[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 24996-24997]
[FR Doc No: 2023-08641]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1357]

Authorization of Emergency Use of a Medical Device During COVID-
19; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the issuance of an Emergency Use Authorization (EUA) (the
Authorization) for a medical device related to the Coronavirus Disease
2019 (COVID-19) public health emergency. FDA has issued the
Authorization indicated in this document under the Federal Food, Drug,
and Cosmetic Act (FD&C Act). This Authorization contains, among other
things, conditions on the emergency use of the authorized product. The
Authorization follows the February 4, 2020, determination by the
Secretary of Health and Human Services (HHS), as amended on March 15,
2023, that there is a public health emergency, or a significant
potential for a public health emergency, that affects, or has a
significant potential to affect, national security or the health and
security of U.S. citizens living abroad and that involves the virus
that causes COVID-19, and the subsequent declarations on February 4,
2020, March 2, 2020, and March 24, 2020, that circumstances exist
justifying the authorization of emergency use of in vitro diagnostics
for detection and/or diagnosis of the virus that causes COVID-19,
personal respiratory protective devices, and medical devices, including
alternative products used as medical devices, respectively, subject to
the terms of any authorization issued under the FD&C Act. The
Authorization, which includes an explanation of the reasons for
issuance, is specified in this document, and can be accessed on FDA's
website from the links indicated.

DATES: The Authorization is effective on the date of issuance.

ADDRESSES: Submit written requests for single copies of an EUA to the
Office of Policy, 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 request or include a Fax number
to which the Authorization may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of
Product Evaluation and Quality, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 3216, Silver Spring, MD 20993-0002,<PHONE_NUMBER> (this is not a
toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
radiological, or nuclear agent or agents. Among other things, section
564 of the FD&C Act allows FDA to authorize the use of an unapproved
medical product or an unapproved use of an approved medical product in
certain situations. With this EUA authority, FDA can help ensure that
medical countermeasures may be used in emergencies to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
a biological, chemical, radiological, or nuclear agent or agents when
there are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
a determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50 of the U.S. Code, of attack with (A)
a biological, chemical, radiological, or nuclear agent or agents; or
(B) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
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    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
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    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use when the Secretary of HHS has declared that
circumstances exist justifying the authorization of emergency use.
Products appropriate for emergency use may include products and uses
that are not approved, cleared, or licensed under section 505, 510(k),
512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b,

or 360e) or section 351 of the PHS Act (42 U.S.C. 262), or
conditionally approved under section 571 of the FD&C Act (21 U.S.C.
360ccc). FDA may issue an EUA only if, after consultation with the HHS
Assistant Secretary for Preparedness and Response, the Director of the
National Institutes of Health, and the Director of the Centers for
Disease Control and Prevention (to the extent feasible and appropriate
given the applicable circumstances), FDA \2\ concludes: (1) that an
agent referred to in a declaration of emergency or threat can cause a
serious or life-threatening disease or condition; (2) that, based on
the totality of scientific evidence available to FDA, including data
from adequate and well-controlled clinical trials, if available, it is
reasonable to believe that (A) the product may be effective in
diagnosing, treating, or preventing (i) such disease or condition; or
(ii) a serious or life-threatening disease or condition caused by a
product authorized under section 564, approved or cleared under the
FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing,
treating, or preventing such a disease or condition caused by such an
agent; and (B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition, outweigh
the known and potential risks of the product, taking into consideration
the material threat posed by the agent or agents identified in a
declaration under section 564(b)(1)(D) of the FD&C Act, if applicable;
(3) that there is no adequate, approved, and available alternative to
the product for diagnosing, preventing, or treating such disease or
condition; (4) in the case of a determination described in section
564(b)(1)(B)(ii), that the request for emergency use is made by the
Secretary of Defense; and (5) that such other criteria as may be
prescribed by regulation are satisfied. No other criteria for issuance
have been prescribed by regulation under section 564(c)(4) of the FD&C
Act.
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    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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II. Electronic Access

    An electronic version of this document and the full text of the
Authorization is available on the internet and can be accessed from
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

III. The Authorization

    Having concluded that the criteria for the issuance of the
following Authorization under section 564(c) of the FD&C Act are met,
FDA has authorized the emergency use of the following product for
diagnosing, treating, or preventing COVID-19 subject to the terms of
each Authorization. The Authorization in its entirety, including any
authorized fact sheets and other written materials, can be accessed
from the FDA web page entitled ``Emergency Use Authorization,''
available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
The list includes the Authorization issued on March 24, 2023, and we
have included an explanation of the reasons for the issuance, as
required by section 564(h)(1) of the FD&C Act. In addition, any EUAs
that have been reissued can be accessed from FDA's web page: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
    FDA is hereby announcing the following Authorization for a
molecular diagnostic and antigen test for COVID-19, excluding
multianalyte tests: \3\
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    \3\ As set forth in the EUA for this product, FDA has concluded
that: (1) SARS-CoV-2 can cause a serious or life-threatening disease
or condition, including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of scientific
evidence available to FDA, it is reasonable to believe that the
product may be effective in diagnosing COVID-19, and that the known
and potential benefits of the product, when used for diagnosing
COVID-19, outweigh the known and potential risks of such product;
and (3) there is no adequate, approved, and available alternative to
the emergency use of the product.
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     BioSynchronicity Corporation's C-Sync COVID-19 Antigen
Test, issued March 24, 2023.

    Dated: April 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08641 Filed 4-24-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Notices]
[Pages 8278-8279]
[FR Doc No: 2020-02895]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC19-32-000]

Commission Information Collection Activities (FERC-725M); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection, FERC-725M (Mandatory Reliability Standards:
Generator Requirements at the Transmission Interface) and submitting
the information collection to the Office of Management and Budget (OMB)
for review. Any interested person may file comments directly with OMB
and should address a copy of those comments to the Commission as
explained below.

