[Federal Register Volume 82, Number 85 (Thursday, May 4, 2017)]
[Notices]
[Pages 20951-20956]
[FR Doc No: 2017-08981]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80554; File No. SR-C2-2017-016]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Related to Rule 6.13

April 28, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 25, 2017, C2 Options Exchange, Incorporated (the
``Exchange'' or ``C2'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I and II below, which Items have been prepared by the
Exchange. The Exchange filed the proposal pursuant to Section
19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange seeks to amend Rule 6.13. The text of the proposed
rule change is provided below.
    (additions are italicized; deletions are [bracketed])
* * * * *

C2 Options Exchange, Incorporated Rules

* * * * *

Rule 6.13. Complex Order Execution

    (a)-(b) No change.
    (c) Process for Complex Order RFR Auction. Prior to routing to the
COB, eligible complex orders may be subject to an automated request for
responses (``RFR'') auction process.
    (1) For purposes of paragraph (c):
    (A) ``COA'' is the automated complex order RFR auction process.
    (B) A ``COA-eligible order'' means a complex order that, as
determined by the Exchange on a class-by-class basis, is eligible for a
COA considering the order's [marketability (defined as a number of
ticks away from the current market),] size, complex order type and
complex order origin types (i.e. non-broker-dealer public customer,
broker-dealers that are not Market-Makers or specialists on an options
exchange, and/or Market-makers or specialists on an options exchange).
Complex orders processed through a COA may be executed without
consideration to prices of the same complex orders that might be
available on other exchanges.
    (2) Initiation of a COA:
    (A) The System will send an RFR message to all Participants who
have elected to receive RFR messages on receipt of (i) a COA-eligible
order with two or more legs that is better than the same side of the
Exchange spread market or (ii) a complex order with three or more legs
that meets the class, size, and complex order type parameters of
subparagraph (c)(1)(B) and is marketable against the Exchange spread
market. Complex orders as described in subparagraph (c)(2)(A)(ii) will
initiate a COA regardless of the order's routing parameters or handling
instructions. Immediate or cancel orders that are not marketable
against the derived net market in accordance with subparagraph
(c)(2)(B) will be cancelled. The RFR message will identify the
component series, the size and side of the market of the COA-eligible
order and any contingencies, if applicable.
    (B) [Notwithstanding the foregoing, Participants may request on an
order-by-order basis that incoming COA-eligible orders not COA (a ``do-
not-COA'' request).] Notwithstanding subparagraph (c)(2)(A)(i), Trading
Permit Holders may request on an order-by-order basis that an incoming
COA-eligible order with two legs not COA (a ``do-not-COA'' request).
Notwithstanding subparagraph (c)(2)(A)(ii), the System will reject back
to a Trading Permit Holder any complex order described in that
subparagraph that includes a do-not-COA request. An order initially
submitted to the Exchange with a do-not-COA request may still COA after
it has rested on the COB pursuant to Interpretation and Policy .02.
    (3)-(9) No change.
    . . . Interpretations and Policies:
    .01-.07 No change.
* * * * *
    The text of the proposed rule change is also available on the
Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, 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
    Exchange seeks to amend Rule 6.13(c) in order to hardcode the
marketability

parameter (i.e., the price at which a complex order may initiate a
COA); amend Rule 6.13(c)(2) related to when a complex order will
initiate a COA to account for risks to Market-Makers associated with
the use of the Exchange's Quote Risk Monitoring (``QRM'') Mechanism;
and amend Rule 6.13(c)(2) to make conforming changes to the ``do-not-
COA'' functionality. The Exchange notes that other than the fact the
proposed rule text does not reference manual order handling or the
Public Automated Routing (``PAR'') workstation (because C2 is entirely
electronic) all of the proposed rule changes are based on and identical
to CBOE Rule 6.53C(d)(i)-(ii).
Marketability
    Currently, the marketability parameter in Rule 6.13(c)(1)(B)
defined as a number of ticks away from the current market, sets the
price at which a complex order will initiate a COA. The Exchange
proposes to remove the marketability parameter from the definition of
``COA-eligible order,'' which will remove the Exchange's flexibility to
set the price at which a complex order will initiate a COA. The
Exchange does not foresee any issues with removing the flexibility to
determine the price at which a COA will be initiated because the
Exchange does not foresee a future need to modify the price at which
auctions are initiated. If unforeseen circumstances arise where the
Exchange believes it is necessary to modify the price at which auctions
are initiated then the Exchange will submit a subsequent rule filing.
Additionally, removing such flexibility may provide increased certainty
to market participants about the price at which a complex order will
initiate a COA, helping to remove impediments to and perfect the
mechanism of a free and open market.
    The Exchange proposes to hardcode the price at which a complex
order may initiate a COA in Proposed Rule 6.13(c)(2)(A). For example,
assuming all of the non-price specific requirements are met, a complex
order with two or more legs under proposed subparagraph (c)(2)(A)(i)
will initiate a COA if the Exchange spread market \5\ is 1-1.20 and the
complex order is to buy at $1.01 or higher or to sell at 1.19 or
lower.\6\ Additionally, assuming the non-price specific requirements
are met, a complex order with three legs under subparagraph
(c)(2)(A)(ii) will initiate a COA if the Exchange Spread Market is 1-
1.20 and the complex order is to buy at $1.20 or higher or to sell at
$1.00 or lower. Initiating a COA in these situations will relieve the
risk to Market-Makers noted below, which helps promote just and
equitable principles of trade by relieving risk to Market-Makers
allowing them to more efficiently and effectively provide important
liquidity.
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    \5\ The term ``Exchange spread market'' means the derived net
market based on the BBOs in the individual series legs comprising a
complex order and, if a stock-option order, the NBBO of the stock
leg. See Rule 1.1.
    \6\ The Exchange notes that the prices at which a complex order
will initiate a COA under subparagraph (c)(2)(A)(i) is consistent
with the current settings for the marketability parameter. This
portion of the proposal simply hardcodes existing settings.
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QRM
    Under Rule 8.12, C2 offers Market-Makers that are obligated to
provide and maintain continuous electronic quotes in an option class
the QRM Mechanism, which is functionality to help Market-Makers manage
their quotes and related risk. Market-Makers with appointments on the
System \7\ must, among other things, provide and maintain continuous
electronic quotes in a specified percentage of series in each class for
a specified percentage of time.\8\ To comply with this requirement,
each Market-Maker may use its own proprietary quotation and risk
management system to determine the prices and sizes at which it quotes.
In addition, each Market-Maker may use QRM.\9\
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    \7\ The term ``System'' means the automated trading system used
by the Exchange for the trading of options contracts. See Rule 1.1.
    \8\ See e.g., Rules 8.5, 8.13, and 8.17.
    \9\ Although Market-Makers or Participant organizations must
establish parameters for an acronym or firm, as applicable, for each
QRM function set forth in Rule 8.12, a Market-Maker or Participant
organization could set the value for the total number of contracts
executed in a class at a level exceeding the total number of
contracts it actually quotes in the class, which allows Market-
Makers or Participant organization who prefer to use their own risk-
management systems to enter values that assure the Exchange
parameters will not be triggered.
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    A Market-Maker's risk in a class is not limited to the risk in a
single series of that class. Rather, a Market-Maker is generally
actively quoting in multiple classes, and each class may comprise
hundreds or thousands of individual series. The System automatically
executes orders against a Market-Maker's quotes in accordance with the
Exchange's priority and allocation rules.\10\ As a result, a Market-
Maker has exposure and risk in all series in which it is quoting in
each of its appointed classes. QRM is an optional functionality that
helps Market-Makers, and Participant organizations with which a Market-
Maker is associated, limit this overall exposure and risk.
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    \10\ See Rules 6.12 and 6.13.
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    Specifically, if a Market-Maker elects to use QRM, the System will
cancel a Market-Maker's quotes in all series in an appointed class if
certain parameters the Market-Maker establishes are triggered. Market-
Makers may set the following QRM parameters (Market-Makers may set
none, some or all of these parameters):
     A maximum number of contracts for that class (the
``contract limit'') and a specified rolling time period in seconds
within which such contract limit is to be measured (the ``measurement
interval'');
     a maximum cumulative percentage (which is the sum of the
percentages of the original quoted size of each side of each series
that trade) (the ``cumulative percentage limit'') that the Market-Maker
is willing to trade within a specified measurement interval; or
     a maximum number of series for which either side of the
quote is fully traded (the ``number of series fully traded'') within a
specified measurement interval.
    If the Exchange determines the Market-Maker has traded more than
the contract limit or cumulative percentage limit, or has traded at
least the number of series fully traded, of a class during the
specified measurement interval, the System will cancel all of the
Market-Maker's electronic quotes in that class (and any other cases
with the same underlying security) until the Market-Maker refreshes
those quotes (a ``QRM Incident''). A Market-Maker, or Participant
organization with which the Market-Maker is associated, may also
specify a maximum number of QRM Incidents that may occur on an
Exchange-wide basis during a specified measurement interval. If the
Exchange determines that a Market-Maker or Participant Organization, as
applicable, has reached its QRM Incident limit during the specified
measurement interval, the System will cancel all of the Market-Maker's
or Participant Organization's quotes, as applicable, and the Market-
Maker's orders resting in the book in all classes and prevent the
Market-Maker and Participant organization from sending additional
quotes or orders to the Exchange until the earlier to occur of (1) the
Market-Maker or Participant organization reactivates this ability or
(2) the next trading day.
    The purpose of the QRM functionality is to allow Market-Makers to
provide liquidity across most series in their appointed classes without
being at risk of executing the full cumulative size of all their quotes
before being given

