[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Notices]
[Pages 35030-35031]
[FR Doc No: 2013-13826]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9823-4]

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's approval of the State of Nevada's
request to revise its National Pollutant Discharge Elimination System
EPA-authorized program to allow electronic reporting.

DATES: EPA's approval is effective June 11, 2013.

FOR FURTHER INFORMATION CONTACT: Evi Huffer, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1697<EMAIL_ADDRESS>or Karen Seeh, U.S. Environmental Protection
Agency, Office of Environmental Information, Mail Stop 2823T, 1200
Pennsylvania Avenue NW., Washington, DC 20460,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the

option of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application and will use electronic document receiving systems
that meet the applicable subpart D requirements.
    On October 10, 2012, the Nevada Division of Environmental
Protection (NDEP) submitted an application titled ``Network Discharge
Monitoring Report System'' for revision of its EPA-authorized
authorized Part 123 program under title 40 CFR. EPA reviewed NDEP's
request to revise its EPA-authorized Part 123--National Pollutant
Discharge Elimination System program and, based on this review, EPA
determined that the application met the standards for approval of
authorized program revision set out in 40 CFR part 3, subpart D. In
accordance with 40 CFR 3.1000(d), this notice of EPA's decision to
approve Nevada's request to revise its Part 123--National Pollutant
Discharge Elimination System program to allow electronic reporting
under 40 CFR part 122 is being published in the Federal Register.
    NDEP was notified of EPA's determination to approve its application
with respect to the authorized program listed above.

    Dated: June 3, 2013.
Andrew Battin,
Director, Office of Information Collection.
[FR Doc. 2013-13826 Filed 6-10-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 155 (Monday, August 16, 2021)]
[Notices]
[Page 45819]
[FR Doc No: 2021-17431]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2018-0204]

Air Carrier Access Act Advisory Committee; Notice of Public
Meeting

AGENCY: Office of the Secretary (``OST''), Department of Transportation
(``DOT'').

ACTION: Notice of public meeting.

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SUMMARY: This notice announces a meeting of the Air Carrier Access Act
Advisory Committee (``ACAA Advisory Committee'').

DATES: The ACAA Advisory Committee will hold virtual meetings on
September 2, 8 and 9, 2021, from 9:00 a.m. to 5:00 p.m., Eastern
Daylight Time.
    Requests to attend the meeting must be received by August 30, 2021.
    Requests for accommodations because of a disability must be
received by August 30, 2021. If you wish to speak during the meeting,
you must submit a written copy of your remarks to DOT by August 30,
2021.
    Requests to submit written materials to be reviewed during the
meeting must be received no later than August 30, 2021.

ADDRESSES: The virtual meetings will be open to the public and held via
the Zoom Webinar Platform. Virtual attendance information will be
provided upon registration. A detailed agenda will be available on the
ACAA Advisory Committee website at https://www.transportation.gov/airconsumer/ACAACommittee at least one week before the meeting, along
with copies of the meeting minutes after the meeting.

FOR FURTHER INFORMATION CONTACT: To register and attend this virtual
meeting, please contact the Department by email at<EMAIL_ADDRESS>Attendance is open to the public subject to any
technical and/or capacity limitations. For further information, please
contact Vinh Nguyen, Senior Attorney, by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The ACAA Advisory Committee was created under the Federal Advisory
Committee Act (``FACA''), in accordance with Section 439 of the FAA
Reauthorization Act of 2018 (``FAA Act''), to identify and assess
barriers to accessible air travel, determine the extent to which DOT's
programs and activities are addressing the barriers, recommend
improvements, and advise the Secretary on implementing the Air Carrier
Access Act. The charter of the ACAA Advisory Committee sets forth
policies for the operation of the advisory committee. The charter is
available at https://www.transportation.gov/individuals/aviation-consumer-protection/charter-air-carrier-access-act-advisory-committee.
    The first meeting of the ACAA Advisory Committee was held on March
10 and 11, 2020, in Washington, DC. The purpose of the first meeting
was to gather information on the barriers encountered by passengers
with disabilities in the following areas: Ticketing; pre-flight seat
assignments; access to bulkhead seating; stowage of assistive devices;
and guide and wheelchair assistance at airports and on aircraft. In
each of these areas, the ACAA Advisory Committee heard from speakers
who provided an overview of: The applicable rules, requirements, and
complaint data; challenges faced by air travelers with disabilities;
and airlines' policies and procedures. In addition, the Department
presented a working draft of the ``Airline Passenger with Disabilities
Bill of Rights'' to the ACAA Advisory Committee for discussion.
    At that first meeting, the ACAA Advisory Committee also discussed
the benefits of establishing subcommittees to help the Committee with
its work. Soon thereafter the Department established three
subcommittees to address: (1) Ticketing practices and seating
accommodations; (2) stowage of assistive devices; and (3) assistance at
airports and on aircraft and related training of carrier personnel and
contractors. The Subcommittees submitted reports with recommendations
to the ACAA Advisory Committee members for their consideration. The
reports are available for public review on the ACAA Advisory
Committee's docket, DOT-OST-2018-0204.

II. Summary of the Agenda

    During the September 2, 8 and 9, 2021 meeting, the ACAA Advisory
Committee will deliberate on the Subcommittees' recommendations and
continue its discussion of the draft Airline Passenger with
Disabilities Bill of Rights. A more detailed agenda will be made
available at least one week before the meeting at https://www.transportation.gov/airconsumer/ACAACommittee.

III. Public Participation

    The meeting will be open to the public and attendance may be
limited due to virtual meeting constraints. To register, please send an
email to the Department as set forth in the FOR FURTHER INFORMATION
CONTACT section. The Department is committed to providing equal access
to this meeting for all participants. If you need alternative formats
or services because of a disability, such as sign language interpreter
or other ancillary aids, please contact the person listed in the FOR
FURTHER INFORMATION CONTACT section above no later than August 30,
2021.
    Members of the public may also present written comments at any
time. The docket number referenced above (DOT-OST-2018-0204) has been
established for committee documents, including any written comments
that may be filed. At the discretion of the Chair or DFO, after
completion of the planned agenda, individual members of the public may
provide comments through the chat feature of the webinar platform or
orally, time permitting. Any oral comments presented must be limited to
the objectives of the committee and will be limited to five (5) minutes
per person. Individual members of the public who wish to present oral
comments must notify the Department of Transportation contact noted
above via email that they wish to attend and present oral comments no
later than August 30, 2021.
    Speakers are requested to submit a written copy of their prepared
remarks for inclusion in the meeting records and for circulation to
ACAA Advisory Committee members by August 30, 2021. All prepared
remarks submitted on time will be accepted and considered as part of
the meeting's record.

IV. Viewing Documents

    You may view documents mentioned in this notice at https://www.regulations.gov. After entering the docket number (DOT-OST-2018-
0204), click the link to ``Open Docket Folder'' and choose the document
to review.

    Issued in Washington, DC, this 10th day of August 2021.
John E. Putnam,
Acting General Counsel.
[FR Doc. 2021-17431 Filed 8-13-21; 8:45 am]
BILLING CODE P


QUESTIONS YOUR RESPONSE 1. Number of CWISs: 3 ( 1 for Gas Cooling, 2 Source Pumps, for vacuum pump seal water/ cooling ( waterflood pumps). Vacuum pump water is simply a slip stream off the water flood system. Only one vacuum pomp runs at a time.

2. Brief description of each CWIS ( e. g., sea chest, simple pipe): Simple pipe to wet leg ( i. e. water in the leg). Water is allowed into leg through a orifice where a J ube used to be. The orifice is technically the CWIS.

