment for the 1-hour
standard; Lansing-East Lansing (Clinton, Eaton, and Ingham counties),
MI request submitted on May 9, 2006 and proposed on December 7, 2006,
70 FR 70915, previously designated Unclassifiable/Attainment for the 1-
hour standard; Mason County, MI request submitted on May 9, 2006 and
proposed on December 7, 2006, 70 FR 70915, previously designated
Unclassifiable/Attainment for the 1-hour standard; Canton-Massillon
(Stark County), OH request submitted on August 24, 2006 and proposed on
December 27, 2006, 71 FR 77678, previously designated Attainment
subject to a maintenance plan for the 1-hour standard; Lima (Allen
County), OH request submitted on August 24, 2006 and proposed on
December 27, 2006, 71 FR 77678, previously designated Unclassifiable/
Attainment for the 1-hour standard; Wheeling, OH-WV (Belmont County,
OH) request submitted on August 24, 2006 and proposed on December 27,
2006, 71 FR 77666, previously designated Unclassifiable/ Attainment for
the 1-hour standard; and Steubenville-Weirton, OH-WV (Jefferson County,
OH) request submitted on October 3, 2006 and proposed on January 8,
2007, 72 FR 711, previously designated Attainment

subject to a maintenance plan for the 1-hour standard.
    This rulemaking also applies to two 8-hour nonattainment areas that
were classified under Subpart 2 for the 8-hour ozone standard. These
areas, Muskegon, (Muskegon county), MI and Cass County, MI, were also
previously designated Attainment subject to a maintenance plan
(Muskegon) and Unclassifiable/Attainment (Cass County) for the 1-hour
standard. The request was submitted on June 13, 2006 and proposed
rulemakings for these areas on January 8, 2007, 72 FR 699.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date, and
page number).
     Follow directions--The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree, suggest alternatives,
and provide substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.
    Commenters wishing to submit proprietary information for
consideration must clearly distinguish such information from other
comments and clearly label it as CBI. Send submissions containing such
proprietary information directly to the following address, and not to
the public docket, to ensure that proprietary information is not
inadvertently placed in the docket: Attention: Mr. Roberto Morales,
U.S. Environmental Protection Agency, OAQPS Document Control Officer,
109 TW Alexander Drive, Room C404-02, Research Triangle Park, NC 27711.
The EPA will disclose information identified as CBI only to the extent
allowed by the procedures set forth in 40 CFR part 2. If no claim of
confidentiality accompanies a submission when it is received by the
EPA, the information may be made available to the public without
further notice to the commenter.

C. Where Can I Obtain Additional Information?

    In addition to being available in the docket, an electronic copy of
this proposed rule is also available on the World Wide Web. Following
signature by the EPA Acting Assistant Administrator for Air and
Radiation, a copy of this proposed rule will be posted on the EPA's
http://www.epa.gov/ozonedesignations/.

D. How Is This Preamble Organized?

    The information presented in this preamble is organized as follows:

I. General Information
    A. Does This Action Apply To Me?
    B. What Should I Consider as I Prepare My Comments for EPA?
    C. Where Can I Obtain Additional Information?
    D. How Is This Preamble Organized?
II. What is the Background for This Action?
III. What are EPA's Views on the Potential Effect of the Court's
Ruling on the Proposed Redesignation Actions Identified in This
Action?
    A. Areas Classified Under Subpart 1
    B. Areas Classified Under Subpart 2: Muskegon and Cass County,
MI
IV. What Action is EPA proposing?
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer Advancement Act
    J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations

II. What Is the Background for This Action?

    On December 22, 2006, the U.S. Court of Appeals for the District of
Columbia Circuit vacated EPA's Phase 1 Implementation Rule for the 8-
hour Ozone Standard (69 FR 23951, April 30, 2004). South Coast Air
Quality Management Dist. v. E.P.A., 472 F.3d 882 (DC Cir. December 22,
2006). The Court held that certain provisions of EPA's Phase 1 Rule
were inconsistent with the requirements of the CAA. The Court rejected
EPA's reasons for implementing the 8-hour ozone standard in
nonattainment areas under subpart 1 in lieu of subpart 2 of Title I,
part D of the CAA. The Court also held that EPA improperly failed to
retain four measures required for 1-hour nonattainment areas in the
anti-backsliding provisions of the regulations: (1) Nonattainment area
New Source Review (NSR) requirements based on an area's 1-hour
nonattainment classification; (2) Section 185 penalty fees for severe
or extreme nonattainment areas; (3) measures to be implemented pursuant
to section 172(c)(9) or 182(c)(9) of the CAA, on the contingency of an
area not making reasonable further progress toward attainment of the 1-
hour NAAQS, or for failure to attain that NAAQS; (4) and the
requirement to demonstrate that certain types of projects meet certain
conformity requirements. The Court upheld EPA's authority to revoke the
1-hour standard provided there were adequate anti-backsliding
provisions. The Court has established March 22, 2007, as the date by
which any rehearing petitions must be filed.

