[Federal Register Volume 87, Number 205 (Tuesday, October 25, 2022)]
[Notices]
[Pages 64533-64534]
[FR Doc No: 2022-23105]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2022-0002-N-16]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA) and its
implementing regulations, this notice announces that FRA is forwarding
the Information Collection Requests (ICRs) abstracted below to the
Office of Management and Budget (OMB) for review and comment. These
ICRs describe the information collections and their expected burdens.
On June 16, 2022, FRA published a notice providing a 60-day period for
public comment on the ICRs.

DATES: Interested persons are invited to submit comments on or before
November 25, 2022.

ADDRESSES: Written comments and recommendations for the proposed ICRs
should be sent within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find the particular ICR by selecting
``Currently under 30-day Review--Open for Public Comments'' or by using
the search function.

FOR FURTHER INFORMATION CONTACT: Ms. Hodan Wells, Information
Collection Clearance Officer at email: [email protected] or
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
issue two notices seeking public comment on information collection
activities before OMB may approve paperwork packages. See 44 U.S.C.
3506, 3507; 5 CFR 1320.8 through 1320.12. On June 16, 2022, FRA
published a 60-day notice in the Federal Register soliciting comment on
the ICRs for which it is now seeking OMB approval. See 87 FR 36366. FRA
received no comments in response to this notice.
    Before OMB decides whether to approve the proposed collections of
information, it must provide 30 days for public comment. Federal law
requires OMB to approve or disapprove paperwork packages between 30 and
60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5
CFR 1320.12(a); see also 60 FR 44978, 44983 (Aug. 29, 1995). OMB
believes the 30-day notice informs the regulated community to file
relevant comments and affords the agency adequate time to digest public
comments before it renders a decision. 60 FR 44983 (Aug. 29, 1995).
Therefore, respondents should submit their respective comments to OMB
within 30 days of publication to best ensure having their full effect.
    Comments are invited on the following ICRs regarding: (1) whether
the information collection activities are necessary for FRA to properly
execute its functions, including whether the information will have
practical utility; (2) the accuracy of FRA's estimates of the burden of
the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (3) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (4) ways to minimize the burden of information
collection activities on the public, including the use of automated
collection techniques or other forms of information technology.
    The summaries below describe the ICRs that FRA will submit for OMB
clearance as the PRA requires:
    Title: Special Notice for Repairs.
    OMB Control Number: 2130-0504.
    Abstract: Under 49 CFR part 216, FRA and State inspectors may issue
a Special Notice for Repairs to notify a railroad in writing of an
unsafe condition involving a locomotive, car, or track. The railroad
must notify FRA in writing when the equipment is returned to service or
the track is restored to a condition permitting operations at speeds
authorized for a higher class, specifying the repairs completed. FRA
and State inspectors use this information to remove from service
freight cars, passenger cars, and locomotives until they can be
restored to a serviceable condition. They also use this information to
reduce the maximum authorized speed on a section of track until repairs
can be made.
    Type of Request: Extension without change (with changes in
estimates) of a currently approved collection.
    Affected Public: Businesses.
    Form(s): FRA F 6180.8; FRA F 6180.8A.
    Respondent Universe: 754 railroads.
    Frequency of Submission: On occasion.
    Total Estimated Annual Responses: 7.
    Total Estimated Annual Burden: 3 hours.
    Total Estimated Annual Burden Hour Dollar Cost Equivalent: $194.

