[Federal Register: September 22, 2006 (Volume 71, Number 184)]
[Notices]
[Page 55461]
[DOCID:fr22se06-75]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12608-000-MA]

Alternatives Unlimited, Inc; Notice of Availability of
Environmental Assessment

September 15, 2006.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's regulations, 18 CFR part
380 (Order No. 486, 52 FR 47879), the Office of Energy Projects has
reviewed the application for exemption from licensing for the
Alternatives Hydro Power Project, to be located on the Mumford River,
in the Town of Northbridge, Worcester County, Massachusetts, and has
prepared an Environmental Assessment (EA). In the EA, Commission staff
analyze the potential environmental impacts of the project and conclude
that exempting the project from licensing, with appropriate
environmental measures, would not constitute a major Federal action
significantly affecting the quality of the human environment.
    A copy of the EA is on file with the Commission and is available
for public inspection. The EA may also be viewed on the Commission's
Web site at http://www.ferc.gov using the ``eLibrary'' link. Enter the

docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC Online
Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>.
    Any comments should be filed within 30 days from the issuance date
of this notice, and should be addressed to the Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Room 1-A,
Washington, DC 20426. Please affix ``Alternatives Hydro Power Project
No. 12608'' to all comments. Comments may be filed electronically via
Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site under the ``eFiling'' link. For further
information, contact Tom Dean at<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-15648 Filed 9-21-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: February 15, 2007 (Volume 72, Number 31)]
[Notices]
[Page 7490-7496]
[DOCID:fr15fe07-120]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55269; File No. SR-NASDAQ-2006-050]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Order Granting Accelerated Approval of a Proposed
Rule Change as Modified by Amendment No. 3 Thereto Adopting Generic
Listing Standards for Exchange-Traded Funds Based on International or
Global Indexes or Indexes Described in Exchange Rules Previously
Approved by the Commission as Underlying Benchmarks for Derivative
Securities

February 9, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby
given that on November 28, 2006, The NASDAQ Stock Market LLC
(``Nasdaq'') 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 Nasdaq. On
November 28, 2006, Nasdaq filed Amendment No. 1 to the proposal. On
January 29, 2007, Nasdaq filed Amendment No. 2 to the proposal. On
February 9, 2007, Nasdaq filed Amendment No. 3 to the proposal. This
order provides notice of the proposal, as amended, and approves the
proposal 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

    Nasdaq proposes to revise its listing standards to include generic
listing standards for series of portfolio depository receipts
(``PDRs'') and index fund shares (``IFSs'') (PDRs and IFSs together
referred to as ``exchange-traded funds'' or ``ETFs'') that are based on
international or global indexes or on indexes described in exchange
rules that have been previously approved by the Commission for the
trading of ETFs or other specified index-based securities. The text of
the proposed rule change is available at Nasdaq, from the Commission's
Public Reference Room, and on Nasdaq's Web site (http://www.nasdaq.com
).

