[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Rules and Regulations]
[Pages 53813-53814]
[FR Doc No: 2018-23319]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0972]

Drawbridge Operation Regulation; Elizabeth River--Eastern Branch,
Norfolk, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Berkley (U.S. 460/S.R. 337) Bridge
across the Elizabeth River--Eastern Branch, mile 0.4, at Norfolk, VA.
The deviation is necessary to allow the bridge to remain in the closed-
to-navigation position to facilitate testing of the emergency drive
motors.

DATES: This deviation is effective from 2:30 a.m. to 6 a.m. on October
28, 2018.

ADDRESSES: The docket for this deviation, [USCG-2018-0972], is
available at http://www.regulations.gov. Type the docket number in the
``SEARCH'' box and click ``SEARCH''. Click on Open Docket Folder on the
line associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Mickey Sanders, Bridge
Administration Branch Fifth District, Coast Guard; telephone (757) 398-
6587, email [email protected].

SUPPLEMENTARY INFORMATION: The Virginia Department of Transportation,
who owns and operates the Berkley (U.S. 460/S.R. 337) Bridge across the
Elizabeth River--Eastern Branch, mile 0.4, at Norfolk, VA, has
requested a temporary deviation from the current operating regulation
set out in 33 CFR 117.1007(b), to facilitate testing of the emergency
drive motor on both spans of the bridge.
    Under this temporary deviation, the bridge will remain in the
closed-to-navigation position from 2:30 a.m. to 6 a.m. on October 28,
2018. The drawbridge has two spans, each with double-leaf bascule
draws, and both spans have a vertical clearance in the closed-to-
navigation position of 48 feet above mean high water.
    The Elizabeth River--Eastern Branch is transited by recreational
vessels, tug and barge traffic, fishing vessels, and small commercial
vessels. The Coast Guard has carefully considered the nature and volume
of vessel traffic on the waterway in publishing this temporary
deviation.
    Vessels able to pass through the bridges in the closed position may
do so at any time. The bridge spans will not be able to open in case of
an emergency and there is no immediate alternate route for vessels to
pass. The Coast Guard will also inform the users of the waterway
through our Local Notice and Broadcast Notices to Mariners of the
change in operating schedule for the bridge so that vessel operators
can arrange their transits to minimize any impact caused by the
temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: October 19, 2018.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2018-23319 Filed 10-24-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45859-45861]
[FR Doc No: 2017-21191]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]

Fee for Using a Material Threat Medical Countermeasure Priority
Review Voucher in Fiscal Year 2018

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rate for using a material threat medical
countermeasure (MCM) priority review voucher for fiscal year (FY) 2018.
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by
the 21st Century Cures Act (Cures Act), authorizes FDA to determine and
collect material threat MCM priority review user fees for certain
applications for review of human drug products when those applications
use a material threat MCM priority review voucher. These vouchers are
awarded to the sponsors of material threat MCM applications that meet
all of the requirements of this program upon FDA approval of such
applications. The amount of the fee for using a material threat MCM
priority review voucher is determined each FY based on the difference
between the average cost incurred by FDA in the review of a human drug
application subject to priority review in the previous FY, and the
average cost incurred in the review of an application that is not
subject to priority review in the previous FY. This notice establishes
the material threat MCM priority review fee rate for FY 2018 and
outlines the payment procedures for such fees.

FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of
Financial Management, Food and Drug Administration, 8455 Colesville
Rd., COLE-14202F, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 3086 of the Cures Act (Pub. L. 114-255) added section 565A
to the FD&C Act (21 U.S.C. 360bbb-4a). In section 565A of the FD&C Act,
Congress encouraged development of material threat MCMs by offering
additional incentives for obtaining FDA approval of such products.
Under section 565A of the FD&C Act, the sponsor of an eligible material
threat MCM application (as defined in section 565A(a)(4)) shall receive
a priority review voucher upon approval of the material threat MCM
application. The recipient of a material threat MCM priority review
voucher may either use the voucher for a future human drug application
submitted to FDA under section 505(b)(1) of the FD&C Act (21 U.S.C.
355(b)(1)) or section 351(a) of the Public Health Service Act (42
U.S.C. 262(a)), or transfer (including by sale) the voucher to another
party. The voucher may be transferred (including by sale) repeatedly
until it ultimately is used for a human drug application submitted to
FDA under section 505(b)(1) of the FD&C Act or section 351(a) of the
Public Health Service Act. A priority review is a review conducted with
a Prescription Drug User Fee Act (PDUFA) goal date of 6 months after
the receipt or filing date, depending on the type of application.
Information regarding PDUFA goals is available at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
    The applicant that uses a material threat MCM priority review
voucher is entitled to a priority review of its eligible human drug
application, but must pay FDA a material threat MCM priority review
user fee in addition to any user fee required by PDUFA for the
application. Information regarding the material threat MCM priority
review voucher program is available at: https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm566498.htm#prv.
    This notice establishes the material threat MCM priority review fee
rate for FY 2018 at $2,830,579 and outlines FDA's procedures for
payment of material threat MCM priority review user fees. This rate is
effective on October 1, 2017, and will remain in effect through
September 30, 2018.

