[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Notices]
[Page 76467]
[FR Doc No: 2015-30914]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL_9931-92-OEI]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, State of Illinois

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's approval of the State of
Illinois's request to revise/modify its EPA Administered Permit
Programs: The National Pollutant Discharge Elimination System EPA-
authorized program to allow electronic reporting.

DATES: EPA's approval is effective December 9, 2015.

FOR FURTHER INFORMATION CONTACT: Karen Seeh, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1175<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the option
of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application and will use electronic document receiving systems
that meet the applicable subpart D requirements.
    On September 15, 2015, the Illinois Environmental Protection Agency
(IEPA) submitted an application titled ``National Network Discharge
Monitoring Report System'' for revision/modification its EPA-approved
Part 123 program under title 40 CFR to allow new electronic reporting.
EPA reviewed IEPA's request to revise/modify its EPA-authorized Part
123--EPA Administered Permit Programs: The National Pollutant Discharge
Elimination System program and, based on this review, EPA determined
that the application met the standards for approval of authorized
program revision/modification set out in 40 CFR part 3, subpart D. In
accordance with 40 CFR 3.1000(d), this notice of EPA's decision to
approve Illinois's request to revise/modify its Part 123--EPA
Administered Permit Programs: The National Pollutant Discharge
Elimination System program to allow electronic reporting if discharge
monitoring report information under 40 CFR part 122 is being published
in the Federal Register.
    IEPA was notified of EPA's determination to approve its application
with respect to the authorized program listed above.

Matthew Leopard,
Director, Office of Information Collection.
[FR Doc. 2015-30914 Filed 12-8-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 28, 2011 (Volume 76, Number 124)]
[Rules and Regulations]
[Page 37649-37650]
[DOCID:fr28jn11-14]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG 2011-0406]

Safety Zone; Northern California Annual Fireworks Events, July
4th Fireworks Display

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce safety zone for the annual July
4th Fireworks Display (Tahoe City 4th of July Fireworks Display). This
action is necessary to control vessel traffic and to ensure the safety
of event participants and spectators. During the enforcement period,
unauthorized persons or vessels are prohibited from entering into,
transiting through, or anchoring in the safety zone, unless authorized
by the Patrol Commander (PATCOM).

DATES: The regulations in 33 CFR 165.1191 will be enforced from 7 a.m.
through 10 p.m. on July 4, 2011.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or e-mail Lieutenant Junior Grade Liezl Nicholas U.S. Coast Guard;
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
for the annual Tahoe City 4th of July Fireworks in 33 CFR 165.1191 on
July 4, 2011, from 7 a.m. through 10 p.m. The fireworks launch site is
approximately 900 feet offshore of Common Beach, Tahoe City in position
39[deg]10'09.09'' N, 120[deg]08'16.33'' W (NAD83) and the safety zone
is approximately 1,000 ft radius surrounding the launch site.
    Under the provisions of 33 CFR 165.1191, unauthorized persons or
vessels are prohibited from entering into, transiting through, or
anchoring in the safety zone during all applicable effective dates and
times, unless authorized to do so by the PATCOM. Additionally, each
person who receives notice of a lawful order or direction issued by an
official patrol vessel shall obey the order of direction. The PATCOM is
empowered to forbid and control the regulated area. The PATCOM shall be
designated by the Commander, Coast Guard Sector San Francisco. The
PATCOM may, upon request, allow the transit of commercial vessels
through regulated areas when it is safe to do so.
    This notice is issued under authority of 33 CFR 165.1191 and 5
U.S.C. 552 (a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with extensive advance
notification of this enforcement period via the Local Notice to
Mariners.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners will be used to grant general permission
to enter the regulated area.

    Dated: June 16, 2011.
Cynthia L. Stowe,
Captain, U.S. Coast Guard, Captain of the Port Sector San Francisco.
[FR Doc. 2011-16104 Filed 6-27-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Pages 47398-47399]
[FR Doc No: 2016-17185]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2013-N-0093]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Evaluation of the
Program for Enhanced Review Transparency and Communication for New
Molecular Entity New Drug Applications and Original Biologics License
Applications in Prescription Drug User Fee Acts

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by August
22, 2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0746.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, 8455
Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Evaluation of the Program for Enhanced Review Transparency and
Communication for New Molecular Entity New Drug Applications (NME NDAs)
and Original Biologics License Applications (BLAs) in Prescription Drug
User Fee Acts (OMB Control Number 0910-0746)--Extension

    As part of its commitments in the Prescription Drug User Fee Act
(PDUFA) V, FDA established a new review Program to promote greater
transparency and increased communication between the FDA review team
and the applicant on the most innovative products reviewed by the
Agency. The Program applies to all NME NDAs and original BLAs that are
received from October 1, 2012, through September 30, 2017. The Program
is described in detail in section II.B of the document entitled ``PDUFA
Reauthorization Performance Goals and Procedures Fiscal Years 2013
through 2017'' (the Commitment Letter) (available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
    The goals of the Program are to increase the efficiency and
effectiveness of the first review cycle and decrease the number of
review cycles necessary for approval so that patients have timely
access to safe, effective, and high-quality new drugs and biologics. A
key aspect of the Program is an interim and final assessment that will
evaluate how well the parameters of the Program have achieved the
intended goals. The PDUFA V Commitment Letter specifies that the
assessments be conducted by an independent contractor and that they
include interviews of pharmaceutical manufacturers who submit NME NDAs
and original BLAs to the Program in PDUFA V. The contractor for the
assessments of the Program is Eastern Research Group, Inc. (ERG), and
the statement of work for the assessments is available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM304793.pdf.
    In accordance with the PDUFA V Commitment Letter, FDA contracted
with ERG to conduct independent interviews of applicants after FDA
issues a first-cycle action for applications reviewed under the
Program. The purpose of these interviews is to collect feedback from
applicants on the success of the Program in increasing review
transparency and communication during the review process. ERG will
anonymize and aggregate sponsor responses prior to inclusion in the
assessments and any

