[Federal Register: June 2, 2010 (Volume 75, Number 105)]
[Notices]
[Page 30829-30830]
[DOCID:fr02jn10-76]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0325; FRL-8824-2]

Antimicrobial Pesticide Products; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of an application to register
new antimicrobial pesticide products containing new active ingredients,
pursuant to the provisions of section 3(c) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended. EPA is publishing
this Notice of such applications, pursuant to section 3(c)(4) of FIFRA.

DATES:  Comments must be received on or before July 2, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ- OPP-2010-0325, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental

Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries are only accepted during the
Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays). Special arrangements
should be made for deliveries of boxed information. The Docket Facility
telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0325. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Demson Fuller, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
     iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
     viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA has received an application to register a pesticide product
containing active ingredients not included in any previously registered
pesticide products. Pursuant to the provisions of section 3(c)(4) of
FIFRA, EPA is hereby providing notice of receipt and opportunity to
comment on this application. Notice of receipt of this application does
not imply a decision by the Agency on this application.
    Registration Number/File Symbol: 85249-R. Docket Number: EPA-HQ-
OPP-2010-0325. Company name and address: NanoSilva, LLC, 2811 NE 14th
Street, Ocala, FL 34470. Active ingredient: Nanosilver. Proposed
Use(s): Antimicrobial and preservative additive used to treat fibers,
plastics, polymers, latex products and ceramics. Contact: Demson
Fuller,<PHONE_NUMBER><EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Antimicrobial pesticides and pest.

    Dated: May 21, 2010.
Joan Harrigan-Farrelly,
Director, Antimicrobials Division, Office of Pesticide Programs.

[FR Doc. 2010-13183 Filed 6-1-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Notices]
[Pages 59135-59142]
[FR Doc No: 2022-21067]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95900; File No. SR-Phlx-2022-36]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Clearly Erroneous Rules

September 23, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 20, 2022, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I and II, below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Equity 4, Rule 3312.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these

statements may be examined at the places specified in Item IV below.
The Exchange has prepared summaries, set forth in sections A, B, and C
below, of the most significant aspects of such statements.

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

1. Purpose
    On September 1, 2022, the Commission approved the proposal of Cboe
BZX Exchange, Inc. (``Cboe BZX'') to (1) adopt on a permanent basis the
pilot program for clearly erroneous executions in Cboe BZX Rule 11.17
and (2) limit the circumstances where clearly erroneous review would
continue to be available during regular trading hours (i.e., Market
Hours) \3\ when the Limit Up-Limit Down (``LULD'') Plan to Address
Extraordinary Market Volatility (the ``LULD Plan'') \4\ already
provides similar protections for trades occurring at prices that may be
deemed erroneous.\5\
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    \3\ See Securities Exchange Act Release No. 95658 (September 1,
2022) (SR-CboeBZX-2022-037).
    \4\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012).
    \5\ The term ``Market Hours'' means the period of time beginning
at 9:30 a.m. ET and ending at 4:00 p.m. ET (or such earlier time as
may be designated by the Exchange on a day when PSX closes early).
See Equity 1, Section 1(g). The Exchange will make conforming
changes throughout Rule 3312 to replace references to ``Regular
Trading Hours'' or ``Regular Market Session'' with ``Market Hours,''
which is the correct defined term.
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    The Exchange now proposes to adopt the same changes in Equity 4,
Rule 3312 (Clearly Erroneous Transactions). The Exchange believes that
these changes are appropriate as the LULD Plan has been approved by the
Commission on a permanent basis,\6\ and in light of amendments to the
LULD Plan, including changes to the applicable Price Bands \7\ around
the open and close of trading.
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    \6\ See Securities Exchange Act Release No. 84843 (December 18,
2018), 83 FR 66464 (December 26, 2018) (``Notice''); 85623 (April
11, 2019), 84 FR 16086 (April 17, 2019) (File No. 4-631)
(``Amendment Eighteen'').
    \7\ ``Price Bands'' refers to the term provided in Section V of
the LULD Plan.
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Proposal To Make the Clearly Erroneous Pilot Permanent
    On September 10, 2010, the Commission approved, on a pilot basis,
changes to Equity 4, Rule 3312 that, among other things: (i) provided
for uniform treatment of clearly erroneous execution reviews in multi-
stock events involving twenty or more securities; and (ii) reduced the
ability of the Exchange to deviate from the objective standards set
forth in the rule.\8\ Following this, on September 30, 2010, the
Exchange adopted changes to conform its Rule 3312 to Nasdaq's and BX's
rules 11890.\9\ In 2013, the Exchange adopted a provision designed to
address the operation of the LULD Plan.\10\ Finally, in 2014, the
Exchange adopted two additional provisions providing that: (i) a series
of transactions in a particular security on one or more trading days
may be viewed as one event if all such transactions were effected based
on the same fundamentally incorrect or grossly misinterpreted issuance
information resulting in a severe valuation error for all such
transactions; and (ii) in the event of any disruption or malfunction in
the operation of the electronic communications and trading facilities
of an Exchange, another SRO, or responsible single plan processor in
connection with the transmittal or receipt of a trading halt, an
Officer, acting on his or her own motion, shall nullify any transaction
that occurs after a trading halt has been declared by the primary
listing market for a security and before such trading halt has
officially ended according to the primary listing market.\11\ These
changes are currently scheduled to operate for a pilot period that
would end at the close of business on October 20, 2022.\12\
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    \8\ See Securities Exchange Act Release No. 62886 (September 10,
2010), 75 FR 56613 (September 16, 2010) (SR-NASDAQ-2010-076).
    \9\ See Securities Exchange Act Release No. 63023 (September 30,
2010), 75 FR 61802 (October 6, 2010) (SR-Phlx-2010-125).
    \10\ See Securities Exchange Act Release No. 68820 (February 1,
2013), 78 FR 9436 (February 8, 2013) (SR-Phlx-2013-12).
    \11\ See Securities Exchange Act Release No. 72434 (June 19,
2014), 79 FR 36110 (June 25, 2014) (SR-Phlx-2014-27).
    \12\ See Securities Exchange Act Release No. 95331 (July 20,
2022), 87 FR 44447 (July 26, 2022) (SR-Phlx-2022-31).
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    When it originally approved the clearly erroneous pilot, the
Commission explained that the changes were ``being implemented on a
pilot basis so that the Commission and the Exchanges can monitor the
effects of the pilot on the markets and investors, and consider
appropriate adjustments, as necessary.'' \13\ In the 12 years since
that time, the Exchange and other national securities exchanges have
gained considerable experience in the operation of the rule, as amended
on a pilot basis. Based on that experience, the Exchange believes that
the program should be allowed to continue on a permanent basis so that
equities market participants and investors can benefit from the
increased certainty provided by the amended rule.
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    \13\ See Securities Exchange Act Release No. 62886 (September
10, 2010), 75 FR 56613 (September 16, 2010) (SR-NASDAQ-2010-076).
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    The clearly erroneous pilot was implemented following a severe
disruption in the U.S. equities markets on May 6, 2010 (``Flash
Crash'') to ``provide greater transparency and certainty to the process
of breaking trades.'' \14\ Largely, the pilot reduced the discretion of
the Exchange, other national securities exchanges, and Financial
Industry Regulatory Authority (``FINRA'') to deviate from the objective
standards in their respective rules when dealing with potentially
erroneous transactions. The pilot has thus helped afford greater
certainty to Members and investors about when trades will be deemed
erroneous pursuant to self-regulatory organization (``SRO'') rules and
has provided a more transparent process for conducting such reviews.
The Exchange proposes to make the current pilot permanent so that
market participants can continue to benefit from the increased
certainty afforded by the current rule.
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    \14\ Id.
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Amendments to the Clearly Erroneous Rules
    When the Participants to the LULD Plan filed to introduce the Limit
Up-Limit Down (``LULD'') mechanism, itself a response to the Flash
Crash, a handful of commenters noted the potential discordance between
the clearly erroneous rules and the Price Bands used to limit the price
at which trades would be permitted to be executed pursuant to the LULD
Plan. For example, two commenters requested that the clearly erroneous
rules be amended so the presumption would be that trades executed
within the Price Bands would not be subject to review.\15\ While the
Participants acknowledged that the potential to prevent clearly
erroneous executions would be a ``key benefit'' of the LULD Plan, the
Participants decided not to amend the clearly erroneous rules at that
time.\16\ In the years since, industry feedback has continued to
reflect a desire to eliminate the discordance between the LULD
mechanism and the clearly erroneous rules so that market participants
would have more certainty that trades executed with the Price Bands
would stand. For example, the Equity Market Structure Advisory
Committee (``EMSAC'') Market Quality Subcommittee included in its April
19, 2016 status report a preliminary recommendation that

