[Federal Register Volume 76, Number 194 (Thursday, October 6, 2011)]
[Notices]
[Pages 62103-62107]
[FR Doc No: 2011-25792]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65448; File No. SR-BYX-2011-024]

Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of
Filing and Order Granting Accelerated Approval of Proposed Rule Change
To Amend BYX Rule 13.3 To Prohibit Members From Voting Uninstructed
Shares on Certain Matters and To Align BYX Rule 13.3, Concerning the
Forwarding of Proxy and Other Material and Proxy Voting, With the Rules
of Other Self-Regulatory Organizations

September 30, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'' or the ``Exchange Act''),\1\ and Rule 19b-4 thereunder,\2\
notice is hereby given that on September 16, 2011, BATS Y-Exchange,
Inc. (the ``Exchange'' or ``BYX'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons and is

approving the proposed rule change on an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is proposing to amend BYX Rule 13.3, entitled
``Forwarding of Issuer Materials,'' in accordance with the provisions
of Section 957 of the Dodd-Frank Wall Street Reform and Consumer
Protection Act (the ``Dodd-Frank Act''). The Exchange is also proposing
changes to BYX Rule 13.3 in order to better align the Exchange's rule
with the rules of other self-regulatory organizations (``SROs'').
    The text of the proposed rule addition is available at the
Exchange's Web site at http://www.batstrading.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Section 957 of the Dodd-Frank Act amends Section 6(b) of the Act
\3\ to require the rules of each national securities exchange to
prohibit any member organization that is not the beneficial owner of a
security registered under Section 12 of the Act \4\ from granting a
proxy to vote the security in connection with certain stockholder
votes, unless the beneficial owner of the security has instructed the
member organization to vote the proxy in accordance with the voting
instructions of the beneficial owner. The stockholder votes covered by
Section 957 include any vote with respect to (i) the election of a
member of the board of directors of an issuer (other than an
uncontested election of a director of an investment company registered
under the Investment Company Act), (ii) executive compensation, or
(iii) any other significant matter, as determined by the Commission, by
rule.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78l.
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    Accordingly, in order to carry out the requirements of Section 957
of the Dodd-Frank Act, the Exchange proposes to add new paragraph (b)
to BYX Rule 13.3 to prohibit a Member from giving a proxy to vote stock
that is registered in its name, unless: (i) Such Member is the
beneficial owner of such stock; (ii) such proxy is given pursuant to
the written instructions of the beneficial owner; or (iii) such proxy
is given pursuant to the rules of any national securities exchange or
association of which it is a member provided that the records of the
Member clearly indicate the procedure it is following. The Exchange is
proposing to adopt these rules because other national securities
exchanges and associations do allow proxy voting under certain limited
circumstances while the current Exchange Rules are silent on such
matters. Therefore, a Member that is also a member of another national
securities exchange or association may vote the shares held for a
customer when allowed under its membership at another national
securities exchange or association, provided that the records of the
Member clearly indicate the procedure it is following.
    Notwithstanding the above, as proposed in new paragraph (c) to Rule
13.3, a Member that is not the beneficial owner of a security
registered under Section 12 of the Exchange Act is prohibited from
granting a proxy to vote the security in connection with a shareholder
vote on the election of a member of the board of directors of an issuer
(except for a vote with respect to uncontested election of a member of
the board of directors of any investment company registered under the
Investment Company Act of 1940), executive compensation, or any other
significant matter, as determined by the Commission, by rule, unless
the beneficial owner of the security has instructed the Member to vote
the proxy in accordance with the voting instructions of the beneficial
owner.
    In order to promote consistency with FINRA Rule 2251, the Exchange
also proposes to add language to the existing text of Rule 13.3 to
state that for beneficial owners, the proxy materials or other
materials to be forwarded on behalf of an issuer can be sent to the
beneficial owner's designated investment adviser, if applicable. In
conjunction with this change, the Exchange proposes to adopt the
definition of ``designated investment adviser'' set forth in FINRA Rule
2251(f) as Interpretation and Policy .01 to Rule 13.3.
    Similarly, the Exchange proposes to add new paragraph (d) to Rule
13.3, based entirely on FINRA Rule 2251(d), to explicitly state that a
Member may give a proxy to vote any stock registered in its name if
such Member holds such stock as executor, administrator, guardian,
trustee, or in a similar representative or fiduciary capacity with
authority to vote. Proposed paragraph (d) will also state that a Member
that has in its possession or within its control stock registered in
the name of another Member and that desires to transmit signed proxies
pursuant to the provisions of paragraph (a) of Rule 13.3, shall obtain
the requisite number of signed proxies from such holder of record.
Lastly, proposed paragraph (d) also states that, notwithstanding the
foregoing: (1) Any Member designated by a named Employee Retirement
Income Security Act of 1974 (as amended) (``ERISA'') Plan fiduciary as
the investment manager of stock held as assets of the ERISA Plan may
vote the proxies in accordance with the ERISA Plan fiduciary
responsibilities if the ERISA Plan expressly grants discretion to the
investment manager to manage, acquire, or dispose of any plan asset and
has not expressly reserved the proxy voting right for the named ERISA
Plan fiduciary; and (2) any designated investment adviser may vote such
proxies.
    The Exchange also proposes modifying the text of Rule 13.3, which
currently would require forwarding of proxy material but which does not
explicitly reference such material, to add such an explicit reference.
The Exchange further proposes to modify the text of Rule 13.3 to
reference ``security holders,'' rather than stockholders, in the
initial sentence, to ensure that the coverage of the rule applies to
all securities, including debt securities to the extent applicable, and
not just equity securities. The Exchange also proposes to incorporate
certain language from FINRA Rule 2251 that provides additional detail
regarding the material that must be provided to beneficial owners in
the event of a proxy solicitation. Specifically, Rule 13.3 as amended
will state that in the event of a proxy solicitation, materials
provided pursuant to the Rule shall include a signed proxy indicating
the number of shares held for such beneficial owner and bearing a
symbol identifying the proxy with proxy records maintained by the
Member, and a letter informing the beneficial owner (or the beneficial
owner's designated investment adviser) of the time limit and necessity
for

completing the proxy form and forwarding it to the person soliciting
proxies prior to the expiration of the time limit in order for the
shares to be represented at the meeting. The Rule will also require a
Member to furnish a copy of the symbols to the person soliciting the
proxies and shall also retain a copy thereof pursuant to the provisions
of Exchange Act Rule 17a-4. Finally, the Exchange proposes to modify
the title of Rule 13.3 to include reference to proxy voting.
    The Exchange believes that these additional changes to Rule 13.3
will help to avoid confusion by Members of the Exchange that are also
members of FINRA by further aligning the Exchange's rules with FINRA
Rule 2251. In addition, the Exchange notes that it is party to an
agreement with FINRA pursuant to which certain regulatory
responsibility to examine and enforce common rules of the Exchange and
FINRA is allocated to FINRA pursuant to Rule 17d-2 under the Act (the
``17d-2 Agreement'').\5\ The proposed changes to Rule 13.3 may be
sufficient to incorporate Rule 13.3 into the 17d-2 Agreement, further
reducing duplicative regulation of Members that are also members of
FINRA.
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    \5\ 17 CFR 240.17d-2.
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2. Statutory Basis
    Approval of the rule change proposed in this submission is
consistent with the requirements of the Act and the rules and
regulations thereunder that are applicable to a national securities
exchange, and, in particular, with the requirements of Section 6(b) of
the Act.\6\ The Exchange believes that proposed Rule 13.3(c) is
consistent with Section 6(b)(10) \7\ requirements that all national
securities exchanges adopt rules prohibiting members from voting,
without receiving instructions from the beneficial owner of shares, on
the election of a member of a board of directors of an issuer (except
for a vote with respect to the uncontested election of a member of the
board of directors of any investment company registered under the
Investment Company Act of 1940), executive compensation, or any other
significant matter, as determined by the Commission, by rule. The
Exchange also believes that proposed Rule 13.3(c) is consistent with
Section 6(b)(5) of the Act,\8\ because it would promote just and
equitable principles of trade, remove impediments to, and perfect the
mechanism of, a free and open market and a national market system, and,
in general, protect investors and the public interest. The Exchange is
adopting proposed Rule 13.3(c) to comply with the requirements of
Section 957 of the Dodd-Frank Act, and therefore believes the proposed
rule change to be consistent with the Act, particularly with respect to
the protection of investors and the public interest.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(10).
    \8\ 15 U.S.C. 78f(b)(5).
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    The Exchange also believes that proposed Rule 13.3(b) is consistent
with Section 6(b)(5) of the Act,\9\ particularly with respect to
removal of impediments to, and perfection the mechanism of, a free and
open market and a national market system, because the proposed changes
will provide for consistent regulation for Members of the Exchange that
are members of other SROs with analogous rules.\10\ Moreover, the
proposed changes to Rule 13.3(a), proposed Rule 13.3(d), and proposed
Interpretation and Policy .01 are consistent with FINRA Rule 2251.
Accordingly, the Exchange believes that the proposal fosters
cooperation amongst SROs because to the extent the Exchange is able to
incorporate Rule 13.3 into the 17d-2 Agreement as a rule in common
between the Exchange and FINRA (a ``Common Rule''), then FINRA will
conduct a review for compliance with the Common Rule to the extent a
Member of the Exchange is also a member of FINRA, and the Exchange will
not conduct a duplicative review of the same activity by that Member.
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    \9\ Id.
    \10\ See, e.g., FINRA Rule 2251, ISE Rule 421, NYSE Arca Rule
9.4, and Nasdaq Rule 2251.
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    Finally, the Exchange believes that the proposal will contribute to
investor protection by defining important requirements to which Members
must abide with respect to proxy solicitation, proxy voting and
delivery of proxy materials.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