II. Material Threat Medical Countermeasure Priority Review User Fee for
FY 2018

    FDA interprets section 565A(c)(2) of the FD&C Act as requiring that
FDA determine the amount of the material threat MCM priority review
user fee each fiscal year based on the difference between the average
cost incurred by FDA in the review of a human drug application subject
to priority review in the previous fiscal year, and the average cost
incurred by FDA in the review of a human drug application that is not
subject to priority review in the previous fiscal year.
    A priority review is a review conducted with a PDUFA goal date of 6
months after the receipt or filing date, depending on the type of
application. Under the PDUFA goals letter, FDA has committed to
reviewing and acting on 90 percent of the applications granted priority
review status within this expedited timeframe. Normally, an application
for a human drug product will qualify for priority review if the
product is intended to treat a serious condition and, if approved,
would provide a significant improvement in safety or effectiveness. An
application that does not receive a priority designation will receive a
standard review. Under the PDUFA goals letter, FDA has committed to
reviewing and acting on 90 percent of standard applications within 10
months of the receipt or filing date, depending on the type of
application. A priority review involves a more intensive level of
effort and a higher level of resources than a standard review.
    As interpreted by FDA, section 565A of the FD&C Act requires that
the fee amount should be based on the difference between the average
cost incurred by the Agency in the review of a human drug application
subject to a priority review in the previous fiscal year, and the
average cost incurred by the Agency in the review of a human drug
application not subject to a priority review in the previous fiscal
year. FDA is setting a fee for FY 2018, which is to be based on
standard cost data from the previous fiscal year, FY 2017. However, the
FY 2017 submission cohort has not been closed out yet, thus the cost
data for FY 2017 are not complete. The latest year for which FDA has
complete cost data is FY 2016. Furthermore, because FDA has never
tracked the cost of reviewing applications that get priority review as
a separate cost subset, FDA estimated this cost based on other data
that the Agency has tracked. FDA uses data that the Agency estimates
and publishes on its Web site each year--standard costs for review. FDA
does not publish a standard cost for ``the review of a human drug
application subject to priority review in the previous fiscal year.''
However, we expect all such applications would contain clinical data.
The standard cost application categories with clinical data that FDA
publishes each year are: (1) New drug applications (NDAs) for a new
molecular entity (NME) with clinical data and (2) biologics license
applications (BLAs).
    The standard cost worksheets for FY 2016 show standard costs
(rounded to the nearest hundred dollars) of $5,929,100 for an NME NDA,
and $4,887,100 for a BLA. Based on these standard costs, the total cost
to review the 49 applications in these two categories in FY 2016 (27
NME NDAs with clinical data and 22 BLAs) was $267,601,900. (Note: These
numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no
investigational new drug review costs are included in this amount.)
Twenty-three of these applications (14 NDAs and 9 BLAs) received
priority review, which would mean that the remaining 26 received
standard reviews. Because a priority review compresses a review
schedule that ordinarily takes 10 months into 6 months, FDA estimates
that a multiplier of 1.67 (10 months divided by 6 months) should be
applied to non-priority review costs in estimating the effort and cost
of a priority review as compared to a standard review. This multiplier
is consistent with published research on this subject that supports a
priority review multiplier in the range of 1.48 to 2.35 (Ref. 1). Using
FY 2016 figures, the costs of a priority and standard review are
estimated using the following formula:

(23 [alpha] x 1.67) + (26 [alpha]) = $267,601,900

Where ``[alpha]'' is the cost of a standard review and ``[alpha]
times 1.67'' is the cost of a priority review.

    Using this formula, the cost of a standard review for NME NDAs and
BLAs is calculated to be $4,154,664 (rounded to the nearest dollar) and
the cost of a priority review for NME NDAs and BLAs is 1.67 times that
amount, or $6,938,289 (rounded to the nearest dollar). The difference
between these two cost estimates, or $2,783,625, represents the
incremental cost of conducting a priority review rather than a standard
review.
    For the FY 2018 fee, FDA will need to adjust the FY 2016
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2017, to adjust the FY 2016 amount
for cost increases in FY 2017. That adjustment, published in the
Federal Register on September 14, 2017 (see 82 FR 43244 at 43245),
setting FY 2018 PDUFA fees, is 1.6868 percent for the most recent year,
not compounded. Increasing the FY 2016 incremental priority review cost
of $2,783,625 by 1.6868 percent (or 0.016868) results in an estimated
cost of $2,830,579 (rounded to the nearest dollar). This is the
material threat MCM priority review user fee amount for FY 2018 that
must be submitted with a priority review voucher for a human drug
application in FY 2018, in addition to any PDUFA fee that is required
for such an application.

III. Fee Schedule for FY 2018

    The fee rate for FY 2018 is set out in table 1:

Table 1--Material Threat Medical Countermeasure Priority Review Schedule
                               for FY 2018
------------------------------------------------------------------------
                                                           Fee rate for
                      Fee category                            FY 2018
------------------------------------------------------------------------
Application submitted with a material threat MCM              $2,830,579
 priority review voucher in addition to the normal PDUFA
 fee....................................................
------------------------------------------------------------------------

IV. Implementation of Material Threat Medical Countermeasure Priority
Review User Fee

    Under section 565A(c)(4)(A) of the FD&C Act, the priority review
user fee is due upon submission of a human drug application for which
the priority review voucher is used. Section 565A(c)(4)(B) of the FD&C
Act specifies that the application will be considered incomplete if the
priority review user fee and all other applicable user fees are not
paid in accordance with FDA payment procedures. In addition, section
565A(c)(4)(C) specifies that FDA may not grant a waiver, exemption,
reduction, or refund of any fees due and payable under this section of
the FD&C Act. FDA's appropriation for FY 2018, states specifically that
``medical