III. What Are EPA's Views on the Potential Effect of the Court's Ruling
on the Proposed Redesignation Actions Identified in This Action?

    This action sets forth EPA's views on the potential effect of the
Court's ruling on the proposed redesignation actions that are the
subject of this document. For the reasons set forth below, EPA does not
believe that the Court's ruling alters any requirements relevant to
these proposed redesignations and does not prevent EPA from finalizing
these redesignations. The EPA believes that the Court's decision, as it
currently stands or as it may be modified based

upon any petition for rehearing that may be filed, imposes no
impediment to moving forward with redesignation of these areas to
attainment, because in either circumstance, redesignation is
appropriate under the relevant redesignation provisions of the CAA and
longstanding policies regarding redesignation requests.

A. Areas Classified Under Subpart 1

1. Possible Subpart 2 Requirements
    With respect to the 16 8-hour nonattainment areas EPA classified
under Subpart 1 at the time of designation, EPA notes that the Court's
ruling rejected EPA's reasons for classifying areas under subpart 1 for
the 8-hour standard and remanded that matter to the Agency.
Consequently, it is possible that these areas could, during a remand to
EPA, be reclassified under Subpart 2. Although any future decision by
EPA to classify these areas under subpart 2 might trigger additional
future requirements for such areas, EPA believes that this does not
mean that redesignation of the areas that are the subject of this
notice cannot now go forward. This belief is based upon: (1) EPA's
longstanding policy of evaluating redesignation requests in accordance
with only the requirements due at the time the request was submitted;
(2) consideration of the inequity of applying retroactively any
requirements that might be applied in the future and, (3) with respect
to certain of the areas that are the subject of this notice, the fact
that the redesignation requests preceded even the earliest possible due
dates of any requirements for Subpart 2 areas.
    First, at the time the redesignation requests for the 16 Subpart 1
areas that are the subject of this notice were submitted, the areas
were classified under Subpart 1 and were obligated to meet the Subpart
1 requirements. Under EPA's longstanding interpretation of section
107(d)(3)(E) of the CAA, to qualify for redesignation, States
requesting redesignation to attainment must meet only the relevant
State Implementation plan (SIP) requirements that came due prior to the
submittal of a complete redesignation request. September 4, 1992
Calcagni memorandum (``Procedures for Processing Requests to
Redesignate Areas to Attainment,'' Memorandum from John Calcagni,
Director, Air Quality Management Division); See also Michael Shapiro
Memorandum, September 17, 1993, and 60 FR 12459, 12465-12466 (March 7,
1995) (redesignation of Detroit-Ann Arbor). Sierra Club v. EPA, 375
F.3d 537 (7th Cir. 2004). See, e.g., also 68 FR 25424, 25427 (May 12,
2003) (redesignation of St. Louis). At the time the redesignation
requests were submitted, the 16 areas were not classified under Subpart
2 and no Subpart 2 requirements were applicable for purposes of
redesignation.
    Moreover, it would be inequitable to retroactively apply any new
SIP requirements that were not applicable at the time the request was
submitted, but which might later become applicable. The DC Circuit has
recognized the inequity in such retroactive rulemaking, See Sierra Club
v. Whitman 285 F. 3d 63 (DC Cir. 2002), in which the DC Circuit upheld
a District Court's ruling refusing to make retroactive an EPA
determination of nonattainment that was past the statutory due date.
Such a determination would have resulted in the imposition of
additional requirements on the area. The Court stated: ``Although EPA
failed to make the nonattainment determination within the statutory
timeframe, Sierra Club's proposed solution only makes the situation
worse. Retroactive relief would likely impose large costs on the
States, which would face fines and suits for not implementing air
pollution prevention plans in 1997, even though they were not on notice
at the time.'' Id. at 68. Similarly, here it would be unfair to
penalize the areas included in this notice by applying to them for
purposes of redesignation any additional SIP requirements under Subpart
2 that were not in effect at the time they submitted their
redesignation requests, but that might apply in the future.
    Third, even if a future Subpart 2 classification were applied to
these areas retroactively, for many of the Subpart 1 areas subject to
this notice, the Subpart 2 requirements would still not be considered
applicable for purposes of redesignation. As set forth above, the
applicable requirements for purposes of redesignation are only those
that became due prior to submission of the redesignation request. In
the case of eight of the areas subject to this rulemaking,\1\ the
submission of the redesignation request preceded even the earliest
possible due date of requirements for areas classified under Subpart 2