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

    In its filing with the Commission, Nasdaq 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. Nasdaq 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 proposes to revise its listing standards to include generic
listing standards for series of PDRs and IFSs that are based on
international or global indexes or on indexes described in rules
previously approved by the Commission for the trading of ETFs or other
specified index-based securities.
    This proposal would enable Nasdaq to list and trade ETFs pursuant
to Rule 19b-4(e) under the Exchange Act.\3\ Rule 19b-4(e) provides that
the listing and trading of a new derivative securities product by a
self-regulatory organization (``SRO'') shall not be deemed a proposed
rule change, pursuant to paragraph (c)(1) of Rule 19b-4, if the
Commission has approved, pursuant to Section 19(b) of the Exchange Act,
the trading rules of the SRO procedures and listing standards for the
product class that would include the new derivatives securities
product, and the SRO has a surveillance program for the product
class.\4\
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    \3\ 17 CFR 240.19b-4(e).
    \4\ When relying on Rule 19b-4(e), the SRO must submit Form 19b-
4(e) to the Commission within five business days after it begins
trading the new derivative securities products. See 17 CFR 240.19b-
4(e)(2)(ii).
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Background
Exchange-Traded Funds
    Currently, Nasdaq Rule 4420(i) allows for the listing and trading
on Nasdaq of PDRs. PDRs represent interests in a unit investment trust
registered under the Investment Company Act of 1940 \5\ (``1940 Act'')
that holds the securities that comprise an index or portfolio. Nasdaq
Rule 4420(j) provides standards for listing IFSs, which are securities
issued by an open-end management investment company registered under
the 1940 Act and based on a portfolio of stocks that seeks to provide
investment results that correspond generally to the price and yield
performance of a specified foreign or domestic stock index. Pursuant to
these rules, PDRs and IFSs, eligible for listing on Nasdaq, must be
issued in a specified aggregate minimum number in return for a deposit
of specified securities and/or a cash amount, with a value equal to the
next determined net asset value (``NAV''). When aggregated in the same
specified minimum number, PDRs or IFSs must be redeemed by the issuer
for the securities and/or cash, with a value equal to the next
determined NAV. The NAV is calculated once a day after the close of the
regular trading day.
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    \5\ 15 U.S.C. 80a.
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    To meet the investment objective of providing investment returns
that correspond to the price and the dividend and yield performance of
the underlying index, an ETF may use a ``replication'' strategy or a
``representative sampling'' strategy with respect to the ETF
portfolio.\6\ An ETF using a replication strategy will invest in each
stock of the underlying index in about the same proportion as that
stock is represented in the index itself. An ETF using a representative
sampling strategy will generally invest in a significant number but not
all of the component securities of the underlying index, and will hold
stocks that, in the aggregate, are intended to approximate the full
index in terms of key characteristics, such as price/earnings ratio,
earnings growth, and dividend yield. In addition, an ETF portfolio may
be adjusted in accordance with changes in the composition of the
underlying index or to maintain compliance with requirements applicable
to a regulated investment company under the Internal Revenue Code.
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    \6\ In either case, an ETF, by its terms, may be considered
invested in the securities of the underlying index to the extent the
ETF invests in sponsored American Depository Receipts (``ADRs''),
Global Depository Receipts (``GDRs''), or European Depository
Receipts (``EDRs'') that trade on exchanges with last-sale reporting
representing securities in the underlying index.
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Generic Listing Standards for Exchange-Traded Funds
    Nasdaq currently does not have generic listing standards for ETFs
that are based on international or global indexes or on previously
approved indexes, but systems operated by Nasdaq and its affiliates
currently trade such ETFs on an over-the-counter basis as facilities of
NASD. Nasdaq proposes that after Nasdaq begins to operate as an
exchange for trading securities not listed on Nasdaq, it would continue
trading such ETFs pursuant to unlisted trading privileges (``UTP'') in
much the same manner as they are being traded currently. Nasdaq also
proposes to makes its facilities available for listing these ETFs.
    The Commission recently approved generic listing standards of the
American Stock Exchange pursuant to Rule 19b-4(e) under the Exchange
Act for ETFs based on international or global indexes, as well as on
indexes described in exchange rule changes that have been previously
approved by the Commission under Section 19(b)(2) of the Exchange Act
for the trading of ETFs or other index-based securities. Nasdaq
believes that approval of its comparable generic listing standards and
applying Rule 19b-4(e) should fulfill the intended objective of that
rule by allowing those ETFs that currently trade on Nasdaq systems to
continue trading on Nasdaq as an exchange, without the need for the
public comment period and Commission approval. The proposed rules have
the potential to reduce the time frame for bringing ETFs to market,
thereby reducing the burdens on issuers and other market participants.
The failure of a particular ETF to comply with the proposed generic
listing standards under Rule 19b-4(e) would not, however, preclude
Nasdaq from submitting a separate filing pursuant to Section 19(b)(2)
requesting Commission approval to list a particular ETF.
Requirements for Listing and Trading ETFs Based on International and
Global Indexes or Previously Approved Indexes
    ETFs that are listed pursuant to the proposed generic listing
standards or that are traded UTP would be traded, in all other
respects, under Nasdaq's existing trading rules and procedures that
apply to ETFs and would be covered under Nasdaq's surveillance program
for ETFs. To list a PDR or an IFS pursuant to the proposed generic
listing standards for international and global indexes, the index
underlying the PDR or IFS must satisfy all the conditions contained in
the proposed amendments to Rule 4420(i) (for PDRs) or Rule 4420(j) (for
IFSs). As with the existing generic standards for ETFs based on
domestic indexes, these generic listing standards are intended to
ensure that stocks with substantial market capitalization and trading
volume account for a substantial portion of the weight of an index or
portfolio. While the standards in this proposal are based on the
standards contained in the current generic listing standards for ETFs
based on domestic indexes, they have been adapted as appropriate to
apply to international and global indexes.

