[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Notices]
[Pages 15683-15685]
[FR Doc No: 2021-06096]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6644]

Fiscal Year 2021 Generic Drug Science and Research Initiatives
Workshop; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``FY 2021 Generic
Drug Science and Research Initiatives Workshop.'' The purpose of the
public workshop is to provide an overview of the status of science and
research initiatives for generic drugs and an opportunity for public
input on these initiatives. FDA is seeking this input from a variety of
stakeholders--industry, academia, patient advocates, professional
societies, and other interested parties--as it fulfills its commitment
under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to
develop an annual list of science and research initiatives specific to
generic drugs. FDA will take the information it obtains from the public
workshop into account in developing its Fiscal Year (FY) 2022 GDUFA
science and research initiatives.

DATES: The public workshop will be held on June 23, 2021, from 8:30
a.m. to 4:30 p.m. Eastern Time. Submit either electronic or written
comments on this public workshop by July 23, 2021. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public workshop will be held virtually.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before July 23, 2021. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of July 23, 2021. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your

comment does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-6644 for ``FY 2021 Generic Drug Science and Research
Initiatives Workshop; Public Workshop; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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>.

FOR FURTHER INFORMATION CONTACT: Sam Raney, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4706, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Robert Lionberger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402-
7957<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In July 2012, Congress passed the Generic Drug User Fee Amendments
of 2012 (GDUFA I) (Pub. L. 112-144). GDUFA I was designed to enhance
public access to safe, high-quality generic drugs and to modernize the
generic drug program. To support this goal, FDA agreed in the GDUFA I
commitment letter to work with industry and interested stakeholders on
identifying science and research initiatives specific to generic drugs
for each fiscal year covered by GDUFA I.
    In August 2017, GDUFA I was reauthorized until September 2022
through the Generic Drug User Fee Amendments of 2017 (GDUFA II) (Pub.
L. 115-52). In the GDUFA II commitment letter,\1\ FDA agreed to conduct
annual public workshops ``to solicit input from industry and
stakeholders for inclusion in an annual list of GDUFA II [r]egulatory
[s]cience initiatives.'' The public workshop scheduled for June 23,
2021, seeks to fulfill this agreement.
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    \1\ The GDUFA II commitment letter is available at https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf.
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II. Topics for Discussion at the Public Workshop

    The purpose of the public workshop is to obtain input from industry
and other interested stakeholders on the identification of generic drug
science and research initiatives for FY 2022.
    FDA is particularly interested in receiving input in the following
five topic areas:
    1. What research is needed to determine how formulation differences
in generic injectable products (that are not qualitatively (Q1) and
quantitatively (Q2) the same as their reference listed drug products)
affect the substitutability of these products?
    2. What research is needed to prepare for generic versions of
oligonucleotide drug products (e.g., siRNA, chemically modified,
antisense oligonucleotides)?
    3. What research relating to artificial intelligence (including
machine learning) and/or the use of integrated data from multiple areas
may facilitate and modernize the development of generic products?
    4. What research is needed to bridge the gap between existing
scientific insights from GDUFA-funded research (e.g., related to
product characterization techniques or modeling and simulation tools)
and the development of suitable test procedures, study designs, model
integrated evidence, and/or approaches for developing generic products?
    5. What research is needed to support identification of best
bioequivalence practices and convergence of global bioequivalence
standards?
    Specific presentations and discussions at this workshop will be
announced at a later date and may differ from the topics above,
however, input in the above topic areas will help the Agency identify
and expand our scientific focus for the next fiscal year.
    FDA will consider all comments made at this workshop or received
through the docket (see ADDRESSES) as it develops its FY 2022 science
and research initiatives. Information concerning the science and
research initiatives for generic drugs can be found at https://www.fda.gov/gdufaregscience.

III. Participating in the Public Workshop

    Registration: Registration is free. Persons interested in attending
this public workshop must register online at https://www.fda.gov/drugs/
news-events-human-drugs/fy-2021-generic-drug-science-and-research-
initiatives-public-

workshop-06232021-06232021. Registration may be performed at any time
before or during the workshop.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present your public comments. Public comment
presentation requests must be submitted by 11:59 p.m. Eastern Time at
the end of April 30, 2021. We will do our best to accommodate requests
to make public comments. Individuals and organizations with common
interests are urged to consolidate or coordinate their presentations,
and request time for a joint presentation, or submit requests for
designated representatives to participate in the workshop. Following
the close of registration on April 30, 2021, at 11:59 p.m. Eastern
Time, we will determine the amount of time allotted to each presenter
and the approximate time each oral presentation is to begin; we will
select and notify participants by May 21, 2021. All requests to make
oral presentations must be received by the close of registration on
April 30, 2021. If selected for presentation, any presentation
materials must be emailed to<EMAIL_ADDRESS>no
later than June 18, 2021, 11:59 p.m. Eastern Time. No commercial or
promotional material will be permitted to be presented or distributed
at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will
be webcast. Please register online (as described above) to attend the
workshop remotely. Unless scheduled to participate in advance,
attendees will not be able to speak or make presentations during the
public comment period or during any other session of the workshop. To
join the workshop via the webcast, please go to https://www.fda.gov/drugs/news-events-human-drugs/fy-2021-generic-drug-science-and-research-initiatives-public-workshop-06232021-06232021.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: As soon as a transcript of the public workshop is
available, it will be accessible at https://www.regulations.gov or at
https://www.fda.gov/gdufaregscience. It may be viewed at the Dockets
Management Staff (see ADDRESSES). Closed caption scrolling text will be
generated by the Adobe Connect system and displayed in real time. The
closed caption scrolling text will also display when streaming the
recorded presentations for viewing at a later date.

    Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06096 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Notices]
[Pages 66011-66012]
[FR Doc No: 2013-26330]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Allergenic Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Allergenic Products Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 11, 2013, from
9 a.m. to approximately 3:30 p.m. and on December 12, 2013, from 8:30
a.m. to approximately 2:45 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    For those unable to attend in person, the meeting will also be
Webcast. The link for the Webcast is available at: https://collaboration.fda.gov/apac.
    Contact Person: Donald W. Jehn or Joanne Lipkind, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852,<PHONE_NUMBER>,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area). A notice in the Federal Register
about last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough to
provide timely notice. Therefore, you should always check the Agency's
Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory committee meeting link, or call
the advisory committee information line to learn about possible
modifications before coming to the meeting.
    Agenda: On December 11, 2013, the committee will meet in open
session to discuss and make recommendations on the safety and efficacy
of Oralair; a sweet vernal, orchard, perennial rye, Timothy, and
Kentucky bluegrass mixed pollens allergen extract tablet for sublingual
use, manufactured by Stallergenes. On December 12, 2013, the committee
will meet in open session to discuss and make recommendations on the
safety and efficacy of Grastek, a Timothy grass pollen allergen extract
tablet for sublingual use, manufactured by Merck.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
December 4, 2013. Oral presentations from the public will be scheduled
between approximately 12 p.m. and 12:30 p.m. on December 11, 2013, and
between approximately 11:10 a.m. and 11:40 a.m. on December 12, 2013.
Those individuals interested in making formal oral presentations should

notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
November 26, 2013. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by November 27,
2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Donald W. Jehn or
Joanne Lipkind at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 29, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-26330 Filed 11-1-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 14 (Thursday, January 22, 2015)]
[Notices]
[Pages 3273-3278]
[FR Doc No: 2015-00967]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74064; File No. SR-NYSEMKT-2015-02]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change To Add a Price
Protection Mechanism To Prevent the Automatic Execution of Incoming
Market Orders and Marketable Limit Orders Outside a Specified Parameter
and Eliminate Liquidity Replenishment Points and the Gap Quote Policy

January 15, 2015.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that on January 8, 2015, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to (i) amend Rule 1000 to add a price
protection mechanism to prevent the automatic execution of incoming
market orders and marketable limit orders outside a specified parameter
and (ii) eliminate its Exchange-specific volatility mechanisms--
Liquidity Replenishment Points (``LRPs'') and its Gap Quote Policy--and
to delete any references thereto from the Exchange rules. The text of
the proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries,

set forth in sections A, B, and C below, of the most significant parts
of such statements.