presentation materials at public meetings. FDA will publish ERG's
assessments, with interview results and findings, in the Federal
Register for public comment.
    Description of Respondents: The respondents to this collection of
information are sponsor representatives for NME NDAs and original BLAs.
    In the Federal Register of December 10, 2015 (80 FR 76699), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
        Portion of study             Number of     responses per   Total  annual    burden  per     Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Pre-test........................               5               1               5             1.5            7.50
Interviews......................             135               1             135             1.5          202.50
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             210
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA typically reviews approximately 40 to 45 NME NDAs and original
BLAs per year. ERG interviews 1 to 3 sponsor representatives at a time
for each application that receives a first-cycle action from FDA, up to
135 sponsor representatives per year. ERG conducts a pretest of the
interview protocol with five respondents. FDA estimates that it will
take 1.0 to 1.5 hours to complete the pretest, for a total of a maximum
of 7.5 hours. We estimate that up to 135 respondents will take part in
the post-action interviews each year, with each interview lasting 1.0
to 1.5 hours, for a total of a maximum of 202.5 hours. Thus, the total
estimated annual burden is 210 hours. FDA's burden estimate is based on
prior experience with similar interviews with the regulated community.

    Dated: July 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17185 Filed 7-20-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 34 (Thursday, February 20, 2020)]
[Notices]
[Pages 9824-9827]
[FR Doc No: 2020-03327]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88200; File No. SR-CboeBZX-2020-015]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Relating
To Amend the Logic That Would Be Used To Cancel MOC Orders Entered for
Participation in the Cboe Market Close in the Event the Exchange
Becomes Impaired

February 13, 2020.
    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 February 4, 2020, Cboe BZX Exchange, Inc. (``BZX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``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

    Cboe BZX Exchange, Inc. (``BZX'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (the ``Commission'') a
proposed rule change to amend the logic that would be used to cancel
MOC orders entered for participation in the Cboe Market Close in the
event the Exchange becomes impaired. The text of the proposed rule
change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), at the Exchange's Office of the Secretary, 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, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange 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 the proposed rule change is to amend the logic that
would be used by the Exchange to cancel Market-On-Close (``MOC'')
orders entered for participation in the Cboe Market Close in the event
the Exchange becomes impaired. The Exchange believes that the proposed
rule would provide greater transparency to members and investors with
regard to how their orders would be handled if the Exchange experiences
a systems or other issue that impacts the ability of the Exchange to
complete the Cboe Market Close in one or more securities.
    The Cboe Market Close is an innovative closing match process for
non-BZX Listed Securities that is designed to match buy and sell MOC
orders at the official closing price for such security published by the
primary listing market.\3\ Currently, Interpretations and Policies .02
to Rule 11.28 provides that the Exchange will cancel all MOC orders
designated to participate in Cboe Market Close in the event the
Exchange becomes impaired prior to the MOC Cut-Off Time and is unable
to recover within 5 minutes from the MOC Cut-Off Time.\4\ When
originally proposed, the Exchange stated that the purpose of this rule
was to provide an opportunity for members to

re-enter their MOC orders on the primary listing market in the event
that the Exchange became impaired and was unable to conduct the Cboe
Market Close.
---------------------------------------------------------------------------

    \3\ The Commission approved the Cboe Market Close on January 21,
2020. See Securities Exchange Act Release No. 88008 (January 21,
2020), 85 FR 4726 (January 27, 2020) (SR-BatsBZX-2017-34).
    \4\ The MOC Cut-Off Time is 3:35 p.m. ET, and represents the
time up until which members may enter, cancel, or replace MOC orders
designated for participation in the Cboe Market Close. See BZX Rule
11.28(a).
---------------------------------------------------------------------------