DATES: Comments on the collection of information are due by March 16,
2020.

ADDRESSES: Comments filed with OMB, identified by the OMB Control No.
1902-0263, should be sent via email to the Office of Information and
Regulatory Affairs<EMAIL_ADDRESS>Attention: Federal Energy
Regulatory Commission Desk Officer.
    A copy of the comments should also be sent to the Commission, in
Docket No. IC19-32-000, by either of the following methods:
     eFiling at Commission's Website: 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 this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

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

SUPPLEMENTARY INFORMATION:
    Title: FERC-725M (Mandatory Reliability Standards: Generator
Requirements at the Transmission Interface).
    OMB Control No.: 1902-0263.
    Type of Request: Three-year extension of the FERC-725M with no
updates to the current reporting requirements.
    Abstract: On August 27, 2019, the Commission published a Notice in
the Federal Register in Docket No. IC19-32-000 requesting public
comments. The Commission received no comments and noting that in the
related submittal to OMB.
    On September 19, 2013, the Commission issued Order No. 785, Docket
No. RM12-16-000, a Final Rule \1\ approving modifications to four
existing Reliability Standards submitted by the North American Electric
Reliability Corporation (NERC), the Commission certified Electric
Reliability Organization. Specifically, the Commission approved
Reliability Standards FAC-001-1 (Facility Connection Requirements),
FAC-003-3 (Transmission Vegetation Management), PRC-004-2.1a (Analysis
and Mitigation of Transmission and Generation Protection System
Misoperations), and

PRC-005-1.1b (Transmission and Generation Protection System Maintenance
and Testing).\2\ The modifications improved reliability either by
extending applicability of the Reliability Standard to certain
generator interconnection facilities, or by clarifying that the
existing Reliability Standard is and remains applicable to generator
interconnection facilities.
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    \1\ Generator Requirements at the Transmission Interface, 144
FERC ] 61,221 (2013).
    \2\ The burden is included in information collection FERC-725M.
    The burdens related to previous versions of Reliability
Standards mentioned in the Final Rule: FAC-001-0 (Facility
Connection Requirements); FAC-003-2 (Transmission Vegetation
Management); PRC-004-2a (Analysis and Mitigation of Transmission and
Generation Protection System Misoperations); and PRC-005-1b
(Transmission and Generation Protection System Maintenance and
Testing) are included in FERC-725A (Mandatory Reliability Standards
for the Bulk-Power System, OMB Control No. 1902-0244).
    The Final Rule states the modifications included in PRC-004-2.1a
and PRC-005-1.1b are clarifications of existing requirements, do not
extend those existing requirements to any new entity or to
additional facilities, and do not affect the existing burden related
to those standards.
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    On April 26, 2016, a Delegated Letter Order was issued, Docket No.
RD16-4-000, approving proposed Reliability Standard FAC-003-4
(Transmission Vegetation Management). Reliability Standard FAC-003-4
reflected revisions to the current Minimum Vegetation Clearance
Distances (MVCDs) in Reliability Standard FAC-003-3 based on additional
testing regarding the appropriate gap factor to be used to calculate
clearance distances for vegetation. NERC explained that Reliability
Standard FAC-003-4 includes higher and more conservative MVCD values
and, therefore, maintained that these revisions would enhance
reliability and provide additional confidence by applying a more
conservative approach to determining the vegetation clearing distances.
In FERC-725M we are:
    (1) Adjusting the burden in FAC-003-4 to reflect the latest number
of applicable entities based on the NERC Compliance Registry as of July
26, 2019.
    (2) Making a program change to administratively remove all one-time
burden \3\ that is being inadvertently counted in FERC-725M and FERC-
725D.
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    \3\ One-time burden is typically performed in the first year of
implementation. All burden associated with FAC-001-3 in this
collection was removed in 2015. The burden in FAC-001-3 was
transferred in 2015 to FERC-725D (OMB Control Number 1902-0247).
    See the November 6, 2014 Delegated Letter Order, Docket No.
RD14-12-000, approving Reliability Standard FAC-001-2 and Order No.
836, Balancing Authority Control, Inadvertent Interchange, and
Facility Interconnection Reliability Standards, 160 FERC ] 61,070
(2017), approving Reliability Standard FAC-001-3.
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    Type of Respondents: Transmission Owner (TO); Generator Owner (GO);
and Regional Entity (RE).
    Estimate of Annual Burden.\4\ The Commission estimates the annual
public reporting burden and cost \5\ for the information collection as:
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    \4\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a federal agency. See 5
CFR 1320 for additional information on the definition of information
collection burden.
    \5\ The estimated hourly cost (salary plus benefits) are based
on the figures for May 2018 posted by the Bureau of Labor Statistics
for the Utilities sector (available at http://www.bls.gov/oes/current/naics2_22.htm) and updated March 2019 for benefits
information (at http://www.bls.gov/news.release/ecec.nr0.htm). The
hourly estimates for salary plus benefits are:
    --Manager (code 11-0000), $95.24
    --Information and Records Clerks (code 43-4199), $40.84
    --Electrical Engineer (code 17-2071), $68.17
    The average hourly burden cost for this collection is $68.08
[($95.24 + $40.84 + $68.17)/3 = $68.08)] and is rounded to $68.00 an
hour.