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

1. Purpose
    The Exchange proposes to amend Rule 1000--Equities to add a price
protection mechanism to prevent the automatic execution of incoming
market orders and marketable limit orders outside a specified parameter
(referred to as a ``Trading Collar''). The Exchange also proposes to
eliminate its Exchange-specific volatility mechanisms--LRPs and Gap
Quote Policy--and to delete any references thereto from the Exchange
rules. The Exchange believes that the proposed Trading Collars would
assist with the maintenance of fair and orderly markets by mitigating
the risks associated with orders sweeping through multiple price
points, resulting in executions at prices that are away from the best
bid or offer and potentially erroneous. As discussed further below, the
discontinuation of the Exchange-specific volatility mechanisms were
anticipated changes following implementation of the Regulation NMS Plan
to Address Extraordinary Market Volatility (the ``Plan'').\4\
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    \4\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498, 33510, n. 182 (June 6, 2012) (File No. 4-631)
(Order Approving, on a Pilot Basis, the Plan) (The Commission
``expects, that upon implementation of the Plan, such exchange-
specific volatility mechanisms would be discontinued by the
respective exchanges.'') See also Securities Exchange Act Release No
71649 (March 5, 2014), 79 FR 13696 (March 11, 2014) (File No. 4-631)
(the Seventh Amendment to the Plan).
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Background: Liquidity Replenishment Points and Gapping the Quote
    Rule 1000--Equities provides for the basic operative principles
regarding the immediate, automatic execution of market orders and
marketable limit orders against the Exchange's published quotation.\5\
The Rule also lists instances in which automatic execution would not be
available due to certain market conditions, including when Exchange-
specific volatility mechanisms, specifically LRPs and gapping the
quote, have been triggered.
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    \5\ Automatic executions may also be against orders on the
Display Book[supreg], Floor broker agency file interest, Floor
broker proprietary file interest, Designated Market Maker (``DMM'')
interest, and interest placed in the Exchange's systems by DMMs
pursuant to a Capital Commitment Schedule in accordance with, and to
the extent provided by, Exchange rules and shall be immediately
reported as Exchange transactions. See Rule 1000(a).
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Liquidity Replenishment Points
    In March 2006, the Exchange implemented the LRP mechanism to
address market volatility on the New York Stock Exchange, LLC
(``NYSE'') and, in 2008, adopted LRPs for use on the Exchange.\6\ The
Exchange has utilized LRPs, which are triggered by rapid price
movements over a short period of time, to moderate volatility in a
security by temporarily converting the electronic market for the
security into an auction market to afford new trading interests the
opportunity to add liquidity.\7\ The Exchange believes that LRPs were
effective in moderating some of the impact from the events of May 6,
2010 for Exchange trading customers, as evidenced by the lack of
erroneous trades on the Exchange.\8\ In 2012, in approving the Plan,
the Commission noted the ``potential for unnecessary complexity that
could result if the Plan were adopted, and exchange-specific volatility
mechanisms were retained''; thus, the Commission stated its
``expect[ation], that upon implementation of the Plan, such exchange-
specific volatility mechanisms would be discontinued by the respective
exchanges.'' \9\
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    \6\ See Securities Exchange Act Release No. 53539 (March 22,
2006), 71 FR 16353 (March 31, 2006) (SR-NYSE-2004-05); see also
Securities Exchange Act Release Nos. 58265 (July 30, 2008), 73 FR
46075 (Aug. 7, 2008) (notice); 58705 (October 1, 2008), 73 FR 58995
(October 8, 2008) (SR-Amex-2008-63) (approval order for the adoption
of NYSE Rules 1-1004 on the Exchange).
    \7\ See Securities Exchange Act Release No. 69294 (April 4,
2013), 78 FR 21441 (April 10, 2013) (SR-NYSEMKT-2013-33).
    \8\ Id.
    \9\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498, 33510, n. 182 (June 6, 2012).
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    In 2013, to coincide with the implementation of the Plan, the
Exchange filed amendments to Rule 1000 that provided for the phasing
out of the functionality associated with LRPs as the Plan was phased in
across all NMS Stocks.\10\ The Plan was fully implemented across all
NMS Stocks on February 24, 2014, and as such, pursuant to Rule
1000(a)(iv)(A), the Exchange has discontinued the use of LRPs for all
NMS Stocks that are subject to the Plan.\11\
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    \10\ See supra n. 7; See Securities Exchange Act Release No.
69696 (June 4, 2013) 78 FR 34687 (June 10, 2013) (SR-NYSEMKT-2013-
46).
    \11\ See Securities and Exchange Act Release No. 71649 (March 5,
2014), 79 FR 13696 (March 11, 2014) (File No. 4-631) (the Seventh
Amendment to the Plan). The Exchange notes that rights and warrants
are not subject to the Plan, and therefore continue to be subject to
LRPs.
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Gapping the Quote
    When an imbalance in a particular security exists, the manual
process known as ``gapping the quote'' occurs--specifically, the DMM
for the security widens the spread between the bid and offer and
publishes a new gapped quote. Order imbalances may occur when the
Exchange receives a sudden influx of orders for a particular security
on the same side of the market within a short time interval, or when
one or more large-size orders for a security are entered, and there is
insufficient offsetting interest. The Exchange first implemented its
policies and procedures for gapping the quote in 1994 and updated the
Gap Quote Policy in 2010.\12\ As stated in the Policy, a DMM gaps a
quote to ``provide public notice of order imbalances for securities,
facilitate price discovery, and minimize short-term price dislocation,
by allowing for the entry of offsetting orders or the cancellation of
orders on the side.'' \13\ A DMM may gap a quote after an LRP has been
reached. A gapped quote is not available for automatic execution.
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    \12\ See Information Memo 94-32 (August 9, 1994), filed as SR-
NYSE-93-48. See Securities Exchange Act Release No. 34303 (July 1,
1994), 59 FR 35157 (July 8, 1994). See also Information Memorandum
10-3 (January 7, 2010), filed as NYSEAmex-2010-05. See Securities
and Exchange Act Release No. 61402 (January 22, 2010), 75 FR 4602
(January 28, 2010) (changing the minimum size and value requirements
for use of gap quotes).
    \13\ See Securities Exchange Act Release No. 61049 (November 23,
2009), 74 FR 62851 (SR-NYSEAmex-2009-82) (December 1, 2009).
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Proposed Trading Collar
    The Exchange proposes to amend Rule 1000--Equities to add a price
protection mechanism to prevent the automatic execution or routing of
incoming market orders, including elected stop orders, and marketable
limit orders \14\ outside a specified parameter (referred to as a
``Trading Collar''). As proposed, an incoming market order or
marketable limit order to buy (sell) would not execute or route to
another market center at a price above (below) the Trading Collar.
Trading Collars would be applicable only when automatic executions are
in effect.\15\ As