3. Rough dimensions of each CWIS and indicate whether CWIS has existing flange: Approximately 12 inches 4. Screen type ( e. g., strainer, wedge wire) with mesh size: Unknown, probably not.

5. Total daily maximum design water intake volumn of each CWIS: Total water through 12 inch orifice equals the sum of the gas cooling water plus waterflood source pump. Not all of the water is used for cooling but would be difficult to ratio. Gas Cooling = ?? Source Pumps 2 each at 30,000 BPD 6. Total daily water intake volume of each CWIS ( set up/ drilling): Gas Cooling plus 30000 BPD 7. Total daily cooling water intake volume of each CWIS ( set up/ drilling): Gas Cooling plus approximately 30000 BPD 8. Design through screen velocity of each CWIS ( i. e., Q= V* A) ( set up/ drilling): Assumes 30000 BPD through 12 inch orifice. 2.47 ft/ sec 9. List purposes of cooling water intake ( e. g., cool crude oil, produced water, power generators, drill pipe brakes): Cool gas, seal water 10. List purposes of non cooling water intakes ( e. g., fire, water, hotel loads) other than ballast water: Waterflood, firewater 11. Total volume of water intake for ballasting, duration of ballast intake, and through screen velocity of ballast intake: NA 12. Describe mitigation measures used for reducing impingement and entrainment of aquatic organisms ( e. g., sea chest screens, strainers): None 13. Describe measures used to reduce or prevent biofouling: None 14. Describe mitigation measures used for reducing exotic species migration through ballast water: NA OCS Lease and Block: Platform Name: Anna Platform COOLING WATER INTAKE STRUCTURE ( CWIS) INFORMATION The following questions apply to cooling water intake structure( s) at oil and gas extraction facility. If you own more than one facilty, please copy the questions and answer separately for each facility.

Prospect or Field Name: Company: Unocal


[Federal Register Volume 87, Number 177 (Wednesday, September 14, 2022)]
[Notices]
[Pages 56457-56463]
[FR Doc No: 2022-19814]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95708; File No. SR-MRX-2022-14]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend MRX's
Pricing Schedule at Options 7, Section 7

September 8, 2022.
    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 August 25, 2022, Nasdaq MRX, LLC (``MRX'' 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 MRX's Pricing Schedule at Options 7,
Section 7.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/mrx/rules, 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
    MRX proposes to amend its Pricing Schedule at Options 7, Section 7,
to assess market data fees, which are not assessed today, and which
have not been assessed since MRX's inception in 2016.\3\ The proposed
changes are designed to update data fees to reflect their current
value--rather than their value when it was a new exchange six years
ago--based on increased market share. Newly-opened exchanges often
charge no fees for market data to attract order flow to an exchange,
and later amend their fees to reflect the true value of those
services.\4\ Allowing newly-opened exchanges time to build and sustain
market share before charging for their market data encourages market
entry and promotes competition.
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    \3\ The Exchange initially filed the proposed pricing changes on
May 2, 2022 (SR-MRX-2022-04) instituting fees for membership, ports
and market data. See Securities Exchange Act Release No. 94901 (May
12, 2022), 87 FR 30305 (May 18, 2022) (SR-MRX-2022-04). On June 29,
2022, the Exchange withdrew that filing, and submitted separate
filings for membership (SR-MRX-2022-07), market data (SR-MRX-2022-
08) and ports (SR-MRX-2022-09). On August 25, 2022, the Exchange
withdrew the market data filing (SR-MRX-2022-08) and replaced it
with the instant filing.
    \4\ See, e.g., Securities Exchange Act Release No 88211
(February 14, 2020), 85 FR 9847 (February 20, 2020) (SR-NYSENAT-
2020-05), also available at https://www.nyse.com/publicdocs/nyse/markets/nyse-national/rule-filings/filings/2020/SR-NYSENat-2020-05.pdf. (initiating market data fees for the NYSE National exchange
after initially setting such fees at zero).
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    This Proposal reflects MRX's assessment that it has gained
sufficient market share to compete effectively against other 15 options
exchanges without waiving market data fees. Such fees are assessed by
options exchanges that compete with MRX--indeed, MRX is the only
options exchange (out of the 16 current options exchanges) not to
assess them today.
    As explained in further detail below, MRX today is in the same
position as NYSE National in 2020, when it sought approval for the
``NYSE National Integrated Feed.'' \5\ The Commission approved the NYSE
National Integrated Feed based on a finding that it ``was subject to
significant substitution-based competitive forces'' based on ``NYSE