    As proposed, the definition section of each of Rule 4420(i) and (j)
would be revised to include definitions of U.S. Component Stock and
Non-U.S. Component Stock. These new definitions would provide the basis
for the standards for indexes with either domestic or international
stocks, or a combination of both. A ``Non-U.S. Component Stock'' would
mean an equity security: (1) That is not registered under Section 12(b)
or 12(g) of the Exchange Act; \7\ (2) that is issued by an entity that
is not organized, domiciled, or incorporated in the United States; and
(3) that is issued by an entity that is an operating company (including
a real estate investment trust (REIT) or income trust, but excluding an
investment trust, unit trust, mutual fund, or derivative). This
definition is designed to create a category of component stocks that
are issued by companies that are not based in the United States, are
not subject to oversight through Commission registration, and would
include sponsored GDRs and EDRs. A ``U.S. Component Stock'' would mean
an equity security that is registered under Section 12(b) or 12(g) of
the Exchange Act or an ADR, the underlying equity security of which is
registered under Section 12(b) or 12(g) of the Exchange Act. An ADR
with an underlying equity security that is registered pursuant to the
Exchange Act is considered a U.S. Component Stock because the issuer of
that security is subject to Commission jurisdiction and must comply
with Commission rules.
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    \7\ 15 U.S.C. 78l(b) or (g).
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    Nasdaq proposes that, to list a PDR or an IFS based on an
international or global index or portfolio pursuant to the generic
listing standards, such index or portfolio must meet the following
criteria:
     Component stocks that in the aggregate account for at
least 90% of the weight of the index or portfolio each shall have a
minimum market value of at least $100 million;
     Component stocks representing at least 90% of the weight
of the index or portfolio each shall have a minimum worldwide monthly
trading volume during each of the last six months of at least 250,000
shares;
     The most heavily weighted component stock may not exceed
25% of the weight of the index or portfolio and the five most heavily
weighted component stocks may not exceed 60% of the weight of the index
or portfolio;
     The index or portfolio shall include a minimum of 20
component stocks; and
     Each U.S. Component Stock in the index or portfolio shall
be listed on a national securities exchange and an NMS stock as defined
in Rule 600 of Regulation NMS under the Exchange Act, and each Non-U.S.
Component Stock in the index or portfolio shall be listed on an
exchange that has last-sale reporting.
    Nasdaq believes that these proposed standards are reasonable for
international and global indexes, and, when applied in conjunction with
the other listing requirements, would result in the listing and trading
on Nasdaq of ETFs that are sufficiently broad-based in scope and not
readily susceptible to manipulation. Nasdaq also believes that the
proposed standards would result in ETFs that are adequately diversified
in weighting for any single security or small group of securities to
significantly reduce concerns that trading in an ETF based on an
international or global index could become a surrogate for the trading
of securities not registered in the United States.
    Nasdaq further notes that, while these standards are similar to
those for indexes that include only U.S. Component Stocks, they differ
in certain important respects and are generally more restrictive,
reflecting greater concerns over portfolio diversification with respect
to ETFs investing in components that are not individually registered
with the Commission. First, in the proposed standards, component stocks
that in the aggregate account for at least 90% of the weight of the
index or portfolio each shall have a minimum market value of at least
$100 million, compared to a minimum market value of at least $75
million for indexes with only U.S. Component Stocks.\8\ Second, in the
proposed standards, the most heavily weighted component stock cannot
exceed 25% of the weight of the index or portfolio, in contrast to a
30% standard for an index or portfolio comprised of only U.S. Component
Stocks. Third, in the proposed standards, the five most heavily
weighted component stocks shall not exceed 60% of the weight of the
index or portfolio, compared to a 65% standard for indexes comprised of
only U.S. Component Stocks. Fourth, the minimum number of stocks in the
proposed standards is 20, in contrast to a minimum of 13 in the
standards for an index or portfolio with only U.S. Component Stocks.
Finally, the proposed standards require that each Non-U.S. Component
Stock included in the index or portfolio be listed and traded on an
exchange that has last-sale reporting.
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    \8\ Market value is calculated by multiplying the total shares
outstanding by the price per share of the component stock.
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    Nasdaq also proposes to modify Rules 4420(i) and (j) to require
that the index value for an ETF listed pursuant to the proposed
standards for international and global indexes be widely disseminated
by one or more major market data vendors at least every 60 seconds
during the time when the ETF shares trade on Nasdaq. If the index value
does not change during some or all of the period when trading is
occurring on Nasdaq, the last official calculated index value must
remain available throughout Nasdaq's trading hours. In contrast, the
index value for an ETF listed pursuant to the existing standards for
domestic indexes must be disseminated at least every 15 seconds during
the trading day. This modification reflects limitations, in some
instances, on the frequency of intra-day trading information with
respect to Non-U.S. Component Stocks and that, in many cases, trading
hours for overseas markets overlap only in part, or not at all, with
Nasdaq's trading hours.
    In addition, Rules 4420(i) and (j) would be modified to define the
term ``Intraday Indicative Value'' (``IIV'') as the estimate of the
value of a share of each ETF that is updated at least every 15 seconds
during regular market hours and during any pre-market trading session
for the ETF.\9\ Nasdaq also proposes to clarify in these rules that the
IIV would be updated at least every 15 seconds during regular market
hours and during any pre-market trading session for the ETF to reflect
changes in the exchange rate between the U.S. dollar and the currency
in which any component stock is denominated. If the IIV does not change
during some or all of the period when trading is occurring on Nasdaq,
then the last official calculated IIV must remain available throughout
Nasdaq's trading hours.
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    \9\ Nasdaq's regular market hours are 9:30 a.m. to 4 p.m. or
4:15 p.m. Eastern Time. Its pre-market session begins at 7 a.m.
Eastern Time, and its post-market session ends at 8 p.m. Eastern
Time.
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    Nasdaq is proposing that it may designate an ETF for trading during
its pre-market session and/or its post-market session as long as the
index value and IIV dissemination requirements of Nasdaq Rules
4420(i)(3)(B)(iii) and 4420(i)(3)(C) and 4420(j)(3)(B)(iii) and
4420(j)(3)(C) are met. If there is no overlap with the trading hours of
the primary market trading the underlying components of an ETF, Nasdaq
may designate the ETF for pre-market trading as long as the last