(C) Self-Regulatory Organization's Statement on Comments on the
Proposed Rule Change Received From Members, Participants or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml ); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BYX-2011-024 on the subject line.

Paper comments

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

All submissions should refer to File Number SR-BYX-2011-024. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BYX-2011-024 and should be
submitted on or before October 27, 2011.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    In its filing, the Exchange requested that the Commission approve
the proposal on an accelerated basis so that the Exchange could comply
with the requirements imposed by the Dodd-Frank Act, and because the
proposed rule text is based upon FINRA Rule

2251, as well as ISE Rule 421, Nasdaq Rule 2251, and NYSE Arca Rule
9.4.\11\ After careful consideration, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\12\
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    \11\ See Securities Exchange Act Release 63139 (October 20,
2010), 75 FR 65680 (October 26, 2010) (SR-ISE-2010-99); 61052
(November 23, 2009), 74 FR 62857 (December 1, 2009) (SR-FINRA-2009-
066) (finding that the proposed rule change was consistent with the
Act because the Rule ``will continue to provide FINRA members with
guidance on the forwarding of proxy and other issuer-related
materials.''); 62992 (September 24, 2010), 75 FR 60844 (October 1,
2010) (SR-NASDAQ-2010-114); and 48735 (October 31, 2003), 68 FR
63173 (November 7, 2003) (SR-PCX-2003-50).
    \12\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
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    The Commission believes that proposed Rule 13.3(b) is consistent
with Section 6(b)(5) \13\ of the Act, which provides, among other
things, that the rules of the Exchange must be designed to promote just
and equitable principles of trade, remove impediments to and perfect
the mechanism of a free and open market and a national market system,
and, in general, to protect investors and the public interest, and are
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \13\ 15 U.S.C. 78f(b)(5).
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    Under proposed Rule 13.3(b), a Member shall be prohibited from
voting uninstructed shares unless (1) That Member is the beneficial
owner of the stock; (2) pursuant to the written instructions of the
beneficial owner; or (3) pursuant to the rules of any national
securities exchange or association of which it is also a member,
provided that the Member's records clearly indicate the procedure it is
following. This provision is based on ISE Rule 421, FINRA Rule 2251 and
NYSE Arca Rule 9.4, which were previously approved by the
Commission.\14\ The Commission notes that the proposed change will
provide clarity to Exchange Members going forward on whether broker
discretionary voting is permitted by Exchange Members under limited
circumstances when the Member is also a member of another national
securities exchange or association that permits broker discretionary
voting. In approving this portion of the proposal, the Commission notes
that Rule 13.3(b) is consistent with the approach taken under the rules
of other national securities exchanges or national securities
association, and for Exchange Members who are not also members of
another national securities exchange or association prohibits broker
discretionary voting on any matter, consistent with investor protection
and the public interest.
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    \14\ See supra note 11.
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    The Commission believes that proposed Rule 13.3(c) is consistent
with Section 6(b)(10) \15\ of the Act, which requires that national
securities exchanges adopt rules prohibiting members that are not
beneficial holders of a security from voting uninstructed proxies with
respect to the election of a member of the board of directors of an
issuer (except for uncontested elections of directors for companies
registered under the Investment Company Act), executive compensation,
or any other significant matter, as determined by the Commission by
rule.
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    \15\ 15 U.S.C. 78f(b)(10).
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    The Commission believes that proposed Rule 13.3(c) is consistent
with Section 6(b)(10) of the Act because it adopts revisions that
comply with that section. As noted in the accompanying Senate Report,
Section 957, which enacted Section 6(b)(10), reflects the principle
that ``final vote tallies should reflect the wishes of the beneficial
owners of the stock and not be affected by the wishes of the broker
that holds the shares.'' \16\ The proposed rule change will make the
Exchange compliant with the new requirements of Section 6(b)(10) by
specifically prohibiting broker-dealers, who are not beneficial owners
of a security, from voting uninstructed shares in connection with a
shareholder vote on the election of a member of the board of directors
of an issuer (except for a vote with respect to the uncontested
election of a member of the board of directors of any investment
company registered under the Investment Company Act of 1940), executive
compensation, or any other significant matter, as determined by the
Commission by rule, unless the member receives voting instructions from
the beneficial owner of the shares.\17\
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    \16\ See S. Rep. No. 111-176, at 136 (2010).
    \17\ The Commission has not, to date, adopted rules concerning
other significant matters where uninstructed broker votes should be
prohibited, although it may do so in the future. Should the
Commission adopt such rules, we would expect the Exchange to adopt
coordinating rules promptly to comply with the statute.
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    The Commission also believes that proposed Rule 13.3(c) is
consistent with Section 6(b)(5) \18\ of the Act, which provides, among
other things, that the rules of the Exchange must be designed to
promote just and equitable principles of trade, remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest, and are not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \18\ 15 U.S.C. 78f(b)(5).
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    The Commission believes that the rule assures that shareholder
votes on the election of the board of directors of an issuer (except
for a vote with respect to the uncontested election of a member of the
board of directors of any investment company registered under the
Investment Company Act of 1940) and on executive compensation matters
are made by those with an economic interest in the company, rather than
by a broker that has no such economic interest, which should enhance
corporate governance and accountability to shareholders.\19\ Based on
the above, the Commission finds that the Exchange's proposal will
further the purposes of Sections 6(b)(5) and 6(b)(10) of the Act
because it should enhance corporate accountability to shareholders
while also serving to fulfill the Congressional intent in adopting
Section 6(b)(10) of the Act.
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    \19\ As the Commission stated in approving NYSE rules
prohibiting broker voting in the election of directors, having those
with an economic interest in the company vote the shares, rather
than the broker who has no such economic interest, furthers the goal
of enfranchising shareholders. See Securities Exchange Act Release
No. 60215 (July 1, 2009), 74 FR 33293 (July 10, 2009) (SR-NYSE-2006-
92).
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    The Commission also believes that Proposed Rule 13.3(a), (d), and
Interpretations and Policies .01 are consistent with Section 6(b)(5) of
the Act \20\ in that they are designed to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, and to remove impediments to and perfect the mechanism
of a free and open market and a national market system. The Commission
notes that the proposed changes will further align Rule 13.3 with FINRA
Rule 2251, which should reduce regulatory confusion amongst Members
that are also members of FINRA, and as the Exchange notes, may also
reduce regulatory duplication should the proposed rule become a Common
Rule under the 17d-2 Agreement. Finally, we note that the changes to
Proposed Rule 13(a), (d), and Interpretations and Policies .01 will
also further investor protection and the public interest by setting
forth proxy voting requirements as to beneficial owner accounts as well
as the requirements that a Member must follow when forwarding proxy or
other

