[Federal Register Volume 76, Number 94 (Monday, May 16, 2011)]
[Notices]
[Pages 28256-28257]
[FR Doc No: 2011-11917]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64457; File No. SR-BX-2011-024]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Codify
the Collection of the Covered Sales Fee

May 10, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 2, 2011, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'') 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 Exchange. The Exchange filed the proposed
rule change pursuant to Section 19(b)(3)(A)(ii) of the Act \3\ and Rule
19b-4(f)(2) thereunder,\4\ which renders the proposal effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Chapter V, Sec. 2 (Fees and Charges)
of the Rules of the Boston Options Exchange Group, LLC (``BOX'') to
codify the collection of the Covered Sales Fee. The text of the
proposed rule change is available at the principal office of the
Exchange, the Commission's Public Reference Room, on the Commission's
Web site at http://www.sec.gov, and also on the Exchange's Internet Web
site at http://nasdaqomxbx.cchwallstreet.com/NASDAQOMXBX/Filings/.

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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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
    Pursuant to Section 31 of the Securities and Exchange Act of 1934
(``the Act'') \5\ and Rule 31 thereunder,\6\ national securities
exchanges and associations (collectively, ``SROs'') are required to pay
a transaction fee to the Securities and Exchange Commission
(``Commission'') that is designed to recover the costs related to the
government's supervision and regulation of the securities markets and
securities professionals. To offset this obligation, Participants are
assessed charges in connection with satisfaction of the Exchange's
payment obligations under Section 31. This fee is collected indirectly
from Participants through their clearing firms by the Options Clearing
Corporation (``OCC'') on behalf of the Exchange. The fee defrays the
cost of the Section 31 fee triggered by the covered sale. The fee
assessed to a Participant is equal to the Section 31 fee assessed by
the Commission for the covered sale. The fee is collected by billing
the Participant's designated clearing firm for the amount owed by the
Participant to the Exchange. Assessing a sale fee is common practice
among national exchanges.\7\
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    \5\ 15 U.S.C. 78ee.
    \6\ 17 CFR 240.31.
    \7\ See e.g. International Securities Exchange (``ISE'') Rule
212 and NASDAQ OMX PHLX (``PHLX'') Rule 607.
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    The Exchange is now proposing to codify this process by adopting
the proposed Section 2(c) to Chapter V of the BOX Trading Rules. This
proposed amendment codifies that the fee now referred to as the Covered
Sale Fee is collected indirectly from Options Participants through
their clearing firms by a designated clearing agency, as defined by the
Act, on behalf of the Exchange and that to the extent there may be any
excess monies collected under this Rule, the Exchange may retain those
monies to help fund its general operating expenses. In addition, newly
proposed Section 2(c) sets forth and explains the circumstances when a
Covered Sale Fee is assessed by the Exchange to an Options Participant
as follows: (i) When a sale in option securities occurs with respect to
which the Exchange is obligated to pay a fee to the Commission under
Section 31 of the Act; and (2) when a sell order in option securities
is routed for execution at an away market other than on BOX, resulting
in a covered sale on that market and an obligation of the Routing
Broker providing routing services for BOX, as described in Chapter XII,
Sec. 5, Supp. Material .01 of the BOX Trading Rules, to pay the related
sales fee of that away market.\8\
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    \8\ Sell orders in options securities entered into BOX that are
routed to another market for execution, however, do not result in a
covered sale on the Exchange. Execution of such routed orders is
facilitated by Routing Broker(s), which executes the routed order on
the away market on behalf of the Participant. Such routed sell
orders result in a covered sale on the away market, which incurs a
Section 31 fee obligation. The away market assesses a sale fee on
the Routing Broker to defray the cost of the Section 31 fee
obligation. In turn, as proposed, the Exchange will assess the
Participant, the original selling party, a Covered Sale Fee to
defray the cost of the Section 31 fee passed on by the away market
pursuant to its sale fee. As such, the Exchange's Covered Sale Fee
offsets the sale fee the Routing Broker(s) is assessed by the away
market, and BOX reimburses the amounts paid by the Routing Broker(s)
to the away markets, the result of which is to place the parties
involved in the transaction in the same position as if the covered
sale had occurred on the Exchange.
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    Finally, the Exchange proposes to reletter the remainder of Section
2.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\9\ in general, and
furthers the objectives of Section (b)(4),\10\ in particular, in that
it

is designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Participants and other persons using
the facilities. The proposed rule is codifying a practice currently
employed by Exchange and the OCC. By adopting this rule, the Exchange
is providing Participants with a description of the Covered Sale Fee
and the process by which the Covered Sale Fee is collected.
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    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Exchange Act \11\ and Rule 19b-4(f)(2)
thereunder,\12\ because it establishes or changes a due, fee, or other
charge applicable only to a member.
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    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \12\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

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

Paper Comments

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

All submissions should refer to File Number SR-BX-2011-024. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BX-2011-024 and should be
submitted on or before June 6, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-11917 Filed 5-13-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 19, 2008 (Volume 73, Number 54)]
[Notices]
[Page 14866]
[DOCID:fr19mr08-124]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2008-11]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATE: Comments on this petition must identify the petition docket
number involved and must be received on or before April 8, 2008.

ADDRESSES: You may send comments identified by Docket Number FAA-2007-
0370 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, D.C. 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jan Thor<PHONE_NUMBER>), Transport
Airplane Directorate, Federal Aviation Administration, 1601 Lind
Avenue, SW., Renton, WA 98057-3356, or Frances Shaver<PHONE_NUMBER>),
Office of Rulemaking, Federal Aviation Administration, 800 Independence
Avenue, SW., Washington, DC 20591.

    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on March 13, 2008.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2007-0370.
    Petitioner: FedEx Express Corporation.
    Section of 14 CFR Affected: Sec.  121.312(e)(1).
    Description of Relief Sought: Operation of nine Boeing Model MD-11F
airplanes, registration numbers N577FE, N574FE, N576FE, N575FE, N526FE,
N527FE, N524FE, N523FE, and N521FE with two cockpit air supply ducts
(BWT 10502-1 Silencer Duct and ABM 7668-1 Duct) that do not meet the
flammability requirements of Sec.  25.856(a).

