Memorandum

November 29, 2018

To:		Docket EPA - HQ - OAR - 2018 - 0226
From: 		Wienke Tax, EPA Region 9, Air Planning Office
Subject: 	Consultation with Ewiiaapaayp Band of Kumeyaay Indians on Proposed Determinations of Attainment by the Attainment Date, Extensions of the Attainment Date, and Reclassification of Several Areas Classified as Moderate for the 2008 Ozone National Ambient Air Quality Standards (83 FR 56781, November 14, 2018)

Attendees:
Ewiiaapaayp Band: 	Will Micklin, Tribal CEO
EPA Region 9:	Amy Zimpfer, Air Division Associate Director
			Anita Lee, Air Planning Office
               Wienke Tax, Air Planning Office

At the request of the Ewiiaapaayp Band of Kumeyaay Indians ("Ewiiaapaayp Band") EPA held consultation with Will Micklin, CEO of the Ewiiaapaayp Band, on November 29, 2018, to discuss the EPA's proposal to reclassify the San Diego 2008 Ozone NAAQS nonattainment area from Moderate to Serious. EPA walked through the PowerPoint presentation (attached) and answered Mr. Micklin's questions related to the 5-factor analysis in determining boundaries for designation purposes. Mr. Micklin indicated the Ewiiaapaayp Band intends to submit comments on the proposed rule.

Attachment (Region 9 PowerPoint presentation)


[Federal Register: December 27, 2007 (Volume 72, Number 247)]
[Notices]
[Page 73388-73392]
[DOCID:fr27de07-105]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56985; File No. SR-NASDAQ-2007-098]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Order Granting Accelerated Approval of Proposed
Rule Change Relating to the Trading of Certain Securities Outside of
the Regular Market Session

December 18, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 7, 2007, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which items have been substantially prepared by the Exchange.
This order provides notice of and approves the proposed rule change on
an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to: (1) Amend NASDAQ Rules 4420(i), 4420(j),
and 4630 to permit the trading of Portfolio Depository Receipts, Index
Fund Shares, and Commodity-Related Securities (collectively, ``ETFs''),
respectively, during NASDAQ's Pre- and Post-Market Sessions; \3\ (2)
add new NASDAQ Rule 4631, which would require certain disclosures to be
made by members to their non-member customers prior to accepting orders
for trading as a result of the proposed extended trading hours for
ETFs; (3) allow certain ETFs currently approved for trading on the
Exchange pursuant to unlisted trading privileges (``UTP'') to trade
during NASDAQ's Pre- and Post-Market Sessions; and (4) make certain
technical, clarifying changes to NASDAQ Rules 4420(i) and 4420(j)
relating to the dissemination of the underlying index value with
respect to Non-US Component Stocks \4\ included in the index. The text
of the proposed rule change is available at the Exchange's principal
office, the Commission's Public Reference Room, and http://nasdaq.complinet.com
.

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    \3\ NASDAQ defines the Pre-Market Session as the trading session
that begins at 7 a.m. and continues until 9:30 a.m. The Post-Market
Session means the trading session that begins at 4 p.m. or 4:15 p.m.
and continues until 8 p.m. The Regular Market Session means the
trading session from 9:30 a.m. until 4 p.m. or 4:15 p.m. See NASDAQ
Rule 4120(b)(4).
    \4\ Non-US Component Stocks are equity securities that: (1) Are
not registered under Sections 12(a) or 12(g) of the Act (15 U.S.C.
78l(a) and 15 U.S. 78l(g)); (2) are issued by an entity that is not
organized, domiciled, or incorporated in the United States; and (3)
are issued by an entity that is an operating company (including Real
Estate Investment Trusts and income trusts, but excluding investment
trusts, unit trusts, mutual funds, and derivatives). See NASDAQ
Rules 4420(i)(1)(D) and 4420(j)(1)(D).
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

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

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

1. Purpose
    NASDAQ states that its members currently trade a wide variety of
ETFs on the Exchange pursuant to UTP in accordance with NASDAQ Rules
4420(i), 4420(j), and 4630 and has confined member trading in such ETFs
to only the Exchange's Regular Market Session. This trading restriction
is premised on the unavailability of an updated current index value
and/or Intraday Indicative Value \5\ during the Pre- and Post-Market
Sessions. Under the proposal, NASDAQ seeks to permit trading in ETFs
during the Pre-Market and Post-Market Sessions, provided that its
members provide non-members certain pre-trade disclosures prior to
accepting non-member orders in such ETFs. Accordingly, the Exchange
proposes to amend NASDAQ Rules 4420(i), 4420(j), and 4630 to allow
members to trade ETFs during all three Market Sessions and limit the
hours during which the dissemination of applicable current index values
and updated Intraday Indicative Values \6\ are required. Because the
applicable current

