[Federal Register Volume 82, Number 186 (Wednesday, September 27, 2017)]
[Notices]
[Pages 45095-45099]
[FR Doc No: 2017-20624]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81670; File No. SR-NYSEAMER-2017-18]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Update
and Amend its Options Rules, as Described Herein, To Reduce Unnecessary
Complexity and To Promote Standardization and Clarity

September 21, 2017.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on September 11, 2017, NYSE American LLC (the ``Exchange''
or ``NYSE American'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the self-
regulatory organization. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to update and amend its options rules, as
described herein, to reduce unnecessary complexity and to promote
standardization and clarity.
    The proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to update and amend its options rules as
follows: (1) Delete Rules 965 and 970 and replace them with new Rules
915NY, 915.1NY, 915.2NY and 915.3NY, in order to update its rules
governing the verification of compared trades and the reconciliation of
uncompared trades, and simultaneously to conform the Exchange's rules
to the rules of NYSE Arca, Inc. (``NYSE Arca''), its affiliated
exchange, and to update the cross-references to Rules 965 and 970 in
Rules 900F and 900H accordingly; (2) amend Rule 900.2NY(29) to clarify
the definition of Floor Market Maker; (3) amend Rule 902NY to replace
an outdated reference to the Options Surveillance Department; (4) amend
Rule 920NY(a) to clarify the definition of Market Maker and to conform
the Exchange's rules to the rules of NYSE Arca; (5) amend Rule 930NY to
replace the definition of ``Professional Customer'' with ``Qualified
Customer'' in connection with the limited public business that
qualified Floor Brokers and their Floor Clerks may conduct; (6) amend
Rule 934NY to update the

references to the current Order Protection Rule; (7) amend Rule 955NY
to replace an outdated reference to a required timestamp synchronized
to the ``NIST Clock'' with a reference to the current operative
Consolidated Audit Trail (``CAT'') clock synchronization rule; and (8)
amend Rule 963NY in order to conform the Exchange's rule governing the
priority of complex orders in open outcry to its rule governing
electronic complex orders. The Exchange proposes to make these rule
changes in order to update its rules, reduce complexity and provide
clarification concerning its rules, delete outdated cross-references,
and standardize and conform its rules to the rules of its affiliated
exchange governing the same subject matter.
Proposed Rule Changes Governing the Verification and Reconciliation of
Trades
    In order to update its rules governing the reconciliation of
uncompared trades and to conform its rules to the rules of NYSE Arca,
its affiliated exchange, the Exchange proposes to delete Rules 965 and
970 and its commentary,\4\ and to replace them with new Rules 915NY and
its commentary, 915.1NY, 915.2NY, and 915.3NY and its commentary. This
proposal is based upon existing NYSE Arca Rules 6.17-O and its
commentary, 6.18-O, 6.19-O, and 6.21-O and its commentary, which rules
govern the same subject matter, and that the Exchange proposes to
renumber and adopt with conforming modifications.\5\
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    \4\ Rule 970 was last amended in 2004 to reflect then-current
data processing and communications technology for comparing options
transactions that were excluded from clearing and for the timely
resolution of such uncompared trades. See Securities Exchange Act
Release No. 49438 (March 17, 2004), 69 FR 13919 (March 24, 2004)
(SR-AMEX-2003-78). Rule 970 emanates from earlier, and contains such
outdated references and anachronistic concepts as a Rejected Option
Transaction Notice (``ROTN'') that must be ``OK'd or DK'd''; a
``ROTN Room'' where members or member organizations or their
representatives must be present in order to resolve ``prior day's
business''; the ``call time'' deadline for parties to check their
contract sheets to reconcile uncompared trades and to verify any
trades where they are identified as the contra-side; and a manual
requirement to include the ``badge number'' of both the executing
and the contra-broker, which required data elements are now captured
electronically in the electronic order capture rule before an order
is sent electronically or represented in open outcry. See Rule 955NY
Order Format and System Entry Requirements.
    \5\ To conform the proposed new rules to the Exchange's existing
rulebook and definitions, the Exchange proposes to substitute ``ATP
Holders'' for ``OTP Holders and OTP Firms'', to substitute ``NYSE
Amex Trade Processing Department'' for ``NYSE Arca Trade Processing
Department'', and to cross-reference Exchange Rule 9200 in lieu of
the cross-reference to NYSE Arca's disciplinary rule.
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    Proposed Rules 915NY et seq. would update the outdated language of
Rules 965 and 970 by clarifying the requirements and processes of
verifying and comparing trades, including the requirement that clearing
members verify and reconcile both compared and uncompared trades
promptly, and routinely compare trades during the course of a trading
session; the issuance by the Exchange of an unreconciled trade report
after the cut-off hour for the receipt of reconciliation reports; the
provision by the Exchange of a report of compared trades to the Options
Clearing Corporation (``OCC''); the provision of notice of trades that
remained uncompared overnight, and for the fixation of the amount of
loss; and would conform the rules of the Exchange to the rules of NYSE
Arca, thus providing further rule uniformity, and the attendant
clarification of processes in options marketplaces.\6\ In addition, the
Exchange believes Rule 970, which includes outdated language,\7\
unnecessarily hinders and delays further technical improvements and
that the requirements of new proposed Rules 915NY et seq. would both
modernize its rulebook to more closely describe the existing options
reconciliation process, in addition to conforming its rulebook to the
extant rules of its affiliated exchange.
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    \6\ See generally NYSE Arca Rules 6.17-O, 6.18-O, 6.19-O, and
6.21-O, now proposed as new Rules 915NY, 915.1NY, 915.2NY, and
915.3NY. NYSE Arca Rule 6.20-O, that addresses time synchronization,
is inapposite to these proposed rule changes governing the
reconciliation of uncompared trades, and is therefore not included
sequentially in new proposed Rules 915NY et seq.; but see, infra,
the rule change proposed by the Exchange amending Rule 955NY, that
would replace an outdated reference to a required timestamp
synchronized to the ``NIST Clock'' with a reference to the current
CAT clock synchronization rule. Separately, NYSE Arca, the
affiliated Exchange, also intends to file a proposed rule change
amending NYSE Arca Rule 6.20-O to replace the same outdated
timestamp reference in its rulebook.
    \7\ See Ftnt. 4, supra.
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    Specifically, new proposed Rule 915NY and its associated commentary
(which is based upon NYSE Arca Rule 6.17-O and its commentary) would
add greater specificity in connection with the obligations of ATP
Holders to both verify compared trades and to reconcile and report
uncompared trades.\8\ Unlike Rule 970's focus upon trades excluded from
clearance, new proposed Rule 915NY and Commentary .01 describes
existing obligations to verify trade information in order to reconcile
uncompared trades--to verify and reconcile compared and uncompared
trades promptly--and to timely report the resulting reconciliations,
corrections and adjustments to the Exchange.\9\
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    \8\ New proposed Rule 915NY would provide that ATP Holders that
are clearing members of the OCC or their delegates shall be
obligated to verify the information shown on the contract lists or
on such electronic display terminals to reconcile all uncompared
trades and advisory trades shown on the uncompared trade list and to
report all reconciliations, corrections and adjustments to the
Exchange in accordance with such procedures as may be established by
the Exchange from time to time. Such reconciliation report shall be
filed with the Exchange prior to such cut-off time as the Exchange
may prescribe and shall be binding on the clearing member on whose
behalf it is filed. New proposed Commentary to Rule 915NY would
provide that Rule 915NY requires clearing members to verify and
reconcile compared and uncompared trades promptly in accordance with
procedures established by the Exchange from time to time; that
trades must be routinely compared during the course of the trading
session; that all executing ATP Holders must be available for the
settlement of uncompared trades throughout the trading day and until
the final trade transmission is sent to the OCC, either in person or
through a designated representative empowered to negotiate
settlement of any dispute in such ATP Holder's name and account;
that for purposes of complying with this provision, the authorized
representative must be physically present on the Trading Floor or be
accessible via telephone or email, until the final trade
transmission is sent to the OCC; that it will be considered a
violation of Rule 915NY if a responsible ATP Holder is not available
to reconcile an uncompared trade when contacted by NYSE Amex Trade
Processing Department; and that, while there may be occasional
instances when a trade must remain uncompared overnight, and be
resolved in conformance with Rule 915.3NY, any ATP Holders
responsible for an undue number of such occurrences will be subject
to disciplinary action pursuant to Rule 9200.
    \9\ Simultaneously, new proposed Rule 915NY would eliminate the
outdated references and anachronistic concepts rampant throughout
Commentary .01 to Rule 970, thus further clarifying the rulebook.
See Ftnt. 4, supra.
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    New proposed Rule 915.1NY (which is based upon NYSE Arca Rule 6.18-
O) would replace Rule 965. Rule 965 is textually identical to NYSE Arca
6.18-O.\10\ Consequently, there is no formative change associated with
the replacement of Rule 965 with proposed Rule 915.1NY but for the
replacement of the cross-reference to Rule 970 with a cross-reference
to new proposed Rule 915.3, the successor rule governing the resolution
of uncompared trades.\11\
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    \10\ New proposed Rule 915.1NY would provide that on each
business day after the cut-off hour for the receipt of
reconciliation reports, the Exchange shall issue to each ATP Holder
which is a clearing member of the OCC or its delegate, an
unreconciled trade report which will contain a list of any new or
remaining uncompared trades and advisory trades of such clearing
member. If any such trades are subsequently reconciled between the
parties, they may be submitted for comparison on the next business
day. Trades which are not so reconciled by the parties shall be
closed in accordance with the provisions of Rule 915.3NY.
    \11\ The Exchange also proposes placing the requirements of Rule
965, which address the issuance of an unreconciled trade report,
within the newly grouped sequence of rules that address the
processes of comparison and reconciliation.
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    New proposed Rule 915.2NY (which is based upon Arca Rule 6.19-O),