effective June 2004. These requests were all submitted before the
earliest such submission date, which was June 15, 2006, for the
emissions statement requirement under section 182(a)(3)(B) and
emissions inventories under section 182(a)(1). Thus for this additional
reason alone these additional Subpart 2 requirements would not be
applicable for purposes of evaluating redesignation requests for these
areas. In addition, to the extent that areas had complied with the
emissions statement requirement for the 1-hour standard under section
182(a)(3)(B), this could also be considered to satisfy the requirement
under the 8-hour standard.
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    \1\ Benzie County, MI, Grand Rapids, MI, Huron County, MI,
Kalamazoo-Battle Creek, MI, Lansing-East Lansing, MI, Benton Harbor,
MI, Mason County, MI, Flint, MI.
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2. Requirements Under the 1-Hour Standard
    With respect to the Court's ruling regarding EPA's revocation of
the 1-hour standard, all of the Subpart 1 areas that are the subject of
the pending redesignation actions were designated attainment or
unclassifiable/ attainment or attainment subject to a maintenance plan
for the 1-hour standard. Those areas designated attainment or
unclassifiable/attainment were never designated nonattainment for the
1-hour standard. Thus, the provisions at issue in the antibacksliding
portion of the Court's decision never applied to these areas and would
not apply. For those areas designated attainment subject to a CAA
section 175A maintenance plan for the 1-hour standard, the Court's
ruling could be interpreted to require continuation of certain
conformity requirements, such as the requirement to submit a
transportation conformity SIP that addresses the 1-hour standard.\2\
EPA approved conformity SIPs for those subpart 1 areas in Michigan and
Ohio that were attainment subject to a maintenance plan for the 1-hour
standard.\3\
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    \2\ CAA section 176(c)(4)(E) currently requires States to submit
revisions to their SIPs to reflect certain Federal criteria and
procedures for determining transportation conformity. Transportation
conformity SIPs are different from the motor vehicle emissions
budgets that are established in control strategy SIPs and
maintenance plans.
    \3\ Grand Rapids (MI), the Genesee County portion of Flint (MI),
Canton-Massillon (OH), the Ohio portion of Steubenville-Weirton (OH)
EPA approved Michigan's conformity SIP on December 18, 1996 (61 FR
66609), and Ohio's on May 30, 2000 (65 FR 34395).
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    Moreover, under longstanding EPA policy, EPA interprets the
conformity SIP requirements as not being applicable requirements for
purposes of evaluating a redesignation request under section 107(d).
See Wall v. EPA, 265 F.3d 426 (6th Cir. 2001), (upholding this
interpretation). See also 60 FR 62748 (Dec. 7. 1995) (Tampa, FL
redesignation). This is because state conformity rules are still
required after redesignation and Federal conformity rules apply where
State rules have not been approved. 40 CFR 93.151 and 40

CFR 51.390. Thus the decision in South Coast should not alter
requirements for these areas that would preclude EPA from finalizing
its proposed redesignations.

B. Areas Classified Under Subpart 2: Muskegon and Cass County, MI

1. Subpart 2 Requirements
    The two 8-hour nonattainment areas listed above are classified
under subpart 2 for the 8-hour standard. We do not believe that any
part of the Court's opinion could require that these subpart 2
classifications be changed upon remand to EPA. However, even assuming
that they may (and Muskegon and Cass County would be subject to a
different classification under a classification scheme created in a
future rule in response to the court's decision) that would not prevent
EPA from finalizing the proposed redesignation for these areas. For the
same reasons set forth above with respect to the applicability of
Subpart 2 requirements to areas that were classified Subpart 1 at the
time of submission of redesignation requests, any additional
requirements that might apply based on that different classification
would not be applicable for purposes of evaluating their redesignation
requests.
2. Requirements Under the 1-Hour Standard
    With respect to the 1-hour standard, since Cass County was never
designated nonattainment for the 1-hour standard, there are no
outstanding 1-hour nonattainment area requirements that it would be
required to meet under the anti-backsliding requirements.
    Muskegon was a maintenance area under the 1-hour standard; thus,
the conformity requirement is the only relevant anti-backsliding
requirement that was at issue before the court. As noted above, EPA
approved Michigan's transportation conformity SIP on December 18, 1996
(61 FR 66609). Also, for the reasons set forth above with respect to
the areas classified under Subpart 1, EPA believes that having an
approved conformity SIP is not an applicable requirement for purposes
of redesignation.

