[Federal Register Volume 84, Number 33 (Tuesday, February 19, 2019)]
[Notices]
[Pages 4864-4868]
[FR Doc No: 2019-02606]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85109; File No. SR-MRX-2019-01]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend the
Exchange's Provisions for Excluding a Day From Its Volume Calculations
for Purposes of Determining Pricing Tiers

February 12, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 31, 2019, Nasdaq MRX, LLC (``MRX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III, below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's provisions for
excluding a day from its volume calculations for purposes of
determining pricing tiers.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqmrx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend the Exchange's
provisions for excluding a day from its volume calculations for
purposes of determining pricing tiers. The Exchange is standardizing
its practice for removing a day from volume calculations in its Pricing
Schedule with its affiliated options market, Nasdaq PHLX LLC
(``Phlx'').\3\ Each change is discussed below.
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    \3\ See Phlx Pricing Schedule, Options 7, Section 1(b). The
Exchange's other affiliated options markets, Nasdaq ISE, Nasdaq
GEMX, Nasdaq BX, and The Nasdaq Options Market will also file
similar rule change proposals to conform to Phlx's rule.
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Background
    To avoid penalizing members when aberrant low volume days result
from systems or other issues at the Exchange, or where the Exchange
closes early for holiday observance, the Exchange currently has
language in its Pricing Schedule allowing it to exclude certain days
from its average daily volume (``ADV'') calculations. Currently,
language in the Exchange's Pricing Schedule provides that, for purposes
of determining ADV for certain incentive programs,\4\ any day that the
market is not open for the entire trading day or the Exchange instructs
members in writing to route their orders to other markets may be
excluded from such calculation; provided that the Exchange will only
remove the day for members that would have a lower ADV with the day
included. The proviso language (hereinafter, the ``better of rule'')
ensures that members would only have the day removed when doing so is
beneficial for the member. As such, the Exchange only applies the
better of rule to ADV calculations, and not for other volume-based
pricing where members would not benefit from having the day excluded
(e.g., straight volume accumulations).
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    \4\ The current language in the Pricing Schedule applies to the
calculations of Total Affiliated and/or Appointed Member ADV used to
determine tiered maker/taker fees for members. See Options 7,
Section 3, Table 3 (Qualifying Tier Thresholds).
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Proposal
    In Options 7, Section 1, the Exchange proposes to adopt subsection
(a) with the title ``Removal of Days for Purposes of Pricing Tiers,''
and renumber the existing first paragraph (related to fee disputes) as
subsection (b). The Exchange also proposes to adopt new language in
subsection (a) that is substantially similar to language currently in
place on Phlx.\5\ Specifically, as proposed:
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    \5\ See note 3 above.
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    (1)(A) Any day that the Exchange announces in advance that it will
not be open for trading will be excluded from the options tier
calculations set forth in its Pricing Schedule; and (B) any day with a
scheduled early market close (``Scheduled Early Close'') may be
excluded from the options tier calculations only pursuant to paragraph
(3) below.
    (2) The Exchange may exclude the following days (``Unanticipated
Events'') from the options tier calculations only pursuant to paragraph
(3) below, specifically any day that: (A) The market is not open for
the entire trading day, (B) the Exchange instructs members in writing
to route their orders to other markets, (C) the Exchange is
inaccessible to members during the 30-minute period before the opening
of trade due to an Exchange system disruption, or (D) the Exchange's
system experiences a disruption that lasts for more than 60 minutes
during regular trading hours.
    (3) If a day is to be excluded as a result of paragraph (1)(B) or
(2) above, the Exchange will exclude the day from

any member's monthly options tier calculations as follows:
    (A) The Exchange may exclude from the ADV calculation any Scheduled
Early Close or Unanticipated Event; and
    (B) the Exchange may exclude from any other applicable options tier
calculation provided for in its Pricing Schedule (together with (3)(A),
``Tier Calculations'') any Scheduled Early Close or Unanticipated
Event.

provided, in each case, that the Exchange will only remove the day for
members that would have a lower Tier Calculation with the day included.
    The proposed language: (i) Applies the rule for excluding days to
all volume based calculations rather than specified incentive
programs,\6\ (ii) expands upon the existing scenarios where the
Exchange may remove a day to adopt two additional situations related to
Exchange systems disruptions, (iii) categorizes the potential excluded
days into days that are known in advance (i.e., days in proposed
paragraph (1), including Scheduled Early Closes) and days that are not
(i.e., Unanticipated Events in proposed paragraph (2)), (iv) clarifies
how the potential excluded days proposed above would be removed from
the ADV and other applicable volume based tier calculations in the
Pricing Schedule, and (v) generally adds more detail to clarify the
application of the better of rule. As it relates to Unanticipated
Events, the Exchange will inform all members if any such day will be
excluded from its Tier Calculations through a system status message
disseminated to all members. The Exchange notes that it is not
proposing to amend the thresholds a member must achieve to become
eligible for, or the dollar amount associated with, the tiered rebates
or fees.
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    \6\ See note 4 above. Since the proposed language will now apply
to all current and future programs administered by the Exchange that
are based on ADV and other applicable volume calculations, the
current rule in Options 7, Section 3 will be replaced by the
proposed language in Section 1(a) with the modifications described
above, including language providing that the rule will apply to all
Tier Calculations in its Pricing Schedule.
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Rule Application
    Currently, the Exchange's rule for removing a day from its ADV
calculations applies to specific ADV calculations of Total Affiliated
\7\ and/or Appointed Member \8\ ADV \9\ and Total Affiliated and/or
Appointed Priority Customer ADV.\10\ As applied, the Exchange can
remove a day from tier calculations for the maker fees \11\ and taker
fees \12\ assessed to members.\13\ The Exchange now believes it is
appropriate to expand this provision to cover all volume based
calculations including ADV rather than limit it to specific enumerated
programs. Applying this rule to all volume based calculations will
benefit members by permitting the Exchange to exclude atypical low
volume days from its volume calculations regardless of the specific
pricing program impacted. As is the case today, the Exchange would only
remove the day for members that would have a lower volume calculation
with the day included. This change will standardize the Exchange's
practice with Phlx, which currently applies its rule to cover all ADV
and other volume calculations set forth in its pricing schedule rather
than specified programs.\14\
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    \7\ An ``Affiliated Member'' is a Member that shares at least
75% common ownership with a particular Member as reflected on the
Member's Form BD, Schedule A.
    \8\ An ``Appointed Member'' is either an Appointed Market Maker
or Appointed Order Flow Provider. An ``Appointed Market Maker'' is a
Market Maker who has been appointed by an Electronic Access Member
pursuant to Section 3, Table 3. An ``Appointed Order Flow Provider''
is an Electronic Access Member who has been appointed by a Market
Maker pursuant to Section 3, Table 3.
    \9\ Total Affiliated and/or Appointed Member ADV means all ADV
executed on the Exchange in all symbols and order types, including
volume executed by Affiliated Members and/or Appointed Members. All
eligible volume from Affiliated Members will be aggregated in
determining applicable tiers. All eligible volume from an Appointed
Order Flow Provider will be aggregated with its designated Appointed
Market Maker's eligible volume in determining the Appointed Market
Maker's applicable tiers, provided the Appointed Market Maker is
designated by the Appointed Order Flow Provider in accordance with
Section 3, Table 3. An Appointed Market Maker is eligible to receive
and aggregate volume credit from both their Affiliated Members and
their Appointed Order Flow Provider. An Appointed Order Flow
Provider will not receive volume credit from its Appointed Market
Maker or the Appointed Market Maker's Affiliated Members in
determining its applicable tiers.
    \10\ Total Affiliated and/or Appointed Priority Customer ADV
means all Priority Customer ADV executed on the Exchange in all
symbols and order types, including volume executed by Affiliated
Members and/or Appointed Members. The Exchange aggregates volume
executed by Affiliated Members and Appointed Members in the same
manner as it aggregates volume for purposes of Total Affiliated and/
or Appointed Member ADV. See note 9 above.
    \11\ Members are charged tiered maker fees in Penny Symbols and
Non-Penny Symbols, all of which are based on Total Affiliated and/or
Appointed Member ADV. See Options 7, Section 3, Table 1.
    \12\ Members are charged tiered taker fees in Penny Symbols and
Non-Penny Symbols, all of which are based on Total Affiliated and/or
Appointed Member ADV. See Options 7, Section 3, Table 1. A reduced
Market Maker taker fee in Penny and Non-Penny Symbols of $0.05 per
contract applies instead of the applicable Market Maker taker fee
when trading with Priority Customer orders entered by an Affiliated
Member or Appointed Member if the Member has a Total Affiliated and/
or Appointed Priority Customer ADV of 5,000 contracts or more. This
Market Maker taker fee is further reduced to $0.00 per contract when
trading with Priority Customer orders entered by an Affiliated
Member or Appointed Member if the Member has a Total Affiliated and/
or Appointed Priority Customer ADV of 50,000 contracts or more. See
Options 7, Section 3, Table 1, note 2.
    \13\ The highest tier threshold attained applies retroactively
in a given month to all eligible traded contracts and applies to all
eligible market participants.
    \14\ See note 3 above.
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Exchange Systems Disruptions
    The Exchange proposes to adopt two additional scenarios as
``Unanticipated Events'' that the Exchange may determine to exclude
from its Tier Calculations. First, the Exchange proposes to exclude
days where the Exchange is inaccessible to members during the 30-minute
period before the opening of trade (i.e., between 9:00 a.m. to 9:30
a.m. Eastern Time) due to an Exchange system disruption, even if the
Exchange does not instruct members to route away to other markets. As
discussed above, the Exchange's current ability to remove days is
limited to days where the market is not open for the entire trading
day, and where the Exchange instructs members to route away to other
markets. This allows the Exchange to exclude days, for example, where
the Exchange honors a market-wide trading halt declared by another
market, closes early for holiday observance, or instructs members to
route away to other markets because of a systems issue in the morning,
which ultimately does not carry over into the trading day. The Exchange
notes, however, that it may not always instruct members to route away.
For instance, the Exchange may be inaccessible to members in the
morning due to a systems disruption but the Exchange resolves the issue
shortly before 9:30 a.m. and as a result, the Exchange does not
instruct members to route away. In such cases, the Exchange is not
permitted to exclude the day from its ADV calculations. The Exchange
generally experiences a high volume of member participation within the
30-minute window leading up to the opening of trade from members who
submit eligible interest be included in the Exchange's opening process.
As a result, days where members are precluded from submitting eligible
interest during this 30-minute time period due to an Exchange systems
disruption, even if the issue is ultimately resolved by the Exchange
before the market opens (and members

