[Federal Register Volume 85, Number 190 (Wednesday, September 30, 2020)]
[Notices]
[Pages 61782-61787]
[FR Doc No: 2020-21554]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89991; File No. SR-MIAX-2020-31]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Exchange Rule 515A, MIAX Price
Improvement Mechanism (``PRIME'') and PRIME Solicitation Mechanism To
Adopt a New ISO Prime Order Type

September 24, 2020.
    Pursuant to the provisions of 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 September 17, 2020, Miami International
Securities Exchange, LLC (``MIAX Options'' or the ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') a 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 is filing a proposal to amend Exchange Rule 515A, MIAX
Price Improvement Mechanism (``PRIME'') and PRIME Solicitation
Mechanism.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/ at MIAX Options'
principal office, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Exchange Rule 515A, MIAX Price
Improvement Mechanism (``PRIME'') and PRIME Solicitation Mechanism, to
adopt a new ISO PRIME order type.
    PRIME is a process by which a Member \3\ may electronically submit
for execution (``Auction'') an order it represents as agent (``Agency
Order'') against principal interest, and/or an Agency Order against
solicited interest.\4\ A Member (the ``Initiating Member'') may
initiate an Auction provided all of the following are met: (i) The
Agency Order is in a class designated as eligible for PRIME as
determined by the Exchange and within the designated Auction order
eligibility size parameters as such size parameters are determined by
the Exchange; (ii) the Initiating Member must stop the entire Agency
Order as principal or with a solicited order at the better of the NBBO
\5\ or the Agency Order's limit price (if the order is a limit order);
and (iii) with respect to Agency Orders that have a size of less than
50 contracts, if at the time of receipt of the Agency Order, the NBBO
has a bid/ask differential of $0.01, the System \6\ will reject the
Agency Order.\7\
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    \3\ The term ``Member'' means an individual or organization
approved to exercise the trading rights associated with a Trading
Permit. Members are deemed ``members'' under the Exchange Act. See
Exchange Rule 100.
    \4\ See Exchange Rule 515A(a).
    \5\ The term ``NBBO'' means the national best bid or offer as
calculated by the Exchange based on market information received by
the Exchange from OPRA. See Exchange Rule 100.
    \6\ The term ``System'' means the automated trading system used
by the Exchange for the trading of securities. See Exchange Rule
100.
    \7\ See Exchange Rule 515A(a)(1).
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    An Intermarket Sweep Order (``ISO'') is defined in Exchange Rule
1400(i) as a limit order for an options series that, simultaneously
with the routing of the ISO, one or more additional ISOs, as necessary,
are routed to execute against the full displayed size of any Protected
Bid,\8\ in the case of a limit order to sell, or any Protected
Offer,\9\ in the case of a limit order to buy, for the options series
with a price that is superior to the limit price of the ISO. A Member
may submit an Intermarket Sweep Order to the Exchange only if it has
simultaneously routed one or more additional Intermarket Sweep Orders
to execute against the full displayed size of any Protected Bid, in the
case of a limit order to sell, or Protected Offer, in the case of a
limit order to buy, for an options series with a price that is superior
to the limit price of the Intermarket Sweep Order. An ISO may be either
an Immediate-Or-Cancel Order \10\ or an order that expires on the day
it is entered.\11\
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    \8\ A ``Protected Bid'' or ``Protected Offer'' means a Bid or
Offer in an options series, respectively, that: (a) Is disseminated
pursuant to the OPRA Plan; and (b) is the Best Bid or Best Offer,
respectively, displayed by an Eligible Exchange. See Exchange Rule
1400(p).
    \9\ Id.
    \10\ An immediate-or-cancel order is an order that is to be
executed in whole or in part upon receipt. Any portion not so
executed is cancelled. An immediate-or-cancel order is not valid
during the opening rotation process described in Rule 503. See
Exchange Rule 516(c).
    \11\ See Exchange Rule 1400(i).
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    The Exchange now proposes to implement an ISO PRIME order type
(``ISO PRIME'') that will allow the submission of an ISO into the
PRIME. Specifically, an ISO PRIME is the transmission of two orders for
crossing pursuant to Rule 515A, MIAX Price Improvement Mechanism
(``PRIME'') and PRIME Solicitation Mechanism, without regard for better
priced Protected Bids or Protected Offers because the Member
transmitting the ISO PRIME order to the Exchange has, simultaneously
with the submission of the ISO PRIME order, routed one or more ISOs, as
necessary, to execute against the full displayed size of any Protected
Bid or Protected Offer that is superior to the starting PRIME Auction
price, and has swept all interest in the Exchange's Book \12\ priced
better than the proposed Auction starting price. Any execution(s)
resulting from such sweeps shall accrue to the PRIME order, meaning
that any executions will be given to the agency side of the order.
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    \12\ The term ``Book'' means the electronic book of buy and sell
orders and quotes maintained by the System. See Exchange Rule 100.
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    The Exchange will accept an ISO PRIME provided that the order
adheres to the current PRIME order acceptance criteria outlined above,
except that the initiating Member is only required to stop the entire
Agency Order as principal or with a solicited order at the Agency
Order's limit price (if the order is a limit order). Therefore, a
Member (the ``Initiating Member'') may initiate an Auction provided
that: (i) The Agency Order is in a class designated as eligible for
PRIME as determined by the Exchange and within the designated Auction
order eligibility size parameters as such size parameters are
determined by the Exchange; and (ii) the Initiating Member must stop
the entire Agency Order as principal or with a solicited order at the
Agency Order's limit price (if the order is a limit order). Also, with