countermeasure priority review voucher user fees authorized by 21
U.S.C. 360bbb-4a, shall be credited to this account, to remain
available until expended.'' (Pub. L. 115-31, Division A, Title VI).
    The material threat MCM priority review fee established in the new
fee schedule must be paid for any application that is received on or
after October 1, 2017, and submitted with a priority review voucher.
This fee must be paid in addition to any other fee due under PDUFA.
Payment must be made in U.S. currency by electronic check, check, bank
draft, wire transfer, credit card, or U.S. postal money order payable
to the order of the Food and Drug Administration. The preferred payment
method is online using electronic check (Automated Clearing House (ACH)
also known as eCheck). Secure electronic payments can be submitted
using the User Fees Payment Portal at https://userfees.fda.gov/pay.
(Note: only full payments are accepted. No partial payments can be made
online.) Once you search for your invoice, select ``Pay Now'' to be
redirected to Pay.gov. Note that electronic payment options are based
on the balance due. Payment by credit card is available for balances
that are less than $25,000. If the balance exceeds this amount, only
the ACH option is available. Payments must be made using U.S. bank
accounts as well as U.S. credit cards.
    FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA Web site after the
user fee ID number is generated.
    If paying with a paper check the user fee identification (ID)
number should be included on the check, followed by the words
``Material Threat Medical Countermeasure Priority Review.'' All paper
checks must be in U.S. currency from a U.S. bank made payable and
mailed to: Food and Drug Administration, P.O. Box 979107, St. Louis, MO
63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery, contact the U.S. Bank at 314-
418-4013. This telephone number is only for questions about courier
delivery). The FDA post office box number (P.O. Box 979107) must be
written on the check. If needed, FDA's tax identification number is 53-
0196965.
    If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. The originating financial
institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required to add that
amount to the payment to ensure that the invoice is paid in full. The
account information is as follows: U.S. Dept. of Treasury, TREAS NYC,
33 Liberty St., New York, NY 10045, Account Number: 75060099, Routing
Number: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 8455 Colesville
Rd., 14th Floor, Silver Spring, MD 20993-0002.

V. Reference

    The following reference is on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing
Drugs for Developing Countries,'' Health Affairs, vol. 25, no. 2,
pp. 313-324, 2006.

    Dated: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21191 Filed 9-29-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 85 (Thursday, May 2, 2019)]
[Notices]
[Pages 18897-18898]
[FR Doc No: 2019-08921]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85737; File No. SR-GEMX-2019-05]

Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Delete the
Exchange Registration Rules and Incorporate by Reference The Nasdaq
Stock Market Rules at General 4

April 26, 2019.
    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 April 18, 2019, Nasdaq GEMX, LLC (``GEMX'' 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

    The Exchange proposes to delete the Exchange's current
Registration, Qualification and Continuing Education rules (``Exchange
Registration Rules'' and, generally, ``Registration Rules'') under the
1200 Series (Rules 1210 through 1250), and incorporate by reference The
Nasdaq Stock Market LLC's (``Nasdaq'') rules at General 4 (``Nasdaq
Registration Rules''), into General 4 of the Exchange's rulebook's
(``Rulebook'') shell structure.\3\
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    \3\ In 2017, the Exchange added a shell structure to its
Rulebook with the purpose of improving efficiency and readability
and to align its rules closer to those of its five sister exchanges,
The Nasdaq Stock Market LLC; Nasdaq BX, Inc.; Nasdaq PHLX LLC;
Nasdaq ISE, LLC; and Nasdaq MRX, LLC (``Affiliated Exchanges''). The
shell structure currently contains eight (8) General sections which,
once complete, will apply a common set of rules to the Affiliated
Exchanges. See Securities Exchange Act Release No. 82171 (November
29, 2017), 82 FR 57516 (December 5, 2017) (SR-GEMX-2017-54).
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    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqgemx.cchwallstreet.com/, at the principal
office of the Exchange, 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 Exchange recently amended, reorganized, and enhanced certain of
its membership, registration, and qualification requirement rules
partly in response to rule changes by the Financial Industry Regulatory
Authority (``FINRA''), and also in order to conform the Exchange's
rules more closely to those of its Affiliated Exchanges in the interest
of uniformity and to facilitate compliance with membership,
registration and qualification regulatory requirements by members of
multiple Affiliated Exchanges including the Exchange.\4\ To that end,
the Exchange adopted a new 1200 Series of rules, captioned
``Registration, Qualification and Continuing Education,'' generally
conforming the Exchange Registration Rules to FINRA's new 1200 Series,
except for a number of Exchange-specific variations.\5\
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    \4\ See Securities Exchange Act Release No. 84448 (October 18,
2018), 83 FR 53669 (October 24, 2018) (SR-GEMX-2018-33).
    \5\ Id.
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    The Exchange now proposes to delete the Exchange Registration
Rules, currently under the 1200 Series (Rules 1210 through 1250), and
incorporate by reference the Nasdaq Registration Rules at General 4 of
Nasdaq's rulebook into General 4 of the Exchange's Rulebook. Relatedly,
the Exchange will make necessary cross-reference updates throughout the
Rulebook. Specifically, the Exchange will amend the cross-reference in
Exchange Rule 100.
    The incorporation by reference of Nasdaq Registration Rules at
General 4 into the Exchange's General 4 title and any necessary cross-
reference updates are regulatory in nature.\6\ The Exchange notes that
as a condition of an exemption, which the Exchange will request and
will need to be approved by the Commission pursuant to Section 36 of
the Act,\7\ the Exchange agrees to provide written notice to its
members whenever Nasdaq proposes a change to its General 4 title.\8\
Such notice will alert Exchange members to the proposed Nasdaq rule
change and give them an opportunity to comment on the proposal. The
Exchange will similarly inform its members in writing when the SEC
approves any such proposed change.
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    \6\ The General 4 rules are categories of rules that are not
trading rules. See 17 CFR 200.30-3(a)(76) (contemplating such
requests). In addition, several other Self-Regulatory Organizations
(``SROs'') incorporate by reference certain regulatory rules of
other SROs and have received from the Commission similar exemptions
from Section 19(b) of the Exchange Act. See e.g., Securities
Exchange Act Release Nos. 57478 (March 12, 2008), 73 FR 14521 (March
18, 2008), 53128 (January 13, 2006), 71 FR 3550 (January 23, 2006);
49260 (February 17, 2004), 69 FR 8500 (February 24, 2004).
    \7\ 15 U.S.C. 78mm.
    \8\ The Exchange will provide such notice via a posting on the
same website location where the Exchange posts its own rule filings
pursuant to Rule 19b-4 within the timeframe required by such rule.
The website posting will include a link to the location on the
Nasdaq website where the applicable proposed rule change is posted.