therefore are not instructed to route away), are likely to have lower
trading volume. Including such days in calculations of ADV will
therefore make it more difficult for members to achieve particular
pricing tiers for that month. Accordingly, excluding such days will
diminish the likelihood of a cost increase occurring because a member
is not able to reach a pricing tier on that date that it would reach on
other trading days during the month. Phlx currently has identical
language allowing it to remove such days from its volume based
tiers.\15\
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    \15\ See id. at paragraph 2(C).
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    Second, the Exchange proposes to exclude days where there is an
Exchange system disruption that lasts for more than 60 minutes during
regular trading hours (i.e., 9:30 a.m. to 4:00 p.m. Eastern Time), even
if such disruption would not be categorized as a complete outage of the
Exchange's system. Such a disruption may occur where a certain options
series traded on the Exchange is unavailable for trading due to an
Exchange systems issue, or where the Exchange may be able to perform
certain functions with respect to accepting and processing orders, but
may have a failure to another significant process, such as routing to
other market centers, that would lead members who rely on such
processes to avoid using the Exchange until the Exchange's entire
system was operational. The Exchange believes that certain system
disruptions that are not complete system outages could preclude some
members from submitting orders to the Exchange. The Exchange notes that
this proposal is consistent with the rules of Phlx and other options
exchanges.\16\
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    \16\ See id. at paragraph 2(D). See also BATS [sic] BZX Options
Exchange Fee Schedule (defining an ``Exchange System Disruption'' as
any day that the exchange's system experiences a disruption that
lasts for more than 60 minutes during regular trading hours); and
NYSE Arca Options Fee Schedule (defining an ``Exchange System
Disruption'' as a disruption affects an Exchange system that lasts
for more than 60 minutes during regular trading hours).
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    The Exchange believes that the two scenarios proposed above are
reasonable and equitable because the intent of the current rule has
always been to avoid penalizing members that might otherwise qualify
for certain tiered pricing but that because of aberrant low volume days
resulting, for instance, from Exchange systems disruptions, did not
participate on the Exchange to the extent they might have otherwise
participated.
    In addition, to avoid penalizing members that step up and trade on
a day with artificially low volume, the Exchange currently only removes
days for members that would have a lower ADV calculation with the day
included (i.e., the better of rule). The Exchange believes that
applying the better of rule to the proposed system disruption-related
scenarios would be similarly helpful as it would ensure that members
that continue to execute a large volume of contracts on such days are
not inadvertently disadvantaged when the Exchange removes a systems
disruption-related day from its calculations of ADV. This is consistent
with the treatment of such days on Phlx.\17\
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    \17\ See note 3 above at paragraph 3.
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Categories of Excluded Days
    Similar to Phlx, the Exchange seeks to restructure the existing
rule by separating out the different scenarios between days that are
known in paragraph (1) and days that are not in paragraph (2), and
define the latter as Unanticipated Events.
    For planned days, the Exchange proposes to further distinguish
between days that the Exchange announces in advance that it will not be
open for trading in paragraph (1)(A) (e.g., Thanksgiving), and
Scheduled Early Closes in paragraph (1)(B) (e.g., the trading day after
Thanksgiving). The Exchange notes that it currently considers Scheduled
Early Closes as a subset of days that the market is not open for the
entire trading day. The Exchange believes it would be more clear to
distinguish Scheduled Early Closes in paragraph (1) as a day that is
planned for in advance, and separately consider days that are not open
for the entire trading day as Unanticipated Events in paragraph (2)(A).
As proposed, (2)(A) would continue to cover unplanned days where the
Exchange declares a trading halt in all securities or honors a market-
wide trading halt declared by another market. The other scenarios that
will be categorized as Unanticipated Events in paragraph (2) are the
two systems-related disruptions proposed above, and days that the
Exchange instructs members in writing to route their orders to other
markets, which is an existing scenario covered under the current rule
as described above.
Exclusion of Days by Tier Calculation
    The Exchange proposes to further amend the existing rule to align
with the Phlx rule by specifying how the days in paragraphs (1) and (2)
will be excluded from its Tier Calculations. As it relates to days
where the Exchange announces in advance that it will not be open for
trading, the Exchange notes that it will exclude those days from all
options tier calculations set forth in its Pricing Schedule.\18\ This
is also the case today since no trading activity occurs on those days,
and the Exchange is only clarifying its current practice within the
proposed rule text in paragraph (1)(A).
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    \18\ See id. at paragraph (1)(A) for similar language on Phlx.
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    As discussed above, the Exchange currently removes Scheduled Early
Closes as provided in paragraph (1)(B), and the Unanticipated Events in
paragraphs (2)(A) and (2)(B), from its calculations of ADV only for
members that would have a lower ADV with the day included. The Exchange
is not changing how it currently excludes these days from the ADV
calculations. And as further discussed above, the Exchange is proposing
to adopt the same principle-based approach for excluding the two
Unanticipated Events related to Exchange system disruptions as provided
in paragraphs (2)(C) and (2)(D). Accordingly, the proposed language in
paragraph (3)(A) will clarify for the ADV calculation that the Exchange
may exclude any Scheduled Early Close or Unanticipated Event, subject
to the better of rule.\19\
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    \19\ See id. at paragraph (3)(A) for similar language on Phlx.
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    Similar to Phlx, the proposal also adds a ``catch-all'' provision
in paragraph (3)(B) that would apply to other applicable volume based
tier calculations that are set forth in its Pricing Schedule, but are
not specified within paragraph (3)(A) (i.e., not an ADV
calculation).\20\ This catch-all provision will provide the Exchange
with flexibility to apply the better of rule going forward to all
pricing programs administered by the Exchange that are based on volume
calculations. The Exchange believes that adopting a similar principle-
based approach for its options volume calculations would ensure that
days are removed from such calculations only if doing so would be
beneficial for the member. Accordingly, the proposed language will not
apply to straight volume accumulations, as is the case today, and the
Exchange will continue to not exclude days from such calculations as
members do not benefit when volume executed on an excluded day is
removed from straight volume accumulations.
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    \20\ See id. at paragraph (3)(C) for similar language on Phlx.
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Clarifying Changes
    The Exchange proposes to add further details similar to Phlx's rule
to bring greater transparency as to how the Exchange will apply the
better of rule when removing days from its Tier Calculations. In
particular, the Exchange

