[Federal Register Volume 79, Number 156 (Wednesday, August 13, 2014)]
[Notices]
[Pages 47502-47504]
[FR Doc No: 2014-19097]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72789; File No. SR-NYSEArca-2014-84]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending the NYSE
Arca Options Fee Schedule Relating to Lead Market Maker Rights Fees

August 7, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on August 1, 2014, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Arca Options Fee Schedule
(``Fee Schedule'') relating to Lead Market Maker (``LMM'') Rights Fees.
The Exchange proposes to implement the fee change effective August 1,
2014. The text of the proposed rule change is available on the
Exchange's Web site at www.nyse.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 self-regulatory organization
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 those 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
    The purpose of this filing is to reduce the Lead Market Maker
Rights Fees for all Lead Market Makers (``LMMs'') that transact a
significant daily volume.
    Currently, LMMs pay a Lead Market Maker Rights Fee (``LMM Rights
Fee'') on each issue in their allocation, ranging from $45 per month to
$1,500 per month, depending on the activity level in the issue. The
monthly LMM Rights Fee is based on the Average National Daily Customer
Contracts. The applicable LMM Rights Fee is directly related to the
number of allocations in an LMM's appointment; the more allocations in
an appointment, the higher the LMM Rights Fee. This is particularly the
case for issues that have higher Average National Daily Customer
Contracts, which have higher LMM Rights Fees associated with them.
Because of the LMM Rights Fees, LMMs that transact a significant amount
of business on the Exchange have been reluctant to take on additional
allocations. At the present time, there are approximately 2,600
different underlying issues listed on NYSE Arca Options. The Exchange
regularly receives five to 10 requests to list new issues each week.
The Exchange then surveys the LMM community to invite applications for
allocation. At present, most surveys only receive one or two responses
per issue, and a key factor in applying for allocation is the
profitability of trading in an issue given the anticipated Rights Fee.
    In order to generate more LMM interest in applying for new issue
allocations, the Exchange is implementing a volume-based metric that
will apply to all LMMs on the Exchange. Any LMM that meets certain
volume criteria will be eligible for a reduced LMM Rights Fee.
    Specifically, the Exchange is proposing that LMMs with daily
contract volume traded electronically of at least 50,000 contracts, of
which 10,000 such contracts are in its LMM appointment, will qualify
for a reduced LMM Rights Fee. LMMs that qualify will be charged a 50%
reduction in total LMM Rights Fees. As proposed, whether an LMM will be
charged 50% of the LMM Rights Fee will be determined based on an
average of the daily contract volume traded electronically each trading
day by that LMM in a calendar month.
    The Exchange believes that providing a means for LMMs that achieve
certain volume levels to be eligible for a reduced monthly LMM Rights
Fees will encourage LMMs that already transact a significant amount of
business on the Exchange, but may be reluctant to apply for additional
allocations, to apply for additional allocations. NYSE Arca proposes
that the volume be in overall electronic Market Maker volume with a
static, specified subset of that contract volume (i.e., 10,000
contracts) from names in the LMM appointment, which the Exchange
believes will enable LMMs that have a smaller number of issues in their
appointment or have a preponderance of low volume issues to achieve
this rate modification along with their larger LMM counterparts.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\4\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\5\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes that the proposed modification to LMM Rights
Fees is reasonable, equitable and not unfairly discriminatory because
by reducing the overhead costs of LMMs that transact a significant
amount of business on the Exchange, the Exchange

would create an incentive for LMMs that meet certain volume standards
to apply for additional allocations. Because of the overhead costs
associated with the LMM Rights Fees, LMMs that meet the proposed volume
standards have expressed that they are unwilling to apply for
additional appointments in new issues. The Exchange believes that the
proposed fee change would promote a fair and orderly market and protect
investors and the public interest because it would encourage LMMs that
engage in significant trading on the Exchange to apply for additional
appointments, thus assuring the availability of an LMM for all new
appointments. The Exchange believes it is also reasonable, equitable
and not unfairly discriminatory to provide a reduced fee to LMMs
because the reduced overhead costs will enhance the ability to provide
liquidity, which will benefit all market participants.
    In addition, the Exchange believes that the proposed rate is
reasonable, equitable and not unfairly discriminatory because it will
recognize those LMMs that meet their obligation to provide liquidity,
as evidenced by achieving a significant yet reasonable electronic
transaction volume. The Exchange believes that the requisite volume
level (i.e., 50,000 contracts) to qualify for the reduced fee is
reasonable, equitable and not unfairly discriminatory because it is
lower than the current average volume traded by LMMs, and therefore it
is a standard well within reach of the preponderance of LMMs,
regardless of whether they have a physical presence on the Floor. In
addition, the static, specific portion to be executed in the LMM's
appointment (i.e., 10,000 contracts) is moderately above the average
traded by LMMs in their appointment. The Exchange therefore believes
that the static portion of the volume requirement is reasonably
tailored to encourage LMMs to actively engage in their LMM appointments
in order to qualify for the proposed LMM Right Fees change. The
Exchange further believes that this requirement is reasonable,
equitable and not unfairly discriminatory because it only requires a
moderate proportion of the volume requirement in the LMM appointment,
which encourages LMMs with fewer names or with a preponderance of low
volume names in their appointments, to be eligible for the proposed fee
change. Further, the proposed reduced rate is reasonable, equitable and
not unfairly discriminatory among LMMs because it is based on an
achievable volume level (i.e., 50,000 contracts is below the average
volume traded by LMMs) with a meaningful volume--10,000 contracts--in
the LMM appointment, which allows the LMM to apply the breath of its
market making business so that the mix of issues in an LMM's
appointment does not become a barrier to achievement. In addition,
because the proposed fee change would be based only on prospective
electronic volume executed on the Exchange, and therefore all LMMs
could attain the volume threshold, the Exchange believes the fee is
reasonable, equitable and not unfairly discriminatory.
    The proposed fee is also reasonable, equitable and not unfairly
discriminatory because the Exchange believes it may indirectly benefit
non-LMM market participants. Specifically, while the LMM Rights Fee is
charged only to LMMs and therefore arguably has no direct impact on
non-LMMs, the Exchange notes that, absent this proposal, LMMs seeking
to avoid large monthly Rights Fees could either decline to apply for
new option allocations and/or choose to relinquish their LMM role in
any number of option issues. The Exchange believes that having LMMs
resign from acting as a LMM in an option issue to reduce the amount of
the LMM Rights Fee they incur would be detrimental to the Exchange and
its participants. Because LMMs have heightened quoting obligations as
compared to Market Makers,\6\ LMMs that may choose to relinquish issues
to reduce their LMM Rights Fees, would result in reduced displayed
liquidity in those issues, thereby harming investors and the public.
Thus, the Exchange believes the proposal is reasonable, equitable and
not unfairly discriminatory to non-LMMs and, in fact, may benefit other
market participants.
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    \6\ See Rule 6.37B(b) and (c) (requiring that LMMs provide
``continuous two-sided quotations throughout the trading day in its
appointed issues for 90% of the time the Exchange is open for
trading in each issue'' while requiring that Marker Makers provide
``continuous two-sided quotations throughout the trading day in its
appointed issues for 60% of the time the Exchange is open for
trading in each issue'').
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    The Exchange notes that the notion of a volume-based metric is not
new or novel in the context of a monthly fee, such as the LMM Rights
Fee. For example, on NYSE MKT LLC, a Floor Market Maker may qualify for
a ``reduced'' options trading permit (``ATP'') fee, which is calculated
on a monthly basis, if, among other things, the Market Maker transacts
most of its volume in open outcry.\7\ Thus, the proposed reduced
monthly LMM Rights Fee is reasonable, equitable and not unfairly
discriminatory as other options exchanges impose similar rate
structures.
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    \7\ See NYSE Amex Options Fee Schedule, dated August 1, 2014,
available here: https://www.theice.com/publicdocs/nyse/markets/amex-options/NYSE_Amex_Options_Fee_Schedule.pdf (providing that ``[a]
Floor Market Maker that purchases no more than two ATPs per month
may purchase them for $5,000 each (`Floor Market Maker ATP Fee') if
the Floor Market Maker transacts at least 75% of its volume,
excluding Qualified Contingent Cross and Strategy Executions,
manually, by public outcry.'')
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    The timing of the calculation of the LMM Rights Fee is reasonable
as it is calculated on the issues in an LMM's appointment on the last
trading day of the month, which gives all LMMs a fixed date to
anticipate what the fees will be and time to meet the volume standards
for the proposed fee.
    Finally, the Exchange believes that it is subject to significant
competitive forces, as described below in the Exchange's statement
regarding the burden on competition.
    For these reasons, the Exchange believes that the proposal is
consistent with the Act.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\8\ the Exchange does
not believe that the proposed rule change will impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The Exchange believes that the proposed rate
reduces the burden on competition because it will enhance the ability
for LMMs to quote competitively in more issues. The Exchange believes
the reduced rate will reduce the burden on competition among LMMs as
the reduced overhead costs will enhance the ability of firms to provide
liquidity, which will benefit all market participants. The Exchange
also believes that the proposed fee reduction will have a positive
impact on competition and may indirectly benefit non-LMM market
participants. Specifically, while the LMM Rights Fee is charged only to
LMMs and therefore arguably has no direct impact on non-LMMs, the
Exchange notes that absent this proposal LMMs seeking to avoid large
monthly Rights Fees could decline to apply for new option allocations
and/or choose to relinquish their LMM role in any number of option
issues. The Exchange believes that having LMMs resign from acting as a
LMM in an option issue to reduce the amount of the LMM Rights Fee they
incur would be detrimental to the Exchange and its participants.
Because LMMs have heightened quoting

