Notice2025-18729
Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Personal Protective Equipment, Medical Consumables, and Medical Equipment, Including Devices
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Published
September 26, 2025
Issuing agencies
Commerce DepartmentIndustry and Security Bureau
Abstract
On September 2, 2025, the Secretary of Commerce initiated an investigation to determine the effects on the national security of imports of personal protective equipment (PPE), medical consumables, and medical equipment including devices. This investigation has been initiated under section 232 of the Trade Expansion Act of 1962, as amended (Section 232). Interested parties are invited to submit written comments, data, analyses, or other information pertinent to the investigation to the Department of Commerce's (Department) Bureau of Industry and Security (BIS), Office of Strategic Industries and Economic Security. This notice identifies issues on which the Department is especially interested in obtaining the public's views.
Full Text
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<title>Federal Register, Volume 90 Issue 185 (Friday, September 26, 2025)</title>
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[Federal Register Volume 90, Number 185 (Friday, September 26, 2025)]
[Notices]
[Pages 46383-46384]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18729]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
[Docket No. 250924-0160]
XRIN 0694-XC134
Notice of Request for Public Comments on Section 232 National
Security Investigation of Imports of Personal Protective Equipment,
Medical Consumables, and Medical Equipment, Including Devices
AGENCY: Bureau of Industry and Security, Office of Strategic Industries
and Economic Security, U.S. Department of Commerce.
ACTION: Notice of request for public comments.
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SUMMARY: On September 2, 2025, the Secretary of Commerce initiated an
investigation to determine the effects on the national security of
imports of personal protective equipment (PPE), medical consumables,
and medical equipment including devices. This investigation has been
initiated under section 232 of the Trade Expansion Act of 1962, as
amended (Section 232). Interested parties are invited to submit written
comments, data, analyses, or other information pertinent to the
investigation to the Department of Commerce's (Department) Bureau of
Industry and Security (BIS), Office of Strategic Industries and
Economic Security. This notice identifies issues on which the
Department is especially interested in obtaining the public's views.
DATES: Comments may be submitted at any time but must be received by
October 17, 2025.
ADDRESSES: Comments on this notice may be submitted to the Federal
rulemaking portal at: <a href="http://www.regulations.gov">www.regulations.gov</a>. The <a href="http://regulations.gov">regulations.gov</a> ID for
this notice is BIS-2025-0258. Please refer to XRIN 0694-XC134 in all
comments.
All filers using the portal should use the name of the person or
entity submitting the comments as the name of their files, in
accordance with the instructions below. Anyone submitting business
confidential information should clearly identify the business
confidential portion at the time of submission, file a statement
justifying nondisclosure and referring to the specific legal authority
claimed, and provide a non-confidential version of the submission.
For comments submitted electronically containing business
confidential information, the file name of the business confidential
version should begin with the characters ``BC.'' Any page containing
business confidential information must be clearly marked ``BUSINESS
CONFIDENTIAL'' on the top of that page. The required corresponding non-
confidential version of those comments must be clearly marked
``PUBLIC.'' The file name of the non-confidential version should begin
with the character ``P.'' Any submissions with file names that do not
begin with either a ``BC'' or a ``P'' will be assumed to be public and
will be made publicly available at: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Commenters submitting business confidential information are encouraged
to scan a hard copy of the non-confidential version to create an image
of the file, rather than submitting a digital copy with redactions
applied, to avoid inadvertent redaction errors which could enable the
public to read business confidential information.
FOR FURTHER INFORMATION CONTACT: Stephen Astle, Director, Defense
Industrial Base Division, Office of Strategic Industries and Economic
Security, Bureau of Industry and Security, U.S. Department of Commerce,
(202) 482-4506, <a href="/cdn-cgi/l/email-protection#e68b83828f85878a8397938f968b838892d4d5d4a6848f95c8828985c8818990"><span class="__cf_email__" data-cfemail="18757d7c717b79747d696d7168757d766c2a2b2a587a716b367c777b367f776e">[email protected]</span></a>. For more information
about the Section 232 program, including the regulations and the text
of previous investigations, see <a href="http://www.bis.doc.gov/232">www.bis.doc.gov/232</a>.
SUPPLEMENTARY INFORMATION:
Background
On September 2, 2025, the Secretary of Commerce initiated an
investigation under Section 232 (19 U.S.C. 1862) to determine the
effects on national security of imports of personal protective
equipment (PPE), medical consumables, and medical equipment, including
devices.
