[Federal Register Volume 87, Number 206 (Wednesday, October 26, 2022)]
[Notices]
[Pages 64830-64831]
[FR Doc No: 2022-23238]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96111; File No. SR-NYSEARCA-2022-70]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Modify Rule
7.44-E

October 20, 2022.
    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 October 11, 2022, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify Rule 7.44-E relating to the Retail
Liquidity Program. The proposed rule change is available on the
Exchange's website 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 modify Rule 7.44-E, which sets forth the
Exchange's Retail Liquidity Program (the ``Program'').\4\ The purpose
of the Program is to attract retail order flow to the Exchange and
allow such order flow to receive potential price improvement. Rule
7.44-E provides for a class of market participant called Retail
Liquidity Providers (``RLPs''), and non-RLP ETP Holders are able to
provide potential price improvement to retail investor orders in the
form of a non-displayed order that is priced better than the best
protected bid or offer, called a Retail Price Improvement Order (``RPI
Order'').\5\ When there is an RPI Order in a particular security, the
Exchange disseminates an indicator, known as the Retail Liquidity
Identifier, that such interest exists.\6\ Retail Member Organizations
(``RMOs'') can submit a Retail Order to the Exchange, which interacts,
to the extent possible, with available contra-side RPI Orders and then
may interact with other liquidity on the Exchange or elsewhere,
depending on the Retail Order's instructions.\7\ The segmentation in
the Program allows retail order flow to receive potential price
improvement as a result of their order flow being deemed more desirable
by liquidity providers. The Program is currently limited to trades in
NYSE Arca-listed securities and securities traded on the Exchange
pursuant to unlisted trading privileges (``UTP Securities''), except
for NYSE-listed securities.\8\
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    \4\ The Program was established on a pilot basis in 2013 and was
approved by the Commission to operate on a permanent basis in 2019.
See Securities Exchange Act Release No. 87350 (October 18, 2019), 84
FR 57106 (October 24, 2019) (SR-NYSEArca-2019-63). In connection
with the Commission's approval of the Program on a pilot basis, the
Commission granted the Exchange's request for exemptive relief from
Rule 612 of Regulation NMS, 17 CFR 242.612 (the ``Sub-Penny Rule''),
which, among other things, prohibits a national securities exchange
from accepting or ranking orders priced greater than $1.00 per share
in an increment smaller than $0.01. See Securities Exchange Act
Release No. 71176 (December 23, 2013), 78 FR 79524 (December 30,
2013) (SR-NYSEArca-2013-107). The Exchange notes that the change
proposed in this filing has no substantive impact under the Sub-
Penny Rule and thus does not require an update or revision to the
exemptive relief previously granted by the Commission.
    \5\ See Rules 7.44-E(a)(1) (defining an RLP) and 7.44-E(a)(4)
(defining RPI Order).
    \6\ See Rule 7.44-E(j).
    \7\ See Rule 7.44-E(a)(2) (defining RMO); Rules 7.44-E(a)(3) and
7.44-E(k) (describing Retail Orders).
    \8\ See Rule 7.44-E(a)(4).
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    The Exchange now proposes to modify Rule 7.44-E to expand the
Program's availability to all securities traded on the Exchange. Rule
7.44-E(a)(4) currently defines an RPI Order as consisting of ``non-
displayed interest in NYSE Arca-listed securities and UTP Securities,
excluding NYSE-listed (Tape A) securities, that would trade at prices
better than the PBB or PBO by at least $0.001 and that is identified as
