[Federal Register Volume 86, Number 144 (Friday, July 30, 2021)]
[Notices]
[Pages 41134-41138]
[FR Doc No: 2021-16231]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92496; File No. SR-Phlx-2021-42]

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

July 26, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 19, 2021, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III, below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Phlx Options 3, Section 8, ``Options
Opening Process.''
    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
    Phlx proposes to amend Options 3, Section 8, ``Options Opening
Process.'' Specifically, the Exchange proposes to amend the definition
of Valid Width Quote at Options 3, Section 8(a)(ix).
    Phlx's Opening Process for an option series is conducted pursuant
to Options 3, Section 8 paragraphs (f)-(k), on or after 9:30 a.m.
Eastern Time the ABBO, if any, is not crossed and the System has
received, within two minutes \3\ of the opening trade or quote on the
market for the underlying security,\4\ a Valid Width Quote. The System
will accept a Lead Market Maker's Valid Width Quote or the Valid Width
Quote of at least one Phlx Electronic Market Maker.\5\ Today, Phlx
requires a Lead Market Maker to enter a Valid Width Quote in 90% of
their assigned series, not later than one minute following the
dissemination of a quote or trade by the market for the underlying
security.\6\ Lead Market Makers must promptly enter a Valid Width Quote
in the remainder of their assigned series, which did not open within
one minute following the dissemination of a quote or trade by the
market for the underlying security.\7\ In either case, the Lead Market
Maker or Phlx Electronic Market Maker must enter a Valid Width Quote to
open an options series. Phlx Options 3, Section 8(a)(ix) defines a
Valid Width Quote as follows:
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    \3\ The Exchange may designated a shorter time provided it is
disseminated to membership on the Exchange's website.
    \4\ In the case of index options, the timing is within two
minutes of the receipt of the opening price in the underlying index
or within two minutes of market opening for the underlying security
in the case of U.S. dollar-settled foreign currency options. In both
cases the Exchange may designated a shorter time provided it is
disseminated to membership on the Exchange's website. The Exchange
proposes an amendment within Options 3, Section 8(d)(i) as described
below.
    \5\ The Exchange proposes an amendment within Options 3, Section
8(d)(i)(B) as described below.
    \6\ In the case of index options, a Lead Market Maker must enter
a Valid Width Quote in 90% of their assigned series, not later than
one minute following the receipt of the opening price in the
underlying index. The Lead Market Maker assigned in a particular
U.S. dollar-settled foreign currency option must enter a Valid Width
Quote, in 90% of their assigned series, not later than one minute
after the announced market opening. See Options 3, Section
8(d)(iii).
    \7\ In the case of index options, Lead Market Makers must
promptly enter a Valid Width Quote in the remainder of their
assigned series, which did not open following the receipt of the
opening price in the underlying index or, with respect to U.S.
dollar-settled foreign currency options, following the announced
market opening. See Options 3, Section 8(d)(iii).

    A Valid Width Quote is a two-sided electronic quotation
submitted by a Phlx Electronic Market Maker that meets the following
requirements: Options on equities and index options bidding and/or
offering so as to create differences of no more than $.25 between
the bid and the offer for each option contract for which the
prevailing bid is less than $2; no more than $.40 where the
prevailing bid is $2 or more but less than $5; no more than $.50
where the prevailing bid is $5 or more but less than $10; no more
than $.80 where the prevailing bid is $10 or more but less than $20;
and no more than $1 where the prevailing bid is $20 or more,
provided that, in the case of equity options, the bid/ask
differentials stated above shall not apply to in-the-money series
where the market for the underlying security is wider than the
differentials set forth above. For such series, the bid/ask
differentials may be as wide as the quotation for the underlying
security on the primary market, or its decimal equivalent rounded
down to the nearest minimum increment. The Exchange may establish
differences other than the above for one or more series or classes
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of options.

