COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities, 7757-7759 [2023-02466]
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Federal Register / Vol. 88, No. 24 / Monday, February 6, 2023 / Notices
Suitability Assessment was included as
an appendix to the park’s 2004 General
Management Plan, the Assessment
remained unfinished until 2022.
NPS will take no action that would
diminish the wilderness eligibility of
the area found to be possessing
wilderness characteristics until the
legislative process of wilderness
designation has been completed, as
required by Chapter 6 of MP 2006. All
of the assessed lands remain subject to
management in accordance with the
NPS Organic Act and all other laws,
Executive orders, regulations, and
policies applicable to units of the
National Park System; the 3,636 acres of
ineligible lands will not be subject to
the additional requirements of MP 2006
Chapter 6.
If/when a formal wilderness study is
conducted to determine which of the
eligible lands, if any, should be
proposed for inclusion in the National
Wilderness Preservation System, tribal
consultation will be initiated, as will
public review and comment under
NEPA and the National Historic
Preservation Act.
Charles F. Sams, III,
Director, National Park Service.
[FR Doc. 2023–02469 Filed 2–3–23; 8:45 am]
BILLING CODE 4312–52–P
INTERNATIONAL TRADE
COMMISSION
[Investigation No. 332–596]
COVID–19 Diagnostics and
Therapeutics: Supply, Demand, and
TRIPS Agreement Flexibilities
United States International
Trade Commission.
ACTION: Notice of investigation and
scheduling of a public hearing.
AGENCY:
Following receipt on
December 16, 2022, of a request from
the U.S. Trade Representative (USTR),
under the Tariff Act of 1930, the U.S.
International Trade Commission
(Commission) instituted Investigation
No. 332–596, COVID–19 Diagnostics
and Therapeutics: Supply, Demand,
and TRIPS Agreement Flexibilities. The
USTR requested that the Commission
conduct an investigation and prepare a
report that analyzes the universe of
existing COVID–19 diagnostics and
therapeutics in relation to the World
Trade Organization (WTO) Agreement
on Trade-Related Aspects of Intellectual
Property Rights (TRIPS Agreement)—
including the range of definitions for
diagnostics and therapeutics;
diagnostics and therapeutics covered by
DDrumheller on DSK120RN23PROD with NOTICES
SUMMARY:
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patents and those in development; an
overview of production, distribution,
and demand; information on market
segmentation of global demand and
consumption; and other information
relevant to the discussion of TRIPS
Agreement flexibilities.
DATES:
March 15, 2023: Deadline for filing
requests to appear at the public hearing.
March 17, 2023: Deadline for filing
prehearing briefs and statements.
March 22, 2023: Deadline for filing
electronic copies of oral hearing
statements.
March 29–30, 2023: Public hearing.
April 12, 2023: Deadline for filing
posthearing briefs and statements.
May 5, 2023: Deadline for filing all
other written submissions.
October 17, 2023: Transmittal of
Commission report to the USTR.
ADDRESSES: All Commission offices,
including the Commission’s hearing
rooms, are located in the U.S.
International Trade Commission
Building, 500 E Street SW, Washington,
DC. All written submissions should be
addressed to the Secretary, U.S.
International Trade Commission, 500 E
Street SW, Washington, DC 20436. The
public record for this investigation may
be viewed on the Commission’s
electronic docket (EDIS) at https://
edis.usitc.gov.
FOR FURTHER INFORMATION CONTACT:
Project Leader Philip Stone (202–205–
3424 or philip.stone@usitc.gov) or
Deputy Project Leader Dixie Downing
(202–205–3164 or dixie.downing@
usitc.gov) for information specific to this
investigation. For information on the
legal aspects of this investigation,
contact Brian Allen (202–205–3034 or
brian.allen@usitc.gov) or William
Gearhart (202–205–3091 or
william.gearhart@usitc.gov) of the
Commission’s Office of the General
Counsel. The media should contact
Jennifer Andberg, Office of External
Relations (202–205–3404 or
jennifer.andberg@usitc.gov). Hearingimpaired individuals are advised that
information on this matter can be
obtained by contacting the
Commission’s TDD terminal on 202–
205–1810. General information
concerning the Commission may be
obtained by accessing its internet
address (https://www.usitc.gov). Persons
with mobility impairments who will
need special assistance in gaining access
to the Commission should contact the
Office of the Secretary at 202–205–2000.