similarly to new proposed Rule 915NY and its commentary, would describe
existing processes of the Exchange: To furnish to the OCC a report of
each clearing member's compared trades based on the comparison service
performed by the Exchange on that business day; thus providing further
rule uniformity and clarification of this part of the process in the
options marketplaces.\12\
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    \12\ New proposed Rule 915.2NY would provide that on each
business day at or prior to such time as may be prescribed by the
OCC, the Exchange shall furnish the OCC a report of each clearing
member's compared trades based on the comparison service performed
by the Exchange on that day. Only trades which have been compared in
accordance with the provisions of this Rule shall be furnished by
the Exchange to the OCC, and the Exchange shall assume no
responsibility with respect to any uncompared trade nor for any
delays or errors in the reporting of trades for comparison.
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    New proposed Rule 915.3NY and its commentary (which is based upon
Arca Rule 6.21-O and its commentary) \13\ describes calculations of the
amounts of loss on uncompared trades,\14\ provisions that Rule 970 did
not specify, and that the Exchange believes would provide helpful
clarification and conformity of its rulebook and processes.\15\
Additionally, Commentary .02 to new proposed Rule 915.3NY also
describes the Exchange's authority to remove from record any
transactions that have, in error, been matched but which are actually
uncompared transactions.\16\
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    \13\ As noted in Ftnt. 6, supra, NYSE Arca Rule 6.20-O is
inapposite to these proposed rule changes governing the
reconciliation of uncompared trades and is therefore not included
sequentially in new proposed Rules 915NY et seq.
    \14\ New proposed Rule 915.3NY would provide that the amount of
loss as a result of an uncompared trade would be the opening price
for such contract on the business day following the trade date;
where the uncompared trade side is one for the purchase of option
contracts and no trade occurred on the opening, the price used in
fixing the amount of the loss would be the offer at the time of the
opening; and, where the uncompared trade side is one for the sale of
option contracts and no trade occurred on the opening, the price
used in fixing the amount of the loss would be the bid price.
    \15\ New proposed Rule 915.3NY would also provide that notice of
uncompared trades must be provided no later than the scheduled
commencement of trading unless directed otherwise by a Trading
Official; that in the event an uncompared transaction involves an
option contract of a series in which trading has been terminated or
suspended before a new Exchange option transaction can be effected
to establish the amount of any loss, the ATP Holder not at fault may
claim damages against the other party involved in the transaction
based on the terms of such transaction; and that all such claims
shall be made promptly but in no event shall such claim be made
after the close of trading on the first business day following the
date of the uncompared transaction in question.
    \16\ New proposed Commentary to Rule 915.3NY would also provide
that in order to ensure that trades can be resolved by the scheduled
commencement of trading in such series or class of options on the
first business day following the trade date, ATP Holder are required
to have an authorized representative of such ATP Holder available to
resolve uncompared trades no later than 45 minutes from the
scheduled commencement of trading on said business day following the
trade date.
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    The Exchange believes that the deliberate assemblage of the
provisions concerning the resolution of uncompared trades in a separate
new rule, new proposed Rule 9.15.3NY, along with the assembly of the
associated rules governing the verification of compared trades and the
reconciliation of uncompared trades, the issuance of an unreconciled
trade report, and the reporting of compared trades to OCC, in new
proposed Rules 915NY, 915.1NY and 915.2NY, respectively, would clarify,
update and make uniform the rules governing the post-trade processing
of options transactions, and would accelerate the reconciliation
process for uncompared options transactions, thereby reducing any
potential risks or inefficiencies inherent in the continued use of
outdated Rules 965 and 970.
    Finally, in a further effort at standardization and clarity, the
Exchange proposes to add the new rules to the ``NY'' series of its
rulebook, which contains the rules principally applicable to the
trading of options contracts. In order to provide further clarification
concerning its rules, the Exchange also proposes to replace the cross-
references to Rules 965 and 970 in Rules 900F and Rule 900H with
updated cross-references to proposed Rules 915NY, 915.1NY, 915.2NY, and
915.3NY.
Other Proposed Rule Changes
    In addition, the Exchange proposes to amend Rule 900.2NY(29) to
streamline the definition of Floor Market Maker. Specifically, the
Exchange proposes to amend Rule 900.2NY(29) so that the proposed
definition would read ``The term `Floor Market Maker' shall mean a
registered Market Maker who makes transactions as a dealer-specialist
while on the Floor of the Exchange.'' In connection with this change,
the Exchange proposes to eliminate ``and provides quotations: (A)
Manually, by public outcry, and (B) electronically through an auto-
quoting device'' as an unnecessarily repetitive description of a Floor
Market Maker's activity, in an effort to promote further clarification
in its rulebook.
    In order to further update and clarify the Exchange's rules
governing conduct on the options trading floor, the Exchange proposes
to amend Rule 902NY(f) to replace an outdated reference to the
``Options Surveillance Department'' with ``NYSE Regulation'', the
current operative entity to which complaints from ATP Holders may be
directed. NYSE Regulation currently oversees the self-regulatory
responsibilities and functions of the Exchange.\17\
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    \17\ See Regulatory Information Memo No. 15-6 available at:
https://www.nyse.com/publicdocs/nyse/markets/nyse/rule-interpretations/2015/NYSE-15-6.pdf
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    In order to add further clarification to its rulebook, and to
conform its definition of Marker Maker to the rules of NYSE Arca, its
affiliated exchange, the Exchange also proposes to add ``making
transactions as a dealer-specialist on the Floor of the Exchange'' to
the beginning of the first sentence of Rule 920NY, and to delete
``verbally on the Trading Floor'' and ``from on the Trading Floor or
remotely from off the Trading Floor'' from the end of that
sentence.\18\ The proposed sentence would read ``A Market Maker is an
ATP Holder that is registered with the Exchange for the purpose of
making transactions as a dealer-specialist on the Floor of the Exchange
or for the purpose of submitting quotes electronically and making
transactions as a dealer-specialist through the System.'' In addition
to being consistent with the definition of a Marker Maker in NYSE Arca
Rule 6.32(a)-O, the Exchange believes that this modification will
promote greater clarity without affecting the definition of market
maker as a dealer-specialist that makes transactions in open outcry on
the floor of the Exchange and electronically through the System.
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    \18\ The Exchange also proposes deleting ``in accordance with
the Rules of the Exchange'' from the end of that first sentence as
unnecessary because adherence to the Exchange's rules is intrinsic
to all rules in its rulebook.
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    In order to clarify its rules, the Exchange also proposes to amend
Rule 930NY(b)(1) and Rule 930NY(b)(2) to replace the definition of
``Professional Customer'' with the single-use term ``Qualified
Customer'' in connection with the limited public business that
qualified Floor Brokers and their Floor Clerks may conduct. Rule
930NY(b) defines both the permissible conduct of a limited public
business and also defines ``Professional Customer'', for purposes of
Rule 930NY(b), as ``not includ[ing] those participants defined in Rule
900.2NY(18A)''.\19\ In order to avoid