    The Exchange proposes to amend a Valid Width Quote to instead
provide:

    A Valid Width Quote is a two-sided electronic quotation
submitted by a Phlx Electronic Market Maker that meets the following
requirements: Options on equities and index options bidding and/or
offering so as to create differences of no more than $5, provided
that, in the case of equity options, the bid/ask differentials
stated above shall not apply to in-the-money series where the market
for the underlying security is wider than the differentials set
forth above. For such series, the bid/ask differentials may be as
wide as the quotation for the underlying security on the primary
market, or its decimal equivalent rounded down to the nearest
minimum increment. The Exchange may establish differences other than
the above for one or more series or classes of options. Such
differences will be posted by the Exchange on its website.

This proposed language is similar to Nasdaq BX, Inc. (``BX'').\8\ The
Exchange proposes to widen the current bid/ask differentials for
several reasons.
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    \8\ BX Options 3, Section 8(a)(9) provides, ``A `Valid Width
Quote' is a two-sided electronic quotation, submitted by a Market
Maker, quoted with a difference not to exceed $5 between the bid and
offer regardless of the price of the bid. However, respecting in-
the-money series where the market for the underlying security is
wider than $5, the bid/ask differential may be as wide as the
quotation for the underlying security on the primary market, or its
decimal equivalent rounded down to the nearest minimum increment.
The Exchange may establish differences other than the above for one
or more series or classes of options.'' See also Securities Exchange
Act Release No. 89731 (September 1, 2020), 85 FR 55524 (September 8,
2020) (SR-BX-2020-016) (Order Approving Proposed Rule Change To
Amend BX's Opening Process in Connection With a Technology
Migration).
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    First, the proposal would conform the Valid Width Quote definition
of Phlx to that of BX. BX refers to a difference not to exceed $5
between the bid and offer within the description of a Valid Width
Quote, similar to BX Options 2, Section 4(f) and 5(d)(2) that describes
intra-day quotes. By amending Phlx's Valid Width Quote, the Exchange
notes that the $5 difference is akin to Phlx's intra-day requirement
within Phlx Options 2, Section 4(c)(1).\9\
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    \9\ Phlx Options 2, Section 4(c)(1) provides, ``Options on
equities (including Exchange-Traded Fund Shares), index options and
options on U.S. dollar-settled FCOs may be quoted electronically
with a difference not to exceed $5 between the bid and offer
regardless of the price of the bid, provided that the foregoing bid/
ask differentials shall not apply to in-the-money series where the
market for the underlying security is wider than the differentials
set forth above. For such series, the bid/ask differentials may be
as wide as the spread between the national best bid and offer in the
underlying security. The Exchange may establish differences other
than the above for one or more series or classes of options.''
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    Second, the proposed differential would simplify the differential
for Lead Market Makers, who would continue to be required to submit a
Valid Width Quote during the Opening Process in their assigned options
series. Widening the differentials would allow Lead Market Makers, and
Electronic Market Makers that elect to quote during the Opening
Process, an ability to quote wider during the Opening Process when an
underlying is volatile. Today, pursuant to Options 3, Section 8(a)(ix),
the Exchange may establish differences other than the established bid/
ask differentials for one or more series or classes of options. With
this proposal, the Exchange is not amending its ability to continue to
establish differences for one or more series or classes of options,
rather the Exchange may continue to set other requirements pursuant to
current Phlx Options 3, Section 8(a)(ix). Today, the Exchange has
established Valid Width Quote differentials which differ

from those described within Options 3, Section 8(a)(ix),\10\ they are:
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    \10\ See https://www.nasdaq.com/docs/2021/03/25/PHLXSystemSettings.pdf.