SUPPLEMENTARY INFORMATION:
Background: As requested in the letter
received from the USTR on December
16, 2022, the Commission has instituted
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7757
an investigation under section 332(g) of
the Tariff Act of 1930 (19 U.S.C.
1332(g)) that analyzes the universe of
existing COVID–19 diagnostics and
therapeutics in relation to the TRIPS
Agreement. Specifically, the USTR has
requested that the Commission prepare
a report that:
• Identifies the range of definitions
for ‘‘diagnostics’’ and ‘‘therapeutics’’ in
the medical field.
• Identifies and defines the universe
of existing COVID–19 diagnostics and
therapeutics covered by patents as well
as COVID–19 diagnostics and
therapeutics in development.
• Provides a broad overview of
relevant COVID–19 diagnostics and
therapeutics, including a description of
the products and any intellectual
property protections, and containing, to
the extent practicable and where data
are available:
Æ An overview of production and
distribution, including key components,
the production processes, key producing
countries, major firms, operational
costs, a description of the supply chain,
and the level of geographic
diversification within the supply chain;
Æ An overview of demand, including
key demand factors, an assessment of
where unmet demand exists, supply
accumulation and distribution, and the
impact of the relationship between
testing and demand for treatment, if any
exists;
Æ Information on market
segmentation of global demand and
consumption, which may be delineated
by low-income countries (LICs), lower
middle-income countries (LMICs),
upper middle-income countries
(UMICs), and high-income countries
(HICs);
Æ Information on availability and
pricing (or manufacturing costs in the
cases where goods are donated) for
COVID–19 diagnostics and therapeutics,
if available; and
Æ Global trade data for COVID–19
diagnostics and therapeutics or
diagnostics and therapeutics in general
if specific data are not available.
• Catalogs, to the extent practicable
based on available information and a
critical review of the literature:
Æ The reasons for market
segmentation and barriers to a more
diverse geographical distribution of the
global manufacturing industries for
COVID–19 diagnostics and therapeutics;
Æ The relationship between patent
protection and innovation in the health
sector and between patent protection
and access to medicine in LICs, LMICs,
UMICs, and HICs;
Æ Actions taken by WTO Members to
use or attempt to use compulsory
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Federal Register / Vol. 88, No. 24 / Monday, February 6, 2023 / Notices
licenses for the production, importation,
or exportation of pharmaceutical
products and the outcomes of those
actions, including the effect on product
access, innovation, and global health;
Æ A description of any alternatives to
compulsory licensing available to WTO
Members, such as voluntary licenses,
including through the Medicines Patent
Pool (MPP); multilateral programs,
including the GlobalFund and United
Nations Children’s Fund (UNICEF);
government-to-government programs;
and private-sector donations; and
Æ The effect, or lack thereof, of the
MPP on access to COVID–19 diagnostics
and therapeutics.
The USTR explicitly asked that the
Commission solicit input on the above
issues from a wide variety of
participants, including foreign
governments, non-governmental health
advocates, organizations such as the
MPP and Foundation for Innovative
New Diagnostics (FIND), and
manufacturers of diagnostics and
therapeutics. The USTR stated that
input on the following would be
particularly salient:
• How the TRIPS Agreement
promotes innovation in and/or limits
access to COVID–19 diagnostics and
therapeutics;
• Successes and challenges in using
existing TRIPS flexibilities;
• The extent to which products not
yet on the market, or new uses for
existing products, could be affected by
an extension of the Ministerial Decision
to diagnostics and therapeutics;
• Whether and how existing TRIPS
rules and flexibilities can be deployed
to improve access to medicines;
• To what extent further clarifications
of existing TRIPS flexibilities would be
useful in improving access to
medicines;
• The relationship between
intellectual property protection and
corporate research and development
expenditures, taking into account other
expenditures, such as share buybacks,
dividends, and marketing;
• The relevance, if any, of the fact
that diagnostic and therapeutic products
used with respect to COVID–19 may
also have application to other diseases;
and
• The location of jobs associated with
the manufacturing of diagnostics and
therapeutics, including in the United
States.