adequate opportunity to adjust their quotes. For example, if a Market-
Maker can enter quotes with a size of 25 contracts in 100 series of
class ABC, its potential exposure is 2,500 contracts in ABC. To
mitigate the risk of having all 2,500 contracts in ABC execute without
the opportunity to evaluate its positions, the Market-Maker may elect
to use QRM. If the Market-Maker elects to use the contract limit
functionality and sets the contract limit at 100 and the measurement
interval at five seconds for ABC, the System will automatically cancel
the Market-Maker's quotes in all series of ABC if 100 or more contracts
in series of ABC execute during any five-second period.
    To assure that all quotations are firm for their full size, the
System performs the parameter calculations after an execution against a
Market-Maker's quote occurs. For example, using the same parameters in
class ABC as above, if a Market-Maker has executed a total of 95
contracts in ABC within the previous three seconds, a quote in a series
of ABC with a size of 25 contracts continues to be firm for all 25
contracts. An incoming order in that series could execute all 25
contracts of that quote, and, following the execution, the total size
parameter would add 25 contracts to the previous total of 95 for a
total of 120 contracts executed in ABC. Because the total size executed
within the previous five seconds now exceeds the 100 contract limit for
ABC, the System would, following the execution, immediately cancel all
of the Market-Maker's quotes in series of ABC. The Market-Maker would
then enter new quotes for series in ABC. Thus, QRM limits the amount by
which a Market-Maker's executions in a class may exceed its contract
limit to the largest size of its quote in a single series of the class
(or 25 in this example).
    The Exchange proposes to amend Rule 6.13 regarding complex orders
to limit a potential source of unintended Market-Maker risk related to
how the System calculates risk parameters under Rule 8.12 when complex
orders leg into the market.\11\ As discussed above, by checking the
risk parameters following each execution in a series, the risk
parameters allow a Market-Maker to provide liquidity across multiple
series of a class without being at risk of executing the full
cumulative size of all its quotes. This is not the case, however, when
a complex order legs into the regular market (i.e., the market for
individual, or simple, orders). Because the execution of each leg of a
complex order is contingent on the execution of the other legs, the
execution of all the legs in the regular market is processed as a
single transaction, not as a series of individual transactions.
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    \11\ Rule 6.13(b)(1)(A) provides that complex orders in the
complex order book (``COB'') may execute against individual orders
or quotes in the book provided the complex order can be executed in
full (or a permissible ratio) by the orders and quotes in the book.
Rule 6.13(c)(5)(A) provides that orders that are eligible for the
complex order auction (``COA'') may trade with individual orders and
quotes in the book provided the COA-eligible order can be executed
in full (or a permissible ratio) by the orders and quotes in the
book. COA is an automated request for responses (``RFR'') auction
process. Upon initiation of a COA, the Exchange sends an RFR message
to all Trading Permit Holders who have elected to receive RFR
messages, which RFR message identifies the series, size and side of
the market of the COA-eligible order and any contingencies. Eligible
market participants may submit responses during a response time
interval. At the conclusion of the response time interval, COA-
eligible orders are allocated in accordance with Rule 6.13(c)(5),
including against individual orders and quotes in the book.
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    For example, if market participants enter into the System
individual orders to buy 25 contracts for the Jan 30 call, Jan 35 call,
Jan 40 call and Jan 45 call in class ABC, the System processes each
order as it is received and calculates the Market-Makers parameters in
class ABC following the execution of each 25-contract call. However, if
a market participant enters into the System a complex order to buy all
four of these strikes in class ABC 25 times, which complex order
executes against bids and offers for the individual series (i.e., legs
into the market), the System will calculate the Market-Maker's
parameters in class ABC following the execution of all 100 contracts.
If the Market-Maker had set the same parameters in class ABC as
discussed above (100-contract limit with five-second measurement
interval) and had executed 95 contracts in class ABC within the
previous three seconds, the amount by which the next transaction might
exceed 100 is limited to the largest size of its quote in a single
series of the class. In that example, since the largest size of the
Market-Maker's quotes in any series was 25 contracts, the Market-Maker
could not have exceeded the 100-contract limit by more than 20
contracts (95 + 25 = 120). However, with respect to the complex order
with four legs 25 times, the next transaction against the Market-
Maker's quotes potentially could be as large as 100 contracts
(depending upon whether there are other market participants at the same
price), creating the potential in this example for the Market-Maker to
exceed the 100-contract limit by 95 contracts (95 + 100 = 195) instead
of 20 contracts.
    As this example demonstrates, legging of complex orders into the
regular market presents higher risk to Market-Makers than executing
their quotes against individual orders entered in multiple series of a
class in the regular market, because it may result in Market-Makers
exceeding their risk parameters by a greater number of contracts. This
risk is directly proportional to the number of legs associated with a
complex order. Market-Makers have expressed concerns to the Exchange
regarding this risk.
    As noted above, it is the legging of complex orders into the
regular market that presents the potential risk to Market-Makers.
Generally, a complex order has the potential to leg into the market
when the complex order is marketable against leg quotes. For example,
if the Exchange spread market of a complex order strategy is 1.00-1.20
and a complex order to buy or sell at $1.10 is entered, the complex
order would not execute against the legs of the regular market because
the leg markets (which make-up the Exchange spread market) cannot
satisfy the order. A complex order to buy at $1.20 or higher or to sell
at $1.00 or lower (i.e., an order that is marketable against the
Exchange spread market) would potentially be executable against the leg
quotes.
    To address this Market-Maker risk, the Exchange proposes to add
subparagraph (2)(A)(ii) to Rule 6.13(c) to require certain orders with
three or more legs to COA prior to entering the COB. But first, for
clarity sake, the Exchange proposes to add subparagraph (2)(A)(i) to
Rule 6.13(c) to provide that the System will initiate a COA upon
receipt of a COA-eligible order (i.e., an order that meets the class,
size, complex order type and complex order origin types parameters)
\12\ with two or more legs that is better than the same side of the
Exchange spread market. The Exchange notes that subparagraph (2)(A)(i)
is not a substantive change. Subparagraph (2)(A)(i) simply reorganizes
the currently effective rule. Whereas today Rule 6.13(c)(2) states that
the System will initiate a COA on receipt of a COA-eligible order,
which currently means an order with two or more legs that meets the
class, marketability, size, order type, and origin type parameters,
proposed subparagraph (2)(A)(i) states that the System will initiate a
COA on receipt of a COA-eligible order (which as proposed in
subparagraph (c)(1)(B) will continue to include the class, size, order
type, and origin type parameters but will no longer include the
marketability parameter as it will be hardcoded into subparagraph
(c)(A)(i)) with two or more