unnecessary complexity or confusion concerning the duplicate
definitions of ``Professional Customer'', the Exchange proposes to
amend Rule 930NY(b) to replace the definition of ``Professional
Customer'' with the single-use term ``Qualified Customer'' in
connection with the limited public business, and to limit the use of
``Qualified Customer'' to Rule 930NY(b).
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    \19\ The definition of ``Professional Customer'' in Rule
900.2NY(18A), which is broader than the definition in Rule 930NY
(b)(2), defines a ``Professional Customer'' as an individual or
organization that is not a Broker/Dealer in securities and places
more than 390 orders in listed options per day on average during a
calendar month for its own beneficial account(s). Rule 900.2NY(18A)
also defines the treatment of a Professional Customer under various
Exchange rules except Rule 930NY(b), and defines how to calculate
the number of Professional Customers orders in connection with
different order types.
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    Furthermore, in order to provide further clarification concerning
its rules, the Exchange proposes to amend Rule 934NY, its crossing
rule, by replacing outdated references to the requirement that
execution prices ``be equal to or better than the NBBO'' with updated
cross-references to the Rule 991NY, the current plenary Order
Protection Rule. In addition, in connection with both customer-to-
customer cross and non-facilitation (regular way) crosses, the Exchange
proposes to delete from Rules 934NY(a)(3)(B) and 934NY(b)(3) two
sentences that provide that ``[t]he orders will be cancelled or posted
in the Book if an execution would take place at a price that is
inferior to the NBBO''. Rule 991NY would also govern in such
situations, and the orders will not be cancelled or posted but would
trade through in accord with the exemptions in Rule 991NY.
    In order to update and clarify the Exchange's rules governing its
order format and system entry requirements, the Exchange proposes to
amend Rule 955NY to replace an outdated reference to a required
timestamp synchronized to the ``NIST Clock'' with a reference to Rule
6820, the current CAT clock synchronization rule. Specifically, in
connection with Rule 955NY(d)(2)(A), which governs contingency
reporting procedures when an exception to the EOC (Electronic Order
Capture System) applies, the Exchange proposes to delete an outdated
reference to ``(a timestamp synchronized with the National Institute of
Standards and Technology Atomic Clock in Boulder Colorado `NIST Clock'
will be available at all ATP Holder booths[sic]'' and instead add the
requirement that all order events must conform to the requirements of
Rule 6820. For further clarity, the Exchange also proposes to delete
``immediately'' from the text of the rule because Rule 6820 sets the
operative standard.
    Finally, the Exchange proposes to conform its rule governing the
priority of complex orders in open outcry to its rule governing
Electronic Complex Orders. Specifically, the Exchange proposes to
conform Rule 963NY(d) to Rule 980NY(b) by amending Rule 963NY(d) to
provide that a Complex Order and Stock/Complex Orders may be executed
at a ``total or'' net debit or credit price.
2. Statutory Basis
    The proposed rule changes are consistent with Section 6(b) \20\ of
the Act, in general, and furthers the objectives of Section
6(b)(5),\21\ in particular, in that they are 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 facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system.
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    \20\ 15 U.S.C. 78f(b).
    \21\ 15 U.S.C. 78f(b)(5).
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    Specifically, the Exchange believes that conforming its
definitional rules to the rules of an affiliated exchange, updating its
rules by deleting and updating outdated cross-references, eliminating
extraneous or redundant, and therefore potentially confusing or
ambiguous, language, clarifying a duplicative definition, updating a
cross-reference to a current operative rule or operative entity, and
updating its post-trading verification and reconciliation rules, and
conforming its rules to the rules of an affiliated exchange governing
the same subject matter, would remove impediments to and perfect a
national market system by simplifying the functionality and complexity
of its rules and regulatory requirements. The Exchange also believes
that these proposed amendments would be consistent with the public
interest and the protection of investors because investors would not be
harmed and, in fact, would benefit from this simplification, updating
and clarification. Further, the Exchange believes that investors would
benefit from the added transparency and clarity of the Exchange's
rules.
    In addition, the Exchange believes, that by updating and conforming
its rules governing the verification of compared trades and the
reconciliation of uncompared trades to the rules of NYSE Arca, its
affiliated exchange, by streamlining the definition of Floor Market
Maker by eliminating extraneous language, by updating and clarifying
the Exchange's rules governing conduct on the options trading floor by
replacing an outdated reference to the ``Options Surveillance
Department'' with ``NYSE Regulation'', by updating and conforming its
definition of Market Maker to the definition of NYSE Arca and deleting
redundant and therefore potentially confusing language, by replacing
the definition of ``Professional Customer'' with the single-use term
``Qualified Customer'' in connection with the limited public business
that qualified Floor Brokers and their Floor Clerks may conduct, by
amending its crossing rule by replacing outdated and potentially
ambiguous references to the NBBO with cross-references to the current
plenary Order Protection Rule, by updating and clarifying its rules
governing its order format and system entry requirements by replacing
an outdated reference with a reference to the current operative CAT
time synchronization rule, and by conforming its rule governing the
priority of complex orders in open outcry to its rule governing
Electronic Complex Orders, would also promote just and equitable
principles of trade, would remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, would help to protect investors and the public interest by
providing transparency as to which rules are operable, and by reducing
potential confusion that may result from having outdated or redundant
rules or cross-references in the Exchange's rulebook. The Exchange
further believes that the proposed rule changes would remove
impediments to and perfect the mechanism of a free and open market by
ensuring that members, regulators and the public can more easily
navigate and understand the Exchange's rulebook.
    For these reasons, the Exchange believes that the proposal is
consistent with the Act.

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

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed changes are not
designed to address any competitive issue but would instead update,
remove, and clarify outdated cross-references and definitions, and
redundant language, and also conform the Exchange's rules and
definitions to the rules of another exchange, thereby reducing
confusion and making the Exchange's rules easier to understand and
navigate.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \22\ and Rule 19b-4(f)(6) thereunder.\23\
Because the 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 prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \22\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \23\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \24\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\25\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \24\ 17 CFR 240.19b-4(f)(6).
    \25\ 17 CFR 240.19b-4(f)(6)(iii).
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    At any time within 60 days of the filing of such 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 under
Section 19(b)(2)(B) \26\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \26\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAMER-2017-18 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-NYSEAMER-2017-18. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at 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-NYSEAMER-2017-18, and should
be submitted on or before October 18, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
Eduardo A. Aleman,
Assistant Secretary.
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2017-20624 Filed 9-26-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 81009-81010]
[FR Doc No: 2011-33097]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Aviation Rulemaking Advisory Committee--New Task

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of new task assignment for the Aviation Rulemaking
Advisory Committee (ARAC).