IV. What Action Is EPA Proposing?

    Thus, for the reasons discussed above, EPA proposes that the
Court's ruling in South Coast, whether it stands as initially rendered
or is modified based on any petition for rehearing or other further
court proceeding, does not alter any requirements applicable for
purposes of evaluating the redesignation requests for these areas that
would prevent the Agency from finalizing its proposed determinations.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under the Executive Order.

B. Paperwork Reduction Act

    This action does not contain any information collection
requirements subject to OMB review under the Paperwork Reduction Act,
44 U.S.C. 3501 et seq. It does not contain any recordkeeping or
reporting requirements.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply, with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
    An Agency does not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The control numbers for EPA's
regulations are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this proposed rule on
small entities, small entity is defined as: (1) A small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of this proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the rule on small entities.'' 5 U.S.C. 603 and 604.
Thus, an agency may certify that a rule will not have a significant
economic impact on a substantial number of small entities if the rule
relieves regulatory burden, or otherwise has a positive economic effect
on all of the small entities subject to the rule.
    This proposed rule sets forth EPA's views on the potential effect
of the ruling of the U.S. Court of Appeals for the District of Columbia
Circuit in South Coast Air Quality Management Dist. v. EPA, 472 F.3d.
882 (DC Cir. December 22, 2006) on a number of areas proposed for
redesignation of the 8-hour ozone standard.
    We continue to be interested in the potential impacts of the
proposed rule on small entities and welcome comments on issues related
to such impacts.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and Tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and Tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
1 year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory

alternatives and adopt the least costly, most cost-effective or least
burdensome alternative that achieves the objectives of the rule. The
provisions of section 205 do not apply when they are inconsistent with
applicable law. Moreover, section 205 allows EPA to adopt an
alternative other than the least costly, most cost-effective or least
burdensome alternative if the Administrator publishes with the final
rule an explanation why that alternative was not adopted. Before EPA
establishes any regulatory requirements that may significantly or
uniquely affect small governments, including Tribal governments, it
must have developed under section 203 of the UMRA a small government
agency plan. The plan must provide for notifying potentially affected
small governments, enabling officials of affected small governments to
have meaningful and timely input in the development of EPA regulatory
proposals with significant Federal intergovernmental mandates, and
informing, educating, and advising small governments on compliance with
the regulatory requirements.
    The EPA has determined that this proposed rule does not contain a
Federal mandate that may result in expenditures of $100 million or more
for State, local, and Tribal governments, in the aggregate, or the
private sector in any 1 year. Since this proposed rule does not impose
a mandate upon any source, this rule is not estimated to result in the
expenditure by State, local and Tribal governments or the private
sector of $100 million in any 1 year. Therefore, the Agency has not
prepared a budgetary impact statement or specifically addressed the
selection of the least costly, most cost-effective, or least burdensome
alternative. Because small governments will not be significantly or
uniquely affected by this rule, the Agency is not required to develop a
plan with regard to small governments. Thus, this proposed rule is not
subject to the requirements of sections 202, 203 and 205 of the UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This proposed action does not have federalism implications. It will
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This proposed action does not
impose any new mandates on State or local governments. Thus, Executive
Order 13132 does not apply to this rule. In the spirit of Executive
Order 13132, and consistent with EPA policy to promote communications
between EPA and State and local governments, EPA specifically solicits
comment on the proposed rule for this action from State and local
officials.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 6, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.''
    This proposed rule does not have Tribal implications. It will not
have substantial direct effects on Tribal governments, on the
relationship between the Federal government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian Tribes, as specified in Executive Order 13175.
This action does not have any direct effects on Indian Tribes. Thus,
Executive Order 13175 does not apply to this proposed rule. The EPA
specifically solicits additional comment on this proposed rule from
Tribal officials where there are applicable Tribal lands in the
affected areas.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    Executive Order 13045: ``Protection of Children From Environmental
Health and Safety Risks'' (62 FR 19885, April 23, 1997) applies to any
rule that: (1) Is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health and safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, EPA must evaluate the environmental health or safety
effects of the planned rule on children, and explain why the planned
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by EPA.
    This proposed action is not subject to Executive Order 13045
because it is not economically significant as defined in Executive
Order 12866, and because EPA does not have reason to believe that the
environmental health risks or safety risks addressed by this proposed
rule present a disproportionate risk or safety risk to children. This
proposed rule sets forth EPA's views regarding the potential effect of
a recent Court's ruling, vacating the Phase 1 Ozone Implementation
rule, on previously proposed redesignation actions. Furthermore, at the
time those actions were proposed in the Federal Register, it was
determined that Executive Order 13045 did not apply to those actions.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This proposed rule is not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) because it
is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer Advancement Act