As requested by the USTR, the
Commission will deliver the report on
October 17, 2023. Since the USTR has
indicated that USTR intends to make
this report available to the public in its
entirety, the Commission will not
include confidential business or
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18:51 Feb 03, 2023
Jkt 259001
national security classified information
in its report. However, as detailed
below, participants may submit
confidential information to the
Commission to inform its understanding
of these issues, and such information
will be protected in accordance with the
Commission’s Rules of Practice and
Procedure. Participants are strongly
encouraged to provide any supporting
data and information along with their
views.
Public Hearing: A public hearing in
connection with this investigation will
be held beginning at 9:30 a.m., March
29, 2023, and continuing, if necessary,
on March 30, 2023, in the Main Hearing
Room of the U.S. International Trade
Commission, 500 E Street SW,
Washington DC 20436. The hearing can
also be accessed remotely using the
WebEx videoconference platform. A
link to the hearing will be posted on the
Commission’s website at https://
www.usitc.gov/calendarpad/
calendar.html.
Requests to appear at the hearing
should be filed with the Secretary to the
Commission no later than 5:15 p.m.,
March 15, 2023, in accordance with the
requirements in the ‘‘Written
Submissions’’ section below. Any
requests to appear as a witness via
videoconference must be included with
your request to appear. Requests to
appear as a witness via videoconference
must include a statement explaining
why the witness cannot appear in
person; the Chairman, or other person
designated to conduct the investigation,
may at their discretion for good cause
shown, grant such requests. Requests to
appear as a witness via videoconference
due to illness or a positive COVID–19
test result may be submitted by 3 p.m.
the business day prior to the hearing.
All prehearing briefs and statements
should be filed no later than 5:15 p.m.,
March 17, 2023. To facilitate the
hearing, including the preparation of an
accurate written public transcript of the
hearing, oral testimony to be presented
at the hearing must be submitted to the
Commission electronically no later than
noon, March 22, 2023. All posthearing
briefs and statements should be filed no
later than 5:15 p.m., April 12, 2023.
Posthearing briefs and statements
should address matters raised at the
hearing. For a description of the
different types of written briefs and
statements, see the ‘‘Definitions’’ section
below.
In the event that, as of the close of
business on March 15, 2023, no
witnesses are scheduled to appear at the
hearing, the hearing will be canceled.
Any person interested in attending the
hearing as an observer or nonparticipant
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should check the Commission website
as indicated above for information
concerning whether the hearing will be
held.
Written submissions: In lieu of or in
addition to participating in the hearing,
interested parties are invited to file
written submissions concerning this
investigation. All written submissions
should be addressed to the Secretary,
and should be received no later than
5:15 p.m., May 5, 2023. All written
submissions must conform to the
provisions of section 201.8 of the
Commission’s Rules of Practice and
Procedure (19 CFR 201.8), as
temporarily amended by 85 FR 15798
(March 19, 2020). Under that rule
waiver, the Office of the Secretary will
accept only electronic filings at this
time. Filings must be made through the
Commission’s Electronic Document
Information System (EDIS, https://
edis.usitc.gov). No in-person paperbased filings or paper copies of any
electronic filings will be accepted until
further notice. Persons with questions
regarding electronic filing should
contact the Office of the Secretary,
Docket Services Division (202–205–
1802), or consult the Commission’s
Handbook on Filing Procedures.
Definitions of types of documents that
may be filed; Requirements: In addition
to requests to appear at the hearing, this
notice provides for the possible filing of
four types of documents: prehearing
briefs, oral hearing statements,
posthearing briefs, and other written
submissions.
(1) Prehearing briefs refers to written
materials relevant to the investigation
and submitted in advance of the
hearing, and includes written views on
matters that are the subject of the
investigation, supporting materials, and
any other written materials that you
consider will help the Commission in
understanding your views. You should
file a prehearing brief particularly if you
plan to testify at the hearing on behalf
of an industry group, company, or other
organization, and wish to provide
detailed views or information that will
support or supplement your testimony.