National's consistently low percentage of market share, the relatively
small number of subscribers to the NYSE National Integrated Feed, and
the sizeable portion of subscribers that terminated their subscriptions
following the proposal of the fees.'' \6\
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    \5\ NYSE National stated that the proposed integrated feed
included depth-of-book order data, last sale data, security status
updates, and stock summary messages. See Securities Exchange Act
Release No 88211 (February 14, 2020), 85 FR 9847 (February 20, 2020)
(SR-NYSENAT-2020-05), also available at https://www.nyse.com/publicdocs/nyse/markets/nyse-national/rule-filings/filings/2020/SR-NYSENat-2020-05.pdf.
    \6\ See id.
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    The three factors cited in the Commission's approval order for NYSE
National are present in MRX today. First, MRX has a consistently low
percentage of market share, starting at approximately 0.2 percent when
it opened as an Exchange and ending in approximately 1.8 percent today.
Second, only a small number of firms purchase market data from MRX
relative to its affiliated options exchanges. Third, a sizeable portion
of subscribers--approximately 15 percent--have terminated their
subscriptions following the implementation of the proposed fees,
demonstrating that customers can and do exercise choice in deciding
whether to purchase the Exchange's market data feeds.
    Disapproval of the Proposal--given that the three factors cited in
the Commission's approval order for NYSE National two years ago are
present in MRX today--would result in differential treatment of
similarly-situated exchanges. Under such circumstances, disapproval of
the Proposal should be rejected as arbitrary and capricious.
    Disapproval would also place a substantial burden on competition.
MRX would be uniquely disadvantaged as the only options exchange unable
to charge for its market data. If the Commission were to disapprove
this Proposal, that action, and not market forces, would determine
whether MRX is successful in its competition with other options
exchanges.
    New exchanges commonly waive data fees to attract market
participants, facilitating their entry into the market and, once there
is sufficient depth and breadth of liquidity, ``graduate'' to compete
against established exchanges and charge fees that reflect the value of
their services. If MRX is incorrect in its assessment, that error will
be reflected in MRX's ability to compete with other options
exchanges.\7\
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    \7\ Nasdaq recently announced that, beginning in 2022, Nasdaq
plans to migrate its North American markets to Amazon Web Services
in a phased approach, starting with Nasdaq MRX, a U.S. options
market. The proposed fee changes are entirely unrelated to this
effort.
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    The Exchange proposes to amend fees for the following market data
feeds within Options 7, Section 7: (1) Nasdaq MRX Depth of Market Data;
\8\ (2) Nasdaq MRX Order Feed; \9\ (3) Nasdaq MRX Top Quote Feed; \10\
(4) Nasdaq MRX Trades Feed; \11\ and (5) Nasdaq MRX Spread Feed.\12\
Currently, no fees are being assessed for these feeds.
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    \8\ Nasdaq MRX Depth of Market Data Feed (``Depth of Market
Feed'') provides aggregate quotes and orders at the top five price
levels on MRX, and provides subscribers with a consolidated view of
tradable prices beyond the BBO, showing additional liquidity and
enhancing transparency for MRX traded options. The data provided for
each option series includes the symbols (series and underlying
security), put or call indicator, expiration date, the strike price
of the series, and whether the option series is available for
trading on MRX and identifies if the series is available for closing
transactions only. In addition, subscribers are provided with total
aggregate quantity, Public Customer aggregate quantity, Priority
Customer aggregate quantity, price, and side (i.e., bid/ask). This
information is provided for each of the top five price levels on the
Depth Feed. The feed also provides order imbalances on opening/
reopening. See Options 3, Section 23(a)(1).
    \9\ Nasdaq MRX Order Feed (``Order Feed'') provides information
on new orders resting on the book (e.g. price, quantity and market
participant capacity). In addition, the feed also announces all
auctions. The data provided for each option series includes the
symbols (series and underlying security), put or call indicator,
expiration date, the strike price of the series, and whether the
option series is available for trading on MRX and identifies if the
series is available for closing transactions only. The feed also
provides order imbalances on opening/reopening. See Options 3,
Section 23(a)(2).
    \10\ Nasdaq MRX Top Quote Feed (``Top Quote Feed'') calculates
and disseminates MRX's best bid and offer position, with aggregated
size (including total size in aggregate, for Professional Order size
in the aggregate and Priority Customer Order size in the aggregate),
based on displayable order and quote interest in the System. The
feed also provides last trade information along with opening price,
daily trading volume, high and low prices for the day. The data
provided for each option series includes the symbols (series and
underlying security), put or call indicator, expiration date, the
strike price of the series, and whether the option series is
available for trading on MRX and identifies if the series is
available for closing transactions only. The feed also provides
order imbalances on opening/reopening. See Options 3, Section
23(a)(3).
    \11\ Nasdaq MRX Trades Feed (``Trades Feed'') displays last
trade information along with opening price, daily trading volume,
high and low prices for the day. The data provided for each option
series includes the symbols (series and underlying security), put or
call indicator, expiration date, the strike price of the series, and
whether the option series is available for trading on MRX and
identifies if the series is available for closing transactions only.
See Options 3, Section 23(a)(4).
    \12\ Nasdaq MRX Spread Feed (``Spread Feed'') is a feed that
consists of: (1) options orders for all Complex Orders (i.e.,
spreads, buy-writes, delta neutral strategies, etc.); (2) data
aggregated at the top five price levels (BBO) on both the bid and
offer side of the market; (3) last trades information. The Spread
Feed provides updates, including prices, side, size and capacity,
for every Complex Order placed on the MRX Complex Order Book. The
Spread Feed shows: (1) aggregate bid/ask quote size; (2) aggregate
bid/ask quote size for Professional Customer Orders; and (3)
aggregate bid/ask quote size for Priority Customer Orders for MRX
traded options. The feed also provides Complex Order auction
notifications. See Options 3, Section 23(a)(5).
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    In addition to the proposed fees for each data feed, the Exchange
is introducing an Internal Distributor Fee \13\ of $1,500 per month for
the Nasdaq MRX Depth of Market Feed, Order Feed, and Top Quote Feed, an
Internal Distributor Fee of $750 per month for the Trades Feed, and an
Internal Distributor Fee of $1,000 per month for the Spread Feed. If a
Member subscribes to both the Trades Feed and the Spread Feed, both
Internal Distributor Fees would be assessed.
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    \13\ A ``distributor'' of Nasdaq MRX data is any entity that
receives a feed or data file of data directly from Nasdaq MRX or
indirectly through another entity and then distributes it either
internally (within that entity) or externally (outside that entity).
All distributors shall execute a Nasdaq Global Data Agreement.
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    The Exchange also proposes to assess an External Distributor Fee of
$2,000 per month for the Nasdaq MRX Depth of Market Feed, Order Feed,
and Top Quote Feed, an External Distributor Fee of $1,000 per month for
the Trades Feed, and an External Distributor Fee of $1,500 per month
for the Spread Feed.
    MRX will also assess Professional \14\ and Non-Professional \15\
subscriber fees. The Professional Subscriber will be $25 per month, and
the Non-Professional Subscriber will be $1 per month. These subscriber
fees (both Professional and Non-Professional) cover the usage of all
five MRX data products identified above and would not be assessed
separately for each product.\16\
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    \14\ A Professional Subscriber is any Subscriber that is not a
Non-Professional Subscriber.
    \15\ A Non-Professional Subscriber is a natural person who is
neither: (i) registered or qualified in any capacity with the
Commission, the Commodities Futures Trading Commission, any state
securities agency, any securities exchange or association, or any
commodities or futures contract market or association; (ii) engaged
as an ``investment adviser'' as that term is defined in Section
201(11) of the Investment Advisors Act of 1940 (whether or not
registered or qualified under that Act); nor (iii) employed by a
bank or other organization exempt from registration under federal or
state securities laws to perform functions that would require
registration or qualification if such functions were performed for
an organization not so exempt.
    \16\ For example, if a firm has one Professional (Non-
Professional) Subscriber accessing Top of Market, Order, and Depth
of Market Feed the firm would only report the Subscriber once and
pay $25 ($1 for Non-Professional).
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    MRX also proposes a Non-Display Enterprise License for $7,500 per
month. This license would lower costs for internal professional
subscribers and lower administrative costs overall by permitting the
distribution of all MRX proprietary direct data feed products to an
unlimited number of internal non-display Subscribers without incurring
additional fees for each internal Subscriber, or requiring the customer
to count internal subscribers. \17\ The Non-

Display Enterprise License is in addition to any other associated
distributor fees for MRX proprietary direct data feed products.
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    \17\ The Non-Display Enterprise License of $7,500 per month is
optional. A firm that does not have a sufficient number of
subscribers to benefit from purchase of the license need not do so.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\18\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\19\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees, and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \18\ See 15 U.S.C. 78f(b).
    \19\ See 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The proposed changes to the pricing schedule are reasonable in
several respects. As a threshold matter, the Exchange is subject to
significant competitive forces in the market for order flow, which
constrains its pricing determinations. The fact that the market for
order flow is competitive has long been recognized by the courts. In
NetCoalition v. Securities and Exchange Commission, the D.C. Circuit
stated, ``[n]o one disputes that competition for order flow is
`fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of
where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because 'no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers'. . . .'' \20\
---------------------------------------------------------------------------

    \20\ See NetCoalition, 615 F.3d at 539 (DC Cir. 2010) (quoting
Securities Exchange Act Release No. 59039 (December 2, 2008), 73 FR
74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-21)).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention to determine
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues, and also recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \21\
---------------------------------------------------------------------------

    \21\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Congress directed the Commission to ``rely on `competition,
whenever possible, in meeting its regulatory responsibilities for
overseeing the SROs and the national market system.'' \22\ As a result,
the Commission has historically relied on competitive forces to
determine whether a fee proposal is equitable, fair, reasonable, and
not unreasonably or unfairly discriminatory. ``If competitive forces
are operative, the self-interest of the exchanges themselves will work
powerfully to constrain unreasonable or unfair behavior.'' \23\
Accordingly, ``the existence of significant competition provides a
substantial basis for finding that the terms of an exchange's fee
proposal are equitable, fair, reasonable, and not unreasonably or
unfairly discriminatory.'' \24\ In its 2019 guidance on fee proposals,
Commission staff indicated that they would look at factors beyond the
competitive environment, such as cost, only if a ``proposal lacks
persuasive evidence that the proposed fee is constrained by significant
competitive forces.'' \25\
---------------------------------------------------------------------------