proposes to make clear that it will only remove days pursuant to the
better of rule by specifying in paragraphs (1)(B) and (2) that such
days may be excluded from the Tier Calculations only pursuant to
paragraph (3).\21\ Paragraph (3) will then provide that if a day is to
be excluded as a result of paragraph (1)(B) or (2), the Exchange will
be required to exclude the day from any member's monthly options volume
tier calculations as detailed within paragraph (3).\22\ With the
proposed changes, the Exchange seeks to clarify that it will exclude
days from any member's Tier Calculations in a uniform manner to ensure
that days are removed only in situations where the member benefits. The
Exchange will look at each potential excluded day in a month and
determine for every member their ADV or other applicable volume
calculation based on their trading volume on that day. If any member
would have a lower Tier Calculation with the particular day included,
the Exchange will exclude that day for that member. This is how the
Exchange applies the better of rule today for ADV calculations. As
such, the proposed changes are intended to make clear that the Exchange
will apply the better of rule in a uniform manner for all members, and
that there is no arbitrary selection of ``winners'' or ``losers'' when
the Exchange excludes days. In addition, the Exchange proposes to make
two technical changes within the better of rule; first, to clarify that
the rule applies in each case of the tier calculations specified in
paragraph (3), and second, to use the defined term Tier Calculations
instead of ADV to reflect the changes proposed herein.
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    \21\ See id. at paragraphs (1)(B) and (2) for similar language
on Phlx.
    \22\ See id. at paragraph (3) for similar language on Phlx.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\23\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\24\ 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.
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    \23\ 15 U.S.C. 78f(b).
    \24\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes that the proposed rule change is reasonable
and equitable as it provides a new framework for removing days from the
Exchange's volume calculations that the Exchange believes is beneficial
to members and consistent with similar provisions already in place on
Phlx. The proposed rule change would permit the Exchange to remove a
day from its pricing tiers in more circumstances, and ensures that the
Exchange will only do so in circumstances where beneficial for the
member because the member would have a lower volume calculation the
with the day included.
    By applying the rule to all volume based calculations rather than
specified incentive programs based on Total Affiliated and/or Appointed
Member ADV and Total Affiliated and/or Appointed Priority Customer ADV,
the Exchange believes that members will be further protected if the
Exchange experiences a systems or other issue that results in a day
being excluded from the Exchange's volume calculations. Without this
change, members would only have the day excluded for the specific ADV
based pricing programs described above, and would not get the benefit
for other un-enumerated programs.
    The Exchange believes it is reasonable and equitable to exclude a
day from its volume based calculations when the Exchange's system
experiences a disruption during the 30-minute period prior to the
opening of trade that renders the Exchange inaccessible to members as
this preserves the Exchange's intent behind adopting volume-based
pricing. Without this change, members that are precluded from
submitting eligible interest during the 30-minute window before the
opening of trade may be negatively impacted, even if the Exchange
resolves the issue before the market opens and as a result, does not
instruct members to route away. The proposed change to exclude such
days will diminish the likelihood of a cost increase occurring because
a member is not able to reach a volume tier calculation on that date
that it would reach on other trading days during the month.
    Similarly, excluding a day where the Exchange's system experiences
a disruption that lasts for more than 60 minutes intra-day is
reasonable and equitable because the proposal seeks to avoid penalizing
members that might otherwise qualify for certain tiered pricing but
that, because of an Exchange systems disruption, did not participate on
the Exchange to the extent they might have otherwise participated. The
Exchange believes that certain systems disruptions could preclude some
members from sending order flow to the Exchange even if such issue is
not actually a complete systems outage.
    In addition, the Exchange believes that it is reasonable and
equitable to apply the better of rule to both systems disruption-
related scenarios. Without these changes, members that step up and
trade significant volume on excluded trading days may be negatively
impacted, resulting in an effective cost increase for those members.
The proposal would align the Exchange's approach to how it applies this
rule today for days where the market is not open for the entire trading
day or where the Exchange instructs members to route away.
    Furthermore, the Exchange believes that categorizing the potential
excluded days is reasonable and equitable because it will bring greater
transparency to the application of its rule. Specifically, the Exchange
is distinguishing between planned and unplanned days in paragraphs (1)
and (2), defining the latter as Unanticipated Events, and stipulating
how the Exchange will exclude such days pursuant to this rule.
Categorizing days in this manner will clarify the application of its
rule in light of the Exchange's proposal to expand the rule to adopt
additional days that may be excluded from its tier calculations.
Providing in paragraph (1)(A) that the Exchange will always exclude
from its tier calculations days that it announces in advance it will
not be open for trading will clarify current practice. Furthermore, the
Exchange believes that the proposed changes to specify how days in
paragraphs (1) and (2) may be excluded from its tier calculations will
bring greater transparency by delineating the various circumstances in
which the better of rule will apply. Providing in paragraph (3) that
the Exchange may exclude any Scheduled Early Close or Unanticipated
Event from the ADV and other Tier Calculations, subject to the better
of rule, will make clear that the Exchange will take a consistent
approach when excluding days for purposes of its volume based pricing
tiers. In addition, having a catch-all in paragraph (3)(B) so that the
better of rule applies to other options volume calculations than ADV to
allow the Exchange to apply the rule going forward to all pricing
programs based on volume calculations will further protect members. The
Exchange notes that aberrant low volume days resulting from, for
instance, an Unanticipated Event, impacts all volume-based
calculations, and allowing the Exchange to exclude such days from any
Tier Calculation if the member would have a lower Tier Calculation with
the day included will further protect members from being inadvertently
penalized.
    Furthermore, the proposed changes specifying that the days in
paragraphs