(2) Oral hearing statements
(testimony) refers to the actual oral
statement that you intend to present at
the hearing. Do not include any
confidential business information (CBI)
in that statement. If you plan to testify,
you must file a copy of your oral
statement by the date specified in this
notice. This statement will allow
Commissioners to understand your
position in advance of the hearing and
will also assist the court reporter in
preparing an accurate transcript of the
hearing (e.g., names spelled correctly).
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Federal Register / Vol. 88, No. 24 / Monday, February 6, 2023 / Notices
(3) Posthearing briefs refers to
submissions filed after the hearing by
persons who appeared at the hearing.
Such briefs: (a) should be limited to
matters that arose during the hearing; (b)
should respond to any Commissioner
and staff questions addressed to you at
the hearing; (c) should clarify, amplify,
or correct any statements you made at
the hearing; and (d) may, at your option,
address or rebut statements made by
other participants in the hearing.
(4) Other written submissions refers to
any other written submissions that
interested persons wish to make,
regardless of whether they appeared at
the hearing, and may include new
information or updates of information
previously provided.
In accordance with the provisions of
section 201.8 of the Commission’s Rules
of Practice and Procedure (19 CFR
201.8) the document must identify on
its cover (1) the investigation number
and title and the type of document filed
(i.e., prehearing brief, oral statement of
(name), posthearing brief, or written
submission), (2) the name and signature
of the person filing it, (3) the name of
the organization that the submission is
filed on behalf of, and (4) whether it
contains CBI. If it contains CBI, it must
comply with the marking and other
requirements set out below in this
notice relating to CBI. Submitters of
written documents (other than oral
hearing statements) are encouraged to
include a short summary of their
position or interest at the beginning of
the document, and a table of contents
when the document addresses multiple
issues.
Confidential business information:
Any submissions that contain CBI must
also conform to the requirements of
section 201.6 of the Commission’s Rules
of Practice and Procedure (19 CFR
201.6). Section 201.6 of the rules
requires that the cover of the document
and the individual pages be clearly
marked as to whether they are the
‘‘confidential’’ or ‘‘nonconfidential’’
version, and that the CBI is clearly
identified by means of brackets. All
written submissions, except for CBI,
will be made available for inspection by
interested parties.
As requested by the USTR, the
Commission will not include any CBI in
its report. However, all information,
including CBI, submitted in this
investigation may be disclosed to and
used: (i) by the Commission, its
employees and Offices, and contract
personnel (a) for developing or
maintaining the records of this or a
related proceeding, or (b) in internal
investigations, audits, reviews, and
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18:51 Feb 03, 2023
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evaluations relating to the programs,
personnel, and operations of the
Commission, including under 5 U.S.C.
Appendix 3; or (ii) by U.S. government
employees and contract personnel for
cybersecurity purposes. The
Commission will not otherwise disclose
any CBI in a way that would reveal the
operations of the firm supplying the
information.
Summaries of written submissions:
Persons wishing to have a summary of
their position included in the report
should include a summary with their
written submission on or before May 5,
2023, and should mark the summary as
having been provided for that purpose.
The summary should be clearly marked
as ‘‘summary for inclusion in the
report’’ at the top of the page. The
summary may not exceed 500 words
and should not include any CBI. The
summary will be published as provided
if it meets these requirements and is
germane to the subject matter of the
investigation. The Commission will list
the name of the organization furnishing
the summary and will include a link
where the written submission can be
found.
By order of the Commission.
Issued: February 1, 2023.
Katherine Hiner,
Acting Secretary to the Commission.
[FR Doc. 2023–02466 Filed 2–3–23; 8:45 am]
BILLING CODE 7020–02–P
INTERNATIONAL TRADE
COMMISSION
[Investigation No. 337–TA–1292]
Certain Replacement Automotive
Lamps II; Notice of Request for
Submissions on the Public Interest
U.S. International Trade
Commission.
ACTION: Notice.