    Title: Bridge Safety Standards.
    OMB Control Number: 2130-0586.\1\
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    \1\ The burden associated with Sec.  214.105(c)(4), formerly
covered under OMB Control No. 2130-0535, is now combined with the
burden under OMB Control No. 2130-0586.
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    Abstract: The Fixing America's Surface Transportation Act (FAST
Act) (Pub. L. 114-94, Dec. 4, 2015), Section 11405, ``Bridge Inspection
Reports,'' provides a means for a State or a political subdivision of a
State to obtain a public version of a bridge inspection report
generated by a railroad for a bridge located within its respective
jurisdiction. While the FAST Act specifies that requests for such
reports are to be filed with the Secretary of Transportation, the
responsibility for fulfilling these requests is delegated to FRA.\2\
FRA developed a form titled ``Bridge Inspection Report Public Version
Request Form'' (FRA F 6180.167) to facilitate such requests by States
and their political subdivisions.
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    \2\ 49 CFR 1.89(a).
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    Additionally, the collection of information set forth under 49 CFR
214.105(c) establishes standards and practices for safety net systems.
Safety nets and net installations must be drop-tested at the job site
after initial installation and before being used as a fall-protection
system, after major repairs, and at 6-month intervals if left at one
site. If a drop-test is not feasible and is not performed, then the
railroad or railroad contractor, or a designated certified person, must
provide written certification the net complies with the safety
standards under Sec.  214.105. FRA and State inspectors use the
information to enforce Federal regulations. The information maintained
at the job site promotes safe bridge worker practices while providing
flexibility at bridge work job sites.
    Furthermore, the collection of information set forth under 49 CFR
part 237 normalized and established Federal requirements for railroad
bridges.\3\ In particular, the collection of information is used by FRA
to confirm that railroads/track owners adopt and implement bridge
management programs to properly inspect, maintain, modify, and repair
all bridges that carry trains for which they are responsible.
Railroads/track owners must conduct annual inspections of railroad
bridges, as well as special inspections that must be carried out if
natural or accidental events cause conditions that warrant such
inspections. Further, railroads/track owners must incorporate
provisions for internal audits into their bridge management programs
and must conduct internal audits of bridge inspection reports. FRA uses
the information collected to ensure that railroads/track owners meet
Federal standards for bridge safety and comply with all the
requirements of part 237.
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    \3\ 75 FR 41281 (July 15, 2010).
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    Type of Request: Extension without change (with changes in
estimates) of a currently approved collection.
    Affected Public: Businesses (railroads and track owners), States,
the District of Columbia (DC), and political subdivisions of States.
    Form(s): FRA F 6180.167.
    Respondent Universe: 784 track owners, 50 States and DC, and 200
political subdivisions of States.
    Frequency of Submission: On occasion and annual.
    Total Estimated Annual Responses: 200,480.
    Total Estimated Annual Burden: 34,616 hours.
    Total Estimated Annual Burden Hour Dollar Cost Equivalent:
$2,680,686.
    FRA informs all interested parties that it may not conduct or
sponsor, and a respondent is not required to respond to, a collection
of information that does not display a currently valid OMB control
number.
    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Deputy Chief Counsel.
[FR Doc. 2022-23105 Filed 10-24-22; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 124 (Wednesday, June 27, 2018)]
[Notices]
[Pages 30206-30207]
[FR Doc No: 2018-13764]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83491; File No. SR-NFA-2018-01]

Self-Regulatory Organizations; National Futures Association;
Notice of Filing and Immediate Effectiveness of Proposed Technical
Amendment to the Interpretive Notice to NFA Compliance Rule 2-9:
Special Supervisory Requirements for Members Registered as Broker-
Dealers Under Section 15(b)(11) of the Securities Exchange Act of 1934

June 21, 2018.
    Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934
(``Exchange Act''),\1\ and Rule 19b-7 under the Exchange Act,\2\ notice
is hereby given that on June 14, 2018, National Futures Association
(``NFA'') filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change described in Items I, II, and
III below, which Items have been prepared by NFA. 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)(7).
    \2\ 17 CFR 240.19b-7.
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    On August 30, 2017, NFA also filed this proposed rule change with
the Commodity Futures Trading Commission (``CFTC'') and requested that
the CFTC make a determination that review of the proposed rule change
of NFA is not necessary. By letter dated September 15, 2017, the CFTC
notified NFA of its determination not to review the proposed rule
change.\3\
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    \3\ See letter from Eileen T. Flaherty, Director, CFTC to Carol
A. Wooding, General Counsel, NFA (``Letter'').
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    The text of the proposed rule change is available at the self-
regulatory organization's office, on the NFA's website at
www.nfa.futures.org, and at the SEC's Public Reference Room.