respect to Agency Orders that have a size of less than 50 contracts, if
at the time of receipt of the Agency Order, the NBBO has a bid/ask
differential of $0.01, the System will reject the Agency Order.\13\
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    \13\ See Exchange Rule 515A(a)(1).
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    The Exchange will process the ISO PRIME order in the same manner
that it currently processes PRIME Orders, except that it will initiate
a PRIME Auction without protecting away prices. The Member transmitting
the ISO PRIME order will bear the responsibility to clear all better
priced interest away simultaneously with the submission of the ISO
PRIME order to the Exchange.
    The Exchange also proposes to adopt a new allocation methodology
specifically for Market Maker \14\ interest that is executed during an
ISO PRIME Auction. Currently, allocation in a PRIME Auction follows the
order allocation methodology defined in Exchange Rule 515A(a)(2)(iii),
which provides that Priority Customer \15\ orders resting on the Book
before, or that are received during, the Response Time Interval \16\
and Priority Customer RFR \17\ responses shall, collectively have first
priority to trade against the Agency Order. The allocation of an Agency
Order against the Priority Customer orders resting in the Book,
Priority Customer orders received during the Response Time Interval,
and Priority Customer RFR responses shall be in the sequence in which
they are received by the System.\18\ Market Maker priority quotes \19\
and RFR responses from Market Makers with priority quotes will
collectively have second priority. The allocation of Agency Orders
against these contra sided quotes and RFR responses shall be on a size
pro rata basis \20\ as defined in Rule 514(c)(2).\21\ Professional
Interest \22\ orders resting in the Book, Professional Interest orders
placed in the Book during the Response Time Interval, Professional
Interest quotes, and Professional Interest RFR responses will
collectively have third priority. The allocation of Agency Orders
against these contra sided orders and RFR Responses shall be on a size
pro rata basis as defined in Rule 514(c)(2).\23\
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    \14\ The term ``Market Makers'' refers to ``Lead Market
Makers'', ``Primary Lead Market Makers'' and ``Registered Market
Makers'' collectively. See Exchange Rule 100.
    \15\ The term ``Priority Customer'' means a person or entity
that (i) is not a broker or dealer in securities, and (ii) does not
place more than 390 orders in listed options per day on average
during a calendar month for its own beneficial account(s). See
Exchange Rule 100.
    \16\ The ``Response Time Interval'' means the period of time
during which responses to the RFR may be entered. The RFR timer is
100 milliseconds. See MIAX Options Regulatory Circular 2017-30,
Change to MIAX Options PRIME Timer Effective June 16, 2017 (June 15,
2017) available at https://www.miaxoptions.com/sites/default/files/circular-files/MIAX_Options_RC_2017_30.pdf.
    \17\ When the Exchange receives a properly designated Agency
Order for auction processing, a Request for Responses (``RFR'')
detailing the option, side, size, and initiating price will be sent
to all subscribers of the Exchange's data feeds. See Exchange Rule
515A(a)(2)(i)(B).
    \18\ See Exchange Rule 515A(a)(2)(iii)(B).
    \19\ To be considered a priority quote, at the time of
execution, each of the following standards must be met: (A) The bid/
ask differential of a Market Maker's two-sided quote pair must be
valid width (no wider than the bid/ask differentials outlined in
Exchange Rule 603(b)(4)); (B) the initial size of both or the Market
Maker's bid and the offer must be in compliance with the
requirements of Exchange Rule 604(b)(2); (C) the bid/ask
differential of a Market Maker's two-sided quote pair must meet the
priority quote width requirements defined in Exchange Rule
517(b)(1)(ii) for each option; and (D) either of the following are
true: 1. At the time a locking or crossing quote or order enters the
System, the Market Maker's two-sided quote pair must be valid width
for that option and must have been resting on the Book; or 2.
Immediately prior to the time the Market Maker enters a new quote
that locks or crosses the MBBO, the Market Maker must have had a
valid width quote already existing (i.e., exclusive of the Market
Maker's new marketable quote or update) among his two-sided quotes
for that option. See Exchange Rule 517(b). The term ``MBBO'' means
the best bid or offer on the Exchange. See Exchange Rule 100.
    \20\ Exchange Rule 514(c)(2), Pro Rata Allocation, states that,
under this method, resting quotes and orders on the Book are
prioritized according to price and time. If there are two or more
quotes or orders at the best price then the contracts are allocated
proportionally according to size (in a pro-rata fashion). If the
executed quantity cannot be evenly allocated, the remaining
contracts will be distributed one at a time based upon price-size-
time priority.
    \21\ See Exchange Rule 515A(a)(2)(iii)(C).
    \22\ The term ``Professional Interest'' means (i) an order that
is for the account of a person or entity that is not a Priority
Customer, or (ii) an order or non-priority quote for the account of
a Market Maker. See Exchange Rule 100.
    \23\ See Exchange Rule 515A(a)(2)(iii)(D).
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    The Exchange now proposes to amend subsection (C) to adopt a new
allocation for Market Maker priority quotes at the conclusion of an
Auction for an ISO PRIME order. The proposed rule text will state that
at the conclusion of an Auction for an ISO PRIME order, the allocation
of Agency Orders at the final Auction price shall be: (i) To Market
Makers that traded in the associated ISO sweep, for up to the full size
of such Market Makers' refreshed priority quotes, as well as any RFR
responses submitted by those Market Makers; (ii) to those Market Makers
with quotes at the Auction start price that were resting and any RFR
responses submitted by those Market Makers at the final Auction price;
and (iii) to all other Market Makers that did not trade in the
associated ISO sweep and did not have resting quotes at the Auction
start price with joining interest at the final Auction price that was
submitted during the Auction. If two or more Market Makers are entitled
to priority under (i), (ii) or (iii) above, priority will be afforded
to the extent practicable on a pro-rata basis.
    This can be demonstrated in the following examples.
    Example 1--(Current PRIME Allocation) Single Price Submission,
Priority Customer has first priority and Market Maker with priority
quotes has second priority
ABBO \24\ = $1.15--$1.25 100 x 100
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    \24\ The term ``ABBO'' or ``Away Best Bid or Offer'' means the
best bid(s) or offer(s) disseminated by other Eligible Exchanges
(defined in Rule 1400(g)) and calculated by the Exchange based on
market information received by the Exchange from OPRA. See Exchange
Rule 100.
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    MM3 = $1.15--$1.25 100 x 100 (priority quote) \25\
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    \25\ The term ``priority quote'' has the meaning set forth in
Rule 517(b)(1)(i). See Exchange Rule 100. See also supra note 19.
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MBBO = $1.15--$1.25 100 x 100
NBBO = $1.15--$1.25 200 x 200

Agency Order to buy 50 contracts with a limit price of $1.20
Initiating Member's Contra Order selling 50 contracts with a single
stop price of $1.20
RFR sent identifying the option, side and size, with initiating price
of $1.20
(Auction Starts)