    \22\ See NetCoalition, 615 F.3d at 534-35; see also H.R. Rep.
No. 94-229 at 92 (1975) (``[I]t is the intent of the conferees that
the national market system evolve through the interplay of
competitive forces as unnecessary regulatory restrictions are
removed.'').
    \23\ See Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74,770 (December 9, 2008) (SR-NYSEArca-2006-21).
    \24\ Id.
    \25\ See U.S. Securities and Exchange Commission, ``Staff
Guidance on SRO Rule filings Relating to Fees'' (May 21, 2019),
available at https://www.sec.gov/tm/staff-guidance-sro-rule-filings-fees.
---------------------------------------------------------------------------

History of MRX Operations
    Over the years, MRX has amended its transactional pricing to
attract order flow to the Exchange.\26\ In June 2019, MRX commenced
offering complex orders.\27\ With the addition of complex order
functionality, MRX offered Members certain order types, an opening
process, auction capabilities and other trading functionality that was
nearly identical to functionality available on ISE.\28\ The added

functionality attracted order flow, which has enhanced the value of its
market data and is the basis for these proposed fee changes.
---------------------------------------------------------------------------

    \26\ See e.g. Securities Exchange Act Release Nos. 77292 (March
4, 2016), 81 FR 12770 (March 10, 2016) (SR-ISEMercury-2016-02)
(Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Establish the Schedule of Fees); 77409 (March 21, 2016),
81 FR 16240 (March 25, 2016) (SR-ISEMercury-2016-05) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
the Schedule of Fees); 81 FR 16238 (March 21, 2016), 81 FR 16238
(March 25, 2016) (SR-ISEMercury-2016-06) (Notice of Filing and
Immediate Effectiveness of Proposed Rule Change To Amend the
Schedule of Fees); 77841 (May 16, 2016), 81 FR 31986 (SR-ISEMercury-
2016-11) (Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Amend the Schedule of Fees); 82537 (January 19,
2018), 83 FR 3784 (January 26, 2018) (SR-MRX-2018-01) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
the Schedule of Fees To Introduce a New Pricing Model); 82990 (April
4, 2018), 83 FR 15434 (April 10, 2018) (SR-MRX-2018-10) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Chapter IV of the Exchange's Schedule of Fees); 28677 (June 14,
2018), 83 FR 28677 (June 20, 2018) (SR-MRX-2018-19) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To
Increase Certain Route-Out Fees Set Forth in Section II.A of the
Schedule of Fees); 84113 (September 13, 2018), 83 FR 47386
(September 19, 2018) (SR-MRX-2018-27) (Notice of Filing and
Immediate Effectiveness of Proposed Rule Change To Relocate the
Exchange's Schedule of Fees); 85143 (February 14, 2019), 84 FR 5508
(February 21, 2019) (SR-MRX-2019-02) (Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change To Amend the Pricing
Schedule at Options 7, Section 3); 85313 (March 14, 2019), 84 FR
10357 (March 20, 2019) (SR-MRX-2019-05) (Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change Relating to PIM
Fees and Rebates); 86326 (July 8, 2019), 84 FR 33300 (July 12, 2019)
(SR-MRX-2019-14) (Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Adopt Complex Order Pricing); 88022 (January
23, 2020), 85 FR 5263 (January 29, 2020) (SR-MRX-2020-02) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
MRX Pricing Schedule); 89046 (June 11, 2020), 85 FR 36633 (June 17,
2020) (SR-MRX-2020-11) (Notice of Filing and Immediate Effectiveness
of Proposed Rule Change To Amend Its Pricing Schedule at Options 7);
89320 (July 15, 2020), 85 FR 44135 (July 21, 2020) (SR-MRX-2020-14)
(Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend Its Pricing Schedule at Options 7, Section 5, Other
Options Fees and Rebates, in Connection With the Pricing for Orders
Entered Into the Exchanges Price Improvement Mechanism); 90503
(November 24, 2020), 85 FR 77317 (December 1, 2020) (SR-MRX-2020-18)
(Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend Its Pricing Schedule at Options 7 for Orders Entered
Into the Exchange's Price Improvement Mechanism); 90434 (November
16, 2020), 85 FR 74473 (November 20, 2020) (SR-MRX-2020-19) (Notice
of Filing and Immediate Effectiveness of Proposed Rule Change To the
Exchange's Pricing Schedule at Options 7 To Amend Taker Fees for
Regular Orders); 90455 (November 18, 2020), 85 FR 75064 (November
24, 2020) (SR-MRX-2020-21) (Notice of Filing and Immediate
Effectiveness of Proposed Rule Change To Amend the Pricing
Schedule); and 91687 (April 27, 2021), 86 FR 23478 (May 3, 2021)
(SR-MRX-2021-04) (Notice of Filing and Immediate Effectiveness of
Proposed Rule Change To Amend the Exchange's Pricing Schedule at
Options 7). Note that ISE Mercury is an earlier name for MRX.
    \27\ See Securities Exchange Act Release No. 86326 (July 8,
2019), 84 FR 33300 (July 12, 2019) (SR-MRX-2019-14) (Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to
Adopt Complex Order Pricing).
    \28\ One distinction is that ISE offered its Members access to
Nasdaq Precise in 2019 and since that time. MRX has never offered
Precise. ``Nasdaq Precise'' or ``Precise'' is a front-end interface
that allows EAMs and their Sponsored Customers to send orders to the
Exchange and perform other related functions. Features include the
following: (1) order and execution management: enter, modify, and
cancel orders on the Exchange, and manage executions (e.g., parent/
child orders, inactive orders, and post-trade allocations); (2)
market data: access to real-time market data (e.g., NBBO and
Exchange BBO); (3) risk management: set customizable risk parameters
(e.g., kill switch); and (4) book keeping and reporting:
comprehensive audit trail of orders and trades (e.g., order history
and done away trade reports). See ISE Supplementary Material .03(d)
of Options 3, Section 7. Precise is also available on GEMX.
---------------------------------------------------------------------------

Market Data Products are Subject to Significant Substitution-Based
Competitive Forces
    An Exchange can show that a product is ``subject to significant
substitution-based competitive forces'' by introducing evidence that
customers can substitute that product with products offered by other
exchanges.
    NYSE National was able to prove exactly this when it sought
approval for the ``NYSE National Integrated Feed'' \29\ in 2020. NYSE
National at the time of its filing was in a similar position to MRX
today--the exchange had an approximately 1.9% market share of executed
volume of equity trades.\30\ The Commission approved the proposal to
establish fees for NYSE National based on a finding that the exchange
``was subject to significant substitution-based competitive forces.''
Citing NetCoalition I,\31\ the Commission stated that ``whether a
market is competitive notwithstanding potential alternatives depends on
factors such as the number of buyers who consider other products
interchangeable and at what prices.'' \32\ Noting that ``many market
participants . . . do not subscribe to . . . the NYSE National
Integrated Feed, even when the feed is offered without charge,'' the
Commission concluded that ``NYSE National's consistently low percentage
of market share, the relatively small number of subscribers to the NYSE
National Integrated Feed, and the sizeable portion of subscribers that
terminated their subscriptions following the proposal of the fees,''
demonstrated that the exchange ``was subject to significant
substitution-based competitive forces'' in setting fees such that the
proposed rule change was consistent with the Act.\33\
---------------------------------------------------------------------------

    \29\ See Securities Exchange Act Release No 88211 (February 14,
2020), 85 FR 9847 (February 20, 2020) (SR-NYSENAT-2020-05), also
available at https://www.nyse.com/publicdocs/nyse/markets/nyse-national/rule-filings/filings/2020/SR-NYSENat-2020-05.pdf.
    \30\ See id.
    \31\ See NetCoalition v. SEC, 615 F.3d 525, 535 (DC 2010)
(``NetCoalition I'')
    \32\ See NYSE National Approval Order (citing NetCoalition I)
    \33\ See id.
---------------------------------------------------------------------------