index values and updated Intraday Indicative Values may not be
available during the Pre- and Post-Market Sessions, the Exchange will
require such updated values to be disseminated only during the Regular
Market Session and the last computed index value and Intraday
Indicative Value to be disseminated when such values do not change.
Specifically with respect to NASDAQ Rule 4630, NASDAQ proposes to
clarify that all securities approved pursuant to this rule are eligible
for trading during all Exchange Market Sessions, provided that its
members provide non-member customers certain disclosures prior to
accepting non-member customer orders for execution in the Pre-Market
and Post-Market Sessions.
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    \5\ The Intraday Indicative Value is also sometimes referred to
as the Indicative Optimized Portfolio Value, the Indicative Fund
Value, the Indicative Trust Value, and the Indicative Partnership
Value, depending on the type of ETF being traded and the terminology
used.
    \6\ See NASDAQ Rules 4420(i)(3)(C) and 4420(j)(3)(C) (describing
the Intraday Indicative Value and its dissemination requirements).
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    NASDAQ proposes to add new Rule 4631, which would require Exchange
members to disclose to non-member customers the risks associated with
trading in the Pre-Market and Post-Market Sessions, including the lack
of dissemination of the applicable updated index value and the Intraday
Indicative Value for ETFs during such sessions. In particular, new
NASDAQ Rule 4631 will require members to disclose that, because the
Intraday Indicative Value is not calculated or widely disseminated
during the Pre-Market and Post-Market Sessions, an investor who is
unable to calculate an implied value for an ETF in those sessions may
be at a disadvantage to market professionals. The Exchange believes
that requiring members to disclose this risk to non-member customers
will facilitate informed participation in extended-hours trading.
NASDAQ notes that NYSE Arca, Inc. has amended its rules to similarly
allow for extended-hours trading in ETFs, as long as similar mandatory
disclosures are made by its members prior to accepting non-member
customer orders.\7\
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    \7\ See Securities Exchange Act Release Nos. 56625 (October 5,
2007), 72 FR 58144 (October 12, 2007) (SR-NYSEArca-2007-73)
(approving certain changes to the generic listing standards for
certain ETFs); 56270 (August 15, 2007), 72 FR 47109 (August 22,
2007) (SR-NYSEArca-2007-74) (requiring disclosure by members of
additional risks associated with trading ETFs during all trading
sessions); and 56627 (October 5, 2007), 72 FR 58145 (October 12,
2007) (SR-NYSEArca-2007-75) (approving extended trading hours for
certain ETFs).
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    The Exchange also proposes to make certain technical changes to
NASDAQ Rules 4420(i) and 4420(j) to make clear that, with respect to
Non-US Component Stocks that are included in an underlying combination
index, the impact on such combination index must be disseminated at
least every 60 seconds during the Regular Market Session. This proposed
change to NASDAQ Rules 4420(i) and 4420(j) corresponds to the
dissemination requirements for indexes based on Non-US Component
Stocks.
    In addition to amending NASDAQ Rules 4420(i), 4420(j), 4630 and
adding new NASDAQ Rule 4631, the Exchange proposes to permit the
trading of ETFs, previously approved by the Commission, during the Pre-
Market and Post-Market Sessions, subject to the mandatory disclosure
requirements proposed in new NASDAQ Rule 4631. Specifically, the
Exchange proposes that the following ETFs be eligible for trading
during the Pre-Market and Post-Market Sessions upon approval of the
proposed amendments to NASDAQ Rules 4420(i), 4420(j), 4630, and new
NASDAQ Rule 4631:
     iShares GSCI Commodity-Indexed Trust; \8\
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    \8\ See Securities Exchange Act Release No. 55861 (June 5,
2007), 72 FR 32153 (June 11, 2007) (SR-NASDAQ-2007-054).
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     the PowerShares DB Energy Fund; the PowerShares DB Oil
Fund; the PowerShares DB Precious Metals Fund; the PowerShares DB Gold
Fund; the PowerShares DB Silver Fund; the PowerShares DB Base Metals
Fund; and the PowerShares DB Agriculture Fund; \9\
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    \9\ See Securities Exchange Act Release No. 55862 (June 5,
2007), 72 FR 32380 (June 12, 2007) (SR-NASDAQ-2007-053).
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     United States Natural Gas Fund; \10\
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    \10\ See Securities Exchange Act Release No. 55781 (May 17,
2007), 72 FR 29191 (May 24, 2007) (SR-NASDAQ-2007-052).
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     PowerShares DB Commodity Index Tracking Fund; \11\
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    \11\ See Securities Exchange Act Release No. 55767 (May 15,
2007), 72 FR 28733 (May 22, 2007) (SR-NASDAQ-2007-051).
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     PowerShares DB G10 Currency Harvest Fund; \12\
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    \12\ See Securities Exchange Act Release No. 55739 (May 10,
2007), 72 FR 27885 (May 17, 2007) (SR-NASDAQ-2007-049).
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     Claymore MACROshares Oil Up Tradeable Shares and Claymore
MACROshares Oil Down Tradeable Shares; \13\
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    \13\ See Securities Exchange Act Release No. 55740 (May 10,
2007), 72 FR 27889 (May 17, 2007) (SR-NASDAQ-2007-048).
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     iPath Exchange-Traded Notes Linked to the Performance of
the GSCI Total Return Index; iPath Exchange-Traded Notes Linked to the
Performance of the Dow Jones--AIG Commodity Index Total Return; and
iPath Exchange Traded Notes Linked to the Performance of the Goldman
Sachs Crude Oil Total Return Index; \14\
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    \14\ See Securities Exchange Act Release No. 55760 (May 15,
2007), 72 FR 28736 (May 22, 2007) (SR-NASDAQ-2007-046).
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     United States Oil Fund, LP; \15\
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    \15\ See Securities Exchange Act Release No. 55761 (May 15,
2007), 72 FR 28739 (May 22, 2007) (SR-NASDAQ-2007-045).
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     PowerShares DB U.S. Dollar Index Bullish Fund and
PowerShares DB U.S. Dollar Index Bearish Fund; \16\
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    \16\ See Securities Exchange Act Release No. 55489 (March 19,
2007), 72 FR 13843 (March 23, 2007) (SR-NASDAQ-2007-023).
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     iShares Silver Trust; \17\
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    \17\ See Securities Exchange Act Release No. 55385 (March 2,
2007), 72 FR 10797 (March 9, 2007) (SR-NASDAQ-2007-018).
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     iShares COMEX Gold Trust; \18\
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    \18\ See Securities Exchange Act Release No. 55380 (March 1,
2007), 72 FR 10280 (March 7, 2007) (SR-NASDAQ-2007-014).
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     Four Ultra Funds listed and traded on the American Stock
Exchange LLC (``Amex'') pursuant to Commission order on May 10, 2006:
(1) Ultra S&P 500; (2) Ultra Nasdaq-100; (3) Ultra Dow 30; and (4)
Ultra S&P MidCap 400; and 27 Ultra Funds listed and traded on Amex
pursuant to Commission order on January 17, 2007: (1) Ultra Russell
2000; (2) Ultra S&P SmallCap 600; (3) Ultra S&P500/Citigroup Value; (4)
Ultra S&P500/Citigroup Growth; (5) Ultra S&P MidCap 400/Citigroup
Value; (6) Ultra S&P MidCap 400/Citigroup Growth; (7) Ultra S&P
SmallCap 600/Citigroup Value; (8) Ultra S&P SmallCap600/Citigroup
Growth; (9) Ultra Basic Materials; (10) Ultra Consumer Goods; (11)
Ultra Consumer Services; (12) Ultra Financials; (13) Ultra Health Care;
(14) Ultra Industrials; (15) Ultra Oil & Gas; (16) Ultra Real Estate;
(17) Ultra Semiconductors; (18) Ultra Technology; (19) Ultra Utilities;
(20) Ultra Russell Midcap Index; (21) Ultra Russell Midcap Growth
Index; (22) Ultra Russell Midcap Value Index; (23) Ultra Russell 1000
Index; (24) Ultra Russell 1000 Growth Index; (25) Ultra Russell 1000
Value Index; (26) Ultra Russell 2000 Growth Index; and (27) Ultra
Russell 2000 Value Index; \19\
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    \19\ See Securities Exchange Act Release No. 55353 (February 26,
2007), 72 FR 9802 (March 5, 2007) (SR-NASDAQ-2007-011).
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     Four Short Funds listed and traded on Amex pursuant to
Commission order on May 10, 2006: (1) Short S&P 500; (2) Short Nasdaq-
100; (3) Short Dow 30; and (4) Short S&P MidCap 400; and 27 Short Funds
listed and traded on Amex pursuant to Commission order on January 17,
2007: (1) Short Russell 2000; (2) Short S&P SmallCap 600; (3) Short
S&P500/Citigroup Value; (4) Short S&P500/Citigroup Growth; (5) Short
S&P MidCap 400/Citigroup Value; (6) Short S&P MidCap 400/Citigroup
Growth; (7) Short S&P SmallCap 600/Citigroup Value; (8) Short S&P
SmallCap 600/Citigroup Growth; (9) Short Basic Materials; (10) Short