official calculated IIV remains available. Although the IIV does not
need to be calculated during Nasdaq's current post-market session, the
last official calculated IIV must also remain available during such
post-market trading session.
    Nasdaq is also proposing to add provisions regarding the creation
and redemption process for ETFs and compliance with federal securities
laws for ETFs listed pursuant to the new generic listing standards.
These new provisions would require that the statutory prospectus or the
application for exemption from provisions of the 1940 Act for the ETF
being listed pursuant to these new standards must state that the ETF
must comply with the federal securities laws in accepting securities
for deposits and satisfying redemptions with redemption securities,
including that the securities accepted for deposits and the securities
used to satisfy redemption requests are sold in transactions that would
be exempt from registration under the Securities Act of 1933.
    Nasdaq also proposes to include, in the generic standards for the
listing of PDRs and IFSs, indexes that have been approved by the
Commission in connection with the listing of options, PDRs, IFSs,
index-linked exchangeable notes, or index-linked securities. Nasdaq
believes that the application of that standard to ETFs is appropriate
because the underlying index would have been subject to detailed and
specific Commission review in the context of the approval of listing of
those other derivatives. This new generic standard would be limited to
stock indexes and would require that each component stock be either:
(1) A U.S. Component Stock that is listed on a national securities
exchange and is an NMS stock as defined in Rule 600 of Regulation NMS;
or (2) a Non-U.S. Component Stock that is listed and traded on an
exchange that has last-sale reporting.
    Nasdaq represents that its surveillance procedures are adequate to
properly monitor the trading of the PDRs and IFSs that would be listed
pursuant to the proposed new listing standards or traded on a UTP
basis. Specifically, Nasdaq would rely on its existing surveillance
procedures governing PDRs and IFSs. Nasdaq has a general policy
prohibiting the distribution of material, non-public information by its
employees. It should also be noted that, as provided by existing Nasdaq
Rule 4420, Nasdaq would commence delisting proceedings for an ETF if
the value of the underlying index or portfolio is no longer calculated
or available.
    Nasdaq also proposes to modify the initial and continued listing
standards relating to disseminated information relating to ETFs to
formalize in the rules existing best practices for providing equal
access to material information about the value of ETFs. Prior to
approving an ETF for listing, Nasdaq would obtain a representation from
the ETF issuer that the NAV per share would be calculated daily and
made available to all market participants at the same time. With regard
to trading halts, the proposed rules specifically set out that if the
IIV or the index value applicable to an ETF that Nasdaq lists is not
being disseminated as required, Nasdaq may halt trading during the day
in which the interruption to the dissemination of the IIV or the index
value occurs. If the interruption to the dissemination of the IIV or
the index value persists past the trading day in which it occurred,
Nasdaq would halt trading no later than the beginning of the trading
day following the interruption. The rule change would also include
language providing that Nasdaq has discretion to halt trading in a
series of PDRs or IFSs based on a consideration of the following
factors: (1) Trading in securities comprising the underlying index
applicable to that series has been halted in the primary market(s); (2)
the extent to which trading has ceased in securities underlying the
index; or (3) the presence of other unusual conditions or circumstances
detrimental to the maintenance of a fair and orderly market.\10\
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    \10\ Nasdaq notes that the new language is reflective of
Nasdaq's existing policies with regard to trading halts of ETFs
listed on Nasdaq, as discussed in the predecessor NASD rule change
to establish listing standards for ETFs. In particular, Nasdaq's
general policy has been to halt trading in an ETF listed on Nasdaq
when securities accounting for 20% or more of the value of the
underlying index are halted or suspended. See Securities Exchange
Act Release No. 45920 (May 13, 2002), 67 FR 35605 (May 20, 2002)
(SR-NASD-2002-45).
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    With respect to PDRs, IFSs, and other ``Derivative Securities
Products'' \11\ that Nasdaq trades on a UTP basis, Nasdaq is adopting a
new trade halt provision to reflect the scope of Nasdaq's deference to
trading halts called by the listing market when a ``Required Value''
relating to the product is not being disseminated. The rule would
define Required Value as: (1) The value of any index underlying a
Derivative Securities Product; and (2) the indicative optimized
portfolio value, intraday indicative value, or other comparable
estimate of the value of a share of a Derivative Securities Product
updated regularly during the trading day.
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    \11\ The term ``Derivative Securities Product'' is defined to
include a series of PDRs, IFSs, or Trust Issued Receipts (as defined
in Nasdaq Rule 4420), a series of Commodity-Based Trust Shares (as
defined in Nasdaq Rule 4630), securities representing interests in
unit investment trusts, investment companies, or commodity pools, or
securities representing interests in partnerships that invest in any
combination of futures contracts, options on futures contracts,
forward contracts, commodities, and/or securities.
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    If a Derivative Securities Product begins trading on Nasdaq in its
Pre-Market Session \12\ and subsequently a temporary interruption
occurs in the calculation or wide dissemination of an applicable
Required Value, Nasdaq may continue to trade the Derivative Securities
Product for the remainder of the Pre-Market Session. During Nasdaq's
Regular Market Session,\13\ if a temporary interruption occurs in the
calculation or wide dissemination of an applicable Required Value with
respect to a Derivative Securities Product that Nasdaq trades pursuant
to UTP, Nasdaq, upon notification by the listing market of a halt due
to such temporary interruption, also shall immediately halt trading in
the Derivative Securities Product on its market.
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    \12\ The rule defines the ``Pre-Market Session'' as the trading
session for that begins at 7 a.m. and continues until 9:30 a.m.
Eastern Time.
    \13\ The rule defines the ``Regular Market Session'' as the
trading session that runs from 9:30 a.m. to 4 or 4:15 p.m. Eastern
Time.
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    If an applicable Required Value continues not to be calculated or
widely disseminated after the close of the Regular Market Session,
Nasdaq may trade the Derivative Securities Product in its Post-Market
Session \14\ only if the listing market traded the Derivative
Securities Product until the close of its regular trading session
without a halt. If an applicable Required Value continues not to be
calculated or widely disseminated as of the beginning of the Pre-Market
Session on the next trading day, Nasdaq shall not commence trading of
the Derivative Securities Product in the pre-market session that day.
If an interruption in the calculation or wide dissemination of a
Required Value continues, Nasdaq may resume trading in the Derivative
Securities Product only if calculation and wide dissemination of the
applicable Required Value resumes or trading in the Derivative
Securities Product resumes in the listing market.
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    \14\ The rule defines the ``Post-Market Session'' as the trading
session for UTP trading that begins at 4 p.m. or 4:15 p.m., and that
continues until 8 p.m. Eastern Time.
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    Nasdaq is also amending Rule 4420 to stipulate that, as provided by