such.'' To expand the program to permit RPI Orders in all securities
traded on the Exchange (including NYSE-listed securities), the Exchange
proposes to modify Rule 7.44-E(a)(4) such that the rule would provide
that an RPI Order is ``non-displayed interest that would trade at
prices better than the PBB or PBO by at least $0.001 and that is
identified as such.''
    Subject to the effectiveness of this proposed rule change, the
Exchange will implement this change in the fourth quarter of 2022 and
announce the implementation date by Trader Update.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\9\ in general, and furthers the objectives of Section 6(b)(5),\10\
in particular, because it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, 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.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes expanding the Program's availability to all
securities traded on the Exchange would 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 by enabling RPI
Orders in all securities to participate in the Program and receive
potential price improvement. The Exchange believes that this expansion
of the Program would benefit retail investors by providing increased
opportunities for price improvement in all securities traded on the
Exchange, including NYSE-listed securities. The Exchange also believes
that the proposed change would allow it to compete with other exchanges
that operate retail price improvement programs that are available to
all securities traded on such exchanges.\11\
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    \11\ See, e.g., Cboe BYX Exchange, Inc. (``BYX'') Rule 11.24
(setting forth BYX's Retail Price Improvement Program, with Retail
Price Improvement Order defined in Rule 11.24(a)(3)); Nasdaq BX,
Inc. (``BX'') Rules 4702(b)(5)(A) (defining ``Retail Price Improving
Order'') and 4780 (setting forth BX's Retail Price Improvement
Program); Investors Exchange LLC (``IEX'') Rule 11.232 (setting
forth IEX's Retail Price Improvement Program).
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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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed change could promote competition by permitting RPI Orders
in all securities traded on the Exchange, thereby supporting price
improvement opportunities for retail investors. The Exchange further
believes that the proposed expansion of the Program to include all
securities traded on the Exchange would promote competition between the
Exchange and other exchanges that offer retail price improvement
programs for which all securities traded on such exchanges are eligible
to participate.\12\
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    \12\ See id.
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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 \13\ and Rule 19b-4(f)(6) thereunder.\14\
Because the proposed rule change does not: (i) significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \13\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \14\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \15\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \15\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEARCA-2022-70 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-NYSEARCA-2022-70. 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-NYSEARCA-2022-70 and should be submitted
on or before November 16, 2022.
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    \16\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-23238 Filed 10-25-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 227 (Tuesday, November 28, 2023)]
[Notices]
[Pages 83134-83136]
[FR Doc No: 2023-26199]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4597]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Shortages Data Collections

