[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Page 47147]
[FR Doc No: 2023-15454]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2796]

Bristol Myers Products Inc.; Withdrawal of Approval of a New Drug
Application for BUFFERIN (Aspirin) Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of a new drug application (NDA) for BUFFERIN
(aspirin) tablets. The basis for the withdrawal is that the holder of
the NDA has repeatedly failed to file required annual reports for this
NDA.

DATES: Approval is withdrawn as of July 21, 2023.

FOR FURTHER INFORMATION CONTACT: Jennifer Forde, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
348-3035, [email protected].

SUPPLEMENTARY INFORMATION: The holder of an approved application to
market a new drug for human use is required to submit annual reports to
FDA concerning its approved application in accordance with Sec.  314.81
(21 CFR 314.81). In the Federal Register of November 23, 2022 (87 FR
71652), FDA published a notice offering an opportunity for a hearing
(NOOH) on a proposal to withdraw approval of NDA 006499 for BUFFERIN
(aspirin) tablets, and all amendments and supplements thereto, on the
grounds that the holder of NDA 006499 has repeatedly failed to file
required annual reports for this NDA.
    NDA 006499 for BUFFERIN (aspirin) tablets became effective on June
30, 1948. The holder of NDA 006499 is currently identified in FDA's
records as Bristol Myers Products Inc. The Agency has received
conflicting information regarding the identity of the current NDA
holder. However, to change the holder of record, information specified
in Sec.  314.72 (21 CFR 314.72) must be provided to the Agency. Since
the time that the holder of record was identified as Bristol Myers
Products Inc., the Agency has not received change of application
ownership information that would satisfy the requirements of Sec.
314.72. The Agency therefore identified Bristol Myers Products Inc. as
the NDA holder of record in the NOOH published in the Federal Register
of November 23, 2022, but if another entity held NDA 006499, the Agency
also provided notice to that entity through the same NOOH.
    Bristol Myers Products Inc. did not respond to the NOOH and nor did
any other party. Failure of the NDA holder to file a written notice of
participation and request for hearing pursuant to Sec.  314.200 (21 CFR
314.200) constitutes an election by the holder of the NDA not to make
use of the opportunity for a hearing concerning the proposal to
withdraw approval of its NDA and a waiver of any contentions concerning
the legal status of the drug product.
    FDA finds that the holder of NDA 006499 has repeatedly failed to
submit reports required by Sec.  314.81. In addition, under Sec.
314.200, FDA finds that the holder of the NDA 006499 has waived the
opportunity for a hearing concerning the withdrawal of approval of this
NDA as well as any contentions concerning the legal status of the drug
product covered by this NDA. Therefore, under these findings, approval
of NDA 006499 and all amendments and supplements thereto is hereby
withdrawn as of July 21, 2023.
    Based on information available to the Agency, it appears that the
product covered by NDA 006499 has not been marketed for many years and
another buffered aspirin drug product, using the same trade name
``BUFFERIN'' but with a different formulation, is currently being
marketed as an over the counter (OTC) monograph drug. The marketing of
this current ``BUFFERIN'' product is subject to the requirements for
legal marketing of OTC monograph drugs under section 505G of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h).
Withdrawal of the approval of NDA 006499 does not impact
nonprescription aspirin products that are legally marketed without an
approved application as OTC monograph drugs in accordance with section
505G of the FD&C Act, including conforming to applicable conditions of
use specified in OTC Monograph M013: Internal Analgesic, Antipyretic,
and Antirheumatic Drug Products for Over-the-Counter Human Use (See OTC
[email protected] web page available at https://www.accessdata.fda.gov/scripts/cder/omuf/?event=reqOrders).

    Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15454 Filed 7-20-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)]
[Notices]
[Pages 1279-1280]
[FR Doc No: 2018-00213]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82441; File No. SR-FINRA-2017-036]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Make Technical and Other Non-Substantive
Changes Within FINRA Rules