 [FR Doc. E8-5482 Filed 3-18-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Notices]
[Page 56415]
[FR Doc No: 2014-22334]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73098; File No. SR-EDGA-2014-16]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To Establish a New Market Data Product Called the BATS One Feed

September 15, 2014.
    On July 14, 2014, EDGA Exchange, Inc. (``Exchange'' or ``EDGA'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
establish a new market data product called the BATS One Feed. The
proposed rule change was published for comment in the Federal Register
on August 1, 2014.\3\ One comment on the proposal has been received.\4\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 72689 (July 28,
2014), 79 FR 44917.
    \4\ See Letter from Suzanne Shatto to Commission (Aug. 19,
2014); see also Letter from Sal Arnuk and Joe Saluzzi, Themis
Trading LLC, to Elizabeth M. Murphy, Secretary, Commission, dated
August 21, 2014 (SR-BATS-2014-028); Letter from Ira D. Hammerman,
General Counsel, SIFMA, to Kevin M. O'Neill, Deputy Secretary,
Commission, dated August 22, 2014 (SR-BATS-2014-028) (letters
commenting on a companion BATS filing that proposes to offer the
same feed).
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    Section 19(b)(2) of the Act \5\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
Commission is extending this 45-day time period.
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    \5\ 15 U.S.C. 78s(b)(2).
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    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change and the
comments received. Accordingly, the Commission, pursuant to Section
19(b)(2) of the Act,\6\ designates October 30, 2014, as the date by
which the Commission shall either approve or disapprove or institute
proceedings to determine whether to disapprove the proposed rule change
(File No. SR-EDGA-2014-16).
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    \6\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(57).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-22334 Filed 9-18-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)]
[Notices]
[Pages 51237-51239]
[FR Doc No: 2016-18321]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 32196; 812-14650]

CSat Investment Advisory, L.P., et al.; Notice of Application

July 28, 2016.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (the ``Act'') for an exemption from
sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1
under the Act, under sections 6(c) and 17(b) of the Act for an
exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under
section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and
12(d)(1)(B) of the Act. The requested order would permit (a) index-
based series of certain open-end management investment companies
(``Funds'') to issue shares redeemable in large aggregations only
(``Creation Units''); (b) secondary market transactions in Fund shares
to occur at negotiated market prices rather than at net asset value
(``NAV''); (c) certain Funds to pay redemption proceeds, under certain
circumstances, more than seven days after the tender of shares for
redemption; (d) certain affiliated persons of a Fund to deposit
securities into, and receive securities from, the Fund in connection
with the purchase and redemption of Creation Units; and (e) certain
registered management investment companies and unit investment trusts
outside of the same group of investment companies as the

Funds (``Funds of Funds'') to acquire shares of the Funds.

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APPLICANTS:  CSat Investment Advisory, L.P. (``CSat''), a Delaware
limited partnership registered as an investment adviser under the
Investment Advisers Act of 1940, ETF Series Solutions (``Trust''), a
Delaware statutory trust registered under the Act as an open-end
management investment company with multiple series, and Quasar
Distributors, LLC (``Distributor''), a Delaware limited liability
company and broker-dealer registered under the Securities Exchange Act
of 1934 (``Exchange Act'').

FILING DATES:  The application was filed on May 11, 2016.

HEARING OR NOTIFICATION OF HEARING:  An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on August 23, 2016, and should be accompanied by proof of
service on applicants, in the form of an affidavit, or for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street
NE., Washington, DC 20549-1090; Applicants: CSAT: 625 Avis Drive, Ann
Arbor, MI 48108; The Trust and the Distributor: Michael Barolsky, Esq.,
615 East Michigan Street, 4th Floor, Milwaukee, WI 53202.

FOR FURTHER INFORMATION CONTACT: Jean E. Minarick, Senior Counsel, at
(202) 551-6811, or Daniele Marchesani, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Summary of the Application

    1. Applicants request an order that would allow Funds to operate as
index exchange traded funds (``ETFs'').\1\ Fund shares will be
purchased and redeemed at their NAV in Creation Units only. All orders
to purchase Creation Units and all redemption requests will be placed
by or through an ``Authorized Participant'', which will have signed a
participant agreement with the Distributor. Shares will be listed and
traded individually on a national securities exchange, where share
prices will be based on the current bid/offer market. Any order
granting the requested relief would be subject to the terms and
conditions stated in the application.
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    \1\ Applicants request that the order apply to CSAT US Equity
ETF and any additional series of the Trust, and any other open-end
management investment company or series thereof (each, included in
the term ``Fund''), each of which will operate as an ETF and will
track a specified index comprised of domestic or foreign equity and/
or fixed income securities (each, an ``Underlying Index''). Any Fund
will (a) be advised by CSat or an entity controlling, controlled by,
or under common control with CSat (each, an ``Adviser'') and (b)
comply with the terms and conditions of the application.
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    2. Each Fund will hold investment positions selected to correspond
generally to the performance of an Underlying Index. In the case of
Self-Indexing Funds, an affiliated person, as defined in section
2(a)(3) of the Act (``Affiliated Person''), or an affiliated person of
an Affiliated Person (``Second-Tier Affiliate''), of the Trust or a
Fund, of the Adviser, of any sub-adviser to or promoter of a Fund, or
of the Distributor will compile, create, sponsor or maintain the
Underlying Index.\2\
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    \2\ Each Self-Indexing Fund will post on its Web site the
identities and quantities of the investment positions that will form
the basis for the Fund's calculation of its NAV at the end of the
day. Applicants believe that requiring Self-Indexing Funds to
maintain full portfolio transparency will help address, together
with other protections, conflicts of interest with respect to such
Funds.
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    3. Shares will be purchased and redeemed in Creation Units and
generally on an in-kind basis. Except where the purchase or redemption
will include cash under the limited circumstances specified in the
application, purchasers will be required to purchase Creation Units by
depositing specified instruments (``Deposit Instruments''), and
shareholders redeeming their shares will receive specified instruments
(``Redemption Instruments''). The Deposit Instruments and the
Redemption Instruments will each correspond pro rata to the positions
in the Fund's portfolio (including cash positions) except as specified
in the application.
    4. Because shares will not be individually redeemable, applicants
request an exemption from section 5(a)(1) and section 2(a)(32) of the
Act that would permit the Funds to register as open-end management
investment companies and issue shares that are redeemable in Creation
Units only.
    5. Applicants also request an exemption from section 22(d) of the
Act and rule 22c-1 under the Act as secondary market trading in shares
will take place at negotiated prices, not at a current offering price
described in a Fund's prospectus, and not at a price based on NAV.
Applicants state that (a) secondary market trading in shares does not
involve a Fund as a party and will not result in dilution of an
investment in shares, and (b) to the extent different prices exist
during a given trading day, or from day to day, such variances occur as
a result of third-party market forces, such as supply and demand.
Therefore, applicants assert that secondary market transactions in
shares will not lead to discrimination or preferential treatment among
purchasers. Finally, applicants represent that share market prices will
be disciplined by arbitrage opportunities, which should prevent shares
from trading at a material discount or premium from NAV.
    6. With respect to Funds that effect creations and redemptions of
Creation Units in kind and that are based on certain Underlying Indexes
that include foreign securities, applicants request relief from the
requirement imposed by section 22(e) in order to allow such Funds to
pay redemption proceeds within fifteen calendar days following the
tender of Creation Units for redemption. Applicants assert that the
requested relief would not be inconsistent with the spirit and intent
of section 22(e) to prevent unreasonable, undisclosed or unforeseen
delays in the actual payment of redemption proceeds.
    7. Applicants request an exemption to permit Funds of Funds to
acquire Fund shares beyond the limits of section 12(d)(1)(A) of the
Act; and the Funds, and any principal underwriter for the Funds, and/or
any broker or dealer registered under the Exchange Act, to sell shares
to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act.
The application's terms and conditions are designed to, among other
things, help prevent any potential (i) undue influence over a Fund
through control or voting power, or in connection with certain
services, transactions, and underwritings, (ii) excessive layering of
fees, and (iii) overly complex fund structures, which are the concerns
underlying the limits in sections 12(d)(1)(A) and (B) of the Act.
    8. Applicants request an exemption from sections 17(a)(1) and
17(a)(2) of the