legs \13\ that is better than the same side of the Exchange spread
market (which is the current setting for marketability). As noted, the
purpose of subparagraph (2)(A)(i) is to provide clarity as it relates
to additional subparagraph (2)(A)(ii), and the Exchange believes
reorganizing current functionality into paragraph (2)(A)(i) will help
bring clarity to subparagraph (2)(A)(ii).
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    \12\ See Rule 6.13(c)(1)(B).
    \13\ Including ``two or more legs'' in proposed subparagraph
(A)(i) is actually superfluous language because the term ``COA-
eligible order'' by definition must be a ``complex order,'' and a
``complex order'' by definition must have two or more legs. See Rule
6.13(c)(1)(B). A ``complex order'' is by definition two or more
legs. See Rule 6.13(a)(1).
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    Now, with regards to subparagraph (2)(A)(ii), the Exchange proposes
to provide that the System will initiate a COA upon receipt of a
complex order with three or more legs that meets the class, size, and
complex order type parameters of subparagraph (c)(1)(B) and is
marketable against the Exchange spread market. The purpose of proposed
subparagraph (2)(A)(ii) of Rule 6.13(c) is simply to allow certain
orders with three legs that will not COA under subparagraph
(c)(2)(A)(i) to COA pursuant to subparagraph (c)(2)(A)(ii). In short,
if an order with three or more legs does not COA pursuant to Rule
6.13(c)(2)(A)(i)--because it is not COA-eligible--it may still COA
pursuant to Rule 6.13(c)(2)(A)(ii), as long as the order meets the
class, size, complex order type parameters of subparagraph (c)(1)(B)
and is marketable against the Exchange Spread market.
    For example, complex orders identified as IOC are not currently
COA-eligible under the current rule (and the Exchange has no plans at
this time to make them COA-eligible pursuant to proposed subparagraph
(2)(A)(i)). However, IOC orders that have a large number of legs that
execute immediately against prices in the leg markets are an example of
orders that cause the risk to Market-Makers described above. Also, such
orders do not appear to have investment strategies similar to
traditional complex orders but instead are specifically designed to
circumvent QRM settings. Thus, proposed subparagraph (2)(A)(ii) will
allow the Exchange to initiate a COA upon receipt of orders with three
or more legs that meet the class, size, order type parameter (including
IOCs) that are marketable against the Exchange spread market.
    The proposed rule change will only impact a small percentage of
complex orders that enter into the System, as a large percentage of
complex orders entered into the System are only two legs. The Exchange
also notes that complex orders with three or more legs will still have
opportunities for execution through COA or on the COB if they do not
execute at the end of the COA (including execution with the leg
markets). Thus, the Exchange believes that requiring complex orders
with three or more legs to COA prior to entering COB and legging into
the regular market does not create any unusual circumstances for the
System. The Exchange believes that the potential risk to Market-Makers
in the regular market of allowing orders with three or more legs to
directly enter COB and leg into the market far outweighs the potential
benefit of continuing to allow COA to be voluntary for a limited number
of orders.
    The Exchange believes that requiring certain complex orders with
three or more legs to COA prior to entering COB and legging into the
market will discourage market participants from continuing to enter the
complex orders that expose Market-Makers to the risk described above.
The proposed rule change eliminates the possibility of immediate
executions of those particular complex orders. Market participants may
still enter those complex orders. However, if they do, those complex
orders will COA, which COA will allow Market-Makers to become aware of
those complex orders and have adequate opportunity to react
accordingly, including to adjust their quotes to avoid circumvention of
their QRM settings. If a Market-Maker receives an RFR for a COA for one
of those complex orders in one of its appointed classes, and the
Market-Maker believes the order may execute against its quotes and
cause executions that significantly exceed its contract limit in that
class, the Market-Maker may adjust its quotes as it deems necessary to
reduce its risk exposure prior to the complex order legging into the
market and being presented to the Market-Maker for execution. The
Exchange believes the proposed rule change will allow Market-Makers to
better manage their risk in their appointments, as it will reduce the
risk of those complex orders causing executions that significantly
exceed Market-Makers' risk parameters. The Exchange believes this
reduced risk will encourage Market-Makers to quote larger size, which
will increase liquidity and enhance competition in those classes.
    The Exchange notes that the proposed rule change does not impact
the allocation of complex orders or relieve Market-Makers of their
obligations to provide continuous electronic quotes under the Exchange
Rules or to provide ``firm'' quotes pursuant to Rule 8.6 or Rule 602 of
Regulation NMS.
Do Not COA
    SR-C2-2015-025 provided, among other things, that rather than have
Participants affirmatively request that their orders COA, incoming COA-
eligible orders would COA by default.\14\ Rule 6.13(c)(2) currently
provides that Participants may request on an order-by-order basis that
a COA-eligible order not COA (referred to as a ``do-not-COA'' request).
The Exchange proposes to make conforming changes to the do-not-COA
request to account for the amendment to Rule 6.13(c)(2)(A)(i) and (ii).
The Exchange proposes to add Rule 6.13(c)(2)(B) to provide that
notwithstanding subparagraph (c)(2)(A)(i), Trading Permit Holders may
request on an order-by-order basis that an incoming COA-eligible order
with two legs not COA. Proposed Rule 6.13(c)(2)(B) also provides that
notwithstanding subparagraph (c)(2)(A)(ii), the System will reject back
to a Trading Permit Holder any complex order described in that
subparagraph that includes a do-not-COA request. This will allow
Participants the ability to request their orders not COA but also
ensure that three-legged orders--which may cause the risk to Market-
Makers described above--to be rejected. In either case, order entry
firms are sophisticated market participants capable of managing their
orders as they see fit.
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    \14\ See Securities Exchange Act Release No. 76621 (December 11,
2015), 80 FR 78793 (December 17, 2015).
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    The Exchange will announce the implementation date of the proposed
rule change in a Regulatory Circular to be published no later than 90
days following the effective date. The implementation date will be no
later than 180 days following the effective date.
2. Statutory Basis
    Exchange believes the proposed rule change is consistent with the
Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\15\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \16\ requirements that the rules of an exchange be
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 mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest. Additionally, the Exchange believes the proposed rule change
is consistent with the Section 6(b)(5) \17\ requirement that the rules
of an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
    \17\ Id.
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    In particular, the Exchange believes the proposed rule change
alleviates a potential risk to Market-Makers that arises through the
use of QRM. Complex orders with three or more legs that meet the class,
size, and order type (including IOCs) parameters of subparagraph
(c)(1)(B) and that are marketable against the derived net market (which
the Exchange has identified as potentially causing risk to Market-
Makers) will initiate a COA, which helps promote just and equitable
principles of trade by relieving risk to Market-Makers allowing them to
more efficiently and effectively provide important liquidity. Orders
that are designated as IOC and meet the class and size parameters of
subparagraph (c)(1)(B), but that are not marketable against the derived
net market, will be cancelled, which allows order entry firms to use
their own sophisticated technology to manage their orders helping to
remove impediments to and perfects the mechanism of a free and open
market.
    The Exchange also believes the proposed rule change to initiate a
COA upon receipt of complex orders with three or more legs that meet
the class, size, and order type (including IOCs) parameters of
subparagraph (c)(1)(B) and that are marketable against the derived net
market is consistent with the requirement that Market-Makers' quotes be
firm under Rule 602 of Regulation NMS.\18\ The proposed rule change
does not relieve Market-Makers of their obligation to provide ``firm''
quotes. If a complex order with three or more legs goes through COA and
then legs into the market for execution upon completion of the COA, at
which point the complex order would execute against a Market-Maker's
quotes based on priority rules, the Market-Maker must execute its
quotes against the order at its then-published bid or offer up to its
published quote size, even if such execution would cause the Market-
Maker to significantly exceed its risk parameters. However, prior to
the end of COA (and thus prior to a complex order legging into the
market), a Market-Maker may adjust its published quotes to manage its
risk in a class as it deems necessary, including to prevent executions
that would exceed its risk parameters. In this case, the firm quote
rule does not obligate the Market-Maker to execute its quotes against
the complex order at the quote price and size that was published when
the order entered the System and initiated the COA. Rather, the Market-
Maker's firm quote obligation applies only to its disseminated quote at
the time an order is presented to the Market-Maker for execution, which
presentation does not occur until the System processes the order
against the leg markets after completion of the COA.\19\ Thus, the
proposed rule change is consistent with the firm quote rule.
---------------------------------------------------------------------------