     @10 milliseconds MM1 response received (did not have a
priority quote on the Book), AOC eQuote to Sell 10 at $1.18
     @30 milliseconds BD4 response received, AOC order to Sell
10 at $1.18
     @50 milliseconds Priority Customer response received, AOC
order to Sell 15 at $1.18
     @75 milliseconds MM3 response received, AOC eQuote to Sell
20 at $1.18
     100 milliseconds (Auction Ends)

    Under this scenario the Agency Order would be executed as follows:

    1. 15 contracts trade with Priority Customer @$1.18
    2. 20 contracts trade with MM3 @$1.18
    3. 8 contracts trade with MM1 @$1.18
    4. 7 contracts trade with BD4 @$1.18 (This fills the entire Agency
Order and Contra Order does not receive an execution)

Example 2--(Proposed ISO PRIME Allocation) Single Price Submission,
Priority Customer has first priority and Market Maker (who initially
traded as part of the associated ISO Sweep) with joining quotes at the
final Auction price has second priority

ABBO = $1.15--$1.17 200 x 200
MM3 = $1.15--$1.17 100 x 10 (priority quote)
MBBO = $1.15--$1.17 100 x 10
NBBO = $1.15--$1.17 300 x 210

ISO PRIME Agency Order to buy 50 contracts with a limit price of $1.20
is received.
It will ISO Sweep resting liquidity priced better than the Auction
start price of $1.20.

    Under this scenario the Agency Order would be executed as follows:

    1. 10 contracts trade with MM3 @1.17
Contemporaneously the balance of the ISO PRIME Agency Order initiates a
PRIME Auction to buy 40 contracts with a limit price of $1.20
Initiating Member's Contra Order selling 50 contracts with a single
stop price of $1.20
RFR sent identifying the option, side and size, with initiating price
of $1.20
    (Auction Starts)

 @10 milliseconds MM1 response received, AOC eQuote to Sell 10
at $1.18
 @30 milliseconds BD4 response received, AOC order to Sell 10
at $1.18
 @40 milliseconds Priority Customer response received, AOC
order to Sell 15 at $1.18
 @65 milliseconds MM3 (who traded as part of the initial
sweep), response received, AOC eQuote to Sell 40 at $1.18
 100 milliseconds (Auction Ends)

    Under this scenario the Agency Order would be executed as follows:

2. 15 contracts trade with Priority Customer @$1.18
3. 25 contracts trade with MM3 @$1.18 (This fills the entire Agency
Order and Contra Order does not receive an execution)

    Example 3--(Proposed ISO PRIME Allocation) Single Price Submission,
Market Maker who has a joining quote at a better price has priority and
Market Maker (who has a resting quote at the Auction start price) that
submits an RFR response at the final Auction price has priority
ABBO = $1.15--$1.17 100 x 100
MM1 = $1.15--$1.17 10 x 10 (priority quote)
MM2 = $1.15--$1.20 20 x 20 (priority quote)
MM3 = $1.15--$1.21 20 x 20 (priority quote)
MBBO = $1.15--$1.17 50 x 10
NBBO = $1.15--$1.17 150 x 110

ISO PRIME Agency Order to buy 50 contracts with a limit price of $1.20
is received.
It will ISO Sweep resting liquidity priced better than the Auction
start price of $1.20.

    Under this scenario the Agency Order would be executed as follows:

    1. 10 contracts trade with MM1 @$1.17
Contemporaneously the balance of the ISO PRIME Agency Order initiates a
PRIME Auction to buy 40 contracts with a limit price of $1.20
Initiating Member's Contra Order selling 50 contracts with a single
stop price of $1.20
RFR sent identifying the option, side and size, with initiating price
of $1.20
    (Auction Starts)

     @10 milliseconds MM4 response received, AOC eQuote to Sell
30 at $1.18
     @30 milliseconds MM3 response received, AOC eQuote to Sell
20 at $1.19
     @75 milliseconds MM2 (who has a resting quote at the
Auction Start Price), response received, AOC eQuote to Sell 20 at $1.19
     100 milliseconds (Auction Ends)

    Under this scenario, the Agency Order would be executed as follows:

    2. 30 contracts trade with MM4 @$1.18
    3. 10 contracts trade with MM2 @$1.19 (This is the final Auction
price and fills the entire Agency Order and Contra Order and MM3 does
not receive an execution)

Example 4--(Proposed ISO PRIME Allocation) Single Price Submission,
Priority Customer has first priority and Market Maker (who initially
traded as part of an ISO Sweep) with joining quotes has second
priority, Market Maker with joining interest that is received during
the associated ISO PRIME Auction that did not trade in the associated
ISO sweep and did not have resting interest at the Auction start price
receives last priority among Market Makers
ABBO = $1.15--$1.17 200 x 200
MM3 = $1.15--$1.17 100 x 10 (priority quote)
MBBO = $1.15--$1.17 100 x10
NBBO = $1.15--$1.17 300 x 210

ISO PRIME Agency Order to buy 50 contracts with a limit price of $1.20
is received.
It will ISO Sweep resting liquidity priced better than the Auction
start price of $1.20.

    Under this scenario, the Agency Order would be executed as follows:

    1. 10 contracts trade with MM3 @1.17

Contemporaneously, the balance of the ISO PRIME Agency Order initiates
a PRIME Auction to buy 40 contracts with a limit price of $1.20
Initiating Member's Contra Order selling 50 contracts with a single
stop price of $1.20
RFR sent identifying the option, side and size, with an initiating
price of $1.20

    (Auction Starts)
    (Auction Starts)
     @10 milliseconds MM1 response received (did not have a
priority quote on the Book), AOC eQuote to Sell 20 at $1.18
 @30 milliseconds BD4 response received, AOC order to Sell 20
at $1.18
 @40 milliseconds Priority Customer response received, AOC
order to Sell 15 at $1.18
 @65 milliseconds MM3 (who traded as part of the initial
sweep), quote response received, AOC eQuote to Sell 20 at $1.18
 @100 milliseconds (Auction Ends)

    Under this scenario, the Agency Order would be executed as follows:

    2. 15 contracts trade with Priority Customer @$1.18
    3. 20 contracts trade with MM3 @$1.18
    4. 3 contracts trade with MM1 @$1.18
    5. 2 contracts trade with BD4 @$1.18 (This fills the entire Agency
Order and the Contra Order does not receive an execution)

    The Exchange believes this allocation methodology, used only for
Market Maker priority interest and only at the conclusion of an ISO
PRIME Auction, will provide an additional incentive for Market Makers
to provide their most aggressive quotes to the market throughout the
entire trading session.
    The Exchange also proposes to amend subsection (J) which currently
states, notwithstanding (a)(2)(iii)(C), (D) above, if the Auction does
not result in price improvement over the Exchange's disseminated price
at the time the Auction began, resting unchanged quotes or orders that
were disseminated at the best price before the Auction began shall have
priority after any Priority Customer order priority and the Initiating
Member's priority (40%) have been satisfied. The new proposed rule text
will provide, notwithstanding (a)(2)(iii)(C), (D) above, (provided the
Auction is not for an ISO PRIME order) if the Auction does not result
in price improvement over the Exchange's disseminated price at the time
the Auction began, resting unchanged quotes or orders that were
disseminated at the best price before the Auction began shall have
priority after any Priority Customer order priority and the

Initiating Member may not participate on any such balance unless the
Agency Order would otherwise go unfilled.
    The Exchange will announce the implementation of this order type in
a Regulatory Circular. The Exchange will announce the implementation
date of the proposed rule change by Regulatory Circular to be published
no later than 90 days following the operative date of the proposed
rule. The implementation date will be no later than 90 days following
the issuance of the Regulatory Circular.
2. Statutory Basis
    MIAX believes that its proposed rule change is consistent with
Section 6(b) of the Act \26\ in general, and furthers the objectives of
Section 6(b)(5) of the Act \27\ in particular, in that it is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in, securities, to remove impediments to and perfect the mechanisms of
a free and open market and a national market system and, in general, to
protect investors and the public interest.
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    \26\ 15 U.S.C. 78f(b).
    \27\ 15 U.S.C. 78f(b)(5).
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    The proposed rule change promotes just and equitable principles of
trade and removes impediments to and perfects the mechanisms of a free
and open market in that it promotes competition as described below.
Specifically, the proposal allows the Exchange to offer its Members an
order type that is already offered by another exchange.\28\ In
addition, the proposal benefits traders and investors because it adds a
new order type for seeking price improvement through the PRIME. ISO
PRIME orders will also be subject to all eligibility requirements that
currently apply to PRIME orders. The Initiating Member, simultaneous
with the routing of the ISO PRIME order to the Exchange, remains
responsible for routing one or more ISOs, as necessary, to execute
against the full displayed size of any Protected Bid or Protected Offer
that is superior to the starting PRIME Auction price and has swept all
interest in the Exchange's Book priced better than the proposed Auction
starting price. Finally, the proposal does not unfairly discriminate
among Members because all Members of the Exchange are eligible to
submit an ISO PRIME order.
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    \28\ See Nasdaq ISE Exchange Rule, Options 3, Section 13,
Supplementary Material .08.
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    The Exchange's proposal to adopt a new allocation at the conclusion
of an ISO PRIME Auction for Market Maker priority quotes and RFR
responses from Market Makers with priority quotes, that participate in
the associated ISO sweep, promotes just and equitable principles of
trade, perfects the mechanisms of a free and open market and a national
market system and, in general, benefits investors as it provides an
additional incentive to Market Makers to provide their most aggressive
quotes to the market at all times. Prioritizing Market Maker interest
such that Market Makers that trade in the associated ISO sweep that
also have joining interest at the final Auction price receive first
priority in allocation provides an incentive to Market Makers to have
their most aggressive quotes on the Book in order to participate in any
potential ISO sweeps.
    The Exchange's proposal does not change the existing allocation
priority for PRIME Auctions. The Exchange's proposal is narrowly
tailored to allocation priority only among Market Makers and only at
the conclusion of a PRIME Auction initiated by an ISO PRIME order.
    The Exchange currently uses priority quotes for trade allocation
purposes as described in Exchange Rule 517(b) which provides that,
quotes will be considered either priority quotes (i.e., trade
allocation will be in accordance with Rule 514(e), which provides
priority quotes with precedence over all Professional Interest) or non-
priority quotes (i.e., trade allocation will be in accordance with Rule
514(e), which also provides non-priority quotes are considered together
with all other Professional Interest) based upon a Market Maker's quote
width at certain times as described.\29\ To be considered a priority
quote, at the time of execution, each of the following standards must
be met: (A) The bid/ask differential of both of the Market Maker's two-
sided quote pair must be valid width (no wider than the bid/ask
differentials outlined in Rule 603(b)(4)); (B) the initial size of both
of the Market Maker's bid and the offer must be in compliance with the
requirements of Rule 604(b)(2); (C) the bid/ask differential of a
Market Maker's two-sided quote pair must meet the priority quote width
requirements defined in Exchange Rule 517(b)(ii) for each option; and
(D) either of the following are true: 1. At the time a locking or
crossing quote or order enters the System, the Market Maker's two-sided
pair must be valid width for that option and must have been resting on
the Book; or 2. Immediately prior to the time the Market Maker enters a
new quote that locks or crosses the MBBO, the Market Maker must have
had a valid width quote already existing (i.e., exclusive of the Market
Maker's new marketable quote or update) among his two-side quotes for
that option.\30\
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    \29\ See Exchange Rule 517(b).
    \30\ See Exchange Rule 517(b)(1)(i).
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    Exchange Rule 514(e) provides that after executions resulting from
Priority Overlays set forth in paragraph (d) of Rule 514, when the pro-
rata allocation method applies: (1) If there is other interest at the
NBBO, after all Priority Customer Orders (if any) at that price have
been filled, executions at that price will be first allocated to other
remaining Market Maker priority quotes, which have not received a
participation entitlement, and have precedence over Professional
Interest. (2) If after all Market Maker priority quotes have been
filled in accordance with (1) above and there remains interest at the
NBBO, executions will be allocated to all Professional Interest at that
price. Professional Interest is defined in Rule 100 and includes among
other interest, Market Maker non-priority quotes (as described in Rule
517(b)(1)(iii)) and Market Maker orders in both assigned and non-
assigned classes.\31\
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    \31\ See Exchange Rule 514(e).
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    The Exchange does not believe that the purpose of the proposed rule
change, to provide priority to a Market Maker at the conclusion of an
ISO PRIME Auction (among other Market Makers) that has also traded in
the associated ISO sweep, is a new or novel concept, as the Exchange
has an existing hierarchy of priority allocation based on priority
quotes as discussed above.
    Additionally, the Exchange believes its proposal to amend
subsection (J) to clarify that the subsection does not apply to
Auctions for ISO PRIME orders, promotes just and equitable principles
of trade, and removes impediments to and perfects the mechanisms of a
free and open market and a national market system and, in general,
protects investors and the public interest by removing any ambiguity in
the Exchange's rulebook about the type of Auctions subsection (J)
pertains to. Current subsection (J) provides additional clarifying
language concerning the priority of allocations at the conclusion of a
PRIME Auction that does not result in price improvement over the
Exchange's disseminated price at the time the Auction began stating
that, ``resting unchanged quotes or orders that were disseminated at
the best price before the Auction began shall have priority after any
Priority Customer order priority . . . .'' The