(1)(B) and (2) may be excluded only pursuant to paragraph (3), and
requiring the Exchange to exclude such days pursuant to the
specifications in paragraph (3) will likewise make clear that the
Exchange will take a consistent approach with respect to excluding days
from its volume calculations. As discussed above, these modifications
will clarify that the Exchange will apply the better of rule in a
uniform manner to all members, and that there is no arbitrary selection
of ``winners'' or ``losers.'' The Exchange also believes that the two
technical changes proposed in the better of rule to reflect the changes
proposed herein will likewise bring greater clarity to its rule.
    Finally, the Exchange further believes that the proposed rule
change is not unfairly discriminatory because it will apply equally to
all members. While the Exchange currently has rules in place for
removing a day from its pricing, the Exchange believes that the
proposed changes will benefit all members by providing more
circumstances to remove a day, and ensuring that such days are removed
only in situations where the member benefits.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed rule change is
designed to protect members from the possibility of a cost increase by
excluding days when overall member participation might be significantly
lower than a typical trading day. The Exchange believes that the
proposed modifications to its tier calculations are pro-competitive and
will result in lower total costs to end users, a positive outcome of
competitive markets. Furthermore, other options exchanges have adopted
rules that are substantially similar to the Exchange's proposal.\25\
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    \25\ See notes 3 and 16 above.
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    The Exchange operates in a highly competitive market in which
market participants can readily direct their order flow to competing
venues. In such an environment, the Exchange must continually review,
and consider adjusting, its fees and rebates to remain competitive with
other exchanges. For the reasons described above, the Exchange believes
that the proposed fee changes reflect this competitive environment.

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.\26\ 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.
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    \26\ 15 U.S.C. 78s(b)(3)(A)(ii).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MRX-2019-01 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MRX-2019-01. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of 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-2019-01 and should be submitted on
or before March 12, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-02606 Filed 2-15-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Notices]
[Page 1153]
[FR Doc No: 2011-37]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL11-13-000]

Atlantic Grid Operations A LLC, Atlantic Grid Operations B LLC,
Atlantic Grid Operations C LLC, Atlantic Grid Operations D LLC and
Atlantic Grid Operations E LLC; Notice of Petition for Declaratory
Order

December 23, 2010.
    Take notice that on December 20, 2010, pursuant sections 205 and
219 of the Federal Power Act, Rule 207 of the Federal Energy Regulatory
Commission's (Commission) Rules of Practice and Procedure, 18 CFR
385.207, and Order No. 679,\1\ Atlantic Grid Operations A LLC, Atlantic
Grid Operations B LLC, Atlantic Grid Operations C LLC, Atlantic Grid
Operations D LLC, and Atlantic Grid Operations E LLC filed a Petition
for Declaratory Order requesting that the Commission grant their
request for incentive rate treatment and approve a return on equity for
their investments in the Atlantic Wind Connection project.
---------------------------------------------------------------------------

    \1\ Promoting Transmission Investment through Pricing Reform,
Order No. 679, 2006-2007 FERC Stats. & Regs., Regs. Preambles ]
31,222, order on reh'g, Order No. 679-A, 2006-2007 FERC Stats. &
Regs., Regs. Preambles ] 31,236 (2006), order on reh'g, Order No.
679-A, 119 FERC ] 61,062 (2007).
---------------------------------------------------------------------------

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on January 19, 2011.

Kimberly D. Bose,
Secretary.
[FR Doc. 2011-37 Filed 1-6-11; 8:45 am]
BILLING CODE 6717-01-P


--------------------------------------------------------------------------------
Hi Bob-
--------------------------------------------------------------------------------
In reference to your email of 2/7/12 and your question regarding the SO2 emissions in Table 10-8 and 10-9, the tables below have been corrected to reflect the sulfur reductions addressed in 9.4.2, specifically the area source reductions resulting from controls of 51,817 TPY. These corrections apply to the 2018 emissions for both MANE-VU and NYS. Those numbers have been corrected and are reflected in Tables 10-8 and 10-9. There is no Table 10-10; this was a numbering error. There are also minor corrections to 10.4.6. Please replace our 3/15/10 version of 10.4.6 with the information below.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
10.4.6 Changes to Emissions by 2018
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
      The emission inventory for New York projects changes to point, area and mobile source inventories by the end of the first implementation period resulting from population growth; industrial, energy and natural resources development; land management; and air pollution control.  A summary of these changes is given in Table 10-9 for emissions of sulfur dioxide.  More detail is provided in:
--------------------------------------------------------------------------------

         * --------------------------------------------------------------------------------
Development of Emissions Projections for 2009, 2012, and 2018 for NonEGU Point, Area, and Non-road Sources in the MANE-VU Region (MACTEC, February 2007) (Appendix E), and
         * --------------------------------------------------------------------------------
Documentation of 2018 Emissions from Electric Generation Units in the Eastern United States for MANE-VU's Regional Haze Modeling (Alpine Geophysics, March 2008) (Appendix W).
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Table 10-8 - Emissions from Point, Area and Mobile Sources in MANE-VU (SO2 tpy)
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Baseline 2002
--------------------------------------------------------------------------------
2018 (with additional measures for RPG)
--------------------------------------------------------------------------------
Area
--------------------------------------------------------------------------------
286,921
--------------------------------------------------------------------------------
 253,620
--------------------------------------------------------------------------------
Non-EGU Point
--------------------------------------------------------------------------------
264,377
--------------------------------------------------------------------------------
91,438
--------------------------------------------------------------------------------
EGU Point
--------------------------------------------------------------------------------
1,643,257
--------------------------------------------------------------------------------
368,717
--------------------------------------------------------------------------------
On-Road Mobile
--------------------------------------------------------------------------------
40,091
--------------------------------------------------------------------------------
8,757
--------------------------------------------------------------------------------
Non-Road Mobile
--------------------------------------------------------------------------------
57,257
--------------------------------------------------------------------------------
8,643
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Table 10-9 - Emissions from Point, Area and Mobile Sources in New York (SO2 tpy)
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Baseline 2002
--------------------------------------------------------------------------------
2018 (with additional measures for RPG)
--------------------------------------------------------------------------------
Area
--------------------------------------------------------------------------------
130,409
--------------------------------------------------------------------------------
 89,591
--------------------------------------------------------------------------------
Non-EGU Point
--------------------------------------------------------------------------------
58,197
--------------------------------------------------------------------------------
 46,038
--------------------------------------------------------------------------------
EGU Point
--------------------------------------------------------------------------------
236,719
--------------------------------------------------------------------------------
72,898
--------------------------------------------------------------------------------
On-Road Mobile
--------------------------------------------------------------------------------
10,229
--------------------------------------------------------------------------------
1,794
--------------------------------------------------------------------------------
Non-Road Mobile
--------------------------------------------------------------------------------
13,288
--------------------------------------------------------------------------------
1,686
--------------------------------------------------------------------------------
Source:  ftp://ftp.marama.org/2018%20Best%20and%20Final%20Modeling%20Files/Summaries/10.4.5 Emissions Tables_032408.xls


[Federal Register Volume 86, Number 121 (Monday, June 28, 2021)]
[Rules and Regulations]
[Pages 33888-33890]
[FR Doc No: 2021-13727]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0457]
RIN 1625-AA00

Safety Zone; Upper Potomac River, Washington, DC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
certain waters of the Upper Potomac River. The safety zone is needed to
protect personnel, vessels, and the marine environment on these
navigable waters at Washington, DC, on July 4, 2021, (with alternate
date of July 5, 2021) from potential hazards during a fireworks display
to commemorate the July 4th holiday. Entry of vessels or persons into
this zone is prohibited unless specifically authorized by the Captain
of the Port, Maryland-National Capital Region or a designated
representative.