Commission Rule 12f-5,\15\ Nasdaq may extend unlisted trading
privileges to any security, such as PDRs or IFSs, for which Nasdaq has
in effect rules providing for transactions in such class or type of
security. Provisions of Rule 4420 that govern trading hours and
surveillance procedures, and that relate to information circulars and
prospectus delivery, also apply to securities traded on a UTP basis (as
do applicable trade halt provisions of Rule 4120). Nasdaq does not,
however, apply quantitative listing standards to securities traded on a
UTP basis. Accordingly, language in Rule 4420(l) that could be read to
require unlisted securities to meet Nasdaq's quantitative listing
standards for Trust Issued Receipts in order to trade on a UTP basis is
being deleted.
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    \15\ 17 CFR 240.12f-5.
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    Proposed rules 4420(i)(3)(B)(iv) and (j)(3)(B)(iv) would be added
to make sure that an entity that advises index providers or calculators
and related entities has in place procedures designed to prevent the
use and dissemination of material non-public information regarding the
index underlying the ETF. Finally, Nasdaq is proposing several minor
and clarifying changes to Rules 4120 and 4420, such as deletion of
certain redundant language, correction of typographical errors, and
clarification of the hours during which ETFs are eligible to trade.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Exchange Act,\16\ in general, and
with Section 6(b)(5) of the Exchange Act,\17\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to remove
impediments to a free and open market and a national market system,
and, in general, to protect investors and the public interest.
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    \16\ 15 U.S.C. 78f.
    \17\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change would result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Exchange Act.

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

    Written comments 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 Exchange 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-NASDAQ-2006-050 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-2006-050. 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. Copies of such
filing also will be available for inspection and copying at the
principal office of Nasdaq. 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-2006-050 and should be submitted on or before
March 8, 2007.