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

SUMMARY: The FAA assigned the Aviation Rulemaking Advisory Committee
(ARAC) a new task to develop a comprehensive program of voluntary
accreditation for commercial air tour operators that are not required
under parts 91 and 135 of Title 14 of the Code of Federal Regulations
(14 CFR) to maintain their aircraft under a continuous airworthiness
maintenance program (CAMP). This task addresses, in part, the ARAC
recommendation developed by the Commercial Air Tours Maintenance (CATM)
Working Group, which the FAA accepted on February 1, 2011. This notice
informs the public of a new ARAC activity and solicits membership for
the new Commercial Air Tour Voluntary Accreditation Program Working
Group.

FOR FURTHER INFORMATION CONTACT: Katherine Haley, Office of Rulemaking,
Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 20591; telephone:<PHONE_NUMBER>, facsimile: (202) 267-
5075; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA established ARAC to provide advice and recommendations to
the FAA Administrator on the FAA's rulemaking activities. ARAC's
objectives are to improve the development of the FAA's regulations by
providing information, advice, and recommendations related to aviation
issues.
    On July 15, 2009, the FAA tasked ARAC (74 FR 34390) to provide
advice and recommendations on a maintenance quality assurance system, a
maintenance training program and a required inspection program for
operators and air carriers that conduct air tours and who operate under
parts 91 and 135 (aircraft type certificated for a passenger seating
configuration, excluding any pilot seat, of 9 or fewer seats). That
tasking was in response to two recommendations from the National
Transportation Safety Board (NTSB) (A-08-32 and A-08-33) and an FAA
recommendation on air tour accidents. The CATM Working Group formed and
met between November 2009 and December 2010 to address the ARAC
tasking. On December 16, 2010, the CATM working group presented the
findings and recommendations to the ARAC Executive Committee. One of
the recommendations was to develop an Advisory Circular (AC) to create
a voluntary accreditation program

modeled after the AC 00-56A, Voluntary Industry Distributor
Accreditation Program. The FAA accepted the recommendations on February
1, 2011.
    This tasking is the FAA's response to one of the CATM
recommendations. The FAA is tasking ARAC to make recommendations on a
program for voluntary accreditation in the form of an AC. The objective
of the accreditation program is to raise the level of safety of
commercial air tour operators not required by regulation to maintain
their aircraft under a continuous airworthiness maintenance program.
    In December 2011, the ARAC Executive Committee met and discussed
the solicited ideas and proposed actions for the tasking. This notice
advises the public that the FAA has assigned, and the Executive
Committee has accepted, a task to develop a recommendation report on a
voluntary accreditation program in the form of an AC.

The Task

    The FAA has tasked the ARAC working group to provide advice and
recommendations on a program for voluntary accreditation in the form of
an AC. The objective of the accreditation program is to raise the level
of safety of commercial air tour operators not required by regulation
to maintain their aircraft under a CAMP.
    The working group is expected to develop a report containing
recommendations on the tasking elements listed below. This report
should document both majority and minority positions on the findings
and the rationale for each position. Any disagreements should be
documented, including the rationale for each position and the reasons
for the disagreement. In developing its recommendations, the working
group shall:
    1. Familiarize itself with AC 00-56A to use as a model for
developing the subject AC.
    2. Establish quality system elements for a maintenance
accreditation program.
    3. Determine acceptable quality system standards.
    4. Establish accreditation organization responsibilities.
    5. Establish audit procedures.
    6. Establish accreditation procedures.
    7. Draft an advisory circular that addresses the elements of 1-6
above.
    Schedule: The recommendations must be forwarded to the ARAC
Executive Committee for review and approval no later than December
2012.

ARAC Acceptance of Task

    The ARAC Executive Committee has accepted the task and assigned it
to the Commercial Air Tour Voluntary Accreditation Program Working
Group. The working group serves as staff to ARAC and assists in the
analysis of the assigned task. ARAC must review and approve the working
group's recommendations. If ARAC accepts the working group's
recommendations, it will send them to the FAA.

Working Group Activity

    The Commercial Air Tour Voluntary Accreditation Program Working
Group must comply with the procedures adopted by ARAC. As part of the
procedures, the working group must:
    1. Recommend a work plan for completion of the task, including the
rationale supporting such a plan, for consideration at the next ARAC
Executive Committee meeting held following publication of this notice.
    2. Provide a status report at each meeting of the ARAC Executive
Committee.
    3. Draft the recommendation report and required analyses and/or any
other related materials or documents.
    4. Present the final recommendations to the ARAC Executive
Committee for review and approval.

Participation in the Working Group

    The Commercial Air Tour Voluntary Accreditation Program Working
Group will be comprised of air tour industry organizations and
technical experts having an interest in the assigned task. A working
group member need not be a representative or a member of the committee.
The FAA would like a wide range of members to ensure all aspects of
rulemaking are considered in development of the recommendations.
    If you wish to become a member of the Commercial Air Tour Voluntary
Accreditation Program Working Group, write the person listed under the
caption FOR FURTHER INFORMATION CONTACT expressing that desire.
Describe your interest in the task and state the expertise you would
bring to the working group. We must receive all requests by January 26,
2012. The ARAC Executive Committee and the FAA will review the requests
and advise you whether or not your request is approved.
    If you are chosen for membership on the working group, you must
actively participate in the working group by attending all meetings,
and providing written comments when requested to do so. You must devote
the resources necessary to support the working group in meeting any
assigned deadlines. You must keep your management chain and those you
may represent advised of working group activities and decisions to
ensure the proposed technical solutions do not conflict with your
sponsoring organization's position when the subject is presented to
ARAC for approval. Once the working group has begun deliberations,
members will not be added or substituted without the approval of the
FAA and the working group chair.
    The Secretary of Transportation determined the formation and use of
ARAC is necessary and in the public interest in connection with the
performance of duties imposed on the FAA by law.
    ARAC meetings are open to the public. However, ARAC Commercial Air
Tour Voluntary Accreditation Program Working Group meetings are not
open to the public, except to the extent individuals with an interest
and expertise are selected to participate. The FAA will make no public
announcement of working group meetings.

    Issued in Washington, DC, on December 19, 2011.
Pamela Hamilton-Powell,
Executive Director, Aviation Rulemaking Advisory Committee.
[FR Doc. 2011-33097 Filed 12-23-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Notices]
[Pages 72063-72066]
[FR Doc No: 2016-25232]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0825]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Approval of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on requirements for premarket
approval of medical devices.

DATES: Submit either electronic or written comments on the collection
of information by December 19, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0825 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Premarket Approval of Medical
Devices'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Premarket Approval of Medical Devices--21 CFR part 814--OMB Control
Number 0910-0231--Extension

