[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37347-37349]
[FR Doc No: 2015-15980]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75283; File No. SR-NASDAQ-2015-063]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Extension of the Exchange's Penny Pilot Program and
Replacement of Penny Pilot Issues That Have Been Delisted

June 24, 2015.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on June 18, 2015, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II, which Items have been prepared by NASDAQ. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NASDAQ is filing with the Commission a proposal to amend chapter
VI, section 5 (Minimum Increments) of the rules of the NASDAQ Options
Market (``NOM'') to extend through June 30, 2016 or the date of
permanent approval, if earlier, the Penny Pilot Program in options
classes in certain issues (``Penny Pilot'' or ``Pilot''), and to change
the date when delisted classes may be replaced in the Penny Pilot.\3\
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    \3\ The Penny Pilot was established in March 2008 and was last
extended in 2014. See Securities Exchange Act Release Nos. 57579
(March 28, 2008), 73 FR 18587 (April 4, 2008) (SR-NASDAQ-2008-026)
(notice of filing and immediate effectiveness establishing Penny
Pilot); and 73686 (November 25, 2014), 79 FR 71477 (December 2,
2014)(SR-NASDAQ-2014-115) (notice of filing and immediate
effectiveness extending the Penny Pilot through June 30, 2015).
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    The text of the amended Exchange rule is set forth immediately
below.
    Proposed new language is in italics and proposed deleted language
is [bracketed].

NASDAQ Stock Market Rules

Options Rules

* * * * *

Chapter VI Trading Systems

* * * * *

Sec. 5 Minimum Increments

    (a) The Board may establish minimum quoting increments for options
contracts traded on NOM. Such minimum increments established by the
Board will be designated as a stated policy, practice, or
interpretation with respect to the administration of this Section
within the meaning of Section 19 of the Exchange Act and will be filed
with the SEC as a rule change for effectiveness upon filing. Until such
time as the Board makes a change in the increments, the following
principles shall apply:
    (1)--(2) No Change.
    (3) For a pilot period scheduled to expire on June 30, [2015]2016
or the date of permanent approval, if earlier, if the options series is
trading pursuant to the Penny Pilot program one (1) cent if the options
series is trading at less than $3.00, five (5) cents if the options
series is trading at $3.00 or higher, unless for QQQQs, SPY and IWM
where the minimum quoting increment will be one cent for all series
regardless of price. A list of such options shall be communicated to
membership via an Options Trader Alert (``OTA'') posted on the
Exchange's Web site.
    The Exchange may replace any pilot issues that have been delisted
with the next most actively traded multiply listed options classes that
are not yet included in the pilot, based on trading activity in the
previous six months. The replacement issues may be added to the pilot
on the second trading day following July 1, 2015 and January 1,
[2015]2016.
    (4) No Change.
    (b) No Change.
* * * * *
    The text of the proposed rule change is available from NASDAQ's Web
site at http://nasdaq.cchwallstreet.com, at NASDAQ's principal office,
and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this filing is to amend chapter VI, section 5 to
extend the Penny Pilot through June 30, 2016 or the date of permanent
approval, if earlier, and to change the date when delisted classes may
be replaced in the Penny Pilot. The Exchange believes that extending
the Penny Pilot will allow for further analysis of the Penny Pilot and
a determination of how the program should be structured in the future.
    Under the Penny Pilot, the minimum price variation for all
participating options classes, except for the Nasdaq-100 Index Tracking
Stock (``QQQQ''), the SPDR S&P 500 Exchange Traded Fund (``SPY'') and
the iShares Russell 2000 Index Fund (``IWM''), is $0.01 for all
quotations in options series that are quoted at less than $3 per
contract and $0.05 for all quotations in options series that are quoted
at $3 per contract or greater. QQQQ, SPY and IWM are quoted in $0.01
increments for all options series. The Penny Pilot is currently
scheduled to expire on June 30, 2015.
    The Exchange proposes to extend the time period of the Penny Pilot
through June 30, 2016 or the date of permanent approval, if earlier,
and to provide a revised date for adding replacement issues to the
Penny Pilot. The Exchange proposes that any Penny Pilot Program issues
that have been delisted may be replaced on the second trading day
following July 1, 2015 and January 1, 2016. The replacement issues will
be selected based on trading activity in the previous six months.\4\
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    \4\ The replacement issues will be announced to the Exchange's
membership via an Options Trader Alert (OTA) posted on the
Exchange's Web site. The Exchange proposes in its Penny Pilot rule
that replacement issues will be selected based on trading activity
in the previous six months. The replacement issues would be
identified based on The Options Clearing Corporation's trading
volume data. For example, for the July replacement, trading volume
from December 1, 2014 through May 30, 2015 would be analyzed. The
month immediately preceding the replacement issues' addition to the
Pilot Program (i.e., June) would not be used for purposes of the
six-month analysis.
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    This filing does not propose any substantive changes to the Penny
Pilot Program; all classes currently participating in the Penny Pilot
will remain the same and all minimum increments will remain unchanged.
The Exchange believes the benefits to public customers and other market
participants who will be able to express their true prices to buy and
sell options have been

demonstrated to outweigh the potential increase in quote traffic.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with section
6(b) of the Act,\5\ in general, and furthers the objectives of section
6(b)(5) of the Act,\6\ 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 mechanism of a free and open
market and a national market system and, in general, to protect
investors and the public interest.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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    In particular, the proposed rule change, which extends the Penny
Pilot for an additional twelve months through June 30, 2016 or the date
of permanent approval, if earlier, and changes the date for replacing
Penny Pilot issues that were delisted to the second trading day
following July 1, 2015 and January 1, 2016, will enable public
customers and other market participants to express their true prices to
buy and sell options for the benefit of all market participants. This
is consistent with the Act.