clearly erroneous rules be amended to conform to the Price Bands--i.e.,
``any trade that takes place within the band would stand and not be
broken and trades outside the LU/LD bands would be eligible for the
consideration of the Clearly Erroneous rules.'' \17\
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    \15\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (File No. 4-631) (n. 33505).
    \16\ Id.
    \17\ See EMSAC Market Quality Subcommittee, Recommendations for
Rulemaking on Issues of Market Quality (November 29, 2016),
available at https://www.sec.gov/spotlight/emsac/emsac-recommendations-rulemaking-market-quality.pdf.
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    The Exchange believes that it is important for there to be some
mechanism to ensure that investors' orders are either not executed at
clearly erroneous prices or are subsequently busted as needed to
maintain a fair and orderly market. At the same time, the Exchange
believes that the LULD Plan, as amended, would provide sufficient
protection for trades executed during Market Hours. Indeed, the LULD
mechanism could be considered to offer superior protection as it
prevents potentially erroneous trades from being executed in the first
instance. After gaining experience with the LULD Plan, the Exchange now
believes that it is appropriate to largely eliminate clearly erroneous
review during Market Hours when Price Bands are in effect. Thus, as
proposed, trades executed within the Price Bands would stand, barring
one of a handful of identified scenarios where such review may still be
necessary for the protection of investors. The Exchange believes that
this change would be beneficial for the U.S. equities markets as it
would ensure that trades executed within the Price Bands are subject to
clearly erroneous review in only rare circumstances, resulting in
greater certainty for Members and investors.
    The current LULD mechanism for addressing extraordinary market
volatility is available solely during Market Hours. Thus, trades during
the Exchange's Pre-Market \18\ or Post-Market Hours \19\ would not
benefit from this protection and could ultimately be executed at prices
that may be considered erroneous. For this reason, the Exchange
proposes that transactions executed during Pre-Market or Post-Market
Hours would continue to be reviewable as clearly erroneous. Continued
availability of the clearly erroneous rule during Pre- and Post-Market
Hours would therefore ensure that investors have appropriate recourse
when erroneous trades are executed outside of the hours where similar
protection can be provided by the LULD Plan. Further, the proposal is
designed to eliminate the potential discordance between clearly
erroneous review and LULD Price Bands, which does not exist outside of
Market Hours because the LULD Plan is not in effect. Thus, the Exchange
believes that it is appropriate to continue to allow transactions to be
eligible for clearly erroneous review if executed outside of Market
Hours.
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    \18\ The term ``Pre-Market Hours'' means the period of time
beginning at 8:00 a.m. ET and ending immediately prior to the
commencement of Market Hours. See Equity 1, Section 1(g). The
Exchange will make conforming changes throughout Rule 3312 to
replace references to ``Pre-Opening Hours'' or ``Pre-Opening Hours
Trading Session'' with ``Pre-Market Hours,'' which is the correct
defined term.
    \19\ The term ``Post-Market Hours'' means the period of time
beginning immediately after the end of Market Hours and ending at
5:00 p.m. ET. See Equity 1, Section 1(g). The Exchange will make
conforming changes throughout Rule 3312 to replace references to
``After Hours'' or ``After Hours Trading Session'' with ``Post-
Market Hours,'' which is the correct defined term.
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    On the other hand, there would be much more limited potential to
request that a transaction be reviewed as potentially erroneous during
Market Hours. With the introduction of the LULD mechanism in 2013,
clearly erroneous trades are largely prevented by the requirement that
trades be executed within the Price Bands. In addition, in 2019,
Amendment Eighteen to the LULD Plan eliminated double-wide Price Bands:
(1) at the Open, and (2) at the Close for Tier 2 NMS Stocks 2 with a
Reference Price above $3.00.\20\ Due to these changes, the Exchange
believes that the Price Bands would provide sufficient protection to
investor orders such that clearly erroneous review would no longer be
necessary during Market Hours. As the Participants to the LULD Plan
explained in Amendment Eighteen: ``Broadly, the Limit Up-Limit Down
mechanism prevents trades from happening at prices where one party to
the trade would be considered `aggrieved,' and thus could be viewed as
an appropriate mechanism to supplant clearly erroneous rules.'' While
the Participants also expressed concern that the Price Bands might be
too wide to afford meaningful protection around the open and close of
trading, amendments to the LULD Plan adopted in Amendment Eighteen
narrowed Price Bands at these times in a manner that the Exchange
believes is sufficient to ensure that investors' orders would be
appropriately protected in the absence of clearly erroneous review. The
Exchange therefore believes that it is appropriate to rely on the LULD
mechanism as the primary means of preventing clearly erroneous trades
during Market Hours.
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    \20\ See Amendment Eighteen, supra note 6.
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    At the same time, the Exchange is cognizant that there may be
limited circumstances where clearly erroneous review may continue to be
appropriate, even during Market Hours. Thus, the Exchange proposes to
amend its clearly erroneous rules to enumerate the specific
circumstances where such review would remain available during the
course of Market Hours, as follows. All transactions that fall outside
of these specific enumerated exceptions would be ineligible for clearly
erroneous review.
    First, pursuant to proposed subparagraph (C)(1)(i) of Rule
3312(a)(2), a transaction executed during Market Hours would continue
to be eligible for clearly erroneous review if the transaction is not
subject to the LULD Plan. In such case, the Numerical Guidelines set
forth in subparagraph (C)(2) of Rule 3312(a)(2) will be applicable to
such NMS Stock. While the majority of securities traded on the Exchange
would be subject to the LULD Plan, certain equity securities, such as
rights and warrants, are explicitly excluded from the provisions of the
LULD Plan and would therefore be eligible for clearly erroneous review
instead.\21\ Similarly, there are instances, such as the opening
auction on the primary listing market,\22\ where transactions are not
ordinarily subject to the LULD Plan, or circumstances where a
transaction that ordinarily would have been subject to the LULD Plan is
not--due, for example, to some issue with processing the Price Bands.
These transactions would continue to be eligible for clearly erroneous
review, effectively ensuring that such review remains available as a
backstop when the LULD Plan would not prevent executions from occurring
at erroneous prices in the first instance.
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    \21\ See Appendix A of the LULD Plan.
    \22\ The initial Reference Price used to calculate Price Bands
is typically set by the Opening Price on the primary listing market.
See Section V(B) of the LULD Plan.
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    Second, investors would also continue to be able to request review
of transactions that resulted from certain systems issues pursuant to
proposed subparagraph (C)(1)(ii). This limited exception would help to
ensure that trades that should not have been executed would continue to
be subject to clearly erroneous review. Specifically, as proposed,
transactions executed during Market Hours would be eligible for clearly
erroneous review pursuant to proposed subparagraph (C)(1)(ii) if the
transaction is the result of an Exchange technology or systems issue
that results in the transaction occurring outside of the applicable
LULD Price Bands pursuant to Rule 3312(g), or is executed after the
primary listing market for the security declares