------------------------------------------------------------------------
                                                     Maximum bid/ask
  Bid price low end of    Bid price high end of        differential
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            $0.00                    $1.99                   $0.75
             2.00                     4.99                    1.20
             5.00                     9.99                    1.50
            10.00                    19.99                    2.40
            20.00                   20.00+                    3.00
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    Also, options with an expiration more than nine months away
continue to be permitted a Valid Width Quote bid/ask differential of
$5.00. The Exchange will continue to utilize the differentials
currently posted on its website until such time as it provides notice
to members and member organizations of a change.
    Third, the Exchange proposes to add rule text to state that such
differences will be posted by the Exchange on its website.\11\ Posting
the current differentials on its website would allow members and member
organizations to easily refer to the quoting obligations for the
Opening Process.
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    \11\ Id.
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Technical Amendment
    The Exchange proposes to add ``Eastern Time'' after 9:30 a.m. and
amend the word ``currency'' to security.'' The Exchange proposes to
amend ``Quotes'' to ``Quote'' within Options 3, Section 8(d)(i)(B).
2. Statutory Basis
    The Exchange believes that its proposal to establish a $5
difference is consistent with Section 6(b) of the Act.\12\
Specifically, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \13\ requirements that the rules of
an exchange be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \14\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
    \14\ Id.
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    The Exchange believes that the proposed $5 difference for the Valid
Width Quote is more appropriate because it reflects the Exchange's
experience in administering the rule and would continue to give Market
Makers flexibility including during the Opening Process. The Exchange
notes that the current standard is not being applied as the Exchange
has established Valid Width Quote differentials which differ from those
described within Options 3, Section 8(a)(8).\15\ Widening the Valid
Width Quote requirement would provide Lead Market Makers and Electronic
Market Makers that elect to quote during the Opening Process,
additional flexibility when submitting Valid Width Quotes during the
Opening Process thereby allowing these Market Makers the ability to
quote wider in instances where the Exchange has not established Valid
Width Quote differentials which differ from those in the rule because
volatile market conditions exist or there is news regarding an
underlying security which may impact pricing. Lead Market Makers are
integral to the Exchange's Opening Process as Phlx is dependent on
receiving a Valid Width Quote to open an options series. With this
proposal, Lead Market Makers would continue to be required to submit a
Valid Width Quote during the Opening Process in their assigned options
series.\16\
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    \15\ See supra note 10.
    \16\ Today, Phlx, Nasdaq GEMX, LLC (``GEMX''), Nasdaq MRX, LLC
(``MRX''), Nasdaq ISE, LLC (``ISE''), Miami International Securities
Exchange, LLC (``MIAX'') and MIAX Emerald, LLC (``Emerald'') and are
the only options markets that require a Primary Market Maker, or
Lead Market Maker in the case of Phlx, to submit a quote to open an
options series.
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    The proposal would conform the Valid Width Quote definition of Phlx
to that of BX.\17\ BX refers to a difference not to exceed $5 between
the bid and offer within the description of a Valid Width Quote,
similar to BX Options 2, Section 4(f) and 5(d)(2) that describes intra-
day quotes. By amending Phlx's Valid Width Quote, the Exchange notes
that the $5 difference is akin to Phlx's intra-day requirement within
Phlx Options 2, Section 4(b)(4).\18\ Also, today, MIAX and Emerald
require market makers to enter a valid width NBBO with a difference of
no more than $5 between the bid and offer.\19\
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    \17\ See supra note 8.
    \18\ See supra note 9.
    \19\ MIAX and Emerald require Market Makers to submit a valid
width NBBO in the opening where the bid and offer of the NBBO differ
no more than differences outlined in MIAX and Emerald Rule
603(b)(4)(i). MIAX and Emerald Rule 603(b)(4)(i) provides that
bidding and offering so as to create differences of no more than $5
between the bid and offer. Rule 603(b)(4)(ii) provides MIAX and
Emerald may establish differences other than the bid/ask
differentials described in (i) above for one or more option series
or classes, respectively. See MIAX and Emerald Rules 503.
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    Not all options markets have bid/ask differentials. In 2019, Cboe
removed its quote width requirements while citing corresponding rules
of its affiliated exchanges.\20\ Cboe noted in the 2019 Rule Change
that the current quote width requirement at the time for generally all
classes was $10, however, its Market-Makers consistently maintained
two-sided quotes that were much tighter than the required width. Cboe
opined that, even if markets experienced periods of stress or
volatility, they remained obligated to maintain two sided markets and
engage in a course of dealings that must be reasonably calculated to
contribute to the maintenance of a fair and orderly market, which
includes refraining from making bids or offers that are inconsistent
with such course of dealings and updating quotations in response to
changed market conditions.\21\ Cboe noted that it did not believe that
continuing to provide for a quote width requirement was necessary nor
would it impact the maintenance of fair and orderly markets because
Market-Makers already quoted at a bid/ask spread much narrower than the
requirements and were required to continuously fulfill their
obligations to engage in a course of dealings reasonably calculated to
contribute to the maintenance of a fair and orderly market.\22\
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    \20\ See Securities Exchange Act Release No. 87024 (September
19, 2019), 84 FR 50545 (September 25, 2019) (SR-Cboe-2019-059)
(``2019 Rule Change'').
    \21\ Id.
    \22\ Id.