discussed below, on arrival, a buy/sell order would be automatically
executed up/down to (and including, but not beyond) the Trading Collar
and any remaining interest shall be cancelled. Unless it is a non-
routable order, the order would route to all markets at or better than
the Trading Collar.\16\
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    \14\ A market order is an ``order to buy or sell a stated amount
of a security at the most advantageous price obtainable after the
order is represented in the Trading Crowd or routed to the Display
Book[supreg].'' See Rule 13--Equities. A marketable limit order is
defined as ``a limit order to buy (sell) priced at or above (below)
the Exchange best offer (bid) at the time such order is routed to
the Display Book[supreg].'' Id. Because a stop order becomes a
market order when elected, the Exchange believes it is appropriate
to provide that elected stop orders would be subject to the proposed
Trading Collar.
    \15\ See proposed Rule 1000(c)(ii)--Equities. Both market orders
and marketable limit orders are ``auto ex orders'' that initiate
automatic executions immediately upon entry into the Exchange
systems. See Rule 13--Equities. Trading Collars would not be
applicable to Set Slow Stocks, or to pre-opening, opening, closing
or manual transactions, and are not in effect during a halt,
suspension, or pause in trading. Trading Collars would apply, and be
determined, when discretionary pricing instructions are triggered.
Trading Collars would not be displayed.
    \16\ If, however, an order that routed to an away market returns
to the Exchange unexecuted, the Trading Collar based on the NBBO in
place at the time of execution would be used for that incoming (now
returning) order, not the Trading Collar based on the NBBO in place
at the time of the original arrival of the order.
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    Pursuant to proposed Rule 1000(c)(i), a Trading Collar would be a
specified percentage away from the National Best Bid or Offer
(``NBBO''), depending on whether it is a buy or sell order, and the
specified percentage would vary depending on the NBBO at the time the
order arrives and/or is executed. For buy orders, the Trading Collar
would be a specified percentage above the National Best Offer
(``NBO''). For sell orders, the Trading Collar would be a specified
percentage below the National Best Bid (``NBB''). The proposed Trading
Collars are set forth in the table below.

------------------------------------------------------------------------
                                                             Percentage
                          NBB/NBO                             away from
                                                             the NBB/NBO
------------------------------------------------------------------------
Greater than $0.00, up to and including $25.00............           10
Greater than $25.00, up to and including $50.00...........            5
Greater than $50.00.......................................            3
------------------------------------------------------------------------

    The Exchange notes that these proposed percentages are based on the
current numerical guidelines for determining whether a clearly
erroneous execution has occurred.\17\ The Exchange further notes that
the proposed percentages are the same as the percentages applicable to
similar trading collar functionality on NYSE Arca Equities, Inc.
(``NYSE Arca Equities'').\18\ The Exchange believes that the proposed
specified percentages are appropriate because the Trading Collar is
designed to reduce the risk of, and to potentially prevent, the
automatic execution of orders at prices that may be considered clearly
erroneous. Because the specified percentage may extend multiple decimal
points, the Exchange proposes to truncate Trading Collars to the
nearest minimum price variation (``MPV'') for the security.\19\
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    \17\ See Rule 128(c)(1)--Equities.
    \18\ See NYSE Arca Equities Rule 7.31(a)(2).
    \19\ See Rule 62--Equities.
---------------------------------------------------------------------------