materials to the beneficial owners of the stock or their designated
investment advisors.
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    \20\ 15 U.S.C. 78f(b)(5).
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    The Commission also finds good cause, pursuant to Section 19(b)(2)
of the Act,\21\ for approving the proposed rule change prior to the
30th day after the date of publication of notice in the Federal
Register. The Commission believes that good cause exists to grant
accelerated approval to the proposed changes to Rule 13.3, because the
proposal will conform the Exchange rule to FINRA Rule 2251, in
particular, as well as ISE Rule 421, NYSE Arca Rule 9.4 and Nasdaq Rule
2251, which were published for public comment in the Federal Register
and approved by the Commission, and for which no comments were
received.\22\ Further, because proposed Rule 13.3 is substantially
similar to the FINRA, ISE, NYSE Arca and Nasdaq rules, we do not
believe it raises any new regulatory issues that were not previously
considered with adoption of the rules for those other self-regulatory
organizations.
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    \21\ 15 U.S.C. 78s(b)(2).
    \22\ See supra notes 11.
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    Moreover, proposed Rule 13.3(c) will conform the Exchange's rules
to the requirements of Section 6(b)(10) of the Act. Section 6(b)(10) of
the Act, enacted under Section 957 of the Dodd-Frank Act, does not
provide for a transition phase, and requires rules of national
securities exchanges to prohibit broker voting on the election of a
member of the board of directors of an issuer (except for a vote with
respect to the uncontested election of a member of the board of
directors of any investment company registered under the Investment
Company Act of 1940), executive compensation, or any other significant
matter, as determined by the Commission by rule. Therefore, the
Commission believes that good cause exists to grant accelerated
approval to proposed Rule 13.3(c), because it will conform the Exchange
rule to the requirements of Section 6(b)(10) of the Act. Moreover,
proposed Rule 13.3(c) is substantially similar to ISE Rule 421 and
Nasdaq Rule 2251.\23\
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    \23\ Id.
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\24\ that the proposed rule change (SR-BYX-2011-024) be, and it
hereby is, approved on an accelerated basis.
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    \24\ 15 U.S.C. 78s(b)(2).
    \25\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-25792 Filed 10-5-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17050-17051]
[FR Doc No: 2015-07273]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0500]

Early Clinical Trials With Live Biotherapeutic Products:
Chemistry, Manufacturing, and Control Information; Guidance for
Industry; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; requests for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a request
for additional comments on the chemistry, manufacturing, and control
(CMC) information that a sponsor of an investigational new drug
application (IND) should provide in its IND in order to meet regulatory
requirements when commercially available foods or dietary supplements
containing live biotherapeutic products (LBPs) are used as
investigational new drugs in early phase clinical trials. The request
for additional comments on the CMC information is related to the
guidance entitled, ``Early Clinical Trials with Live Biotherapeutic
Products: Chemistry, Manufacturing, and Control Information; Guidance
for Industry,'' dated February 2012 (February 2012 guidance).

DATES: Submit either electronic or written comments on the requested
CMC information by May 29, 2015.

ADDRESSES: Submit written requests for single copies of the February
2012 guidance to the Office of Communication, Outreach and Development,
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
the office in processing your requests. The guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit electronic comments on the requested CMC information 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.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a request for additional comments on the CMC
information that a sponsor of an IND should provide in its IND in order
to meet the requirements under Sec.  312.23 (21 CFR 312.23), when
commercially available foods or dietary supplements containing LBPs are
subject to study as investigational new drugs in early phase clinical
trials.
    In the Federal Register of February 21, 2012 (77 FR 9947), FDA
announced the publication of a final guidance entitled ``Early Clinical
Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and
Control Information; Guidance for Industry,'' dated February 2012. The
guidance provides IND sponsors with recommendations regarding CMC
information that should be included in IND submissions for early
clinical trials with LBPs, including LBPs lawfully marketed as foods or
dietary supplements in the United States and proposed for clinical uses
regulated under section 351 of the Public Health Service Act (42 U.S.C.
262). The guidance also outlines the Drug Substance and Drug Product
information that should be provided in the CMC section of an IND to
meet the requirements under Sec.  312.23 and to support proceeding to
clinical evaluation of an LBP in human subjects.

II. CMC Information

    FDA is considering modifying the February 2012 guidance to address
the CMC information that should be provided in an IND, under certain
conditions. Specifically, FDA is considering whether to revise the
guidance to address when the label on the commercially available
product(s) would be considered adequate to satisfy the requirement for
CMC information under Sec.  312.23. For example, we are considering
whether the label would be adequate to satisfy the CMC information when
the following conditions are met: (1) The LBP product that is proposed
for investigational use is a commercially available food or dietary
supplement; (2) the investigation does not involve a route of
administration, dose, patient population, or other factor that
significantly increases the risk (or decreases the acceptability of
risk) associated with the use of the food or dietary supplement; (3)
the investigation is not intended to support a marketing application
for a drug claim for the food or dietary supplement; and (4) the
investigation is conducted in compliance with the requirements for INDs
(part 312), the requirements for review by an institutional review
board (21 CFR part 56), and with the requirements for informed consent
(21 CFR part 50). FDA is seeking public comment on this issue.

III. Comments

    Interested persons may submit either electronic comments regarding
the requested CMC information to http://www.regulations.gov or written
comments to the Division of Dockets Management (see ADDRESSES). It is
only necessary to send one set of comments. Identify comments 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, and will be posted to
the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the February 2012
guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07273 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Page 46664]
[FR Doc No: 2016-16894]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL16-90-000]

Panda Liberty LLC; Notice of Institution of Section 206
Proceeding and Refund Effective Date

    On July 12, 2016, the Commission issued an order in Docket No.
EL16-90-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2012), instituting an investigation into the justness and
reasonableness of Panda Liberty LLC's proposed reactive power rate
schedule. Panda Liberty LLC, 156 FERC ] 61,033 (2016).
    The refund effective date in Docket No. EL16-90-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.

    Dated: July 12, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-16894 Filed 7-15-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 233 (Monday, December 5, 2011)]
[Notices]
[Pages 75886-75887]
[FR Doc No: 2011-31146]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0826]

Determination That DEMULEN 1/50-28 (Ethinyl Estradiol; Ethynodiol
Diacetate) Tablet and Four Other Drug Products Were Not Withdrawn From
Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that the
five drug products listed in this document were not withdrawn from sale
for reasons of safety or effectiveness. This determination means that
FDA will not begin procedures to withdraw approval of abbreviated new
drug applications (ANDAs) that refer to these drug products, and it
will allow FDA to continue to approve ANDAs that refer to the products
as long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT:
Olivia Pritzlaff, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6308,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for reasons
of safety or effectiveness, the Agency will initiate proceedings that
could result in the withdrawal of approval of the ANDAs that refer to
the listed drug.
    FDA has become aware that the drug products listed in the table in
this document are no longer being marketed.

------------------------------------------------------------------------
        Application No.                  Drug               Applicant
------------------------------------------------------------------------
NDA 016936....................  DEMULEN 1/50-28         GD Searle, LLC,
                                 (ethinyl estradiol;     4901 Searle
                                 ethynodiol diacetate)   Pkwy., Skokie,
                                 Tablet, 0.05 mg; 1 mg.  IL 60077.
NDA 018160....................  DEMULEN 1/35-28         Do.
                                 (ethinyl estradiol;
                                 ethynodiol diacetate)
                                 Tablet, 0.035 mg; 1
                                 mg.

NDA 018168....................  DEMULEN 1/35-21         Do.
                                 (ethinyl estradiol;
                                 ethynodiol diacetate)
                                 Tablet, 0.035 mg; 1
                                 mg.
NDA 019190....................  TRIPHASIL-28 (ethinyl   Wyeth
                                 estradiol;              Pharmaceuticals
                                 levonorgestrel)         , Inc., P.O.
                                 Tablet, 0.03 mg, 0.04   Box 8299,
                                 mg, 0.03 mg; 0.05 mg,   Philadelphia,
                                 0.075 mg, 0.125 mg.     PA 19101-8299.
NDA 019192....................  TRIPHASIL-21 (ethinyl   Do.
                                 estradiol;
                                 levonorgestrel)
                                 Tablet, 0.03 mg, 0.04
                                 mg, 0.03 mg; 0.05 mg,
                                 0.075 mg, 0.125 mg.
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. Additional ANDAs that refer to these products may also be
approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: November 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31146 Filed 12-2-11; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 11, 2006 (Volume 71, Number 91)]
[Proposed Rules]
[Page 27440-27447]
[DOCID:fr11my06-16]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R03-OAR-2005-0480; FRL-8168-6]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; Redesignation of the City of Weirton PM-10 Nonattainment
Area to Attainment and Approval of the Maintenance Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: On May 24, 2004, the State of West Virginia submitted a
request that EPA redesignate the Weirton nonattainment area (Weirton
Area) to attainment for the national ambient air quality standards
(NAAQS) for particulate matter with an aerodynamic diameter less than
or equal to a nominal 10 micrometers (PM-10), and concurrently
requested approval of a limited maintenance plan (LMP) as a revision to
the West Virginia State Implementation Plan (SIP). In this action, the
EPA proposes to approve the LMP for the Weirton Area in West Virginia
and grant the State's request to redesignate the area from
nonattainment to attainment. EPA's proposed approval is based on its
determination that the area has met the criteria for redesignation for
attainment specified in the Clean Air Act (CAA). EPA is also proposing
to determine that, because the Weirton Area has continued to attain the
PM-10 NAAQS, certain attainment demonstration requirements, along with
other related requirements of the CAA, are not applicable to the
Weirton Area.