obligations as compared to Market Makers,\9\ LMMs that may choose to
relinquish issues to reduce their LMM Rights Fees, would result in
reduced displayed liquidity in those issues, thereby harming investors
and the public. In this regard, the Exchange believes the proposal does
have a meaningful positive impact on competition.
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    \8\ 15 U.S.C. 78f(b)(8).
    \9\ See supra n. 6.
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    The Exchange notes that it operates in a highly competitive market
in which market participants can readily favor competing venues, and
providing a reduced LMM Rights Fees will allow LMMs to both expand the
number of issues allocated to them and to reduce the overhead which in
turn encourages liquidity to compete for business. The Exchange
believes that basing the qualification for the LMM Rights Fee on
electronic transaction volume will encourage competition that is in
furtherance of the Act by attracting business with enhanced liquidity
and reduced market spread.
    In such an environment, the Exchange must continually review, and
consider adjusting, its fees and credits to remain competitive with
other exchanges. For the reasons described above, the Exchange believes
that the proposed rule change reflects this competitive environment.

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

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \10\ of the Act and subparagraph (f)(2) of Rule
19b-4 \11\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \12\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \12\ 15 U.S.C. 78s(b)(2)(B).
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IV. 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 email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2014-84 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2014-84. This
file number should be included on the subject line if email 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
10:00 a.m. and 3:00 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-NYSEArca-2014-84, and should
be submitted on or before September 3, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-19097 Filed 8-12-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 29, 2010 (Volume 75, Number 209)]
[Notices]
[Page 66817-66818]
[DOCID:fr29oc10-140]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63160; File No. SR-CBOE-2010-093]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Modify the Fee Schedule for the CBOE Stock
Exchange

October 22, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 15, 2010, the Chicago Board Options Exchange,
Incorporated (the ``Exchange'' or ``CBOE'') filed with the Securities
and Exchange Commission (the ``Commission'') the proposed rule change
as described in Items I, II, and III 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.
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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

    CBOE proposes to amend the Fee Schedule of the CBOE Stock Exchange
(``CBSX'') to modify certain transaction fees. The text of the proposed
rule change is available on the Exchange's Web site (http://
www.cboe.org/legal), at the Exchange's principal office, 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 self-regulatory organization
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 those 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On August 23, 2010, the Commission published an immediately
effective rule filing to modify the transaction fees for 24 securities
traded on CBSX (the following symbols: BAC, C, DXD, EMC, EWJ, F, FAX,
FAZ, GE, INTC, MOT, MSFT, MU, NOK, Q, QID, S, SIRI, SKF, T, TWM, UNG,
UWM, XLF).\3\ On September 9, 2010, the Commission published an
immediately effective rule filing to modify the transaction fees for 51
more securities traded on CBSX (the following symbols: AA, AMAT, AMD,
BGZ, BP, BSX, CMCSA, COCO, CSCO, CX, DELL, DUK, EBAY, EEM, EWT, FAS,
FLEX, HBAN, IYR, MDT, MGM, IYR, MDT, MGM, NLY, NVDA, NWSA, ORCL, PFE,
QCOM, QQQQ, SBUX, SH, SLV, SMH, SSO, SYMC, TBT, TSM, TXN, UCO, USO,
VALE, VWO, WFC, XHB, XLB, XLK, XLP, XLU, XLV, XLY, XRX, YHOO).\4\ On
September 28, 2010, the Commission published an immediately effective
rule filing to modify the transaction fees for 51 more securities
traded on CBSX (the following symbols: ARNA, ATML, BKC, BRCD, CIM, DOW,
DRYS, EFA, EWZ, FITB, FXI, GBG, GDX, GLD, GLW, HPQ, IDIX, IWM, JPM,
KEY, LVLT, LVS, MFE, MO, MRVL, ONNN, PBR, PCBC, QLD, RF, RFMD, RIMM,
RRI, RSCR, SDS, SNDK, SPLS, SPY, TEVA, TLT, TNA, TZA, UYG, VXX, VZ, X,
XLE, XLI, XOM, XRT).\5\
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    \3\ See Securities Exchange Act Release No. 34-62758 (August 23,
2010), 75 FR 52792 (August 27, 2010) (SR-CBOE-2010-075).
    \4\ See Securities Exchange Act Release No. 34-62878 (September
9, 2010), 75 FR 56627 (September 16, 2010) (SR-CBOE-2010-079).
    \5\ See Securities Exchange Act Release No. 34-63000 (September
28, 2010), 75 FR 61549 (October 5, 2010) (SR-CBOE-2010-089).
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    CBSX now proposes to modify its transaction fees so that all
securities are subject to the Maker and Taker fees and rebates to which
the aforementioned securities became subject. The Taker rebate shall be
$0.0014 per share for transactions in all securities traded on CBSX
that are priced $1 or greater. The Maker fee shall be $0.0018 per share
for transactions in all securities traded on CBSX that are priced $1 or
greater.
    Additionally, CBSX proposes to modify the Maker and Taker fees and
rebates for transactions in securities priced less than $1. The Taker
fee for such transactions shall be 0.05% of the dollar value of the
transaction. The Maker rebate for such transaction shall be 0.01% of
the dollar value of the transaction.
    Consistent with the new fees set forth above, CBSX also proposes to
amend the fee and rebate for NBBO Step-Up Trades. For stocks priced $1
and over, the order that is flashed will receive a $0.0014 per share
rebate and the responder will be charged $0.0018 per share. For stocks
priced under $1, the maker/taker fees will correspond to those in place
for non-flashed executions (i.e., the Taker fee for such transactions
shall be 0.05% of the dollar value of the transaction, and the Maker
rebate for such transaction shall be 0.01% of the dollar value of the
transaction).
    The fee changes will become effective on October 18, 2010.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\6\ in general, and furthers the objectives of