Act to permit persons that are Affiliated Persons, or Second Tier
Affiliates, of the Funds, solely by virtue of certain ownership
interests, to effectuate purchases and redemptions in-kind. The deposit
procedures for in-kind purchases of Creation Units and the redemption
procedures for in-kind redemptions of Creation Units will be the same
for all purchases and redemptions and Deposit Instruments and
Redemption Instruments will be valued in the same manner as those
investment positions currently held by the Funds. Applicants also seek
relief from the prohibitions on affiliated transactions in section
17(a) to permit a Fund to sell its shares to and redeem its shares from
a Fund of Funds, and to engage in the accompanying in-kind transactions
with the Fund of Funds.\3\ The purchase of Creation Units by a Fund of
Funds directly from a Fund will be accomplished in accordance with the
policies of the Fund of Funds and will be based on the NAVs of the
Funds.
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    \3\ The requested relief would apply to direct sales of shares
in Creation Units by a Fund to a Fund of Funds and redemptions of
those shares. Applicants, moreover, are not seeking relief from
section 17(a) for, and the requested relief will not apply to,
transactions where a Fund could be deemed an Affiliated Person, or a
Second-Tier Affiliate, of a Fund of Funds because an Adviser or an
entity controlling, controlled by or under common control with an
Adviser provides investment advisory services to that Fund of Funds.
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    9. Section 6(c) of the Act permits the Commission to exempt any
persons or transactions from any provision of the Act if such exemption
is necessary or appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act. Section 12(d)(1)(J) of the Act
provides that the Commission may exempt any person, security, or
transaction, or any class or classes of persons, securities, or
transactions, from any provision of section 12(d)(1) if the exemption
is consistent with the public interest and the protection of investors.
Section 17(b) of the Act authorizes the Commission to grant an order
permitting a transaction otherwise prohibited by section 17(a) if it
finds that (a) the terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned; (b) the proposed transaction is consistent with the policies
of each registered investment company involved; and (c) the proposed
transaction is consistent with the general purposes of the Act.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-18321 Filed 8-2-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Notices]
[Pages 57805-57806]
[FR Doc No: 2015-24374]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file

associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic 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, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

------------------------------------------------------------------------
            Docket No.              File date    Presenter or requester
------------------------------------------------------------------------
Prohibited:
    1. CP14-96-000...............       9-8-15  Nuclear Information and
                                                 Resource Service.
Exempt:
    1. CP15-93-000...............       9-8-15  U.S. Representative Tim
                                                 Murphy.
    2. CP13-483-000, CP13-492-000       9-8-15  FERC Staff.\1\
    3. CP09-6-001................      9-11-15  FERC Staff.\2\
    4. CP14-347-000..............      9-15-15  FERC Staff.\3\
    5. P-2464-000, P-2484-000....      9-16-15  FERC staff.\4\
------------------------------------------------------------------------
\1\ Notes from 9-2-15 telephone conference call with federal cooperating
  agencies regarding production of the final environmental impact
  statement.
\2\ Summary of 9-2-15 telephone conference with Oregon LNG
  Representatives and DOT PHMSA Staff.
\3\ Minutes from 9-3-15 meeting with National Marine Fisheries Service,
  US Army Corps of Engineers, Magnolia, and their respective
  contractors.
\4\ eMails from 3-27-15 to 7-2-15 regarding the license application and
  environmental assessment for the Upper and Weed Dams.

    Dated: September 21, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-24374 Filed 9-24-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Notices]
[Pages 22971-22972]
[FR Doc No: 2018-10535]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG18-85-000.
    Applicants: Pegasus Wind, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Pegasus Wind, LLC.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5115.
    Comments Due: 5 p.m. ET 6/1/18.

    Docket Numbers: EG18-86-000.
    Applicants: Thunder Spirit Wind, LLC.
    Description: Self-Certification of EG or FC of Thunder Spirit Wind,
LLC.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5193.
    Comments Due: 5 p.m. ET 6/1/18.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1437-006.
    Applicants: Tampa Electric Company.
    Description: Second Supplement to June 30, 2017 Triennial Market
Power Update for the Southeast Region [Asset Appendix] of Tampa
Electric Company.
    Filed Date: 5/10/18.
    Accession Number: 20180510-5212.
    Comments Due: 5 p.m. ET 5/31/18.

    Docket Numbers: ER10-2507-016.
    Applicants: Westar Energy, Inc.
    Description: Notice of Non-Material Change in Status of Westar
Energy, Inc.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5162.
    Comments Due: 5 p.m. ET 6/1/18.

    Docket Numbers: ER13-136-004; ER13-135-004; ER13-137-004; ER13-138-
004; ER13-141-004; ER13-142-004.
    Applicants: Georgia-Pacific Brewton LLC.
    Description: Supplement to December 19, 2017 Triennial Market-Power
Analyses of the Georgia-Pacific Entities in the Southeast Region.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5163.
    Comments Due: 5 p.m. ET 6/1/18.

    Docket Numbers: ER18-1386-001.
    Applicants: Southern California Edison Company.
    Description: Tariff Amendment: Amended LGIA Desert Harvest Revised
ITCC to be effective 4/19/2018.
    Filed Date: 5/10/18.
    Accession Number: 20180510-5149.
    Comments Due: 5 p.m. ET 5/31/18.