a regulatory trading halt, suspension, or pause pursuant to Rule
3312(i). A transaction subject to review pursuant to this paragraph
shall be found to be clearly erroneous if the price of the transaction
to buy (sell) that is the subject of the complaint is greater than
(less than) the Reference Price, described in subparagraph (D) of this
Rule, by an amount that equals or exceeds the applicable Percentage
Parameter defined in Appendix A to the LULD Plan (``Percentage
Parameters'').
    Third, the Exchange proposes to narrowly allow for the review of
transactions during Market Hours when the Reference Price, described in
proposed subparagraph (D), is determined to be erroneous by an Officer
of the Exchange or senior level employee designee. Specifically, a
transaction executed during Market Hours would be eligible for clearly
erroneous review pursuant to proposed subparagraph (C)(1)(iii) of Rule
3312(a)(2) if the transaction involved, in the case of (1) a corporate
action or new issue or (2) a security that enters a Trading Pause
pursuant to the LULD Plan and resumes trading without an auction,\23\ a
Reference Price that is determined to be erroneous by an Officer of the
Exchange or senior level employee designee because it clearly deviated
from the theoretical value of the security. In such circumstances, the
Exchange may use a different Reference Price pursuant to proposed
subparagraph (D)(2) of this Rule. A transaction subject to review
pursuant to this paragraph shall be found to be clearly erroneous if
the price of the transaction to buy (sell) that is the subject of the
complaint is greater than (less than) the new Reference Price,
described in subparagraph (D)(2) below, by an amount that equals or
exceeds the applicable Numerical Guidelines or Percentage Parameters,
as applicable depending on whether the security is subject to the LULD
Plan. Specifically, the Percentage Parameters would apply to all
transactions except those in an NMS Stock that is not subject to the
LULD Plan, as described in subparagraph (C)(1)(i).
---------------------------------------------------------------------------

    \23\ The Exchange notes that the ``resumption of trading without
an auction'' provision of the proposed rule text applies only to
securities that enter a Trading Pause pursuant to LULD and does not
apply to a corporate action or new issue.
---------------------------------------------------------------------------