Section 6(b)(4) \7\ of the Act in particular, in that it is designed to
provide for the equitable allocation of reasonable dues, fees, and
other charges among CBOE members and other persons using its
facilities.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The proposed rule change is designated by the Exchange as
establishing or changing a due, fee, or other charge, thereby
qualifying for effectiveness on filing pursuant to Section
19(b)(3)(A)(ii) \8\ of the Act and subparagraph (f)(2) of Rule 19b-4
\9\ thereunder.
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    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. 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-CBOE-2010-093 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-CBOE-2010-093. 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 CBOE. 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-CBOE-2010-093 and should be
submitted on or before November 19, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-27359 Filed 10-28-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 26, 2008 (Volume 73, Number 59)]
[Rules and Regulations]
[Page 15883]
[DOCID:fr26mr08-12]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2008-N-0160] (formerly Docket No. 2002N-0276)

Registration of Food Facilities Under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002; Technical
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to change the fax number to which food facility
registration forms under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the Bioterrorism Act) can be
sent. This action is editorial in nature and is intended to improve the
accuracy of the agency's regulations.

DATES: This rule is effective March 26, 2008.

FOR FURTHER INFORMATION CONTACT: Catherine Copp, Center for Food Safety
and Applied Nutrition (HFS-4), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in part 1
(21 CFR part 1). Several sections in part 1 cite a fax number to which
food facility registration forms under the Bioterrorism Act (Public Law
107-188) can be sent. This rule replaces the obsolete information with
correct information.
    The final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
    Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). These
amendments remove obsolete information and are not substantive. FDA
therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3)
that notice and comment are unnecessary.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
1 is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 continues to read as
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355,
360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262,
264.

0
2. Section 1.231 is amended by revising paragraph (b)(2) to read as
follows:

Sec.  1.231  How and where do you register?

* * * * *
    (b) * * *
    (2) When you receive the form, you must fill it out completely and
legibly and either mail it to the address in paragraph (b)(1) of this
section or fax it to<PHONE_NUMBER> or 1-800-573-0846.
* * * * *

0
3. Section 1.234 is amended by revising paragraph (d)(2) to read as
follows:

Sec.  1.234  How and when do you update your facility's registration
information?

* * * * *
    (d) * * *
    (2) When you receive the form, you must legibly fill out the
sections of the form reflecting your updated information and either
mail it to the address in paragraph (d)(1) of this section or fax it to
301-436-2804 or
1-800-573-0846.
* * * * *

0
4. Section 1.235 is amended by revising paragraph (d)(2) to read as
follows:

Sec.  1.235  How and when do you cancel your facility's registration
information?

* * * * *
    (d) * * *
    (2) When you receive the form, you must completely and legibly fill
out the form and either mail it to the address in paragraph (d)(1) of
this section or fax it to<PHONE_NUMBER> or 1-800-573-0846.
* * * * *

    Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6052 Filed 3-25-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Notices]
[Pages 35334-35335]
[FR Doc No: 2013-13889]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69709; File No. SR-FICC-2013-03]

Self-Regulatory Organizations; The Fixed Income Clearing
Corporation; Order Granting Approval of a Proposed Rule Change To Amend
Mortgage-Backed Securities Division Rules Relating To Allocation of an
Indemnity Claim Made in Connection With the Use of the Federal
Reserve's National Settlement Service

June 6, 2013.

I. Introduction

    On April 15, 2013, the Fixed Income Clearing Corporation (``FICC'')
filed with the Securities and Exchange Commission (``Commission'')
proposed rule change SR-FICC-2013-03 pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder.\2\ The proposed rule change was published for comment in
the Federal Register on April 29, 2013.\3\ The Commission received no
comment letters. This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 69434 (April 23, 2013),
78 FR 25121 (April 29, 2013).
---------------------------------------------------------------------------

II. Description

    FICC's Government Securities Division (``GSD'') and Mortgage-Backed
Securities Division (``MBSD'') each use the Board of Governors of the
Federal Reserve's (``FRB'') National Settlement Service (``NSS'') for
Funds-Only Settlement \4\ and Cash Settlement \5\ purposes,
respectively. GSD's Rule 13 and MBSD's Rule 11 address the situation
where the FRB makes an indemnity claim in connection with the use of
the NSS service by FICC. Pursuant to the GSD and MBSD rules, if FICC
receives an FRB indemnity claim, FICC will apportion the entire
liability to the GSD netting members or MBSD clearing members, as
applicable, for whom the settling bank was acting at the time.\6\ If
such amounts are not sufficient to fully satisfy the FRB indemnity
claim, each of the GSD and MBSD rules currently provide different
directives as to how FICC should handle the remaining loss. The GSD
rules state that FICC will treat the remaining loss as an ``Other
Loss,'' as defined in GSD Rule 4, and allocate accordingly.\7\ In
contrast, MBSD Rule 11, Section 5(o), states that FICC will allocate
the remaining loss among all MBSD clearing members in proportion to
their relative use of the MBSD services (based on fees).
---------------------------------------------------------------------------

    \4\ ``Fund-Only Settlement Amount'' is defined under Rule 1 of
GSD's Rulebook as the net dollar amount of a netting member's
obligation, calculated pursuant to GSD's Rule 13, either to make a
funds-only payment to GSD or to receive a funds-only payment from
GSD. See GSD Rule 13 for the rules related to funds-only settlement.
    \5\ ``Cash Settlement'' is defined under Rule 1 of MBSD's
Clearing Rules as the payment each business day by MBSD to a member
or by a member to MBSD. See MBSD Rule 11 for the rules related to
cash settlement.
    \6\ See GSD's Rule 13 Section 5(o) and MBSD Rule 11, Section
5(o).
    \7\ Rule 4(f) of GSD's Rulebook.
---------------------------------------------------------------------------

    The purpose of the rule change is to correct MBSD's Rule 11 in
order to accurately reflect the correct manner in which FICC should
allocate an indemnity claim made in connection with the use of the
FRB's NSS. The MBSD provision in Rule 11 was drafted prior to the MBSD
becoming a central counterparty and adopting a loss mutualization
process similar to the GSD process. When FICC filed its rule change to
provide guaranteed settlement

and central counterparty services,\8\ which among other things
established the loss mutualization process, the MBSD NSS indemnity
provision requiring the current loss allocation process was
inadvertently overlooked and therefore not updated during FICC's
efforts to harmonize the GSD and MBSD rules. Accordingly, the rule
change corrects this oversight by revising MBSD Rule 11, Section 5(o),
to reflect that all remaining losses from a FRB indemnity claim should
be treated as an ``Other Loss'' as defined in MBSD Rule 4 and allocated
accordingly.
---------------------------------------------------------------------------