    MRX today is in essentially the same position as NYSE National in
2020, and all three of the factors cited in the Commission's approval
order for NYSE National are present in MRX today. First, MRX has a
consistently low percentage of market share, starting at approximately
0.2 percent when it opened as an Exchange and ending in approximately
1.8 percent today. Second, only a small number of firms purchase market
data from MRX relative to its affiliated options exchanges. Third, a
sizeable portion of subscribers--approximately 15 percent--have
terminated their subscriptions following the implementation of the
proposed fees, demonstrating that customers can and do exercise choice
in deciding whether to purchase the Exchange's market data feeds.
    As of May 2, 2022, the date that MRX initially proposed these
market data fees, MRX reported that two customers had terminated their
market data subscriptions.\34\ As of today, a total of five firms have
cancelled, amounting to approximately 15 percent of the 34 customers
that had been taking MRX feeds in the first quarter of 2022.\35\
---------------------------------------------------------------------------

    \34\ See Securities Exchange Act Release No. 94901 (May 12,
2022), 87 FR 30305 (May 18, 2022) (SR-MRX-2022-04).
    \35\ These terminations were limited to market data; none of
these customers were members of MRX and therefore purchased neither
memberships nor ports from the Exchange.
---------------------------------------------------------------------------

    Commission Staff have requested additional information pertaining
to: (i) the types of feeds available to these customers prior to
termination, (ii) the characteristics of the customers that terminated
their feeds, and (iii) whether such customers traded on the Exchange.
    With respect to the types of data feeds accessed, two of the five
customers had access to all five feeds: Nasdaq MRX Depth of Market
Data, Nasdaq MRX Order Feed, Nasdaq MRX Top Quote Feed, Nasdaq MRX
Trades Feed, and Nasdaq MRX Spread Feed. The three remaining customers
had access to only two feeds: the Order Feed and the Top Quote Feed.
All five customers cancelled all feeds available to them.
    With respect to the types of customers cancelling feeds, three of
the five were either data vendors or technology suppliers. Data vendors
purchase exchange data and redistribute it to downstream customers,
while technology suppliers incorporate exchange data into software
solutions, which are sold to downstream customers. The remaining two
firms engage in options trading, either on their own behalf or that of
a customer.
    With respect to trading, the three data vendors/technology
suppliers do not trade on their own behalf or on the behalf of any
downstream customs, although their customers may do so. The Exchange
understands that these three firms cancelled due to insufficient demand
from their downstream customers for MRX data. The two remaining firms,
which do engage in options trading, have not traded on MRX, but are
active traders on other Nasdaq options exchanges.\36\
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    \36\ NYSE National did not provide similarly detailed
information regarding the characteristics of cancelling customers.
Nevertheless, the Exchange believes that the characteristics of such
customers are similar for both NYSE National and MRX, and the same
competitive forces apply to all exchanges.
---------------------------------------------------------------------------

    Detailed information supporting the first step in the analysis of
substitution-based competitive forces--low market share--is set forth
in Chart 1, which shows the January 2022 market share for multiply-
listed options by exchange. Of the 16 operating options exchanges, none
currently has more than a 13.1% market share, and MRX has the smallest
market share at 1.8%. Customers widely distribute their transactions
across exchanges according to their business needs and the ability of
each exchange to meet those needs through technology, liquidity and
functionality. Average market share for the 16 options exchanges is
6.26 percent, with the median at 5.8, and a range between 1.8 and 13.1
percent.

[GRAPHIC] [TIFF OMITTED] TN14SE22.000

    Market share is the percentage of volume on a particular exchange
relative to the total volume across all exchanges, and indicates the
amount of order flow directed to that exchange. High levels of market
share enhance the value of market data.
    The second step in this analysis--demonstrating that only a small
number of firms purchase market data relative to affiliated options
exchanges--is shown in Chart 2, which compares the number of firms with
access to market data from MRX to the number of firms purchasing market
data from the four MRX-affiliated options exchanges, GEMX, ISE, The
Nasdaq Stock Market LLC (``NOM'') and Nasdaq PHLX, LLC (``Phlx'').
[GRAPHIC] [TIFF OMITTED] TN14SE22.001

    Chart 2 shows that 34 firms subscribed to at least one market data
product from MRX in the first quarter of 2022. This is the second
lowest number of firms purchasing market data from the Nasdaq-
affiliated options exchanges.
    The third step in this analysis--showing that a sizable number of
customers terminated subscriptions following the proposal of the fees--
is confirmed by the five customer cancellations. As explained above,
all five customers terminated all feeds available to them. Although not
all

customers took all of the MRX feeds, each one of these feeds was
cancelled by at least one customer, demonstrating that customers can
and do exercise choice with respect to each feed. These cancellations
reduced the number of firms with access to at least one MRX market data
feed from 34 to 29, an approximately 15 percent reduction in usage,
demonstrating that firms can and do exercise choice in determining
whether to purchase market data from the Exchange.
    MRX lists no proprietary options products that are entirely unique
to MRX. Firms can substitute MRX market data with feeds from exchanges
that provide a high degree of functionality, including complex orders.
Full market data options are available, for example, from Cboe,\37\
MIAX,\38\ and NYSE Arca Options.\39\ Because MRX does not list options
on products that are exclusively available on MRX, consumers can
substitute MRX data with data from any exchange that lists such
multiply-listed options, or through OPRA. Moreover, all broker-dealers
involved in order routing must take consolidated data from OPRA, and
proprietary data feeds cannot be used to meet that particular
requirement. As such, all proprietary data feeds are optional.
---------------------------------------------------------------------------

    \37\ See Cboe DataShop, available at https://datashop.cboe.com/.
    \38\ See MIAX Options Market Data & Offerings, available at
https://www.miaxoptions.com/market-data-offerings.
    \39\ See NYSE Options Markets, available at https://www.nyse.com/options.
---------------------------------------------------------------------------

    This analysis must be viewed in the context of a field with
relatively low barriers to entry. MRX, like many new entrants to the
field, offered market data for free to establish itself and gain market
share. As new entrants enter the field, MRX can also expect competition
from these new entrants. Those new entrants, like MRX, are likely to
set market data fees to zero, increasing marketplace competition.
    The Proposal is not unfairly discriminatory. The five market data
feeds at issue here--the Depth of Market Feed, Order Feed, Top Quote
Feed, Trades Feed, and Spreads Feed--are used by a variety of market
participants for a variety of purposes. Users include regulators,
market makers, competing exchanges, media, retail, academics, portfolio
managers. Market data feeds will be available to members of all of
these groups on a non-discriminatory basis.
    With respect to the proposed Non-Display Enterprise License,
enterprise licenses in general have been widely recognized as an
effective and not unfairly discriminatory method of distributing market
data. Enterprise licenses are widely employed by options exchanges, and
the proposal here is typical of such licenses.
    After 6 years, MRX proposes to commence assessing market data fees,
just as all other options exchanges do now.\40\ The introduction of
these fees will not impede access to MRX, but rather will allow MRX to
continue to compete and grow its marketplace so that it may continue to
offer a robust trading architecture, a quality opening process, an
array of simple and complex order types and auctions, and competitive
transaction pricing. If MRX is incorrect in its assessment of the value
of its services, that assessment will be reflected in MRX's ability to
compete with other options exchanges.
---------------------------------------------------------------------------

    \40\ Today, MRX is the only options exchange that does not
assess market data fees.
---------------------------------------------------------------------------