    Docket Numbers: ER18-1569-000.
    Applicants: Emera Maine.
    Description: Compliance filing: Order No. 842 Compliance to be
effective 5/15/2018.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5021.
    Comments Due: 5 p.m. ET 6/1/18.

    Docket Numbers: ER18-1570-000.
    Applicants: NorthWestern Corporation.
    Description: Compliance filing: Order No. 842 Compliance Filing--
Montana OATT to be effective 5/15/2018.

    Filed Date: 5/11/18.
    Accession Number: 20180511-5023.
    Comments Due: 5 p.m. ET 6/1/18.

    Docket Numbers: ER18-1571-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits First Quarter 2018
Capital Budget Report.
    Filed Date: 5/10/18.
    Accession Number: 20180510-5218.
    Comments Due: 5 p.m. ET 5/31/18.

    Docket Numbers: ER18-1572-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3446 Group NIRE/SPS
Facilities Construction Agreement to be effective 7/10/2018.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5043.
    Comments Due: 5 p.m. ET 6/1/18.

    Docket Numbers: ER18-1573-000.
    Applicants: Erie Power, LLC.
    Description: Tariff Cancellation: Notice of cancellation--July 13
2018 to be effective 7/13/2018.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5069.
    Comments Due: 5 p.m. ET 6/1/18.

    Docket Numbers: ER18-1574-000.
    Applicants: NSTAR Electric Company.
    Description: Sec.  205(d) Rate Filing: Related Facilities Agreement
between NSTAR Electric Co. and Milford Power, LLC to be effective 4/30/
2018.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5076.
    Comments Due: 5 p.m. ET 6/1/18.

    Docket Numbers: ER18-1575-000.
    Applicants: NorthWestern Corporation.
    Description: Compliance filing: Order No. 842 Compliance Filing--
South Dakota OATT to be effective 5/15/2018.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5077.
    Comments Due: 5 p.m. ET 6/1/18.

    Docket Numbers: ER18-1576-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Unexecuted GIA & Distrib
Serv Agmt LACFCD--San Gabriel Dam Hydroelectric Plant to be effective
5/1/2018.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5164.
    Comments Due: 5 p.m. ET 6/1/18.

    Docket Numbers: ER18-1577-000.
    Applicants: Thunder Spirit Wind, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 5/14/2018.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5184.
    Comments Due: 5 p.m. ET 6/1/18.

    Docket Numbers: ER18-1578-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Revisions to OATT Sch. 12--
Appx A re: RTEP Projects Approved by April 2018 to be effective 8/9/
2018.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5210.
    Comments Due: 5 p.m. ET 6/1/18.

    Docket Numbers: ER18-1579-000.
    Applicants: Western Interconnect LLC.
    Description: Sec.  205(d) Rate Filing: Revised LGIA with Grady Wind
Energy to be effective 7/10/2018.
    Filed Date: 5/11/18.
    Accession Number: 20180511-5211.
    Comments Due: 5 p.m. ET 6/1/18.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES18-38-000.
    Applicants: MidAmerican Energy Company.
    Description: Application under Section 204 of the Federal Power Act
for Authorization to Issue and Sell Debt Securities of MidAmerican
Energy Company.
    Filed Date: 5/10/18.
    Accession Number: 20180510-5221.
    Comments Due: 5 p.m. ET 5/31/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 11, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-10535 Filed 5-16-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 22, 2008 (Volume 73, Number 36)]
[Notices]
[Page 9847-9849]
[DOCID:fr22fe08-121]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Noise Exposure Map Notice: Receipt of Noise Compatibility Program
and Request for Review for Centennial Airport, Englewood, CO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION:  Notice.

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

SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the noise-exposure maps (NEM's) submitted for
Centennial Airport, Englewood, CO, under the provisions of 49 U.S.C.
47501 et seq. (Aviation Safety and Noise Abatement Act) and 14 CFR Part
150, are in compliance with applicable requirements. In conjunction
with the NEM's, the FAA also announces that it is reviewing a proposed
noise compatibility program (NCP) submitted for Centennial Airport, per
14 CFR Part 150. This program will be approved or disapproved on or
before August 12, 2008.

DATES: Effective Date: The effective date of the FAA's determination on
the NEM's and the start of the FAA's review

of the associated NCP is February 14, 2008.

DATES: Comments must be received on or before April 22, 2008.

FOR FURTHER INFORMATION CONTACT: Linda Bruce, Federal Aviation
Administration, Denver Airports District Office, 26805 E. 68th Avenue,
Suite 224, Denver, CO 80249, telephone:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>Comments on the proposed noise compatibility
program also should be submitted to the above office.

SUPPLEMENTARY INFORMATION: This notice announces the FAA's finding that
NEM's submitted for Centennial Airport are in compliance with
applicable requirements of 14 CFR Part 150, effective February 14,
2008. Further, the FAA is reviewing that airport's proposed NCP, which
will be approved or disapproved on or before August 12, 2008. This
notice also announces the availability of this proposed program for
public review and comment.
    Under 49 U.S.C., section 47503 (the Aviation Safety and Noise
Abatement Act, hereinafter referred to as ``the Act''), an airport
operator may submit to the FAA NEM's that meet applicable regulations
and depict non-compatible land uses, as of the date of submission of
such maps; a description of projected aircraft operations; and the ways
in which such operations will affect such maps. The Act requires such
maps to be developed in consultation with interested and affected
parties in the local community, government agencies, and persons using
the airport.
    An airport operator who has submitted NEM's that are found by the
FAA to be in compliance with the requirements of Title 14 Code of
Federal Regulations, Part 150, Airport Noise Compatibility Planning (14
CFR Part 150), promulgated pursuant to the Act, may submit to the FAA
for approval a NCP that sets forth the measures the operator has taken
or proposes to take to reduce existing non-compatible uses and prevent
the introduction of additional non-compatible uses.
    The Arapahoe County Public Airport Authority owns and operates
Centennial Airport, located in the Denver suburb of Englewood, CO. In
April 2002, the Executive Director of the Arapahoe County Public
Airport Authority requested the FAA to review the NCP and NEM's for
Centennial Airport, contained in the Centennial Airport FAR Part 150
Noise Exposure and Land Use Compatibility Study Program. The FAA
requested corrections be made to the NCP, and worked with the airport
authority to revise the study. Subsequently, the airport authority
submitted to FAA a revised version of the compatibility study program
in August 2003. Due to unrelated issues, FAA action on the study was
delayed until June 2006, when the FAA issued a grant to the Arapahoe
County Public Airport Authority to update Centennial Airport's noise
exposure maps. This update was completed in November 2007.
    On December 1, 2007, the Executive Director of the Arapahoe County
Public Airport Authority submitted to the FAA NEM's, descriptions, and
other documentation developed as part of an update to the Centennial
Airport FAR Part 150 Noise Exposure and Land Use Compatibility Study
Program. The authority requested the FAA to review this material and
the NEM's, as described in section 47503 of the Act; and approve the
noise mitigation measures, to be implemented jointly by the airport and
surrounding communities, as a NCP under section 47504 of the Act.
    These updated NEM's reference in this notice are the maps that FAA
has determined are in compliance with application requirements.
Further, the NCP submitted in conjunction with these updated NEM's and
referenced in this notice, is the final version of the Centennial
Airport FAR Part 150 Noise Exposure and Land Use Compatibility Study
Program, dated August 2003.
    The FAA has completed its review of the NEM's and related
descriptions submitted for Centennial Airport. The specific
documentation determined to constitute the NEM's includes the following
from the Centennial Airport FAR Part 150 Noise Exposure and Land Use
Compatibility Study Program and Centennial Airport Noise Contour Map
Update:
     Supplemental chapter, titled Centennial Airport Noise
Contour Map Update: Noise Contour and Population Analysis, provides--