    In the context of a corporate action or a new issue, there may be
instances where the security's Reference Price is later determined by
the Exchange to be erroneous (e.g., because of a bad first trade for a
new issue), and subsequent LULD Price Bands are calculated from that
incorrect Reference Price. In determining whether the Reference Price
is erroneous in such instances, the Exchange would generally look to
see if such Reference Price clearly deviated from the theoretical value
of the security. In such cases, the Exchange would consider a number of
factors to determine a new Reference Price that is based on the
theoretical value of the security, including but not limited to, the
offering price of the new issue, the ratio of the stock split applied
to the prior day's closing price, the theoretical price derived from
the numerical terms of the corporate action transaction such as the
exchange ratio and spin-off terms, and the prior day's closing price on
the OTC market for an OTC up-listing.\24\ In the foregoing instances,
the theoretical value of the security would be used as the new
Reference Price when applying the Percentage Parameters under the LULD
Plan (or Numerical Guidelines if the transaction is in an NMS Stock
that is not subject to the LULD Plan) to determine whether executions
would be cancelled as clearly erroneous.
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    \24\ Using transaction data reported to the FINRA OTC Reporting
Facility, FINRA disseminates via the Trade Data Dissemination
Service a final closing report for OTC equity securities for each
business day that includes, among other things, each security's
closing last sale price.
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    The following illustrate the proposed application of the rule in
the context of a corporate action or new issue:
    Example 1:
    1. ABCD is subject to a corporate action, 1 for 10 reverse split,
and the previous day close was $5, but the new theoretical price based
on the terms of the corporate action is $50.
    2. The security opens at $5, with LULD bands at $4.50 x $5.50.
    3. The bands will be calculated correctly but the security is
trading at an erroneous price based on the valuation of the remaining
outstanding shares.
    4. The theoretical price of $50 would be used as the new Reference
Price when applying LULD bands to determine if executions would be
cancelled as clearly erroneous.
    Example 2:
    1. ABCD is subject to a corporate action, the company is doing a
spin off where a new issue will be listed, BCDE. ABCD trades at $50,
and the spinoff company is worth \1/5\ of ABCD.
    2. BCDE opens at $50 in the belief it is the same company as ABCD.
    3. The theoretical values of the two companies are ABCD $40 and
BCDE $10.
    4. BCDE would be deemed to have had an incorrect Reference Price
and the theoretical value of $10 would be used as the new Reference
Price when applying the LULD Bands to determine if executions would be
cancelled as clearly erroneous.
    Example 3:
    1. ABCD is an uplift from the OTC market, the prior days close on
the OTC market was $20.
    2. ABCD opens trading on the new listing exchange at $0.20 due to
an erroneous order entry.
    3. The new Reference Price to determine clearly erroneous
executions would be $20, the theoretical value of the stock from where
it was last traded.
    In the context of the rare situation in which a security that
enters a LULD Trading Pause and resumes trading without an auction
(i.e., reopens with quotations), the LULD Plan requires that the new
Reference Price in this instance be established by using the mid-point
of the best bid and offer (``BBO'') on the primary listing exchange at
the reopening time.\25\ This can result in a Reference Price and
subsequent LULD Price Band calculation that is significantly away from
the security's last traded or more relevant price, especially in less
liquid names. In such rare instances, the Exchange is proposing to use
a different Reference Price that is based on the prior LULD Band that
triggered the Trading Pause, rather than the midpoint of the BBO.
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    \25\ See LULD Plan, Section I(U) and V(C)(1).
---------------------------------------------------------------------------

    The following example illustrates the proposed application of the
rule in the context of a security that reopens without an auction:
    Example 4:
    1. ABCD stock is trading at $20, with LULD Bands at $18 x $22.
    2. An incoming buy order causes the stock to enter a Limit State
Trading Pause and then a Trading Pause at $22.
    3. During the Trading Pause, the buy order causing the Trading
Pause is cancelled.
    4. At the end of the 5-minute halt, there is no crossed interest
for an auction to occur, thus trading would resume on a quote.
    5. Upon resumption, a quote that was available prior to the Trading
Pause (e.g., a quote was resting on the book prior to the Trading
Pause), is widely set at $10 x $90.
    6. The Reference Price upon resumption is $50 (mid-point of BBO).
    7. The SIP will use this Reference Price and publish LULD Bands of
$45 x $55 (i.e., far away from BBO prior to the halt).
    8. The bands will be calculated correctly, but the $50 Reference
Price is subsequently determined to be incorrect as the price clearly
deviated from where it previously traded prior to the Trading Pause.

