[Federal Register: November 29, 2006 (Volume 71, Number 229)]
[Notices]
[Page 69149-69150]
[DOCID:fr29no06-84]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Pub. L. 94-409, that the Securities and
Exchange Commission will hold the following meetings during the week of
December 4, 2006:
    An open meeting will be held on Monday, December 4, 2006 at 10 a.m.
in the Auditorium, Room LL-002 and a closed meeting will be held on
Wednesday, December 6, 2006 at 11 a.m.
    Commissioners, Counsels to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the closed meeting.
Certain staff members who have an interest in the matters may also be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), (9)(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), (9)(ii), and (10) permit consideration of the
scheduled matters at the closed meeting.
    Commissioner Campos, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matters of the open meeting scheduled for Monday,
December 4, 2006 will be:
    1. The Commission will consider whether to approve the budget of
the Public Company Accounting Oversight Board and will consider the
annual accounting support fees under section 109 of the Sarbanes-Oxley
Act of 2002.
    2. The Commission will consider whether to propose a new rule under
the Securities Act of 1933 to revise the criteria for natural persons
to be considered ``accredited investors'' for purposes of investing in
certain privately offered investment vehicles.
    3. The Commission will consider whether to propose a new rule under
the Investment Advisers Act of 1940 to prohibit advisers from making
false or misleading statements to investors in certain pooled
investment vehicles they manage, including hedge funds.
    4. The Commission will consider whether to propose amendments to
Rule 105 of Regulation M that would further safeguard the integrity of
the capital raising process and protect issuers from manipulative
activity that can reduce issuers' offering proceeds and dilute security
holder value.
    5. The Commission will consider whether to propose an amendment to
the short sale price test of Rule 10a-1. In addition, the Commission
will consider whether to propose an amendment to the ``short exempt''
marking requirement of Regulation SHO.
    The subject matters of the closed meeting scheduled for Wednesday,
December 6, 2006 will be:

Formal orders of investigation;
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings of an
enforcement nature;

Resolution of litigation claims; and
Adjudicatory matters.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: November 27, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. 06-9474 Filed 11-27-06; 3:55 pm]

BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Pages 15204-15205]
[FR Doc No: 2015-06524]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13702-002]

FFP Missouri 2, LLC; Notice of Application Ready for
Environmental Analysis, and Soliciting Comments, Recommendations, Terms
and Conditions, and Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original Major License--Existing Dam.
    b. Project No.: 13702-002.
    c. Date filed: November 13, 2013.
    d. Applicant: FFP Missouri 2, LLC.
    e. Name of Project: Grenada Lake Hydroelectric Project.
    f. Location: The proposed project would be located at the U.S. Army
Corps of Engineers' (Corps) existing Grenada Lake Dam, on the Yalobusha
River, near the Town of Grenada,