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. To the contrary, this proposal
is pro-competitive because it allows Penny Pilot issues to continue
trading on the Exchange. Moreover, the Exchange believes that the
proposed rule change will allow for further analysis of the Pilot and a
determination of how the Pilot should be structured in the future; and
will serve to promote regulatory clarity and consistency, thereby
reducing burdens on the marketplace and facilitating investor
protection. The Pilot is an industry-wide initiative supported by all
other option exchanges. The Exchange believes that extending the Pilot
will allow for continued competition between market participants on the
Exchange trading similar products as their counterparts on other
exchanges, while at the same time allowing the Exchange to continue to
compete for order flow with other exchanges in option issues trading as
part of the Pilot.

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

    Written comments were neither solicited nor received.

III. 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 \7\ and Rule 19b-4(f)(6) thereunder.\8\
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 and Rule 19b-
4(f)(6)(iii) thereunder.
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    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \9\ normally
does not become operative prior to 30 days after the date of the
filing.\10\ However, pursuant to Rule 19b-4(f)(6)(iii),\11\ the
Commission may designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because doing so will allow the Pilot Program to continue without
interruption in a manner that is consistent with the Commission's prior
approval of the extension and expansion of the Pilot Program and will
allow the Exchange and the Commission additional time to analyze the
impact of the Pilot Program. Accordingly, the Commission designates the
proposed rule change as operative upon filing with the Commission.\12\
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    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 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 the 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 pre-filing requirement.
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
    \12\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
section 19(b)(2)(B) \13\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \13\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2015-063 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2015-063. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and

printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549-1090 on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of the filing will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2015-063 and should
be submitted on or before July 21, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-15980 Filed 6-29-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Page 66980]
[FR Doc No: 2013-26662]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70797; File No. SR-BOX-2013-43]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Designation of Longer Period for Commission Action on Proposed Rule
Change To Permit Complex Orders To Participate in Price Improvement
Periods

November 1, 2013.
    On September 5, 2013, BOX Options Exchange LLC (``Exchange'' or
``BOX'') 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 add new BOX Rule 7245 to permit Complex Orders
to participate in Price Improvement Periods (the ``COPIP'') and to make
certain other conforming and clarifying changes to accommodate the new
COPIP Rule. The proposed rule change was published for comment in the
Federal Register on September 23, 2013.\3\ The Commission has received
no comment letters on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 70427 (September 17,
2013), 78 FR 58364.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ 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 these proposed rule changes should be disapproved.
The 45th day for this filing is November 7, 2013.
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    \4\ 15 U.S.C. 78s(b)(2).
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    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. 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 and
take action on the Exchange's proposed rule change.
    Accordingly, pursuant to Section 19(b)(2)(A)(ii)(I) of the Act \5\
and for the reasons stated above, the Commission designates December
20, 2013, as the date by which the Commission should either approve or
disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-BOX-2013-43).
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    \5\ 15 U.S.C. 78s(b)(2)(A)(ii)(I).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(31).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-26662 Filed 11-6-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Page 80365]
[FR Doc No: 2023-25498]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 35047; File No. 812-15459]

Saratoga Investment Advisors, LLC, et al.

November 14, 2023.
AGENCY: Securities and Exchange Commission (``Commission'' or ``SEC'').

ACTION: Notice.

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    Notice of application for an order (``Order'') under sections 17(d)
and 57(i) of the Investment Company Act of 1940 (the ``Act'') and rule
17d-1 under the Act to permit certain joint transactions otherwise
prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1
under the Act.

Summary of Application: Applicants request an order to permit certain
business development companies (``BDCs'') and closed-end management
investment companies to co-invest in portfolio companies with each
other and with certain affiliated investment entities.

Applicants: Saratoga Investment Advisors, LLC, Saratoga Management
Company LLC, Saratoga Investment Corp., Saratoga Investment Corp. SBIC
LP, Saratoga Investment Corp. SBIC II LP, Saratoga Investment Corp.
SBIC III LP, Saratoga Investment Corp. CLO 2013-1 LTD, Saratoga
Investment Funding II, LLC, SIA-Avionte, Inc., SIA-AX, Inc., SIA-GH,
Inc., SIA-G4, Inc., SIA-MAC, Inc., SIA-ARC, Inc., SIA-PP, Inc., SIA-TG,
Inc., SIA-TT, Inc., SIA-Vector, Inc., SIA-VR, Inc., SIA-AAP, Inc.,
Saratoga Credit Fund I L.P., SIA-MDP Inc., and SIA-SZ, Inc.

Filing Dates: The application was filed on April 25, 2023, and amended
on September 1, 2023.

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 on any application by emailing
the SEC's Secretary at [email protected] and serving the
Applicants with a copy of the request by email, if an email address is
listed for the relevant Applicant below, or personally or by mail, if a
physical address is listed for the relevant Applicant below. Hearing
requests should be received by the Commission by 5:30 p.m. on, December
11, 2023, 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 emailing the Commission's Secretary at
[email protected].

ADDRESSES:
    The Commission: [email protected].
    Applicants: Rochelle Kracoff, Assistant Chief Compliance Officer,
Saratoga Investment Corp., at [email protected], and Steven
B. Boehm, Esq., Payam Siadatpour, Esq., and Anne G. Oberndorf, Esq.,
Eversheds Sutherland (US) LLP, at [email protected].