    Consider an example where the NBBO is $24.95 x 25.01. In such
scenario, the Trading Collar for buy orders would be $26.26 (i.e.,
$25.01 + 5% = $26.2605, truncated to $26.26) and the Trading Collar for
sell orders would be $22.44 [sic] (i.e., $24.95 - 10% = $22.455,
truncated to $22.45).
    The Exchange proposes that if the NBBO is crossed, the Exchange
would use the Exchange Best Offer (``BO'') instead of the NBO for buy
orders, and the Exchange Best Bid (``BB'') instead of the NBB for sell
orders.
    The Exchange believes it is appropriate to use the BB/BO when the
NBBO is crossed as a crossed NBBO is generally indicative of an
erroneously priced or stale bid and/or offer, and may not be
appropriate reference prices for calculating Trading Collars. The
Exchange believes that this practice will help ensure that market
participants obtain timely executions of their market orders and
marketable limit orders while still being afforded the price protection
benefit of the Trading Collars. As proposed, in the event there is no
NBB or BB, the lower boundary of the Trading Collar would be zero
because there would be no reference price against which to determine
the appropriate Trading Collar. Similarly, in the event there is no NBO
or BO, the upper boundary of the Trading Collar would be set to the
maximum price that the System could handle. Notwithstanding the Trading
Collar, any incoming market orders or marketable limit orders would
still be subject to the Plan and could not execute outside of the Upper
(Lower) Price Band, as defined in Rule 80C--Equities.
    Pursuant to proposed Rule 1000(c)(ii), an incoming market order,
including an elected stop order, or marketable limit order would
execute and/or route up or down to (and including) the Trading Collar
and any remaining interest would be cancelled. The Exchange believes
that Trading Collars, working in conjunction with the Plan, could help
limit potential harm from extreme price volatility by preventing
executions that could occur at a price significantly away from the
contra side. As proposed, if the Trading Collar for incoming buy (sell)
interest is lower (higher) than or equals the Upper (Lower) Price Band
\20\, the Exchange would cancel any remaining interest. The Plan,
however, would take priority over the Trading Collars where the Plan
affords more price protection to incoming orders. Specifically, if the
Upper (Lower) Price Band is lower (higher) than the Trading Collar, the
order would execute at the more restrictive Upper (Lower) Price Band
and not beyond and any remaining interest would be displayed or
repriced to the Price Band, consistent with Rule 80C(a)(5)--Equities.
---------------------------------------------------------------------------

    \20\ See Rule 80C--Equities.
---------------------------------------------------------------------------

    The Exchange notes that if there is no execution opportunity at the
Exchange for an incoming buy (sell) order at a price above (below) the
NBO (NBB), the Exchange would not be obligated to route the order to an
away market protected offer (bid) because the incoming order would not
be trading through such protected quotation. The Exchange therefore
proposes that if there is no execution opportunity at the Exchange for
an incoming buy (sell) order at a price above (below) the NBO (NBB) and
at or below (above) the Trading Collar, a buy (sell) order that is
priced at or above (below) the Trading Collar would be cancelled. The
Exchange further proposes that a similarly-priced, partially-executed
order would also be cancelled.
    For example, assume the NBO is 10.00, based on a quote from an away
market, and therefore the proposed Trading Collar is 11.00. Assume
further that the Exchange's best offer is 11.05 and with these
conditions, the Exchange receives an incoming buy order priced at
11.02. Because there is no execution opportunity for the incoming buy
order above the NBO and at or below the Trading Collar, and because the
order's limit price exceeds the Trading Collar, the incoming buy order
would be cancelled. The buy order would cancel rather than route
because the Exchange would not trade through another market. Similarly,
assuming the same facts, but the Exchange has non-displayed interest to
sell priced at 9.99. An incoming buy order priced at 11.02 would
execute against that 9.99 non-displayed sell interest, and then any
remainder of the buy order would similarly be cancelled because there
is no execution opportunity priced above the NBO of 10.00 or at or
below the Trading Collar of 11.00.
    Finally, pursuant to proposed Rule 1000(c)(iii), during a Short
Sale Price Test,\21\ if the NBBO is crossed, short sale orders that
would be re-priced to a Trading Collar would be cancelled. Under Rule
201 of Regulation SHO,\22\ when the NBBO is crossed, a short sale order
in a covered security may be displayed or executed at a price that is
less than or equal to the current national

best bid.\23\ Accordingly, if the NBBO is crossed, a short sale order
priced at or below the Trading Collar could be re-priced to the Trading
Collar, which is by definition a price below the NBB. In the spirit of
Rule 201 of Regulation SHO, which is to prevent the display or
execution of short sale orders at prices equal to or below the NBB, the
Exchange believes that it is appropriate during a crossed market to
cancel a short sale order that would be re-priced to a Trading Collar
rather than display the order at that price.
---------------------------------------------------------------------------

    \21\ See Rule 440B(b)--Equities.
    \22\ 17 CFR part 242.201.
    \23\ See SEC Division of Trading and Markets: Responses to
Frequently Asked Questions Concerning Rule 201 of Regulation Show,
FAQ 6.1, available at: http://www.sec.gov/divisions/marketreg/rule201faq.htm.
---------------------------------------------------------------------------

    The Exchange also proposes to amend Rule 70.25(b)(i)--Equities,
regarding price discretion or ``d-Quotes,'' which states that ``[a]
Floor broker may set a discretionary price range that specifies the
prices at which the Floor broker is willing to trade.'' Specifically,
the Exchange proposes to amend this Rule to provide that d-Quotes are
subject to the Trading Collar and/or the Price Bands and, thus,
pursuant to the amended rule, Floor Brokers may use discretion to
initiate or participate in a trade with interest capable of trading at
a price within the discretionary price range ``unless the interest
reaches a Trading Collar or Price Band, whichever is reached first.''
\24\ The Exchange believes it is appropriate to similarly afford
Trading Collar price protection to d-Quotes to prevent the execution of
orders with discretionary price instructions at prices outside the
prevailing market price from causing significant price dislocation in
the market.\25\
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    \24\ See proposed Rule 70.25(b)(i).
    \25\ The Trading Collar applies to d-Quotes in the same manner
as other order types. See supra n. 15 (Trading Collars apply when
discretionary pricing instructions are triggered, but do not apply
to openings, re-openings, or closing trades).
---------------------------------------------------------------------------