--Updates to Forecasts of Aviation Activity (see pages 1-4)
--Figure 4, Revised 2006 Existing Noise Exposure Map (page 13)
--Figure 5, Revised Future 2012 Noise Exposure Map (page 15)

     Section B describes prior forecasts of aviation activity.
     Section C describes noise analysis used to develop the
existing and future contours.
     Section D describes land use analysis.
     Section F describes the noise abatement alternative
evaluation, including prior existing Noise Exposure Map (Figure F.17).
     Section G summarizes actions and recommendations,
including prior Future Noise Exposure Map (Figure G.4).
     Section H--Public and Airport User Consultation Summary.
     Appendix--Public Hearing Comments and Responses and Public
Involvement Plan.
    The FAA has determined that these maps for Centennial Airport are
in compliance with applicable requirements. This determination is
effective on February 14, 2008. The FAA's determination on an airport
operator's NEM's is limited to a finding that the maps were developed
in accordance with the procedures contained in appendix A of 14 CFR
part 150. Such determination does not constitute approval of the
applicant's data, information or plans, or a commitment to approve a
NCP or to fund the implementation of that program.
    If questions arise concerning the precise relationship of specific
properties to noise exposure contours depicted on a NEM submitted under
section 47503 of the Act, it should be noted that the FAA is not
involved in any way in determining the relative locations of specific
properties with regard to the depicted noise contours, or in
interpreting the NEM's to resolve questions concerning, for example,
which properties should be covered by the provisions of section 47506
of the Act. These functions are inseparable from the ultimate land use
control and planning responsibilities of local government. These local
responsibilities are not changed in any way under 14 CFR Part 150 or
through the FAA's review of NEM's. Therefore, the responsibility for
the detailed overlaying of noise exposure contours onto the map
depicting properties on the surface rests exclusively with the airport
sponsor that submitted those maps, or with those public agencies and
planning agencies with which consultation is required under section
47503 of the Act. The FAA has relied on the certification by the
airport sponsor, under 14 CFR Part 150.21, that the statutorily
required consultation has been accomplished.
    The FAA has formally received the NCP for Centennial Airport, also
effective on February 14, 2008. Preliminary review of the submitted
material indicates that it conforms to the requirements for the
submittal of a NCP, but requires further review prior to approval or
disapproval of the program. The formal review period, limited by law to
a maximum of 180 days, will be completed on or before August 12, 2008.
    The FAA's detailed evaluation will be conducted under the
provisions of 14

CFR Part 150.33. The primary considerations in the evaluation process
are whether the proposed measures may reduce the level of aviation
safety, create an undue burden or interstate or foreign commerce, or be
reasonably consistent with obtaining the goal of reducing existing non-
compatible land uses and preventing the introduction of additional non-
compatible land uses.
    Interested persons are invited to comment on the proposed program
with specific reference to these factors. The FAA will consider, to the
extent practicable, all comments, other than those properly addressed
to local land use authorities. Electronic versions of the noise
exposure map update and the proposed noise compatibility program are
available at the following Internet sites:
    1. http://www.faa.gov/airports_airtraffic/airports/regional_
guidance/northwest mountain/environmental/.
    2. www.centennialairport.com.

ADDRESSES: Paper copies of these documents are available for
examination at the following locations:
    1. Federal Aviation Administration, Airports Division, 1601 Lind
Avenue, SW., Suite 315, Renton, Washington 98057-3356,<PHONE_NUMBER>.
    2. Federal Aviation Administration, Denver Airports District
Office, 26805 E. 68th Avenue, Suite 224, Denver, CO 80249-6361, (303)
342-1264.
    3. Arapahoe County Public Airport Authority, 7800 South Peoria
Street, Englewood, CO 80112,<PHONE_NUMBER>.

    Issued in Renton, Washington, on February 14, 2008.
Donna P. Taylor,
Manager, Airports Division, Northwest Mountain Region.
[FR Doc. 08-788 Filed 2-21-08: 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Notices]
[Pages 67287-67288]
[FR Doc No: 2018-28220]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0536]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on Form FDA 3601, entitled ``Medical Device
User Fee Cover Sheet,'' which must be submitted along with certain
medical device product applications, supplements, and fee payment of
those applications.