    The Exchange believes, however, that the current wording of the
rule is ambiguous. Specifically, the present language does not specify
whether MOC orders should be cancelled five minutes after the MOC Cut-
Off Time (i.e., at 3:40 p.m. ET), or five minutes before the MOC Cut-
Off Time (i.e., at 3:30 p.m. ET). In addition, the Exchange believes
that the length of the impairment is a relevant factor that should be
considered in determining if MOC orders entered into the Cboe Market
Close should be cancelled, as impairments of a longer duration may
indicate more significant issues with the closing match process. The
Exchange therefore proposes to amend Interpretations and Policies .02
to Rule 11.28 to increase the clarity of the rule and generally improve
the process for handling such impairments.
    As proposed, the Exchange would cancel all MOC orders designated to
participate in the Cboe Market Close if the Exchange becomes impaired
prior to the MOC Cut-Off Time, and is unable to recover before the MOC
Cut-Off Time, or becomes impaired after the MOC Cut-Off Time but before
completing the closing match process in a security. Thus, the MOC Cut-
Off Time would, as intended, establish an upper bound for conducting
the Cboe Market Close. The Exchange believes that this would continue
to ensure that members would have an opportunity to re-enter their MOC
orders on the primary listing market in the event that the Exchange
became impaired and is unable to conduct the Cboe Market Close due to
an impairment that cannot be resolved prior to the time that the
closing match process would ordinarily be conducted.
    If the Exchange is able to recover prior to the MOC Cut-Off Time,
however, the Exchange's handling would be dependent on the length of
the impairment. Specifically, if the impairment lasts less than five
minutes, the Exchange would cancel only those MOC orders designated to
be cancelled by the member. For impairments lasting five minutes or
more, the Exchange would cancel all MOC orders, thereby giving members
the opportunity to enter such orders for trading in the closing auction
to be conducted by the primary listing market. For example, the
Exchange would cancel all MOC orders if an impairment starts at 3:05
p.m. ET and continues past 3:10 p.m. ET. If instead the impairment was
resolved at 3:08 p.m. ET then members' order persistence settings would
govern which MOC orders are subject to cancellation. A member's
election for cancelling orders in the event of a matching engine
disconnect would be applied for purposes of determining whether to
cancel such MOC orders.\5\ As a result, members would have the
flexibility to determine how they would like their MOC orders handled
in the event of a short impairment but would have all MOC orders
cancelled in the event of a longer impairment that could indicate a
more significant issue.
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    \5\ The cancel on matching engine disconnect setting is
similarly used to handle impairments today, including situations
where there the primary matching engine fails over to a secondary
matching engine due, for example, to a software error, network
problem, etc.
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    In addition, the current rule provides that if the Exchange were to
become impaired after the MOC Cut-Off Time, it would retain all matched
MOC orders and execute those orders at the official closing price once
it is operational. The Exchange continues to believe that it is
important to ensure that paired MOC orders ultimately receive an
execution at the official closing price. As such, the amended
Interpretations and Policies .02 to Rule 11.28 would continue to
include similar language that states that if the Exchange becomes
impaired after completing the closing match process in a security, it
would retain all matched MOC orders and execute those orders at the
official closing price once the impairment is resolved. The proposed
language differs from the current language in two respects, which are
merely designed to increase clarity around these rules. First, the
proposed rules would reference the Exchange becoming impaired after
``completing the closing match process in a security'' rather than
after the MOC Cut-Off Time. While the Exchange would perform the
closing match process at the MOC Cut-Off Time, this language would
ensure that it is clear that matched MOC orders would be retained only
if the closing match process (i.e., the process for matching MOC
orders) is completed in the security. As discussed earlier in this
proposed rule change, all MOC orders designated to participate in the
Cboe Market Close would be cancelled if the Exchange becomes impaired
after the MOC Cut-Off Time but before completing the closing match
process in a security. Second, the proposed language would reference
executing those matched MOC orders ``once the impairment is resolved''
rather than ``once it is operational.'' Since the language in the
proposed rule discusses the process for handling a systems impairment,
the Exchange believes that the language in this portion of the rule
should similarly reference the resolution of this impairment.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \6\ in general, and furthers the objectives of Section
6(b)(5) of the Act \7\ in particular, in that it is designed to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system and, in general, to
protect investors and the public interest. Specifically, the Exchange
believes that the proposed rule change would protect investors and the
public interest because the amended rule would continue to ensure that
members have an opportunity to re-enter their orders on the primary
listing market if the Exchange experiences an impairment that would
impact the ability of the Exchange to successfully conduct the Cboe
Market Close in one or more securities, and would provide greater
transparency to members and investors with regard to how their orders
would be handled if the Exchange experiences such an issue. While the
Exchange believes that such events are likely to be rare, providing
greater certainty about how orders are handled in such rare situations
is consistent with the maintenance of a fair and orderly market.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that it would be beneficial to allow members
to choose how their orders are handled by using the member's order
persistence settings, where appropriate, to determine whether their
orders should be cancelled in the event that a systems impairment may
impact the ability of the Exchange to execute the Cboe Market Close. As
such, the Exchange has proposed to allow members to specify whether
their MOC orders should be cancelled in the event of a short impairment
that is resolved within five minutes, and would apply member's chosen
order persistence settings to do so. Using this setting would ensure
that members' continue to have the flexibility to determine how their
orders are handled in the event of a systems impairment, and would
ensure that MOC orders are handled similarly to other orders in such
circumstances. At the same time, for longer impairments with a duration
exceeding five minutes, the Exchange

believes that all members should have their orders cancelled so that
they have an opportunity to send those orders to the primary listing
market to participate in the closing auction and receive an execution
at the official closing price.
    Further, since all MOC orders would be cancelled if the Exchange is
unable to recover prior to the MOC Cut-Off Time of 3:35 p.m. ET,
members would be provided with more than sufficient time to enter their
orders for participation in the closing auction on the primary listing
market. For example, if the Exchange experienced an impairment that is
not resolved at of 3:35 p.m. ET, all MOC orders would be cancelled, and
members would have fifteen minutes until the 3:55 p.m. ET cutoff time
for entering MOC orders on The Nasdaq Stock Market LLC (``Nasdaq''),\8\
ten minutes until the 3:50 p.m. ET cutoff time for entering MOC orders
on New York Stock Exchange LLC (``NYSE''),\9\ and nineteen minutes
until the start of the 3:59 p.m. ET closing auction imbalance freeze on
NYSE Arca, Inc. (``Arca'').\10\ Of course, an impairment that begins
earlier in the trading day would result in orders being subject to
cancellation earlier, thus providing additional time for members to
redirect their MOC orders to the primary listing market. The Exchange
therefore believes that the amended rule would continue to provide an
adequate opportunity for members to re-enter their MOC orders on the
primary listing market in the event that the Exchange became impaired
and is unable to conduct the Cboe Market Close.
---------------------------------------------------------------------------