Grenada County, Mississippi. The proposed project would occupy
approximately 35.5 acres of federal land administered by the Corps.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Ramya Swaminathan, Rye Development, 745
Atlantic Avenue, 8th Floor, Boston, MA 02111; telephone<PHONE_NUMBER>.
    i. FERC Contact: Jeanne Edwards, telephone<PHONE_NUMBER> and email
<EMAIL_ADDRESS>or Patti Leppert, telephone<PHONE_NUMBER> and
email<EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments, recommendations, terms and conditions, and prescriptions
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-13702-002.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. The proposed Grenada Lake Project would utilize the following
existing Corps' Grenada Lake Dam facilities: (1) A 13,900-foot-long,
80-foot-high earth fill embankment dam; (2) a reservoir; and (3) outlet
works consisting of a concrete intake tower, three gated inlets that
combine to direct flow through a 377.5-foot-long, 17-foot-diameter
concrete outlet conduit, and a stilling basin.
    The proposed Grenada Lake Project would consist of the following
new facilities: (1) A 327.5-foot-long, 16-foot-diameter steel liner
installed within the existing outlet conduit; (2) a 50-foot-long,
variable width steel-lined, concrete bifurcation chamber containing two
hydraulically-operated gates used to control the amount of flow
diverted from the existing stilling basin to the powerhouse; (3) a 260-
foot-long, 14-foot-diameter steel penstock; (4) a 78-foot wide, 50-
foot-long, 86-foot-high steel and reinforced concrete forebay housing
trashracks and a fish bypass outlet gate; (5) a 120-foot-long, 60-foot-
wide concrete powerhouse containing two vertical Kaplan turbine-
generator units having a combined installed capacity of 9.0 megawatts;
(6) a 150-foot-long, 70-foot-wide tailrace; (7) a 670-foot-long, 4.16-
kilovolt (kV) buried cable; (8) a substation; and (9) a 1,980-foot-
long, 12.5-kV overhead transmission line extending from the substation
to a utility-owned distribution line. The average annual generation
would be 31,000 megawatt-hours.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room, or may 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. A copy is available for inspection and
reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    All filings must: (1) Bear in all capital letters the title
``COMMENTS,'' ``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS''; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b) and 385.2010.
    n. Procedural Schedule:
    The application will be processed according to the following
revised hydro licensing schedule. Revisions to the schedule may be made
as appropriate.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Filing of recommendations, terms and        May 2015.
 conditions, and prescriptions.
Commission issues Draft EA................  December 2015.
Comments on Draft EA Due..................  January 2016.
Commission Issues Final EA................  May 2016.
------------------------------------------------------------------------

    o. Public notice of the filing of the initial development
application, which has already been given, established the due date for
filing competing applications or notices of intent. Under the
Commission's regulations, any competing development application must be
filed in response to and in compliance with public notice of the
initial development application. No competing applications or notices
of intent may be filed in response to this notice.

    Dated: March 16, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-06524 Filed 3-20-15; 8:45 am]
 BILLING CODE 6717-01P


[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Notices]
[Pages 56317-56318]
[FR Doc No: 2018-24654]

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

[EPA-HQ-OECA-2011-0256; FRL-9986-00-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Emission Guidelines for Existing Other Solid
Waste Incineration Units (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Emission Guidelines for Existing
Other Solid Waste Incineration Units (EPA ICR No. 2164.06, OMB Control
No. 2060-0562), to the Office of Management and Budget (OMB), for
review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through November 30, 2018. Public comments were previously requested,
via the Federal Register on June 29, 2017, during a 60-day comment
period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. An agency may neither conduct
nor sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before December 13,
2018.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2011-0256, to: (1) EPA online using www.regulations.gov (our

preferred method), or by email to [email protected], or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to [email protected]. Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change, including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The Emission Guidelines for Existing Other Solid Waste
Incineration (OSWI) Units (40 CFR part 60, subpart FFFF) apply to any
air quality program in either a state or a United States protectorate
with one or more existing OSWI units or air curtain incinerators that
commenced construction either on or before December 9, 2004. The
affected OSWI units include two sub-categories: Very small municipal
waste combustion (VSMWC) units that combust less than 35 tons per day
of waste and institutional waste incineration (IWI) units. This Subpart
does not directly affect incineration unit owners and operators;
however, they must comply with the state's plan that was developed by
the air quality program administrator to implement the emission
guidelines. In general, all emission guidelines require initial
notifications, performance tests, and periodic reports by the owners/
operators of the affected facilities. They are also required to
maintain records of the occurrence and duration of any startup,
shutdown, or malfunction in the operation of an affected facility, or
any period during which the monitoring system is inoperative. These
notifications, reports, and records are essential in determining
compliance with 40 CFR part 60, subpart FFFF.
    Form Numbers: None.
    Respondents/affected entities: OSWI units, which include two
subcategories--VSMWC units that combust less than 35 tons per day of
waste and IWI units.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart FFFF).
    Estimated number of respondents: 99 (total).
    Frequency of response: Initially, occasionally, semiannually, and
annually.
    Total estimated burden: 70,200 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $8,190,000 (per year), which includes
$495,000 in annualized capital/startup and/or operation & maintenance
costs.
    Changes in the Estimates: There is no change in the labor hours or
cost in this ICR compared to the previous ICR. This is due to two
considerations: (1) The regulations have not changed over the past
three years, and are not anticipated to change over the next three
years; and (2) the growth rate for the industry is very low, negative
or non-existent, so there is no significant change in the overall
burden.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018-24654 Filed 11-9-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 31, 2010 (Volume 75, Number 61)]
[Notices]
[Page 16217-16219]
[DOCID:fr31mr10-147]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61775; File No. SR-NYSEArca-2010-17]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NYSE Arca, Inc. Regarding the
Listing of the ProShares Ultra MSCI Mexico Investable Market Fund