DATES: Submit either electronic or written comments on the collection
of information by February 26, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 26, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2012-N-0536 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device User Fee Cover
Sheet, Form FDA 3601.'' Received comments, those filed in a timely
manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Device User Fee Cover Sheet, Form FDA 3601

OMB Control Number 0910-0511--Extension

    The Federal Food, Drug, and Cosmetic Act, as amended by the Medical
Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), and
the Medical Device User Fee Amendments of 2007 (title II of the Food
and Drug Administration Amendments Act of 2007), authorizes FDA to
collect user fees for certain medical device applications. Under this
authority, companies pay a fee for certain new medical device
applications or supplements submitted to the Agency for review. Because
the submission of user fees concurrently with applications and
supplements is required, the review of an application cannot begin
until the fee is submitted. Form FDA 3601, the ``Medical Device User
Fee Cover Sheet,'' is designed to provide the minimum necessary
information to determine whether a fee is required for review of an
application, to determine the amount of the fee required, and to
account for and track user fees. The form provides a cross-reference
between the fees submitted for an application with the actual submitted
application by using a unique number tracking system. The information
collected is used by FDA's Center for Devices and Radiological Health
and the Center for Biologics Evaluation and Research to initiate the
administrative screening of new medical device applications and
supplemental applications.
    The total number of annual responses is based on the average number
of cover sheet submissions received by FDA in recent years. The number
of received annual responses includes cover sheets for applications
that were qualified for small businesses and fee waivers or reductions.
The estimated hours per response are based on past FDA experience with
the various cover sheet submissions, and range from 5 to 30 minutes.
The hours per response are based on the average of these estimates (18
minutes).
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                               Number of
       FDA form No.            Number of     responses per   Total annual    Average burden per     Total hours
                              respondents     respondent       responses          response
----------------------------------------------------------------------------------------------------------------
3601......................           6,379               1           6,379  0.30 (18 minutes)...           1,914
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an
overall increase of 350 hours and a corresponding increase of 1,165
responses/records. We attribute this adjustment to an increase in the
number of submissions we received over the last few years.

    Dated: December 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-28220 Filed 12-27-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Rules and Regulations]
[Pages 68200-68203]
[FR Doc No: 2010-28007]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. FDA-2008-N-0273]

Medical Devices; Radiology Devices; Reclassification of Full-
Field Digital Mammography System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
reclassification of the full-field digital mammography (FFDM) system
from class III (premarket approval) to class II (special controls). The
device type is intended to produce planar digital x-ray images of the
entire breast; this generic type of device may include digital
mammography acquisition software, full-field digital image receptor,
acquisition workstation, automatic exposure control, image processing
and reconstruction programs, patient and equipment supports, component
parts, and accessories. The special control that will apply to the
device is the guidance document entitled ``Class II Special Controls
Guidance Document: Full-Field Digital Mammography System.'' FDA is
reclassifying the device into class II (special controls) because
general controls along with special controls will provide a reasonable
assurance of safety and effectiveness of the device. Elsewhere in this
issue of the Federal Register, FDA is announcing the availability of
the guidance document that will serve as the special control for this
device.

DATES: This rule is effective December 6, 2010.

FOR FURTHER INFORMATION CONTACT:

Mary Pastel, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. G304, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or
Kyle J. Myers, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 62, rm. 3118,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Statutory Framework for Device Classification

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
301 et seq.), as amended by the Medical Device Amendments of 1976 (Pub.
L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.
105-115), and the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85), among other amendments, established a comprehensive
system for the regulation of medical devices intended for human use.
Section 513 of the FD&C Act (21 U.S.C. 360c) established three
categories (classes) of devices, depending on the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513 of the FD&C Act, FDA refers to devices that were
in commercial distribution before May 28, 1976 (the date of enactment
of the 1976 amendments), as ``preamendments devices.'' FDA classifies
these devices after the Agency has taken the following steps:
    1. Receives a recommendation from a device classification panel (an
FDA advisory committee);
    2. Publishes the panel's recommendation for comment, along with a
proposed regulation classifying the device; and
    3. Publishes a final regulation classifying the device type.
    FDA has classified most preamendments devices under these
procedures.
    FDA refers to devices that were not in commercial distribution
before May 28, 1976, as ``postamendments devices.'' These devices are
classified automatically by statute (section 513(f) of the FD&C Act)
into class III without any FDA rulemaking process. These device types
remain in class III and require premarket approval, unless and until:
    1. FDA reclassifies the device type into class I or II;
    2. FDA issues an order classifying the device type into class I or
II in accordance with section 513(f)(2) of the FD&C Act, as amended by
FDAMA; or
    3. FDA issues an order finding the device to be substantially
equivalent, under section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
    Reclassification of classified postamendments devices is governed
by section 513(f)(3) of the FD&C Act. This section provides that FDA
may initiate the reclassification of a device classified into class III
under section 513(f)(1) of the FD&C Act, or the manufacturer or
importer of a device may petition the Secretary of Health and Human
Services (the Secretary) for the issuance of an order classifying the
device into class I or class II. FDA's regulations in 21 CFR 860.134
set forth the procedures for the filing and review of a petition for
reclassification of these class III devices. To change the
classification of the device, the proposed new class must

have sufficient regulatory controls to provide reasonable assurance of
the safety and effectiveness of the device for its intended use.
    Under section 513(f)(3)(B)(i) of the FD&C Act, the Secretary may
ask for a recommendation from a device classification panel on a
proposed reclassification, whether initiated by FDA or a petitioner.
The panel will make a recommendation to FDA concerning the proposed
reclassification. The recommendation must contain the following
information: (1) A summary of the reasons for the recommendation, (2) a
summary of the data upon which the recommendation is based, and (3) an
identification of the risks to health (if any) presented by the device
that is the subject of the proposed reclassification.
    Following the effective date of this final rule, any firm
submitting a 510(k) for an FFDM system will need to address the issues
covered in the special controls guidance. However, the firm need only
show that its device meets the recommendations of the guidance or in
some other way provides equivalent assurances of safety and
effectiveness.

II. Regulatory History of the Device

    An FFDM system is a postamendments device classified into class III
under section 513(f)(1) of the FD&C Act. This generic type of device
cannot be placed in commercial distribution unless it is reclassified
under section 513(f)(3) of the FD&C Act or subject to an approval of a
premarket approval (PMA) application under section 515 of the FD&C Act
(21 U.S.C. 360e). In accordance with section 513(f)(3) of the FD&C Act
and based on information regarding the device, FDA, on its own
initiative, is reclassifying this device type from class III to class
II when intended to produce planar digital x-ray images of the entire
breast. This generic type of device may include digital mammography
acquisition software, full-field digital image receptor, acquisition
workstation, automatic exposure control, image processing and
reconstruction programs, patient and equipment supports, component
parts, and accessories. Consistent with the FD&C Act and the
regulation, FDA referred the proposed reclassification to the
Radiological Devices Panel (the Panel) for its recommendation on the
requested change in classification.
    At a public meeting on May 23, 2006, the Panel unanimously
recommended that the FFDM system be reclassified from class III to
class II (special controls). The Panel believed that class II with a
special controls guidance document, in addition to general controls,
would provide reasonable assurance of the safety and effectiveness of
the device (Ref. 1).
    Accordingly, in the Federal Register of May 30, 2008 (73 FR 31040),
FDA issued a proposed rule to reclassify the device, full-field digital
mammography system, from class III (premarket approval) into class II
(special controls). FDA invited interested persons to comment on the
proposed rule by August 28, 2008.
    A second meeting of the Panel was held on November 17, 2009. This
meeting was called because the comments received on the proposed rule
raised the following new questions: Are separate data needed to
demonstrate the equivalence of FFDM for screening and diagnosis
indications? Are statistically significant clinical studies needed to
demonstrate equivalence or can equivalence be demonstrated with
laboratory and phantom studies along with limited clinical
demonstrations? Are clinical data on various subgroups necessary to
demonstrate equivalence?
    The Panel unanimously recommended that the FFDM system be
reclassified from class III to class II (special controls). The Panel
also indicated that separate data are necessary for screening and
diagnostic claims; that laboratory and phantom studies with limited
clinical demonstration are adequate to establish equivalence; and that
subcategory analysis is unnecessary.

