Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Section 232 National Security Adjustments to Imports of Specialty Pharmaceuticals and Associated Ingredients

Issuing agencies

Abstract

The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment on the OMB approved emergency collection for the Temporary Final Rule "Section 232 National Security Adjustments to Imports of Specialty Pharmaceuticals and Associated Ingredients" September 23, 2026, (91 FR 60360).

Full Text

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[Federal Register Volume 91, Number 214 (Friday, November 6, 2026)]
[Notices]
[Pages 70045-70046]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22725]


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DEPARTMENT OF COMMERCE

Bureau of Industry and Security


Agency Information Collection Activities; Submission to the 
Office of Management and Budget (OMB) for Review and Approval; Comment 
Request; Section 232 National Security Adjustments to Imports of 
Specialty Pharmaceuticals and Associated Ingredients

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Notice of information collection, request for comment.

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SUMMARY: The Department of Commerce, in accordance with the Paperwork 
Reduction Act of 1995 (PRA), invites the general public and other 
Federal agencies to comment on proposed, and continuing information 
collections, which helps us assess the impact of our information 
collection requirements and minimize the public's reporting burden. The 
purpose of this notice is to allow for 60 days of public comment on the 
OMB approved emergency collection for the Temporary Final Rule 
``Section 232 National Security Adjustments to Imports of Specialty 
Pharmaceuticals and Associated Ingredients'' September 23, 2026, (91 FR 
60360).

DATES: To ensure consideration, comments regarding this proposed 
information collection must be received on or before January 5, 2027.

ADDRESSES: Interested persons are invited to submit comments by email 
to Nancy Kook, IC Liaison, Bureau of Industry and Security, at 
<a href="/cdn-cgi/l/email-protection#d282809392b0bba1fcb6bdb1fcb5bda4"><span class="__cf_email__" data-cfemail="90c0c2d1d0f2f9e3bef4fff3bef7ffe6">[email&#160;protected]</span></a> or to <a href="/cdn-cgi/l/email-protection#3767657654585a5a525943447753585419505841"><span class="__cf_email__" data-cfemail="e3b3b1a2808c8e8e868d9790a3878c80cd848c95">[email&#160;protected]</span></a>. Please reference OMB Control 
Number 0694-0150 in the subject line of your comments. Do not submit 
Confidential Business Information or otherwise sensitive or protected 
information.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or 
specific questions related to collection activities should be directed 
to Nancy Kook, IC Liaison, Bureau of Industry and Security, phone 202-
482-2440 or by email at <a href="/cdn-cgi/l/email-protection#50000211103239237e343f337e373f26"><span class="__cf_email__" data-cfemail="c9999b8889aba0bae7ada6aae7aea6bf">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Abstract

    On April 1, 2025, Commerce initiated an investigation to determine 
the effects on the national security of imports of pharmaceuticals and 
pharmaceutical ingredients under Section 232 of the Trade Expansion Act 
of 1962, as amended (19 U.S.C. 1862). Section 232 provides authority 
for Commerce to

[[Page 70046]]

conduct investigations to determine the effects of imports of an 
article on the national security of the United States and for the 
President to adjust the imports of the article and its derivatives 
based on such an investigation and an affirmative determination that 
the article is being importing into the United States in such 
quantities or under such circumstances as to threaten to impair the 
national security of the United States.
    On April 2, 2026, following the completion of the above 
investigation, the President issued Presidential Proclamation 11020 
entitled ``Adjusting Imports of Pharmaceuticals and Pharmaceutical 
Ingredients Into the United States'' which imposed ad valorem tariffs 
on imports of certain patented pharmaceuticals and associated 
pharmaceutical ingredients. The Proclamation also directed a tariff 
rate of zero percent for certain designated specialty pharmaceutical 
products and their associated pharmaceutical ingredients, provided that 
Commerce (in consultation with the Office of the U.S. Trade 
Representative and Health & Human Services) determines that the 
products are either products of a jurisdiction that has a current or 
forthcoming trade and security framework agreement with the United 
States or otherwise meet an urgent health need in the United States. 
The President determined that these actions were necessary to address 
the affirmative determination by Commerce that imports of 
pharmaceuticals and pharmaceutical ingredients posed a threat to the 
national security of the United States.
    Commerce will be required to collect certain critical information 
from companies seeking to obtain the ad valorem tariff rate of zero 
percent for imports of specialty pharmaceutical products and their 
associated pharmaceutical ingredients that meet an urgent health need 
in the United States. These collection requirements include 
organization information, a description of the imported product 
(including HTSUS Classification, Country of Origin, and Importer of 
Record) and a detailed rationale of how the imported product meets an 
urgent health need in the United States (including information such as 
the type of disease treated and an assessment of alternative therapies 
or lack of alternative therapies for the type of disease the product 
treats, the number of domestic patients) as well as other information 
required to substantiate the applications under Section 232, hereby 
referenced as Urgent Health Need Requests. This information will be 
submitted via email to Commerce. The materials are reviewed by Commerce 
before receiving a final determination by the Secretary.

II. Method of Collection

    Electronic

III. Data

    OMB Control Number: 0694-0150.
    Type of Information Collection: Regular submission.
    Affected Public: Business or other for-profit organizations.
    Estimated Number of Respondents: 250.
    Average Responses per Year: 1.
    Average Number of Responses: 250.
    Estimated Time per Response: 8 hours.
    Estimated Total Annual Burden Hours: 2,000 hours.
    Respondent's Obligation: Voluntary.
    Legal Authority: Section 232 of the Trade Expansion Act of 1962 (19 
U.S.C. 1862).

IV. Request for Comments

    We are soliciting public comments to permit the Department/Bureau 
to: (a) Evaluate whether the proposed information collection is 
necessary for the proper functions of the Department, including whether 
the information will have practical utility; (b) Evaluate the accuracy 
of our estimate of the time and cost burden for this proposed 
collection, including the validity of the methodology and assumptions 
used; (c) Evaluate ways to enhance the quality, utility, and clarity of 
the information to be collected; and (d) Minimize the reporting burden 
on those who are to respond, including the use of automated collection 
techniques or other forms of information technology.
    Comments that you submit in response to this notice are a matter of 
public record. We will include or summarize each comment in our request 
to OMB to approve this ICR. Before including your address, phone 
number, email address, or other personal identifying information in 
your comment, you should be aware that your entire comment--including 
your personal identifying information--may be made publicly available 
at any time. While you may ask us in your comment to withhold your 
personal identifying information from public review, we cannot 
guarantee that we will be able to do so.

Sheleen Dumas,
Departmental PRA Compliance Officer, Office of the Under Secretary for 
Economic Affairs, Commerce Department.
[FR Doc. 2026-22725 Filed 11-5-26; 8:45 am]
BILLING CODE 3510-33-P


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