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collections
associated with Shortages Data Collections and with notifications to
FDA of an interruption or permanent discontinuance in manufacturing of
certain medical devices as required by the Federal Food, Drug, and
Cosmetic Act (FD&C Act).

DATES: Either electronic or written comments on the collection of
information must be submitted by January 29, 2024.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 29, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2023-N-4597 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Shortages Data Collections.''
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: 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: Under the 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, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Shortages Data Collections

OMB Control Number 0910-0491--Extension

    Under section 1003(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)), the
Commissioner of Food and Drugs is authorized to implement general
powers (including conducting research) to carry out effectively the
mission of FDA. After the events of September 11, 2001, and as part of
broader counterterrorism and emergency preparedness activities, FDA's
Center for Devices and Radiological Health (CDRH) began developing
operational plans and interventions that would enable CDRH to
anticipate and respond to medical device shortages that might arise in
the context of federally declared disasters/emergencies or regulatory
actions. In particular, CDRH identified the need to acquire and
maintain detailed data on domestic inventory, manufacturing
capabilities, distribution plans, and raw material constraints for
medical devices that would be in high demand and/or would be vulnerable
to shortages in specific disaster/emergency situations or following
specific regulatory actions. Such data could support prospective risk
assessment, help inform risk mitigation strategies, support real-time
decision making by the Department of Health and Human Services (HHS)
during actual emergencies or emergency preparedness exercises, and
mitigate or prevent harm to the public health.
    This voluntary data collection process consists of outreach to
firms that have been identified as producing or distributing medical
devices that may be considered essential to the response effort. In
this initial outreach, the intent and goals of the data collection
effort will be described, and the specific data request made. Data are
collected, using the least burdensome methods, in a structured manner
to answer specific questions. After the initial outreach, we will
request updates to the information periodically to keep the data
current and accurate. Additional followup correspondence may
occasionally be needed to verify/validate data, confirm receipt of
followup correspondence(s), and/or request additional details to
further inform FDA's public health response.
    The Coronavirus Aid, Relief, and Economic Security Act (CARES Act)
(Pub. L. 116-136) was enacted on March 27, 2020. Section 3121 of the
CARES Act amended the FD&C Act by adding section 506J to the FD&C Act
(21 U.S.C. 356j). Section 506J of the FD&C Act provides FDA with new
authorities intended to help prevent or mitigate medical device
shortages by requiring medical device manufacturers to inform FDA about
changes in device manufacturing that could potentially lead to a device
shortage. Apprised with that information, section 506J of the FD&C Act
authorizes FDA to take several actions that may help to mitigate or
avoid supply disruptions.
    Section 506J of the FD&C Act requires manufacturers of certain
devices,\1\ to notify FDA ``of a permanent discontinuance in the
manufacture of the device'' or ``an interruption of the manufacture of
the device that is likely to lead to a meaningful disruption in supply
of that device in the United States'' during or in advance of a
declared public health emergency, and the reason for such
discontinuance or interruption.\2\ Section 506J of the FD&C Act
requires FDA to take action based on that information, including (1)
publicly posting a list of devices it determines to be in shortage, (2)
publicly posting the reasons for the shortage, and (3) issuing letters
to manufacturers that fail to comply with the notification requirements
of section 506J of the FD&C Act.
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    \1\ Under section 506J of the FD&C Act, manufacturers of the
following devices must notify FDA of an interruption or permanent
discontinuance in manufacturing:
     Devices that are critical to public health during a
public health emergency, including those that are life-supporting,
life-sustaining, or intended for use in emergency medical care or
during surgery; or
     Devices for which FDA determines information on
potential meaningful supply disruptions is needed during a public
health emergency. See section 506J(a)(1), (2) of the FD&C Act.
    \2\ See section 506J(a) of the FD&C Act.
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    On December 29, 2022, the Prepare for and Respond to Existing
Viruses, Emerging New Threats, and Pandemics Act was signed into law as
part of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328)
(hereafter referred to as the ``FY 2023 Omnibus''). Section 2514(c) of
the fiscal year (FY) 2023 Omnibus directed FDA to issue or revise
guidance regarding requirements under section 506J of the FD&C Act and
include a list of each device product code for which a manufacturer of
such device is required to notify FDA in accordance with section 506J.
Section 2514 of the FY 2023 Omnibus amended section 506J of the FD&C
Act to add section 506J(h), ``Additional Notifications'' and directed
FDA to issue guidance ``to facilitate voluntary notifications.''
    In the Federal Register of November 17, 2023 (88 FR 80310), FDA
announced the availability of the final guidance entitled ``Notifying
FDA of a Permanent Discontinuance or Interruption in Manufacturing of a
Device Under Section 506J of the FD&C Act'' \3\ and the draft guidance
entitled ``Select Updates for the 506J Guidance: 506J Device List and
Additional Notifications.'' \4\ The final guidance, ``Notifying FDA of
a Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the FD&C Act'' (hereafter referred to as the
``506J Guidance'') assists stakeholders in the Agency's implementation
of section 506J. This guidance serves as the baseline for information
about notifications under section 506J during or in advance of any
public health emergency (PHE). FDA provides additional clarification on
who is