    As noted in the proposed rule, Section 12(d) of the National
Technology Transfer Advancement Act of 1995 (``NTTAA''), Public Law
104-113, section 12(d), (15 U.S.C. 272 note) directs EPA to use
voluntary consensus standards in its regulatory activities unless to do
so would be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted by voluntary consensus
standards bodies. The NTTAA directs EPA to provide Congress, through
OMB, with explanations when the Agency decides not to use available and
applicable voluntary consensus standards.
    This proposed rulemaking does not involve technical standards.
Therefore, EPA is not considering the use of any voluntary consensus
standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
Federal executive policy on environmental

justice. Its main provision directs Federal agencies, to the greatest
extent practicable and permitted by law, to make environmental justice
part of their mission by identifying and addressing, as appropriate,
disproportionately high and adverse human health or environmental
effects of their programs, policies, and activities on minority
populations and low-income populations in the United States.
    The EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of health or environmental protection, but instead
merely sets forth EPA's views on the potential effect of the ruling of
the U.S. Court of Appeals for the District of Columbia Circuit in South
Coast Air Quality Management Dist. v. EPA, 472 F.3d 882 (DC Cir.
December 22, 2006) on a number of areas proposed for redesignation of
the 8-hour ozone standard.

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen oxides,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

40 CFR Part 81

    Air pollution control, National parks, Wilderness areas.

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

    Dated: March 16, 2007.
William L. Wehrum,
Acting Assistant Administrator for Air and Radiation.
[FR Doc. E7-5352 Filed 3-21-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 224 (Monday, November 21, 2011)]
[Notices]
[Pages 71980-71982]
[FR Doc No: 2011-29888]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0176]

SEDASYS Computer-Assisted Personalized Sedation System; Ethicon
Endo-Surgery, Incorporated's Petition for Review of the Food and Drug
Administration's Denial of Premarket Approval; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The topic to be
discussed is the Center for Device and Radiological Health's (CDRH's)
denial of a premarket approval application (PMA) for the SEDASYS
computer-assisted personalized sedation system (SEDASYS) submitted by
Ethicon Endo-Surgery Inc. (EES)--the sponsor for SEDASYS. The meeting
will be open to the public.
    Name of Committee: Medical Devices Dispute Resolution Panel of the
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on scientific disputes between CDRH and
sponsors, applicants, and manufacturers
    Date and Time: The meeting will be held on December 14, 2011, from
8 a.m. to 6 p.m.
    Location: The meeting will be held at the Hilton Washington, DC/
North, Salons A, B, C, and D of the Ballroom, 620 Perry Pkwy.,
Gaithersburg, MD.
    Contact Person: Nancy Braier, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5454, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX: (301) 847-
8510, email<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-(800) 741-8138<PHONE_NUMBER> in the Washington, DC
area), and follow the prompts to the desired center or product area.
Please call the Information Line for up-to-date information on this
meeting. A notice in the Federal Register about last minute
modifications that affect a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the Agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Registration and Presentations: Interested persons may present
data, information, or views, orally or in writing, on issues pending
before the committee. Written submissions from persons other than EES
and CDRH may be made to the docket on or before December 7, 2011.
Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD,
20852. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify all
written and electronic comments and submissions with the docket number
found in brackets in the heading of this document. All written and
electronic comments and submissions will be considered to be publicly
disclosable.
    Oral presentations from persons other than EES and CDRH will be
scheduled between approximately 8:15 to 8:45 a.m., and 2:15 to 2:45
p.m. on December 14, 2011. If you wish to make an oral presentation
during the meeting, you should register on or before November 30, 2011.
Send registration information (including name, title, firm name,
address, telephone, and FAX number), and requests to make oral
presentations to Nancy Braier (see Contact Person). You should provide
the docket number appearing in the heading of this notice. You also
should submit a brief summary of the presentation, including the
discussion topic(s) that will be addressed and the approximate time
requested for your presentation. The amount of time to be allotted to
each presenter may be limited to provide opportunities to as many
persons wishing to present as possible. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for that session. We encourage
individuals and organizations with common interests to consolidate or
coordinate their presentations to allow adequate time for each request
for presentation. Nancy Braier will notify interested persons regarding
their request to speak by December 5, 2011. On the day of the meeting
scheduled open public speakers should identify themselves at the
registration desk.
    After the scheduled speakers have spoken, the Chair of the advisory
committee may ask them to remain if the advisory committee wishes to
question them further. The Chair may recognize unscheduled speakers
should time allow.