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

    After careful review, the Commission finds that the proposed rule
change, as amended, is consistent with the requirements of the Exchange
Act and the rules and regulations thereunder applicable to a national
securities exchange.\18\ In particular, the Commission finds that the
proposal is consistent with section 6(b)(5) of the Exchange Act \19\ 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 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.
---------------------------------------------------------------------------

    \18\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \19\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Currently, Nasdaq does not have generic listing standards for ETFs
based on international or global indexes or on indexes described in
exchange rules that have been previously approved by the Commission,
but systems operated by Nasdaq and its affiliates currently trade such
ETFs on an over-the-counter basis as facilities of NASD. After Nasdaq
begins to operate as an exchange for non-Nasdaq-listed securities,
Nasdaq proposes to continue trading such ETFs pursuant to UTP in
substantially the same manner as they trade currently and to trade
additional ETFs as the original listing market. Rule 19b-4(e) provides
that the listing and trading of a new derivative securities product by
an SRO will not be deemed a proposed rule change pursuant to Rule 19b-
4(c)(1) if the Commission has approved, pursuant to section 19(b) of
the Exchange Act, the SRO's trading rules, procedures, and listing
standards for the product class that would include the new derivative
securities product, and the SRO has a surveillance program for the
product class. Nasdaq's proposed rules for the listing and trading of
ETFs pursuant to Rule 19b-4(e) based on (1) Certain indexes with
components that include foreign securities or (2) indexes or portfolios
previously described in exchange rules that have been approved by the
Commission as underlying benchmarks for derivative securities, fulfill
these requirements. Use of Rule 19b-4(e) by Nasdaq to list and trade
such ETFs should promote competition, reduce burdens on issuers and
other market participants, and make such ETFs available to investors
more quickly.\20\
---------------------------------------------------------------------------

    \20\ The Commission notes, however, that the failure of a
particular ETF to meet these generic listing standards would not
preclude Nasdaq from submitting a separate proposed rule change to
list and trade the ETF.

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

    The Commission previously has approved generic listing standards
for other exchanges, the American Stock Exchange LLC (``Amex'') and the
New York Stock Exchange LLC (``NYSE''), that are substantially similar
to those proposed here by Nasdaq.\21\ This proposal does not appear to
raise any novel regulatory issues. Therefore, the Commission finds that
Nasdaq's proposal is consistent with the Exchange Act on the same basis
that it approved Amex's and NYSE's generic listing standards for ETFs
based on international or global indexes or on indexes or portfolios
described in exchange rules that have been previously approved by the
Commission as underlying benchmarks for derivative securities.
---------------------------------------------------------------------------

    \21\ See Securities Exchange Act Release No. 54739 (November 9,
2006), 71 FR 66993 (November 17, 2006) (SR-Amex-2006-78) (approving
generic listing standards for ETFs based on international or global
indexes or indexes described in exchange rules that have been
previously approved by the Commission as underlying benchmarks for
derivative securities); Securities Exchange Act Release No. 55018
(December 28, 2006), 72 FR 1040 (January 9, 2007) (SR-Amex-2006-109)
(making clarifying changes to the generic listing standards set
forth in SR-Amex-2006-78); Securities Exchange Act Release No. 55113
(January 17, 2007), 72 FR 3179 (January 24, 2007) (SR-NYSE-2006-101)
(approving generic listing standards for ETFs based on international
or global indexes or indexes described in exchange rules that have
been previously approved by the Commission as underlying benchmarks
for derivative securities).
---------------------------------------------------------------------------

    Proposed Nasdaq Rules 4420(i)(3)(A)(ii) and 4420(j)(3)(A)(ii)
establish standards for the composition of an index or portfolio
underlying an ETF. These requirements are designed, among other things,
to require that components of an index or portfolio underlying the ETF
are adequately capitalized and sufficiently liquid, and that no one
security dominates the index. The Commission believes that, taken
together, these standards are reasonably designed to ensure that
securities with substantial market capitalization and trading volume
account for a substantial portion of any underlying index or portfolio,
and with the other applicable listing requirements will permit the
listing and trading of ETFs that are sufficiently broad-based to
minimize potential manipulation. The Commission further believes that
the proposed listing standards are reasonably designed to preclude
Nasdaq from listing and trading ETFs that might be used as surrogate
for trading in unregistered securities. The requirement that each
component security underlying an ETF be an NMS stock (in the case of a
U.S. Component Stock) or listed on an exchange and subject to last-sale
reporting (in the case of a Non-U.S. Component Stock) also should
contribute to the transparency of the market for these ETFs.
    The proposed generic listing standards will permit Nasdaq to list
and trade an ETF if the Commission has previously approved an SRO rule
that contemplates listing and trading a derivative product based on the
same underlying index. Nasdaq would be able to rely on that earlier
approval order, provided that: (1) The securities comprising the
underlying index consist of U.S. Component Stocks or Non-U.S. Component
Stocks, as set forth in proposed Nasdaq Rules 4420(i)(1)(C) and (D) and
4420(j)(1)(C) and (D); and (2) Nasdaq complies with the commitments
undertaken by the other SRO set forth in the prior order, including any
surveillance-sharing arrangements with a foreign market.
    The Commission believes that Nasdaq's proposal is consistent with
section 11A(a)(1)(C)(iii) of the Exchange Act,\22\ which sets forth
Congress' finding that it is in the public interest and appropriate for
the protection of investors and the maintenance of fair and orderly
markets to assure the availability to brokers, dealers, and investors
of information with respect to quotations for and transactions in
securities. Nasdaq's proposal requires the value of the index or
portfolio underlying an ETF based on a global or international index to
be disseminated at least once every 60 seconds during Nasdaq trading
hours.\23\ Nasdaq has represented that, if an underlying index or
portfolio value is no longer calculated or available, it would commence
delisting proceedings for the associated ETF. Furthermore, these
generic listing standards provide that the issuer of an ETF must
represent that it will calculate the NAV and make it available daily to
all market participants at the same time.\24\
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78k7-1(a)(1)(C)(iii).
    \23\ See proposed Nasdaq Rules 4420(i)(3)(B)(iii)(b) and (c) and
4420(j)(3)(B)(iii)(b) and (c). If an index or portfolio value does
not change for some of the time that the ETF trades on the Exchange,
the last official calculated value must remain available throughout
Exchange trading hours.
    \24\ See proposed Nasdaq Rules 4420(i)(6)(A)(ii) and
4420(j)(6)(A)(ii).
---------------------------------------------------------------------------