I. Self-Regulatory Organization's Description and Text of the Proposed
Rule Change

    The technical amendment to NFA's Interpretive Notice entitled ``NFA
Compliance Rule 2-9: Special Supervisory Requirements for Members
Registered as Broker-Dealers'' (``Interpretive Notice'') references the
Form 3-R. The amendment eliminates the reference to the Form 3-R. The
text of the proposed technical amendment to the Interpretive Notice is
found in Exhibit 4.

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

    In its filing with the Commission, NFA 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. NFA 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
    Section 15A(k) of the Exchange Act \4\ makes NFA a national
securities association for the limited purpose of regulating the
activities of NFA Members (``Members'') who are registered as brokers
or dealers in security futures products under Section 15(b)(11) of the
Exchange Act.\5\ NFA's Interpretive Notice applies to all Members who
meet the criteria in the Interpretive Notice and could apply to Members
registered under Section 15(b)(11) of the Exchange Act.
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    \4\ 15 U.S.C. 78o-3(k).
    \5\ 15 U.S.C. 78o(b)(11).
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    NFA's registration rules need to be amended to implement the CFTC's
retiring of the Form 3-R, which had been used to report changes to
registration information. The CFTC eliminated the Form 3-R recognizing
that in the electronic era, changes are made directly to the
registration information rather than via filing a Form 3-R.
    In August 2012, the CFTC eliminated the requirement that
registrants and individuals use CFTC Form 3-R to update and file
changes to their registration information because the online Forms 7-R
and 8-R can be updated directly in NFA's Online Registration System and
automatically create a record of changes equivalent to a completed Form
3-R. This amendment removes the Form 3-R reference and replaces it with
the direction to report updates and file changes to registration
information by, ``. . . an update to the Form 7-R.''
    Amendments to the Interpretive Notice were previously filed with
the SEC in SR-NFA-2007-07, Exchange Act Release No. 34-57142 (Jan. 14,
2008).
2. Statutory Basis
    The rule change is authorized by, and consistent with, Section
15A(k) of the Exchange Act.\6\ The proposed changes are nothing more
than technical amendments to remove a reference to the Form 3-R.
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    \6\ 15 U.S.C. 78o-3(k).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change will have little or no impact on
competition. The proposed amendment to the Interpretive Notice does not
impose new requirements on Members.

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

    NFA did not publish the rule change to the membership for comment.
NFA did not receive comment letters concerning the rule change.

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

    The CFTC notified NFA of its determination not to review the
proposed rule change.\7\ The proposed rule change became effective on
September 15, 2017.
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    \7\ See Letter, Supra note 3.
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    At any time within 60 days of the date of effectiveness of the
proposed rule change, the Commission, after consultation with the CFTC,
may summarily abrogate the proposed rule change and require that the
proposed rule change be refiled in accordance with the provisions of
Section 19(b)(1) of the Exchange Act.\8\
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    \8\ 15 U.S.C. 78s(b)(1).
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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 Exchange Act. Comments may be submitted
by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NFA-2018-01 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-NFA-2018-01. 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 website (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 website 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 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of NFA. All comments received will
be posted without change. Persons submitting comments are cautioned
that we do not redact or edit personal identifying information from
comment submissions. You should submit only information that you wish
to make publicly available. All submissions should refer to File Number
SR-NFA-2018-01 and should be submitted on or before July 18, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(73).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-13764 Filed 6-26-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 32 (Thursday, February 16, 2012)]
[Notices]
[Pages 9288-9290]
[FR Doc No: 2012-3613]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66377; File No. SR-NYSEArca-2012-12]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Implementing
Changes to the NYSE Arca Options Fee Schedule Relating to Post
Liquidity Credits

February 10, 2012.
    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 January 31, 2012, NYSE Arca, Inc. (the ``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. 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

    The Exchange proposes to amend the NYSE Arca Options Fee Schedule
(``Fee Schedule'') to increase the Post Liquidity credits on Customer
posted electronic executions and to delete references to Royalty Fees
for foreign currency options, which the Exchange no longer trades. The
text of the proposed rule change is available at the Exchange, the
Commission's Public Reference Room, and www.nyse.com.