    \8\ See Nasdaq Rule 4702(b)(11)(A).
    \9\ See NYSE Rule 123C(2)(a)(i).
    \10\ See Arca Rule 7.35-E(d)(2).
---------------------------------------------------------------------------

    Finally, similar to language in the current rule, the amended rule
would explain that matched MOC orders would be retained and executed at
the official closing price once an impairment is resolved. The amended
rule contains minor language changes that are designed to increase
clarity around this process, including referencing that matched MOC
orders would be retained on completion of the closing match process in
a security rather than simply referencing the MOC Cut-Off Time, and
referencing that orders would be executed when the impairment is
resolved rather than more general language about the Exchange becoming
operational. While these changes do not significantly alter the
operation of the rule, the Exchange believes that the amendments
enhance the clarity of the proposed rules for handling these
situations. For example, while the closing match process would be
performed at the MOC Cut-Off Time it is possible that an impairment
could occur after the Exchange has begun performing the closing match
process but before that process has completed in one or more
securities. The proposed amendments make clear that in such an event
MOC orders would be retained only in those securities where the closing
match process has been completed. The Exchange would not retain matched
MOC orders if the closing match process in a security had started but
is interrupted by a systems impairment.

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Cboe Market Close is
designed to increase competition in the U.S. equities market by
offering an alternative to the primary listing markets' closing auction
processes. The proposed amendments do not address any competitive
issue, but would instead implement operational changes to the
Exchange's process for dealing with situations involving a systems
impairment that would impact the Exchange's ability to conduct a timely
closing match process. These changes are designed to both provide
transparency to members and investors about how the Exchange intends to
handle such situations, and to ensure that market participants have an
opportunity to have their orders executed as desired in the event of an
impairment. As such, the Exchange believes that the proposed rule
change would not burden competition, and indeed would further the
competitive benefits sought by the introduction of the Cboe Market
Close.

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

    No comments were solicited or received on the proposed rule change.

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

    Because the foregoing proposed rule change does not:
    A. Significantly affect the protection of investors or the public
interest;
    B. impose any significant burden on competition; and
    C. become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) of the Act \11\ and
Rule 19b-4(f)(6) \12\ thereunder. At any time within 60 days of the
filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission will institute proceedings to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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-CboeBZX-2020-015 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-CboeBZX-2020-015. 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 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. 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
available publicly. All submissions should refer to File Number SR-
CboeBZX-2020-015, and should be submitted on or before March 12, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2020-03327 Filed 2-19-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 181 (Wednesday, September 20, 2017)]
[Notices]
[Page 43958]
[FR Doc No: 2017-20017]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-2457-000]

Rock Creek Wind Project, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Rock Creek Wind Project, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 4, 2017.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

    Dated: September 14, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-20017 Filed 9-19-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Notices]
[Pages 9977-9979]
[FR Doc No: 2013-03097]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68838; File No. SR-Phlx-2013-08]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
the Routing Functionality of the NASDAQ OMX PSX Market

 February 6, 2013.
    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 January 23, 2013, NASDAQ OMX PHLX LLC (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II 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 is filing with the Commission a proposal to add
routing functionality to the NASDAQ OMX PSX Market (``System'').
Specifically, the Exchange proposes to amend Rule 3315, Order Routing.
    Proposed new language is italicized.
* * * * *

NASDAQ OMX PSX

NASDAQ OMX PSX (Rules 3000-3407)

Rule 3000. NASDAQ OMX PSX

* * * * *

3315. Order Routing

    (a) Order Routing Process
    (1) No change.
    (A) No change.
    (i)-(vii) No change.
    (viii) XDRK is a routing option under which orders check the System
for available shares and simultaneously route the remaining shares to
destinations on the System routing table that are not posting Protected
Quotations within the meaning of Regulation NMS. If shares remain un-
executed after routing, they are posted on the book. Once on the book,
should the order subsequently be locked or crossed by another market
center, the System will not route the order to the locking or crossing
market center.
    (ix) XCST is a routing option under which orders check the System
for available shares and simultaneously route the remaining shares to
destinations on the System routing table that are not posting Protected
Quotations within the meaning of Regulation NMS and to certain, but not
all, exchanges. If shares remain un-executed after routing, they are
posted on the book. Once on the book, should the order subsequently be
locked or crossed by another market center, the System will not route
the order to the locking or crossing market center.
    (B) No change.
    (b)-(d) Not applicable.
* * * * *
    (b) and (c) Not applicable.
* * * * *