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Implementation
    The Exchange proposes that this rule change becomes operative at
such time as it receives approval for an exemption from the Securities
and Exchange Commission, pursuant to its authority under Section 36 of
the Act and Rule 0-12 \9\ thereunder, from the Section 19(b) rule
filing requirements to separately file a proposed rule change to amend
the Exchange's General 4 title.
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    \9\ See 17 CFR 240.0-12; Exchange Act Release No. 39624
(February 5, 1998), 63 FR 8101 (February 18, 1998).
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\10\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\11\ in particular, in that it is designed to
promote just and equitable principles of trade, 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, by consolidating its rules into a single rule set. The
Exchange intends to also file similar proposed rule changes for the
Nasdaq BX, Inc.; Nasdaq PHLX LLC; Nasdaq ISE, LLC; and Nasdaq MRX, LLC
markets so that the General 4 rules which govern Registration Rules are
conformed.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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    Incorporating by reference the Nasdaq Registration Rules at General
4 into the Exchange's General 4 title will provide an easy reference
for Exchange members seeking to comply with registration and
qualification requirements on multiple markets. As noted, the Exchange
intends to file similar proposed rule changes for other Affiliated
Exchanges so that Nasdaq General 4 is the source document for all
Registration Rules. The Exchange notes that the current rule is not
changing and that Exchange members will be required to continue to
comply with the Nasdaq Registration Rules as though such rules are
fully set forth in Exchange's Rulebook. The Exchange desires to conform
its rules and locate those rules within the same location in each
Rulebook to provide Exchange members the ability to quickly locate
rules.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes that this
rule change does not impose an undue burden on competition because the
Exchange is merely incorporating by reference the Nasdaq Registration
Rules at General 4 into its own Rulebook. The Exchange Registration
Rules are not being amended and therefore no member is impacted.

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

    No written comments were either solicited or 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)(iii) of the Act \12\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\13\
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    \12\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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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. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

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-GEMX-2019-05 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-GEMX-2019-05. 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-GEMX-2019-05 and should be submitted on
or before May 23, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-08921 Filed 5-1-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Notices]
[Pages 4362-4363]
[FR Doc No: 2016-01489]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2015-0079 Notice 1]

Notice of Receipt of Petition for Decision That Nonconforming
2010 Harley-Davidson FX, XL and VR Motorcycles Are Eligible for
Importation

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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

SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
nonconforming 2010 Harley-Davidson FX, XL and VR motorcycles that were
not originally manufactured to comply with all applicable Federal motor
vehicle safety standards (FMVSS), are eligible for importation into the
United States because they are substantially similar to vehicles that
were originally manufactured for sale in the United States and that
were certified by their manufacturer as complying with the safety
standards (the U.S.-certified version of the 2010 Harley-Davidson FX,
XL and VR motorcycles) and they are capable of being readily altered to
conform to the standards.

DATES: The closing date for comments on the petition is February 25,
2016.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to read comments submitted to the docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://www.regulations.gov. Follow the online instructions for accessing the
dockets. The docket ID number and title of this notice are shown at the
heading of this document notice. Please note that even after the
comment closing date, we will continue to file relevant information in
the Docket as it becomes available. Further, some people may submit
late comments. Accordingly, we recommend that you periodically search
the Docket for new material.

FOR FURTHER INFORMATION CONTACT: George Stevens, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for importation into and sale in the United
States, certified under 49 U.S.C. 30115, and of the same model year as
the model of the motor vehicle to be compared, and is capable of being
readily altered to conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    Skytop Rover Co., of Philadelphia, PA (Registered Importer R-06-
343) (Skytop) has petitioned NHTSA to decide whether nonconforming 2010
Harley-Davidson FX, XL and VR motorcycles are eligible for importation
into the United States. The vehicles which Skytop believes are
substantially similar are 2010 Harley-Davidson FX XL and VR motorcycles
that were manufactured for sale in the United States and certified by
their manufacturer as conforming to all applicable FMVSS.
    The petitioner claims that it compared non-U.S. certified 2010
Harley-Davidson FX, XL and VR motorcycles to their U.S.-certified
counterparts, and found the vehicles to be substantially similar with
respect to compliance with most FMVSS.
    Skytop submitted information with its petition intended to
demonstrate that non-U.S. certified 2010 Harley-Davidson FX, XL and VR
motorcycles as originally manufactured, conform to many FMVSS in the
same manner as their U.S. certified counterparts, or are capable of
being readily altered to conform to those standards.
    Specifically, the petitioner claims that non-U.S. certified 2010
Harley-Davidson FX, XL and VR motorcycles are identical to their U.S.
certified counterparts with respect to compliance with: Standard Nos.
106 Brake Hoses, 111 Rear Visibility, 116 Motor Vehicle Brake Fluids,
119 New pneumatic tires for motorcycles, and 122 Motorcycle brake
system.
    The petitioner further contends that the vehicles are capable of
being readily altered to meet the following standards, in the manner
indicated:
    108 Lamps, Reflective Devices and Associated Equipment: Replacement
of front and rear turn signal lamps, front, rear and side mounted
reflex reflectors, headlamps, rear taillamps, stop lamps and license
plate lamps with U.S. certified components on vehicles that are not
already so equipped.
    120 Tire selection and Rims for Motor Vehicles Other Than Passenger
Cars: Installation of a tire information placard.
    123 Motorcycle Controls and Displays: Inspection of each vehicle
and replacement of non-conforming speedometers with U.S.-model
components on vehicles not already so equipped.
    205 Glazing Materials Inspection of each vehicle and removal of

noncompliant glazing or replacement of the glazing with U.S. certified
components on vehicles not already so equipped.
    The petitioner additionally states that the vehicles meet the
requirements of 49 CFR part 565 VIN Requirements.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority: 49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49
CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-01489 Filed 1-25-16; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013)]
[Notices]
[Pages 64484-64486]
[FR Doc No: 2013-25438]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. IC13-19-000 and IC13-20-000]

Commission Information Collection Activities (FERC-511 and FERC-
515); Comment Request

AGENCY: Federal Energy Regulatory Commission.