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

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

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

1. Purpose
    The Exchange proposes to amend the Fee Schedule to increase the
Post Liquidity credits on Customer posted electronic executions and to
delete references to Royalty Fees for foreign currency options, which
the Exchange no longer trades. The Exchange proposes to make the rule
change operative on February 1, 2012.
Post Liquidity Credits
    Electronic transactions in Penny Pilot issues \3\ are assessed Take
Liquidity fees and credited with Post Liquidity credits. Under the
current Fee Schedule, the Post Liquidity credit is $0.25 per contract
for Customers, $0.32 per contract for Lead Market Makers and Market
Makers, and $0.10 per contract for Firms and Broker Dealers. OTP
Holders that provide aggregated Customer posting volume in Penny Pilot
issues that exceeds certain thresholds receive higher Post Liquidity
credits on all Customer posted electronic executions. Specifically, an
OTP Holder sending Customer orders that in the aggregate exceed 500,000
contracts executed in a month from posting liquidity receives a Post
Liquidity credit of $0.32 per contract on all executions resulting from
posted liquidity. If such aggregated Customer orders exceed 800,000
contracts executed in a month from posting liquidity, the OTP Holder
receives a Post Liquidity credit of $0.34 per contract on all
executions resulting from posted liquidity. If such aggregated Customer
orders exceed 1,200,000 contracts executed in a month from posting
liquidity, the OTP Holder receives a Post Liquidity credit of $0.38 per
contract on all executions resulting from posted liquidity. The volume
thresholds are intended to incentivize firms to route additional
Customer orders to the Exchange.
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    \3\ Under NYSE Arca Options Rule 6.72, options on certain issues
have been approved to trade in a minimum price variation of $0.01 as
part of a pilot program that is scheduled to expire on June 30,
2012.
---------------------------------------------------------------------------

    The Exchange proposes to amend the volume thresholds for the Post
Liquidity credits by lowering the initial volume threshold to qualify
for the first level of higher Post Liquidity credits, generally raising
the amount of the Post Liquidity

credits for the next two volume thresholds, and creating a new higher
volume threshold that will pay a higher Post Liquidity credit than is
currently offered. The Exchange notes, however, that under the proposed
volume thresholds, an OTP Holder that sends Customer orders that in the
aggregate exceed 500,000 but not 800,000 contracts executed in a month
will receive a lower Post Liquidity credit of $0.28 per contract, which
is lower than the $0.32 Post Liquidity credit under the current Fee
Schedule. The Exchange believes that the overall redistribution of the
credits will in turn increase order flow to add liquidity on the
Exchange and encourage greater participation by the largest market
participants. The proposed volume thresholds and Post Liquidity credits
are as follows:

------------------------------------------------------------------------
                                    Monthly total
                                  customer contracts   Per contract rate
                                 executed from posted    on all posted
                                      liquidity            liquidity
------------------------------------------------------------------------
Threshold 1...................  More than 350,000....             -$0.28
Threshold 2...................  More than 800,000....              -0.36
Threshold 3...................  More than 1,200,000..              -0.42
Threshold 4...................  More than 3,500,000..              -0.43
------------------------------------------------------------------------