FOR FURTHER INFORMATION CONTACT: Michael Schrader, Senior Counsel, or
Terri Jordan, Branch Chief, at<PHONE_NUMBER> (Division of Investment
Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: For Applicants' representations, legal
analysis, and conditions, please refer to Applicants' first amended and
restated application, dated September 1, 2023, which may be obtained
via the Commission's website by searching for the file number at the
top of this document, or for an Applicant using the Company name search
field, on the SEC's EDGAR system. The SEC's EDGAR system may be
searched at, http://www.sec.gov/edgar/searchedgar/legacy/companysearch.html. You may also call the SEC's Public Reference Room
at<PHONE_NUMBER>.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-25498 Filed 11-16-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 159 (Thursday, August 18, 2022)]
[Notices]
[Page 50902]
[FR Doc No: 2022-17748]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95497; File No. SR-CboeEDGX-2022-004]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Withdrawal of a Proposed Rule Change To Codify Certain Practices and
Requirements Related to the Exchange's Port Message Rate Thresholds

August 12, 2022.
    On January 21, 2022, Cboe EDGX Exchange, Inc. (``Exchange'') 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 codify
certain practices and requirements related to the Exchange's port
message rate thresholds. The proposed rule change was published for
comment in the Federal Register on February 9, 2022.\3\ On March 23,
2022, pursuant to Section 19(b)(2) of the Act,\4\ the Commission
designated a longer period within which to approve the proposed rule
change, disapprove the proposed rule change, or institute proceedings
to determine whether to disapprove the proposed rule change.\5\ On May
10, 2022, the Commission instituted proceedings under Section
19(b)(2)(B) of the Act \6\ to determine whether to approve or
disapprove the proposed rule change.\7\ The Commission has received no
comment letters on the proposed rule change. On July 21, 2022, the
Exchange withdrew the proposed rule change (CboeEDGX-2022-004).
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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. 94144 (February 3,
2022), 87 FR 7519.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 94496, 87 FR 18410
(March 30, 2022). The Commission designated May 10, 2022 as the date
by which the Commission shall approve or disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change.
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 94883, 87 FR 29776
(May 16, 2022).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-17748 Filed 8-17-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 1 (Tuesday, January 3, 2012)]
[Proposed Rules]
[Pages 23-24]
[FR Doc No: 2011-33623]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 77, No. 1 / Tuesday, January 3, 2012 /
Proposed Rules

DEPARTMENT OF THE TREASURY

Office of the Comptroller of the Currency

12 CFR Part 44

[Docket No. OCC-2011-0014]
RIN 1557-AD44

FEDERAL RESERVE SYSTEM

12 CFR Part 248

[Docket No. 2011-1432]
RIN 7100-AD 82

FEDERAL DEPOSIT INSURANCE CORPORATION

12 CFR Part 351

RIN 3064-AD85

SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 255

[Release No. 34-66057; File No. S7-41-11]
RIN 3235-AL07

Prohibitions and Restrictions on Proprietary Trading and Certain
Interests in, and Relationships With, Hedge Funds and Private Equity
Funds

AGENCIES: Office of the Comptroller of the Currency, Treasury (OCC);
Board of Governors of the Federal Reserve System (Board); Federal
Deposit Insurance Corporation (FDIC); and U.S. Securities and Exchange
Commission (SEC).

ACTION: Proposed rule; extension of comment period.

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SUMMARY: On November 7, 2011, the OCC, Board, FDIC, and SEC
(collectively, the ``Agencies'') published in the Federal Register a
joint notice of proposed rulemaking for public comment to implement
section 619 of the Dodd-Frank Wall Street Reform and Consumer
Protection Act (``Dodd-Frank Act'') which contains certain prohibitions
and restrictions on the ability of a banking entity and nonbank
financial company supervised by the Board to engage in proprietary
trading and have certain interests in, or relationships with, a hedge
fund or private equity fund (``proposed rule'').
    Due to the complexity of the issues involved and to facilitate
coordination of the rulemaking among the responsible agencies as
provided in section 619 of the Dodd-Frank Act, the Agencies have
determined that an extension of the comment period until February 13,
2012 is appropriate. This action will allow interested persons
additional time to analyze the proposed rules and prepare their
comments.

DATES: Comments on the proposed rule must be received on or before
February 13, 2012.

ADDRESSES: You may submit comments by any of the methods identified in
the proposed rule.\1\ Please submit your comments using only one
method.
---------------------------------------------------------------------------

    \1\ See 76 FR 68846.

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FOR FURTHER INFORMATION CONTACT:

OCC: Deborah Katz, Assistant Director, or Ursula Pfeil, Counsel,
Legislative and Regulatory Activities Division,<PHONE_NUMBER>; Roman
Goldstein, Senior Attorney, Securities and Corporate Practices
Division,<PHONE_NUMBER>; Kurt Wilhelm, Director for Financial Markets
Group,<PHONE_NUMBER>; Stephanie Boccio, Technical Expert for Asset
Management Group, or Joel Miller, Group Leader for Asset Management
Group,<PHONE_NUMBER>, Office of the Comptroller of the Currency, 250 E
Street SW., Washington, DC 20219.
Board: Christopher M. Paridon, Counsel, Legal Division,<PHONE_NUMBER>;
Sean D. Campbell, Deputy Associate Director, Division of Research and
Statistics,<PHONE_NUMBER>; David Lynch, Manager,<PHONE_NUMBER>, or
Jeremy R. Newell, Division of Bank Supervision and Regulation, (202)
452-3239, Board of Governors of the Federal Reserve System, 20th and C
Streets NW., Washington, DC 20551.
FDIC: Bobby R. Bean, Associate Director, Capital Markets (202) 898-
6705, or Karl R. Reitz, Senior Capital Markets Specialist, (202) 898-
6775, Division of Risk Management Supervision; Michael B. Phillips,
Counsel,<PHONE_NUMBER>, or Gregory S. Feder, Counsel,<PHONE_NUMBER>,
Legal Division, Federal Deposit Insurance Corporation, 550 17th Street
NW., Washington, DC 20429-0002.
SEC: Josephine Tao, Assistant Director, Elizabeth Sandoe, Senior
Special Counsel, David Bloom, Branch Chief, or Angela Moudy, Attorney
Advisor, Office of Trading Practices, Division of Trading and Markets,
(202) 551-5720; Daniel S. Kahl, Assistant Director, Tram N. Nguyen,
Branch Chief, Michael J. Spratt, Senior Counsel, Paul Schlichting,
Senior Counsel, or Parisa Haghshenas, Law Clerk, Office of Investment
Adviser Regulation, Division of Investment Management,<PHONE_NUMBER>,
U.S. Securities and Exchange Commission, 100 F Street NE., Washington,
DC 20549.