ACTION: Request for comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory
Commission (Commission or FERC) is submitting the information
collections, FERC-511 (Transfer of Hydropower License \1\) and FERC-515
(Rules of Practice and Procedure: Declaration of Intention), to the
Office of Management and Budget (OMB) for review of the information
collection requirements. Any interested person may file comments
directly with OMB and should address a copy of those comments to the
Commission as explained below. The Commission issued Notices in the
Federal Register (for FERC-511 at 78 FR 49490, 8/14/2013, and for FERC-
515 at 78 FR 49489, 8/14/2013) requesting public comments. FERC
received no comments.
---------------------------------------------------------------------------

    \1\ This collection was formerly called the ``Application for
Transfer of License''; the reporting requirements are not being
revised.

DATES: Comments on the collections of information are due November 29,
---------------------------------------------------------------------------
2013.

ADDRESSES: Comments filed with OMB, identified by the OMB Control Nos.
1902-0069 (FERC-511) and 1902-0079 (FERC-515) should be sent via email
to the Office of Information and Regulatory Affairs at<EMAIL_ADDRESS>Attention: Federal Energy Regulatory Commission
Desk Officer. The OMB Desk Officer may also be reached via telephone at
202-395-4718.
    A copy of the comments should also be sent to the Federal Energy
Regulatory Commission, identified by the Docket Nos. IC13-19-000 and
IC13-20-000, by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in these dockets or in viewing/downloading comments and
issuances in these dockets may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION: This notice is combined for administrative
purposes only. The FERC-511 and FERC-515 will remain separate
information collections with separate OMB Control Numbers.

FERC-511

    Title: Transfer of Hydropower License.
    OMB Control No.: 1902-0069.
    Type of Request: Three-year extension of the FERC-511 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: The Commission uses the information collected under the
requirements of FERC-511 to implement the statutory provisions of
Sections 4(e) and 8 of the Federal Power Act (FPA).\2\ Section 4(e)
authorizes the Commission to issue licenses for the construction,
operation and maintenance of reservoirs, powerhouses, and transmission
lines or other facilities necessary for the development and improvement
of

navigation and for the development, transmission, and utilization of
power.\3\ Section 8 of the FPA provides that the voluntary transfer of
any license is made only with the written approval of the Commission.
Any successor to the licensee may assign the rights of the original
licensee but is subject to all of the conditions of the license. The
information filed with the Commission is a mandatory requirement
contained in the format of a written application for transfer of
license, executed jointly by the parties of the proposed transfer. The
sale or merger of a licensed hydroelectric project may occasion the
transfer of a license. The Commission's staff uses the information
collection to determine the qualifications of the proposed transferee
to hold the license and to prepare the transfer of the license order.
Approval by the Commission of transfer of a license is contingent upon
the transfer of title to the properties under license, delivery of all
license instruments, and evidence that such transfer is in the public
interest. The Commission implements these filing requirements in the
Code of Federal Regulations (CFR) under 18 CFR Part 9.
---------------------------------------------------------------------------

    \2\ 16 U.S.C. 797(e) and 801.
    \3\ Refers to facilities across, along, from, or in any of the
streams or other bodies of water over which Congress has
jurisdiction under its authority to regulate commerce with foreign
nations and among the several States, or upon any part of public
lands and reservations of the United States, or for the purpose of
utilizing the surplus water or water power from any Government dam.
---------------------------------------------------------------------------

    Type of Respondents: Hydropower Project Licensees.
    Estimate of Annual Burden: \4\ The Commission estimates the total
annual Public Reporting Burden for this information collection as:
---------------------------------------------------------------------------

    \4\ The Commission defines burden as the total time, effort, or
financial resources expended by persons to generate, maintain,
retain, disclose, or provide information to or for a Federal agency.
For further explanation of what is included in the information
collection burden, refer to 5 CFR 1320.3.

                                    FERC-511--Transfer of Hydropower License
----------------------------------------------------------------------------------------------------------------
                                                 Number of                      Average  burden
            Number of respondents              responses per   Total number of     hours  per    Estimated total
                                                 respondent       responses         response      annual burden
(A)                                                      (B)    (A) x (B) = (C)            (D)                (C) x (D)
----------------------------------------------------------------------------------------------------------------
23..........................................               1               23               40              920
----------------------------------------------------------------------------------------------------------------

    The total estimated annual cost burden to respondents is $64,496
[(920 hours/2080 hours per year) * $145,818/year \5\ = $64,496].
---------------------------------------------------------------------------

    \5\ FY (Fiscal Year) 2013 Estimated Average Annual Cost per FTE,
including salary plus benefits, is $145,818. There are 2,080 hours
per workyear.
---------------------------------------------------------------------------