    \18\ Rule 602(b)(2) obligates a Market-Maker to execute any
order to buy or sell a subject security presented to it by another
broker or dealer or any other person belonging to a category of
persons with whom the Market-Maker customarily deals, at a price at
least as favorable to the buyer or sell as the Market-Maker's
published bid or offer in any amount up to its published quotation
size. Rule 602(b)(3) provides that no Market-Maker is obligated to
execute a transaction for any subject security to purchase or sell
that subject security in an amount greater than its revised
quotation size if, prior to the presentation of an order for the
purchase or sale of a subject security, the Market-Maker
communicated to the Exchange a revised quotation size. Similarly, no
Market-Maker is obligated to execute a transaction for any subject
security if, before the order sought to be executed is presented,
the Market-Maker has communicated to the Exchange a revised bid or
offer. C2 Rule 8.6 imposes a similar obligation (Market-Maker bids
and offers are firm for all orders under Rule 8.6 and SEC Rule 602
for the number of contracts specified in the bid or offer).
    \19\ See Staff Legal Bulletin No. 16, Transaction in Listed
Options Under Exchange Act Rule 11Ac1-1, U.S. Securities and
Exchange Commission, Division of Market Regulation, January 20, 2004
(``Scenario 3: When an Order is ``Presented'' . . . If an individual
market maker generates its own quotations . . . and exchange systems
route incoming orders to the responsible broker-dealer with
priority, when is an order presented to a responsible broker-dealer?
Response: . . . . When each market maker is the responsible broker-
dealer with respect to its own quote, an order is presented to it
when received by the market maker from the exchange system.''). When
a complex order is processing through COA, the order is still in the
System and has not yet been presented to a broker or dealer
(including a Market-Maker) for execution. Only after completion of
the COA, when the System allocates the complex order for execution
in accordance with priority rules, will that order be ``presented''
to the Market-Maker for firm quote purposes.
---------------------------------------------------------------------------

    Additionally, the Exchange is removing flexibility with regards to
the marketability parameter. Although the Exchange prefers flexibility,
the Exchange does not foresee the need to retain flexibility with
regards to the marketability parameter and hardcoding the parameter may
help avoid confusion with regards to the price at which a complex order
will initiate a COA, which also helps to remove impediments to and
perfect the mechanism of a free and open market.
    Finally, the proposed rule change will allow Participants to use
their knowledge and experience to evaluate then-current market
conditions and determine if they do not want to COA orders based on
those conditions, which also removes impediments to and perfects the
mechanism of a free and open market. This allows Participants to, for
example, have two-legged orders routed to the COB for potential
immediate execution or three-legged orders to be rejected if they do
not want to have three-legged orders delayed by COA.
    The Exchange notes that other than the fact the proposed rule text
does not reference manual order handling or the Public Automated
Routing (``PAR'') workstation (because C2 is entirely electronic) all
of the proposed rule changes are based on and identical to CBOE Rule
6.53C(d)(i)-(ii).

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

    C2 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 does not believe
the proposed rule change will impose any burden on intramarket
competition because the proposed rule change is intended to reduce risk
to Market-Makers that are quoting in the regular market. C2 believes
that the proposed rule change will promote competition by encouraging
Market-Makers to increase the size of and to more aggressively price
their quotes, which will increase liquidity on the Exchange. To the
extent that the rule change makes C2 a more attractive marketplace,
market participants are free to become Trading Permit Holders on C2 and
other exchanges are free to amend their rules in a similar manner.
Furthermore, the Exchange also does not believe that the hardcoding of
the price at which a complex order may initiate a COA instead of the
Exchange having the flexibility to modify the price parameter will
impose a burden on competition as the hardcoded parameter will apply
equally to all participants. Finally, the Exchange does not believe
allowing Participants to determine not to have their orders COA will
impose a burden on competition as it will also apply equally to all
participants and allow Participants to use their knowledge and
experience executing orders to determine whether they want an order to
COA. The Exchange notes

that other than the fact the proposed rule text does not reference
manual order handling or the Public Automated Routing (``PAR'')
workstation (because C2 is entirely electronic) all of the proposed
rule changes are based on and identical to CBOE Rule 6.53C(d)(i)-(ii).

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \20\ and Rule 19b-
4(f)(6) thereunder.\21\
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78s(b)(3)(A).
    \21\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of 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.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule change 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-C2-2017-016 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-C2-2017-016. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-C2-2017-016 and should be
submitted on or before May 25, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-08981 Filed 5-3-17; 8:45 am]
BILLING CODE 8011-01-P


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[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 55025-55028]
[FR Doc No: 2021-21746]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93206; File No. SR-FINRA-2021-025]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Establish an Administration and Delivery Fee
for the Municipal Advisor Principal Examination

September 30, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 27, 2021, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by FINRA.
FINRA has designated the proposed rule change as ``establishing or
changing a due, fee or other charge'' under Section 19(b)(3)(A)(ii) of
the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\ which renders the
proposal effective upon receipt of this filing by the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    FINRA is proposing to amend Section 4(c) of Schedule A to the FINRA
By-Laws to establish an administration and delivery fee for the new
Municipal Advisor Principal Examination (``Series 54 examination'').
    Below is the text of the proposed rule change. Proposed new
language is in italics; proposed deletions are in brackets.
* * * * *

Schedule A to the By-Laws of the Corporation

* * * * *

Section 4--Fees \5\
---------------------------------------------------------------------------

    \5\ Amendments to some Examination Fees in Section 4 of Schedule
A to the FINRA By-Laws were approved in SR-FINRA-2020-032 and become
effective on January 1, 2022. See Securities Exchange Act Release
No. 90176 (October 14, 2020), 85 FR 66592 (October 20, 2020) (Notice
of Filing and Immediate Effectiveness of File No. SR-FINRA-2020-
032).
---------------------------------------------------------------------------

    (a) through (b) No Change.
    (c) The following fees shall be assessed to each individual who
takes an examination as described below. These fees are in addition
to the registration fee described in paragraph (b) and any other
fees that the owner of an examination that FINRA administers may
assess.

------------------------------------------------------------------------
       Examination No.            Examination name      Examination fee
------------------------------------------------------------------------
N/A.........................  Securities Industry                    $60
                               Essentials (SIE)
                               Examination.
Series 4....................  Registered Options                     105
                               Principal Examination.
Series 6....................  Investment Company                      40
                               Products and Variable
                               Contracts
                               Representative
                               Examination.
Series 7....................  General Securities                     245
                               Representative
                               Examination.
Series 9....................  General Securities                      80
                               Sales Supervisor
                               Examination--Options
                               Module.
Series 10...................  General Securities                     125
                               Sales Supervisor
                               Examination--General
                               Module.

Series 14...................  Compliance Official                    350
                               Examination.
Series 16...................  Supervisory Analyst                    240
                               Examination.
Series 22...................  Direct Participation                    40
                               Programs
                               Representative
                               Examination.
Series 23...................  General Securities                     100
                               Principal Examination--
                               Sales Supervisor
                               Module.
Series 24...................  General Securities                     120
                               Principal Examination.
Series 26...................  Investment Company                     100
                               Products and Variable
                               Contracts Principal
                               Examination.
Series 27...................  Financial and                          120
                               Operations Principal
                               Examination.
Series 28...................  Introducing Broker-                    100
                               Dealer Financial and
                               Operations Principal
                               Examination.
Series 39...................  Direct Participation                    95
                               Programs Principal
                               Examination.
Series 50...................  Municipal Advisor                      115
                               Representative
                               Examination.
Series 51...................  Municipal Fund                         105
                               Securities Limited
                               Principal Examination.
Series 52...................  Municipal Securities                   110
                               Representative
                               Examination.
Series 53...................  Municipal Securities                   115
                               Principal Examination.
Series 54...................  Municipal Advisor                      115
                               Principal Examination.
Series 57...................  Securities Trader                       60
                               Examination.
Series 79...................  Investment Banking                     245
                               Representative
                               Examination.
Series 82...................  Private Securities                      40
                               Offering
                               Representative
                               Examination.
Series 86...................  Research Analyst                       185
                               Examination--Analysis.
Series 87...................  Research Analyst                       130
                               Examination--Regulator
                               y.
Series 99...................  Operations Professional                 40
                               Examination.
------------------------------------------------------------------------