Exchange's proposal concerning allocation at the conclusion of an
Auction for an ISO PRIME order provides a more nuanced and detailed
hierarchy of allocation for Market Makers which would be applicable in
the scenario contemplated by subsection (J). Therefore, the Exchange is
proposing to exclude the application of subsection (J) to Auctions that
are initiated by ISO PRIME orders. The Exchange believes this change
eliminates any potential conflict regarding the application of the
Exchange's rules and it is in the public interest for rules to be
accurate and concise so as to eliminate the potential for confusion.
    The Exchange believes this change will benefit market participants
as it encourages Market Makers to participate in ISO PRIME Auctions and
will provide additional incentive to Market Makers to provide their
most aggressive quotes to the market throughout the trading session and
may also result in increased liquidity being available during the
Auction.

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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes the
proposed rule change will benefit inter-market competition as it will
allow the Exchange to compete with other markets that already allow an
ISO order type in their price improvement mechanisms.\32\
---------------------------------------------------------------------------

    \32\ See supra note 28.
---------------------------------------------------------------------------

    The Exchange's proposal to adopt an ISO PRIME order type benefits
intra-market competition because it will enable the Exchange to provide
market participants with an additional method of seeking price
improvement through the PRIME. The Exchange does not believe that the
proposed rule change will impose any burden on intra-market competition
as the Rules of the Exchange apply equally to all Exchange Members, and
all Exchange Members may submit an ISO PRIME order.
    The Exchange does not believe its proposal to further apportion
Market Maker allocation at the conclusion of an Auction of an ISO PRIME
order will impose any burden on intra-market competition but rather
promotes intra-market competition as it provides further incentive to
Market Makers to provide their most aggressive quotes to the market
throughout the entire trading session and may increase liquidity
available during a PRIME Auction. The proposal provides Market Makers
with priority quotes on the Book, that participate in an associated ISO
sweep, with priority over other Market Makers, which benefits intra-
market competition as it also provides an incentive to Market Makers to
provide their most aggressive quotes to the market during the entire
trading session to be in position to participate in any potential ISO
sweeps.
    The Exchange does not believe its proposal will impose any burden
on inter-market competition that is not necessary or appropriate in
furtherance of the purposes of the Act, but rather will promote inter-
market competition as it provides an additional incentive to Market
Makers on the Exchange to provide their most aggressive quotes to the
market at all times which could result in tighter quotes and greater
liquidity being available in the market place, which would benefit all
investors.
    The Exchange believes its proposal to amend subparagraph (J)
promotes just and equitable principles of trade and removes impediments
to and perfects the mechanism of a free and open market and a national
market system because the proposed rule change provides additional
detail and further clarifies the rule. It is in the public interest for
rules to be accurate and concise so as to eliminate the potential for
confusion.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \33\ and Rule 19b-4(f)(6) \34\
thereunder.
---------------------------------------------------------------------------

    \33\ 15 U.S.C. 78s(b)(3)(A).
    \34\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MIAX-2020-31 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-MIAX-2020-31. 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-MIAX-2020-31 and should be
submitted on or before October 21, 2020.
---------------------------------------------------------------------------

    \35\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\35\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-21554 Filed 9-29-20; 8:45 am]
BILLING CODE 8011-01-P


23073 Federal Register / Vol. 68, No. 83 / Wednesday, April 30, 2003 / Rules and Regulations [ FR Doc. 03   10262 Filed 4   29   03; 8: 45 a. m.]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0147; FRL   7302   4]

Bacillus thuringiensis Cry1F Protein in Cotton; Temporary Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry1F protein in cotton when applied/ used as a plant incorporated protectant. Mycogen Seeds, c/ o Dow AgroSciences LLC, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA), requesting the temporary/ tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus thuringiensis Cry1F protein in cotton. The temporary tolerance exemption will expire on May 1, 2004. DATES: This regulation is effective April 30, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0147, must be received by EPA on or before June 30, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Leonard Cole, Biopesticides and Pollution Prevention Division ( 7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   5412; e mail address: cole. leonard@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0147. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the Federal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml _ 00/ Title _ 40/ 40cfr180 _ 00. html, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of October 9, 2002 ( 67 FR 62971) ( FRL   7196   2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of a pesticide tolerance petition ( PP 2G6494) by Mycogen Seeds, c/ o Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268   1054. This notice included a summary of the petition prepared by the petitioner Mycogen Seeds, c/ o Dow AgroSciences LLC. Comments were received in response to the notice of filing. These comments were from grower groups, state agencies, and academia. All comments were in support of the registration of Dow AgroSciences' stacked gene plant incorporated protectant. The petition requested that 40 CFR part 180 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production in cotton. New section 408( c)( 2)( A)( i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is `` safe.'' Section 408( c)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *'' Additionally, section 408( b)( 2)( D) of the FFDCA requires that the Agency consider `` available information concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' EPA performs a number of analyses to determine the risks from aggregate VerDate Jan< 31> 2003 16: 41 Apr 29, 2003 Jkt 200001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 30APR1. SGM 30APR1 23074 Federal Register / Vol. 68, No. 83 / Wednesday, April 30, 2003 / Rules and Regulations exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