    Under section 515 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360e) all devices placed into class III by FDA are
subject to premarket approval requirements. Premarket approval (PMA) is
the process of scientific and regulatory review to ensure the safety
and effectiveness of class III devices. An approved PMA is, in effect,
a private license granted to the applicant for marketing a particular
medical device. A class III device that fails to meet PMA requirements
is considered to be adulterated under section 501(f) of the FD&C Act 21
U.S.C. 351(f)) and cannot be marketed. Premarket approval requirements
apply differently to preamendments devices, postamendments devices, and
transitional class III devices.
    Manufacturers of class III preamendments devices, devices that were
in commercial distribution before May 28, 1976, are not required to
submit a PMA until 30 months after the issuance of a final
classification regulation or until 90 days after the publication of a
final regulation requiring the submission of a PMA, whichever period is
later. FDA may allow more than 90 days after issuance of a final rule
for submission of a PMA.
    A postamendments device is one that was first distributed
commercially on or after May 28, 1976. Postamendments devices
determined by FDA to be substantially equivalent to preamendments class
III devices are subject to the same requirements as the preamendments
devices. FDA determines substantial equivalence after reviewing an
applicant's premarket notification submitted in accordance with section
510(k) of the FD&C Act (21 U.S.C. 360(k)). Postamendments devices
determined by FDA to be not substantially equivalent to either
preamendments devices or postamendments devices classified into class I
or II are ``new'' devices and fall automatically into class III. Before
such devices can be marketed, they must have an approved premarket
approval application or be must reclassified into class I or class II.
    The Food and Drug Modernization Act of 1997 (FDAMA) (Pub. L. 105-
115) was enacted on November 21, 1997, to implement revisions to the
FD&C Act by streamlining the process of bringing safe and effective
drugs, medical devices, and other therapies to the U.S. market. FDAMA
added section 515(d)(6) to the FD&C Act, which provided that PMA
supplements were required for all device changes that affect safety and
effectiveness unless such changes are modifications to manufacturing
procedures or method of manufacture. That type of manufacturing change
will require a 30-day notice, or where FDA

finds such notice inadequate, a 135-day PMA supplement.
    The implementing regulations, contained in part 814 (21 CFR part
814), further specify the contents of a PMA for a medical device and
the criteria FDA will employ in approving, denying, or withdrawing
approval of a PMA and supplements to PMAs. The regulations' purpose is
to establish an efficient and thorough procedure for FDA's review of
PMAs and supplements to PMAs for class III medical devices. The
regulations facilitate the approval of PMAs and supplements to PMAs for
devices that have been shown to be reasonably safe and effective and
otherwise meet the statutory criteria for approval. The regulations
also ensure the denial of PMAs and supplements to PMAs for devices that
have not been shown to be reasonably safe and effective and that do not
otherwise meet the statutory criteria for approval.
    The industry-wide burden estimate for PMAs is based on an FDA
average fiscal year (FY) annual rate of receipt of PMA submissions data
FY 2013 through 2015 and our expectation of submissions to come in the
next few years. The burden data for PMAs is based on data provided by
applicants by device type and cost element in an earlier study.
    Reporting Burden: The reporting burden can be broken out by certain
sections of the PMA regulations and the FD&C Act as follows:
    Sec.  814.15(b)--Research Conducted Outside the United States. Each
foreign study should be performed in accordance with the ``Declaration
of Helsinki'' or the laws and regulations of the country in which the
study was conducted. If the study was conducted in accordance with the
laws of the country, the PMA applicant is required to explain to FDA in
detail the differences between the laws of the country and the
``Declaration of Helsinki.'' Based on the number of PMAs received that
contained studies from overseas, FDA estimates that the burden estimate
necessary to meet this requirement is 50 hours.
    Sec.  814.20--Application. Included in this requirement are the
conduct of laboratory and clinical trials as well as the analysis,
review, and physical preparation of the PMA application. FDA estimates
that 35 applicants, including hospital re-manufacturers of single-use
devices, will be affected by these requirements which are based on the
actual average of FDA receipt of new PMA applications in FY 2013
through 2015. FDA's estimate of the hours per response (668) was
derived through FDA's experience and consultation with industry and
trade associations. In addition, FDA also based its estimate on the
results of an earlier study that accounts for the bulk of the hourly
burden for this requirement, which is identified by applicants.
    Sec.  814.37(a) through (c) and (e)--PMA Amendments and Resubmitted
PMAs. As part of the review process, FDA often requests the PMA
applicant to submit additional information regarding the device
necessary for FDA to file the PMA or to complete its review and make a
final decision. The PMA applicant may, also on their own initiative,
submit additional information to FDA during the review process. These
amendments contain information ranging from additional test results,
re-analysis of the original data set, to revised device labeling.
Almost all PMAs received by the Agency have amendments submitted during
the review process.
    Sec.  814.39(a)--PMA Supplements. This information collection
includes the requirements for the range of PMA supplements (panel
track, 180-day fee-based, 180-day non-fee based, and real-time
supplements).
    Sec.  814.39(d)--Special PMA Supplements--Changes Being Affected.
This type of supplement is intended to enhance the safety of the device
or the safe use of the device. The number of PMA supplements received
that fit this category averaged 88 per year based on the numbers
received from FY 2013 through FY 2015. Because of the minimal data
required to be included in this type of supplement, FDA estimates that
the burden hours necessary to satisfy this requirement are 528 hours.
    Sec.  814.39(f)--30-Day Notice. Under section 515(d) of the FD&C
Act, modifications to manufacturing procedures or methods of
manufacture that affect the safety and effectiveness of a device
subject to an approved PMA do not require submission of a PMA
supplement under paragraph (a) of this section and are eligible to be
the subject of a 30-day notice. A 30-day notice shall describe in
detail the change, summarize the data or information supporting the
change, and state that the change has been made in accordance with the
requirements of part 820 (21 CFR part 820). The applicant may
distribute the device 30 days after the date on which FDA receives the
30-day notice, unless FDA notifies the applicant within 30 days from
receipt of the notice, that it is not adequate.
    Sec.  814.82(a)(9)--Postapproval Requirements. Postapproval
requirements concerns approved PMAs that were not reclassified and
require a periodic report. After approval, all PMAs require a
submission of an annual report. A majority of the submitted PMAs
require associated postapproval studies, i.e., followup of patients
used in clinical trials to support the PMA or additional preclinical
information that is labor-intensive to compile and complete; the
remaining PMAs require minimal information.
    Sec.  814.84(b)--Periodic Reports. Postapproval requirements
described in Sec.  814.82(a)(7) require submission of an annual report
for each approved PMA. FDA estimates that respondents will average
about 10 hours in preparing their reports to meet this requirement.
This estimate is based on FDA's experience and consultation with
industry.
    Expedited or Priority Review--Section 515(d)(5) of the FD&C Act.
FDA will provide special review, which can include expedited processing
of a PMA application, for certain devices intended to treat or diagnose
life threatening or irreversibly debilitating diseases or conditions.
To receive special review, the devices must meet one of the following
criteria:
     The device represents a breakthrough technology;
     There are no approved alternatives;
     The use of the device offers significant advantages over
existing approved alternatives;
     Availability is in the best interest of the patients.
    Agreement Meeting--Section 520(g)(7) of the FD&C Act (21 U.S.C.
360j(g)(7)). Applicants planning to submit a PMA may submit a written
request to reach agreement with FDA on the key parameters of the
investigational plan.
    Determination Meeting--Section 513(a)(3)(D) of the FD&C Act (21
U.S.C. 360c(a)(3)(D)). Applicants planning to submit a PMA may submit a
written request to FDA for a meeting to determine the type of
information (valid scientific evidence) necessary to support the
effectiveness of their device.
    Panel of Experts--Section 515(c)(3) of the FD&C Act. An original
PMA or panel track PMA supplement is taken to an advisory panel of
experts unless FDA determines that the information in the application
substantially duplicates information which has previously been reviewed
by the panel.
    Day 100 Meeting--Section 515(d)(3) of the FD&C Act. FDA must, upon
the written request of the applicant, meet with that party within 100
days of receipt of the filed PMA application to discuss the review
status of the application. With the concurrence of the applicant, a
different schedule may be established. Prior to this meeting, FDA must
inform the applicant in writing of

any identified deficiencies and what information is required to correct
those deficiencies. FDA must also promptly notify the applicant if FDA
identifies additional deficiencies or of any additional information
required to complete Agency review.