DATES: Written comments must be received on or before June 12, 2006.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2005-0480 by one of the following methods:
    A. http://www.regulations.gov. Follow the online instructions for

submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2005-0480, Makeba Morris, Chief, Air Quality
Planning and Analysis Branch, Mailcode 3AP21, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2005-0480. 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, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://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 http://www.regulations.gov or in hard copy during normal business

hours at the Air Protection Division, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
Copies of the State submittal are available at West Virginia Department
of Environmental Protection, Division of Air Quality, 601 57th Street,
SE., Charleston, WV 25304.

FOR FURTHER INFORMATION CONTACT: Linda Miller,<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we'',
``us'', or ``our'' are used, we mean EPA.

Table of Contents

I. Background
    A. What NAAQS Are Considered in Today's Rulemaking?
    B. What is a State Implementation Plan (SIP)?
    C. What are the Requirements for Redesignating a Nonattainment
Area to Attainment?
    D. What is the Background of the SIP for the Weirton Area?
    E. What are the Air Quality Characteristics of the Weirton Area?
II. Review of the West Virginia State Submittal Addressing the
Requirements for Redesignation
    A. Does the Submittal Meet the Criteria for Redesignation?
    1. Has the State Demonstrated that the Weirton Area has attained
the applicable NAAQS?
    2. Does the Weirton Area have a fully approved SIP under Section
110(k) of the Act that meets all requirements applicable under
Section 110 and Part D of the Act for Purposes of Redesignation?
    3. Clean Data Policy
    4. Has the State Demonstrated that the Air Quality Improvement
is due to permanent and enforceable reductions?
III. Review of the Limited Maintenance Plan
    A. What is a Maintenance Plan?
    B. What is the LMP Option for PM-10 Nonattainment Areas seeking
Redesignation to Attainment
    C. Does the Weirton Area Qualify for the LMP Option?
    D. Does the LMP submitted meet all the requirements for a Fully
Approved Maintenance Plan?
    E. Has the State met conformity requirements?
IV. Proposed Action
V. Statutory and Executive Order Reviews

I. Background

A. What NAAQS Are Considered in Today's Rulemaking?

    Particulate matter with an aerodynamic diameter less than or equal
to a nominal ten microns (PM-10) is the pollutant subject to this
action. The NAAQS are safety thresholds for certain ambient air
pollutants set to protect public health and welfare. PM-10 is among the
ambient air pollutants for which we have established such a health-
based standard. PM-10 causes adverse health effects by penetrating deep
in the lung, aggravating the cardiopulmonary system. Children, the
elderly, and people with asthma and heart conditions are the most
vulnerable. On July 1, 1987 (52 FR 24634) we revised the NAAQS for
particulate matter with an indicator that includes those particles with
an aerodynamic diameter less than or equal to a nominal 10 micrometers.
See 40 CFR 50.6. The annual primary PM-10 standard is 50 [mu]/m\3\ as
an annual arithmetic mean. The 24-hour primary PM-10 standard is 150
[mu]g/m3 with no more than one expected exceedance per year.
The secondary PM-10 standards, promulgated to protect against adverse
welfare effects, are identical to the primary standards.

B. What Is a State Implementation Plan (SIP)?

    The Act requires states to attain and maintain ambient air quality
equal to or better than the NAAQS. Section 107(d)(1)(A)(I) of the Act
defines nonattainment area as any area that does not meet (or that
contributes to ambient air quality in a nearby area that does not meet)
the national primary or secondary ambient air quality standard for that
pollutant.
    A state's strategy for attaining and maintaining the NAAQS are
outlined in the state implementation plan (SIP). The SIP is a planning
document that, when implemented, is designed to ensure the achievement
of the NAAQS by the applicable attainment date. The Act requires that
states make SIP revisions periodically, as necessary, to provide
continued compliance with the standards.
    SIPs include, among other things, the following: (1) A current,
accurate and comprehensive inventory of emission sources; (2) statutes
and regulations adopted by the State Legislature and executive
agencies; (3) air quality analyses that include demonstrations that
adequate controls are in place to meet the NAAQS; and (4) contingency
measures to be undertaken if an area fails to attain the standard or
make reasonable progress toward attainment by the required date.
    A state must make the SIP and subsequent revisions available for
public review and comment through a public hearing, it must be adopted
by the State, and submitted to EPA by the Governor or the Governor's
designee. EPA takes action to approve the SIP, thus rendering the rules
and regulations federally enforceable. The approved SIP is the state's
commitment to take actions that will reduce or eliminate air quality
problems. Any subsequent revisions to the SIP must go through the
formal SIP revision process specified in the Act.

C. What are the Requirements for Redesignating a Nonattainment Area to
Attainment?

    Nonattainment areas can be redesignated to attainment after the
area has measured air quality data showing it has attained the NAAQS
and when certain additional requirements are met. Section 107(d)(3)(E)
of the Act provides the criteria for redesignation. These criteria are
further clarified in the ``General Preamble for the Implementation of
Title I of the Clean Air Act Amendments of 1990'' (57 FR 13498, April
16, 1992, as supplemented 57 FR 18070, April 28, 1992) (the General
Preamble), and in a guidance memorandum from John Calcagni, Director,
Air Quality Management Division, EPA Office of Air Quality Planning and
Standards dated September 4, 1992, ``Procedures for Processing Requests
to Redesignate Areas to Attainment, (Calcagni memo).'' The criteria for
redesignation are:
    (1) A determination that the area has attained the applicable
NAAQS;
    (2) Full approval of the applicable SIP for the area under section
110(k) of the Act;
    (3) The state containing the area has met all requirements
applicable to the area under section 110 and part D of the Act;
    (4) A determination that the improvement in air quality is due to
permanent and enforceable reductions in emissions resulting from
implementation of the applicable implementation plan, applicable
Federal air pollution control regulations, and other permanent and
enforceable reductions; and
    (5) Full approval of a maintenance plan for the area as meeting the
requirements of section 175A of the Act.

D. What is the Background of the SIP for the Weirton Area?

    The Weirton Area, consisting of Hancock County and part of Brooke
County, West Virginia, was designated

by EPA as a moderate PM-10 nonattainment area on December 21, 1993 (58
FR 67334).
    On May 16, 2001 (66 FR 27034), EPA promulgated a final rule
entitled, ``Determination of Attainment of the NAAQS for PM-10 in the
Weirton, West Virginia Nonattainment Area'' finding that the Weirton
PM-10 nonattainment had attained the NAAQS for PM-10 by its applicable
December 31, 2000 attainment date.
    In order to be redesignated from nonattainment to attainment, West
Virginia requested that EPA apply its clean data policy to the Weirton
Area in a letter dated October 14, 2003. West Virginia submitted a
request to redesignate the Weirton Area to attainment for PM-10 and a
SIP submittal for the related maintenance plan on May 24, 2004.
    EPA published a direct final rule (DFR) and notice of proposed
rulemaking (NPR) in which we determined that certain attainment
demonstration requirements, along with other related requirements of
the Act, are not applicable to the Weirton Area. In the same October
27, 2004 DFR and NPR, EPA also approved the request from the State of
West Virginia to redesignate the Weirton Area from nonattainment to
attainment of the NAAQS for PM-10, and to approve the 10-year
maintenance plan for the area submitted by the WVDEP as a revision to
the West Virginia SIP. (October 27, 2004, 69 FR 62591 and 69 FR 62637).
    EPA published a correcting amendment to the DFR and NPR on November
9, 2004 (69 FR 64860) to include additional explanation of why motor
vehicle emissions do not contribute significantly to any nonattainment
with the PM-10 NAAQS in the Weirton Area.
    EPA received adverse comments on the October 27, 2004 DFR/NPR from
one commenter. Therefore, EPA withdrew the DFR on December 20, 2004 (69
FR 75847). The withdrawal of the DFR converted EPA's action to a
proposal based on the October 27, 2004 NPR. In a separate rulemaking in
today's Federal Register, EPA is withdrawing the October, 27 2004 NPR
and the November 9, 2004 amendment thereto, and issuing this current
proposal. Because we are withdrawing the earlier action, we will not
respond to the comments received on the withdrawn DFR and NPR. Any
person wishing to comment on this current proposal must submit comments
pursuant to the instructions given in this notice of proposed
rulemaking.