    The Exchange also proposes to amend Rule 512--Equities to state
that Trading Collars would apply to UTP Securities.\26\ Although LRPs
do not apply to UTP Securities, the Exchange believes it is appropriate
to afford these securities Trading Collar protection because
application of the Trading Collar is a straightforward and objective
process that does not raise the same issue as was at issue for UTP
Securities, i.e., identifying appropriate LRP values for actively-
traded symbols that have low volume on the Exchange.
---------------------------------------------------------------------------

    \26\ Current Rule 512--Equities states that LRPs will not apply
to UTP Securities. See Information Memo 10-34 (July 12, 2010)
(explaining that the Nasdaq Securities newly-listed on the Exchange
would ``be more thinly traded on the Exchange, with lower volume and
less liquidity than its listed securities, and that prices for
Nasdaq Securities will therefore be more volatile'' and thus ``in
order to avoid triggering too many `slow' trading situations, the
Exchange removed the application of LRP parameters for trading
Nasdaq Securities.''). In 2014, the Exchange expanded the UTP
Program beyond Nasdaq securities. See Securities Exchange Act
Release No. 71952 (April 16, 2014) 79 FR 22558 (April 22, 2014) (SR-
NYSEMKT-2014-32).
---------------------------------------------------------------------------

Proposed Elimination of LRPs and Gap Quote Policy
    As noted above, by rule, the Exchange has already discontinued the
use of LRPs for any security subject to the Plan. However, LRPs
continue to be available for rights and warrants, which are not subject
to the Plan. The Exchange believes that with the introduction of
Trading Collars it will have in place appropriate price protections for
rights and warrants and the Exchange will no longer need LRPs for those
securities. Accordingly, the Exchange proposes to complete the
Exchange's discontinuation of LRPs in their entirety by deleting
references to LRPs in the following Equities Rules: 60, 79A, 104, 128,
501, 508, 512, and 1000.
    For similar reasons, the Exchange believes it appropriate to
discontinue the Gap Quote Policy. Accordingly, the Exchange proposes to
eliminate its Gap Quote Policy in its entirety and to delete references
thereto in the following Equities Rules: 60, 79A, 104, 501, 508, and
1000.
    Relatedly, the Exchange also proposes to amend Rule 1000(e)
(Executions at and Outside the Exchange Best Bid or Offer) to add
references to Trading Collars and/or Price Bands, in certain cases to
replace deleted references to LRPs. The Exchange believes these
proposed changes will add transparency and clarity to the Exchange's
rules.
Other Proposed Amendments
    In connection with the addition of the Trading Collar, the Exchange
also proposes to amend the definition of market order, in Rule 13--
Equities, to state that if a market order to sell has exhausted all
eligible buy interest, any unfilled balance of the market order to sell
will be cancelled. The Exchange believes that this is appropriate
because it assures that a market order to sell will not be held at a
price that it is not executable, i.e., $0.00.
    Finally, unrelated to issues raised in present filing, the Exchange
is also proposing technical, non-substantive edits to delete from the
Exchange rules the outdated/obsolete references to securities operating
in ``Non-Firm Mode,'' including in Rule 60(c)(ii)(A) and Rule
1000(a)(i), or the block template, referred to in Rule 60(ii)(B), which
is the ``manual reporting of a block-sized transaction.'' The Exchange
also proposes to delete the reference to ``S-quotes'' in Rule 60(d),
1000(a) and 1000(e)(iii)(A), as DMM interest is no longer solely
referred to in this manner and the Exchange believes the proposed
amendment will remove this outmoded and narrow reference. The Exchange
also proposes to amend the last sentence of Rule 60(d), regarding
``[a]utoquoting of highest bid/lowest offer,'' to account for the
impact of the Trading Collars.\27\ In addition, the Exchange proposes
to amend Rule 1000(e)(iii)(A)(4) to replace an incorrect reference to
NYSE with a reference to the Exchange. The Exchange proposes to delete
Rule 79A.15(ii)(C)(6), which is an outmoded reference to bonds that
does not conform to how bonds currently operate on the Exchange or the
NYSE, and to renumber the remaining subparts of this rule accordingly.
Finally, the Exchange proposes to delete an erroneous reference in Rule
1000(e)(iv) to paragraph (d)(iii), as there is no such paragraph in the
Rule.
---------------------------------------------------------------------------

    \27\ As proposed, the final sentence of Rule 60(d) would state
the following: ``When the Exchange's highest bid or lowest offer has
been executed or cancelled in its entirety, the Exchange will
autoquote a new bid or offer reflecting the total size of
displayable orders at the next highest (in the case of a bid) or
lowest (in the case of an offer) price.''
---------------------------------------------------------------------------