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. For all of the reasons set
forth above, the Exchange is subject to ``significant substitution-
based competitive forces'': (i) it has a consistently low percentage of
market share, starting at approximately 0.2 percent when it opened as
an Exchange and ending in approximately 1.8 percent today; (ii) only a
small number of firms purchase market data from MRX relative to its
affiliated options exchanges; and (iii) a sizeable portion of
subscribers--approximately 15 percent--have terminated their
subscriptions following the implementation of the proposed fees,
demonstrating that customers can and do exercise choice in deciding
whether to purchase market data.
    Nothing in the Proposal burdens inter-market competition (the
competition among self-regulatory organizations) because approval of
the Proposal does not impose any burden on the ability of other options
exchanges to compete. Each of the remaining 15 options exchanges
currently sells its market data, and is capable of modifying its fees
in response to the proposed changes by MRX. Moreover, allowing MRX, or
any new market entrant, to waive fees for a period of time to allow it
to become established encourages market entry and thereby ultimately
promotes competition.
    Nothing in the Proposal burdens intra-market competition (the
competition among consumers of exchange data) because each customer
will be able to decide whether or not to purchase the Exchange's market
data, as demonstrated by the fact that a significant number of the
Exchange's customers have already elected to terminate their access to
such feeds.
    The Exchange operates in a highly competitive market in which
market participants can readily favor competing venues if they deem fee
levels at a particular venue to be excessive. Because competitors are
free to modify their own fees in response, and because market
participants may readily adjust their order routing practices, the
Exchange believes that the degree to which fee changes in this market
may impose any burden on competition is extremely limited. If the
changes proposed herein are unattractive to market participants, it is
likely that the Exchange will lose market share.\41\
---------------------------------------------------------------------------

    \41\ The Exchange notified market participants of the new fees
on December 20, 2021. See Data News #2021-11 (December 20, 2021,
available at http://www.nasdaqtrader.com/TraderNews.aspx?id=dn2021-11. As such, market participants have had ample notice of the
proposed fee changes and will be able to adjust their purchases of
exchange services accordingly.
---------------------------------------------------------------------------

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.\42\ 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.
---------------------------------------------------------------------------

    \42\ 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 protected]. Please include
File Number SR-MRX-2022-14 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-MRX-2022-14. 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-MRX-2022-14 and should be submitted on
or before October 5, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\43\
---------------------------------------------------------------------------

    \43\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-19814 Filed 9-13-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Proposed Rules]
[Pages 3533-3535]
[FR Doc No: 2015-00943]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-1047; Directorate Identifier 2014-NM-157-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A318, A319, A320, and A321 series airplanes. This
proposed AD was prompted by a report that, during the assembly process,
several gaps between the two parts of the girt bar fittings for the aft
passenger doors were found to exceed tolerances. This proposed AD would
require an inspection of the gap between the two parts of the girt bar
fittings on left-hand (LH) and right-hand (RH) aft passenger doors, and
corrective actions if necessary. We are proposing this AD to detect and
correct incorrect gaps between the girt bar fittings. Detachment of a
girt bar could lead to the separation of the slide or slide-raft from
the fuselage, making the emergency exit inoperative, which could impede
an emergency evacuation.

DATES: We must receive comments on this proposed AD by March 9, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
1047; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-1047;
Directorate Identifier 2014-NM-157-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each

substantive verbal contact we receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0178, dated July 25, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Airbus Model
A318, A319, A320, and A321 series airplanes. The MCAI states:

    During final assembly line process, several AFT passenger door
lower fitting gaps were found excessive and out of tolerance between
two parts of the girt bar fittings. The gap contributes to the
correct locking of the girt bar during the door lifting movement,
ensuring the retention of the girt bar when the loads applied on the
girt by the slide are directed from the outside to the inside. If
the gap is too large, there is a risk that the girt bar, when
subjected to these loads, will detach from one of the girt bar
fittings.
    This condition, if not detected and corrected, could lead to the
separation of the slide/slide-raft from the fuselage, making the
emergency exit inoperative and, consequently, significantly reducing
the safety margin for the occupants during an evacuation.
    For the reason described above, this [EASA] AD requires a
detailed inspection (DET) to check the gap between the two parts of
the girt bar fittings, on AFT passenger doors, left-hand (LH) and
right-hand (RH) sides, and, depending on findings, accomplishment of
the applicable corrective actions [such as modifiying or replacing
the automatic latch].

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
1047.

Related Service Information

    Airbus has issued Service Bulletin A320-53-1289, dated May 28,
2014. The service information describes procedures for a detailed
inspection of the gap in the girt bar fittings of the aft passenger
doors, LH and RH sides, and corrective actions. The actions described
in this service information are intended to correct the unsafe
condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Explanation of ``RC'' Procedures and Tests in Service Information

    The FAA worked in conjunction with industry, under the
Airworthiness Directives Implementation Aviation Rulemaking Committee
(AD ARC), to enhance the AD system. One enhancement was a new process
for annotating which procedures and tests in the service information
are required for compliance with an AD. Differentiating these
procedures and tests from other tasks in the service information is
expected to improve an owner's/operator's understanding of crucial AD
requirements and help provide consistent judgment in AD compliance. The
actions specified in the service information identified previously
include procedures and tests that are identified as RC (required for
compliance) because these procedures have a direct effect on detecting,
preventing, resolving, or eliminating an identified unsafe condition.
    As specified in a NOTE under the Accomplishment Instructions of the
specified service information, procedures and tests identified as RC
must be done to comply with the proposed AD. However, procedures and
tests that are not identified as RC are recommended. Those procedures
and tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an alternative method
of compliance (AMOC), provided the procedures and tests identified as
RC can be done and the airplane can be put back in a serviceable
condition. Any substitutions or changes to procedures or tests
identified as RC will require approval of an AMOC.

Costs of Compliance

    We estimate that this proposed AD affects 838 airplanes of U.S.
registry.
    We also estimate that it would take about 3 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $213,690, or $255
per product.
    In addition, we estimate that any necessary follow-on actions would
take about 4 work-hours and require parts costing $435, for a cost of
$775 per product. We have no way of determining the number of aircraft
that might need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Airbus: Docket No. FAA-2014-1047; Directorate Identifier 2014-NM-
157-AD.

(a) Comments Due Date

    We must receive comments by March 9, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus airplanes identified in paragraphs
(c)(1) through (c)(4) of this AD, certificated in any category,
except those on which Airbus Modification 154966 has been embodied
during production.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -231, -232, and -233 airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by a report that, during the assembly
process, several gaps between the two parts of the girt bar fittings
for the aft passenger doors were found to exceed tolerances. We are
issuing this AD to detect and correct incorrect gaps between the
girt bar fittings. Detachment of a girt bar could lead to the
separation of the slide or slide-raft from the fuselage, making the
emergency exit inoperative, which could impede an emergency
evacuation.

(f) Compliance

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

(g) Inspection and Corrective Action

    Except as provided by paragraph (h) of this AD, within 36 months
after the effective date of this AD, do a detailed inspection of the
gap in the girt bar fittings of the aft passenger doors, LH and RH
sides, and do all applicable corrective actions, in accordance with
the Accomplishment Instructions of Airbus Service Bulletin A320-53-
1289, dated May 28, 2014. Do all applicable corrective actions
before further flight.