                                FERC-725M, Mandatory Reliability Standards: FAC-003-4 (Transmission Vegetation Management
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          Number of     Annual number                                              Total annual burden
                                         respondents    of responses    Total number    Average burden hours &     hours & total annual      Cost per
                                             \6\       per respondent   of responses       cost per response               cost             respondent
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                                                  (1)             (2)  (1)*(2) = ( 3)  (4).....................  (3)*(4) = (5)..........   ($) (5) / (1)
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                                                     FAC-003-4 (Transmission Vegetation Management)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Generator Owners, Regional Entities:          101 \7\               4             404  0.25 hrs.; $17.00.......  101 hrs.; $6,868.00....          $68.00
 Quarterly Reporting (Compliance 1.4).
Generator Owners: Annual Veg.                      95               1              95  2 hrs.; $136.00.........  190 hrs.; $12,920.00...          136.00
 inspect. Doc. (M6); Work Plan (M7);
 Evidence of Mgt. of Veg. (M1 & M2);
 Confirmed Veg. Condition (M4); &
 Corrective Action (M5).
Generator Owners, Transmission                    423               1             423  1 hr.; $68.00...........  423 hrs.; $28,764.00...           68.00
 Owners: Record Retention (Compliance
 1.2).
                                      ------------------------------------------------------------------------------------------------------------------
    TOTAL............................  ..............  ..............             922  ........................  714 hrs.: $48,552.00...          272.00
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    Comments: Comments are invited on: (1) Whether the collection of
information is 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 collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
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    \6\ According to the NERC Compliance Registry as of July 26,
2019, there are 946 generator owners and 328 transmission owners
registered in North America. We estimate that approximately 10
percent (or 95) of these generator owners have interconnection
facilities that are applicable to the standard.
    \7\ The estimated number of respondents (101) includes 95
generator owners and 6 Regional Entities.

    Dated: February 3, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-02895 Filed 2-12-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 20 (Wednesday, January 30, 2013)]
[Notices]
[Pages 6368-6371]
[FR Doc No: 2013-01969]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68717; File No. SR-BX-2013-005]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating To
Routing Fees

January 24, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 16, 2013, NASDAQ OMX BX, Inc. (``BX'' 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 amend Chapter XV, Section 2 entitled ``BX
Options Market--Fees and Rebates'' to amend various fees for routing
options to away markets.
    While these amendments are effective upon filing, the Exchange has
designated the proposed amendments to be operative on February 1, 2013.
    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
Web site at http://nasdaqomxbx.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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this filing is to amend the Routing Fees in Section
2(4) of Chapter XV in order to recoup costs the Exchange incurs for
routing and executing certain orders in equity options to away markets.
    Currently, the fees for routing Customer, Firm, Market Maker,
Broker-Dealer and Professional orders are as follows:

----------------------------------------------------------------------------------------------------------------
                                                                            Firm/market maker/
                        Exchange                              Customer        broker-dealer       Professional
----------------------------------------------------------------------------------------------------------------
BATS (Penny Pilot).....................................              $0.55              $0.55              $0.55
BATS (Non-Penny Pilot).................................               0.86               0.94               0.94
BOX....................................................               0.11               0.55               0.31
CBOE...................................................               0.11               0.55               0.41
CBOE orders greater than 99 contracts in ETFs and ETNs)               0.29                N/A                N/A
C2.....................................................               0.55               0.55               0.55
ISE (Standard).........................................               0.11               0.55               0.31
ISE (Select Symbols)*..................................               0.35               0.55               0.44
MIAX...................................................               0.11               0.55               0.36
NOM (Penny Pilot)......................................               0.55               0.55               0.55
NOM (Non-Penny Pilot)..................................               0.93               0.94               0.94
NYSE Arca (Penny Pilot)................................               0.55               0.55               0.55
NYSE Arca (Non-Penny Pilot)............................               0.90               0.94               0.90
NYSE Amex..............................................               0.11               0.55               0.31
PHLX (for all options other than PHLX Select Symbols)..               0.11               0.55               0.36
PHLX Select Symbols **.................................               0.11               0.55               0.55
----------------------------------------------------------------------------------------------------------------