III. Toxicological Profile Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Data were submitted, reviewed, and determined acceptable for product characterization of Cry1F expressed in cotton ( construct pAGM281). Adequate product characterization data also were submitted to demonstrate that the Cry1F protein expressed in or on cotton and Cry1F protein expressed in or on corn were the same protein ( Ref. 2). The registrant requested that the data submitted for corn ( construct PHI 8999) be used to support the acute oral toxicity, in vitro digestibility, and heat stability studies for Cry1F protein expressed in or on cotton based on the substantial similarity to Cry1F protein expressed in corn which is already exempt from the requirement of a tolerance ( 40 CFR 180.1217). EPA reviewed the product characterization data for both Cry1F expressed in or on cotton and corn and determined that the Cry1F proteins are the same. Therefore, EPA has concluded that the data which supported the tolerance exemption for Cry1F and its genetic material necessary for its production in corn can also support Cry1F and its genetic material necessary for its production in or on cotton. Adequate data also was submitted to demonstrate that the Cry1F test material derived from microbial cultures was biochemically and, functionally similar to the protein produced by the plantincorporated protectant expressed in cotton ( Ref. 2). Production of microbially produced protein was chosen in order to obtain sufficient material for testing and because a diet of only cotton seed would not provide an adequate diet for test animals. The FIFRA Scientific Advisory Panel has supported this approach. See Mammalian Toxicity Assessment Guidelines for Protein Plant Pesticides ( SAP Report No. 2000   03B, September 28, 2000) at http:// www. epa. gov/ scipoly/ sap/ 2000/ June/ finbtmamtox. pdf. Given that the Cry1F protein produced in corn and cotton have been determined to be the same protein, EPA has determined that the acute oral toxicity ( MRID numbers 446911   01 and 450201   18), heat stability ( MRID numbers 452748   01 and 449717   01), and in vitro digestibility ( MRID number 447149   03) studies which support 40 CFR 180.1217 also support this exemption from the requirement of a tolerance. Although Cry1F expression level data were required for an environmental fate and effects assessment, residue chemistry data were not required for a human health effects assessment of the subject plant incorporated protectant ingredients because of the lack of mammalian toxicity. Data were submitted and reviewed which demonstrate the lack of mammalian toxicity at high levels of exposure to the pure Cry1F protein ( Ref. 3). These data adequately demonstrate the safety of the Cry1F protein at levels well above maximum possible exposure levels that are reasonably anticipated in the cotton crops ( Ref. 2). This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial Bacillus thuringiensis products from which this plant incorporated protectant was derived. See 40 CFR 158.740( b)( 2)( i). For microbial products, further toxicity testing and residue data are triggered by significant acute effects in studies such as the mouse oral toxicity study, to verify the observed effects and clarify the source of these effects ( Tiers II and III). Refer to the Bacillus thuringiensis Plant Incorporated Protectants Reassessment Biopesticide Regulatory Action Document ( BRAD) dated October 15, 2001 ( Ref. 3). The acute oral toxicity data ( MRID numbers 446911   01 and 450201   18) submitted support the prediction that the Cry1F protein is non toxic to humans. Male and female mice ( 5 of each) were dosed with 15% ( w/ v) of the test substance, which consisted of Bacillus thuringiensis var. aizawai Cry1F protein at a net concentration of 11.4%. Two doses were administered approximately an hour apart to achieve the dose totaling 33.7 milliliter/ kilogram ( mL/ kg) body weight. Outward clinical signs and body weights were observed and recorded throughout the 14   day study. Gross necropsies performed at the end of the study indicated no findings of toxicity. No mortality or clinical signs were noted during the study. A lethal dose ( LD) 50 was estimated at greater than 5,050 mg/ kg body weight of this microbially produced test material. The actual dose administered contained 576 mg Cry1F protein/ kg body weight. At this dose, no LD50 was demonstrated as no toxicity was observed. Cry1F cotton seeds contain 0.0017 to 0.0034 mg of Cry1F/ gram of cotton tissue which is a much lower level than the highest no observable effect level. When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels ( Ref. 1). Therefore, since no effects were shown to be caused by the plant incorporated protectant, even at relatively high dose levels, the Cry1F protein is not considered toxic. Further, amino acid sequence comparisons showed no similarity between Cry1F protein to known toxic proteins available in public protein data bases. Since Cry1F is a protein, allergenic sensitivities were considered. Current scientific knowledge suggests that common food allergens tend to be resistant to degradation by heat, acid, and proteases may be glycosylated and present at high concentrations in the food ( Ref. 3). Data were submitted and reviewed, and these data demonstrate that the Cry1F protein is rapidly degraded by gastric fluid in vitro and is non glycosylated. In a solution of Cry1F: pepsin at a molar ratio of 1: 100, complete degradation of Cry1F to amino acids and small peptides occurred in 5 minutes. A heat lability study demonstrated the loss of bioactivity of Cry1F protein to neonate tobacco budworm larvae after 30 minutes at 75 ° C. Studies submitted to EPA using laboratory animals have not indicated any potential for allergic reactions to Bacillus thuringiensis or its components, including the deltaendotoxin of the crystal protein. Additionally, a comparison of amino acid sequences of known allergens uncovered no evidence of any homology with Cry1F, even at the level of eight contiguous amino acids residues. The potential for the Cry1F protein to be a food allergen is minimal ( Ref. 2). Regarding toxicity to the immune system, the acute oral toxicity data submitted support the prediction that the Cry1F proteins are non toxic to humans. When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels ( Ref. 1). Therefore, since no effects were shown to be caused by the plant incorporated protectant, even at relatively high dose levels, the Cry1F protein is not considered toxic.