III. Summary of Final Rule

    The final rule contains revisions to the identification of the
device type, FFDM system in the draft classification regulation, 21 CFR
892.1715. The final rule uses the term ``planar'' instead of ``full-
field'' to describe digital x-ray images of the entire breast. The
sentence stating what the generic type of device may include was
revised by adding automatic exposure control, image processing and
reconstruction programs, patient and equipment supports, component
parts, and accessories, and by eliminating signal analysis programs.
This change was made to clarify the description by explicitly listing
aspects of the device and excluding signal analysis programs that are
contained within the display devices, which are regulated separately.
Display devices are not part of the FFDM system but rather are separate
class II devices. The identification now reads: Intended to produce
planar digital x-ray images of the entire breast. This generic type of
device may include digital mammography acquisition software, full-field
digital image receptor, acquisition workstation, automatic exposure
control, image processing and reconstruction programs, patient and
equipment supports, component parts, and accessories.

IV. Comments and FDA's Response

    During the public comment period, 23 respondents submitted
comments. The comments included manufacturers, professional
organizations, trade associations, and individual medical
professionals. All comments supported the reclassification of the FFDM
system from class III (premarket approval) to class II (special
controls).
    (Comment 1) One comment suggested that the identification's use of
the term ``signal analysis'' can be confusing in the context of FFDM
systems and suggested that some items were not completely incorporated
into the FFDM identification from the film/screen identification that
should have been incorporated for clarity. The comment suggested that
the regulation use the following identification to address those
concerns: A full-field digital mammography system is a device intended
to produce full-field digital x-ray images of the breast. This generic
type of device may include one or more of the following: Digital
mammography acquisition software, full-field digital image receptor,
acquisition workstation, automatic exposure control, and image
processing and reconstruction programs, patient and equipment supports,
component parts, and accessories.
    (Response) FDA agrees with the comment and has revised the
identification to be similar to the language suggested by the comment.

V. FDA's Conclusions

    Based on the information discussed in the preamble to the proposed
rule (73 FR 31040) and comments on the proposed rule and draft special
controls guidance, FDA concludes that special controls, in addition to
general controls, will provide reasonable assurance of the safety and
effectiveness of the full-field digital mammography system. The Agency
is reclassifying the full-field digital mammography system from class
III (premarket approval) to class II (special controls) when intended
to produce planar digital x-ray images of the entire breast. This
generic type of device may include digital mammography acquisition
software, full-field digital image receptor, acquisition workstation,
automatic exposure control, image processing and reconstruction
programs, patient and equipment supports, component parts, and
accessories.

    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of the guidance entitled ``Class II Special Controls
Guidance Document: Full-Field Digital Mammography System'' that the
Agency intends to use as the special control for this device. The
guidance addresses the information FDA believes should be included in a
premarket notification submission (510(k)) for the FFDM system. FDA has
identified the risks to health associated with the use of the device in
the first column of table 1 of the special controls guidance document.
The recommended mitigation measures are identified in the second column
of table 1 of the special controls guidance document.

VI. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VII. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Agency believes that
this final rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because classification of this device into class II
will relieve manufacturers of the cost of complying with the premarket
approval requirements of section 515 of the FD&C Act and may permit
small potential competitors to enter the marketplace by lowering their
costs, the Agency certifies that the final rule will not have a
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and Tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
    FFDM devices are intended to produce planar digital x-ray images of
the entire breast. This generic type of device may include digital
mammography acquisition software, full-field digital image receptor,
acquisition workstation, automatic exposure control, image processing
and reconstruction programs, patient and equipment supports, component
parts, and accessories. Based on the history of use of this type of
device since the first PMA was approved in 2000, FDA concludes that
reclassification from class III into class II (special controls) would
ensure safety and effectiveness of these devices without undue
regulatory burden. Manufacturers must address the issues identified by
the special controls guidance document. Manufacturers of new or
modified FFDM devices would be subject to premarket notification
requirements, but the burden of submitting a 510(k) would be
substantially less than that of preparing a PMA.

VIII. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain State requirements ``different from or in
addition to'' certain Federal requirements applicable to devices. 21
U.S.C. 360k; See Medtronic v. Lohr 518 U.S. 470 (1996); Riegel v.
Medtronic, 552 U.S. 312 (2008). The special controls established by
this final rule create ``requirements'' to address each identified risk
to health presented by these specific medical devices under 21 U.S.C.
360k, even though product sponsors may have flexibility in how they
meet those requirements. Cf. Papike v. Tambrands, Inc., 107 F.3d 737,
740-42 (9th Cir. 1997).

IX. Paperwork Reduction Act of 1995

    This final rule establishes as special controls a guidance document
that 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). Elsewhere in this issue of
the Federal Register, FDA is issuing a document announcing the
availability of the guidance document that will serve as the special
control for this device. That document contains an analysis of the
paperwork burden for the guidance document.

X. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but we are not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
    1. Radiological Devices Panel, Transcript, pp. 142-156, available
at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=659, May 23, 2006.
    2. Pisano, E., C. Gatsonis, E. Hendrick, et al., ``Digital
Mammographic Imaging Screening Trial (DMIST) Investigators Group,''
``Diagnostic Performance of Digital Versus Film Mammography for Breast-
Cancer Screening,'' New England Journal of Medicine, 353: 1773-1783,
2005.
    3. Yaffe, M., A. Bloomquist, G. Mawdsley, et al., ``Quality Control
for Digital Mammography: Part II Recommendations From the ACRIN DMIST
Trial,'' Medical Physics, 33(3): 737-752, 2006.
    4. Thomas, J., K. Chakrabarti, R. Kaczmarek, et al., ``Contrast
Detail Phantom Scoring Methodology,'' Medical Physics, 32(3), 807,
2005.
    5. Device Recalls Are Described in FDA's Briefing Information,
Slide Number 12, available at http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4219b1_04_draft%20FDA%20presentation.pdf, May 23, 2006.