    The Exchange proposes to adopt new Routing Fees when routing and
executing orders in equity options to BATS Exchange, Inc. (``BATS''),
BOX Options Exchange LLC (``BOX''), the Chicago Board Options Exchange,
Incorporated (``CBOE''), C2 Options Exchange, Incorporated (``C2''),
International Securities Exchange, LLC (``ISE''), the Miami
International Securities Exchange, LLC (``MIAX''), NASDAQ Options
Market (``NOM''), NYSE Arca, Inc. (``NYSE Arca''), NYSE MKT (``NYSE
Amex'') and NASDAQ OMX PHLX LLC (``Phlx''). The Exchange is proposing
to eliminate the current Routing Fees located in Section 2(4) of
Chapter XV and instead assess BX Options Participants a fixed fee plus
the away market transaction fee as noted below.
    Today, the Exchange calculates Routing Fees by assessing a fixed
Routing Fee of $0.11 per contract, which is comprised of certain
Exchange costs related to routing orders to away markets plus the away
market's transaction fee. With respect to the fixed costs, the Exchange
incurs a fee when it utilizes Nasdaq Options Services LLC (``NOS''), a
member of the Exchange and the Exchange's exclusive order router.\3\
Each time NOS routes an order to an away market, NOS is charged a
clearing fee \4\ and, in the case of certain exchanges, a transaction
fee is also charged in certain symbols, which fees are passed through
to the Exchange. The Exchange currently recoups clearing and
transaction charges incurred by the Exchange as well as certain other
costs incurred by the Exchange when routing to away markets, such as
administrative and technical costs associated with operating NOS,
membership fees at away markets, Options Regulatory Fees (``ORFs'') and
technical costs associated with routing options. With respect to away
market transaction fees, the Exchange does not assess actual
transaction fees in all cases today, but rather has limited fees in
certain circumstances. In those cases the Exchange does not recover all
of its costs for routing to the away market.\5\
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    \3\ See BX Rules at Chapter VI, Section 11(e) (Order Routing).
    \4\ The Options Clearing Corporation (``OCC'') assesses $0.01
per contract side.
    \5\ In some cases the Exchange filed a rule change which noted
that the Exchange would not assess the actual transaction charge,
but a lower amount where the transaction fees at an away market were
higher than other markets.
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    Today, the Exchange amends its Routing Fees to reflect amendments
to away market transaction fees by filing proposed rule changes. The
Exchange proposes to eliminate the current Routing Fees and instead
assess the actual away market fee assessed by the away exchange at the
time that the order was entered into the Exchange's trading system.
This transaction fee would be calculated on an order-by-order basis
since different away markets charge different amounts.\6\ The Exchange
analyzed its clearing costs,\7\ administrative and technical costs
associated with operating NOS, membership fees at away markets and
regulatory costs in determining the fixed fee for routing. With respect
to BATS, BOX, C2, CBOE, ISE, MIAX, NYSE Amex and NYSE Arca the Exchange
proposes to continue to assess $0.11 per contract in addition to the
away market's transaction fee.\8\ While this proposal does not change
the fixed cost assessed to away markets other than Phlx and NOM, the
Exchange would assess the actual transaction fees that are in place at
the various away markets and will no longer limit those transaction
fees as it does today in certain circumstances.\9\ While clearing costs
have recently decreased,\10\ the Exchange would continue to assess
$0.11 per contract because of other increased costs. Specifically,
several exchanges have increased ORFs or adopted ORFs and the Exchange
proposes to assess the same fixed costs Routing Fee for non-NASDAQ OMX
exchanges despite the decreased clearing fee.\11\
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    \6\ This is similar to the methodology utilized by ISE in
assessing Routing Fees. See ISE's Fee Schedule.
    \7\ OCC recently amended its clearing fee from $0.03 per
contract side to $0.01 percontract side. See Securities Exchange Act
Release No. 68025 (October 10, 2012), 77 FR 63398 (October 16, 2012)
(SR-OCC-2012-18).
    \8\ The $0.11 per contract fixed fee would apply to all options
exchanges other than Phlx and NOM. The Exchange anticipates that if
other options exchanges are approved by the Commission after the
filing of this proposal, those exchanges would be assessed the $0.11
per contract fee applicable to ``all other options exchanges.'' The
Exchange currently assesses $0.11 per contract for costs incurred by
the Exchange.
    \9\ Today, the Exchange caps certain Routing Fees at certain
levels. For example, the Exchange caps BATS, NYSE Arca and BX
Options Routing Fees at $0.94 per contract.
    \10\ See note 7.
    \11\ CBOE recently increased its ORF from $.0065 to $.0085 per
contract. See Securities Exchange Act Release No. 68480 (December
19, 2012), 77 FR 76119 (December 26, 2012) (SR-CBOE-2012-118). C2
recently increased its ORF from $.0015 to $.002 per contract. See
Securities Exchange Act Release No. 68479 (December 19, 2012), 77 FR
76131 (December 26, 2012) (SR-C2-2012-040). NYSE Amex recently
increased its ORF from $0.004 to $0.005 per contract. See Securities
Exchange Act Release No. 68183 (November 8, 2012), 77 FR 68186
(November 15, 2012) (SR-NYSEMKT-2012-54). NYSE Arca recently
increased its ORF from $0.004 to $0.005 per contract. See Securities
Exchange Act Release No. 68174 (November 7, 2012), 77 FR 67845
(November 14, 2012) (SR-NYSEArca-2012-118). MIAX recently adopted an
ORF of $0.0040 per contract side. See SR-MIAX-2012-06 (not yet
published).
---------------------------------------------------------------------------

    The Exchange also analyzed costs related to routing to Phlx and NOM
and determined to assess a lower fee of $0.05 per contract as compared
to other away markets because NOS is utilized by all three exchanges to
route orders.\12\ Phlx, BX and NOM all utilize NOS which lowers the
cost of routing to those markets as compared to other away markets. In
addition the fixed costs are reduced because NOS is owned and operated
by NASDAQ OMX and the three exchanges and NOS share common technology
and related operational functions. The Exchange proposes to assess a
$0.05 per contract fixed fee in addition to the away market's
transaction fee to route to Phlx and NOM. This proposal would reduce
the fixed fees assessed today on average to route to Phlx and NOM from
$0.11 to $0.05 per contract.
---------------------------------------------------------------------------

    \12\ See BX Rules at Chapter VI, Section 11 of the NASDAQ and BX
Rules and Phlx Rule 1080(m)(iii)(A).
---------------------------------------------------------------------------

    For all Routing Fees, the transaction fee is based on the away
market's transaction fee or rebate for particular market participants
and in the case that there is no transaction fee or rebate assessed by
the away market, the only fee assessed would be the $0.05 or $0.11 per
contract fixed fee assessed by the Exchange to recoup its costs. The
Exchange proposes to pass along any rebate paid by the away market
where there is such a rebate. Today, the Exchange does not pass along
rebates. Any rebate available would be netted against a fee assessed by
the Exchange. For example, if a Customer order is routed to BOX, and
BOX offers a customer rebate of $0.20 per contract, the Exchange would
assess a $0.11 per contract fixed fee which would net against the
rebate ($0.20 per contract in this example). The market participant for
whom the Customer contract was routed would receive a $0.09 per
contract rebate. Today the market participant does not receive a rebate
and only pays the current Routing Fees.
    As with all fees, the Exchange may adjust these Routing Fees in
response to competitive conditions by filing a new proposed rule
change.
2. Statutory Basis
    BX believes that the proposed rule changes are consistent with the
provisions of Section 6 of the Act,\13\ in general, and with Section
6(b)(4) of the