    (1) through (4) No Change.
    (d) through (i) No Change.
* * * * *

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

    In its filing with the Commission, FINRA 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. FINRA 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
    FINRA is proposing amendments to Schedule A to the FINRA By-Laws to
establish an administration and delivery fee for the Series 54
examination. The Municipal Securities Rulemaking Board (``MSRB'') has
established qualification classifications for municipal advisor
professionals. The Commission approved amendments to MSRB Rule G-3 that
established two new registration classifications for municipal
advisors: \6\ (1) Municipal advisor representatives (i.e., those
individuals who engage in municipal advisory activities); and (2)
municipal advisor principals (i.e., those individuals who engage in the
management, direction or supervision of the municipal advisory
activities of the municipal advisor or its associated persons).\7\ Both
municipal advisor representatives and municipal advisor principals are
required to pass the Municipal Advisor Representative Examination
(``Series 50 examination'') to be qualified in accordance with MSRB
rules.\8\
---------------------------------------------------------------------------

    \6\ The term ``municipal advisor'' is defined to mean a person
that: (i) Provides advice to or on behalf of a municipal entity or
obligated person with respect to municipal financial products or the
issuance of municipal securities, including advice with respect to
the structure, timing, terms, and other similar matters concerning
such financial products or issues; or (ii) undertakes a solicitation
of a municipal entity. The definition includes financial advisors,
guaranteed investment contract brokers, third-party marketers,
placement agents, solicitors, finders, and swap advisors that are
engaged in municipal advisory activities, unless they are
statutorily excluded. The definition does not include a municipal
entity or an employee of a municipal entity. See 15 U.S.C. 78o-
4(e)(4).
    \7\ See Securities Exchange Act Release No. 74384 (February 26,
2015), 80 FR 11706 (March 4, 2015) (Notice of Filing of Amendment
Nos. 1 & 2 and Order Granting Accelerated Approval of File No. SR-
MSRB-2014-08).
    \8\ See Securities Exchange Act Release No. 75865 (September 9,
2015), 80 FR 55407 (September 15, 2015) (Notice of Filing and
Immediate Effectiveness of File No. SR-FINRA-2015-031).
---------------------------------------------------------------------------

    MSRB Rule G-3(e)(ii)(A) was amended to establish additional
qualification requirements for municipal advisor principals, including
the requirement to pass the Series 54 examination.\9\ Under the amended
rule, municipal advisor principals are required to pass both the Series
50 examination and the Series 54 examination prior to becoming
qualified as a municipal advisor principal.\10\
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 84630 (November 20,
2018), 83 FR 60927 (November 27, 2018) (Order Approving File No. SR-
MSRB-2018-07).
    \10\ Supra note 9.
---------------------------------------------------------------------------

    To provide persons who function as municipal advisor principals
with sufficient time to satisfy the requirement to pass the new Series
54 examination, the MSRB initially included a one-year grace period
from the effective date of the Series 54 examination, during which a
person functioning as a municipal advisor principal would be permitted
to continue to engage in the management, direction or supervision of
the municipal advisory activities of the municipal advisor and its
associated persons so long as such person is qualified with the Series
50 examination.\11\
---------------------------------------------------------------------------

    \11\ Supra note 9.
---------------------------------------------------------------------------

    The date by which individuals are required to become qualified with
the Series 54 examination has been extended three times due to impacts
related to the pandemic. In April 2020, the MSRB extended the date by
which individuals were required to become qualified with the Series 54
examination from November 12, 2020 to March 31, 2021.\12\ In December
2020, the MSRB further extended the time period from March 31, 2021 to
November 12, 2021.\13\ In September 2021, the MSRB further extended the
time period from November 12, 2021 to November 30, 2021.\14\
---------------------------------------------------------------------------

    \12\ See Securities Exchange Act Release No. 88694 (April 20,
2020), 85 FR 23088 (April 24, 2020) (Notice of Filing and Immediate
Effectiveness of File No. SR-MSRB-2020-01).
    \13\ See Securities Exchange Act Release No. 90621 (December 9,
2020), 85 FR 81254 (December 15, 2020) (Notice of Filing and
Immediate Effectiveness of File No. SR-MSRB-2020-09).
    \14\ See Securities Exchange Act Release No. 92938 (September
10, 2020), 86 FR 51696 (September 16, 2021) (Notice of Filing and
Immediate Effectiveness of File No. SR-MSRB-2021-05).
---------------------------------------------------------------------------

    FINRA develops, maintains, and delivers all FINRA qualification
examinations for individuals who are registered or seeking registration
with FINRA. FINRA also administers and delivers examinations developed
by the

MSRB and other self-regulatory organizations.\15\ The SEC has
designated FINRA to administer and deliver the Series 54 examination
for municipal advisors.\16\
---------------------------------------------------------------------------

    \15\ In this regard, the Exchange Act provides that a registered
securities association shall administer required qualification
examinations for municipal securities brokers and municipal
securities dealers who are members of the association. See 15 U.S.C.
78o-4(c)(7)(A)(i).
    \16\ See Securities Exchange Act Release No. 75714 (August 17,
2015) 80 FR 50883 (August 21, 2015) (Designation of the Financial
Industry Regulatory Authority to Administer Professional
Qualification Tests for Associated Persons of Registered Municipal
Advisors). Section 15B(c)(7)(A)(iii) of the Exchange Act requires
that the SEC or its designee administer qualification examinations
for municipal advisors. The SEC previously designated FINRA to
examine FINRA members' activities as registered municipal advisors
and evaluate compliance by such members with federal securities
laws, SEC rules and regulations, and MSRB rules applicable to
municipal advisors. See Securities Exchange Act Release No. 70462
(September 20, 2013), 78 FR 67468 (November 12, 2013) (S7-45-10)
(Registration of Municipal Advisors).
---------------------------------------------------------------------------

    FINRA currently administers examinations electronically through the
PROCTOR[supreg] system \17\ at testing centers operated by vendors
under contract with FINRA.\18\ For qualification examinations sponsored
by a FINRA client and administered by FINRA, FINRA charges an
administration and delivery fee that represents either a portion of or
the entire examination fee. Consistent with this practice, FINRA
charges an administration and delivery fee of $115 for the Series 50
examination.\19\
---------------------------------------------------------------------------

    \17\ PROCTOR is a computer system that is specifically designed
for the administration and delivery of computer-based testing and
training.
    \18\ The MSRB has temporarily allowed the Series 54 examination
to be taken online as an interim accommodation for individuals who
need to become appropriately qualified as a municipal advisor
principal before the compliance date. See supra note 14.
    \19\ The administration and delivery fee represents a portion of
the entire examination fee when a FINRA client has established an
additional fee for an examination that it sponsors. The fee to take
the Series 50 examination is $265. Of this amount, $115 is the FINRA
administration and delivery fee, and $150 is the development fee
determined by the FINRA client, the MSRB. See MSRB Rule A-16. See
also supra note 8.
---------------------------------------------------------------------------

    The proposed administration and delivery fee for the Series 54 exam
is also $115.\20\ The proposed administration and delivery fee will
offset FINRA's costs associated with the administration and delivery of
the Series 54 examination and, as discussed below, contribute to
supporting FINRA's other operations.
---------------------------------------------------------------------------

    \20\ The fee to take the Series 54 examination is $265. Of this
amount, $115 is the FINRA administration and delivery fee, and $150
is the development fee determined by the FINRA client, the MSRB. See
MSRB Rule A-16. See also Securities Exchange Act Release No. 85135
(February 14, 2019), 84 FR 5513, 5514 n.15 (February 21, 2019)
(Notice of Filing and Immediate Effectiveness of File No. SR-MSRB-
2019-02).
---------------------------------------------------------------------------

    FINRA has filed the proposed rule change for immediate
effectiveness. The effective date and the implementation date will be
the date of filing.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(5) of the Act,\21\ which requires, among
other things, that FINRA rules provide for the equitable allocation of
reasonable dues, fees and other charges among members and issuers and
other persons using any facility or system that FINRA operates or
controls.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78o-3(b)(5).
---------------------------------------------------------------------------

Reasonableness of the Proposed Fee
    FINRA believes that the proposed administration and delivery fee
for the Series 54 examination is reasonable. In establishing an
administration and delivery fee of $115 for the Series 54 examination,
FINRA applied the same criteria as it does for establishing the fees
for other examinations with similar characteristics related to test
length and volume. In particular, the Series 54 examination fee is
consistent with the fee charged for the Series 50 examination, which
has the same number of questions (and thus requires the same testing
time).
    The proposed administration and delivery fee will be used to cover
FINRA's costs associated with the administration and delivery of the
Series 54 examination, including the fees that vendors charge FINRA for
delivering qualification examinations through their test delivery
networks and PROCTOR system maintenance and enhancement expenses. The
proposed fee also will contribute to supporting FINRA's other
operations. As FINRA has explained previously, it is not feasible to
associate a direct affiliated revenue stream for each of its programs
and thus numerous operations and services must be funded by other
revenue sources, which include both general regulatory assessments and
use-based fees.\22\
---------------------------------------------------------------------------

    \22\ See supra note 5.
---------------------------------------------------------------------------

The Proposed Fee Is Equitable and Not Unfairly Discriminatory
    FINRA believes that the proposed administration and delivery fee
for the Series 54 examination is equitable and not unfairly
discriminatory. The proposed fee is a use-based fee and FINRA will
charge the fee each time a municipal advisor representative accesses
the content. Thus, the exam for municipal advisor principals will be
available on the same terms to every municipal advisor representative.