SUPPLEMENTARY INFORMATION: On November 7, 2011, the proposed rule was
published in the Federal Register.\2\ The proposed rule implements
section 619 of the Dodd-Frank Act which added a new section 13 to the
Bank Holding Company Act of 1956 (``BHC Act'') and contains certain
prohibitions and restrictions on the ability of a banking entity and
nonbank financial company supervised by the Board to engage in
proprietary trading and have certain interests in, or relationships
with, a hedge fund or private equity fund.
---------------------------------------------------------------------------

    \2\ See id.
---------------------------------------------------------------------------

    In recognition of the complexities of the issues involved and the
variety of considerations involved in its impact and implementation,
the Agencies requested that commenters respond to numerous questions.
The proposed rule stated that the public comment period would close on
January 13, 2012.\3\
---------------------------------------------------------------------------

    \3\ See id.
---------------------------------------------------------------------------

    The Agencies have received requests from the public for an
extension of the comment period to allow for additional time for
comments related to the provisions of the proposed rule.\4\ The
Agencies believe that the additional period for comment will facilitate
public comment on the provisions of the proposed rule and the questions
posed by the Agencies, and coordination of the

rulemaking among the responsible agencies as provided in section 619 of
the Dodd-Frank Act. Therefore, the Agencies are extending the comment
period for the proposed rule from January 13, 2012 to February 13,
2012.
---------------------------------------------------------------------------

    \4\ See, e.g., comment letters to the Agencies from Center for
Capital Markets Competitiveness of the U.S. Chamber of Commerce
(November 17, 2011); American Bankers Association et al. (November
30, 2011); and Representative Neugebauer et al. (December 20, 2011).

    Dated: December 22, 2011.
John Walsh,
Acting Comptroller of the Currency.

    By order of the Board of Governors of the Federal Reserve
System, acting through the Secretary under delegated authority,
December 23, 2011.
Jennifer J. Johnson,
Secretary of the Board.

    By delegated authority from the Board of Directors of the
Federal Deposit Insurance Corporation.

Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.

    By the Securities and Exchange Commission.

    Dated: December 23, 2011.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-33623 Filed 12-30-11; 8:45 am]
BILLING CODE 4810-33-P; 6714-10-P; 6210-01-P


[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42194-42195]
[FR Doc No: 2017-18859]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission; Office of FOIA Services; 100 F Street NE.; Washington, DC
20549-2736

Extension:
    Form N-6F, SEC File No. 270-185, OMB Control No. 3235-0238

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    The title for the collection of information is ``Form N-6F (17 CFR
274.15), Notice of Intent to Elect to be Subject to Sections 55 through
65 of the Investment Company Act of 1940.'' The purpose of Form N-6F is
to notify the Commission of a company's intent to file a notification
of election to become

subject to Sections 55 through 65 of the Investment Company Act of 1940
(15 U.S.C. 80a-1 et seq.) (``1940 Act''). Certain companies may have to
make a filing with the Commission before they are ready to elect to be
regulated as a business development company.\1\ A company that is
excluded from the definition of ``investment company'' by Section
3(c)(1) because it has fewer than one hundred shareholders and is not
making a public offering of its securities may lose such an exclusion
solely because it proposes to make a public offering of securities as a
business development company. Such company, under certain conditions,
would not lose its exclusion if it notifies the Commission on Form N-6F
of its intent to make an election to be regulated as a business
development company. The company only has to file a Form N-6F once.
---------------------------------------------------------------------------

    \1\ A company might not be prepared to elect to be subject to
Sections 55 through 65 of the 1940 Act because its capital structure
or management compensation plan is not yet in compliance with the
requirements of those sections.
---------------------------------------------------------------------------

    The Commission estimates that on average approximately 12 companies
file these notifications each year. Each of those companies need only
make a single filing of Form N-6F. The Commission further estimates
that this information collection imposes burden of 0.5 hours, resulting
in a total annual PRA burden of 6 hours. Based on the estimated wage
rate, the total cost to the industry of the hour burden for complying
with Form N-6F would be approximately $2,070.
    The collection of information under Form N-6F is mandatory. The
information provided under the form is not kept confidential. An agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email
to<EMAIL_ADDRESS>
    Dated: August 31, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-18859 Filed 9-5-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 79 (Thursday, April 24, 2014)]
[Rules and Regulations]
[Pages 22774-22776]
[FR Doc No: 2014-08610]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2012-0951; FRL-9800-2]

Approval and Promulgation of Air Quality Implementation Plans;
Massachusetts; Revisions to Fossil Fuel Utilization Facilities and
Source Registration Regulations and Industrial Performance Standards
for Boilers

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving several
State Implementation Plan (SIP) revisions submitted by the Commonwealth
of Massachusetts. The revisions add new monitoring, inspection,
maintenance and testing requirements for certain fossil fuel
utilization facilities, rename and clarify stationary source emission
reporting requirements, and establish compliance and certification
standards for new boilers. The intended effect of this action is to
approve the Commonwealth's revised ``Fossil Fuel Utilization Facility''
regulation, ``Source Registration'' regulation, and new ``Industrial
Performance Standards for Boilers.'' This action is being taken under
the Clean Air Act.