Implementation
    The Exchange will announce the implementation date of the proposed
rule change by Trader Update.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \28\ that an Exchange have rules that
are designed to promote the just and equitable principles of trade, 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.
---------------------------------------------------------------------------

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

    As an initial matter, the Exchange notes that the proposed Trading
Collar, which is designed to designed to promote the just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, is similar to
the price protection features offered on other markets, including NYSE
Arca Equities.\29\ As noted above, the specified

percentages relating to the Trading Collar are based on the current
numerical guidelines for determining whether a clearly erroneous
execution has occurred and are the same as the approved specified
percentages applicable to similar trading collar functionality on NYSE
Arca Equities.\30\
---------------------------------------------------------------------------

    \29\ See e.g., NYSE Arca Equities Rule 7.31(a)(2). See also BATS
Exchange, Inc. (``BATS) Rule 11.9(a)(2); BATS Y-Exchange, Inc.
(``BATS-Y'') Rule 11.9(a)(2); EDGA Exchange, Inc. (``EDGA'') Rule
11.8(a)(7); EDGX Exchange, Inc. (``EDGX'') Rule 11.8(a)(7); Nasdaq
Stock Market LLC (``Nasdaq'') Rule 4751(f)(13).
    \30\ See supra nn. 17-18.
---------------------------------------------------------------------------

    Moreover, the Exchange believes that the proposed Trading Collar
assists with the maintenance of fair and orderly markets by helping to
mitigate the risks associated with orders sweeping through multiple
price points, thereby resulting in executions that are potentially
erroneous, which, in turn, protects investors from potentially
receiving executions away from the prevailing prices at any given time.
Specifically, the Exchange believes the Trading Collars will remove
impediments to and perfect the mechanisms of a free and open market
because the Trading Collars will operate in tandem with the Plan and
will only execute/route incoming market orders or marketable limit
orders priced within the Trading Collars or within the Upper (Lower)
Band set forth in the Plan, if the latter is more conservative. The
Exchange believes this mechanism will mitigate the risk of potentially
erroneous executions, which protects investors and the public interest.
    The Exchange also believes its use of the BB/BO when the NBBO is
crossed assists with the maintenance of fair and orderly markets as a
crossed NBBO is generally indicative of an erroneously priced bid and/
or offer, and should not be considered reliable for the purposes of
determining the specified percentages for a Trading Collar. The
Exchange believes that this practice will help ensure that market
participants obtain timely executions of their market orders and
marketable limit orders while still being afforded the price protection
benefit of Trading Collar functionality, which protects investors and
the public interest.
    Similarly, the Exchange believes that affording Trading Collar
price protection to d-Quotes as well as to UTP Securities would remove
impediments to and perfect the mechanism of a free and open market as
the Trading Collar would prevent the execution of d-Quotes and UTP
Securities that are priced far away from the prevailing market price
from causing significant price dislocation in the market, which, in
turn, benefits investors and is in the public interest.
    The Exchange believes that the technical, non-substantive proposed
amendments and/or deletions related to the Trading Collar in rules
other than Rule 1000--Equities, as described above, remove impediments
to and perfect the mechanism of a free and open market and a national
market system and, in general, protect investors and the public
interest. Specifically, the Exchange believes that the proposed changes
add transparency and clarity to the Exchange's rules and will enhance
the understanding of market participants by reducing potential
confusion that the obsolete references would otherwise create.
    Finally, the Exchange previously committed to discontinue the
Exchange-specific volatility mechanisms; thus, the elimination of LRPs
and the Exchange's Gap Quote Policy are expected changes.\31\ Moreover,
the implementation of the Plan, together with the proposed Trading
Collars eliminates the necessity for these Exchange-specific volatility
mechanisms, as the Exchange will have in place appropriate price
protections for all securities traded on the Exchange, including for
rights and warrants.
---------------------------------------------------------------------------

    \31\ See supra nn. 4, 7-9.
---------------------------------------------------------------------------

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 believes the
adding of Trading Collar protection will provide market participants
with additional protection from anomalous executions. Thus, the
Exchange does not believe the proposal creates any significant impact
on competition.