January 4, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 22, 2017, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as constituting a ``non-
controversial'' rule change under paragraph (f)(6) of Rule 19b-4 under
the Act,\3\ which renders the proposal effective upon receipt of this
filing by the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to make technical and other non-substantive
changes within FINRA rules.
    The text of the proposed rule change is available on FINRA's
website at http://www.finra.org, at the principal office of FINRA 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, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    On September 13, 2016, the SEC approved changes to FINRA Rules 2210
(Communications with the Public), 2213 (Requirements for the Use of
Bond Mutual Fund Volatility Ratings), and 2214 (Requirements for the
Use of Investment Analysis Tools) that, among other things, eliminated
the filing requirements for investment analysis tool report templates
and retail communications concerning such tools and instead requires
members to provide FINRA staff with access to investment analysis tools
upon request.\4\ The implementation date for the changes was January 9,
2017.\5\
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    \4\ See Securities Exchange Act Release No. 78823 (September 13,
2016), 81 FR 64240 (September 19, 2016) (Order Approving File No.
SR-FINRA-2016-018).
    \5\ See Regulatory Notice 16-41 (October 2016).
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    The proposed rule change would delete FINRA Rule 2214.03 to
eliminate the requirement to re-file a written-report template or
retail communication concerning an investment analysis tool, and
conform the rule to changes approved in SR-FINRA-2016-018. In addition,
the proposed rule change would renumber FINRA Rule 2214.04 through
2214.07 as 2214.03 through 2214.06, accordingly.
    Also, the proposed rule change would make technical changes to
FINRA Rule 7730 (Trade Reporting and Compliance Engine (TRACE)). On
July 11, 2017, the SEC approved SR-FINRA-2017-015, which added the
definition of ``End-of-Day TRACE Transaction File'' to Rule 7730 as
paragraph (g)(6). On August 4, 2017, the SEC approved SR-FINRA-2017-
021, which added ``TRACE Security Activity Report'' also as paragraph
(g)(6). The proposed rule change would redesignate Rule 7730(g)(6)
(TRACE Security Activity Report) as 7730(g)(7) to avoid duplication.\6\
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    \6\ See Securities Exchange Act Release No. 81114 (July 11,
2017), 82 FR 32728 (July 17, 2017) (Order Approving File No. SR-
FINRA-2017-015) and Securities Exchange Act Release No. 81318
(August 4, 2017), 82 FR 37484 (August 10, 2017) (Order Approving
File No. SR-FINRA-2017-021).
---------------------------------------------------------------------------

    Finally, the proposed rule change would update a reference in FINRA
Rule 9217 (Violations Appropriate for Disposition Under Plan Pursuant
to SEA Rule 19b-1(c)(2)) to reflect that FINRA Rule 7430
(Synchronization of Member Business Clocks) has been renumbered as
FINRA Rule 4590 (Synchronization of Member Business Clocks) to conform
with SEC approval in SR-FINRA-2016-005.\7\
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    \7\ See Securities Exchange Act Release No. 77565 (April 8,
2016), 81 FR 22136 (April 14, 2016) (Order Approving File No. SR-
FINRA-2016-005); see also Regulatory Notice 16-23 (July 2016).
---------------------------------------------------------------------------

    FINRA has filed the proposed rule change for immediate
effectiveness. The implementation date for the proposed changes to
FINRA Rules 2214 and 9217 will be January 22, 2018. The implementation
date for the proposed changes to FINRA Rule 7730 will be February 1,
2018, to coincide with the implementation date of earlier changes to
the rule.\8\
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    \8\ See Regulatory Notice 17-36 (November 2017).
---------------------------------------------------------------------------

2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\9\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in

general, to protect investors and the public interest. FINRA believes
the proposed rule change will provide greater clarity to members and
the public regarding FINRA's rules by deleting the re-filing
requirements in Rule 2214.03 to conform to changes approved in SR-
FINRA-2016-018 and by making technical updates in Rules 7730(g)(6) and
9217.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The proposed rule change brings
clarity and consistency to FINRA rules without adding any burden on
firms.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6) thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-FINRA-2017-036 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-FINRA-2017-036. 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 FINRA. 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-FINRA-2017-036, and should be submitted
on or before January 31, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-00213 Filed 1-9-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: November 29, 2007 (Volume 72, Number 229)]
[Notices]
[Page 67618-67619]
[DOCID:fr29no07-44]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56836; File No. SR-Phlx-2007-55]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to the Elimination of the Short Sale Price Test