Request for Public Comments
This investigation is being undertaken in accordance with part 705
of the National Security Industrial Base Regulations (15 CFR parts 700
to 709) (NSIBR). Interested parties are invited to submit written
comments, data, analyses, or information pertinent to this
investigation to BIS's Office of Strategic Industries and Economic
Security no later than October 17, 2025. For purposes of this
investigation:
Personal protective equipment (PPE) refers to PPE used in health
care settings. PPE includes, but is not limited to, surgical masks, N95
respirators, gloves, gowns, and related medical parts and components.
Medical consumables refers to single-use or short-term-use items
used for patient diagnosis, treatment, and
[[Page 46384]]
prevention of conditions. Medical consumables include but are not
limited to: medical/surgical instruments (e.g., syringes, needles,
infusion (IV) pumps, forceps, scalpels); medical/surgical supplies
(e.g., intravenous (IV) bags, catheters, tracheostomy tubes, anesthesia
equipment, gauze/bandages, sutures, diagnostic and laboratory
reagents); and related medical parts and components. Pharmaceuticals,
such as prescription drugs, over-the-counter drugs, biologics, and
specialty drugs, will not be covered under this investigation as those
imports are being examined in a separate Section 232 investigation.
Medical equipment refers broadly as durable equipment, tools, and
machines used in healthcare to support patient care. Examples include
but are not limited to: carriages and wheelchairs; crutches; and
hospital beds.
A medical device is any instrument, apparatus, or machine used in
the diagnosis, monitoring, or treatment of medical conditions. Examples
include but are not limited to: pacemakers; insulin pumps; coronary
stents; heart valves; hearing aids; robotic and non-robotic
prosthetics; blood glucose monitors; orthopedic appliances;
electromedical apparatus (e.g., computed tomography scanners, magnetic
resonance imaging machines); electrosurgical apparatus; x-ray
apparatus/other radiation equipment; respiratory machines (e.g.,
ventilators, respirators, oxygen apparatus); and MRI machines.
The Department is particularly interested in comments and
information directed at the criteria listed in Sec. 705.4 of the
regulations as they affect national security, including the following:
(i) The current and projected demand for PPE, medical consumables,
and medical equipment, including devices, in the United States;
(ii) the extent to which domestic production of PPE, medical
consumables, and medical equipment, including devices, can meet
domestic demand;
(iii) the role of foreign supply chains, particularly of major
exporters, in meeting United States demand for PPE, medical
consumables, and medical equipment, including devices;
(iv) the concentration of U.S. imports of PPE, medical consumables,
and medical equipment, including devices, from a small number of
suppliers or foreign nations and the associated risks;
(v) the impact of foreign government subsidies and predatory trade
practices on the competitiveness of PPE, medical consumables, and
medical equipment, including devices, manufacturers, in the United
States;
(vi) the economic impact of artificially suppressed prices of PPE,
medical consumables, and medical equipment, including devices, due to
foreign unfair trade practices and state-sponsored overproduction;
(vii) the potential for export restrictions by foreign nations,
including the ability of foreign nations to weaponize their control
over supplies of PPE, medical consumables, and medical equipment
(including devices);
(viii) the feasibility of increasing domestic capacity for PPE,
medical consumables, and medical equipment, including devices, to
reduce import reliance;
(ix) the impact of current trade policies on domestic production of
PPE, medical consumables, and medical equipment, including devices, and
whether additional measures, including tariffs or quotas, are necessary
to protect national security;
(x) the potential for foreign control or exploitation of supply
chains for PPE, medical consumables, and medical equipment, including
devices, supply chain;
(xi) the ability of foreign persons to weaponize the capabilities
or attributes of foreign-built PPE, medical consumables, and medical
equipment, including devices; and
(xii) any other relevant factors.
Material submitted by members of the public that is business
confidential information will be exempted from public disclosure as
provided for by Sec. 705.6 of the regulations (see the ADDRESSES
section of this notice). Communications from agencies of the United
States Government will not be made available for public inspection. BIS
does not maintain a separate public inspection facility. Requesters
should first view the Bureau's web page, which can be found at: <a href="https://efoia.bis.doc.gov/">https://efoia.bis.doc.gov/</a> (see ``Electronic FOIA'' heading). If requesters
cannot access the website, they may call (202) 482-0795 for assistance.
The records related to this assessment are made accessible in
accordance with the regulations published at 15 CFR 4.1, et seq.
Julia A. Khersonsky,
Deputy Assistant Secretary for Strategic Trade.
[FR Doc. 2025-18729 Filed 9-24-25; 4:15 pm]
BILLING CODE 3510-33-P
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