DATES: This rule is effective from 8 p.m. on July 4, 2021, through 11
p.m. on July 5, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0457 in the ``SEARCH'' box and click ``SEARCH.'' Next, in the
Document Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Ron Houck, Sector Maryland--National Capital Region
Waterways Management Division, U.S. Coast Guard; telephone 410-576-
2674, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that it is
impracticable and contrary to the public interest to publish an NPRM
because we must take immediate action to establish this safety zone by
July 4, 2021, to respond to potential safety hazards associated with
the the fireworks display. Potential safety hazards include the
accidental discharge of fireworks, dangerous projectiles, and falling
hot embers or other debris. Event planners did not notify the Coast
Guard of the event until June 17, 2021.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
respond to the potential safety hazards associated with the fireworks
display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port, Maryland--
National Capital Region (COTP) has determined that potential hazards
associated with the fireworks to be used in this July 4, 2021, display
will be a safety concern for anyone near these fireworks discharge
sites. This rule is needed to protect personnel, vessels, and the
marine environment in the navigable waters within the safety zone
before, during, and after the scheduled event.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from 8 p.m. on July
4, 2021, to 11 p.m. on July 5, 2021. The safety zone will cover all
navigable waters of the Upper Potomac River, including the Tidal Basin,
encompassed by a line connecting the following points: Beginning at the
shoreline of West Potomac Park at position latitude 38[deg]53'04.2'' N,
longitude 077[deg]02'52.7'' W, thence southwest to latitude
38[deg]52'57.1'' N, longitude 077[deg]02'59.9'' W, thence southeast to
the northern extent of the George Mason Bridge at latitude
38[deg]52'36.9'' N, longitude 077[deg]02'29.0'' W, thence northeast
along the bridge to the shoreline at latitude 38[deg]52'44.1'' N,
longitude 077[deg]02'21.8'' W, thence west and north along the
shoreline to latitude 38[deg]52'55.6'' N, longitude 077[deg]02'15.0''
W, thence northwest across the Tidal Basin to the shoreline at latitude
38[deg]53'11.3'' N, longitude 077[deg]02'27.9'' W, thence south and
west along the shoreline to and terminating at the point of origin
located in Washington, DC. The duration of the zone is intended to
protect personnel, vessels, and the marine environment in these
navigable waters before, during, and after the scheduled 9:09 to 9:20
p.m. fireworks display. No vessel or person will be permitted to enter
the safety zone without obtaining permission from the COTP or a
designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action'' under Executive Order 12866. Accordingly, this rule
has not been reviewed by the

Office of Management and Budget (OMB).
    This regulatory action determination is based on the location,
duration, and time-of-day of the safety zone. Vessel traffic will be
able to safely transit around this safety zone, which will impact a
small designated area of the Upper Potomac River for 3 hours during the
evening when vessel traffic is normally low. Moreover, the Coast Guard
will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16
about the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting only 3 hours that will prohibit entry within a
portion of the Upper Potomac River, including the Tidal Basin. It is
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T05-0457 to read as follows:

Sec.  165.T05-0457   Safety Zone; Upper Potomac River, Washington, DC.

    (a) Location. The following area is a safety zone: All navigable
waters of the Upper Potomac River, including the Tidal Basin,
encompassed by a line connecting the following points: Beginning at the
shoreline of West Potomac Park at position latitude 38[deg]53'04.2'' N,
longitude 077[deg]02'52.7'' W, thence southwest to latitude
38[deg]52'57.1'' N, longitude 077[deg]02'59.9'' W, thence southeast to
the northern extent of the George Mason Bridge at latitude
38[deg]52'36.9'' N, longitude 077[deg]02'29.0'' W, thence northeast
along the bridge to the shoreline at latitude 38[deg]52'44.1'' N,
longitude 077[deg]02'21.8'' W, thence west and north along the
shoreline to latitude 38[deg]52'55.6'' N, longitude 077[deg]02'15.0''
W, thence northwest across the Tidal Basin to the shoreline at latitude
38[deg]53'11.3'' N, longitude 077[deg]02'27.9'' W, thence south and
west along the shoreline to and terminating at the point of origin,
located in Washington, DC. These coordinates are based on datum NAD
1983.

    (b) Definitions. As used in this section--
    Captain of the Port (COTP) means the Commander, U.S. Coast Guard
Sector Maryland--National Capital Region.
    Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port Maryland--National Capital Region to assist in enforcing the
safety zone described in paragraph (a) of this section.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by telephone at<PHONE_NUMBER> or on Marine Band Radio
VHF-FM channel 16 (156.8 MHz). The Coast Guard vessels enforcing this
section can be contacted on Marine Band Radio VHF-FM channel 16 (156.8
MHz).
    (3) Those in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
    (d) Enforcement officials. The U.S. Coast Guard may be assisted in
the patrol and enforcement of the safety zone by Federal, State, and
local agencies.
    (e) Enforcement period. This section will be enforced from 8 p.m.
to 11 p.m. on July 4, 2021, or if necessary due to inclement weather on
July 4, 2021, from 8 p.m. to 11 p.m. on July 5, 2021.

    Dated: June 22, 2021.
David E. O'Connell,
Captain, U.S. Coast Guard, Captain of the Port Maryland--National
Capital Region.
[FR Doc. 2021-13727 Filed 6-25-21; 8:45 am]
BILLING CODE 9110-04-P


prior notice when PNSI or OASIS is not working, the final rule has been revised by providing
the outage notification at one web address (http://www.fda.gov).  In order to provide more
flexibility to respond to various contingencies, the final rule has also been revised by stating that
FDA will accept prior notice submissions in the format it deems appropriate during the system(s)
outage.
FDA has posted information on the Systems Status Web site located at
http://www.cfsan.fda.gov/~furls/fisstat.html regarding system downtime that states “Most
problems will be temporary. Try accessing the system again in 15 minutes.” This site also
provides information about scheduled maintenance, which states that “Periodically FDA Industry

172
Systems will need to undergo maintenance and upgrades. All scheduled maintenance will take
place on Saturdays 3 a.m. to 8 a.m. Eastern Time (Saturday 8 a.m. to 1 p.m. GMT).  If you are
having trouble accessing FDA Industry Systems during that time, please try again after 8 a.m.
Eastern Time on Saturday (1 p.m. GMT).”  This site also provides a status history of the system.
(Comments) One comment suggests that FDA should develop and publish a form that
could be used if it were ever necessary to file prior notice by fax.  The comment asserts that a
form also would assist importers in gathering the information necessary to file a prior notice and
also would clear up the confusion that currently exists in foreign countries.  The comment
believes that it was obvious that FDA contemplated issuing a form when it first proposed the
prior notice regulations and complains that no explanation has been given by FDA for not
producing the form.
(Response) FDA disagrees.  A form to be used during contingencies is posted on FDA’s
Web site only when an applicable system outage is encountered.  During a system outage when
fax submissions are being accepted, FDA will publish the fax telephone number for the PNC at
http://www.access.fda.gov, http://www.fda.gov, http://www.cfsan.fda.gov/~furls/fisstat.html and
http://www.cfsan.fda.gov/~pn/pnoview.html, as well as through messages in ABI/ACS.  Fax
transmission is not allowed except when posted and submitted during PNSI downtimes or
specified emergencies.  FDA believes that if the form was available and posted even as a
reference, there is the potential for misuse or confusion.  Our experience with use of the fax form
is that submitters will continue to fax the form even after they have been instructed that the form
will not be accepted.
(Comments) Some comments express concern that submission of all prior notices relies
on electronic systems (even the fax).  The comments suggest that the usual flow of goods should