    9. The new Reference Price would be $22 (i.e., the last effective
Price Band that was in a limit state before the Trading Pause), and the
LULD Bands would be applied to determine if the executions should be
cancelled as clearly erroneous.
    In all of the foregoing situations, investors would be left with no
remedy to request clearly erroneous review without the proposed
carveouts in subparagraph (C)(1)(iii) because the trades occurred
within the LULD Price Bands (albeit LULD Price Bands that were
calculated from an erroneous Reference Price). The Exchange believes
that removing the current ability for the Exchange to review in these
narrow circumstances would lessen investor protections.
Numerical Guidelines
    Today, subparagraph (C)(i) defines the Numerical Guidelines that
are used to determine if a transaction is deemed clearly erroneous
during Market Hours, or during the Pre-Market and Post-Market Hours.
With respect to Market Hours, trades are generally deemed clearly
erroneous if the execution price differs from the Reference Price
(i.e., last sale) by 10% if the Reference Price is greater than $0.00
up to and including $25.00; 5% if the Reference Price is greater than
$25.00 up to and including $50.00; and 3% if the Reference Price is
greater than $50.00. Wider parameters are also used for reviews for
Multi-Stock Events, as described in subparagraph (C)(ii). With respect
to transactions in Leveraged ETF/ETN securities executed during Market
Hours, Pre-Market and Post-Market Hours, trades are deemed clearly
erroneous if the execution price exceeds the Market Hours Numerical
Guidelines multiplied by the leverage multiplier.
    Given the changes described in this proposed rule change, the
Exchange proposes to amend the way that the Numerical Guidelines are
applied during Market Hours in the handful of instances where clearly
erroneous review would continue to be available. Specifically during
Market Hours, the Exchange would continue to apply the Numerical
Guidelines, which would be relocated from subparagraph (C)(i) to
(C)(2)(i) under this proposal, to transactions eligible for review
pursuant proposed subparagraph (C)(1)(i) (i.e., transactions in NMS
Stocks that are not subject to the LULD Plan). In addition, as applied
to the circumstances described in proposed subparagraphs (C)(1)(ii) and
(iii), the Exchange would not apply the Numerical Guidelines in
proposed subparagraph (C)(2)(i) during Market Hours, and would instead
apply the Percentage Parameters used to calculate Price Bands, as set
forth in Appendix A to the LULD Plan. Without this change, a
transaction that would otherwise stand if Price Bands were properly
applied to the transaction may end up being subject to review and
deemed clearly erroneous solely due to the fact that the Price Bands
were not available due to a systems or other issue. The Exchange
believes that it makes more sense to instead base the Price Bands on
the same parameters as would otherwise determine whether the trade
would have been allowed to execute within the Price Bands. The Exchange
also proposes to modify the Numerical Guidelines applicable to
leveraged ETF/ETN securities during Market Hours. As noted above, the
Numerical Guidelines will only be applicable to transactions eligible
for review pursuant subparagraph (C)(1)(i) (i.e., to NMS Stocks that
are not subject to the LULD Plan). As leveraged ETF/ETN securities are
subject to LULD and thus the Percentage Parameters will be applicable
during Market Hours, the Exchange proposes to eliminate the Numerical
Guidelines for leveraged ETF/ETN securities traded during Market Hours.
However, as no Price Bands are available outside of Market Hours, the
Exchange proposes to keep the existing Numerical Guidelines in place
for transactions in leveraged ETF/ETN securities that occur during Pre-
Market and Post-Market Hours.
    The Exchange also proposes to move existing subparagraphs (C)(ii)
(Multi-Stock Events Involving Twenty or More Securities) and (C)(iii)
(Additional Factors) as proposed subparagraphs (C)(2)(ii) and
(C)(2)(iii), respectively, and also proposes to make clear that Multi-
Stock Events and Additional Factors will only be subject to clearly
erroneous review if those NMS Stocks are not subject to the LULD Plan
or occur during the Pre-Market or Post-Market Hours. The Exchange
proposes to make similar changes to existing subparagraph (A)(iii)
(Outlier Transactions) to make clear that such transactions will only
be subject to clearly erroneous review if those NMS Stocks are not
subject to the LULD Plan or occur during Pre-Market or Post-Market
Hours. Further, given the proposal to move existing subparagraphs
(C)(2) and (C)(3) to subparagraphs (C)(2)(ii) and (C)(2)(iii),
respectively, the Exchange also proposes to amend applicable rule
references throughout subparagraph (C)(2)(i). Further, the Exchange
proposes to update applicable rule references in subparagraph (A)(iii)
based on the above-described structural changes to the Rule.
Reference Price
    As proposed, the Reference Price used would continue to be based on
last sale and would be memorialized in proposed subparagraph (D).
Continuing to use the last sale as the Reference Price is necessary for
operational efficiency as it may not be possible to perform a timely
clearly erroneous review if doing so required computing the arithmetic
mean price of eligible reported transactions over the past five
minutes, as contemplated by the LULD Plan. While this means that there
would still be some differences between the Price Bands and the clearly
erroneous parameters, the Exchange believes that this difference is
reasonable in light of the need to ensure timely review if clearly
erroneous rules are invoked. The Exchange also proposes to allow for an
alternate Reference Price to be used as prescribed in proposed
subparagraphs (D)(1), (2), and (3). Specifically, the Reference Price
may be a value other than the consolidated last sale immediately prior
to the execution(s) under review (1) in the case of Multi-Stock Events
involving twenty or more securities, as described in subparagraph
(C)(2)(ii) above, (2) in the case of an erroneous Reference Price, as
described in subparagraph (C)(1)(iii) above,\26\ or (3) in other
circumstances, such as, for example, relevant news impacting a security
or securities, periods of extreme market volatility, sustained
illiquidity, or widespread system issues, where use of a different
Reference Price is necessary for the maintenance of a fair and orderly
market and the protection of investors and the public interest,
provided that such circumstances occurred during Pre-Market or Post-
Market Hours or are eligible for review pursuant to subparagraph
(C)(1)(i).
---------------------------------------------------------------------------

    \26\ As discussed above, in the case of (C)(1)(iii)(1), the
Exchange would consider a number of factors to determine a new
Reference Price that is based on the theoretical value of the
security, including but not limited to, the offering price of the
new issue, the ratio of the stock split applied to the prior day's
closing price, the theoretical price derived from the numerical
terms of the corporate action transaction such as the exchange ratio
and spin-off terms, and the prior day's closing price on the OTC
market for an OTC up-listing. In the case of (C)(1)(iii)(2), the
Reference Price will be the last effective Price Band that was in a
limit state before the Trading Pause.
---------------------------------------------------------------------------

System Disruption or Malfunction
    To conform with the structural changes described above, the
Exchange now proposes to remove paragraph (b)(1), System Disruption or
Malfunctions, and renumber existing paragraph (b)(2) as (b)(1).
Additionally,