March 24, 2010.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on March 18, 2010, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a et seq.
    \3\ 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, through its wholly-owned subsidiary NYSE Arca
Equities, Inc. (``NYSE Arca Equities''), proposes to list and trade
shares (``Shares'') of the following fund of the ProShares Trust
(``Trust''): ProShares Ultra MSCI Mexico Investable Market. The text of
the proposed rule change is available at the Exchange, the Commission's
Public Reference Room, and http://www.nyse.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, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to list and trade the Shares of the following
fund under NYSE Arca Equities Rule 5.2(j)(3), the Exchange's listing
standards for Investment Company Units (``ICUs''): \4\ ProShares Ultra
MSCI Mexico Investable Market (the ``Fund'').
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    \4\ An Investment Company Unit is a security that represents an
interest in a registered investment company that holds securities
comprising, or otherwise based on or representing an interest in, an
index or portfolio of securities (or holds securities in another
registered investment company that holds securities comprising, or
otherwise based on or representing an interest in, an index or
portfolio of securities). See NYSE Arca Equities Rule 5.2(j)(3)(A).
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    The Fund is an ``index fund'' that seeks to provide daily
investment results that, before fees and expenses, correspond to twice
(200%) of the daily performance of the MSCI Mexico Investable Market
Index (``Index''). The Fund does not seek to achieve its stated
objective over a period of time greater than one day.
    According to the Trust's Registration Statement,\5\ the Index
measures the performance of the Mexican equity market. The Index is a
capitalization-weighted index that aims to capture 99% of the publicly
available total market capitalization. Component companies are adjusted
for available float and must meet objective criteria for inclusion in
the Index, taking into consideration unavailable strategic
shareholdings and limitations to foreign ownership. As of February 26,
2010, the Index was concentrated in the telecommunications services
industry group, which comprised 35.84% of the market capitalization of
the Index, and included companies with capitalizations between $124.10
million and 44.68 billion. The average capitalization of the companies
comprising the Index was approximately $5.84 billion.
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    \5\ See the Trust's Registration Statement on Form N-1A, dated
February 26, 2010 (File Nos. 333-89822 and 811-21114)
(``Registration Statement'').
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    The Exchange is submitting this proposed rule change because the
Index for the Fund does not meet all of the ``generic'' listing
requirements of Commentary .01(a)(B) to NYSE Arca Equities Rule
5.2(j)(3) applicable to listing of ICUs based on international or