    In addition, an IIV, which represents an estimate of the value of a
share of each ETF, must be updated and disseminated at least once every
15 seconds during regular market hours and during any pre-market
trading session for the ETF. The IIV must reflect changes in the
exchange rate between the U.S. dollar and the currency in which any
component stock is denominated. When there is no overlap with the
trading hours of the primary market or markets trading the underlying
components of an ETF, Nasdaq may trade such ETF during any pre-market
trading session without an IIV being updated, as long as the last
official calculated IIV remains available. Although the IIV is not
calculated during any post-market trading session, the last official
calculated IIV must also remain available during such post-market
session. The Commission believes that the proposed rules regarding the
dissemination of the index value and the IIV are reasonably designed to
promote transparency in the pricing of ETFs and thus are consistent
with the Exchange Act.
    Similarly, Nasdaq's trading halt rules are reasonably designed to
prevent trading in an ETF when transparency cannot be assured. Proposed
Nasdaq Rule 4120(a)(9) provides that, when Nasdaq is the listing
market, Nasdaq may halt trading when an interruption occurs in the
calculation or dissemination of the IIV or index value applicable to an
ETF. If the interruption continues, Nasdaq would halt trading no later
than the beginning of the next trading day. In addition, proposed
Nasdaq Rule 4120(b) sets forth trading halt procedures when Nasdaq
trades the ETF pursuant to UTP. This rule is substantially similar to
those recently adopted by other exchanges and found by the Commission
to be consistent with the Exchange Act.\25\
---------------------------------------------------------------------------

    \25\ See NYSE Arca Equities Rule 7.34; NYSE Rule 1100(f)(2);
Securities Exchange Act Release No. 54997 (December 21, 2006), 71 FR
78501 (December 29, 2006) (SR-NYSEArca-2006-77); Securities Exchange
Act Release No. 55113 (January 17, 2007), 72 FR 3179 (January 24,
2007) (SR-NYSE-2006-101).
---------------------------------------------------------------------------

    In approving this proposal, the Commission relied on Nasdaq's
representation that its surveillance procedures are adequate to
properly monitor the trading of the PDRs and IFSs listed pursuant to
the proposed new listing standards or traded on a UTP basis. This
approval is conditioned on the continuing accuracy of that
representation.
Acceleration
    The Commission finds good cause for approving the proposed rule
change, as amended, prior to the 30th day after the date of publication
of the notice of filing thereof in the Federal Register. The Commission
notes that Nasdaq's proposal is substantially similar to Amex and NYSE
proposals that have been approved by the Commission.\26\

The Commission does not believe that Nasdaq's proposal raises any novel
regulatory issues and, therefore, that good cause exists for approving
the filing before the conclusion of a notice-and-comment period.
Accelerated approval of the proposal will expedite the listing and
trading of additional ETFs by Nasdaq, subject to consistent and
reasonable standards. Furthermore, accelerated approval of this
proposal will facilitate Nasdaq's ability to continue trading certain
non-Nasdaq-listed ETFs as Nasdaq becomes an exchange with respect to
non-Nasdaq-listed securities, where there appears to be no regulatory
concerns about such trading. Therefore, the Commission finds good
cause, consistent with section 19(b)(2) of the Exchange Act,\27\ to
approve the proposed rule change, as amended, on an accelerated basis.
---------------------------------------------------------------------------