DATES: This rule is effective on May 27, 2014.

ADDRESSES: EPA has established a docket for this action under Docket
Identification Number EPA-R01-OAR-2012-0951. All documents in the
docket are listed on the www.regulations.gov Web site. Although listed
in the index, some information is not publicly available, i.e., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
through www.regulations.gov or in hard copy at the U.S. Environmental
Protection Agency, EPA New England Regional Office, Office of Ecosystem
Protection, Air Permits, Toxics and Indoor Programs Unit, 5 Post Office
Square--Suite 100, Boston, MA. EPA requests that if at all possible,
you contact the contact listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding legal holidays.
    Copies of the documents relevant to this action are also available
for public inspection during normal business hours, by appointment at
the Division of Air Quality Control, Department of Environmental
Protection, One Winter Street, 8th Floor, Boston, MA 02108.

FOR FURTHER INFORMATION CONTACT: Brendan McCahill, Air Permits, Toxics
and Indoor Programs Unit, Office of Ecosystem Protection, U.S.
Environmental Protection Agency Region 1, 5 Post Office Square--Suite
100, (Mail code OEP05-2), Boston, MA 02109-3912, Telephone number (617)
918-1652, Fax number<PHONE_NUMBER>, Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. What action is EPA approving in this document?
II. What portions of the SIP submittals will EPA incorporate into
the SIP?
III. Final Action.
IV. Statutory and Executive Order Reviews.

I. What action is EPA approving in this document?

    On February 7, 2013 (78 FR 9016), EPA published a Notice of
Proposed Rulemaking (NPR) for the Commonwealth of Massachusetts.
    The NPR proposed approval of the following SIP submittals:
     A June 28, 1990 and a July 11, 2001 SIP amendment revising
310 CMR 7.04 entitled, ``U Fossil Fuel Utilization Facilities,''
     A July 11, 2001 SIP amendment revising 310 CMR 7.12
entitled, ``U Source Registration,''
     A September 14, 2006 SIP amendment adopting 310 CMR
7.26(30)-(37) entitled, ``Industrial Performance Standards--U Boiler,''
and
     A February 13, 2008 SIP amendment that, among other
things, revises 310 CMR 7.04, corrects several typographical errors,
clarifies certain requirements to 310 CMR 7.12 and 310 CMR 7.26(30)-
(37) and updates the list of Massachusetts cities in 310 CMR 7.00.
    The specific requirements of four SIP submittals and the rationale
for EPA's proposed action are explained in the NPR and will not be
restated here. EPA did not receive any public comments on the NPR.

II. What portions of the SIP submittals will EPA incorporate into the
SIP?

    On January 18, 2013, the Massachusetts Department of Environmental
Protection (MassDEP) issued a letter to EPA withdrawing outdated and
obsolete submittals and replacing them with SIP submittals containing
effective versions of the regulations for approval into the SIP. The
letter included two attachments. Attachment I identified the
regulations that MassDEP requests EPA to approve into the SIP. The
attachment includes struck out versions of those regulations MassDEP is
withdrawing from consideration and the final version of the regulations
(without strikeout) that MassDEP requests to be included in the SIP.
    Attachment 2 includes a list of regulations previously submitted to
EPA for approval. The list indicates the regulation name and CMR
regulation number, CMR page number, the MassDEP disposition of the rule
(i.e., whether to withdraw it or have EPA act upon it), and the reason
for the MassDEP's disposition.
    Based on the information from the two attachments, EPA is
incorporating the latest versions of 310 CMR 7.00, ``Massachusetts
Cities & Towns with Corresponding DEP Regional Offices and Air
Pollution Districts,'' 310 CMR 7.04(2) and 7.04(4)(a), 310 CMR 7.12 and
310 CMR 7.26(30-37) into the SIP. The February 13, 2008 SIP submittal
included the latest version of the 310 CMR 7.00, 310 CMR 7.04(2) and
7.04(4)(a) and 310 CMR 7.26(30-37). Numerous SIP submittals provided a
portion of 310 CMR 7.12. The August 9, 2001 SIP submittal included
provision 310 CMR 7.12(1)(a)1. The September 14, 2006 SIP submitted
included provisions 310 CMR 7.12(2)(c), 310 CMR 7.12(3) and 310 CMR
7.12(4). The February 13, 2008 SIP submittal included provisions 310
CMR 7.12(1)(a)2-9, (1)(b) and (1)(c), and 310 CMR 7.12(2)(a) and (b).
    These versions of the regulations are the versions that were made
available in the docket for the February 7, 2013 NPR. We are re-stating
this information here, not because anything has changed since the
publication of the NPR, but rather for clarity given the complex
history of these submissions
    In addition, as described in the January 18, 2013 letter, the
MassDEP has withdrawn the following regulations from inclusion into the
SIP; 310 CMR 7.02, 310 CMR 7.03, 310 CMR 7.11, and 310 CMR 7.26(28)-
(29).

III. Final Action

    EPA is approving the following SIP submittals as a revision to the
Massachusetts SIP:
     The June 28, 1990 SIP amendment revising 310 CMR 7.04,
     The July 11, 2001 SIP amendment revising 310 CMR 7.12,
     The September 14, 2006 SIP amendment revising 310 CMR
7.12, and
     The February 13, 2008 SIP amendment revising 310 CMR 7.04,
310 CMR 7.12, 310 CMR 7.26(30)-(37), and updating the list of
Massachusetts cities in 310 CMR 7.00.
    With today's final action, EPA has completed its action on
Massachusetts's February 13, 2008 SIP submittal. Nothing more regarding
this submittal is pending before EPA.
    The Agency has reviewed this request for revision of the Federally-
approved State implementation plan for conformance with the provisions
of the 1990 amendments enacted on November 15, 1990. The Agency has
determined that this action conforms with those requirements
irrespective of the fact that the submittal preceded the date of
enactment.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 23, 2014. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: March 27, 2013.
H. Curtis Spalding,
Regional Administrator, EPA New England.