E. What are the Air Quality Characteristics of the Weirton Area?

    The primary years used by EPA for the purposes of establishing PM-
10 designations and classifications were 1987 to 1989. For this base
year period, the Weirton Area 24-hour average PM-10 design value was
198 [mu]g/m3. This value exceeded the NAAQS of 150 [mu]g/
m3. The Weirton Area has never exceeded the annual average
standard of 50 [mu]g/m3. As provided in the WV SIP
submittal, for the 2000 to 2002 period, the comparable 24-hour average
design value is 112 [mu]g/m3 and the PM-10 annual average
design value is 32 [mu]g/m. Both values meet the NAAQS. Based on the
certified ambient air quality data through the close of calendar year
2005, EPA proposes to determine that the area continues to attain the
PM-10 NAAQS. Furthermore, there have been no recorded exceedances of
the 24-hour PM-10 standard or the annual PM-10 standard from 1997
through the end of 2005 in the Weirton Area, and the highest annual
value in the Weirton area for the years 2003-2005 is 29 [mu]g/
m3. See also the discussion in Section II.A.1. and the
technical support document (TSD) accompanying this rulemaking.

II. Review of the West Virginia Submittal Addressing the Requirements
for Redesignation

A. Does the Submittal Meet the Criteria for Redesignation?

1. Has the State demonstrated that the Weirton Area has attained the
applicable NAAQS?
    States must demonstrate that an area has attained the PM-10 NAAQS
through analysis of ambient air quality data from an ambient air
monitoring network representing peak PM-10 concentrations. The data
should be stored in the EPA Air Quality System (AQS) database. The 24-
hour PM-10 NAAQS is 150 [mu]g/m3. An area has attained the
24-hour standard when the average number of expected exceedences per
year is less than or equal to one, when averaged over a three-year
period (40 CFR 50.6). To make this determination, three consecutive
years of complete ambient air quality data must be collected in
accordance with Federal requirements (40 CFR part 58, including
appendices). The annual PM-10 NAAQS is 50 [mu]g/m3. To
determine attainment, the standard is compared to the expected annual
mean, which is the average of the weighted annual mean for three
consecutive years. More detailed monitoring data is available in the
TSD.
    EPA previously determined in ``A Determination of Attainment of the
NAAQS for PM-10 in the Weirton, West Virginia Nonattainment Area'' on
May 16, 2001 (66 FR 27034) that the area had attained the PM-10 NAAQS.
As previously stated, the most recent air quality monitoring continues
to support this determination. Thus, EPA proposes to determine that the
Weirton Area has satisfied the criterion of section 107(d)(3)(E)(I)
that the area has attained the PM-10 NAAQS.
2. Does the Weirton Area have a Fully Approved SIP under section 110(k)
of the Act that meets all requirements applicable under section 110 and
Part D for Purposes of Redesignation?
    In order to qualify for redesignation, the SIP must satisfy all
requirements that apply to the area for purposes of redesignation. EPA
interprets the Act to require state adoption and EPA approval of the
requirements applicable for purposes of redesignation under section 110
and part D before EPA may approve a redesignation request. Thus in
order to qualify for redesignation, the SIP for the area must be fully
approved under section 110(k) with respect to all requirements that
apply to the area for purposes of redesignation.
    As we explain more fully in later sections of this action, EPA has
determined that West Virginia has met all SIP requirements applicable
for purposes of redesignation under section 110 of the CAA and has also
determined that the West Virginia SIP meets requirements applicable for
purposes of redesignation under Part D, Title I of the CAA. EPA has
analyzed the SIP codified at 40 CFR part 52, subpart XX, and determined
that it is consistent with the requirements of section 110 applicable
for purposes of redesignation.
    The air quality planning requirements for moderate PM-10
nonattainment areas under part D of Title I of the CAA are set out in
subparts 1 and 4. Subpart 1 of part D, found in sections 172-176 of the
CAA, sets forth the basic requirements applicable to all nonattainment
areas. Subpart 4 of part D, found in section 189 of the CAA,
establishes additional specific requirements for PM-10 areas depending
upon the area's nonattainment classification. For purposes of
evaluating the redesignation request, EPA is proposing to determine
that these applicable requirements have been met for the reasons
discussed in later sections of this notice.
    The Part D provisions that the Weirton Area must evaluate prior to
redesignation as attainment include an emissions inventory, conformity,
a

permit program for new and modified stationary sources (called new
source review or NSR), Reasonably Available Control Measure (RACM)
requirements contained in sections 172 and 189 of the Act), a
demonstration of reasonable further progress (RFP) toward attainment,
an attainment demonstration, and contingency measures. We address how
the Weirton Area has met the RACM, RFP, attainment demonstration and
contingency measure requirements in the next section of this notice
(Clean Data Policy).
    With respect to the emissions inventory requirement, the Calcagni
memo notes that the requirements for an emission inventory will be
satisfied by the inventory requirements of the maintenance plan. An
attainment year emissions inventory for the Weirton Area has been
included in the maintenance plan, and thus this requirement has been
satisfied.
    With respect to the conformity requirement, section 176(c) of the
CAA requires states to establish criteria and procedures to ensure the
Federally supported or funded projects ``conform'' to the air quality
planning goals in the applicable SIP. The requirement to determine
conformity applies to transportation plans, programs, and projects
developed, funded or approved under Title 23 U.S.C and the Federal
Transit Act (``transportation conformity'') as well as to other
Federally supported or funded projects (``general conformity''). State
conformity revisions must be consistent with Federal conformity
regulations relating to consultation, enforcement and enforceability
that the CAA required the EPA to promulgate.
    EPA believes it is reasonable to interpret the conformity SIP
requirements as not applying for purposes of evaluating a redesignation
request under section 107(d) because state conformity rules are still
required after redesignation and federal conformity rules apply where
state rules have not been approved. See Wall v. EPA, 265F 3d 426 (6th
Cir. 2001), upholding this interpretation. See, also, 60 FR 62748
(December 7, 1995).
    With respect to the NSR program requirement, EPA has determined
that areas being redesignated need not have an approved NSR program
prior to redesignation, provided that the area demonstrates maintenance
of the standard without Part D NSR in effect. The rationale for this
view is described in a memorandum for Mary Nichols, Assistant
Administrator for Air and Radiation, dated October 14, 1994, entitled
``Part D New Source Review Requirements of Areas Requesting
Redesignation to Attainment.'' The State has demonstrated that the area
will be able to maintain the standard without Part D NSR in effect, and
therefore the State need not have a fully approved Part D NSR program
prior to approval of the redesignation request. The State's Prevention
of Significant Deterioration (PSD) program will become effective in the
area upon redesignation to attainment. Detroit, MI (60 FR 12467-12468,
March 7, 1995); Cleveland-Akron-Lorrain, OH (61 FR 20458, 20469-20470,
May 7, 1996); Louisville, KY (66 FR 53665, October 23 2001); Grand
Rapids, MI (61 FR 31834-31837, June 21, 1996).
3. Clean Data Policy
    In some designated nonattainment areas, monitored data demonstrates
that the NAAQS has already been achieved. Based on its interpretation
of the Act, EPA has determined that certain requirements of part D,
subpart 1 and 2 of the Act do not apply and therefore do not require
certain submissions for an area that has attained the NAAQS. These
include reasonable further progress (RFP) requirements, attainment
demonstrations and contingency measures, because these provisions have
the purpose of helping achieve attainment of the NAAQS.
    The so-called Clean Data Policy is the subject of two EPA memoranda
setting forth our interpretation of the provisions of the Act as they
apply to areas that have attained the relevant NAAQS. EPA also
finalized the statutory interpretation set forth in the policy in a
final rule, 40 CFR 51.918, as part of its Final Rule to Implement the
8-hour Ozone National Ambient Air Quality Standard--Phase 2 (Phase 2
Final Rule). See discussion in the preamble to the rule at 70 FR 71645-
71646 (November 29, 2005). EPA believes that the legal bases set forth
in detail in our Phase 2 Final rule, our May 10, 1995 memorandum from
John S. Seitz, entitled ``Reasonable Further Progress, Attainment
Demonstration, and Related Requirements for Ozone Nonattainment Areas
Meeting the Ozone National Ambient Air Quality Standard'' (Seitz memo),
and our December 14, 2004 memorandum from Stephen D. Page entitled
``Clean Data Policy for the Fine Particle National Ambient Air Quality
Standards'' (Page memo), are equally pertinent to the interpretation of
provisions of subparts 1 and 4 applicable to PM-10. EPA's
interpretation of how the provisions of the Act apply to areas with
``clean data'' is not logically limited to ozone and PM-2.5, because
the rationale is not dependent upon the type of pollutant. Our
interpretation that an area that is attaining the standard is relieved
of obligations to demonstrate reasonable further progress (RFP) and to
provide an attainment demonstration and contingency measures pursuant
to part D of the CAA, pertains whether the standard is PM-10, ozone or
PM-2.5.
    The reasons for relieving an area that has attained the relevant
standard of certain part D, subpart 1 and 2 (sections 171 and 172)
obligations, applies equally as well to part D, subpart 4, which
contains specific attainment demonstration and RFP provisions for PM-10
nonattainment areas. As we have explained in the Phase 2 Final Rule and
our ozone and PM-2.5 clean data memoranda, EPA believes it is
reasonable to interpret provisions regarding RFP and attainment
demonstrations, along with related requirements, so as not to require
SIP submissions if an area subject to those requirements is already
attaining the NAAQS (i.e., attainment of the NAAQS is demonstrated with
three consecutive years of complete, quality-assured air quality
monitoring data). Three U.S. Circuit Courts of Appeals have upheld EPA
rulemakings applying its interpretation of subparts 1 and 2 with
respect to ozone. Sierra Club v. EPA, 99F.3d 1551 (10th Cir. 1996);
Sierra Club v. EPA, 375 F. 3d 537 (7th Cir. 2004); Our Children's Earth
Foundation v. EPA, N. 04-73032 (9th Cir. June 28, 2005) (memorandum
opinion). It has been EPA's longstanding interpretation that the
general provisions of part D, subpart 1 of the Act (sections 171 and
172) do not require the submission of SIP revisions concerning RFP for
areas already attaining the ozone NAAQS. In the General Preamble, we
stated:

    [R]equirements for RFP will not apply in evaluating a request
for redesignation to attainment, since, at a minimum, the air
quality data for the area must show that the area has already
attained. A showing that the State will make RFP toward attainment
will, therefore, have no meaning at that point. 57 FR at 13564.

    EPA believes the same reasoning applies to the PM-10 provisions of
part D, subpart 4.
    With respect to RFP, section 171(1) states that, for purposes of
part D of title I, RFP ``means such annual incremental reductions in
emissions of the relevant air pollutant as are required by this part or
may reasonably be required by the Administrator for the purpose of
ensuring attainment of the applicable NAAQS by the applicable date.''
Thus, whether dealing with the general RFP requirement of section
172(c)(2), the ozone-specific RFP requirements of

sections 182(b) and (c), or the specific RFP requirements for PM-10
areas of part D, subpart 4, section 189(c)(1), the stated purpose of
RFP is to ensure attainment by the applicable attainment date. Section
189(c)(1) states that:

    Plan revisions demonstrating attainment submitted to the
Administrator for approval under this subpart shall contain
quantitative milestones which are to be achieved every 3 years until
the area is redesignated attainment and which demonstrate reasonable
further progress, as defined in section 7501(l) of this title,
toward attainment by the applicable date.

    Although this section states that revisions shall contain
milestones which are to be achieved until the area is redesignated to
attainment, such milestones are designed to show reasonable further
progress ``toward attainment by the applicable date'', as defined by
section 171. Thus it is clear that once the area has attained the
standard, no further milestones are necessary or meaningful. This
interpretation is supported by language in section 189(c)(3), which
mandates that a state that fails to achieve a milestone must submit a
plan that assures that the state achieve the next milestone or attain
the NAAQS if there is no next milestone. Section 189(c)(3) assumes that
the requirement to submit and achieve milestones does not continue
after attainment of the NAAQS.
    If an area has in fact attained the standard, the stated purpose of
the RFP requirement will have already been fulfilled.\1\ EPA took this
position with respect to the general RFP requirement of section
172(c)(2) in the April 16, 1992 General Preamble and also in the May
10, 1995 memorandum with respect to the requirements of sections
182(a)(b) and (c). We are extending that interpretation to the specific
provisions of part D, subpart 4. In the General Preamble, we stated, in
the context of a discussion of the requirements applicable to the
evaluation of requests to redesignate nonattainment areas to
attainment, that the ``requirements for RFP will not apply in
evaluating a request for redesignation to attainment since, at a
minimum, the air quality data for the area must show that the area has
already attained. Showing that the State will make RFP towards
attainment will, therefore, have no meaning at that point.'' (57 FR at
13564). See also Calcagni memo, p.6.
---------------------------------------------------------------------------

    \1\ Thus we believe that it is a distinction without a
difference that section 189(c)(1) speaks of the RFP requirement as
one to be achieved until an area is ``redesignated as attainment'',
as opposed to section 172(c)(2), which is silent on the period to
which the requirement pertains, or the ozone nonattainment area RFP
requirements in sections 182(b)(1) or 182(c)(2), which refer to the
RFP requirements as applying until the ``attainment date'', since,
section 189(c)(1) defines RFP by reference to section 171(l) of the
Act. Reference to 171(l) clarifies that, as with the general RFP
requirements in section 172(c)(2) and the ozone-specific
requirements of section 182(b)(1) and 182(c)(2), the PM-specific
requirements may only be required ``for the purpose of ensuring
attainment of the applicable national ambient air quality standard
by the applicable date.'' 42 U.S.C. section 7501(1). As discussed in
the text of this rulemaking, EPA interprets the RFP requirements, in
light of the definition of RFP in section 171(l), and incorporated
in section 189(c)(1), to be a requirement that no longer applies
once the standard has been attained.
---------------------------------------------------------------------------

    With respect to the attainment demonstration requirements of
section 189(a)(1)(B) an analogous rationale leads to the same result.
Section 189(a)(1)(B) requires that the plan provide for ``a
demonstration (including air quality modeling) that the [SIP] will
provide for attainment by the applicable attainment date.* * *'' As
with the RFP requirements, if an area is already monitoring attainment
of the standard, EPA believes there is no need for an area to make a
further submission containing additional measures to achieve
attainment. This is also consistent with the interpretation of the
section 172(c) requirements provided by EPA in the General Preamble,
the Page memo and of the section 182(b) and (c) requirements set forth
in the Seitz memo. As EPA stated in the General Preamble, no other
measures to provide for attainment would be needed by areas seeking
redesignation to attainment since ``attainment will have been
reached.'' (57 FR at 13564).
    Other SIP submission requirements are linked with these attainment
demonstration and RFP requirements, and similar reasoning applies to
them. These requirements include the contingency measure requirements
of sections 172(c)(9) and 182(c)(9). We have interpreted the
contingency measure requirements of sections 172(c)(9) and 182(c)(9) as
no longer applying when an area has attained the standard because those
``contingency measures are directed at ensuring RFP and attainment by
the applicable date.'' (57 FR at 13564); Seitz memo, pp. 5-6.
    Both sections 172(c) and 189(a)(1)(c) require ``provisions to
assure that reasonable available control measures'' (i.e, RACM) are
implemented in a nonattainment area. However, the Weirton Area was able
to attain the PM-10 NAAQS without any additional measures being
implemented. The General Preamble, 57 FR 13560 (April 16, 1992) states
that EPA interprets section 172(c)(1) so that RACM requirements are a
``component'' of an area's attainment demonstration. Thus, for the same
reason the attainment demonstration no longer applies by its own terms,
the requirement for RACM no longer applies. EPA has consistently
interpreted this provision to require only implementation of potential
RACM measures that could contribute to reasonable further progress or
to attainment. General Preamble, 57 FR at 13498. Thus, where an area is
already attaining the standard, no additional RACM measures are
required.\2\ EPA is interpreting section 189(a)(1)(c) consistent with
its interpretation of section 172(c)(1). Therefore, there is no
requirement for the West Virginia SIP to contain RACM for the Weirton
Area in order for EPA to redesignate that area as attainment for the
PM-10 NAAQS.
---------------------------------------------------------------------------