FERC-515

    Title: Rules of Practice and Procedure: Declaration of Intention.
    OMB Control No.: 1902-0079.
    Type of Request: Three-year extension of the FERC-515 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: The Commission uses the information collected under the
requirements of FERC-515 to implement the statutory provisions of
Section 23(b) of the FPA.\6\ Section 23(b) authorized the Commission to
make a determination as to whether it has jurisdiction over a proposed
water project \7\ not affecting navigable waters \8\ but across, along,
over, or in waters over which Congress has jurisdiction under its
authority to regulate commerce with foreign nations and among the
several States. Section 23(b) requires that any person intending to
construct project works on such waters must file a declaration of their
intention with the Commission. If the Commission finds the proposed
project will have an impact on interstate or foreign commerce, then the
entity intending to construct the project must obtain a Commission
license or exemption before starting construction.\9\ The information
is collected in the form of a written application, containing
sufficient details to allow the Commission staff to research the
jurisdictional aspects of the project. This research includes examining
maps and land ownership records to establish whether or not there is
Federal jurisdiction over the lands and waters affected by the project.
A finding of non-jurisdictional by the Commission eliminates a
substantial paperwork burden for the applicant who might otherwise have
to file for a license or exemption application. The Commission
implements these filing requirements under 18 CFR Part 24.
---------------------------------------------------------------------------

    \6\ 16 U.S.C. 817.
    \7\ Dams or other project works. (See 16 U.S.C. 817.)
    \8\ See 16 U.S.C. 796(8) for the definition of ``Navigable
Waters.''
    \9\ Upon a finding of non-jurisdictional by the Commission, and
if no public lands or reservations are affected, permission is
granted upon compliance with State laws.
---------------------------------------------------------------------------

    Type of Respondents: Persons intending to construct project works
on certain waters described above.
    Estimate of Annual Burden: The Commission estimates the total
annual Public Reporting Burden for this information collection as:

                       FERC-515--Rules of Practice and Procedure: Declaration of Intention
----------------------------------------------------------------------------------------------------------------
                                                 Number of                      Average  burden
            Number of respondents              responses per   Total number of     hours  per    Estimated total
                                                 respondent       responses         response      annual burden
(A)                                                      (B)    (A) x (B) = (C)            (D)                (C) x (D)
----------------------------------------------------------------------------------------------------------------
10..........................................               1               10               80              800
----------------------------------------------------------------------------------------------------------------

    The total estimated annual cost burden to respondents is $56,084
[(800 hours/2080 hours per year) * $145,818/year \10\ = $56,084].
    Comments on FERC-511 and FERC-515: Comments are invited on: (1)
Whether the collections of information are necessary for the proper
performance of the functions of the

Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimates of the burden and
cost of the collections of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collections; and (4) ways to
minimize the burden of the collections of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
---------------------------------------------------------------------------

    \10\ FY (Fiscal Year) 2013 Estimated Average Annual Cost per
FTE, including salary plus benefits, is $145,818. There are 2,080
hours per workyear.

    Dated: October 21, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-25438 Filed 10-28-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12769-12770]
[FR Doc No: 2016-05325]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77295; File No. SR-Phlx-2016-32]

Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Provisions
Related to Options Disputes

March 4, 2016.
    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 25, 2016, NASDAQ PHLX LLC (``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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend Rule 124, Disputes-Options and the
corollary Options Floor Procedure Advice F-27, Options Exchange
Official Rulings,\3\ in a number of ways described below.
---------------------------------------------------------------------------

    \3\ Options floor procedures advices generally correspond to
Exchange rules and comprise the Exchange's minor rule violation plan
establishing preset fines for certain violations pursuant to Rule
19d-1(c) under the Act. 17 CFR 240.19d-1(c).
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/, at the principal
office of the Exchange, 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 proposal is to update the rules under which
disputes can be addressed, as described below. Rule 124 pertains to
disputes on the options trading floor. Disputes occurring on and
relating to the trading floor, if not settled by agreement between the
members interested, shall be settled, if practicable, by vote of the
members knowing of the transaction in question; if not so settled, they
shall be settled by an Options Exchange Official.
    In issuing decisions for the resolution of trading disputes, an
Options Exchange Official shall institute the course of action deemed
to be most fair to all parties under the circumstances at the time. An
Options Exchange Official may direct the execution of an order on the
floor, or adjust the transaction terms or participants to an executed
order on the floor. An Options Exchange Official may nullify a
transaction if the Options Exchange Official determines the transaction
to have been in violation of certain rules that are listed in Rule 124.
    The Exchange proposes to delete from this list the rules that are
now entirely automated such that they do not operate on the trading
floor and would not be subject to the provisions of Rule 124.
Specifically, Rule 1017, Openings in Options, and Rule 1080, Phlx XL
and Phlx XL II,\4\ are proposed to be deleted from Rule 124. Both of
these rules pertain only to automated activity. Because errors
resulting from automated order handling and execution are handled
pursuant to Rule 1092, there is no need for the Rule 124 process to
apply.
---------------------------------------------------------------------------

    \4\ The Exchange intends to separately update Rule 1080 in a
variety of ways to make clear that it only applies to automated
trading system activity.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with section
6(b) of the Act \5\ in general, and furthers the objectives of section
6(b)(5) of the Act \6\ in particular, in that it is designed to promote
just and equitable principles of trade and to protect investors and the
public interest, by maintaining a framework to handle disputes on the
trading floor, consistent with the current market structure for trading
options on the Exchange. The proposed change to delete two rules from
the list of rules that, if violated, could result in a trade
nullification should promote just and equitable principles of trade by
recognizing that due to increased automation those disputes are handled
by a different rule, Rule 1092.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of intra-market
competition, the proposal applies to all trading floor participants and
does not affect competition among such participants. The proposal does
not burden competition among options markets, which is fierce, because
it merely updates an internal dispute process on the Phlx options
trading floor.

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

    No written comments were either solicited or 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)(iii) of the Act \7\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(a)(iii).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.