Royalty Fees for Foreign Currency Options
    The current Fee Schedule sets forth Royalty Fees for certain
foreign currency options. Because the Exchange no longer trades foreign
currency options, it proposes to delete references to such Royalty
Fees.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Securities Exchange Act of 1934 (the ``Act'')
\4\ in general and Section 6(b)(4) of the Act \5\ in particular because
it is designed to provide for the equitable allocation of reasonable
dues, fees, and other charges among its members and other persons using
its facilities and does not unfairly discriminate between customers,
issuers, brokers or dealers. The proposed change is equitably allocated
and not unfairly discriminatory because it will apply uniformly to all
similarly situated OTP Holders that direct Customer orders to the
Exchange. The proposed fees also are equitably allocated and reasonable
because they create an incrementally higher incentive for OTP Holders
to bring additional liquidity to the Exchange, thereby contributing to
price discovery and benefiting investors generally. Moreover, the
difference between (1) the Post Liquidity credits received by OTP
Holders that aggregate Customer orders, and (2) the Post Liquidity
credit received by Firms and Broker Dealers is not inequitable or
unfairly discriminatory because the Exchange believes that it has
structured its Fee Schedule in a manner to attract order flow from all
such entities. In this regard, the Exchange has found that the higher
Post Liquidity credit for Firms and Broker Dealers has not caused them
to send additional order flow to the Exchange. Based on its
observations, the Exchange believes that such entities focus on the
ability to trade with Customer order flow to capture the spread rather
than on rebates and fees. Accordingly, the Exchange is proposing to
further generally increase the Post Liquidity credits for Customer
order flow to attract such order flow to the Exchange. Although certain
OTP Holders that send Customer orders that in the aggregate exceed
500,000 but not 800,000 contracts executed in a month will receive a
slightly lower Post Liquidity credit than they currently do, other OTP
Holders that previously did not qualify for the credit will qualify
going forward. The Exchange believes that overall redistribution of the
credits will in turn increase order flow to add liquidity on the
Exchange and encourage greater participation by the largest market
participants. With the anticipated increase in such order flow to the
Exchange, the Exchange expects to attract additional order flow from
Firms and Broker Dealers to trade with such order flow. The Exchange
further believes that the proposed change is reasonable because other
exchanges offer comparable tiers of credits for adding Customer
liquidity in Penny Pilot issues.\6\
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4).
    \6\ See, e.g., Nasdaq Options Market pricing, available at
http://nasdaqtrader.com/Micro.aspx?id=OptionsPricing, and BATS BZX
Exchange Fee Schedule, Effective January 3, 2012, available at
http://batstrading.com/FeeSchedule/.
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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 that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

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

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \7\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \8\ thereunder, because it establishes a due, fee, or other charge
imposed by the NYSE Arca.
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    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.

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-NYSEArca-2012-12 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary,

Securities and Exchange Commission, 100 F Street NE., Washington, DC
20549-1090.

All submissions should refer to File Number SR-NYSEArca-2012-12. 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, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2012-12 and should
be submitted on or before March 8, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-3613 Filed 2-15-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 75 (Wednesday, April 18, 2018)]
[Rules and Regulations]
[Pages 17077-17078]
[FR Doc No: 2018-08139]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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

Federal Register / Vol. 83, No. 75 / Wednesday, April 18, 2018 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 29

[Docket No. FAA-2017-1129; Notice No. 29-042-SC]

Special Conditions: Bell Helicopter Textron, Inc. (BHTI), Model
525 Helicopter; Mode Annunciation

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions.

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SUMMARY: These special conditions are issued for the BHTI Model 525
helicopter. This helicopter will have a novel or unusual design feature
associated with fly-by-wire flight control system (FBW FCS) functions
that affect the pilot awareness of the flight control modes while
operating the helicopter. The applicable airworthiness regulations do
not contain adequate or appropriate safety standards for this design
feature. These special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

DATES: April 18, 2018.

