Notice2025-06587
Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients
Primary source
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Published
April 16, 2025
Issuing agencies
Commerce DepartmentIndustry and Security Bureau
Abstract
The Secretary of Commerce initiated an investigation to determine the effects on the national security of imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items. This investigation has been initiated under section 232 of the Trade Expansion Act of 1962, as amended. 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 72 (Wednesday, April 16, 2025)</title>
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[Federal Register Volume 90, Number 72 (Wednesday, April 16, 2025)]
[Notices]
[Pages 15951-15952]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06587]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
[Docket No. 250414-0065]
XRIN 0694-XC120
Notice of Request for Public Comments on Section 232 National
Security Investigation of Imports of Pharmaceuticals and Pharmaceutical
Ingredients
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: The Secretary of Commerce initiated an investigation to
determine the effects on the national security of imports of
pharmaceuticals and pharmaceutical ingredients, including finished drug
products, medical countermeasures, critical inputs such as active
pharmaceutical ingredients, and key starting materials, and derivative
products of those items. This investigation has been initiated under
section 232 of the Trade Expansion Act of 1962, as amended. 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
May 7, 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-2025-0022. Please refer to XRIN 0694-XC120 in all
comments.
All filers using the portal should use the name of the person or
entity
[[Page 15952]]
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 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) 482-2533, <a href="/cdn-cgi/l/email-protection#53233b32213e3261606113313a207d373c307d343c25"><span class="__cf_email__" data-cfemail="b0c0d8d1c2ddd1828382f0d2d9c39ed4dfd39ed7dfc6">[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 April 1, 2025, the Secretary of Commerce initiated an
investigation under section 232 of the Trade Expansion Act (19 U.S.C.
1862) to determine the effects on national security of imports of
pharmaceuticals and pharmaceutical ingredients, and their derivative
products. This includes both finished generic and non-generic drug
products, medical countermeasures, critical inputs such as active
pharmaceutical ingredients and key starting materials, and derivative
products of those items.
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
through 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 May 7, 2025. 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 pharmaceuticals and
pharmaceutical ingredients in the United States;
(ii) the extent to which domestic production of pharmaceuticals and
pharmaceutical ingredients can meet domestic demand;
(iii) the role of foreign supply chains, particularly of major
exporters, in meeting United States demand for pharmaceuticals and
pharmaceutical ingredients;
(iv) the concentration of United States imports of pharmaceuticals
and pharmaceutical ingredients from a small number of suppliers and the
associated risks;
(v) the impact of foreign government subsidies and predatory trade
practices on United States pharmaceuticals industry competitiveness;
(vi) the economic impact of artificially suppressed prices of
pharmaceuticals and pharmaceutical ingredients 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 pharmaceuticals supplies;
(viii) the feasibility of increasing domestic capacity for
pharmaceuticals and pharmaceutical ingredients to reduce import
reliance;
(ix) the impact of current trade policies on domestic production of
pharmaceuticals and pharmaceutical ingredients, and whether additional
measures, including tariffs or quotas, are necessary to protect
national security; and
(x) 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. The
Bureau of Industry and Security 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 through 4.11.
Eric Longnecker,
Deputy Assistant Secretary for Technology Security.
[FR Doc. 2025-06587 Filed 4-14-25; 4:15 pm]
BILLING CODE 3510-33-P
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