    \26\ See supra note 21.
    \27\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to section 19(b)(2) of the
Exchange Act,\28\ that the proposed rule change (SR-NASDAQ-2006-050),
as amended, be, and it hereby is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \28\ Id.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\29\
---------------------------------------------------------------------------

    \29\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-2664 Filed 2-14-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: August 18, 2006 (Volume 71, Number 160)]
[Notices]
[Page 47797]
[DOCID:fr18au06-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-448-000]

Northern Border Pipeline Company; Notice of Proposed Changes in
FERC Gas Tariff

August 1, 2006.
    Take notice that on July 27, 2006, Northern Border Pipeline Company
(Northern Border) tendered for filing to become part of its FERC Gas
Tariff, First Revised Volume No. 1, the following tariff sheets to
become effective August 28, 2006:

Second Revised Sheet No. 186,
Second Revised Sheet No. 190,
Fourth Revised Sheet No. 191.

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is 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 docket(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. E6-13758 Filed 8-17-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 244 (Thursday, December 19, 2019)]
[Notices]
[Page 69758]
[FR Doc No: 2019-27302]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4465-DR; Docket ID FEMA-2019-0001]

North Carolina; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Carolina (FEMA-4465-DR), dated October 4, 2019,
and related determinations.

DATES: This amendment was issued December 9, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of North Carolina is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of October 4, 2019.

    Bladen and Chowan Counties for Public Assistance.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-27302 Filed 12-18-19; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 4 (Thursday, January 7, 2016)]
[Notices]
[Pages 786-787]
[FR Doc No: 2016-00066]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1295]

Regulatory Requirements for Hearing Aid Devices and Personal
Sound Amplification Products; Draft Guidance for Industry and Food and
Drug Administration Staff; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is reopening
the comment period for the draft guidance entitled ``Regulatory
Requirements for Hearing Aid Devices and Personal Sound Amplification
Products.'' A notice of availability requesting comments on the draft
guidance document appeared in the Federal Register of November 7, 2013.
The Agency is reopening the comment period to receive updated comments
and any new information.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 6, 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 Submissions

    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-2013-D-1295 for ``Regulatory Requirements for Hearing Aid Devices
and Personal Sound Amplification Products'' draft guidance. 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.
    An electronic copy of the draft guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the draft guidance. Submit
written requests for a single hard copy of the draft guidance document
entitled ``Regulatory Requirements for Hearing Aid Devices and Personal
Sound Amplification Products'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Eric Mann, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2438, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 7, 2013 (78 FR 66940), FDA
published a notice of availability with a 90-day comment period to
request comments on the draft guidance entitled ``Regulatory
Requirements for Hearing Aid Devices and Personal Sound Amplification
Products.''
    Since issuance of the November 7, 2013, draft guidance entitled
``Regulatory Requirements for Hearing Aid Devices and Personal Sound
Amplification Products,'' FDA has become aware of other efforts by the
President's Council of Advisors on Science and Technology (PCAST) and

Institute of Medicine (IOM) regarding hearing aids and personal sound
amplification products (PSAP). In order to allow FDA and other
interested parties to consider the PCAST recommendations and
information presented and discussed during the recent public IOM
meetings on this issue, FDA is reopening the comment period. This will
further allow FDA to ensure consistent interpretation, consistent
application of relevant regulatory requirements, and adequate
protection of the public health.
    FDA is reopening the comment period for 120 days. The Agency
believes that a 120-day extension allows adequate time for interested
parties to submit comments without significantly delaying finalizing
the draft guidance on these important issues.

II. Other Issues for Consideration

    FDA is soliciting comments on the availability, accessibility, and
use of hearing aids and PSAPs for consumers with hearing impairment.
Further, FDA requests interested parties to comment on the key issues
and recommendations identified in the PCAST reporting, including: (1)
The degree to which current FDA regulatory requirements may be acting
as a barrier to hearing aid accessibility, affordability, and use of
hearing aids; (2) the appropriateness of creating a ``basic'' category
of hearing aids for consumers with ``bilateral, gradual onset, mild-to-
moderate age-related hearing loss'' with appropriate labeling for over-
the-counter sale; and (3) whether the benefits of expanded, over-the-
counter access to hearing aids in this age-related hearing loss
population outweigh the risks of forgoing the condition for sale (that
the consumer may waive) that requires a medical evaluation to rule out
treatable, potentially progressive causes of hearing loss.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Regulatory Requirements for
Hearing Aid Devices and Personal Sound Amplification Products'' may
send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document. Please use the document number1832 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 801 have been approved under
OMB control number 0910-0485, and the collections of information in 21
CFR part 807 subpart E have been approved under OMB control number
0910-0120.

    Dated: December 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00066 Filed 1-6-16; 8:45 am]
BILLING CODE 4164-01-P