I. Background

    FDA is announcing that, in accordance with section 515(g)(2) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(g)(2)),
a public advisory committee will review CDRH's denial of a PMA for the
SEDASYS Computer-Assisted Personalized Sedation System submitted by
EES--the sponsor for SEDASYS.
    On March 25, 2008, EES submitted a PMA (PMA P080009) for SEDASYS.
SEDASYS is an integrated patient monitoring and drug delivery system.
The device's proposed indication is for the intravenous administration
of 1 percent (10 milligrams per milliliter (mg/mL)) propofol injectable
emulsion for the initiation and maintenance of minimal-to-moderate
sedation in adult patients (American Society of Anesthesiology physical
status I and II) undergoing colonoscopy and esophagogastroduodenoscopy
(EGD) procedures.
    At a May 28, 2009 meeting, the Anesthesiology and Respiratory
Therapy Devices Panel met to discuss, and provide recommendations
regarding, the PMA. The panel recommended, by a vote of 8-2, that the
PMA be found ``approvable with conditions.''

    On February 26, 2010, CDRH issued a letter to EES indicating that
PMA P080009 was not approvable under Sec.  814.44(f) (21 CFR 814.44(f))
because CDRH concluded that the data and information offered in support
of the PMA did not provide a reasonable assurance that the device is
safe under the conditions of use prescribed, recommended, or suggested
in the proposed labeling, as required by section 515(d)(2)(A) of the
FD&C Act.
    On March 25, 2010, EES requested review of the not approvable
letter. Submitted in the form of a petition for reconsideration under
21 CFR 10.33 (see Sec.  814.44(f)(2)), EES's petition stated that, in
accordance with Sec.  814.44(f), EES considered the not approvable
letter to be a denial of approval of PMA P080009 under Sec.  814.45 (21
CFR 814.45). In accordance with section 515(d)(4) of the FD&C Act, EES
requested review of this denial under section 515(g)(2) of the FD&C
Act.
    Subsequently, on October 26, 2010, CDRH issued an order denying
approval of the SEDASYS PMA (Denial Order), as required by Sec.
814.45(e)(3). On November 5, 2010, in accordance with section 515(g)(2)
of the FD&C Act, FDA granted EES's petition for review of the order
denying PMA P080009.
    In accordance with section 515(g)(2) of the FD&C Act, the Office of
the Commissioner referred PMA P080009 and the basis for the order
denying its approval to the Medical Devices Dispute Resolution Panel,
an advisory committee of experts established, in part, to receive
referrals of petitions for advisory committee review under section
515(g)(2)(B) of the FD&C Act. (See 76 FR 15321, March 21, 2011.) The
advisory committee of experts for this review consists of nine persons,
qualified by training and experience to evaluate the clinical and
scientific basis of CDRH's order denying approval of the PMA. After
independent study of the data and information furnished to it by the
Office of the Commissioner, and other data and information before it,
this advisory committee will submit to the Chief Scientist and Deputy
Commissioner for Science and Public Health (Chief Scientist), the
Commissioner's designee and an official authorized to perform all
delegable functions of the Commissioner, a report and recommendation
with respect to the order, together with the underlying data and
information and a statement of the reasons or basis for the
recommendation. (See section 515(g)(2)(A) of the FD&C Act.)
    The Office of the Commissioner will make the report and
recommendation public in accordance with section 515(g)(2)(C) of the
FD&C Act. The Office of the Commissioner will also provide a copy of
that report and recommendation to EES and CDRH, and will offer EES and
CDRH the opportunity to submit comments on the report and
recommendation before a final order is rendered. In accordance with
section 515(g)(2)(C) of the FD&C Act, the Chief Scientist will issue an
order either affirming or reversing the order denying PMA P080009 and,
if appropriate, approving or denying approval of the PMA.