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

    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

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-Phlx-2016-32 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-Phlx-2016-32. 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 such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2016-32, and should be
submitted on or before March 31, 2016.
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Brent J. Fields,
Secretary.
[FR Doc. 2016-05325 Filed 3-9-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 145 (Monday, July 31, 2023)]
[Notices]
[Pages 49503-49504]
[FR Doc No: 2023-16132]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2023-0003]

National Advisory Committee on Occupational Safety and Health
(NACOSH); Request for Nominations

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for nominations.

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

SUMMARY: OSHA invites interested persons to submit nominations for
membership on the National Advisory Committee on Occupational Safety
and Health (NACOSH).

DATES: Nominations for NACOSH membership must be submitted (postmarked,
sent, transmitted, or received) by August 30, 2023.

ADDRESSES:
    Electronically: You may submit nominations, including attachments,
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the online instructions for making
submissions.
    OSHA will post submissions in response to this Federal Register
notice, including personal information, in the public docket, which
will be available online. Therefore, OSHA cautions interested parties
about submitting personal information such as Social Security numbers
and birthdates.
    Docket: To read or download submissions or other material in the
docket, go to http://www.regulations.gov. All documents in the public
docket are listed in the index; however, some documents (e.g.,
copyrighted material) are not publicly available to read or download
through www.regulations.gov. All submissions, including copyrighted
material, are available for inspection through the OSHA Docket Office.
Contact the OSHA Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>)
for assistance in locating docket submissions.

FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications, U.S. Department of Labor; telephone:<PHONE_NUMBER>;
email: [email protected].
    General information and technical inquiries: Ms. Lisa Long, Deputy
Director, Directorate of Standards and Guidance, OSHA, U.S. Department
of Labor; telephone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION: The Secretary of Labor (Labor Secretary)
invites interested individuals to submit nominations for membership on
NACOSH.

I. Background

    The Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C.
651, 656) established NACOSH to advise, consult with, and make
recommendations to the Labor Secretary and the Secretary of Health and
Human Services (HHS Secretary) on matters relating to the
administration of the OSH Act. NACOSH is a continuing advisory
committee of indefinite duration.
    NACOSH operates in accordance with the Federal Advisory Committee
Act (FACA) (5 U.S.C. App. 2), implementing regulations (41 CFR part
102-3), the OSH Act, and OSHA's regulations on NACOSH (29 CFR part
1912a).
    The Committee meets at least two times a year (29 U.S.C.
656(a)(2)). Committee members serve without compensation, but OSHA
provides travel and per diem expenses. NACOSH members serve staggered
terms, unless the member becomes unable to serve, resigns, ceases to be
qualified to serve, or is removed by the Labor Secretary. The term of
two Health and Human Services-designated NACOSH members will expire on
November 15, 2023.

II. NACOSH Membership

    NACOSH is comprised of 12 members appointed by the Secretary of
Labor, four of which are designated by the HHS Secretary. Accordingly,
the Labor Secretary seeks committed members to serve a two-year term.
If a vacancy occurs before a term expires, the Labor Secretary may
appoint a new member who represents the same interest as the
predecessor to serve the remainder of the unexpired term. The U.S.
Department of Labor is committed to equal opportunity in the workplace
and seeks a broad-based and diverse NACOSH membership.
    Nominations of new members, or resubmissions of current or former
members, will be accepted to fill vacancies in two categories of
membership. Interested persons may nominate themselves or submit the
name of another person whom they believe to be interested in and
qualified

to serve on NACOSH. Nominations may also be submitted by organizations
from one of the categories listed.
    OSHA invites nominations for the following Health and Human
Services-designated NACOSH positions:
     One (1) public representative (HHS); and
     One (1) occupational health professional representative
(HHS).

III. Submission Requirements

    Any individual or organization may nominate one or more qualified
persons for membership on NACOSH. Nominations must include the
following information:
    1. The nominee's name, contact information, and current employment
or position;
    2. The nominee's resume or curriculum vitae, including prior
membership on NACOSH and other relevant organizations and associations;
    3. The categories that the nominee is qualified to represent;
    4. A summary of the background, experience, and qualifications that
address the nominee's suitability for membership;
    5. A list of articles or other documents the nominee has authored
that indicates the nominee's experience in worker safety and health;
and
    6. A statement that the nominee is aware of the nomination, is
willing to regularly attend and participate in NACOSH meetings, and has
no conflicts of interest that would preclude membership on NACOSH.
    OSHA will conduct a basic background check of candidates before
their appointment to NACOSH. The background check will involve
accessing publicly available, internet-based sources.

IV. Member Appointment

    The Labor Secretary will appoint two NACOSH members, both of which
will be designated by the HHS Secretary, based on their experience,
knowledge, and competence in the field of occupational safety and
health (29 CFR 1912a.2). Information received through this nomination
process, in addition to other relevant sources of information, will
assist the Labor Secretary in appointing members to NACOSH. In
selecting NACOSH members, the Labor Secretary will consider individuals
nominated in response to this Federal Register notice, as well as other
qualified individuals. OSHA will publish a list of the newly appointed
NACOSH members in the Federal Register.

Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice under the authority granted by 29 U.S.C. 656, 5 U.S.C. app. 2,
29 CFR parts 1912 and 1912a; 41 CFR part 102-3; and Secretary of
Labor's Order No. 8-2020 (85 FR 58393, Sept. 18, 2020).