AGENCY:
Notice is hereby given that on
January 24, 2023, the presiding
administrative law judge (‘‘ALJ’’) issued
an Initial Determination on Violation of
Section 337. The ALJ also issued a
Recommended Determination on
remedy and bonding should a violation
be found in the above-captioned
investigation. The Commission is
soliciting submissions on public interest
issues raised by the recommended relief
should the Commission find a violation.
This notice is soliciting comments from
the public only.
FOR FURTHER INFORMATION CONTACT:
Lynde Herzbach, Esq., Office of the
General Counsel, U.S. International
SUMMARY:
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7759
Trade Commission, 500 E Street SW,
Washington, DC 20436, telephone (202)
205–3228. Copies of non-confidential
documents filed in connection with this
investigation may be viewed on the
Commission’s electronic docket (EDIS)
at https://edis.usitc.gov. For help
accessing EDIS, please email
EDIS3Help@usitc.gov. General
information concerning the Commission
may also be obtained by accessing its
internet server at https://www.usitc.gov.
Hearing-impaired persons are advised
that information on this matter can be
obtained by contacting the
Commission’s TDD terminal on (202)
205–1810.
Section
337 of the Tariff Act of 1930 provides
that, if the Commission finds a
violation, it shall exclude the articles
concerned from the United States
unless, after considering the effect of
such exclusion upon the public health
and welfare, competitive conditions in
the United States economy, the
production of like or directly
competitive articles in the United
States, and United States consumers, it
finds that such articles should not be
excluded from entry. (19 U.S.C.
1337(d)(1)).
SUPPLEMENTARY INFORMATION:
The Commission is soliciting
submissions on public interest issues
raised by the recommended relief
should the Commission find a violation,
specifically: a limited exclusion order
directed to certain replacement
automotive lamps imported, sold for
importation, and/or sold after
importation by respondents TYC
Brother Industrial Co., Ltd. of Tainan,
Taiwan, Genera Corporation (dba. TYC
Genera) of Brea, California, LKQ
Corporation of Chicago, Illinois, and
Keystone Automotive Industries, Inc. of
Exeter, Pennsylvania. Parties are to file
public interest submissions pursuant to
19 CFR 210.50(a)(4).
The Commission is interested in
further development of the record on
the public interest in this investigation.
Accordingly, members of the public are
invited to file submissions of no more
than five (5) pages, inclusive of
attachments, concerning the public
interest in light of the ALJ’s
Recommended Determination on
Remedy and Bonding issued in this
investigation on January 24, 2023.
Comments should address whether
issuance of the recommended remedial
orders in this investigation, should the
Commission find a violation, would
affect the public health and welfare in
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]]>Agencies
[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Notices]
[Pages 7757-7759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02466]
=======================================================================
-----------------------------------------------------------------------
INTERNATIONAL TRADE COMMISSION
[Investigation No. 332-596]
COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS
Agreement Flexibilities
AGENCY: United States International Trade Commission.
ACTION: Notice of investigation and scheduling of a public hearing.
-----------------------------------------------------------------------
SUMMARY: Following receipt on December 16, 2022, of a request from the
U.S. Trade Representative (USTR), under the Tariff Act of 1930, the
U.S. International Trade Commission (Commission) instituted
Investigation No. 332-596, COVID-19 Diagnostics and Therapeutics:
Supply, Demand, and TRIPS Agreement Flexibilities. The USTR requested
that the Commission conduct an investigation and prepare a report that
analyzes the universe of existing COVID-19 diagnostics and therapeutics
in relation to the World Trade Organization (WTO) Agreement on Trade-
Related Aspects of Intellectual Property Rights (TRIPS Agreement)--
including the range of definitions for diagnostics and therapeutics;
diagnostics and therapeutics covered by patents and those in
development; an overview of production, distribution, and demand;
information on market segmentation of global demand and consumption;
and other information relevant to the discussion of TRIPS Agreement
flexibilities.
DATES:
March 15, 2023: Deadline for filing requests to appear at the
public hearing.
March 17, 2023: Deadline for filing prehearing briefs and
statements.
March 22, 2023: Deadline for filing electronic copies of oral
hearing statements.
March 29-30, 2023: Public hearing.