    \2\ The EPA's interpretation that the statute only requires
implementaion of RACM measures that would advance attainment was
upheld by the United States Court of Appeals for the Fifth Circuit
(Sierra Club v. EPA, 314 F.3d 735, 743-745 (5th Cir. 2002)), and by
the United States Court of Appeals for the D.C. Circuit (Sierra Club
v. EPA, 294 F3d 155, 162-163 (D.C. Cir. 2002)).
---------------------------------------------------------------------------

    Here, as in both our Phase 2 final rule and ozone and PM-2.5 clean
data memoranda, we emphasize that the suspension of a requirement to
submit SIP revisions concerning these RFP, attainment demonstration,
RACM, and other related requirements exists only for as long as a
nonattainment area continues to monitor attainment of the standard. If
such an area experiences a violation of the NAAQS, the basis for the
requirements being suspended would no longer exist. Therefore, the area
would again be subject to a requirement to submit the pertinent SIP
revision or revisions and would need to address those requirements.
Thus, a determination that an area need not submit one of the SIP
submittals amounts to no more than a suspension of the requirement for
so long as the area continues to attain the standard. However, once EPA
ultimately redesignates the area to attainment, the area will be
entirely relieved of these requirements to the extent the maintenance
plan for the area does not rely on them.
    Therefore, we believe that, for the reasons set forth here and
established in our prior ``clean data'' memoranda and rulemakings, a
PM-10 nonattainment area that has ``clean data,'' should be relieved of
the part D, subpart 4 obligations to provide an attainment
demonstration pursuant to section 189(a)(1)(B) the RACM provisions of
189(a)(1)(c), and the RFP provisions established by section 189(c)(1)
of the Act, as well as the aforementioned attainment demonstration,
RACM, RFP and contingency measure provisions of

part D, subpart 1 contained in section 172 of the Act.\3\
---------------------------------------------------------------------------

    \3\ In prior rulemakings involving the Clean Data Policy and PM-
10, EPA has applied criteria in addition to that of attainment of
the standard. See e.g., 67 FR 43020 (June 26, 2002). EPA does not
believe that those additional criteria are required by statute or
are necessary for application of the policy for PM-10 areas, and
does not employ them in applying the policy to ozone and
PM2.5 areas. EPA intends to make its application of the
policy consistent for ozone, PM-10, and PM2.5, and does
not intend to require an area to meet additional criteria for PM-10.
---------------------------------------------------------------------------

    Should EPA at some future time determine that an area that had
clean data, but which has not yet been redesignated as attainment for a
NAAQS has violated the relevant standard, the area would again be
required to submit the pertinent requirements under the SIP for the
area. Attainment determinations under the policy do not shield an area
from other required actions, such as provisions to address pollution
transport.
    As set forth, above, EPA proposes to find that because the Weirton
Area has continued to attain the NAAQS the requirement of an attainment
demonstration, reasonable further progress, reasonably available
control measures and contingency measures no longer apply.
    Thus, EPA has determined that all provisions of CAA section 110 and
part D applicable to the Weirton Area for purposes of redesignation
have been approved into the West Virginia SIP.
4. Has the State demonstrated that the air quality improvement is due
to permanent and enforceable reductions?
    The State must be able to reasonably attribute the improvement in
air quality to permanent and enforceable emission reductions. In making
this showing, the State must demonstrate that air quality improvements
are the result of actual enforceable emission reductions. The control
measures for the area, which were responsible for bringing the area
into attainment, are contained in a Consent Order (CO) between the
State of West Virginia and the Weirton Steel Corporation. The control
measures and emission limits established in the CO were made permanent
and enforceable when EPA approved them into the West Virginia SIP on
May 5, 2004 (69 FR 24986). These control measures resulted in a
reduction of 1345.5 tons per year of allowable PM-10 emissions and a
reduction of 886 tons per year of actual PM-10 emissions. EPA approved
these measures as RACT in the West Virginia SIP on May 4, 2004 (69 FR
24986).

III. Review of the Limited Maintenance Plan

A. What is a Maintenance Plan?

    As discussed in section II of this action, to be redesignated to
attainment, the Weirton Area is required to have a fully approved
maintenance plan under section 175A of the CAA. A maintenance plan
should identify the level of air emissions from cars, industry and
other sources which is sufficient to attain the NAAQS. The State must
commit to re-evaluate the maintenance plan. The plan must also show
that the area will maintain clean air for at least 10 years after
redesignation. Additionally, the plan must include a list of
contingency measures to be implemented should the NAAQS be violated.
The requirements for the contingency measures is found in paragraph (d)
of CAA section 175A.

B. What is the LMP Option for PM-10 Nonattainment Areas Seeking
Redesignation to Attainment

    On August 9, 2001, EPA issued guidance on streamlined maintenance
plan provisions for certain moderate PM-10 nonattainment areas seeking
redesignation to attainment (Memorandum from Lydia Wegman, Director,
Air Quality Standards and Strategies Division, entitled ``Limited
Maintenance Plan Option for Moderate PM-10 Nonattainment Areas'',
(Wegman memo). The Wegman memo contains a statistical demonstration
that areas meeting certain air quality criteria will, with a high
degree of probability, maintain compliance with the standard 10 years
into the future. Thus, EPA has already provided the maintenance
demonstration for areas that meet the air quality criteria outlined in
the Wegman memo. The Wegman memo streamlines the full maintenance plan
requirements and establishes the LMP option. The LMP option does not
require air quality modeling estimates that clean air can be
maintained, a projection of emissions into the future, or some of the
standard analyses to determine conformity with the air quality
standards. The Wegman memo identifies core provisions that must be
included in the LMP. These provisions include an attainment year
emission inventory, assurance of continued operation of an EPA-approved
air quality monitoring network, and contingency provisions.

C. Does the Weirton Area qualify for the LMP option?

    To qualify for the LMP option, the area must have attained the PM-
10 NAAQS, and the average annual PM-10 design value for the area, based
upon the most recent 5 years of air quality data at all monitors in the
area, should be at or below 40 [mu]g/m3, and the 24 hour design value
should be at or below 98 [mu]g/m3. If an area cannot meet this test, it
may still be able to qualify for the LMP Option if the average design
value (ADV) for the site is less than the site-specific critical design
values (CDV) (as those terms are used in the Wegman memo). In addition,
the area should expect only limited growth in on-road motor vehicle PM-
10 emissions (including fugitive dust) and should have passed a motor
vehicle regional emissions analysis test.
    To show that future emissions will not exceed the level of the
attainment inventory, the WVDEP determined the CDV. The CDV is a
statistical technique based upon the average design value and its
observed variability to estimate the probability of exceeding the NAAQS
in the future.
    When applied specifically to the Weirton Area 24-hour data for the
years 2000 through 2004, the CDV is 137 [mu]g/m3. The actual
5-year average design value for the Weirton Area is 96.8 [mu]g/
m3 which is below the level of 98 [mu]g/m3
established for the LMP option. Furthermore, the maximum site average
design value of 105.2 [mu]g/m3 is less than the area-
specific CDV of 137 [mu]g/m3.
    There is no expected population growth in the Weirton Area. The
impact of vehicle emissions in the Weirton Area has been determined to
be an insignificant contributor to PM-10 nonattainment in the area.
Details can be found in the TSD.
    Based on our foregoing analysis, we have determined that the
Weirton Area qualifies for use of the LMP option.