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    Unlike Cboe, Phlx does require its Market Makers to quote both
during the Opening Process and intra-day within certain established
bid/ask differentials. The Exchange notes that widening its Valid Width
Quote differential during the Opening Process will not impact the
maintenance of fair and orderly markets because Market Makers on Phlx,
unlike other markets that do not require quoting during the Opening
Process, will continue to require that its Market Makers provide Valid
Width Quotes during the Opening Process, thereby ensuring liquidity.
Also, Market Makers may quote tighter than the defined Valid Width
Quote differential. Finally, similar to Cboe's argument in the 2019
Rule Change, Market Makers are required to continuously fulfill their
obligations to engage in a course of dealings reasonably calculated to
contribute to the maintenance of a fair and orderly market.
    Today, the Exchange has discretion to set other differentials,\23\
similar to MIAX and Emerald.\24\ The Exchange currently is utilizing
that discretion to set different bid/ask differentials based on its
observation of market openings. Currently, the Exchange requires Market
Makers to submit Valid Width Quotes which are tighter than the proposed
$5 difference.
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    \23\ See Options 3, Section 8(a)(8), the Exchange may establish
differences other than the established bid/ask differentials for one
or more series or classes of options.
    \24\ See MIAX and Emerald Rules 503.
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    The Exchange's robust Opening Process seeks to encourage quality
markets. As noted herein, unlike a majority of options markets,\25\ it
requires Lead Market Makers to quote during the Opening Process to
ensure liquidity as well as an efficient Opening Process where options
series are opened quickly and at fair prices.
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    \25\ See supra note 16.
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    The proposal to add rule text to state that such differences will
be posted by the Exchange on its website \26\ would allow members and
member organizations to easily refer to the quoting obligations for the
Opening Process.
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    \26\ Id.
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Technical Amendment
    The Exchange's proposal to add ``Eastern Time'' after 9:30 a.m.,
amend the word ``currency'' to security,'' and amend ``Quotes'' to
``Quote'' within Options 3, Section 8(d)(i)(B) will bring greater
clarity to the Exchange's Rules.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange's proposal to
require Lead Market Makers and Electronic Market Makers to bid and/or
offer an option series with differences of no more than $5 for options
on equities and index options does not impose an undue burden on
competition. All Lead Market Makers, and Electronic Market Makers who
elect to quote during the Opening Process, would be subject to the same
requirement to submit a Valid Width Quote when submitting quotes during
the Opening Process. Differentials would be available on the Exchange's
website and therefore transparent, allowing members and member
organizations to easily refer to the quoting obligations for the
Opening Process. Finally, the proposal would also align quoting
requirements more closely to intra-day requirements within Phlx Options
2, Section 4(c)(1).
    With respect to inter-market competition, the Exchange notes that
most options markets do not require market makers to quote during the
opening.\27\ The Exchange notes that MIAX and Emerald have quoting
requirements in the opening similar to the differential proposed
herein. Also, ISE, GEMX, and MRX are filing similar rule changes to
this proposal.\28\
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    \27\ See supra note 16 citing the options markets that require
bid/ask differentials.
    \28\ See SR-ISE-2021-17, SR-GEMX-2021-07 and SR-MRX-2021-09.
These rule changes are not yet noticed.
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Technical Amendment
    The Exchange's proposal to add ``Eastern Time'' after 9:30 a.m.,
amend the word ``currency'' to security,'' and amend ``Quotes'' to
``Quote'' within Options 3, Section 8(d)(i)(B) will bring greater
clarity to the Exchange's Rules.

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 \29\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\30\
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    \29\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \30\ 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.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2021-42 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-2021-42. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the

Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for website viewing and printing in the Commission's Public
Reference Room, 100 F Street NE, Washington, DC 20549, on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
Phlx-2021-42 and should be submitted on or before August 20, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
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    \31\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-16231 Filed 7-29-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Notices]
[Pages 29334-29335]
[FR Doc No: 2012-11947]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9517-1]

Agency Information Collection Activities OMB Responses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This document announces the Office of Management and Budget
(OMB) responses to Agency Clearance requests, in compliance with the
Paperwork Reduction Act (44 U.S.C. 3501 et. seq.). An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. The OMB control numbers for EPA regulations are listed
in 40 CFR part 9 and 48 CFR chapter 15.