required to notify FDA, when such notifications are required, what
information FDA expects manufacturers to include in such notifications,
and how to submit notifications. Additionally, FDA describes how FDA
determines that a device is in shortage and additional actions FDA may
take to help prevent or mitigate a potential device shortage.
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    \3\ https://www.fda.gov/media/155245/download.
    \4\ https://www.fda.gov/media/173800/download.
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    In the draft guidance ``Select Updates for the 506J Guidance: 506J
Device List and Additional Notifications,'' FDA proposes updates to the
506J Guidance. Specifically, FDA has developed a list of devices, by
FDA product code, for which a manufacturer of such devices is required
to notify FDA in accordance with section 506J (hereafter referred to as
the ``506J Device List''). The 506J Device List is based on the
requirements under section 506J(a) of the FD&C Act. In section 2514 of
the FY 2023 Omnibus, Congress directed FDA to issue guidance on the
requirements under section 506J and to include ``a list of each device
product code for which a manufacturer of such device is required to
notify the Secretary in accordance with section 506J.'' Thus,
manufacturers of a device on the 506J Device List must notify FDA in
accordance with 506J for each such device. For more information,
manufacturers should see the 506J Device List web page, available at
https://www.fda.gov/medical-devices/medical-device-supply-chain-and-shortages/506j-device-list. Additionally, consistent with section
506J(h), FDA is proposing to clarify for stakeholders that
manufacturers may submit, and FDA may receive, voluntary notifications
regarding supply chain issues at any time, unrelated to the declaration
or potential declaration of a PHE.
    The guidance documents include additional voluntary items that
manufacturers could provide the Agency, including additional
information about device manufacturing and supply, and updates to
initial notifications.
    Respondents may notify FDA about an interruption or permanent
discontinuance in device manufacturing (506J notification) on our
website at https://fda-cdrh.my.salesforce-sites.com/shortages/.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of       Total
                    Activity                        Number of     responses per     annual       Average burden per response  (hours)       Total hours
                                                   respondents     respondent     responses
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Shortages outreach data collection.............           1,000               4        4,000  1.........................................           4,000
Information collection under section 506J......           8,400               1        8,400  0.25 (15 minutes).........................           2,100
Additional voluntary collections related to               8,400               1        8,400  0.25 (15 minutes).........................           2,100
 section 506J.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............       20,800  ..........................................           8,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

I. Shortages Outreach Data Collection

    FDA bases these estimates on our recent experience and informal
direct contact with respondents. We estimate up to 1,000 manufacturers,
distributors, healthcare systems, healthcare providers, group
purchasing organizations, and sterilizers for which there may be
targeted outreach because their devices may be essential to the
response effort. This targeted outreach will be conducted periodically
either to obtain primary data or to verify/validate updated data
(although additional outreach may be undertaken as needed). The data
being requested represent common data elements that respondents monitor
and track as part of routine business operations and, therefore, are
readily available. It is anticipated that for most respondents, the
estimated time to fulfill CDRH's data request will not exceed 1 hour
per request, or 4 hours per year.

II. Information Collection Under Section 506J of the FD&C Act and
Related Voluntary Collections

    Based on current registration and listing data (approved under OMB
control number 0910-0625), we estimate the number of respondents that
will submit a notification under section 506J of the FD&C Act to be
approximately 20 percent of currently registered manufacturers. Data
from our Registration and Listing system indicate that there are
approximately 42,000 unique FDA Establishment Identification registered
manufacturers. Therefore, we estimate 8,400 respondents per year. We
believe that the burden, including the provision of required
information under section 506J of the FD&C Act, as well as additional
voluntary information (including additional issues that may impact the
availability of the device, such as information about critical
suppliers, potential mitigations, production capacity and market share,
and notification updates), is minimal and such information is readily
available to respondents. Therefore, we estimate the burden of this
information collection to be 15 minutes or less per notification.
    Since the last OMB approval, we have updated the Number of
Respondents and Average Burden per Response for the Shortages Outreach
Data Collection element based on our recent experience with the
information collection and informal direct contact with respondents.
The updates result in an adjustment of an additional 3,000 hours and
2,000 responses annually.

    Dated: November 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26199 Filed 11-27-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83077-83078]
[FR Doc No: 2020-28102]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[Region 4 Library; FRL-10017-91-Region 4]

Notice of Library Changes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Informational notice.

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SUMMARY: The Environmental Protection Agency (EPA) is issuing this
notice to advise the public of upcoming changes to the Region 4
Library. Region 4 will be reducing the size of its library space,
decreasing the amount of print materials maintained in its collection,
and ceasing all on-site library support services. The library will
retain a small, targeted collection of reference material on-site which
will be accessible by appointment only to EPA staff and the public (For
appointments, see contact information below). In addition, EPA staff
and the public will continue to have remote access to the full suite of
library services available at EPA through the Andrew W. Breidenbach
Environmental Research Center (AWBERC) Library, located in Cincinnati,
Ohio. The AWBERC Library can be reached by email
<EMAIL_ADDRESS>or by phone<PHONE_NUMBER>). For more
information about the EPA National Library Network and

its information resources and services, visit https://www.epa.gov/libraries.