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. FINRA believes that the
establishment of the administration and delivery fee for the Series 54
examination will have a limited economic impact on the industry.
    MSRB rules require every municipal advisor to have at least one
municipal advisor principal.\23\ There are approximately 500 registered
municipal advisors.\24\ The administration and delivery fees may be
paid by the individuals taking the examination or their associated
firms.
---------------------------------------------------------------------------

    \23\ MSRB Rule G-3(e)(iii).
    \24\ See MSRB-Registered Municipal Advisor Firms with Series-50
Qualified Representatives (Sept. 20, 2021, 2:06 p.m.), https://msrb.org/MARegistrants.
---------------------------------------------------------------------------

    FINRA administers this examination as a service provider to the
MSRB as designated by the SEC. In providing this service, FINRA is not
exercising regulatory discretion and therefore is not itself imposing
burdens on those individuals who may choose to sit for the examination.
FINRA does exercise discretion in establishing the administration and
delivery fee. Regardless of whether individuals pay the fee or some
part of the fee is paid by firms, FINRA believes that the proposal is
likely to have minimal effects on firms' costs or liquidity. The
proposal will therefore have at most minimal competitive effects.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \25\ and paragraph (f)(2) of Rule 19b-4
thereunder.\26\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
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.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(3)(A).
    \26\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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-FINRA-2021-025 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-FINRA-2021-025. 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 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of FINRA. 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-
FINRA-2021-025 and should be submitted on or before October 26, 2021.

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

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

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-21746 Filed 10-4-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 180 (Tuesday, September 21, 2021)]
[Notices]
[Pages 52474-52478]
[FR Doc No: 2021-20393]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0952]

Final Administrative Orders for Over-the-Counter Monographs;
Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability on its website of certain final administrative orders
(final orders), including for over-the-counter (OTC) drug monographs,
that were deemed to be final orders by the Coronavirus Aid, Relief, and
Economic Security Act (CARES Act), which added a new section to the
Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is also announcing
the process for making these final orders available. Finally, FDA is
announcing its plan for withdrawing regulations that established final
OTC drug monographs prior to the passage of the CARES act, and
withdrawing or making technical changes to the procedures governing the
OTC drug review.

DATES: The announcement of the availability on FDA's website of certain
final orders as deemed by section 505G of the FD&C Act and other
actions related to section 505G is published in the Federal Register on
September 21, 2021.

ADDRESSES: You may view the final orders in the OTC [email protected]
portal at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm.
     Instructions: For access to the final orders, go to
https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm. Under the
``Administrative Orders'' banner, click on the desired link under the
``Order ID'' heading and follow the prompts.

FOR FURTHER INFORMATION CONTACT: Helen Lee, Center for Drug Evaluation
and Research (HFD-600), Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On March 27, 2020, the CARES Act was signed into law. The CARES Act
includes provisions that govern the way certain OTC drugs are regulated
in the United States. In particular, the CARES Act added section 505G
to the FD&C Act (21 U.S.C. 355g), which reforms and modernizes the OTC
drug review process that was established in 1972. Under the OTC drug
review, OTC drug monographs (also referred to as OTC monographs) for
different therapeutic categories are established. OTC drugs are
generally recognized as safe and effective (GRASE) if they meet the
conditions of an OTC monograph, including the specified active
ingredients, uses (indications), doses, routes of administration,
labeling, and testing, along with other applicable requirements.

A. Regulatory Framework for OTC Monograph Drugs Prior to the Passage of
the CARES Act

    Prior to passage of the CARES Act, OTC monographs were established,
revised, and amended using the rulemaking process set out by the
Administrative Procedure Act in 21 U.S.C. 553. Final OTC monographs
(final monographs) were codified in regulations under title 21 of the
CFR. The OTC monograph process was set forth in 21 CFR part 330 (part
330). Prior to establishment of a final monograph, GRASE conditions for
a therapeutic category were set forth in proposed rules as tentative
final monographs. At the time of the passage of the CARES Act, certain
OTC monographs were still at the proposed rulemaking stage, either in
whole or in part.
    In the course of the OTC drug review, FDA also determined when
there was not sufficient evidence to demonstrate certain conditions
(e.g., active ingredients for specific uses) were GRASE. In such cases,
FDA often expressly codified these determinations that certain
conditions were not GRASE (see, e.g., Sec.  310.545 (21 CFR 310.545)).
In addition, part 201, subpart G (21 CFR part 201, subpart G), includes
specific labeling requirements for certain drugs, including OTC
monograph drugs (see, e.g., Sec.  201.326, requiring warnings and other
labeling for OTC drug products containing internal analgesic and
antipyretic active ingredients).

B. Regulatory Framework for OTC Monograph Drugs Under the CARES Act

    The CARES Act added section 505G to the FD&C Act, which revised the
framework for the regulation of OTC

monograph drugs.\1\ Under section 505G of the FD&C Act, the rulemaking
process for establishing, revising, and amending OTC monographs was
replaced with an administrative order process. In addition, among other
things, section 505G of the FD&C Act provides a baseline status that,
as of the date of enactment of the CARES Act, a drug that satisfies
certain requirements described in section 505G(a)(1) or (2) is: (1)
Deemed to be generally recognized as safe and effective under section
201(p)(1) of the FD&C Act (21 U.S.C. 321(p)(1); (2) not a new drug
under section 201(p) of the FD&C Act; and (3) not subject to section
503(b)(1) of the FD&C Act (21 U.S.C. 353(b)(1)). To obtain this status,
among other things, a drug either must be one that is in conformity
with the requirements for nonprescription use of a final monograph
issued under part 330 (except as provided in section 505G(a)(2) of the
FD&C Act),\2\ as well as other requirements; \3\ or must be one that
is: (1) Classified in category I for safety and effectiveness under a
tentative final monograph that is the most recently applicable proposal
or determination issued under part 330 and (2) in conformity with the
proposed requirements for nonprescription use of such tentative final
monograph and any applicable subsequent determination by FDA, as well
as other requirements.\4\ Other applicable requirements in section
505G(a)(1) of the FD&C Act include conditions or requirements under
section 505G(b), (c), and (k) of the FD&C Act.
---------------------------------------------------------------------------

    \1\ OTC drugs that are governed by the provisions of section
505G of the FD&C Act are referred to as OTC monograph drugs.
    \2\ Section 505G(a)(2) of the FD&C Act provides specific
requirements for sunscreen drugs in terms of conformity with a final
monograph, for purposes of section 505G(a)(1)(A)(i) of the FD&C Act.
    \3\ Section 505G(a)(1)(A) of the FD&C Act.
    \4\ Section 505G(a)(1)(B) of the FD&C Act.
---------------------------------------------------------------------------