List of Subjects in 21 CFR Part 892

    Medical devices, Radiation protection, X-rays.

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

PART 892--RADIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 892 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 892.1715 is added to subpart B to read as follows:

Sec.  892.1715  Full-field digital mammography system.

    (a) Identification. A full-field digital mammography system is a
device intended to produce planar digital x-ray images of the entire
breast. This generic type of device may include digital mammography
acquisition software, full-field digital image receptor, acquisition
workstation, automatic exposure control, image processing and
reconstruction programs, patient and equipment supports, component
parts, and accessories.
    (b) Classification. Class II (special controls). The special
control for the device is FDA's guidance document entitled ``Class II
Special Controls Guidance Document: Full-Field Digital Mammography
System.'' See Sec.  892.1(e) for the availability of this guidance
document.

    Dated: November 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28007 Filed 11-4-10; 8:45 am]
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[Federal Register Volume 84, Number 40 (Thursday, February 28, 2019)]
[Notices]
[Pages 6777-6778]
[FR Doc No: 2019-03443]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 9100-041]

James M. Knott; James M. Knott, Jr.; Notice of Application for
Transfer of License and Soliciting Comments, Motions To Intervene, and
Protests

    On January 8, 2019, James M. Knott, Jr. (transferee) filed an
application for an after-the-fact transfer of license of the Riverdale
Mills Project No. 9100. The project is located on the Blackstone River
in Worcester County, Massachusetts. The project does not occupy Federal
lands.
    The applicant seeks Commission approval to transfer the license for
the Riverdale Mills Project from James M. Knott (transferor) to the
transferee. James M. Knott passed away on August 16, 2018 and James M.
Knott, Jr. has been operating the project since that time.
    Applicant's Contacts: Mr. James M. Knott, Jr., CFO, 130 Riverdale
Street, PO Box 920, Northbridge, MA 01534-0920, Phone:<PHONE_NUMBER>,
Email<EMAIL_ADDRESS>and Mr. Kevin Young, President, 2112
Talmage Drive, Leland, NC 28541, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, and protests:
30 days from the date that the Commission issues this notice. The
Commission strongly encourages electronic filing. Please file comments,
motions to intervene, and protests 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<PHONE_NUMBER> (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-9100-041.

    Dated: February 21, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-03443 Filed 2-27-19; 8:45 am]
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[Federal Register Volume 77, Number 170 (Friday, August 31, 2012)]
[Notices]
[Pages 53250-53251]
[FR Doc No: 2012-21544]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

International Civil Aviation Organization's (ICAO) Dangerous
Goods Panel; Notice of Public Meeting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of public meeting.

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SUMMARY: In preparation for the International Civil Aviation
Organization's (ICAO) Dangerous Goods Panel's (DGP's) Fall Working
Group to be held October 15-19, 2012, in Montreal, Canada, the FAA's
Office of Hazardous Materials Safety and the Pipeline and Hazardous
Materials Safety Administration's (PHMSA) Office of Hazardous Materials
Safety announce a public meeting.

DATES: The public meeting will be held on October 10, 2012 from 9:00
a.m. until 12:30 p.m.

ADDRESSES: The public meeting will be held at FAA Headquarters (FOB
10A), Bessie Coleman Conference Center, 2nd Floor, 800 Independence
Avenue SW., Washington, DC 20591.
    Participants are requested to register by using the following email
address<EMAIL_ADDRESS>    Please include your name, organization, email address, and whether
you will be attending in person or participating via conference call.
    Conference call connection information will be provided to those
who register and indicate that they will participate via conference
call.

FOR FURTHER INFORMATION CONTACT: Questions regarding the meeting should
be directed to Ms. Janet McLaughlin, Deputy Director, Office of
Hazardous Materials Safety, ADG-2, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone (202) 385-
4900. Email<EMAIL_ADDRESS>    We are committed to providing equal access to this meeting for all
participants. If you need alternative formats or other reasonable
accommodations, please call<PHONE_NUMBER> or email<EMAIL_ADDRESS>with your request by close of business on October 1st.

Purpose of the Public Meeting

    Information and viewpoints provided by stakeholders are requested
as the United States delegation prepares for the International Civil
Aviation Organization's Dangerous Goods Panel's (ICAO DGP's) Working
Group of the Whole 12. The agenda for the Working Group is as follows:

Agenda Item 1: Development of proposals, if necessary, for amendments
to Annex 18--The Safe Transport of Dangerous Goods by Air
Agenda Item 2: Development of recommendations for amendments to the
Technical Instructions for the Safe Transport of Dangerous Goods by Air
(Doc 9284) for incorporation in the 2015-2016 Edition
Agenda Item 3: Development of recommendations for amendments to the
Supplement to the Technical Instructions for the Safe Transport of
Dangerous Goods by Air (Doc 9284SU) for incorporation in the 2015-2016
Edition
Agenda Item 4: Development of recommendations for amendments to the
Emergency Response Guidance for Aircraft Incidents involving Dangerous
Goods (Doc 9481) for incorporation in the 2015-2016 Edition
Agenda Item 5: Issues related to lithium batteries
Agenda Item 6: Resolution, where possible, of the non-recurrent work
items identified by the Air Navigation Commission or the panel:
    6.1: Competency-based training
    6.2: Incident data collection
    6.3: State of overflight involvement in the exemption process
    6.4: Coordination with the Operations Panel with regard to Annex 6
    6.5: Coordination with international organizations (e.g. UPU)
Agenda Item 7: Other business

    Papers relevant to these agenda items can be viewed at the
following Web page: http://www.icao.int/safety/DangerousGoods/Pages/DGP.aspx.

Public Meeting Procedures

    A panel of representatives from the FAA and PHMSA will be present.
The meetings are intended to be informal, non-adversarial, and to
facilitate the public comment process. No individual will be subject to
questioning by any other participant. Government representatives on the
panel may ask questions to clarify statements. Unless otherwise stated,
any statement made during the meetings by a panel member should not be
construed as an official position of the US government.

    The meeting will be open to all persons, subject to the capacity of
the meeting room and phone lines available for those participating via
conference call. Every effort will be made to accommodate all persons
wishing to attend. The FAA and PHMSA will try to accommodate all
speakers, subject to time constraints.

    Issued in Washington, DC, on August 24, 2012.
Christopher Glasow,
Director, Office of Hazardous Materials.
[FR Doc. 2012-21544 Filed 8-30-12; 8:45 am]
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