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 Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange 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 the proposed rule change is to attract additional
business to and enhance the functionality offered by the Exchange's
NASDAQ OMX PSX equities market by providing additional optional
outbound routing services. Most equities exchanges today provide
routing services and the Exchange offers a variety of routing
strategies. Currently, Rule 3315, Order Routing, describes the order
routing process and states that all routing shall be in compliance with
Rule 611 of Regulation NMS under the Act.\3\ Furthermore, it enumerates
PSX's routing strategies: PSTG, PSKN, PSCN, PSKP, PTFY, PMOP and PCRT.
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    \3\ 17 CFR 242.611.
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    Proposed Rule 3315(a)(1)(A)(viii) will provide that XDRK is a
routing option under which orders check the System for available shares
and simultaneously route to certain destinations on the System routing
table that are not posting Protected Quotations within the meaning of
Regulation NMS (i.e. ``dark venues'' or ``dark pools''). If shares
remain un-executed after routing, they are posted on the book. Once on
the book, should the order subsequently be locked or crossed by another
market center, the System will not route the order to the locking or
crossing market center. This strategy is intended to attract market
participants that seek to execute on PSX or on dark pools without
executing on another exchange. Members may seek to execute in this
manner to interact with resting liquidity in addition to that available
on PSX, while also minimizing market impact and transaction fees.
    For example, if the National Best Bid/Offer (``NBBO'') is $10.00-
$10.01, and PSX, DarkVenueA and ARCA each offer 100 shares at $10.01, a
XDRK order to buy 1000 shares at $10.01 IOC will be handled as follows:
100 shares for execution on PSX and 100 shares routed to DarkVenueA
simultaneously at $10.01; the remaining 800 shares are not routed and
not executed, and cancelled back to the entering participant because it
was an IOC order. The order did not route to ARCA because it is not a
dark venue. As a second example, if the NBBO is $10.00-$10.01, and PSX,
DarkVenueA and ARCA each offer 100 shares at $10.01, a XDRK order to
buy 1000 shares at $10.01 DAY will be handled as follows: 100 shares
for execution on PSX and 100 shares routed to DarkVenueA simultaneously
at $10.01; the remaining 800 shares are posted on the PSX book (because
it is a DAY order). Once again, the order did not route to ARCA because
it is not a dark venue.
    Proposed Rule 3315(a)(1)(A)(ix) will provide that XCST is a routing
option under which orders check the System for available shares and
simultaneously route to select dark venues and to certain low cost
exchanges. If shares remain un-executed after routing, they

are posted on the book. Once on the book, should the order subsequently
be locked or crossed by another market center, the System will not
route the order to the locking or crossing market center. This strategy
is also intended to attract market participants who seek to save on
trading fees by only executing on the Exchange, on dark venues, or on
no cost and low cost exchanges.
    For example, if the NBBO is $10.00-$10.01, and PSX, DarkVenueA and
ARCA each offer 100 shares at $10.01, a XCST order to buy 1000 shares
at $10.01 DAY will be handled as follows: 100 shares for execution on
PSX and 100 shares routed to DarkVenueA simultaneously at $10.01; the
remaining 800 shares are posted on the PSX book (because it is a DAY
order). The order did not route to ARCA because it is neither a dark
venue nor a no cost or low cost exchange. As a second example, if the
NBBO is $9.90-$10.00, with BYX offering 100 shares at $10.00 and PSX,
DarkVenueA and ARCA each offer 100 shares at $10.01, a XCST order to
buy 1000 shares at $10.01 DAY will be handled as follows: 100 shares
routed to BYX at $10.00, 100 shares for execution on PSX and 100 shares
routed to DarkVenueA simultaneously at $10.01; the remaining shares are
posted on the PSX book (because it is a DAY order). The order did not
route to ARCA because it is neither a dark venue nor a no cost or low
cost exchange.
    In all cases, these routing strategies are designed to comply with
SEC Rule 611 and the other provisions of Regulation NMS.\4\
Accordingly, both XDRK and XCST will honor Protected Quotations within
the meaning of Regulation NMS and will not route to any market centers
included in their respective routing table at a price inferior to an
available Protected Quotation. For example, if the NBBO is $9.90-
$10.00, with NYSE offering 100 shares at $10.00 and PSX, DarkVenueA and
ARCA each offering 100 shares at $10.01, a XCST order to buy 1000
shares at $10.01 DAY will not be routed because NYSE's Protected
Quotation is not included in the routing table, by definition, for
XCST.
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    \4\ 17 CFR 242.611.
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    The Exchange will notify its membership of the implementation date,
which the Exchange expects will be on or about the 30th day after this
filing.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\5\ in general, and with
Sections 6(b)(5) of the Act,\6\ in particular, in that the proposal 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 regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest, because PSX
will be better able to serve its customers and compete with other
markets by offering additional optional routing services. Specifically,
the two new routing strategies will provide market participants with
greater flexibility in routing orders without developing order routing
strategies on their own.
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    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(5).
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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
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. PSX
competes with many exchanges and other execution venues for the
execution of orders in equities. Market participants can choose where
to send their orders. Accordingly, the proposal is pro-competitive in
that it affords the Exchange the opportunity to compete with other
exchanges in terms of offering new routing strategies.

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

    Because the foregoing 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 for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \7\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\8\
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. The Exchange has
provided the Commission written notice of its intent to file the
proposed rule change, along with a brief description and text of the
proposed rule change, at least five business days prior to the date of
filing of the proposed rule change.

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>include File Number SR-Phlx-2013-08 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-Phlx-2013-08. 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-Phlx-2013-08 and should be
submitted on or before March 5, 2013.