FOR FURTHER INFORMATION CONTACT: Rick Westlund<PHONE_NUMBER>, or email
at<EMAIL_ADDRESS>and please refer to the appropriate EPA
Information Collection Request (ICR) Number.

SUPPLEMENTARY INFORMATION:

OMB Responses to Agency Clearance Requests

OMB Approvals

    EPA ICR Number 1695.11; Emissions Certification and Compliance
Requirements for Nonroad Spark-ignition Engines (Transfer Burden from
2060-0603); 40 CFR parts 1048, 1051, 1065 and 1068; was approved on 04/
03/2012; OMB Number 2060-0338; expires on 08/31/2012; Approved without
change.
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Plants; 40 CFR part 63 subparts A and SSSS; was approved on 04/04/2012;
OMB Number 2060-0487; expires on 04/30/2015; Approved without change.
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Ferromanganese and Silicomanganese; 40 CFR part 63 subparts A and XXX;
was approved on 04/04/2012; OMB Number 2060-0391; expires on 04/30/
2015; Approved without change.
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Clearance and Clearance Testing Requirements for the Renovation,
Repair, and Painting Program''; 40 CFR part 745; was approved on 04/06/
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change.
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Sources; 40 CFR part 63 subparts A and WWWWWW; was approved on 04/12/
2012; OMB Number 2060-0623; expires on 04/30/2015; Approved without
change.
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and Spandex; 40 CFR part 63 subparts A and YY; was approved on 04/12/
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approved on 04/20/2012; OMB Number 2070-0158; expires on 04/30/2015;
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271.23; was approved on 04/24/2012; OMB Number 2050-0041; expires on
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257

and 258; was approved on 04/24/2012; OMB Number 2050-0152; expires on
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2012; OMB Number 2025-0003; expires on 04/30/2015; Approved without
change.
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change.
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40 CFR part 63 subpart B; was approved on 04/24/2012; OMB Number 2060-
0373; expires on 04/30/2015; Approved without change.
    EPA ICR Number 1055.10; NSPS for Kraft Pulp Mills; 40 CFR part 60
subparts A and BB; was approved on 04/24/2012; OMB Number 2060-0021;
expires on 04/30/2015; Approved without change.
    EPA ICR Number 1789.07; NESHAP for Natural Gas Transmission and
Storage; 40 CFR part 63 subparts A and HHH; was approved on 04/24/2012;
OMB Number 2060-0418; expires on 04/30/2015; Approved without change.
    EPA ICR Number 2207.04; Exchange Network Grants Progress Reports
(Renewal); was approved on 04/24/2012; OMB Number 2025-0006; expires on
04/30/2015; Approved without change.
    EPA ICR Number 2137.06; NESHAP for Coal- and Oil-fired Electric
Utility Steam Generating Units; 40 CFR part 63 subparts A and UUUUU;
was approved on 04/25/2012; OMB Number 2060-0567; expires on 04/30/
2015; Approved without change.
    EPA ICR Number 1710.06; Residential Lead-Based Paint Hazard
Disclosure Requirements (Renewal); 24 CFR part 35 subpart H; and 40 CFR
part 745 subpart F; was approved on 04/25/2012; OMB Number 2070-0151;
expires on 04/30/2015; Approved with change.

Comment Filed

    EPA ICR Number 2323.03; Reconsideration of Chemical Manufacturing
Area Sources National Emission Standards for Hazardous Air Pollutants
(Proposed Rule); in 40 CFR part 63 subparts A and subpart VVVVVV; OMB
filed comment on 04/04/2012.
    EPA ICR Number 2453.01; NESHAP for Secondary Aluminum Production;
in 40 CFR part 63 subparts A and RRR; OMB filed comment on 04/04/2012.
    EPA ICR Number 1611.09; NESHAP for Chromium Emissions from Hard and
Decorative Chromium Electroplating and Chromium Anodizing Tanks; in 40
CFR part 63 subparts A and N; OMB filed comment on 04/04/2012.
    EPA ICR Number 2455.01; Revision to the Export Provisions of the
Cathode Ray Tube (CRT) Rule (Proposed Rule); in 40 CFR 261.39 and
261.41; OMB filed comment on 04/24/2012.