November 21, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''), \1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on July 31, 2007, the Philadelphia Stock Exchange, Inc. (``Phlx''
or ``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II below, which Items have been substantially prepared by
the Phlx. Phlx has designated the proposed rule change as constituting
a ``non-controversial'' rule change under paragraph (f)(6) of Rule 19b-
4 under the Act.\3\ The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Phlx, pursuant to Section 19(b)(1) of the Act \4\ and Rule 19b-
4 thereunder,\5\ proposes to amend Phlx Rules 185, 455, 785 and 1072 to
reflect the elimination of the short sale price test, including any
tick or bid test of any self-regulatory organization (``Price Test'')
and the elimination of the ``short exempt'' marking requirement.\6\
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(1).
    \5\ 17 CFR 240.19b-4.
    \6\ See Securities Exchange Act Release No. 55970 (June 28,
2007).
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange,
on the Exchange's Web site at http://www.Phlx.com, 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 Phlx included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Phlx has prepared summaries, set forth in sections
A, B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to conform Phlx Rules to
Rules 200(g) and 201(b) of Regulation SHO.\7\ On June 28, 2007, the SEC
approved final rules deleting the price test of Rule 10a-1 \8\ and
amending Regulation SHO to prohibit any SRO from having a price test in
place. In addition, Rule 200(g) of Regulation SHO was modified to
remove the requirement upon broker-dealers to mark sell orders as
``short exempt.''
---------------------------------------------------------------------------

    \7\ 17 CFR 242.200(g) and 17 CFR 242.201(b).
    \8\ 17 CFR 240.10a-1.
---------------------------------------------------------------------------

    Phlx Rules 185, 455, 785 and 1072 contain language regarding the
Price Test and the ``short exempt'' marking requirement. Phlx Rule 185
contains language regarding the entry, display and execution of sell
short orders on XLE, Phlx's electronic equity trading system, that are
subject to the Price Test. With the elimination of the Price Test, sell
short orders will not be handled any differently by XLE and the
amendments to this rule will so reflect. Phlx Rule 455 stated that XLE
will not execute a sell order unless effected in compliance with Rule
10a-1. Rule 10a-1 contained the Price Test and is being eliminated. The
amendments to Phlx Rule 455 will reflect this.
    Phlx Rule 785 requires member organizations to make an automated
submission of trading data, including marking orders as short exempt,
where appropriate. Phlx Rule 785 will be amended to reflect the
elimination of the ``short exempt'' marking requirement. Phlx Rule 1072
outlines the requirements on options specialists and Registered Options
Traders (``ROTs'') regarding their use of an exception to the NASD (n/
k/a Financial Industry Regulatory Authority, Inc.) bid test (which was
a type of Price Test) available to hedging options transactions. The
elimination of the Price Test extended to the NASD bid test and
therefore options specialist and ROTs will not need the exemption
outlined in Phlx Rule 1072. Phlx Rule 1072 will be deleted.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b)

of the Act \9\ in general, and furthers the objectives of Section
6(b)(5) of the Act \10\ in particular, in that it is designed to
promote 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.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not:
    (i) Significantly affect the protection of investors or the public
interest;
    (ii) Impose any significant burden on competition; and
    (iii) Become operative within 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective upon filing pursuant to Section 19(b)(3)(A) of the Act
\11\ and Rule 19b-4(f)(6) thereunder.\12\ Phlx has requested that the
Commission waive the 5-day pre-filing notice requirement and the 30-day
operative delay of the proposal. The Commission believes that such
waivers are consistent with the protection of investors and the public
interest because the proposed rule change conforms Phlx's rules to
currently effective Commission Rules and should eliminate potential
confusion relating to orders on XLE.\13\ For this reason, the
Commission designates the proposal to be operative upon filing with the
Commission.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ For purposes only of waiving the 30-day pre-operative
period, the Commission has considered the impact of the proposed
rule change on efficiency, competition and capital formation. 15
U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-Phlx-2007-55 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2007-55. This file
number should be included on the subject line if e-mail 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 inspection and
copying 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 the filing also will be available for
inspection and copying at the principal office of the Phlx. 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-Phlx-2007-55 and should be
submitted on or before December 20, 2007.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Nancy M. Morris,
Secretary.
[FR Doc. E7-23171 Filed 11-28-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: June 15, 2009 (Volume 74, Number 113)]
[Notices]
[Page 28233-28234]
[DOCID:fr15jn09-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR09-8-002]