    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. 2013-03097 Filed 2-11-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Notices]
[Pages 44614-44616]
[FR Doc No: 2016-16201]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1270]

Use of Standards in the Food and Drug Administration's Regulatory
Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used
for Diagnosing Germline Diseases; Draft Guidance for Stakeholders and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Use of Standards in
FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In
Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases.'' As
part of the White House's Precision Medicine Initiative (PMI),\1\ FDA
is issuing this draft guidance to provide FDA's proposed approach on
the content and possible use of standards in providing oversight for
targeted and whole exome human DNA sequencing (WES) NGS-based tests
intended to aid in the diagnosis of individuals with suspected germline
diseases or other conditions. This document provides recommendations
for designing, developing, and validating NGS-based tests for germline
diseases, and also discusses possible use of FDA-recognized standards
for regulatory oversight of these tests. These recommendations are
based on FDA's understanding of the tools and processes needed to run
an NGS-based test along with the design and analytical validation
considerations appropriate for such tests. This draft guidance is not
final nor is it in effect at this time.
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    \1\ The Precision Medicine Initiative found on the White House's
Web site at: https://www.whitehouse.gov/precision-medicine.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
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guidance by October 6, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to

the docket unchanged. Because your comment will be made public, you are
solely responsible for ensuring that your comment does not include any
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-1270 for ``Use of Standards in FDA Regulatory Oversight of
Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used
for Diagnosing Germline Diseases.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Use of Standards in FDA Regulatory Oversight of Next Generation
Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing
Germline Diseases'' to the Office of the Center Director, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002; 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 request.

FOR FURTHER INFORMATION CONTACT: Personalized Medicine Staff, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 4544, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>; or<EMAIL_ADDRESS>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,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    As part of the PMI, FDA is committed to implementing a flexible and
adaptive regulatory oversight approach, which fosters innovation and
simultaneously assures that patients have access to accurate and
meaningful test results. FDA held two public workshops on this issue:
``Optimizing FDA's Regulatory Oversight of Next Generation Sequencing
Diagnostic Tests Public Workshop'' held on February 20, 2015, and
``Standards Based Approach to Analytical Performance Evaluation of Next
Generation Sequencing In Vitro Diagnostic Tests'' held on November 12,
2016. This guidance document, when finalized, provides recommendations
for designing, developing, and validating for targeted and whole exome
human DNA sequencing (WES) NGS-based tests intended to aid in the
diagnosis of individuals with suspected germline diseases or other
conditions (hereinafter referred to as ``NGS-based tests for germline
diseases'' or ``NGS-based tests''). It also outlines considerations for
possibly classifying certain NGS-based tests for germline diseases in
class II and exempting them from premarket notification requirements.
Upon finalization of this guidance, these recommendations should be
used as guidelines for test developers for premarket submissions.
However, the longer-term goal is for these recommendations to form the
basis for standards that FDA could recognize or for special controls
and/or conditions for premarket notification (510(k)) exemption. FDA is
also issuing a draft guidance entitled ``Use of Public Human Genetic
Variant Databases to Support Clinical Validity for Next Generation
Sequencing (NGS)-Based In Vitro Diagnostics'' which is being issued
concurrently elsewhere in this issue of the Federal Register.

II. Significance of Guidance

    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 use of
standards in FDA regulatory oversight of NGS-based IVDs used for
diagnosing germline diseases. 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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, and for
Center for Biologics Evaluation and Research guidance documents is
available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Use of Standards in FDA
Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro
Diagnostics (IVDs) Used for Diagnosing Germline Diseases'' may send an
email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 16009 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
801 and 21 CFR 809.10, regarding labeling, have been approved under OMB
control number 0910-0485; the collections of information in 21 CFR part
814, subparts A through E, regarding premarket approval, have been
approved under OMB control number 0910-0231; the collections of
information in 21 CFR part 820, regarding the quality system
regulation, have been approved under OMB control number 0910-0073; and
the collections of information in the guidance document ``Requests for
Feedback on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff'' have been approved
under OMB control number 0910-0756.

V. Other Issues for Consideration

    The Agency invites comments on the draft guidance document entitled
``Use of Standards in FDA Regulatory Oversight of Next Generation
Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing
Germline Diseases,'' in general, and on the following questions, in
particular:
    1. Does the draft guidance content adequately address the
analytical performance of targeted and whole exome human DNA sequencing
(WES) NGS-based tests intended to aid in the diagnosis of individuals
with suspected germline diseases or other conditions (referred to as
``NGS-based tests for germline diseases'' or ``NGS-based tests'' in the
guidance)? For example, do the recommendations outlined in the draft
guidance adequately address the analytical performance of NGS-based
tests used as an aid in diagnosis of patients with signs and symptoms
of developmental delay or intellectual disability, undiagnosed
diseases, or hereditary cancer syndromes? If not, what additional test
design, development, or validation activities are necessary for
analytical validation of such tests? Are there specific indications
within this broad intended use that require different or additional
test design, development, or validation activities from those described
in the draft guidance?
    2. Do the recommendations in the draft guidance adequately address
the analytical validation of NGS-based tests that use targeted panels
or WES? Targeted sequencing panels? Are there differences between the
use of targeted panels and WES that were not adequately distinguished
in the recommendations described in the draft guidance?
    3. The recommendations in this document focus on WES and targeted
NGS-based tests for germline diseases. Are the recommendations outlined
in the guidance sufficient to address analytical validation for whole
genome sequencing (WGS) NGS-based tests for germline diseases? If not,
what additional test design, development, and validation activities are
needed to address the analytical validation of such tests?
    4. Accuracy is generally described using an agreement, typically
positive and negative percent agreement (PPA and NPA), between a new
test and an accepted reference method. For NGS-based tests, positive
predictive value (PPV) may be a more meaningful metric than NPA when
calculating the likelihood that a variant call detected by the test is
a true positive. If PPV is calculated using only analytical results
without taking into account prevalence in a population, it is sometimes
called ``technical'' PPV (TPPV) to distinguish it from prevalence-based
PPV. What are the benefits and weaknesses to assessing NGS-based test
accuracy using TPPV in addition to PPA and NPA, or instead of NPA?
    5. Are the minimum performance thresholds presented in this draft
guidance appropriate, or are alternative thresholds more appropriate?
Are there ``best ways'' to determine acceptable thresholds for each
metric? Are there performance metrics that do not require minimum
thresholds? Are there test scenarios where minimum thresholds are not
useful or relevant?
    6. How can bias and over-fitting be minimized or accounted for if
known ``reference'' samples are used as comparators in accuracy
studies?