D. Does the LMP Submitted Meet all the Requirements for a Fully
Approved Maintenance Plan?

    The Weirton Area meets the criteria for using a LMP for
redesignation. The LMP does not require a modeling demonstration to
show maintenance of the NAAQS. A projected emissions inventory is also
not required. The LMP does require the following:
    1. An attainment year emissions inventory
    2. Assurance of continued operation of an EPA-approved air quality
monitoring network
    3. Contingency provisions.
    The LMP for the Weirton Area, dated May 24, 2004 includes the
necessary provisions for approval. Specifically, it contains the
following:
1. Attainment Year Emission Inventory
    In the May 24, 2004 submittal, an inventory of allowable emissions
of

sources in the nonattainment area was included in the maintenance plan.
This inventory will be approved into the SIP as part of the LMP. The
inventory is presented in the TSD.
2. Continued Operation of Air Quality Monitoring Network
    The LMP includes a commitment to continue to monitor PM-10 in the
Weirton Area throughout the 10-year term of the maintenance plan to
verify continued attainment of the NAAQS. The monitoring procedures
will be determined in accordance with 40 CFR parts 53 and 58.
3. Contingency Measures
    Pursuant to section 175A of the Act, 42 U.S.C. 7505A, a maintenance
plan must include such contingency measures, as EPA deems necessary, to
promptly correct any violation of the NAAQS which may occur after
redesignation of the area to attainment. As explained in the Wegman and
Calcagni memos, these contingency measures do not have to be fully
adopted at the time of redesignation.
    The State will rely on monitored ambient air data to determine the
need to implement contingency measures. In the event of an exceedance
of the PM-10 standard, the State will review the monitored data, the
local meteorological data, and the compliance of certain local
facilities identified in the maintenance plan. If all such facilities
are in compliance with applicable SIP and permit emission limits, the
State will then determine the additional control measures the state
will need to impose on the area's stationary sources in order to
continue to maintain the NAAQS.
    In the event of three exceedances of the 24-hour PM-10 standard
within a three-year period, the State will notify the stationary
sources in the Weirton Area that the potential exists for a NAAQS
violation, and that if a violation occurs, these sources will need to
implement the measures previously identified. Within six months of
receiving notice from the State, the stationary sources must submit a
detailed plan of action to WVDEP to implement the identified additional
control measures within 18 months after the state notifies the source
of an actual violation of the NAAQS. The sources' additional control
measure plans will be submitted to EPA for approval and incorporation
into the SIP.

E. Has the State met Conformity Requirements?

    As we stated previously in this notice, EPA believes the conformity
SIP requirements do not apply for purposes of evaluating a
redesignation request, because conformity rules are still required
after redesignation and Federal conformity rules apply where state
rules have not been approved. The transportation conformity rule (40
CFR parts 51 and 93) and the general conformity rule (40 CFR parts 51
and 93) apply to nonattainment areas and maintenance areas covered by
an approved maintenance plan. Under either conformity rule, an
acceptable method of demonstrating that a Federal action conforms to
the applicable SIP is to demonstrate that expected emissions from the
planned action are consistent with the emissions budget for the area.
    While EPA's LMP policy does not exempt an area from the need to
demonstrate conformity, it explains that the area may demonstrate
conformity without submitting an emissions budget. Under the LMP
policy, emissions budgets are treated as essentially not constraining
for the length of the maintenance period because it is unreasonable to
expect that the qualifying areas would experience so much growth in
that period that a violation of the PM-10 NAAQS would result. For
transportation conformity purposes, EPA concludes that mobile source
emissions in these areas need not be capped at any level for the
maintenance period, and therefore the requirement for a regional
emissions analysis would be considered to be met. Similarly, Federal
actions subject to the general conformity rule could be considered to
satisfy the ``budget test'' specified in Sec.  93.158(a)(5)(i)(A) for
the same reasons that the budgets are essentially considered to be
unlimited.
    For Federal actions which are required to address the specific
requirements of the general conformity rule, one set of requirements
applies particularly to ensuring that emissions from the action will
not cause or contribute to new violations of the NAAQS, exacerbate
current violations, or delay timely attainment. One way that this
requirement can be met is to demonstrate that ``the total of direct and
indirect emissions from the action (or portion thereof) is determined
and documented by the State agency primarily responsible for the
applicable SIP to result in a level of emissions which, together with
all other emissions in the nonattainment area, would not exceed the
emissions budgets specified in the applicable SIP.'' 40 CFR
93.158(a)(5)(i)(A).
    The decision about whether to include specific allocations of
allowable emissions increases to sources is one made by the State and
local air quality agencies. These emissions budgets are not the same as
those used in transportation conformity. Emissions budgets in
transportation conformity are required to limit and restrain emissions.
Emissions budgets in general conformity allow increases in emissions up
to specified levels. West Virginia has chosen not to include specific
emissions allocations for Federal projects that would be subject to the
provisions of general conformity.
    While areas with maintenance plans approved under the LMP option
are thus essentially not subject to the budget test, the areas remain
subject to other transportation conformity requirements of 40 CFR part
93, subpart A. Thus, the metropolitan planning organization (MPO) in
the area or the State will still need to document and ensure that: (a)
Transportation plans and projects provide for timely implementation of
SIP transportation control measures in accordance with 40 CFR 93.113;
(b) transportation plans and projects comply with the fiscal constraint
element per 40 CFR 93.108; (c) the MPO's interagency consultation
procedures meet applicable requirements of 40 CFR 93.105; (d)
conformity of transportation plans is determined no less frequently
than every four years, and conformity of plan amendments and
transportation projects is demonstrated in accordance with the timing
requirements specified in 40 CFR 93.104; (e) the latest planning
assumptions and emissions model are used as set forth in 40 CFR 93.110
and 40 CFR 93.111; (6) projects do not cause or contribute to any new
localized carbon monoxide or particulate matter violations, in
accordance with procedures specified in 40 CFR 93.123; and, (7) project
sponsors and/or operators provide appropriate written commitments as
specified in 40 CFR 93.125.

IV. Proposed Action

    Based on the foregoing analysis, we have determined that the
Weirton Area fulfills the criteria for redesignation as attainment with
the PM-10 NAAQS. EPA has determined that the submitted maintenance plan
meets the requirements of the Act, and the Weirton Area fulfills the
criteria for redesignation to attainment for the PM-10 NAAQS based on
the State's May 24, 2004 submission. EPA is proposing to determine that
the area has continued to attain the PM-10 NAAQS and to determine that
certain attainment demonstration requirements, along with other related
requirements of part D title I of the CAA as set forth above, are not
applicable to the area. EPA is proposing to redesignate the Weirton PM-
10

moderate nonattainment area to attainment and to approve the West
Virginia SIP revision for the 10-year maintenance plan for the Weirton
Area, submitted on May 24, 2004. EPA is soliciting public comments on
the issues discussed in this document. These comments will be
considered before taking final action.

V. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
proposed action is not a ``significant regulatory action'' and
therefore is not subject to review by the Office of Management and
Budget. For this reason, this action is also not subject to Executive
Order 13211, ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355 (May 22, 2001)).
This action merely proposes to approve state law as meeting Federal
requirements and imposes no additional requirements beyond those
imposed by state law. Redesignation of an area to attainment under
section 107(d)(3)(e) of the Clean Air Act does not impose any new
requirements on small entities. Redesignation is an action that affects
the status of a geographical area and does not impose any new
regulatory requirements on sources. Accordingly, the Administrator
certifies that this proposed rule will not have a significant economic
impact on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.). Because this rule proposes to
approve pre-existing requirements under state law and does not impose
any additional enforceable duty beyond that required by state law, it
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). This proposed rule also does not have a
substantial direct effect on one or more Indian tribes, 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 by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it 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 (64 FR 43255, August 10, 1999), because it
merely proposes to affect the status of a geographical area, does not
impose any new requirements on sources, or allow the state to avoid
adopting or implementing other requirements, and does not alter the
relationship or the distribution of power and responsibilities
established in the Clean Air Act. This proposed rule also is not
subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because
it is not economically significant.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Redesignation is an
action that affects the status of a geographical area and does not
impose any new requirements on sources. Thus, the requirements of
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of
Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this
proposed rule, EPA has taken the necessary steps to eliminate drafting
errors and ambiguity, minimize potential litigation, and provide a
clear legal standard for affected conduct. EPA has complied with
Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the
takings implications of the rule in accordance with the ``Attorney
General's Supplemental Guidelines for the Evaluation of Risk and
Avoidance of Unanticipated Takings'' issued under the executive order.
    This proposed rule to redesignate the Weirton Area to attainment
with the PM-10 NAAQS and approve the LMP as a SIP revision does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Particulate matter, Reporting and recordkeeping
requirements.

40 CFR Part 81

    Environmental protection, Air Pollution Control, National parks,
Wilderness areas.

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

    Dated: May 3, 2006.
Donald S. Welsh,
Regional Administrator, Region III.
[FR Doc. E6-7216 Filed 5-10-06; 8:45 am]

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