    Complementary to the requirements for conformity to tentative final
or final monographs described in section 505G(a)(1) and (2) of the FD&C
Act, Congress provided that, under section 505G(b)(8) of the FD&C Act,
a final monograph or tentative final monograph that establishes
conditions of use for a drug described in section 505G(a)(1) or (2) of
the FD&C Act and that represents the most recently issued version of
the conditions of use, including as modified, in whole or in part, by
any proposed or final rule, is deemed to be a final order. These deemed
final orders provide the current OTC drug monograph conditions that are
in effect for each therapeutic category addressed by them. Final orders
may be amended, revoked, or otherwise modified in accordance with the
procedures of section 505G of the FD&C Act. Under section 505G(b)(8)(C)
of the FD&C Act, the deemed establishment of a final order is construed
to include technical amendments necessary to ensure that the final
order is appropriately harmonized, in terms of terminology or cross-
references, with the applicable provisions of the FD&C Act (and
regulations) and any other final orders issued under section 505G.
    Congress also deemed certain regulations, as in effect on the day
before the date of the enactment of the CARES Act (i.e., March 26,
2020), to be final orders under section 505G(b) of the FD&C Act. In
particular, section 505G(k)(2)(A) of the FD&C Act deemed the provisions
of Sec.  310.545 to be a final order under section 505G(b). Also,
section 505G(k)(2)(B) of the FD&C Act deemed regulations establishing
requirements for specific nonprescription drugs marketed pursuant to
section 505G (including such requirements in 21 CFR parts 201 and 250)
to be final orders under section 505G(b), as they apply to drugs
subject to section 505G(a)(1) through (4) or otherwise subject to an
order under section 505G.
    In addition, section 505G(k)(3) of the FD&C Act provides that
regulations establishing final monographs and the procedures governing
the OTC drug review under part 330 and other relevant parts of title 21
of the CFR, shall be withdrawn or revised to make technical changes to
ensure conformity with appropriate terminology and cross-references.
Section 505G(k)(3) of the FD&C Act also provides that any such
withdrawal or technical changes shall be made without public notice and
comment and shall be effective upon publication through notice in the
Federal Register (or upon such date as specified in such notice).

II. Procedures for Posting Final Orders as Deemed by Section 505G of
the FD&C Act

    The final orders as deemed by section 505G of the FD&C Act were
made effective upon enactment of the CARES Act on March 27, 2020. By
this notice, FDA is announcing the availability on its website of
certain deemed final orders and providing the public information on the
process for making available deemed final orders, including details on
how the public can access and view the final orders. FDA is posting
these final orders to provide the public a convenient resource to view
OTC monographs and non-monograph conditions. The process for FDA
issuing proposed, final, and interim final orders under section 505G(b)
of the FD&C Act to add, modify, or remove OTC monograph conditions is
generally described in section 505G(b) and is not addressed in this
Notice. Additional information, including questions and answers on this
process, can be found on FDA's OTC monograph web page at https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act, and further information
will be provided when FDA issues its first proposed order.

A. Process for Making Available Final Orders as Deemed by Section
505G(b)(8) of the FD&C Act

    FDA is announcing its process for making available final orders as
deemed by section 505G(b)(8) of the FD&C Act. FDA reviewed all final
monographs published in the CFR, beginning with 21 CFR part 331, and
the rulemaking histories for each OTC monograph therapeutic category,
to identify all relevant final monographs and tentative final
monographs that established conditions of use for a drug described in
section 505G(a)(1) of the FD&C Act and that represented the most
recently issued version of the conditions of use, including as
modified, in whole or in part, by any proposed or final rule. As noted
above, the relevant requirements for sunscreen drugs subject to section
505G of the FD&C Act, in terms of conformity with a final monograph for
purposes of section 505G(a)(1)(A)(i), were set forth in section
505G(a)(2) and consist of the requirements specified in 21 CFR part
352, as published on May 21, 1999, except that the applicable
requirements governing effectiveness and labeling are those specified
in Sec.  201.327. Altogether, as indicated in table 1 below, FDA
identified 32 final orders created by section 505G(b)(8) of the FD&C
Act.
    As further discussed below, FDA also identified certain regulations
that established requirements for specific nonprescription drugs
marketed pursuant to section 505G of the FD&C Act and, therefore, were
deemed final orders by section 505G(k)(2)(B), only as they apply to
drugs subject to section 505G(a)(1) through (4) or otherwise subject to
an order under section 505G (e.g., Sec.  201.326, which set forth
certain labeling requirements regarding warnings for OTC drug products
containing internal analgesic and antipyretic active ingredients). To
the extent regulations that were deemed to be final orders by section
505G(k)(2)(B) of the FD&C Act apply to OTC drugs addressed by a final
order embodying an

OTC monograph, as deemed by section 505G(b)(8) of the FD&C Act, the
relevant provisions may be incorporated into the final order(s)
embodying the OTC monograph(s).
    FDA assigned OTC monograph numbers to the resulting deemed final
orders (see table 1). Table 1 provides the corresponding OTC monograph
number and title for each of these OTC monographs and identifies the
CFR citation, if applicable. Additionally, an order ID will be assigned
in sequential order upon posting of all orders, including the deemed
final orders.
    Each OTC monograph embodied by a deemed final order is accompanied
by a summary and a background section. In the background section, FDA
describes the relevant proposed and final rules that constitute the
deemed final order. Additionally, pursuant to section 505G(b)(8)(C) of
the FD&C Act, OTC monographs embodied by deemed final orders include
any technical amendments that are determined to be necessary to ensure
that they are appropriately harmonized, in terms of terminology and
cross-references, with applicable provisions of the FD&C Act, FDA
regulations, and any other orders issued under section 505G. The
background section generally describes any differences between the
deemed final order and the proposed and final rules that constitute the
order.
    Some OTC monographs incorporate by reference specified material,
published by an entity other than the United States government (e.g.,
an ISO standard). This incorporated material is available for
inspection at FDA. For further information about inspecting
incorporated materials, see https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act. Copies of incorporated material may also be available
from its publisher.

Table 1--OTC Monographs as Represented by Final Orders Deemed by Section
                       505G(b)(8) of the FD&C Act
------------------------------------------------------------------------
                        CFR citation in
 OTC monograph number      title 21            OTC monograph title
------------------------------------------------------------------------
M001.................  Part 331........  Antacid Products for OTC Human
                                          Use.
M002.................  Part 332........  Antiflatulent Products for OTC
                                          Human Use.
M003.................  N/A \1\.........  First Aid Antiseptic Drug
                                          products for OTC Human Use.
M004.................  Part 333,         First Aid Antibiotic Drug
                        subpart B.        Products for OTC Human Use.
M005.................  Part 333,         Topical Antifungal Drug
                        subpart C.        Products for OTC Human Use.
M006.................  Part 333,         Topical Acne Drug Products for
                        subpart D.        OTC Human Use.
M007.................  N/A\1\..........  Laxative Drug Products for OTC
                                          Human Use.
M008.................  Part 335........  Antidiarrheal Drug Products for
                                          OTC Human Use.
M009.................  Part 336........  Antiemetic Drug Products for
                                          OTC Human Use.
M010.................  Part 338........  Nighttime Sleep Aid Drug
                                          Products for OTC Human Use.
M011.................  Part 340........  Stimulant Drug Products for OTC
                                          Human Use.
M012.................  Part 341........  Cold, Cough, Allergy,
                                          Bronchodilator, and
                                          Antiasthmatic Drug Products
                                          for OTC Human Use.
M013.................  Part 343........  Internal Analgesic,
                                          Antipyretic, and Antirheumatic
                                          Drug Products for OTC Human
                                          Use.
M014.................  Part 344........  Topical Otic Drug Products for
                                          OTC Human Use.
M015.................  Part 346........  Anorectal Drug Product for OTC
                                          Human Use.
M016.................  Part 347........  Skin Protectant Drug Products
                                          for OTC Human Use.
M017.................  Part 348........  External Analgesic Drug Product
                                          for OTC Human Use.
M018.................  Part 349........  Ophthalmic Drug Products for
                                          OTC Human Use.
M019.................  Part 350........  Antiperspirant Drug Products
                                          for OTC Human Use.
M020.................  Part 352........  Sunscreen Drug Products for OTC
                                          Human Use.
M021.................  Part 355........  Anticaries Drug Products for
                                          OTC Human Use.
M022.................  N/A \1\.........  Oral Health Care Drug Products
                                          for OTC Human Use.
M023.................  N/A \1\.........  Poison Treatment Drug Products
                                          for OTC Human Use.
M024.................  Part 357,         Anthelminic Drug Products for
                        subpart B.        OTC Human Use.
M025.................  Part 357,         Cholecystokinetic Drug Products
                        subpart C.        for OTC Human Use.
M026.................  Part 357,         Deodorant Drug Products for
                        subpart I.        Internal Use for OTC Human
                                          Use.
M027.................  N/A \1\.........  Orally Administered Menstrual
                                          Drug Products for OTC Human
                                          Use.
M028.................  Part 358,         Wart Remover Drug Products for
                        subpart B.        OTC Human Use.
M029.................  Part 358,         Ingrown Toenail Relief Drug
                        subpart D.        Products for OTC Human Use.
M030.................  Part 358,         Corn and Callus Remover Drug
                        subpart F.        Products for OTC Human Use.
M031.................  Part 358,         Pediculicide Drug Products for
                        subpart G.        OTC Human Use.
M032.................  Part 358,         Drug Products for the Control
                        subpart H.        of Dandruff, Seborrheic
                                          Dermatitis, and Psoriasis for
                                          OTC Human Use.
------------------------------------------------------------------------
\1\ Not applicable as there is no relevant CFR citation (i.e., there
  were no final monographs at the time of enactment of the CARES Act).