    Dated: July 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16201 Filed 7-7-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 74 (Tuesday, April 20, 2021)]
[Notices]
[Page 20491]
[FR Doc No: 2021-08071]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-16-000]

Transcontinental Gas Pipe Line Company, LLC; Notice of Request
for Extension of Time

    Take notice that on April 12, 2021, Transcontinental Gas Pipe Line
Company, LLC, (Transco) requested that the Federal Energy Regulatory
Commission (Commission) grant an extension of time, until May 1, 2023,
to complete, in part, approximately thirteen miles of pipeline looping
needed to complete Phase III of its Hillabee Expansion Project, as
authorized in the February 2, 2016 Order Issuing Certificates and
Approving Abandonment (February 2 Order).\1\ Ordering Paragraph (F)(1)
of the February 2 Order, as amended, provides a deadline of May 1,
2021, for Transco to construct the remaining facilities and place them
into service.\2\
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    \1\ Florida Southeast Connection, LLC, et al., 154 FERC ] 61,080
(2016) (February 2 Order), order on reh'g, Florida Southeast
Connection, LLC, et al., 156 FERC ] 61,160 (2016), order on remand,
Florida Southeast Connection, LLC, et al., 162 FERC ] 61,233 (2018).
    \2\ Florida Southeast Connection, LLC, et al., 156 FERC ]
61,160, P 50.
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    Transco states that, due to unforeseen delays caused by current
economic conditions, additional time is now required in order to
complete the construction of the authorized project facilities.
    This notice establishes a 15-calendar day intervention and comment
period deadline. Any person wishing to comment on the applicant's
request for an extension of time may do so. No reply comments or
answers will be considered. If you wish to obtain legal status by
becoming a party to the proceedings for this request, you should, on or
before the comment date stated below, file a motion to intervene in
accordance with the requirements of the Commission's Rules of Practice
and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the
Natural Gas Act (18 CFR 157.10).\3\
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    \3\ Only motions to intervene from entities that were party to
the underlying proceeding will be accepted. Algonquin Gas
Transmission, LLC, 170 FERC ] 61,144, at P 39 (2020).
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    As a matter of practice, the Commission itself generally acts on
requests for extensions of time to complete construction for Natural
Gas Act facilities when such requests are contested before order
issuance. For those extension requests that are contested,\4\ the
Commission will aim to issue an order acting on the request within 45
days.\5\ The Commission will address all arguments relating to whether
the applicant has demonstrated there is good cause to grant the
extension.\6\ The Commission will not consider arguments that re-
litigate the issuance of the certificate order, including whether the
Commission properly found the project to be in the public convenience
and necessity and whether the Commission's environmental analysis for
the certificate complied with the National Environmental Policy Act.\7\
At the time a pipeline requests an extension of time, orders on
certificates of public convenience and necessity are final and the
Commission will not re-litigate their issuance.\8\ The OEP Director, or
his or her designee, will act on all of those extension requests that
are uncontested.
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    \4\ Contested proceedings are those where an intervenor disputes
any material issue of the filing. 18 CFR 385.2201(c)(1) (2019).
    \5\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
    \6\ Id. at P 40.
    \7\ Similarly, the Commission will not re-litigate the issuance
of an NGA section 3 authorization, including whether a proposed
project is not inconsistent with the public interest and whether the
Commission's environmental analysis for the permit order complied
with NEPA.
    \8\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
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    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments
in lieu of paper using the ``eFile'' link at http://www.ferc.gov. In
lieu of electronic filing, you may submit a paper copy. Submissions
sent via the U.S. Postal Service must be addressed to: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street
NE, Room 1A, Washington, DC 20426. Submissions sent via any other
carrier must be addressed to: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    Comment Date: 5:00 p.m. Eastern Time on April 29, 2021.

    Dated: April 14, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2021-08071 Filed 4-19-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36869-36870]
[FR Doc No: 2015-15688]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75255; File No. SR-OCC-2015-012]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Concerning Administrative Changes to The Options Clearing Corporation's
Financial Resources Monitoring and Call Procedure

June 22, 2015.
    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 June 18, 2015, The Options Clearing Corporation (``OCC'') 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 OCC. OCC filed the proposal pursuant to section
19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(1) thereunder \4\ so that
the proposal was effective upon filing with the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(1).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    This proposed rule change concerns administrative changes to The
Options Clearing Corporation's (``OCC'') Financial Resources Monitoring
and Call Procedure (``Procedure''). Specifically, OCC is proposing to
change the method by which Dashboard Reports (defined below) are
distributed to OCC's senior management and the Risk Committee of OCC's
Board of Directors (``Risk Committee'').