Consumer Goods; (11) Short Consumer Services; (12) Short Financials;
(13) Short Health Care; (14) Short Industrials; (15) Short Oil & Gas;
(16) Short Real Estate; (17) Short Semiconductors; (18) Short
Technology; (19) Short Utilities; (20) Short Russell Midcap Index; (21)
Short Russell Midcap Growth Index; (22) Short Russell Midcap Value
Index; (23) Short Russell 1000 Index; (24) Short Russell 1000 Growth
Index; (25) Short Russell 1000 Value Index; (26) Short Russell 2000
Growth Index; and (27) Short Russell 2000 Value Index; \20\
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    \20\ See id.
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     Four UltraShort Funds listed and traded on Amex pursuant
to Commission order on June 23, 2006: (1) UltraShort S&P 500; (2)
UltraShort Nasdaq-100; (3) UltraShort Dow 30; and (4) UltraShort S&P
MidCap 400; and 27 UltraShort funds listed and traded on Amex pursuant
to Commission order on January 17, 2007: (1) UltraShort Russell 2000;
(2) UltraShort S&P SmallCap 600; (3) UltraShort S&P500/Citigroup Value;
(4) UltraShort S&P500/Citigroup Growth; (5) UltraShort S&P MidCap 400/
Citigroup Value; (6) UltraShort S&P MidCap 400/Citigroup Growth; (7)
UltraShort S&P SmallCap 600/Citigroup Value; (8) UltraShort S&P
SmallCap 600/Citigroup Growth; (9) UltraShort Basic Materials; (10)
UltraShort Consumer Goods; (11) UltraShort Consumer Services; (12)
UltraShort Financials; (13) UltraShort Health Care; (14) UltraShort
Industrials; (15) UltraShort Oil & Gas; (16) UltraShort Real Estate;
(17) UltraShort Semiconductors; (18) UltraShort Technology; (19)
UltraShort Utilities; (20) UltraShort Russell Midcap Index; (21)
UltraShort Russell Midcap Growth Index; (22) UltraShort Russell Midcap
Value Index; (23) UltraShort Russell 1000 Index; (24) UltraShort
Russell 1000 Growth Index; (25) UltraShort Russell 1000 Value Index;
(26) UltraShort Russell 2000 Growth Index; and (27) UltraShort Russell
2000 Value Index; \21\
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    \21\ See id.
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     iShares Lehman TIPS Bond Fund; iShares Lehman Aggregate
Bond Fund; iShares iBoxx $ Investment Grade Corporate Bond Fund;
iShares Lehman 20+ Year Treasury Bond Fund; iShares 7-10 Year Treasury
Bond Fund; iShares Lehman 1-3 Year Treasury Bond Fund; iShares Lehman
Short Treasury Bond Fund; iShares Lehman 3-7 Year Treasury Bond Fund;
iShares Lehman 10-20 Year Treasury Bond Fund; iShares Lehman 1-3 Year
Credit Bond Fund; iShares Lehman Intermediate Credit Bond Fund; iShares
Lehman Credit Bond Fund; iShares Lehman Intermediate Government/Credit
Bond Fund; and iShares Lehman Government/Credit Bond Fund; \22\ and
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    \22\ See Securities Exchange Act Release No. 55300 (February 15,
2007), 72 FR 8227 (February 23, 2007) (SR-NASDAQ-2007-002).
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     CurrencyShares\TM\ Australian Dollar Trust that issues
Australian Dollar Shares; CurrencyShares\TM\ British Pound Sterling
Trust that issues British Pound Sterling Shares; CurrencyShares\TM\
Canadian Dollar Trust that issues Canadian Dollar Shares;
CurrencyShares\TM\ Euro Trust that issues Euro Shares;
CurrencyShares\TM\ Japanese Yen Trust that issues Japanese Yen Shares;
CurrencyShares\TM\ Mexican Peso Trust that issues Mexican Peso Shares;
CurrencyShares\TM\ Swedish Krona Trust that issues Swedish Krona
Shares; and CurrencyShares\TM\ Swiss Franc Trust that issues Swiss
Franc Shares.\23\
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    \23\ See Securities Exchange Act Release No. 55344 (February 23,
2007), 72 FR 9799 (March 5, 2007) (SR-NASDAQ-2006-057).
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    In support of this proposed rule change, the Exchange states that
the representations in the Commission approval orders for the foregoing
ETFs continue to apply and would be applicable to trading during all
three trading sessions on NASDAQ. Specifically, the Exchange makes the
following representations:
    1. The Exchange has appropriate rules to facilitate transactions in
shares of the above ETFs during all trading sessions. The Exchange
deems such shares to be equity securities, thus rendering trading in
such shares subject to NASDAQ's existing rules governing the trading of
equity securities.
    2. NASDAQ's surveillance procedures are adequate to properly
monitor trading of shares of the above ETFs in all trading
sessions.\24\
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    \24\ NASDAQ states that it may obtain information via the
Intermarket Surveillance Group (``ISG'') from other exchanges that
are members or affiliate members of ISG. In addition, as referenced
in the applicable Commission approval orders, NASDAQ has in place
information sharing agreements with the relevant exchange(s).
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    3. NASDAQ has distributed an Information Circular to members prior
to the commencement of trading of the shares of the above ETFs on the
Exchange that explains the terms, characteristics, and risks of trading
such shares.
    4. NASDAQ will require members with a customer who purchases newly-
issued shares of the above ETFs in any trading session on the Exchange
to provide that customer with a product description, if available, or a
prospectus, and has noted this delivery requirement in the Information
Circular.
    5. When NASDAQ is the UTP trading market, NASDAQ will cease trading
in the shares of ETFs during all trading sessions if (a) the listing
market stops trading such shares, or (b) the listing market delists
such shares. Additionally, NASDAQ may cease trading the shares if such
other event shall occur or condition exists which, in the opinion of
the Exchange, makes further dealings on NASDAQ inadvisable. UTP trading
in the shares of ETFs is also governed by the trading halt provisions
of NASDAQ Rules 4120 and 4121.
    6. When NASDAQ is the listing market, NASDAQ may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the shares of an ETF. Trading may be halted because of
market conditions or for reasons that, in the view of the Exchange,
make trading in the shares inadvisable. Factors for consideration may
include (a) the extent to which trading is not occurring in the
securities or other instruments underlying an ETF, or (b) whether other
unusual conditions or circumstances detrimental to the maintenance of a
fair and orderly market are present. In addition, trading in the shares
of listed ETFs are subject to trading halts caused by extraordinary
market volatility pursuant to NASDAQ's ``circuit breaker'' rule (NASDAQ
Rule 4121) or by the halt or suspension of trading of the underlying
securities or other instruments underlying an ETF. If the Intraday
Indicative Value or the index value applicable to a series of shares is
not being disseminated as required, the Exchange may halt trading
during the day in which the interruption to the dissemination of the
Intraday Indicative Value or the index value occurs. If the
interruption to the dissemination of the Intraday Indicative Value or
the index value persists past the trading day in which it occurred, the
Exchange will halt trading no later than the beginning of the trading
day following the interruption.
    7. The Intraday Indicative Value and/or index value (or value of
the underlying asset or instrument, if not an index) will continue to
be disseminated during all three trading sessions, as reflected in the
relevant proposed rule changes filed by the Exchange and approved by
the Commission.
    NASDAQ intends to distribute to its members and make available on
its Web site at http://www.nasdaqtrader.com a Regulatory Alert titled

``Exchange-Traded Funds--Extended Trading Hours'' that discloses, among
other things: (1) That the current underlying index value and Intraday
Indicative Value may not be updated during the