II. Meeting Issues and Process

A. Issues

    Two major disputed clinical and scientific issues raised in CDRH's
Denial Order are as follows: (1) Whether, given CDRH's view that, as it
states in that order, ``the SEDASYS System is associated with an
increased incidence of deeper-than-intended sedation'' in the pivotal
study, the PMA provides a reasonable assurance that SEDASYS is safe for
its proposed intended use by health care providers who have not been
trained in the administration of general anesthesia; and (2) the
adequacy and appropriateness of the control arm used by EES in the
pivotal clinical trial for the device.
    Regarding the first issue, CDRH's Denial Order maintained that the
data provided demonstrates that ``the SEDASYS System is associated with
an increased incidence of deeper-than-intended sedation, including
episodes of general anesthesia, compared to the `Current Standard of
Care' arm that was used as a control.'' CDRH asserted in that order
that it considered these observations to represent a ``serious safety
signal'' that would require restricting use of the device to persons
trained in the administration of general anesthesia. EES's position is
that the five patients experiencing transient episodes of general
anesthesia do not represent a safety concern because none experienced
any apnea or oxygen desaturation, that the device has built-in safety
features designed to avoid progression to apnea or oxygen desaturation,
and that SEDASYS was associated with a significant reduction in the
primary safety endpoint (AUCDesat), among other reasons.
    CDRH's Denial Order also maintained that EES's ``current proposal
to mitigate the risks associated with the observed increased incidence
of deeper-than-intended sedation, namely a targeted-training program,
is inadequate because an outcome-based clinical study that would enable
evaluation of the proposed training protocol has not been conducted.''
EES's petition for review of CDRH's Not Approvable determination
countered that EES's proposed training program for SEDASYS ``is
validated by the training the pivotal study investigators received
prior to the start of the study and the outcomes of the study.''
    With respect to the control arm used in the clinical trial, EES's
pivotal study was a non-blinded comparison of propofol administration
by gastroenterology teams via SEDASYS with administration of
benzodiazepine/opioid combinations by gastroenterology teams. CDRH
maintains that, given the risks involved in administering propofol with
SEDASYS that it believed were demonstrated in the pivotal study, the
use of the device by the intended group of clinicians needs to be
compared to propofol administration in a treatment arm without the
device by health care professionals trained in the administration of
general anesthesia, as contemplated by the drug labeling for propofol.
EES's position is that the clinical trial design appropriately compares
the device with the ``current standard of care''--benzodiazepine/opioid
combinations--that it would supplant and provides reasonable assurance
of safety and effectiveness.
    Questions for the advisory committee to consider relative to the
safety issue are:
    1. Do the incidents of deeper-than-intended sedation observed in
the SEDASYS pivotal trial, including general anesthesia in five
patients in the SEDASYS group compared to one patient in the control
group, represent a clinically significant safety concern?
    2. Do any probable benefits to health from use of SEDASYS outweigh
any probable risks?
    3. Was the clinical trial comparing propofol administration by
gastroenterology teams via SEDASYS with administration of
benzodiazepine/opioid combinations by gastroenterology teams
appropriate to determine whether there is a reasonable assurance that
the device is safe for its proposed intended use?
    4. Should a clinical trial instead compare administration of
propofol by gastroenterology teams via SEDASYS with administration of
propofol without the device by persons trained in the administration of
general anesthesia?
    5. Does the PMA demonstrate that the training EES proposed for the
intended user group adequately addresses the risk of incidents of
deeper-than-intended sedation, including the incidents of general
anesthesia seen in the pivotal

trial, and the possible consequences of these events?
    6. Does the training program need to be validated to ensure that it
adequately mitigates such risks, and, if so, how could this be done?