FOR FURTHER INFORMATION CONTACT: George Harrum, Aerospace Engineer,
Rotorcraft Standards Branch, Policy and Innovation Division, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    On December 15, 2011, BHTI applied for a type certificate for a new
transport category helicopter designated as the Model 525. The aircraft
is a medium twin-engine rotorcraft. The design maximum takeoff weight
is 20,500 pounds, with a maximum capacity of 19 passengers and a crew
of 2.
    The BHTI Model 525 helicopter will be equipped with a four-axis
full authority digital FBW FCS that provides for aircraft control
through pilot input and coupled flight director modes. Current
regulations are inadequate in the area of pilot awareness of the flight
control modes while operating the helicopter. The proposed special
condition will require that suitable mode annunciation be provided to
the flight crew for events that significantly change the operating mode
of the system but do not merit the traditional warnings, cautions, and
advisories.

Type Certification Basis

    Under the provisions of 14 CFR 21.17, BHTI must show that the Model
525 helicopter meets the applicable provisions of part 29, as amended
by Amendment 29-1 through 29-55 thereto. The BHTI Model 525
certification basis date is December 31, 2013, the effective date of
application to the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 29) do not contain adequate or
appropriate safety standards for the BHTI Model 525 because of a novel
or unusual design feature, special conditions are prescribed under the
provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, the special conditions would also
apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the BHTI Model 525 helicopter must comply with the noise
certification requirements of 14 CFR part 36, and the FAA must issue a
finding of regulatory adequacy under section 611 of Public Law 92-574,
the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The BHTI Model 525 helicopter will incorporate the following novel
or unusual design features: A four-axis full authority digital FBW FCS.
Pilot control inputs, through the mechanically linked cockpit controls
(cyclic, collective, directional pedals), are transmitted electrically
to each of the three Flight Control Computers (FCCs). The pilot control
input signals are then processed and transmitted to the hydraulic
flight control actuators which affect control of the main and tail
rotors. The FCCs process the pilot control input signals depending on
the flight control mode in affect.

Discussion

    The current 14 CFR 29 standards do not provide adequate standards
for pilot awareness of the flight control modes while operating the
helicopter. These special conditions require that suitable mode
annunciation be provided to the flight crew for events that
significantly change the operating mode of the system but do not merit
the traditional warnings, cautions, and advisories.

Discussion of Comments

    Notice of proposed special conditions No. 29-042-SC for the BHTI
Model 525 helicopter was published in the Federal Register on December
7, 2017 (82 FR 57687). One commenter, Sikorsky Aircraft (Sikorsky),
responded to the Notice.
    Sikorsky requested that the annunciation required by the proposed
special conditions be placed within the immediate field of view of the
pilot. Sikorsky also requested that because the word ``significantly''
in the proposed special conditions may be subjective, the following
language be added to provide clarification: ``in such a way as to alter
the pilots primary control strategy.''
    The FAA agrees. We have revised the special conditions accordingly.

Applicability

    As discussed above, these special conditions are applicable to the
BHTI Model 525 helicopter. Should BHTI apply at a later date for a
change to the type certificate to include another model incorporating
the same novel or unusual design feature, these special conditions
would apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on one model of rotorcraft. It is not a rule of general applicability.

List of Subjects in 14 CFR Part 29

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

0
 Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for the Bell Helicopter Textron, Inc.,
Model 525 helicopter:
    Mode Annunciation: A means must be provided, within the pilots'
primary field of view, to indicate to the crew any mode that
significantly changes or degrades the handling or operational
characteristics of the rotorcraft in such a way as to alter the pilots'
primary control strategy.

    Issued in Fort Worth, Texas, on March 30, 2018.
Jorge Castillo,
Acting Manager, Rotorcraft Standards Branch, Policy and Innovation
Division, Aircraft Certification Service.
[FR Doc. 2018-08139 Filed 4-17-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Proposed Rules]
[Pages 69910-69912]
[FR Doc No: 2010-28820]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2010-0906; FRL-9227-1]

Revisions to the California State Implementation Plan, California
Air Resources Board--Consumer Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the California Air
Resources Board portion of the California State Implementation Plan
(SIP). These revisions concern volatile organic compound (VOC)
emissions from consumer products. We are approving a local rule that
regulates these emission sources under the Clean Air Act as amended in
1990 (CAA or the Act). We are taking comments on this proposal and plan
to follow with a final action.