    \8\ Exchange Act Release No. 66550 (March 9, 2012), 77 FR 15155
(March 14, 2012) [File No. SR-FICC-2008-01] (order approving amended
proposed rule change to allow MBSD to provide guaranteed settlement
and central counterparty services).
---------------------------------------------------------------------------

III. Discussion

    Section 19(b)(2)(C) of the Act \9\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that such proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to such organization. Section 17A(b)(3)(F) of the Act
requires, among other things, that the rules of a clearing agency be
designed to promote the prompt and accurate clearance and settlement of
securities transactions and to remove impediments to and perfect the
mechanism of a national system for the prompt and accurate clearance
and settlement of securities transactions.\10\ The Commission finds
that FICC's rule change should facilitate the prompt and accurate
clearance and settlement of securities transactions by correcting
MBSD's rules to accurately reflect the loss allocation procedures in
connection with NSS and to ensure that there is consistent treatment of
such losses between the MBSD and GSD rules.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2)(C).
    \10\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act,
particularly with the requirements of Section 17A of the Act, and the
rules and regulations thereunder.
    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\11\ that the proposed rule change (File No. SR-FICC-2013-03) be
and hereby is approved.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2).
    \12\ In approving this proposal, the Commission has considered
its impact on efficiency, competition, and capital formation. 15
U.S.C. 78c(f).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-13889 Filed 6-11-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 209 (Friday, October 28, 2016)]
[Proposed Rules]
[Pages 74962-74966]
[FR Doc No: 2016-26043]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 514 and 556

[Docket No. FDA-2012-N-1067]
RIN 0910-AG17

New Animal Drugs; Updating Tolerances for Residues of New Animal
Drugs in Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; supplemental notice of proposed rulemaking.

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

SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
amend our 2012 document entitled ``New Animal Drugs; Updating
Tolerances for Residues of New Animal Drugs in Food.'' The document
proposed to revise the animal drug regulations regarding tolerances for
residues of approved and conditionally approved new animal drugs in
food by standardizing, simplifying, and clarifying the determination
standards and codification style. We also proposed to add definitions
for key terms. We are taking this action to more clearly explain our
current thinking about certain provisions of the 2012 document based on
comments from stakeholders, and to more accurately reflect the
rationale FDA relied on in the past to approve certain new animal drugs
without a tolerance. We are reopening the comment period only with
respect to the specific issues identified in this supplemental proposed
rule.

DATES: Submit either electronic or written comments on this proposed
rule by December 27, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submission

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-N-1067 for this proposed rulemaking. Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Dong Yan, Center for Veterinary
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
    Purpose and Coverage of the Supplemental Notice of Proposed
Rulemaking
    Summary of the Major Provisions of the Supplemental Notice of
Proposed Rulemaking
I. Background
    A. Introduction
    B. Comments to the 2012 Proposed Rule for Updating Tolerances
for Residues of New Animal Drugs in Food
II. Proposed Revisions to Subpart A--General Provisions
    A. Analytical Method
    B. Proposed Revisions to Definitions (Proposed Sec.  556.3)
    C. Proposed Revisions to General Considerations (Proposed Sec.
556.5)
III. Proposed Conforming Change to 21 CFR Part 514
IV. Legal Authority
V. Economic Analysis of Impacts
VI. Paperwork Reduction Act of 1995
VII. Analysis of Environmental Impact
VIII. Federalism
IX. References

Executive Summary

Purpose and Coverage of the Supplemental Notice of Proposed Rulemaking

    We previously proposed to revise the animal drug regulations
regarding tolerances for residues of approved and conditionally
approved new animal drugs in food. In addition to proposing to
standardize, simplify, and clarify the standards of determination and
codification style for tolerances, we proposed a new definition
section. In this document, we are proposing to revise or remove some of
the previously proposed definitions, taking into account comments we
received that have led us to clarify our current thinking, and to more
accurately reflect the rationale FDA relied on in the past to approve
certain new animal drugs without a tolerance.

Summary of the Major Provisions of the Supplemental Notice of Proposed
Rulemaking

    The previously proposed rule (2012 proposed rule) did not
adequately explain our current view that methods other than the
``regulatory method'' derived from the method submitted by a sponsor as
part of the new animal drug application can be used to determine the
quantity of residue in edible tissues for surveillance and enforcement
purposes. Therefore, we are removing the proposed definition for
``regulatory method'' and are reserving the term for use with
carcinogenic compounds. We are also removing the use of this term from
proposed Sec.  556.5(d) (21 CFR 556.5(d)). We are proposing to revise
portions of the 2012 proposed rule to better align the proposed rule
with our current thinking and practice that an analytical method other
than the practicable method(s) submitted by the sponsor as part of the
new animal drug application can be used for surveillance and
enforcement purposes for non-carcinogenic compounds, as long as the
performance criteria of that method are comparable to those of the
practicable method. However, as described in section II.C, we are not
proposing similar changes to the regulations concerning carcinogenic
compounds because our current interpretation of the relevant provisions
in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) is that,
unlike for non-carcinogenic compounds, the regulatory method prescribed
in the approval of the new animal drug must be used for surveillance
and enforcement purposes for carcinogenic compounds.
    We are also revising the proposed definitions for ``marker
residue'', ``tolerance'', ``not required'', and ``zero''. We are
removing the definition for ``acceptable single-dose intake'' and
adding a definition for ``acute reference dose''.

                   Table of Abbreviations and Acronyms
------------------------------------------------------------------------
             Abbreviation/acronym                    What it means
------------------------------------------------------------------------
ARfD.........................................  Acute reference dose.
ASDI.........................................  Acceptable single-dose
                                                intake.
CFR..........................................  Code of Federal
                                                Regulations.
CVM..........................................  Center for Veterinary
                                                Medicine.
FDA..........................................  U.S. Food and Drug
                                                Administration.
FD&C Act.....................................  Federal Food, Drug, and
                                                Cosmetic Act.
JECFA........................................  World Health Organization/
                                                Food and Agriculture
                                                Organization of the
                                                United Nations Joint
                                                Expert Committee on Food
                                                Additives.
VICH.........................................  International Cooperation
                                                on Harmonisation of
                                                Technical Requirements
                                                for Registration of
                                                Veterinary Medicinal
                                                Products.
------------------------------------------------------------------------

I. Background

A. Introduction

    In the Federal Register of December 5, 2012 (77 FR 72254), we
issued a document to revise part 556 (21 CFR part 556) by standardizing
and simplifying the codification style, revising the general
considerations section, adding a scope section, and adding a definition
section to define key terms used in the part. The definition section
was proposed to include the terms used by FDA in the determination of
tolerances. Some of the terms had been used previously in part 556, but
never defined, and some terminology that had been used was outdated or
resulted in confusion to users of the part. We proposed a general
considerations section (proposed Sec.  556.5) to provide additional
information and clarification for the tolerances listed in proposed
subpart B. We are issuing this supplemental notice of proposed
rulemaking to revise the proposed changes to part 556 to align with our
current thinking.