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

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart W--Massachusetts

0
2. Section 52.1120 is amended by adding paragraph (c)(140) to read as
follows:

Sec.  52.1120  Identification of plan.

* * * * *
    (c) * * *
    (140) Revisions to the State Implementation Plan submitted by the
Massachusetts Department of Environmental Protection on Protection on
August 9, 2001, September 14, 2006, and February 18, 2008.
    (i) Incorporation by reference.
    (A) Provision 310 CMR 7.12(1)(a)1 of 310 CMR 7.12, ``U Source
Registration'' effective on August 3, 2001.
    (B) Provisions 310 CMR 7.12(2)(c), 7.12(3), and 7.12(4) of 310 CMR
7.12, ``U Source Registration'' effective on September 23, 2005.
    (C) Provision 310 CMR 7.00, Table entitled, ``Massachusetts Cities
& Towns with Corresponding DEP Regional Offices and Air Pollution
Districts'' effective on December 28, 2007.
    (D) Provisions 310 CMR 7.04(2) and 7.04(4)(a) of 310 CMR 7.04, ``U
Fossil Fuel Utilization Facilities'' effective on December 28, 2007.
    (E) Provisions 310 CMR 7.12(1)(a)2 through 9, (1)(b), (1)(c),
(2)(a) and (b) of 310 CMR 7.12, ``U Source Registration'' effective on
December 28, 2007.
    (F) Provisions 310 CMR 7.26(30) through (37) of 310 CMR 7.26
``Industry Performance Standards'' effective on December 28, 2007.
    (ii) Additional materials.
    (A) A letter from the Massachusetts Department of Environmental
Protection dated August 9, 2001 submitting a

revision to the State Implementation Plan.
    (B) A letter from the Massachusetts Department of Environmental
Protection dated September 14, 2006 submitting a revision to the State
Implementation Plan.
    (C) A letter from the Massachusetts Department of Environmental
Protection dated February 13, 2008 submitting a revision to the State
Implementation Plan.
    (D) A letter from the Massachusetts Department of Environmental
Protection dated January 18, 2013 withdrawing certain outdated and
obsolete regulation submittals and replacing them with currently
effective versions of the regulation for approval and inclusion into
the SIP.

0
3. In Sec.  52.1167, Table 52.1167 is amended by adding new entries in
numerical order for 310 CMR 7.00, 310 CMR 7.04(2), 310 CMR 7.04(4)(a),
310 CMR 7.12, and 310 CMR 7.26(30)-(37) to read as follows:

Sec.  52.1167  EPA-approved Massachusetts State regulations.

* * * * *

                                                    Table 52.1167--EPA-Approved Rules and Regulations
                                                               [See Notes at end of Table]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Date         Date
           State citation                  Title/Subject       submitted   approved by     Federal Register      52.1120(c)      Comments/Unapproved
                                                                by state       EPA             citation                                sections
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
310 CMR 7.00........................  Table of MA cities and     11/13/07      4/24/14  [Insert Federal                 140  ...........................
                                       towns with                                        Register page number
                                       corresponding DEP                                 where the document
                                       Regional offices.                                 begins].

                                                                      * * * * * * *
310 CMR 7.04(2).....................  U Fossil fuel              11/13/07      4/24/14  [Insert Federal                 140  Clarifies new applicability
                                       Utilization                                       Register page number                 requirements for smoke
                                       Facilities.                                       where the document                   density instrument removal
                                                                                begins].                             for certain facilities.
310 CMR 7.04(4)(a)..................  U Fossil Fuel              11/13/07      4/24/14  [Insert Federal                 140  Requires inspection,
                                       Utilization                                       Register page number                 maintenance testing at
                                       Facilities.                                       where the document                   facilities with heat
                                                                                begins].                             inputs over 3 MMBtu/ hr
                                                                                (excluding combustion
                                                                                turbines and engines);
                                                                                requires posting of test
                                                                                results near facilities.

                                                                      * * * * * * *
310 CMR 7.12........................  U Source Registration.  5/31/01, 8/      4/24/14  [Insert Federal                 140  Revises applicability
                                                              23/05 & 11/                Register page number                 threshold emission levels,
                                                                    13/07                where the document                   expands list of sources
                                                                                begins].                             required to report
                                                                                emissions, and clarifies
                                                                                types of information
                                                                                reported.

                                                                      * * * * * * *
310 CMR 7.26(30)-(37)...............  Industry Performance       11/13/07      4/24/14  [Insert Federal                 140  Sets standards for certain
                                       Standards--U Boilers.                             Register page number                 types of new boilers:
                                                                                where the document                   replaces requirements to
                                                                                begins].                             obtain a plan approval
                                                                                under 310 CMR 7.02(2).

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes:
1. This table lists regulations adopted as of 1972. It does not depict regulatory requirements which may have been part of the Federal SIP before this
  date.
2. The regulations are effective statewide unless otherwise stated in comments or title section.

    Editorial Note: This document was received for publication by the
Office of the Federal Register on April 11, 2014.