(h) Exception

    For any airplane that has been modified to a configuration where
one or both LH and RH aft passenger doors are permanently
inoperative or deactivated: If any aft passenger door is
reactivated, after reactivation but before further flight, do the
detailed inspection of the reactivated aft passenger door(s) and all
applicable corrective actions, as required by paragraph (g) of this
AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Required for Compliance (RC): If the service information
contains procedures or tests that are identified as RC, those
procedures and tests must be done to comply with this AD; any
procedures and tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in a serviceable
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.
    (3) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) European Aviation Safety Agency (EASA) Airworthiness
Directive 2014-0178, dated July 25, 2014, for related information.
This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2014-1047.
    (2) For service information identified in this AD, contact
Airbus, Airworthiness Office-EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Renton, Washington, on January 14, 2015.
John P. Piccola,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-00943 Filed 1-22-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Notices]
[Page 56832]
[FR Doc No: 2012-22671]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP11-2137-000.
    Applicants: Dominion Cove Point LNG, LP.
    Description: DCP-RP11-2137 and RP12-937 Refund Report.
    Filed Date: 9/6/12.
    Accession Number: 20120906-5063.
    Comments Due: 5 p.m. ET 9/18/12.

    Docket Numbers: RP12-1023-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: Negotiated Rate Agreement--CP and L to be effective
11/1/2012.
    Filed Date: 9/6/12.
    Accession Number: 20120906-5038.
    Comments Due: 5 p.m. ET 9/18/12.

    Docket Numbers: RP12-1024-000.
    Applicants: Bobcat Gas Storage.
    Description: BGS Initial ACA Filing to be effective 10/1/2012.
    Filed Date: 9/7/12.
    Accession Number: 20120907-5095.
    Comments Due: 5 p.m. ET 9/19/12.

    Docket Numbers: RP12-1025-000.
    Applicants: Egan Hub Storage, LLC.
    Description: Egan Initial ACA Filing to be effective 10/1/2012.
    Filed Date: 9/7/12.
    Accession Number: 20120907-5098.
    Comments Due: 5 p.m. ET 9/19/12.

    Docket Numbers: RP12-1026-000.
    Applicants: Saltville Gas Storage Company L.L.C.
    Description: SGSC Initial ACA Filing to be effective 10/1/2012.
    Filed Date: 9/7/12.
    Accession Number: 20120907-5099.
    Comments Due: 5 p.m. ET 9/19/12.

    Docket Numbers: RP12-1027-000.
    Applicants: Steckman Ridge, LP.
    Description: SR Initial ACA Filing to be effective 10/1/2012.
    Filed Date: 9/7/12.
    Accession Number: 20120907-5100.
    Comments Due: 5 p.m. ET 9/19/12.

    Docket Numbers: RP12-965-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 09/07/12 ACA 2012 Withdrawal.
    Filed Date: 9/7/12.
    Accession Number: 20120907-5122.
    Comments Due: 5 p.m. ET 9/19/12.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP12-915-002.
    Applicants: Petal Gas Storage, L.L.C.
    Description: Compliance Filing to be effective 9/1/2012.
    Filed Date: 9/7/12.
    Accession Number: 20120907-5093.
    Comments Due: 5 p.m. ET 9/19/12.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: September 10, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-22671 Filed 9-13-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 107 (Tuesday, June 4, 2019)]
[Rules and Regulations]
[Page 25685]
[FR Doc No: 2019-11656]

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

Federal Emergency Management Agency

44 CFR Part 206

[Docket ID FEMA-2014-0005]
RIN 1660-AA83

Factors Considered When Evaluating a Governor's Request for
Individual Assistance for a Major Disaster; Correction

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule; correction.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) is correcting a
final rule that published in the Federal Register on March 21, 2019.
The rule revises the Individual Assistance factors FEMA uses to measure
the severity, magnitude, and impact of a disaster. This document
corrects two typographical errors in the preamble to the final rule and
corrects the authority citation.

DATES: Effective June 1, 2019.

FOR FURTHER INFORMATION CONTACT: Mark Millican, FEMA, Individual
Assistance Division, 500 C Street SW, Washington, DC 20472-3100,
(phone)<PHONE_NUMBER> or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In FR Doc. 2019-05388 appearing on page
10632 in the Federal Register of Thursday, March 21, 2019, the
following corrections are made:
    1. On page 10647, in the third column, in the first full paragraph,
``highlight'' is corrected to read ``highly''. that shows that TTR and
population are highly correlated.''
    2. On page 10653, in the first column, in footnote 61, in the first
sentence, ``Table 6'' is corrected to read ``Table 5''.

PART 206--[CORRECTED]

0
3. On page 10663, in the second column, in amendatory instruction 1,
the authority citation for part 206 is corrected to read as follows:

    Authority: Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 through 5207; Homeland Security Act
of 2002, 6 U.S.C. 101 et seq.; Department of Homeland Security
Delegation 9001.1.

Peter Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-11656 Filed 5-31-19; 4:15 pm]
BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79913-79915]
[FR Doc No: 2015-32250]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1211]

Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a document entitled ``Revised Recommendations for
Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood
and Blood Products; Guidance for Industry.'' The guidance document
provides blood establishments that collect blood or blood components,
including Source Plasma, with revised donor deferral recommendations
for individuals at increased risk for transmitting human
immunodeficiency virus (HIV) infection. The guidance document
recommends corresponding revisions to donor educational materials,
donor history questionnaires and accompanying materials, along with
revisions to donor requalification, product management, and testing
procedures. The guidance announced in this notice finalizes the draft
guidance of the same title dated May 2015 and supersedes the memorandum
to blood establishments entitled ``Revised Recommendations for the
Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood
and Blood Products'' dated April 23, 1992 (1992 blood memo). While this
guidance represents FDA's current thinking on the subject, our
recommendations may evolve over time as new scientific evidence becomes
available.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

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-2015-D-1211 for ``Revised Recommendations for Reducing the Risk of
Human Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry.'' 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 Communication, Outreach, and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled,
``Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry.'' The emergence of Acquired Immune Deficiency
Syndrome (AIDS) in the early 1980s and the recognition that it could be
transmitted by blood and blood products had profound effects on the