B. Comments to the 2012 Proposed Rule for Updating Tolerances for
Residues of New Animal Drugs in Food

    We received several stakeholder comments to the proposed rule
including a comment that requests clarification on the proposed
definition for ``regulatory method'' and on the use of the term in
proposed Sec.  556.5(d), which stated that FDA requires that a drug
sponsor develop a regulatory method to measure drug residues in edible
tissues of approved target species. This comment notes that a
regulatory method has historically been used to refer to the ``required
determinative and confirmatory procedures for regulatory surveillance
of residue concentrations in meat products entering the food supply for
comparison to the tolerance post-commercialization of the product.''
The comment also states the context of the proposal appears to be the
method(s) used to collect data to support the setting of the tolerances
preapproval. The comment also asks if the proposal implies that
tolerances may be established using

analytical procedures other than the determinative procedure. In
addition, the comment states it should be clarified if regulatory
method is referring to method(s) used preapproval for setting the
tolerance versus a finite method(s) used for determining post-
commercialization residue to compare to the tolerance.
    We realize that the term ``regulatory method'' proposed in Sec.
556.3 and used in proposed Sec.  556.5(d) has caused some confusion. As
a result of the comments, we are taking this opportunity to better
explain our current thinking about analytical methods used to determine
residue levels in tissues for new animal drugs intended for use in
food-producing animals.

II. Proposed Revisions to Subpart A--General Provisions

A. Analytical Method

    An analytical method other than the practicable method can be used
for surveillance and enforcement purposes for non-carcinogenic
compounds, as long as the performance criteria (e.g., sensitivity,
specificity, accuracy, and precision) of that method are comparable to
those of the practicable method submitted by the sponsor as part of the
new animal drug application. Such an analytical method would need to
have the same capability as the practicable method to determine the
quantity of the drug residues so that the tolerance, withdrawal period,
or other use restrictions continue to ensure that the use of the drug
will be safe. However, as described in section II.C, for carcinogenic
compounds, the regulatory method prescribed in the approval of the new
animal drug must be used for surveillance and enforcement purposes for
carcinogenic compounds (see 21 CFR part 500, subpart E).
    FDA establishes tolerances using the practicable method submitted
by a sponsor as part of the new animal drug application as required by
section 512(b)(1)(G) of the FD&C Act (21 U.S.C. 360b(b)(1)(G)). The
practicable method has to meet certain performance criteria, including
evaluation of accuracy, precision, and sensitivity. We use the
practicable method submitted by the sponsor as part of the new animal
drug application to determine the quantity of the drug residues that
can safely remain in edible tissues (i.e., the tolerance), the
withdrawal period, and any other use restrictions necessary to ensure
that the proposed use of the drug will be safe, and make these use
restrictions part of the conditions of approval. These conditions of
use are designed to ensure that the proposed use of the drug will be
safe Sec.  514.1(b)(7) (21 CFR 514.1(b)(7)). In the past, the
practicable method was often used for determining the quantity of
residue in edible tissue when monitoring the food supply. However, as
technologies have evolved, many of the older methods have become
obsolete. In addition, there is an increased reliance on multiresidue
methods in the monitoring of the food supply (i.e., methods that
analyze for a number of different drug residues at the same time). As a
result, we are clarifying that an analytical method other than the
practicable method can be used for surveillance and enforcement
purposes for non-carcinogenic compounds, provided it meets the same
performance criteria as the practicable method to determine the
quantity of the relevant drug residues. Therefore, we are proposing to
revise some of the definitions in proposed Sec.  556.3 of the 2012
proposed rule as well as revise some of the language under ``General
Considerations'' in proposed Sec.  556.5, to more accurately reflect
our current thinking.

B. Proposed Revisions to Definitions (Proposed Sec.  556.3)

    In the 2012 proposed rule, we included a section of definitions
(proposed Sec.  556.3). We propose to revise four of the definitions,
remove two definitions, and add a new definition in proposed Sec.
556.3.
    In the definition of ``marker residue'', we propose to delete
``selected for assay by the regulatory method'' because we are
reserving the term ``regulatory method'' for use with carcinogenic
compounds (see part 500, subpart E). Also, we propose to delete the
explanatory text that follows the first sentence of the definition
because an explanation of how the tolerance is used is not needed in
this definition. In addition, we are removing the term ``target
tissue'' in the definition and replacing it with ``an edible tissue''.
    In the definition of ``not required'', we propose to more
accurately reflect the rationale FDA relied on in the past to approve
certain new animal drugs without a tolerance. Currently, our general
practice is to establish a tolerance for all new animal drugs we
approve.
    In the definition of ``tolerance'', we propose to delete the
explanatory text that follows the first sentence of the definition
because an explanation of how the tolerance is used is not needed in
this definition.
    In the definition of ``zero'', we propose to delete ``when using a
method of detection prescribed or approved by FDA'' because, as
discussed previously, an analytical method other than the practicable
method can be used for surveillance and enforcement purposes for non-
carcinogenic compounds. The additional proposed revisions to this
definition are intended to clarify the meaning of the term ``zero'' as
used in part 556 so that ``zero'' means any residues detected in the
tissue renders it unsafe.
    We propose to remove the definition of ``acceptable single-dose
intake (ASDI)''. See discussion for ``acute reference dose (ARfD)''
further in this section for the explanation.
    We propose to remove the definition of ``regulatory method''
because we are reserving the term ``regulatory method'' for use with
carcinogenic compounds, consistent with our current interpretation of
the FD&C Act (see part 500, subpart E).
    We propose to add the definition of ``acute reference dose (ARfD)''
to mean ``an estimate of the amount of residues expressed on a body
weight basis that can be ingested in a period of 24 hours or less
without adverse effects or harm to the health of the human consumer.''
ARfD would be used in place of ASDI wherever this term is currently
used in the tolerances listed in subpart B of part 556.
    In the 2012 proposed rule, we explained that sometimes the concept
of an ASDI was used to calculate tolerances. We proposed to define the
ASDI as ``the amount of total residue that may safely be consumed in a
single meal. The ASDI may be used to derive the tolerance for residue
of a drug at the injection site where the drug is administered
according to the label.'' The definition of the ASDI was based on the
U.S. Environmental Protection Agency definition of ARfD and chosen, in
part, to provide additional clarity for the veterinary drug health
based guidance value. Since that time, the use of the term ARfD has
been more broadly applied by scientific and regulatory authorities, as
further discussed in this section.
    The United States is an active member of the Codex Alimentarius and
the Codex Committee for Residues of Veterinary Drugs in Food, which
rely on the World Health Organization/Food and Agriculture Organization
of the United Nations Joint Expert Committee on Food Additives (JECFA)
for scientific advice. The JECFA uses the guidance Environmental Health
Criteria (EHC) 240, Principles and Methods for the Risk Assessment of
Chemicals in Food in its evaluations (Ref. 1). This guidance defines
and discusses the term ARfD. More importantly for FDA, the

International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH) has also
developed guidelines that discuss the ARfD. The United States is a
member of VICH and adopts finalized VICH guidelines for technical
requirements for new animal drug approvals in the United States. On
June 1, 2015 (80 FR 31041), we announced a draft guidance (Guidance for
Industry #232 (VICH GL54)) entitled ``Studies to Evaluate the Safety of
Residues of Veterinary Drugs in Human Food: General Approach to
Establish an Acute Reference Dose (ARfD)'', in which the term ``acute
reference dose (ARfD)'' is used to describe the same concept as the
2012 proposed definition of ASDI (Ref. 2). There are no fundamental
differences between the meaning of ASDI and ARfD.
    We consider it appropriate to propose using the VICH definition of
ARfD to replace the 2012 proposed definition of ASDI. The ARfD may be
used in the same manner as the ASDI, which is to derive the tolerance
for residues of a drug at an injection site where the drug is
administered according to the label, or to derive the tolerance for
residues of a drug in other edible tissues as a result of concern for
the acute toxicity of the residues of the veterinary drug.