DATES: Any comments must arrive by December 16, 2010.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2010-0906, by one of the following methods: Federal eRulemaking Portal:
http://www.regulations.gov. Follow the on-line instructions.
    1. E-mail<EMAIL_ADDRESS>    2. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or e-mail. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send e-mail directly to EPA, your e-mail address will be
automatically captured and included as part of the public comment. If
EPA cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available in either location
(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed in the
FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Stanley Tong, EPA Region IX, (415)
947-4122<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rule did the State submit?
    B. Are there other versions of this rule?
    C. What is the purpose of the submitted rule revision?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rule?
    B. Does the rule meet the evaluation criteria?
    C. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rule did the State submit?

    Table 1 lists the rule addressed by this proposal with the date
that it was adopted by the State and submitted by the California Air
Resources Board (CARB).

                                             Table 1--Submitted Rule
----------------------------------------------------------------------------------------------------------------
                  Regulation                            Regulation title              Amended        Submitted
----------------------------------------------------------------------------------------------------------------
California Code of Regulations, Title 17,       Article 2--Consumer Products....        05/05/09        02/16/10
 Division 3, Chapter 1, Subchapter 8.5--
 Consumer Products.
----------------------------------------------------------------------------------------------------------------

    On May 25, 2010, EPA determined that the submittal for the
California Code of Regulations, Title 17, Division 3, Chapter 1,
Subchapter 8.5, Article 2--Consumer Products, met the completeness
criteria in 40 CFR Part 51, Appendix V, which must be met before formal
EPA review.

B. Are there other versions of this rule?

    We approved an earlier version of Article 2 of CARB's Consumer
Products regulation into the SIP on November 4,

2009 (74 FR 57074). CARB adopted revisions to the SIP-approved version
on May 5, 2009 and submitted them to us on February 16, 2010.

C. What is the purpose of the submitted rule revisions?

    VOCs help produce ground-level ozone and smog, which harm human
health and the environment. Section 110(a) of the CAA requires States
to submit regulations that control VOC emissions.
    The California Health and Safety Code (Section 41712(b)) requires
CARB to adopt regulations to achieve the maximum feasible reduction in
volatile organic compounds emitted by consumer products if the state
board determines:
    (1) The regulations are necessary to attain state and federal
ambient air quality standards.
    (2) The regulations are commercially and technologically feasible
and necessary.
    CARB's current amendments to the consumer products regulations
establish new or lower VOC limits on 19 consumer product categories.
Included in these changes are limits for eight new categories
(astringent/toner, fabric softener--single use dryer product, floor
maintenance product, vehicle wash, odor remover/eliminator, pressurized
gas duster, tire or wheel cleaner, and windshield water repellent).
    The amendments clarify several definitions, impose a 0.05 grams of
VOC per use limit for fabric softeners--single use dryer products,
remove an exemption for personal fragrance products with 20 percent or
less fragrance, prohibit the use of the toxic air contaminants
methylene chloride, perchloroethylene, or trichloroethylene in certain
product categories, prohibit the use of compounds with a global warming
potential (GWP) of 150 or greater in pressurized gas dusters, and
establish a 25 percent by weight VOC limit for multipurpose lubricants
and penetrants. The 25 percent VOC limit for multipurpose lubricants
and penetrants is effective December 31, 2013 and the category also
includes a technology forcing second tier VOC limit of 10 percent by
December 31, 2015.
    CARB received many comments during the public comment period,
ranging from general support for many of the amendments and suggestions
for additional categories (e.g., janitorial cleaning products) to
regulate, to concerns from industry about the technological
difficulties posed by the revised VOC limits and effective dates for
multi-purpose lubricants. CARB addressed these comments in their Final
Statement of Reasons for Rulemaking.
    CARB estimates these amendments, when fully implemented, will
achieve VOC reductions of 5.76 tons per day, greenhouse gas emission
reductions equivalent to approximately 0.20 million metric tons of
carbon dioxide per year, and air toxics emission reductions of 0.2 tons
per day.
    EPA's technical support document (TSD) has more information about
this rule.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rule?