U.S. blood system. Although initially identified in men who have sex
with men (MSM) and associated with male-to-male sexual contact, AIDS
was soon noted to be potentially transmitted by transfusion of blood
products, and by infusion of clotting factor concentrates in
individuals with hemophilia. Beginning in 1983, FDA issued
recommendations for providing donors with educational material on risk
factors for AIDS and for deferring donors at increased risk for AIDS in
an effort to prevent transmission of the agent responsible for AIDS
(later understood to be caused by HIV) by blood and blood products. MSM
(originally identified as gay or bisexual men) were deferred due to the
strong clustering of AIDS illness among MSM and the subsequent
discovery of high rates of HIV infection in that population. FDA's
recommendation for deferral of MSM was modified over time to improve
its clarity and to promote compliance, including a shift of focus from
a deferral based on group identification to a deferral based on
specific behavior (male sex with another male).
    Since September 1985, FDA has recommended that blood establishments
indefinitely defer male donors who have had sex with another male, even
one time, since 1977. On April 23, 1992, FDA issued the 1992 blood
memo, which consolidated its recommendations regarding the deferral of
donors at risk of HIV, including the deferral for MSM, as well as
deferral recommendations for other persons with behaviors associated
with high rates of HIV exposure, namely commercial sex workers, those
who inject non-prescription drugs, and certain other individuals with
HIV risk factors.
    The use of donor educational material, specific deferral questions,
and advances in HIV donor testing have reduced the risk of HIV
transmission from blood transfusion from about 1 in 2500 transfusions
prior to HIV testing to a current estimated residual risk of about 1 in
1.47 million transfusions. Since the implementation in 1985 of donor
testing for antibodies to HIV, FDA and the U.S. Department of Health
and Human Services (HHS) have held a number of public meetings,
including public scientific workshops and meetings of the Blood
Products Advisory Committee and the HHS Advisory Committee on Blood
Safety and Availability (ACBSA) to further review evidence and discuss
FDA's blood donor deferral policies to reduce the risk of transmission
of HIV by blood and blood products. Consistent with recommendations of
the ACBSA in June 2010, studies that might support a policy change were
carried out by the Public Health Service in 2011 to 2014. A
recommendation for a policy change to the blood donor deferral period
for MSM from indefinite deferral to 1 year since the last sexual
contact was announced by the Commissioner of Food and Drugs in December
2014. This guidance implements that recommended policy change.
    In addition, the guidance provides donor deferral recommendations
for other individuals at increased risk for transmitting HIV infection,
including commercial sex workers, non-prescription injection drug
users, women who have sex with MSM, and certain other individuals with
other risk factors. The guidance provides revised recommendations for
donor educational materials, donor history questionnaires and
accompanying materials, as well as for donor requalification and
product management procedures.
    In the Federal Register of May 15, 2015 (80 FR 27973), FDA
announced the availability of the draft guidance of the same title
dated May 2015. FDA received over 700 comments on the draft guidance
and those comments were carefully considered as the guidance was
finalized. Comments were received from a variety of organizations,
including patient advocacy groups representing users of blood products;
lesbian, gay, bisexual and transgender advocacy groups; medical and
professional societies; academic institutions; human rights
organizations; local governments; members of Congress; and, the blood
industry. Comments were also received from hundreds of individual
commenters.
    Approximately one-half of the comments opposed FDA's time-based
deferral policy for MSM and considered the proposed policy to be
discriminatory and lacking a scientific rationale. Many of these
comments recommended that FDA adopt an individual risk assessment based
approach, regardless of an individual's sexual orientation or gender
identity. Other comments supported a time-based deferral policy shorter
than 1year, or no deferral period at all, because of advances in blood
donor testing technologies that permit earlier detection of new HIV
infections. Comments requested that FDA commit to reexamining its
deferral policies as new technologies, such as pathogen reduction
technology are implemented and data regarding compliance with the
revised policies become available.
    Most of the remaining comments advocated for the continuation of
the indefinite deferral policy for MSM and expressed concern regarding
the safety of the blood should the revised policy for MSM donors be
adopted. Opponents of the proposed change commented on the HIV
incidence and prevalence rates among MSM; the potential failure of HIV
tests to capture window-period infections; the risk of emerging
pathogens for which testing does not exist; and, the potential for
decreased compliance rates with the new deferral policy. Other comments
argued that FDA should not compromise public health and the safety of
the blood supply to satisfy special interest groups.
    A smaller number of comments, including those from certain patient
advocacy organizations, supported the proposed 1-year deferral policy
for MSM predicated on the establishment of a transfusion-transmitted
infectious disease monitoring system to enhance safety monitoring and
allow rapid responses to emerging threats to the blood supply. Further,
similar comments advocated for an evaluation of the effectiveness of
the donor educational materials and donor history questionnaires prior
to the implementation of new donor deferral policies.
    Finally, comments received from the blood industry were generally
supportive of the revised MSM donor deferral policy. However, some
comments noted that manufacturers of plasma for further manufacturing
use (i.e., to make injectable products), including Source Plasma,
collected in the United States and intended for further manufacturing
use in other countries, may need to retain an indefinite deferral
policy for MSM to comply with the indefinite deferral policies
established in other countries. Industry commenters also requested
revisions to certain other donor deferral criteria for HIV risk and
disagreed with FDA's proposal to include the signs and symptoms
associated with HIV infection in the donor educational materials.
Comments requested clarification regarding the eligibility of donors
with false-positive HIV tests and on recommendations for product
retrieval and notification of consignees of distributed blood
components collected from a donor who should have been deferred for HIV
risk factors. Some comments were also supportive of the additional
guidance provided by FDA regarding transgender donors.
    Finally numerous commenters requested FDA to clarify the
recommendation for deferral of women who have had sex with MSM.
    FDA carefully considered all of the comments received in response
to the draft guidance and the available scientific data, including the
results of

recent studies conducted by the Public Health Service and revised the
guidance accordingly. FDA considered several options to address the
comments in response to the revised MSM donor deferral policy. Because
evidence indicates that the indefinite deferral policy for MSM may have
become less effective over time, FDA has determined that a change in
policy is warranted at this time. Data on the limitations of nucleic
acid tests to identify antibody negative window period HIV infections
suggests that donor testing alone, absent any deferral for MSM, would
result in an unacceptable increased risk of transfusion-transmitted
HIV. Similarly, pretesting at risk donors with a rapid HIV test prior
to donation would be logistically challenging and would not necessarily
identify newly HIV-infected individuals. While individual donor
assessment for risk has been implemented in a few countries, the
implementation of this strategy in the United States would present
significant practical challenges and currently there is no validated
and accepted individual risk assessment tool or questionnaire.
Therefore, FDA concluded a time-based deferral for history of male-male
sex is the most appropriate policy to maintain the safety of the U.S.
blood supply. Scientific data regarding the effectiveness of a 1-year
deferral in Australia, a country with similar HIV epidemiology to the
United States, supports FDA's policy change to the blood donor deferral
period for MSM from indefinite deferral to 1 year since the last sexual
contact. Scientifically robust data are not available for time-based
deferrals of less than 1 year. FDA also concluded that scientific data
are not currently available that would support revisions to the
indefinite deferral policy for commercial sex workers or intravenous
drug users.
    In response to comments, FDA made the following changes when
finalizing the guidance: (1) Amended the recommendations regarding the
inclusion of signs and symptoms associated with HIV in the donor
educational materials; (2) revised the recommendation for the deferral
of female donors who have had sex with MSM; (3) stated that FDA no
longer recommends deferral for individuals who have had sex with an
individual with hemophilia or related clotting deficiencies requiring
treatment with clotting factor concentrates; and (4) revised the
recommendations regarding product retrieval and consignee notification
of distributed blood products collected from a donor who should have
been deferred for HIV risk factors. In addition, FDA made the following
changes to clarify certain recommendations in the guidance, which are
consistent with current policy: (1) Clarified that donors who have been
determined to have a false-positive HIV test may be reentered according
to a requalification method found acceptable to FDA; (2) noted that
recipients of allogeneic blood transfusions (i.e., not autologous
transfusions), should be temporarily deferred; (3) provided reference
to an FDA guidance on the collection of blood components from donors at
risk of HIV infection; and (4) clarified the deferral by the
responsible physician of a blood establishment of any donor if the
donation could affect the health of the donor or the safety of the
blood component. Additionally, the background section has been expanded
to summarize FDA's evaluation of the available policy options under the
available evidence relevant to the MSM deferral policy. Minor editorial
changes have also been made to the guidance.
    FDA remains committed to exploring options and engaging in public
discussions regarding enhancements to donor and public education
regarding safe blood donors and evaluating the effectiveness of the
donor history questionnaire. Further, with the implementation of a
transfusion transmitted infectious disease monitoring system, FDA will
be able to monitor donor risk factors and the safety of the blood
supply, as well as investigate and refine blood safety measures in the
future. FDA's recommendations may evolve over time as new scientific
data become available on strategies to maintain or improve blood
safety.
    The guidance announced in this notice finalizes the draft guidance
dated May 2015 and supersedes the 1992 blood memo.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on recommendations for reducing the risk of HIV
transmission by blood and blood products. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    The 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 601.12 have been approved under
OMB control number 0910-0338; the collections of information in 21 CFR
606.171 have been approved under OMB control number 0910-0458; and the
collections of information in 21 CFR 610.46, 630.6, 640.3 and 640.63
have been approved under OMB control number 0910-0116.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: December 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32250 Filed 12-22-15; 8:45 am]
BILLING CODE 4164-01-P