Pre-Market and Post-Market Sessions; (2) that commodity and currency
spot prices are available during the Regular Market Session, and
commodity and currency futures prices generally will not be available
during the Pre-Market and Post-Market Sessions; \25\ (3) that lower
liquidity in the Pre-Market and Post-Market Sessions may impact
pricing; (4) that higher volatility in the Pre-Market and Post-Market
Sessions may impact pricing; (5) that wider spreads may occur in the
Pre-Market and Post-Market Sessions; (6) the circumstances that trigger
trading halts; (7) required customer disclosures; \26\ and (8)
suitability requirements.
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    \25\ Nasdaq states that, in certain cases, the futures or
options markets for a particular commodity may be closed during part
of the Regular Market Session, and the Intraday Indicative Value
would be static for that particular future or options price, but
widely disseminated. In addition, the prices of certain futures
contracts in commodities (e.g., gold) and currencies are available
on a 24-hour basis.
    \26\ See proposed NASDAQ Rule 4631.
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    The Exchange believes that, with this additional disclosure, it is
appropriate to permit trading during all three of NASDAQ's trading
sessions, notwithstanding the absence of a disseminated updated index
value or Intraday Indicative Value during all or part of NASDAQ's
trading hours. In addition, NASDAQ notes that, if the official index
value does not change during some or all of the period when trading is
occurring on the Exchange (for example, because of time zone
differences or holidays in countries where the index component stocks
trade), then the last calculated official index value must remain
available throughout NASDAQ trading hours. Similarly, if the Intraday
Indicative Value does not change during any portion of NASDAQ trading
hours, then the last official calculated Intraday Indicative Value must
remain available throughout NASDAQ trading hours.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with section 6(b) of the Act,\27\ in general, and furthers the
objectives of section 6(b)(5) of the Act,\28\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices;
to promote just and equitable principles of trade; to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities; to remove impediments to and
perfect the mechanism of a free and open market and a national market
system; and, in general, to protect investors and the public interest.
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    \27\ 15 U.S.C. 78f(b).
    \28\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is 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

    Written comments on the proposed rule change were neither solicited
nor received.

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send e-mail to<EMAIL_ADDRESS>Please include File

Number SR-NASDAQ-2007-098 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2007-098. 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 inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File number SR-NASDAQ-2007-098 and should
be submitted on or before January 17, 2008.

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

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\29\ In particular, the Commission finds that the proposed
rule change is consistent with section 6(b)(5) of the Act,\30\ which
requires, among other things, that the rules of a national securities
exchange be designed to promote just and equitable principles of trade;
to foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect to,
and facilitating transactions in securities; to remove impediments to
and perfect the mechanism of a free and open market and a national
market system; and, in general, to protect investors and the public
interest.
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    \29\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \30\ 15 U.S.C. 78f(b)(5).
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    The Commission believes that the proposal reasonably balances the
removal of impediments to a free and open market with the protection of
investors and the public interest, two principles set forth in section
6(b)(5) of the Act. Trading during extended hours carries more risks
than during regular business hours. With ETFs in particular, customers
who trade when a fund's Intraday Indicative Value is not calculated and
publicly disseminated may be at a disadvantage to professional traders
who have their own means of calculating a reliable estimate of the
fund's net asset value or ``NAV.'' The Exchange has represented that it
will distribute to its members a Regulatory Alert that discusses this
particular risk and other risks of trading ETFs outside of the Regular
Market Session. In view of these additional disclosures, the Commission
believes it is reasonable and consistent with the Act for the Exchange
to extend the trading hours of

the ETFs in the manner described in this proposal.
    The Commission finds good cause for approving the proposed rule
change before the 30th day after the date of publication of notice of
filing thereof in the Federal Register. The Commission notes that it
has previously approved similar proposals made by another national
securities exchange.\31\ Those proposals were subject to full notice-
and-comment periods before Commission action, and no comments were
received. The Commission presently is not aware of any regulatory issue
that should cause it to revisit those findings or should preclude the
extension of trading hours of the ETFs on the Exchange. Therefore, the
Commission believes that accelerating approval of this proposal is
reasonable.
---------------------------------------------------------------------------

    \31\ See Securities Exchange Act Release Nos. 56625 (October 5,
2007), 72 FR 58144 (October 12, 2007) (SR-NYSEArca-2007-73)
(approving certain changes made to the generic listing standards for
certain ETFs) and 56627 (October 5, 2007), 72 FR 58145 (October 12,
2007) (SR-NYSEArca-2007-75) (approving extended trading hours for
certain ETFs).
---------------------------------------------------------------------------

V. Conclusion

    IT IS THEREFORE ORDERED, pursuant to section 19(b)(2) of the
Act,\32\ that the proposed rule change (SR-NASDAQ-2007-098) be, and it
hereby is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \32\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\33\
---------------------------------------------------------------------------

    \33\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-24989 Filed 12-26-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 226 (Friday, November 25, 2022)]
[Rules and Regulations]
[Pages 72381-72382]
[FR Doc No: 2022-25639]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31457; Amdt. No. 4034]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures for operations at certain airports. These
regulatory actions are needed because of the adoption of new or revised
criteria, or because of changes occurring in the National Airspace
System, such as the commissioning of new navigational facilities,
adding new obstacles, or changing air traffic requirements. These
changes are designed to provide for the safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective November 25, 2022. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of November 25, 2022.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Information Services, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA).
    For information on the availability of this material at NARA, email
[email protected] or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center online at nfdc.faa.gov
to register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg 29 Room 104, Oklahoma
City, OK 73169. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends 14 CFR part 97 by amending
the referenced SIAPs. The complete regulatory description of each SIAP
is listed on the appropriate FAA Form 8260, as modified by the National
Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is
incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14
CFR 97.20. The large number of SIAPs, their complex nature, and the
need for a special format make their verbatim publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, but refer to their graphic depiction
on charts printed by publishers of aeronautical materials. Thus, the
advantages of incorporation by reference are realized and publication
of the complete description of each SIAP contained on FAA form
documents is unnecessary. This amendment provides the affected CFR
sections, and specifies the SIAPs and Takeoff Minimums and ODPs with
their applicable effective dates. This amendment also identifies the
airport and its location, the procedure and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPs, Takeoff