April 12, 2023: Deadline for filing posthearing briefs and
statements.
May 5, 2023: Deadline for filing all other written submissions.
October 17, 2023: Transmittal of Commission report to the USTR.
ADDRESSES: All Commission offices, including the Commission's hearing
rooms, are located in the U.S. International Trade Commission Building,
500 E Street SW, Washington, DC. All written submissions should be
addressed to the Secretary, U.S. International Trade Commission, 500 E
Street SW, Washington, DC 20436. The public record for this
investigation may be viewed on the Commission's electronic docket
(EDIS) at https://edis.usitc.gov.
FOR FURTHER INFORMATION CONTACT: Project Leader Philip Stone (202-205-
3424 or [email protected]) or Deputy Project Leader Dixie Downing
(202-205-3164 or [email protected]) for information specific to
this investigation. For information on the legal aspects of this
investigation, contact Brian Allen (202-205-3034 or
[email protected]) or William Gearhart (202-205-3091 or
[email protected]) of the Commission's Office of the General
Counsel. The media should contact Jennifer Andberg, Office of External
Relations (202-205-3404 or [email protected]). Hearing-
impaired individuals are advised that information on this matter can be
obtained by contacting the Commission's TDD terminal on 202-205-1810.
General information concerning the Commission may be obtained by
accessing its internet address (https://www.usitc.gov). Persons with
mobility impairments who will need special assistance in gaining access
to the Commission should contact the Office of the Secretary at 202-
205-2000.
SUPPLEMENTARY INFORMATION:
Background: As requested in the letter received from the USTR on
December 16, 2022, the Commission has instituted an investigation under
section 332(g) of the Tariff Act of 1930 (19 U.S.C. 1332(g)) that
analyzes the universe of existing COVID-19 diagnostics and therapeutics
in relation to the TRIPS Agreement. Specifically, the USTR has
requested that the Commission prepare a report that:
Identifies the range of definitions for ``diagnostics''
and ``therapeutics'' in the medical field.
Identifies and defines the universe of existing COVID-19
diagnostics and therapeutics covered by patents as well as COVID-19
diagnostics and therapeutics in development.
Provides a broad overview of relevant COVID-19 diagnostics
and therapeutics, including a description of the products and any
intellectual property protections, and containing, to the extent
practicable and where data are available:
[cir] An overview of production and distribution, including key
components, the production processes, key producing countries, major
firms, operational costs, a description of the supply chain, and the
level of geographic diversification within the supply chain;
[cir] An overview of demand, including key demand factors, an
assessment of where unmet demand exists, supply accumulation and
distribution, and the impact of the relationship between testing and
demand for treatment, if any exists;
[cir] Information on market segmentation of global demand and
consumption, which may be delineated by low-income countries (LICs),
lower middle-income countries (LMICs), upper middle-income countries
(UMICs), and high-income countries (HICs);
[cir] Information on availability and pricing (or manufacturing
costs in the cases where goods are donated) for COVID-19 diagnostics
and therapeutics, if available; and
[cir] Global trade data for COVID-19 diagnostics and therapeutics
or diagnostics and therapeutics in general if specific data are not
available.
Catalogs, to the extent practicable based on available
information and a critical review of the literature:
[cir] The reasons for market segmentation and barriers to a more
diverse geographical distribution of the global manufacturing
industries for COVID-19 diagnostics and therapeutics;
[cir] The relationship between patent protection and innovation in
the health sector and between patent protection and access to medicine
in LICs, LMICs, UMICs, and HICs;
[cir] Actions taken by WTO Members to use or attempt to use
compulsory
[[Page 7758]]
licenses for the production, importation, or exportation of
pharmaceutical products and the outcomes of those actions, including
the effect on product access, innovation, and global health;
[cir] A description of any alternatives to compulsory licensing
available to WTO Members, such as voluntary licenses, including through
the Medicines Patent Pool (MPP); multilateral programs, including the
GlobalFund and United Nations Children's Fund (UNICEF); government-to-
government programs; and private-sector donations; and
[cir] The effect, or lack thereof, of the MPP on access to COVID-19
diagnostics and therapeutics.