Act,\14\ in particular, in that they provide for the equitable
allocation of reasonable dues, fees and other charges among members and
issuers and other persons using any facility or system which BX
operates or controls.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f.
    \14\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the proposed Routing Fees are reasonable
because they seek to recoup costs that are incurred by the Exchange
when routing Customer, Firm, Market Maker, Broker-Dealer and
Professional orders to away markets on behalf of members. Each
destination market's transaction charge varies and there is a cost
incurred by the Exchange when routing orders to away markets. The costs
to the Exchange include clearing costs, administrative and technical
costs associated with operating NOS, membership fees at away markets,
ORFs and technical costs associated with routing options. The Exchange
believes that the proposed Routing Fees would enable the Exchange to
recover the costs it incurs to route orders to away markets in addition
to transaction fees assessed to market participants for the execution
of Customer, Firm, Market Maker, Broker-Dealer and Professional orders
by the away market. Specifically, other options exchanges have
increased ORFs that are assessed per transaction.\15\ The Exchange
believes that it is reasonable to recoup these costs borne by the
Exchange on each transaction.
---------------------------------------------------------------------------

    \15\ CBOE recently increased its ORF from $.0065 to $.0085 per
contract. See Securities Exchange Act Release No. 68480 (December
19, 2012), 77 FR 76119 (December 26, 2012) (SR-CBOE-2012-118). C2
recently increased its ORF from $.0015 to $.002 per contract. See
Securities Exchange Act Release No. 68479 (December 19, 2012), 77 FR
76131 (December 26, 2012) (SR-C2-2012-040). NYSE Amex recently
increased its ORF from $0.004 to $0.005 per contract. See Securities
Exchange Act Release No. 68183 (November 8, 2012), 77 FR 68186
(November 15, 2012) (SR-NYSEMKT-2012-54). NYSE Arca recently
increased its ORF from $0.004 to $0.005 per contract. See Securities
Exchange Act Release No. 68174 (November 7, 2012), 77 FR 67845
(November 14, 2012) (SR-NYSEArca-2012-118). MIAX recently adopted an
ORF of $0.0040 per contract side. See SR-MIAX-2012-06 (not yet
published).
---------------------------------------------------------------------------

    In addition, the Exchange notes that it would assess a fixed fee of
$0.11 per contract, as it does today, for costs incurred by the
Exchange with respect to non-NASDAQ OMX exchanges. The Exchange
believes that the proposed fee is reasonable because while the clearing
fee itself was lowered by OCC (from $0.03 to $0.01 per contract side),
other fees, such as ORFs, have increased in recent months. The
Exchange, in analyzing its actual costs, has determined to continue to
assess a $0.11 per contract fee to represent the overall cost to the
Exchange for technical, administrative, clearing, regulatory,
compliance and other costs, in addition to the transaction fee assessed
by the away market. Also, the Exchange will assess the actual
transaction fees that are in place at the various away markets and will
no longer limit those transaction fees as it does today in certain
circumstances. The Exchange believes that it is reasonable for it to
recoup its actual costs associated with routing orders to away markets.
BX Options Participants would be entitled to receive rebates offered by
away markets with this proposal, which rebates would net against fees
assessed by the Exchange for routing orders. The Exchange believes that
the opportunity to collect a rebate will reduce Routing Fees.
    In addition, the Exchange believes that it is equitable and not
unfairly discriminatory to assess a fixed cost of $0.11 per contract,
which is mostly comprised of technology, infrastructure and away market
non-transaction fee costs, to route orders to non-NASDAQ OMX away
markets because the Exchange would be assessing an overall lower fixed
fee. While the clearing cost was reduced, other fees have increased and
therefore the Exchange believes that a $0.11 per contract fee continues
to be reasonable because it represents the costs to route to non-NASDAQ
OMX away markets. The proposed $0.11 per contract fixed fee would be
assessed uniformly on all market participants in addition to the actual
transaction fees on all orders routed to non-NASDAQ OMX markets.
    The Exchange believes that it is equitable and not unfairly
discriminatory to assess a fixed cost of $0.05 per contract to route
orders to NASDAQ OMX away markets (Phlx and NOM) because the cost, in
terms of actual cash outlays, to the Exchange to route to those markets
is lower. For example, costs related to routing to Phlx and NOM are
lower as compared to other away markets because NOS is utilized by all
three exchanges to route orders.\16\ NOS and the three NASDAQ OMX
options markets have a common data center and staff that are
responsible for the day-to-day operations of NOS. Because the three
exchanges are in a common data center, Routing Fees are reduced because
costly expenses related to, for example, telecommunication lines to
obtain connectivity are avoided when routing orders in this instance.
The costs related to connectivity to route orders to other NASDAQ OMX
exchanges are de minimis. When routing orders to non-NASDAQ OMX
exchanges, the Exchange incurs costly connectivity charges related to
telecommunication lines and other related costs. The proposed fixed fee
for routing orders to non-NASDAQ OMX exchanges is therefore increased
as compared to the fees for routing orders to NASDAQ OMX exchanges
(Phlx and NOM), $0.11 per contract versus $0.05 per contract,
respectively. The proposed $0.05 per contract fixed fee would be
assessed uniformly on all orders routed to NASDAQ OMX markets in
addition to the actual away market transaction fee assessed by the
destination market. The Exchange also believes that it is equitable and
not unfairly discriminatory for market participants to receive rebates
on orders routed to away markets that pay rebates. Today, the Exchange
does not pay such rebates when routing orders. The Exchange would pay
rebates offered by away markets uniformly to market participants when
their orders are routed to a destination market that offers a rebate.
---------------------------------------------------------------------------

    \16\ See BX Rules at Chapter VI, Section 11 of the NASDAQ and BX
Options Rules and Phlx Rule 1080(m)(iii)(A).
---------------------------------------------------------------------------