John Moses,
Director, Collections Strategies Division.
[FR Doc. 2012-11947 Filed 5-16-12; 8:45 am]
BILLING CODE 6560-50-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA/ Office of Enforcement and Compliance Assurance/ Office of Compliance 2. OMB control number b. G None a. 2060 0019 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NSPS for Nitric Acid Plants ( 40 CFR part 60, subpart G)

8. Agency form number( s) ( If applicable) EPA ICR 1056.08 9. Keywords Nitric, nitrogen oxides, pollution control.

10. Abstract Each nitric acid plant for which construction or modification commenced after August 17, 1971 is subject to the subpart. The information gathered is needed to determine whether these facilities are in compliance with the standards.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 24 b. Total annual responses 51 1. Percentage of these responses collected electronically 10 _________ % c. Total hours requested 1,290 d. Current OMB inventory 1,796 e. Difference ( 506)

f. Explanation of difference 1. Program Change 2. Adjustment ( 506) 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 68 b. Total annual costs ( O& M) 2,400 c. Total annualized cost requested 2,468 d. Current OMB inventory 3,568 e. Difference ( 1,100) f. Explanation of difference 1. Program change 2. Adjustment ( 1,100)

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. Application for benefits e. Program planning or management b. Program evaluation f. Research c. General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. XQ Recordkeeping b. Q Third party disclosure c. X Q Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe) Initially 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Learia A. Williams Phone: ( 202) 564 4113 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3):

( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement. Signature of Program Official Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance Office of Enforcement and Compliance Assurance Date Signature of Senior Official or designee Deborah Williams, Acting Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C. § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of:

"( i) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number." OMB 83 I ( Instructions) 10/ 95


[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72978-72981]
[FR Doc No: 2021-27891]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1149]

Transition Plan for Medical Devices Issued Emergency Use
Authorizations During the Coronavirus Disease 2019 Public Health
Emergency; Draft Guidance for Industry and Food and Drug Administration
Staff; Availability; Agency Information Collection Activities; Proposed
Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Transition Plan for
Medical Devices Issued Emergency Use Authorizations (EUAs) During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' FDA
recognizes that it will take time for device manufacturers, healthcare
facilities, healthcare providers, patients, consumers, and FDA to
adjust from policies adopted and operations implemented during the
declared public health emergency (PHE) to normal operations. To provide
a clear policy for all stakeholders and FDA staff, the Agency is
issuing this guidance to describe FDA's general recommendations for
this transition process with respect to devices issued EUAs during the
COVID-19 PHE, including recommendations regarding submitting a
marketing submission, as applicable, and taking other actions with
respect to these devices. This draft guidance is not final nor is it in
effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by March 23, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
on the proposed collection of information in the draft guidance by
February 22, 2022.

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-2021-D-1149 for ``Transition Plan for Medical Devices Issued
Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019
(COVID-19) Public Health Emergency.'' 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)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for