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    This proposed rule change concerns administrative changes to the
Procedure in that information concerning OCC's Clearing Fund that is
reported to OCC's senior management and the Risk Committee on a weekly
basis through dashboards (``Dashboard Reports'') would now be first
distributed to the Legal Department's Corporate Assistant for
subsequent dissemination to OCC's senior management and the Risk
Committee.
    By way of background, the Commission has recently approved,
pursuant to Section 19(b)(2) of the Act,\5\ and issued a Notice of No-
Objection to, pursuant to section 806(e)(1)(I) of the Payment,
Clearing, and Settlement Supervision Act of 2010,\6\ OCC's adoption of
the Procedure.\7\ The Procedure sets forth the steps that clarify, for
clearing members and market participants, the manner in which OCC
would, if necessary, collect additional financial resources through
intra-day margin calls and intra-month increases of is [sic] Clearing
Fund. As part of the Procedure, information concerning OCC's Clearing
Fund is reported to OCC's senior management and the Risk Committee on a
weekly basis through Dashboard Reports.
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    \5\ 15 U.S.C. 78s(b)(2).
    \6\ 12 U.S.C. 5465(e)(1)(I).
    \7\ See Securities Exchange Act Release No. 74980 (May 15,
2015), 80 FR 29364 (May 21, 2015) (SR-OCC-2015-009). See also
Securities Exchange Act Release No. 74981 (May 15, 2015), 80 FR
29367 (May 21, 2015) (SR-OCC-2014-811).
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    When OCC first adopted the Procedure, Dashboard Reports were
distributed to OCC's senior management and the Risk Committee directly
by OCC's Financial Risk Management Department's management. In an order
[sic] to harmonize the manner in which Dashboard Reports are provided
to the Risk Committee with the manner in which materials are provided
to the Risk Committee generally, OCC is proposing to make an
administrative amendment to section 3.5 of the Procedure such that
Dashboard Reports would be provide [sic] to the Legal Department's
Corporate Assistant by the Financial Risk Management Department's
management for subsequent dissemination to OCC's senior management and
the Risk Committee. The ultimate reviewers of Dashboard Reports would
not be changed in any manner.
    In addition to the above, OCC also proposes to correct
typographical errors throughout the Procedure.
2. Statutory Basis
    OCC believes the proposed rule change is consistent with section
17A(b)(3)(F) of the Act,\8\ and the rules and regulations thereunder
because it is designed to promote the prompt and accurate clearance and
settlement of securities transactions. As described above, the manner
in which senior management and the Risk Committee are provided with
Dashboard Reports would be harmonized with the manner in which the Risk
Committee is provided with information generally. This practice would
better ensure that the Risk Committee is provided with appropriate
information in a timely manner to discharge its responsibilities as a
committee of OCC's Board of Directors,\9\ thereby promoting the

prompt and accurate clearance and settlement of securities
transactions. This proposed rule change is also consistent with Rule
17Ad-22(d)(8) \10\ because it would promote the effectiveness of OCC's
risk management procedures by better ensuring that the Risk Committee
is provided with appropriate information in a timely manner to
discharge its responsibilities as a committee of OCC's Board of
Directors.\11\ The proposed rule change is not inconsistent with the
existing rules of OCC, including any other rules proposed to be
amended.
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    \8\ 15 U.S.C. 78q-1(b)(3)(F).
    \9\ See Securities Exchange Act Release No. 71751 (March 19,
2014), 79 FR 16414 (March 25, 2014) (SR-OCC-2014-04).
    \10\ 17 CFR 240.17Ad-22(d)(8).
    \11\ See Footnote 7.
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(B) Clearing Agency's Statement on Burden on Competition

    OCC does not believe that the proposed rule change would impose any
burden on competition.\12\ OCC believes that the proposed rule change
would not unfairly inhibit access to OCC's services or disadvantage or
favor any particular user in relationship to another user because the
proposed rule solely concerns administrative matters, mainly the manner
in which Dashboard Reports are disseminated to OCC's senior management
and Risk Committee, and does not concern any particular user, or
clearing member, of OCC.
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    \12\ 15 U.S.C. 78q-1(b)(3)(I).
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    For the foregoing reasons, OCC believes that the proposed rule
change is in the public interest, would be consistent with the
requirements of the Act applicable to clearing agencies, and would not
impose a burden on competition.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    Written comments on the proposed rule change were not and are not
intended to be solicited with respect to the proposed rule change and
none have been received.

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

    The foregoing rule change has become effective pursuant to section
19(b)(3)(A) of the Act and paragraph (f) of Rule 19b-4 thereunder. At
any time within 60 days of the filing of the proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2015-012 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-OCC-2015-012. 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 OCC and on OCC's
Web site at http://www.theocc.com/components/docs/legal/rules_and_bylaws/sr_occ_15_012.pdf. 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-OCC-2015-012 and should be submitted on
or before July 17, 2015.
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    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-15688 Filed 6-25-15; 8:45 am]
 BILLING CODE 8011-01-P