    The Exchange believes it is reasonable, equitable and not unfairly
discriminatory to pass along savings realized by leveraging NASDAQ
OMX's infrastructure and scale to market participants when those orders
are routed to Phlx and NOM.\17\ Orders are routed to away markets in
accordance with Exchange rules based on price.\18\ Market participants
may submit orders to the Exchange as ineligible for routing or ``DNR''
to avoid incurring the Routing Fees proposed herein.\19\
---------------------------------------------------------------------------

    \17\ Today, the Exchange assesses a $0.11 per contract fixed fee
for routing orders to Phlx and NOM. That fee is proposed to be
reduced to a $0.05 per contract fixed fee, which would be in
addition to the actual transaction fee assessed by the away market.
    \18\ See BX Rules at Chapter XII (Options Order Protection and
Locked and Crossed Market Rules).
    \19\ See BX Rules at Chapter VI, Section 11(e) (Order Routing).
---------------------------------------------------------------------------

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

    BX 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 the rule change
would allow the Exchange to recoup its costs when routing orders
designated as available for routing by the market participant. BX
Options Participants may choose to mark the order as ineligible for
routing to avoid incurring these fees.\20\ Today, other options

exchanges also assess similar fees to recoup costs to route orders to
away markets. With respect to routing to Phlx and NOM at a lower cost
as compared to other away markets, the Exchange does not believe that
the proposed amendments to increase those fees, while maintaining the
same fee differential imposes a burden because all market participants
would be assessed the same fees depending on the away market. Also, the
Exchange is proposing to recoup costs incurred only when members
request the Exchange route their orders to an away market. The Exchange
is passing along savings realized by leveraging NASDAQ OMX's
infrastructure and scale to market participants when those orders are
routed to Phlx and NOM and is providing those saving to all market
participants. Finally, the Exchange routes orders to away markets where
the Exchange's disseminated bid or offer is inferior to the national
best bid (best offer) (``NBBO'') price and based on price first.\21\
---------------------------------------------------------------------------

    \20\ See BX Rules at Chapter VI, Section 11(e) (Order Routing).
    \21\ See BX Rules at Chapter XII (Options Order Protection and
Locked and Crossed Market Rules).
---------------------------------------------------------------------------

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\22\ 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.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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-BX-2013-005 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2013-005. 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 BX's principal office. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-BX-2013-005, and should be
submitted on or before February 20, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-01969 Filed 1-29-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Notices]
[Page 52883]
[FR Doc No: 2019-21497]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP17-494-000 and CP17-495-000]

Pacific Connector Gas Pipeline LP and Jordan Cove Energy Project
L.P.; Notice of Revised Schedule for the Environmental Review and the
Final Order for the Jordan Cove Energy Project

    This notice identifies the Federal Energy Regulatory Commission
(Commission) staff's revised schedule for the completion of the
environmental impact statement (EIS) for the Jordan Cove Energy
Project. Previously, a notice was issued identifying October 11, 2019
and January 9, 2020 as the respective dates for the final EIS and Order
issuances. The U.S. Forest Service, who is a cooperating agency in the
EIS preparation, only recently received critical information from the
project proponent that is necessary for it to complete its land and
resource management plan amendments; therefore, additional time is
required in order to incorporate this new information into the final
EIS. Accordingly, staff has revised the schedule for issuance of the
final EIS as follows.

Schedule for Environmental Review

Issuance of Notice of Availability of the final EIS--November 15, 2019
90-day Federal Authorization Decision Deadline--February 13, 2020

    Based on the revised final EIS schedule, the Commission currently
anticipates issuing a final Order for the project no later than:

Issuance of Final Order--February 13, 2020

    If a schedule change becomes necessary, an additional notice will
be provided so that the relevant agencies are kept informed of the
project's progress.

Additional Information

    In order to receive notification of the issuance of the EIS and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the eLibrary link, select General
Search from the eLibrary menu, enter the selected date range and Docket
Number excluding the last three digits (i.e., CP17-494 and CP17-495),
and follow the instructions. For assistance with access to eLibrary,
the helpline can be reached at<PHONE_NUMBER>, TTY<PHONE_NUMBER>, or
at<EMAIL_ADDRESS>The eLibrary link on the FERC website
also provides access to the texts of formal documents issued by the
Commission, such as orders, notices, and rulemakings.

    Dated: September 27, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-21497 Filed 10-2-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 13, 2008 (Volume 73, Number 157)]
[Notices]
[Page 47200-47201]
[DOCID:fr13au08-104]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2008-0263]

Collection of Information Under Review by Office of Management
and Budget: OMB Control Number: 1625-0011

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
request for comments announces that the U.S. Coast Guard is forwarding
an Information Collection Request (ICR), abstracted below, to the
Office of Information and Regulatory Affairs (OIRA), Office of
Management and Budget (OMB) requesting an extension of their approval
for the following collection of information: 1625-0011, Applications
for Private Aids to Navigation and for Class I Private Aids to
Navigation on Artificial Islands/Fixed Structures. Our ICR describes
the information we seek to collect from the public. Review and comments
by OIRA ensure we only impose paperwork burdens commensurate with our
performance of duties.