Recordkeeping

    Sec.  814.82(a)(5) and (a)(6)--Maintenance of Records. The
recordkeeping burden under this section requires the maintenance of
records, used to trace patients and the organization and indexing of
records into identifiable files to ensure the device's continued safety
and effectiveness. These records are required of all applicants who
have an approved PMA.
    PMAs have been required since 1976, and there are 725 active PMAs
that could be subject to these requirements, based on actual FDA data,
and approximately 30 new PMAs are approved every year. The aggregate
burden for the estimated 422 PMA holders of approved original PMAs for
the next few years is estimated to be 7,174 hours.
    The applicant determines which records should be maintained during
product development to document and/or substantiate the device's safety
and effectiveness. Records required by the current good manufacturing
practices for medical devices regulation (21 CFR part 820) may be
relevant to a PMA review and may be submitted as part of an
application. In individual instances, records may be required as
conditions of approval to ensure the device's continuing safety and
effectiveness.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
   Activity/21 CFR or FD&C Act       Number of    responses  per   Total annual   Average burden    Total hours
             section                respondents      respondent      responses     per response
----------------------------------------------------------------------------------------------------------------
Research conducted outside the                25               1              25               2              50
 United States (814.15(b))......
PMA application (814.20)........              35               1              35             668          23,380
PMA amendments and resubmitted             1,222               1           1,222             167         204,074
 PMAs (814.37(a)-(c) and (e))...
PMA supplements (814.39(a)).....             695               1             695              60          41,700
Special PMA supplement--changes               88               1              88               6             528
 being affected (814.39(d)).....
30-day notice (814.39(f)).......           1,710               1           1,710              16          27,360
Postapproval requirements                    340               1             340             135          45,900
 (814.82(a)(9)).................
Periodic reports (814.84(b))....             695               1             695              10           6,950
Agreement meeting (520(g)(7))...               1               1               1              50              50
Expedited review request                       6               1               6              10              60
 (515(d)(5) of the FD&C Act)....
Determination Meeting                          1               1               1              50              50
 (513(1)(3)(D) of the FD&C Act).
Panel meeting (515(c)(3) of the                9               1               9              30             270
 FD&C Act)......................
Day 100 meeting (515(d)(3) of                 19               1              19              10             190
 the FD&C Act)..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         350,562
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Average  burden
                      Activity/21 CFR section                           Number of       records  per     Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of records (814.82(a)(5) and (a)(6))...................             422                1              422               17            7,174
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25232 Filed 10-18-16; 8:45 am]
 BILLING CODE 4164-01-P


                      Appendix D  -  Analysis of Changes

The table below presents all line items from the ICR with a greater than 50 percent change (positive or negative) from the currently approved ICR (i.e., OMB's inventory). It also includes an explanation of the reason for the change and the quality assurance actions to verify the validity of these changes.

Reference Code Activity Description Respondent Type Total Hours / Year (Renewal) Total Hours / Year (OMB) % Change Reason for Change 2.16 Great Lakes Antidegradation Demonstration Nonmunicipal - BCCs 140 351 -60% Burden for the activity was divided by two because some of the burden is accounted for in the Water Quality Standards ICR. 2.17 Great Lakes Antidegradation Demonstration Nonmunicipal - non-BCCs 93 234 -60%

4.65 Other Noncompliance Reports CAFOs 0 790 -100% Burden moved to the Animal Sector ICR 4.66 Other noncompliance Reports (CAFO Permittees) NPDES States 0 306 -100%

1.23 Permit Consolidation Industry 0 4 -100% EPA anticipates that 0 facilities will file Permit Consolidation Requests each year  1.24 Permit Consolidation NPDES States, Facilities 0 1 -100%

7.2 Request for NPDES Partial Program Approval NPDES States 0 693 -100% EPA anticipates that no states that currently are not authorized to implement the NPDES program will seek partial program authorization during the life of this ICR.   6.3 Section 308(a) Letters General Stormwater Permittees Industrial 3,208 1,712 87% EPA estimates that 1,200 permittees will be required to respond to a section 308(a) letter. These are allocated based on the number of permits and the type of permits. The change in stormwater permittees affects the allocation of these letters. 6.4 Section 308(a) Letters MS4s (Phase I and II) 248 120 107%

7.1 Request for NPDES Program Approval NPDES States 0 693 -100% EPA expects that no states will request full program authorization during the life of this ICR.

2.83 Development of SWPPP Large construction sites (>5 acres) in NPDES States 1,260,277 5,262,057 -76% EPA generated a new estimate of construction sites based on data collected for the development of the final Construction Effluent Limitation Guidelines. The Agency revised its estimate of the number of large and small construction sites covered by this ICR downward from 243,076 to 84,472 sites annually (Continued through 2.84 Development of SWPPP Large construction sites (>5 acres) EPA Perm Auth no ESA 41,059 187,314 -78%

2.85 Development of SWPPP Large construction sites (>5 acres) EPA Perm Auth informal ESA 25,516 116,444 -78%

2.86 Development of SWPPP Large construction sites (>5 acres) EPA Perm Auth formal ESA 1,856 8,445 -78%

3.98 Routine site inspection Large construction sites (>5 acres) in NPDES States 450,099 1,879,306 -76%

3.99 Routine site inspection Large construction sites (>5 acres) EPA Perm Auth no ESA 14,664 66,898 -78%

3.1 Routine site inspection Large construction sites (>5 acres) EPA Perm Auth informal ESA 9,113 41,587 -78%

3.101 Routine site inspection Large construction sites (>5 acres) EPA Perm Auth formal ESA 663 3,016 -78%

4.319 Permittee Report of Planned Facility Changes Construction Stormwater General Permittees 1,640 4,772 -66%

4.320 Permittee Report of Planned Facility Changes NPDES States, Construction Stormwater General Permittees 8,200 23,860 -66%

4.321 Permittee Report of Anticipated Noncompliance Construction Stormwater General Permittees 410 1,195 -66%

4.322 Permittee Report of Anticipated Noncompliance NPDES States, Construction Stormwater General Permittees 780 2,260 -66%

4.323 Facility and Permit Transfer Report Construction Stormwater General Permittees 246 717 -66%

4.324 Facility and Permit Transfer Report NPDES States, Construction Stormwater General Permittees 312 904 -66%

4.325 Permittee Report of Inaccurate Previous Information Construction Stormwater General Permittees 82 238 -66%

4.326 Permittee Report of Inaccurate Previous Information NPDES States, Construction Stormwater General Permittees 156 448 -65%

4.327 Unanticipated Bypass / Upset Reports (Verbal Reports) Construction Stormwater General Permittees 410 1,195 -66%

4.328 Unanticipated Bypass / Upset Report (Verbal Notification) NPDES States, Construction Stormwater General Permittees 78 225 -65%

4.329 Unanticipated Bypass / Upset Report (Immediate Action) NPDES States, Construction Stormwater General Permittees 39 113 -65%

4.330 Unanticipated Bypass / Upset Reports (Written Reports) Construction Stormwater General Permittees 124 358 -65%

4.331 Unanticipated Bypass / Upset Report (Written Report) NPDES States, Construction Stormwater General Permittees 118 338 -65%

4.332 Maximum Daily Violation Reports (Verbal Reports) Construction Stormwater General Permittees 234 675 -65%

4.333 Maximum Daily Violation Report (Verbal Notification) NPDES States, Construction Stormwater General Permittees 78 225 -65%

4.334 Maximum Daily Violation Report (Immediate Action) NPDES States, Construction Stormwater General Permittees 39 113 -65%

4.335 Maximum Daily Violation Reports (Written Reports) Construction Stormwater General Permittees 78 226 -66%

4.336 Maximum Daily Violation Report (Written Report) NPDES States, Construction Stormwater General Permittees 78 226 -66%

4.337 Other Noncompliance Reports Construction Stormwater General Permittees 4,105 11,930 -66%

4.338 Other Noncompliance Reports (NPDES Permittee Reports) NPDES States, Construction Stormwater General Permittees 1,556 4,504 -66%