DATES: Region 4's Library changes will be effective February 1, 2021.

FOR FURTHER INFORMATION CONTACT: The Region 4 Federal Library Manager,
Shayla Patillo at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
    Dated: December 14, 2020.
Mary Walker,
Regional Administrator, Region 4.
[FR Doc. 2020-28102 Filed 12-18-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 10 (Tuesday, January 17, 2012)]
[Notices]
[Page 2290]
[FR Doc No: 2012-695]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12857-002; Project No. 14073-000]

FFP Project 18, LLC, Northland Power Mississippi River LLC;
Notice Announcing Preliminary Permit Drawing

    The Commission has received two preliminary permit applications
deemed filed on February 1, 2011, at 8:30 a.m.,\1\ for proposed
projects to be located on the Mississippi River, in St. James Parish,
Louisiana. The applications were filed by FFP Project 18, LLC for
Project No. 12857-002, and Northland Power Mississippi River LLC for
Project No. 14073-000.
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    \1\ Under the Commission's Rules of Practice and Procedure, any
document received after regular business hours is considered filed
at 8:30 a.m. on the next regular business day. 18 CFR 385.2001(a)(2)
(2011).
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    On January 17, 2012, at 9 a.m. (eastern time), the Secretary of the
Commission, or her designee, will conduct a random drawing to determine
the filing priority of the applicants identified in this notice. The
Commission will select among competing permit applications as provided
in section 4.37 of its regulations.\2\ The priority established by this
drawing will be used to determine which applicant, among those with
identical filing times, will be considered to have the first-filed
application.
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    \2\ 18 CFR 4.37 (2011).
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    The drawing is open to the public and will be held in room 2C, the
Commission Meeting Room, located at 888 First St. NE., Washington, DC
20426. A subsequent notice will be issued by the Secretary announcing
the results of the drawing.

    Dated: January 10, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-695 Filed 1-13-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Page 45841]
[FR Doc No: 2017-21059]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-493-000]

Colorado Interstate Gas Company, LLC'; Notice of Application

    Take notice that on September 14, 2017, Colorado Interstate Gas
Company, LLC (CIG), Post Office Box 1087, Colorado Springs, Colorado
80944, filed in Docket No. CP17-493-000 an application pursuant to
section 7(b) of the Natural Gas Act (NGA) requesting an order
authorizing the abandonment of certain facilities related to the
Rawlins Processing Plant, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection. The filing may also be viewed on the web at http://www.ferc.gov using the eLibrary link. Enter the docket number excluding
the last three digits in the docket number field to access the
document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to
Francisco Tarin, Director, Regulatory Affairs, Colorado Interstate Gas
Company, LLC, P.O. Box 1087, Colorado Springs, Colorado, 80944 at (719)
667-7517 or Mark A. Minich, Assistant General Counsel, Colorado
Interstate Gas Company, LLC, P.O. Box 1087, Colorado Springs, Colorado,
80944 at<PHONE_NUMBER>.
    Specifically, CIG is requesting approval for the abandonment in
place of the Rawlins lean oil processing and fractionation plants, as
well as natural gas liquids truck off-loading facilities, and natural
gas liquids interconnecting facilities that tie into the Overland Pass
Pipeline Company all located in Carbon County, Wyoming; and the
abandonment by sale of natural gas liquids pipelines, associated
natural gas liquids measurement facilities, and natural gas liquids
rail loading facilities to Sinclair Wyoming Refining Company.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either complete
its environmental assessment (EA) and place it into the Commission's
public record (eLibrary) for this proceeding; or issue a Notice of
Schedule for Environmental Review. If a Notice of Schedule for
Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit original and 7 copies of filings made with the Commission and
must mail a copy to the applicant and to every other party in the
proceeding. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for review in the Commission's Public
Reference Room in Washington, DC. There is an eSubscription link on the
Web site that enables subscribers to receive email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on October 17, 2017.

    Dated; September 26, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-21059 Filed 9-29-17; 8:45 am]
BILLING CODE 6717-01-P