[FR Doc. 2014-08610 Filed 4-23-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 86 (Thursday, May 3, 2018)]
[Proposed Rules]
[Pages 19466-19469]
[FR Doc No: 2018-09070]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0361; Product Identifier 2017-NM-160-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A318, A319, and A320 series airplanes, and Model
A321-111, -112, -131, -211, -212, -213, -231, -232, -251N, -253N, and -
271N airplanes. This proposed AD was prompted by a determination that
more restrictive maintenance requirements and airworthiness limitations
are necessary. This proposed AD would require revising the maintenance
or inspection program, as applicable, to incorporate the specified
maintenance requirements and airworthiness limitations. We are
proposing this AD to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by June 18, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:

     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Airbus,
Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44
51; email [email protected]; internet http://www.airbus.com. You may view this service information at the FAA,
Transport Standards Branch, 2200 South 216th Street, Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0361; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Operations
office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th Street, Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0361;
Product Identifier 2017-NM-160-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM based on
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2017-0215, dated October 24, 2017 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Airbus Model
A318, A319, and A320 series airplanes, and Model A321-111, -112, -131,
-211, -212, -213, -231, -232, -251N, -253N, and -271N airplanes. The
MCAI states:

    The airworthiness limitations for Airbus A320 family aeroplanes,
which are approved by EASA, are currently defined and published in
the A318, A319, A320 and A321 Airworthiness Limitations Section
(ALS) document(s). The Safe Life Airworthiness Limitation Items are
specified in ALS Part 1. These instructions have been identified as
mandatory for continued airworthiness.
    Failure to accomplish these instructions could result in an
unsafe condition.
    Previously, EASA issued AD 2012-0008 [which corresponds to FAA
AD 2015-05-02, Amendment 39-18112 (80 FR 15152, March 23, 2015)
(``AD 2015-05-02'')] to require the implementation of the
airworthiness limitations as specified in Airbus A318/A319/A320/A321
ALS Part 1 Revision 02, and EASA AD 2014-0141 [which corresponds to
FAA AD 2015-22-08, Amendment 39-18313 (80 FR 68434, November 5,
2015) (``AD 2015-22-08'')] to require the implementation of specific
life limits for the main landing gear (MLG) upper cardan pin Part
Number (P/N) 201163620.
    Since those ADs were issued, studies were conducted in the frame
of in-service events or during life extension campaigns, the results
of which prompted revision of the life limits of several components
installed on A320 family aeroplanes. Consequently, Airbus
successively issued Revision 03, Revision 04 and Revision 05 of the
A318/A319/A320/A321 ALS Part 1. ALS Part 1 Revision 05 also includes
the life limits required by EASA AD 2014-0141. A318/A319//A321 ALS
Part 1 Revision 05 issue 02 was issued to provide clarifications.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2012-0008 and EASA AD 2014-0141, which are
superseded, and requires accomplishment of the actions specified in
A318/A319/A320/A321 ALS Part 1 Revision 05.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0361.

Relationship of Proposed AD to AD 2015-05-02 and AD 2015-22-08

    This NPRM would not supersede AD 2015-05-02 or AD 2015-22-08.
Rather, we have determined that a stand-alone AD would be more
appropriate to address the changes in the MCAI. This NPRM would require
revising the maintenance or inspection program to incorporate the new
maintenance requirements and airworthiness limitations. Accomplishment
of the proposed actions would then terminate all requirements of AD
2015-05-02 and AD 2015-22-08.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Airbus A318/A319/A320/A321 Airworthiness
Limitations Section (ALS) Part 1 Safe Life Airworthiness Limitations
(SL-ALI), Revision 05, Issue 02, dated April 19, 2017. This service
information describes new maintenance requirements and airworthiness
limitations. This service information is reasonably available because
the interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance according to paragraph
(j)(1) of this proposed AD. The request should include a description of
changes to the required inspections that will ensure the continued
operational safety of the airplane.

Differences Between This Proposed AD and the MCAI or Service
Information

    The MCAI specifies that if there are findings from the ALS
inspection tasks, corrective actions must be accomplished in accordance
with Airbus maintenance documentation. However, this proposed AD does
not include that requirement. Operators of U.S.-registered airplanes
are required by general airworthiness and operational regulations to
perform maintenance using methods that are acceptable to the FAA. We
consider those methods to be adequate to address any corrective actions
necessitated by the findings of ALS inspections required by this
proposed AD.

Airworthiness Limitations Based on Type Design

    The FAA recently became aware of an issue related to the
applicability of ADs that require incorporation of an ALS revision into
an operator's maintenance or inspection program.
    Typically, when these types of ADs are issued by civil aviation
authorities of other countries, they apply to all airplanes covered
under an identified type certificate (TC). The corresponding FAA AD
typically retains applicability to all of those airplanes.
    In addition, U.S. operators must operate their airplanes in an
airworthy condition, in accordance with 14 CFR 91.7(a). Included in
this obligation is the requirement to perform any maintenance or
inspections specified in the ALS, and in accordance with the ALS as
specified in 14 CFR 43.16 and 91.403(c), unless an alternative has been
approved by the FAA.
    When a type certificate is issued for a type design, the specific
ALS, including revisions, is a part of that type design, as specified
in 14 CFR 21.31(c).
    The sum effect of these operational and maintenance requirements is
an obligation to comply with the ALS defined in the type design
referenced in the manufacturer's conformity statement. This obligation
may introduce a conflict with an AD that requires a specific ALS
revision if new airplanes are delivered with a later revision as part
of their type design.
    To address this conflict, the FAA has approved alternative methods
of compliance (AMOCs) that allow operators to incorporate the most
recent ALS revision into their maintenance/inspection programs, in lieu
of the ALS revision required by the AD. This eliminates the conflict
and enables the operator to comply with both the AD and the type
design.
    However, compliance with AMOCs is normally optional, and we
recently became aware that some operators choose to retain the AD-
mandated ALS revision in their fleet-wide maintenance/inspection
programs, including those for new airplanes delivered with later ALS
revisions, to help standardize the maintenance of the fleet. To ensure
that operators comply with the applicable ALS revision for newly
delivered airplanes containing a later revision than that specified in
an AD, we plan to limit the applicability of ADs that mandate ALS
revisions to those airplanes that are subject to an earlier revision of
the ALS, either as part of the type design or as mandated by an earlier
AD. This proposed AD therefore would apply to Airbus Model A318, A319,
and A320 series airplanes, and Model A321-111, -112, -131, -211, -212,
-213, -231, -232, -251N, -253N, and -271N airplanes with an original
certificate of airworthiness or original export certificate of
airworthiness that was issued on or before the date of approval of the
ALS revision identified in this proposed AD. Operators of airplanes
with an original certificate of airworthiness or original export
certificate of airworthiness issued after that date must comply with
the airworthiness limitations specified as part of the approved type
design and referenced on the type certificate data sheet.