the Exchange proposes to add rule text in renumbered (b)(1) (Senior
Official Acting on Own Motion) to specify that a Senior Official,
acting on his or her own motion, may review potentially erroneous
transactions that occur only during Pre-Market or Post-Market Hours or
that are eligible for review pursuant to proposed paragraph
(a)(2)(C)(1).
    The Exchange also proposes new subparagraph (C)(1)(ii) of Rule
3312(a)(2). Specifically, as described in subparagraph (C)(1)(ii),
transactions occurring during Market Hours that are executed outside of
the LULD Price Bands due to an Exchange technology or system issue, may
be subject to clearly erroneous review pursuant to proposed paragraph
(g) of Rule 3312. Proposed subparagraph (C)(1)(ii) further provides
that a transaction subject to review pursuant to this paragraph shall
be found to be clearly erroneous if the price of the transaction to buy
(sell) that is the subject of the complaint is greater than (less than)
the Reference Price, described in subparagraph (D), by an amount that
equals or exceeds the applicable Percentage Parameter defined in
Appendix A to the LULD Plan.
Securities Subject to Limit Up-Limit Down Plan
    The Exchange proposes to rename paragraph (g) (Securities Subject
to LULD Plan) as ``Transactions Occurring Outside of LULD Price
Bands.'' Given that proposed subparagraph (C)(1) of Rule 3312(a)(2)
defines the LULD Plan, the Exchange also proposes to eliminate
redundant language from paragraph (g). Finally, the Exchange also
proposes to update references to the LULD Plan and Price Bands so that
they are uniform throughout the Rule and to update rule references
throughout the paragraph to conform to the structural changes to the
Rule described above.
Conforming Changes
    In connection with the changes proposed above, the Exchange
proposes to make a conforming change in paragraph (a)(2) to replace the
reference to ``Numerical Guidelines'' to ``guidelines'' as clearly
erroneous review will now be based on both the existing Numerical
Guidelines and the Percentage Parameters in the manner specified above.
In addition, the Exchange proposes to modify the text of paragraphs (e)
(Fees), (h) (Multi-Day Event), and (i) (Trading Halts) to reference the
Percentage Parameters as well as the Numerical Guidelines, and to
update rule references therein to conform to the structural changes to
the Rule described above. Specifically, the existing text of paragraph
(e) provides that adjustments or voluntary breaks negotiated by the
Exchange to trades executed at prices that meet the Numerical
Guidelines set forth in (a)(2)(C)(i) count as breaks by the Exchange
for purposes of this paragraph. The Exchange now proposes to amend the
rule text to state that adjustments or voluntary breaks negotiated by
the Exchange to trades executed at prices that meet the Percentage
Parameters or Numerical Guidelines set forth in (a)(2)(C)(2) count as
breaks by the Exchange for purposes of this paragraph.
    In addition, the existing text of paragraphs (h) and (i) provides
that any action taken in connection with this paragraph will be taken
without regard to the Numerical Guidelines set forth in this Rule. The
Exchange proposes to amend the rule text to provide that any action
taken in connection with this paragraph will be taken without regard to
the Percentage Parameters or Numerical Guidelines set forth in this
Rule, with the Percentage Parameters being applicable to an NMS Stock
subject to the LULD Plan and the Numerical Guidelines being applicable
to an NMS Stock not subject to the LULD Plan.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b) of the Act,\27\ in general, and
Section 6(b)(5) of the Act,\28\ in particular, in that it is designed
to remove impediments to and perfect the mechanism of a free and open
market and a national market system, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest and not to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78f(b).
    \28\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    As explained in the purpose section of this proposed rule change,
the current pilot was implemented following the Flash Crash to bring
greater transparency to the process for conducting clearly erroneous
reviews, and to help assure that the review process is based on clear,
objective, and consistent rules across the U.S. equities markets. The
Exchange believes that the amended clearly erroneous rules have been
successful in that regard and have thus furthered fair and orderly
markets. Specifically, the Exchange believes that the pilot has
successfully ensured that such reviews are conducted based on objective
and consistent standards across SROs and has therefore afforded greater
certainty to Members and investors. The Exchange therefore believes
that making the current pilot a permanent program is appropriate so
that equities market participants can continue to reap the benefits of
a clear, objective, and transparent process for conducting clearly
erroneous reviews. In addition, the Exchange understands that the other
U.S. equities exchanges and FINRA will also file largely identical
proposals to make their respective clearly erroneous pilots permanent.
The Exchange therefore believes that the proposed rule change would
promote transparency and uniformity across markets concerning review of
transactions as clearly erroneous and would also help assure consistent
results in handling erroneous trades across the U.S. equities markets,
thus furthering fair and orderly markets, the protection of investors,
and the public interest.
    Similarly, the Exchange believes that it is consistent with just
and equitable principles of trade to limit the availability of clearly
erroneous review during Market Hours. The LULD Plan was approved by the
Commission to operate on a permanent rather than pilot basis. As a
number of market participants have noted, the LULD Plan provides
protections that ensure that investors' orders are not executed at
prices that may be considered clearly erroneous. Further, amendments to
the LULD Plan approved in Amendment Eighteen serve to ensure that the
Price Bands established by the LULD Plan are ``appropriately tailored
to prevent trades that are so far from current market prices that they
would be viewed as having been executed in error.'' \29\ Thus, the
Exchange believes that clearly erroneous review should only be
necessary in very limited circumstances during Market Hours.
Specifically, such review would only be necessary in instances where a
transaction was not subject to the LULD Plan, or was the result of some
form of systems issue, as detailed in the purpose section of this
proposed rule change. Additionally, in narrow circumstances where the
transaction was subject to the LULD Plan, a clearly erroneous review
would be available in the case of (1) a corporate action or new issue
or (2) a security that enters a Trading Pause pursuant to LULD and
resumes trading without an auction, where the Reference Price is
determined to be erroneous by an Officer of the Exchange or senior
level employee designee because it clearly deviated from the
theoretical value of the security. Thus, eliminating clearly

erroneous review in all other instances will serve to increase
certainty for Members and investors that trades executed during Market
Hours would typically stand and would not be subject to review.
---------------------------------------------------------------------------

    \29\ See Amendment Eighteen, supra note 6.
---------------------------------------------------------------------------

    Given the fact that clearly erroneous review would largely be
limited to transactions that were not subject to the LULD Plan, the
Exchange also believes that it is necessary to change the parameters
used to determine whether a trade is clearly erroneous. Specifically,
due to the different parameters currently used for clearly erroneous
review and for determining Price Bands, it is possible that a trade
that would have been permitted to execute within the Price Bands would
later be deemed clearly erroneous, if, for example, a systems issue
prevented the dissemination of the Price Bands. The Exchange believes
that this result is contrary to the principle that trades within the
Price Bands should stand, and has the potential to cause investor
confusion if trades that are properly executed within the applicable
parameters described in the LULD Plan are later deemed erroneous. By
using consistent parameters for clearly erroneous reviews conducted
during Market Hours and the calculation of the Price Bands, the
Exchange believes that this change would also serve to promote greater
certainty with regards to when trades may be deemed erroneous.
    Finally, the proposed rule changes make organizational updates to
Rule 3312 as well as minor updates and corrections to the Rule to
improve readability and clarity.

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposal would ensure
the continued, uninterrupted operation of harmonized clearly erroneous
execution rules across the U.S. equities markets while also amending
those rules to provide greater certainty to Members and investors that
trades will stand if executed during Market Hours where the LULD Plan
provides adequate protection against trading at erroneous prices.
    The Exchange understands that the other national securities
exchanges and FINRA will also file similar proposals, the substance of
which are identical to this proposal. Thus, the proposed rule change
will help to ensure consistency across SROs without implicating any
competitive issues.

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

    No written comments were either solicited or received.