5.44 Recordkeeping Large construction sites (>5 acres) in NPDES States 13,849 57,825 -76%

5.45 Recordkeeping Large construction sites (>5 acres) EPA Perm Auth no ESA 451 2,058 -78%

5.46 Recordkeeping Large construction sites (>5 acres) EPA Perm Auth informal ESA 280 1,280 -78%

5.47 Recordkeeping Large construction sites (>5 acres) EPA Perm Auth formal ESA 20 93 -78%

5.48 Recordkeeping of Inspections Stormwater General Permittees, Construction 328,294 954,316 -66%

6.34 Inspection & Investigation of NPDES permittees - Stormwater General (large Construction) - RI NPDES States 13,848 57,824 -76%

1.124 NOI preparation & submittal Large construction sites (>5 acres) in NPDES States 51,935 216,843 -76%

1.125 NOI preparation & submittal Large construction sites (>5 acres) EPA Perm Auth no ESA 1,692 7,719 -78%

1.126 NOI preparation & submittal Large construction sites (>5 acres) EPA Perm Auth informal ESA 4,206 19,194 -78%

1.127 NOI preparation & submittal Large construction sites (>5 acres) EPA Perm Auth formal ESA 1,020 4,640 -78%

1.128 NOI Processing & review NPDES States, Large construction sites (>5 acres)  34,623 144,562 -76%

1.133 Prepare and submit a NOT Large construction sites (>5 acres) 18,252 76,569 -76%

1.134 NOT processing NPDES States, Large Construction 8,656 36,141 -76%

3.102 Monitoring Construction Sites  35,031 10,135 246% Formula correction from previous ICR.  4.137 Permittee Report of Inaccurate Previous Information Minor Municipal 378 208 82% Formula correction from previous ICR.  4.138 Permittee Report of Inaccurate Previous Information NPDES States, Minor Municipal 744 408 82%

6.20 Inspection & Investigation of NPDES permittees - PCI NPDES States 0 21,408 -100% This burden has been transferred to the Pretreatment ICR (OMB Control No. 2040-0009). 1.104 Form 1 Individual Stormwater Permits, New 258 166 55% More new individual NPDES stormwater permits were issued in the last 3-years than in the 3 years prior to the last ICR Update. (86 vs. 55) 1.105 Form 1 NPDES States, New Facilities  Individual Stormwater Facilities 42 27 56%

5.38 Recordkeeping (Develop recordkeeping system; enter data; train personnel; and file information) Individual Stormwater Permits New 129 83 55%

1.50 Form 2S PrOTWs, Sludge Only 572 378 52% Number of Sludge Only Nonmunicipal permits in ICIS is proportionally larger than the number of permits reported in PCS. More states are under ICIS now. 5.13 Recordkeeping (Develop recordkeeping system; enter data; train personnel; and file information) Nonmunicipal, Sludge Only 99 65 52%

4.15 Permittee Report of Inaccurate Previous Information Minor Nonmunicipal 1,126 710 59% Significant reduction in the number of Existing Minor NPDES Permits based on EPA's direction to account for data entry errors in ICIS.  4.16 Permittee Report of Inaccurate Previous Information NPDES States, Minor Nonmunicipal 2,212 1,392 59%

7.5 Request for NPDES Program Modification - Update Legal Authority in Other Areas NPDES States 3,083 333 825% The Agency anticipates that all authorized states will revise their programs to update their legal authorities in response to the multiple rulemakings anticipated in the NPDES program.  4.106 Permittee Report of Anticipated Noncompliance NPDES States, Nonmunicipal Sludge 0 10 -100% The previous ICR had one permittee responding to this activity. Mathematical restriction to prevent less than full permittees (i.e., rounding) to be counted and the combination of updating the number of permits and the allocation of permits to authorized vs. non-authorized states based on the number of permits and not population. 4.108 Facility and Permit Transfer Report NPDES States, Nonmunicipal Sludge 0 4 -100%

4.110 Permittee Report of Inaccurate Previous Information NPDES States, Nonmunicipal Sludge 0 4 -100%

4.193 Facility and Permit Transfer Report NPDES States, Municipal Sludge 0 4 -100%

3.57 DMR Sampling Minor Municipal Dischargers, Bimonthly Reporting 2,650 580 357% The total number of Minor (Municipal) Dischargers that report Bimonthly has increased. Reporting frequency fields in ICIS are easier to interpret than those in PCS. More States are now under ICIS. 3.63 DMR Sampling Analysis Minor Municipal Dischargers, Bimonthly Reporting 5,630 1,232 357%

4.147 DMR Reporting Minor Municipal Dischargers, Bimonthly Reporting 1,152 252 357%

4.148 DMR Administration NPDES States, Minor Municipal Dischargers, Bimonthly Reporting 149 34 343%

3.3 DMR Sampling Minor Nonmunicipal Dischargers, Bimonthly Reporting 9,853 4,885 102% The total number of Minor (nonmunicipal) Dischargers that report Bimonthly has increased. Reporting frequency fields in ICIS are easier to interpret than those in PCS. More States are now under ICIS. 3.1 DMR Sampling Analysis Minor Nonmunicipal Dischargers, Bimonthly Reporting 20,938 10,381 102%

4.25 DMR Reporting Minor Nonmunicipal Dischargers, Bimonthly Reporting 4,284 2,124 102%

4.26 DMR Administration NPDES States, Minor Nonmunicipal Dischargers, Bimonthly Reporting 562 278 102%

3.81 DMR Sampling General Non-stormwater Permittees (State) - Semi-Annually 977 0 N/A Total Number of Non-Stormwater General Permittees decreased by EPA. (Jackie Clark) Additionally, the percent of Non-stormwater General Permittees not required to report has increased, and there is a move from monthly and quarterly sampling to semiannual and annual. 3.82 DMR Sampling General Non-stormwater Permittees (State) - Quarterly 47,538 109,944 -57%

3.83 DMR Sampling General Non-stormwater Permittees (State) - Bimonthly 49,194 23,720 107%

3.87 DMR Sampling Analysis General Non-stormwater Permittees (State) - Semi-Annually 651 0 N/A

3.88 DMR Sampling Analysis General Non-stormwater Permittees (State) - Quarterly 31,692 73,296 -57%

3.89 DMR Sampling Analysis General Non-stormwater Permittees (State) - Bimonthly 32,796 15,813 107%

4.225 DMR Reporting General Non-stormwater Permittees (State) - Semi-Annually 868 0 N/A

4.226 DMR Reporting General Non-stormwater Permittees (State) - Quarterly 42,256 97,728 -57%

4.227 DMR Reporting General Non-stormwater Permittees (State) - Bimonthly 43,728 21,084 107%

3.47 DMR Sampling Sludge Only, Class I Mgmt Facilities (Industrial) 2,440 536 355% Uncertainty attached to sludge permits (i.e., unknown sludge class) has decreased in the number reported in ICIS from the numbers reported in PCS. This increases the number of Class I facilities and reduces the number of Non-Class I facilities. 3.51 DMR Sampling Analysis Sludge Only, Class I Mgmt Facilities (Industrial) 7,319 1,607 355%