173
be allowed to continue unhindered, with the paperwork sorted out afterwards.  One comment
further suggests that rather than providing for PNSI as a contingency system when ABI is down,
prior notice submissions should function according to all other submissions processed through
ABI when CBP declares either a "national snow day" or "power outage."  The comment
recommends that if ABI is not working, the shipment should be allowed to proceed, pending
later issuance of a prior notice confirmation via ABI.
(Response) FDA does not agree that if ABI is not working the shipment should be
allowed to proceed.  In that instance, prior notice can, and therefore should, be submitted via
PNSI.
In all contingency situations, except for power failure, some electronic means of prior
notice submission is required, either by PNSI, e-mail, or fax.  However, in the case of a localized
or regional power failure, the Contingency Plan guidance recommends that filers should submit
the required prior notice information to FDA at the port of arrival, or if there is no FDA officer at
a given port, to CBP via a paper copy of the prior notice e-mail contingency form (FDA 3540) at
the time of cargo release.
(Comments) One comment explains that various companies are organizing contingency
plans whereby the prior notice confirmation number will be included in the delivery order, which
then will be faxed to the office of the steamship line at the port of entry so that the requisite
paperwork is in hand when the product is offloaded from the carrier.  The comment further
explains that this contingency plan takes into account the unique circumstances posed by
transporting goods by steamship line insofar as the customs broker or purchaser may not always
be able to send the prior notice confirmation number to the carrier prior to the carrier’s arrival.
The comment asserts that the procedure satisfies FDA's requirements that the prior notice

174
confirmation number must accompany the food when it “arrives in the United States" and be
provided to CBP or FDA “upon arrival."  The comment further urges FDA to include this course
of action in its guidance documents.
(Response) FDA agrees that the described scenario satisfies the requirement under  §
1.279(g) that the prior notice confirmation number must accompany any article of food for which
the prior notice was submitted through PNSI when the article arrives in the United States and
must be provided to CBP or FDA upon arrival. FDA does not believe, however, that it is
necessary to include this specific business practice in its guidance documents, as there are
various means that private entities may choose to use to comply with the regulation.
As described in the contingency plan guidance, if prior notice already has been submitted
via ABI/ACS prior to an interface outage, and confirmation from FDA already has been
received, then the submitter may proceed with prior notice using the standard process under the
following scenarios:
•
ACS, OASIS, and PNSI are all operational, but the link between ACS and OASIS is
down on FDA’s or CBP’s side of the system interface;
•
ACS, PNSI, and the link between ACS and OASIS are operational, but OASIS is non-
operational;
•
ACS and the link between ACS and OASIS are operational, but OASIS is non-
operational and PNSI is non-operational or unavailable due to Internet service
interruptions;
•
OASIS, PNSI and the link between ACS and OASIS are operational but ACS is non-
operational; or

175
•
ACS is non-operational, PNSI is non-operational or unavailable due to Internet service
interruptions, and OASIS and the link between ACS and OASIS are either operational or
non-operational.
The standard process does not include presentation of the prior notice confirmation
number to FDA or CBP upon arrival if the prior notice was submitted by ABI/ACS.
If prior notice already has been submitted via ABI/ACS and confirmation from FDA has
not been received prior to the interface outage, FDA and CBP recommend that rather than
resubmitting via PNSI, submitters should provide to CBP officers, at the time of cargo release,
an endorsed (signed) copy of the ABI transmission or some other evidence adequate to show that
prior notice has been submitted via ABI/ACS.
If prior notice has been submitted via PNSI prior to the system outage and a confirmation
number already has been received, the confirmation number must accompany the article of food
(§ 1.279(g)). In addition, FDA and CBP recommend that the submitter also provide the PNSI
confirmation page, including the prior notice confirmation number and time stamp, to CBP
officers for cargo release.  If the prior notice confirmation page is not provided, this may delay
cargo release while the CBP officer contacts FDA for verification of the prior notice
confirmation number(s) and time of submission.
(Final rule) The final rule in § 1.280(a) requires that prior notice must be submitted
electronically to FDA in the English language, except that an individual's name, the name of a
company, and the name of a street may be submitted in a foreign language. All information,
including these items, must be submitted using the Latin (Roman) alphabet.
Section 1.280(a)(1) and (2) of the final rule provides for two methods of electronic
submission of prior notice: (1) The CBP Automated Broker Interface of the Automated

176
Commercial System (ABI/ACS); or (2) The FDA PN System Interface (PNSI) at
http://www.access.fda.gov.  We corrected a reference in paragraph (a) to state that unless §
1.280(c) applies, prior notice must be submitted through either ABI/ACS or PNSI.
The final rule requires submission of prior notice via PNSI for articles of food imported
or offered for import by international mail, and other transaction types that cannot be made
through ABI/ACS.  Prior notice for articles of food that have been refused under section
801(m)(1) of the act must be submitted through PNSI until such time as ACS or its successor
system can accommodate such transactions.
The final rule also provides for contingencies if involved systems were not working, e.g.,
a custom broker's or self-filer's system, ABI/ACS, PNSI, or OASIS.  The final rule requires that
prior notice must be submitted through PNSI if a customhouse broker’s or self-filer’s system or
if the ABI/ACS interface is not working.  The final rule states that if PNSI or OASIS is not
working, FDA will post prominent notification and instructions at http://www.fda.gov.  FDA will
accept prior notice submissions in the format it deems appropriate during the system(s) outage.
The final rule does not exempt any specific categories of food articles from prior notice if
systems are not performing.
H. What Information Must Be in a Prior Notice? (§ 1.281)
The Bioterrorism Act requires the submission to the Secretary of a notice providing the
identity of each of the following: The article; the manufacturer and shipper of the article; if
known within the specified period of time that notice is required to be provided, the grower of
the article; the country from which the article originates; the country from which the article is
shipped; and the anticipated port of entry for the article.

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The IFR requires in § 1.281(a), (b), and (c) that specific information be submitted in prior
notice: Section 1.281(a) covers general information requirements which apply to all shipments
except those arriving by international mail; section 1.281(b) covers limited information
requirements for food arriving by international mail; and section § 1.281(c) covers information
requirements for food refused under section 801(m) of the act  (e.g., food that has already arrived
in the United States).
The preamble to the IFR discusses the term, “an article of food,” and states that “the
description of an ‘article’ of food is not the same as the definition of ‘food’ in § 1.276(b)(5).  An
‘article’ refers to a single food that is associated with the same complete FDA Product Code, the
same package size, and the same manufacturer or grower.  These requirements are found in the
information required in the IFR in § 1.281(a)(5), (a)(6), or (a)(7) and again in § 1.281(b) and (c)”
(68 FR 58974 at 59003).
The comments are discussed in order of the information requirement in the IFR,
beginning with comments generally addressing the information requirements.
1. General Comments
(Comments) Several comments express concern that the IFR requires significantly more
information than the Bioterrorism Act requires and ask that FDA reduce the number of data
elements.  One comment notes that the Bioterrorism Act names only six or seven specific items
that must be provided.  One comment indicates that the information required for prior notice is
far in excess of that required in the Codex Committee on Food Import and Export Inspection and
Certification Systems Guidelines for Generic Official Certificate Formats and the Production and
Issuance of Certificates (CAC/GL 38-2001).  One comment adds that the required information
far exceeds what is necessary to enable FDA to identify articles of food that need to be inspected.