Washington Gas Light Company; Notice of Filing

June 9, 2009.
    Take notice that on May 29, 2009, Washington Gas Light Company
(Washington Gas) filed a revised Firm Interstate Transportation Service
Operating Statement (FITSOS) pursuant to section 284.123(e) of the
Commission's regulations. Washington Gas states that it is making the
revisions in order to update its new transportation rates for service
to Mountaineer Gas Company and to make minor, non-substantive
revisions.
    Any person desiring to participate in this proceeding must file a
motion to intervene or to protest this filing must file in accordance
with Rules 211 and 214 of the Commission's Rules of Practice and
Procedure (18 CFR 385.211 and 385.214). Protests will be

considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 23, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-14026 Filed 6-12-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 140 (Friday, July 22, 2022)]
[Notices]
[Pages 43877-43880]
[FR Doc No: 2022-15699]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1584]

Authorization of Emergency Use of Certain Medical Devices During
COVID-19; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the issuance of Emergency Use Authorizations (EUAs) (the
Authorizations) for certain medical devices related to the Coronavirus
Disease 2019 (COVID-19) public health emergency. FDA has issued the
Authorizations listed in this document under the Federal Food, Drug,
and Cosmetic Act (FD&C Act). These Authorizations contain, among other
things, conditions on the emergency use of the authorized products. The
Authorizations follow the February 4, 2020, determination by the
Secretary of Health and Human Services (HHS) that there is a public
health emergency that has a significant potential to affect national
security or the health and security of U.S. citizens living abroad and
that involves the virus that causes COVID-19, and the subsequent
declarations on February 4, 2020, March 2, 2020, and March 24, 2020,
that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of the virus
that causes COVID-19, personal respiratory protective devices, and
medical devices, including alternative products used as medical
devices, respectively, subject to the terms of any authorization issued
under the FD&C Act. These Authorizations, which include an explanation
of the reasons for issuance, are listed in this document, and can be
accessed on FDA's website from the links indicated.

DATES: These Authorizations are effective on their date of issuance.

ADDRESSES: Submit written requests for single copies of an EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION

section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
radiological, or nuclear agent or agents. Among other things, section
564 of the FD&C Act allows FDA to authorize the use of an unapproved
medical product or an unapproved use of an approved medical product in
certain situations. With this EUA authority, FDA can help ensure that
medical countermeasures may be used in emergencies to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
a biological, chemical, radiological, or nuclear agent or agents when
there are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
a determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50 of the U.S. Code, of attack with (A)
a biological, chemical, radiological, or nuclear agent or agents; or
(B) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
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    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
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    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use when the Secretary of HHS has declared that
circumstances exist justifying the authorization of emergency use.
Products appropriate for emergency use may include products and uses
that are not approved, cleared, or licensed under section 505, 510(k),
512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, or 360e) or
section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved
under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an
EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \2\ concludes: (1) that an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that (A) the product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; (4) in
the case of a determination described in section 564(b)(1)(B)(ii), that
the request for emergency use is made by the Secretary of Defense; and
(5) that such other criteria as may be prescribed by regulation are
satisfied. No other criteria for issuance have been prescribed by
regulation under section 564(c)(4) of the FD&C Act.
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    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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II. Electronic Access

    An electronic version of this document and the full text of the
Authorizations are available on the internet and can be accessed from
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

III. The Authorizations

    Having concluded that the criteria for the issuance of the
following Authorizations under section 564(c) of the FD&C Act are met,
FDA has authorized the emergency use of the following products for
diagnosing, treating, or preventing COVID-19 subject to the terms of
each Authorization. The Authorizations in their entirety, including any
authorized fact sheets and other written materials, can be accessed
from the FDA web page entitled ``Emergency Use Authorization,''
available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
The lists that follow include Authorizations issued from January 25,
2022, through June 15, 2022, and we have included explanations of the
reasons for their issuance, as required by section 564(h)(1) of the
FD&C Act. In addition, the EUAs that have been reissued can be accessed
from