Minimums and ODPs as identified in the amendatory language for Part 97
of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on criteria
contained in the U.S. Standard for Terminal Instrument Procedures
(TERPS). In developing these changes to SIAPs and Takeoff Minimums and
ODPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    Because of the close and immediate relationship between these
SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on October 28, 2022.
Thomas J Nichols,
Aviation Safety, Flight Standards Service Manager, Standards Section,
Flight Procedures & Airspace Group, Flight Technologies & Procedures
Division.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, 14 CFR part
97 is amended by amending Standard Instrument Approach Procedures and
Takeoff Minimums and ODPs, effective at 0901 UTC on the dates
specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
      AIRAC date           State             City                 Airport          FDC No.      FDC date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
1-Dec-22..............  MT           Great Falls.........  Great Falls Intl....       2/0727      10/4/22  This NOTAM, published in Docket No. 31455,
                                                                                Amdt No. 4032, TL 22-25, (87 FR 68628,
                                                                                November 16, 2022) is hereby rescinded in
                                                                                its entirety.
1-Dec-22..............  IA           Vinton..............  Vinton Veterans Meml       2/2320      9/26/22  This NOTAM, published in Docket No. 31455,
                                                            Airpark.                                        Amdt No. 4032, TL 22-25, (87 FR 68628,
                                                                                November 16, 2022) is hereby rescinded in
                                                                                its entirety.
1-Dec-22..............  NC           Hickory.............  Hickory Rgnl........       2/0446     10/17/22  RNAV (GPS) RWY 24, Amdt 1C.
1-Dec-22..............  NC           Hickory.............  Hickory Rgnl........       2/0447     10/17/22  RNAV (GPS) RWY 6, Amdt 1B.
1-Dec-22..............  MT           Great Falls.........  Great Falls Intl....       2/3449     10/18/22  RNAV (RNP) Z RWY 3, Orig-C.
1-Dec-22..............  FL           West Palm Beach.....  Palm Beach Intl.....       2/3490     10/24/22  RNAV (RNP) Z RWY 10L, Amdt 2.
1-Dec-22..............  PR           San Juan............  Luis Munoz Marin           2/9138     10/17/22  VOR OR TACAN RWY 10, Amdt 2B.
                                                            Intl.
1-Dec-22..............  OR           Grants Pass.........  Grants Pass.........       2/9326     10/17/22  RNAV (GPS) RWY 13, Amdt 1.
1-Dec-22..............  OR           Grants Pass.........  Grants Pass.........       2/9327     10/17/22  RNAV (GPS)-A, Orig-A.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2022-25639 Filed 11-23-22; 8:45 a.m.]
BILLING CODE 4910-13-P


[Federal Register: February 1, 2010 (Volume 75, Number 20)]
[Notices]
[Page 5071-5072]
[DOCID:fr01fe10-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Project No. 13636-000, Project No. 13637-000, Project No. 13650-000]

Mississippi L&D 21, LLC, Mississippi River No. 21 Hydropower
Company Lock + \TM\ Hydro Friends Fund XXXII, LLC; Notice of
Preliminary Permit Applications Accepted for Filing and Soliciting
Comments, Motions To Intervene, and Competing Applications

January 22, 2010.
    On December 1, 2009, Mississippi L&D 21, LLC (Mississippi LLC)
filed an application for a preliminary permit for the proposed
Mississippi River Lock and Dam No. 21 Hydroelectric Project No. 13636.
On December 2, 2009, Mississippi River No. 21 Hydropower Company
(Hydropower Company) filed an application for a preliminary permit for
the proposed Mississippi River No. 21 Hydropower Project No. 13637. On
January 8, 2010, Lock + TM Hydro Friends Fund XXXII, LLC
(Lock + Hydro) filed an application for a preliminary permit for the
proposed Hulk Project No. 13650. The permit applications were filed
pursuant to section 4(f) of the Federal Power Act (FPA), proposing to
study the feasibility of the projects, to be located on the Mississippi
River, in Adams County, Illinois, and Marion County, Missouri. The
projects would be located at the existing Mississippi River Lock and
Dam No. 21 owned and operated by the U.S. Corps of Engineers that
includes a reservoir, a lock and dam equipped with

roller and tainter gates, and an earth dike.
    Mississippi LLC's proposed project would consist of: (1) A new 75-
foot-wide by 150-foot-long powerhouse located adjacent to the earth
dike containing four 13-megawatt (MW) turbine generating units with a
total capacity of 52 MW; (2) a new 6.8-mile-long, 136-kilovolt (kV)
transmission line; and (3) appurtenant facilities. The project would
produce an estimated average annual generation of 199,600 megawatt-
hours.
    Mississippi LLC Contact: Mr. Brent Smith, CCO, Symbiotics, LLC,
P.O. Box 535, Rigby, Idaho 83442,<PHONE_NUMBER>.
    Hydropower Company's proposed project would consist of: (1) A new
66-foot-wide by 800-foot-long powerhouse located adjacent to the earth
dike containing thirty 500-kilowatt turbine generating units with a
total capacity of 15 MW; (2) either a new 1.57-mile-long, 69-kV
transmission line located in Missouri, a new 0.5-mile-long, 34.5-kV
transmission line, or a new 1.5-mile-long, 34.5-kV transmission line
located in Illinois; and (3) appurtenant facilities. The project would
produce an estimated average annual generation of 71,400 megawatt-
hours.
    Hydropower Company Contact: Mr. John Spring, President, Mississippi
River No. 21 Hydropower Company, 730 Maine Street, Quincy, Illinois
62301,<PHONE_NUMBER>.
    Lock + Hydro's proposed project would consist of: (1) Two new
underwater frame modules located adjacent to the earth dike each
containing nine turbine generating units with a total capacity of about
9.45 megawatts; (2) a new 220-foot, 450-foot-long intake conduit; (3) a
new 220-foot-wide, 50-foot-long tailrace; and (4) a new 3-mile-long, 69
kilovolt transmission line. The project would produce an estimated
average annual generation of about 61,129 megawatt-hours.
    Lock + Hydro Contact: Wayne F. Krouse, Chairman and CEO, Hydro
Green Energy, LLC, 5090 Richmond Avenue, Suite 290, Houston, TX 77056,
(877) 556-6566.
    FERC Contact: Tom Dean,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``eFiling'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of the Commission's Web site at http:/
/ www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13636, 13637, or 13650) in the docket number field to access the
document. For assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-1982 Filed 1-29-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 6, 2008 (Volume 73, Number 45)]
[Notices]
[Page 12169-12170]
[DOCID:fr06mr08-59]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-1065; FRL-8351-3]

Experimental Use Permit; Receipt of Application

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of an application 71049-EUP-U
from KIM-CI, LLC requesting an experimental use permit (EUP) for the
plant growth regulator Forchlorfenuron (CPPU). The Agency has
determined that the application may be of regional and national
significance. Therefore, in accordance with 40 CFR 172.11(a), the
Agency is soliciting comments on this application.

DATES: Comments must be received on or before April 7, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-1065, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-1065. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Tawanda Maignan, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to those persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA) or the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). Since other entities may also be interested,
the Agency has not attempted to describe all the specific entities that
may be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in

accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

    KIM-C1, LLC, 135 W. Shaw, Suite 102, Fresno, CA 93704, has
submitted an application for an EUP and Temporary Tolerance for plant
growth regulator CPPU, on six crops (almonds, cherry, fig, pear,
pistachio, and plum/prune) to permit experimental use under semi-
commercial conditions, which will include collection of additional
residue data where necessary. The application proposes use in four
states (California, Idaho, Oregon, and Washington) on less than 2,000
total acres for a major use; i.e., almonds and nearly 100 total acres
for minor crops, i.e., cherry, fig, pear, pistachio, and plum/prune
during the first year. KIM-CI proposes to initiate applications in
April 2008 to facilitate three full years of data collection.

III. What Action is the Agency Taking?

    Following the review of the KIM-CI application and any comments and
data received in response to this notice, EPA will decide whether to
issue or deny the EUP request for this EUP program, and if issued, the
conditions under which it is to be conducted. Any issuance of an EUP
will be announced in the Federal Register.