global indexes. The Index meets all such requirements except for those
set forth in Commentary .01(a)(B)(3).\6\ The Exchange represents that
(1) except for the requirement under Commentary .01(a)(B)(3) to NYSE
Arca Equities Rule 5.2(j)(3) that the most heavily weighted component
stock shall not exceed 25% of the weight of the Index, the Shares of
the Fund currently satisfy all of the generic listing standards under
NYSE Arca Equities Rule 5.2(j)(3); (2) the continued listing standards
under NYSE Arca Equities Rules 5.2(j)(3) and 5.5(g)(2) applicable to
ICUs shall apply to the Shares; and (3) the Trust is required to comply
with Rule 10A-3 \7\ under the Securities Exchange Act of 1934 (the
``Act'') for the initial and continued listing of the Shares. In
addition, the Exchange represents that the Shares will comply with all
other requirements applicable to ICUs including, but not limited to,
requirements relating to the dissemination of key information such as
the Index value and Intraday Indicative Value, rules governing the
trading of equity securities, trading hours, trading halts,
surveillance,\8\ and Information Bulletin to ETP Holders, as set forth
in Exchange rules for ICUs and in prior Commission orders approving the
generic listing rules applicable to the listing and trading of ICUs.\9\
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    \6\ Specifically, the Index fails to meet the requirement that
the most heavily weighted component stock shall not exceed 25% of
the weight of the Index. As of February 26, 2010, the most heavily
weighted component stock (America Movil S.A.B. de C.V.) represented
27.50% of the Index weight.
    \7\ 17 CFR 240.10A-3.
    \8\ The Exchange may obtain information for surveillance
purposes via the Intermarket Surveillance Group (``ISG'') from other
exchanges who are members of ISG. For a list of current members of
ISG, see http://www.isgportal.org. However, the Exchange does not
have in place a comprehensive surveillance agreement with the Bolsa
Mexicana de Valores and such exchange is not an ISG member.
    \9\ See, e.g. Securities Exchange Act Release Nos. 55621 (April
12, 2007), 72 FR 19571 (April 18, 2007) (SR-NYSEArca-2006-86) (order
approving generic listing standards for ICUs based on international
or global indexes); 44551 (July 12, 2001), 66 FR 37716 (July 19,
2001) (SR-PCX-2001-14) (order approving generic listing standards
for ICUs and Portfolio Depositary Receipts); 41983 (October 6,
1999), 64 FR 56008 (October 15, 1999) (SR-PCX-98-29) (order
approving rules for listing and trading of ICUs).
---------------------------------------------------------------------------

    Detailed descriptions of the Fund, the Index, procedures for
creating and redeeming Shares, transaction fees and expenses,
dividends, distributions, taxes, risks, and reports to be distributed
to beneficial owners of the Shares can be found in the Trust's
Registration Statement or on the Web site for the Fund (http://
www.proshares.com), as applicable.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \10\ of
the Act, in general, and furthers the objectives of Section
6(b)(5),\11\ 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 facilitating transactions in securities, and to
remove impediments to and perfect the mechanisms of a free and open
market and a national market system. The Exchange believes that the
proposed rule change will facilitate the listing and trading of an
additional type of exchange-traded product that will enhance
competition among market participants, to the benefit of investors and
the marketplace.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

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

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \12\ and Rule 19b-4(f)(6) thereunder.\13\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \14\ and Rule 19b-
4(f)(6) thereunder.\15\
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    \12\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \16\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\17\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has
requested that the Commission waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The Exchange
states that the proposed rule change does not significantly affect the
protection of investors or the public interest and does not impose any
significant burden on competition. In addition, the Exchange believes
that it has developed adequate trading rules, procedures, surveillance
programs, and listing standards for the continued listing and trading
of the Shares.
---------------------------------------------------------------------------

    \16\ 17 CFR 240.19b-4(f)(6).
    \17\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
The Commission notes that the Index fails to meet only one of the
requirements set forth in Commentary .01(a)(B)(3) to NYSE Arca Equities
Rule 5.2(j)(3) by only a small amount and that the Exchange has
represented that the Shares of the Fund currently satisfy all of the
other generic listing standards under NYSE Arca Equities Rule 5.2(j)(3)
and all other requirements applicable to ICUs, as set forth in Exchange
rules and prior Commission orders approving the generic listing rules
applicable to the listing and trading of ICUs. Therefore, the
Commission believes that the listing and trading of the Shares do not
present any novel or significant issues or impose any significant
burden on competition, and that waiving the 30-day operative delay will
benefit the market and investors by providing market participants with
additional investing choices. For these reasons, the Commission
designates the proposed rule change as operative under upon filing.\18\
---------------------------------------------------------------------------