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

    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)(iii) of the Act \30\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\31\
---------------------------------------------------------------------------

    \30\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \31\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \32\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \33\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposed
rule change may become operative on October 1, 2022. The Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest, as it will allow the
Exchange to coordinate its implementation of the revised clearly
erroneous execution rules with the other national securities exchanges
and FINRA, and will help ensure consistency across the SROs.\34\ For
this reason, the Commission hereby waives the 30-day operative delay
and designates the proposed rule change as operative upon filing.\35\
---------------------------------------------------------------------------

    \32\ 17 CFR 240.19b-4(f)(6).
    \33\ 17 CFR 240.19b-4(f)(6)(iii).
    \34\ See SR-CboeBZX-2022-37 (July 8, 2022).
    \35\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-Phlx-2022-36 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-Phlx-2022-36. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of 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. 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-Phlx-2022-36 and should be submitted on or before October 20,
2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\36\
---------------------------------------------------------------------------

    \36\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-21067 Filed 9-28-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 129 (Thursday, July 7, 2022)]
[Notices]
[Pages 40544-40545]
[FR Doc No: 2022-14498]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2022-0019; OMB No. 1660-NW151]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Survey Following the National Test of the Wireless
Emergency Alert (WEA) System

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: 60-Day notice of new collection and request for comments.

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

SUMMARY: The Federal Emergency Management Agency (FEMA), as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public to take this opportunity to comment on a new
information collection. In accordance with the Paperwork Reduction Act
of 1995, this notice seeks comments concerning a survey following the
upcoming national test of the Wireless Emergency Alert (WEA) system.

DATES: Comments must be submitted on or before September 6, 2022.

ADDRESSES: Please submit comments at www.regulations.gov under Docket
ID FEMA-2022-0019. Follow the instructions for submitting comments.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy and
Security Notice that is available via a link on the homepage of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Ward D. Hagood, IPAWS DS2 T&E Manager,
FEMA HQ/PNP-NCP-CCD-IPAWS, phone:<PHONE_NUMBER>, email:
[email protected]. You may contact the Information Management
Division for copies of the proposed collection of information at email
address: [email protected].

SUPPLEMENTARY INFORMATION: Public Law 114-143, the Integrated Public
Alert and Warning System Modernization Act of 2015, and Presidential
Executive Order 13407, Public Alert and Warning System, require FEMA to
implement the public alert and warning system to disseminate timely and
effective warnings to people in situations of war, terrorist attack,
natural disaster, or other hazards to public safety and wellbeing, and
conduct tests of the public alert and warning system at least once
every three years. The Act also requires public education efforts and a
general market awareness campaign to ensure understanding of the
functions of the public alert and warning system. The Integrated Public
Alert and Warning System (IPAWS) is the Department of Homeland
Security's (DHS) response to the Executive Order. The Stafford Act
(U.S.C. title 42, Chapter 68, Subchapter II) requires that FEMA make
IPAWS available to Federal, state, local, tribal, and territorial
agencies for the purpose of providing warning to governmental
authorities and the civilian population in areas endangered by
disasters. FEMA is planning a national test of a key component of
IPAWS, the Wireless Emergency Alert (WEA) system, to satisfy the
testing and public education requirements of the IPAWS Modernization
Act of 2015 (Pub. L. 114-143). The WEA system broadcasts alerts to cell
phones configured to receive such alerts (which, at this point, is most
phones sold in the United States). The WEA national test will be
announced in advance by FEMA and widely publicized. The test will help
FEMA assess WEA's geographic reach, along with additional key
parameters outlined in the IPAWS Modernization Act of

2015. This will help FEMA and other WEA stakeholders, such as the
Federal Communications Commission (FCC) and Congressional committees,
enhance and expand WEA, and thus further improve emergency alerting
capabilities, leading to a better prepared and more resilient nation.
FEMA will implement a survey to capture key technical performance
factors of WEA, such as geographic coverage and carrier-related issues,
as well as non-technical aspects essential to WEA's role in national
alerting, including alerting effectiveness in reaching diverse
populations, including traditionally underserved populations. The
survey will also assess public awareness of the WEA system.

Collection of Information

    Title: Survey Following the National Test of the Wireless Emergency
Alert (WEA) System.
    Type of Information Collection: New information collection.
    OMB Number: 1660-NW151.
    FEMA Form: FEMA Form FF-302-FY-22-101, WEA National Test Survey.
    Abstract: FEMA will field a survey following a national test of the
WEA system. The survey will capture key technical performance factors,
such as geographic coverage and carrier-related issues, and non-
technical aspects essential to WEA's role in national alerting,
including effectiveness in reaching diverse populations. FEMA will use
this information to improve the performance of the WEA system and
assess public awareness.
    Affected Public: Individuals or households.
    Estimated Number of Respondents: 82,586.
    Estimated Number of Responses: 82,586.
    Estimated Total Annual Burden Hours: 6,739.
    Estimated Total Annual Respondent Cost: $273,671.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $2,080,008.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Millicent Brown Wilson,
Records Management Branch Chief, Office of the Chief Administrative
Officer, Mission Support, Federal Emergency Management Agency,
Department of Homeland Security.
[FR Doc. 2022-14498 Filed 7-6-22; 8:45 am]
BILLING CODE 9111-AB-P


[Federal Register: November 18, 2008 (Volume 73, Number 223)]
[Notices]
[Page 68431-68432]
[DOCID:fr18no08-88]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0559]