IV. What is the Agency's Authority for Taking this Action?

    The Agency's authority for taking this action is under FIFRA
section 5.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: February 26, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. E8-4355 Filed 3-5-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 80, Number 24 (Thursday, February 5, 2015)]
[Notices]
[Pages 6510-6511]
[FR Doc No: 2015-02293]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD15-5-000]

Available Transfer Capability Standards for Wholesale Electric
Transmission Services; Supplemental Notice of Workshop on Available
Transfer Capability Standards

    As announced in a Notice issued on December 30, 2014, the Federal
Energy Regulatory Commission (Commission) staff will hold a workshop on
Thursday, March 5, 2015 to discuss standards for calculating Available
Transfer Capability (ATC) for wholesale electric transmission services.
The workshop will be held in the Commission Meeting Room at the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426. It will commence at 8:45 a.m. and conclude at 4:15 p.m. This
workshop is free of charge and open to the public. Commission members
may participate in the workshop.
    The agenda for this workshop is attached.
    Those who plan to attend the workshop are encouraged to complete
the registration form located at: https://www.ferc.gov/whats-new/registration/03-05-15-form.asp. There is no registration deadline.
    Those wishing to participate in the technical sessions should
submit nominations no later than close of business on February 6, 2015
online at: https://www.ferc.gov/whats-new/registration/03-05-15-speaker-form.asp.
    Transcripts of the workshop will be available for a fee from Ace-
Federal Reporters, Inc.<PHONE_NUMBER> or 1-800-336-6646). Additionally,
there will be a free Webcast of the workshop. The Webcast will allow
persons to listen to the workshop but not participate. Anyone with
Internet access who wants to listen to the workshop can do so by
navigating to the Calendar of Events at www.ferc.gov, locating the
technical workshop in the Calendar, and clicking on the Webcast link.
The Capitol Connection provides technical support for the Webcast and
offers the option of listening to the workshop via phone-bridge for a
fee. If you have any questions, visit www.CapitolConnection.org or call
703-993-3100.
    While this workshop is not convened for the purpose of discussing
specific cases, the workshop may address matters that are at issue in
the following pending Commission proceeding: North American Electric
Reliability Corporation, Docket No. RM14-7-000.
    Commission workshops are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For further information on this workshop, please contact:

Logistical Information

    Sarah McKinley, Office of External Affairs, Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426,
(202) 502-8368<EMAIL_ADDRESS>
Technical Information

    Christopher Young, Office of Energy Policy and Innovation, Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426,<PHONE_NUMBER><EMAIL_ADDRESS>
Legal Information

    Richard Wartchow, Office of the General Counsel, Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426,
(202) 502-8744<EMAIL_ADDRESS>
    Dated: January 30, 2015.
Kimberly D. Bose,
Secretary.

Available Transfer Capability Standards for Wholesale Electric
Transmission Services

Staff-Led Workshop

Docket No.: AD15-5-000; March 5, 2015; Agenda
    This workshop is being convened to discuss actions the Commission
could take to ensure that transmission providers continue to calculate
and post available transfer capability (ATC) in a manner that ensures
nondiscriminatory access to wholesale electric transmission services.
This workshop is prompted by the filing by the North American Electric
Reliability Corporation (NERC) proposing changes to its ATC-related
reliability standards,\1\ and the initiative to replace some of these
standards with similarly focused business practice standards to be
developed by the North American Energy Standards Board (NAESB).\2\
---------------------------------------------------------------------------

    \1\ NERC's proposal is currently pending before the Commission
in the rulemaking: Modeling, Data, and Analysis Reliability
Standards, Notice of Proposed Rulemaking, Docket No. RM14-7-000; 79
FR 36,269 (June 26, 2014).
    \2\ See, e.g., the December 18, 2014 status report filed by
NAESB in Docket Nos. RM05-5-000 and RM14-7-000.
---------------------------------------------------------------------------

    The workshop will address the consistent calculation and
transparency of ATC to ensure continued access to the grid by
transmission customers on a nondiscriminatory basis, as articulated in
Order No. 890 and other Commission orders.\3\ In Order No. 890, the
Commission required public utilities to work through NERC to develop
consistent methodologies for ATC calculation.\4\ In Order No. 693,\5\
the Commission approved several reliability standards related to ATC
while also directing NERC to prospectively modify them.\6\ In Order No.
729, the Commission approved six reliability standards that address
ATC, making them mandatory and enforceable; concurrently the Commission
issued Order No. 676-E, which incorporated by reference in its
regulations certain related business practice standards adopted by the
Wholesale Electric Quadrant of NAESB.\7\ Subsequently, NERC has
proposed to retire six standards and replace them with a single
modified standard focused on reliability issues.\8\ At the workshop,
Commission staff will seek input on the appropriate mechanisms to
ensure the continued transparency and consistency

of ATC calculation methodologies, and posting of ATC on OASIS.
---------------------------------------------------------------------------

    \3\ See, e.g.; Preventing Undue Discrimination and Preference in
Transmission Service, Order No. 890, FERC Stats. & Regs. ] 31,241,
at P 68, order on reh'g, Order No. 890-A, FERC Stats. & Regs. ]
31,261 (2007), order on reh'g, Order No. 890-B, 123 FERC ] 61,299
(2008), order on reh'g, Order No. 890-C, 126 FERC ] 61,228, order on
clarification, Order No. 890-D, 129 FERC ] 61,126 (2009); Mandatory
Reliability Standards for the Calculation of Available Transfer
Capability, Capacity Benefit Margins, Transmission Reliability
Margins, Total Transfer Capability, and Existing Transmission
Commitments and Mandatory Reliability Standards for the Bulk-Power
System, Order No. 729, 129 FERC ] 61,155 (2009), order on
clarification, Order No. 729-A, 131 FERC ] 61,109 (2010), order on
reh'g, Order No. 729-B, 132 FERC ] 61,027 (2010); et al.
    \4\ See Order No. 890 (supra) P 2, P 193-196, etc.
    \5\ Mandatory Reliability Standards for the Bulk-Power System,
Order No. 693, 72 FR 16416 (Apr. 4, 2007), FERC Stats. & Regs. ]
31,242, at P 1022 (2007), order on reh'g, Order No. 693-A, 120 FERC
] 61,053 (2007), P 1013.
    \6\ See Order No. 693 (supra).
    \7\ 129 FERC ] 61,162
    \8\ Modeling, Data, and Analysis Reliability Standards, Notice
of Proposed Rulemaking, 147 FERC ] 61,208 (2014).
---------------------------------------------------------------------------