IV. Aggregate Exposures In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information VerDate Jan< 31> 2003 12: 41 Apr 29, 2003 Jkt 200001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 30APR1. SGM 30APR1 23075 Federal Register / Vol. 68, No. 83 / Wednesday, April 30, 2003 / Rules and Regulations concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings ( residential and other indoor uses). The Agency has considered the product characterization data showing expression levels of Cry1F protein in cotton seed exposure levels of consumers ( and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances. These considerations include dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for the plant incorporated protectants' chemical residue, and exposure from non occupational sources. Exposure via the skin or inhalation is not likely since the plant incorporated protectant is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. Oral exposure, at very low levels, may occur from ingestion of processed cottonseed oils and, potentially, drinking water. However, a lack of mammalian toxicity and the digestibility of the plant incorporated protectants have been demonstrated. The use sites for the Cry1F protein are all agricultural for control of insects. Therefore, exposure via residential or lawn use to infants and children is not expected. Even if negligible exposure should occur, the Agency concludes that such exposure would present no risk due to the lack of toxicity demonstrated for the Cry1F protein. Refer to the Bacillus thuringiensis Reassessment BRAD dated October 15, 2001.

V. Cumulative Effects Pursuant to FFDCA section 408( b)( 2)( D)( v), EPA has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations included the cumulative effects on infants and children of such residues and other substances with a common mechanism of toxicity. Because there is no indication of mammalian toxicity to these plantincorporated protectants, EPA concludes that there are no cumulative effects for the Cry1F protein. VI. Determination of Safety for U. S. Population, Infants and Children A. Toxicity and Allergenicity Conclusions The product characterization data are acceptable for Cry1F protein expressed in cotton. The Agency was able to determine that the Cry1F protein expressed in cotton was the same protein as the Cry1F expressed in corn which is covered by an existing tolerance exemption ( 40 CFR 180.1217). Also the Cry1F protein produced by microbial culture was biochemically and functionally similar to the protein produced by the plant incorporated protectant in cotton. Therefore, the Agency was able to bridge mammalian toxicity data from a previous submission for Cry1F protein expressed in corn to cover the mammalian toxicity studies required for Cry1F protein expressed in cotton. These studies are the acute oral toxicity ( MRID numbers 446911   01 and 450201   18), heat stability, amino acid homology ( MRID numbers 452749   01 and 449717   01) and in vitro digestibility ( MRID number 447149   03) studies. The data submitted and cited regarding potential health effects for the Cry1F protein include the characterization of the expressed Cry1F protein in corn, as well as the acute oral toxicity, heat stability, and in vitro digestibility of the proteins. The results of these studies were determined applicable to evaluate human risk and the validity, completeness, and reliability of the available data from the studies were considered. The acute oral toxicity data submitted supports the prediction that the Cry1F protein would be non toxic to humans. When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels ( Ref. 1). Since no effects were shown to be caused by Cry1F protein, even at relatively high dose levels (> 5,050 mg test substance/ kg body weight; 576 mg Cry1F/ kg body weight), the Cry1F protein is not considered toxic. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial Bacillus thuringiensis products from which this plantincorporated protectant was derived. See 40 CFR 158.740( b)( 2)( i). For microbial products, further toxicity testing and residue data are triggered by significant acute effects in studies such as the mouse oral toxicity study to verify the observed effects and clarify the source of these effects ( Tiers II and III). Although Cry1F expression level data were required for an environmental fate and effects assessment, residue chemistry data were not required for a human health effects assessment of the subject plant incorporated protectant ingredients because of the lack of mammalian toxicity. Both: available information concerning the dietary consumption patterns of consumers ( and major identifiable subgroups of consumers including infants and children); and safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives, are generally recognized as appropriate for the use of animal experimentation data. The lack of mammalian toxicity at high levels of exposure to the Cry1F protein demonstrates the safety of the product at levels well above possible maximum exposure levels anticipated in the crop. Refer to the Bacillus thuringiensis Reassessment BRAD dated October 15, 2001. Its genetic material necessary for the production of the plant incorporated protectant active ingredients are the nucleic acids ( DNA, RNA) which comprise genetic material encoding these proteins and their regulatory regions. The genetic material ( DNA, RNA) necessary for the production of Cry1F protein in cotton has been exempted under the blanket exemption for all nucleic acids ( 40 CFR 174.175).

B. Infants and Children Risk Conclusions FFDCA section 408( b)( 2)( C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408( B)( 2)( C) also provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different margin of safety will be safe for infants and children. In this instance, based on all the available information, the Agency concludes that there is a finding of no toxicity for the Cry1F protein and its genetic material necessary for its production in or on cotton. Thus, there are no threshold effects of concern and, as a result, the provision requiring an additional margin of safety does not apply. Further, the provisions of consumption patterns, special VerDate Jan< 31> 2003 12: 41 Apr 29, 2003 Jkt 200001 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 30APR1. SGM 30APR1 23076 Federal Register / Vol. 68, No. 83 / Wednesday, April 30, 2003 / Rules and Regulations susceptibility, and cumulative effects do not apply.

C. Overall Safety Conclusion There is a reasonable certainty that no harm will result from aggregate exposure to the U. S. population, including infants and children, to the Cry1F protein and its genetic material necessary for its production in or on cotton. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion because, as discussed above, no toxicity to mammals has been observed for the plant incorporated protectants.

VII. Other Considerations A. Endocrine Disruptors The pesticidal active ingredients are proteins, derived from sources that are not known to exert an influence on the endocrine system. Therefore, the Agency is not requiring information on the endocrine effects of these plantprotectants at this time.

B. Analytical Method A method for extraction and direct enzyme linked immunosorbent assay analysis of Cry1F in cotton has been submitted ( MRID number 458084   23). This method is adequate to support a temporary tolerance exemption.

C. Codex Maximum Residue Level No Codex maximum residue levels exists for the plant incorporated protectants Bacillus thuringiensis Cry1F protein and its genetic material necessary for its production in or on cotton.

VIII. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d), as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2003   0147 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before June 30, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VIII. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2003   0147, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32).

VerDate Jan< 31> 2003 12: 41 Apr 29, 2003 Jkt 200001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 30APR1. SGM 30APR1 23077 Federal Register / Vol. 68, No. 83 / Wednesday, April 30, 2003 / Rules and Regulations IX. References 1. Sjoblad, Roy D., et al. `` Toxicological Considerations for Protein Components of Biological Pesticide Products,'' Regulatory Toxicology and Pharmacology 15L, 3 9 ( 1992). 2. U. S. EPA. Memorandum, S. R. Matten, Ph. D. to L. Cole. March 26, 2003. 3. U. S. EPA. Bacillus thuringiensis Plant Incorporated Protectants Reassessment BRAD. October 15, 2001.