B. Process

    Although no statute or regulation requires that separation of
functions be applied to this proceeding, the Agency is observing
separation of functions as a matter of policy in this matter. As the
Center responsible for the action under review, CDRH will be, like EES,
a party to the advisory committee meeting and will be responsible for
presenting its position at that meeting.
    In addition, as a corollary to its decision to observe a separation
of functions, until the Commissioner issues an order either affirming
or reversing the order denying approval of PMA P080009, the Office of
the Commissioner will not engage in any ex parte communication (see 21
CFR 10.3(a)) with anyone participating as a party or any person outside
the Agency with respect to the matter under consideration. Any written
ex parte communication has been and will continue to be immediately
served on the two parties and filed in the docket. Any oral ex parte
communication has been and will continue to be immediately memorialized
in writing, served on both parties, and filed in the docket.
    At the meeting, each party will be provided 2 hours during the
first portion of the meeting to present relevant information or views
orally. The parties may use the allotted time as desired, consistent
with an orderly meeting, and may be accompanied by additional persons,
who may present relevant information or views. The parties will
subsequently be allowed 15 minutes for rebuttal. During the advisory
committee's open discussion, the advisory committee members may pose
questions to, or requests for clarification from, EES and/or CDRH.
Thereafter, each party will be allocated 15 minutes for summation,
after which advisory committee deliberation and voting will occur.
    FDA welcomes the public's attendance at this advisory committee
meeting and will make every effort to accommodate persons with physical
disabilities or special needs. If you need special accommodations due
to a disability, please contact Nancy Braier (see Contact Person) at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Because this is a public meeting before an advisory committee, it
is subject to our regulations concerning the policy and procedures for
electronic media coverage of public agency administrative proceedings
(Sec. Sec.  10.200 through 10.206 (21 CFR 10.200 through 10.206)).
These procedures are primarily intended to expedite media access to our
public proceedings. Representatives of the electronic media may be
permitted, subject to certain limitations, to videotape, film, or
otherwise record our public administrative proceedings, including the
testimony of witnesses in the proceedings. Accordingly, the parties and
nonparty participants, and all other interested persons, are directed
to Sec.  10.200 through 10.206, for a more complete explanation of
those regulations' effect on this meeting.
    All documents filed or posted in this matter are available for
public review under Docket No. FDA-2010-P-0176 in the Division of
Dockets Management (see Registration and Presentations) between 9 a.m.
and 4 p.m., Monday through Friday. Persons with access to the Internet
may obtain documents at http://www.regulations.gov. FDA intends to make
background material, including briefing materials for the advisory
committee provided by CDRH and EES, available to the public no later
than 2 business days before the meeting. If FDA is unable to provide
the background material prior to the meeting, the background material
will be made publicly available at the location of the advisory
committee meeting, and the background material will be available in the
Division of Dockets Management (see Registration and Presentations) and
at http://www.regulations.gov after the meeting.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

III. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD.

    Dated: November 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29888 Filed 11-18-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: February 24, 2010 (Volume 75, Number 36)]
[Notices]
[Page 8416]
[DOCID:fr24fe10-151]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold an Open Meeting on February 24, 2010
at 10 a.m., in the Auditorium, Room L-002.
    Commissioner Casey, as duty officer, determined that no earlier
notice thereof was possible.
    The subject matter of the Open Meeting will be:
    Item 1: The Commission will consider whether to adopt amendments to
Rules 201 and 200(g) of Regulation SHO relating to short sale
restrictions.
    Item 2: The Commission will consider whether to publish a statement
regarding its continued support for a single-set of high-quality
globally accepted accounting standards and its ongoing consideration of
incorporating International Financial Reporting Standards into the
financial reporting system for U.S. issuers.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: February 19, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-3792 Filed 2-22-10; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register: November 25, 2005 (Volume 70, Number 226)]
[Notices]
[Page 71130-71131]
[DOCID:fr25no05-75]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filingand Soliciting Motions
To Intervene, Protests, and Comments

November 18, 2005.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12613-000.
    c. Date filed: September 19, 2005.
    d. Applicant: Tygart, LLC.
    e. Name of Project: Tygart Dam Hydroelectric Project.
    f. Location: The project would be located in the Tygart Creek, in
Taylor County, West Virginia. The project would use the Tygart Dam
owned by the U.S. Army Corps of Engineers.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Robert Larson, Tygart, LLC, 500 IDS
Center, Minneapolis, MN 55402, Phone<PHONE_NUMBER>.

    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project would use the U.S.
Army Corps of Engineer's Tygart Dam and consist of: (1) A proposed
powerhouse containing two generating units with a total installed
capacity of 20 megawatts, (2) a proposed 6,700-foot-long, 138-kilovolt
transmission line; and (3) appurtenant facilities. The project would
have an annual generation of 117 gigawatt hours, which would be sold to
a local utility.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street NE., Room 2A,
Washington, DC 20426, or by calling<PHONE_NUMBER>. This filing may
also be viewed on the Commission's Web site at http://www.ferc.gov

using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item
h. above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies Under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions To Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001 (a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``COMPETING
APPLICATION'', ``RECOMMENDATIONS FOR TERMS AND CONDITIONS'',
``PROTEST'', or ``MOTION TO INTERVENE'', as applicable, and the Project
Number of the particular application to which the filing refers. Any of
the above-named documents must be filed by providing the original and
the number of copies provided by the Commission's regulations to: The
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    t. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6495 Filed 11-23-05; 8:45 am]

BILLING CODE 6717-01-P