8:45 a.m.-9:00 a.m. Welcome and Opening Remarks
9:00 a.m.-10:30 a.m. Session 1: Overview and Context of ATC
Determination and Posting
    Session 1 will explore the role of consistent and transparent ATC
determination and posting in ensuring open access to the interstate
transmission system. The goal of the session will be to understand the
types of high-level decisions that need to be made to develop ATC
standards and discuss the proper venue for making those high-level
decisions. Participants should address, among other things: (1) The
extent to which the currently-effective standards have proven effective
for meeting the needs of the industry and the Commission, (2) in
general, whether the ATC information currently available to
transmission customers is sufficient and sufficiently transparent, (3)
the appropriate level of detail or specificity necessary for any rules
or standards to ensure transparency and consistency and the elimination
of transmission provider discretion in this highly technical topic
area, and (4) the appropriate administrative mechanism or form of any
rules needed to continue to achieve these goals. Participants may also
be asked to discuss how to distinguish reliability concerns from
requirements necessary to maintain the open access assurances required
in Order Nos. 890 and 729. Further, participants may be asked to
discuss the appropriate forum for identifying any gaps or areas of
ambiguity in Order Nos. 890 and 729 that should be clarified with
respect to ATC. Finally, considering that accurate ATC determination is
important to the ultimate assurance of consistency and transparency and
to minimize the discretion of transmission providers in calculating
ATC, the session may address which aspects of any rules addressing ATC,
such as requirements regarding calculations, data inputs or frequency
of updates, among other possible examples, are most important for the
Commission to consider.
10:30 a.m.-10:45 a.m. Break
10:45 a.m.-12:15 p.m. Session 2: Specific ATC Topics and Requirements
    Session 2 will address specific details of ATC, its constituent
parts, and related concepts and the degree to which the Commission
should include in the pro forma OATT or the Commission's regulations
requirements addressing these details. For example, staff may seek
information about the level of detail required in the ``ATC
Implementation Document'' (ATCID) to ensure transparency, the
relationship between a transmission provider's planning of operations
and the calculation of Total Transfer Capability (TTC) or ATC for the
same time periods, and the computation and use of Capacity Benefit
Margin and Transmission Reliability Margin. Possible discussion items
could also include the determination of TTC and Existing Transmission
Commitments (ETC), the requirements in the three existing
``methodology'' standards (Area Interchange Methodology, Rated System
Path Methodology, and Flowgate Methodology) that establish a basis for
determining the TTC and ETC components of ATC, the interrelationship
between the NERC ``MOD A'' standards and other reliability standards,
NAESB business practice standards, and the Commission's regulations and
the possible need for information sharing between and among
transmission providers and other entities. For each of the discussion
items, participants may be asked to indicate whether formal Commission
guidance, in the form of pro forma OATT requirements or new regulations
would help to ensure that goals of Order Nos. 890 and 729 are met.
12:15 p.m.-1:15 p.m. Lunch
1:15 p.m.-2:15 p.m. Session 2, Continued
2:15 p.m.-2:30 p.m. Break
2:30 p.m.-4:00 p.m. Session 3: Lessons Learned and Opportunities for
Improvement
    Session 3, in light of NERC's proposal and NAESB efforts to revise
standards for ATC calculations and transparency, will explore what
types of changes, if any, need to be taken by NERC, NAESB and/or the
Commission to ensure that transmission providers continue to calculate
and post ATC in a manner that ensures nondiscriminatory access to
wholesale electric transmission services. This session will synthesize
the discussion from the first two sessions to explore whether there are
changes needed, and the level of detail or guidance needed, in the
Commission's regulations or the pro forma Open Access Transmission
Tariff. Time permitting, there may be a discussion of whether there are
opportunities to apply industry's experience to date, including
potential areas for improvement that could enhance the consistency of
the three existing calculation methods, and whether the rules
addressing ATC could be made more efficient, clear or easier to comply
with than they currently are, without compromising open access.
4:00 p.m.-4:15 p.m. Closing
[FR Doc. 2015-02293 Filed 2-4-15; 8:45 a.m.]
BILLING CODE 6717-01-P


[Federal Register: October 17, 2006 (Volume 71, Number 200)]
[Notices]
[Page 61043-61044]
[DOCID:fr17oc06-92]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

October 10, 2006.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER96-780-015; ER01-1633-004; ER00-3240-007; ER03-
1383-007.
    Applicants: Southern Company Services, Inc.; Southern Company-
Florida LLC; Oleander Power Project, L.P.; DeSoto County Generating
Company, LLC.
    Description: Southern Company Services, Inc. on behalf of Alabama
Power Co. et al. submits a notice of non-material change in status
regarding the characteristics that FERC previously authorized to
transact market-base rates.
    Filed Date: 10/02/2006.
    Accession Number: 20061006-0026.
    Comment Date: 5 p.m. Eastern Time on Monday, October 23, 2006.

    Docket Numbers: ER02-783-005; ER02-852-005; ER02-855-005; ER01-
2262-007.
    Applicants: EPCOR Merchant and Capital (US) Inc.; EPCOR Power
Development, Inc.; EPDC, Inc.; Frederick Power L.P.
    Description: EPCOR Merchant and Capital (US) Inc. et al. submits an
amendment to its 8/14/06 filing of a Notice of Change in Status re
Market-Based Rate Authority.
    Filed Date: 10/03/2006.
    Accession Number: 20061005-0216.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 24, 2006.

    Docket Numbers: ER03-891-002.
    Applicants: Gulf States Energy Investments L.P.
    Description: Gulf States Energy Investments, LP submits an amended
triennial updated market power analysis in compliances with FERC's
Order 652.
    Filed Date: 10/06/2006.
    Accession Number: 20061010-0030.
    Comment Date: 5 p.m. Eastern Time on Friday, October 27, 2006.

    Docket Numbers: ER03-1288-002.
    Applicants: Rocky Mountain Energy Center, LLC.
    Description: Rocky Mountain Energy Center, LLC submits an triennial
updated market analysis in accordance with the Commission's 10/3/03
letter order.
    Filed Date: 10/03/2006.
    Accession Number: 20061005-0044.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 24, 2006.

    Docket Numbers: ER05-1508-003.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits an amendment to its 9/8/06 filing of the Large Generator
Interconnection Agreement with Power Partners Midwest, LLC and
Interstate Power & Company.
    Filed Date: 10/04/2006.
    Accession Number: 20061006-0005.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 25, 2006.

    Docket Numbers: ER06-1001-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits its Substitute Third Revised Sheet 969 et al. to FERC Electric
Tariff, Third Revised Volume No. 1.
    Filed Date: 10/04/2006.
    Accession Number: 20061005-0188.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 25, 2006.

    Docket Numbers: ER06-1331-000.
    Applicants: CalPeak Power LLC.
    Description: CalPeak Power LLC supplements its 8/2/06 application
for acceptance of their initial market-based rate tariff etc, to
clarify a statement in the application.
    Filed Date: 10/04/2006.
    Accession Number: 20061006-0001.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 25, 2006.

    Docket Numbers: ER06-1306-000.
    Applicants: Sunbury Generation, LP.
    Description: Sunbury Generation LP submits a notice of amendment to
its 8/24/06 filing, notice of succession.
    Filed Date: 10/04/2006.
    Accession Number: 20061005-0218.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 25, 2006.

    Docket Numbers: ER06-1422-001.
    Applicants: Louisville Gas & Electric Company; Kentucky Utilities
Company
    Description: Louisville Gas and Electric Co and Kentucky Utilities
Co submit requests that the Commission find that they continue to be
authorized to make sales of ARS energy to BREC not-withstanding recent
changes to market based rate tariff.
    Filed Date: 10/04/2006.
    Accession Number: 20061006-0004.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 25, 2006.

    Docket Numbers: ER07-12-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits its revised
rate sheets to the Interconnection Facilities Agreement with NM Mid-
Valley Genco, LLC.
    Filed Date: 10/04/2006.
    Accession Number: 20061006-0006.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 25, 2006.