The USTR explicitly asked that the Commission solicit input on the
above issues from a wide variety of participants, including foreign
governments, non-governmental health advocates, organizations such as
the MPP and Foundation for Innovative New Diagnostics (FIND), and
manufacturers of diagnostics and therapeutics. The USTR stated that
input on the following would be particularly salient:
How the TRIPS Agreement promotes innovation in and/or
limits access to COVID-19 diagnostics and therapeutics;
Successes and challenges in using existing TRIPS
flexibilities;
The extent to which products not yet on the market, or new
uses for existing products, could be affected by an extension of the
Ministerial Decision to diagnostics and therapeutics;
Whether and how existing TRIPS rules and flexibilities can
be deployed to improve access to medicines;
To what extent further clarifications of existing TRIPS
flexibilities would be useful in improving access to medicines;
The relationship between intellectual property protection
and corporate research and development expenditures, taking into
account other expenditures, such as share buybacks, dividends, and
marketing;
The relevance, if any, of the fact that diagnostic and
therapeutic products used with respect to COVID-19 may also have
application to other diseases; and
The location of jobs associated with the manufacturing of
diagnostics and therapeutics, including in the United States.
As requested by the USTR, the Commission will deliver the report on
October 17, 2023. Since the USTR has indicated that USTR intends to
make this report available to the public in its entirety, the
Commission will not include confidential business or national security
classified information in its report. However, as detailed below,
participants may submit confidential information to the Commission to
inform its understanding of these issues, and such information will be
protected in accordance with the Commission's Rules of Practice and
Procedure. Participants are strongly encouraged to provide any
supporting data and information along with their views.
Public Hearing: A public hearing in connection with this
investigation will be held beginning at 9:30 a.m., March 29, 2023, and
continuing, if necessary, on March 30, 2023, in the Main Hearing Room
of the U.S. International Trade Commission, 500 E Street SW, Washington
DC 20436. The hearing can also be accessed remotely using the WebEx
videoconference platform. A link to the hearing will be posted on the
Commission's website at https://www.usitc.gov/calendarpad/calendar.html.
Requests to appear at the hearing should be filed with the
Secretary to the Commission no later than 5:15 p.m., March 15, 2023, in
accordance with the requirements in the ``Written Submissions'' section
below. Any requests to appear as a witness via videoconference must be
included with your request to appear. Requests to appear as a witness
via videoconference must include a statement explaining why the witness
cannot appear in person; the Chairman, or other person designated to
conduct the investigation, may at their discretion for good cause
shown, grant such requests. Requests to appear as a witness via
videoconference due to illness or a positive COVID-19 test result may
be submitted by 3 p.m. the business day prior to the hearing. All
prehearing briefs and statements should be filed no later than 5:15
p.m., March 17, 2023. To facilitate the hearing, including the
preparation of an accurate written public transcript of the hearing,
oral testimony to be presented at the hearing must be submitted to the
Commission electronically no later than noon, March 22, 2023. All
posthearing briefs and statements should be filed no later than 5:15
p.m., April 12, 2023. Posthearing briefs and statements should address
matters raised at the hearing. For a description of the different types
of written briefs and statements, see the ``Definitions'' section
below.
In the event that, as of the close of business on March 15, 2023,
no witnesses are scheduled to appear at the hearing, the hearing will
be canceled. Any person interested in attending the hearing as an
observer or nonparticipant should check the Commission website as
indicated above for information concerning whether the hearing will be
held.
Written submissions: In lieu of or in addition to participating in
the hearing, interested parties are invited to file written submissions
concerning this investigation. All written submissions should be
addressed to the Secretary, and should be received no later than 5:15
p.m., May 5, 2023. All written submissions must conform to the
provisions of section 201.8 of the Commission's Rules of Practice and
Procedure (19 CFR 201.8), as temporarily amended by 85 FR 15798 (March
19, 2020). Under that rule waiver, the Office of the Secretary will
accept only electronic filings at this time. Filings must be made
through the Commission's Electronic Document Information System (EDIS,
https://edis.usitc.gov). No in-person paper-based filings or paper
copies of any electronic filings will be accepted until further notice.