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Another comment suggests that some of the information required for a prior notice is already
“covered” by the registration requirement of section 305 of the Bioterrorism Act (see the
Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 interim final rule, 21 CFR part 1, subpart H, confirmed 70 FR 57505
(October 3, 2005), so FDA will already have this information.  Another comment suggests that
the prior notice could be simplified, thus reducing the possibility of errors and potential trade
disruptions, by quoting the registration number and only adding information specific to a
particular shipment.  One comment notes that CBP’s data fulfill FDA’s needs; therefore, the
IFR’s duplicate system is a waste of resources, and FDA should use CBP’s system.
(Response) FDA disagrees with the comments that ask for a reduction in the number of
required data elements.  FDA has selected those data elements that will allow FDA to meet its
statutory obligation to receive, review, and respond to prior notices efficiently and effectively.
In addition to the Bioterrorism Act’s requirements of the identities of the article of food, the
manufacturer and shipper, the grower, if known, the country from which the article originates,
the country from which the article is shipped, and the anticipated port of entry for the article,
FDA determined that certain additional information is required for efficient enforcement of the
Bioterrorism Act, primarily for the means of identifying the article of food and effective
enforcement of refusals.  For example, the identification of the individual and the firm, if
applicable, submitting the prior notice is needed so that FDA knows who is responsible for the
information in the prior notice and can communicate with them when necessary via mail, phone,
or email.  The information also is necessary to followup when audits, inspections, or
enforcement are necessary.  Therefore, FDA does not agree with one of the comment’s assertions

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that the prior notice rule should only require the registration number and other information
specific to a particular shipment.
The goals of the Bioterrorism Act and the Codex Committee differ, and thus, the
requirements of the prior notice rule will differ from that of the Codex Committee on Food
Import and Export Inspection and Certification Systems.  The purpose of prior notice is to enable
FDA to conduct inspections of imported foods at U.S. ports upon arrival and target foods that
may pose a significant risk to public health, based on the information submitted.  The Codex
Committee on Food Import and Export Certification and Inspection Systems is charged with
developing principles and guidelines for food import and export certification and inspection
systems.
We also do not agree with the comment’s assertion that FDA should use CBP’s data to
fulfill FDA’s needs under the Bioterrorism Act.  Information that is submitted at the time of CBP
entry processing is not useful for prior notice as this information can be submitted or changed
after the food has already arrived in the United States and thus does not fulfill the express intent
of the Bioterrorism Act that FDA receive information about a shipment before it arrives in the
United States.
FDA also does not agree that some of the prior notice information is already "covered"
by the food facility registration requirement.  For example, facilities typically provide general
product categories as part of the registration process.  This generalized information would not
provide the identity of the article being imported or offered for import and, therefore, would not
meet the prior notice requirements as defined in section 801(m) of the act.  Therefore, we do not
agree that some of the registration information could be used to meet the prior notice information
needs.  Moreover, a facility’s registration contains all of the general food product categories the

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facility manufactures, processes, packs or holds; and would not allow FDA to know specifically
which article of food is the subject of the prior notice, which precludes an effective assessment
of risk.
(Comments) Several comments recommend that the limited information requirements
associated with food arriving by international mail in § 1.281(b) be applied to all importations.
One comment suggests that by eliminating such data as the entry type and identifier, the port of
entry, the FDA Product code, and the HTS code, all prior notices could be submitted via FDA’s
PNSI at an earlier time.  The comment further asserts that the requirement for these types of data
is the primary reason that 80 to 90 percent of prior notices are submitted via ABI/ACS rather
than PNSI.  Another comment reasons that as the manufacturer and facility identification
numbers are not provided for homemade food or postal shipments, the necessity of providing this
information for other types and modes should be examined.  Another comment recommends that
the notification procedure should be simplified, and that the data elements should be limited to
the minimum, such as the shipper’s name and its contact point, the food facility registration
number, and food product codes.
(Response) FDA disagrees.  The type of information required for prior notice
submissions of food arriving by international mail are limited because of the process by which
international mail enters the United States.  For international mail shipments, the IFR and the
final rule requires the identification of the U.S. recipient rather than the importer, owner, or
ultimate consignee because mail is sent only to a U.S. recipient rather than the multiple entities
that may be involved in a traditional commercial importation.  The final rule does not require an
entry identifier because international mail will always receive a system-generated identifier, as
international mail shipments cannot be submitted via ABI/ACS.   Because the port of entry and

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time and date of entry are completely subject to the international mail process, the IFR requires
only that the submitter identify the date of shipment, i.e., the date the food is shipped, which
provides the most information possible to satisfy the anticipated port of entry.  Moreover, since
international mail is always in the custody of CBP until it is released for delivery to the recipient,
no additional shipment information is necessary for communication between FDA and CBP.
FDA also disagrees that information, such as the entry type and identifier, the port of
entry, and the FDA Product Code should be eliminated from the prior notice requirements.  The
anticipated port of entry is specifically required by the statute and FDA has determined that the
best possible method of determining product identity is the FDA Product Code.  We have
eliminated the HTS code in the final rule because it has not been a necessary factor for
enhancing communication between FDA and CBP for the purpose of inspection at the port of
arrival.  However, the entry type and identifier are critical elements in communications between
FDA and CBP so that the appropriate food is either held at the port of arrival as appropriate, or
allowed to proceed.
FDA also disagrees with the suggestion that the manufacturer and facility registration
numbers are not provided for homemade food or postal shipments and, therefore, should not be
required for other types of shipments. The IFR excludes homemade food from prior notice
requirements entirely, and this exclusion also is in the final rule.  Both the IFR and the final rule
require submission of the identity of the manufacturer and the manufacturer’s registration
number in the prior notice for food arriving by international mail.
FDA agrees with the comments that prior notice requirements should be limited to the
minimum, and has selected those data elements that will allow FDA to expeditiously meet its
statutory obligation to receive, review, and respond to prior notices.  FDA, however, does not

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agree with the comments that the shipper’s name and its contact point, the registration number of
food facility, and food product codes are the only data elements FDA needs to fulfill this
mandate.  In addition to the Bioterrorism Act requirements of the identities of the article of food,
the manufacturer and shipper, the grower, if known, the country from which the article
originates, the country from which the article is shipped, and the anticipated port of entry for the
article, FDA determined that certain additional information is required for efficient enforcement
of the Bioterrorism Act, primarily for the means of identifying the article of food and effective
enforcement of refusals.
FDA also notes that it is not surprising that 80 to 90 percent of prior notices are
submitted via ABI/ACS.  Numerous comments on the proposed rule urged FDA to use the
existing ACS-OASIS interface between CBP and FDA to accept prior notice information. As
stated in the IFR, FDA and CBP agreed with the recommendation that the agencies provide a
single point of data entry for CBP and FDA for as many kinds of entries as possible, and
modified our systems to allow prior notice to be filed by either CBP’s ABI/ACS or FDA’s PNSI
beginning with the December 12, 2003, effective date of the IFR.  FDA also noted at that time
that it expected approximately 90 percent of prior notice submissions for all importations of
foods to be transmitted by a customs broker or self-filer through the ABI/ACS interface to FDA.
(See 68 FR 58974 at 58976, October 10, 2003.)  Since implementation, this estimate has proven
true, as approximately 83% of all prior notices are filed through the ABI/ACS interface.
(Comments) Several comments suggest that all prior notice information requirements
that are duplicative of information requirements for CBP via AMS for Advanced Electronic
Information or in ABI/ACS for Entry should be eliminated.  One comment recommends that