    Docket Numbers: ER07-13-000.
    Applicants: Dynegy Midwest Generation, Inc.
    Description: Dynegy Midwest Generation, Inc submits revisions to
its market-based rate tariff that would

remove the outdated restriction on sales to Illinois Power Co.
    Filed Date: 10/04/2006.
    Accession Number: 20061006-0009.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 25, 2006.

    Docket Numbers: ER07-14-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits notices of
cancellation for Network Operating Agreements.
    Filed Date: 10/04/2006.
    Accession Number: 20061006-0008.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 25, 2006.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and Sec.
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-17173 Filed 10-16-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)]
[Notices]
[Pages 42508-42509]
[FR Doc No: 2018-18071]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2904]

Expanding Access to Effective Treatment for Opioid Use Disorder:
Provider Perspectives on Reducing Barriers to Evidence-Based Care;
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
following public meeting entitled ``Expanding Access to Effective
Treatment for Opioid Use Disorder: Provider Perspectives on Reducing
Barriers to Evidence-Based Care.'' Convened by the Duke-Robert J.
Margolis, MD, Center for Health Policy at Duke University and supported
by a cooperative agreement with FDA, the public meeting is intended to
generate a discussion with providers and health system stakeholders on
the armamentarium of medications to treat opioid use disorder (OUD),
current barriers to appropriate use of these medications, opportunities
to further reduce stigma, and methods to expand access to effective
pharmacotherapies as part of an evidence-based approach to OUD
treatment.

DATES: The public meeting will be held on September 20, 2018, from 9
a.m. to 4 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public meeting will be held at the National Press Club,
529 14th St. NW, Washington, DC 20045. For additional travel and hotel
information, please refer to the following web page: https://healthpolicy.duke.edu/events/expanding-access-to-treatment-for-OUD.
There will also be a live webcast for those unable to attend the
meeting in person (see Streaming Webcast of the Public Meeting).

FOR FURTHER INFORMATION CONTACT: Mitra Ahadpour, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 4546, Silver Spring, MD 20993-0002, 301-
796-8469, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The opioid epidemic remains a growing public health crisis. FDA
efforts to address the opioid crisis have included, among other things,
revision of the document entitled ``FDA Education Blueprint for Health
Care Providers Involved in the Management or Support of Patients with
Pain'' (https://www.fda.gov/Drugs/NewsEvents/ucm553931.htm), to support
rational prescribing, packaging, storage, and disposal of opioids;
stemming illegal opioid sales; expanding the Risk Evaluation and
Mitigation Strategy to cover immediate-release opioid formulations;
monitoring the abuse potential of marketed opioids and taking
regulatory action as needed; and addressing barriers to new drug
development for non-opioid alternative treatment of pain. Despite these
efforts and those of others, opioid misuse, OUD, and overdose remain
major public health challenges (Refs. 1 and 2).
    Over 2.1 million persons aged 12 or older suffer from opioid use
disorders related to prescription opioid analgesics or heroin (Ref. 2),
and the majority of those suffering from OUD still lack access to
evidence-based treatment. Although there is no one-size-fits-all
approach to OUD treatment, there is strong evidence demonstrating the
effectiveness of FDA-approved medications, combined with counseling and
behavioral therapies, for these patients. Promoting the wider use of
these safe and effective therapies is a key priority of FDA. However,
substantial challenges remain in patient access and provider use of
medications for OUD treatment.
    This public meeting is intended to serve as a platform to engage in
and generate an active discussion with provider communities and health
system stakeholders on the armamentarium of medications to treat OUD,
barriers to appropriate use of these medications, opportunities to
further reduce stigma, and methods to expand access to effective OUD
treatment.

II. Topics for Discussion at the Public Meeting

    During the public meeting, speakers and participants will cover
issues related to expanding access to effective treatment for OUD,
specifically in regard to provider perspectives on reducing barriers to
evidence-based care. Topics will include, but are not limited to, the
following:
     The role of FDA and the Department of Health and Human
Services in confronting and combatting the opioid epidemic;
     The current state of knowledge on addiction, clinical
approaches for identifying and assessing OUD, and use of medication-
assisted treatment;
     Gaps in the pharmacological armamentarium for treating
OUD, including shortfalls or unmet needs that should be considered in
developing new therapies;
     Innovative and evidence-based approaches to OUD treatment
delivery, lessons learned, and challenges to broader implementation;
     Legal, regulatory, and cultural barriers to access for
treatment for OUD and potential opportunities to reduce stigma and
expand access to effective OUD treatment;
     Care models and challenges for increasing access to OUD
treatment for vulnerable and medically underserved populations; and
     Clinical, health system, and economic perspectives on
defining successful outcomes for OUD treatment, including how
establishing outcome measures may facilitate quality improvement,
innovative payment approaches, and access to effective care.
    During meeting sessions, audience and webcast participants will be
invited to actively participate in the discussion regarding provider
and clinical expert perspectives on treatment for OUD and barriers to
care.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting
must register online at https://healthpolicy.duke.edu/expanding-access-to-treatment-for-OUD by September 19, 2018, by 5 p.m. Eastern Time.
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email address, and
telephone number.
    Registration is free and based on space availability, with priority
given to early registrants. Early registration is recommended because
seating is limited; therefore, FDA may limit the number of participants
from each organization. Registrants will receive confirmation when the
registration has been accepted. If time and space permit, onsite
registration on the day of the public meeting will be provided
beginning at 8 a.m. We will let registrants know if registration closes
before the day of the public meeting.
    If you need special accommodations due to a disability, please
contact Sarah Supsiri at the Duke-Margolis Center for Health Policy
(202-791-9561, [email protected]) no later than September 13,
2018.
    Streaming Webcast of the Public Meeting: This public meeting will
also be webcast, and archived video footage will be available at the
Duke-Margolis

Center's website following the meeting: https://healthpolicy.duke.edu/events/expanding-access-to-treatment-for-OUD. Webcast participants will
be able to submit questions and comments via the webcast portal.
Persons interested in participating in the live webcast must register
online by September 19, 2018, by 5 p.m. Eastern Time (see Registration
section above). Early registration is recommended because webcast
connections are limited. Organizations are required to register all
participants; however, we request that organizations view the meeting
using one connection per location whenever possible.
    Other Issues for Consideration: All event materials will be
provided to registered attendees via email prior to the meeting and
will be made publicly available at the Duke-Margolis Center's website:
https://healthpolicy.duke.edu/events/expanding-access-to-treatment-for-OUD. A 1-hour lunch break is scheduled, but food will not be provided.
There are multiple restaurants within walking distance of the
Conference Center.

IV. References

    The following references are on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 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 https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. Hedegaard, H., M. Warner, and A.M. Mini[ntilde]o, ``Drug Overdose
Deaths in the United States, 1999-2016,'' NCHS Data Brief, no. 294,
Hyattsville, MD: National Center for Health Statistics. 2017
(available at https://www.cdc.gov/nchs/products/databriefs/db294.htm), accessed June 27, 2018.
2. Substance Abuse and Mental Health Services Administration, Center
for Behavioral Health Statistics and Quality, ``Results from the
2016 National Survey on Drug Use and Health: Detailed Tables.''
September 8, 2016 (available at https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.htm), accessed
June 27, 2018.

    Dated: August 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18071 Filed 8-21-18; 8:45 am]
 BILLING CODE 4164-01-P