3.69 DMR Sampling Sludge Only, Class I Mgmt Facilities (Municipal Biosolids) 10,784 1,927 460%

3.70 DMR Sampling Sludge Only, Non-Class I Mgmt Facilities  (Municipal Biosolids) 31 5,916 -100%

3.73 DMR Sampling Analysis Sludge Only, Class I Mgmt Facilities (Municipal Biosolids) 32,353 5,780 460%

3.74 DMR Sampling Analysis Sludge Only, Non-Class I Mgmt Facilities  (Municipal Biosolids) 52 9,861 -100%

4.111 DMR Reporting Sludge Only, Class I Mgmt Facilities (Industrial) 1,626 357 355%

4.112 DMR Administration NPDES States Sludge Only, Class I Mgmt Facilities (Industrial) 82 25 224%

4.114 DMR Administration NPDES States Sludge Only, Non-Class I Mgmt Facilities (Industrial) 15 31 -51%

4.196 DMR Reporting Sludge Only, Class I Mgmt Facilities (Municipal Biosolids) 7,190 1,284 460%

4.197 DMR Administration NPDES States Sludge Only, Class I Mgmt Facilities (Municipal Biosolids) 364 90 303%

4.198 DMR Reporting Sludge Only, Non-Class I Mgmt Facilities  (Municipal Biosolids) 2 394 -100%

4.199 DMR Administration NPDES States Sludge Only, Non-Class I Mgmt Facilities  (Municipal Biosolids) 1 277 -100%

5.14 DMR Recordkeeping Sludge Only, Class I Mgmt Facilities (Industrial) 138 30 355%

5.26 DMR Recordkeeping Sludge Only, Class I Mgmt Facilities (Municipal Biosolids) 611 109 460%

5.27 DMR Recordkeeping Sludge Only, Non-Class I Mgmt Facilities  (Municipal Biosolids) 0 34 -100%

5.31 DMR Recordkeeping Only Sludge Only, Non-Class I Mgmt Facilities  (Municipal Biosolids) 14 2,662 -100%

1.140 NOI Filing Tank Ships  731 402 82% Vessels Universe updated based on information in the Economic and Benefits Analysis of the 2013 Vessel General Permit (VGP), September 2011. One time reporting activities already completed by most permitted vessels. NOI  1.143 NOI Filing Passenger Vessels 66 248 -73%

3.105 Routine Inspections Tank Ships  2,014 1,011 99%

3.106 Routine Inspections Commercial Fishing  1,168 4,813 -76%

3.108 Routine Inspections Passenger Vessels 918 2,270 -60%

3.114 Annual Inspections Tank Ships  6,739 3,661 84%

3.115 Annual Inspections Commercial Fishing  1,184 4,813 -75%

3.117 Annual Inspections Passenger Vessels 990 2,321 -57%

4.339 One Time Reporting Cruise Ships  2 18 -90%

4.340 One Time Reporting Freight Ships  290 613 -53%

4.342 One Time Reporting Commercial Fishing  0 963 -100%

4.343 One Time Reporting Freight Barges  820 3,171 -74%

4.344 One Time Reporting Passenger Vessels 0 466 -100%

4.346 One Time Reporting Utility Vessels  23 642 -96%

4.347 One Time Reporting Tank Barges  229 488 -53%

5.51 Recordkeeping Activities Tank Ships  2,020 1,074 88%

5.52 Recordkeeping Activities Commercial Fishing  1,175 4,813 -76%

5.54 Recordkeeping Activities Passenger Vessels 949 2,292 -59%

2.30 Documenting Nine Minimum Control Measures - O&M POTWs - Small                                                                               0                                                                              17                                                                         -100.0% All CSO permits or enforcement orders have fulfill the obligation of Phase I technology-based CSO control requirements (Nine Minimum Controls) 2.31 Documenting Nine Minimum Control Measures - O&M POTWs - Medium                                                                               0                                                                              13                                                                         -100.0%

2.32 Documenting Nine Minimum Control Measures - O&M POTWs - Large                                                                               0                                                                              27                                                                         -100.0%

2.33 Documenting Nine Minimum Control Measures - Max. Storage of System POTWs - Small                                                                               0                                                                              35                                                                         -100.0%

2.34 Documenting Nine Minimum Control Measures - Max. Storage of System POTWs - Medium                                                                               0                                                                              27                                                                         -100.0%

2.35 Documenting Nine Minimum Control Measures - Max. Storage of System POTWs - Large                                                                               0                                                                              53                                                                         -100.0%

2.36 Documenting Nine Minimum Control Measures - Pretreatment POTWs - Small                                                                               0                                                                              17                                                                         -100.0%

2.37 Documenting Nine Minimum Control Measures - Pretreatment POTWs - Medium                                                                               0                                                                              13                                                                         -100.0%

2.38 Documenting Nine Minimum Control Measures - Pretreatment POTWs - Large                                                                               0                                                                              27                                                                         -100.0%

2.39 Documenting Nine Minimum Control Measures - Max. Flow POTWs - Small                                                                               0                                                                              35                                                                         -100.0%

2.40 Documenting Nine Minimum Control Measures - Max. Flow POTWs - Medium                                                                               0                                                                              27                                                                         -100.0%

2.41 Documenting Nine Minimum Control Measures - Max. Flow POTWs - Large                                                                               0                                                                              53                                                                         -100.0%

2.42 Documenting Nine Minimum Control Measures - Dry-weather Overflows POTWs - Small                                                                               0                                                                              78                                                                         -100.0%

2.43 Documenting Nine Minimum Control Measures - Dry-weather Overflows POTWs - Medium                                                                               0                                                                              13                                                                         -100.0%

2.44 Documenting Nine Minimum Control Measures - Dry-weather Overflows POTWs - Large                                                                               0                                                                              27                                                                         -100.0%

2.45 Documenting Nine Minimum Control Measures - Control Solids POTWs - Small                                                                               0                                                                              17                                                                         -100.0%

2.46 Documenting Nine Minimum Control Measures - Control Solids POTWs - Medium                                                                               0                                                                              13                                                                         -100.0%

2.47 Documenting Nine Minimum Control Measures - Control Solids POTWs - Large                                                                               0                                                                              27                                                                         -100.0%

2.48 Documenting Nine Minimum Control Measures - Pollution Prevention POTWs - Small                                                                               0                                                                              17                                                                         -100.0%

2.49 Documenting Nine Minimum Control Measures - Pollution Prevention POTWs - Medium                                                                               0                                                                              13                                                                         -100.0%

2.50 Documenting Nine Minimum Control Measures - Pollution Prevention POTWs - Large                                                                               0                                                                              27                                                                         -100.0%

2.51 Documenting Nine Minimum Control Measures - Public Notification POTWs - Small                                                                               0                                                                              17                                                                         -100.0%

2.52 Documenting Nine Minimum Control Measures - Public Notification POTWs - Medium                                                                               0                                                                              13                                                                         -100.0%

2.53 Documenting Nine Minimum Control Measures - Public Notification POTWs - Large                                                                               0                                                                              27                                                                         -100.0%

2.54 Documenting Nine Minimum Control Measures - Monitor POTWs - Small                                                                               0                                                                              69                                                                         -100.0%

2.55 Documenting Nine Minimum Control Measures - Monitor POTWs - Medium                                                                               0                                                                              27                                                                         -100.0%

2.56 Documenting Nine Minimum Control Measures - Monitor POTWs - Large                                                                               0                                                                              27                                                                         -100.0%

2.57 Documenting Nine Minimum Control Measures - General Reporting POTWs - Small                                                                               0                                                                              35                                                                         -100.0%

2.58 Documenting Nine Minimum Control Measures - General Reporting POTWs - Medium                                                                               0                                                                              27                                                                         -100.0%

2.59 Documenting Nine Minimum Control Measures - General Reporting POTWs - Large                                                                               0                                                                              53                                                                         -100.0%

2.60 Documenting Nine Minimum Control Measures - Recordkeeping POTWs - Small                                                                               0                                                                              35                                                                         -100.0%

2.61 Documenting Nine Minimum Control Measures - Recordkeeping POTWs - Medium                                                                               0                                                                              27                                                                         -100.0%

2.62 Documenting Nine Minimum Control Measures - Recordkeeping POTWs - Large                                                                               0                                                                              53                                                                         -100.0%

2.63 Review NMC Documentation NPDES States                                                                               0                                                                             267                                                                         -100.0%

5.58 CSO State Oversight - Recordkeeping NPDES States                                                                               0                                                                               7                                                                         -100.0%