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prior notice be aligned with CBP “ACI” rules, for both timing and data elements.  The comment
believes that this could lead to a possible reduction in data elements.
(Response) FDA disagrees.  Information that is submitted for CBP entry processing is not
useful for prior notice as this information can be submitted or changed after the food already has
arrived in the United States and prior notice is required before the food arrives.
Moreover, no interface currently exists between AMS and the existing interface with
FDA's OASIS through the ABI/ACS entry processes, which means FDA does not have access to
AMS data.  FDA and CBP have discussed interfacing with AMS for manifest data and
determined that the general cargo data in AMS are not suitable to accommodate the detailed
information requirements of section 801(m) of the act.  For example, its collection of the
identities of the article of food and its manufacturer differs from the way those are collected
under the prior notice interim final and final rules in such a way that the data would not meet our
needs in carrying out the purpose of section 801(m) of the act.
(Comments) Many comments suggest that submitters consolidate similar prior notices
into one prior notice based on a variety of reasons, e.g., one prior notice per consignee with all
food products consolidated; one prior notice per shipment with all information consolidated; one
prior notice per commodity regardless of the quantity, size, color or species; one prior notice per
bill of lading; one prior notice per truck or conveyance and one prior notice for the same food
type regardless of brand.
(Response) The Bioterrorism Act requires notice for each article of food and requires in
that notice, for each article of food, certain information.  As stated in the IFR, an "article" refers
to a single food that is associated with the same complete FDA Product Code, the same package
size, and the same manufacturer or grower (68 FR 58974 at 59003).  This is consistent with how

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entry is filed with CBP.  An article of food is a unique item related to a specific manufacturer or
grower and a specific process or size.  All of these pieces of information are critical for a risk-
based assessment of the food.  The ABI/ACS system provides the capability to submit
information for multiple food items as lines in a single entry, when entry level information is
consistent for a number of articles in a shipment.  For example, shipment level information, such
as estimated time of arrival, can be captured once for all articles within a shipment.  The ability
to minimize data entry by copying specific information from one article, or line, to another
depends upon the sophistication of the software being used by the submitter to create the
submission to CBP.  The FDA PNSI allows for simplified submission of similar articles of food
by allowing the submitter to easily repeat common information (e.g., FDA product code,
manufacturer, etc.) while entering different quantities (e.g., amount and package size).  Both
systems thus significantly reduce the amount of repetitive entry.  The prior notice requirements
in the IFR or the final rule do not require the submission of the brand for the article of food.
(Comments) One comment suggests that different programs should not require different
information requirements.  The comment particularly focuses on FAST and C-TPAT and
recommends that prior notice submissions for those participating in these programs should be
subject to fewer information requirements.
(Response) FDA disagrees.  All of the information required in a prior notice is necessary
for determining what articles to inspect upon arrival and otherwise carrying out section 801(m)
of the act.  The information is initially screened electronically in order to expedite the PNC’s
review.  If less information is provided, regardless of whether the food is covered by some other
program, then the result of that screening would be less reliable.  This issue is discussed further

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in section III.D.6.a. of this document (“Additional Exclusions Requested – Special Programs (C-
TPAT/FAST) and Flexible Alternatives--General Comments”)
(Comments) Two comments refer to submission of “blanket” prior notices; one
referencing repetitive shipments of analytical samples and the other suggesting a summary of
daily shipments.
(Response) FDA disagrees that it should change its approach from the IFR.  As stated in
the preamble to the IFR (see 68 FR at 59003), an article of food is a unique item related to a
specific manufacturer or grower and a specific process or size. All of these pieces of information
are critical for a risk-based assessment of the food. FDA currently receives most of this
information from customs brokers or self-filers via ABI/ACS. The ABI/ACS system also
provides the capability to submit information for multiple food items as lines in a single entry,
when entry level information is consistent for a number of articles in a shipment. For example,
shipment level information, such as estimated time of arrival, can be captured once for all
articles within a shipment. The ability to minimize data entry by copying specific information
from one article, or line, to another depends upon the sophistication of the software being used to
create the submission to CBP. The FDA PNSI is designed to allow for simplified submission of
similar articles of food by allowing the submitter to easily repeat common information (e.g.,
FDA product code, manufacturer, etc.) while entering different quantities (e.g., amount and
package size). Both systems will thus significantly reduce the amount of repetitive entry of
information while preserving the identity of each article of food.  Moreover, the purpose of prior
notice is for FDA to receive, prior to arrival, information about each article of food being
imported or offered for import for the purpose of enabling such article to be inspected at ports of
entry into the United States.  Receiving blanket prior notices would not provide the necessary

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information nor would a daily summary, which by definition would be after-the-fact, not prior to
arrival.
2. The Submitter
In § 1.281(a)(1), (b)(1), and (c)(1), the IFR requires submission of the name of the
individual submitting the prior notice and his/her business address, telephone number, fax
number, e-mail address, and the name and address of the submitting firm, if applicable.  If a
registration number is provided, city and country may be provided instead of the full address.
(Comments) Several comments assert that it is duplicative and unnecessary to require not
only the corporate name and address of the submitter but an individual's name, telephone
number, fax number and e-mail address as well.  The comments contend that this information
already should exist in the FDA registration database and that the name of the submitting firm
should be sufficient.  The comments assert that in today’s job market, individuals change jobs
more frequently, thereby making the maintenance of this level of specificity in a database time
consuming with minimal benefit.
However, another comment states that the regulatory provisions in the prior notice IFR
are silent regarding which person(s) will be contacted by FDA and/or CBP when an issue or
problem arises regarding a prior notice and urge FDA to clarify that in refusal circumstances, the
agency will contact the person who submitted the prior notice (i.e., the submitter or the
transmitter.)  The comment further states that by reason of his or her knowledge and/or access to
the necessary information, as well as having the implicit authority and responsibility to properly
file the prior notice, the submitter or transmitter typically will be in the best position to take
corrective action as expeditiously as possible.

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(Response) FDA has determined that a fax number is not necessary for communication
with the submitter.  However, the identification of the individual and the firm, if applicable,
submitting the prior notice is needed so that FDA knows who is responsible for the information
in the prior notice and can communicate with them when necessary via mail, phone, or email.
The information submitted must provide sufficient information to enable FDA to communicate
questions, concerns, or enforcement information with the submitter.  See section III.J.1 of this
document regarding inadequate prior notice (§ 1.283(a)(1)) for a discussion of communication of
refusals.
(Comments) One comment suggests that there should be an option to identify whether or
not the submitter is C-TPAT certified.
(Response) As we previously explained in the discussion under our assessment of
timeframes (see section III.F of this document), C-TPAT participation will not affect timeframes,
the amount of information required to be submitted under prior notice, or decisions made during
the prior notice review process.  Thus, the costs to submitters and the government of submitting
such information would not provide benefits.  FDA will continue to coordinate with CBP for
administration of C-TPAT as it applies to FDA-regulated products, particularly as it relates to
admissibility decisions under section 801(a) of the act.  However, the prior notice final rule will
not require that the submitter self-declare as C-TPAT certified or not C-TPAT certified.
(Comments) One comment asks if it is possible for a submitter to have his/her legal
residence in the country of origin.
(Response) Neither the IFR nor the final rule limits the residence or location of the
submitter.  Section 1.278 of the final rule states that any person with the knowledge of the
required information may submit a prior notice.

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(Final rule) The final rule requires in § 1.281(a)(1), (b)(1), and (c)(1) the submission of
the name of the individual submitting the prior notice and his/her business address, telephone
number, and e-mail address, and the name and address of the submitting firm, if applicable.  We
reworded the last sentence of these paragraphs for clarity to state that if the business address of
the individual submitting the prior notice is a registered facility, then the facility’s registration
number, city, and country may be provided instead of the facility’s full address.
3. The Transmitter
Section 1.281(a)(2), (b)(2), and (c)(2) of the IFR requires the submission of the identity
of the transmitter, if different from the submitter. The IFR requires the name of the individual
and firm, if applicable, transmitting the prior notice on behalf of the submitter and his/her
business address, and phone number, fax number, and e-mail address.  If a registration number is
provided, city and country may be provided instead of the full address.
(Comments) A comment states that the regulatory provisions in the prior notice IFR are
silent regarding which person(s) will be contacted by FDA and/or CBP when an issue or problem
arises regarding a prior notice and urges FDA to clarify that in refusal circumstances, the agency