    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is

necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2010-17 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2010-17. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.
    All submissions should refer to File Number SR-NYSEArca-2010-17 and
should be submitted on or before April 21, 2010.
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-7110 Filed 3-30-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 90 (Thursday, May 9, 2019)]
[Notices]
[Pages 20370-20371]
[FR Doc No: 2019-09530]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1814]

Preparation of Food Contact Notifications for Food Contact
Substances in Contact With Infant Formula and/or Human Milk; Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a final guidance for industry entitled ``Preparation of
Food Contact Notifications for Food Contact Substances in Contact with
Infant Formula and/or Human Milk.'' This guidance is intended to
provide industry with our current thinking on how to prepare a food
contact notification (FCN) submission for our review and evaluation of
the safety of food contact substances (FCSs) used in contact with
infant formula and/or human milk.

DATES: The announcement of the guidance is published in the Federal
Register on May 9, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2016-D-1814 for ``Preparation of Food Contact Notifications for
Food Contact Substances in Contact with Infant Formula and/or Human
Milk.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to
Division of Food Contact Notifications/Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Vanee Komolprasert, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Preparation of Food Contact Notifications for Food Contact
Substances in Contact with Infant Formula and/or Human Milk.'' We are
issuing the guidance consistent with our good guidance practices
regulation (21 CFR 10.115). The guidance represents the current
thinking of FDA on this topic. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
    Section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 348) establishes an FCN process as the primary method by
which we regulate food additives that are FCSs. As defined in section
409(h)(6) of the FD&C Act, the term ``food contact substance'' means
any substance intended for use as a component of materials used in
manufacturing, packing, packaging, transporting, or holding food if
such use is not intended to have any technical effect in such food.
    Pursuant to section 409(h) of the FD&C Act and FDA's implementing
regulations \1\, FCN submissions must contain a comprehensive
discussion of the basis for the manufacturer's or supplier's
determination that the use of the FCS that is the subject of the
notification is safe. This guidance contains recommendations regarding
how the scientific information in FCNs for infant food use should
demonstrate that the FCS is safe for the specific intended use in
contact with infant food. For purposes of the guidance, infant food is
limited to infant formula and/or human milk, and this guidance focuses
on infants 0-6 months in age. The guidance discusses our
recommendations and provides information for: A. Chemistry
Recommendations, including Migration Testing and Exposure Estimation;
B. Toxicology Recommendations including Exposure Based Testing Tiers,
Minimum Testing Recommendations, and Age Dependent Cancer Risk Analysis
of Carcinogenic Constituents; and C. Administrative Recommendations
including Acknowledgment of an FCN, Non-acceptance of an FCN, Final
Letter, Inventory of Effective FCNs, and Premarket Notification
Consultations (PNCs).
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    \1\ 21 CFR 170.101(a) (https://www.ecfr.gov/cgi-bin/text-idx?SID=56face021b3741c1fba7e997df53d3de&mc=true&node=pt21.3.170&rgn=div5#se21.3.170_1101).
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    In the Federal Register of December 9, 2016 (81 FR 89110), we
announced a draft guidance for industry and gave interested parties an
opportunity to submit comments by February 7, 2017, for us to consider
before beginning work on the final version of the guidance. We received
a few comments on the draft guidance and have modified the final
guidance where appropriate. Changes to the guidance include modifying
the Exposure Based Testing Tiers 2 and 3 to be consistent with FDA's
``Guidance for Industry: Preparation of Food Contact Notifications for
Food Contact Substances: Toxicology Recommendations. Specifically, the
upper bound of Tier 2 now includes an exposure equal to or less than
2.5 micrograms per kilogram of body weight per day ([micro]g/kg bw/day)
and lower bound of Tier 3 is now greater than 2.5 [micro]g/kg bw/day.
The guidance announced in this notice finalizes the draft guidance
dated December 2016.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that 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
collection of information in this guidance was approved under OMB
control number 0910-0495.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: May 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09530 Filed 5-8-19; 8:45 am]
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