B. Process for Making Available Final Orders as Deemed by Section
505G(k)(2) of the FD&C Act

    Under section 505G(k)(2)(A) of the FD&C Act, the non-monograph
conditions in Sec.  310.545 in effect on the day before the date of
enactment of the CARES Act (i.e., March 26, 2020) were deemed to be a
final order under section 505G(b). The provisions of Sec.  310.545 list
active ingredients for which there is not sufficient data to establish
general recognition of the safety and effectiveness for the specified
use in OTC drug products. Before posting the deemed final order
containing these provisions, FDA intends to remove the compliance dates
found in the regulation because the dates are no longer relevant, since
any current product would have been introduced or delivered for
introduction into interstate commerce well after the compliance date.
FDA also intends to rearrange the listed active ingredients within each
provision regarding a particular therapeutic category so that they
generally appear in alphabetical order. When posting this final order,
FDA will assign a final order ID and OTC non-monograph conditions
number.
    In addition, under section 505G(k)(2)(B) of the FD&C Act,
regulations in effect on March 26, 2020, establishing requirements for
specific

nonprescription drugs marketed pursuant to section 505G of the FD&C Act
were deemed final orders under section 505G(b), only as they apply to
drugs subject to section 505G(a)(1) through (4) of the FD&C Act or
otherwise subject to a final order under section 505G. As discussed
above, provisions from a regulation that was deemed to be a final order
by section 505G(k)(2)(B) of the FD&C Act may be incorporated into a
relevant final order embodying an OTC monograph under section
505G(b)(8). A deemed final order under section 505G(k)(2)(B) of the
FD&C Act may also be posted as a separate, standalone final order. In
the latter case, FDA intends to issue an accompanying notice in the
Federal Register announcing its availability on our website.
Regulations deemed to be final orders by section 505G(k)(2)(B) of the
FD&C Act will remain in the CFR to the extent they also apply to drugs
that are not subject to section 505G(a)(1) through (4) or otherwise
subject to an order under section 505G.

C. Availability of Final Orders Including Those Deemed by Section 505G
of the FD&C Act

    FDA has established a new IT system with a web portal, OTC
[email protected], which can be accessed through FDA's website. The portal
will provide access to a repository of final orders under section 505G
of the FD&C Act and is available at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm. To access the final orders, go to the OTC
[email protected] portal at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm. Under the ``Administrative Orders'' banner, click on
the desired link under the ``Order ID'' heading and follow the prompts.
    For ease of reference, FDA also is posting in the OTC
[email protected] portal the individual OTC monographs embodied by final
orders under section 505G(b) of the FD&C Act, without any sections that
accompany the monograph, such as the background section. To access just
the OTC monographs, under the ``OTC Monographs'' banner, click on the
desired link under the ``OTC Monograph ID'' heading and follow the
prompts.
    FDA will make available deemed final orders embodying OTC
monographs in batches on a rolling basis until all 32 such orders,
discussed above in section II.A (see also table 1), are available in
the repository. FDA will also make available in the repository the
final order that reflects the provisions of Sec.  310.545, as deemed by
section 505G(k)(2)(A) of the FD&C Act, and final orders regarding
requirements for specific nonprescription drugs, as deemed by section
505G(k)(2)(B).
    FDA is announcing that the OTC [email protected] portal currently
includes an initial batch of four deemed final orders embodying OTC
monographs (see table 2). The posting of the remainder of these 32
deemed final orders, as well as the deemed final order under section
505G(k)(2)(A) of the FD&C Act, will not be announced in the Federal
Register but will be announced on FDA's OTC monograph web page, https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act. FDA plans to issue a
notice of availability in the Federal Register when posting in the
repository final orders deemed by section 505G(k)(2)(B) of the FD&C
Act.

              Table 2--Initial Batch of Posted Final Orders Deemed by Section 505G of the FD&C Act
----------------------------------------------------------------------------------------------------------------
                                                          CFR citation in
         Order ID              OTC monograph number          Title 21                OTC monograph title
----------------------------------------------------------------------------------------------------------------
OTC000001.................  M002.....................  Part 332............  Antiflatulent Products for OTC
                                                                              Human Use.
OTC000002.................  M010.....................  Part 338............  Nighttime Sleep-Aid Drug Products
                                                                              for OTC Human Use.
OTC000003.................  M014.....................  Part 344............  Topical Otic Drug Products for OTC
                                                                              Human Use.
OTC000004.................  M030.....................  Part 358, Subpart F.  Corn and Callus Remover Drug
                                                                              Products for OTC Human Use.
----------------------------------------------------------------------------------------------------------------

    FDA encourages the public to frequently view our website at https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act and the OTC
[email protected] portal for the most up-to-date information about the
status of posted final orders as deemed by section 505G of the FD&C
Act. Questions regarding these final orders can be submitted to FDA at
<EMAIL_ADDRESS>    In the future, the repository will also include proposed orders,
final orders, and interim final orders to add, amend, or remove OTC
monograph conditions that are issued by FDA either on its own
initiative or pursuant to an OTC monograph order request under section
505G(b)(5) of the FD&C Act. Information on the process for FDA issuing
proposed, final, and interim final orders is provided in section
505G(b) of the FD&C Act. Additional information, including questions
and answers on this process, can be found on FDA's OTC monograph web
page (https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act), which
will continue to be updated as FDA issues new orders.

III. Procedures for Withdrawing Regulations for Final Monographs and
the Procedures Governing the OTC Drug Review, and Withdrawing and
Making Technical Changes to Regulations in Part 330 and Other Relevant
Parts of Title 21 of the CFR

    Under section 505G(k)(3) of the FD&C Act, regulations establishing
final monographs and the procedures governing the OTC drug review under
part 330 and other relevant parts of title 21 of the CFR (as in effect
on March 26, 2020) shall be withdrawn or revised to make technical
changes to ensure conformity with appropriate terminology and cross-
references. Section 505G(k)(3) of the FD&C Act also provides that any
such withdrawal or technical changes shall be made without public
notice and comment and shall be effective upon publication through
notice in the Federal Register (or upon such date as specified in such
notice).
    FDA intends to issue a notice to withdraw the regulations
establishing final monographs in title 21 of the CFR at a later date
once all the relevant deemed final orders have been posted on FDA's OTC
[email protected] web portal (i.e., 21 CFR parts 331, 332, 333, 335, 336,
338, 340, 341, 343, 344, 346, 347, 348, 349, 350, 352, 355, 357, and
358). Prior to the withdrawal of such regulations, the public should
reference the OTC monographs posted in the OTC

[email protected] portal at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm, to the extent the corresponding deemed final order has
been added to the portal. Additionally, in either the same notice or a
separate notice in the Federal Register, pursuant to section 505G(k)(3)
of the FD&C Act, FDA intends to withdraw certain portions of the
regulations governing the OTC drug review, and to make certain
technical changes.

IV. Paperwork Reduction Act of 1995

    Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act
of 1995 (Chapter 35 of title 44, United States Code) does not apply to
collections of information made under section 505G of the FD&C Act.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required for collections of
information, if any, in orders deemed to be final orders by section
505G of the FD&C Act.

    Dated: September 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20393 Filed 9-20-21; 8:45 am]
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[Federal Register: April 27, 2010 (Volume 75, Number 80)]
[Notices]
[Page 22168-22169]
[DOCID:fr27ap10-100]

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

SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Global Medical Products Holdings, Inc., Order of Suspension of
Trading

April 23, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Global Medical Products Holdings, Inc. because it has not filed any
periodic reports since the period ended June 30, 2003.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed company is suspended for
the period from 9:30 a.m. EDT on April 23, 2010, through 11:59 p.m. EDT
on May 6, 2010.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-9811 Filed 4-23-10; 4:15 pm]
BILLING CODE 8011-01-P