FDA's web page: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
    FDA is hereby announcing the following Authorizations for molecular
diagnostic and antigen tests for COVID-19, excluding multianalyte
tests: \3\
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    \3\ As set forth in the EUAs for these products, FDA has
concluded that: (1) SARS-CoV-2, the virus that causes COVID-19, can
cause a serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this virus; (2)
based on the totality of scientific evidence available to FDA, it is
reasonable to believe that the products may be effective in
diagnosing COVID-19, and that the known and potential benefits of
the products, when used for diagnosing COVID-19, outweigh the known
and potential risks of such products; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
products.
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     Fluidigm Corporation's Advanta Dx COVID-19 EASE Assay,
issued February 7, 2022;
     Uh-Oh Labs Inc.'s UOL COVID-19 Test, issued February 8,
2022;
     Oceanit Foundry LLC's ASSURE-100 Rapid COVID-19 Test,
issued February 28, 2022;
     Siemens Healthcare Diagnostics, Inc.'s ADVIA Centaur SARS-
CoV-2 Antigen (CoV2Ag), issued March 11, 2022;
     Siemens Healthcare Diagnostics, Inc.'s Atellica IM SARS-
CoV-2 Antigen (CoV2Ag), issued March 11, 2022;
     Minute Molecular Diagnostics, Inc.'s DASH SARS-CoV-2/S
Test, issued March 15, 2022;
     PHASE Scientific International, Ltd.'s INDICAID COVID-19
Rapid Antigen At-Home Test, issued March 16, 2022;
     Helix OpCo LLC's (dba Helix) Helix SARS-CoV-2 Test, issued
March 17, 2022;
     Quest Diagnostics Nichols Institute's Quest RC COVID-19
PCR DTC, issued March 21, 2022;
     Quest Diagnostics Nichols Institute's Quest PF COVID-19
PCR DTC, issued March 21, 2022;
     Quest Diagnostics Nichols Institute's Quest COVID-19 PCR
DTC, issued March 21, 2022;
     DC Department of Health's Test Yourself DC At-Home COVID-
19 Collection Kit, issued April 6, 2022;
     OSANG LLC's OHC COVID-19 Antigen Self Test, issued April
6, 2022;
     Xiamen Boson Biotech Co., Ltd.'s Rapid SARS-CoV-2 Antigen
Test Card, issued April 6, 2022;
     UCSD BCG EXCITE Lab's UCSD EXCITE COVID-19 EL Test, issued
April 7, 2022;
     MicroGEM U.S., Inc.'s MicroGEM Sal6830 SARS-CoV-2 Saliva
Test, issued April 14, 2022;
     LGC, Biosearch Technologies's Biosearch Technologies SARS-
CoV-2 ultra-high-throughput End-Point RT-PCR Test, issued April 26,
2022;
     Abbott Diagnostics Scarborough, Inc.'s ID NOW COVID-19
2.0, issued May 6, 2022;
     Cepheid's Xpert Xpress CoV-2 plus, issued May 10, 2022;
     Nexus Medical Labs, LLC.'s Nexus High Throughput SARS-CoV-
2 Assay, issued May 17, 2022;
     DxLab Inc.'s DxLab COVID-19 Test, issued June 1, 2022;
     Roche Molecular Systems, Inc.'s cobas SARS-CoV-2 Duo for
use on the cobas 6800/8800 Systems (cobas SARS-CoV-2 Duo), issued June
14, 2022;
    FDA is hereby announcing the following Authorizations for serology
tests: \4\
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    \4\ As set forth in the EUAs for these products, FDA has
concluded that: (1) SARS-CoV-2 can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the products may be effective in diagnosing recent or prior
infection with SARS-CoV-2 by identifying individuals with an
adaptive immune response to the virus that causes COVID-19, and that
the known and potential benefits of the products when used for such
use, outweigh the known and potential risks of the products; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the products.
---------------------------------------------------------------------------

     LG Chem, Ltd.'s AdvanSure SARS-CoV-2 IgG(S1) ELISA, issued
May 19, 2022;
     LG Chem, Ltd.'s AdvanSure SARS-CoV-2 IgG(RBD) ELISA,
issued May 31, 2022.
    FDA is hereby announcing the following Authorizations for
multianalyte in vitro diagnostics:
     Cleveland Clinic Robert J. Tomsich Pathology and
Laboratory Medicine Institute's SelfCheck cobas SARS-CoV-2 + Flu Assay,
issued April 11, 2022; \5\
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    \5\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 through the simultaneous qualitative
detection and differentiation of SARS-CoV-2, influenza A virus, and/
or influenza B virus ribonucleic acid (RNA) and that the known and
potential benefits of the product when used for diagnosing COVID-19,
outweigh the known and potential risks of the product; and (3) there
is no adequate, approved, and available alternative to the emergency
use of the product.
---------------------------------------------------------------------------