DATES: Please submit comments on or before September 12, 2008.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2008-0263] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT) or to OIRA. To avoid
duplication, please submit your comments by only one of the following
means:
    (1) Electronic submission. (a) To Coast Guard docket at http://
www.regulation.gov. (b) To OIRA by e-mail via: oira_
<EMAIL_ADDRESS>    (2) Mail or Hand delivery. (a) DMF (M-30), DOT, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590-0001. Hand deliver between the hours of 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays. The telephone number is 202-
366-9329. (b) To OIRA, 725 17th Street, NW., Washington, DC 20503, to
the attention of the Desk Officer for the Coast Guard.
    (3) Fax. (a) To DMF,<PHONE_NUMBER>. (b) To OIRA at<PHONE_NUMBER>. To
ensure your comments are received in time, mark the fax to the
attention of the Desk Officer for the Coast Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this notice as being available in the docket, will become part of this
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find this docket on the Internet
at http://www.regulations.gov.
    A copy of the complete ICR is available through this docket on the
Internet at http://www.regulations.gov. Additionally, copies are
available from Commandant (CG-611), U.S. Coast Guard Headquarters,
(Attn: Mr. Arthur Requina), 2100 2nd Street, SW., Washington, DC 20593-
0001. The telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Arthur Requina, Office of
Information Management, telephone<PHONE_NUMBER> or fax<PHONE_NUMBER>, for
questions on these documents. Contact Ms. Renee V. Wright, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:
    The Coast Guard invites comments on whether this information
collection request should be granted based on it being necessary for
the proper performance of Departmental functions. In particular, the
Coast Guard would appreciate comments addressing: (1) The practical
utility of the collections; (2) the accuracy of the estimated burden of
the collections; (3) ways to enhance the quality, utility, and clarity
of information subject to the collections; and (4) ways to minimize the
burden of collections on respondents, including the use of automated
collection techniques or other forms of information technology.
    Comments to Coast Guard or OIRA must contain the OMB Control Number
of the ICR. Comments to Coast Guard must contain the docket number of
this request, [USCG 2008-0263]. For your comments to OIRA to be
considered, it is best if they are received on or before the September
12, 2008.
    Public participation and request for comments: We encourage you to
respond to this request by submitting comments and related materials.
We will post all comments received, without change, to http://
www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
paragraph on DOT's ``Privacy Act Policy'' below.
    Submitting comments: If you submit a comment, please include the
docket number [USCG-2008-0263], indicate the specific section of the
document to which each comment applies, providing a reason for each
comment. We recommend you include your name, mailing address, an e-mail
address, or other contact information in the body of your document so
that we can contact you if we have questions regarding your submission.
You may submit comments and material by electronic means, mail, fax, or
delivery to the DMF at the address under ADDRESSES; but please submit
them by only one means. If you submit them by mail or delivery, submit
them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable
for copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period. We may change the
documents supporting this collection of information or even the
underlying requirements in view of them. The Coast Guard and OIRA will
consider all comments and material received during the comment period.
    Viewing comments and documents: Go to http://www.regulations.gov to
view documents mentioned in this Notice as being available in the
docket. Enter the docket number [USCG-2008-0263] in the Search box, and
click, ``Go>>.'' You may also visit the DMF in room W12-140 on the West
Building Ground Floor, 1200 New Jersey Avenue, SE., Washington, DC,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    Privacy Act: Anyone can search the electronic form of all comments

received in 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 the Privacy
Act Statement of DOT in the Federal Register published on April 11,
2000 (65 FR 19477), or by visiting http://DocketsInfo.dot.gov.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard has published the 60-day notice (73 FR 26125, May 8, 2008)
required by 44 U.S.C. 3506(c)(2). That notice elicited no comments.

Information Collection Request

    Title: Applications for Private Aids to Navigation and for Class I
Private Aids to Navigation on Artificial Islands/Fixed Structures.
    OMB Control Number: 1625-0011.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Owners of private aids to navigation.
    Abstract: Under provisions of 14 U.S.C. 633 and 33 U.S.C. 409, the
Secretary of the Department of Homeland Security may prescribe
regulations for the marking of sunken vessels. These requirements for
notifying the Coast Guard are set forth in 33 CFR 64.11. The
information collected for the rule can only be obtained from the
owners. The information collection requirements for private aids to
navigation and aids to navigation on artificial islands/fixed
structures are contained in 33 CFR 66.01-5 and 67.35-5, respectively.
    Burden Estimate: The estimated annual burden remains 3,000 hours
per year.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
chapter 35, as amended.

    Dated: August 4, 2008.
M. B. Lytle,
Captain, U.S. Coast Guard, Acting Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. E8-18633 Filed 8-12-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28238-28240]
[FR Doc No: 2018-12939]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2155]

Foods Produced Using Animal Cell Culture Technology; Public
Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing a
public meeting entitled ``Foods Produced Using Animal Cell Culture
Technology.'' FDA is holding the public meeting to provide the public
with an opportunity to provide comments related to the production of
foods using animal cell culture technology.

DATES: The public meeting will be held on July 12, 2018, from 8:30 a.m.
until 3 p.m. EST. Submit either electronic or written comments on this
public meeting by September 25, 2018. See the SUPPLEMENTARY INFORMATION
section for registration date and information.

ADDRESSES: The public meeting will be held at the Food and Drug
Administration, Center for Food Safety and Applied Nutrition, Wiley
Auditorium, 5001 Campus Dr., College Park, MD 20740.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before September 25, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 25, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-2155 for ``Foods Produced Using Animal Cell Culture
Technology; Public Meeting; Request for Comments.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly

available, you can provide this information on the cover sheet and not
in the body of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Juanita Yates, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Technological advances and consumer interest are spurring
development of commercial-scale production of foods that are intended
to resemble traditional meat, poultry, and seafood but are manufactured
using, generally, a small amount of cells from the type of animal the
food is intended to resemble. The collected cells are multiplied using
nontraditional food technologies adapted from cell culture applications
widely used in research and increasingly in medicine. We expect that
most or all starter cells for food applications will come from living
animals for the foreseeable future for commercial and marketing reasons
(for example, firms currently working on developing these food
applications appear to be targeting consumers motivated by animal
welfare concerns). Currently, animal cells can be produced from the
starter cells in bioreactors, a scaled-up application of traditional
cell culture techniques. Firms are also working to commercialize
processes by which cells can be cultured using biocompatible
scaffolding or other techniques to permit the formation of complex
tissues, similar to strategies being explored for therapeutic organ or
tissue replacement. In either case, a significant technical challenge
with respect to the use of animal cell culture technology to develop
foods intended to resemble traditional meat, poultry, and seafood
products involves the development of the growth medium used to multiply
the cells and ensure that they differentiate into the correct cell
types. Commercial incentives are driving research into non-animal
derived components for such media instead of traditional animal-derived
materials. Finally, after creation, both suspension-cultured
(unstructured) and scaffold-cultured (structured) products would be
further processed using traditional food technologies, including
seasoning, forming, and packaging.
    Just as we have been in the past with respect to rapidly evolving
areas of technological innovation in food, FDA will be involved in the
regulation of foods generated by animal cell culture technology in
light of our broad statutory authority and our extensive expertise and
experience in relevant scientific areas. Currently, FDA evaluates
microbial, algal, and fungal cells generated by large-scale culture and
used as direct food ingredients, administers safety assessment programs
for a broad array of food ingredients and foods derived from
genetically engineered plants, manages safety issues associated with
animal cell culture technology in therapeutic settings, and manages
risks associated with the processing, manufacture, and packaging of
food incorporating seafood tissues.
    Under the Federal Food, Drug, and Cosmetic Act, FDA has
jurisdiction over ``food,'' which includes ``articles used for food''
and ``articles used for components of any such article.'' Thus, as a
starting point, both substances used in the manufacture of these
products of animal cell culture technology and the products themselves
that will be used for food are subject to FDA's jurisdiction and
applicable statutory and regulatory food safety and food labeling
requirements.
    The use of animal cell culture technology as a method of food
production and manufacturing involves many interesting issues from both
technical and regulatory perspectives. FDA believes that all
stakeholders will benefit from a robust and open dialogue that explores
these issues and gathers relevant data and information. The primary
subject of this notice is food safety, but FDA recognizes the
importance of other issues related to foods produced through animal
cell culture technology such as naming. Although not the primary
subject of this notice, FDA welcomes comment on these other issues and
expects that they will be the focus of future engagement with
stakeholders and the public.

II. Topics for Discussion at the Public Meeting

    FDA is holding the public meeting to provide the public with an
opportunity to provide comments related to production of foods using
animal cell culture technology. We invite interested persons, including
those participating in the public meeting, to provide information on
topics such as the following (a more detailed agenda will be made
available prior to the meeting):
     FDA has evaluated a variety of foods produced by cell
culture, including microbial (e.g., probiotics), algal (e.g.,
spirulina), and fungal products (e.g., mycoprotein). What
considerations specific to animal cell culture technology would be
appropriate to include in evaluation of food produced by this method of
manufacture?
     FDA has issued guidance on how to assess the effects of
significant manufacturing process changes on the safety of a food
ingredient. (See ``Guidance for Industry: Assessing the Effects of
Significant Manufacturing Process Changes, Including Emerging
Technologies, on the Safety and Regulatory Status of Food Ingredients
and Food Contact Substances, Including Food Ingredients that Are Color
Additives'' at https://www.fda.gov/RegulatoryInformation/Guidances/ucm300661.htm.) What kinds of variations in manufacturing methods would
be relevant to safety for foods produced by animal cell culture
technology?
     FDA has a variety of pre- and postmarket programs for
evaluating the safety of substances used in the production and
manufacture of foods, including, for example, food additive and color
additive regulations and preventive control requirements. What kinds of
substances would be used in the manufacture of foods produced using
animal cell culture technology and what considerations would be
appropriate in evaluating the safety of these uses?
     Are the hazards associated with production of foods using
animal cell culture technology different from those associated with
traditional food production/processing (such as, for example,
insanitary conditions, improper temperature controls, or control of
contaminants)? Is there a need for unique control measures to address
the hazards associated with production of foods using animal cell
culture technology?

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the
following

website: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register by July 5, 2018. Early registration is
recommended because seating is limited; therefore, FDA may limit the
number of participants from each organization. Registrants will receive
confirmation when they have been accepted.
    If you need special accommodations due to a disability, please
contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later
than June 28, 2018.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation. Following the
close of registration, we will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to
begin, and will select and notify participants by July 3, 2018.
Speakers will be limited to making oral remarks; there will not be an
opportunity to display materials such as slide shows, videos, or other
media during the meeting. All requests to make oral presentations must
be received by June 28, 2018. No commercial or promotional material
will be permitted to be presented or distributed at the public meeting.
    Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. Webcast participants are asked to preregister at
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    Other Issues for Consideration: A summary of key information on
participating in the meeting follows:

                                                  Table 1--Information on Participation in the Meeting
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Submit either
              Date                      Address           Preregister     Electronic address  Request to make an        Special          electronic or
                                                                                oral presentation    accommodations     written comments
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 12, 2018, from 8:30 a.m.     Food and Drug       July 5, 2018:       https://            June 28, 2018.....  June 28, 2018:      Submit Comments by
 until 3 p.m. EDT.                 Administration,     Closing date for    www.fda.gov/Food/                       Closing date to     September 25,
                                   Center for Food     registration.       NewsEvents/                             request special     2018 to: https://
                                   Safety and                              WorkshopsMeetings                       accommodations      www.regulations.g
                                   Applied                                 Conferences/                            due to a            ov, or Dockets
                                   Nutrition, Wiley                        default.htm.                            disability.         Management Staff
                                   Auditorium, 5001                                                                                (HFA-305), Food
                                   Campus Drive,                                                                                and Drug
                                   College Park, MD                                                                                Administration,
                                   20740.                                                                                5630 Fishers
                                                                                Lane, Rm. 1061,
                                                                                Rockville, MD
                                                                                20852.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12939 Filed 6-15-18; 8:45 am]
 BILLING CODE 4164-01-P