information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Transition Plan for Medical Devices Issued Emergency Use
Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19)
Public Health Emergency'' to the Office of Policy, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT:
    With regard to the draft guidance: Joshua Silverstein, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002,
301-796-5155; or Jacqueline Gertz, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1655, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    With regard to the proposed collection of information: Amber
Sanford, Office of Operations, Food and Drug Administration, Three
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance applies to devices that have been issued EUA
under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360bbb-3) on the basis of a device-related COVID-19 EUA
declaration. This draft guidance does not apply to devices for which
FDA has revoked the EUA under section 564(g)(2)(B)-(C) of the FD&C Act
because the criteria under section 564(c) of the FD&C Act were no
longer met or because other circumstances made such revocation
appropriate to protect the public health or safety. FDA is concurrently
issuing a companion guidance to describe FDA's recommendations for
transitioning devices that fall within enforcement policies issued
during the COVID-19 PHE.
    Given the magnitude of the COVID-19 PHE, FDA recognizes that some
continued flexibility, while still providing necessary oversight, will
be appropriate to facilitate an orderly and transparent transition back
to normal operations. Further, FDA is taking into account that the
manufacture, distribution, and use of devices in the context of the
COVID-19 PHE raises unique considerations. These unique considerations
include, for example, the manufacturing of devices by non-traditional
manufacturers to address supply issues and the distribution and use of
capital or reusable equipment (e.g., ventilators, extracorporeal
membrane oxygenation systems) under an EUA.
    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 current thinking of FDA on ``Transition
Plan for Medical Devices Issued Emergency Use Authorizations (EUAs)
During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency.'' 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.
    FDA is concurrently issuing a companion draft guidance to describe
FDA's recommendations for transitioning devices that fall within
enforcement policies issued during the COVID-19 PHE.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This draft guidance is also
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Transition Plan for Medical Devices
Issued Emergency Use Authorizations (EUAs) During the COVID-19 Public
Health Emergency'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 21012 and complete title to identify the
draft guidance you are requesting.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), 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 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.

Transition Plan for Medical Devices Issued Emergency Use Authorizations
(EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency OMB Control Number 0910-0595; Revision

    The following paragraphs discuss the one-time burdens associated
with information collections found in the draft guidance, ``Transition
Plan for Medical Devices Issued Emergency Use Authorizations (EUAs)
During the COVID-19 Public Health Emergency.''
    The draft guidance is intended to help facilitate continued
patient, consumer, and healthcare provider access to devices needed in
the prevention, treatment, and diagnosis of COVID-19. The information
collections proposed in the draft guidance would assist the Agency in
resource planning for marketing submission review and providing
increased support to manufacturers. The information collections also
include recommended information to provide in labeling for certain
devices to inform potential users of the device's regulatory status,
including physical labeling for life-supporting/life-sustaining
devices.
    FDA estimates the burden of this collection of information as
follows:

                                     Table 1--Estimated One-Time Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Notification of intent..........             100               1             100               1             100
Transition plan.................             340               1             340               2             680
Labeling mitigation for reusable             170               1             170            1.25             213
 devices........................
Labeling mitigation for devices              340               1             340            1.25             425
 under FDA review after the EUA
 termination date...............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,418
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Notification of intent: In section V.A of the draft guidance, ``
`Notifications of Intent' for Certain Reusable Life-Supporting or Life-
Sustaining Devices,'' FDA recommends that manufacturers of certain
life-supporting or life-sustaining devices submit to FDA information
regarding whether or not they intend to submit a marketing submission
to continue distributing their product after the EUA termination date.
The draft guidance recommends that manufacturers of such devices
include in this notification: (1) General information (e.g., contact
information); (2) the EUA request number; (3) a list of all model
numbers or other device identifying information; (4) whether the
manufacturer plans to submit a marketing submission; and (5) if not
planning to submit a marketing submission, the manufacturer should
discuss, as applicable, its plan to stop distribution of the device, to
restore the device to a previously FDA-cleared or approved version, to
provide a physical copy or electronic updated labeling, and any other
efforts to address or mitigate potential risks of devices that remain
distributed after the EUA termination date. The manufacturer should
submit this information designated with the EUA number as an ``EUA
report.'' FDA recommends that manufacturers notate the following on the
cover letter of the submission: ``Attention: Notification of Intent.''
    Based on the current EUA submissions and authorizations, we
estimate we will receive 100 notifications of intent for certain life-
supporting or life-sustaining devices. Considering the recommended
content of a notification, we estimate that the average burden per
response is 1 hour.
    Transition implementation plan: Section V.B.1 of the draft guidance
recommends that manufacturers who intend to continue distribution of
their device include with their marketing submissions a ``transition
implementation plan'' that addresses the manufacturers' plans for
devices already distributed in the case of a positive decision or a
negative decision on its marketing submission. The ``transition
implementation plan'' should include information regarding the
estimated number of devices distributed under an EUA currently in U.S.
distribution, and a benefit-risk based plan for disposition of
distributed product as detailed in the draft guidance.
    Considering the current EUA submissions and authorizations, the
amount of these products that are 510(k) exempt, and the amount of
respondents we estimate are likely to pursue marketing submission, we
estimate that we will receive transition plans for approximately two-
thirds of these products, or about 340 products. Based on the
recommended content of a transition plan, we estimate that the average
burden per response is 2 hours.
    Labeling mitigation for reusable devices: The draft guidance
indicates that when manufacturers of certain reusable devices do not
intend to distribute their device beyond the EUA termination date, FDA
does not intend to object to the disposition of already distributed
devices (i.e., FDA does not intend to request market removal), as
detailed in the draft guidance.
    The draft guidance states that FDA does not intend to object to
reusable, non-life-supporting/non-life-sustaining devices that were
distributed before the EUA termination date remaining distributed and
being used by their end user. Such devices should either be restored by
the manufacturer to the previously FDA-cleared or approved version or
have publicly available labeling that accurately describes the product
features and regulatory status (i.e., that the product lacks FDA
clearance or approval). In addition, the draft guidance recommends that
reusable life-supporting/life-sustaining devices (e.g., ventilators,
extracorporeal membrane oxygenation systems, continuous renal
replacement therapy systems) that were distributed before the EUA
termination date remain distributed. Such devices should either be
restored by the manufacturer to the previously FDA-cleared or approved
version of the device, or have both publicly available and a physical
copy of labeling that specifies that the device lacks FDA clearance or
approval. We estimate that, on average, updating the labeling will take
approximately 1 hour and 15 minutes. We estimate 170 respondents, which
is about one-third of devices currently under an EUA issued during the
COVID-19 PHE, will make such labeling available.
    Labeling mitigation for devices under FDA review after the EUA
termination date: During the period after the EUA termination date, for
devices for which a marketing submission has been accepted by FDA but
before FDA has taken final action on the submission, labeling should be
updated to accurately state that the product was authorized under an
EUA issued during the COVID-19 PHE and remains under FDA review for
clearance or approval. We believe updating this labeling will also take
approximately 1 hour and 15 minutes per device. We estimate that the
majority of devices for which manufacturers pursue a marketing
submission may remain under FDA review for clearance or approval during
the period after the EUA termination date.
    This draft guidance also refers to previously approved FDA
collections of information. The collections of information in the
following FDA regulations and guidance have been approved by OMB as
listed in the following table:

                   Table 2--Guidances and Collections
------------------------------------------------------------------------
                                                            OMB Control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)''.
``Requests for Feedback and      Q-submissions..........       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
803............................  Medical Devices;              0910-0437
                                  Medical Device
                                  Reporting;
                                  Manufacturer
                                  reporting, importer
                                  reporting, user
                                  facility reporting,
                                  distributor reporting.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
807, subparts A through D......  Electronic Submission         0910-0625
                                  of Medical Device
                                  Registration and
                                  Listing.
806............................  Corrections and               0910-0359
                                  Removals.
830 and 801.20.................  Unique Device                 0910-0720
                                  Identification.
800, 801, and 809..............  Medical Device Labeling       0910-0485
``Emergency Use Authorization    Emergency Use                 0910-0595
 of Medical Products and          Authorization.
 Related Authorities''.
------------------------------------------------------------------------

IV. Other Issues for Consideration

    As discussed in the draft guidance, FDA understands that it will
take time for device manufacturers, healthcare facilities, healthcare
providers, patients, consumers, and FDA to adjust from policies adopted
and operations implemented during the declared PHE to normal
operations. FDA encourages all stakeholders to comment on the following
topics:
    1. Whether the 180-day period proposed for advance notice of
termination of each EUA declaration pertaining to devices would
sufficiently allow for an appropriate transition period that avoids
exacerbating product shortages and supply chain disruptions.
    2. Whether FDA's issuance of this draft guidance with a proposed
transition policy and requesting public comment may help the Agency to
satisfy, or otherwise determine how to best satisfy, while also
effectively managing Agency resources, the requirement in section
564(b)(2)(B) of the FD&C Act to consult with a manufacturer that was
issued an EUA for an unapproved product on the appropriate disposition
of the product.

    Dated: December 20, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27891 Filed 12-22-21; 8:45 am]
BILLING CODE 4164-01-P