C. Proposed Revisions to General Considerations (Proposed Sec.  556.5)

    We propose to revise proposed Sec.  556.5(d) to align with our
current thinking. In addition, we propose to remove the term
``regulatory method'' from this provision because we are reserving this
term for use with carcinogenic compounds (part 500, subpart E).
    Although the proposed revisions would clarify that an analytical
method other than the practicable method may be used for surveillance
and enforcement purposes for residue levels of non-carcinogenic animal
drugs, with regard to approved carcinogenic compounds, our current
interpretation of the relevant provisions of the FD&C Act is that it
requires that a regulatory method be prescribed for such a compound and
used for surveillance and enforcement purposes. Under the Delaney
Clause, section 512(d)(1)(I) of the FD&C Act, FDA cannot approve an
application for a new animal drug if it is found to induce cancer when
ingested by humans or animals. An exception to this provision, referred
to as the DES (diethylstilbestrol) Proviso, allows for the approval of
a carcinogenic compound if FDA finds that, under the approved
conditions of use, the drug will not adversely affect treated animals
and no residue of the drug will be found (by methods of examination
prescribed or approved by the Secretary by regulations) (emphasis
added) in any food for human consumption derived from the treated
animals (see section 512(d)(1)(I)(i) and (ii) of the FD&C Act). FDA has
issued regulations defining the operational definition of no residue
and regulatory method for purposes of measuring carcinogenic compounds
(21 CFR 500.82 and 500.88).

III. Proposed Conforming Change to 21 CFR Part 514

    We are proposing a conforming change to the language in the
introductory text of Sec.  514.1(b)(7) by removing the term
``regulatory'' in the last sentence to reflect the fact that we are
reserving this term for use with carcinogenic compounds. (See
discussion in section II.C.)

IV. Legal Authority

    Our authority for issuing this proposed rule is provided by
sections 512(b)(1)(G) and (H), 512(d)(1)(F), 512(d)(2), 512(i),
571(a)(2)(A), and 571(b)(1) of the FD&C Act (21 U.S.C. 360b(b)(1)(G)
and (H), 360b(d)(1)(F), 360(d)(2), 360b(i), 360ccc(a)(2)(A), and
360ccc(b)(1)). These provisions relate to the information new animal
drug and conditional approval applicants provide with respect to
proposed tolerances, withdrawal periods, and practicable methods, and
the process by which FDA establishes and publishes regulations setting
tolerances for residues of approved and conditionally approved new
animal drugs. In addition, section 701(a) of the FD&C Act (21 U.S.C.
371(a)) gives FDA general rulemaking authority to issue regulations for
the efficient enforcement of the FD&C Act.

V. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this proposed rule would not impose compliance costs
on the current or future sponsors of any approved and conditionally
approved new animal drugs, we proposed to certify that the proposed
rule would not have a significant economic impact on a substantial
number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $146 million, using the most current (2015) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.

VI. Paperwork Reduction Act of 1995

    We tentatively conclude that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

VII. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(i) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the proposed rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

IX. References

    The following references are on display in the Division of Dockets

Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. International Programme on Chemical Safety, ``Environmental
Health Criteria 240, Principals and Methods for the Risk Assessment
of Chemicals in Food,'' 2009. (http://www.who.int/foodsafety/publications/chemical-food/en/). Accessed on February 11, 2016.
2. FDA, ``Draft Guidance for Industry #232: Studies to Evaluate the
Safety of Residues of Veterinary Drugs in Human Food: General
Approach to Establish an Acute Reference Dose (ARfD), VICH GL54,''
(http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM448430.pdf),
June 2015. Accessed on February 11, 2016.

List of Subjects

21 CFR Part 514

    Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.

21 CFR Part 556

    Animal drugs, Foods.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR chapter I, subchapter E, be amended as follows:

PART 514--NEW ANIMAL DRUG APPLICATIONS

0
1. The authority citation for part 514 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b,
360ccc, 371, 379e, 381.

Sec.  514.1  [Amended]

0
2. In Sec.  514.1(b)(7) introductory text, remove the word
``regulatory'' from the last sentence.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
3. The authority citation for part 556, as proposed to be revised on
December 5, 2012 (77 FR 72254), continues to read as follows:

    Authority: 21 U.S.C. 342, 360b, 360ccc, 371.

0
4. Amend Sec.  556.3, as proposed to be added on December 5, 2012 (77
FR 72254), as follows:
0
a. Remove the definition of ``Acceptable single-dose intake'';
0
b. Add, in alphabetical order, a definition for ``Acute reference
dose'';
0
c. Revise the definitions for ``Marker residue'' and ``Not required'';
0
d. Remove the definition of ``Regulatory method''; and
0
e. Revise the definitions for ``Tolerance'' and ``Zero''.
    The revisions and additions read as follows:

Sec.  556.3  Definitions.

* * * * *
    Acute reference dose (ARfD) means an estimate of the amount of
residues expressed on a body weight basis that can be ingested in a
period of 24 hours or less without adverse effects or harm to the
health of the human consumer.
* * * * *
    Marker residue means the residue whose concentration is in a known
relationship to the concentration of total residue in an edible tissue.
* * * * *
    Not required, in reference to tolerances in this part, means that
at the time of approval:
    (1) No withdrawal period was necessary for residues of the drug to
deplete to or below the concentrations considered to be safe, or an
adequate withdrawal period was inherent in the proposed drug use, and
there was a rapid depletion of residues, so there was no concern about
residues resulting from misuse or overdosing; or
    (2) No withdrawal period was necessary because the drug was poorly
absorbed or metabolized rapidly so as to make selection of an analyte
impractical or impossible.
* * * * *
    Tolerance means the maximum concentration of a marker residue, or
other residue indicated for monitoring, that can legally remain in a
specific edible tissue of a treated animal.
* * * * *
    Zero, in reference to tolerances in this part, means any residues
detected in the tissue renders it unsafe.
0
5. Amend Sec.  556.5, as proposed to be added on December 5, 2012 (77
FR 72254), by revising paragraph (d) to read as follows:

Sec.  556.5  General considerations.

* * * * *
    (d) FDA requires that a drug sponsor submit a practicable method as
part of their new animal drug application. FDA uses the practicable
method to determine the quantity of the drug residues that can safely
remain in edible tissues (i.e., the tolerance), the withdrawal period,
and any other use restrictions necessary to ensure that the proposed
use of the drug will be safe.

    Dated: October 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26043 Filed 10-27-16; 8:45 am]
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[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Rules and Regulations]
[Pages 26854-26857]
[FR Doc No: 2017-12019]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2016-0244; FRL-9962-54-Region 9]

Approval and Promulgation of Implementation Plans; State of
California; Coachella Valley; Attainment Plan for 1997 8-Hour Ozone
Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving state
implementation plan (SIP) revisions submitted by the State of
California to provide for attainment of the 1997 8-hour ozone national
ambient air quality standards (NAAQS or ``standards'') in the Coachella
Valley nonattainment area. The EPA finds the emissions inventories to
be acceptable and is approving the reasonably available control
measures, transportation control strategies and measures, rate of
progress and reasonable further progress demonstrations, attainment
demonstration, and vehicle miles traveled offset demonstration. We have
determined that motor vehicle emissions budgets are not required for
the 1997 8-hour ozone standards so we

are not taking final action on this portion of the plan.