     OPTI Medical Systems, Inc.'s OPTI SARS-CoV-2/Influenza A/B
RT-PCR Test (Version 1 and Version 2), issued April 21, 2022; \6\
---------------------------------------------------------------------------

    \6\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 through the simultaneous qualitative
detection and differentiation of SARS-CoV-2, influenza A virus, and/
or influenza B virus RNA and that the known and potential benefits
of the product when used for diagnosing COVID-19, outweigh the known
and potential risks of the product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
---------------------------------------------------------------------------

     Laboratory Corporation of America's (Labcorp's) Labcorp
Seasonal Respiratory Virus RT-PCR DTC Test, issued May 16, 2022; \7\
---------------------------------------------------------------------------

    \7\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 through the simultaneous qualitative
detection and differentiation of SARS-CoV-2, influenza A virus,
influenza B virus and/or respiratory syncytial virus (RSV) RNA and
that the known and potential benefits of the product when used for
diagnosing COVID-19, outweigh the known and potential risks of the
product; and (3) there is no adequate, approved, and available
alternative to the emergency use of the product.
---------------------------------------------------------------------------

     Laboratory Corporation of America's (Labcorp's) Labcorp
Seasonal Respiratory Virus RT-PCR Test, issued May 17, 2022; \8\
---------------------------------------------------------------------------

    \8\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 through the simultaneous qualitative
detection and differentiation of SARS-CoV-2, influenza A virus,
influenza B virus and/or RSV RNA and that the known and potential
benefits of the product when used for diagnosing COVID-19, outweigh
the known and potential risks of the product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the product.
---------------------------------------------------------------------------

    FDA is hereby announcing the following Authorization for a SARS-
CoV-2 genotyping test:
     Laboratory Corporation of America's (Labcorp's) Labcorp
VirSeq SARS-CoV-2 NGS Test, issued June 10, 2022.\9\
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    \9\ As set forth in the EUAs for this product, FDA has concluded
that: (1) SARS-CoV-2, the virus that causes COVID-19, can cause a
serious or life-threatening disease or condition, including severe
respiratory illness, to humans infected by this virus; (2) based on
the totality of scientific evidence available to FDA, it is
reasonable to believe that the product may be effective in
diagnosing COVID-19, through the identification and differentiation
of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak
(PANGO) lineages, and that the known and potential benefits of the
product, when used for diagnosing COVID-19, outweigh the known and
potential risks of such product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
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    FDA is hereby announcing the following Authorization for a SARS-
CoV-2 diagnostic test that analyzes breath samples:

     InspectIR Systems LLC's InspectIR COVID-19 Breathalyzer,
issued April 14, 2022; \10\
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    \10\ As set forth in the EUAs for this product, FDA has
concluded that: (1) SARS-CoV-2, the virus that causes COVID-19, can
cause a serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this virus; (2)
based on the totality of scientific evidence available to FDA, it is
reasonable to believe that the product may be effective in
diagnosing COVID-19, and that the known and potential benefits of
the product, when used for diagnosing COVID-19, outweigh the known
and potential risks of such product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
---------------------------------------------------------------------------

    FDA is hereby announcing the following Authorizations for other
medical devices:
     Quest Diagnostics Nichols Institute's Quest COVID-19 PCR
Test Home Collection Kit, issued March 21, 2022; \11\
---------------------------------------------------------------------------

    \11\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19, by serving as an appropriate means to
collect and transport human specimens so that an authorized
laboratory can detect SARS-CoV-2 RNA from the home-collected human
specimen, and that the known and potential benefits of the product
when used for diagnosing COVID-19, outweigh the known and potential
risks of the product; and (3) there is no adequate, approved, and
available alternative to the emergency use of the product.
---------------------------------------------------------------------------

     Audere's [email protected] Fusion, issue April 26,
2022.\12\
---------------------------------------------------------------------------

    \12\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 by serving as an appropriate means to collect
and transport human specimens so that an authorized laboratory can
detect SARS-CoV-2 RNA from the collected human specimen, and that
the known and potential benefits of the product when used for such
use, outweigh the known and potential risks of the product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the product.

    Dated: July 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15699 Filed 7-21-22; 8:45 am]
BILLING CODE 4164-01-P