Persons with questions regarding electronic filing should contact the
Office of the Secretary, Docket Services Division (202-205-1802), or
consult the Commission's Handbook on Filing Procedures.
Definitions of types of documents that may be filed; Requirements:
In addition to requests to appear at the hearing, this notice provides
for the possible filing of four types of documents: prehearing briefs,
oral hearing statements, posthearing briefs, and other written
submissions.
(1) Prehearing briefs refers to written materials relevant to the
investigation and submitted in advance of the hearing, and includes
written views on matters that are the subject of the investigation,
supporting materials, and any other written materials that you consider
will help the Commission in understanding your views. You should file a
prehearing brief particularly if you plan to testify at the hearing on
behalf of an industry group, company, or other organization, and wish
to provide detailed views or information that will support or
supplement your testimony.
(2) Oral hearing statements (testimony) refers to the actual oral
statement that you intend to present at the hearing. Do not include any
confidential business information (CBI) in that statement. If you plan
to testify, you must file a copy of your oral statement by the date
specified in this notice. This statement will allow Commissioners to
understand your position in advance of the hearing and will also assist
the court reporter in preparing an accurate transcript of the hearing
(e.g., names spelled correctly).
[[Page 7759]]
(3) Posthearing briefs refers to submissions filed after the
hearing by persons who appeared at the hearing. Such briefs: (a) should
be limited to matters that arose during the hearing; (b) should respond
to any Commissioner and staff questions addressed to you at the
hearing; (c) should clarify, amplify, or correct any statements you
made at the hearing; and (d) may, at your option, address or rebut
statements made by other participants in the hearing.
(4) Other written submissions refers to any other written
submissions that interested persons wish to make, regardless of whether
they appeared at the hearing, and may include new information or
updates of information previously provided.
In accordance with the provisions of section 201.8 of the
Commission's Rules of Practice and Procedure (19 CFR 201.8) the
document must identify on its cover (1) the investigation number and
title and the type of document filed (i.e., prehearing brief, oral
statement of (name), posthearing brief, or written submission), (2) the
name and signature of the person filing it, (3) the name of the
organization that the submission is filed on behalf of, and (4) whether
it contains CBI. If it contains CBI, it must comply with the marking
and other requirements set out below in this notice relating to CBI.
Submitters of written documents (other than oral hearing statements)
are encouraged to include a short summary of their position or interest
at the beginning of the document, and a table of contents when the
document addresses multiple issues.
Confidential business information: Any submissions that contain CBI
must also conform to the requirements of section 201.6 of the
Commission's Rules of Practice and Procedure (19 CFR 201.6). Section
201.6 of the rules requires that the cover of the document and the
individual pages be clearly marked as to whether they are the
``confidential'' or ``nonconfidential'' version, and that the CBI is
clearly identified by means of brackets. All written submissions,
except for CBI, will be made available for inspection by interested
parties.
As requested by the USTR, the Commission will not include any CBI
in its report. However, all information, including CBI, submitted in
this investigation may be disclosed to and used: (i) by the Commission,
its employees and Offices, and contract personnel (a) for developing or
maintaining the records of this or a related proceeding, or (b) in
internal investigations, audits, reviews, and evaluations relating to
the programs, personnel, and operations of the Commission, including
under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and
contract personnel for cybersecurity purposes. The Commission will not
otherwise disclose any CBI in a way that would reveal the operations of
the firm supplying the information.
Summaries of written submissions: Persons wishing to have a summary
of their position included in the report should include a summary with
their written submission on or before May 5, 2023, and should mark the
summary as having been provided for that purpose. The summary should be
clearly marked as ``summary for inclusion in the report'' at the top of
the page. The summary may not exceed 500 words and should not include
any CBI. The summary will be published as provided if it meets these
requirements and is germane to the subject matter of the investigation.
The Commission will list the name of the organization furnishing the
summary and will include a link where the written submission can be
found.
By order of the Commission.
Issued: February 1, 2023.
Katherine Hiner,
Acting Secretary to the Commission.
[FR Doc. 2023-02466 Filed 2-3-23; 8:45 am]
BILLING CODE 7020-02-P