DATES: Effective Date: This final rule is effective on July 12, 2017.

ADDRESSES: The EPA has established docket number EPA-R09-OAR-2016-0244
for this action. Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov or in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California 94105-
3901. While all documents in the docket are listed at http://www.regulations.gov, some information may be publicly available only at
the hard copy location (e.g., copyrighted material, large maps, multi-
volume reports), and some may not be available in either location
(e.g., confidential business information (CBI)). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Tom Kelly, Air Planning Office (AIR-
2), EPA Region IX,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, the terms ``we,''
``us,'' and ``our'' refer to the EPA.

Table of Contents

I. Summary of Proposed Action
II. Public Comments
III. Final Action
IV. Statutory and Executive Order Reviews

I. Summary of Proposed Action

    On November 1, 2016, the EPA proposed to approve, under section
110(k)(3) of the Clean Air Act (CAA), portions of several submittals
from the California Air Resources Board (CARB) as revisions to the
California SIP for the Coachella Valley ozone nonattainment area.\1\ 81
FR 75764. The proposal identified the following SIP submittals
addressing the CAA planning requirements for attaining the 1997 8-hour
ozone NAAQS for the Coachella Valley (and other areas as noted):
---------------------------------------------------------------------------

    \1\ For a precise description of the geographic boundaries of
the Coachella Valley ozone nonattainment area, see 40 CFR 81.305.
---------------------------------------------------------------------------

     ``Final 2007 Air Quality Management Plan,'' South Coast
Air Quality Management District, June 2007 (``2007 AQMP'');
     ``2007 State Strategy for the California State
Implementation Plan,'' CARB, Release Date April 26, 2007, and
Appendices A-G, CARB, Release Date May 7, 2007 (``2007 State
Strategy'');
     ``Status Report on the State Strategy for California's
2007 State Implementation Plan (SIP) and Proposed Revision to the SIP
Reflecting Implementation of the 2007 State Strategy,'' CARB, Release
Date March 24, 2009 (``2009 State Strategy Status Report'');
     ``Progress Report on Implementation of PM2.5
State Implementation Plans (SIP) for the South Coast and San Joaquin
Valley Air Basins and Proposed SIP Revisions,'' CARB, Release Date
March 29, 2011 (``2011 State Strategy Progress Report''); and
     ``Staff Report, Proposed Updates to the 1997 8-Hour Ozone
Standard, State Implementation Plans; Coachella Valley and Western
Mojave Desert,'' CARB, Release Date: September 22, 2014 (``2014 SIP
Update'').
    We refer to these submittals collectively as the ``Coachella Valley
Ozone Plan'' or ``Plan.''
    The Coachella Valley is classified as Severe-15 with an attainment
date no later than June 15, 2019. See 75 FR 24409 (May 5, 2010). The
relevant CAA requirements appear at Title I, Part D of the CAA, under
which states must implement the 1997 8-hour ozone (primary and
secondary) standards.\2\ The EPA codified rules for the 1997 8-hour
ozone standards at 40 CFR part 51, subpart X. See 69 FR 23951 (April
30, 2004); 70 FR 71612 (November 29, 2005). The EPA revoked the 1997 8-
hour ozone NAAQS in 2015; \3\ notwithstanding this revocation, areas
that were designated as nonattainment for the 1997 8-hour ozone NAAQS
at the time the standards were revoked continue to be subject to
certain SIP requirements that previously applied based on area
classifications for the standards, under ``anti-backsliding''
regulations that the EPA promulgated to govern the transition from the
1-hour ozone standards to the 8-hour ozone standards. Id. at 12296; 40
CFR 51.1105 and 51.1100(o). Thus, in general, the Coachella Valley
remains subject to the requirements of the 1997 8-hour ozone NAAQS
applicable to ``Severe'' nonattainment areas.
---------------------------------------------------------------------------

    \2\ Title I, Part D of the CAA includes section 172,
``Nonattainment Plan Provisions in General,'' and subpart 2,
``Additional Provisions for Ozone Nonattainment Areas'' (sections
181-185).
    \3\ 80 FR 12264 (March 6, 2015).
---------------------------------------------------------------------------

    In the November 1, 2016 proposed rule, we proposed to approve the
following elements of the Coachella Valley Ozone Plan under applicable
statutory and regulatory requirements: The reasonably available control
measures (RACM) demonstration; the rate of progress (ROP) and
reasonable further progress (RFP) demonstrations; the attainment
demonstration; and the demonstration that the SIP provides for
transportation control strategies and measures sufficient to offset any
growth in emissions from growth in vehicle miles traveled (VMT) or the
number of vehicle trips, and to provide for RFP and attainment. More
specifically, we determined that:
     No additional RACM, beyond the controls identified in the
2007 AQMP and 2007 State Strategy as revised by the 2009 State Strategy
Status Report and 2011 State Strategy Progress Report, would advance
attainment of the 1997 8-hour ozone standards in the Coachella Valley
to an attainment year of 2017. Therefore, the Coachella Valley Ozone
Plan provides for the implementation of all RACM as required by CAA
section 172(c)(1) and 40 CFR 51.1105(a)(1) and 51.1100(o)(17) (see 81
FR 75769-72 of the proposed rule).
     The ROP and RFP demonstrations in the 2014 SIP Update meet
the requirements of CAA sections 172(c)(2) and 182(c)(2)(B) and 40 CFR
51.1105(a)(1) and 51.1100(o)(4) (see 81 FR 75774-76 of the proposed
rule).
     The air quality modeling in the 2007 AQMP is adequate to
support the attainment date of June 15, 2019 (attainment year 2018),
and the 2007 AQMP's attainment demonstration meets the requirements of
CAA section 182(c)(2)(A) and 40 CFR 51.1105(a)(1) and 51.100(o)(12)
(see 81 FR 75772-73 of the proposed rule and the Technical Support
Document (TSD) for the proposal \4\).
---------------------------------------------------------------------------

    \4\ This document is available online at www.regulations.gov in
the docket EPA-R09-OAR-2016-0244, or from the EPA contact listed at
the beginning of this notice.
---------------------------------------------------------------------------

     Appendices D and E of the 2014 SIP Update demonstrate that
the State has adopted sufficient transportation control strategies and
measures to offset any growth in emissions from increasing VMT and
vehicle trips in Coachella Valley, and complies with the VMT emissions
offset requirement in CAA section 182(d)(1)(A) and 51.1105(a)(1) and
51.1100(o)(10) (see 81 FR 75777-79 of the proposed rule).
    We also proposed to approve updated motor vehicle emission budgets
(MVEBs) for transportation conformity included in the 2014 SIP Update.
See 81 FR 75776-77 of the proposed rule. Additionally, although
emissions inventories are not a specific requirement under the anti-
backsliding provisions, we found that the baseline and milestone year
emissions inventories were adequate to support the other elements of
the Coachella Valley Ozone Plan, including the RACM, RFP, ROP and
attainment

demonstrations. See 81 FR 75768-69 of the proposed rule. We did not
propose any action on the Coachella Valley Ozone Plan's contingency
measures. The EPA's analysis and findings supporting our proposed
actions are summarized in our proposal and are also discussed in the
TSD for the proposal.
    In today's action, the EPA is finalizing all actions from the
proposal, with the sole exception that we are not finalizing approval
of the MVEBs in the 2014 SIP Update. As discussed further below, the
MVEBs are not a continuing applicable requirement for the Coachella
Valley under the EPA's anti-backsliding regulations, and our approval
of the MVEBs is therefore not required under the CAA.