X. Statutory and Executive Order Reviews This final rule establishes a temporary exemption from the requirement of a tolerance under section 408( d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the temporary exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects 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.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, 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, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

XI. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule '' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: April 11, 2003. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

 Therefore, 40 CFR chapter I is amended as follows:

PART 180   AMENDED  1. The authority citation for part 180 continues to read as follows:

Authority: 21 U. S. C. 321( q), 346( a) and 371.

 2. Section 180.1227 is added to subpart D to read as follows:

§ 180.1227 Bacillus thuringiensis Cry1F protein and its genetic material necessary for its production in or on cotton; temporary exemption from the requirement of a tolerance.

Bacillus thuringiensis Cry1F protein and its genetic material necessary for its production in cotton are exempt from the requirement of a tolerance when used as a plant incorporated protectant in the food and feed commodity of cotton. This temporary tolerance exemption expires on May 1, 2004.

[ FR Doc. 03   10663 Filed 4   29   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [ FRL   7490   3]

National Priorities List for Uncontrolled Hazardous Waste Sites AGENCY: Environmental Protection Agency.

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[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Notices]
[Page 11779]
[FR Doc No: 2014-04518]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER14-1343-000]

Bargain Energy, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Bargain Energy, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is March 17, 2014.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 24, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-04518 Filed 2-28-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 165 (Tuesday, August 25, 2020)]
[Notices]
[Page 52340]
[FR Doc No: 2020-18581]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-506-000]

ANR Pipeline Company; Notice of Request Under Blanket
Authorization

    Take notice that on August 4, 2020, ANR Pipeline Company (ANR), 700
Louisiana Street Houston, Texas 77002-2700, filed in the above
referenced docket, a prior notice request pursuant to sections 157.205
and 157.216(b) of the Commission's regulations under the Natural Gas
Act (NGA) and ANR's blanket certificate issued in Docket No. CP82-480-
000, for authorization to abandon in place by cut and capping ten
storage injection/withdrawal wells within the Lincoln Freeman Storage
Field in Clare County, Michigan in order to minimize the potential
impact of gas leakage into underground fresh water reservoirs (2020
Lincoln Freeman Plug and Abandonment Project). Details of ANR's 2020
Lincoln Freeman Plug and Abandonment Project is more fully set forth in
the application which is on file with the Commission and open to public
inspection. In addition to publishing the full text of this document in
the Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions regarding this prior notice request should be
directed to Sorana Linder, Director, Modernization & Certificates, ANR
Pipeline Company, 700 Louisiana Street, Houston, Texas 77002-2700,
phone:<PHONE_NUMBER> or email<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention. Any person filing to intervene, or
the Commission's staff may, pursuant to section 157.205 of the
Commission's Regulations under the NGA (18 CFR 157.205) file a protest
to the request. If no protest is filed within the time allowed
therefore, the proposed activity shall be deemed to be authorized
effective the day after the time allowed for protest. If a protest is
filed and not withdrawn within 30 days after the time allowed for
filing a protest, the instant request shall be treated as an
application for authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all federal authorizations
within 90 days of the date of issuance of the Commission staff's EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commenters will not be required to serve
copies of filed documents on all other parties. However, the non-party
commenters will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments
in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. In
lieu of electronic filing, you may submit a paper copy. Submissions
sent via the U.S. Postal Service must be addressed to: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street
NE, Room 1A, Washington, DC 20426. Submissions sent via any other
carrier must be addressed to: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852.

    Dated: August 17, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-18581 Filed 8-24-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4257-4258]
[FR Doc No: 2022-01605]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6752]

Information Requests and Discipline Review Letters Under Generic
Drug User Fee Amendments; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Information Requests and Discipline Review Letters Under GDUFA.''
This guidance explains how FDA will issue and use an information
request (IR) and/or a discipline review letter (DRL) during the
assessment of an original abbreviated new drug application (ANDA) under
the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance
finalizes the draft guidance of the same title issued on December 18,
2017.

DATES: The announcement of the guidance is published in the Federal
Register on January 27, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6752 for ``Information Requests and Discipline Review
Letters Under GDUFA.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002 or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: David Coppersmith, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993-0002, 301-
796-9193, [email protected]; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Information Requests and Discipline Review Letters Under
GDUFA.''
    In negotiations held as part of the Generic Drug User Fee
Amendments of 2017 (GDUFA II), it was agreed that FDA will: (1) Issue
an IR to request further information or clarification that is needed or
would be helpful to allow completion of a discipline assessment and/or
(2) issue a new type of letter for ANDAs, known as a DRL, to convey
preliminary thoughts on possible deficiencies found by a discipline
assessor and/or assessment team for its or their portion of the
application under assessment at the conclusion of a discipline
assessment.\1\
---------------------------------------------------------------------------

    \1\ FDA Reauthorization Act of 2017 (FDARA), Public Law 115-52
(2017). FDARA includes GDUFA II, and by reference, the GDUFA
Reauthorization Performance Goals and Program Enhancements Fiscal
Years 2018-2022 (GDUFA II Commitment Letter).

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

    This guidance explains how FDA will issue and use an IR and a DRL
during the assessment of an original ANDA under section 505(j) of the
FD&C Act (21 U.S.C. 355(j)), as contemplated under GDUFA II. This
guidance does not apply to an amendment made in response to a Complete
Response Letter, a supplement, or an amendment to a supplement.
    This guidance identifies the timing of FDA's issuance of an IR or a
DRL and the effect FDA's issuance of an IR or a DRL will have on the
assessment clock for a given assessment cycle.
    This guidance finalizes the draft guidance entitled ``Information
Requests and Discipline Review Letters Under GDUFA'' issued on December
18, 2017 (82 FR 60018). FDA considered comments received on the draft
guidance as the guidance was finalized. Minor changes were made from
the draft to the final guidance, primarily to reflect current
terminology.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Information Requests and Discipline Review
Letters Under GDUFA.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 314 for approval of abbreviated new drug
applications have been approved under OMB control number 0910-0001. The
collections of information that support FDA's guidance for industry on
controlled correspondence related to generic drug development have been
approved under OMB control number 0910-0797.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: January 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01605 Filed 1-26-22; 8:45 am]
BILLING CODE 4164-01-P