Costs of Compliance

    We estimate that this proposed AD affects 1,250 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:
    We have determined that revising the maintenance or inspection
program takes an average of 90 work-hours per operator, although we
recognize that this number may vary from operator to operator. In the
past, we have estimated that this action takes 1 work-hour per
airplane. Since operators incorporate maintenance or inspection program
changes for their affected fleet(s), we have determined that a per-
operator estimate is more accurate than a per-airplane estimate.
Therefore, we estimate the total cost per operator to be $7,650 (90
work-hours x $85 per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes to the Director of the System Oversight
Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus: Docket No. FAA-2018-0361; Product Identifier 2017-NM-160-AD.

(a) Comments Due Date

    We must receive comments by June 18, 2018.

(b) Affected ADs

    This AD affects AD 2015-05-02, Amendment 39-18112 (80 FR 15152,
March 23, 2015) (``AD 2015-05-02'') and AD 2015-22-08, Amendment 39-
18313 (80 FR 68434, November 5, 2015) (``AD 2015-22-08'').

(c) Applicability

    This AD applies to the Airbus airplanes identified in paragraphs
(c)(1) through (c)(4) of this AD, certificated in any category, with
an original certificate of airworthiness or original export
certificate of airworthiness issued on or before April 19, 2017.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, -233, -251N,
and -271N airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, -232, -
251N, -253N, and -271N airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that more restrictive
maintenance requirements and airworthiness limitations are
necessary. We are issuing this AD to prevent the failure of certain
life-limited parts, which could result in reduced structural
integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Revision of Maintenance or Inspection Program

    Within 90 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to incorporate
Airbus A318/A319/A320/A321 Airworthiness Limitations Section (ALS)
Part 1 Safe Life Airworthiness Limitations (SL-ALI), Revision 05,
Issue 02, dated April 19, 2017. The initial compliance times for new
or revised tasks are at the applicable times specified in Airbus
A318/A319/A320/A321 ALS Part 1 Safe Life Airworthiness Limitations
(SL-ALI), Revision 05, Issue 02, dated April 19, 2017, or within 90
days after the effective date of this AD, whichever occurs later.

(h) No Alternative Actions and Intervals

    After the maintenance or inspection program has been revised as
required by paragraph (g) of this AD, no alternative actions (e.g.,
inspections) or intervals may be used unless the actions and
intervals are approved as an alternative method of compliance (AMOC)
in accordance with the procedures specified in paragraph (j)(1) of
this AD.

(i) Terminating Action for AD 2015-05-02 and AD 2015-22-08

    Accomplishing the actions required by this AD terminates all
requirements of AD 2015-05-02 and AD 2015-22-08.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (k)(2) of this AD. Information
may be emailed to: [email protected]. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Airbus's EASA Design Organization Approval
(DOA). If approved by the DOA, the approval must include the DOA-
authorized signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2017-0215, dated October 24, 2017, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0361.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th Street, Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email [email protected]; internet http://www.airbus.com. You may view this service information at the FAA,
Transport Standards Branch, 2200 South 216th Street, Des Moines, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on April 20, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-09070 Filed 5-2-18; 8:45 am]
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[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56857-56859]
[FR Doc No: 2018-24763]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3931]

Nonmetastatic, Castration-Resistant Prostate Cancer:
Considerations for Metastasis-Free Survival Endpoint in Clinical
Trials; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations
for Metastasis-Free Survival Endpoint in Clinical Trials.'' This draft
guidance provides recommendations to sponsors regarding the use of
metastasis-free survival (MFS) as an endpoint in clinical trials for
nonmetastatic, castration-resistant prostate cancer (nmCRPC)
development programs for drug or biological products regulated by the
Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER).

DATES: Submit either electronic or written comments on the draft
guidance by January 14, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2018-D-3931 for ``Nonmetastatic, Castration-Resistant Prostate
Cancer: Considerations for Metastasis-Free Survival Endpoint in
Clinical Trials.'' 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 draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240-
402-0489; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Nonmetastatic, Castration-Resistant Prostate Cancer:
Considerations for Metastasis-Free Survival Endpoint in Clinical
Trials.'' This draft guidance provides recommendations to sponsors
regarding the use of MFS as an endpoint in clinical trials for nmCRPC
development programs for drug or biological products regulated by CDER
and CBER.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations
for Metastasis-Free Survival Endpoint in Clinical Trials.'' 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.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in 21 CFR part 312 has been approved under
OMB control number 0910-0014. The collections of information in 21 CFR
parts 50 and 56 (Protection of Human Subjects: Informed Consent;
Institutional Review Boards) have been approved under OMB control
number 0910-0755.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24763 Filed 11-13-18; 8:45 am]
 BILLING CODE 4164-01-P