II. Public Comments

    The EPA's proposed action provided a 30-day public comment period.
We received no substantive adverse comments during this period.

III. Final Action

    For the reasons discussed in our November 1, 2016 proposal and
summarized above, the EPA is approving, under CAA section 110(k)(3),
most elements of the Coachella Valley Ozone Plan as proposed.
Specifically, the EPA is taking final action to approve the following
the following elements as meeting the specified requirements for the
revoked 1997 8-hour ozone standards:
     The RACM demonstration as meeting the requirements of CAA
section 172(c)(1) and 40 CFR 51.1105(a)(1) and 51.1100(o)(17).
     the ROP and RFP demonstrations as meeting the requirements
of CAA sections 172(c)(2) and 182(c)(2)(B) and 40 CFR 51.1105(a)(1) and
51.1100(o)(4).
     the attainment demonstration as meeting the requirements
of CAA section 182(c)(2)(A) and 40 CFR 51.1105(a)(1) and
51.1100(o)(12).
     the demonstration that the SIP provides for transportation
control strategies and measures sufficient to offset any growth in
emissions from growth in VMT or the number of vehicle trips, and to
provide for RFP and attainment, as meeting the requirements of CAA
section 182(d)(1)(A) and 40 CFR 51.1105(a)(1) and 51.1100(o)(10).
    As noted in our proposal, we are not acting on the Plan's
contingency measures. Contingency measures are a distinct provision of
the CAA that we may act on separately from the attainment requirements.
    Upon further reflection, we are not finalizing our proposed
approval of the MVEBs in the 2014 SIP Update. The CAA requires
transportation conformity only in areas that are designated
nonattainment or maintenance. Since the revocation of the 1997 8-hour
ozone NAAQS, transportation conformity no longer applies to the
Coachella Valley with respect to the revoked standards. 80 FR 12264,
12284 (March 6, 2015). Therefore, we have determined that it is not
necessary to approve these budgets, given that they were developed for
the now-revoked 1997 8-hour ozone NAAQS. However, consistent with the
EPA's transportation conformity rule,\5\ the MVEBs from CARB's 2008
Ozone Early Progress Plan \6\ will remain in effect for the Coachella
Valley until emission budgets are established and found adequate or are
approved for the 2008 ozone NAAQS.
---------------------------------------------------------------------------

    \5\ 40 CFR part 93, subpart A.
    \6\ ``Early Progress Plans Demonstrating Progress Toward
Attaining the 8-hour National Air Quality Standards for Ozone and
Setting Transportation Conformity Budgets for Ventura County,
Antelope Valley--Western Mojave Desert, Coachella Valley, Eastern
Kern County, and Imperial County'' (revised), CARB (February 27,
2008). The EPA previously determined that the budgets in the Ozone
Early Progress Plan are adequate for transportation conformity
purposes. See 73 FR 25694 (May 7, 2008).
---------------------------------------------------------------------------

    In this action, we are also amending 40 CFR 52.220 to clarify the
scope of an earlier partial approval of the 2007 AQMP. In 2011, we
approved portions of the 2007 AQMP as providing for attainment of the
1997 fine particulate matter NAAQS in the Los Angeles-South Coast area.
76 FR 69928 (November 9, 2011). However, the regulatory text that we
adopted in that action did not specify that our approval extended only
to those portions of the 2007 AQMP that CARB had submitted to us as SIP
revisions,\7\ and only to those portions of the submitted material
specified for approval in the preamble to that rulemaking. Today's
action corrects the regulatory text to reflect that portions of the
2007 AQMP were excluded from the 2011 approval, including a portion
applicable to the Coachella Valley that we are approving in today's
action, and does not affect the substance of our prior final action, 76
FR 69928 (November 9, 2011).
---------------------------------------------------------------------------

    \7\ See CARB Resolution 07-41 (September 27, 2007).
---------------------------------------------------------------------------

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must

submit a rule report, which includes a copy of the rule, to each House
of the Congress and to the Comptroller General of the United States.
The EPA will submit a report containing this action and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. A major rule cannot take effect until
60 days after it is published in the Federal Register. This action is
not a ``major rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by August 11, 2017. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

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

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

    Dated: April 20, 2017.
Alexis Strauss,
Acting Regional Administrator, Region IX.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart F--California

0
2. Section 52.220 is amended by revising paragraph (c)(398)(ii)(A)(1)
and adding paragraphs (c)(398)(ii)(A)(4) and (c)(486) to read as read
as follows:

Sec.  [thinsp]52.220  Identification of plan--in part.

* * * * *
    (c) * * *
    (398) * * *
    (ii) * * *
    (A) * * *
    (1) Final South Coast 2007 Air Quality Management Plan (excluding
those portions of Chapter 4 (``AQMP Control Strategy'') and Chapter 7
(``Implementation'') addressing District-recommended measures for
adoption by CARB and references to those measures (pp. 4-43 through 4-
54 and the section titled ``Recommended Mobile Source and Clean Fuel
Control Measures'' in table 7-3, pp. 7-8 and 7-9); those portions of
Chapter 6 (``Clean Air Act Requirements'') and Chapter 7
(``Implementation'') addressing California Clean Air Act Requirements
(pp. 6-13 through 6-22 and page 7-3); those portions of Chapter 4
(``AQMP Control Strategy'') addressing emission and risk reduction
goals identified in the AQMP's proposed control measure MOB-03
(``Proposed Backstop Measures for Indirect Sources of Emissions from
Ports and Port-Related Facilities'') (p. 4-24); the motor vehicle
emissions budgets in Chapter 6 (``Clean Air Act Requirements'') (pp. 6-
24 through 6-26), and Chapter 8 (``Future Air Quality--Desert
Nonattainment Areas'')), adopted on June 1, 2007.
* * * * *
    (4) Final South Coast 2007 Air Quality Management Plan, Chapter 8
(``Future Air Quality--Desert Nonattainment Areas'') (excluding pp. 8-
14 to 8-17 (regarding transportation conformity budgets)), adopted on
June 1, 2007.a
* * * * *
    (486) The following plan was submitted on November 6, 2014, by the
Governor's designee.
    (i) [Reserved]
    (ii) Additional materials. (A) California Air Resources Board.
    (1) California Air Resources Board, Staff Report, Proposed Updates
to the 1997 8-Hour Ozone Standard, State Implementation Plans;
Coachella Valley and Western Mojave Desert (excluding section III (pp.
8-12), Table A-2, Table B-2, Table C-2, the bottom row of Table E-1,
Table E-3 and accompanying discussion of Western Mojave Desert ROG
calculations on p. E-7, and Figure E-2 (regarding Western Mojave
Desert); Table B-3 (regarding contingency measures); and Appendix D
(regarding transportation conformity budgets)), adopted on October 24,
2014.

[FR Doc. 2017-12019 Filed 6-9-17; 8:45 am]
BILLING CODE 6560-50-P