    Generally, SIP rules must be enforceable (see section 110(a) of the
Act), and must not relax existing requirements (see sections 110(l) and
193). California's consumer products regulation covers VOC area sources
and not stationary sources.
    In 1998 EPA promulgated a national rule to regulate VOC emissions
from consumer products (63 FR 48831, September 11, 1998). EPA's
national rule largely parallels CARB's earlier SIP-approved consumer
products rule. The amendments we are proposing to approve today
regulate more consumer product categories and are more stringent than
EPA's national standards.
    Rules, guidance and policy documents that we use to evaluate
enforceability and SIP revisions include the following:
    1. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' EPA, May 25, 1988, revised January 11, 2000 (the
Bluebook).
    2. State Implementation Plans, General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990 (57
FR 13498; April 16, 1992).
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    4. 40 CFR 59 Subpart C, National Volatile Organic Compound Emission
Standards for Consumer Products.

B. Does the rule meet the evaluation criteria?

    We believe this rule is consistent with the relevant policy and
guidance regarding enforceability, and SIP relaxations. CARB's Consumer
Products regulation contains more stringent limits and covers more than
twice the number of categories covered by EPA's national Consumer
Products rule. The TSD has more information on our evaluation.

C. Public Comment and Final Action

    Because EPA believes the submitted rule fulfills all relevant
requirements, we are proposing to fully approve it under section
110(k)(3) of the Act. We will accept comments from the public on this
proposal for the next 30 days. Unless we receive convincing new
information during the comment period, we intend to publish a final
approval action that will incorporate this rule into the federally
enforceable SIP.

III. 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.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

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

    Dated: November 3, 2010.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2010-28820 Filed 11-15-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Notices]
[Pages 4494-4495]
[FR Doc No: 2018-01892]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1586 and FDA-2017-E-4452]

Determination of Regulatory Review Period for Purposes of Patent
Extension; CRESEMBA--New Drug Application 207501

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for CRESEMBA as approved under
new drug application (NDA) 207501 and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of applications to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product as approved
under NDA 207501.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
2, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by July 30, 2018. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

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 April 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 2, 2018. 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 Nos.
FDA-2016-E-1586 and FDA-2017-E-4452 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; CRESEMBA--NDA 207501.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the dockets 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 Sec.  10.20 (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: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product CRESEMBA
(isavuconazonium sulfate). CRESEMBA is indicated for use in the
treatment of invasive aspergillosis and invasive mucormycosis.
Subsequent to this approval, the USPTO received patent term restoration
applications for CRESEMBA as approved under NDA 207501 (U.S. Patent
Nos. 6,812,238 and 7,459,561) from Basilea Pharmaceutica International
Ltd., and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
July 28, 2016, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of CRESEMBA
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
CRESEMBA is 3,528 days. Of this time, 3,286 days occurred during the
testing phase of the regulatory review period, while 242 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: July 10, 2005. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on July 10, 2005.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: July 8,
2014. FDA has verified the applicant's claim that the NDA for CRESEMBA
(NDA 207501) was initially submitted on July 8, 2014.
    3. The date the application was approved: March 6, 2015. FDA has
verified the applicant's claim that NDA 207501 was approved on March 6,
2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension
based on NDA 207501, this applicant seeks 5 years or 1,264 days of
patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES), must be
filed in accordance with Sec.  10.20, must contain sufficient facts to
merit an FDA investigation, and must certify that a true and complete
copy of the petition has been served upon the patent applicant. (See H.
Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions
should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01892 Filed 1-30-18; 8:45 am]
 BILLING CODE 4164-01-P