Draft Guidance for Industry on Process Validation: General
Principles and Practices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Process
Validation: General Principles and Practices.'' FDA is revising its
guidance for industry entitled ``Guideline on General Principles of
Process Validation,'' which issued in May 1987 (the 1987 guidance). The
revised draft guidance promotes a ``lifecycle'' approach to process
validation that includes scientifically sound design practices, robust
qualification, and process verification. When finalized, this draft
guidance will replace the 1987 guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by January 20, 2009.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or to
the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448; or to the Communications Staff (HFV-12), Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one self-addressed adhesive label to assist
that office in processing your requests. The draft guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
Brian Hasselbalch, Center for Drug Evaluation and Research (HFD-320),
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm.
4364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
Grace McNally, Center for Drug Evaluation and Research (HFD-320), Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4374,
Silver Spring, MD 20993-0002, 301-301-796-3286;
Christopher Joneckis, Center for Biologics Evaluation and Research
(HFM-1), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>; or
Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Process Validation: General Principles and Practices.'' This
guidance outlines the general principles and approaches that FDA
considers to be appropriate elements of process validation for the
manufacture of human and animal drug and biological products, including
active pharmaceutical ingredients (API or drug substance). This
guidance incorporates principles and approaches that all manufacturers
can use in validating a manufacturing process.
    In the Federal Register of May 11, 1987 (52 FR 17638), FDA issued a
notice announcing the availability of a guidance entitled ``Guideline
on General Principles of Process Validation'' (the 1987 guidance).
Since then, we have obtained additional experience through our
regulatory oversight that allows us to update our recommendations to
industry on this topic. The draft guidance conveys FDA's current
thinking on process validation and is consistent with basic principles
first introduced in the 1987 guidance. The draft guidance also provides
recommendations that reflect some of the goals of FDA's initiative
entitled ``Pharmaceutical CGMPs for the 21st Century--A Risk-Based
Approach,'' particularly with regard to the use of technological
advances in pharmaceutical manufacturing, as well as implementation of
modern risk management and quality system tools and concepts. When
finalized, this guidance will replace the 1987 guidance.
    FDA's current good manufacturing practice (CGMP) regulations for
validating pharmaceutical (drug) manufacturing require that drug
products be produced with a high degree of assurance that they meet all
the attributes they are intended to possess (21 CFR 211.100(a) and
211.110(a)). Effective process validation contributes significantly to
the assurance of drug quality. FDA has the authority and responsibility
to inspect and evaluate process validation performed by manufacturers.
    This guidance aligns process validation activities with the product
lifecycle concept and with existing FDA guidance, including
International Conference on Harmonisation (ICH) guidance documents,
``Q8 Pharmaceutical Development,'' ``Q9 Quality Risk Management,'' and
when it is finalized, ``Q10 Pharmaceutical Quality System'' (a notice
of availability for the May 2007 ICH Q10 draft guidance published in
the Federal Register on July 13, 2007 (72 FR 38604)) (the guidances are
available on the Internet at http://www.fda.gov/cder/guidance/
index.htm). The lifecycle concept links product and process
development, qualification of the commercial manufacturing process, and
maintenance of the process in a state of control during routine
commercial production. This guidance promotes modern manufacturing
principles, process improvement innovation, and sound science.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the general
principles and practices of process validation. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information requested in the draft guidance is covered
under FDA regulations at 21 CFR part 211, and is approved under OMB
Control Number 0910-0139.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/
guidelines.htm, http://www.fda.gov/cvm/guidance/published.htm, or
http://www.regulations.gov.

    Dated: November 10, 2008.
Jeffery Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27321 Filed 11-17-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83552-83554]
[FR Doc No: 2023-26306]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4095]

Using Relative Supersaturation To Support ``Urinary Tract
Health'' Claims for Adult Maintenance Cat Food; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry #284
entitled ``Using Relative Supersaturation to Support ``Urinary Tract
Health'' Claims for Adult Maintenance Cat Food.'' FDA's Center for
Veterinary Medicine (CVM) has evaluated the use of relative
supersaturation (RSS) methodology to support urinary tract health
claims for certain adult maintenance cat food. RSS is a measurement
that estimates the potential for crystal formation and bladder stone
growth, which is a common affliction in cats. This draft guidance
provides recommendations for how pet food manufacturers can use RSS
methodology to substantiate general structure or function claims that
an adult maintenance cat food supports urinary tract health by
promoting a healthy mineral content in the urinary tract.

DATES: Submit either electronic or written comments on the draft
guidance by February 28, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

do not wish to be made available to the public, submit the comment as a
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions):Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-4095 for ``Using Relative Supersaturation to Support
``Urinary Tract Health'' Claims for Adult Maintenance Cat Food.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Karen Donnelly, Center for Veterinary
Medicine (HFV-227), Food and Drug Administration, 12225 Wilkins Avenue,
Rockville, MD 20852,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
#284 entitled ``Using Relative Supersaturation to Support ``Urinary
Tract Health'' Claims for Adult Maintenance Cat Food.'' RSS methodology
is a measurement that estimates the potential for crystal formation and
bladder stone (urolith) growth, which is a common affliction in cats.
One of the primary conditions for urolith formation in any species is
oversaturation of the urine with dissolved substances (solutes) that
have the potential to precipitate out of solution and form crystals.
These crystals can eventually grow into uroliths. The two most common
types of uroliths in cats are magnesium ammonium phosphate (struvite)
and calcium oxalate (CaOx).
    Based on concerns about uroliths, pet food manufacturers use
various formulation strategies to make adult maintenance cat food, with
general structure or function claims, that support urinary tract health
(UTH cat food). Historically, manufacturers of UTH cat food restricted
the magnesium content and/or formulated their cat food to produce
slightly acidic urine (pH of 5.9 to 6.4). The slight acidity and low
magnesium content create a urinary environment that is unfavorable for
struvite crystallization and urolith growth but may be favorable for
CaOx urolith growth in predisposed cats. Formulating cat food based on
RSS methodology is a more recent dietary strategy that some pet food
manufacturers use to create UTH cat food. RSS provides a numerical
measurement of the degree of saturation of a specific urolith-forming
substance, and thus a quantitative method to evaluate the risk of
urolith formation. The principles of RSS apply to all urolith types, so
UTH cat food based on RSS methodology has the potential to help protect
cats from both struvite and CaOx uroliths.
    In response to requests from pet food manufacturers, CVM has
evaluated the use of RSS methodology to support urinary tract health
claims for certain adult maintenance cat food. This draft guidance
provides recommendations for how a cat food manufacturer can use RSS
methodology to substantiate general structure or function claims that
an adult maintenance cat food supports urinary tract health by
promoting a healthy mineral content in the urinary tract. This draft
guidance also includes information we recommend the manufacturer
submits to us to ensure the urinary tract health claim is
substantiated.
    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on ``Using
Relative Supersaturation to Support ``Urinary Tract Health'' Claims for
Adult Maintenance Cat Food.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: November 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26306 Filed 11-29-23; 8:45 am]
BILLING CODE 4164-01-P


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