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

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

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \32\ and Rule 19b-4(f)(6) thereunder.\33\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \34\ and Rule 19b-
4(f)(6)(iii) thereunder.\35\
---------------------------------------------------------------------------

    \32\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \33\ 17 CFR 240.19b-4(f)(6).
    \34\ 15 U.S.C. 78s(b)(3)(A).
    \35\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \36\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\37\ the Commission
may 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. The Exchange
asserts that the rule change proposed herein would meet the
Commission's previously stated expectation that the Exchange
discontinue its LRPs.\38\ Furthermore, the Exchange states its belief
that meeting this expectation as soon as the technology becomes
available, which the Exchange represents would be before the end of the
operative-delay period, is consistent with the protection of investors
and the public interest because it would implement the discontinuation
of its LRPs as expeditiously as possible. Finally, the Exchange asserts
that the proposed rule change would also add market collars that are
similar to existing mechanisms on other markets and would reduce the
potential of a clearly erroneous execution occurring on the Exchange.
The Exchange, therefore, concludes that waiver of the operative delay
so that it can market collars as soon as the technology is available is
not only consistent with the protection of investors and the public
interest, but would also benefit investors and the public interest.
Because the proposed rule change would eliminate the Exchange's LRPs,
consistent with the adoption of the Plan, and because the proposed rule
change is designed to prevent clearly erroneous order executions, the
Commission

believes that waiver of the operative delay is consistent with investor
protection and the public interest. Accordingly, the Commission hereby
waives the 30-day operative delay and designates the proposal operative
upon filing.\39\
---------------------------------------------------------------------------

    \36\ 17 CFR 240.19b-4(f)(6).
    \37\ 17 CFR 240.19b-4(f)(6)(iii).
    \38\ See supra n. 4.
    \39\ For purposes only of waiving the 30-day operative delay,
the Commission has 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 change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2015-02 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-NYSEMKT-2015-02. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal offices of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2015-02, and should
be submitted on or before February 12, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\40\
---------------------------------------------------------------------------

    \40\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-00967 Filed 1-21-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 84 (Monday, May 2, 2022)]
[Notices]
[Page 25636]
[FR Doc No: 2022-09333]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2018-0692, FRL-9359-01-OLEM]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Generator Standards Applicable to Laboratories Owned
by Eligible Academic Entities, EPA ICR No. 2317.05, OMB Control No.
2050-0204

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit the information collection request (ICR Generator Standards
Applicable to Laboratories Owned by Eligible Academic Entities (EPA ICR
No. 2317.04, OMB Control No. 2050-0204) to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act (PRA). Before doing so, the EPA is soliciting public
comments on specific aspects of the proposed information collection as
described in SUPPLEMENTARY INFORMATION. This is a proposed extension of
the ICR, which is currently approved through December 31, 2022. 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.

DATES: Comments must be submitted on or before July 1, 2022.

ADDRESSES: Submit your comments, referencing by Docket ID No. EPA-HQ-
OLEM-2018-0692, at https://www.regulations.gov (our preferred method),
or the other methods identified in the ADDRESSES section. Once
submitted, comments cannot be edited or removed from the docket. The
EPA may publish any comment received to its public docket. Do not
submit to EPA's docket at https://www.regulations.gov any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    Due to public health concerns related to COVID-19, the EPA Docket
Center and Reading Room are open to the public by appointment only. Our
Docket Center staff also continues to provide remote customer service
via email, phone, and webform. Hand deliveries or couriers will be
received by scheduled appointment only. For further information and
updates on EPA Docket Center services, please visit us online at
https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID-19.

FOR FURTHER INFORMATION CONTACT: Kristen Fitzgerald, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov. Out of an abundance of caution for members of the
public and our staff, the EPA Docket Center and Reading Room is closed
to the public, with limited exceptions, to reduce the risk of
transmitting COVID-19. Our Docket Center staff will continue to provide
remote customer service via email, phone and webform. For further
information about the EPA's public docket, Docket Center services and
the current status, please visit us online at https://www.epa.gov/dockets. The telephone number for the Docket Center is<PHONE_NUMBER>.
    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) 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; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) 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. The
EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval. At that time, the EPA will issue another Federal
Register notice to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB.
    Abstract: Subpart K within 40 CFR part 262 provides a flexible and
protective set of regulations that address the specific nature of
hazardous waste generation and accumulation in laboratories owned by
colleges and universities, including teaching hospitals and non-profit
research institutes that are either owned by or formally affiliated
with a college or university. In addition, eligible academic entities
have the discretion to determine the most appropriate and effective
method of compliance with these requirements--by allowing them the
choice of either managing their hazardous wastes in accordance with the
alternative regulations as set forth in Subpart K, or remaining subject
to the existing generator regulations.
    Form Numbers: None.
    Respondents/affected entities: Business and other for-profit, as
well as State, Local, and Tribal governments.
    Respondent's obligation to respond: Required to obtain or retain a
benefit (Sections 2002, 3001, 3002, 3004 of RCRA).
    Estimated number of respondents: 307.
    Frequency of response: On occasion.
    Total estimated burden: 157,969 hours per year. Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $13,452,536 (per year), which includes
$255,366 in annualized capital or operation & maintenance costs.
    Changes in Estimates: The burden hours are likely to stay
substantially the same.

    Dated: April 22, 2022.
Carolyn Hoskinson,
Director, Office of Resource Conservation and Recovery.
[FR Doc. 2022-09333 Filed 4-29-22; 8:45 am]
BILLING CODE 6560-50-P