    Signed at Washington, DC, on July 24, 2023.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-16132 Filed 7-28-23; 8:45 am]
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[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29869-29870]
[FR Doc No: 2016-11237]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0971]

Infectious Disease Next Generation Sequencing Based Diagnostic
Devices: Microbial Identification and Detection of Antimicrobial
Resistance and Virulence Markers; Draft Guidance for Industry and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Infectious Disease Next
Generation Sequencing Based Diagnostic Devices: Microbial
Identification and Detection of Antimicrobial Resistance and Virulence
Markers.'' This draft guidance provides recommendations to assist
industry in designing studies to establish the analytical and clinical
performance characteristics of infectious disease next generation
sequencing- based diagnostic devices for microbial identification and
detection of antimicrobial resistance and virulence markers. This draft
guidance is neither final nor is it in effect at this time.

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
guidance by August 11, 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-0971 for ``Infectious Disease Next Generation Sequencing
Based Diagnostic Devices: Microbial Identification and Detection of
Antimicrobial Resistance and Virulence Markers; Draft Guidance for
Industry; Availability.'' 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.
    Submit written requests for single copies of the guidance 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. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Heike Sichtig, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4526, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance provides recommendations to assist industry in
designing studies to establish the analytical and clinical performance
characteristics of ``Infectious Disease Next Generation Sequencing
Based Diagnostic Devices'' for microbial identification and detection
of antimicrobial resistance and virulence markers (hereinafter referred
to as ``Infectious Disease NGS Dx devices''). Infectious Disease NGS Dx
devices are intended for use as an aid in the diagnosis of microbial
infection and in selecting appropriate therapies for

which next generation sequencing (NGS) technology can now be used to
detect the presence of clinically important pathogenic organisms in
human specimens.
    In contrast to human sequencing diagnostics, infectious disease
sequencing diagnostics carry an absolute need for immediate and
actionable results, sometimes within hours, as incorrect initial
diagnoses potentially leads to fatalities. Furthermore, the broad range
of specimen types (e.g., urine, blood, cerebrospinal fluid (CSF),
stool, sputum, etc.) and the large diversity of the infectious disease
agents that can be present in the sample do not allow straightforward
pre-analytical-, biochemical-, or bioinformatics processes. Each unique
specimen type may require a different nucleic acid extraction
procedure, a different library preparation protocol, and even a
different bioinformatics algorithm to generate the final clinical
result. The opportunity for repeat testing is expected to be limited
due to a frequently small specimen quantity (e.g., CSF) and the
necessity to make a prompt and timely infectious disease treatment
decision for the patient.
    This draft guidance, when finalized, provides detailed information
on the types of studies the FDA recommends to support a premarket
application for these devices. This draft guidance specifically
addresses Infectious Disease NGS devices that employ targeted or
agnostic (metagenomic) sequencing, to identify the presence or absence
of infectious disease organisms, and/or to detect the presence or
absence of antimicrobial resistance and virulence markers. This draft
guidance is not intended to address devices that utilize detection
mechanisms other than nucleic acid based approaches. Further, this
draft guidance does not apply to devices that are intended to screen
donors of blood and blood components as well as donors of human cells,
tissues, and cellular and tissue-based products for communicable
diseases.

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 Agency's current thinking on ``Infectious
Disease Next Generation Sequencing Based Diagnostic Devices: Microbial
Identification and Detection of Antimicrobial Resistance and Virulence
Markers.'' It neither creates nor confers any rights for or on any
person and is not binding on FDA or the public. An alternative approach
may be used if such approach 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. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Infectious Disease Next
Generation Sequencing Based Diagnostic Devices: Microbial
Identification and Detection of Antimicrobial Resistance and Virulence
Markers; Draft Guidance for Industry and Food and Drug Administration
Staff; Availability'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1500016 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 801 and 809 have been
approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
812 have been approved under OMB control number 0910-0078; and the
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231.

    Dated: May 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11237 Filed 5-12-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 142 (Tuesday, July 26, 2022)]
[Notices]
[Pages 44415-44416]
[FR Doc No: 2022-15900]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2022-0341; OMB Control Number 1625-0104]

Information Collection Request to Office of Management and Budget

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0104,
Barges Carrying Bulk Hazardous Materials; without change. Our ICR
describes the information we seek to collect from the public. Before
submitting this ICR to OIRA, the Coast Guard is inviting comments as
described below.

DATES: Comments must reach the Coast Guard on or before September 26,
2022.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2022-0341] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: COMMANDANT (CG-6P), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S.
COAST GUARD, 2703 MARTIN LUTHER KING JR. AVE SE, STOP 7710, WASHINGTON,
DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. 3501 et seq., chapter 35, as amended. An ICR is an
application to OIRA seeking the approval, extension, or renewal of a
Coast Guard collection of information (Collection). The ICR contains
information describing the Collection's purpose, the Collection's
likely burden on the affected public, an explanation of the necessity
of the Collection, and other important information describing the
Collection. There is one ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) the practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology.
    In response to your comments, we may revise this ICR or decide not
to seek an extension of approval for the Collection. We will consider
all comments and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2022-0341], and
must be received by September 26, 2022.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's eRulemaking System
of Records notice (85 FR 14226, March 11, 2020).

Information Collection Request

    Title: Barges Carrying Bulk Hazardous Materials.
    OMB Control Number: 1625-0104.
    Summary: This information is needed to ensure the safe shipment of
bulk hazardous liquids in barges. The requirements are necessary to
ensure that barges meet safety standards and to ensure that barge's
crewmembers have the information necessary to operate barges safely.
    Need: 46 U.S.C. 3703 authorizes the Coast Guard to prescribe rules
related to the carriage of liquid bulk dangerous cargoes. 46 CFR 151
prescribes rules for barges carrying bulk liquid hazardous materials.
    Forms: N/A.
    Respondents: Owners and operators of tank barges.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from
24,752 hours a year to 27,262 hours, due to an increase in the
estimated annual number of respondents.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended.

    Dated: July 20, 2022.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2022-15900 Filed 7-25-22; 8:45 am]
BILLING CODE 9110-04-P